Lucid Diagnostics Provides Business Update and First Quarter 2024 Financial Results
Quarterly EsoGuard® test volume increased 10 percent
Strengthened balance sheet following completion of
MolDX pre-submission meeting scheduled for
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 first quarter and recent weeks and look forward to exciting very near-term milestones for our business," said
Highlights from the first quarter and recent weeks:
- For the quarter, EsoGuard® revenue was
$1.0M , which was flat compared to 4Q23 and represents a 124 percent annual increase from 1Q23. - Lucid's CLIA-certified clinical laboratory performed 2,420 commercial EsoGuard Esophageal DNA Tests in 1Q24, which represents a 10 percent increase sequentially from 4Q23 and a 31 percent annual increase from 1Q23.
- Continuous revenue cycle management improvements, including prior authorization appeals, physician advocacy, etc., while maintaining stable out-of-network allowed amounts averaging
~$1,800 . - Strengthened balance sheet by completing
$29.8 million Series B Preferred Stock Offering. -
Peer-reviewed publication of positive data from landmark
National Cancer Institute (NCI)-sponsored clinical validation study of EsoGuard esophageal precancer testing demonstrating unprecedented early cancer detection. The publication of data strengthens EsoGuard's clinical data supporting ongoing engagement to secure commercial and Medicare payor coverage. - Secured
July 17, 2024 MolDX pre-submission meeting to review data for technical assessment (TA) seeking EsoGuard coverage under its foundational Local Coverage Determination (LCD). - 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
March 31, 2024 , EsoGuard related revenues were$1.0 million . Operating expenses were approximately$11.8 million , which included stock-based compensation expenses of$0.9 million . GAAP net loss attributable to common stockholders was approximately$18.1 million or$(0.40) 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
March 31, 2024 was approximately$9.4 million or$(0.21) per common share. - Lucid had cash and cash equivalents of
$24.8 million as ofMarch 31, 2024 , compared to$18.9 million as ofDecember 31, 2023 . Subsequent toMarch 31, 2024 , the Company completed an issuance of Convertible Preferred Stock Series B-1 resulting in gross proceeds of approximately$11.6 million . - The unaudited financial results for the three months ended
March 31, 2024 , were filed with theSEC on Form 10-Q onMay 13, 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 months ended
March 31, 2024 , and 2023 are as follows:
Condensed consolidated statements of operations (unaudited) |
||||
(in thousands except per-share amounts) |
|
For the three months ended
|
||
|
|
2024 |
|
2023 |
|
|
|
|
|
Revenue |
|
$ 1,001 |
|
$ 446 |
|
|
|
|
|
Operating expenses |
|
11,793 |
|
14,763 |
Other (Income) expense |
|
(180) |
|
1,930 |
Net Loss |
|
(10,612) |
|
(16,247) |
Net income (loss) per common share, basic and diluted |
|
$ (0.40) |
|
$ (0.40) |
Net loss attributable to common stockholders |
|
(18,108) |
|
(16,247) |
Preferred Stock dividends and deemed dividends |
|
7,496 |
|
— |
Net income (loss) as reported |
|
(10,612) |
|
(16,247) |
Adjustments: |
|
|
|
|
Depreciation and amortization expense1 |
|
501 |
|
612 |
Interest expense (income), net2 |
|
(56) |
|
(45) |
EBITDA |
|
(10,167) |
|
(15,680) |
|
|
|
|
|
Other non-cash or financing related expenses: |
|
|
|
|
Stock-based compensation expense3 |
|
933 |
|
3,208 |
ResearchDx acquisition paid in stock1 |
|
— |
|
713 |
Change in FV convertible debt2 |
|
(291) |
|
789 |
Offering costs convertible debt2 |
|
— |
|
1,186 |
Debt extinguishments loss - Senior Secured Convertible Note2 |
|
167 |
|
— |
Non-GAAP adjusted (loss) |
|
$ (9,358) |
|
$ (9,784) |
Basic and Diluted shares outstanding |
|
45,014 |
|
40,971 |
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
|
||
|
|
2024 |
|
2023 |
Cost of revenues |
|
$ 1,656 |
|
$ 1,338 |
Stock-based compensation expense3 |
|
(36) |
|
(19) |
Net cost of revenues |
|
1,620 |
|
1,319 |
|
|
|
|
|
Amortization of intangible assets |
|
372 |
|
505 |
|
|
|
|
|
Sales and marketing |
|
4,194 |
|
4,127 |
Stock-based compensation expense3 |
|
(350) |
|
(356) |
Net sales and marketing |
|
3,844 |
|
3,771 |
|
|
|
|
|
General and administrative |
|
4,070 |
|
6,900 |
Depreciation expense |
|
(129) |
|
(107) |
RDx Settlement in Stock |
|
— |
|
(713) |
Stock-based compensation expense3 |
|
(330) |
|
(2,668) |
Net general and administrative |
|
3,611 |
|
3,412 |
|
|
|
|
|
Research and development |
|
1,501 |
|
1,893 |
Stock-based compensation expense3 |
|
(217) |
|
(165) |
Net research and development |
|
1,284 |
|
1,728 |
|
|
|
|
|
Total operating expenses |
|
11,793 |
|
14,763 |
Depreciation and amortization expense |
|
(501) |
|
(612) |
RDx Settlement in Stock |
|
— |
|
(713) |
Stock-based compensation expense3 |
|
(933) |
|
(3,208) |
Net operating expenses |
|
$ 10,359 |
|
$ 10,230 |
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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