Lucid's quarterly revenue increased 392
percent sequentially
Veris Health commercial expansion efforts
underway, with next-generation Veris Cancer Care Platform launching
in Q4
Conference call and webcast to be held
tomorrow, November 15th at
8:30 AM EST
NEW
YORK, Nov. 14, 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 nine months ended September 30, 2023.
Conference Call and Webcast
The webcast will take place on Wednesday, November 15, 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
"Lucid's sustained commercial success and Veris's future
commercial execution will be the primary drivers of PAVmed's
long-term success," said Lishan
Aklog, M.D., PAVmed's Chairman and Chief Executive Officer.
"As noted in yesterday's Lucid business update, Q3 was the most
important quarter in Lucid's, and therefore PAVmed's, history, as
we have now begun to translate increasing commercial activity into
revenue and revenue growth. Whether it be commercial execution,
revenue cycle management, laboratory operations, or clinical
research productivity, Lucid is firing on all cylinders. As we have
done with Lucid, we are now laying the foundation for Veris's
future commercial success. This includes upgrading the Veris Cancer
Care Platform to incorporate early adopter feedback; restructuring
and expanding the commercial infrastructure; engaging with large
academic cancer centers; and initiating dialogue with large pharma
companies to have our platform serve as a digital companion to
novel cancer therapeutics undergoing market surveillance."
Highlights from the third quarter and recent weeks include:
- Yesterday, Lucid Diagnostics reported that quarterly EsoGuard
testing volumes increased 17 percent sequentially from 2Q23 and 137
percent annually from 3Q22.
- Lucid's upgraded revenue cycle management infrastructure showed
sustained impact, driving $783K in
quarterly revenue, representing a 392 percent increase sequentially
from 2Q23 and a 930 percent annual increase from 3Q22.
- Lucid substantially increased its clinical utility data
portfolio to support in-network payor coverage engagement, with
near-perfect clinical utility data (98-100 percent concordance)
from three studies.
- Lucid launched EsoGuard 2.0, the next generation of the
EsoGuard Esophageal DNA test, which enhances performance and lowers
per-sample costs.
- Veris restructured its commercial organization, including two
new hires, with expansion efforts now underway aiming to accelerate
patient enrollment at small-to-medium sized oncology practices and
to secure strategic accounts, such as large academic cancer
centers.
- Veris advanced development of the next-generation Veris Cancer
Care Platform incorporating feedback from early adopters, including
key enhancements for practice workflow and provider billing, with
version 2.0 launching during 4Q23.
- Veris is in active discussions with several pharma companies to
incorporate the platform as a digital companion for novel cancer
therapeutics. The biopharma module will facilitate market
surveillance to allow these drugs to become first- or second-line
treatment options.
- Veris is working to upgrade the platform from an FDA-designated
Medical Device Data System ("MDDS"), to a
Software-as-a-Medical-Device ("SaMD"), with the goal of an FDA
510(k) submission next year. The upgraded platform will provide
unlimited potential to grow into a 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.
- Veris remains on track for a 2024 regulatory submission of its
implantable cardiac and physiologic monitor, designed to be
implanted in conjunction with a vascular access port. The team has
held multiple, successful FDA pre-submission meetings on various
design features.
Financial Results:
- For the three months ended September 30,
2023, revenues were $0.8
million. Operating expenses were approximately $16.3 million, which include stock-based
compensation expenses of $2.2
million. GAAP net loss attributable to common stockholders
was approximately $17.7 million, or
$(0.16) 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 September 30, 2023, was approximately
$9.7 million or $(0.09) per common share.
- PAVmed had cash and cash equivalents of $26.4 million as of September 30, 2023, compared to $37.2 million as of June
30, 2023.
- The unaudited financial results for the three months ended
September 30, 2023 were filed with
the SEC on Form 10-Q on November 13,
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 nine months ended September 30, 2023, and 2022 are as follows:
|
|
For the three months
ended
September
30,
|
|
For the nine months
ended
September
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
(in thousands except
per-share amounts)
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
791
|
|
$
76
|
|
$
1,403
|
|
$
265
|
Operating
expenses
|
|
16,319
|
|
23,443
|
|
53,815
|
|
66,751
|
Other (Income)
Expense
|
|
6,222
|
|
6,565
|
|
9,443
|
|
12,180
|
Net
Loss
|
|
21,750
|
|
29,932
|
|
61,855
|
|
78,666
|
Net income (loss)
per common share, basic and diluted
|
|
$
(0.16)
|
|
$
(0.29)
|
|
$
(0.48)
|
|
$
(0.78)
|
Net loss
attributable to common stockholders
|
|
(17,748)
|
|
(26,197)
|
|
(50,365)
|
|
(68,732)
|
Preferred Stock
dividends and deemed dividends
|
|
77
|
|
71
|
|
226
|
|
209
|
Net income (loss) as
reported
|
|
(17,671)
|
|
(26,126)
|
|
(50,139)
|
|
(68,523)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense1
|
|
733
|
|
700
|
|
2,207
|
|
1,731
|
Interest expense,
net2
|
|
35
|
|
471
|
|
162
|
|
986
|
NCI ownership share of
Interest and Depreciation adjustments
|
|
(159)
|
|
(136)
|
|
(470)
|
|
(312)
|
EBITDA
|
|
(17,062)
|
|
(25,091)
|
|
(48,240)
|
|
(66,118)
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense3
|
|
2,245
|
|
4,764
|
|
9,171
|
|
14,583
|
ResearchDx acquisition
paid in stock
|
|
—
|
|
188
|
|
713
|
|
427
|
Change in FV
convertible debt2
|
|
4,392
|
|
(261)
|
|
5,772
|
|
1,739
|
Offering costs
convertible debt2
|
|
—
|
|
1,232
|
|
1,186
|
|
4,332
|
Loss on debt
extinguishment
|
|
1,764
|
|
5,123
|
|
3,032
|
|
5,123
|
Change in fair value -
derivative liability
|
|
31
|
|
—
|
|
291
|
|
—
|
Other non-cash
charges
|
|
—
|
|
25
|
|
—
|
|
82
|
NCI ownership share of
non-GAAP adjustments
|
|
(1,040)
|
|
(864)
|
|
(2,733)
|
|
(2,721)
|
Non-GAAP adjusted
(loss)
|
|
$
(9,670)
|
|
$
(14,884)
|
|
$
(30,808)
|
|
$
(42,553)
|
Basic and Diluted
shares outstanding
|
|
111,941
|
|
89,759
|
|
104,516
|
|
87,724
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.09)
|
|
$(0.17)
|
|
$(0.29)
|
|
$(0.49)
|
|
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
September
30,
|
|
For the nine months
ended
September
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
Cost of
revenue
|
|
$
1,779
|
|
$
1,626
|
|
$
4,809
|
|
$
1,996
|
Stock-based
compensation expense3
|
|
(32)
|
|
(9)
|
|
(86)
|
|
(9)
|
Net cost of
revenue
|
|
1,747
|
|
1,617
|
|
4,723
|
|
1,987
|
|
|
|
|
|
|
|
|
|
Amortization of
acquired intangible assets
|
|
505
|
|
505
|
|
1,516
|
|
1,278
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
4,016
|
|
4,736
|
|
12,893
|
|
13,559
|
Stock-based
compensation expense3
|
|
(403)
|
|
(643)
|
|
(1,302)
|
|
(1,859)
|
Net sales and
marketing
|
|
3,613
|
|
4,093
|
|
11,591
|
|
11,700
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
6,858
|
|
10,374
|
|
23,916
|
|
31,254
|
Depreciation
expense
|
|
(228)
|
|
(195)
|
|
(691)
|
|
(453)
|
Stock-based
compensation expense3
|
|
(1,499)
|
|
(3,854)
|
|
(6,761)
|
|
(12,016)
|
Net general and
administrative
|
|
5,131
|
|
6,325
|
|
16,464
|
|
18,785
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
3,161
|
|
6,202
|
|
10,681
|
|
18,664
|
Stock-based
compensation expense3
|
|
(311)
|
|
(258)
|
|
(1,022)
|
|
(699)
|
Net research and
development
|
|
2,850
|
|
5,944
|
|
9,659
|
|
17,965
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
16,319
|
|
23,443
|
|
53,815
|
|
66,751
|
Depreciation and
amortization expense
|
|
(733)
|
|
(700)
|
|
(2,207)
|
|
(1,731)
|
Stock-based
compensation expense3
|
|
(2,245)
|
|
(4,764)
|
|
(9,171)
|
|
(14,583)
|
Net operating
expenses
|
|
$
13,341
|
|
$
17,979
|
|
$
42,437
|
|
$
50,437
|
|
|
|
|
|
|
|
|
|
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, 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.