Lucid Diagnostics Provides Business Update and Third Quarter 2024 Financial Results
Lucid Diagnostics reported Q3 2024 financial results with EsoGuard® revenue of $1.2M, showing a 20% sequential increase from Q2 and 50% annual growth. The company performed 2,787 commercial EsoGuard tests in Q3, with October setting a single-month record of over 1,400 tests. Operating expenses were $12.9M, resulting in a GAAP net loss of $12.4M or $(0.25) per share. Cash position stood at $14.5M as of September 30, 2024. The company has secured agreements for $21.75M in Senior Secured Convertible Notes and expects to increase its cash runway by approximately $13.2M after redemption of existing notes.
Lucid Diagnostics ha riportato i risultati finanziari del terzo trimestre 2024 con entrate di EsoGuard® pari a 1,2 milioni di dollari, mostrando un incremento del 20% rispetto al secondo trimestre e una crescita annuale del 50%. L'azienda ha effettuato 2.787 test commerciali di EsoGuard nel terzo trimestre, con ottobre che ha segnato un record mensile di oltre 1.400 test. Le spese operative sono state di 12,9 milioni di dollari, portando a una perdita netta GAAP di 12,4 milioni di dollari, pari a $(0,25) per azione. La posizione di cassa era di 14,5 milioni di dollari al 30 settembre 2024. L'azienda ha ottenuto accordi per 21,75 milioni di dollari in Note Convertibili Senior Garantite e si aspetta di aumentare la sua liquidità di circa 13,2 milioni di dollari dopo il rimborso delle note esistenti.
Lucid Diagnostics reportó los resultados financieros del tercer trimestre de 2024 con ingresos de EsoGuard® de 1,2 millones de dólares, mostrando un aumento secuencial del 20% respecto al segundo trimestre y un crecimiento anual del 50%. La empresa realizó 2,787 pruebas comerciales de EsoGuard en el tercer trimestre, siendo octubre el mes con récord de más de 1,400 pruebas. Los gastos operativos fueron de 12.9 millones de dólares, resultando en una pérdida neta GAAP de 12.4 millones de dólares o $(0.25) por acción. La posición de efectivo era de 14.5 millones de dólares a fecha del 30 de septiembre de 2024. La empresa ha asegurado acuerdos por 21.75 millones de dólares en Notas Convertibles Senior Garantizadas y espera aumentar su liquidez en aproximadamente 13.2 millones de dólares tras el reembolso de las notas existentes.
루시드 진단(Lucid Diagnostics)는 2024년 3분기 재무 결과를 발표했으며, EsoGuard® 매출이 120만 달러로 2분기 대비 20% 증가하고 연간 50% 성장했습니다. 회사는 3분기에 2,787건의 상업적 EsoGuard 테스트를 수행했으며, 10월에는 1,400건 이상의 테스트로 단일 월 기록을 세웠습니다. 운영 비용은 1,290만 달러였으며, GAAP 기준 순손실은 1,240만 달러 또는 주당 $(0.25)입니다. 2024년 9월 30일 기준 현금 잔고는 1,450만 달러였습니다. 이 회사는 2,175만 달러 규모의 선도 보증 전환사채에 대한 계약을 체결했으며, 기존 사채 상환 후 약 1,320만 달러의 현금 유동성을 늘릴 것으로 예상하고 있습니다.
Lucid Diagnostics a publié les résultats financiers du troisième trimestre 2024 avec des revenus d'EsoGuard® de 1,2 million de dollars, affichant une augmentation séquentielle de 20 % par rapport au deuxième trimestre et une croissance annuelle de 50 %. L'entreprise a réalisé 2 787 tests commerciaux d'EsoGuard au troisième trimestre, avec octobre établissant un record mensuel de plus de 1 400 tests. Les dépenses d'exploitation se sont élevées à 12,9 millions de dollars, entraînant une perte nette GAAP de 12,4 millions de dollars, soit $(0,25) par action. La position de trésorerie était de 14,5 millions de dollars au 30 septembre 2024. L'entreprise a sécurisé des accords pour 21,75 millions de dollars en Obligations Convertibles Senior Garanties et s'attend à augmenter sa liquidité d'environ 13,2 millions de dollars après le remboursement des obligations existantes.
Lucid Diagnostics gab die finanziellen Ergebnisse des 3. Quartals 2024 bekannt, mit Einnahmen aus EsoGuard® von 1,2 Millionen US-Dollar, was einem sequenziellen Anstieg von 20% im Vergleich zum 2. Quartal und einem jährlichen Wachstum von 50% entspricht. Das Unternehmen führte im 3. Quartal 2.787 kommerzielle EsoGuard-Tests durch, wobei der Oktober mit über 1.400 Tests einen Monatsrekord aufstellte. Die Betriebsausgaben betrugen 12,9 Millionen US-Dollar, was zu einem GAAP-Nettoverlust von 12,4 Millionen US-Dollar oder $(0,25) pro Aktie führte. Zum 30. September 2024 betrug die Liquidität 14,5 Millionen US-Dollar. Das Unternehmen hat Vereinbarungen für 21,75 Millionen US-Dollar in Senior Secured Convertible Notes gesichert und erwartet, seine Liquiditätsreserve nach Rückzahlung der vorhandenen Anleihen um etwa 13,2 Millionen US-Dollar zu erhöhen.
- EsoGuard revenue grew 20% sequentially and 50% year-over-year to $1.2M
- Record testing volume with 2,787 tests in Q3 and over 1,400 in October alone
- Secured $21.75M in new financing through convertible notes
- Clinical evidence package completed for Medicare coverage submission
- Operating loss of $12.9M in Q3
- Cash position decreased from $18.9M to $14.5M since December 2023
- Net loss of $12.4M or $(0.25) per share
Insights
The Q3 results reveal mixed signals for Lucid Diagnostics. Revenue growth shows positive momentum with
However, concerning metrics include significant operating losses with
The completion of clinical evidence package for Medicare coverage submission is a important milestone, but the path to profitability remains challenging with substantial quarterly losses of
The acceptance of the ESOGUARD BE-1 clinical validation study by the American Journal of Gastroenterology marks a significant milestone. This publication completes the clinical evidence package required for Medicare coverage submission, potentially opening access to a broader patient population. The analytical validation study demonstrates strong technical performance with excellent accuracy and reproducibility.
The expansion of testing programs, including the shift to contracted #CYFT Precancer Testing Events and entry into concierge medicine, shows promising strategic diversification. The meeting with CMS Medicare Administrative Contractor suggests progress toward reimbursement, though approval timelines and outcomes remain uncertain.
EsoGuard® revenue up 20 percent sequentially
Clinical evidence package for Medicare coverage submission complete
Direct contracting initiative expanded to multiple programs to drive near-term revenue growth
Conference call and webcast to be held today, November 13th at 8:30 AM EST
Conference Call and Webcast
The webcast will take place on Wednesday, November 13, 2024, 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,
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
"The third quarter and recent weeks have been a transformational period for Lucid, including two key milestones announced last week," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We are now fully armed with a complete body of outstanding clinical data to go along with a renewed commercial focus on programs designed to drive near-term revenue. Our team is ready to make our final push towards broad reimbursement, including our upcoming submission formally seeking Medicare coverage of EsoGuard. We are energized by the vast clinical and market opportunity before us as we seek to expand patient access to our groundbreaking technologies to detect esophageal precancer, and drive shareholder value."
Highlights from the third quarter and recent weeks:
- For the quarter, EsoGuard® Esophageal DNA Test revenue was
$1.2M - Lucid's CLIA-certified clinical laboratory performed 2,787 commercial EsoGuard tests in 3Q24. Additionally, for the month of October, the lab performed a single-month record of more than 1,400 tests, contributing to the largest three-month total in the Company's history.
- ESOGUARD BE-1 clinical validation study accepted for peer-reviewed publication in the American Journal of Gastroenterology. This publication completes Lucid's clinical evidence package for submission to formally seek Medicare coverage.
- Company leveraging complete clinical evidence package to expand direct contracting initiative with multiple programs focused on driving near-term revenue growth, including a shift to fully-contracted #CYFT Precancer Testing Events, broadening employer markets activity, and a new foray into the concierge medicine sector.
- Met with CMS Medicare Administrative Contractor (MAC) Palmetto GBA's Molecular Diagnostics Program (MolDX) to discuss EsoGuard clinical evidence package for upcoming submission for Medicare coverage.
- Peer-reviewed publication of EsoGuard analytical validation study, demonstrating excellent analytical accuracy, repeatability, and reproducibility of the assay.
- Received Notice of Allowance for key patent underlying EsoGuard.
Financial Results
- For the three months ended September 30, 2024, EsoGuard related revenues were
$1.2 million $12.9 million $1.2 million $12.4 million $(0.25) - 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 September 30, 2024 was approximately
$10.1 million $(0.20) - Lucid had cash and cash equivalents of
$14.5 million $18.9 million $21.75 million $13.2 million - The unaudited financial results for the three and nine months ended September 30, 2024, were filed with the SEC on Form 10-Q on November 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 nine months ended September 30, 2024, and 2023 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, | ||||||
2024 | 2023 | 2024 | 2023 | |||||
Revenue | $ 1,172 | $ 783 | $ 3,149 | $ 1,388 | ||||
Operating expenses | 12,866 | 11,911 | 36,826 | 38,417 | ||||
Other (Income) expense | 677 | 3,080 | 311 | 4,807 | ||||
Net Loss | (12,371) | (14,208) | (33,988) | (41,836) | ||||
Net income (loss) per common share, basic and diluted | $ (0.25) | $ (0.34) | $ (0.87) | $ (1.01) | ||||
Net loss attributable to common stockholders | (12,371) | (14,208) | (41,484) | (41,836) | ||||
Preferred Stock dividends and deemed dividends | — | — | 7,496 | — | ||||
Net income (loss) as reported | (12,371) | (14,208) | (33,988) | (41,836) | ||||
Adjustments: | ||||||||
Depreciation and amortization expense1 | 215 | 625 | 945 | 1,870 | ||||
Interest expense, net2 | (80) | 33 | (237) | 75 | ||||
EBITDA | (12,236) | (13,550) | (33,280) | (39,891) | ||||
Other non-cash or financing related expenses: | ||||||||
Stock-based compensation expense3 | 1,228 | 1,252 | 3,363 | 5,859 | ||||
ResearchDx acquisition paid in stock1 | — | — | — | 713 | ||||
Operating expenses issued in stock1 | 135 | — | 248 | 23 | ||||
Change in FV convertible debt2 | 322 | 3,021 | (568) | 3,520 | ||||
Offering costs convertible debt2 | — | — | — | 1,186 | ||||
Debt extinguishments loss - Senior Secured Convertible Note2 | 435 | 26 | 1,116 | 26 | ||||
Non-GAAP adjusted (loss) | $ (10,116) | $ (9,251) | $ (29,121) | $ (28,564) | ||||
Basic and Diluted shares outstanding | 50,374 | 41,863 | 47,876 | 41,559 | ||||
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 September 30, | For the nine months ended September 30, | ||||||
2024 | 2023 | 2024 | 2023 | |||||
Cost of revenues | $ 1,684 | $ 1,634 | $ 4,954 | $ 4,522 | ||||
Stock-based compensation expense3 | (41) | (26) | (121) | (70) | ||||
Net cost of revenues | 1,643 | 1,608 | 4,833 | 4,452 | ||||
Amortization of intangible assets | 105 | 505 | 582 | 1,516 | ||||
Sales and marketing | 4,056 | 3,837 | 12,459 | 11,996 | ||||
Stock-based compensation expense3 | (351) | (334) | (1,066) | (1,056) | ||||
Net sales and marketing | 3,705 | 3,503 | 11,393 | 10,940 | ||||
General and administrative | 5,355 | 4,320 | 14,292 | 15,049 | ||||
Depreciation expense | (110) | (120) | (363) | (354) | ||||
RDx Settlement in Stock | — | — | — | (713) | ||||
Operating expenses issued in stock | (135) | — | (248) | (23) | ||||
Stock-based compensation expense3 | (700) | (728) | (1,640) | (4,239) | ||||
Net general and administrative | 4,410 | 3,472 | 12,041 | 9,720 | ||||
Research and development | 1,666 | 1,615 | 4,539 | 5,334 | ||||
Stock-based compensation expense3 | (136) | (164) | (536) | (494) | ||||
Net research and development | 1,530 | 1,451 | 4,003 | 4,840 | ||||
Total operating expenses | 12,866 | 11,911 | 36,826 | 38,417 | ||||
Depreciation and amortization expense | (215) | (625) | (945) | (1,870) | ||||
RDx Settlement in Stock | — | — | — | (713) | ||||
Operating expenses issued in stock | (135) | — | (248) | (23) | ||||
Stock-based compensation expense3 | (1,228) | (1,252) | (3,363) | (5,859) | ||||
Net operating expenses | $ 11,288 | $ 10,034 | $ 32,270 | $ 29,952 | ||||
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 American College of Gastroenterology (ACG) clinical practice guideline and an American Gastroenterological Association (AGA) 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
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, NYS CLEP approved 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 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. 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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SOURCE Lucid Diagnostics
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