Lucid Diagnostics Provides Business Update and Second Quarter 2024 Financial Results
Lucid Diagnostics Inc. (NASDAQ: LUCD) reported its Q2 2024 financial results and business update. Key highlights include:
- EsoGuard® test volume increased 31% quarterly and 44% annually
- EsoGuard revenue was $1.0M, flat compared to Q1 but up 514% year-over-year
- 3,147 commercial EsoGuard tests performed, a single-quarter record
- Positive clinical data released from ENVET-BE and ESOGUARD BE-1 studies
- Cash and cash equivalents of $24.9M as of June 30, 2024
- GAAP net loss of $11.0M or $(0.23) per share
- Non-GAAP adjusted loss of $9.7M or $(0.20) per share
The company is focused on securing broad coverage and reimbursement to drive EsoGuard revenue growth.
Lucid Diagnostics Inc. (NASDAQ: LUCD) ha riportato i risultati finanziari e un aggiornamento aziendale per il secondo trimestre del 2024. Punti salienti includono:
- Il volume di test EsoGuard® è aumentato del 31% rispetto al trimestre precedente e del 44% rispetto all'anno scorso
- I ricavi di EsoGuard sono stati di 1,0 milioni di dollari, stabili rispetto al primo trimestre ma in aumento del 514% rispetto all'anno precedente
- Sono stati eseguiti 3.147 test commerciali EsoGuard, un record per un singolo trimestre
- Sono stati rilasciati dati clinici positivi dagli studi ENVET-BE e ESOGUARD BE-1
- La liquidità e le disponibilità liquide ammontano a 24,9 milioni di dollari al 30 giugno 2024
- Perdite nette GAAP di 11,0 milioni di dollari, ovvero $(0,23) per azione
- Perdite rettificate non-GAAP di 9,7 milioni di dollari, ovvero $(0,20) per azione
L'azienda è concentrata nel garantire un'ampia copertura e risarcimento per sostenere la crescita dei ricavi di EsoGuard.
Lucid Diagnostics Inc. (NASDAQ: LUCD) reportó sus resultados financieros y actualización empresarial para el segundo trimestre de 2024. Los aspectos destacados incluyen:
- El volumen de pruebas de EsoGuard® aumentó un 31% trimestral y un 44% anual
- Los ingresos de EsoGuard fueron de 1.0 millones de dólares, estables en comparación con el primer trimestre, pero un 514% más que el año anterior
- Se realizaron 3,147 pruebas comerciales de EsoGuard, un récord para un solo trimestre
- Se publicaron datos clínicos positivos de los estudios ENVET-BE y ESOGUARD BE-1
- Efectivo y equivalentes de efectivo de 24.9 millones de dólares al 30 de junio de 2024
- Pérdida neta GAAP de 11.0 millones de dólares, o $(0.23) por acción
- Pérdida ajustada no GAAP de 9.7 millones de dólares, o $(0.20) por acción
La empresa se centra en asegurar una amplia cobertura y reembolso para impulsar el crecimiento de los ingresos de EsoGuard.
루시드 다이아그노스틱스 주식회사 (NASDAQ: LUCD)가 2024년 2분기 재무 결과와 사업 업데이트를 발표했습니다. 주요 하이라이트는 다음과 같습니다:
- EsoGuard® 테스트 양이 분기 대비 31%, 연간 44% 증가했습니다.
- EsoGuard의 수익은 100만 달러로, 1분기와 동일하지만 전년 대비 514% 증가했습니다.
- 3,147개의 상업 EsoGuard 테스트가 수행되어 단일 분기 기록을 세웠습니다.
- ENVET-BE 및 ESOGUARD BE-1 연구에서 긍정적인 임상 데이터가 발표되었습니다.
- 2024년 6월 30일 현재 현금 및 현금성 자산은 2490만 달러입니다.
- GAAP 기준 순손실은 1100만 달러 또는 주당 $(0.23)입니다.
- 비 GAAP 조정 손실은 970만 달러 또는 주당 $(0.20)입니다.
회사는 EsoGuard 수익 성장을 추진하기 위해 폭넓은 보장 및 환급을 확보하는 데 집중하고 있습니다.
Lucid Diagnostics Inc. (NASDAQ: LUCD) a annoncé ses résultats financiers et sa mise à jour commerciale pour le deuxième trimestre de 2024. Les points clés incluent :
- Le volume de tests EsoGuard® a augmenté de 31 % par rapport au trimestre précédent et de 44 % par rapport à l'année dernière
- Les revenus d'EsoGuard étaient de 1,0 million de dollars, stables par rapport au premier trimestre mais en hausse de 514 % par rapport à l'année précédente
- 3 147 tests commerciaux EsoGuard ont été réalisés, un record pour un seul trimestre
- Des données cliniques positives ont été publiées à partir des études ENVET-BE et ESOGUARD BE-1
- Trésorerie et équivalents de trésorerie de 24,9 millions de dollars au 30 juin 2024
- Perte nette GAAP de 11,0 millions de dollars ou $(0,23) par action
- Perte ajustée non-GAAP de 9,7 millions de dollars ou $(0,20) par action
L'entreprise se concentre sur la sécurisation d'une large couverture et d'un remboursement pour stimuler la croissance des revenus d'EsoGuard.
Lucid Diagnostics Inc. (NASDAQ: LUCD) hat seine Finanz Ergebnisse und Geschäftsnachricht für das zweite Quartal 2024 veröffentlicht. Wichtige Punkte sind:
- Das Testvolumen von EsoGuard® stieg um 31% im Vergleich zum Vorquartal und um 44% im Vergleich zum Vorjahr
- Der Umsatz von EsoGuard betrug 1,0 Millionen Dollar, stabil im Vergleich zum ersten Quartal, jedoch um 514% im Jahresvergleich gestiegen
- Es wurden 3.147 kommerzielle EsoGuard-Tests durchgeführt, ein Rekord für ein einzelnes Quartal
- Positive klinische Daten aus den Studien ENVET-BE und ESOGUARD BE-1 wurden veröffentlicht
- Bargeld und liquide Mittel betragen zum 30. Juni 2024 24,9 Millionen Dollar
- GAAP-Nettverlust von 11,0 Millionen Dollar oder $(0,23) pro Aktie
- Bereinigter Nicht-GAAP-Verlust von 9,7 Millionen Dollar oder $(0,20) pro Aktie
Das Unternehmen konzentriert sich darauf, eine umfassende Abdeckung und Erstattungen zu sichern, um das Umsatzwachstum von EsoGuard voranzutreiben.
- EsoGuard test volume increased 31% quarterly and 44% annually
- EsoGuard revenue up 514% year-over-year to $1.0M
- Record 3,147 commercial EsoGuard tests performed in Q2
- Positive clinical data from ENVET-BE and ESOGUARD BE-1 studies
- Cash position improved to $24.9M from $18.9M at end of 2023
- Raised $11.6M through Series B-1 Convertible Preferred Stock issuance
- GAAP net loss of $11.0M for the quarter
- Operating expenses increased to $12.2M
- EsoGuard revenue flat compared to Q1 2024
Insights
Lucid Diagnostics' Q2 2024 results show mixed signals. On the positive side, EsoGuard test volume increased 31% quarterly and 44% annually, indicating growing market adoption. Revenue was
The cash position improved to
Overall, while test volume growth is encouraging, Lucid needs to significantly improve its path to profitability and secure broader insurance coverage to become financially sustainable long-term.
The release of positive clinical data for EsoGuard is a significant development. The ENVET-BE study showed a 2.4-fold increased positive yield of invasive endoscopy when using EsoGuard as a triage tool. Additionally, the ESOGUARD BE-1 study demonstrated 88% sensitivity and 99% negative predictive value. These results strongly support EsoGuard's clinical utility and accuracy.
The American Foregut Society's advocacy for EsoGuard coverage aligns with these findings and could influence insurance decisions. However, it's important to note that while these results are promising, broader acceptance and coverage by major insurers will be key to EsoGuard's commercial success. The meeting with CMS Medicare Administrative Contractor is a positive step, but concrete outcomes are yet to be seen.
Lucid's market strategy shows promise but faces challenges. The #CheckYourFoodTube Precancer Testing Events, especially those with upfront contracted payments, indicate growing market acceptance and could be a significant revenue driver if scaled effectively.
The company's focus on securing medical policy coverage in biomarker legislation states and pilots with national plans is strategic. However, the success of this approach remains to be seen. The robust pipeline of direct contracting engagements with benefits brokers and self-insured entities could provide a more immediate path to revenue growth.
While test volume growth is encouraging, the flat quarter-over-quarter revenue suggests pricing or reimbursement challenges. Lucid's ability to convert clinical success and market strategies into sustainable revenue growth will be important for long-term success.
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, August 12th at 8:30 AM EDT
Conference Call and Webcast
The webcast will take place on Monday, August 12, 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
"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 Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "We are now fully armed with a complete body of clinical data and well-positioned for our final push towards broad coverage and reimbursement to drive EsoGuard revenue and revenue growth."
Highlights from the second quarter and recent weeks:
- For the quarter, EsoGuard® Esophageal DNA Test revenue was
, which was flat compared to 1Q24 and represents a 514 percent annual increase from 2Q23.$1.0M - 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 of99% . - 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
. Operating expenses were approximately$1.0 million , which included stock-based compensation expenses of$12.2 million . GAAP net loss attributable to common stockholders was approximately$1.2 million or$11.0 million $(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
million or$9.7 per common share.$(0.20) - Lucid had cash and cash equivalents of
as of June 30, 2024, compared to$24.9 million as of December 31, 2023. During the quarter ended June 30, 2024, he Company issued Series B-1 Convertible Preferred Stock Series resulting in gross proceeds of approximately$18.9 million .$11.6 million - The unaudited financial results for the three and six months ended June 30, 2024, were filed with the SEC on Form 10-Q on August 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 June 30, | For the six months ended June 30, | ||||||
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 June 30, | For the six months ended June 30, | ||||||
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 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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