EsoGuard® test volume continues to
grow as Lucid makes strides with commercial expansion and
additional supporting data
Veris Health prepares to launch the next
generation of the Veris Cancer Care Platform along with strategic
initiatives to develop a biopharma companion digital module to
support new cancer therapeutics and to seek FDA clearance as a
SaMD
Conference call and webcast to be held
tomorrow, August 16th at
8:30 AM EST
NEW
YORK, Aug. 15, 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 and six months ended June 30, 2023.
Conference Call and Webcast
The webcast will take place on Wednesday, August 16, 2023, at 8:30 AM and is 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 1-833-816-1419 and international
listeners should dial 412-317-0512. All listeners should provide
the operator with the conference call name "PAVmed Business Update"
to join.
Following the conclusion of the conference call, a replay will
be available for 30 days on the investor relations section of the
Company's website at pavmed.com.
Business Update Highlights
"Both Lucid and Veris have strong momentum as we enter the
second half of the year and we look forward to both delivering on
their commercial and strategic plans in the coming quarters,"
said Lishan Aklog, M.D.,
PAVmed's Chairman and Chief Executive Officer.
"The Veris Cancer Care Platform is having a meaningful impact on
the care of enrolled cancer patients at early adopter practices, as
we have focused on optimizing customer acceptance and validation
together with customization and integration with their respective
EHR platforms. A next generation version of the platform
incorporating early feedback will launch later this year.
Gary Manning, President of Veris
Health, has accelerated our progress, completing a detailed review
of the software and hardware programs, revamping the commercial
operation with plans to expand the commercial team this year, and
launching two exciting strategic initiatives which we believe will
significantly expand the company's value proposition. These include
a biopharma module to serve as a companion to novel cancer
therapeutics and an upgrade of the platform to an FDA-cleared
Software as a Medical Device clinical decision support tool," Dr.
Aklog added.
"We covered exciting developments and strategic accomplishments
at Lucid in some depth yesterday, highlighting strong
EsoGuard® test volume growth, our revenue cycle
management upgrade and its immediate impact on claims and payment,
our first direct contract with an employer, upcoming release of
critical clinical utility data and unprecedented results from an
NCI-funded study," Dr. Aklog concluded.
Highlights from the first quarter and recent weeks include:
- The Veris Cancer Care Platform is delivering on its promise to
enhance personalized cancer care at recently onboarded oncology
practices, with a strong focus on delivering world-class customer
integration and support, while ensuring that the platform provides
streamlined and efficient processes for practice operations and
billing.
- Feedback from this early adopter experience has led to the
development of the next-generation Veris Cancer Care Platform,
which adds key enhancements for remote patient monitoring, practice
workflow and provider billing, and is expected to launch in early
4Q23.
- Under the leadership of its new President, Veris is actively
restructuring and expanding its commercial team seeking to
accelerate patient enrollment and subscription revenue in 2H23 and
launching two strategic initiative which expand its long-term
commercial potent.
- Veris has committed to build a Biopharma Companion Digital
Platform module to extend the Veris Cancer Care Platform as a
companion solution for biopharmaceutical companies developing novel
cancer therapeutics. The module will provide these companies with a
long-term patient monitoring solution tightly linked to their
cancer therapeutic—from clinical-stage through full
commercialization. This includes support for clinical trials and
post-marketing surveillance to enhance safety by reducing adverse
events, expedite regulatory filings, lower regulatory hurdles, and
accelerate speed to market. The business model seeks to replicate
the widespread success of companion diagnostics tightly linked to
therapeutics.
- Veris has also committed to upgrading the Veris Cancer Care
Platform from an FDA-designated Medical Device Data System
("MDDS"), limited to displaying medical data for clinicians without
modification, to a Software-as-a-Medical-Device ("SaMD"). As a
SaMD, the platform will have unlimited potential to grow into a
full-bore clinical decision support tool that includes threshold
alarms for faster provider response, analytical algorithms for
effective triage, and digital biomarkers based on artificial
intelligence and machine learning that will provide a risk
assessment for cancer patients. The first step will be to
incorporate the key features in the next generation product and
initiate validation testing to support FDA 510(k) submission as a
SaMD next year.
- Veris continued to make progress toward regulatory submission
of its implantable cardiac and physiologic monitor, designed to be
implanted in conjunction with a vascular access port, which is
targeted for FDA submission and commercial launch next year.
Multiple FDA pre-submission meetings seeking feedback on various
design features have gone well.
- Yesterday, Lucid Diagnostics provided a detailed update of its
commercial and financial performance. Quarterly EsoGuard testing
volume increased 20 percent sequentially and 159 percent annually,
with Satellite Lucid Test Center (sLTC) activity increasing
substantially. High volume testing events continue to grow, and the
company secured its first direct contract with an employer. Lucid's
upgraded revenue cycle management infrastructure upgrade was
completed in June and resulted in an immediate positive impact on
all reimbursement metrics.
- The clinical evidence for EsoGuard's clinical utility and
clinical validity continues to expand. Lucid expects to release and
submit for publication critical clinical utility data, encompassing
over 500 patients from two studies, later this month. On the
clinical validity front, an NCI-funded consortium released
unprecedented results from a case control study, with EsoGuard
detecting 100 percent of cancers and over 80% of precancers.
Financial Results:
- For the three months ended June 30,
2023, EsoGuard related revenues were $0.2 million. Operating expenses were
approximately $16.7 million, which
include stock-based compensation expenses of $2.5 million. GAAP net loss attributable to
common stockholders was approximately $14.6
million, or $(0.14) 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 June 30, 2023, was approximately $9.9 million or $(0.09) per common share.
- PAVmed had cash and cash equivalents of $37.2 million as of June
30, 2023, compared to $49.3
million as of March 31,
2023.
- The unaudited financial results for the three months ended
June 30, 2023 were filed with the SEC
on Form 10-Q on August 14, 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 and six months ended June 30,
2023, and 2022 are as follows:
|
|
For the three months
ended
June 30,
|
|
For the six months
ended
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
(in thousands except
per-share amounts)
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
166
|
|
$
—
|
|
$
612
|
|
$
189
|
Operating
expenses
|
|
16,650
|
|
23,484
|
|
37,496
|
|
43,308
|
Other (Income)
Expense
|
|
1,408
|
|
5,617
|
|
3,222
|
|
5,615
|
Net
Loss
|
|
17,892
|
|
29,101
|
|
40,106
|
|
48,734
|
Net income (loss)
per common share, basic and diluted
|
|
$
(0.14)
|
|
$
(0.29)
|
|
$
(0.32)
|
|
$
(0.49)
|
Net loss
attributable to common stockholders
|
|
(14,612)
|
|
(25,595)
|
|
(32,617)
|
|
(42,535)
|
Preferred Stock
dividends and deemed dividends
|
|
75
|
|
70
|
|
149
|
|
138
|
Net income (loss) as
reported
|
|
(14,537)
|
|
(25,525)
|
|
(32,468)
|
|
(42,397)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense1
|
|
747
|
|
815
|
|
1,474
|
|
1,031
|
Interest expense,
net2
|
|
65
|
|
516
|
|
128
|
|
514
|
EBITDA
|
|
(13,725)
|
|
(24,194)
|
|
(30,866)
|
|
(40,852)
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense3
|
|
2,507
|
|
5,007
|
|
6,926
|
|
9,820
|
ResearchDx acquisition
paid in stock
|
|
—
|
|
66
|
|
713
|
|
239
|
Change in FV
convertible debt2
|
|
340
|
|
2,000
|
|
1,380
|
|
2,000
|
Offering costs
convertible debt2
|
|
—
|
|
3,101
|
|
1,186
|
|
3,101
|
Loss on debt
extinguishment
|
|
743
|
|
—
|
|
1,268
|
|
—
|
Change in fair value -
derivative liability
|
|
260
|
|
—
|
|
260
|
|
—
|
Other non-cash
charges
|
|
—
|
|
28
|
|
—
|
|
57
|
Non-GAAP adjusted
(loss)
|
|
(9,875)
|
|
(13,992)
|
|
(19,133)
|
|
(25,635)
|
Basic and Diluted
shares outstanding
|
|
104,350
|
|
86,957
|
|
100,743
|
|
86,690
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.09)
|
|
$(0.16)
|
|
$(0.19)
|
|
$(0.30)
|
|
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:
|
Reconciliation of
GAAP Operating Expenses to Non-GAAP Net Operating
Expenses
|
(in thousands except
per-share amounts)
|
|
For the three months
ended
June 30,
|
|
For the six months
ended
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
Cost of
revenue
|
|
1,685
|
|
—
|
|
3,030
|
|
369
|
Stock-based
compensation expense3
|
|
(31)
|
|
—
|
|
(54)
|
|
—
|
Net cost of
revenue
|
|
1,654
|
|
—
|
|
2,976
|
|
369
|
|
|
|
|
|
|
|
|
|
Amortization of
acquired intangible assets
|
|
505
|
|
650
|
|
1,010
|
|
773
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
4,339
|
|
4,898
|
|
8,877
|
|
8,823
|
Stock-based
compensation expense3
|
|
(455)
|
|
(591)
|
|
(899)
|
|
(1,216)
|
Net sales and
marketing
|
|
3,884
|
|
4,307
|
|
7,978
|
|
7,607
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
6,652
|
|
11,196
|
|
16,670
|
|
20,672
|
Depreciation
expense
|
|
(242)
|
|
(165)
|
|
(464)
|
|
(258)
|
Stock-based
compensation expense3
|
|
(1,674)
|
|
(4,162)
|
|
(5,262)
|
|
(8,164)
|
Net general and
administrative
|
|
4,736
|
|
6,869
|
|
10,944
|
|
12,250
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
3,469
|
|
6,740
|
|
7,909
|
|
12,671
|
Stock-based
compensation expense3
|
|
(347)
|
|
(254)
|
|
(711)
|
|
(440)
|
Net research and
development
|
|
3,122
|
|
6,486
|
|
7,198
|
|
12,231
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
16,650
|
|
23,484
|
|
37,496
|
|
43,308
|
Depreciation and
amortization expense
|
|
(747)
|
|
(815)
|
|
(1,474)
|
|
(1,031)
|
Stock-based
compensation expense3
|
|
(2,507)
|
|
(5,007)
|
|
(6,926)
|
|
(9,820)
|
Net operating
expenses
|
|
13,396
|
|
17,662
|
|
29,096
|
|
32,457
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 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 mitigate the risks of esophageal cancer
deaths. Its other 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.
For more and for more information about PAVmed, please
visit pavmed.com.
For more information about Lucid Diagnostics, please
visit luciddx.com.
For more information about Veris Health, please
visit verishealth.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. 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.