EsoGuard® test volume gains
momentum as Lucid expands high-volume testing events
PAVmed appoints President for Veris Health and
expands commercial footprint
Conference call and webcast to be held
tomorrow, May 17th at
8:30 AM EST
NEW
YORK, May 16, 2023 /PRNewswire/ -- PAVmed
Inc. (NASDAQ: PAVM, PAVMZ) ("PAVmed" or the "Company"), a
diversified commercial-stage medical technology company, operating
in the medical device, diagnostics, and digital health sectors,
today provided a business update for the Company and its
subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") and
Veris Health Inc. ("Veris"), and presented financial results for
the Company for the three months ended March
31, 2023.
Conference Call and Webcast
The webcast will take place on Wednesday, May 17, 2023, at 8:30 AM and will be accessible in the investor
relations section of the Company's website at pavmed.com.
Alternatively, to access the conference call by telephone,
U.S.-based callers should dial 1-866-652-5200 and international
listeners should dial 412-317-6060. All listeners should provide
the operator with the conference call name "PAVmed Business Update"
to join.
Business Update Highlights
"Since our business update in January, the PAVmed team has
continued to execute on our near-term strategy focused on our two
commercial subsidiaries, Lucid and Veris, to fulfill our vision to
build a high-growth, diversified medical technology company,"
said Lishan Aklog, M.D.,
PAVmed's Chairman and Chief Executive Officer. "To that end, we
continue to expand utilization of our Veris Cancer Care Platform,
while broadening our long-term commercial strategy under the
leadership of our new Veris
President, Gary Manning.
Similarly, Lucid continues to accelerate test volume growth,
including through an expanded use of satellite Lucid Test Centers
(sLTC) and #CheckYourFoodTube events. Collectively, the teams are
delivering on key metrics while continuing to preserve cash even as
we press through near-term inflection points."
Highlights from the first quarter and recent weeks include:
- Since the Veris Cancer Care Platform went "live" in February,
Veris added two additional accounts, expanding utilization of the
product to a total of six locations across three oncology practices
while building a robust, nationwide pipeline.
- In April, Gary Manning joined
PAVmed to become the President of Veris Health. Mr. Manning has a
track record of success spanning three decades, including leading
companies in the medical device, wearable, and digital health
arenas and commercializing products in the global market. Mr.
Manning is leveraging this experience to hone strategy and expand
commercial horizons.
- Veris continues to make progress toward regulatory submission
of its implantable monitor which is targeted for commercial launch
next year. The device, which is designed to be implanted in
conjunction with a chemotherapy vascular access port, will further
the power of the Veris Cancer Care Platform by assuring full
patient compliance with RPM data reporting requirements. It
recently completed an animal study which demonstrated excellent
device performance, consistent with its design and clinical
specifications, over an extended implant period.
- Yesterday, Lucid provided a detailed update of its commercial
and financial performance. Quarterly EsoGuard testing volume
increased with a 57 percent increase sequentially from 4Q22 and a
245 percent annual increase from 1Q22.
- Satellite Lucid Test Center (sLTC) activity, where Lucid
clinicians collect samples at physician offices and high-volume
testing events, continues to increase rapidly, with Lucid
clinicians now performing more than half of all cell collection
procedures through an sLTC.
- In the first quarter and recent weeks, Medicare Administrative
Contractors Palmetto GBA MolDX and Noridian Healthcare Solutions
published foundational Future Effective Local Coverage
Determinations ("LCD"), both titled "Molecular Testing for
Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and
Neoplasia".
Financial Results:
- For the three months ended March 31,
2023, EsoGuard related revenues were $0.4 million. Operating expenses were
approximately $20.8 million, which
include stock-based compensation expenses of $4.4 million. GAAP net loss attributable to
common stockholders was approximately $18.0
million, or $(0.19) per common
share.
- As shown below and for the purpose of illustrating the effect
of stock-based compensation and other non-cash income and expenses
on the Company's financial results, the Company's preliminary
non-GAAP adjusted loss for the three months ended March 31, 2023, was approximately $9.3 million or $(0.10) per common share.
- PAVmed had cash and cash equivalents of $49.3 million as of March
31, 2023, compared to $39.7
million as of December 31,
2022.
- The unaudited financial results for the three months ended
March 31, 2023 were filed with the
SEC on Form 10-Q on May 15, 2023, and
are available at www.pavmed.com or www.sec.gov.
PAVmed 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 the 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 months ended March 31,
2023, and 2022 are as follows:
|
|
|
For the three months
ended
March 31,
|
|
|
2023
|
|
2022
|
(in thousands except
per-share amounts)
|
|
|
|
|
Revenue
|
|
$
446
|
|
$
189
|
Operating
expenses
|
|
20,847
|
|
19,824
|
Other (Income)
Expense
|
|
1,813
|
|
(2)
|
Net
Loss
|
|
22,214
|
|
19,633
|
Net income (loss)
per common share, basic and diluted
|
|
$
(0.19)
|
|
$
(0.20)
|
Net loss
attributable to common stockholders
|
|
(18,005)
|
|
(16,940)
|
Preferred Stock
dividends and deemed dividends
|
|
74
|
|
68
|
Net income (loss) as
reported
|
|
(17,931)
|
|
(16,872)
|
Adjustments:
|
|
|
|
|
Depreciation and
amortization expense1
|
|
727
|
|
216
|
Interest expense,
net2
|
|
62
|
|
(2)
|
EBITDA
|
|
(17,142)
|
|
(16,658)
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
Stock-based
compensation expense3
|
|
4,419
|
|
4,814
|
ResearchDx acquisition
paid in stock
|
|
713
|
|
—
|
Change in FV
convertible debt2
|
|
1,040
|
|
—
|
Offering costs
convertible debt2
|
|
1,186
|
|
—
|
Loss on debt
extinguishment
|
|
525
|
|
—
|
Non-GAAP adjusted
(loss)
|
|
(9,259)
|
|
(11,844)
|
Basic and Diluted
shares outstanding
|
|
97,095
|
|
86,336
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.10)
|
|
$(0.14)
|
|
1
Included in general and administrative expenses in the financial
statements.
|
2 Included
in other income and expenses.
|
3
Stock-based compensation ("SBC") expense included in operating
expenses is detailed
as follows in the table below by category within operating expenses
for the non-GAAP
Net operating expenses:
|
|
|
|
For the three months
ended
March 31,
|
|
|
2023
|
|
2022
|
(in thousands except
per-share amounts)
|
|
|
|
|
Cost of
revenue
|
|
1,346
|
|
369
|
Stock-based
compensation expense3
|
|
(23)
|
|
—
|
Net cost of
revenue
|
|
1,323
|
|
369
|
|
|
|
|
|
Amortization of
acquired intangible assets
|
|
505
|
|
123
|
|
|
|
|
|
Sales and
marketing
|
|
4,539
|
|
3,925
|
Stock-based
compensation expense3
|
|
(444)
|
|
(625)
|
Net sales and
marketing
|
|
4,095
|
|
3,300
|
|
|
|
|
|
General and
administrative
|
|
10,018
|
|
9,475
|
Depreciation
expense
|
|
(222)
|
|
(93)
|
Stock-based
compensation expense3
|
|
(3,588)
|
|
(4,002)
|
Net general and
administrative
|
|
6,208
|
|
5,380
|
|
|
|
|
|
Research and
development
|
|
4,439
|
|
5,932
|
Stock-based
compensation expense3
|
|
(364)
|
|
(187)
|
Net research and
development
|
|
4,075
|
|
5,745
|
|
|
|
|
|
Total operating
expenses
|
|
20,847
|
|
19,824
|
Depreciation and
amortization expense
|
|
(727)
|
|
(216)
|
Stock-based
compensation expense3
|
|
(4,419)
|
|
(4,814)
|
Net operating
expenses
|
|
15,701
|
|
14,794
|
About PAVmed and its Subsidiaries
PAVmed Inc. is a diversified commercial-stage medical technology
company operating in the medical device, diagnostics, and digital
health sectors. Its majority-owned subsidiary, Veris Health Inc.,
is a digital health company focused on enhanced personalized cancer
care through remote patient monitoring using implantable biologic
sensors with wireless communication along with a custom suite of
connected external devices. Veris is concurrently developing an
implantable physiological monitor, designed to be implanted
alongside a chemotherapy port, which will interface with the Veris
Cancer Care Platform. Its other majority-owned
subsidiary, Lucid Diagnostics Inc. (NASDAQ: LUCD), is a
commercial-stage cancer prevention medical diagnostics company that
markets the EsoGuard® Esophageal DNA Test and
EsoCheck® Esophageal Cell Collection Device—the
first and only commercial tools for widespread early detection of
esophageal precancer to prevent esophageal cancer deaths.
For more and for more information about PAVmed, please
visit pavmed.com.
For more information about Veris Health, please
visit verishealth.com.
For more information about Lucid Diagnostics, please
visit luciddx.com.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risks and uncertainties. Forward-looking statements are any
statements that are not historical facts. Such forward-looking
statements, which are based upon the current beliefs and
expectations of PAVmed's and Lucid'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 and Lucid's common stock; PAVmed's Series
Z warrants; general economic and market conditions; the
uncertainties inherent in research and development, including the
cost and time required to advance PAVmed's and Lucid's products to
regulatory submission; whether regulatory authorities will be
satisfied with the design of and results from PAVmed's and Lucid's
clinical and preclinical studies; whether and when PAVmed's and
Lucid's products are cleared by regulatory authorities; market
acceptance of PAVmed's and Lucid's products once cleared and
commercialized; PAVmed's and Lucid's ability to raise additional
funding as needed; and other competitive developments. In addition,
new risks and uncertainties may arise from time to time and are
difficult to predict. For a further list and description of these
and other important risks and uncertainties that may affect
PAVmed's and Lucid's future operations, see Part I, Item 1A, "Risk
Factors," in PAVmed's and Lucid'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
Report on Form 10-Q filed by PAVmed or Lucid after its most recent
Annual Report. PAVmed and Lucid disclaim 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.
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SOURCE PAVMED INC.