Conference call to be held today at 4:30 PM
EDT
PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company”
or “PAVmed”), a highly differentiated, multi-product,
commercial-stage medical device company, today provided a business
update for the Company and its major subsidiary, Lucid Diagnostics
Inc. (“Lucid”), and discussed preliminary financial results for the
three and six months ended June 30, 2021.
“I am pleased to report on the solid momentum we have
experienced during the second quarter of 2021 and in subsequent
weeks,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief
Executive Officer. “In late 2020, we decided to embark on a bigger
and bolder strategic plan for PAVmed and its subsidiaries to fully
realize their long-term potential for success. We decided to
accelerate our plans to grow the company on multiple fronts
including expanding and expediting our EsoGuard commercialization
plans, laying the groundwork to take Lucid public, more
aggressively seeking out attractive partnerships, licensing, and
M&A opportunities, bringing fresh perspectives, experiences,
skill sets and diversity to our two Boards, critically evaluate and
assess ways to future-proof our relationship with a couple of
mission-critical partners, and to do all this while strengthening
our balance sheet and growing shareholder value. Nine months later,
I am very pleased this strategic plan is bearing fruit and
enhancing shareholder value.”
Conference Call and Webcast
A conference call and webcast for today’s business update and
second quarter 2021 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. or (201) 493-6780, and ask to join
the “PAVmed, Inc. Business Update Conference Call”. The conference
call will be available live via webcast and for replay at the
investor relations section of the Company’s website at
www.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,
followed by the PIN number: 13720826.
Business Update Highlights
- Lucid began testing patients referred by primary care
physicians (“PCPs”) at three Lucid Test Centers in the Phoenix
metropolitan area. Patients with chronic heartburn, also known as
gastroesophageal reflux disease (“GERD”), who are referred to the
centers are now undergoing an esophageal precancer procedure,
performed by Lucid-employed clinical personnel, using Lucid’s
EsoCheck® Cell Collection Device (“EsoCheck”) to collect surface
esophageal cells for its EsoGuard® Esophageal Test
(“EsoGuard”).
- EsoGuard testing accelerated as the company continued to see
good results from its initial engagements with gastroenterologists.
Lucid performed 202 EsoGuard tests in the second quarter
representing a 110% increase sequentially compared to an upward
revised 96 tests performed in the first quarter.
- Lucid entered into a definitive agreement with UpScriptHealth
(“UpScript”), a leading, nationwide, direct-to-consumer
telemedicine company for UpScript to support Lucid’s upcoming
EsoGuard Telemedicine Program by providing a Lucid-branded
web-based telemedicine platform for patients with GERD to request
video evaluation by a physician and, if clinically indicated,
referred to a Lucid Test Center for EsoGuard testing.
- Lucid received CE Mark certification for EsoCheck, and
completed CE Mark self-certification for EsoGuard, indicating both
may be marketed in CE Mark European countries.
- Lucid continued the process of transferring EsoCheck
manufacturing to Coastline International Inc., a high-volume
manufacturer based in San Diego, CA with production facilities in
Mexico, by the end of 2021, which will increase EsoCheck
manufacturing capacity up to one million devices per year.
- Lucid held a successful advisory board meeting with medical
directors of major insurers which provided positive feedback and
indicated good alignment with its strategic approach, including
expectations for the portfolio of clinical utility and healthcare
economic data which would be needed to secure payment and
coverage
- Lucid began enrolling patients at European sites for its
international multi-center clinical studies, to support a PMA
application for FDA IVD registration of EsoGuard on samples
collected using EsoCheck.
- PAVmed launch of a new subsidiary, digital health company,
Veris Health, which acquired Oncodisc Inc., a digital health
company with groundbreaking tools to improve personalized cancer
care through remote patient monitoring. Oncodisc’s core
technologies include the first intelligent implantable vascular
access port with biologic sensors and wireless communication,
combined with an oncologist-designed remote digital healthcare
platform. Veris has launched both device and software design
efforts and is engaging third party device and software partners.
Veris has also initiated discussions for a potential collaboration
with a large global software company.
- PAVmed’s new CarpX national sales manager began work in June
and has begun the reboot of CarpX initial commercialization
efforts. Multiple cadaver training sessions have been scheduled or
completed and CarpX cases have been scheduled.
PRELIMINARY FINANCIAL RESULTS
For the three months ended June 30, 2021, commercial operations
expenses were approximately $2.0 million, general and
administrative expenses were $6.7 million, and research and
development expenses were $4.3 million. GAAP net loss attributable
to common stockholders was approximately $11.5 million, or $(0.14)
per common share. As shown below and for the purpose of
illustrating the effect of derivative accounting and other non-cash
income and expenses on the Company’s financial results, the Company
reported a non-GAAP adjusted loss for the three months ended June
30, 2021, of approximately $6.4 million or $(0.08) per common
share.
PAVmed had cash and cash equivalents of $43.2 million as of June
30, 2021, compared with $17.3 million as of December 31, 2020.
The unaudited financial results for the three and six months
ended June 30, 2021, will be filed with the SEC on Form 10-Q in the
coming days and will be available at www.pavmed.com or
www.sec.gov.
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 and six months ended June 30, 2021, and 2020 is as
follows:
For the three months ended June
30,
For the six months ended June
30,
(ooo's except per-share amounts)
2021
2020
2021
2020
Net income (loss) per common share, basic and diluted
$
(0.14
)
$
(0.13
)
$
(0.27
)
$
(0.46
)
Net loss attributable to common stockholders
(11,545
)
(5,649
)
(21,051
)
(20,194
)
Preferred Stock dividends and deemed dividends
74
71
149
141
Net income (loss) as reported
(11,471
)
(5,578
)
(20,902
)
(20,053
)
Adjustments: Depreciation and amortization expense1
16
6
22
9
Interest expense, net3
-
-
-
52
EBITDA
(11,455
)
(5,572
)
(20,880
)
(19,992
)
Other non-cash or financing related expenses:
Stock-based compensation expense2
5,203
528
6,639
872
Debt extinguishment/debt forgiveness3
(300
)
2,750
3,415
3,937
Acquisition related
133
-
133
-
Change in FV convertible debt3
-
(2,120
)
(1,682
)
5,888
Offering costs convertible debt3
-
200
-
610
Non-GAAP adjusted (loss)
(6,419
)
(4,214
)
(12,375
)
(8,685
)
Basic and Diluted shares outstanding
82,235
44,781
78,118
44,140
Non-GAAP adjusted (loss) income per share
($0.08
)
($0.09
)
($0.16
)
($0.20
)
1
Included in general and administrative
expenses in the financial statements
2
For the three months ended June 30, 2021
includes $4,599 of stock based compensation expense reported as
general and administrative expense, $298 as commercial operations
expense, and $306 reported as research and development expense. For
the three months ended June 30, 2020 includes $343 of stock based
compensation expense reported as general and administrative
expense, $64 as commercial operations expense, and $122 reported as
research and development expense. For the six months ended June 30,
2021 includes $5,618 of stock based compensation expense reported
as general and administrative expense, $500 as commercial
operations expense, and $521 reported as research and development
expense. For the six months ended June 30, 2020 includes $586 of
stock based compensation expense reported as general and
administrative expenses, $98 as sales and marketing expenses, and
$188 reported as research and development expense.
3
Included in other income and expenses
About PAVmed PAVmed is a highly differentiated,
multi-product, commercial-stage medical technology company with a
diversified product pipeline addressing unmet clinical needs
encompassing a broad spectrum of clinical areas with attractive
regulatory pathways and market opportunities. Major subsidiary,
Lucid Diagnostics Inc., markets the first and only commercial tools
for widespread early detection of esophageal precancer and cancer –
the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell
Collection Device. Its GI Health division also includes the
complementary EsoCure™ Esophageal Ablation Device with Caldus™
Technology. Its Minimally Invasive Interventions division markets
its CarpX® Minimally Invasive Device for Carpal Tunnel Syndrome.
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.
Other divisions include Infusion Therapy (PortIO™ Implantable
Intraosseous Vascular Access Device and NextFlo™ Intravenous
Infusion Set), and Emerging Innovations (non-invasive laser-based
glucose monitoring, pediatric ear tubes, and mechanical circulatory
support). For more information, please visit www.pavmed.com, follow
us on Twitter, connect with us on LinkedIn, and watch our videos on
YouTube. For more information on our majority owned subsidiary,
Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid
on Twitter, and connect with Lucid on LinkedIn. For detailed
information on EsoGuard, please visit www.EsoGuard.com and follow
us on Twitter, Facebook and Instagram.
Forward-Looking Statements This press release includes
forward-looking statements that involve risks and uncertainties.
Forward-looking statements are statements that are not historical
facts. Such forward-looking statements, based upon the current
beliefs and expectations of PAVmed’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 common stock, Series W Warrants and Series
Z Warrants; general economic and market conditions; the
uncertainties inherent in research and development, including the
cost and time required advance PAVmed’s products to regulatory
submission; whether regulatory authorities will be satisfied with
the design of and results from PAVmed’s preclinical studies;
whether and when PAVmed’s products are cleared by regulatory
authorities; market acceptance of PAVmed’s products once cleared
and commercialized; our ability to raise additional funding and
other competitive developments. PAVmed has not yet received
clearance from the FDA or other regulatory body to market many of
its products. The Company has been monitoring the COVID-19 pandemic
and its impact on our business. The Company expects the
significance of the COVID-19 pandemic, including the extent of its
effect on the Company’s financial and operational results, to be
dictated by, among other things, the success of efforts to contain
it and the impact of actions taken in response. New risks and
uncertainties may arise from time to time and are difficult to
predict. All of these factors are difficult or impossible to
predict accurately and many of them are beyond PAVmed’s control.
For a further list and description of these and other important
risks and uncertainties that may affect PAVmed’s future operations,
see Part I, Item IA, “Risk Factors,” in PAVmed’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. PAVmed disclaims 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/20210812005856/en/
Investors Mike Havrilla Director of
Investor Relations (814) 241-4138 JMH@PAVmed.com
Media Katie Gallagher / Kristi
Bruno LaVoieHealthScience (617) 792-3937 / (617) 865-3940
PAVmed@lavoiehealthscience.com
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