Lucid Diagnostics Inc (LUCD) Provides Business Update, Reports Prelim Q4
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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
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
"We are very pleased with the excellent progress Lucid has made on multiple fronts in the fourth quarter and recent weeks," said
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 endedDecember 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 ofDecember 31, 2023 , compared to$22.5 million as ofDecember 31, 2022 . Subsequent toDecember 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 onMarch 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 | For the year ended | ||||||
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 | ||||||||
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 year ended | ||||||
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 | ||||
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