Lucid reports record quarterly
EsoGuard® test volume and held productive meeting with
CMS Medicare Administrative Contractor (MAC) Palmetto GBA's
MolDX Program
Veris Health actively pursuing financing
following launch of pilot program with The Ohio State's James Cancer Hospital
Conference call and webcast to be held today,
August 13th at
8:30 AM EDT
NEW
YORK, Aug. 13, 2024 /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 June
30, 2024.
Conference Call and Webcast
The webcast will take place on Tuesday, August 13, 2024, 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 1-800-836-8184 and international
listeners should dial 1-646-357-8785. 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
"Our strategy for PAVmed remains to strengthen its finances and
long-term stability by seeking to have each of its subsidiaries
become independently financeable and well-positioned to leverage
PAVmed's shared infrastructure," said Lishan Aklog, M.D., PAVmed's Chairman and Chief
Executive Officer. "Lucid remains PAVmed's strongest asset and it
has been able to independently finance its operations and continue
to make solid progress over multiple fronts towards fulfilling its
large commercial potential. PAVmed's two other subsidiaries, Veris
Health and the PMX incubator are also advancing consistent with
this strategy, with Veris and PMX asset PortIO actively pursuing
independent financing.
Highlights from the second quarter and recent weeks:
- Lucid reported that 2Q24 EsoGuard® Esophageal DNA
Test revenue was $1.0 million, which
was flat compared to 1Q24 and represents a 514 percent increase
from 2Q23.
- Lucid's CLIA-certified clinical laboratory performed 3,147
commercial EsoGuard tests in 2Q24, which represents a
single-quarter record and 31 percent increase sequentially from
1Q24 and a 44 percent annual increase from 2Q23.
- Released positive data from both the ENVET-BE clinical utility
study and ESOGUARD BE-1 clinical validation study
- Held productive meeting with CMS Medicare Administrative
Contractor (MAC) Palmetto GBA's Molecular Diagnostics Program
(MolDX) focused on EsoGuard's clinical data.
- Lucid held first major #CheckYourFoodTube Precancer Testing
Event with upfront contracted payment.
- Veris launched pilot program with The Ohio
State's James Cancer Hospital and enrolled first patients
onto the Veris Cancer Care Platform.
- Veris actively pursuing financing to relaunch the development
of its implantable monitor.
- PMX incubator making meaningful advancements in its efforts to
raise capital for PortIO Corp.
Financial Results:
- For the three months ended June 30,
2024, EsoGuard related revenues were $1.0 million. Operating expenses were
approximately $14.6 million, which
includes stock-based compensation expenses of $1.9 million. GAAP net loss attributable to
common stockholders was approximately $10.9
million, or $(1.19) 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 non-GAAP adjusted
loss was approximately $7.7 million
or $(0.84) per common share.
- PAVmed had cash and cash equivalents of $25.5 million as of June
30, 2024, compared to $19.6
million as of December 31,
2023.
- The unaudited financial results for the three months ended
June 30, 2024 were filed with the SEC
on Form 10-Q on August 12, 2024, and
are available at www.pavmed.com or www.sec.gov.
PAVmed Non-GAAP Measures
- To supplement our 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 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,
2024 and 2023 are as follows:
|
Condensed
Consolidated Statement of Operations (Unaudited)
|
|
|
For the three months
ended
June 30,
|
|
For the six months
ended
June 30,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
(in thousands except
per-share amounts)
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
979
|
|
$
166
|
|
$
1,989
|
|
$
612
|
|
Operating
expenses
|
|
14,663
|
|
16,650
|
|
29,711
|
|
37,496
|
|
Other (Income)
Expense
|
|
1,230
|
|
1,408
|
|
5,704
|
|
3,222
|
|
Net
Loss
|
|
14,914
|
|
17,892
|
|
33,426
|
|
40,106
|
|
Net income (loss)
per common share, basic and diluted
|
|
$
(1.19)
|
|
$
(2.10)
|
|
$
(3.78)
|
|
$
(4.86)
|
|
Net loss
attributable to common stockholders
|
|
(10,908)
|
|
(14,612)
|
|
(33,696)
|
|
(32,617)
|
|
Preferred Stock
dividends and deemed dividends
|
|
81
|
|
75
|
|
7,657
|
|
149
|
|
Net income (loss) as
reported
|
|
(10,827)
|
|
(14,537)
|
|
(26,039)
|
|
(32,468)
|
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense1
|
|
305
|
|
747
|
|
891
|
|
1,474
|
|
Interest expense,
net2
|
|
(99)
|
|
65
|
|
(156)
|
|
128
|
|
NCI ownership share of
Interest and Depreciation adjustments
|
|
(40)
|
|
(225)
|
|
(180)
|
|
(403)
|
|
EBITDA
|
|
(10,661)
|
|
(13,950)
|
|
(25,484)
|
|
(31,269)
|
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense3
|
|
1,904
|
|
2,507
|
|
3,786
|
|
6,926
|
|
ResearchDx
acquisition/settlement paid in stock1
|
|
—
|
|
—
|
|
—
|
|
713
|
|
Operating expenses
issued in stock1
|
|
140
|
|
625
|
|
163
|
|
625
|
|
Change in FV
convertible debt2
|
|
566
|
|
340
|
|
2,728
|
|
1,380
|
|
Offering costs
convertible debt2
|
|
—
|
|
—
|
|
—
|
|
1,186
|
|
Loss on debt
extinguishment2
|
|
763
|
|
743
|
|
1,132
|
|
1,268
|
|
Debt modification
expense
|
|
—
|
|
—
|
|
2,000
|
|
—
|
|
Other non-cash
charges
|
|
—
|
|
—
|
|
—
|
|
—
|
|
NCI ownership share of
non-GAAP adjustments
|
|
(363)
|
|
(450)
|
|
(602)
|
|
(2,192)
|
|
Non-GAAP adjusted
(loss)
|
|
$
(7,651)
|
|
$
(10,185)
|
|
$
(16,277)
|
|
$
(21,363)
|
|
Basic and Diluted
shares outstanding
|
|
9,153
|
|
6,957
|
|
8,924
|
|
6,716
|
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.84)
|
|
$(1.46)
|
|
$(1.82)
|
|
$(3.18)
|
|
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,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenue
|
|
$
1,666
|
|
$
1,685
|
|
$
3,411
|
|
$
3,030
|
|
Stock-based
compensation expense3
|
|
(44)
|
|
(31)
|
|
(80)
|
|
(54)
|
|
Net cost of
revenue
|
|
1,622
|
|
1,654
|
|
3,331
|
|
2,976
|
|
|
|
|
|
|
|
|
|
|
Amortization of
acquired intangible assets
|
|
105
|
|
505
|
|
477
|
|
1,010
|
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
4,242
|
|
4,339
|
|
8,552
|
|
8,877
|
|
Stock-based
compensation expense3
|
|
(387)
|
|
(455)
|
|
(790)
|
|
(899)
|
|
Net sales and
marketing
|
|
3,855
|
|
3,884
|
|
7,762
|
|
7,978
|
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
7,009
|
|
6,652
|
|
13,688
|
|
17,060
|
|
Depreciation
expense
|
|
(200)
|
|
(242)
|
|
(414)
|
|
(464)
|
|
ResearchDx
acquisition/settlement paid in stock
|
|
—
|
|
—
|
|
—
|
|
(713)
|
|
Operating expenses
issued in stock
|
|
(140)
|
|
(625)
|
|
(163)
|
|
(625)
|
|
Stock-based
compensation expense3
|
|
(1,214)
|
|
(1,674)
|
|
(2,292)
|
|
(5,262)
|
|
Net general and
administrative
|
|
5,455
|
|
4,111
|
|
10,819
|
|
9,996
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
1,641
|
|
3,469
|
|
3,583
|
|
7,519
|
|
Stock-based
compensation expense3
|
|
(259)
|
|
(347)
|
|
(624)
|
|
(711)
|
|
Net research and
development
|
|
1,382
|
|
3,122
|
|
2,959
|
|
6,808
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
14,663
|
|
16,650
|
|
29,711
|
|
37,496
|
|
Depreciation and
amortization expense
|
|
(305)
|
|
(747)
|
|
(891)
|
|
(1,474)
|
|
ResearchDx
acquisition/settlement paid in stock
|
|
—
|
|
—
|
|
—
|
|
(713)
|
|
Operating expenses
issued in stock
|
|
(140)
|
|
(625)
|
|
(163)
|
|
(625)
|
|
Stock-based
compensation expense3
|
|
(1,904)
|
|
(2,507)
|
|
(3,786)
|
|
(6,926)
|
|
Net operating
expenses
|
|
$
12,314
|
|
$
12,771
|
|
$
24,871
|
|
$
27,758
|
|
|
|
|
|
|
|
|
|
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 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 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.