Conference call to be held May 31, 2017 at
4:30 p.m. Eastern time
PAVmed Inc. (Nasdaq: PAVM, PAVMW), a highly
differentiated, multiproduct medical device company, today
announced financial results for the three months ended March 31,
2017 and provided a business update.
“During the first quarter we continued to make solid progress in
advancing our growth strategy and multiproduct pipeline towards
commercialization, utilizing our capital- and time-efficient
business model,” said Lishan Aklog, M.D., PAVmed’s Chairman and
Chief Executive Officer. “The first of our products, the PortIO™
implantable intraosseous vascular access device, is being evaluated
by the U.S. Food and Drug Administration and we are hopeful it will
receive initial 510(k) clearance in the near future. Our second
product, the CarpX™ percutaneous device designed to treat carpal
tunnel syndrome, is in the midst of pre-submission verification and
validation testing and we expect to file for 510(k) clearance later
this year.
“PortIO was designed to eliminate many of the shortcomings of
existing implantable vascular access devices and intraosseous
infusion systems, which gives it the potential to be game-changing
with respect to improved outcomes and reduced costs. CarpX, as a
completely percutaneous device, is designed to eliminate the need
for invasive carpal tunnel surgery and has the potential to
decrease costs, reduce pain, accelerate recovery and lower the
threshold for intervention. More than 600,000 patients per year
undergo invasive surgery for carpal tunnel syndrome and up to three
times more suffer in silence to avoid surgery, which gives CarpX an
addressable market of over $1 billion.”
Dr Aklog added, “During the quarter we also took important steps
to strengthen our corporate infrastructure, improve our
capitalization and enhance shareholder value. Medical device
industry veteran Dennis McGrath joined the PAVmed team as Executive
Vice President and Chief Financial Officer, bringing a proven track
record of delivering results and driving shareholder value through
numerous public and private financings, mergers and acquisitions,
joint ventures and licensing deals. We raised $2.5 million in gross
proceeds from an ongoing private placement of convertible preferred
stock units.”
Financial results
Research and development expenses for the first quarter of 2017
were $656,713. General and administrative expenses for the first
quarter of 2017 were $1,499,552.
PAVmed reported an operating loss for the first quarter of 2017
of $2,156,265 and a GAAP net loss of $4,270,088. Included in the
net loss was a non-cash charge of $3,124,285 related to the
issuance of preferred stock units, non-cash gains totaling
$1,010,462 related to a change in the fair value of Series A
warrant liability plus a related change in fair value of a Series A
Convertible Preferred stock conversion option embedded derivative
liability, stock-based compensation expense of $272,680 and
depreciation of $1,702.
For the first quarter of 2017, GAAP net loss attributable to
common stockholders was $4,296,528, or $0.32 per common share. As
illustrated below and for the purpose of helping the reader to
understand the effect of derivative accounting for non-cash charges
on the Company’s financial performance, the Company reported a
non-GAAP adjusted loss for the first quarter of 2017 of $1,881,883,
or $0.14 per common share.
PAVmed had cash and cash equivalents of $905,656 as of March 31,
2017, compared with $585,680 as of December 31, 2016.
Full first quarter financial results 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 PAVmed’s consolidated financial statements
presented in accordance with GAAP, management provides certain
non-GAAP measures of financial performance. These non-GAAP measures
include non-GAAP adjusted (loss), non-GAAP adjusted (loss) per
share, and EBITDA (loss before interest, taxes, depreciation, and
amortization) and are intended to help the reader understand the
effect on financial performance of the loss on issuance of the
Preferred Stock Units and derivative accounting for non-cash
charges.
Management’s reference to these non-GAAP financial measures
should be considered in addition to results prepared under current
accounting standards, but are not a substitute for, nor superior
to, GAAP results. These non-GAAP financial measures are provided to
enhance investors' overall understanding of PAVmed's current
financial performance and to provide further information and
transparency in making comparisons to our historical financial
results of operations. A reconciliation to the most directly
comparable GAAP measure of all non-GAAP measures included in this
press release is as follows:
Three Months Ended March 31,
2017
2016
Net loss per common share, basic and diluted ($0.32)
($0.06)
Net loss attributable to common stockholders
(4,296,528) (696,880) Series A Convertible Preferred Stock
dividends 26,440 -
Net loss as reported
(4,270,088) (696,880)
Adjustments:
Depreciation expense1 1,702 132 Interest expense, net - - Income
tax (benefit) expense - -
EBITDA
(4,268,386)
(696,748)
Other non-cash expenses:
Stock-based compensation expense2 272,680 - Loss from issuance of
Preferred Stock Units3 3,124,285 - Change in fair value of Series A
Warrant Liabiity3 (786,397) - Change in fair value of Series A
Preferred Stock conversion option embedded derivative liabiity3
(224,065) -
Non-GAAP adjusted (loss)
(1,881,883)
(696,748)
Basic and Diluted shares outstanding at
March 31
13,330,891
12,250,000
Non-GAAP adjusted (loss) income per
share
($0.14)
($0.06)
1
Included in general and administrative expenses in the
financial statements
2
Includes $242,452 of stock based compensation expense reported as
general and administrative expenses and $30,228 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 on May 31,
2017 at 4:30 p.m. Eastern time. During this call, Dr. Aklog, Mr.
McGrath and Brian de Guzman, M.D., the Company’s Chief Medical
Officer, will discuss these financial results and provide a
business update including an overview of the Company’s nearterm
milestones and growth strategy, as well as a focused discussion of
its CarpX™ device.
To access the conference call, U.S.-based participants should
dial (888) 803-5993 and international participants should dial
(706) 634-5454. All participant should provide the following
passcode: 19406912. Individuals interested in listening to the live
conference call via the Internet may do so by logging on to the
Company’s website at www.pavmed.com.
Following the conclusion of the conference call, a replay will
be available through June 6, 2017 and can be accessed by dialing
(855) 859-2056 from within the U.S. or (404) 537-3406 from outside
the U.S. All listeners should provide passcode 19406912.
About PAVmed
PAVmed Inc. is a highly differentiated, multiproduct medical
device company employing a unique business model designed to
advance products from concept to commercialization much more
rapidly and with significantly 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. PAVmed’s diversified pipeline of
products address unmet clinical needs, have attractive regulatory
pathways and market opportunities and encompass a broad spectrum of
clinical areas including carpal tunnel syndrome (CarpX™), medical
infusions (NextFlo™ and NextCath™), interventional radiology
(PortIO™ and NextCath™), tissue ablation and cardiovascular
intervention (Caldus™) and pediatric ear infections (DisappEAR™).
The Company intends to further expand its pipeline through
engagements with clinician innovators and leading academic medical
centers. For further information, please visit www.pavmed.com
Forward-Looking Statements
This press release includes forward-looking statements that
involve risks and uncertainties. Forwardlooking statements are
statements that are not historical facts. Such forward-looking
statements, based upon the current beliefs and expectations of the
Company’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, the uncertainties inherent in research
and development, including the cost and time required advance our
products to regulatory submission; whether regulatory authorities
will be satisfied with the design of and results from our
preclinical studies; whether and when our products are cleared by
regulatory authorities; market acceptance of our 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 any of
its products. 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 our control. For a further list and description of these and
other important risks and uncertainties that may affect our future
operations, see Part I, Item IA, “Risk Factors,” in our 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 us after
our most recent Annual Report. We disclaim any intention or
obligation to publicly update or revise any forwardlooking
statement to reflect any change in our 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170522006275/en/
InvestorsLHAKim Sutton Golodetz,
212-838-3777kgolodetz@lhai.comorMediaRooneyPartnersKate Barrette,
212-223-0561Kbarrette@rooneyco.com
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