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
preliminary financial results for the three months ended March 31,
2022.
Conference Call and Webcast
A conference call and webcast for today’s business update and
first quarter 2022 financial results will take place at 4:30 PM
EDT. To access the conference call, listeners should dial
800-458-4121 toll-free in the U.S., and international listeners
should dial 856-344-9290, 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: 7771455.
Business Update Highlights
“I am delighted to report that PAVmed is making excellent
progress on all fronts and that we continue to lay a solid
foundation for our long-term growth strategy,” said Lishan Aklog,
M.D., PAVmed’s Chairman and Chief Executive Officer. “Our combined
team has grown to over one hundred employees and is singularly
focused on growing the PAVmed enterprise while enhancing long-term
shareholder value. Our balance sheet remains strong, providing us
with the resources to execute this strategy. Given the current
market volatility we are particularly focused on deploying our
capital as efficiently and effectively as possible to accomplish
our strategic goals while preserving and extending our cash
runway.”
Highlights from the first quarter and recent weeks include:
- The American College of Gastroenterology (“ACG”) updated its
clinical guideline for the diagnosis and management of esophageal
precancer, endorsing, for the first time, nonendoscopic biomarker
screening to detect precancer and prevent highly lethal esophageal
cancer, providing support for esophageal precancer screening
utilizing Lucid’s EsoGuard® DNA Test on samples collected with its
EsoCheck® Cell Collection Device, the only such nonendoscopic
biomarker screening test available.
- Lucid processed 533 commercial EsoGuard tests in the first
quarter of 2022, which represents a 76% increase sequentially from
the fourth quarter of 2021 and a nearly 500% increase annually from
the first quarter of 2021. The Company continued to expand its
sales infrastructure consistent with its year-end goals.
- Lucid completed the first stage of its Lucid Test Center
program and subsequently launched the second stage of the program
and plans to open test centers in nine additional states this year.
The Company hired an experienced Director of Clinical Services to
oversee the expansion.
- LucidDx Labs Inc. (“LucidDx Labs”), a wholly owned subsidiary
of Lucid, acquired the assets necessary to operate its own
CLIA-certified, CAP-accredited clinical laboratory and hired an
experienced VP of Laboratory Operations. It also upgraded it
revenue cycle management provider which for the first time will
begin billing and processing claims directly on behalf of
Lucid.
- LucidDx Labs entered into Lucid’s first commercial payer
agreement—a participating provider agreement with MediNcrease
Health Plans, LLC, a national, directly-contracted, multi-specialty
PPO provider network with over 8 million lives covered through its
clients and payers.
- Veris expanded its team to include a Chief Commercial Officer
and four data scientists and engineers.
- Veris software development is progressing well with three
interconnected software platforms to facilitate on schedule to
launch with connected devices in late 2022. Veris implantable smart
device development progressing along two paths, a monitoring device
separate from port and a fully integrated monitoring port.
- The first round of CarpX product improvements from limited
commercial release have been completed; cadaver training has
recommenced; and clinical cases are being scheduled. The next
generation device with integrated ultrasound imaging is progressing
well.
- NextFlo pre-DV testing showed good regulation but currently
paused for root cause analysis and exploration of possible
redesigns to improve repeatability, before restarting pre-FDA
submission testing.
- PortIO first-in-human study is progressing with three new sites
approved in Colombia, South America and will begin enrolling next
month.
- EsoCure development progressing well with favorable
head-to-head histopathologic performance compared to market leading
esophageal ablation device.
Preliminary Financial Results
- For the three months ended March 31, 2022, EsoGuard related
revenues were $0.2 million. Operating expenses were approximately
$19.3 million, which include stock-based compensation expenses of
$4.8 million. GAAP net loss attributable to shareholders was
approximately $16.9 million, or $(0.20) 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, 2022,
was approximately $11.7 million or $(0.14) per common share.
- PAVmed had cash and cash equivalents of $64.7 million as of
March 31, 2022, compared with $77.3 million as of December 31,
2021. Not included in these cash balances is approximately $24.5
million in net proceeds from issuing a senior secured convertible
note to an institutional investor in April 2022.
The unaudited financial results for the three months ended March
31, 2022, are expected to be filed with the SEC on Form 10-Q on May
16, 2022 and will then be 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 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, 2022, and 2021 is as follows:
For the three months ended March 31,
2022
2021
Revenue
$
189
$
-
Gross profit
(180
)
-
Operating expenses
19,280
8,077
Other Expense
173
-
Net Loss
(19,633
)
(8,077
)
Net income (loss) per common share, basic and diluted
$
(0.20
)
$
(0.13
)
Net loss attributable to common stockholders
(16,869
)
(9,431
)
Preferred Stock dividends and deemed dividends
(68
)
(75
)
Net income (loss) as reported
(16,937
)
(9,506
)
Adjustments: Depreciation and amortization expense1
216
12
Interest expense, net2
-
-
EBITDA
(16,721
)
(9,494
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
4,814
1,436
Debt extinguishment2
-
3,715
Acquisition related2
173
-
Change in FV convertible debt2
-
(1,682
)
Offering costs convertible debt2
-
-
Non-GAAP adjusted (loss)
(11,734
)
(6,025
)
Basic and Diluted shares outstanding
86,336
73,954
Non-GAAP adjusted (loss) income per share
($
0.14
)
($
0.08
)
1
Included in general and administrative expenses in the financial
statements
2
Included in other income and expenses
3
Stock-based compensation ("SBC") expenses: For the three
months ended March 31,
2022
2021
Sales and marketing expense
3,925
1,387
Stock-based compensation expense
(625
)
(202
)
Net commercial operations expense
excluding SBC
3,300
1,185
General and administrative expense total
9,423
3,375
Stock-based compensation expense
(4,002
)
(1,124
)
Net general and administrative
expense excluding SBC
5,421
2,251
Research and development expense total
5,932
3,315
Stock-based compensation expense
(187
)
(110
)
Net research and development
expense excluding SBC
5,745
3,205
Total operating expenses
19,280
8,077
Stock-based compensation expense
(4,814
)
(1,436
)
Net operating expenses excluding
SBC
14,466
6,641
Lucid Diagnostics (Nasdaq: LUCD) Preliminary Financial
Results
- For the three months ended March 31, 2022, EsoGuard related
revenues were $0.2 million. Operating expenses were approximately
$11.9 million, which include stock-based compensation expenses of
$3.8 million. GAAP net loss attributable to common stockholders was
approximately $12.3 million, or $(0.35) 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, 2022,
was approximately $8.2 million or $(0.23) per common share.
- Lucid had cash and cash equivalents of $47.9 million as of
March 31, 2022, compared to $53.7 as of December 31, 2021.
- On March 28, 2022, the Company entered into a Common Stock
Purchase Agreement (the “Purchase Agreement”) with CF Principal
Investments LLC (“Cantor”), an affiliate of Cantor Fitzgerald,
relating to a committed equity facility (the “Facility”). Pursuant
to the Purchase Agreement, the Company has the right to sell to
Cantor up to $50.0 million of its common shares (the “Shares”),
subject to certain conditions and limitations set forth in the
Purchase Agreement. While there are distinct differences, the
Facility is structured similarly to a traditional at-the-market
equity facility, insofar as it allows the Company to raise primary
equity capital on a periodic basis at a price related to the
current market price.
- Sales of the Shares to Cantor under the Purchase Agreement, and
the timing of any sales, will be determined by the Company from
time to time at its sole discretion and will depend on a variety of
factors, including, among other things, market conditions, the
trading price of the Shares and determinations by the Company
regarding the use of proceeds of such Shares. Upon the satisfaction
of the conditions to Cantor’s obligation to purchase Shares, the
Company will have the right, from time to time during the 36-month
period after the commencement of the Facility, to direct Cantor to
purchase up to a maximum number of Shares on any trading day. The
purchase price of the Shares will be 96% of the volume-weighted
average price of the Shares on such trading day.
- The unaudited financial results for the three months ended
March 31, 2022, will be filed with the SEC on Form 10-Q in the
coming days and will be 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 ended March 31, 2022, and 2021 is as
follows:
For the three months ended March 31,
2022
2021
Revenue
$
189
$
-
Gross profit
(180
)
-
Operating expenses
11,917
3,653
Other expense
173
-
Net loss
(12,270
)
(3,653
)
Net income (loss) per common share, basic and diluted
$
(0.35
)
$
(0.26
)
Adjustments: Depreciation and amortization expense1
24
3
EBITDA
(12,246
)
(3,650
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
3,835
805
Fair value adjustments2
173
-
Non-GAAP adjusted (loss)
(8,238
)
(2,845
)
Basic and Diluted shares outstanding
35,123
14,114
Non-GAAP adjusted (loss) income per share
($
0.23
)
($
0.20
)
1
Included in general and administrative expenses in the financial
statements
2
Included in other income and expenses For the three months ended
March 31,
2022
2021
3
Stock-based compensation ("SBC") expenses: Sales and
Marketing expense total
3,318
689
Stock-based compensation expense
(440
)
-
Net commercial operations expense excluding SBC
2,878
689
General and administrative expense total
5,718
1,212
Stock-based compensation expense
(3,269
)
(789
)
Net general and administrative expense excluding SBC
2,449
423
Research and development expense total
2,881
#
1,752
Stock-based compensation expense
(126
)
(16
)
Net research and development expense excluding SBC
2,755
1,736
Total operating expenses
11,917
3,653
Stock-based compensation expense
(3,835
)
(805
)
Net operating expenses excluding SBC
8,082
2,848
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), 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. Another major
subsidiary, Veris Health Inc., is a digital health company
developing the first intelligent implantable vascular access port
with biologic sensors and wireless communication to improve
personalized cancer care through remote patient monitoring.
PAVmed’s CarpX® Minimally Invasive Device for Carpal Tunnel
Syndrome is currently in limited commercial release. The product
pipeline also includes the EsoCure™ Esophageal Ablation Device with
Caldus™ Technology, which complements EsoGuard and EsoCheck, which
complements EsoGuard and EsoCheck, the NextFlo™ Intravenous
Infusion Set, the PortIO™ Implantable Intraosseous Vascular Access
Device, and other earlier stage technologies. For more information
on PAVmed, please visit www.pavmed.com, follow PAVmed on Twitter,
connect with it on LinkedIn, and watch its videos on YouTube. For
more information on Lucid, please visit www.luciddx.com, follow
Lucid on Twitter, and connect with it on LinkedIn. For detailed
information on EsoGuard, please visit www.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/20220512006022/en/
Investors Adrian K. Miller PAVmed
Inc. AKM@PAVmed.com
Media Shani Lewis
LaVoieHealthScience (609) 516-5761
PAVmed@lavoiehealthscience.com
PAVmed (NASDAQ:PAVM)
Historical Stock Chart
From Mar 2024 to Apr 2024
PAVmed (NASDAQ:PAVM)
Historical Stock Chart
From Apr 2023 to Apr 2024