Lucid’s EsoGuard test volume grows 60% and
LucidDx Labs fully operational
Veris Health Cancer Care Platform to
commercially launch this year
Conference call to be held today at 4:30 PM
EDT
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), 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 three and six months ended June 30, 2022.
Conference Call and Webcast
A conference call and webcast for today’s business update and
second quarter 2022 financial results will take place at 4:30 PM
EDT. To access the conference call, listeners should dial
877-407-3982 toll-free in the U.S., and international listeners
should dial 201-493-6780, and ask to join the “PAVmed Inc. Business
Update Conference Call”. The conference call will be available live
via a webcast and for replay at the investor relations section of
the Company’s website at https://ir.pavmed.com/. Following the
conclusion of the conference call, a replay will be available for
one week and can be accessed by dialing 844-512-2921 toll-free in
the U.S. or 412-317-6671 from outside the U.S., followed by the PIN
number: 13730495.
Business Update Highlights
“PAVmed and its subsidiaries continue to make solid progress as
we push forward on our long-term growth strategy and mission to
create a leading, diversified medical technology company across all
three sectors – medical devices, diagnostics and digital health,”
said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive
Officer. “Our combined team has grown to over one hundred and fifty
employees and is singularly focused on growing the PAVmed
enterprise while enhancing long-term shareholder value. Lucid,
Veris and our pre-commercial products are all moving on a solid
path forward.”
Highlights from the second quarter and recent weeks include:
- Lucid’s wholly owned CLIA-certified, CAP-accredited clinical
laboratory, now fully operational as an independent entity,
processed 850 commercial EsoGuard tests in the second quarter of
2022, which represents a 60% increase sequentially from the first
quarter of 2022 and an over 300% increase annually from the second
quarter of 2021. The laboratory has commenced submitting claims to
commercial payers and has entered into four new participating
provider agreements.
- Lucid continued its steady expansion of its commercial
infrastructure. Expansion of the sales team is progressing towards
its end-of-year target of sixty and Lucid Test Centers in four new
metropolitan areas: Orange County, California, the Dallas-Fort
Worth, Texas metropolitan area, Palm Beach County, Florida and
Columbus, Ohio.
- Both leading gastroenterology specialty associations published
updated guidelines which now support Lucid’s EsoCheck® Cell
Collection Device and EsoGuard® Esophageal DNA Test as an
acceptable alternative to endoscopy, and expand the target
population and addressable market opportunity for these
products.
- Lucid and over a dozen partner entities participated in the now
completed public comment periods following publication of a
proposed “foundational” Local Coverage Decision by two Medicare
Administrative Contractors and await their response.
- Veris Health is on schedule to complete software development
and commercially launch its Veris Cancer Care Platform this year in
conjunction with VerisBox™—a bundle of Veris-branded OEM
Bluetooth-enabled connected health care devices.
- Pre-commercial pipeline consisting of CarpX® Ultrasound
(minimally invasive carpal tunnel release with integrated
intraluminal ultrasound imaging), Veris Mercury™ (modular
implantable monitor paired with vascular access port), and EsoCure™
(endoscopic esophageal ablation device) are progressing well
through development towards FDA submission and clearance next
year.
- PortIO’s first-in-human study is progressing with three new
sites approved in Colombia, South America. First phase with
seven-day implantation duration has been completed, and we are
proceeding with the second phase including a sixty-day implantation
duration.
Preliminary Financial Results
- For the three months ended June 30, 2022, due to an extended
transition period following the opening of our LucidDx Lab and the
onboarding of a new revenue cycle management (“RCM”) partner,
initial submission of claims by our RCM provider did not occur
until after June 30, 2022. Presently recognized revenue for GAAP
purposes is measured by actual collections during the period.
Accordingly, there were no EsoGuard revenues recorded for the 850
tests performed for the three months ending June 30, 2022.
Operating expenses were approximately $23.5 million, which includes
stock-based compensation expenses of $5.0 million. GAAP net loss
attributable to shareholders was approximately $25.5 million, or
$(0.29) 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, 2022,
was approximately $14.5 million or $(0.17) per common share.
- PAVmed had cash and cash equivalents of $65.2 million as of
June 30, 2022, compared with $77.3 million as of December 31,
2021.
The unaudited financial results for the three months ended June
30, 2022 were filed with the SEC on Form 10-Q on August 15, 2022,
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 and six months ended June 30, 2022, and 2021 is as
follows:
For the three months ended June
30,
For the six months ended June
30,
2022
2021
2022
2021
Revenue
$
-
$
-
$
189
$
-
Gross profit
-
-
(180
)
-
Operating expenses
23,477
12,970
42,930
21,046
Other (Income) Expense
5,624
(300
)
5,624
1,733
Net Loss
(29,101
)
(12,670
)
(48,734
)
(22,779
)
Net income (loss) per common share, basic and diluted
$
(0.29
)
$
(0.14
)
$
(0.49
)
$
(0.27
)
Net loss attributable to common stockholders
(25,595
)
(11,545
)
(42,535
)
(21,051
)
Preferred Stock dividends and deemed dividends
70
74
138
149
Net income (loss) as reported
(25,525
)
(11,471
)
(42,397
)
(20,902
)
Adjustments: Depreciation and amortization expense1
815
16
1,031
28
EBITDA
(24,710
)
(11,455
)
(41,366
)
(20,821
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
5,007
5,203
9,820
6,639
Debt extinguishment2
(300
)
-
3,415
Acquisition related2
66
133
239
133
Change in FV convertible debt2
2,000
-
2,000
(1,682
)
Offering costs convertible debt2
3,101
-
3,101
-
Other non-cash charges
28
-
57
-
Non-GAAP adjusted (loss)
(14,508
)
(6,419
)
(26,149
)
(12,316
)
Basic and Diluted shares outstanding
86,957
82,235
86,690
78,118
Non-GAAP adjusted (loss) income per share
($
0.17
)
($
0.08
)
($
0.30
)
($
0.16
)
1
Included in general and administrative expenses in the financial
statements
2
Included in other income and expenses
3
Stock-based compensation ("SBC") expenses: (ooo's except per-share
amounts)
For the three months ended June
30,
For the six month ended June
30,
2022
2021
2022
2021
Sales and marketing expense
4,898
1,875
8,823
3,262
Stock-based compensation expense
(591
)
(298
)
(1,216
)
(500
)
Net commercial operations expense excluding SBC
4,307
1,577
7,607
2,762
General and administrative expense total
11,839
6,837
21,436
10,211
Stock-based compensation expense
(4,162
)
(4,599
)
(8,164
)
(5,722
)
Net general and administrative expense excluding SBC
7,677
2,238
13,272
4,489
Research and development expense total
6,740
4,258
12,671
7,573
Stock-based compensation expense
(254
)
(306
)
(440
)
(417
)
Net research and development expense excluding SBC
6,486
3,952
12,231
7,156
Total operating expenses
23,477
12,970
42,930
21,046
Stock-based compensation expense
(5,007
)
(5,203
)
(9,820
)
(6,639
)
Net operating expenses excluding SBC
18,470
7,767
33,110
14,407
Lucid Diagnostics (Nasdaq: LUCD)
Preliminary Financial Results
- For the three months ended June 30, 2022, due to an extended
transition period following the opening of our LucidDx Labs and the
onboarding of a new revenue cycle management (“RCM”) partner,
initial submission of claims by our RCM provider did not occur
until after June 30, 2022. Presently, recognized revenue for GAAP
purposes is measured by actual collections during the period.
Accordingly, there were no EsoGuard revenues recorded for the 850
tests performed for the three months ending June 30, 2022.
Operating expenses were approximately $14.6 million, which include
stock-based compensation expenses of $3.8 million. GAAP net loss
attributable to common stockholders was approximately $14.6
million, or $(0.41) 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, 2022,
was approximately $10.1 million or $(0.28) per common share.
- Lucid had cash and cash equivalents of $32.7 million as of June
30, 2022, compared to $53.7 as of December 31, 2021.
- The unaudited financial results for the three months ended June
30, 2022, were filed with the SEC on Form 10-Q on August 15, 2022,
and are available at www.luciddx.com or www.sec.gov.
Lucid 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 and other
non-cash income and expenses, if any. 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 and six months ended June 30, 2022, and 2021
is as follows:
For the three months ended June 30, For the six months ended June
30,
2022
2021
2022
2021
Revenue
$
-
$
-
$
189
$
-
Gross profit
-
-
(180
)
-
Operating expenses
14,624
6,016
26,714
9,669
Other (Income) expense
-
147
-
147
Net loss
(14,624
)
(6,163
)
(26,894
)
(9,816
)
Net income (loss) per common share, basic and diluted
$
(0.41
)
$
(0.44
)
$
(0.76
)
$
(0.70
)
Adjustments: Depreciation and amortization expense1
704
-
728
3
Interest expense, net3
-
147
-
147
EBITDA
(13,920
)
(6,016
)
(26,166
)
(9,666
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
3,843
2,580
7,679
3,384
Non-GAAP adjusted (loss)
(10,077
)
(3,436
)
(18,487
)
(6,282
)
Basic and Diluted shares outstanding
35,760
14,115
35,444
14,115
Non-GAAP adjusted (loss) income per share
($
0.28
)
($
0.24
)
($
0.52
)
($
0.45
)
1
Included in general and administrative expenses in the financial
statements For the three months ended June 30, For the six months
ended June 30,
2022
2021
2022
2021
2
Stock-based compensation ("SBC") expenses: Sales and
Marketing expense total
3,873
1,021
7,191
1,710
Stock-based compensation expense
(375
)
-
(816
)
-
Net commercial operations expense excluding SBC
3,498
1,021
6,375
1,710
General and administrative expense total
7,311
3,122
13,202
4,334
Stock-based compensation expense
(3,390
)
(2,505
)
(6,659
)
(3,294
)
Net general and administrative expense excluding SBC
3,921
617
6,543
1,040
Research and development expense total
3,440
1,873
6,321
3,625
Stock-based compensation expense
(78
)
(75
)
(204
)
(90
)
Net research and development expense excluding SBC
3,362
1,798
6,117
3,535
Total operating expenses
14,624
6,016
26,714
9,669
Stock-based compensation expense
(3,843
)
(2,580
)
(7,679
)
(3,384
)
Net operating expenses excluding SBC
10,781
3,436
19,035
6,285
About PAVmed
PAVmed Inc. is a diversified commercial-stage medical technology
company operating in the medical device, diagnostics, and digital
health sectors. Its major subsidiary, Lucid Diagnostics Inc.
(Nasdaq: LUCD), is a commercial-stage cancer prevention medical
diagnostics company which 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. Lucid operates its
own CLIA-certified, CAP-approved molecular diagnostic laboratory,
LucidDx Labs and a network of Lucid Test Centers. Another major
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. The product pipeline also includes the CarpX® Minimally
Invasive Device for Carpal Tunnel Syndrome, EsoCure™ Esophageal
Ablation Device with Caldus™ Technology, which complements EsoGuard
and EsoCheck, NextFlo™ Intravenous Infusion Set, PortIO™
Implantable Intraosseous Vascular Access Device, and other earlier
stage technologies. For more information on PAVmed, please visit
PAVmed.com and follow PAVmed on Twitter, LinkedIn, and YouTube. For
more information on Lucid, please visit LucidDx.com and follow
Lucid on Twitter, and LinkedIn. For detailed information on
EsoGuard, please visit EsoGuard.com and follow EsoGuard on Twitter,
Facebook and Instagram.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risk 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
W and 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,
PAVmed and Lucid have been monitoring the COVID-19 pandemic and the
pandemic’s impact on PAVmed’s and Lucid’s businesses. PAVmed and
Lucid expect the significance of the COVID-19 pandemic, including
the extent of its effect on its financial and operational results,
to be dictated by, among other things, the success of efforts to
contain the pandemic and the impact of such efforts on PAVmed’s and
Lucid’s businesses. These factors are difficult or impossible to
predict accurately and many of them are beyond PAVmed’s and Lucid’s
control. 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 IA, “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 after
its most recent Annual Report and Lucid’s Registration Statement
No. 333-259721 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220816005894/en/
Investors Adrian K. Miller PAVmed
Inc. AKM@PAVmed.com Media Shani Lewis
LaVoieHealthScience (609) 516-5761
PAVmed@lavoiehealthscience.com
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