Quarterly EsoGuard® test volume and
revenue increased 17 percent and 392 percent sequentially,
respectively
Conference call and webcast to be held
tomorrow, November 14th at
8:30 AM EST
NEW
YORK, Nov. 13, 2023 /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
three and nine months ended September 30,
2023.
Conference Call and Webcast
The webcast will take place on Tuesday,
November 14, 2023, at 8:30 AM
and will 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
1-833-816-1418 and international listeners should dial
412-317-0511. 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
"I can confidently say that Q3 was the most important quarter in
Lucid's history," said Lishan Aklog,
M.D., Lucid's Chairman and Chief Executive Officer. "We crossed
several critical milestones necessary to translate test volume
growth into revenue and revenue growth. The initial impact that we
saw in the second quarter from the upgrade to our revenue cycle
management infrastructure has been sustained, driving record
revenues this past quarter. Key metrics, such as the percentage of
allowed claims and the average allowed payment, have held up nicely
during this period. A key driver supporting in-network payor
coverage engagement, along with claims history, is a solid base of
clinical utility data. We went from no clinical utility data in the
second quarter to over 1,500 patients across three clinical utility
studies with near-perfect results—two published and one pending
peer review."
Highlights from the third quarter and recent weeks:
- Lucid's CLIA-certified clinical laboratory performed 2,575
commercial EsoGuard® Esophageal DNA Tests in 3Q23, which
represents a 17 percent increase sequentially from 2Q23 and a 137
percent annual increase from 3Q22. Lucid personnel performed cell
collection for 82 percent of tests in the quarter, reflecting a
steady increase in Satellite Lucid Test Center activity.
High-volume #CYFT testing events continue to strongly contribute to
test volume growth. Gaining traction with strategic accounts at
health systems and academic medical centers.
- For the quarter, EsoGuard revenue was $783K, which represents a 392 percent increase
sequentially from 2Q23 and a 930 percent annual increase from
3Q22.
- Upgrade to revenue cycle management infrastructure showed
sustained impact during the quarter. Allowed claims percentage and
average allowed payment amount also held up well. Active pipeline
of claims going through appeals with success based on medical
necessity vs. guidelines.
- Substantial increase in clinical utility data to support
in-network payor coverage engagement. Near-perfect clinical utility
data (99-100 percent concordance) from three studies—CLUE, the
PREVENT Registries, and the SAFD Study—totaling over 1,500 patients
released during the quarter. Two manuscripts published in peer
reviewed journals, and one pending peer review.
- Accelerating activity in Direct Contracting with employers to
offer EsoGuard as a benefit. First contract signed and on-site
testing has begun. New VP, Employer Markets with 30 plus years of
experience in employer benefits sales starts this week.
- EsoGuard 2.0 with multiplexed triplicate consensus launched
last week, improving already unprecedented cancer and precancer
detection results. Analytical validation studies to be presented at
this week's Association of Molecular Pathology Annual Meeting (AMP
2023). Upgrading NGS-sequencing platform to a higher-throughput
NextSeq 1000 to accommodate increased EsoGuard testing volume.
Updated assay and platform expected to significantly lower
per-sample sequencing costs.
Financial Results
- For the three months ended September 30,
2023, EsoGuard related revenues were $0.8 million. Operating expenses were
approximately $11.9 million,
including stock-based compensation expenses of $1.3 million. GAAP net loss was approximately
$14.2 million, or $(0.34) 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 September 30, 2023, was approximately
$9.3 million or $(0.22) per common share.
- Lucid had cash and cash equivalents of $24.1 million as of September 30, 2023, compared to $32.6 million as of June
30, 2023.
- The unaudited financial results for the three months ended
September 30, 2023, will be filed
with the SEC on Form 10-Q on November 14,
2023, and 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 and nine months ended September 30, 2023, and 2022 are as follows:
Condensed
consolidated statements of operations (unaudited)
|
(in thousands except
per-share amounts)
|
|
For the three months
ended
September
30,
|
|
For the nine months
ended
September
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
783
|
|
$
76
|
|
$
1,388
|
|
$
265
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
11,911
|
|
14,453
|
|
38,417
|
|
41,541
|
Other (Income)
expense
|
|
3,080
|
|
(28)
|
|
4,807
|
|
(33)
|
Net
Loss
|
|
(14,208)
|
|
(14,349)
|
|
(41,836)
|
|
(41,243)
|
Net income (loss)
per common share, basic and
diluted
|
|
$
(0.34)
|
|
$
(0.39)
|
|
$
(1.01)
|
|
$
(1.15)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Depreciation and
amortization expense1
|
|
625
|
|
593
|
|
1,870
|
|
1,321
|
Interest expense,
net2
|
|
33
|
|
(28)
|
|
75
|
|
(33)
|
EBITDA
|
|
(13,550)
|
|
(13,784)
|
|
(39,891)
|
|
(39,955)
|
|
|
|
|
|
|
|
|
|
Other non-cash or
financing related expenses:
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense3
|
|
1,252
|
|
3,571
|
|
5,859
|
|
11,251
|
ResearchDx acquisition
paid in stock1
|
|
—
|
|
—
|
|
713
|
|
—
|
Change in FV
convertible debt2
|
|
3,021
|
|
—
|
|
3,520
|
|
—
|
Offering costs
convertible debt2
|
|
—
|
|
—
|
|
1,186
|
|
—
|
Debt extinguishments
loss - Senior Secured Convertible
Note2
|
|
26
|
|
—
|
|
26
|
|
—
|
Non-GAAP adjusted
(loss)
|
|
$
(9,251)
|
|
$
(10,213)
|
|
$
(28,587)
|
|
$
(28,704)
|
Basic and Diluted
shares outstanding
|
|
41,863
|
|
36,406
|
|
41,559
|
|
35,768
|
Non-GAAP adjusted
(loss) income per share
|
|
$(0.22)
|
|
$(0.28)
|
|
$(0.69)
|
|
$(0.80)
|
|
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
September
30,
|
|
For the nine months
ended
September
30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Cost of
revenues
|
|
$
1,634
|
|
$
1,626
|
|
$
4,522
|
|
$
1,996
|
Stock-based
compensation expense3
|
|
(26)
|
|
(9)
|
|
(70)
|
|
(9)
|
Net cost of
revenues
|
|
1,608
|
|
1,617
|
|
4,452
|
|
1,987
|
|
|
|
|
|
|
|
|
|
Amortization of
intangible assets
|
|
505
|
|
505
|
|
1,516
|
|
1,144
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
3,837
|
|
3,930
|
|
11,996
|
|
11,121
|
Stock-based
compensation expense3
|
|
(334)
|
|
(414)
|
|
(1,056)
|
|
(1,230)
|
Net sales and
marketing
|
|
3,503
|
|
3,516
|
|
10,940
|
|
9,891
|
|
|
|
|
|
|
|
|
|
General and
administrative
|
|
4,320
|
|
5,688
|
|
15,049
|
|
18,465
|
Depreciation
expense
|
|
(120)
|
|
(88)
|
|
(354)
|
|
(177)
|
Stock-based
compensation expense3
|
|
(728)
|
|
(3,068)
|
|
(4,239)
|
|
(9,728)
|
Net general and
administrative
|
|
3,472
|
|
2,532
|
|
10,456
|
|
8,560
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
1,615
|
|
2,704
|
|
5,334
|
|
8,815
|
Stock-based
compensation expense3
|
|
(164)
|
|
(80)
|
|
(494)
|
|
(284)
|
Net research and
development
|
|
1,451
|
|
2,624
|
|
4,840
|
|
8,531
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
11,911
|
|
14,453
|
|
38,417
|
|
41,541
|
Depreciation and
amortization expense
|
|
(625)
|
|
(593)
|
|
(1,870)
|
|
(1,321)
|
Stock-based
compensation expense3
|
|
(1,252)
|
|
(3,571)
|
|
(5,859)
|
|
(11,251)
|
Net operating
expenses
|
|
$
10,034
|
|
$
10,289
|
|
$
30,688
|
|
$
28,969
|
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, cancer prevention medical diagnostics company,
and subsidiary of PAVmed Inc. 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 -
the first and only commercially available tools designed with the
goal of preventing esophageal cancer and cancer deaths through
widespread, early detection of esophageal precancer in at-risk
patients.
For more information, please visit luciddx.com and for
more information about its parent company PAVmed, please
visit 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 Diagnostics'
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 Diagnostics'
common stock; general economic and market conditions; the
uncertainties inherent in research and development, including the
cost and time required to advance Lucid Diagnostics' products to
regulatory submission; whether regulatory authorities will be
satisfied with the design of and results from Lucid Diagnostics'
clinical and preclinical studies; whether and when Lucid
Diagnostics' products are cleared by regulatory authorities; market
acceptance of Lucid Diagnostics' products once cleared and
commercialized; Lucid Diagnostics' ability to raise additional
funding as needed; and other competitive developments. In addition,
Lucid Diagnostics continues to monitor the COVID-19 pandemic and
the pandemic's impact on Lucid Diagnostics' businesses. These
factors are difficult or impossible to predict accurately and many
of them are beyond Lucid Diagnostics' 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
Diagnostics' future operations, see Part I, Item 1A, "Risk
Factors," in Lucid Diagnostics' 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 Diagnostics 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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