Full Press Release Details
Diagnostics Provides Business Update and
Quarter 2022 Financial Results
test volume increased 28% sequentially and 436% annually
call and webcast to be held today at 4:30 PM EDT
YORK, November 14, 2022 (BUSINESS WIRE)-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, 2022.
conference call and webcast for today's business update and third quarter 2022 financial results will take place at 4:30 PM EDT.
To access the conference call, listeners should dial 877-407-0789 toll-free in the U.S., and international listeners should dial 201-689-8562
and ask to join the "Lucid Diagnostics Business Update Conference Call". The webcast presentation and conference call
will be available live and for replay at the investor relations section of the Company's website at https://ir.luciddx.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: 13732743.
recent transformational milestones behind us, the Lucid team is now intensely focused on executing on our long-term growth strategy and
delivered solid results for the past quarter," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer.
"I am particularly proud that the team is delivering these results well under budget for the quarter and year, as we continue to
keep a close eye on cash preservation to protect our long-term position. Testing volume continues to grow at a steady clip, consistent
with the mid-throttle' strategy we have implemented until reimbursement becomes more predictable. I am also gratified that
the claims submission process, which we launched mid-quarter, is starting to bear fruit in terms of payments and recognized revenue."
from the third quarter and recent weeks include:
| LucidDx Labs Inc. ("LucidDx Labs"), Lucid's wholly owned CLIA-certified, CAP-accredited clinical laboratory, performed 1,088 commercial EsoGuard Esophageal DNA Tests in the third quarter of 2022, which represents a 28% increase sequentially from the second quarter of 2022 and a 436% annual increase from the third quarter of 2021. | |
| Lucid continued the steady expansion of its sales team to 37 professionals, particularly sales representatives who call on primary care physicians, and is progressing well towards its near-term target of 58 sales professionals early in the new year. | |
| Lucid now operates 13 Lucid Test Centers (LTC) in 11 states, including one recently opened in the Chicago metropolitan area. Test centers in three new cities are targeted to launch by the end of the year. Satellite LTC activity is rapidly increasing, representing 22% of patients tested in the third quarter. | |
| LucidDx Labs' is now operating independently and has rapidly enhanced key quality and efficiency metrics, including reducing average EsoGuard test turn-around time to less than one week. | |
| In August, LucidDx Labs began submitting claims for tests performed since the February transfer of the CLIA laboratory operations, which were held until its new revenue cycle management partner was in place. LucidDx Labs began receiving some payments for claims during the quarter. | |
| Lucid commenced production of its EsoCheck Esophageal Cell Collection Devices ("EsoCheck") at Coastline International, Inc., a high-volume manufacturer headquartered in San Diego, CA with plants in Mexico, which is expected to decrease per-unit manufacturing costs by 60% and provide scalable manufacturing capacity to accommodate accelerating growth in EsoGuard testing volume. |
| For the three months ended September 30, 2022, EsoGuard related revenues were $0.1 million. Operating expenses were approximately $14.4 million, including stock-based compensation expenses of $3.6 million. GAAP net loss attributable to common stockholders was approximately $14.3 million, or $(0.39) 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, 2022, was approximately $10.2 million or $(0.28) per common share. | |
| Lucid had cash and cash equivalents of $26.9 million as of September 30, 2022, compared to $53.7 million as of December 31, 2021. | |
| In March 2022, Lucid entered into a committed equity facility with an affiliate of Cantor Fitzgerald ("Cantor"). Under the terms of the facility, Cantor has committed to purchase up to $50 million of Lucid common stock from time to time upon the request of Lucid. Through September 30, 2022, 680,263 Lucid shares were issued under this facility for total proceeds of $1.8 million. | |
| The unaudited financial results for the three months ended September 30, 2022, were filed with the SEC on Form 10-Q on November 14, 2022, and will be available at www.luciddx.com or www.sec.gov . |
| 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 and nine months ended September 30, 2022, and 2021 are as follows: |
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | 76 | $ | 200 | $ | 265 | $ | 200 | ||||||||
| Operating expenses | 14,425 | 6,710 | 41,508 | 16,378 | ||||||||||||
| Other (Income) expense | - | 447 | - | 594 | ||||||||||||
| Net loss | (14,349 | ) | (6,957 | ) | (41,243 | ) | (16,772 | ) | ||||||||
| Net income (loss) per common share, basic and diluted | $ | (0.39 | ) | $ | (0.49 | ) | $ | (1.15 | ) | $ | (1.19 | ) | ||||
| Adjustments: | ||||||||||||||||
| Depreciation and amortization expense | 593 | - | 1,321 | 3 | ||||||||||||
| Interest expense, net | - | 447 | - | 147 | ||||||||||||
| EBITDA | (13,756 | ) | (6,510 | ) | (39,922 | ) | (16,622 | ) | ||||||||
| Other non-cash or financing related expenses: | ||||||||||||||||
| Stock-based compensation expense | 3,572 | 2,772 | 11,251 | 6,156 | ||||||||||||
| Non-GAAP adjusted (loss) | $ | (10,184 | ) | $ | (3,738 | ) | $ | (28,671 | ) | $ | (10,466 | ) | ||||
| Basic and Diluted shares outstanding | 36,406 | 14,115 | 35,768 | 14,115 | ||||||||||||
| Non-GAAP adjusted (loss) income per share | $ | (0.28 | ) | $ | (0.26 | ) | $ | (0.80 | ) | $ | (0.74 | ) |
| Non-GAAP Operating Expenses | For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Cost of revenue | 1,626 | 144 | 1,996 | 144 | ||||||||||||
| Stock-based compensation expense (SBC) | (9 | ) | - | (9 | ) | - | ||||||||||
| Net cost of revenue | $ | 1,617 | $ | 144 | $ | 1,987 | $ | 144 | ||||||||
| Amortization of acquired intangible assets | 505 | - | 1,144 | - | ||||||||||||
| Sales and marketing expense total | 3,930 | 918 | 11,121 | 2,627 | ||||||||||||
| Stock-based compensation expense | (414 | ) | - | (1,230 | ) | - | ||||||||||
| Net sales and marketing expense | $ | 3,516 | $ | 918 | $ | 9,891 | $ | 2,627 | ||||||||
| General and administrative expense total | 5,660 | 3,458 | 18,223 | 7,793 | ||||||||||||
| Depreciation and amortization expense | (88 | ) | - | (177 | ) | (3 | ) | |||||||||
| Stock-based compensation expense | (3,069 | ) | (2,695 | ) | (9,728 | ) | (5,988 | ) | ||||||||
| Net general and administrative expense | $ | 2,503 | $ | 763 | $ | 8,318 | $ | 1,802 | ||||||||
| Research and development expense total | 2,704 | 2,190 | 9,024 | 5,814 | ||||||||||||
| Stock-based compensation expense | (80 | ) | (77 | ) | (284 | ) | (168 | ) | ||||||||
| Net research and development expense | $ | 2,624 | $ | 2,113 | $ | 8,740 | $ | 5,646 | ||||||||
| Total operating expenses | 14,425 | 6,710 | 41,508 | 16,378 | ||||||||||||
| Depreciation and amortization | (593 | ) | - | (1,321 | ) | (3 | ) | |||||||||
| Stock-based compensation expense | (3,572 | ) | (2,772 | ) | (11,251 | ) | (6,156 | ) | ||||||||
| Net Non-GAAP operating expenses | $ | 10,260 | $ | 3,938 | $ | 28,936 | $ | 10,219 |
EsoGuard and EsoCheck
of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC").
Over 80% 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% 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% to 15%
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.
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% 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
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 nonendoscopic 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.
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% sensitivity and specificity at detecting esophageal precancer
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.
Diagnostics Inc. (Nasdaq: LUCD) is a commercial-stage, cancer prevention medical diagnostics company, and majority-owned 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 multiple ongoing clinical trials. Lucid is
building nationwide direct sales and marketing teams targeting primary care physicians, specialists, and institutions, 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
press release includes forward-looking statements that involve risks 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, 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 after its most recent Annual Report and Lucid's Registration Statement No. 333-259721 filed with the Securities
and Exchange Commission. 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.