Quarterly EsoGuard® revenue
increased 33 percent sequentially
Expanding EsoGuard clinical validity and
clinical utility data poised to drive medical policy coverage,
including line of sight to Medicare coverage
Conference call and webcast to be held
tomorrow, March 26th at
8:30 AM ET
NEW
YORK, March 25, 2024 /PRNewswire/ -- Lucid
Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the
"Company") a commercial-stage, cancer prevention medical
diagnostics company, and majority-owned subsidiary of PAVmed Inc.
(Nasdaq: PAVM, PAVMZ) ( "PAVmed"), today provided a business update
for the Company and presented financial results for the year ended
December 31, 2023.
Conference Call and Webcast
The webcast will take place on March 26, 2024, at 8:30
AM, and be accessible in the investor relations section of
the Company's website at luciddx.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 "Lucid Diagnostics 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 luciddx.com.
Business Update Highlights
"We are very pleased with the excellent progress Lucid has made
on multiple fronts in the fourth quarter and recent weeks," said
Lishan Aklog, M.D., Lucid's Chairman
and Chief Executive Officer. "We saw solid revenue growth on stable
test volume and our revenue cycle management processes are yielding
improving allowances and stable pricing. Our #CYFT program
targeting firefighters and other groups is thriving and we have a
robust pipeline of scheduled high-volume testing events. Most
importantly, we have rapidly built our clinical validity and
clinical utility evidence base to drive positive medical policy
coverage, including what now we believe is line of sight to
Medicare coverage. Equipped with sufficient data, we have for the
first time engaged with medical directors at major commercial
payors to request positive coverage. Our direct contracting
initiative is also accelerating and we are excited about the
near-term prospects of delivering contracts, testing and
revenue."
Highlights from the fourth quarter and recent weeks
include:
- 4Q23 EsoGuard revenue was $1.04M,
which represents a 33 percent increase sequentially from 3Q23 and
an 829 percent annual increase from 4Q22.
- Lucid's CLIA-certified clinical laboratory performed 2,201
commercial EsoGuard® Esophageal DNA Tests in
4Q23.
- High-volume #CYFT health fair testing events continue to gain
traction with a robust roster of events scheduled through
July.
- Lucid initiated EsoGuard testing at over a dozen strategic
accounts at health systems and academic medical centers with
several dozen more engagements in process.
- Since upgrading to a new revenue cycle management provider in
mid-June, Lucid has submitted claims to commercial and governmental
payors representing approximately $20
million in pro forma revenue. The vast majority of these
claims have been adjudicated with nearly half resulting in an
allowable amount of approximately $1,800 per test, on average.
- EsoGuard's clinical validity and clinical utility data evidence
base has expanded significantly in the fourth quarter and recent
months. Lucid now has publicly-released data from three clinical
validity studies demonstrating excellent EsoGuard sensitivity and
negative predictive value, including unprecedented performance of a
molecular diagnostic test in detecting precancer. In addition,
three published clinical utility studies have documented
near-perfect concordance between EsoGuard results and physician
referral for upper gastrointestinal endoscopy. These data provide a
strong foundation of critical evidence needed to support broad
EsoGuard medical policy coverage. Lucid expects to leverage this
data in its upcoming re-engagement with the MolDX program to secure
Medicare coverage under the final and effective foundational Local
Coverage Determination.
- Held several meetings in recent months with medical directors
of major commercial payors to discuss clinical validity and utility
data and formally request positive medical policy determinations
for EsoGuard. The Company also participated in a Blue Cross Blue
Shield Association of America webinar with dozens of medical
directors in attendance, during which Nicholas Shaheen, M.D., M.P.H., a leading
esophageal precancer expert and lead author of the American College
of Gastroenterology's guidelines, advocated for coverage of
non-endoscopic biomarker testing consistent with the ACG
guidelines. Lucid also expects recent expansion of legislation
requiring coverage of certain biomarker tests, now effective in
fourteen states, will help drive medical policy coverage.
- Established that EsoGuard testing can be offered as a covered
benefit within health and wellness programs as a means to drive
contractually-guaranteed revenues. Lucid has built a robust
pipeline of direct contracting counterparties, including benefits
brokers, third-party administrators, and self-insured entities. The
Company expects to drive direct contract testing events with
meaningful revenues in the coming quarters. The Company is adding
resources to the direct contracting team to accelerate this
initiative
Financial Results
- For the three months ended December 31,
2023, EsoGuard related revenues were $1.0 million, while for the year ended
December 31, 2023, revenues were
$2.4 million. Fourth quarter and full
year 2023 operating expenses were approximately $12.5 million and $50.9
million, respectively, including stock-based compensation
expenses of $1.0 million and
$6.8 million, respectively. GAAP net
loss for the fourth quarter and full year 2023 were approximately
$10.8 million and $52.7 million, or $(0.26) and $(1.26)
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 for the fourth quarter and full year 2023, were approximately
$9.9 million and $38.4 million or $(0.23) and $(0.92)
per common share.
- Lucid had cash and cash equivalents of $18.9 million as of December 31, 2023, compared to $22.5 million as of December 31, 2022. Subsequent to December 31, 2023, the Company completed an
issuance of Convertible Preferred Series B resulting in gross
proceeds of approximately $18.1
million.
- The audited financial results for the year ended December 31, 2023, were filed with the SEC on
Form 10-K on March 25, 2024, and
available at www.luciddx.com or www.sec.gov.
Lucid Non-GAAP Measures
- To supplement our audited 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 audited 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 year ended December
31, 2023, and 2022 are as follows:
Condensed
consolidated statements of operations (unaudited)
|
|
(in thousands except
per-share amounts)
|
|
For the three months
ended
December 31,
|
|
For the year
ended
December 31,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
1,040
|
|
$
112
|
|
$
2,428
|
|
$
377
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
12,493
|
|
15,086
|
|
50,910
|
|
56,628
|
Other (Income)
expense
|
|
(624)
|
|
(47)
|
|
4,184
|
|
(80)
|
Net
Loss
|
|
(10,829)
|
|
(14,927)
|
|
(52,666)
|
|
(56,171)
|
Net income (loss)
per common share, basic and
diluted
|
|
$
(0.26)
|
|
$
(0.40)
|
|
$
(1.26)
|
|
$
(1.55)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense1
|
|
629
|
|
615
|
|
2,499
|
|
1,936
|
Interest expense,
net2
|
|
(84)
|
|
(47)
|
|
(8)
|
|
(80)
|
EBITDA
|
|
(10,284)
|
|
(14,359)
|
|
(50,175)
|
|
(54,315)
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense3
|
|
964
|
|
3,740
|
|
6,822
|
|
14,991
|
ResearchDx acquisition
paid in stock1
|
|
—
|
|
—
|
|
713
|
|
—
|
Change in FV
convertible debt2
|
|
(540)
|
|
—
|
|
2,980
|
|
—
|
Offering costs
convertible debt2
|
|
—
|
|
—
|
|
1,186
|
|
—
|
Debt extinguishments
loss - Senior Secured Convertible
Note2
|
|
—
|
|
—
|
|
26
|
|
—
|
Non-GAAP adjusted
(loss)
|
|
$
(9,860)
|
|
$
(10,619)
|
|
$
(38,448)
|
|
$
(39,324)
|
Basic and Diluted
shares outstanding
|
|
42,330
|
|
37,373
|
|
41,756
|
|
36,172
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.23)
|
|
$(0.28)
|
|
$(0.92)
|
|
$(1.09)
|
|
|
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
December 31,
|
|
For the year
ended
December 31,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Cost of
revenues
|
|
$
1,458
|
|
$
1,618
|
|
$
5,979
|
|
$
3,614
|
Stock-based
compensation expense3
|
|
(30)
|
|
(6)
|
|
(100)
|
|
(16)
|
Net cost of
revenues
|
|
1,428
|
|
1,612
|
|
5,879
|
|
3,598
|
|
|
|
|
|
|
|
|
|
Amortization of
intangible assets
|
|
505
|
|
505
|
|
2,021
|
|
1,649
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
4,408
|
|
5,012
|
|
16,404
|
|
16,134
|
Stock-based
compensation expense3
|
|
(355)
|
|
(393)
|
|
(1,411)
|
|
(1,622)
|
Net sales and
marketing
|
|
4,053
|
|
4,619
|
|
14,993
|
|
14,512
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
4,204
|
|
5,509
|
|
19,254
|
|
23,974
|
Depreciation
expense
|
|
(124)
|
|
(110)
|
|
(478)
|
|
(287)
|
RDx Settlement in
Stock
|
|
—
|
|
—
|
|
(713)
|
|
—
|
Stock-based
compensation expense3
|
|
(390)
|
|
(3,227)
|
|
(4,628)
|
|
(12,953)
|
Net general and
administrative
|
|
3,690
|
|
2,172
|
|
13,435
|
|
10,734
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
1,918
|
|
2,442
|
|
7,252
|
|
11,257
|
Stock-based
compensation expense3
|
|
(189)
|
|
(114)
|
|
(683)
|
|
(400)
|
Net research and
development
|
|
1,729
|
|
2,328
|
|
6,569
|
|
10,857
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
12,493
|
|
15,086
|
|
50,910
|
|
56,628
|
Depreciation and
amortization expense
|
|
(629)
|
|
(615)
|
|
(2,499)
|
|
(1,936)
|
RDx Settlement in
Stock
|
|
—
|
|
—
|
|
(713)
|
|
—
|
Stock-based
compensation expense3
|
|
(964)
|
|
(3,740)
|
|
(6,822)
|
|
(14,991)
|
Net operating
expenses
|
|
$
10,900
|
|
$
10,731
|
|
$
40,876
|
|
$
39,701
|
About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing
esophageal precancer and a highly lethal form of esophageal cancer
("EAC"). Over 80 percent of EAC patients die within five years of
diagnosis, making it the second most lethal cancer in the U.S. The
mortality rate is high even in those diagnosed with early stage
EAC. The U.S. incidence of EAC has increased 500 percent over the
past four decades, while the incidences of other common cancers
have declined or remained flat. In nearly all cases, EAC silently
progresses until it manifests itself with new symptoms of advanced
disease. All EAC is believed to arise from esophageal precancer,
which occurs in approximately 5 percent to 15 percent of at-risk
GERD patients. Early esophageal precancer can be monitored for
progression to late esophageal precancer which can be cured with
endoscopic esophageal ablation, reliably halting progression to
cancer.
Esophageal precancer screening is already recommended by
clinical practice guidelines in millions of GERD patients with
multiple risk factors, including age over 50 years, male gender,
White race, obesity, smoking history, and a family history of
esophageal precancer or cancer. Unfortunately, fewer than 10
percent of those recommended for screening undergo traditional
invasive endoscopic screening. The profound tragedy of an EAC
diagnosis is that likely death could have been prevented if the
at-risk GERD patient had been screened and then undergone
surveillance and curative treatment.
The only missing element for a viable esophageal cancer
prevention program has been the lack of a widespread screening tool
that can detect esophageal precancer. Lucid believes EsoGuard,
performed on samples collected with EsoCheck, is the missing
element – the first and only commercially available test capable of
serving as a widespread screening tool to prevent esophageal cancer
deaths through the early detection of esophageal precancer in
at-risk GERD patients. An updated American College of
Gastroenterology clinical practice guideline and an
American Gastroenterological Association clinical
practice update both endorse non-endoscopic biomarker tests as
an acceptable alternative to costly and invasive endoscopy for
esophageal precancer screening. EsoGuard is the only such test
currently available in the United
States.
EsoGuard is a bisulfite-converted NGS DNA assay performed on
surface esophageal cells collected with EsoCheck, which quantifies
methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1
(CCNA1). The assay was evaluated in a 408-patient, multicenter,
case-control study published in Science Translational Medicine and
showed greater than 90 percent sensitivity and specificity at
detecting esophageal precancer and cancer.
EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive
swallowable balloon capsule catheter device capable of sampling
surface esophageal cells in a less than five-minute office
procedure. It consists of a vitamin pill-sized rigid plastic
capsule tethered to a thin silicone catheter from which a soft
silicone balloon with textured ridges emerges to gently swab
surface esophageal cells. When vacuum suction is applied, the
balloon and sampled cells are pulled into the capsule, protecting
them from contamination and dilution by cells outside of the
targeted region during device withdrawal. Lucid believes this
proprietary Collect+Protect™ technology makes EsoCheck the only
noninvasive esophageal cell collection device capable of such
anatomically targeted and protected sampling. The sample is sent by
overnight express mail to Lucid's CLIA-certified, CAP-accredited
laboratory, LucidDx Labs, for EsoGuard testing.
About Lucid Diagnostics
Lucid Diagnostics Inc. is a
commercial-stage medical diagnostics company focused on cancer
prevention, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is
focused on the millions of patients with gastroesophageal reflux
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 for at-risk patients to mitigate the
risks of cancer and cancer deaths through early detection of
esophageal precancer.
For more information, please visit www.luciddx.com and
for more information about its parent company PAVmed, please
visit www.pavmed.com.
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 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 Lucid's common stock; general
economic and market conditions; the uncertainties inherent in
research and development, including the cost and time required to
advance Lucid's products to regulatory submission; whether
regulatory authorities will be satisfied with the design of and
results from Lucid's clinical and preclinical studies; whether and
when Lucid's products are cleared by regulatory authorities; market
acceptance of Lucid's products once cleared and commercialized;
Lucid's ability to raise additional funding as needed; and other
competitive developments. In addition, Lucid continues to monitor
the COVID-19 pandemic and the pandemic's impact on Lucid's
businesses. These factors are difficult or impossible to predict
accurately and many of them are beyond 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
Lucid's future operations, see Part I, Item 1A, "Risk Factors," in
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 Lucid Diagnostics after its most recent Annual
Report. Lucid 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.
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