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 year ended December 2021.
Conference Call and Webcast
A conference call and webcast for today’s business update and
fourth quarter and year ended December 31, 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: 13727143.
Business Update Highlights
“I am happy to report that PAVmed and its subsidiaries are
making solid progress on all fronts and are laying a solid
foundation for us to continue driving our long-term growth strategy
and mission to create a leading, diversified medical technology
company,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief
Executive Officer. “This includes EsoGuard commercialization,
advancing our Veris Health portfolio, CarpX’s limited commercial
release, preparing to commercially launch NextFlo, PortIO
first-in-human cases, and advancing the rest of our portfolio
towards commercialization. Over the past several quarters we have
transformed our business model, expanded our infrastructure and
substantially grown our team to accommodate our transition from a
technology-focused to a commercial-focused enterprise.”
- Lucid processed 303 commercial EsoGuard tests in the fourth
quarter of 2021, which represents an approximately 50% increase
sequentially from the third quarter and a nearly 200% increase
annually from the fourth quarter of 2020. The Lucid Test Center
program completed its first stage and now covers seven metropolitan
areas in the Southwest and Pacific Northwest. Lucid is now
launching the next stage of the program, with accelerated expansion
into nine larger states. Lucid significantly expanded its sales
infrastructure and operations. The team now consists of twenty-two
sales professionals including ten sales representatives. It expects
team to double in size and the number of sales reps to triple by
the end of the calendar year.
- LucidDx Labs, a wholly owned subsidiary of Lucid, acquired the
assets to operate its own new CLIA-certified, CAP-accredited
clinical laboratory where it is now performing all EsoGuard
testing. LucidDx Labs has upgraded its revenue cycle management
provider and will start submitting Medicare claims using the
effective $1938 Medicare payment rate. It continues to wait for
Medicare Administrative Contractor Palmetto GBA’s MolDx program to
issue a draft local coverage determination (LCD). The laboratory
has been submitting claims to private payors and has been receiving
approximately $1,150 per test representing approximately 60%
out-of-network coverage.
- Veris is successfully advancing its software, device, and data
programs with the with the help of world-class technology and
medical advisory boards and working very closely with Microsoft, as
a member of its Global Partner program, and its software
development partner, Loka Inc. The software platform is on schedule
to launch commercially in 2H2022. Veris is hiring a Chief
Commercial Officer and building its own data & analytics team
to advance its data monetization strategy.
- Veris successfully completed feasibility animal testing of
multiple prototypes of an implantable device as well as an FDA
pre-submission meeting. Based on FDA feedback it has developed a
three-phase pipeline, an initial platform launch in 2H2022 with
wearables and connected medical devices, a subsequent FDA 510(k)
path clearance of separate implantable monitoring device to be
implanted alongside a traditional port, and an FDA de novo and EU
CE Mark path for a fully integrated intelligent vascular access
port.
- NextFlo product development is progressing well with FDA
submission and commercial launch targeted for the second half of
this year. PAVmed has hired a VP, Sales for NextFlo who is working
closely with Deloitte to lay the foundation for commercial launch
targeting inpatient, outpatient, and home infusions.
- CarpX continues with its limited commercial release utilizing
early adopter key opinion leaders to advance procedural and product
improvements. Eight new surgeons have been trained and five more
are scheduled for training. Seven CarpX cases were performed in the
fourth quarter of 2021. Clinical cases were then held to implement
the product improvements and will restart this coming quarter.
Development of next generation CarpX device incorporating
integrated ultrasound imaging is progressing well.
- PortIO launched its first-in-human clinical study in Colombia,
South America with three successful implants. Although the Company
remains engaged with FDA regarding its requirements for an IDE
study, it has expanded its strategy to pursue a European study to
support EU CE Mark clearance and provide additional human data for
U.S. approval.
- In March 2022, both the PAVmed and Lucid boards of directors
approved entering into an intercompany license between PAVmed and
Lucid such that Lucid will be granted the rights to commercialize
EsoCure for the endoscopic treatment of late esophageal precancer
(dysplastic Barrett’s Esophagus), including a royalty arrangement
whereby Lucid will pay PAVmed a 5% royalty on all EsoCure sales up
to $100 million per calendar year, and 8% above that
threshold.
- In March 2022, both the PAVmed and Lucid boards of directors
approved entering into a purchase and sale of the CapNostics, LLC
assets, including the EsophaCap® non-endoscopic sponge-based
esophageal cell collection device, from PAVmed to Lucid as well as
transferring the consulting agreement with the principal owner of
CapNostics, LLC prior to the purchase by PAVmed on October 5,
2021.
Preliminary Financial Results
- For the fourth quarter of 2021, EsoGuard related revenues were
$0.3 million while for the year ended December 31, 2021, revenues
were $0.5 million. Fourth-quarter and full-year 2021 operating
expenses were approximately $19.5 million and $54.3 million,
respectively, which include stock-based compensation expenses of
$4.4 million and $15.0 million, respectively. GAAP net loss
attributable to shareholders for the fourth quarter and full-year
2021 were approximately $17.3 million and $50.6 million, or $(0.20)
and $(0.65) 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 fourth quarter and year ended
December 31, 2021, were approximately $12.7 million and $33.2
million or $(0.15) and $(0.43) per common share.
- PAVmed had cash and cash equivalents of $77.3 million as of
December 31, 2021, compared with $17.3 million as of December 31,
2020.
- 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 year ended December 31, 2021, will be
filed with the SEC on Form 10-K in the coming days and will 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 fourth quarter and year ended December 31, 2021, and 2020 is as
follows:
For the three months endedDecember 31, For the year endedDecember
31,
2021
2020
2021
2020
Revenue
$
300
$
-
$
500
$
-
Gross profit
(229
)
-
(85
)
-
Operating expenses
19,538
7,556
54,308
23,351
Loss from operations
(19,767
)
(7,556
)
(54,393
)
(23,351
)
Net income (loss) per common share, basic and diluted
$
(0.20
)
$
(0.14
)
$
(0.65
)
$
(0.73
)
Net loss attributable to common stockholders
(17,285
)
(8,812
)
(50,630
)
(34,563
)
Preferred Stock dividends and deemed dividends
67
72
283
287
Net income (loss) as reported
(17,218
)
(8,740
)
(50,347
)
(34,276
)
Adjustments: Depreciation and amortization expense1
166
6
226
23
Interest expense, net2
-
-
-
53
EBITDA
(17,052
)
(8,734
)
(50,121
)
(34,200
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
4,380
586
15,009
2,044
Debt extinguishment/debt forgiveness2
-
1,897
3,415
6,497
Acquisition related1
-
-
133
-
Change in FV convertible debt2
-
(194
)
(1,682
)
5,327
Offering costs convertible debt2
-
-
-
660
Non-GAAP adjusted (loss)
(12,672
)
(6,445
)
(33,246
)
(19,672
)
Basic and Diluted shares outstanding
86,368
63,820
77,516
47,432
Non-GAAP adjusted (loss) income per share
($
0.15
)
($
0.10
)
($
0.43
)
($
0.41
)
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
December 31,
For the year ended December
31,
2021
2020
2021
2020
Commercial operations expense total
3,103
1,257
8,895
2,789
Stock-based compensation expense
(337
)
(95
)
(1,177
)
(278
)
Net commercial operations expense excluding SBC
2,766
1,162
7,718
2,511
General and administrative expense total
9,466
2,657
25,566
9,599
Stock-based compensation expense
(3,737
)
(356
)
(12,799
)
(1,304
)
Net general and administrative expense excluding SBC
5,729
2,301
12,767
8,295
Research and development expense total
6,969
3,642
19,847
10,963
Stock-based compensation expense
(306
)
(135
)
(1,033
)
(462
)
Net research and development expense excluding SBC
6,663
3,507
18,814
10,501
Total operating expenses
19,538
7,556
54,308
23,351
Stock-based compensation expense
(4,380
)
(586
)
(15,009
)
(2,044
)
Net operating expenses excluding SBC
15,158
6,970
39,299
21,307
Lucid Diagnostics (Nasdaq: LUCD) Preliminary Financial
Results
- For the fourth quarter of 2021, EsoGuard related revenues were
$0.3 million, while for the year ended December 31, 2021, revenues
were $0.5 million. Fourth-quarter and full-year 2021 operating
expenses were approximately $11.1 million and $27.3 million,
respectively, which include stock-based compensation expenses of
$3.2 million and $9.6 million, respectively. GAAP net loss
attributable to common stockholders for the fourth quarter and
full-year 2021 were approximately $11.3 million and $28.1 million,
or $(0.32) and $(1.51) 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 fourth quarter and year ended
December 31, 2021, were approximately $7.7 million and $17.8
million or $(0.22) and $(0.96) per common share.
- Lucid had cash and cash equivalents of $53.7 million as of
December 31, 2021, compared to $0.1 million as of December 31,
2020.
- 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 year ended December 31,
2021, will be filed with the SEC on Form 10-K 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 fourth quarter and year ended December 31, 2021, and 2020 is as
follows:
For the three months endedDecember 31, For the year endedDecember
31,
2021
2020
2021
2020
Revenue
$
300
$
-
$
500
$
-
Gross profit
(141
)
-
(85
)
-
Operating expenses
11,100
2,731
27,334
8,280
Interest expense
65
-
659
-
Net loss
(11,306
)
(2,731
)
(28,078
)
(8,280
)
Net income (loss) per common share, basic and diluted
$
(0.32
)
$
(0.19
)
$
(1.51
)
$
(0.59
)
Adjustments: Depreciation and amortization expense1
-
-
3
-
Interest expense, net3
65
-
659
-
EBITDA
(11,241
)
(2,731
)
(27,416
)
(8,280
)
Other non-cash or financing related expenses:
Stock-based compensation expense3
3,542
16
9,599
65
Non-GAAP adjusted (loss)
(7,699
)
(2,715
)
(17,817
)
(8,215
)
Basic and Diluted shares outstanding
34,918
14,115
18,604
14,114
Non-GAAP adjusted (loss) income per share
($
0.22
)
($
0.19
)
($
0.96
)
($
0.58
)
1
Included in general and administrative expenses in the financial
statements
2
Included in other income and expenses For the three months
endedDecember 31, For the year endedDecember 31,
2021
2020
2021
2020
3
Stock-based compensation ("SBC") expenses: Commercial
operations expense total
2,571
633
5,260
1,305
Stock-based compensation expense
-
-
(210
)
-
Net commercial operations expense excluding SBC
2,571
633
5,050
1,305
General and administrative expense total
5,047
272
12,778
1,532
Stock-based compensation expense
(3,123
)
-
(9,111
)
-
Net general and administrative expense excluding SBC
1,924
272
3,667
1,532
Research and development expense total
3,482
1,826
9,296
5,443
Stock-based compensation expense
(110
)
(16
)
(278
)
(65
)
Net research and development expense excluding SBC
3,372
1,810
9,018
5,378
Total operating expenses
11,100
2,731
27,334
8,280
Stock-based compensation expense
(3,233
)
(16
)
(9,599
)
(65
)
Net operating expenses excluding SBC
7,867
2,715
17,735
8,215
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, the
NextFlo™ Intravenous Infusion Set, the PortIO™ Implantable
Intraosseous Vascular Access Device, novel pediatric ear tubes,
mechanical circulatory support technology and glucose monitoring.
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.
About Lucid Diagnostics
Lucid Diagnostics Inc. (Nasdaq: LUCD) is a commercial-stage,
cancer prevention medical diagnostics company, and subsidiary of
PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of
patients with gastroesophageal disease (GERD), also known as
chronic heartburn, who are at risk of developing esophageal
precancer and cancer. Lucid’s EsoGuard® Esophageal DNA Test,
performed on samples collected in a brief, noninvasive office
procedure with its EsoCheck® Esophageal Cell Collection Device, is
the first and only commercially available diagnostic test capable
of serving as a widespread screening tool to prevent cancer and
cancer deaths through early detection of esophageal precancer in
at-risk GERD patients. EsoGuard is commercialized in the U.S. as a
Laboratory Developed Test (LDT). EsoCheck is commercialized in the
U.S. as a 510(k)-cleared esophageal cell collection device.
EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device
designation and is the subject of two large, actively enrolling,
international multicenter clinical trials to support FDA PMA
approval. Lucid is building nationwide direct sales and marketing
team targeting primary care physicians, gastroenterologists, and
consumers, as well as a network of Lucid Test Centers where at-risk
GERD patients can undergo the EsoCheck procedure for EsoGuard
testing. For more information, 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 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 f 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 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/20220329005979/en/
Investors Adrian K. Miller PAVmed
Inc. AKM@PAVmed.com
Media Shani Lewis
LaVoieHealthScience (609) 516-5761
PAVmed@lavoiehealthscience.com
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