Lucid Diagnostics Provides Business Update and Second Quarter 2024 Financial Results
EsoGuard® test volume increased 31 percent quarterly; 44 percent annually
Clinical data now well-positioned for final push towards broad coverage and reimbursement
Over 50 high-volume #CheckYourFoodTube Precancer Testing Events in 2Q24, including first with upfront contracted payment
Conference call and webcast to be held today,
Conference Call and Webcast
The webcast will take place on
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 am very pleased with the excellent progress Lucid has made on multiple fronts during the second quarter and recent weeks, specifically the progress made related to EsoGuard's clinical data," said
Highlights from the second quarter and recent weeks:
- For the quarter, EsoGuard® Esophageal DNA Test revenue was
$1.0M , which was flat compared to 1Q24 and represents a 514 percent annual increase from 2Q23. - Lucid's CLIA-certified clinical laboratory performed 3,147 commercial EsoGuard tests in 2Q24, a single-quarter record, which represents a 31 percent increase sequentially from 1Q24 and a 44 percent annual increase from 2Q23.
- Released ENVET-BE clinical utility study positive data showing that triaging with a noninvasive EsoGuard test results in a 2.4-fold increased positive yield of invasive endoscopy.
- Released ESOGUARD BE-1 clinical validation study positive data showing excellent EsoGuard sensitivity of 88% and NPV of 99%.
- Held productive meeting with CMS Medicare Administrative Contractor (MAC)
Palmetto GBA's Molecular Diagnostics Program (MolDX) focused on EsoGuard's clinical data. - Held first major #CheckYourFoodTube Precancer Testing Event with upfront contracted payment.
- American Foregut Society published formal statement strongly advocating for commercial payor coverage of EsoGuard to align with guidelines and biomarker legislation.
- Continuous revenue cycle management improvements, including prior authorization appeals, physician advocacy, etc., while maintaining stable out-of-network allowed amounts.
- Robust pipeline of direct contracting engagements with benefits brokers, third-party administrators, and self-insured entities.
- Actively executing on aggressive market access strategy focused on securing medical policy coverage with regional plans in biomarker legislation states and pilots with national plans.
Financial Results
- For the three months ended
June 30, 2024 , EsoGuard related revenues were$1.0 million . Operating expenses were approximately$12.2 million , which included stock-based compensation expenses of$1.2 million . GAAP net loss attributable to common stockholders was approximately$11.0 million or $(0.23) 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 three months ended
June 30, 2024 was approximately$9.7 million or$(0.20) per common share. - Lucid had cash and cash equivalents of
$24.9 million as ofJune 30, 2024 , compared to$18.9 million as ofDecember 31, 2023 . During the quarter endedJune 30, 2024 , he Company issued Series B-1 Convertible Preferred Stock Series resulting in gross proceeds of approximately$11.6 million . - The unaudited financial results for the three and six months ended
June 30, 2024 , were filed with theSEC on Form 10-Q onAugust 12, 2024 , 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 underU.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 six months ended
June 30, 2024 , and 2023 are as follows:
Condensed consolidated statements of operations (unaudited) |
||||||||
(in thousands except per-share amounts) |
|
For the three months ended
|
|
For the six months ended
|
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
|
Revenue |
|
$ 976 |
|
$ 159 |
|
$ 1,977 |
|
$ 605 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
12,168 |
|
11,743 |
|
23,960 |
|
26,505 |
Other (Income) expense |
|
(187) |
|
(203) |
|
(366) |
|
1,728 |
Net Loss |
|
(11,005) |
|
(11,381) |
|
(21,617) |
|
(27,628) |
Net income (loss) per common share, basic and diluted |
|
$ (0.23) |
|
$ (0.27) |
|
$ (0.62) |
|
$ (0.40) |
Net loss attributable to common stockholders |
|
(11,005) |
|
(11,381) |
|
(29,113) |
|
(27,628) |
Preferred Stock dividends and deemed dividends |
|
— |
|
— |
|
7,496 |
|
— |
Net income (loss) as reported |
|
(11,005) |
|
(11,381) |
|
(21,617) |
|
(27,628) |
Adjustments: |
|
|
|
|
|
|
|
|
Depreciation and amortization expense1 |
|
229 |
|
633 |
|
730 |
|
1,245 |
Interest expense, net2 |
|
(101) |
|
87 |
|
(157) |
|
43 |
EBITDA |
|
(10,877) |
|
(10,661) |
|
(21,044) |
|
(26,340) |
|
|
|
|
|
|
|
|
|
Other non-cash or financing related expenses: |
|
|
|
|
|
|
|
|
Stock-based compensation expense3 |
|
1,201 |
|
1,399 |
|
2,135 |
|
4,607 |
ResearchDx acquisition paid in stock1 |
|
— |
|
— |
|
— |
|
713 |
Operating expenses issued in stock1 |
|
90 |
|
23 |
|
113 |
|
23 |
Change in FV convertible debt2 |
|
(599) |
|
(290) |
|
(890) |
|
499 |
Offering costs convertible debt2 |
|
— |
|
— |
|
— |
|
1,186 |
Debt extinguishments loss - Senior Secured Convertible Note2 |
|
513 |
|
— |
|
681 |
|
— |
Non-GAAP adjusted (loss) |
|
$ (9,672) |
|
$ (9,529) |
|
$ (19,005) |
|
$ (19,312) |
Basic and Diluted shares outstanding |
|
48,212 |
|
41,834 |
|
46,613 |
|
41,405 |
Non-GAAP adjusted (loss) income per share |
|
|
|
|
|
|
|
|
|
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
|
|
For the six months ended
|
||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Cost of revenues |
|
$ 1,614 |
|
$ 1,549 |
|
$ 3,269 |
|
$ 2,887 |
Stock-based compensation expense3 |
|
(44) |
|
(25) |
|
(80) |
|
(44) |
Net cost of revenues |
|
1,570 |
|
1,524 |
|
3,189 |
|
2,843 |
|
|
|
|
|
|
|
|
|
Amortization of intangible assets |
|
105 |
|
505 |
|
477 |
|
1,010 |
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
4,210 |
|
4,032 |
|
8,404 |
|
8,159 |
Stock-based compensation expense3 |
|
(365) |
|
(367) |
|
(715) |
|
(723) |
Net sales and marketing |
|
3,845 |
|
3,665 |
|
7,689 |
|
7,436 |
|
|
|
|
|
|
|
|
|
General and administrative |
|
4,867 |
|
3,830 |
|
8,937 |
|
10,730 |
Depreciation expense |
|
(124) |
|
(128) |
|
(253) |
|
(235) |
RDx Settlement in Stock |
|
— |
|
— |
|
— |
|
(713) |
Operating expenses issued in stock |
|
(90) |
|
(23) |
|
(113) |
|
(23) |
Stock-based compensation expense3 |
|
(610) |
|
(844) |
|
(941) |
|
(3,512) |
Net general and administrative |
|
4,043 |
|
2,835 |
|
7,630 |
|
6,247 |
|
|
|
|
|
|
|
|
|
Research and development |
|
1,372 |
|
1,827 |
|
2,873 |
|
3,719 |
Stock-based compensation expense3 |
|
(182) |
|
(163) |
|
(399) |
|
(328) |
Net research and development |
|
1,190 |
|
1,664 |
|
2,474 |
|
3,391 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
12,168 |
|
11,743 |
|
23,960 |
|
26,505 |
Depreciation and amortization expense |
|
(229) |
|
(633) |
|
(730) |
|
(1,245) |
RDx Settlement in Stock |
|
— |
|
— |
|
— |
|
(713) |
Operating expenses issued in stock |
|
(90) |
|
(23) |
|
(113) |
|
(23) |
Stock-based compensation expense3 |
|
(1,201) |
|
(1,399) |
|
(2,135) |
|
(4,607) |
Net operating expenses |
|
$ 10,648 |
|
$ 9,688 |
|
$ 20,982 |
|
$ 19,917 |
About EsoGuard and EsoCheck
Millions of patients with gastroesophageal reflux disease (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
Esophageal precancer screening is already recommended by clinical practice guidelines for the millions of GERD patients with multiple risk factors, including age over 50 years, male sex, 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 death could likely have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment at the precancer stage.
The only missing element for a viable esophageal cancer prevention program has been the lack of an easily-accessible, in-office screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected non-endoscopically 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
EsoGuard is a Next Generation Sequencing (NGS) based DNA methylation 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 initially 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 a CE Marked and FDA 510(k) cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than three-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,
About
For more information, please visit luciddx.com and for more information about its parent company
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
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