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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2022
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD
FROM
TO
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Commission File Number 001-39516
Owlet, Inc.
(Exact name of Registrant as specified in its Charter)
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Delaware |
85-1615012 |
(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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3300 North Ashton Boulevard, Suite 300
Lehi, Utah
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84043 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (844)
334-5330
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
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Trading
Symbol(s)
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Name of each exchange on which registered |
Class A Common stock, $0.0001 par value per share |
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OWLT |
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New York Stock Exchange |
Warrants to purchase Class A Common Stock |
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OWLT WS |
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New York Stock Exchange |
Securities registered pursuant to Section 12(g) of the
Act:
None
Indicate by check mark if the Registrant is a well-known seasoned
issuer, as defined in Rule 405 of the Securities
Act. YES ☐ NO ☒
Indicate by check mark if the Registrant is not required to file
reports pursuant to Section 13 or 15(d) of the Act.
YES ☐ NO ☒
Indicate by check mark whether the Registrant: (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the Registrant was required to
file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
YES ☒ NO ☐
Indicate by check mark whether the Registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter
period that the Registrant was required to submit such files).
YES ☒ NO ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the
Registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Indicate by check mark whether the Registrant has filed a report on
and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section
404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the
registered public accounting firm that prepared or issued its audit
report. ☐
If securities are registered pursuant to Section 12(b) of the Act,
indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an
error to previously issued financial
statements. ☐
Indicate by check mark whether any of those error corrections are
restatements that required a recovery analysis of
incentive-based compensation received by any of the registrant’s
executive officers during the relevant recovery period
pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the Registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
YES ☐ NO ☒
The aggregate market value of the voting and non-voting common
equity held by non-affiliates of the Registrant was approximately
$122.6 million based on the closing market price as of the
close of business on June 30, 2022, the last business day of the
Registrant's most recently completed second fiscal
quarter.
The number of shares of Registrant’s Common Stock outstanding as of
April 3, 2023 was 117,465,938.
DOCUMENTS INCORPORATED BY REFERENCE
Part III incorporates certain information by reference from the
registrant’s proxy statement for the 2023 Annual Meeting of
Stockholders. Such proxy statement will be filed no later than 120
days after the close of the registrant’s fiscal year ended December
31, 2022.
Table of Contents
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Report”) contains
certain statements that are "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995
(the "Reform Act"). All statements other than statements of
historical facts contained in this Report, including statements
concerning possible or assumed future actions, business strategies,
events or results of operations, and any statements that refer to
projections, forecasts or other characterizations of future events
or circumstances, including any underlying assumptions, are
forward-looking statements. These statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements.
In some cases, you can identify forward-looking statements by terms
such as “may,” “should,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of
these terms or other similar expressions. The forward-looking
statements in this Report are only predictions. We have based these
forward-looking statements largely on our current expectations and
projections about future events and financial trends that we
believe may affect our business, financial condition and results of
operations. These forward-looking statements speak only as of the
date of this Report and are subject to a number of risks,
uncertainties and assumptions described under the sections in this
Report entitled "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" and
elsewhere in this Report. These forward-looking statements are
subject to numerous risks, including, without limitation, the
following:
• our limited operating
history;
• our history of net losses and our ability
to achieve or maintain profitability;
•the
impact of the warning letter, dated October 1, 2021, from the
United States Food and Drug Administration (the “FDA”), later
corrected in an amendment to such letter dated October 5, 2021 (the
letter and amendment collectively, the “Warning Letter”) the
subsequent suspension of distribution of the Owlet Smart Sock (the
“Smart Sock”) in the U.S. and our ability to obtain necessary
marketing authorization for the medical device features of the
Owlet Dream Sock (the “Dream Sock”) and the Smart Sock where
required;
•our
ability to grow and manage growth profitably, which may be affected
by, among other things, our capital resources, inflation,
recession, competition and the impact of discretionary consumer
spending, retail sector and demographic trends, employee
availability and other economic, business and regulatory
conditions;
•our
ability to enhance future operating and financial results and
continue as a going concern;
•our
ability to obtain additional financing in the future;
•risks
associated with our current loan and debt agreements, including
compliance with debt covenants, restrictions on our access to
capital, the impact of our overall debt levels and our ability to
generate sufficient future cash flows from operations to meet our
debt service obligations and operate our business;
•our
business strategies and plans and our ability to pursue and
implement our strategic initiatives, reduce costs and grow
revenues, as well as innovate existing products, continue
developing new products, meet evolving customer demands and adapt
to changes in consumer preferences and retail trends;
•the
regulatory pathway for our products and communications from
regulators, including the FDA and similar regulators outside of the
United States, as well as legal proceedings, regulatory disputes
and governmental inquiries;
•our
ability to acquire, defend and protect our intellectual property
and satisfy regulatory requirements, including but not limited to
laws and requirements concerning privacy and data protection,
privacy or data breaches, data loss and other risks associated with
our digital platform and technologies;
•any
defects in new products or enhancements to existing
products;
•our
ability to obtain and maintain regulatory approval or certification
for our products, and any related restrictions and limitations of
any approved or certified product;
•expectations
regarding developments with regulatory bodies, and the timeline for
related submissions by us and decisions by the regulatory bodies
and notified bodies (including UK approved bodies);
•our
ability to hire, retain, manage and motivate employees, including
key personnel;
•our
ability to upgrade and maintain our information technology
systems;
•changes
in and our compliance with laws and regulations applicable to our
business; and
•the
impact and disruption to our business, financial condition, results
of operations, supply chain constraints and logistics due to
economic and other conditions beyond our control, such as health
epidemics or pandemics, macro-economic uncertainties, social
unrest, hostilities, natural disasters or other catastrophic
events.
These risks and other important factors, including those discussed
in this Report, may cause our actual results, performance or
achievements to differ materially from any future results,
performance or achievements expressed or implied by these
forward-looking statements. Moreover, we operate in an evolving
environment. New risk factors and uncertainties may emerge from
time to time, and it is not possible for management to predict all
risk factors and
uncertainties. Given these risks and uncertainties, you are
cautioned not to place undue reliance on such forward-looking
statements. The forward-looking statements included elsewhere in
this Report are not guarantees of future performance and our actual
results of operations, financial condition and liquidity, and the
development of the industry in which we operate, may differ
materially from the forward-looking statements included elsewhere
in this Report. In addition, even if our results of operations,
financial condition and liquidity, and events in the industry in
which we operate, are consistent with the forward-looking
statements included elsewhere in this Report, they may not be
predictive of results or developments in future
periods.
Any forward-looking statement that we make in this Report speaks
only as of the date of such statement. Except as required by law,
we do not undertake any obligation to update or revise, or to
publicly announce any update or revision to, any of the
forward-looking statements, whether as a result of new information,
future events or otherwise, after the date of this Report. For all
of our forward-looking statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Reform
Act.
As used in this Report, unless otherwise stated or the context
otherwise requires: “we,” “us,” “our,” “Owlet,” the “Company,” and
similar references refer to Owlet, Inc. and its subsidiaries,
“common stock” refers to our Class A common stock and “warrants”
refers to our publicly traded warrants.
Summary of Principal Risks Associated with Our
Business
Our business is subject to numerous risks and uncertainties that
represent challenges that we face in connection with the successful
implementation of our strategy and the growth of our business. In
particular, the following considerations, among others, may offset
our competitive strengths or have a negative effect on our business
strategy or operating results, which could cause a decline in the
price of shares of our common stock:
•We
have a limited operating history.
•We
have a history of net losses, and we may not achieve or maintain
profitability in the future.
•We
ceased distribution of the Smart Sock in the U.S. in October 2021
following receipt of a Warning Letter from the U.S. Food and Drug
Administration (the “FDA”) our ability to market and sell the
medical device features of the Owlet Dream Sock (the “Dream Sock”)
may be limited until we receive marketing authorization from the
FDA, which we may not receive in a timely fashion, or at
all.
•In
January 2022 we launched a new product in the U.S. called the Dream
Sock. We are pursuing marketing authorization pursuant to a de novo
classification request for certain notification and display
features within the Dream Sock related to oxygen level and heart
rate, including those features that were the subject of the Warning
Letter in the U.S, and we may not receive such marketing
authorization in a timely fashion, or at all.
•If
any governmental authority or notified body were to require
marketing authorization or similar certification for the Smart
Sock, Dream Sock, or for any other product that we sell and which
Owlet does not believe requires such marketing authorization or
certification, we could be subject to regulatory enforcement action
and/or required to cease selling or recall the product pending
receipt of marketing authorization or similar certification from
such other governmental authority or notified body, which can be a
lengthy and time-consuming process, harm financial results and have
long-term negative effects on our operations.
•Our
products rely on mobile applications to function and we rely on
Apple’s App Store and the Google Play Store for distribution of our
mobile applications and Apple or Google may unilaterally remove our
mobile applications from distribution.
•A
substantial portion of our sales comes through a limited number of
channel partners and resellers.
•We
will need to continue to manage our ability to grow and manage
growth profitably, which may be affected by, among other things,
our capital resources, inflation, recession, competition and the
impact of discretionary consumer spending, retail sector and
demographic trends, employee availability and other economic,
business and regulatory conditions.
•We
are required to obtain and maintain marketing authorizations or
certifications from the FDA, foreign regulatory authorities or
notified bodies for any products intended to be and/or classified
as medical device products in the U.S. or in foreign jurisdictions,
which can be a lengthy and time-consuming process, and a failure to
do so on a timely basis, or at all, could severely harm our
business.
•We
currently rely on a single manufacturer for the assembly of the
Smart Sock and Dream Sock and a single manufacturer for the
assembly of the Owlet Cam and expect to rely on limited
manufacturers for future products. If we encounter manufacturing
problems or delays, we may be unable to promptly transition to
alternative manufacturers and our ability to generate revenue will
be limited.
•If
we are unable to obtain key materials and components from sole or
limited source suppliers, we will not be able to deliver our
products to customers.
•If
we are unable to adequately protect our intellectual property
rights, or if we are accused of infringing on the intellectual
property rights of others, our competitive position could be harmed
or we could be required to incur significant expenses to enforce or
defend our rights or to pay damages.
•We
rely significantly on information technology (“IT”) and any
failure, inadequacy, interruption or security lapse of that
technology, including any cybersecurity incidents, could lead to
misappropriation of confidential or otherwise protected information
and harm our business and our ability to operate our business
effectively.
•We
are involved, and may become involved in the future, in disputes
and other legal or regulatory proceedings that, if adversely
decided or settled, could materially and adversely affect our
business, financial condition and results of
operations.
•We
face the risk of product liability claims and the amount of
insurance coverage held now or in the future may not be adequate to
cover all liabilities we might incur.
•Increased
expansion into international markets, including Europe, Asia, the
Middle East, Africa and Latin America, exposes us to additional
business, political, regulatory, operational, financial and
economic risks.
•Our
success depends substantially on our reputation and
brand.
•Some
of our products and services are in development or have been
recently introduced into the market and may not achieve market
acceptance, which could limit our growth and adversely affect our
business, financial condition and results of
operations.
•We
have identified material weaknesses in our internal control over
financial reporting and we may identify additional material
weaknesses in the future or otherwise fail to maintain effective
internal control over financial reporting, which may result in
material misstatements of our consolidated financial statements,
cause us to fail to meet our periodic reporting obligations or
cause our access to the capital markets to be
impaired.
•We
may need to raise additional capital in the future in order to
execute our strategic plan, which may not be available on terms
acceptable to us, or at all.
•Our
business, financial condition, results of operations and growth may
be impacted by the continued effects of the COVID-19
pandemic.
PART I
Item 1. Business.
We are Owlet
Becoming a parent is a life-changing milestone. New mothers and
fathers become caregivers overnight and share the same primary
concerns of sleep, safety, health and well-being. Parents, who are
increasingly older and busier, assume the roles of doctor,
dietitian, and sleep trainer. In many cases, parents receive
minimal guidance, counseling, or affirmation of how well they are
caring for their newborn, which often leads to increased anxiety
and feelings of worry.
Enter Owlet. Kurt Workman, Jordan Monroe, Zack Bomsta, and Jake
Colvin founded Owlet because they wanted access to real-time data
to give them peace of mind as new parents. Infant monitoring
solutions were highly fragmented and provided limited real-time
awareness, leading to a less-than-optimal solution for concerned
parents. There was also no product on the market available for
parents to track a baby’s sleep patterns, oxygen levels, and heart
rate at home. Our founders’ love for their children inspired them
to launch Owlet in 2012 and create the Owlet Smart Sock (the "Owlet
Smart Sock"), which was first sold in 2015.
Our Company's mission is to empower parents with the right
information at the right time, to give them more peace of mind and
help them find more joy in the journey of parenting. Our digital
parenting platform aims to give parents real-time data and insights
to help parents feel calmer and more confident. We believe that
every parent deserves peace of mind and the opportunity to feel
well-rested. We also believe that every child deserves to live a
long, happy, and healthy life, and are working to develop products
to help further those beliefs. Our ecosystem of digital parenting
solutions is helping to transform modern parenting by providing
parents data-driven insights into their children’s well-being in
the comfort of their own home. We are also developing in-home
pediatric monitoring and analytics technologies, which we believe
have the potential to provide parents with additional information
about their children and are also designed to notify parents and
caregivers of certain biometric findings with the goal of reducing
risk of infant death due to Sudden Unexplained Infant Death (SUID)
and Sudden Infant Death Syndrome (SIDS) and opportunistically
detecting infant ailments such as respiratory syncytial virus (RSV)
and supraventricular tachycardia (SVT).
Our Platform
Our purpose-built suite of connected digital parenting products and
services is designed to help parents know more about their children
and gain peace of mind in their roles as caregivers. We have
developed deep and enduring relationships with our users and brand
advocates around the world. These relationships continue to grow
and develop as a result of our novel product and software additions
to our connected ecosystem, feature enhancements, omni-channel
distribution, and marketing efforts.
In order to make our products and services easy to find, our
products are available for purchase at global and national retail
stores as well as through online channels on Amazon.com and other
online retail sites as well as our direct-to-consumer channel on
our country-specific websites. Through these websites, we connect
directly with our users, offer education on products and software,
and gain valuable feedback from our users.
Superior Solutions for Parenting
Through our existing platform and future development pipeline of
products and services designed to span from conception to
kindergarten, we are committed to changing what it means to be a
parent in the modern age. Through innovative hardware and software
solutions utilizing proprietary algorithms, we give parents access
to information about their children, in addition to the ability to
see and hear their children wherever they may be. These offerings
are designed to complement parents’ intuition, leading to a more
joyful parenting experience.
Interactions with the FDA
On October 1, 2021, we received a Warning Letter from the FDA in
which the FDA asserted that the Smart Sock is a medical device
requiring marketing authorization from the FDA due to its marketing
and functionality in measuring blood oxygen saturation and pulse
rate and providing an alarm to notify users that these measurements
are outside of preset values. Prior to receipt of the Warning
Letter, we were dependent on sales of the Smart Sock in the U.S.
for a majority of our revenue. Following receipt of the Warning
Letter, we ceased distribution of the Smart Sock in the U.S. and
have been in regular communications with the FDA regarding our
plans to pursue marketing authorization for the notification
features that were the subject of the Warning Letter. Although the
FDA has not requested or required that we recall Smart Sock
products that had already been distributed prior to our decision
to
cease distribution, we spent considerable efforts and resources in
2022 managing returns of the Smart Sock from our U.S. retailers and
customers, while launching our Dream Sock starting in early
2022.
Following our launch of the Dream Sock, we interacted closely with
FDA and the FDA asserted that certain features of the Dream Sock
were medical device features requiring marketing authorizations. As
a result of those interactions, we submitted a de novo
classification request in December 2022 for the Dream Sock’s heart
rate and oxygen displays, along with certain new features not
currently offered for the Dream Sock (namely, notifications or
alarms when these measures fall outside of preset values). The FDA
has indicated to us that it does not anticipate the need for
enforcement action pending a decision on the marketing application
provided that the FDA does not determine that a change in
enforcement approach is appropriate, for reasons such as if new
information changes the FDA’s assessment of the risk or if the
marketing application is deleted or withdrawn by us. In October
2022, we separately announced the submission of a premarket
notification under Section 510(k) of the Federal Food, Drug, and
Cosmetic Act (“FDCA”), also known as a 510(k) clearance, for a
prescription-only medical device to be used in home for babies
under the supervision of a physician, which we refer to as
BabySat.
Existing Offerings
•Sock
Monitor Offerings
•Dream
Sock and Dream Sock Plus–
With initial distribution to our ecosystem partners in December
2021, and a consumer launch in the retail and direct-to-consumer
channels in January 2022, the award-winning Dream Sock helps
parents understand their baby's sleep and know when to assist their
baby for better sleep. The Dream Sock and accompanying Owlet Dream
App allow parents to view their baby's sleep quality indicators,
including wakings, heart rate, and movement. The Dream Sock Plus
utilizes the same core technology as the Dream Sock and is designed
to grow with children, from newborn to five years through an
expanded fabric sock set. The Dream Sock and Dream Sock Plus are
only available in the U.S. and Canadian markets.
•Smart
Sock–
The award-winning Smart Sock is the first intelligent baby monitor
to track an infant’s oxygen levels, heart rate, and sleep trends.
The Smart Sock allows parents to view their baby’s heart rate and
oxygen readings in real time from the Owlet application. If the
baby’s readings leave preset zones, parents are notified through
the Owlet Care App and a nearby base station. The Smart Sock is not
currently available for sale in the U.S. We are engaging with
international regulatory bodies and notified bodies to obtain
similar authorization and certification in certain foreign
jurisdictions, as required, for any features of the Smart Sock
considered by those regulatory bodies to render them medical
devices. We sell the Smart Sock in international
markets.
•Owlet
Cam Offerings
•Cam
1
– The Owlet Cam turns any smartphone into an intelligent baby
monitor, allowing parents to hear and see everything that is most
important to them from anywhere in high-definition clarity. The
Owlet Cam includes a wide-angle view, sound and motion
notifications, and background audio to ensure parents never miss a
moment. The Owlet Cam streams secure, encrypted video to parents’
own private accounts on the Owlet application.
•Cam
2
– In 2022, Owlet launched its second generation camera, Owlet Cam
2, which has all the features included in the Cam 1 and also
provides predictive sleep technology, cry notifications, and video
clips. Predictive sleep technology calculates when a baby is ready
for sleep and helps parents recognize when a baby starts to show
sleepy cues. Cry notifications filter out noises that don’t require
a response with adjustable sensitivity levels to match a family’s
needs. Video clips are downloadable for up to seven days, helping
parents to capture and share memories.
•Monitor
Duo / Dream Duo
– The Owlet Monitor Duo and Dream Duo offer the award-winning Sock
Monitor offerings paired with the Owlet Cam offerings, combining
the intelligence of our Sock Monitor offerings with high-definition
video, offering parents the most complete picture of their baby’s
sleep. The Owlet Monitor Duo is not available in the U.S. or
Canada, and the Dream Duo is only available in the
U.S.
•Accessories–
Owlet's accessories product line includes the Owlet Sleeper, a
wearable rayon blanket that encourages safe sleep, best for babies
ages 3-6 months old, and an Owlet Sock Travel Case. The Owlet
Sleeper features a full-length zipper for easy access during late
night changes. The Owlet Travel Case provides travel and extra
accident protection for our Owlet sock products while also keeping
the components organized.
In addition to our existing offerings, we believe our development
pipeline will provide us an opportunity to increase our total
addressable market and customer lifetime value. We are designing
these pipeline offerings to complement our existing suite of
solutions and create a more connected and comprehensive digital
parenting ecosystem.
Monitoring and Health Notifications Pipeline
•Sock
Versions:
•Health
Notifications
with Dream Sock as an over-the-counter offering software as a
medical device ("SaMD") — In December 2022, we submitted to the FDA
a de novo classification request for certain features of the Dream
Sock that are software-as-a-medical-device to offer
over-the-counter heart rate and oxygen notifications (and displays)
in conjunction with the existing Dream Sock sleep monitoring
capabilities. The application requests marketing authorization for
features that include both the display of heart rate and oxygen
currently in the Dream Sock and additional notification features
that are not currently in the Dream Sock.
•BabySat–
Based on the Owlet Sock technology, the Owlet BabySat is under
development as a medical device that would, if authorized by the
FDA, be sold for prescription use only. The Owlet BabySat is
designed to be able to be utilized by various telehealth platforms
and is designed specifically for babies with diagnosed illnesses
and health conditions. In October 2022, we submitted a 510(k)
premarket notification to the FDA for a new prescription monitoring
device for infants. The device, which we internally call Babysat,
uses pulse oximetry technology and is intended to be prescribed by
physicians to assist with the in-home monitoring of babies under a
physician’s care. The device is designed to provide alerts to
parents when their baby’s heart rate or oxygen saturation level (or
SpO2) does not fall within prescribed ranges. We believe BabySat
has the potential to provide significant advantages to the large,
wired hospital monitoring technologies on the market today with its
wireless, wearable form factor and cloud connected data integration
designed for home use.
Platform Pipeline
We plan to complement our monitoring pipeline with our connected
ecosystem pipeline to create a more unified digital parenting
experience. We believe our strong brand and platform provide a
strong position to develop adjacent products and services. For
example, we plan to develop the Smart Crib, which would connect
with our Sock Monitor offerings to understand a baby’s sleep cycles
and would utilize automated motion technology to lull babies back
to sleep when they wake up. As we develop additional products, we
believe parents will increasingly rely on our connected ecosystem
for digital parenting solutions.
In addition, Owlet has collected one of the largest data sets of
infant health and sleep and we believe that data will be an
invaluable tool in bridging the current gap of sleep and health at
home. We will continue to develop our software and data in order to
bring additional solutions into the home. One example in 2022 was
the launch of our Predictive Sleep technology that uses the data
collected from the sock and advanced algorithm work based on best
sleep practices to predict the optimal sleep windows for each child
individually. Many parents rely on online information which is time
consuming and not tailored to the individual needs of their baby or
they hire a sleep coach which is an expensive alternative. Through
leveraging our data, we believe we can help bridge the gap and
better democratize access to individualized care. We believe
obtaining FDA marketing authorization and similar authorizations
and certifications (as applicable) from foreign authorities and
notified bodies for our Dream Sock with Health Notifications
products and Owlet BabySat products will allow us to directly
engage medical professionals to provide an end-to-end digital
healthcare solution for our customers. After obtaining required
marketing authorizations and certifications, we plan to use our
data and customer relationship to build predictive health and sleep
services that will better bridge the gap between the hospital and
home.
Our Strategies
We are excited to expand the Company’s footprint, and we plan to
execute the following strategies:
Achieve Adjusted EBITDA Break Even in 2023 -
We are focused on achieving adjusted EBITDA break even by the end
of 2023 and will continue to bring down operating expenses and
variable marketing spend while growing our customer base. We
believe that many of the elements from the Warning Letter that
impacted Owlet’s financial condition in 2021 and 2022 are behind
us.
Obtain Marketing Authorizations and Potentially Open the Door to
Coverage and Reimbursement.
If we are successful in obtaining marketing authorization from the
FDA for the Owlet BabySat, we believe we could build further
credibility for our platform with the medical community and help
open new medical channels and markets. We are developing the Owlet
Dream Sock with Health Notifications for healthy babies with no
underlying medical conditions. We believe that FDA marketing
authorization for either of these products would help open the door
to expanded services. We also continue to work with foreign
regulatory authorities on obtaining similar marketing
authorizations, as needed, for our products.
Leverage Brand Awareness & Grow Distribution to Increase
Penetration.
We intend to continue our efforts to become one of the most
recognizable brand names in the digital parenting category. We
believe becoming a recognizable brand helps our offerings stand out
in a highly fragmented market of legacy companies lacking a
category leader. We see ample room for growth as our existing
product suite is in the beginning phase of market penetration. We
plan to leverage our paid and organic marketing efforts across
social media, display advertising, and email marketing to boost
top-of-mind awareness and acquire new users at a sustainable
cost.
Adding New Data-Driven Products to Expand the Digital Parenting
Ecosystem.
We are building a platform with the goal to be parents’ go-to brand
in the areas of sleep, safety, health and well-being, from
conception through kindergarten. We will remain focused on
achieving profitability and obtaining FDA marketing authorization
to commercialize our Dream Sock with Health Notifications and
BabySat device which we believe will open the door to launch
additional products and services to continue the expansion of our
platform.
Leverage Brand to Expand into New Markets.
While our existing primary market is the U.S., our mid to long-term
goal is to continue to use our operating knowledge to successfully
and meaningfully expand into new countries. We made substantial
progress in 2022 with our expansion into Europe, Australia, and
Korea and the opening of additional retail channels in those
markets. We’ve also made substantial progress towards our
applications to obtain medical device certification in the UK and
EU and continue to maintain our MDSAP and ISO13485 certifications,
passing several audits in 2022 which will allow us to commercialize
medical devices in the UK and EU . As our retail penetration
increases and brand awareness grows outside of the U.S., we intend
to further leverage retail channels and locations to ensure
efficient and strategic global customer acquisition in key markets
in the future.
Our Users
The majority of our users are millennials, a brand-conscious and
technological savvy generation, with annual income of $50,000 or
more. These parents are more likely to be early technology adopters
and have a high affinity towards actionable insight to care for
their children. This is evidenced by the millions of downloads of
the Owlet applications and increasing social media engagement
across our multiple platforms.
Research and Development
We are committed to ongoing research and development to create new
products and improve the design, operation, and quality of existing
products. Our research and development organization includes
individuals with expertise in fields including engineering, product
design, clinical science, consumer electronics, and embedded
software design. Our technical capabilities and commitment to
innovation have allowed us to deliver significant product
enhancements on a rapid development timeline, which we believe has
helped us to support a compelling new product roadmap. In 2022 we
were able to launch the Dream Sock, our new generation camera ("Cam
2"), a new sleep software system called Predictive Sleep and submit
two applications to FDA. As we continue into 2023, we will continue
to develop new software for our sock and cam products while
preparing for the potential commercialization of our medical
devices, BabySat and Dream Sock with Health Notifications, subject
to receipt of FDA marketing authorization and similar foreign
regulatory authorities marketing authorizations, and certifications
from notified bodies. From designing innovative and groundbreaking
products to employing sophisticated software with proprietary
algorithms and backend support, we believe we have built a strong
competitive moat and early-mover advantage over potential
competition in the connected nursery field. We have a vast infant
data set which leads to stronger insights and allows us to develop
better products and services, which we believe in turn leads to
happier users and drives product purchases.
Our current research and development efforts are focused on
enhancing the customer experience of our existing products, while
preparing for the potential commercialization of our medical
devices.
Competition
Historically, baby monitors and nursery products have been
fragmented product categories with multiple players and limited
brand loyalty, and have integrated limited amounts of technology
and data into the caregiver’s experience. However, we expect the
industry in which we operate will continue to evolve and may be
significantly affected by
new product introductions and other market activities of industry
participants. Certain potential competitors have substantially
greater capital resources, larger product portfolios, larger user
bases, larger sales forces and greater geographic presence, and
have built relationships with retailers and distributors that may
be more effective than ours. Our products and services face
additional competition from companies developing products and
services for use with third-party monitoring systems, as well as
from companies that currently market similar products and services
of their own, and may face further pressure from technology
companies that have not historically operated in our
industry.
Continuing technological advances and new product introductions
within the home-use childcare electronics and service industry
place our products and services at risk of obsolescence. Our
long-term success depends upon the development and successful
commercialization of new products and services, new or improved
technologies and additional applications for our existing
technologies, including products or applications that may be
subject to the oversight of the FDA or comparable foreign
regulatory authorities and could require marketing authorization by
the FDA or similar approval, clearance, authorization or
certification from comparable foreign regulatory authorities. The
research and development process is time-consuming and costly and
may not result in products and services or applications that we can
successfully commercialize.
We believe that the primary competitive factors in our market
are:
•product
quality and performance, including the size, quality, comfort,
battery life, reliability, connectivity of the device to the
application and/or monitor, and accuracy of our data provided to
customers;
•customer
purchasing experience;
•pricing;
•product
support and service;
•effective
marketing and education;
•brand
recognition;
•breadth
and depth of offerings;
•greater
market penetration;
•technological
innovation, product enhancements and speed of
innovation
•FDA
marketing authorizations and similar foreign regulatory authorities
marketing authorizations and notified bodies certifications;
and
•sales
and distribution capabilities.
We believe our ability to continue to compete effectively in our
industry will also depend in part on our ability to respond more
quickly and effectively than our peers to new or changing
opportunities, technologies, regulatory standards or customer
requirements. We anticipate that we will face increased competition
in the future as existing companies and competitors develop new or
improved products and distribution strategies and as new companies
enter the market with new technologies and distribution strategies.
Increased competition in the future could adversely affect our
revenue, revenue growth rate, margins and market
share.
Owlet remains focused on developing the best consumer experience to
empower parents with the right information at the right time. As we
pursue marketing authorization from applicable regulatory
authorities and certification from notified bodies, we believe
Owlet could be positioned as a category leader with significant
competitive barriers. Further expansion of our ecosystem synergies
is also a focus.
Manufacturing
We rely on several third-party suppliers for single source
components used in our devices, including the WiFi chips,
microcontrollers, batteries, accelerometers, temperature sensors,
plastics and circuit boards.
We follow strict quality guidelines, including a detailed
risk-based audit plan following our ISO 9001 quality policy that
dictates how often and to what degree we audit our suppliers. We
check all quality, regulatory, and safety standards for products
that our contract manufacturers make. We deploy a robust
manufacturer and supplier selection process including site audits,
tooling design and setup quotes, open book pricing, quality
specifications, and vendor guides. The Smart Sock and Dream Sock
are currently manufactured at ISO 13485 certified manufacturing
sites. We received ISO 13485 and MDSAP certifications, as we work
to implement the requirements applicable to medical device
manufacturer quality management systems. We believe that
third-party facilities will be adequate to meet our current and
anticipated manufacturing needs. We do not currently plan to
manufacture our products or any related components
ourselves.
Manufacturing Services Agreement with Benchmark
Electronics
In October 2017, we entered into a manufacturing services agreement
with Benchmark Electronics, Inc. (“Benchmark”), pursuant to which
Benchmark provides us certain manufacturing and related services
for the production of our Sock Monitoring offerings out of its
facilities in Thailand, including procuring materials and
assembling and testing finished products.
The initial term of the agreement expired in October 2018, but the
term of the agreement automatically extends for additional one-year
periods until either we or Benchmark provide notice of non-renewal
at least 90 days prior to the end of the then-current term or
extension. Among other things, either party may terminate the
agreement for convenience upon 90-day notice, in the case of Owlet,
or 180 day notice, in the case of Benchmark, to the other party.
Either party may also terminate the agreement under certain other
customary conditions, including for uncured breaches of the
agreement or if the other party if the other party materials
breaches the agreement or in the event of the other party’s
insolvency.
In connection with the services provided under the agreement, we
have agreed to indemnify Benchmark against certain claims,
including infringement of third-party intellectual property rights
and noncompliance of our products with safety or other regulations.
We are also entitled to customary indemnification rights, subject
to certain caps.
Manufacturing Services Agreement with Aoni
In June 2018, we entered into a manufacturing and supply agreement
with Shenzhen Aoni Electronic Co., Ltd (“Aoni”), pursuant to which
Aoni provides certain manufacturing and related services for the
production of our Owlet Cam product, including procuring materials
and assembling and packaging finished products.
Following the expiration of the initial term of the agreement in
June 2019, we extended the agreement through June 2022. We have the
right to terminate the agreement, without cause, upon six months’
prior written notice to Aoni. Additionally, either party may
terminate the agreement under certain other customary conditions,
including for uncured breaches of the agreement or in the event of
the other party’s insolvency.
In connection with the services provided under the agreement, Aoni
has agreed to indemnify us against certain claims and liabilities,
including claims arising in connection with product defects, breach
of the agreement, negligence and violations of applicable
law.
Government Regulation
Certain of our products or their features and our operations could
be subject to extensive regulation by the U.S. Food and Drug
Administration, or FDA, and other federal and state authorities in
the U.S., as well as comparable authorities in foreign
jurisdictions. For example, certain of our products may be subject
to regulation as medical devices in the U.S. under the FDCA, as
implemented and enforced by the FDA.
U.S. Regulation
The FDA regulates the development, design, non-clinical and
clinical research, manufacturing, safety, efficacy, labeling,
packaging, storage, installation, servicing, recordkeeping,
premarket clearance or approval, adverse event reporting,
advertising, promotion, marketing and distribution, and import and
export of medical devices to ensure that medical devices
distributed domestically are safe and effective for their intended
uses and otherwise meet the requirements of the FDCA.
FDA Premarket Clearance and Approval Requirements
Unless an exemption applies, each medical device commercially
distributed in the U.S. requires either FDA clearance of a
premarket notification submitted under Section 510(k) of the
FDCA, or approval of a premarket approval application, or PMA.
Under the FDCA, medical devices are classified into one of three
classes—Class I, Class II or Class III—depending on
the degree of risk associated with each medical device and the
extent of manufacturer and regulatory control needed to ensure its
safety and effectiveness. Class I includes devices with the
lowest risk to the patient and are those for which safety and
effectiveness can be assured by adherence to the FDA’s General
Controls for medical devices, which include compliance with the
applicable portions of the Quality System Regulation, or QSR,
facility registration and product listing, reporting of adverse
medical events, and truthful and non-misleading labeling,
advertising, and promotional materials. Class II devices are
subject to the FDA’s General Controls, and special controls as
deemed necessary by the FDA to ensure the safety and effectiveness
of the device. These special controls can include performance
standards, post-market surveillance, patient registries and FDA
guidance documents.
While most Class I devices are exempt from the 510(k)
premarket notification requirement, manufacturers of most
Class II devices are required to submit to the FDA a premarket
notification under Section 510(k) of the FDCA requesting
permission to commercially distribute the device. The FDA’s
permission to commercially distribute a device subject to a 510(k)
premarket notification is generally known as 510(k) clearance.
Devices deemed by the FDA to pose the greatest risks, such as life
sustaining, life supporting or some implantable devices, or devices
that have a new intended use, or use advanced technology that is
not substantially equivalent to that of a legally marketed device,
are placed in Class III, requiring approval of a PMA. Some
pre-amendment devices are unclassified, but are subject to FDA’s
premarket notification and clearance process in order to be
commercially distributed.
510(k) Clearance Marketing Pathway
To obtain 510(k) clearance, we must submit to the FDA a premarket
notification submission demonstrating that the proposed device is
“substantially equivalent” to a legally marketed predicate device.
A predicate device is a legally marketed device that is not subject
to premarket approval, i.e., a device that was legally marketed
prior to May 28, 1976 (pre-amendments device) and for which a
PMA is not required, a device that has been reclassified from
Class III to Class II or I, or a device that was found
substantially equivalent through the 510(k) process. The FDA’s
510(k) clearance process usually takes from three to twelve months
but may take longer. The FDA may require additional information,
including clinical data, to make a determination regarding
substantial equivalence. In addition, FDA collects user fees for
certain medical device submissions and annual fees and for medical
device establishments.
If the FDA agrees that the device is substantially equivalent to a
predicate device currently on the market, it will grant 510(k)
clearance to commercially market the device. If the FDA determines
that the device is “not substantially equivalent” to a previously
cleared device, the device is automatically designated as a
Class III device. The device sponsor must then fulfill more
rigorous PMA requirements, or can request a risk-based
classification determination for the device in accordance with the
“de
novo”
process, which is a route to market for novel medical devices that
are low to moderate risk and are not substantially equivalent to a
predicate device.
After a device receives 510(k) clearance, any modification that
could significantly affect its safety or effectiveness, or that
would constitute a major change or modification in its intended
use, will require a new 510(k) clearance or, depending on the
modification, PMA approval. The FDA requires each manufacturer to
determine whether the proposed change requires submission of a
510(k) or a PMA in the first instance, but the FDA can review any
such decision and disagree with a manufacturer’s determination. If
the FDA disagrees with a manufacturer’s determination, the FDA can
require the manufacturer to cease marketing and/or request the
recall of the modified device until such marketing authorization
has been granted. Also, in these circumstances, the manufacturer
may be subject to significant regulatory fines or
penalties.
Over the last several years, the FDA has proposed reforms to its
510(k) clearance process, and such proposals could include
increased requirements for clinical data and a longer review
period, or could make it more difficult for manufacturers to
utilize the 510(k) clearance process for their
products.
PMA Approval Pathway
Class III devices require PMA approval before they can be
marketed, although some pre-amendment Class III devices for
which FDA has not yet required a PMA are cleared through the 510(k)
process. The PMA process is more demanding than the 510(k)
premarket notification process. In a PMA, the manufacturer must
demonstrate that the device is safe and effective, and the PMA must
be supported by extensive data, including data from preclinical
studies and human clinical trials. The PMA must also contain a full
description of the device and its components, a full description of
the methods, facilities, and controls used for manufacturing, and
proposed labeling. Following receipt of a PMA, the FDA determines
whether the application is sufficiently complete to permit a
substantive review. If the FDA accepts the application for review,
it has 180 days under the FDCA to complete its review of a PMA,
although in practice, the FDA’s review often takes significantly
longer, and can take up to several years. An advisory panel of
experts from outside the FDA may be convened to review and evaluate
the application and provide recommendations to the FDA as to the
approvability of the device. The FDA may or may not accept the
panel’s recommendation. In addition, the FDA will generally conduct
a pre-approval inspection of the applicant or its third-party
manufacturers’ or suppliers’ manufacturing facility or facilities
to ensure compliance with the QSR.
The FDA will approve the new device for commercial distribution if
it determines that the data and information in the PMA constitute
valid scientific evidence and that there is reasonable assurance
that the device is safe and effective for its intended use(s). The
FDA may approve a PMA with post-approval conditions intended to
ensure the safety and effectiveness of the device, including, among
other things, restrictions on labeling, promotion, sale and
distribution, and collection of long-term follow-up data from
patients in the clinical study that supported PMA approval or
requirements to conduct additional clinical studies post-approval.
The FDA may condition PMA approval on some form of post-market
surveillance when deemed necessary to protect the public health or
to provide
additional safety and efficacy data for the device in a larger
population or for a longer period of use. In such cases, the
manufacturer might be required to follow certain patient groups for
a number of years and to make periodic reports to the FDA on the
clinical status of those patients. Failure to comply with the
conditions of approval can result in material adverse enforcement
action, including withdrawal of the approval.
Certain changes to an approved device, such as changes in
manufacturing facilities, methods, or quality control procedures,
or changes in the design performance specifications, which affect
the safety or effectiveness of the device, require submission of a
PMA supplement. PMA supplements often require submission of the
same type of information as a PMA, except that the supplement is
limited to information needed to support any changes from the
device covered by the original PMA and may not require as extensive
clinical data or the convening of an advisory panel. Certain other
changes to an approved device require the submission of a new PMA,
such as when the design change causes a different intended use,
mode of operation, and technical basis of operation, or when the
design change is so significant that a new generation of the device
will be developed, and the data that were submitted with the
original PMA are not applicable for the change in demonstrating a
reasonable assurance of safety and effectiveness.
De Novo Classification
Medical device types that the FDA has not previously classified as
Class I, II, or III are automatically classified into
Class III regardless of the level of risk they pose. The Food
and Drug Administration Modernization Act of 1997 established a new
route to market for low to moderate risk medical devices that are
automatically placed into Class III due to the absence of a
predicate device, called the “Request for Evaluation of Automatic
Class III Designation,” or the
de novo
classification procedure. This procedure allows a manufacturer
whose novel device is automatically classified into Class III
to request down-classification of its medical device into
Class I or Class II on the basis that the device presents
low or moderate risk, rather than requiring the submission and
approval of a PMA application. Prior to the enactment of the Food
and Drug Administration Safety and Innovation Act, or FDASIA, in
July 2012, a medical device could only be eligible for
de novo
classification if the manufacturer first submitted a 510(k)
premarket notification and received a determination from the FDA
that the device was not substantially equivalent. FDASIA
streamlined the
de novo
classification pathway by permitting manufacturers to
request
de novo
classification directly without first submitting a 510(k) premarket
notification to the FDA and receiving a not substantially
equivalent determination.
Clinical Trials
Clinical trials are almost always required to support a PMA
and
de novo
classification and are sometimes required to support a 510(k)
submission. All clinical investigations of devices to determine
safety and effectiveness must be conducted in accordance with the
FDA’s investigational device exemption, or IDE, regulations which
govern investigational device labeling, prohibit promotion of the
investigational device, and specify an array of recordkeeping,
reporting and monitoring responsibilities of study sponsors and
study investigators. If the device presents a “significant risk” to
human health, as defined by the FDA, the FDA requires the device
sponsor to submit an IDE application to the FDA, which must become
effective prior to commencing human clinical trials. If the device
under evaluation does not present a significant risk to human
health, then the device sponsor is not required to submit an IDE
application to the FDA before initiating human clinical trials, but
must still comply with abbreviated IDE requirements when conducting
such trials. A significant risk device is one that presents a
potential for serious risk to the health, safety or welfare of a
patient and either is implanted, used in supporting or sustaining
human life, substantially important in diagnosing, curing,
mitigating or treating disease or otherwise preventing impairment
of human health, or otherwise presents a potential for serious risk
to a subject. An IDE application must be supported by appropriate
data, such as animal and laboratory test results, showing that it
is safe to test the device in humans and that the testing protocol
is scientifically sound. The IDE will automatically become
effective 30 days after receipt by the FDA unless the FDA notifies
the company that the investigation may not begin. If the FDA
determines that there are deficiencies or other concerns with an
IDE for which it requires modification, the FDA may permit a
clinical trial to proceed under a conditional
approval.
Regardless of the degree of risk presented by the medical device,
clinical studies must be approved by, and conducted under the
oversight of, an Institutional Review Board, or IRB, for each
clinical site. The IRB is responsible for the initial and
continuing review of the IDE, and may impose additional
requirements for the conduct of the study. If an IDE application is
approved by the FDA and one or more IRBs, human clinical trials may
begin at a specific number of investigational sites with a specific
number of patients, as approved by the FDA. If the device presents
a non-significant risk to the patient, a sponsor may begin the
clinical trial after obtaining approval for the trial by one or
more IRBs without separate approval from the FDA, but must still
follow abbreviated IDE requirements, such as monitoring the
investigation, ensuring that the investigators obtain informed
consent, and complying with labeling and record-keeping
requirements. In some cases, an IDE supplement must be submitted
to, and approved by, the FDA before a sponsor or investigator may
make a change to the investigational plan that may affect its
scientific soundness, study plan or the rights, safety or welfare
of human subjects.
During a study, the sponsor is required to comply with the
applicable FDA requirements, including, for example, trial
monitoring, selecting clinical investigators and providing them
with the investigational plan, ensuring IRB review, adverse event
reporting, record keeping and prohibitions on the promotion of
investigational devices or on making safety or effectiveness claims
for them. The clinical investigators in the clinical study are also
subject to FDA’s regulations and must obtain patient informed
consent, rigorously follow the investigational plan and study
protocol, control the disposition of the investigational device,
and comply with all reporting and recordkeeping requirements.
Additionally, after a trial begins, we, the FDA or the IRB could
suspend or terminate a clinical trial at any time for various
reasons, including a belief that the risks to study subjects
outweigh the anticipated benefits.
Post-market Regulation
After a device is cleared or approved for marketing, numerous and
pervasive regulatory requirements continue to apply. These
include:
•establishment
registration and device listing with the FDA;
•QSR
requirements, which require manufacturers, including third-party
manufacturers, to follow stringent design, testing, control,
documentation and other quality assurance procedures during all
aspects of the design and manufacturing process;
•labeling
regulations and FDA prohibitions against the promotion of
investigational products, or the promotion of “off-label” uses of
cleared or approved products;
•requirements
related to promotional activities;
•clearance
or approval of product modifications to 510(k)-cleared devices that
could significantly affect safety or effectiveness or that would
constitute a major change in intended use of one of our cleared
devices, or approval of certain modifications to PMA-approved
devices;
•medical
device reporting regulations, which require that a manufacturer
report to the FDA if a device it markets may have caused or
contributed to a death or serious injury, or has malfunctioned and
the device or a similar device that it markets would be likely to
cause or contribute to a death or serious injury, if the
malfunction were to recur;
•correction,
removal and recall reporting regulations, which require that
manufacturers report to the FDA field corrections and product
recalls or removals if undertaken to reduce a risk to health posed
by the device or to remedy a violation of the FDCA that may present
a risk to health;
•the
FDA’s recall authority, whereby the agency can order device
manufacturers to recall from the market a product that is in
violation of governing laws and regulations; and
•post-market
surveillance activities and regulations, which apply when deemed by
the FDA to be necessary to protect the public health or to provide
additional safety and effectiveness data for the
device.
Manufacturing processes for medical devices are required to comply
with the applicable portions of the QSR, which cover the methods
and the facilities and controls for the design, manufacture,
testing, production, processes, controls, quality assurance,
labeling, packaging, distribution, installation and servicing of
finished devices intended for human use. The QSR also requires,
among other things, maintenance of a device master file, device
history file, and complaint files. As a manufacturer, we are
subject to periodic scheduled and unscheduled inspections by the
FDA. Failure to maintain compliance with the QSR requirements could
result in the shut-down of, or restrictions on, manufacturing
operations and the recall or seizure of marketed products. The
discovery of previously unknown problems with any marketed
products, including unanticipated adverse events or adverse events
of increasing severity or frequency, whether resulting from the use
of the device within the scope of its clearance or approval, or
off-label by a physician in the practice of medicine, could result
in restrictions on the device, including the removal of the product
from the market or voluntary or mandatory device
recalls.
The FDA has broad regulatory compliance and enforcement powers. If
the FDA determines that a manufacturer has failed to comply with
applicable regulatory requirements, it can take a variety of
compliance or enforcement actions, which may result in any of the
following sanctions:
•warning
letters, untitled letters, fines, injunctions, consent decrees and
civil penalties;
•recalls,
withdrawals, or administrative detention or seizure of our
products;
•operating
restrictions or partial suspension or total shutdown of
production;
•refusing
or delaying requests for 510(k) clearance or PMA approvals of new
products or modified products;
•withdrawing
510(k) clearances or PMA approvals that have already been
granted;
•refusal
to grant export approvals for our products; or
•criminal
prosecution.
Low Risk General Wellness Products
The FDA has established a compliance policy for certain products
that may fall within the definition of a medical device, but that
are intended for only “general wellness use” and present a low risk
to the safety of users and other persons. The FDA defines a
“general wellness use” to be (i) an intended use that relates to
maintaining or encouraging a general state of health or a healthy
activity, or (ii) an intended use that relates the role of healthy
lifestyle with helping to reduce the risk or impact of certain
chronic diseases or conditions and where it is well understood and
accepted that healthy lifestyle choices may play an important role
in health outcomes for the disease or condition. For example, the
FDA identifies sleep management – such as a product intended to
track sleep trends – as an intended use of a product that falls
within a general wellness use, provided that the product claims do
not make reference to any diseases or conditions. Specifically, the
FDA has issued guidance explaining that for such low-risk products,
FDA does not intend to examine whether the product constitutes a
medical device, and if the product is a medical device, whether the
product complies with the premarket review and post-market
regulatory requirements of the FDCA. As such, if a medical device
falls within the definition of a “low risk general wellness
product,” the product may nevertheless be subject to enforcement
discretion under the FDA’s compliance policy for such products,
meaning that the FDA will not enforce its medical device
authorities with respect to that product.
Foreign Government Regulation
In addition to U.S. regulations, we are subject to a variety of
foreign government regulations applicable to general consumer
products and medical devices.
Regulation of General Consumer Products in the European
Union
In the European Union ("EU"), consumer products must comply with
the General Product Safety Directive No 2001/95/EC. This Directive
covers all products intended for consumers or likely to be used by
consumers, placed onto the EU market, unless a specific product
safety regulation applies. The General Product Safety Directive
provides safety and conformity requirements as well as post-market
surveillance obligations for manufacturers and importers.
Manufacturers must undertake and document a conformity assessment
that covers the risks and risk categories associated with the
product. The recommended method of undertaking such an assessment
is through the application of voluntary European Harmonized
Standards, but other options are available, such as using European
Commission guidelines and using product safety codes of good
practice. The required conformity assessment consists of a
self-assessment with no requirement to involve a third party.
Manufacturers also have the obligation to report to the national
competent authorities of the different EU member states any risks
to the consumer that are incompatible with the general safety
requirements. The Directive further imposes other obligations such
as collecting information related to use of products after they
have been made available to consumers.
Additional regulations may apply to our products and impose further
requirements, including the possible application of EU Regulation
No 1007/2011 on textile products, which imposes specific labeling
and marking requirements. In addition, we may also need to comply
with requirements set forth by RoHs Directive No 2011/65/EU, which
imposes specific restrictions on the use of hazardous substances in
electrical and electronic equipment, and/or the Registration,
Evaluation, Authorization, and Restriction of Chemicals (“REACH”)
Regulation (EU) No 1907/2006, which restricts substances of very
high concern and imposes substance registration
requirements.
Contrary to EU regulations (which are directly applicable in all EU
member states), directives must be implemented by individual member
states and may be applied in a way that is not always uniform
across the EU. In addition, member states determine the penalties
applicable to infringements of the national provisions adopted
pursuant to the General Product Safety Directive and other
directives and shall take all measures necessary to ensure that
they are implemented. Additional national requirements may be
applicable to our products, as well.
The advertising and promotion of consumer products is subject to EU
directives concerning misleading and comparative advertising and
unfair commercial practices and specific EU member state
legislation governing the advertising and promotion of these
products.
The aforementioned EU rules are generally applicable in the
European Economic Area (EEA) which consists of the 27 EU member
states plus Norway, Liechtenstein and Iceland.
Regulation of Medical Devices in the European Union
The EU has adopted specific directives and regulations regulating
the design, manufacture, clinical investigations, conformity
assessment, labeling and adverse event reporting for medical
devices. Until May 25, 2021, medical devices were regulated by the
Council Directive 93/42/EEC (the EU Medical Devices Directive),
which has been repealed and replaced by Regulation (EU) No 2017/745
(the EU Medical Devices Regulation). Unlike the EU Medical Devices
Directive, the EU Medical Devices Regulation is directly applicable
in all EU member states without the need for member states to
implement into national law.
In the EU, there is currently no premarket government review of
medical devices. However, all medical devices placed on the market
in the EU must meet the relevant general safety and performance
requirements laid down in Annex I to the EU Medical Devices
Regulation including the requirement that a medical device must be
designed and manufactured in such a way that, during normal
conditions of use, it is suitable for its intended purpose. The
medical device must be safe and effective and must not compromise
the clinical condition or safety of patients, or the safety and
health of users and – where applicable – other persons, provided
that any risks which may be associated with their use constitute
acceptable risks when weighed against the benefits to the patient
and are compatible with a high level of protection of health and
safety, taking into account the generally acknowledged state of the
art. The European Commission has adopted various standards
applicable to medical devices. These include standards governing
common requirements, such as sterilization and safety of medical
electrical equipment and product standards for certain types of
medical devices. There are also harmonized standards relating to
design and manufacture. While not mandatory, compliance with these
standards is viewed as the easiest way to satisfy the general
safety and performance requirements as a practical matter as it
creates a rebuttable presumption that the device satisfies that
general safety and performance requirement.
Compliance with the general safety and performance requirements of
the EU Medical Devices Regulation is a prerequisite for European
Conformity Marking (CE mark) without which medical devices cannot
be marketed or sold in the EU. To demonstrate compliance with the
general safety and performance requirements laid down in Annex I to
the EU Medical Devices Regulation, medical device manufacturers
must undergo a conformity assessment procedure, which varies
according to the type of medical device and its (risk)
classification. As a general rule, demonstration of conformity of
medical devices and their manufacturers with the general safety and
performance requirements must be based, among other things, on the
evaluation of clinical data supporting the safety and performance
of the products during normal conditions of use. Specifically, a
manufacturer must demonstrate that the device achieves its intended
performance during normal conditions of use, that the known and
foreseeable risks, and any adverse events, are minimized and
acceptable when weighed against the benefits of its intended
performance, and that any claims made about the performance and
safety of the device are supported by suitable evidence. Except for
low-risk medical devices (Class I), where the manufacturer can
self-assess the conformity of its products with the general safety
and performance requirements (except for any parts which relate to
sterility or metrology or reuse aspects), a conformity assessment
procedure requires the intervention of a notified body. Notified
bodies are independent organizations designated by EU member states
to assess the conformity of devices before being placed on the
market. A notified body would typically audit and examine a
product’s technical dossiers and the manufacturer's quality system
(notified body must presume that quality systems which implement
the relevant harmonized standards – which is ISO 13485:2016 for
Medical Devices Quality Management Systems – conform to these
requirements). If satisfied that the relevant product conforms to
the general safety and performance requirements, the notified body
issues a certificate of conformity, which the manufacturer uses as
a basis for its own declaration of conformity. The manufacturer may
then apply the CE mark to the device, which allows the device to be
placed on the market throughout the EU.
Throughout the term of the certificate of conformity, the
manufacturer will be subject to periodic surveillance audits to
verify continued compliance with the applicable requirements. In
particular, there will be a new audit by the notified body before
it will renew the relevant certificate(s).
The EU Medical Devices Regulation requires that before placing a
device, other than a custom-made device, on the market,
manufacturers (as well as other economic operators such as
authorized representatives and importers) must register by
submitting identification information to the European Database for
Medical Devices ("EUDAMED"), unless they have already registered.
The information to be submitted by manufacturers (and authorized
representatives) also includes the name, address and contact
details of the person or persons responsible for regulatory
compliance. The regulation also requires that before placing a
device, other than a custom-made device, on the market,
manufacturers must assign a unique identifier to the device and
provide it along with other core data to the unique device
identifier (UDI) database. These new requirements aim at ensuring
better identification and traceability of the devices. Each device
– and as applicable, each package – will have a UDI composed of two
parts: a device identifier (UDI-DI) specific to a device, and a
production identifier (UDI-PI) to identify the unit producing the
device. Manufacturers are also notably responsible for entering the
necessary data on EUDAMED, which includes the UDI database, and for
keeping it up to date. The obligations for registration in EUDAMED
will become applicable at a later date (as EUDAMED is not yet fully
functional). Until EUDAMED is fully functional, the corresponding
provisions of the EU Medical Devices Directive continue to apply
for the purpose of meeting the
obligations laid down in the provisions regarding exchange of
information, including, and in particular, information regarding
registration of devices and economic operators.
All manufacturers placing medical devices into the market in the EU
must comply with the EU medical device vigilance system which has
been reinforced by the EU Medical Devices Regulation. Under this
system, serious incidents and Field Safety Corrective Actions
(FSCAs) must be reported to the relevant authorities of the EU
member states. These reports will have to be submitted through
EUDAMED – once functional – and aim to ensure that, in addition to
reporting to the relevant authorities of the EU member states,
other actors such as the economic operators in the supply chain
will also be informed. Until EUDAMED is fully functional, the
corresponding provisions of the EU Medical Devices Directive
continue to apply. Manufacturers are required to take FSCAs, which
are defined as any corrective action for technical or medical
reasons to prevent or reduce a risk of a serious incident
associated with the use of a medical device that is made available
on the market. A serious incident is any malfunction or
deterioration in the characteristics or performance of a device on
the market (e.g., inadequacy in the information supplied by the
manufacturer, undesirable side-effect), which, directly or
indirectly, might lead to either the death or serious deterioration
of the health of a patient, user, or other persons, or to a serious
public health threat. An FSCA may include the recall, modification,
exchange, destruction or retrofitting of the device. FSCAs must be
communicated by the manufacturer or its legal representative to its
customers and/or to the end users of the device through Field
Safety Notices. For similar serious incidents that occur with the
same device or device type and for which the root cause has been
identified or a FSCA implemented or where the incidents are common
and well documented, manufacturers may provide periodic summary
reports instead of individual serious incident
reports.
The advertising and promotion of medical devices is subject to some
general principles set forth in EU legislation. According to the EU
Medical Devices Regulation, only devices that are CE marked may be
marketed and advertised in the EU in accordance with their intended
purpose. Directive 2006/114/EC concerning misleading and
comparative advertising and Directive 2005/29/EC on unfair
commercial practices, while not specific to the advertising of
medical devices, also apply to the advertising thereof and contain
general rules, for example, requiring that advertisements are
evidenced, balanced and not misleading. Specific requirements are
defined at a national level. EU member states’ laws related to the
advertising and promotion of medical devices, which vary between
jurisdictions, may limit or restrict the advertising and promotion
of products to the general public and may impose limitations on
promotional activities with healthcare professionals.
Many EU member states have adopted specific anti-gift statutes that
further limit commercial practices for medical devices, in
particular vis-à-vis healthcare professionals and organizations.
Additionally, there has been a recent trend of increased regulation
of payments and transfers of value provided to healthcare
professionals or entities and many EU member states have adopted
national “Sunshine Acts” which impose reporting and transparency
requirements (often on an annual basis), similar to the
requirements in the U.S., on medical device manufacturers. Certain
countries also mandate implementation of commercial compliance
programs. The aforementioned EU rules are generally applicable in
the EEA.
In the EU, regulatory authorities have the power to carry out
announced and, if necessary, unannounced inspections of companies,
as well as suppliers and/or sub-contractors and, where necessary,
the facilities of professional users. Failure to comply with
regulatory requirements (as applicable) could require time and
resources to respond to the regulatory authorities' observations
and to implement corrective and preventive actions, as appropriate.
Regulatory authorities have broad compliance and enforcement powers
and if such issues cannot be resolved to their satisfaction can
take a variety of actions, including untitled or warning letters,
fines, consent decrees, injunctions, or civil or criminal
penalties.
Brexit and Regulation of Medical Devices in the United
Kingdom
Since the end of the Brexit transition period on January 1, 2021,
Great Britain (England, Scotland and Wales) has not been directly
subject to EU laws, however under the terms of the Protocol on
Ireland/Northern Ireland, EU laws generally apply to Northern
Ireland. On February 27, 2023, the United Kingdom (UK) Government
and the European Commission reached a political agreement on the
“Windsor Agreement” which is likely to lead to further amendments
to the Protocol on Ireland/Northern Ireland in order to address
some of the perceived shortcomings in its operation. These proposed
changes need to be codified and agreed by the respective
parliaments of the UK and EU before taking effect.
The EU laws that have been transposed into UK law through secondary
legislation remain applicable in Great Britain. However, under the
Retained EU Law (Revocation and Reform) Bill 2022, which is
currently before the UK parliament, any retained EU law not
expressly preserved and “assimilated” into domestic law or extended
by ministerial regulations (to no later than June 23, 2026) will
automatically expire and be revoked by December 31, 2023. In
addition, new legislation such as the EU Medical Devices Regulation
is not applicable in Great Britain.
The UK government has passed a new Medicines and Medical Devices
Act 2021, which introduces delegated powers in favor of the
Secretary of State or an ‘appropriate authority’ to amend or
supplement existing regulations in the area of medicinal products
and medical devices. This allows new rules to be introduced in the
future by way of secondary legislation, which aims to allow
flexibility in addressing regulatory gaps and future changes in the
fields of human medicines, clinical trials and medical
devices.
The EU-UK Trade and Cooperation Agreement (TCA) came into effect on
January 1, 2021. The TCA does not specifically refer to medical
devices but does provide for cooperation and exchange of
information in the area of product safety and compliance, including
market surveillance, enforcement activities and measures,
standardization related activities, exchanges of officials, and
coordinated product recalls (or other similar actions). For medical
devices that are locally manufactured but use components from other
countries, the “rules of origin” criteria will need to be
reviewed.
Since January 1, 2021, the Medicines and Healthcare Products
Regulatory Agency (MHRA) has become the sovereign regulatory
authority responsible for Great Britain. New regulations require
all medical devices to be registered with the MHRA, and since
January 1, 2022, manufacturers based outside the UK have been
required to appoint a UK responsible person that has a registered
place of business in the UK to register devices with the
MHRA.
On June 26, 2022, the MHRA published its response to a 10-week
consultation on the post-Brexit regulatory framework for medical
devices. The MHRA seeks to amend the UK Medical Devices Regulations
2002 (which are based on EU legislation, primarily the EU Medical
Devices Directive and the EU In Vitro Diagnostic Medical Devices
Directive), in particular to create a new access pathway to support
innovation, create an innovative framework for regulating software
and artificial intelligence as medical devices, reform medical
devices regulation and foster sustainability through the reuse and
remanufacture of medical devices. Regulations implementing the new
regime were originally scheduled to come into force in July 2023,
but the Government has recently confirmed that this date has been
postponed until July 2024. Devices which have valid a valid
certificate issued by EU notified bodies under the EU Medical
Devices Regulation (or EU Medical Devices Directive) are subject to
transitional arrangements. In its consultation response, the MHRA
indicated that the future regulations in Great Britain will allow
medical devices with valid certification to continue being placed
on the market in Great Britain under the CE mark until either the
certificate expires or for five years after the new regulations
take effect, whichever is sooner. Following these transitional
periods, it is expected that all medical devices will require a UK
Conformity Assessment (UKCA) mark. Manufacturers may choose to use
the UKCA mark on a voluntary basis prior to the regulations coming
into force. However, from July 2024, products which do not have
existing and valid certification under the EU Medical Devices
Regulation (or EU Medical Devices Directive) and are therefore not
subject to the transitional arrangements will be required to carry
the UKCA mark if they are to be sold into the market in Great
Britain. UKCA marking will not be recognized in the EU. The rules
for placing medical devices on the market in Northern Ireland,
which is part of the UK, differ from those in Great Britain and
continues to be based on EU law.
Under the terms of the Ireland/Northern Ireland Protocol, Northern
Ireland follows EU rules on medical devices, including the EU
Medical Devices Regulation, and medical devices marketed in
Northern Ireland require assessment according to the EU regulatory
regime. Such assessment may be conducted by an EU notified body, in
which case a CE mark is required before placing the device on the
market in Northern Ireland. Alternatively, if a UK approved body
conducts such assessment, a 'UKNI' mark is applied and the device
may only be placed on the market in Northern Ireland and not the
EU.
Other Foreign Regulations
Similarly, we are subject to regulations and product registration
requirements in many foreign countries in which we may sell our
products, including in the areas of:
•design,
development, manufacturing, and testing;
•product
standards;
•product
safety;
•product
safety reporting;
•marketing,
sales, and distribution;
•packaging
and storage requirements;
•labeling
requirements;
•content
and language of instructions for use;
•record
keeping procedures;
•advertising
and promotion;
•recalls
and field corrective actions;
•import
and export restrictions; and
•tariff
regulations, duties, and tax requirements;
We may also become subject to the following additional requirements
in many foreign countries in which we may sell future medical
devices, including in the areas of:
•clinical
testing;
•post-market
surveillance, including reporting of deaths or serious injuries and
malfunctions that, if they were to recur, could lead to death or
serious injury;
•registration
for reimbursement; and
•necessity
of testing performed in country by distributors for
licensees.
Other Healthcare Laws and Regulations
Other Healthcare Laws
Medical device manufacturers are subject to additional healthcare
regulation and enforcement by the federal government and by
authorities in the states and foreign jurisdictions in which they
conduct their business and may constrain the financial arrangements
and relationships through which we research, as well as, sell,
market and distribute any products for which we obtain marketing
approval or certification. Such laws include, without limitation,
federal and state anti-kickback, fraud and abuse, false claims, and
physician and other healthcare provider payment transparency laws
and regulations. If their operations are found to be in violation
of any of such laws or any other governmental regulations that
apply, they may be subject to penalties, including, without
limitation, administrative, civil and criminal penalties, damages,
fines, disgorgement, the curtailment or restructuring of
operations, integrity oversight and reporting obligations,
exclusion from participation in federal, state, and foreign
healthcare programs and imprisonment.
Coverage and Reimbursement
With respect to our current products, including the Dream Sock and
Owlet Cam, we utilize a direct-to-consumer model where consumers
purchase our products directly from us or one of our retailers.
Currently, these products are not covered or reimbursed by any
third-party payor. We are actively developing a strategy to enable
healthcare providers to obtain reimbursement for products for which
we successfully obtain FDA authorization or similar authorization
or certification in foreign jurisdictions, including the BabySat,
or the services associated with such products. However, this new
strategy may not be successful as payors may refuse to provide
coverage and reimbursement for these products even if we obtain FDA
authorization or similar authorization or certification in foreign
jurisdictions.
Sales of any product that we may develop and for which we may
obtain marketing authorization or certification from the FDA and/or
comparable foreign regulatory authorities or notified bodies
depend, in part, on the extent to which such product or services
associated with such product will be covered by third-party payors,
such as federal, state, and foreign government healthcare programs,
commercial insurance and managed healthcare organizations, and the
level of reimbursement for such product or services associated with
such product by third-party payors. Even though a new product may
have been cleared or otherwise authorized, or certified for
commercial distribution by the FDA, foreign regulatory authorities
or notified bodies, we may find limited demand for the product
unless and until reimbursement approval has been obtained from
governmental and private third-party payors.
Decisions regarding the extent of coverage and amount of
reimbursement to be provided are made on a plan-by-plan basis.
These third-party payors are increasingly reducing reimbursements
for medical devices and services. In addition, the U.S. government,
state legislatures and foreign governments have continued
implementing cost-containment programs, including price controls,
restrictions on coverage and reimbursement and requirements for
substitution of generic products. Adoption of price controls and
cost-containment measures, and adoption of more restrictive
policies in jurisdictions with existing controls and measures,
could further limit sales of any product. Decreases in third-party
reimbursement for any product or a decision by a third-party payor
not to cover the product or the services associated with the
product could reduce physician usage and patient demand for the
product and also have a material adverse effect on
sales.
Healthcare Reform
The U.S. and some foreign jurisdictions are considering or have
enacted a number of legislative and regulatory proposals to change
the healthcare system in ways that could affect our ability to sell
our products that obtain
marketing authorization or certification from the FDA and/or
comparable foreign regulatory authorities or notified bodies
profitably. Among policy makers and payors in the U.S. and
elsewhere, there is significant interest in promoting changes in
healthcare systems with the stated goals of containing healthcare
costs, improving quality or expanding access. Current and future
legislative proposals to further reform healthcare or reduce
healthcare costs may limit coverage of or lower reimbursement for
the services associated with the use of our products. The cost
containment measures that payors and providers are instituting and
the effect of any healthcare reform initiative implemented in the
future could impact our revenue from the sale of our
products.
In the U.S., the implementation of the Affordable Care Act, or ACA,
for example, has changed healthcare financing and delivery by both
governmental and private insurers substantially, and affected
medical device manufacturers significantly. The ACA included, among
other things, incentives to programs that increase the federal
government’s comparative effectiveness research and implemented
payment system reforms including a national pilot program on
payment bundling to encourage hospitals, physicians and other
providers to improve the coordination, quality and efficiency of
certain healthcare services through bundled payment models.
Additionally, the ACA expanded eligibility criteria for Medicaid
programs and created a new Patient-Centered Outcomes Research
Institute to oversee, identify priorities in, and conduct
comparative clinical effectiveness research, along with funding for
such research.
Since its enactment, there have been executive, judicial and
Congressional challenges to certain aspects of the ACA. On
June 17, 2021, the U.S. Supreme Court dismissed the most
recent judicial challenge to the ACA brought by several states
without specifically ruling on the constitutionality of the ACA.
Prior to the Supreme Court’s decision, President Biden issued an
executive order initiating a special enrollment period from
February 15, 2021 through August 15, 2021 for purposes of
obtaining health insurance coverage through the ACA marketplace.
The executive order also instructed certain governmental agencies
to review and reconsider their existing policies and rules that
limit access to healthcare. It is unclear how healthcare reform
measures enacted by Congress or implemented by the Biden
administration, if any, will impact our business.
In addition, other legislative changes have been proposed and
adopted since the ACA was enacted. For example, the Budget Control
Act of 2011, among other things, reduced Medicare payments to
providers, effective on April 1, 2013 and, due to subsequent
legislative amendments to the statute, will remain in effect
through 2032, with the exception of a temporary suspension from
May 1, 2020 through March 31, 2022, unless additional
Congressional action is taken. Additionally, the American Taxpayer
Relief Act of 2012, among other things, reduced Medicare payments
to several providers, including hospitals, and increased the
statute of limitations period for the government to recover
overpayments to providers from three to five years. The Medicare
Access and CHIP Reauthorization Act of 2015 repealed the formula by
which Medicare made annual payment adjustments to physicians and
replaced the former formula with fixed annual updates and a new
system of incentive payments, which began in 2019, that are based
on various performance measures and physicians’ participation in
alternative payment models, such as accountable care
organizations.
We expect additional state, federal or foreign healthcare reform
measures to be adopted in the future, any of which could limit the
amounts that federal, state or foreign governments will pay for
healthcare products and services, which could result in reduced
demand for our products for which we obtain marketing authorization
or certification or additional pricing pressure.
In the EU, similar developments may affect our ability to
profitably commercialize our products, if certified. In December
2021, Regulation No 2021/2282 on Health Technology Assessment (HTA)
amending Directive 2011/24/EU, was adopted. While the Regulation
entered into force in January 2022, it will only begin to apply
from January 2025 onwards, with preparatory and
implementation-related steps to take place in the interim. Once the
Regulation becomes applicable, it will have a phased implementation
depending on the concerned products. This regulation intends to
boost cooperation among EU member states in assessing health
technologies, including certain high-risk medical devices, and
providing the basis for cooperation at the EU level for joint
clinical assessments in these areas. The regulation will permit EU
member states to use common HTA tools, methodologies, and
procedures across the EU, working together in four main areas,
including joint clinical assessment of the innovative health
technologies with the most potential impact for patients, joint
scientific consultations whereby developers can seek advice from
HTA authorities, identification of emerging health technologies to
identify promising technologies early, and continuing voluntary
cooperation in other areas. Individual EU member states will
continue to be responsible for assessing non-clinical (e.g.,
economic, social, ethical) aspects of health technology, and making
decisions on pricing and reimbursement.
Data Privacy and Security Laws
Numerous state, federal and foreign laws, including consumer
protection laws and regulations, govern the collection,
dissemination, use, access to, confidentiality and security of
personal information, including health-related
information. In the U.S., numerous federal and state laws and
regulations, including data breach notification laws, health
information privacy and security laws and consumer protection laws
and regulations that govern the collection, use, disclosure, and
protection of health-related and other personal information could
apply to our operations or the operations of our partners. In
addition, certain foreign laws govern the privacy and security of
personal data, including health-related data in certain
circumstances, many of which differ from each other in significant
ways and may not have the same effect, thus complicating compliance
efforts. Failure to comply with these laws, where applicable, can
result in the imposition of significant civil and/or criminal
penalties and private litigation. Privacy and security laws,
regulations, and other obligations are constantly evolving, may
conflict with each other to complicate compliance efforts, and can
result in investigations, proceedings, or actions that lead to
significant civil and/or criminal penalties and restrictions on
data processing.
Anti-Bribery and Corruption Laws
We may also be subject to similar anti-corruption legislation
implemented in Europe through EU Member State laws and under the
Organization for Economic Co-operation and Development’s Convention
on Combating Bribery of Foreign Public Officials in International
Business Transactions.
Intellectual Property
Since inception, we have been methodical around our intellectual
property strategy. We rely on a combination of patent, copyright,
trademark and trade secret laws and confidentiality and invention
assignment agreements to protect our intellectual property rights.
As of December 31, 2022, we had 68 issued patents (with
numerous others pending) and 51 registered trademarks. Our patents
include utility patents covering technology ranging from placement
of electrodes to the base of the baby monitor. We have foreign
patents and patent applications pending in the EU, Australia,
Canada, and China. Our issued patents with claims generally
directed to an infant sock comprised of a sensing device in a
sleeve in the sock and a strap are expected to expire in the U.S.
in 2032 and in China in 2035. Our issued patents with claims
generally directed to placement of fabric electrodes and assembly
of such are each expected to expire in the U.S., the EU, Australia,
China and Canada in 2038. Pending applications in the
aforementioned countries will have expiration dates between 2034
and 2040. We continually review our development efforts to assess
the existence and patentability of new intellectual
property.
Our pending patent applications may not result in issued patents,
and we cannot assure you that any current or subsequently issued
patents will protect our intellectual property rights. Third
parties may challenge certain patents issued to us as invalid, may
independently develop similar or competing technologies or may
design around any of our patents. We cannot be certain that any of
the steps we have taken will prevent the misappropriation of our
intellectual property, particularly in foreign countries where the
laws may not protect our proprietary rights in these countries as
fully as in the U.S.
Ayla Subscription Agreement
In May 2014, we entered into a subscription agreement with Ayla
Networks, Inc. (“Ayla”), pursuant to which Ayla has granted us a
non-exclusive, royalty free license to certain cloud services and
product software used in our Smart Sock product and to support the
transfer of data to the cloud and back to Owlet and the
customer.
The initial term of the agreement expired in December 2015, but we
have extended the term of the agreement until January 1, 2024.
We may terminate the agreement at any time. Additionally, either
party may terminate the agreement upon 30 days’ notice if the other
party materially breaches the agreement.
Under the agreement, we have agreed to indemnify Ayla against
certain claims arising in connection with or breach of the
agreement or our use, or misuse, of the services provided by Ayla
under the agreement. We are also entitled to indemnification from
Ayla under certain scenarios arising from third-party claims of
intellectual property infringement by Ayla.
In connection with the subscription agreement, we also entered into
a data processing agreement with Ayla, pursuant to which Ayla has
agreed to implement appropriate data security measures and treat
all personal data as strictly confidential.
We currently utilize Ayla to support both our Smart Sock and Dream
Sock product offerings.
Service and License Agreement with ThroughTek
In January 2018, we entered into a service and license agreement
with ThroughTek Co., Ltd. (“TUTK”), pursuant to which TUTK has
granted us a non-exclusive, royalty free license to its “Kalay”
platform. TUTK provides the data transfer services from the Owlet
Cam to the Owlet application so users can view the video
feed.
Under the agreement, we paid an initial license fee of $25,000 plus
a low-single digit dollar amount per device license fee to access
TUTK’s services (“UID”). The UID cost per unit is subject to change
at any time by our mutual agreement but shall not increase by more
than a low single-digit percentage per year. We also pay certain
negotiated services fees to TUTK, which are also subject to a low
single digit percentage increase.
The initial term of the agreement expired in January 2021, but
automatically renewed for an additional one-year period. The
agreement will continue to automatically renew for one-year
periods, unless terminated by us or TUTK at least 90 days prior to
the end of the then-current renewal period. Among other things,
either party may terminate the agreement under certain customary
conditions, including for non-payment, uncured breaches of the
agreement or in the event of the other party’s
insolvency.
In connection with the services provided under the agreement, we
and TUTK have agreed to mutually indemnify the other party against
certain claims resulting from infringement of third-party
intellectual property.
Environmental Matters
Our operations, properties and products are subject to a variety of
U.S. and foreign environmental laws and regulations governing,
among other things, air emissions, wastewater discharges,
management and disposal of hazardous and non-hazardous materials
and waste and remediation of releases of hazardous materials. We
believe, based on current information, that we are in material
compliance with environmental laws and regulations applicable to
us. However, our failure to comply with present and future
requirements under these laws and regulations, or environmental
contamination or releases of hazardous materials on our leased
premises, as well as through disposal of our products, could cause
us to incur substantial costs, including clean-up costs, personal
injury and property damage claims, fines and penalties, costs to
redesign our products or upgrade our facilities and legal costs, or
require us to curtail our operations, any of which could seriously
harm our business.
Human Capital Resources
As of December 31, 2022, we had 106 full-time employees. None
of our employees is represented by a labor union, and we consider
our employee relations to be good. Our human capital resources
objectives include, as applicable, identifying, recruiting,
retaining, incentivizing and integrating our existing and
additional employees. The principal purposes of our equity
incentive plans are to attract, retain and motivate selected
employees, consultants and directors through the granting of
stock-based compensation awards and cash-based performance bonus
awards.
We believe our innovation and operational excellence stems directly
from the diversity in our community and our common commitment to
equity, inclusion, and equal access to healthcare. As of December
31, 2022, over 45% of our employees were women and over 27% were
from minority groups.
Corporate Information
Owlet Baby Care Inc. was incorporated in Delaware on February 24,
2014 as a Delaware corporation. SBG was incorporated in Delaware on
June 23, 2020. On July 15, 2021, SBG closed the Merger with Owlet
Baby Care Inc. As a result of the Merger, Owlet Baby Care, Inc.
became a wholly-owned subsidiary of SBG, and SBG changed its name
to Owlet, Inc.
Available Information
Our website address is www.owletcare.com. The contents of, or
information accessible through, our website are not part of this
Annual Report on Form 10-K. We make our filings with the SEC,
including our Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and all amendments to those
reports, as well as beneficial ownership filings available free of
charge on our website as soon as reasonably practicable after we
file such reports with, or furnish such reports to, the
SEC.
We may use our website as a distribution channel of material
information about the Company. Financial and other important
information regarding the Company is routinely posted on and
accessible through the Investors sections of its website at
https://investors.owletcare.com. In addition, you may automatically
receive email alerts and other information about the Company when
you enroll your email address under the “Resources” menu on the
Investors section of our website at https://
investors.owletcare.com.
The reference to our website address does not constitute
incorporation by reference of the information contained on or
available through our website, and you should not consider such
information to be a part of this Annual Report on Form
10-K.
Item 1A. Risk Factors.
Our business is subject to numerous risks and uncertainties that
you should be aware of in evaluating our business. If any such
risks and uncertainties actually occur, our business, prospects,
financial condition and results of operations could be materially
and adversely affected. The risks described below are not the only
risks that we face. Additional risks and uncertainties not
currently known to us, or that we currently deem to be immaterial
may also materially adversely affect our business, prospects,
financial condition and results of operations. The risk factors
described below should be read together with the other information
set forth in this Annual Report on Form 10-K, including our
consolidated financial statements and the related notes, as well as
in other documents that we file with the Securities and Exchange
Commission ("SEC").
Risks Related to Our Business and Operations
We have a limited operating history.
We were organized in 2014 and began selling our Smart Sock in 2015,
our Owlet Cam in 2018, and launched our Dream Sock in January 2022.
Accordingly, we have a limited operating history, which makes an
evaluation of our future prospects difficult. Our operating results
have fluctuated in the past, and we expect our future quarterly and
annual operating results to fluctuate as we focus on increasing the
demand for our products and services. We may need to make business
decisions that could adversely affect our operating results, such
as modifications to our pricing strategy, business structure or
operations.
We have not been profitable to date, and operating losses could
continue, which could materially and adversely affect our business,
financial condition and results of operations, including our
ability to continue as a going concern.
The success of our business depends on our ability to increase
revenues to offset expenses. We experienced year over year revenue
declines in 2022 compared to 2021, and since our inception, we have
incurred recurring operating losses, generated negative cash flows
from operations, and financed our operations principally through
equity investments and borrowings. Those factors, coupled with our
current cash balance and noncompliance with one of our revenue
covenants, raise substantial doubt as to our ability to continue as
a going concern.
Any measures we undertake to address these financial conditions may
not be successful. For example, we have undertaken cost-saving
measures and implemented a company-wide restructuring program,
which significantly reduced our employee headcount and is expected
to reduce our operating spend and improve cost efficiency. These
cost-saving and restructuring actions include reductions in
consulting and outside services and marketing programs and
prioritizations and sequencing of research and development
projects.
Future profitability is difficult to predict with certainty, and
failure to achieve profitability could materially and adversely
affect our overall value and ability to obtain additional financing
and capital. There can be no assurance that the Company will
generate sufficient future cash flows from operations due to
various potential factors, including but not limited to inflation,
recession or decreased demand for our products. If our revenues
further decrease from current levels, we may be unable to further
reduce costs, or such cost reductions may limit our ability to
pursue and implement strategic initiatives and grow revenues in the
future. Also, there can be no assurance as to whether or when we
will be able to obtain additional debt or equity financing on
acceptable terms. Our ability to reduce operating expenses or raise
capital from external sources, if at all, may have a material
adverse effect on our business, financial condition and operating
results.
We have experienced fluctuations in the growth of our business and
anticipate this will continue. If we fail to manage our growth
effectively, our business could be materially and adversely
affected.
Prior to the receipt of the Warning Letter described below, we
experienced rapid growth. For example, our revenue increased from
$54.4 million for the nine months ended September 30, 2020 to $78.4
million for the nine months ended September 30, 2021, and the
number of our full-time employees increased from 111 as of December
31, 2020 to 200 as of December 31, 2021. Following receipt of the
Warning Letter, our revenue decreased from $75.2 million for the
year ended December 31, 2021 to $69.2 million for the year ended
December 31, 2022. Further, as part of a restructuring program
implemented in the third quarter of 2022 to increase cost
efficiencies across the organization, we commenced a workforce
reduction of 74 employees, and as of December 31, 2022 the number
of our full-time employees decreased to 106. We anticipate that
fluctuations in the growth of our business will continue as we
adapt our plans and strategies to changing business and
macroeconomic conditions.
Fluctuations in our growth have placed significant demands on our
management, financial, operational, technological and at the time
of other resources, and we expect that such fluctuations will
continue to place significant demands on our management and other
resources and will require us to continue developing and improving
our operational, financial and other internal controls. Any growth
strategy that we may decide to execute will require that
we:
•manage
our commercial operations effectively;
•identify,
recruit, retain, incentivize and integrate additional
employees;
•provide
adequate training and supervision to maintain our high-quality
standards and preserve our culture and values;
•manage
our internal development and operational efforts effectively while
carrying out our contractual obligations to third parties;
and
•continue
to improve our operational, financial and management controls,
reports systems and procedures.
Rapid growth increases the challenges involved in addressing these
goals in a cost-effective or timely manner, or at all. If we do not
effectively manage our growth, we may not be able to execute on our
business plan, respond to competitive pressures, take advantage of
market opportunities, satisfy customer requirements or maintain
high-quality product offerings, which could have a material adverse
effect on our business, financial condition and results of
operations.
In addition, we also expect to continue to incur additional legal,
accounting, and other expenses as a public company. These
investments may be more costly than we expect, and if we do not
achieve the benefits anticipated from these investments, or if the
realization of these benefits is delayed, they may not result in
increased revenue or growth in our business. If we are not able to
achieve or maintain positive cash flow in the long term, we may
require additional financing, which may not be available on
favorable terms or at all or which would be dilutive to our
stockholders. If we are unable to successfully address these risks
and challenges as we encounter them, our business, results of
operations, and financial condition would be adversely affected.
Our failure to achieve or maintain profitability could negatively
impact the value of our common stock and warrants.
We are also highly dependent on our senior management, other key
officers, our engineers, marketing and field sales team, and may be
increasingly dependent on healthcare and clinical specialists for
the sale of any medical devices we may market, if approved. We face
significant competition for talent from other healthcare,
technology and high-growth companies, which include both large
enterprises and privately-held companies. To attract top talent, we
have had to offer, and believe we will need to continue to offer,
highly competitive compensation packages before we can validate the
productivity of those employees. In addition, we may not be able to
hire new employees quickly enough to meet our needs and
fluctuations in the price of our common stock may make it more
difficult or costly to use equity compensation to motivate,
incentivize and retain our employees.
We may not successfully execute or achieve the expected benefits of
our restructuring program and other cost-saving measures we may
take in the future, and our efforts may result in further actions
and may materially and adversely affect our business, financial
condition and results of operations.
In July 2022, we implemented a company-wide restructuring program
designed to position the Company for long-term profitable growth by
prioritizing the sell-through of our products to end consumers,
obtaining required marketing authorizations from applicable
regulatory authorities and certifications from notified bodies and
managing our liquidity. The program included streamlining our
organizational structure in response to current business
conditions, reducing our operating expenses and conserving our cash
resources. The restructuring program was based on various
estimates, assumptions and forecasts, which were subject to known
and unknown risks and uncertainties, including but not limited to
assumptions regarding cost savings, cash burn rate, access to
restricted cash, gross profit improvements and effectiveness of
reduced marketing spend. Accordingly, we face risks of not being
able to fully realize the cost savings, enhanced liquidity and
other benefits anticipated from the restructuring program.
Additionally, implementation of any cost-saving initiatives or cash
preservation strategies may be costly and disruptive to our
business, the expected costs and charges may be greater than we
forecasted, and the estimated cost savings may be lower than we
forecasted. If we don't pay our vendors timely, they may cease
providing services or products that we need to operate our
business.
We will need to raise additional capital in the future in order to
execute our strategic plan, which may not be available on terms
acceptable to us, or at all.
We have experienced recurring losses from operations and negative
cash flows from operations, and we expect to continue operating at
a loss for the foreseeable future. As of December 31, 2022, we had
an accumulated deficit of $222.8 million and cash and cash
equivalents of $11.2 million. Year over year declines in revenue,
our low, current cash balance, recurring operating losses, and
negative cash flows from operations since inception raise
substantial
doubt about our ability to continue as a going concern within one
year after the date that the accompanying consolidated financial
statements are issued.
While we were able to announce the closing of a private equity
offering in February 2023 which provided an infusion of capital of
$30.0 million and as of March 27, 2023 we were able to amend our
existing debt and line of credit held by Silicon Valley Bank, now a
division of First Citizens Bank and Trust Company (“SVB”), we
anticipate needing to raise additional capital to fund our future
operations in order to remain as a going concern. There can be no
assurance that we will be able to obtain additional funding on
acceptable terms, if at all. To the extent that we raise additional
capital through future equity offerings, the ownership interest of
common stockholders will be diluted, which dilution may be
significant. However, we cannot guarantee that we will be able to
obtain any or sufficient additional funding or that such funding,
if available, will be obtainable on terms satisfactory to us.
Failure to secure additional funding may require us to modify,
delay or abandon some of our planned future development, or to
otherwise enact further operating cost reductions, which could have
a material adverse effect on our business, operating results,
financial condition and ability to achieve our intended business
objectives.
Substantial doubt about our ability to continue as a going concern
may materially and adversely affect the price per share of our
common stock, and it may be more difficult for us to obtain
financing. If potential investors decline to participate in any
future financings due to such concerns, our ability to increase our
cash position may be limited. The perception that we may not be
able to continue as a going concern may cause others to choose not
to deal with us due to concerns about our ability to meet our
contractual obligations.
We have prepared our consolidated financial statements on a going
concern basis, which contemplates the realization of assets and the
satisfaction of liabilities and commitments in the normal course of
business. Our consolidated financial statements included in this
Report do not include any adjustments to reflect the possible
inability to continue as a going concern within one year after the
date of the filing of this Report. If we are unable to continue as
a going concern, you could lose all or part of your
investment.
We maintain the majority of our cash and cash equivalents in
accounts with primarily SVB, and our deposits at SVB exceed insured
limits. Recently, we have worked closely with SVB during its
announced March 2023 reconstitution as a FDIC bridge bank and its
sale to First Citizens Bank & Trust Company. SVB has publicly
confirmed that its depositors will have access to their funds in
this process and we have also recently completed an amendment to
our Third Amended and Restated Loan and Security Agreement in order
to have SVB waive certain events of default, defer payments and
improve our access to borrowing on our line of credit. While we
anticipate that SVB shall continue to operate as a division of
First Citizens, there could be risks in this transition. In the
event of failure of any of the financial institutions where we
maintain our cash and cash equivalents, there can be no assurance
that we would be able to access uninsured funds in a timely manner
or at all. Any inability to access or delay in accessing these
funds could adversely affect our business and financial
position.
We will still need additional funding to fund our operations, but
additional funds may not be available to us on acceptable terms on
a timely basis, if at all. We may seek funds through borrowings or
through additional rounds of financing, including private or public
equity or debt offerings, or by other means. Our future capital
requirements will depend on many factors, including:
•the
timing, receipt and amount of sales from our current and future
products and services;
•the
cost of manufacturing, either ourselves or through third party
manufacturers, our products and services;
•the
cost and timing of expanding our sales, marketing and distribution
capabilities;
•the
terms and timing of any other partnership, licensing and other
arrangements that we may establish;
•the
costs and timing of securing regulatory approvals or
certifications;
•any
product liability or other lawsuits related to our current or
future products and services;
•the
expenses needed to attract, hire and retain skilled
personnel;
•the
costs associated with being a public company;
•the
duration and severity of the COVID-19 pandemic and its impact on
our business and financial markets generally;
•costs
associated with any adverse market conditions or other
macroeconomic factors;
•the
costs involved in preparing, filing, prosecuting, maintaining,
defending and enforcing our intellectual property portfolio;
and
•the
extent to which we acquire or invest in businesses, products or
technologies.
Additional funds may not be available to us on acceptable terms on
a timely basis, if at all.
If we raise additional funds through further issuances of equity or
convertible debt securities, our existing stockholders could suffer
significant dilution, and any new equity securities we issue could
have rights, preferences, and privileges superior to those of
holders of our common stock. If we are unable to obtain adequate
financing or financing on terms satisfactory to us, when we require
it, our ability to continue to pursue our business objectives and
to respond to business opportunities, challenges, or unforeseen
circumstances could be significantly limited, and our business,
financial condition and results of operations could be materially
adversely affected. We also could be required to seek funds through
arrangements with partners or others that may require us to
relinquish rights or jointly own some aspects of our technologies,
products or services that we would otherwise pursue on our
own.
We ceased distribution of the Smart Sock in the U.S. in October
2021 following receipt of a Warning Letter from the FDA, and we
will not be able to market and sell the Smart Sock with the same
features and claims unless and until we receive marketing
authorization from the FDA. Moreover, although we launched a new
product called the Dream Sock in the U.S. without the notification
features that were the subject of the Warning Letter, the FDA
asserted that the Dream Sock has certain features that classify it
as a medical device that requires FDA marketing
authorization.
On October 1, 2021, we received a Warning Letter from the FDA in
which the FDA asserted that the Smart Sock is a medical device
requiring marketing authorization from the FDA due to its marketing
and functionality in measuring blood oxygen saturation and pulse
rate, and providing an alarm to notify users that these
measurements are outside of preset values. Prior to receipt
of the Warning Letter, we were dependent on sales of the Smart Sock
in the U.S. for a majority of our revenue and expected to continue
to be dependent for the foreseeable future. Following receipt of
the Warning Letter, we ceased distribution of the Smart Sock in the
U.S., and we have been in communications with the FDA regarding our
plans to pursue marketing authorization for the notification
features that were the subject of the Warning Letter.
Although the FDA has not requested or required that we recall Smart
Sock products that had already been distributed prior to our
decision to cease distribution, we cannot assure you that the FDA’s
position regarding a recall will not or cannot change. Any such
recall could have a material adverse effect on our business,
financial condition and results of operations.
We may not be successful in our efforts to obtain marketing
authorization from the FDA for the features of the Smart Sock that
the FDA has asserted are medical device features requiring
marketing authorization, and even if we do, it may take
significantly longer than we anticipate. The FDA marketing
authorization process can be expensive, lengthy and uncertain. For
example, the process of pursuing and obtaining clearance of a
premarket notification under Section 510(k) of the FDCA, also known
as a 510(k) clearance, usually takes from three to 12 months, but
can take longer. The process of obtaining marketing authorization
via a de novo classification can be more costly and uncertain than
the 510(k) clearance process and can often take over a year from
the time the application is submitted to the FDA. Despite the time,
effort and cost, a device may not obtain marketing authorization by
the FDA. Any delay or failure to obtain necessary regulatory
marketing authorizations would harm our business. Furthermore, even
if we are granted such marketing authorization, it may include
significant limitations on the uses, which may limit the potential
commercial market for the device.
Although we have ceased distribution of the Smart Sock in the
United States, we have launched and are marketing a new product,
the Dream Sock, which we did not believe would be regulated by the
FDA as a medical device based on the device's functionality and
claims, including that the device does not have the Smart Sock’s
notification features. The FDA informed us that the FDA believes
that although sleep quality and tracking functions for healthy
infants within the Dream Sock are not device functions, certain
features of the Dream Sock – namely its display of pulse rate and
blood oxygen saturation, even without any notifications or alarms
when those measures fall outside preset values – are medical device
features requiring marketing authorization. We advised the FDA of
our plan to submit a de novo classification request for marketing
authorization with respect to the Dream Sock’s heart rate and
oxygen displays, along with certain new features not currently
offered for the Dream Sock (namely, notifications or alarms when
these measures fall outside of preset values) and we submitted this
application in December 2022. The FDA indicated to us that it does
not anticipate the need for enforcement action pending a decision
on the marketing application, which was submitted timely, provided
that the FDA does not determine that a change in enforcement
approach is appropriate, for reasons such as if new information
changes the FDA’s assessment of the risk or if the marketing
application is deleted or withdrawn by us. Despite our timely
submission, if the FDA changes its enforcement approach to the
Dream Sock or if we are unable to obtain marketing authorization,
we may be required to recall product that has already been
distributed or otherwise cease distribution of or otherwise be
restricted from selling the product as currently designed with
these specific display features until after marketing authorization
from the FDA has been received. We could also be subject to
regulatory enforcement action. In addition, we may be required to
modify the product’s functionality or limit our marketing claims
for the product, whether or not we obtain such marketing
authorization. In any such event, our business could be
substantially harmed.
If any governmental authority or notified body were to require
marketing authorization or similar certification for any product
that we sell, we could be subject to regulatory enforcement actions
and/or be required to cease selling or recall the product pending
receipt of marketing authorization or similar certification from
such other governmental authority or notified body, which can be a
lengthy and time-consuming process, harm financial results and have
long-term negative effects on our operations.
We currently sell the Smart Sock and Dream Sock in certain
countries outside of the U.S., and we have not obtained any medical
device marketing authorization, approval, or certification from any
other governmental authority or notified body. In response to
inquiries from the FDA and regulatory authorities in other
jurisdictions regarding the marketing of the Smart Sock and Dream
Sock, we have communicated our beliefs that such products are not
medical devices that require medical device or similar marketing
authorization or certification from such other regulatory
authorities or notified bodies. However, certain regulatory
authorities have expressed that they do not agree with that
conclusion and in some instances have required us to obtain
marketing authorization, such as a clearance or approval, or other
certification to continue to sell the product.
For example, in addition to our communications with the FDA, the
Medicines and Healthcare products Regulatory Agency (“MHRA”), the
regulatory authority responsible for the United Kingdom (“UK”)
medical device market, has asserted that the Smart Sock requires
certification by a notified body and subsequent registration as a
medical device in the UK, but has indicated it will allow us to
continue to market the Smart Sock in the UK while we are working
towards that certification and registration, as long as we are
progressing on that certification with our notified body and
providing monthly updates to MHRA. Our efforts may be unsuccessful,
and we may not be able to obtain such certification and may not be
able to register the Smart Sock as a medical device, at which point
we would be required to cease marketing the Smart Sock in the UK.
In addition, Owlet has been corresponding with the Medical Devices
Directorate, Canada's medical device regulatory authority within
Health Canada, regarding the device classification requirements of
the Smart Sock and Dream Sock. As a result of these exchanges,
Owlet ceased selling and advertising the Smart Sock in Canada on
December 10, 2021. Currently, the Company is in the process of
exchanging information regarding the Dream Sock, which is being
sold in Canada, for device classification purposes under Canadian
regulation.
Obtaining authorization or certification to sell the Smart Sock or
Dream Sock as medical devices is a time-consuming and costly
process and we may be precluded from selling these products if we
are required to obtain marketing authorization, such as a clearance
or approval, or other certification. If granted, a marketing
authorization or certification could require conditions to sale,
such as a prescription requirement. If regulatory authorities
require such marketing authorization, including clearance or
approval, or other certifications for the products that we sell, we
could be subject to regulatory enforcement action, time-consuming
and costly marketing authorization and certification application
processes, or required to cease selling or to recall the product in
the corresponding jurisdiction pending receipt of such marketing
authorization or certification. We also could be required to modify
the product’s functionality or limit our marketing claims for the
product, whether or not we obtain such marketing authorization or
other required certification. In any such event, our business could
be substantially harmed.
Our products rely on mobile applications to function and we rely on
Apple’s App Store and the Google Play Store for distribution of our
mobile applications.
Our products rely on the installation of our mobile applications to
function properly. We develop mobile applications on Apple’s iOS
platform and Google’s Android platform. Our customers download our
mobile applications on Apple’s App Store and the Google Play Store.
The App Store and Google Play Store are controlled entirely by
Apple and Google, respectively. Mobile applications on the iOS
platform are subject to approval by Apple and mobile applications
on the Android platform are subject to approval by Google. The
terms and policies for maintenance of existing applications and the
approval process of new applications are very broad and subject to
interpretation and frequent changes, and Apple and Google have
complete control over the approval or removal of each mobile
application submitted to or offered on their respective platforms.
If either Apple or Google changes its standard terms and conditions
for maintaining or approving mobile applications in a way that is
detrimental to us or decide to remove our mobile applications from
their stores, it will be much more difficult or may not be possible
for users to install the mobile applications and receive updates to
the mobile applications, and our current or future products may
cease to function as intended. Apple has informed us that it will
remove our mobile applications from the App Store in any country in
which any Owlet product requires marketing authorization or
certification from any governmental authority or notified body. As
a result, we have designed a new mobile application called the
Dream App that is currently available for Dream Sock and Owlet Cam
users in the U.S. on the App Store and Google Play Store. However,
in the event that Apple determines the Dream App implicates the
functionalities and claims that the FDA asserted rendered the Smart
Sock a medical device in the Warning Letter, Apple may remove the
Dream App from the App Store. If Apple removes the Dream App from
the App Store or Google removes the Dream App from the Google Play
Store, our Dream Sock and Dream Duo products would not function as
intended, and we may be required to recall our products, issue
refunds and accept returns, and we may be subject to costly
litigation.
A substantial portion of our sales comes through a limited number
of retailers.
Historically, we have relied on a limited number of retailers for a
substantial portion of our total sales. For example, sales through
our top three retail customers represented 50% of our revenue for
the year ended December 31, 2021 and 46% for the year ended
December 31, 2022. These retailers work with us on a
non-exclusive basis. If we are unable to establish, maintain or
grow these relationships over time, or if these relationships grow
more slowly than we anticipate, we are likely to fail to recover
these costs and our operating results will suffer. The loss of any
significant retail customer, whether or not related to our business
or our products or services, could have an impact on the growth
rate of our revenue as we work to obtain new retail customers or
replacement relationships. Contracts with retailers may typically
be terminated or renegotiated before their term expires for various
reasons, subject to certain conditions. For example, after a
specified period, certain of our contracts are terminable for
convenience by such retailers, subject to a notice period.
Additionally, certain contracts may be terminated immediately by
the retailer if we go bankrupt or if we fail to comply with certain
specified laws. Any renegotiation of the commercial agreements may
result in less favorable economic terms for us. Retailers may also
consolidate their operations, reducing the overall number of
locations in which they sell our products and services.
Historically, we have had retail customers declare bankruptcy and
stop operations, negatively affecting our sales and business. If
regulatory actions such as the Warning Letter we received in
October 2021 regarding the regulatory status of the Smart Sock are
threatened or taken against us or our products, retailers may stop
carrying our products. After this Warning Letter, U.S. retailers
suspended U.S. sales of the Smart Sock and Owlet Monitor Duo. In
response to the Warning Letter, our retail customers have returned
or are returning existing inventory of the Smart Sock and Owlet
Monitor Duo. Such returns have had, and may continue to have, a
material adverse effect on our business, financial condition and
results of operations.
In order to grow our business, we anticipate that we will continue
to depend on our relationships with third parties, including our
retailers. Identifying retailers, and negotiating and documenting
relationships with them, requires significant time and resources.
Our competitors may be effective in providing incentives to third
parties to favor their products or services. If we are unsuccessful
in establishing, or maintaining or strengthening our relationships
with third parties, our ability to compete in the marketplace or to
grow our revenue could be impaired and our results of operations
may suffer. Even if we are successful, these relationships may not
result in increased customer use of our services or increased
revenue.
If our distributors or retail customers experience financial
difficulties due to various factors, we may not be able to collect
our receivables, which could materially or adversely affect our
profitability, cash flows, working capital and business
operations.
The timely collection of our receivables allows us to generate cash
flows, provide working capital and continue our business
operations. Our distributors and retail customers may experience
financial difficulties for a number of reasons, such as
macroeconomic or volatile market conditions, which could impact a
distributor’s or retailer’s financial condition or cause its delay
or failure to pay us. This could result in longer payment cycles,
delay or default in payment or increased credit risk, which, in
turn, could cause our cash collections to decrease and allowance
for doubtful accounts to increase. While we may resort to
alternative collection remedies or other methods to pursue claims
with respect to receivables, these alternatives are expensive and
time consuming, and successful collection is not guaranteed.
Failure to collect our receivables or prevail on related claims
could adversely affect our profitability, cash flows, working
capital and business operations.
We are subject to risks associated with our distributors’ and
retailers’ Owlet product inventories and sell-through to end
consumers, which could adversely affect our revenues and results of
operations.
Our distributors and retail customers typically stock and maintain
their own inventories of Owlet products and sell a large portion of
those products through to our end consumers. Substantially all of
our revenues in 2022 were derived from product sales, and we
recognize revenue when control of goods and services is transferred
to customers, such as upon product shipment to our distributors and
retailers.
In a given period, if these distributors and retailers are unable
to sell an adequate amount of their Owlet product inventories, or
if they decide to decrease or become unwilling to manage or sell
their Owlet product inventories for any reason, our sales to and
through these third parties could decline, which could result in
lower sales volume or increased sales returns, excess inventory or
inventory write-offs. Various factors could impact their ability or
desire to sell their Owlet product inventories through to end
consumers, including but not limited to economic conditions or
downturns, pricing discounts or credits, marketing and promotion,
customer incentives or other business arrangements. In addition,
any deterioration in the financial condition of our distributors
and retail customers could adversely impact the flow of our
products to our consumers and thus our revenues and results of
operations.
We currently rely on a single manufacturer for the assembly of our
Smart Sock and Dream Sock products and a single manufacturer for
the assembly of our Owlet Cam. We will likely rely on single
manufacturers for future products we may develop. If we encounter
manufacturing problems or delays, we may be unable to promptly
transition to alternative manufacturers and our ability to generate
revenue will be limited.
We have no manufacturing capabilities of our own. We currently rely
on a single manufacturer located in Thailand, Benchmark, for the
manufacture of our Owlet Sock products. Additionally, we currently
rely on a separate single manufacturer located in China, Shenzhen
Aoni Electronic, for the manufacture of our Owlet Cam. We expect to
rely on limited manufacturers for future products we may develop.
For example, we have relied upon and expect to continue to rely
upon a single manufacturer for the supply of the Owlet Band, a
product that we are developing and may commercially launch in the
future. For us to be successful, our contract manufacturers must be
able to provide us with products in substantial quantities, in
compliance with regulatory requirements, in accordance with agreed
upon specifications, at acceptable costs and on a timely basis.
While our existing manufacturers have generally met our demand
requirements on a timely basis in the past, their ability and
willingness to continue to do so going forward may be limited for
several reasons, including our relative importance as a customer of
each manufacturer or their respective ability to provide assembly
services to manufacture our products, which may be affected by the
COVID-19 pandemic or other natural or man-made disasters.
Earthquakes are of particular significance since our headquarters
are located in an earthquake-prone area. We are also vulnerable to
damage from other types of disasters, including power loss, attacks
from extremist or terrorist organizations, epidemics, communication
failures, fire, floods and similar events. Furthermore, our
manufacturing agreements can be terminated by our contract
manufacturers without cause by giving us prior notice of six months
or less. The facilities and the manufacturing equipment used to
produce our products would be difficult to replace and could
require substantial time to repair if significant damage were to
result from any of these occurrences. An interruption in our
commercial operations could occur if we encounter delays or
difficulties in securing these manufactured products for any reason
and we cannot obtain an acceptable substitute.
Any transition to a new contract manufacturer, or any transition of
products between existing manufacturers, could be time-consuming
and expensive, may result in interruptions in our operations and
product delivery, could affect the performance specifications of
our products, could require that we modify the design of our
products, or could require clearance, approval by the FDA, or
similar clearances, approvals, or certifications from foreign
regulatory authorities or notified bodies, depending on the nature
of the product and the changes associated with the transition to
the new manufacturer. If we are required to change a contract
manufacturer, we will be required to verify that the new
manufacturer maintains facilities, procedures and operations that
comply with our quality standards and applicable regulatory
requirements, which could further impede our ability to manufacture
our products in a timely manner. We may not be able to identify and
engage alternative contract manufacturers on similar terms or
without delay. Furthermore, our contract manufacturers could
require us to move to a different production facility. The
occurrence of any of these events could harm our ability to meet
the demand for our products in a timely and cost-effective manner,
which could have a material adverse effect on our business,
financial condition and results of operations.
The manufacture of our products is complex and requires the
integration of a number of components from several sources of
supply. Our contract manufacturers must manufacture and assemble
these complex products in commercial quantities in compliance with
regulatory requirements and at an acceptable cost. Our products
require significant expertise to manufacture, and our contract
manufacturers may encounter difficulties in scaling up production
of our products, including problems with quality control and
assurance, component supply shortages, increased costs, shortages
of qualified personnel, the long lead time required to develop
additional facilities for purposes of testing our products or
difficulties associated with compliance with local, state, federal
and foreign regulatory requirements. Manufacturing or quality
control problems may arise in connection with the scale-up of the
manufacture of our products. If we are unable to obtain a
sufficient supply of product, maintain control over product quality
and cost or otherwise adapt to anticipated growth, or if we
underestimate growth, we may not have the capability to satisfy
market demand, and our business and reputation in the marketplace
will suffer. Conversely, if demand for our products decreases, we
may have excess inventory, which could result in inventory
write-offs that would have a material adverse effect on our
business, financial condition and results of operations. We may
also encounter defects in materials or workmanship, which could
lead to a failure to adhere to regulatory requirements. Any defects
could delay operations at our contract manufacturers’ facilities,
lead to regulatory fines or halt or discontinue manufacturing
indefinitely. Any of these outcomes could have a material adverse
effect on our business, financial condition and results of
operations.
If we are unable to obtain key materials and components from sole
or limited source suppliers, we will not be able to deliver our
products to customers.
We are currently devoting substantial resources to the development
of new or advanced products and services. However, we may not be
able to complete development on a timely basis, or at all. In
addition, some of our products and products in development may be
regulated by the FDA or foreign regulatory agencies as medical
devices, which
may require marketing authorization or similar certification from
applicable regulatory authorities or notified bodies, including
marketing authorization from the FDA, prior to commercialization.
Our products and services, particularly those needing to meet FDA
or other regulatory standards, may have higher manufacturing costs
than legacy products and services, which could negatively impact
our gross margins and operating results during these stages,
without guarantees we will be able to successfully commercialize
any such products.
If we successfully develop such products and services, we must
still successfully manage their introductions to the market.
Products and services that are not well-received by the market may
lead to excess inventory and discounting of our existing products
and services. Inventory levels in excess of consumer demand may
result in inventory write-downs or write-offs and the sale of
inventory at discounted prices may affect our gross margin and
could impair the strength of our brand. Reserves and write-downs
for rebates, promotions and excess inventory are recorded based on
our forecast of future demand. Actual future demand could be less
than our forecast, which may result in additional reserves and
write-downs in the future, or actual demand could be stronger than
our forecast, which may result in increased shipping costs and a
reduction to previously recorded reserves and write-downs in the
future and increase the volatility of our operating
results.
Introductions of new or advanced products and services could also
adversely impact the sales of our existing products and services to
consumers. For instance, the introduction or announcement of new or
advanced products and services may shorten the life cycle of our
existing products or reduce demand, thereby reducing any benefits
of successful product or service introductions and potentially
leading to challenges in managing write-downs or write-offs of
inventory of existing products and services.
We have in the past experienced challenges managing the inventory
of our products, which has led and may in the future lead to
increased shipping costs for air freight in order to fulfill
customer orders in a timely manner, which has affected our gross
margin.
Adapting our production capacities to evolving patterns of demand
is expensive, time-consuming and subject to significant
uncertainties. We may not be able to adequately predict consumer
trends and may be unable to adjust our production in a timely
manner.
We market our products directly to consumers in the U.S. and a
select number of international countries. If demand increases, we
will be required to increase production proportionally. Adapting to
changes in demand inherently lags behind the actual changes because
it takes time to identify the change the market is undergoing and
to implement any measures taken as a result. Finally, capacity
adjustments are inherently risky because there is imperfect
information, and market trends may rapidly intensify, ebb or even
reverse. We have in the past not always been, and may in the future
not be, able to accurately or timely predict trends in demand and
consumer behavior or to take appropriate measures to mitigate risks
and exploit opportunities resulting from such trends. Any inability
in the future to identify or to adequately and effectively react to
changes in demand could have a material adverse effect on our
business, financial condition and results of
operations.
Some of our products and services are in development or have been
recently introduced into the market and may not achieve market
acceptance, which could limit our growth and adversely affect our
business, financial condition and results of
operations.
Our portfolio of products and services continues to expand, and we
are investing significant resources to enter into, and in some
cases create, new markets for these products and services. We are
continuing to invest in sales and marketing resources to achieve
market acceptance of these products and services, but our
technologies may not achieve general market acceptance. New
products and services, such as the Dream Sock, may also fail to
achieve the market acceptance that our existing products and
services, such as the Smart Sock, have historically
achieved.
The degree of market acceptance of these products and services will
depend on a number of factors, including:
•perceived
benefits from and safety of our products and services;
•perceived
cost effectiveness of our products and services;
•our
ability to obtain any required marketing authorizations or
certifications for our products and services and the label
requirements of any marketing authorizations or certifications we
may obtain;
•coverage
and reimbursement available through government and private
healthcare programs for using some of our products and services;
and
•introduction
and acceptance of competing products and services or
technologies.
If our products and services do not gain market acceptance or if
our customers prefer our competitors’ products and services, our
potential revenue growth would be limited, which would adversely
affect our business, financial condition and results of
operations.
If we are unable to successfully develop and effectively manage the
introduction of new products and services, our business may be
adversely affected.
We must successfully manage introductions of new or advanced
products, such as the BabySat and our Dream Sock with Health
Notifications, and services, such as the development of our
software platform. Development of new products and services
requires the expenditure of considerable time and resources, but we
may not be able to successfully develop and introduce such products
on a timely basis, or at all. Products and services that are not
well-received by the market may lead to excess inventory and
discounting of our existing products and services. Inventory levels
in excess of consumer demand may result in inventory write-downs or
write-offs and the sale of inventory at discounted prices, may
affect our gross margin and could impair the strength of our brand.
Reserves and write-downs for rebates, promotions and excess
inventory are recorded based on our forecast of future demand.
Actual future demand could be less than our forecast, which may
result in additional reserves and write-downs in the future, or
actual demand could be stronger than our forecast, which may result
in increased shipping costs and a reduction to previously recorded
reserves and write-downs in the future and increase the volatility
of our operating results.
Introductions of new or advanced products and services could also
adversely impact the sales of our existing products and services to
consumers. For instance, the introduction or announcement of new or
advanced products and services may shorten the life cycle of our
existing products or reduce demand, thereby reducing any benefits
of successful product or service introductions and potentially
leading to challenges in managing write-downs or write-offs of
inventory of existing products and services. In addition, some of
our products are regulated by the FDA or foreign regulatory
agencies as medical devices, which will require marketing
authorization from the FDA or similar marketing authorization or
certification from other applicable regulatory authorities or
notified bodies prior to commercialization. New products,
particularly those products needing to meet FDA or other regulatory
requirements, may have higher manufacturing costs than legacy
products, which could negatively impact our gross margins and
operating results. Accordingly, if we fail to effectively manage
introductions of new or advanced products and services, our
business may be adversely affected.
We have in the past experienced challenges managing the inventory
of our products, which has led and may in the future lead to
increased shipping costs for air freight in order to fulfill
customer orders in a timely manner, which has affected our gross
margin and could impair the strength of our brand.
The size and expected growth of our addressable market has not been
established with precision and may be smaller than we
estimate.
Our estimates of the addressable market for our current products
and services and future products and services are based on a number
of internal and third-party estimates and assumptions, including
birth rate, income levels and demographic profiles. While we
believe our assumptions and the data underlying our estimates are
reasonable, these assumptions and estimates may not be correct. In
addition, the statements in this
Report
relating to, among other things, the expected growth in the market
for baby products and services are based on a number of internal
and third-party estimates and assumptions and may prove to be
inaccurate. For example, although we expect that the number of
births will continue to increase, those trends could shift and the
number of births could decrease. Furthermore, even if the birth
rate increases as we expect, technological or medical advances
could provide alternatives to our products and services and reduce
demand. As a result, our estimates of the addressable market for
our current or future products and services may prove to be
incorrect. If the actual number of consumers who would benefit from
our products and services, the price at which we can sell future
products and services or the addressable market for our products
and services is smaller than we estimate, it could have a material
adverse effect on our business, financial condition and results of
operations.
We spend significant amounts on advertising and other marketing
campaigns to acquire new customers, which may not be successful or
cost effective.
We market our products and services through a mix of digital and
traditional marketing channels. These include paid search, digital
display advertising, email marketing, affiliate marketing, and
select print advertising. We also leverage our database of
prospects and customers to further drive customer acquisition and
referrals. We spend significant amounts on advertising and other
marketing campaigns to acquire new customers, and we expect our
marketing expenses to increase in the future as we continue to
spend significant amounts to acquire new customers and increase
awareness of our products and services. While we seek to structure
our marketing campaigns in the manner that we believe is most
likely to encourage consumers to use our products and services, we
may fail to identify marketing opportunities that satisfy our
anticipated return on marketing spend as we scale our investments
in marketing, accurately predict customer acquisition, or fully
understand or estimate the conditions and behaviors that drive
consumer behavior. Further, state, federal and foreign laws and
regulations governing the privacy and security of personal
information are evolving rapidly and could impact our ability to
identify and market to potential
and existing customers. If federal, state, local or foreign laws
governing our marketing activities become more restrictive or are
interpreted by governmental authorities to prohibit or limit these
activities, our ability to attract new customers and retain
customers would be affected and our business could be materially
harmed. In addition, any failure, or perceived failure, by us, to
comply with any federal, state, or foreign laws or regulations
governing our marketing activities could adversely affect our
reputation, brand, and business, and may result in claims,
proceedings, or actions against us by governmental entities,
consumers, suppliers or others or other liabilities or may require
us to change our operations and/or cease using certain marketing
strategies. If any of our marketing campaigns prove less successful
than anticipated in attracting new customers, we may not be able to
adequately recover our marketing spend, and our rate of customer
acquisition may fail to meet market expectations, either of which
could have a material adverse effect on our business, financial
condition and results of operations. Our marketing efforts may not
result in increased sales of our products and
services.
Further, web and mobile browser developers, such as Apple,
Microsoft or Google, have implemented and may continue to implement
changes, including requiring additional user permissions, in their
browser or device operating system that impair our ability to
measure and improve the effectiveness of advertising of our
products and services. Such changes include limiting the use of
first-party and third-party cookies and related tracking
technologies, such as mobile advertising identifiers, and other
changes that limit our ability to collect information that allows
us to attribute consumer actions on advertisers’ websites to the
effectiveness of advertising campaigns run by us. For example,
Apple launched its Intelligent Tracking Prevention (“ITP”) feature
in its Safari browser. ITP blocks some or all third-party cookies
by default on mobile and desktop and ITP has become increasingly
restrictive over time. Apple’s related Privacy-Preserving Ad Click
attribution, intended to preserve some of the functionality lost
with ITP, would limit cross-site and cross-device attribution,
prevent measurement outside a narrowly-defined attribution window,
and prevent ad re-targeting and optimization. Similarly, Google
recently announced that it plans to stop supporting third-party
cookies in its Google Chrome browser. Google has also put forth a
new initiative called the Privacy Sandbox, which is meant to
curtail improper tracking while continuing to allow ad targeting
within Google Chrome. Under Google’s Privacy Sandbox initiative,
cookies will be replaced by five browser application programming
interfaces (“APIs”) that will allow advertisers to receive
aggregated data without using cookies. Google Privacy Sandbox is
still being developed, but if it is adopted, could require us to
make changes to how we collect information on our consumers and our
marketing activities. Further, Apple announced certain changes,
including introducing an AppTrackingTransparency framework that
will limit the ability of mobile applications to request an iOS
device’s advertising identifier and may also affect our ability to
track consumer actions.
In addition, we believe that building a strong brand and developing
and achieving broad awareness of our brand is critical to achieving
market success. If any of our brand-building activities prove less
successful than anticipated in attracting new customers, we may not
be able to recover our brand-building spend, and our rate of
customer acquisition may fail to meet market expectations, either
of which could have a material adverse effect on our business,
financial condition and results of operations. There can be no
assurance that our brand-building efforts will result in increased
sales of our products and services.
If we are unable to continue to drive consumers to our website, it
could adversely affect our revenue.
Many consumers find our website, www.owletcare.com by searching for
baby products and services through internet search engines or from
word-of-mouth and personal recommendations. A critical factor in
attracting visitors to our website is how prominently we are
displayed in response to search queries. Accordingly, we use search
engine marketing as a means to provide a significant portion of our
customer acquisition. Search engine marketing includes both paid
website visitor acquisition on a cost-per-click basis and visitor
acquisition on an unpaid basis, often referred to as organic or
algorithmic search.
One method we employ to acquire visitors via organic search is
commonly known as search engine optimization (“SEO”). SEO involves
developing our website in a way that enables the website to rank
high for search queries for which our website’s content may be
relevant. We also rely heavily on favorable recommendations from
our existing customers to help drive traffic to our website. If our
website is listed less prominently or fails to appear in search
result listings for any reason, it is likely that we will attract
fewer visitors to our website, which could adversely affect our
revenue.
Our success depends substantially on our reputation and
brand.
Our success is dependent in large part upon our ability to maintain
and enhance our reputation and brand. Brand value can be severely
damaged even by isolated incidents, particularly if the incidents
receive considerable negative publicity or result in litigation.
Some of these incidents may relate to actions taken (or not taken)
with respect to social, environmental, and community outreach
initiatives, the personal conduct of individuals actually, or
perceived to be associated, with our brand, and our growth or
rebranding strategies. We are heavily dependent on
customers
who use our products and services, in particular our Smart Sock, to
provide good reviews and word-of-mouth recommendations to
contribute to the growth of our brand and reputation. Customers who
are dissatisfied with their experiences with our products and
services or services may post negative reviews. We may also be the
subject of blog, forum or other media postings that include
statements that create negative publicity. If the FDA or other
regulatory body makes public its determination that any of our
products is a medical device that is not in compliance with
applicable requirements, such as occurred in the FDA’s October 1,
2021 Warning Letter with respect to the Smart Sock, or takes some
other public action such as issuing a public enforcement action or
recommending or mandating a recall, customers may react negatively
and stop purchasing or recommending our products or services, or
may demand refunds. Any negative reviews or publicity, whether real
or perceived, disseminated by word-of-mouth, by the general media,
by electronic or social networking means or by other methods, could
harm our reputation and brand and could severely diminish consumer
confidence in our products and services.
Operations in international markets will expose us to additional
business, political, regulatory, operational, financial and
economic risks.
Further expanding our business to attract customers in countries
other than the U.S. is a key element of our long-term business
strategy. International operations expose us and our
representatives, agents and distributors to risks inherent in
operating in foreign jurisdictions, and such exposure will increase
as our international presence and activities increase. These risks
include:
•the
imposition of additional U.S. and foreign governmental controls or
regulations;
•the
imposition of costly and lengthy new export licensing
requirements;
•the
imposition of requirements to maintain data and the processing of
that data on servers located within the U.S. or in foreign
countries;
•a
shortage of high-quality employees, sales people and
distributors;
•the
loss of any key personnel that possess proprietary knowledge, or
who are otherwise important to our success in certain international
markets;
•changes
in duties and tariffs, license obligations and other non-tariff
barriers to trade;
•the
imposition of new trade restrictions;
•the
imposition of restrictions on the activities of foreign agents,
representatives and distributors;
•compliance
with or changes in foreign tax laws, regulations and requirements
and economic and trade sanctions programs including, for example,
the U.S., UK and EU sanctions relating to the Russian Federation,
Ukraine and the Republic of Belarus initially implemented in
February 2022;
•evolution
in regulatory landscapes, such as on account of the UK leaving the
EU, and uncertainties that arise from such evolution;
•pricing
pressure;
•changes
in foreign currency exchange rates;
•laws
and business practices favoring local companies;
•political
instability and actual or anticipated military or political
conflicts;
•financial
and civil unrest worldwide;
•outbreaks
of illnesses, pandemics or other local or global health
issues;
•natural
or man-made disasters;
•the
inability to collect amounts paid by foreign government customers
to our appointed foreign agents;
•longer
payment cycles, increased credit risk and different collection
remedies with respect to receivables; and
•difficulties
in enforcing or defending intellectual property
rights.
In addition, we purchase a portion of our raw materials and
components from international sources. The sale and shipment of our
products and services across international borders, as well as the
purchase of materials and components from international sources,
subject us to extensive U.S. and foreign governmental trade
regulations, including those related to conflict minerals.
Compliance with such regulations is costly and we could be exposed
to potentially significant penalties if we are found not to be in
compliance with such regulations. Any failure to comply with
applicable legal and regulatory obligations could impact us in a
variety of ways that include, but are not limited to, significant
criminal, civil and administrative penalties, including
imprisonment of individuals, fines and penalties, denial of export
privileges, seizure of shipments, restrictions on certain business
activities, and exclusion
or debarment from government contracting. Also, the failure to
comply with applicable legal and regulatory obligations could
result in the disruption of our shipping, manufacturing and sales
activities. Any material decrease in our international sales would
adversely affect our business, financial condition and results of
operations.
We face and expect to face increasing competition from other
companies, many of which have substantially greater resources than
we do. If we do not successfully develop and commercialize enhanced
or new products and services that remain competitive with products
and services or alternative technologies developed by others, we
could lose revenue opportunities and customers, and our ability to
grow our business would be impaired, adversely affecting our
financial condition and results of operations.
We expect the industry in which we operate will continue to evolve
and may be significantly affected by new product introductions and
other market activities of industry participants. Certain potential
competitors have substantially greater capital resources, larger
product portfolios, larger user bases, larger sales forces and
greater geographic presence, and have built relationships with
retailers and distributors that may be more effective than ours.
Our products and services face additional competition from
companies developing products and services for use with third-party
monitoring systems, as well as from companies that currently market
similar products and services of their own and may face further
pressure from technology companies that have not historically
operated in our industry.
Continuing technological advances and new product introductions
within the home-use childcare electronics and service industry
place our products and services at risk of obsolescence. Our
long-term success depends upon the development and successful
commercialization of new products and services, new or improved
technologies and additional applications for our existing
technologies, including products or applications that may be
subject to the oversight of the FDA or comparable foreign
regulatory authorities and could require marketing authorization by
the FDA or similar marketing authorization or certification from
comparable foreign regulatory authorities or notified bodies. The
research and development process is time-consuming and costly and
may not result in products and services or applications that we can
successfully commercialize.
If we do not successfully adapt our products and services and
applications, we could lose revenue opportunities and customers.
Furthermore, in the event any of our products is regulated as a
medical device and obtains marketing authorization from the FDA or
similar marketing authorization or certification from comparable
foreign regulatory authorities or notified bodies, one or more of
our competitors may develop products that compete. For example, in
the U.S., if any of our products is regulated as a medical device
that is subject to and that obtains marketing authorization
pursuant to the 510(k) clearance or
de novo
classification pathways, competitors may develop products that the
FDA determines are substantially equivalent to our products and may
use our products as predicate devices to obtain 510(k) clearances
for their competing products.
Global health developments and economic uncertainty resulting from
COVID-19 have adversely impacted, and may continue to adversely
impact, our business, results of operations, cash flows and
financial position.
Our operations, revenues and overall financial condition have been,
and may continue to be, negatively impacted by the fear of exposure
to or actual effects of the COVID-19 pandemic, or by reactions of
the private sector, governments and the public in an effort to
contain the spread of COVID-19 or variants of COVID-19 or address
its impacts. This includes, but is not limited to, disruption of
global financial markets, a recession or market correction,
unemployment rates, disruption to global supply chains, facilities
closures and production suspensions.
The extent to which these events may continue to impact our
business, financial condition, cash flows and results of operations
will depend on factors beyond our knowledge or control, including
the duration and severity of any outbreak of COVID-19 and any
variant strains thereof, as well as third-party or governmental
actions taken to contain its spread and mitigate its public health
effects.
The overall economic impact brought by and the duration of the
COVID-19 pandemic has resulted in, and may continue to result in,
significant disruption of global financial markets, affecting our
ability to access capital, which could in the future negatively
affect our liquidity. In addition, a recession or market correction
resulting from the any outbreaks of COVID-19 or variants thereof
could materially affect our business and the value of our common
stock. The COVID-19 pandemic has also resulted in a significant
increase in unemployment in the U.S. which may continue even after
the pandemic subsides. The occurrence of any such events may lead
to reduced disposable income which could adversely affect the
number of our products and services sold after the pandemic has
subsided.
We are involved, and may become involved in the future, in disputes
and other legal or regulatory proceedings that, if adversely
decided or settled, could materially and adversely affect our
business, financial condition and results of
operations.
We are, and may in the future become, party to litigation,
regulatory proceedings or other disputes. In general, claims made
by or against us in disputes and other legal or regulatory
proceedings can be expensive and time-consuming to bring or defend
against, requiring us to expend significant resources and divert
the efforts and attention of our management and other personnel
from our business operations. These potential claims may include
but are not limited to personal injury and class action lawsuits,
intellectual property claims and regulatory investigations relating
to the advertising and promotional claims about our products and
services and employee claims against us based on, among other
things, discrimination, harassment or wrongful termination. Any one
of these claims, even those without merit, may divert our financial
and management resources that would otherwise be used to benefit
the future performance of our operations. Any adverse determination
against us in these proceedings, or even the allegations contained
in the claims, regardless of whether they are ultimately found to
be without merit, may also result in settlements, injunctions or
damages that could have a material adverse effect on our business,
financial condition and results of operations.
Additionally, in the past, securities class action litigation has
often been brought against a company following a decline in the
market price of its securities. In November 2021, we and certain of
our executive officers and directors were named as defendants in
two pending purported securities class action lawsuits. The
complaints were filed on behalf of all investors who: (a) purchased
the Company’s common stock between March 31, 2021 and October 4,
2021; or (b) held common stock in SBG as of June 1, 2021, and were
eligible to vote in the Special Meeting held on July 14, 2021. The
complaints alleged that we and certain executive officers and
directors made false and/or misleading statements and failed to
disclose certain information regarding the FDA’s likely
classification of the Smart Sock as a medical device requiring
marketing authorization. These lawsuits and any future lawsuits to
which we may become a party are subject to inherent uncertainties
and will likely be expensive and time-consuming to investigate,
defend and resolve. Any litigation to which we are a party may
result in an onerous or unfavorable judgment that may not be
reversed upon appeal, or in payments of substantial monetary
damages or fines, or we may decide to settle this or other lawsuits
on similarly unfavorable terms, which could have a material adverse
effect on our business, financial condition, results of operations
or stock price.
Our business and operations may suffer in the event of information
technology system failures, cyberattacks or deficiencies in our
cybersecurity.
We collect and maintain information in digital form that is
necessary to conduct our business, and we are increasingly
dependent on IT systems and infrastructure to operate our business.
In the ordinary course of our business, we collect, store and
transmit large amounts of confidential information, including
intellectual property, proprietary business information and
personal information of customers and our employees and
contractors. However, our IT systems and those of our those of our
users, customers, partners, suppliers and third-party service
providers are vulnerable to attack and damage or interruption from
computer viruses and malware (e.g. ransomware), malicious code,
natural disasters, terrorism, war, telecommunication and electrical
failures, hacking, cyberattacks, phishing attacks and other social
engineering schemes, employee theft or misuse, human error, fraud,
denial or degradation of service attacks, sophisticated
nation-state and nation-state-supported actors or unauthorized
access or use by persons inside our organization, or persons with
access to systems inside our organization. Attacks upon IT systems
are also increasing in their frequency, levels of persistence,
sophistication and intensity, and are being conducted by
sophisticated and organized groups and individuals with a wide
range of motives and expertise. For example, we have been and in
the future may be the target of phishing and other scams and
attacks. We have not always been successful in detecting these
attacks, and while we have not experienced any significant loss or
material expense as a result of these cybersecurity attacks or
other information security breaches, there can be no assurance that
we will not suffer additional attacks or incur material financial
consequences or expense in the future. As a result of the COVID-19
pandemic and the continued hybrid work environment, we may also
face increased cybersecurity risks due to our reliance on internet
technology and the number of our employees who are working
remotely, which may create additional opportunities for
cybercriminals to exploit vulnerabilities.
Cybersecurity attacks in particular are evolving and because the
techniques used to obtain unauthorized access to, or to sabotage,
systems change frequently and often are not recognized until
launched against a target, we may be unable to anticipate these
techniques or implement adequate preventative measures. We may
experience security breaches that may remain undetected for an
extended period. Even if identified, we may be unable to adequately
investigate or remediate incidents or breaches due to attackers
increasingly using tools and techniques that are designed to
circumvent controls, to avoid detection, and to remove or obfuscate
forensic evidence. There can be no assurance that our protective
measures will prevent or detect security breaches that could have a
significant impact on our business, reputation, financial condition
and results of operations.
If such an event were to occur and cause interruptions in our
operations, it could result in a material disruption of our
development programs and our business operations due to a loss of
our trade secrets and confidential information, negative publicity
and damage to our reputation, loss of customers, loss of or delay
in market acceptance of our products and services, loss of
competitive position, loss of revenue or liability for damages or
other similar disruptions. Depending on the nature of the attack, a
successful attack may also bring into question our
internal
control over financial reporting. If a security breach or other
incident were to result in the unauthorized access to or
unauthorized use, disclosure, release or other processing of
personal information, it may be necessary to notify individuals,
governmental authorities, supervisory bodies, the media and other
parties pursuant to privacy and security laws. Any security
compromise affecting us, our customers, partners, suppliers,
third-party service providers or our industry, whether real or
perceived, could harm our reputation, erode confidence in the
effectiveness of our security measures and lead to regulatory
scrutiny. Furthermore, federal, state and international laws and
regulations can expose us to enforcement actions and investigations
by regulatory authorities, and potentially result in regulatory
penalties, fines and significant legal liability, if our
information technology security efforts fail. We may also be
exposed to a risk of loss or litigation and potential liability,
which could materially and adversely affect our business, results
of operations or financial condition.
Our ability to effectively manage and maintain our internal
business information, and to ship products and provide services to
customers and invoice them on a timely basis, depends significantly
on our enterprise resource planning system and other IT systems.
Portions of our IT systems may experience interruptions, delays or
cessations of service or produce errors in connection with ongoing
systems implementation work. In addition, interfaces between our
products and services and our customers’ computer networks could
provide additional opportunities for cybersecurity attacks on us
and our customers. The failure of these systems to operate or
integrate effectively with other internal, customer, supplier or
third-party service provider systems and to protect the underlying
IT system and data integrity, including from cyberattacks,
intrusions or other breaches or unauthorized access of these
systems, or any failure by us to remediate any such attacks or
breaches, may also result in damage to our reputation or
competitiveness, delays in product fulfillment and reduced
efficiency of our operations, and could require significant capital
investments to remediate any such failure, problem or breach, all
of which could adversely affect our business, financial condition
and results of operations. Further, our insurance coverage may not
be sufficient to cover the financial, legal, business or
reputational losses that may result from an interruption or breach
of our systems.
Any disruption of service at our third-party data and call centers
or other cloud infrastructure services could interrupt or delay our
ability to deliver our services to our customers.
Because our products and services are used by caregivers to monitor
infants, it is critical that our products and services be
accessible without interruption or degradation of performance.
Customers may become dissatisfied by any system failure that
interrupts our ability to provide our services to them. Sustained
or repeated system failures would reduce the attractiveness of our
products or services to customers. Moreover, negative publicity
arising from these types of disruptions could damage our reputation
and may adversely impact use of our products and
services.
We currently host our products and services, serve our customers
and support our operations in the U.S. primarily from third-party
data and call centers and other cloud-based services. For example,
we rely on cloud services and bespoke software services provided by
Ayla Networks for our Dream Sock and Smart Sock products to support
the transfer of data to the cloud and back to us and the user.
Additionally, we rely on the data transfer services of ThroughTek
to enable video viewing access for the Owlet Cam. We do not have
control over the operations of the services or the facilities of
any of those providers. These facilities are vulnerable to damage
or interruption from earthquakes, hurricanes, floods, fires, cyber
security attacks, terrorist attacks, power losses,
telecommunications failures and similar events. The occurrence of a
natural disaster or an act of terrorism, a decision to close the
facilities without adequate notice, or other unanticipated problems
could result in lengthy interruptions in our services. The
facilities also could be subject to break-ins, computer viruses,
sabotage, intentional acts of vandalism and other misconduct. We
may not be able to easily switch our cloud operations to another
cloud provider if there are disruptions or interference with such
providers.
None of our third-party cloud-based providers has an obligation to
renew their agreements with us on commercially reasonable terms, or
at all. If we are unable to renew our agreements with these
providers on commercially reasonable terms, if our agreements with
our providers are prematurely terminated, or if in the future we
add additional cloud-based providers, we may experience costs or
downtime in connection with the transfer to, or the addition of,
new providers. If these providers were to increase the cost of
their services, we may have to increase the price of our products
and services, and our operating results may be materially adversely
affected.
We are subject to a number of risks related to the credit extended
by our manufacturing providers.
Our manufacturers extend credit to us and may revoke that credit.
We use that credit to scale operations and increase production of
our products. If our manufacturers revoke our credit, it could
adversely affect our ability to meet demand for our products and
adversely affect our business, financial condition and results of
operations. Given the concentration of our manufacturing providers,
their willingness to provide credit and support our business is
critical for our long-term growth, and losing that credit could
create material adverse impact on our operations.
We are subject to a number of risks related to the credit card and
debit card payments we accept.
We accept payments through credit and debit card transactions. For
credit and debit card payments, we pay interchange and other fees,
which may increase over time. An increase in those fees may require
us to increase the prices we charge and would increase our
operating expenses, either of which could have a material adverse
effect on our business, financial condition and results of
operations.
If we or our processing vendors fail to maintain adequate systems
for the authorization and processing of credit and debit card
transactions, it could cause one or more of the major credit card
companies to disallow our continued use of their payment products.
In addition, if these systems fail to work properly and, as a
result, we do not charge our customers’ credit or debit cards on a
timely basis, or at all, it could have a material adverse effect on
our business, financial condition and results of
operations.
The payment methods that we offer also subject us to potential
fraud and theft by criminals, who are becoming increasingly more
sophisticated in exploiting weaknesses that may exist in the
payment systems. If we fail to comply with applicable rules or
requirements for the payment methods we accept, or if
payment-related data is compromised due to a breach, we may be
liable for significant costs incurred by payment card issuing banks
and other third parties or subject to fines and higher transaction
fees, or our ability to accept or facilitate certain types of
payments may be impaired. In addition, our customers could lose
confidence in certain payment types, which may result in a shift to
other payment types or potential changes to our payment systems
that may result in higher costs. If we fail to adequately control
fraudulent credit card transactions, we may face civil liability,
diminished public perception of our security measures and
significantly higher card-related costs, each of which could have a
material adverse effect on our business, financial condition and
results of operations.
We are also subject to payment card association operating rules,
certification requirements and rules governing electronic funds
transfers, which could change or be reinterpreted to make it more
difficult for us to comply. We are subject to the Payment Card
Industry Data Security Standard (“PCI DSS”) issued by the PCI
Council, which includes guidelines with regard to the security
policies and practices we should adopt regarding the physical and
electronic storage, processing and transmission of cardholder data.
Compliance with the PCI DSS and implementing related procedures,
technology and information security measures requires significant
resources and ongoing attention, and any security incident
involving cardholder data could subject us to significant penalties
and liability. Failure to comply with this standard may violate
payment card association operating rules, federal and state laws
and regulations and the terms of our contracts with payment
processors. Any failure to comply fully also may subject us to
fines, penalties, damages and civil liability, and may result in
the loss of our ability to accept credit and debit card payments.
Further, there is no guarantee that such compliance will prevent
illegal or improper use of our payment systems or the theft, loss
or misuse of data pertaining to credit and debit cards, cardholders
and transactions.
If we are unable to maintain our chargeback rate or refund rates at
acceptable levels, our processing vendor may increase our
transaction fees or terminate its relationship with us. Any
increases in our credit and debit card fees could harm our results
of operations, particularly if we elect not to raise our rates for
our products and services to offset the increase. The termination
of our ability to process payments on any major credit or debit
card would significantly impair our ability to operate our
business.
Our loan and security agreement contains certain covenants and
restrictions that may limit our flexibility in operating our
business and any failure to satisfy those covenants and
restrictions could adversely affect our business and financial
condition.
Our loan and security agreement with Silicon Valley Bank, now a
division of First Citizens Bank & Trust Company, contains
various affirmative and negative covenants and restrictions that
limit our ability to engage in specific types of transactions,
including:
•conveying,
selling, leasing, transferring, or otherwise disposing of certain
assets;
•consolidating,
merging, selling or otherwise disposing of all or substantially all
of our assets or acquiring all or substantially all of the capital
stock or property of another person;
•incurring
specified types of additional indebtedness (including guarantees or
other contingent obligations); and
•paying
dividends on, repurchasing or making distributions in respect of
any capital stock or making other restricted payments, subject to
specified exceptions.
In addition, under the loan and security agreement, we are required
to satisfy and maintain certain financial ratios, including
financial maintenance covenants. A breach of any of these ratios or
covenants, including as a result of events beyond our control,
would result in a default under the loan and security agreement.
Upon the occurrence of an event of default, SVB could elect to
declare all amounts outstanding under the loan and security
agreement immediately due and payable, terminate all commitments to
extend further credit and pursue legal remedies for recovery, all
of which could adversely affect our business and financial
condition. While as of March 27, 2023, we
were able to amend our existing debt and line of credit held SVB to
have SVB waive certain stated events of default under that
agreement and expand our access to capital, we cannot assure that
in the future we will always be able to satisfy and maintain all
bank covenants. As of December 31, 2022, $8.0 million in
aggregate principal amount was outstanding under the loan. See Part
II. Item 8. "Financial Statements and Supplementary Data - Note 7,"
included in this
Report.
Changes in tax laws may impact our future financial position and
results of operations.
New income, sales, use or other tax laws, statutes, rules,
regulations or ordinances could be enacted at any time, or
interpreted, changed, modified or applied adversely to us, any of
which could adversely affect our business operations and financial
performance. For example, the U.S. government may enact significant
changes to the taxation of business entities including, among
others, an increase in the corporate income tax rate, an increase
in the tax rate applicable to the global intangible low-taxed
income and elimination of certain exemptions, and the imposition of
minimum taxes or surtaxes on certain types of income. No specific
U.S. tax legislation has been proposed at this time and the
likelihood of these changes being enacted or implemented is
unclear. We are currently unable to predict whether such changes
will occur and, if so, the ultimate impact on our business. To the
extent that such changes have a negative impact on us, our
suppliers or our customers, including as a result of related
uncertainty, these changes may materially and adversely affect our
business, financial condition, results of operations and cash
flows.
In addition, as we expand our business internationally, the
application and implementation of existing, new or future
international laws regarding indirect taxes (such as a Value Added
Tax) could materially and adversely affect our business, financial
condition and results of operations.
The applicability of sales, use and other tax laws or regulations
on our business is uncertain. Adverse tax laws or regulations could
be enacted or existing laws could be applied to us or our
customers, which could subject us to additional tax liabilities and
related interest and penalties, increase the costs of our products
and adversely impact our business.
State, local and foreign tax jurisdictions have differing rules and
regulations governing sales, use, value-added and other taxes, and
these rules and regulations can be complex and are subject to
varying interpretations that may change over time. Existing tax
laws, statutes, rules, regulations, or ordinances could be
interpreted, changed, modified, or applied adversely to us
(possibly with retroactive effect).
One or more states, countries or other jurisdictions may seek to
impose sales, use, value added or other tax collection obligations
on us, including for past sales. A successful assertion by a state,
country or other jurisdiction that we should have been or should be
collecting additional sales, use, value added or other taxes on our
products could, among other things, result in substantial tax
liabilities for past sales, create significant administrative
burdens for us, or otherwise harm our business, results of
operations, and financial condition.
Our ability to use our net operating loss carryforwards and certain
other tax attributes may be limited.
We have incurred substantial net operating losses (“NOLs”) since
inception, and we may not achieve profitability in the future. U.S.
federal and certain state NOLs generated in taxable years beginning
after December 31, 2017 are not subject to expiration. U.S. federal
NOLs generally may not be carried back to prior taxable years
except that, under the Coronavirus Aid, Relief and Economic
Security Act (the "CARES Act"), U.S. federal NOLs generated in
2018, 2019 and 2020 may be carried back to each of the five taxable
years preceding the taxable year in which the loss arises.
Additionally, for taxable years beginning after December 31, 2020,
the deductibility of U.S. federal NOLs is limited to 80% of our
taxable income in such taxable year. NOLs generated in tax years
before 2018 may still be used to offset future taxable income
without regard to the 80% limitation, although they have the
potential to expire without being utilized if we do not achieve
profitability in the future. However, under the rules of Sections
382 and 383 of the Internal Revenue Code of 1986, as amended (the
“Code”), if a corporation undergoes an “ownership change,”
generally defined as a greater than 50 percentage point change (by
value) in its equity ownership over a rolling three-year period,
the corporation’s ability to use its pre-change NOLs and other
pre-change tax attributes to offset its post-change taxable income
or taxes may be limited. The applicable rules generally operate by
focusing on changes in ownership among stockholders considered by
the rules as owning, directly or indirectly, 5% or more of the
stock of a corporation, as well as changes in ownership arising
from new issuances of stock by the corporation. If finalized,
Treasury Regulations currently proposed under Section 382 of the
Code may further limit our ability to utilize our pre-change NOLs
or other pre-change tax attributes if we undergo a future ownership
change. We could experience one or more ownership changes in the
future, including in connection with this Merger and as a result of
future changes in our stock ownership, some of which may be outside
our control. As a result, if we earn net taxable income, our
ability to use our pre-change NOL carryforwards to offset
post-change taxable income may be subject to limitations. For these
reasons, we may not be able to utilize a material portion of our
NOLs and other tax attributes, which could adversely affect our
future cash flows.
We have identified material weaknesses in our internal control over
financial reporting and we may identify additional material
weaknesses in the future or otherwise fail to maintain effective
internal control over financial reporting, which may result in
material misstatements of our consolidated financial statements,
cause us to fail to meet our periodic reporting obligations, or
cause our access to the capital markets to be
impaired.
As previously reported, in connection with the re-issuance of our
consolidated financial statements as of and for the fiscal year
ended December 31, 2019, we identified material weaknesses in our
internal control over financial reporting. These identified
material weaknesses in our internal control over financial
reporting continued to exist as of December 31, 2022. Further,
during the year ended December 31, 2022, we identified additional
material weaknesses to our internal control over financial
reporting.
We did not design and maintain an effective control environment
commensurate with our financial reporting requirements.
Specifically, we did not maintain a sufficient complement of
personnel with an appropriate degree of internal controls and
accounting knowledge, experience, and training commensurate with
our accounting and financial reporting requirements. This material
weakness contributed to the following additional material
weaknesses:
•We
did not design and maintain effective controls over the segregation
of duties related to journal entries. Specifically, certain
personnel have the ability to both create and post journal entries
within the Company’s general ledger system. This material weakness
did not result in any adjustments to the consolidated financial
statements.
•We
did not design and maintain effective controls over the accounting
for the accuracy and existence of inventory, nor controls which
verified the completeness and accuracy of accrued liabilities. Each
of these material weaknesses resulted in immaterial adjustments
that were recorded as out-of-period adjustments within the year
ended December 31, 2022.
•We
did not design and maintain effective controls over the accounting
for convertible preferred stock and warrant arrangements. Further,
we did not design and maintain effective controls to verify the
completeness and accuracy of sales returns and accrued sales tax.
Each of these material weaknesses resulted in material adjustments
to several account balances and disclosures in the consolidated
financial statements as of and for the year ended December 31,
2019. The sales returns material weakness also resulted in
immaterial adjustments to revenue and accrued and other expenses as
of and for the year ended December 31, 2022.
•We
did not design and maintain effective controls over IT general
controls for information systems that are relevant to the
preparation of our consolidated financial statements. Specifically,
we did not design and maintain (i) program change management
controls to ensure that IT program and data changes affecting
financial IT applications and underlying accounting records are
identified, tested, authorized and implemented appropriately, (ii)
user access controls to ensure appropriate segregation of duties
and that adequately restrict user and privileged access to
financial applications, programs, and data to appropriate Company
personnel, (iii) computer operations controls to ensure that
critical batch jobs are monitored, and data backups are authorized
and monitored, and (iv) testing and approval controls for program
development to ensure that new software development is aligned with
business and IT requirements. This material weakness did not result
in any adjustments to the consolidated financial
statements.
Additionally, each of the material weaknesses described above could
result in a misstatement of one or more account balances or
disclosures that would result in a material misstatement to the
interim or annual consolidated financial statements that would not
be prevented or detected.
See Part II. Item 9A. "Controls and Procedures" included in this
Report for a discussion of our remediation plan to address these
material weaknesses.
As a public company, we are required pursuant to Section 404(a) of
the Sarbanes-Oxley Act, subject to certain exceptions, to furnish a
report by management on, among other things, the effectiveness of
our internal control over financial reporting for each annual
report on Form 10-K to be filed with the SEC. This assessment needs
to include disclosure of any material weaknesses identified by our
management in internal control over financial reporting. Once we
cease to be an emerging growth company, our independent registered
public accounting firm will also be required, pursuant to Section
404(b) of the Sarbanes-Oxley Act, to attest to the effectiveness of
our internal control over financial reporting in each annual report
on Form 10-K to be filed with the SEC. We are required to disclose
material changes made in our internal control over financial
reporting on a quarterly basis. Failure to comply with the
Sarbanes-Oxley Act could potentially subject us to sanctions or
investigations by the SEC, the stock exchange on which our
securities are listed or other regulatory authorities, which would
require additional financial and management resources. We are in
the costly and challenging process of compiling the system and
processing
documentation necessary to perform the evaluation needed to comply
with Section 404, but we may not be able to complete our testing
and any required remediation in a timely fashion.
Risks Related to Regulation of Our Industry and
Products
We are required to obtain and maintain marketing authorizations or
certifications from the FDA, foreign regulatory authorities or
notified bodies for medical device products in the U.S.
or in foreign jurisdictions, which can be a lengthy and
time-consuming process, and a failure to do so on a timely basis,
or at all, could severely harm our business.
During the year ended December 31, 2022, the FDA informed the
Company that certain features of the Dream Sock – namely its
display of pulse rate and blood oxygen saturation are medical
device features requiring marketing authorization. The Company
advised the FDA of its plan to submit a de novo classification
request for marketing authorization, which was submitted by the
Company in December 2022 and accepted for substantive review by the
FDA. The FDA has indicated that it does not anticipate the need for
enforcement action pending a decision on the marketing application.
If the FDA changes its enforcement approach to the Dream Sock
pending the FDA’s review and decision on the application, or if the
FDA does not grant marketing authorization for these features, we
may be required to recall product or otherwise be restricted from
selling the product as currently designed with these specific
display features until after FDA marketing authorization has been
received.
Medical devices are subject to extensive regulation in the U.S. by
local government, state government and the federal government,
including by the FDA. The FDA regulates virtually all aspects of a
medical device’s design, development, testing, manufacturing,
labeling, storage, record keeping, reporting, sale, promotion,
distribution and shipping. In the U.S., unless an exemption
applies, any medical device that we seek to market in the U.S. must
first undergo the FDA’s premarket review pursuant to the FDCA, and
must receive the FDA’s marketing authorization either via clearance
of a 510(k) premarket notification,
de novo
classification, or approval of a PMA application, depending on the
type of device. In the 510(k) clearance process, before a device
may be marketed, the FDA must determine that a proposed device is
“substantially equivalent” to a legally-marketed “predicate”
device. To be “substantially equivalent,” the proposed device must
have the same intended use as the predicate device, and either have
the same technological characteristics as the predicate device or
have different technological characteristics and not raise
different questions of safety or effectiveness than the predicate
device. Clinical data are sometimes required to support substantial
equivalence.
In the PMA process, the FDA must determine that a proposed device
is safe and effective for its intended use based, in part, on
extensive data, including, but not limited to, technical,
pre-clinical, clinical trial, manufacturing and labeling data. The
PMA process is typically required for devices that are deemed to
pose the greatest risk, such as life-sustaining, life-supporting or
implantable devices. However, some devices are automatically
subject to the PMA pathway regardless of the level of risk they
pose because they have not previously been classified into a lower
risk class by the FDA. Manufacturers of these devices may request
that the FDA review such devices in accordance with the
de novo
classification procedure, which allows a manufacturer whose novel
device would otherwise require the submission and approval of a PMA
prior to marketing to request down-classification of the device on
the basis that the device presents low or moderate risk. If the FDA
agrees with the down classification, the applicant will then
receive authorization to market the device. This device can then be
used as a predicate device for future 510(k)
submissions.
Modifications to products that are approved through a PMA
application may require FDA approval. Similarly, certain
modifications made to products cleared through a 510(k) premarket
notification or de novo classification may require a new 510(k)
clearance. The PMA approval, de novo classification, and the 510(k)
clearance process can be expensive, lengthy and uncertain. The
FDA’s 510(k) clearance process usually takes from three to 12
months, but can last longer. The process of obtaining a PMA is much
more costly and uncertain than the 510(k) clearance process and
generally takes from one to three years, or even longer, from the
time the application is filed with the FDA. In addition, a PMA
and
de novo
classification generally require the performance of one or more
clinical trials, and a 510(k) clearance sometimes requires clinical
data to support clearance. Despite the time, effort and cost, any
particular device may not be authorized for marketing by the FDA.
Any delay or failure to obtain necessary marketing authorizations
could harm our business.
Even if marketing authorization is granted, such marketing
authorization may be limited to only certain indications for use.
Medical devices may be marketed only for the indications of use for
which they are authorized. Additionally, the FDA might not grant
marketing authorizations on a timely basis, if at all, for products
or new uses of existing products that are regulated as medical
devices and that are determined to require such marketing
authorization. In addition, even if FDA marketing authorization is
obtained, if safety or effectiveness problems are later identified
with any medical device products, we may need to initiate a product
recall.
To support any submissions to the FDA seeking marketing
authorizations, we may be required to conduct clinical testing of
our product candidates. Such clinical testing must be conducted in
compliance with FDA requirements pertaining to research with human
subjects. Among other requirements, we must obtain informed consent
from study subjects and approval by institutional review boards
(“IRB”) before such studies may begin. We must also comply with
other FDA requirements such as monitoring, record-keeping,
reporting and the submission of information regarding certain
clinical trials to a public database maintained by the National
Institutes of Health. In addition, if the study involves a
significant risk device, we are required to obtain the FDA’s
approval of the study under an Investigational Device Exemption
(“IDE”). Compliance with these requirements can require significant
time and resources. If the FDA determines that we have not complied
with such requirements, the FDA may refuse to consider the data to
support our submissions seeking marketing authorization or may
initiate enforcement actions.
Moreover, clinical testing is expensive and can take many years to
complete, and its outcome is inherently uncertain. Failure can
occur at any time during the clinical trial process. The results of
preclinical studies and early clinical trials may not be predictive
of the results of later-stage clinical trials. Product candidates
in later stages of clinical trials may fail to show the desired
safety and efficacy traits despite having progressed through
preclinical studies and initial clinical trials. A number of
companies have suffered significant setbacks in advanced clinical
trials due to lack of efficacy or adverse safety profiles,
notwithstanding promising results in earlier trials. Our future
clinical trial results may not be successful. We may also be
delayed in our clinical trials, including as related to, among
other things: obtaining authorization to initiate clinical trials;
reaching agreement on acceptable terms with vendors, clinical trial
sites, and contract research organizations; obtaining IRB
approvals, recruiting subjects and having them complete the study;
experiencing deviations from clinical trial protocols; and adding
new clinical sites. We could encounter delays if a clinical trial
is suspended or terminated due to a number of factors, including
failure to conduct the clinical trial in accordance with regulatory
requirements or our clinical protocols, inspection of the clinical
trial operations or trial site by the FDA or other regulatory
authorities resulting in the imposition of a clinical hold,
unforeseen safety issues or adverse side effects, failure to
demonstrate a benefit from using a drug, changes in governmental
regulations or administrative actions or lack of adequate funding
to continue the clinical trial. If we experience delays in the
completion of, or termination of, any clinical trial of our medical
device products we seek to develop, the commercial prospects of our
proposed products will be harmed, and our ability to generate
product revenues from any of these products will be delayed. In
addition, any delays in completing our clinical trials will
increase our costs, slow down our product development and
jeopardize our ability to generate product sales and
revenues.
In addition, we believe that some of the products we plan to market
could be subject to an FDA enforcement discretion policy, meaning
that even if the products are medical devices, they are not subject
to FDA premarket or post-market regulatory requirements. For
example, the FDA has established a compliance policy for certain
products that may fall within the definition of a medical device,
but that are intended for only “general wellness use” and present a
low risk to the safety of users and other persons. The FDA defines
a “general wellness use” to be (i) an intended use that relates to
maintaining or encouraging a general state of health or a healthy
activity, or (ii) an intended use that relates the role of healthy
lifestyle with helping to reduce the risk or impact of certain
chronic diseases or conditions and where it is well understood and
accepted that healthy lifestyle choices may play an important role
in health outcomes for the disease or condition. The FDA identifies
sleep management – such as a product intended to track sleep trends
– as an intended use of a product that falls within a general
wellness use, provided that the product claims do not make
reference to any diseases or conditions. Specifically, the FDA has
issued guidance explaining that for such low-risk products, FDA
does not intend to examine whether the product constitutes a
medical device, and if the product is a medical device, whether the
product complies with the premarket review and post-market
regulatory requirements of the FDCA. As such, if a medical device
falls within the definition of a “low risk general wellness
product,” the product may nevertheless be subject to enforcement
discretion under the FDA’s compliance policy for such products,
meaning that the FDA will not enforce its medical device
authorities with respect to that product. To the extent that we
pursue the marketing of any products as a “low risk general
wellness product,” the FDA may disagree that the product qualifies
and may determine that the product is a medical device requiring
marketing authorization. If the FDA makes this determination with
respect to any product that we believe is a device but qualifies
for enforcement discretion, we could be required to cease
commercial distribution of the product or recall the product
pending receipt of any required marketing authorization, and we
could be subject to enforcement action, litigation, and negative
publicity as a result, any of which could materially, adversely
affect our business.
The FDA’s interpretations of its laws and regulations are subject
to change. If the FDA changes its policy or concludes that the
marketing of any of our products is not in accordance with current
policies, regulations or statutory requirements, or if the FDA
changes its applicable policies or if changes are introduced to
applicable laws or regulations, we may be required to seek
clearance or approval or other marketing authorization for these
products through the 510(k),
de novo
classification or PMA processes, may not be permitted to continue
marketing these products until marketing authorization is obtained,
or may be the subject of regulatory enforcement actions or
recalls.
Disruptions at the FDA, other agencies or notified bodies caused by
funding shortages or global health concerns could hinder their
ability to hire, retain, or deploy key leadership and other
personnel, or otherwise prevent new or modified products from being
developed, cleared or approved, or commercialized in a timely
manner, or at all, which could negatively impact our
business.
The ability of the FDA, other agencies and notified bodies to
review and authorize or certify for marketing new products can be
affected by a variety of factors, including government budget and
funding levels, statutory, regulatory and policy changes, agency’s
or notified body's ability to hire and retain key personnel and
accept the payment of user fees, and other events that may
otherwise affect the agency’s or notified body's ability to perform
routine functions. Average review times at the FDA and other
agencies and notified bodies have fluctuated in recent years as a
result. In addition, government funding of other government
agencies that fund research and development activities is subject
to the political process, which is inherently fluid and
unpredictable. Disruptions at the FDA, other agencies and notified
bodies may also slow the time necessary for new medical devices or
modifications to be reviewed and/or cleared, approved or certified
by necessary agencies or notified bodies, which would adversely
affect our business. For example, over the last several years, the
U.S. government has shut down several times and certain regulatory
agencies, such as the FDA, have had to furlough critical FDA
employees and stop critical activities.
Separately, in response to the global COVID-19 pandemic, the FDA
postponed most inspections of domestic and foreign manufacturing
facilities at various points. Even though the FDA has since resumed
standard inspection operations of domestic facilities where
feasible, the FDA has continued to monitor and implement changes to
its inspectional activities to ensure the safety of its employees
and those of the firms it regulates as it adapts to the evolving
COVID-19 pandemic, and any resurgence of the virus or emergence of
new variants may lead to further inspectional delays. Regulatory
authorities outside the United States may adopt similar policy
measures in response to the COVID-19 pandemic. If a prolonged
government shutdown occurs, or if global health concerns continue
to prevent the FDA or other regulatory authorities from conducting
their regular inspections, reviews, or other regulatory activities,
it could significantly impact the ability of the FDA or other
regulatory authorities to timely review and process our regulatory
submissions, which could have a material adverse effect on our
business.
In the EU, notified bodies must be officially designated to certify
products and services in accordance with the MDR. While several
notified bodies have been designated the COVID-19 pandemic has
significantly slowed down their designation process and the current
designated notified bodies are facing a large amount of requests
with the new regulation as a consequence of which review times have
lengthened although a new regulation amending the EU MDR was
recently adopted in March 2023, extending existing transitional
provisions. This situation could significantly impact the ability
of notified bodies to timely review and process our regulatory
submissions, which could have a material adverse effect on our
business in the EU and EEA (which consists of the 27 EU member
states plus Norway, Liechtenstein and Iceland).
We are expanding into international markets, and we will be
required to obtain and maintain regulatory authorizations,
including clearances or approvals, or other certifications in order
to commercialize certain of our products in certain international
markets. Failure to obtain such regulatory authorizations or
certifications in relevant foreign jurisdictions may prevent us
from marketing medical device products abroad.
We currently market and intend to continue to market our products
and services internationally. We expect certain of our pipeline
products to be regulated as medical devices, and we have received
communications from certain regulatory authorities inquiring as to
the regulatory status of our Smart Sock, and whether such product
is regulated as a medical device in such jurisdictions. In these
communications, some regulatory authorities have asserted that the
Smart Sock is a medical device that must comply with medical device
requirements in those jurisdictions. For example, Health Canada,
Canada's medical device regulatory authority, has also determined
that the Smart Sock meets the definition of a medical device that
requires a medical device license. We plan to pursue a medical
device license for the Smart Sock from Health Canada.
In addition, the MHRA, the regulatory authority responsible for the
UK medical device market, has asserted that the Smart Sock requires
certification by a notified body and subsequent registration as a
medical device in the UK, but has indicated it will allow us to
continue to market the Smart Sock in the UK while we are working
towards that certification and registration, as long as we are
progressing on that certification with our notified body and
providing monthly updates to MHRA. We plan to pursue such
certification and registration for the Dream Sock with Health
Notifications in the UK, but we may not be able to obtain
certification by a notified body and subsequent registration as a
medical device in the UK, at which point we may be required to
cease marketing the Smart Sock in the UK, unless the MHRA grants us
an extension.
Elsewhere in Europe, we can generally market a medical device only
if we receive a certification by a notified body, i.e., an
independent organization accredited or designated by an EU member
state or a marketing authorization from other foreign regulatory
authorities (and meet certain pre-marketing requirements) and, in
some cases, pricing
approval, from the appropriate regulatory authorities. The path to
market varies among international jurisdictions and may require
additional or different product testing than required to obtain FDA
marketing authorization. We may be unable to obtain foreign
certifications or marketing authorizations on a timely basis, if at
all, and we may also incur significant costs in attempting to
obtain foreign certifications or marketing
authorizations.
In order to sell medical devices in the EU, products must comply
with the general safety and performance requirements of the EU
Medical Devices Regulation (2017/745 or “MDR”). Compliance with
these requirements is a prerequisite to be able to affix the
European Conformity (“CE”) mark to medical devices, without which
they cannot be sold or marketed in the EU. All medical devices
placed on the market in the EU must meet the general safety and
performance requirements laid down in Annex I to the MDR including
the requirement that a medical device must be designed and
manufactured in such a way that, during normal conditions of use,
it is suitable for its intended purpose. Medical devices must be
safe and effective and must not compromise the clinical condition
or safety of patients, or the safety and health of users and –
where applicable – other persons, provided that any risks which may
be associated with their use constitute acceptable risks when
weighed against the benefits to the patient and are compatible with
a high level of protection of health and safety, taking into
account the generally acknowledged state of the art. To demonstrate
compliance with the general safety and performance requirements, we
must undergo a conformity assessment procedure, which varies
according to the type of medical device and its (risk)
classification. Except for low risk medical devices (Class I),
where the manufacturer can self-assess the conformity of its
products with the general safety and performance requirements
(except for any parts which relate to sterility, metrology or reuse
aspects), a conformity assessment procedure requires the
intervention of a notified body. The notified body would typically
audit and examine the technical file and the quality system for the
manufacture, design and final inspection of our devices. If
satisfied that the relevant product conforms to the relevant
general safety and performance requirements, the notified body
issues a certificate of conformity, which the manufacturer uses as
a basis for its own declaration of conformity. The manufacturer may
then apply the CE mark to the device, which allows the device to be
placed on the market throughout the EU. If we fail to comply with
applicable laws and regulations, we would be unable to affix the CE
mark to any medical devices, which would prevent us from selling
them within the EU. These modifications are likely to have an
effect on the way we conduct our business in the EU. For example,
as a result of the transition towards the new regime, notified body
review times have lengthened, and product future introductions or
modifications could be delayed or canceled despite the new
regulation extending the existing transitional provisions, which
could adversely affect our ability to grow our business and our
future products. The aforementioned EU rules are generally
applicable in the EEA. Non-compliance with the above requirements
would also prevent us from selling medical devices in these
countries.
In addition, marketing authorization by the FDA does not ensure
marketing authorization, including clearance or approval, or other
certification by foreign regulatory authorities or notified bodies.
However, a failure to obtain such marketing authorization by the
FDA may have a negative impact on our ability to obtain any
necessary marketing authorizations, including clearances or
approvals, or similar certifications in foreign jurisdictions.
Moreover, certifications or marketing authorizations from one
foreign regulatory authority or notified body does not ensure
certification or marketing authorization by any other foreign
regulatory authority or notified body or by the FDA. If we fail to
receive necessary certifications or marketing authorizations to
commercialize our products in foreign jurisdictions on a timely
basis, or at all, or if we later lose such certifications or
marketing authorizations, our business, financial condition and
results of operations could be adversely affected. Furthermore,
foreign regulatory requirements may change from time to time, which
could adversely affect our ability to market new products and
services, or continue to market existing products and services,
internationally.
Following Brexit, EU laws no longer apply directly in Great
Britain. The regulations on medical devices in Great Britain
continue to be based largely on the three EU Directives which
preceded the EU MDR, as implemented into national law. However,
under the terms of the Protocol on Ireland/Northern Ireland, the EU
MDR does apply to Northern Ireland. Consequently, there are
currently different regulations in place in Great Britain as
compared to both Northern Ireland and the EU, respectively. Ongoing
compliance with both sets of regulatory requirements may result in
increased costs for our business.
Furthermore, the UK Government is currently drafting amendments to
the existing legislation which is likely to result in further
changes to the Great Britain regulations in the near future. For
example, subject to transitional periods for validly-certified
devices, the new Great Britain regulations are likely to require
medical devices placed on the Great Britain market to be “UKCA”
certified by a UK approved body in order to be lawfully placed on
the market. The UK Government has stated that the amended
regulations are likely to apply from July 2024; understanding and
ensuring compliance with any new such requirements is likely to
lead to further complexity and increased costs to our business. If
there is insufficient UK approved body capacity, there is a risk
that our product certification could be delayed which might impact
our ability to market products in Great Britain after the
respective transition periods.
We have relied and expect to continue to rely on third parties to
conduct our nonclinical and clinical studies and perform other
tasks for us. If these third parties do not successfully carry out
their contractual duties, meet expected deadlines, or comply with
regulatory requirements, we may not be able to obtain marketing
authorization or other required certifications to commercialize our
medical device products and our business could be substantially
harmed.
We have relied upon and plan to continue to rely upon third parties
for execution of our nonclinical and clinical studies, and we
control only certain aspects of their activities. Nevertheless, we
are responsible for ensuring that each of our studies is conducted
in accordance with the applicable protocol, legal, regulatory, and
scientific standards and our reliance on third parties does not
relieve us of our regulatory responsibilities. We and our third
party contractors may be required to comply with Good Clinical
Practice (“GCP”) requirements and Good Laboratory Practice
requirements which are regulations and guidelines enforced by the
FDA and other regulatory authorities for the conduct of certain
clinical and nonclinical studies, respectively. Regulatory
authorities enforce these regulations through periodic inspections
of study sponsors, principal investigators, study sites, and other
contractors. If we or any of our third party contractors fail to
comply with applicable regulations, the data generated in our
studies may be deemed unreliable and the FDA and other regulatory
authorities or bodies may require us to perform additional
nonclinical and clinical studies before issuing any marketing
authorizations or other certifications for any medical device
products we seek to market. Upon inspection by a given regulatory
authority, such regulatory authority may determine that our
clinical studies do not comply with GCP regulations. Our or our
third party contractors’ failure to comply with these regulations
may require us to repeat clinical studies, which would delay or
prevent any required marketing authorization or similar
certification from being granted.
If any of our relationships with these third parties terminate, we
may not be able to enter into arrangements with alternative third
parties or do so on commercially reasonable terms. In addition, our
contractors are not our employees, and except for remedies
available to us under our agreements with them, we cannot control
whether or not they devote sufficient time and resources to our
development programs. If these third parties do not successfully
carry out their contractual duties or obligations or meet expected
deadlines, if they need to be replaced or if the quality or
accuracy of the data they obtain is compromised due to the failure
to adhere to our protocols, regulatory requirements, or for other
reasons, our studies may be extended, delayed, or terminated and we
may not be able to obtain marketing authorizations or other
required certifications to successfully commercialize our proposed
medical device products. Third parties may also generate higher
costs than anticipated. As a result, our results of operations and
the commercial prospects for our proposed products would be harmed,
our costs could increase, and our ability to generate revenue could
be delayed.
We rely on third parties to manufacture our products. Failure of
those third parties to provide us with sufficient quantities of our
products, in compliance with applicable regulatory requirements, or
to do so at acceptable quality levels or prices could adversely
impact our business.
We do not currently have nor do we plan to acquire the
infrastructure or capability internally to completely manufacture
our commercial products or our development-stage products, and we
lack the resources and the capability to manufacture any of our
current or future products in the future. We do not control the
manufacturing process of, and are completely dependent on, our
contract manufacturing partners for compliance with applicable
regulatory requirements for any medical device products we seek to
market. For example, the FDA requires adherence to current good
manufacturing practice requirements for medical devices, known as
the Quality System Regulation (“QSR”). If our contract
manufacturers cannot successfully manufacture material that
conforms to our specifications and the strict regulatory
requirements of the FDA or other regulators, our products may not
be able to be lawfully marketed. In addition, we have no control
over the ability of our contract manufacturers to maintain adequate
quality control, quality assurance and qualified personnel. If the
FDA or a comparable foreign regulatory authority or notified body
does not consider these facilities adequate for the manufacture of
our products, we may need to find alternative manufacturing
facilities, which would significantly impact our ability to
develop, obtain marketing authorization or similar certification
for or to market any medical device products we may seek to develop
and commercialize.
Moreover, failure by us or one of our manufacturers or suppliers to
comply with applicable statutes and regulations administered by the
FDA or comparable regulatory bodies could result in, among other
things, any of the following:
•warning
letters or untitled letters issued by the FDA or FTC and their
counterparts in international jurisdictions;
•litigation,
fines, civil penalties, in rem forfeiture proceedings, injunctions,
consent decrees and criminal prosecution;
•import
alerts and holds;
•unanticipated
expenditures to address or defend such actions;
•delays
in clearing, approving, authorizing, or certifying, or refusal to
clear, approve, authorize, or certify, our products, where
applicable;
•withdrawals
or suspensions of clearance, approval, authorization or
certification of our products or those of our third-party suppliers
by the FDA or other regulatory authorities or notified bodies,
where applicable;
•product
recalls or seizures;
•adverse
publicity;
•orders
for device repair, replacement or refund;
•interruptions
of production or inability to export to certain foreign countries;
and
•operating
restrictions.
If any of these items were to occur, it would harm our reputation
and adversely affect our business, financial condition and results
of operations.
We rely on third-party manufacturers to purchase from third-party
suppliers the materials necessary to produce our products. There
are a limited number of suppliers for raw materials that are used
in the manufacture of our products and that we anticipate will be
able to supply materials for the production of our future products,
and there may be a need to assess alternate suppliers to prevent a
possible disruption of the manufacture of the materials. We do not
have any control over the process or timing of the acquisition of
these raw materials by our manufacturers. If our manufacturers or
we are unable to purchase these raw materials, the commercial
launch of any medical device products we may seek to develop would
be delayed or there would be a shortage in supply, which would
impair our ability to generate revenues from the sale of such
products, if authorized for marketing.
We expect to continue to depend on third-party contract
manufacturers for the foreseeable future. We have not entered into
long-term agreements with our current contract manufacturers or
with any alternate suppliers, and we may be unable to enter into
such an agreement or do so on commercially reasonable
terms.
Regulatory reforms may impact our ability to develop and
commercialize our products and services and
technologies.
From time to time, legislation is drafted and introduced that could
significantly change the regulatory frameworks governing our
products and services. In addition, regulations and guidance are
often revised or reinterpreted by the government agency in ways
that may significantly affect our business or products and
services. FDA requirements related to digital health have evolved
over time as the FDA has gained additional experience with these
kinds of products and modified its approach to regulation in light
of changes to its statutory authority. For example, in 2016, the
21st Century Cures Act was enacted to, among other things, amend
the FDCA to remove certain software functions from the definition
of a “device.” The FDA also issued guidance in 2016, which was
updated in 2019, establishing a policy of enforcement discretion
for certain low risk general wellness products, including certain
such products with software functions. The FDA’s approach to
digital health continues to evolve, and the FDA continues to
publish new guidance on its approach to software as a medical
device, including, most recently in September 2022. Any new
statutes, regulations, or policies, or revisions or
reinterpretations of existing statutes, regulations, or policies,
including those in the digital health area, may increase our costs
or subject us to additional regulation or the need for marketing
authorization or similar certification requirements for our
products, or may lengthen review times of certain products or make
it more difficult to obtain clearance or approval for, manufacture,
market or distribute such products.
We cannot predict the likelihood, nature, or extent of the impact
on our business of any legislation, regulations, or
reinterpretations thereof that may be enacted or adopted in the
future. However, future regulatory changes could make it more
difficult for us to obtain or maintain any necessary marketing
authorization or certification for our products and services, or to
develop and commercialize future medical devices and
technologies. If we are slow or unable to adapt to changes in
existing requirements or the adoption of new requirements or
policies, or if we are not able to maintain regulatory compliance,
we would not be able to market the affected products and may lose
any marketing authorizations or certifications that we may have
obtained, which could materially and adversely affect our business,
financial condition, results of operations and growth
prospects.
Promotion of any medical devices using claims that are off-label,
unsubstantiated, false or misleading could subject us to
substantial penalties and enforcement action.
Obtaining FDA or foreign regulatory authorities marketing
authorization or notified bodies certification would permit us to
promote the subject medical device only for the specific use(s)
cleared, approved, certified or otherwise authorized by the FDA,
foreign regulatory authorities or notified bodies. Use of a medical
device outside its authorized or certified indications is known as
“off-label” use. Although physicians may use any medical devices
we
market off-label because the FDA and foreign regulatory authorities
do not restrict or regulate a physician’s choice of treatment
within the practice of medicine, we are prohibited from marketing
or promoting any medical devices for off-label use. While we may
pursue FDA or foreign regulatory authorities marketing
authorizations or notified bodies certifications for certain
indications for any medical devices we seek to market, the FDA or
foreign regulatory authorities or notified bodies may deny those
requests, require additional expensive clinical data to support any
additional indications or impose limitations on the intended use of
any authorized or certified product as a condition of marketing
authorization or certification. If the FDA or foreign regulatory
authorities determine that our products authorized or certified for
marketing as medical devices were promoted for off-label use, or
that false, misleading or inadequately substantiated promotional
claims have been made by us or our commercial partners, it could
request that we or our commercial partners modify those promotional
materials or take regulatory or enforcement actions, including the
issuance of an untitled letter or warning letter, injunction,
seizure, civil fine and criminal penalties.
It is also possible that other federal, state or foreign
enforcement authorities may take action if they consider our
communications, including promotional or training materials, to
constitute promotion of an uncleared, uncertified or unapproved use
of a medical device. If not successfully defended, enforcement
actions related to off-label promotion could result in significant
fines or penalties under other statutory authorities, such as laws
prohibiting false claims for reimbursement. In any such event, our
reputation could be damaged, adoption of our products could be
impaired and we could be subject to extensive fines and
penalties.
Additionally, we must have adequate substantiation for the claims
we make for our products and services. If any of our claims are
determined to be false, misleading or deceptive, our products and
services could be considered misbranded under the FDCA or in
violation of the Federal Trade Commission Act. We could also face
lawsuits from our competitors under the Lanham Act alleging that
our marketing materials are false or misleading.
Foreign jurisdictions have their own laws and regulations
concerning medical device marketing authorizations and
certifications, including communications, claims and promotional or
training materials surrounding those medical devices. Failure to
comply with those laws and regulations could result in actions
against us, including fines, penalties and exclusion from the
market. Any such actions could adversely affect our ability to
market new products and services or continue to market existing
products and services in those jurisdictions.
Changes in and failures to comply with U.S. and foreign privacy and
data protection laws, regulations and standards may adversely
affect our business, operations and financial
performance.
The global data protection landscape is rapidly evolving, and we
are or may become subject to numerous state, federal and foreign
laws, requirements and regulations governing the collection, use,
disclosure, retention, and security of health-related and other
personal information, including information we collect about
children and infants, their parents and other consumers who
purchase our products and services, as well as information that we
may now or in the future collect in connection with clinical trials
in the U.S. and abroad. Implementation standards and enforcement
practices are likely to remain uncertain for the foreseeable
future, and we cannot yet determine the impact future laws,
regulations, standards, or perception of their requirements may
have on our business. This evolution may create uncertainty in our
business, affect our ability to operate in certain jurisdictions or
to collect, store, transfer, use and share personal information,
necessitate the acceptance of more onerous obligations in our
contracts, result in liability or impose additional costs on us.
The cost of compliance with these laws, regulations and standards
is high and is likely to increase in the future. Any failure or
perceived failure by us to comply with federal, state or foreign
laws or regulations, our internal policies and procedures, or our
contracts governing our processing of personal information could
result in negative publicity, government investigations and
enforcement actions, claims by third parties and damage to our
reputation, any of which could have a material adverse effect on
our operations, financial performance and business.
As our operations and business grow, we may become subject to or
affected by new or additional data protection laws and regulations
and face increased scrutiny or attention from regulatory
authorities. In the U.S., the Health Insurance Portability and
Accountability Act, as amended by the Health Information Technology
for Economic and Clinical Health Act of 2009, and regulations
promulgated thereunder (collectively, “HIPAA”) imposes, among other
things, certain standards relating to the privacy, security,
transmission and breach reporting of individually identifiable
health information. Certain states have also adopted comparable
privacy and security laws and regulations, which govern the
privacy, processing and protection of health-related and other
personal information and some of which may be more stringent than
HIPAA. Such laws and regulations will be subject to interpretation
by various courts and other governmental authorities, thus creating
potentially complex compliance issues for us and our future
customers and strategic partners.
For example, the California Consumer Privacy Act (“CCPA”) went into
effect on January 1, 2020. The CCPA creates individual privacy
rights for California consumers and increases the privacy and
security obligations of entities handling certain personal data.
The CCPA provides for civil penalties for violations, as well as a
private
right of action for data breaches that has increased the likelihood
of, and risks associated with data breach litigation. Further, the
California Privacy Rights Act (“CPRA”) generally went into effect
on January 1, 2023 in California and significantly amends the CCPA.
It imposes additional data protection obligations on covered
businesses, including additional consumer rights processes,
limitations on data uses, new audit requirements for higher risk
data, and opt outs for certain uses of sensitive data. It also
creates a new California data protection agency authorized to issue
substantive regulations and could result in increased privacy and
information security enforcement. Additional compliance investment
and potential business process changes may be required. Similar
laws have passed in Virginia, Connecticut, Utah and Colorado, and
have been proposed in other states and at the federal level,
reflecting a trend toward more stringent privacy legislation in the
U.S. The enactment of such laws could have potentially conflicting
requirements that would make compliance challenging. In the event
that we are subject to or affected by HIPAA, the CCPA, the CPRA or
other domestic privacy and data protection laws, any liability from
failure to comply with the requirements of these laws could
adversely affect our financial condition.
Furthermore, the FTC and many state Attorneys General continue to
enforce federal and state consumer protection laws against
companies for online collection, use, dissemination and security
practices that appear to be unfair or deceptive. For example,
according to the FTC, failing to take appropriate steps to keep
consumers’ personal information secure can constitute unfair acts
or practices in or affecting commerce in violation of Section 5(a)
of the Federal Trade Commission Act. The FTC expects a company’s
data security measures to be reasonable and appropriate in light of
the sensitivity and volume of consumer information it holds, the
size and complexity of its business, and the cost of available
tools to improve security and reduce vulnerabilities.
We are also or may become subject to rapidly evolving data
protection laws, rules and regulations in foreign jurisdictions.
For example, the GDPR went into effect in May 2018 and imposes
strict requirements for processing the personal data of individuals
within the EEA, including in relation to use, collection, analysis,
and transfer (including cross-border transfer) of such personal
data. The law is also developing rapidly and, in July 2020, the
Court of Justice of the EU (“CJEU”) limited how organizations could
lawfully transfer personal data from the EEA to the U.S. by
invalidating the Privacy Shield for purposes of international
transfers and imposing further restrictions on the use of standard
contractual clauses (“SCCs”). In March 2022, the U.S. and EU
announced a new regulatory regime intended to replace the
invalidated regulations; however, this new EU-U.S. Data Privacy
Framework has not been implemented beyond an executive order signed
by President Biden on October 7, 2022 on Enhancing Safeguards for
United States Signals Intelligence Activities. European court and
regulatory decisions subsequent to the CJEU decision of July 2020
have taken a restrictive approach to international data transfers.
As we continue to expand into other foreign countries and
jurisdictions, we may be subject to additional laws and regulations
that may affect how we conduct business. The GDPR imposes strict
obligations on the ability to process health-related and other
personal data of individuals within the EEA, including in relation
to use, collection, analysis, and transfer (including cross-border
transfer) of such personal data. The law is also developing rapidly
and, in July 2020, the Court of Justice of the EU (“CJEU”) limited
how organizations could lawfully transfer personal data from the
EEA to the U.S.
Although we work to comply with applicable laws, regulations and
standards, our contractual obligations and other legal obligations,
these requirements are evolving and may be modified, interpreted
and applied in an inconsistent manner from one jurisdiction to
another, and may conflict with one another or other legal
obligations with which we must comply. Any failure or perceived
failure by us or our employees, representatives, contractors,
consultants, collaborators, or other third parties to comply with
such requirements or adequately address privacy and security
concerns, even if unfounded, could result in additional cost and
liability to us, damage our reputation, and adversely affect our
business and results of operations.
To the extent we market any medical devices or other healthcare
products and services, our relationships with customers, physicians
and third-party payors may be subject, directly or indirectly, to
federal, state and foreign healthcare fraud and abuse laws, false
claims laws, and other healthcare laws and regulations. If we or
our employees, independent contractors, consultants, commercial
partners, or vendors violate these laws, we could face substantial
penalties.
To the extent we market any medical devices or other healthcare
products and services, our relationships with healthcare customers,
physicians, and third-party payors may be subject, directly or
indirectly, to federal, state and foreign healthcare fraud and
abuse laws, false claims laws, and other healthcare laws and
regulations. These laws may impact, among other things, our
proposed and future sales, marketing, and education programs. In
particular, the promotion, sales and marketing of healthcare items
and services is subject to extensive laws and regulations designed
to prevent fraud, kickbacks, self-dealing, and other abusive
practices. These laws and regulations may restrict or prohibit a
wide range of pricing, discounting, marketing and promotion, sales
commission, customer incentive, and other business arrangements. We
may also be subject to federal, state and foreign laws governing
the privacy and security of identifiable patient information. The
healthcare laws and regulations that may affect our ability to
operate include, but are not limited to:
•the
federal Anti-Kickback Statute, which prohibits, among other things,
any person or entity from knowingly and willfully offering, paying,
soliciting or receiving any remuneration, directly or indirectly,
overtly or covertly, in cash or in kind, to induce, or in return
for, the purchasing, leasing, ordering or arranging for the
purchase, lease, or order of any item or service reimbursable under
Medicare, Medicaid or other federal healthcare programs. The term
“remuneration” has been broadly interpreted to include anything of
value. A person or entity does not have to have actual knowledge of
this statute or specific intent to violate it to have committed a
violation;
•federal
civil and criminal false claims laws, including the federal civil
False Claims Act, and civil monetary penalty laws, which prohibit,
among other things, individuals or entities from knowingly
presenting, or causing to be presented, claims for payment or
approval from Medicare, Medicaid, or other federal government
programs that are false or fraudulent or knowingly making a false
statement to improperly avoid, decrease or conceal an obligation to
pay money to the federal government, including federal healthcare
programs. In addition, the government may assert that claim
includes items or services resulting from a violation of the
federal Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the false claims statute;
•HIPAA,
which created new federal civil and criminal statutes that prohibit
knowingly and willfully executing, or attempting to execute, a
scheme to defraud any healthcare benefit program or obtain, by
means of false or fraudulent pretenses, representations, or
promises, any of the money or property owned by, or under the
custody or control of, any healthcare benefit program, including
private third-party payors and knowingly and willfully falsifying,
concealing or covering up by any trick, scheme or device, a
material fact or making any materially false, fictitious or
fraudulent statements in connection with the delivery of, or
payment for, healthcare benefits, items or services. Similar to the
federal Anti-Kickback Statute, a person or entity does not have to
have actual knowledge of this statute or specific intent to violate
it to have committed a violation;
•the
federal Physician Payments Sunshine Act, which requires certain
manufacturers of drugs, devices, biologicals and medical supplies
for which payment is available under Medicare, Medicaid or the
Children’s Health Insurance Program (with certain exceptions) to
report annually to CMS information related to payments or other
transfers of value made to physicians (defined to include doctors,
dentists, optometrists, podiatrists and chiropractors), certain
non-physician practitioners (nurse practitioners, certified nurse
anesthetists, physician assistants, clinical nurse specialists,
anesthesiology assistants and certified nurse midwives), and
teaching hospitals, as well as ownership and investment interests
held by physicians and their immediate family members;
•federal
consumer protection and unfair competition laws, which broadly
regulate marketplace activities and activities that potentially
harm consumers; and
•state
and foreign equivalents of each of the healthcare laws described
above, some of which may be broader in scope.
Because of the breadth of these laws and the narrowness of the
statutory exceptions and regulatory safe harbors available, it is
possible that some of our business activities, or any arrangements
with physicians, could be subject to challenge under one or more of
such laws. It is not always possible to identify and deter employee
misconduct or business noncompliance, and the precautions we take
to detect and prevent inappropriate conduct may not be effective in
controlling unknown or unmanaged risks or losses or in protecting
us from governmental investigations or other actions or lawsuits
stemming from a failure to be in compliance with such laws or
regulations. Efforts to ensure that our business arrangements will
comply with applicable healthcare laws may involve substantial
costs. It is possible that governmental and enforcement authorities
will conclude that our business practices may not comply with
current or future statutes, regulations or case law interpreting
applicable fraud and abuse or other healthcare laws and
regulations. If we or our employees, independent contractors,
consultants, commercial partners and vendors violate these laws, we
may be subject to investigations, enforcement actions or
significant penalties, including the imposition of significant
civil, criminal and administrative penalties, damages,
disgorgement, monetary fines, imprisonment, possible exclusion from
participation in Medicare, Medicaid and other federal healthcare
programs, contractual damages, reputational harm, diminished
profits and future earnings, additional reporting requirements or
oversight if we become subject to a corporate integrity agreement
or similar agreement to resolve allegations of non-compliance with
these laws, and curtailment of our operations, any of which could
adversely affect our ability to operate our business and our
results of operations. In addition, any regulatory approvals or
certifications (as applicable) and commercialization of our
products outside the U.S. will also likely subject us to foreign
equivalents of the healthcare laws mentioned above, among other
foreign laws. Any action against us for violation of these laws,
even if we successfully defend against such action, could cause us
to incur significant legal expenses and divert our management’s
attention from the operation of our business.
Expanding our commercial strategy based on third-party payor
coverage and reimbursement may not be successful and will subject
us to new risks, including, without limitation, changes in
third-party payor coding,
coverage and reimbursement rates for our products that obtain FDA
or foreign regulatory authorities authorization or notified bodies
certification which could affect the adoption of such products and
negatively impact our future revenue.
With respect to our current products, including the Dream Sock,
Smart Sock and Owlet Cam, we utilize a direct-to-consumer model
where consumers purchase our products directly from us or one of
our retailers. Currently, these products are not covered or
reimbursed by any third-party payor. We are actively developing a
strategy to enable healthcare providers to obtain reimbursement for
products for which we successfully obtain FDA authorization and
similar foreign authorization or certification (when applicable),
including for BabySat, or the services associated with such
products. However, this new strategy may not be successful as
payors may refuse to provide coverage and reimbursement for these
products even if we obtain FDA authorization and similar foreign
authorization or certification (when applicable).
In the U.S., healthcare providers who may purchase these products
generally rely on third-party payors, including Medicare, Medicaid
and private health insurance plans, to pay for all or a portion of
the cost of our products. To contain costs of new technologies,
governmental healthcare programs and third-party payors are
increasingly scrutinizing new and existing medical devices by
requiring extensive evidence of favorable clinical outcomes. To the
extent we market any medical devices, are successful in obtaining
FDA marketing authorization to the extent applicable, and
third-party payors determine that our products are medically
necessary and clinically effective, the resulting reimbursement
payment rates might not be adequate or may require co-payments that
patients find unacceptably high. Third-party payors regularly
update reimbursement amounts and may also revise the methodologies
from time to time used to determine reimbursement amounts. This
includes routine updates to payments to physicians for services
provided. These updates could directly impact the demand for our
products in the event our products or services using our products
are covered and/or reimbursed by third-party payors. Although we
believe that healthcare providers may be able to bill third-party
payors using existing Current Procedural Terminology (“CPT”) codes
for the remote monitoring of patients using products for which we
obtain FDA authorization, including the initial set-up and patient
education on the use of such products, their inability to obtain
adequate reimbursement from third-party payors may adversely affect
our business.
In addition, foreign jurisdictions have their own unique healthcare
systems and regulation regimes that differ substantially from the
U.S. and other international markets. Successfully navigating those
regimes will require significant resources and may ultimately be
unsuccessful. As a result, our financial performance could be
harmed, our costs could increase, and our ability to generate
revenue could be delayed.
Given the evolving nature of the healthcare industry and on-going
healthcare cost reforms, the likelihood of success of our new
commercial strategy is, and will continue to be, subject to changes
in the level of third-party payor coverage and reimbursement for
these products and services.
Legislative and regulatory changes in the healthcare industry could
have a negative impact on our financial performance. Furthermore,
our business, financial condition, results of operations and cash
flows could be significantly and adversely affected by healthcare
reform legislation in the U.S. or in potential key international
markets.
Changes in the healthcare industry in the U.S. and abroad could
adversely affect the demand for our potential medical devices and
the way in which we conduct our business. For example, the Patient
Protection and Affordable Care Act, as amended by the Health Care
and Education Reconciliation Act (collectively, the
“ACA”),
enacted in 2010, required most individuals to have health
insurance, established new regulations on health plans, created
insurance-pooling mechanisms and reduced Medicare spending on
services provided by hospitals and other providers. Since its
enactment, there have been legislative, executive and judicial
challenges to certain aspects of the ACA. On June 17, 2021, the
U.S. Supreme Court dismissed the most recent judicial challenge to
the ACA brought by several states without specifically ruling on
the constitutionality of the ACA. Prior to the Supreme Court’s
decision, President Biden issued an executive order initiating a
special enrollment period from February 15, 2021 through August 15,
2021 for purposes of obtaining health insurance coverage through
the ACA marketplace. The executive order also instructed certain
governmental agencies to review and reconsider their existing
policies and rules that limit access to healthcare. It is unclear
how healthcare reform measures, if any, will impact our
business.
Any medical devices we market and related business activities would
be subject to rigorous regulation by the FDA and other federal,
state and international governmental authorities. These authorities
and members of Congress have been increasing their scrutiny over
the medical device industry. In recent years, Congress, the
Department of Justice, the Office of Inspector General of the
Department of Health and Human Services, and the Department of
Defense have issued subpoenas and other requests for information to
medical device manufacturers, primarily related to financial
arrangements with healthcare providers, regulatory compliance and
marketing and product promotional practices. Furthermore, certain
state governments have enacted legislation to limit or increase
transparency of
interactions with healthcare providers, pursuant to which we are
required by law to disclose payments and other transfers of value
to healthcare providers licensed by certain states.
We anticipate that the government will continue to scrutinize the
medical device industry closely, and any new regulations or
statutory provisions could result in delays or increased costs
during the periods of product development, clinical trials and
regulatory review and marketing authorization or certification, as
applicable, as well as increased costs to assure compliance. For
instance, in December 2021, the EU Regulation No 2021/2282 on
Health Technology Assessment (“HTA”), amending Directive
2011/24/EU, was adopted. While the regulation entered into force in
January 2022, it will only begin to apply from January 2025
onwards, with preparatory and implementation-related steps to take
place in the interim. Once the regulation becomes applicable, it
will have a phased implementation depending on the concerned
products. This regulation which entered into force in January 2022
intends to boost cooperation among EU member states in assessing
health technologies, including some medical devices, and providing
the basis for cooperation at the EU level for joint clinical
assessments in these areas. The regulation foresees a three-year
transitional period and will permit EU member states to use common
HTA tools, methodologies, and procedures across the EU, working
together in four main areas, including joint clinical assessment of
the innovative health technologies with the most potential impact
for patients, joint scientific consultations whereby developers can
seek advice from HTA authorities, identification of emerging health
technologies to identify promising technologies early, and
continuing voluntary cooperation in other areas. Individual EU
member states will continue to be responsible for assessing
non-clinical (e.g., economic, social, ethical) aspects of health
technologies, and making decisions on pricing and
reimbursement.
We may be subject to regulatory reporting requirements if our
products and services cause or contribute to a death or serious
injury or malfunction in a way that would likely cause or
contribute to a death or serious injury, or in certain other
scenarios, and we may need to initiate voluntary corrective actions
such as the recall of our products.
Regulatory agencies in many countries require us to report
potential safety issues with our products and services under a
variety of circumstances. For example, the FDA’s Medical Device
Reporting regulations require that for any medical device we
market, we report when we become aware of information that
reasonably suggests that the product may have caused or contributed
to a death or serious injury, or has malfunctioned in a way that,
if the malfunction were to recur, would likely cause or contribute
to a death or serious injury. We may fail to report adverse events
of which we become aware within the prescribed timeframe. We may
also fail to recognize that we have become aware of a reportable
adverse event, especially if it is not reported to us as an adverse
event or if it is an adverse event that is unexpected or removed in
time from the use of the implant system. If we fail to comply with
our reporting obligations, the FDA could take action, including
warning letters, untitled letters, administrative actions, criminal
prosecution, imposition of civil monetary penalties, revocation of
our device clearance, seizure of our products or delay in clearance
of future products. Similarly, under the CPSC consumer product
reporting requirements, we are required to report to the CPSC any
incident in which a CPSC-regulated product of ours creates an
unreasonable risk of serious injury or death, contains a defect
which could create a substantial product hazard, fails to comply
with an applicable consumer product safety rule, or fails to comply
with any other rule, regulation, standard or ban enforced by the
CPSC. In addition, all manufacturers placing medical devices on the
market in the EU are legally required to immediately report any
serious incidents and field safety corrective actions involving
products produced or sold by the manufacturer to the relevant
authority in those jurisdictions where any such incident occurred.
As to general consumer products, where manufacturers and
distributors know or ought to know that a product that they have
placed on the market poses risks to the consumer that are
incompatible with the general safety requirements, they shall
immediately inform the relevant authority in the relevant
jurisdictions. The FDA, CPSC and similar foreign regulatory
authorities have the authority to require the recall of our
commercialized products under certain circumstances and depending
on the type of product. For example, the FDA must find that there
is a reasonable probability that a medical device would cause
serious adverse health consequences or death in order to require a
recall. The standard for ordering a mandatory recall may be
different for each regulatory agency and in foreign jurisdictions.
In addition, manufacturers may, under their own initiative, correct
or remove a marketed product for any reason and under any
circumstance, which may constitute a recall if the product violates
applicable laws. A government-mandated or voluntary recall by us or
by one of our distributors could occur as a result of component
failures, manufacturing errors, design or labeling defects or other
deficiencies and issues.
We may initiate certain field actions, such as a correction or
removal of our products in the future. Any correction or removal
initiated by us to reduce a health risk posed by a medical device,
or to remedy a regulatory violation caused by the device that may
present a risk to health, must be reported to the FDA. Other
regulatory authorities may have similar reporting requirements. If
the regulatory agency subsequently determines that a report was
required for a correction or removal of our products that we did
not believe required a report, we could be subject to enforcement
actions.
Any recalls of our products or enforcement actions would divert
managerial and financial resources and could have an adverse effect
on our financial condition and results of operations. In addition,
given our dependence upon
consumer perceptions, any negative publicity associated with any
recalls could materially and adversely affect our business,
financial condition, results of operations and growth
prospects.
We face the risk of product liability claims and the amount of
insurance coverage we hold now or in the future may not be adequate
to cover all liabilities we might incur.
Our products are predominantly used in the home and expose us to
product liability claims and product recalls, including, but not
limited to, those that may arise from off-label use, malfunctions,
design flaws or manufacturing defects related to our products or
the use of our products with incompatible components or systems. In
addition, as we continue to expand our product portfolio, we may
enter or create new markets, including consumer markets, which may
expose us to additional product liability risks. Any such product
liability claims may include allegations of defects in
manufacturing, defects in design, a failure to warn of dangers
inherent in the product, negligence, strict liability and a breach
of warranty. Claims could also be asserted under state consumer
protection acts. If we cannot successfully defend ourselves against
product liability claims, we may incur substantial liabilities or
be required to limit commercialization of our products. Even
successful defense would require significant financial and
management resources. Regardless of the merits or eventual outcome,
liability claims may result in decreased demand for our current or
future products, injury to our reputation, costs to defend the
related litigation, a diversion of management’s time and our
resources, substantial monetary awards to customers, regulatory
investigations, product recalls, withdrawals or labeling, marketing
or promotional restrictions, loss of revenue, and the inability to
sell our current or any future products.
Our product liability insurance may not be sufficient to cover any
or all damages for product liability claims that may be brought
against us in the future. Furthermore, we may not be able to obtain
or maintain insurance in the future at satisfactory rates or in
adequate amounts to protect us against any product liability
claims. Additionally, the laws and regulations regarding product
liability are constantly evolving, both through the passage of new
legislation at the state and federal levels and through new
interpretations of existing legislation. As the legal and
regulatory landscape surrounding product liability change, we may
become exposed to greater liability than currently
anticipated.
We may incur environmental and personal injury liabilities related
to certain hazardous materials used in our operations.
Certain manufacturing processes for our products may involve the
storage, use, generation and disposal of certain hazardous
materials and wastes, including lead, silicone adhesives, solder
and solder paste, sealants, epoxies and various solvents such as
methyl ethyl ketone, acetone and isopropyl alcohol. As a result, we
are subject to certain environmental laws, as well as certain other
laws and regulations, which restrict the materials that can be used
in our products or in our manufacturing processes. For example,
products that we sell in Europe are subject to regulation in the EU
markets under the Restriction of the Use of Hazardous Substances
Directive (“RoHS”). RoHS prohibits companies from selling products
that contain certain hazardous materials in EU member states. In
addition, the EU’s Registration, Evaluation, Authorization, and
Restriction of Chemicals Regulation also restricts substances of
very high concern in products. Compliance with such regulations may
be costly and, therefore, we may incur significant costs to comply
with these laws and regulations.
In addition, new environmental laws may further affect how we
manufacture our products, how we use, generate or dispose of
hazardous materials and waste, or further affect what materials can
be used in our products. Any required changes to our operations may
increase our manufacturing costs, detrimentally impact the
performance of our products, add greater testing lead-times for
product introductions or have other similar effects.
In connection with our research and manufacturing activities, we
use, and our employees may be exposed to, materials that are
hazardous to human health, safety or the environment. The risk of
accidental injury to our employees or contamination from these
materials cannot be eliminated, and we could be held liable for any
resulting damages, the related liability for which could exceed our
reserves. We do not specifically insure against environmental
liabilities. If an enforcement action were to occur, our reputation
and our business and financial condition may be harmed, even if we
were to prevail or settle the action on terms favorable to
us.
Changes to government immigration regulations may materially affect
our workforce and limit our supply of qualified professionals, or
increase our cost of securing workers.
We recruit professionals on a global basis and must comply with the
immigration laws in the countries in which we operate, including
the U.S. Some of our employees are working under Owlet-sponsored
temporary work visas, including H1-B visas. Statutory law limits
the number of new H1-B temporary work permit petitions that may be
approved in a fiscal year. Furthermore, there is a possibility that
the current U.S. immigration visa program may be significantly
overhauled, and the number of H1-B visas available, as well as the
process to obtain them, may be subject to significant change. Any
resulting changes to this visa program could impact our ability to
recruit, hire and
retain qualified skilled personnel. If we are unable to obtain work
visas in sufficient quantities or at a sufficient rate for a
significant period of time, our business, operating results and
financial condition could be adversely affected.
Changing laws and increasingly complex corporate governance and
public disclosure requirements could have an adverse effect on our
business and operating results.
Changing laws, regulations and standards relating to corporate
governance and public disclosure and new regulations issued by the
SEC and the New York Stock Exchange ("NYSE") have and will create
additional compliance requirements for us. For example, the
Dodd-Frank Act includes provisions regarding, among other things,
advisory votes on named executive officer compensation and
“conflict minerals” reporting. Complying with these rules and
regulations has increased and will increase our legal and financial
compliance costs, make some activities more difficult,
time-consuming or costly and increase demand on our systems and
resources. As a result, management’s attention may be diverted from
other business concerns, which could adversely affect our business,
financial condition and results of operations. We may also need to
hire additional employees or engage outside consultants to comply
with these requirements, which will increase our costs and
expenses. To maintain high standards of corporate governance and
public disclosure, we have invested in, and intend to continue to
invest in, reasonably necessary resources to comply with evolving
standards.
In addition, stockholder litigation surrounding executive
compensation and disclosure of executive compensation has increased
with the passage of the Dodd-Frank Act. Furthermore, our
stockholders may not continue to approve our advisory vote on named
executive officer compensation that is required to be voted on by
our stockholders annually pursuant to the Dodd-Frank Act. If we are
involved in a lawsuit related to compensation matters or any other
matters not covered by our directors’ and officers’ liability
insurance, we may incur significant expenses in defending against
such lawsuits, or be subject to significant fines or required to
take significant remedial actions, each of which could adversely
affect our business, financial condition and results of
operations.
Changes in the regulation of the internet could adversely affect
our business.
Laws, rules and regulations governing internet communications,
advertising and e-commerce are dynamic, and the extent of future
government regulation is uncertain. Federal and state regulations
govern various aspects of our online business, including
intellectual property ownership and infringement, trade secrets,
the distribution of electronic communications, marketing and
advertising, user privacy and data security, search engines and
internet tracking technologies. Governmental authorities continue
to evaluate the privacy implications inherent in the use of
third-party “cookies” and other methods of online tracking for
behavioral advertising and other purposes. In the U.S., federal and
state governments have enacted, and may in the future enact,
legislation or regulations impacting the ability of companies and
individuals to engage in these activities, such as by regulating
the level of consumer notice and consent required before a company
can employ cookies or other electronic tracking tools or the use of
data gathered with such tools. Additionally, some providers of
consumer devices and web browsers have implemented, or announced
plans to implement, limits on behavioral or targeted advertising
and/or means to make it easier for internet users to prevent the
placement of cookies or to block other tracking technologies, which
could, if widely adopted, result in the decreased effectiveness or
use of third-party cookies and other methods of online tracking,
targeting or re-targeting. The regulation of the use of these
cookies and other current online tracking and advertising practices
or a loss in our ability to make effective use of services that
employ such technologies could increase our costs of operations and
limit our ability to acquire new consumers on cost-effective terms
and consequently, materially and adversely affect our business,
financial condition and results of operations. Further, in the EU
and the UK, regulators are increasingly focusing on compliance with
requirements in the online behavioral advertising ecosystem, and
current national laws that implement the ePrivacy Directive are
highly likely to be replaced by an EU regulation known as the
ePrivacy Regulation, which will significantly increase fines for
non-compliance. In the EU and the UK, informed consent is required
for the placement of a cookie or similar technologies on a user’s
device and for direct electronic marketing. The GDPR also imposes
conditions on obtaining valid consent, such as a prohibition on
pre-checked consents and a requirement to ensure separate consents
are sought for each type of cookie or similar technology. While the
text of the ePrivacy Regulation is still under development, a
recent European court decision and regulators’ recent guidance are
driving increased attention to cookies and tracking technologies.
If regulators start to enforce the strict approach in recent
guidance, this could lead to substantial costs, require significant
systems changes, limit the effectiveness of our marketing
activities, divert the attention of our technology personnel,
adversely affect our margins, increase costs and subject us to
additional liabilities.
Future taxation on the use of the internet or e-commerce
transactions could also be imposed. Existing or future regulation
or taxation could increase our operating expenses and expose us to
significant liabilities. To the extent any such regulations require
us to take actions that negatively impact us, they could have a
material adverse effect on our business, financial condition and
results of operations.
Risks Related to Our Intellectual Property
Our success depends in part on our proprietary technology, and if
we are unable to obtain, maintain or successfully enforce our
intellectual property rights, the commercial value of our products
and services will be adversely affected, our competitive position
may be harmed and we may be unable to operate our business
profitably.
Our intellectual property includes the content of our website, our
software code, our unregistered copyrights, our registered and
unregistered trademarks, and our patents and patent applications.
Our success and ability to compete depend in part on our ability to
maintain and enforce existing intellectual property and to obtain,
maintain and enforce further intellectual property protection for
our products and services, both in the U.S. and in other countries.
We attempt to protect our intellectual property rights through a
combination of patent, trademark, copyright and trade secret laws,
as well as licensing agreements and third-party and employee
confidentiality and assignment agreements. Our intellectual
property rights could also be challenged, invalidated, infringed or
circumvented, or may not be sufficient to permit us to take
advantage of current market trends or to otherwise provide
competitive advantages. If we are unable to adequately protect our
intellectual property rights or if they are challenged or otherwise
prove ineffective, we may be required to undertake costly product
redesign efforts or discontinue certain products, or our
competitive position may be harmed.
We rely on our portfolio of issued and pending patent applications
in the U.S. and other countries to protect our intellectual
property and our competitive position. However, the patent
positions of technology-based companies may involve complex legal
and factual questions, and, therefore, the scope, validity and
enforceability of any patent claims that we may obtain cannot be
predicted with certainty. Accordingly, we cannot provide any
assurances that any of our issued patents have, or that any of our
currently pending or future patent applications that mature into
issued patents will include claims with a scope sufficient to
protect our products and services. Our pending and future patent
applications may not result in the issuance of patents or, if
issued, may not issue in a form that will be advantageous to us.
While we generally apply for patents in those countries where we
intend to make, have made, use or sell patented products and
services, we may not accurately predict all of the countries where
patent protection will ultimately be desirable. If we fail to
timely file for a patent, we may be precluded from doing so at a
later date. Additionally, any patents issued to us may be
challenged, narrowed, invalidated, held unenforceable or
circumvented, or may not be sufficiently broad to prevent third
parties from producing competing products and services similar in
design to our products and services.
In recent years, the U.S. Supreme Court has ruled on several patent
cases and several laws have been enacted that, in certain
situations, potentially narrow the scope of patent protection
available and weaken the rights of patent owners. We may not be
successful in securing additional patents on commercially desirable
improvements, that such additional patents will adequately protect
our innovations or offset the effect of expiring patents, or that
competitors will not be able to design around our patents. In
addition, third parties may challenge our issued patents through
procedures such as Inter-Partes Review (“IPR”). In many IPR
challenges, the U.S. Patent and Trademark Office (“PTO”) cancels or
significantly narrows issued patent claims. IPR challenges could
increase the uncertainties and costs associated with the
maintenance, enforcement and defense of our issued and future
patents and could have a material adverse effect on our business,
financial condition and results of operations.
We also utilize unpatented proprietary technology and know-how and
often rely on confidentiality agreements and intellectual property
assignment agreements with our employees, independent distributors
and consultants to protect and transfer to us such unpatented
proprietary technology and know-how. However, such agreements may
not be enforceable or may not provide meaningful protection for our
proprietary information in the event of unauthorized use or
disclosure or other breaches of the agreements, or in the event
that our competitors discover or independently develop similar or
identical designs or other proprietary information.
We rely on the use of common law copyrights with respect to the
code, algorithms and trade secrets in our business and our products
and services. Common law copyrights provide less protection than
registered copyrights. Copyrights, common law or registered, do not
generally prevent others from independently developing the same or
similar code, algorithms or trade secrets, so our copyrights would
not offer protection against our competitors to the extent they are
able to independently generate similar code, algorithms or trade
secrets as our own. Loss of rights in our copyrights could
adversely affect our business, financial condition and results of
operations.
We rely on the use of registered and common law trademarks with
respect to the brand names of some of our products and services.
Common law trademarks provide less protection than registered
trademarks. If a third party were to register trademarks similar to
our unregistered trademarks in a given jurisdiction, particularly
outside the U.S., our ability to continue using our unregistered
trademarks in the applicable jurisdiction could be substantially
restricted and we may be subject to potentially costly and
burdensome claims for trademark infringement. Loss of rights in our
trademarks could adversely affect our business, financial condition
and results of operations.
If our trademarks and trade names are not adequately protected, we
may not be able to build name recognition in our markets of
interest and our competitive position may be harmed.
We rely on our trademarks, logos, and trade names to distinguish
our products and services from the products and services of our
competitors and have registered or applied to register many of
these trademarks. There can be no assurance that our trademark
applications will be approved. While we generally apply for
trademarks in those countries where we intend to sell our products
and services, we may not accurately predict all of the countries
where registered trademarks will be desirable. We may also fail to
register appropriate localized versions of our trademarks. If we
fail to timely file for a trademark application in a country, we
may be precluded from doing so at a later date and our ability to
sell products and services using our existing brands in such
countries could ultimately be restricted. Third parties may also
oppose our trademark applications or otherwise challenge our use of
the trademarks. In the event that our trademarks are successfully
challenged, we could be forced to rebrand our products and
services, which could result in loss of brand recognition, and
could require us to devote resources to advertising and marketing
new brands. Further, there can be no assurance that competitors
will not infringe our trademarks or that we will have adequate
resources to enforce our trademarks or will be successful in
enforcing our trademarks. If competitors or other third parties use
similar trademarks for similar products and services, the value and
recognition of our brand and trademarks may be diluted or
diminished.
We also license third parties to use our trademarks. In an effort
to preserve our trademark rights, we enter into license agreements
with these third parties, which govern the use of our trademarks
and require our licensees to abide by quality control standards
with respect to the goods and services that they provide under our
trademarks.
Although we make efforts to monitor the use of our trademarks by
our licensees, there can be no assurance that these efforts will be
sufficient to ensure that our licensees abide by the terms of their
licenses. In the event that our licensees fail to do so, our
trademark rights could be diluted. Any of the foregoing could have
a material adverse effect on our competitive position, business,
financial condition, results of operations, and
prospects.
We rely on third-party technology solutions, including software and
software services, to support our IT infrastructure and in our
products and services.
Both our IT infrastructure and our products and services leverage
third-party technology solutions, software and software services.
While much of this third-party technology is commercially
available, off-the-shelf technology procured on standard terms and
conditions, we cannot be assured that the applicable vendors will
continue to make this third-party technology available on the same
terms and conditions. Because this technology has been integrated
into our operations and may have been configured for our specific
needs, replacement of such technology could result in substantial
delay, additional costs, and possible business interruptions. In
addition, if third-party vendors, including any cloud service
providers, were to experience unplanned downtime, delays or other
similar issues, our products, services and internal operations
could be significantly and adversely impacted.
Increased use of social media could create or amplify the effects
of negative publicity and adversely affect sales and operating
results.
As part of our marketing efforts, we rely on search engine
marketing and social media platforms to attract and retain
customers. These efforts may not be successful, and pose a variety
of other risks, including the improper disclosure of proprietary
information, the posting of negative comments about our brand, the
exposure of personally identifiable information, fraud, use of
out-of-date information or failure to comply with regulations
regarding such practices. Negative or false commentary about us or
our products or services may be posted on social media platforms
and may harm our reputation or business and social media has also
given users the ability to more effectively organize collective
actions, such as boycotts, which could be taken against us or our
products or services. Customers value readily available information
and often act on such information without affording us an
opportunity for redress or correction. The inappropriate use of
social media vehicles, including a failure to abide by applicable
laws and regulations, in the use of social media by us or our
influencers, employees, contractors, suppliers, customers or other
third parties associated or perceived to be associated with us
could increase our costs, lead to litigation, fines or regulatory
action or result in negative publicity that could damage our
reputation. The occurrence of any such developments could have an
adverse effect on our business results.
In addition, events such as the Warning Letter reported in the
media, including social media, whether or not accurate or involving
us or our products or services, could create or amplify negative
publicity for us or for the industry or market segments in which we
operate. These and other types of social media risks could reduce
demand for products and services offered by us and/or shift
consumer preferences to competitors and could result in a decrease
in customer demand for our products and services.
If we fail to execute enforceable invention assignment and
confidentiality agreements with our employees and contractors
involved in the development of intellectual property or are unable
to protect the confidentiality of our trade secrets, the value of
our products and services and our business and competitive position
could be harmed.
In addition to patent protection, we also rely on protection of
copyrights, trade secrets, know-how and confidential and
proprietary information. We generally enter into confidentiality
and invention assignment agreements with our employees, consultants
and third parties upon their commencement of a relationship with
us. However, we may not enter into such agreements with all
employees, consultants and third parties who have been involved in
the development of our intellectual property and such agreements
may not be enforceable in accordance with the terms in every
jurisdiction where such employees, consultants or third parties
reside or are employed. In addition, these agreements may not
provide meaningful protection against the unauthorized use or
disclosure of our trade secrets or other confidential information,
and adequate remedies may not exist if unauthorized use or
disclosure were to occur. The exposure of our trade secrets and
other proprietary information would impair our competitive
advantages and could have a material adverse effect on our
business, financial condition and results of operations. In
particular, a failure to protect our proprietary rights may allow
competitors to copy our technology, which could adversely affect
our pricing and market share. Further, other parties may
independently develop substantially equivalent know-how and
technology.
In addition to contractual measures, we try to protect the
confidential nature of our proprietary information using commonly
accepted physical and technological security measures. Such
measures may not, for example, in the case of misappropriation of a
trade secret by an employee or third party with authorized access,
provide adequate protection for our proprietary information. Our
security measures may not prevent an employee or consultant from
misappropriating our trade secrets and providing them to a
competitor, and recourse we take against such misconduct may not
provide an adequate remedy to protect our interests fully.
Unauthorized parties may also attempt to copy or reverse engineer
certain aspects of our products and services that we consider
proprietary and a trade secret. Enforcing a claim that a party
illegally disclosed or misappropriated a trade secret can be
difficult, expensive and time-consuming, and the outcome is
unpredictable. Even though we use commonly accepted security
measures, trade secret violations are often a matter of state law,
and the criteria for protection of trade secrets can vary among
different jurisdictions. In addition, trade secrets may be
independently developed by others in a manner that could prevent
legal recourse by us. We also have agreements with our employees,
consultants and third parties that obligate them to assign their
inventions to us, however these agreements may not be
self-executing, not all employees or consultants may enter into
such agreements, or employees or consultants may breach or violate
the terms of these agreements, and we may not have adequate
remedies for any such breach or violation. If any of our
intellectual property or confidential or proprietary information,
such as our trade secrets, were to be disclosed or misappropriated,
or if any such information was independently developed by a
competitor, it could have a material adverse effect on our
competitive position, business, financial condition, results of
operations, and prospects.
The laws of foreign countries may not adequately protect our
intellectual property rights.
Intellectual property protection laws in foreign jurisdictions
differ substantially from those in the U.S. If we fail to apply for
intellectual property protection in foreign jurisdictions, or if we
cannot adequately protect our intellectual property rights in these
foreign jurisdictions, our competitors may be able to compete more
effectively against us, which could adversely affect our
competitive position, as well as our business, financial condition
and results of operations.
If third parties claim that we infringe their intellectual property
rights, we may incur liabilities and costs and may have to redesign
or discontinue selling certain products and services.
Searching for existing third-party intellectual property rights and
evaluating its applicability to our products and services can be a
costly and time-consuming process. Such searches and evaluation may
not reveal important intellectual property and our competitors may
also have filed for patent protection, which may not be publicly
available information, or claimed trademark rights that have not
been revealed through our searches. We may not undertake such
searches and evaluation of third-party intellectual property rights
and, as a result, may not be aware of intellectual property rights
that could be asserted against our products or services. In
addition, some of our employees were previously employed at other
consumer product, medical device and Internet of Things/smart
device companies. We may be subject to claims that our employees
have disclosed, or that we have used, trade secrets or other
proprietary information of our employees’ former employers. Our
efforts to identify and avoid infringing on third parties’
intellectual property rights may not always be successful. Any
claims of patent or other intellectual property infringement
against us, even those without merit, could:
•be
expensive and time-consuming to defend and result in payment of
significant damages to third parties;
•force
us to stop making or selling products and services that incorporate
the intellectual property;
•require
us to redesign, reengineer or rebrand our products and services,
product candidates and technologies;
•require
us to enter into royalty agreements that would increase the costs
of our products and services;
•require
us to indemnify third parties pursuant to contracts in which we
have agreed to provide indemnification for intellectual property
infringement claims;
•divert
the attention of our management and other key employees;
and
•result
in our customers or potential customers deferring or limiting their
purchase or use of the affected products and services impacted by
the claims until the claims are resolved;
any of which could have a material adverse effect on our business,
financial condition and results of operations. In addition, new
patents obtained by our competitors could threaten the continued
commercialization of our products and services in the market even
after they have already been introduced.
We may become involved in lawsuits to protect or enforce our
intellectual property, which could be expensive, time consuming and
unsuccessful.
Third parties, including our competitors, could be infringing,
misappropriating or otherwise violating our intellectual property
rights. We do not regularly conduct monitoring for unauthorized use
at this time. From time to time, we seek to analyze our
competitors’ products and services, or seek to enforce our rights
against potential infringement, misappropriation or violation of
our intellectual property. However, the steps we have taken, or
take in the future, to protect our proprietary rights may not be
adequate to enforce our rights as against such infringement,
misappropriation or violation of our intellectual property. We may
not be able to detect unauthorized use of, or take appropriate
steps to enforce, our intellectual property rights. Any inability
to meaningfully enforce our intellectual property rights could harm
our ability to compete and reduce demand for our products and
services.
We believe some of the new market entrants in our industry,
including some of the world’s largest technology companies, may in
the future infringe our intellectual property, and we may be
required to engage in litigation to protect or enforce our
intellectual property rights. An adverse result in any litigation
proceeding could harm our business. In any lawsuit we bring to
enforce our intellectual property rights, a court may refuse to
stop the other party from using the technology at issue on grounds
that our intellectual property rights do not cover the technology
or actions in question. If we initiate legal proceedings against a
third party to enforce a patent covering a product, the defendant
could counterclaim that such patent is invalid or unenforceable. In
patent litigation in the U.S., defendant counterclaims alleging
invalidity or unenforceability are commonplace.
Grounds for a validity challenge could be an alleged failure to
meet any of several statutory requirements, including lack of
novelty, obviousness, or non-enablement. Grounds for an
unenforceability assertion could be an allegation that someone
connected with prosecution of the patent withheld relevant
information from the PTO, or made a misleading statement, during
prosecution. Mechanisms for such challenges include re-examination,
post-grant review, IPR, interference proceedings, derivation
proceedings, and equivalent proceedings in foreign jurisdictions
(e.g., opposition proceedings). Such proceedings could result in
the revocation of, cancellation of, or amendment to our patents in
such a way that they no longer cover our products and services, or
any future products and services that we may develop.
The outcome following legal assertions of invalidity and
unenforceability is unpredictable. With respect to the validity
question, for example, we cannot be certain that there is no
invalidating prior art, of which we and the patent examiner were
unaware during prosecution. If a third party were to prevail on a
legal assertion of invalidity or unenforceability, we would lose at
least part, and perhaps all, of the patent protection on our
products and services. Such a loss of patent protection would have
a material adverse impact on our business, financial condition,
results of operations, and prospects.
Because of the substantial amount of discovery required in
connection with intellectual property litigation, there is a risk
that some of our confidential information could be compromised by
disclosure during litigation. There could also be public
announcements of the results of hearing, motions, or other interim
developments. If securities analysts or investors perceive these
results to be negative, it could have a material adverse effect on
the price of shares of our common stock. Even if we ultimately
prevail, a court may decide not to grant an injunction against
further infringing activity and instead award only monetary
damages, which may not be an adequate remedy. Furthermore, the
monetary cost of such litigation and the diversion of the attention
of our management could outweigh any benefit we receive as a result
of the proceedings. Uncertainties resulting from the initiation and
continuation of patent litigation or other proceedings could have a
material adverse effect on our business.
We may be subject to claims that we or our employees have
misappropriated the intellectual property of a third party,
including trade secrets or know-how, or are in breach of
non-competition or non-solicitation agreements with our competitors
and third parties may claim an ownership interest in intellectual
property we regard as our own.
Many of our employees and consultants were previously employed at
or engaged by other companies, including our competitors or
potential competitors. Some of these employees, consultants and
contractors may have executed
proprietary rights, non-disclosure and non-competition agreements
in connection with such previous employment. Although we try to
ensure that our employees and consultants do not use the
intellectual property, proprietary information, know-how or trade
secrets of others in their work for us, we may be subject to claims
that we or these individuals have, inadvertently or otherwise,
misappropriated the intellectual property or disclosed the alleged
trade secrets or other proprietary information, of these former
employers, competitors or other third parties. Additionally, we may
be subject to claims from third parties challenging our ownership
interest in or inventorship of intellectual property we regard as
our own, based on claims that our agreements with employees or
consultants obligating them to assign intellectual property to us
are ineffective or in conflict with prior or competing contractual
obligations to assign inventions to another employer, to a former
employer, or to another person or entity. Litigation may be
necessary to defend against claims, and it may be necessary or we
may desire to enter into a license to settle any such claim;
however, there can be no assurance that we would be able to obtain
a license on commercially reasonable terms, if at all. If our
defense to those claims fails, in addition to paying monetary
damages or a settlement payment, a court could prohibit us from
using technologies, features or other intellectual property that
are essential to our products and services, if such technologies or
features are found to incorporate or be derived from the trade
secrets or other proprietary information of the former employers.
An inability to incorporate technologies, features or other
intellectual property that are important or essential to our
products and services could have a material adverse effect on our
business and competitive position, and may prevent us from selling
our products and services. In addition, we may lose valuable
intellectual property rights or personnel. Even if we are
successful in defending against these claims, litigation could
result in substantial costs and could be a distraction to
management. Any litigation or the threat thereof may adversely
affect our ability to hire employees or contract with independent
sales representatives. A loss of key personnel or their work
product could hamper or prevent our ability to commercialize our
products and services, which could materially and adversely affect
our business, financial condition, operating results, cash flows
and prospects.
Our proprietary software may not operate properly, which could
damage our reputation, give rise to claims against us, or divert
application of our resources from other purposes, any of which
could harm our business and operating results.
Proprietary software and hardware development is time-consuming,
expensive and complex, and may involve unforeseen difficulties. We
may encounter technical obstacles, and it is possible that we
discover additional problems or design defects that prevent our
proprietary software from operating properly. We have experienced
product design issues in the past and continue to work to address
those and anticipate additional concerns. If our services do not
function reliably, malfunction, or fail to achieve customer
expectations in terms of performance, customers could assert
liability claims against us or attempt to cancel their contracts
with us. This could damage our reputation and impair our ability to
attract or maintain customers.
The software underlying our products and services is highly complex
and may contain undetected errors or vulnerabilities, some of which
may only be discovered after our products and services have been
used by our customers. Any real or perceived errors, failures, bugs
or other vulnerabilities discovered in our products or services
could result in negative publicity and damage to our reputation,
loss of customers, loss of or delay in market acceptance of our
products and services, loss of competitive position, loss of
revenue or liability for damages, fines or regulatory actions,
overpayments or underpayments, any of which could harm our
enrollment rates. Similarly, any real or perceived errors,
failures, design flaws or defects in our devices could have similar
negative results. In such an event, we may be required or may
choose to expend additional resources in order to help correct the
problem. Such efforts could be costly, or ultimately unsuccessful.
Even if we are successful at remediating issues, we may experience
damage to our reputation and brand. There can be no assurance that
provisions typically included in our agreements with partners that
attempt to limit our exposure to claims would be enforceable or
adequate or would otherwise protect us from liabilities or damages
with respect to any particular claim. Even if unsuccessful, a claim
brought against us by any customers or partners would likely be
time-consuming and costly to defend and could seriously damage our
reputation and brand.
Risks Related to Our Common Stock and Warrants
The price of our common stock and warrants may be
volatile.
The price of our common stock and warrants may fluctuate due to a
variety of factors, including:
•actual
or anticipated fluctuations in our operating results or future
prospects;
•our
announcements or our competitors’ announcements of new products and
services;
•the
public’s reaction to our press releases, our other public
announcements and our filings with the SEC;
•strategic
actions by us or our competitors, such as acquisitions or
restructurings;
•new
laws or regulations or new interpretations of existing laws or
regulations applicable to our business;
•regulatory
or other governmental actions such as the Warning Letter issued to
us on October 1, 2021, and actions taken in response to those
actions;
•changes
in accounting standards, policies, guidance, interpretations or
principles;
•changes
in our growth rates or our competitors’ growth rates;
•developments
regarding our patents or proprietary rights or those of our
competitors;
•ongoing
legal proceedings;
•commencement
of, or involvement in, litigation involving the combined
company;
•our
ability to raise additional capital as needed;
•changes
in our capital structure, such as future issuances of securities or
the incurrence of new or additional debt;
•the
volume of shares of common stock available for public sale and the
size of our public float;
•conversion
of our outstanding Series A Convertible Preferred Stock and
exercise of our outstanding warrants, and the resale of such shares
into the market;
•additions
and departures of key personnel;
•concerns
or allegations as to the safety or efficacy of our products and
services;
•sales
of stock by us or members of our management team, our board of
directors (the “Board”) or certain significant
stockholders;
•changes
in stock market analyst recommendations or earnings estimates
regarding our stock, other comparable companies or our industry
generally; and
•changes
in financial markets or general economic conditions, including the
effects of recession or slow economic growth in the U.S. and
abroad, interest rates, fuel prices, international currency
fluctuations, corruption, political instability, acts of war,
including the Russian Federation's invasion of Ukraine in February
2022, acts of terrorism, and the COVID-19 pandemic or other public
health crises.
These market and industry factors may materially reduce the market
price of our common stock and warrants regardless of our operating
performance.
An active, liquid trading market for our common stock may not be
sustained.
There can be no assurance that we will be able to maintain an
active trading market for our common stock on the NYSE or any other
exchange. On November 29, 2022, we were notified by the NYSE that
we are not in compliance with Section 802.01C of the NYSE Listed
Company Manual because the average closing price of our common
stock was less than $1.00 over a consecutive 30-trading-day period.
Under NYSE rules, we have a period of six months from receipt of
the NYSE Notification or our 2023 annual meeting of stockholders to
cure the stock price deficiency and regain compliance with the
NYSE’s continued listing standards. The notice has no immediate
impact on the listing of our common stock, which will continue to
be listed and traded on the NYSE during the period allowed to
regain compliance, subject to our compliance with other listing
standards. We informed the NYSE that we intend to cure the
deficiency and to return to compliance with the NYSE continued
listing requirements. If an active market for our common stock is
not maintained, or if we fail to satisfy the continued listing
standards of the NYSE for any reason and our common stock is
delisted, it may be difficult for our stockholders to sell their
common stock without depressing the market price for our common
stock, or at all. Further, an inactive trading market may also
impair our ability to raise capital by selling our securities or to
attract and motivate employees through equity incentive
awards.
If securities or industry analysts issue an adverse or misleading
opinion regarding our common stock or warrants, the price and
trading volume of our common stock and warrants could
decline.
The trading market for our common stock and warrants will be
influenced by the research and reports that industry or securities
analysts publish about us or our business. We currently have
limited research coverage by securities and industry analysts. If
any of the analysts who cover us issue an adverse or misleading
opinion regarding us, our business model, our intellectual property
or the performance of our common stock or warrants, or if our
operating results fail to meet the expectations of analysts, the
price of our common stock and warrants would likely decline. If one
or more of these analysts cease coverage of us or fail to publish
reports on us regularly, we could lose visibility in the financial
markets, which in turn could cause the price and trading volume of
our common stock and warrants to decline.
Concentration of ownership among our existing directors, executive
officers and principal stockholders may prevent new investors from
influencing significant corporate decisions.
Our directors and executive officers and their affiliates
beneficially own a significant amount of our common stock. Subject
to any fiduciary duties owed to our other stockholders under
Delaware law, these stockholders may be able to exercise
significant influence over matters requiring stockholder approval,
including the election of directors and approval of significant
corporate transactions, and will have some control over our
management and policies. Some of these persons or entities may have
interests that are different from yours. For example, these
stockholders may support proposals and actions with which you may
disagree or which are not in your best interests. The concentration
of ownership could delay or prevent a change in control of us, or
otherwise discourage a potential acquirer from attempting to obtain
control of us, which in turn could reduce the price of our
stock.
In addition, these stockholders could use their voting influence to
maintain our existing management and directors in office or support
or reject other management and Board proposals that are subject to
stockholder approval, such as amendments to our employee stock
plans and approvals of significant financing
transactions.
We may acquire other businesses or form other joint ventures or
make investments in other companies or technologies that could
negatively affect our operating results, dilute our stockholders’
ownership, increase our debt or cause us to incur significant
expense.
We may pursue acquisitions of businesses and assets. We also may
pursue strategic alliances and additional joint ventures that
leverage our technology and industry experience to expand our
offerings or distribution. We have no experience with acquiring
other companies and limited experience with forming strategic
partnerships. We may not be able to find suitable partners or
acquisition candidates, and we may not be able to complete such
transactions on favorable terms, if at all. If we make any
acquisitions, we may not be able to integrate these acquisitions
successfully into our existing business, and we could assume
unknown or contingent liabilities. Any future acquisitions also
could result in the incurrence of debt, contingent liabilities or
future write-offs of intangible assets or goodwill, any of which
could have a material adverse effect on our financial condition,
results of operations and cash flows. Integration of an acquired
company also may disrupt ongoing operations and require management
resources that we would otherwise focus on developing our existing
business. We may experience losses related to investments in other
companies, which could have a material negative effect on our
results of operations and financial condition. We may not realize
the anticipated benefits of any acquisition, technology license,
strategic alliance or joint venture. To finance any acquisitions or
joint ventures, we may choose to issue shares of our common stock
as consideration, which would dilute the ownership of our
stockholders. Additional funds may not be available on terms that
are favorable to us, or at all. If the price of our common stock is
low or volatile, we may not be able to acquire other companies or
fund a joint venture project using our stock as
consideration.
We also expect to continue to carry out internal strategic
initiatives that we believe are necessary to grow our revenues and
expand our business, both in the U.S. and abroad. For example, we
have continued to invest in international expansion programs
designed to increase our worldwide presence and take advantage of
market expansion opportunities around the world. Although we
believe our investments in these initiatives continue to be in the
long-term best interests of Owlet and our stockholders, there are
no assurances that such initiatives will yield favorable results
for us. Accordingly, if these initiatives are not successful, our
business, financial condition and results of operations could be
adversely affected.
If these risks materialize, our stock price could be materially
adversely affected. Any difficulties in the integration of acquired
businesses or unexpected penalties, liabilities or asset
impairments in connection with such acquisitions or investments
could have a material adverse effect on our business, financial
condition and results of operations.
The obligations associated with being a public company involve
significant expenses and require significant resources and
management attention, which may divert from our business
operations.
We are subject to the reporting requirements of the Exchange Act
and the Sarbanes-Oxley Act. The Exchange Act requires that we file
annual, quarterly and current reports with respect to our business
and financial condition. The Sarbanes-Oxley Act requires, among
other things, that we establish and maintain effective internal
control over financial reporting. As a result, we will incur
increased legal, accounting and other expenses that we did not
previously incur. Our entire management team and many of our other
employees will need to devote substantial time to compliance and
may not effectively or efficiently manage our operation as a public
company.
In addition, the need to establish the corporate infrastructure
demanded of a public company may also divert management’s attention
from implementing our business strategy, which could prevent us
from improving our business, results of operations and financial
condition. We have made, and will continue to make, changes to our
internal control over financial reporting, including IT controls,
and procedures for financial reporting and accounting systems to
meet our reporting obligations as a public company. However, the
measures we take may not be sufficient to satisfy our obligations
as a public company. If we do not continue to develop and implement
the right processes and tools to manage our changing enterprise and
maintain our culture, our ability to compete successfully and
achieve our business objectives could be impaired, which could
negatively impact our business, financial
condition and results of operations. In addition, we cannot predict
or estimate the amount of additional costs we may incur to comply
with these requirements. We anticipate that these costs will
materially increase our general and administrative
expenses.
These rules and regulations result in our incurring legal and
financial compliance costs and will make some activities more
time-consuming and costly. For example, we expect these rules and
regulations to make it more difficult and more expensive for us to
obtain director and officer liability insurance, and we may be
required to accept reduced policy limits and coverage or incur
substantially higher costs to obtain the same or similar coverage.
As a result, it may be more difficult for us to attract and retain
qualified people to serve on our Board, on our Board committees or
as executive officers.
As a public reporting company, we are subject to rules and
regulations established from time to time by the SEC regarding our
internal control over financial reporting. If we fail to establish
and maintain effective internal control over financial reporting
and disclosure controls and procedures, we may not be able to
accurately report our financial results or report them in a timely
manner.
We are subject to the rules and regulations established from time
to time by the SEC and NYSE. These rules and regulations require,
among other things that we establish and periodically evaluate
procedures with respect to our internal control over financial
reporting. Reporting obligations as a public company are likely to
place a considerable strain on our financial and management
systems, processes and controls, as well as on our
personnel.
In addition, as a public company, we are required to document and
test our internal control over financial reporting pursuant to
Section 404 of the Sarbanes-Oxley Act so that our management can
certify as to the effectiveness of our internal control over
financial reporting.
Unstable market and economic conditions may have serious adverse
consequences on our business, financial condition and stock
price.
The global economy, including credit and financial markets, has
recently experienced extreme volatility and disruptions, including,
for example, severely diminished liquidity and credit availability,
rising interest and inflation rates, crises involving banking and
financial institutions, declines in consumer confidence, declines
in economic growth, increases in unemployment rates and uncertainty
about economic stability. If the equity and credit markets continue
to deteriorate, or the United States enters a recession, it may
make any necessary debt or equity financing more difficult to
obtain in a timely manner or on favorable terms, more costly or
more dilutive. In addition, there is a risk that one or more of our
suppliers or other third-party providers may not survive an
economic downturn or recession. As a result, our business, results
of operations and price of our common stock may be adversely
affected.
The increasing focus on environmental sustainability and social
initiatives could increase our costs, harm our reputation and
adversely impact our financial results.
There has been increasing public focus by investors, patients,
environmental activists, the media and governmental and
nongovernmental organizations on a variety of environmental, social
and other sustainability matters. We may experience pressure to
make commitments relating to sustainability matters that affect us,
including the design and implementation of specific risk mitigation
strategic initiatives relating to sustainability. Expectations
regarding the management of ESG initiatives continues to evolve
rapidly. While we may from time to time engage in various
initiatives (including but not limited to voluntary disclosures,
policies, or goals) to improve our ESG profile or respond to
stakeholder expectations, we cannot guarantee that these
initiatives will have the desired effect. If we are not effective
in addressing environmental, social and other sustainability
matters affecting our business, or setting and meeting relevant
sustainability goals, our reputation and financial results may
suffer. In addition, even if we are effective at addressing such
concerns, we may experience increased costs as a result of
executing upon our sustainability goals that may not be offset by
any benefit to our reputation, which could have an adverse impact
on our business and financial condition. In addition, this emphasis
on environmental, social and other sustainability matters has
resulted and may result in the adoption of new laws and
regulations, including new reporting requirements. If we fail to
comply with new laws, regulations or reporting requirements, our
reputation and business could be adversely impacted.
Because we do not anticipate paying any cash dividends on our
capital stock in the foreseeable future, capital appreciation, if
any, will be your sole source of gain.
We have never declared or paid cash dividends on our capital stock.
We currently intend to retain all of our future earnings, if any,
to finance the growth and development of our business. In addition,
under certain circumstances, our loan and security agreement
preclude us from paying dividends, and the terms of our Series A
Convertible Preferred Stock preclude us from paying dividends
without the consent of the holders of at least a majority of
the
outstanding shares of Series A Convertible Preferred Stock. As a
result, capital appreciation, if any, of our common stock will be
your sole source of gain for the foreseeable future.
The redemption of our outstanding Series A Convertible Preferred
Stock on or after February 17, 2028 may require us to make a
significant cash payment.
At any time from and after February 17, 2028, the holders of at
least a majority of our then outstanding shares of Series A
Convertible Preferred Stock may specify a date and time or the
occurrence of an event by vote or written consent that all, and not
less than all, of such outstanding shares will automatically be:
(i) converted into shares of common stock at the conversion rate
then in effect, (ii) subject to certain exceptions and limitations,
redeemed for an amount per share of Series A Preferred Stock equal
to the liquidation preference of $1,000 per share plus all accrued
or declared but unpaid dividends as of the redemption date and time
or (iii) a combination of the foregoing.
Our corporate documents and Delaware law contain provisions that
could discourage, delay or prevent a change in control of our
company, prevent attempts to replace or remove current management
and reduce the market price of our common stock and
warrants.
Provisions in our certificate of incorporation and bylaws may
discourage, delay or prevent a merger or acquisition involving us
that our stockholders may consider favorable. For example, our
certificate of incorporation and bylaws authorize our Board to
issue up to 100 million shares of preferred stock. As a result,
without further stockholder approval, our Board will have the
authority to attach special rights, including voting and dividend
rights, to this preferred stock, including pursuant to a
stockholder rights plan. With these rights, preferred stockholders
could make it more difficult for a third-party to acquire us. In
addition, our certificate of incorporation and bylaws provide for a
staggered Board, whereby directors serve for three-year terms, with
one-third of the directors coming up for reelection each year. A
staggered Board will make it more difficult for a third-party to
obtain control of our Board through a proxy contest, which may be a
necessary step in an acquisition of us that is not favored by our
Board. We are also subject to anti-takeover provisions under the
Delaware General Corporation Law ("DGCL"). Under these provisions,
if anyone becomes an “interested stockholder,” we may not enter
into a “business combination” with that person for three years
without special approval, which could discourage a third-party from
making a takeover offer and could delay or prevent a change in
control of us. For purposes of these provisions, an “interested
stockholder” generally means someone owning 15% or more of our
outstanding voting stock or an affiliate of ours that owned 15% or
more of our outstanding voting stock during the past three years,
subject to certain exceptions as described in the
DGCL.
We are an “emerging growth company” and the reduced disclosure
requirements applicable to emerging growth companies may make our
common stock and warrants less attractive to
investors.
We are an “emerging growth company,” as defined in the JOBS Act. As
an emerging growth company, we may follow reduced disclosure
requirements and do not have to make all of the disclosures that
public companies that are not emerging growth companies do. We will
remain an emerging growth company until the earlier of (a) the last
day of the fiscal year in which we have total annual gross revenues
of $1.235 billion or more; (b) December 31, 2025; (c) the date on
which we have issued more than $1.0 billion in nonconvertible debt
during the previous three years; or (d) the date on which we are
deemed to be a large accelerated filer under the rules of the SEC,
which means the market value of our Common Stock that is held by
non-affiliates exceeds $700.0 million as of the prior June 30th.
For so long as we remain an emerging growth company, we are
permitted and intend to rely on exemptions from certain disclosure
requirements that are applicable to other public companies that are
not emerging growth companies. These exemptions
include:
•not
being required to comply with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act;
•not
being required to comply with any requirement that may be adopted
by the Public Company Accounting Oversight Board regarding
mandatory audit firm rotation or a supplement to the auditor’s
report providing additional information about the audit and the
consolidated financial statements (i.e., an auditor discussion and
analysis)
•reduced
disclosure obligations regarding executive compensation in our
periodic reports, proxy statements and registration statements;
and
•exemptions
from the requirements of holding a nonbinding advisory vote of
stockholders on executive compensation, stockholder approval of any
golden parachute payments not previously approved and having to
disclose the ratio of the compensation of our chief executive
officer to the median compensation of our employees.
In addition, the JOBS Act provides that an emerging growth company
can take advantage of an extended transition period for complying
with new or revised accounting standards. This allows an emerging
growth company to delay the adoption of certain accounting
standards until those standards would otherwise apply to private
companies. We
have elected to use the extended transition period for complying
with new or revised accounting standards; and as a result of this
election, our consolidated financial statements may not be
comparable to companies that comply with public company effective
dates.
We may choose to take advantage of some, but not all, of the
available exemptions for emerging growth companies. We cannot
predict whether investors will find our common stock or warrants
less attractive if we rely on these exemptions. If some investors
find our common stock or warrants less attractive as a result,
there may be a less active trading market for our common stock and
warrants and our share and warrant price may be more
volatile.
Our bylaws provide that the state or federal courts located within
the State of Delaware are the exclusive forum for substantially all
disputes between us and our stockholders, which could limit our
stockholders’ ability to obtain a favorable judicial forum for
disputes with us or our directors, officers or
employees.
Our bylaws provide that the state or federal courts located within
the State of Delaware are the sole and exclusive forum for: (i) any
derivative action, suit or proceeding brought on our behalf, (ii)
any action, suit or proceeding asserting a claim of breach of
fiduciary duty owed by any of our directors, officers or
stockholders to our stockholders, (iii) any action, suit or
proceeding asserting a claim against us arising pursuant to any
provision of the DGCL, our bylaws, or (iv) any action, suit or
proceeding asserting a claim governed by the internal affairs
doctrine. However, this choice of forum provision does not apply to
(a) actions in which the Court of Chancery in the State of Delaware
concludes that an indispensable party is not subject to the
jurisdiction of Delaware courts, or (b) actions in which a federal
court has assumed exclusive jurisdiction to a proceeding. This
choice of forum provision is not intended to apply to any actions
brought under the Exchange Act. Section 27 of the Exchange Act
creates exclusive federal jurisdiction over all suits brought to
enforce any duty or liability created by the Exchange Act or the
rules and regulations thereunder. As a result, the exclusive forum
provision will not apply to suits brought to enforce any duty or
liability created by the Exchange Act or any other claim for which
the federal courts have exclusive jurisdiction. Our bylaws also
provide that the federal district courts of the U.S. of America
will be the exclusive forum for the resolution of any complaint
asserting a cause of action arising under the Securities Act of
1933, as amended (the Securities Act). This choice of forum
provision may limit a stockholder’s ability to bring a claim in a
judicial forum that it finds favorable for disputes with us or our
directors, officers or other employees or stockholders, which may
discourage such lawsuits against us and our directors, officers and
other employees or stockholders.
Furthermore, the enforceability of similar choice of forum
provisions in other companies’ certificates of incorporation has
been challenged in legal proceedings, and it is possible that a
court could find these types of provisions to be inapplicable or
unenforceable. If a court were to find the choice of forum
provision in our bylaws to be inapplicable or unenforceable in an
action, we may incur additional costs associated with resolving
such action in other jurisdictions, which could adversely affect
our business, financial condition and results of
operations.
You may only be able to exercise our public warrants on a “cashless
basis” under certain circumstances, and if you do so, you will
receive fewer shares of common stock from such exercise than if you
were to exercise such warrants for cash.
In the following circumstances holders of warrants who seek to
exercise their warrants will not be permitted to do so for cash and
will, instead, be required to do so on a cashless basis in
accordance with Section 3(a)(9) of the Securities Act: (i) if the
shares of common stock issuable upon exercise of the warrants are
not registered under the Securities Act in accordance with the
terms of the warrant agreement; (ii) if we have so elected and the
shares of common stock are at the time of any exercise of a warrant
not listed on a national securities exchange such that they satisfy
the definition of “covered securities” under Section 18(b)(1) of
the Securities Act; and (iii) if we have so elected and we call the
public warrants for redemption. If you exercise your public
warrants on a cashless basis, you would pay the warrant exercise
price by surrendering the warrants for that number of shares of
common stock equal to (A) the quotient obtained by dividing (x) the
product of the number of shares of common stock underlying the
warrants, multiplied by the excess of the “Fair Market Value” (as
defined in the next sentence) over the exercise price of the
warrants by (y) the Fair Market Value and (B) 0.361 per whole
warrant. The “Fair Market Value” is the average reported last sale
price of the common stock as reported for the 10 trading day period
ending on the trading day prior to the date on which the notice of
exercise is received by the warrant agent or on which the notice of
redemption is sent to the holders of warrants, as applicable. As a
result, you would receive fewer shares of common stock from such
exercise than if you were to exercise such warrants for
cash.
We may amend the terms of the warrants in a manner that may have an
adverse effect on holders of public warrants with the approval by
the holders of at least 50% of the then outstanding public
warrants. As a result, the exercise price of your warrants could be
increased, the exercise period could be shortened and the number of
shares of common stock purchasable upon exercise of a warrant could
be decreased, all without your approval.
Our warrants were issued in registered form under a warrant
agreement between Continental Stock Transfer & Trust Company
(the "Warrant Agreement"), as warrant agent, and us. The Warrant
Agreement provides that the terms of the warrants may be amended
without the consent of any holder for the purpose of (i) curing any
ambiguity or curing, correcting or supplementing any defective
provision or (ii) adding or changing any provisions with respect to
matters or questions arising under the Warrant Agreement as the
parties to the Warrant Agreement may deem necessary or desirable
and that the parties deem to not adversely affect the interests of
the registered holders of the warrants, provided that the approval
by the holders of at least 50% of the then-outstanding public
warrants is required to make any change that adversely affects the
rights of the registered holders of public warrants. Accordingly,
we may amend the terms of the public warrants in a manner adverse
to a holder of public warrants if holders of at least 50% of the
then outstanding public warrants approve of such amendment.
Although our ability to amend the terms of the public warrants with
the consent of at least 50% of the then outstanding public warrants
is unlimited, examples of such amendments could be amendments to,
among other things, increase the exercise price of the warrants,
convert the warrants into cash or shares, shorten the exercise
period or decrease the number of shares of common stock purchasable
upon exercise of a warrant.
Our Warrant Agreement designates the courts of the State of New
York or the U.S. District Court for the Southern District of New
York as the sole and exclusive forum for certain types of actions
and proceedings that may be initiated by holders of the warrants,
which could limit the ability of warrant holders to obtain a
favorable judicial forum for disputes with us.
Our Warrant Agreement provides that, subject to applicable law, (i)
any action, proceeding or claim against us arising out of or
relating in any way to the Warrant Agreement, including under the
Securities Act, will be brought and enforced in the courts of the
State of New York or the U.S. District Court for the Southern
District of New York, and (ii) that we irrevocably submit to such
jurisdiction, which jurisdiction shall be the exclusive forum for
any such action, proceeding or claim. We will waive any objection
to such exclusive jurisdiction and that such courts represent an
inconvenient forum. Notwithstanding the foregoing, these provisions
of the Warrant Agreement will not apply to suits brought to enforce
any liability or duty created by the Exchange Act or any other
claim for which the federal district courts of the U.S. are the
sole and exclusive forum.
This choice-of-forum provision may limit a warrant holder’s ability
to bring a claim in a judicial forum that it finds favorable for
disputes with us, which may discourage such lawsuits.
Alternatively, if a court were to find this provision of our
Warrant Agreement inapplicable or unenforceable with respect to one
or more of the specified types of actions or proceedings, we may
incur additional costs associated with resolving such matters in
other jurisdictions, which could materially and adversely affect
our business, financial condition and results of operations and
result in a diversion of the time and resources of our management
and Board.
We may redeem your unexpired warrants prior to their exercise at a
time that is disadvantageous to you, thereby making your warrants
worthless.
We have the ability to redeem outstanding warrants at any time
after they become exercisable and prior to their expiration, (a) at
a price of $0.01 per warrant, provided that the closing price of
our common stock equals or exceeds $18.00 per share (as adjusted
for share splits, share capitalizations, reorganizations,
recapitalizations and the like) for any 20 trading days within a 30
trading-day period ending on the third trading day prior to the
date on which we give proper notice of such redemption to the
warrant holders and provided certain other conditions are met, or
(b) at a price of $0.10 per warrant, provided that the closing
price of our common stock equals or exceeds $10.00 per share (as
adjusted for share splits, share capitalizations, reorganizations,
recapitalizations and the like) for any 20 trading days within a 30
trading-day period ending on the third trading day prior to the
date on which we give proper notice of such redemption to the
warrant holders and provided certain other conditions are met. If
and when the warrants become redeemable by us, we may exercise our
redemption right even if we are unable to register or qualify the
underlying securities for sale under all applicable state
securities laws. Redemption of the
outstanding warrants could force you to (i) exercise your warrants
and pay the exercise price therefor at a time when it may be
disadvantageous for you to do so, (ii) sell your warrants at the
then-current market price when you might otherwise wish to hold
your warrants or (iii) accept the nominal redemption price which,
at the time the outstanding warrants are called for redemption, is
likely to be substantially less than the market value of your
warrants. None of the private placement warrants will be redeemable
by us so long as they are held by Sandbridge Acquisition Holdings
LLC or its permitted transferees.
Item 1B. Unresolved Staff Comments.
None
Item 2. Properties.
Our corporate headquarters are located in Lehi, Utah, where we
lease approximately 56,000 square feet of office space. We use this
leased space primarily for management, marketing, finance, legal,
regulatory compliance, human resources and general administrative
teams,
research and development, engineering and laboratory
space.
This lease is set to expire on July 31, 2024, subject to our option
to extend the term through July 31, 2034.
As a result of a transition to a primarily remote working
environment during 2021, the Company entered into agreements to
sub-lease its office space through July 31, 2024, but maintains the
ability to re-occupy the space subsequent to the expiration of the
sub-lease. The Company has entered into an office lease in 2022
with approximately 7,600 square feet, suitable for its current
needs. This newly leased space is intended to be utilized primarily
for research and development, engineering and laboratory
space.
Item 3. Legal Proceedings.
In the ordinary course of business we face various claims brought
by third parties, and we may, from time to time, make claims or
take legal actions to assert our rights, including intellectual
property rights as well as claims relating to employment matters
and the safety or efficacy of our products. Any of these claims
could subject us to costly litigation, and, while we generally
believe that we have adequate insurance to cover many different
types of liabilities, our insurance carriers may deny coverage, may
be inadequately capitalized to pay on valid claims, or our policy
limits may be inadequate to fully satisfy any damage awards or
settlements. If this were to happen, the payment of any such awards
could have a material adverse effect on our business, financial
condition and results of operations. Additionally, any such claims,
whether or not successful, could damage our reputation and
business.
In November 2021, two putative class action complaints were filed
against us in the U.S. District Court for the Central District of
California, Butala v. Owlet, Inc., et al., Case No. 2:21-cv-09016,
and Cherian v. Owlet, Inc., et al., Case No. 2:21-cv-09293. Both
complaints allege violations of the Securities Exchange Act of 1934
against the Company and certain of its officers and directors on
behalf of a putative class of investors who (i) purchased the
Company’s common stock between March 31, 2021 and October 4, 2021
or (ii) held common stock in Sandbridge Acquisition Corporation
(“SBG”) as of June 1, 2021 and were eligible to vote at SBG’s
special meeting held on July 14, 2021. Both complaints allege,
among other things, that the Company and certain of its officers
and directors made false and/or misleading statements and failed to
disclose certain information regarding the FDA’s likely
classification of the Smart Sock product as a medical device
requiring marketing authorization. The Court has consolidated the
Butala and Cherian cases but has yet to appoint a lead plaintiff.
The Company intends to vigorously defend itself against these
claims, including by filing a motion to dismiss on behalf of itself
and the named officers and directors.
Item 4. Mine Safety Disclosures.
Not applicable.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder
Matters and Issuer Purchases of Equity Securities.
Market information for Common Stock
Our common stock and our publicly traded warrants to purchase our
common stock are listed on the NYSE under the symbols “OWLT” and
“OWLT WS”, respectively.
Holders of Record
As of April 3, 2023, there were 143 holders of record. The
number of holders of record does not include a substantially
greater number of “street name” holders or beneficial holders,
whose shares are held of record by banks, brokers and other
financial institutions.
Dividend Policy
We have never declared or paid dividends on our capital stock. We
currently intend to retain any future earnings to fund the
development and growth of our business, and therefore do not expect
to pay any dividends in the foreseeable future. Any future
determination as to the declaration and payment of dividends, if
any, will be at the discretion of our board of directors, subject
to compliance with contractual restrictions and covenants in the
agreements governing our current and future indebtedness, including
our current loan and security agreement. Additionally, the terms of
our Series A Convertible Preferred Stock preclude us from paying
dividends without the consent of the holders of at least a majority
of the outstanding shares of Series A Convertible Preferred Stock.
Any such determination will also depend upon our business
prospects, results of operations, financial condition, cash
requirements and availability and other factors that our board of
directors may deem relevant.
Recent Sales of Unregistered Securities; Purchases of Equity
Securities by the Issuer or Affiliated Purchaser
Sales of Unregistered Equity Securities
We did not have any sales of unregistered equity securities during
the year ended December 31, 2022.
Purchases of Equity Securities
We did not repurchase shares of our common stock during the three
months ended December 31, 2022.
Item 6. [Reserved]
Item 7. Management’s Discussion and Analysis of Financial Condition
and Results of Operations.
Overview
The following discussion and analysis should be read in conjunction
with the audited consolidated financial statements and notes
thereto included elsewhere in this Annual Report (this "Report").
This discussion contains forward-looking statements about our
business, operations and industry that involve risks and
uncertainties, such as statements regarding our plans, objectives,
expectations and intentions. Our results may differ materially from
those currently described in the sections entitled "Risk Factors"
and "Cautionary Note Regarding Forward-Looking Statements"
disclosed in this Report. Throughout this Item 7, unless otherwise
noted, "we", "us", "our" and the "Company" refer to Owlet Baby Care
Inc. and its consolidated subsidiary before the Merger transaction
with Sandbridge Acquisition Corporation and to Owlet, Inc. and its
consolidated subsidiaries after the Merger transaction with
Sandbridge Acquisition Corporation.
Overview
Our mission is to empower parents with the right information at the
right time, to give them more peace of mind and help them find more
joy in the journey of parenting. Our digital parenting platform
aims to give parents real-time data and insights to help parents
feel calmer and more confident. We believe that every parent
deserves peace of mind and the opportunity to feel their
well-rested best. We also believe that every child deserves to live
a long, happy, and healthy life, and we are working to develop
products to help facilitate that belief.
2023 Private Placement Financing
On February 17, 2023, the Company consummated a sale of newly
issued Series A Convertible Preferred Stock ("Series A Preferred
Stock") and warrants to purchase its Class A common stock ("2023
Private Placement Warrants") involving participation from new and
existing investors, for aggregate gross proceeds of $30.0
million.
Pursuant to the terms of the definitive agreements, Owlet issued
shares of Series A Preferred Stock that are convertible into
approximately 61.2 million shares of common stock. Each purchaser
also received a warrant to purchase 180% of the number of shares of
common stock into which their Series A preferred stock is
convertible. The 2023 Private Placement Warrants have a per share
exercise price of $0.333 and are exercisable by the holder at any
time on or before February 17, 2028.
NYSE Notification
On November 29, 2022, we received notice (the “NYSE Notification”)
from the New York Stock Exchange (“NYSE”) indicating that we are
not in compliance with Section 802.01C of the NYSE Listed Company
Manual (“Section 802.01C”) because the average closing price of our
common stock was less than $1.00 over a consecutive 30 trading-day
period. The NYSE Notification does not result in the immediate
delisting of our common stock from the NYSE. We have notified the
NYSE of our intent to cure the stock price deficiency and return to
compliance with the NYSE continued listing standards. Under NYSE
rules, we have until six months from receipt of the NYSE
Notification or our 2023 annual meeting of stockholders to cure the
stock price deficiency and regain compliance with the NYSE’s
continued listing standards. Our common stock will continue to be
listed and trade on the NYSE during this cure period, subject to
our compliance with other NYSE continued listing standards. If our
common stock is delisted, it may be difficult for our stockholders
to sell their common stock without depressing the market price for
our common stock, or at all. See Part I, Item 1A. “Risk Factors—An
active, liquid trading market for our common stock may not be
sustained” in this Report.
Components of Operating Results
Revenues
We recognize revenue primarily from products and the associated
mobile applications. Revenues are recognized when control of goods
and services is transferred to customers in an amount that reflects
the consideration expected to be received by us in exchange for
those goods and services. Substantially all of the Company's
revenues were derived from product sales.
Cost of Revenues
Cost of revenues consists of product costs, including contract
manufacturing, shipping and handling, depreciation and amortization
relating to tooling and manufacturing equipment and software,
warranty replacement, fulfillment costs, warehousing, hosting, and
reserves for excess and obsolete inventory.
Operating Expenses
General and Administrative.
General and administrative expenses consist primarily of salaries,
benefits, stock-based compensation, and bonuses for finance and
accounting, legal, human resources and administrative executives
and employees; third-party legal, accounting, and other
professional services; corporate travel and entertainment;
depreciation and amortization of property and equipment; and
facilities rent.
Sales and Marketing.
Sales and marketing expenses consist primarily of salaries,
commissions, benefits, stock-based compensation, commissions, and
bonuses for sales and marketing employees and contractors;
third-party marketing expenses such as social media and search
engine marketing; email marketing and print marketing.
Research and Development.
Research and development expenses consist primarily of salaries,
benefits, stock-based compensation, and bonuses for employees and
contractors engaged in the design, development, maintenance and
testing of our products and platforms.
Other Income (Expense)
Interest Expense, Net.
Interest expense consists of interest incurred on our outstanding
borrowings and amortization of the associated deferred financing
costs net of interest income earned on our money market
account.
Interest Expense from Contingent Beneficial Conversion
Feature.
Interest expense from contingent beneficial conversion feature
relates to a charge associated with the contingent beneficial
conversion feature described in Part II. Item 8. "Financial
Statements and Supplementary Data - Note 8," included in
this
Report.
Preferred Stock Warrant Liability Adjustment.
Mark to market adjustment to recognize the change in fair value of
the preferred stock warrant liability in other income
(expense).
Common Stock Warrant Liability Adjustment.
Mark to market adjustment to recognize the change in fair value of
the common stock warrant liability in other income
(expense).
Gain on Loan Forgiveness.
Gain on loan forgiveness consists of the gain recognized subsequent
to the forgiveness of the Small Business Administration Paycheck
Protection Program loan.
Other Income (Expense), Net.
Other income (expense), net includes our net gain (loss) on foreign
exchange transactions and loss on extinguishment of
debt.
Income Tax Provision.
Income tax provision consists primarily of U.S. federal and state
income taxes related to the tax jurisdictions in which we conduct
business.
Results of Operations
The following table sets forth our results of operations for the
periods indicated in millions (note that amounts within this Item 7
shown in millions may not sum due to rounding):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
|
|
|
|
2022 |
|
2021 |
Revenues |
|
|
|
|
$ |
69.2 |
|
|
$ |
75.8 |
|
Cost of revenues |
|
|
|
|
45.9 |
|
|
40.8 |
|
Gross profit |
|
|
|
|
23.3 |
|
|
35.1 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
General and administrative |
|
|
|
|
41.5 |
|
|
32.3 |
|
Sales and marketing |
|
|
|
|
38.5 |
|
|
37.1 |
|
Research and development |
|
|
|
|
27.9 |
|
|
21.4 |
|
Total operating expenses |
|
|
|
|
107.9 |
|
|
90.9 |
|
Operating loss |
|
|
|
|
(84.6) |
|
|
(55.8) |
|
Other income (expense): |
|
|
|
|
|
|
|
Interest expense, net |
|
|
|
|
(1.1) |
|
|
(1.8) |
|
Interest expense from contingent beneficial conversion
feature |
|
|
|
|
— |
|
|
(26.1) |
|
Preferred stock warrant liability adjustment |
|
|
|
|
— |
|
|
(5.6) |
|
Common stock warrant liability adjustment |
|
|
|
|
6.3 |
|
|
15.7 |
|
Gain on loan forgiveness |
|
|
|
|
— |
|
|
2.1 |
|
Other income (expense), net |
|
|
|
|
0.1 |
|
|
(0.3) |
|
Total other income (expense), net |
|
|
|
|
5.3 |
|
|
(15.9) |
|
Loss before income tax provision |
|
|
|
|
(79.3) |
|
|
(71.7) |
|
Income tax provision |
|
|
|
|
0.0 |
|
|
0.0 |
|
Net loss and comprehensive loss |
|
|
|
|
$ |
(79.3) |
|
|
$ |
(71.7) |
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
Change |
(dollars in millions) |
|
2022 |
|
2021 |
|
$ |
|
% |
Revenues |
|
$ |
69.2 |
|
|
$ |
75.8 |
|
|
$ |
(6.6) |
|
|
(8.8 |
%) |
Revenues decreased by $6.6 million, or 8.8%, from $75.8 million for
the year ended December 31, 2021 to $69.2 million for the year
ended December 31, 2022. The decrease was primarily due to
lower sales of Owlet Sock products, impacted by lower consumer
sell-through levels and retailers targeting lower inventory levels,
reflecting macroeconomic conditions. Provisions for returns and
chargeback allowances decreased significantly as compared to the
prior year, primarily due to the impact of the FDA Warning Letter.
During the fourth quarter of 2021 and for the year ended
December 31, 2021, the Company recorded a contra-revenue
adjustment of $23.2 million resulting from received and
anticipated returns of the Smart Sock and Owlet Monitor Duo product
from U.S. retailers. Customer discounts increased year over year,
reflecting higher promotional activity for the introduction of the
Dream Sock and in response to lower consumer sell-through
levels.
Cost of Revenues and Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
Change |
(dollars in millions) |
|
2022 |
|
2021 |
|
$ |
|
% |
Cost of revenues |
|
$ |
45.9 |
|
|
$ |
40.8 |
|
|
$ |
5.1 |
|
|
12.5 |
% |
Gross profit |
|
$ |
23.3 |
|
|
$ |
35.1 |
|
|
$ |
(11.7) |
|
|
(33.5 |
%) |
Gross margin |
|
33.7 |
% |
|
46.2 |
% |
|
|
|
|
Cost of revenues increased by $5.1 million, or 12.5%, from $40.8
million for the year ended December 31, 2021 to $45.9 million
for the year ended December 31, 2022. The increase was
primarily due to cost inflation, including increased material,
transportation, and hosting costs. Gross margin decreased from
46.2% for the year ended December 31, 2021 to 33.7% for the
year ended December 31, 2022 primarily due to higher cost of
revenues.
General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
Change |
(dollars in millions) |
|
2022 |
|
2021 |
|
$ |
|
% |
General and administrative |
|
$ |
41.5 |
|
|
$ |
32.3 |
|
|
$ |
9.2 |
|
|
28.5 |
% |
General and administrative expense increased by $9.2 million, or
28.5%, from $32.3 million for the year ended December 31, 2021
to $41.5 million for the year ended December 31, 2022. The
increase was driven primarily by compensation expense, primarily
share-based compensation, from additional general and
administrative headcount and increased bad debt expense for certain
distributor and retail customers.
Sales and Marketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
Change |
(dollars in millions) |
|
2022 |
|
2021 |
|
$ |
|
% |
Sales and marketing |
|
$ |
38.5 |
|
|
$ |
37.1 |
|
|
$ |
1.4 |
|
|
3.8 |
% |
Sales and marketing expense increased by $1.4 million, or 3.8%,
from $37.1 million for the year ended December 31, 2021 to
$38.5 million for the year ended December 31, 2022. The
increase was primarily driven by increases in compensation expense,
including share-based compensation, from additional sales and
marketing headcount, substantially offset by decreases in digital
advertising and marketing spend.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
Change |
(dollars in millions) |
|
2022 |
|
2021 |
|
$ |
|
% |
Research and development |
|
$ |
27.9 |
|
|
$ |
21.4 |
|
|
$ |
6.5 |
|
|
30.2 |
% |
Research and development expense increased by $6.5 million, or
30.2%, from $21.4 million for the year ended December 31, 2021
to $27.9 million for the year ended December 31, 2022. These
increases were primarily driven by an increase in compensation
expense, including share-based compensation, from additional
research and development headcount and an increase in consulting
and outside services spend, including services associated with
regulatory approval.
Other Income (Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
Change |
(dollars in millions) |
|
2022 |
|
2021 |
|
$ |
|
% |
Interest expense, net |
|
$ |
(1.1) |
|
|
$ |
(1.8) |
|
|
$ |
0.7 |
|
|
(37.7 |
%) |
Interest expense from contingent beneficial conversion
feature |
|
$ |
— |
|
|
$ |
(26.1) |
|
|
$ |
26.1 |
|
|
(100.0 |
%) |
Preferred stock warrant liability adjustment |
|
$ |
— |
|
|
$ |
(5.6) |
|
|
$ |
5.6 |
|
|
(100 |
%) |
Common stock warrant liability adjustment |
|
$ |
6.3 |
|
|
$ |
15.7 |
|
|
$ |
(9.4) |
|
|
(59.8 |
%) |
Gain on loan forgiveness |
|
$ |
— |
|
|
$ |
2.1 |
|
|
$ |
(2.1) |
|
|
(100 |
%) |
Other income (expense), net |
|
$ |
0.1 |
|
|
$ |
(0.3) |
|
|
$ |
0.4 |
|
|
(125.2 |
%) |
|
|
|
|
|
|
|
|
|
For the year ended December 31, 2021, we recognized a gain of
$2.1 million on the forgiveness of our SBA PPP
loan.
For the year ended December 31, 2021, we recognized interest
expense from the contingent beneficial conversion feature as a
charge recorded at the date of the Merger, which is described in
the notes to the consolidated financial statements in Item
8.
For the year ended December 31, 2021, we recognized a loss of
$5.6 million resulting from the increase in the fair value of
the preferred stock warrants prior to the Merger. We recognized a
gain of $15.7 million and $6.3 million for the mark to
market adjustment for common stock warrants resulting from the
decrease in the fair value of the common stock warrants for the
years ended December 31, 2021 and December 31, 2022,
respectively.
Liquidity and Capital Resources
We have historically funded our operations primarily with proceeds
from issuances of our convertible preferred stock, issuances of our
common stock, borrowings under our loan facilities, issuances of
convertible promissory notes, and sales of our products and
services. In connection with the Merger, the Company raised $133.9
million net proceeds, which combined with the sale of products and
services funded our operations from the date of the Merger through
the year ended December 31, 2022. As of December 31, 2022, we
had cash and cash equivalents of $11.2 million.
On February 17, 2023, the Company consummated a sale of newly
issued Series A Preferred Stock and 2023 Private Placement Warrants
for aggregate gross proceeds of $30.0 million, prior to deducting
offering expenses.
The Series A Preferred Stock is convertible into common stock at
the option of the holder at any time after February 17, 2023 and
ranks, with respect to dividend rights, rights of redemption and
rights upon a liquidation event, (i) senior to the common stock and
all other classes or series of equity securities of the Company
established after February 17, 2023, unless such shares or equity
securities expressly provide that they rank in parity with or
senior to the Series A Preferred Stock with respect to dividend
rights, rights of redemption or rights upon a liquidation event,
(ii) on parity with each class or series of equity securities of
the Company established after the February 17, 2023, the terms of
which expressly provide that it ranks on parity with the Series A
Preferred Stock with respect to dividend rights, rights of
redemption and rights upon a liquidation event and (iii) junior to
each class or series of equity securities of the Company
established after February 17, 2023, the terms of which expressly
provide that it ranks senior to the Series A Preferred Stock with
respect to dividend rights, rights of redemption and rights upon a
liquidation event.
At any time from and after February 17, 2023, the holders of at
least a majority of the then outstanding shares of Series A
preferred stock may specify a date and time or the occurrence of an
event by vote or written consent that all, and not less than all,
of the outstanding shares of Series A preferred stock will
automatically be: (i) converted into shares of common stock at the
Conversion Rate, (ii) subject to certain exceptions and
limitations, redeemed for an amount per share of Series A preferred
stock equal to the liquidation preference of one thousand dollars
per share, plus all accrued or declared but unpaid dividends as of
the redemption date and time or (iii) a combination of the
foregoing. The Series A Preferred Stock has a liquidation
preference of $1,000.00 per share.
Subject to certain exceptions, upon the occurrence of a fundamental
change, voluntary or involuntary liquidation, dissolution or
winding-up of the Company, the Company will be required to pay an
amount per share of Series A Preferred Stock equal to the greater
of (i) one thousand dollars per share or (ii) the consideration per
share of Series A Preferred Stock as would have been payable had
all such shares been converted to common stock immediately prior to
the liquidation event, plus, in each case, the aggregate amount of
all declared but unpaid dividends thereon to the date of final
distribution to the holders of Series A Preferred
Stock.
Each purchaser also received a 2023 Private Placement Warrant to
purchase 180% of the number of shares of common stock into which
their Series A Preferred Stock is convertible. The 2023 Private
Placement Warrants have a per share exercise price of $0.333 and
are exercisable by the holder at any time on or before February 17,
2028. The 2023 Private Placement Warrants also provide for an
exercise on a cash or cashless net exercise basis at any time after
February 17, 2023 and will be automatically exercised on a cashless
basis if not exercised prior to the expiration of the five-year
term. Upon a fundamental change or other liquidation event, the
2023 Private Placement Warrants will automatically net exercise if
not exercised before the consummation of such event.
On March 10, 2023, Silicon Valley Bank ("SVB") was closed by the
California Department of Financial Protection and Innovation, which
appointed the Federal Deposit Insurance Corporation ("FDIC") as
receiver. On March 12, 2023, the
Secretary of the Treasury, the chair of the Federal Reserve Board
and the chairman of the FDIC released a joint statement related to
the FDIC's resolution of the SVB receivership, which provided that
all depositors would have access to all their money starting March
13, 2023. As of the date of this Annual Report, all cash deposited
with SVB by the Company has been accessible by the
Company.
Funding Requirements and Going Concern
In accordance with Accounting Standards Update No. 2014-15,
Disclosure of Uncertainties about an Entity’s Ability to Continue
as a Going Concern (Subtopic 205-40), the Company has evaluated
whether there are conditions and events, considered in the
aggregate, that raise substantial doubt about the Company’s ability
to continue as a going concern within one year after the date that
the consolidated financial statements are issued.
Since inception, the Company has experienced recurring operating
losses and generated negative cash flows from operations, which
have resulted in an accumulated deficit of $222.8 million and
$143.4 million as of December 31, 2022 and December 31,
2021, respectively, and negative cash flows from operations of
$81.4 million and $40.6 million for the years ended
December 31, 2022 and December 31, 2021,
respectively.
Year over year declines in revenue, the low, current cash balance,
recurring operating losses, and negative cash flows from operations
since inception raise substantial doubt about the Company’s ability
to continue as a going concern within one year after the date that
the accompanying consolidated financial statements are issued. The
accompanying consolidated financial statements have been prepared
on a going concern basis and accordingly, do not include any
adjustments relating to the recoverability and classification of
asset carrying amounts, or the amount and classification of
liabilities that might result should the Company be unable to
continue as a going concern.
As the Company continues to address these financial conditions,
management has undertaken the following actions:
•The
Company consummated a sale of newly issued Series A Convertible
Preferred Stock ("Series A preferred stock") and warrants to
purchase its common stock ("2023 private placement warrants")
involving participation from new and existing investors, for
aggregate gross proceeds of $30.0 million.
•As
described in Note 7, in March 2023 the Company further amended its
financing arrangement with SVB, under which the principal payments
on the term note will be deferred until September 2023. This most
recent amendment also revised the financial covenants for future
periods.
•During
the year ended December 31, 2022, the Company undertook
restructuring actions, which included significantly reducing
employee headcount and reducing operating spend, significantly
reducing run-rate expenses existing the quarter ended December 31,
2022.
We have not generated sufficient cash flows from operations to
satisfy our capital requirements. There can be no assurance that
the Company will generate sufficient future cash flows from
operations due to potential factors, including but not limited to
inflation, recession, reduced demand for the Company’s products, or
the FDA's denial of the Company's de novo classification request
for marketing authorization. If revenues further decrease from
current levels, the Company may be unable to further reduce costs,
or such reductions may limit our ability to pursue strategic
initiatives and grow revenues in the future.
There can be no assurance that we will be able to obtain additional
financing on terms acceptable to us, if at all. Failure to secure
additional funding may require us to modify, delay or abandon some
of our planned future
development, or to otherwise enact further operating cost
reductions, which could have a material adverse effect on our
business, operating results, financial condition and ability to
achieve our intended business objectives.
If we raise additional funds through further issuances of equity or
convertible debt securities, our existing stockholders could suffer
significant dilution, and any new equity securities we issue could
have rights, preferences, and privileges superior to those of
holders of our common stock. If we are unable to obtain adequate
financing or financing on terms satisfactory to us when we require
it, our ability to continue to pursue our business objectives and
to respond to business opportunities, challenges, or unforeseen
circumstances could be significantly limited, and our business,
financial condition and results of operations could be materially
adversely affected. We also could be required to seek funds through
arrangements with partners or others that may require us to
relinquish rights or jointly own some aspects of our technologies,
products or services that we would otherwise pursue on our
own.
Loan and Security Agreement with Silicon Valley Bank
On November 23, 2022, the Company entered into the Third Amended
and Restated Loan and Security Agreement (the “LSA”) with Silicon
Valley Bank. The LSA amended, restated and replaced in its entirety
the prior Second Amended and Restated Loan and Security Agreement,
dated April 22, 2020, and all prior amendments. On March 27, 2023,
the Company entered into the first amendment to the LSA with
Silicon Valley Bank, now a division of First Citizens Bank and
Trust Company (the “SVB Amendment”), that (i) deferred certain
payments of principal by the Company until September 1, 2023, (ii)
had Silicon Valley bank waive certain stated events of default,
(iii) to expand the eligibility of inventory and accounts that the
Company can borrow against, (iv) to modify certain financial
covenants required of the Company, and (v) certain other revisions
in the first amendment.
Line of Credit
The LSA provides for a $17.5 million revolving line of credit (the
“SVB Revolver”), with a reduced maximum availability of
$10.0 million as of December 31, 2022. The SVB Revolver
is an asset based lending facility subject to borrowing base
availability which is limited by specified percentages of eligible
accounts receivable and eligible inventory. Borrowing base
availability can be impacted based upon the period's eligible
accounts receivable and eligible inventory, and may be
significantly lower than the maximum borrowing base
availability.
The SVB Revolver facility matures and terminates on April 22, 2024.
As of December 31, 2022, the SVB Revolver bore interest on the
outstanding principal amount at a floating rate per annum equal to
the greater of (i) 5.00% and (ii) the prime rate plus the prime
rate margin, which is 1.25% or 1.75%, dependent upon the Company's
liquidity, as defined by the LSA.
Term Loan
The LSA also provides for an $8.5 million term loan (the “Term
Loan”), replacing the term loans made under the previous agreement,
of which $8.0 million was outstanding as of December 31, 2022.
The Term Loan amortizes with equal monthly installments of $500,000
and matures on October 1, 2024.
The Term Loan accrues interest on the outstanding principal amount
at a floating rate per annum equal to the greater of (i) five and
three-quarters percent (5.75%) and (ii) the prime rate plus the
prime rate margin (as defined in the LSA), and such interest is
payable (a) monthly in arrears, (b) on each prepayment date and (c)
on the Term Loan Maturity Date. All outstanding principal and
accrued and unpaid interest and all other Term Loan-related
outstanding obligations shall become due and payable in full on the
Term Loan maturity date.
As of December 31, 2022, the Company was in violation of its
minimum net revenue requirement for the three months ended
December 31, 2022. In March 2023, the Company further amended
its financing arrangement with SVB, under which the principal
payments on the Term Loan will be deferred until September 2023.
This most recent amendment also revised the financial covenants for
future periods.
If the Company is in violation of its covenants in future periods,
SVB can elect to take certain actions, including terminating the
line of credit and declaring the principal amount of the Term Loan
and line of credit as immediately due and payable.
Financed Insurance Premium
In July 2022, the Company renewed its director and officer
liability policies and entered into a new short-term commercial
premium finance agreement with First Insurance Funding to be paid
in eleven equal monthly payments, accruing interest at a rate of
4.40%. The remaining principal balance on the financed insurance
premium was $2.4 million as of December 31,
2022.
Paycheck Protection Program Loan
In April 2020, we applied for and received proceeds from the U.S.
Small Business Administration (‘‘SBA’’) Paycheck Protection Program
(‘‘PPP’’) in the amount of $2.1 million, with SVB as lender for the
loan (the ‘‘PPP Loan’’). Under the PPP, we applied for forgiveness
for all of the PPP Loan. On June 15, 2021, we received forgiveness
for the PPP loan for the full amount of $2.1 million of principal.
As a result of the PPP loan being forgiven, we recognized a $2.1
million gain for the year ended December 31, 2021.
Cash Flows
The following table summarizes our cash flow (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
2022 |
|
2021 |
Net cash used in operating activities |
$ |
(81.4) |
|
|
$ |
(40.6) |
|
Net cash used in investing activities |
(1.6) |
|
|
(2.0) |
|
Net cash provided by financing activities |
(0.9) |
|
|
120.6 |
|
Net change in cash and cash equivalents |
$ |
(83.8) |
|
|
$ |
78.0 |
|
Operating Activities
For the year ended December 31, 2022, net cash used in
operating activities was $81.4 million as compared to net cash used
in operating activities of $40.6 million in the prior year.
The change in operating cash flows was primarily driven by (i) a
higher net loss, (ii) lower non-cash charges, net, primarily driven
by the interest expense from contingent beneficial conversion
features in the prior year, and (iii) cash used for net assets and
liabilities, impacted by the payment of returns accrued as of
December 31, 2021 from accepted and anticipated customer
returns for products subject to the Warning Letter, which were paid
during paid during the year ended December 31,
2022.
Investing Activities
For the year ended December 31, 2022, net cash used in
investing activities decreased to $1.6 million from $2.0 million
for the year ended December 31, 2021 due to lower capital
expenditures.
Financing Activities
For the year ended December 31, 2022, net cash provided by
financing activities decreased to $0.9 million from $120.6 million
for the year ended December 31, 2021, primarily driven by cash
provided from the reverse recapitalization and PIPE financing in
the prior year.
Indemnification
In the ordinary course of business, we enter into agreements that
may include indemnification provisions. Pursuant to such
agreements, we may indemnify, hold harmless, and defend an
indemnified party for losses suffered or incurred by the
indemnified party. Some of the provisions will limit losses to
those arising from third-party actions. In some cases, the
indemnification will continue after the termination of the
agreement. The maximum potential amount of future payments we could
be required to make under these provisions is not determinable. We
have never incurred material costs to defend lawsuits or settle
claims related to these indemnification provisions.
In connection with the consummation of the Merger, we entered into
indemnification agreements with our directors and officers that may
require us to indemnify our directors and officers against
liabilities that may arise by reason of their status or service as
directors or officers to the fullest extent permitted by Delaware
corporate law. We currently have directors’ and officers’ insurance
coverage that reduces our exposure and enables us to recover a
portion of any future amounts paid. We believe the estimated fair
value of these indemnification agreements in excess of applicable
insurance coverage is immaterial.
Critical Accounting Policies and Estimates
Our significant accounting policies are fundamental to
understanding our results of operations and financial condition as
they require that we use estimates and assumptions that may affect
the value of our assets or liabilities and financial results. For a
summary of the Company’s significant accounting policies,
estimates, and methods used in the preparation of the consolidated
financial statements, see Part II. Item 8. "Financial Statements
and Supplementary Data” - Note 2.
The accounting policies and estimates described below are those the
Company considers most critical in preparing its consolidated
financial statements because they require management to make
subjective and complex judgments about matters that are inherently
uncertain. Actual results may differ from these estimates under
different assumptions or conditions.
Sales Returns, Rebates, Discounts, and Allowances
Our contract liabilities include promises to provide customers
rights of return as well as promises to issue discounts and provide
rebates or allowances to certain retail channel customers if
specified conditions are met. Revenues are reduced in the
accompanying consolidated statements of operations and
comprehensive loss for anticipated sales returns, discounts, and
allowances, based on our analysis of historical sales returns and
contractual discounts and allowances. Expected returns, as well as
estimated discounts and allowances that have been earned but not
yet honored or paid out, are included in accrued and other expenses
in the accompanying balance sheets. Actual returns may vary from
estimates if we experience a change in actual sales returns or
exchange patterns due to unanticipated changes in products or
competitive pressures.
Sales return rates, excluding the impact of regulatory actions,
have been sufficiently predictable to allow us to estimate expected
future returns. We review the actual returns in our direct to
consumer channels as a percentage of sales to determine the
historical rate of return. The historical rate of return is used as
a basis for estimating future returns based on current sales. The
sales return estimate can be affected by the release of new
products and changes to sales channels. Actual returns may vary
from estimates if we experience a change in actual sales returns or
exchange patterns due to unanticipated changes in products,
competitive pressures, or regulatory actions.
Sales rebates, discounts, and allowances provided to our customers
have been sufficiently predictable to allow us to estimate expected
future discounts and allowances. Discounts and allowances are
estimable based on existing and expected promotional programs and
contractual terms in place at the time of sale. New promotional
programs or changes to existing promotional programs could impact
the estimated sales rebates, discounts, and allowances
Income Taxes
In evaluating the ability to recover our deferred income tax
assets, we consider all available positive and negative evidence,
including our operating results, ongoing tax planning and forecasts
of future taxable income on a jurisdiction-by-jurisdiction basis.
In the event we determine that we would be able to realize our
deferred tax assets in the future in excess of their net recorded
amount, we would make an adjustment to the valuation allowance that
would reduce the provision for income taxes. Conversely, in the
event that all or part of the net deferred tax assets are
determined to not be realizable in the future, an adjustment to the
valuation allowance would be charged to earnings in the period when
such a determination is made. As of December 31, 2022 and
December 31, 2021, we recorded a full valuation allowance on
our deferred tax assets.
Uncertain tax positions are recorded when it is more likely than
not that a given tax position would not be sustained upon
examination by taxing authorities. Based on positions taken in our
tax filings, we concluded that there are no significant uncertain
tax positions requiring disclosure as of December 31, 2022 and
December 31, 2021, and that there are no material amounts of
unrecognized tax benefits. Our policy for recording interest and
penalties related to income taxes, including uncertain tax
positions, is to record such items as a component of the provision
for income taxes.
Emerging Growth Company Status
Following the Merger, we qualify as an emerging growth company
(‘‘EGC’’) as defined in the Jumpstart our Business Startups
(‘‘JOBS’’) Act. The JOBS Act permits companies with EGC status to
take advantage of an extended transition period to comply with new
or revised accounting standards, delaying the adoption of these
accounting standards until they would apply to private companies.
We intend to use this extended transition period to enable us to
comply with new or revised accounting standards that have different
effective dates for public and private companies until the earlier
of the date we (i) are no longer an EGC or (ii) affirmatively and
irrevocably opt out of the extended transition period provided in
the JOBS Act. As a result, our consolidated financial statements
may not be comparable to companies that comply with the new or
revised accounting standards as of public company effective
dates.
In addition, we intend to rely on the other exemptions and reduced
reporting requirements provided by the JOBS Act. Subject to certain
conditions set forth in the JOBS Act, as an EGC, we are not
required to, among other things: (i) provide an auditor’s
attestation report on our system of internal control over financial
reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;
(ii) provide all of the compensation disclosures that may be
required of non-EGCs under the Dodd-Frank Wall Street Reform and
Consumer Protection Act; (iii) comply with the requirements of the
Public Company Accounting Oversight Board regarding the
communication of critical audit matters in the auditor’s report on
the consolidated financial statements (auditor discussion and
analysis); and (iv) disclose certain executive compensation-related
items such as the correlation between executive compensation and
performance and comparisons of the Chief Executive Officer’s
compensation to median employee compensation.
We anticipate that we will remain an EGC under the JOBS Act until
the earliest of (i) December 31, 2025, (ii) the last date of our
fiscal year in which we have total annual gross revenues of at
least $1.235 billion, (iii) the date on which we are deemed to be a
‘‘large accelerated filer’’ under the rules of the SEC, or (iv) the
date on which we have issued more than $1.0 billion in
non-convertible debt securities during the previous three
years.
Smaller Reporting Company
Additionally, we are a “smaller reporting company” as defined in
Item 10(f)(1) of Regulation S-K. Smaller reporting
companies may take advantage of certain reduced disclosure
obligations, including, among other things, providing only two
years of audited consolidated financial statements. We will remain
a smaller reporting company until the last day of the fiscal year
in which (i) the market value of our Common Stock held
by non-affiliates exceeds $250 million as of the
prior June 30, or (ii) our annual revenues exceeded
$100 million during such completed fiscal year and the market
value of our Common Stock held by non-affiliates exceeds
$700 million as of the prior June 30.
Item 7A. Quantitative and Qualitative Disclosures About Market
Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the
Exchange Act and are not required to provide the information
otherwise required under this Item.
Item 8. Financial Statements and Supplementary Data.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting
Firm
To the Board of Directors and Stockholders of Owlet,
Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of
Owlet, Inc. and its subsidiaries (the “Company”) as of December 31,
2022 and 2021, and the related consolidated statements of
operations and comprehensive loss, of redeemable convertible
preferred stock and stockholders’ equity (deficit) and of cash
flows for the years then ended, including the related notes
(collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements
present fairly, in all material respects, the financial position of
the Company as of December 31, 2022 and 2021, and the results of
its operations and its cash flows for the years then ended in
conformity with accounting principles generally accepted in the
United States of America.
Substantial Doubt About the Company’s Ability to Continue as a
Going Concern
The accompanying consolidated financial statements have been
prepared assuming that the Company will continue as a going
concern. As discussed in Note 1 to the consolidated financial
statements, the Company, since inception, has experienced recurring
losses from operations and generated negative cash flows from
operations that raise substantial doubt about its ability to
continue as a going concern. Management's plans in regard to these
matters are also described in Note 1. The consolidated financial
statements do not include any adjustments that might result from
the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of
the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on
our audits. We are a public accounting firm registered with the
Public Company Accounting Oversight Board (United States) (PCAOB)
and are required to be independent with respect to the Company in
accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and
the PCAOB.
We conducted our audits of these consolidated financial statements
in accordance with the standards of the PCAOB. Those standards
require that we plan and perform the audits to obtain reasonable
assurance about whether the consolidated financial statements are
free of material misstatement, whether due to error or fraud. The
Company is not required to have, nor were we engaged to perform, an
audit of its internal control over financial reporting. As part of
our audits we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of
expressing an opinion on the effectiveness of the Company's
internal control over financial reporting. Accordingly, we express
no such opinion.
Our audits included performing procedures to assess the risks of
material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures that
respond to those risks. Such procedures included examining, on a
test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation
of the consolidated financial statements. We believe that our
audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Salt Lake City, Utah
April 6, 2023
We have served as the Company’s auditor since 2020.
Owlet, Inc.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
December 31, 2022 |
|
December 31, 2021 |
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
11,231 |
|
|
$ |
95,054 |
|
Accounts receivable, net of allowance for doubtful accounts of
$3,013 and $403, respectively
|
|
15,958 |
|
|
10,468 |
|
Inventory |
|
18,515 |
|
|
17,980 |
|
Prepaid expenses and other current assets |
|
5,558 |
|
|
12,313 |
|
Total current assets |
|
51,262 |
|
|
135,815 |
|
Property and equipment, net |
|
1,108 |
|
|
1,870 |
|
Right of use assets, net |
|
2,260 |
|
|
— |
|
Intangible assets, net |
|
2,279 |
|
|
1,696 |
|
Other assets |
|
1,195 |
|
|
666 |
|
Total assets |
|
$ |
58,104 |
|
|
$ |
140,047 |
|
Liabilities and Stockholders’ Equity (Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
30,432 |
|
|
$ |
27,765 |
|
Accrued and other expenses |
|
19,984 |
|
|
31,730 |
|
Current portion of deferred revenues |
|
1,148 |
|
|
1,061 |
|
Line of credit |
|
4,685 |
|
|
— |
|
Current portion of long-term debt |
|
10,353 |
|
8,534 |
|
Total current liabilities |
|
66,602 |
|
|
69,090 |
|
Long-term debt, net |
|
— |
|
|
7,993 |
|
Noncurrent lease liability |
|
1,162 |
|
|
— |
|
Common stock warrant liability |
|
724 |
|
|
7,061 |
|
Other long-term liabilities |
|
251 |
|
|
712 |
|
Total liabilities |
|
68,739 |
|
|
84,856 |
|
Commitments and contingencies (Note 9)
|
|
|
|
|
Stockholders’ equity (deficit): |
|
|
|
|
Common stock, $0.0001 par value, 1,000,000,000 shares authorized as
of December 31, 2022 and December 31, 2021; 115,388,135
and 112,996,568 shares issued and outstanding as of
December 31, 2022 and December 31, 2021,
respectively.
|
|
12 |
|
|
11 |
|
Additional paid-in capital |
|
212,111 |
|
|
198,602 |
|
Accumulated deficit |
|
(222,758) |
|
|
(143,422) |
|
Total stockholders’ equity (deficit) |
|
(10,635) |
|
|
55,191 |
|
Total liabilities and stockholders’ equity (deficit) |
|
$ |
58,104 |
|
|
$ |
140,047 |
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated
financial statements.
Owlet, Inc.
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
For the years ended December 31, |
|
2022 |
|
2021 |
Revenues |
$ |
69,202 |
|
|
$ |
75,842 |
|
Cost of revenues |
45,889 |
|
|
40,784 |
|
Gross profit |
23,313 |
|
|
35,058 |
|
Operating expenses: |
|
|
|
General and administrative |
41,547 |
|
|
32,339 |
|
Sales and marketing |
38,489 |
|
|
37,084 |
|
Research and development |
27,896 |
|
|
21,427 |
|
Total operating expenses |
107,932 |
|
|
90,850 |
|
Operating loss |
(84,619) |
|
|
(55,792) |
|
Other income (expense): |
|
|
|
Interest expense, net |
(1,104) |
|
|
(1,772) |
|
Interest expense from contingent beneficial conversion
feature |
— |
|
|
(26,061) |
|
Preferred stock warrant liability adjustment |
— |
|
|
(5,578) |
|
Common stock warrant liability adjustment |
6,337 |
|
|
15,745 |
|
Gain on loan forgiveness |
— |
|
|
2,098 |
|
Other income (expense), net |
79 |
|
|
(313) |
|
Total other income (expense), net |
5,312 |
|
|
(15,881) |
|
Loss before income tax provision |
(79,307) |
|
|
(71,673) |
|
Income tax provision |
(29) |
|
|
(31) |
|
Net loss and comprehensive loss |
$ |
(79,336) |
|
|
$ |
(71,704) |
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.71) |
|
|
$ |
(1.13) |
|
Weighted average number of shares outstanding used to compute net
loss per share attributable to common stockholders, basic and
diluted |
111,310,604 |
|
|
63,216,912 |
|
The accompanying notes are an integral part of these consolidated
financial statements.
Owlet, Inc.
Consolidated Statements of Redeemable Convertible Preferred Stock
and Stockholders’ Equity (Deficit)
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock
Series A (1) |
|
Preferred Stock
Series A-1 (1) |
|
Preferred Stock
Series B (1) |
|
Preferred Stock
Series B-1 (1) |
|
Common Stock (1) |
|
|
|
|
|
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Additional Paid-in
Capital |
|
Accumulated
Deficit |
|
Total Stockholders'
Equity (Deficit) |
Balance as of December 31, 2020 |
26,157,622 |
|
|
$ |
9,569 |
|
|
20,238,201 |
|
|
$ |
14,083 |
|
|
12,366,306 |
|
|
$ |
18,854 |
|
|
3,047,183 |
|
|
$ |
4,682 |
|
|
22,118,619 |
|
|
$ |
2 |
|
|
$ |
3,707 |
|
|
$ |
(71,718) |
|
|
$ |
(68,009) |
|
Conversion of redeemable convertible preferred stock into common
stock in connection with the reverse recapitalization (Note
3) |
(26,157,622) |
|
|
(9,569) |
|
(20,238,201) |
|
|
(14,083) |
|
(12,366,306) |
|
|
(18,854) |
|
(3,047,183) |
|
|
(4,682) |
|
61,809,312 |
|
|
6 |
|
47,182 |
|
— |
|
47,188 |
Conversion of convertible promissory notes to common stock in
connection with the reverse recapitalization (Note 3) |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
4,633,507 |
|
|
1 |
|
7,121 |
|
— |
|
7,122 |
Beneficial conversion feature of convertible promissory notes in
connection with the reverse recapitalization (Note 3) |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
26,061 |
|
— |
|
26,061 |
Conversion of preferred stock warrants and common stock warrants in
connection with the reverse recapitalization (Note 3) |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,771,231 |
|
|
— |
|
8,571 |
|
— |
|
8,571 |
Reverse recapitalization transaction, net of fees |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
21,959,227 |
|
|
2 |
|
101,259 |
|
— |
|
101,261 |
Issuance of common stock upon exercise of stock options |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
704,672 |
|
|
— |
|
442 |
|
|
— |
|
442 |
Stock-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
4,259 |
|
|
|
|
4,259 |
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
— |
|
(71,704) |
|
(71,704) |
Balance as of December 31, 2021 |
— |
|
|
$ |
— |
|
|
— |
|
|
$ |
— |
|
|
— |
|
|
$ |
— |
|
|
— |
|
|
$ |
— |
|
|
$ |
112,996,568 |
|
|
$ |
11 |
|
|
$ |
198,602 |
|
|
$ |
(143,422) |
|
|
$ |
55,191 |
|
Issuance of common stock upon exercise of stock options |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
816,866 |
|
|
— |
|
258 |
|
— |
|
258 |
Issuance of common stock for restricted stock units
vesting |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,324,812 |
|
|
1 |
|
— |
|
— |
|
1 |
Issuance of common stock for employee stock purchase
plan |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
249,889 |
|
|
— |
|
359 |
|
— |
|
359 |
Share-based compensation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
12,892 |
|
— |
|
12,892 |
Net loss |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
— |
|
|
(79,336) |
|
|
$ |
(79,336) |
|
Balance as of December 31, 2022 |
— |
|
|
$ |
— |
|
|
— |
|
|
$ |
— |
|
|
— |
|
|
$ |
— |
|
|
— |
|
|
$ |
— |
|
|
$ |
115,388,135 |
|
|
$ |
12 |
|
|
$ |
212,111 |
|
|
$ |
(222,758) |
|
|
$ |
(10,635) |
|
(1) The shares of the Company’s common and redeemable
convertible preferred stock, prior to the Merger, have been
retrospectively adjusted as shares reflecting the exchange ratio of
approximately 2.053 established in the Merger (see Note
3).
The accompanying notes are an integral part of these consolidated
financial statements.
Owlet, Inc.
Consolidated Statements of Cash Flows
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31, |
|
2022 |
|
2021 |
Cash flows from operating activities: |
|
|
|
Net loss |
$ |
(79,336) |
|
|
$ |
(71,704) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation and amortization |
1,418 |
|
|
1,133 |
|
Share-based compensation |
12,856 |
|
|
4,259 |
|
Bad debt expense |
3,014 |
|
|
201 |
|
Write-down of inventory to net realizable value |
646 |
|
|
1,581 |
|
Preferred stock warrant liability adjustment |
— |
|
|
5,578 |
|
Common stock warrant liability adjustment |
(6,337) |
|
|
(15,745) |
|
Amortization of right of use assets |
1,253 |
|
|
|
Gain on loan forgiveness |
— |
|
|
(2,098) |
|
Interest expense from contingent beneficial conversion
feature |
— |
|
|
26,061 |
|
Other adjustments, net |
307 |
|
|
725 |
|
Changes in assets and liabilities: |
|
|
|
Accounts receivable |
(8,504) |
|
|
(144) |
|
Prepaid expenses and other assets |
6,226 |
|
|
(10,493) |
|
Inventory |
(1,181) |
|
|
(11,649) |
|
Accounts payable and accrued and other expenses |
(10,720) |
|
|
32,117 |
|
Other, net |
(1,022) |
|
|
(378) |
|
Net cash used in operating activities |
(81,380) |
|
|
(40,556) |
|
Cash flows from investing activities |
|
|
|
Purchase of property and equipment |
(636) |
|
|
(969) |
|
Purchase of intangible assets |
(929) |
|
|
(1,051) |
|
Net cash used in investing activities |
(1,565) |
|
|
(2,020) |
|
< |