PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multi-product,
commercial-stage medical device company, today reported financial
results for the three and six months ended June 30, 2020 and
provided a business update for the Company and its subsidiaries,
Lucid Diagnostics Inc. (“Lucid”) and Solys Diagnostics Inc.
(“Solys”).
“The second quarter of 2020 and subsequent weeks
constitute an unprecedented period of major accomplishments for
PAVmed and its subsidiaries, despite significant Covid-19 headwinds
in the late spring and early summer,” said Lishan Aklog, M.D.,
PAVmed’s Chairman and Chief Executive Officer. “These
accomplishments include a preliminary CMS payment determination,
FDA clearance and commercial launch of a lead product, consummation
of critical partnership agreements, and steady progress on the
commercial, clinical, regulatory, development and intellectual
property fronts. Our expanding team of talented professionals,
joined by world-class partners and advisors, and supported by a
strong balance sheet, are well-poised to build on these
accomplishments and achieve important value-inflection milestones
in the coming months.”
RECENT ACCOMPLISHMENTS
- Secured U.S. Center for Medicare
and Medicare Services (“CMS”) Clinical Laboratory Fee Schedule Test
Code Preliminary Determination for EsoGuard™ Esophageal DNA Test
(CPT code 0114U) of $1,938.01 in 38 states and $2,690.00 in 12
states (including Florida, New Jersey and Pennsylvania) and two
U.S. territories.
- Received 510(k) marketing clearance
from the U.S. Food and Drug Administration (“FDA”) for CarpX™
minimally invasive carpal tunnel device.
- Commercially launched CarpX,
including FDA commercial device registration and listing in the
GUDID database, as well as the initial release of inventory for
fulfillment by third party logistics and warehousing partner
HealthLink Europe and International.
- Expanded commercial management team
to seven professionals adding in the quarter a CarpX national sales
manager, a Lucid regional sales manager, and a marketing director
to support an independent sales organization of 35
professionals.
- Accelerated Lucid commercial
activities, with active sales processes involving over 500
customers and product in stock at approximately 50 clinical sites.
Resumed in-person procedural training.
- Activated 27 sites for ESOGUARD
BE-1 and 2 clinical trials in support of FDA registration of
EsoGuard/EsoCheck as an In-Vitro Diagnostic (IVD) device. Resumed
enrollment with six new patients and successful EsoCheck
administration in all patients.
- Enrolled first patient in clinical
trial evaluating EsoCheck in Eosinophilic Esophagitis (EoE)
patients at the University of Pennsylvania.
- Entered into a definitive agreement
with global manufacturer Canon Inc.’s United States manufacturing
and technology center, Canon Virginia, Inc. to develop and utilize
Canon Virginia’s commercial grade aqueous silk fibroin molding
process to manufacture its DisappEAR™ molded pediatric ear tubes
for commercialization.
- Entered into a manufacturing agreement with medical device
contract manufacturer Coastline International Inc. to serve as a
high-volume, lower-cost manufacturer of PAVmed and Lucid products
including EsoCheck and NextFlo.
- Successfully completed European
Union notified body stage 1 audits of PAVmed and Lucid quality
management systems in support of upcoming CE Mark regulatory
submissions of PAVmed and Lucid products.
- Successfully completed pre-clinical
feasibility animal study of its EsoCure™ Esophageal Ablation Device
demonstrating excellent, controlled circumferential ablation of the
esophageal mucosal lining.
- Successfully completed preliminary
human testing of Solys laser-based non-invasive blood glucose
device demonstrating testing accuracy within established FDA and
ISO 15197 regulatory standards in normal human volunteers with
moderate post-prandial hyperglycemia.
- Granted U.S. patent for EsoCheck™
Cell Collection Device (10,660,621) and Caldus™ Technology
underlying EsoCure (10,687,883) as well as Chinese patent for
CarpX.
- Diagnostics industry titan, Stanley
Lapidus, founder, former Chairman and CEO of Exact Sciences, joined
Lucid as a Strategic Advisor.
- Received approximately $10.6
million in net proceeds from two private placements of Senior
Convertible Promissory Notes with an existing institutional
investor.
UPCOMING KEY ACTIVITIES AND
MILESTONES
- Accelerate and expand EsoGuard and
EsoCheck commercial activities as elective clinical procedures
continue to resume from Covid-19 limitations.
- Expand EsoGuard educational and
marketing activities targeting physicians and consumers, including
upcoming Access Health segment on the Lifetime Network highlighting
Barrett’s Esophagus as well as the role of EsoGuard and
EsoCheck.
- Begin CarpX commercial activities
focusing on key opinion leaders and innovators capable of serving
as CarpX trainers, proctors and educators.
- Secure CMS coverage determination
for EsoGuard and extend payment and coverage process to private
payors.
- Complete stage 2 audits of PAVmed
and Lucid’s quality management systems and submit EU CE Mark
regulatory clearance applications for EsoCheck, EsoGuard, CarpX and
PortIO™.
- Activate remaining 27 U.S. and
European clinical trial sites for ESOGUARD-BE-1 and 2 and
accelerate clinical trial enrollment as elective clinical
procedures continue to resume from Covid-19 limitations.
- Complete ongoing clinical trial
evaluating EsoCheck in EoE patients at the University of
Pennsylvania.
- Launch clinical trial of EsoCheck
with BE progression markers at Fred Hutchinson Cancer Research
Center in Seattle.
- Launch additional Lucid-sponsored
clinical trials of EsoGuard and EsoCheck to support commercial
activities including EsoGuard registry, Barrett’s Esophagus EGD
Yield study and Integrated Health System Referral study.
- Complete M&A process and
consummate licensing agreement for NextFlo™ technology in
disposable infusion pumps. Complete device qualification and FDA
510(k) submission for NextFlo Intravenous Infusion System.
- Secure FDA clearance for an Investigational Device Exemption
(IDE) to begin a clinical safety study in the U.S. evaluating
PortIO in dialysis patients with a one-week implant duration to
support its de novo application.
- Initiate PortIO long-term clinical
study in Colombia, South America to demonstrate up to 60-day
maintenance free implant durations in humans.
- Advance Solys development to
achieve FDA and ISO 15197 accuracy standards for a full range of
glucose measurements including severe hyperglycemia.
FINANCIAL RESULTS
For the three months ended June 30, 2020,
research and development expenses were $2.1 million and general and
administrative expenses were $2.9 million. GAAP net loss
attributable to common stockholders was $5.6 million, or $(0.13)
per common share. As illustrated below and for the purpose of
helping the reader understand the effect of derivative accounting
and other non-cash income and expenses on the Company’s financial
results, the Company reported a non-GAAP adjusted loss for the
three months ended June 30, 2020 of $4.2 million, or $(0.09) per
common share.
PAVmed had cash and cash equivalents of $7.1
million as of June 30, 2020, compared with $6.2 million as of
December 31, 2019. Subsequently, in early August 2020, the Company
received approximately $7 million in proceeds from a private
placement with an existing institutional investor for the sale of a
Senior Secured Convertible Note.
The unaudited financial results for the three
and six months ended June 30, 2020 as reported to the SEC on Form
10-Q can be obtained
at www.pavmed.com or www.sec.gov.
Non-GAAP Measures
To supplement our unaudited financial results
presented in accordance with U.S. generally accepted accounting
principles (GAAP), management provides certain non-GAAP financial
measures of the Company’s financial results. These non-GAAP
financial measures include net loss before interest, taxes,
depreciation and amortization (EBITDA) and non-GAAP adjusted loss,
which further adjusts EBITDA for stock-based compensation expense,
loss on the issuance or modification of convertible securities, the
periodic change in fair value of convertible securities, and loss
on debt extinguishment. The foregoing non-GAAP financial measures
of EBITDA and non-GAAP adjusted loss are not recognized terms under
U.S. GAAP.
Non-GAAP financial measures are presented with
the intent of providing greater transparency to information used by
us in our financial performance analysis and operational
decision-making. We believe these non-GAAP financial measures
provide meaningful information to assist investors, shareholders
and other readers of our unaudited financial statements in making
comparisons to our historical financial results and analyzing the
underlying performance of our results of operations. These non-GAAP
financial measures are not intended to be, and should not be, a
substitute for, considered superior to, considered separately from
or as an alternative to, the most directly comparable GAAP
financial measures.
Non-GAAP financial measures are provided to
enhance readers’ overall understanding of our current financial
results and to provide further information for comparative
purposes. Management believes the non-GAAP financial measures
provide useful information to management and investors by isolating
certain expenses, gains and losses that may not be indicative of
our core operating results and business outlook. Specifically, the
non-GAAP financial measures include non-GAAP adjusted loss and its
presentation is intended to help the reader understand the effect
of the loss on the issuance or modification of convertible
securities, the periodic change in fair value of convertible
securities, the loss on debt extinguishment and the corresponding
accounting for non-cash charges on financial performance. In
addition, management believes non-GAAP financial measures enhance
the comparability of results against prior periods.
A reconciliation to the most directly comparable
GAAP measure of all non-GAAP financial measures included in this
press release for the three and six months ended June 30, 2020 and
2019 is as follows:
|
|
For the three months ended June 30, |
|
|
For the six months ended June 30, |
|
(ooo’s except per-share
amounts) |
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
common share, basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.27 |
) |
Net loss attributable
to common stockholders |
|
|
(5,649 |
) |
|
|
(3,660 |
) |
|
|
(20,194 |
) |
|
|
(7,261 |
) |
Preferred Stock dividends and
deemed dividends |
|
|
71 |
|
|
|
66 |
|
|
|
141 |
|
|
|
132 |
|
Net income (loss) as reported |
|
|
(5,578 |
) |
|
|
(3,594 |
) |
|
|
(20,053 |
) |
|
|
(7,129 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense1 |
|
|
5 |
|
|
|
3 |
|
|
|
9 |
|
|
|
7 |
|
Interest expense, net3 |
|
|
- |
|
|
|
- |
|
|
|
52 |
|
|
|
- |
|
EBITDA |
|
|
(5,573 |
) |
|
|
(3,591 |
) |
|
|
(19,992 |
) |
|
|
(7,122 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense2 |
|
|
529 |
|
|
|
388 |
|
|
|
873 |
|
|
|
847 |
|
Debt extinguishment3 |
|
|
2,750 |
|
|
|
259 |
|
|
|
3,937 |
|
|
|
260 |
|
Change in FV convertible debt3 |
|
|
(2,120 |
) |
|
|
161 |
|
|
|
5,888 |
|
|
|
720 |
|
Offering costs convertible debt3 |
|
|
200 |
|
|
|
- |
|
|
|
610 |
|
|
|
- |
|
Non-GAAP adjusted
(loss) |
|
|
(4,214 |
) |
|
|
(2,783 |
) |
|
|
(8,684 |
) |
|
|
(5,295 |
) |
Basic and Diluted shares outstanding |
|
|
44,781 |
|
|
|
27,606 |
|
|
|
44,140 |
|
|
|
27,344 |
|
Non-GAAP adjusted (loss) income per share |
|
$ |
(0.09 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.19 |
) |
1 |
Included in general and
administrative expenses in the financial statements |
2 |
For the three months ended June 30, 2020 includes $407 of stock
based compensation expense reported as general and administrative
expenses and $122 reported as research and development expense. For
the three months ended June 30, 2019 includes $299 of stock based
compensation expense reported as general and administrative
expenses and $89 reported as research and development expense. For
the six months ended June 30, 2020 includes $684 of stock based
compensation expense reported as general and administrative
expenses and $189 reported as research and development expense. For
the six months ended June 30, 2019 includes $584 of stock based
compensation expense reported as general and administrative
expenses and $263 reported as research and development
expense. |
3 |
Included in other income and
expenses |
Conference Call and Webcast
The Company will hold a conference call and
webcast today at 4:30 p.m. Eastern time. During the call, Lishan
Aklog, M.D., Chairman and Chief Executive Officer of the Company,
will provide a business update including an overview of the
Company’s near-term milestones and growth strategy. In addition,
Dennis McGrath, President and Chief Financial Officer, will review
second quarter 2020 financial results.
To access the conference call, U.S.-based
listeners should dial (877) 407-3982 and international listeners
should dial (201) 493-6780. All listeners should provide the
operator with the conference call name “PAVmed, Inc. Business
Update Conference Call” to join. Individuals interested in
listening to the live conference call via webcast may do so by
visiting the investor relations section of the Company’s website at
www.pavmed.com.
Following the conclusion of the conference call,
a replay will be available for one week and can be accessed by
dialing (844) 512-2921 from within the U.S. or (412) 317-6671 from
outside the U.S. To access the replay, all listeners should provide
the following pin number: 13707223. The webcast will be available
for replay on the investor relations section of the Company’s
website at www.pavmed.com.
About PAVmed
PAVmed Inc. is a highly differentiated,
multi-product, commercial-stage medical device company employing a
unique business model designed to advance innovative products to
commercialization rapidly and with less capital than the typical
medical device company. This proprietary model enables PAVmed to
pursue an expanding pipeline strategy with a view to enhancing and
accelerating value creation while seeking to further expand its
pipeline through relationships with its network of clinician
innovators at leading academic centers. PAVmed’s diversified
product pipeline addresses unmet clinical needs encompassing a
broad spectrum of clinical areas with attractive regulatory
pathways and market opportunities. Its four operating divisions
include GI Health (EsoGuard™ Esophageal DNA Test, EsoCheck™
Esophageal Cell Collection Device, and EsoCure™ Esophageal Ablation
Device with Caldus™ Technology), Minimally Invasive Interventions
(CarpX™ Minimally Invasive Device for Carpal Tunnel Syndrome),
Infusion Therapy (PortIO™ Implantable Intraosseus Vascular Access
Device and NextFlo™ Highly Accurate Disposable Intravenous Infusion
Set), and Emerging Innovations (non-invasive laser-based glucose
monitoring, pediatric ear tubes, and mechanical circulatory
support). For more information, please visit www.pavmed.com,
follow us on Twitter, connect with us on LinkedIn, and watch our
videos on YouTube. For more information on our majority owned
subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com,
follow Lucid on Twitter, and connect with Lucid on LinkedIn.
Forward-Looking Statements
This press release includes forward-looking
statements that involve risks and uncertainties. Forward-looking
statements are statements that are not historical facts. Such
forward-looking statements, based upon the current beliefs and
expectations of PAVmed’s management, are subject to risks and
uncertainties, which could cause actual results to differ from the
forward-looking statements. Risks and uncertainties that may cause
such differences include, among other things, volatility in the
price of PAVmed’s common stock, Series W Warrants and Series Z
Warrants; general economic and market conditions; the uncertainties
inherent in research and development, including the cost and time
required advance PAVmed’s products to regulatory submission;
whether regulatory authorities will be satisfied with the design of
and results from PAVmed’s preclinical studies; whether and when
PAVmed’s products are cleared by regulatory authorities; market
acceptance of PAVmed’s products once cleared and commercialized;
our ability to raise additional funding and other competitive
developments. PAVmed has not yet received clearance from the FDA or
other regulatory body to market many of its products. The Company
has been monitoring the COVID-19 pandemic and its impact on our
business. The Company expects the significance of the COVID-19
pandemic, including the extent of its effect on the Company’s
financial and operational results, to be dictated by, among other
things, the success of efforts to contain it and the impact of
actions taken in response. New risks and uncertainties may arise
from time to time and are difficult to predict. All of these
factors are difficult or impossible to predict accurately and many
of them are beyond PAVmed’s control. For a further list and
description of these and other important risks and uncertainties
that may affect PAVmed’s future operations, see Part I, Item IA,
“Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K
filed with the Securities and Exchange Commission, as the same may
be updated in Part II, Item 1A, “Risk Factors” in any Quarterly
Reports on Form 10-Q filed by PAVmed after its most recent Annual
Report. PAVmed disclaims any intention or obligation to publicly
update or revise any forward-looking statement to reflect any
change in its expectations or in events, conditions, or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements.
Contacts:
InvestorsMike HavrillaDirector of Investor
Relations(814) 241-4138JMH@PAVmed.com
MediaShaun O’NeilChief Commercial Officer(518)
812-3087SMO@PAVmed.com
PAVmed (NASDAQ:PAVM)
Historical Stock Chart
From Mar 2024 to Apr 2024
PAVmed (NASDAQ:PAVM)
Historical Stock Chart
From Apr 2023 to Apr 2024