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Lucid Diagnostics Inc. (LUCD) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2025-11-12 15:16
Lucid Diagnostics Inc. (LUCD) came out with a quarterly loss of $0.1 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to a loss of $0.2 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -66.67%. A quarter ago, it was expected that this company would post a loss of $0.09 per share when it actually produced a loss of $0.1, delivering a surprise of -11.11%.Over the last four quarters, the company has ...
Lucid Diagnostics(LUCD) - 2025 Q3 - Earnings Call Transcript
2025-11-12 14:30
Financial Data and Key Metrics Changes - In Q3 2025, the company reported revenue of approximately $1.2 million from 2,841 EsoGuard tests, maintaining volume and revenue levels consistent with the previous quarter [5][22] - The quarterly burn rate was $10.3 million, slightly better than the average burn rate of the previous four quarters [22][28] - The company ended the quarter with $47.3 million in cash, bolstered by a public offering that netted approximately $27 million [9][22] Business Line Data and Key Metrics Changes - EsoGuard test volume remained within the target range of 2,500-3,000 tests per quarter, essential for ongoing engagements with commercial payers [5][8] - Revenue recognition for the majority of claims is based on the probability of collection, with 76% of claims submitted in Q3 adjudicated [26][30] Market Data and Key Metrics Changes - The company is focusing on expanding its market access, particularly targeting Medicare patients, which represent about 50% of the 30 million target population [7][8] - The company has strengthened its market access leadership team to enhance payer engagement and secure broader commercial insurance coverage [6][11] Company Strategy and Development Direction - The company is in the final stages of securing positive Medicare coverage policy outcomes, following a successful Contractor Advisory Committee meeting [4][9] - The strategy includes transitioning to target Medicare patients while maintaining volume with commercial payers [5][8] - The company is also hosting events to strengthen relationships with fire departments, focusing on esophageal cancer prevention [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Medicare coverage, anticipating a draft local coverage determination soon [12][14] - The company is actively engaging with commercial payers and has seen positive movement in discussions, indicating a shift in strategy to pursue coverage even before Medicare approval [45][48] Other Important Information - The company has a strong pipeline of contracted testing events and is expanding its efforts to drive Medicare testing [20][19] - The company reported a non-GAAP net loss of $10.3 million for Q3, consistent with previous quarters [28][30] Q&A Session Summary Question: Can you provide insights on the recent CCLA meeting and its implications? - Management highlighted that the meeting was positive, with significant time spent discussing the company's CAC meeting, reinforcing confidence in the Medicare coverage process [34][35] Question: What is the expected timeline for the draft LCD? - Management indicated that they believe the timeline for the draft LCD publication is reasonable, with expectations for it to be issued by year-end 2025 [43][44] Question: How is the company engaging with commercial payers? - Management noted that there has been increased activity and positive movement in discussions with commercial payers, with expectations for positive coverage policies to emerge soon [45][48] Question: What is the conversion rate for referrals to EsoGuard tests? - Management stated that the conversion rate for patients referred for EsoGuard tests is over 90%, indicating strong follow-through on testing [78]
Lucid Diagnostics(LUCD) - 2025 Q3 - Earnings Call Presentation
2025-11-12 13:30
Business Performance - Lucid Diagnostics achieved a record quarterly revenue of $1.2 million in Q3 2024, a 20% increase compared to the previous quarter[6] - EsoGuard test volume reached 2,787 in Q3 2024[6] - Over 7,000 firefighters have undergone EsoGuard esophageal precancer testing[6] - Year-to-date revenue for 3Q24 reached $3.149 million, a $1.761 million increase compared to $1.388 million in 3Q23[34] Strategic Accomplishments - The ESOGUARD BE-1 clinical validation study was accepted for peer-reviewed publication[8] - A key patent underlying EsoGuard received a Notice of Allowance[8] - Lucid Diagnostics 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[8] Financials - Cash reserves decreased from $24.920 million in 2Q24 to $14.489 million in 3Q24, a decrease of $10.431 million[32] - Net loss for 3Q24 was $(12.371) million, compared to $(14.208) million in 3Q23, an improvement of $1.837 million[34] - Non-GAAP adjusted loss per share improved from $(0.22) in 3Q23 to $(0.20) in 3Q24[34] - Shares outstanding increased from 49.3 million in 2Q24 to 51.6 million in 3Q24, an increase of 2.3 million shares[32]
Lucid Diagnostics(LUCD) - 2025 Q3 - Quarterly Results
2025-11-12 13:15
Financial Performance - Processed 2,841 EsoGuard tests and recognized 3Q25 revenue of $1.2 million, with operating expenses of approximately $13.0 million[7] - GAAP net loss attributable to common stockholders was approximately $10.4 million or $(0.10) per common share[9] - Non-GAAP adjusted loss for 3Q25 was approximately $10.3 million or $(0.10) per common share[9] - EsoGuard related revenues for the nine months ended September 30, 2025, were $3.2 million, compared to $3.1 million for the same period in 2024[9] - Operating expenses for the nine months ended September 30, 2025, were approximately $38.8 million, compared to $36.8 million for the same period in 2024[9] Cash Position - Ended 3Q25 with over $47 million in proforma cash, extending runway through 2026[7] - Completed a public offering netting approximately $27.0 million in proceeds during the quarter[7] Market Access and Coverage - Unanimous expert consensus from the Multi-Jurisdictional Contractor Advisory Committee supports Medicare coverage for EsoGuard[5] - The company is preparing to accelerate EsoGuard commercialization as Medicare coverage and other reimbursement milestones are secured[5] Leadership Changes - Appointed Danielle Scelfo as Senior Vice President, Market Access & Government Affairs to enhance market access infrastructure[7]
Lucid Diagnostics(LUCD) - 2025 Q3 - Quarterly Report
2025-11-12 13:01
Revenue and Financial Performance - The Company recognized revenue from the delivery of EsoGuard test results, with gross margin expected to fluctuate based on test volume and operating efficiencies [126]. - Revenue for the three months ended September 30, 2025, remained relatively level at $1.2 million compared to the same period in 2024 [137]. - For the nine months ended September 30, 2025, revenue was $3.2 million, an increase from $3.1 million in the same period in 2024 [145]. - The company experienced a net loss of approximately $41.7 million and used approximately $33.9 million of cash in operations during the nine months ended September 30, 2025 [155]. - The company ended the quarter with cash on hand of $47.3 million as of September 30, 2025 [155]. - The Company was in compliance with all financial covenants as of September 30, 2025 [161]. Expenses - Cost of revenue for the same period was approximately $1.7 million, also remaining relatively level year-over-year [138]. - Sales and marketing expenses increased to approximately $4.3 million in Q3 2025, up from $4.1 million in Q3 2024, reflecting a net increase of $0.2 million [139]. - General and administrative expenses rose to approximately $5.6 million in Q3 2025, compared to $5.4 million in Q3 2024, marking a net increase of $0.2 million [140]. - Research and development costs decreased to approximately $1.3 million in Q3 2025 from $1.7 million in Q3 2024, a net decrease of $0.4 million [140]. - General and administrative costs for the nine months ended September 30, 2025, were approximately $17.4 million, up from $14.3 million in the prior year, reflecting a net increase of $3.1 million [147]. Clinical and Regulatory Developments - EsoGuard demonstrated a sensitivity of approximately 90% for detecting disease across the esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of around 99% [108]. - The Company submitted a clinical evidence package to secure Medicare coverage for EsoGuard, which included six new peer-reviewed publications [111]. - The ENVET-BE study showed a 2.4-fold increase in Barrett's Esophagus (BE) detection compared to the performance goal, with a 2.7-fold increase in the cohort meeting ACG criteria [114]. - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York state, effective May 26, 2025 [123]. - An $8 million NIH grant was awarded to evaluate esophageal precancer detection using EsoCheck and EsoGuard among at-risk individuals without GERD symptoms [124]. - EsoCheck is an FDA 510(k) and CE Mark cleared device that allows for non-invasive sampling of esophageal cells in under two minutes [109]. Capital and Stock Transactions - The Company closed on the sale of 28,750,000 shares at $1.00 per share in September 2025, raising approximately $27.0 million for working capital [116]. - The company closed on the sale of 28,750,000 shares of common stock at a price of $1.00 per share in September 2025, generating net proceeds of approximately $27.0 million [158]. Operational Insights - The Company anticipates an increase in sales and marketing expenses as it expands commercial operations and insurance reimbursement coverage for EsoGuard [129]. - The MSA Fee incurred by the Company is currently $1.05 million per month [162]. - There have been no material changes to the Company's critical accounting estimates in the nine months ended September 30, 2025 [163].
What Makes Lucid Diagnostics Inc. (LUCD) a Strong Momentum Stock: Buy Now?
ZACKS· 2025-10-16 17:01
Core Insights - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] - The Zacks Momentum Style Score helps investors identify stocks with strong momentum, addressing the challenges of defining momentum [2] Company Overview: Lucid Diagnostics Inc. (LUCD) - Lucid Diagnostics Inc. currently holds a Momentum Style Score of B, indicating potential for solid momentum [3] - The company has a Zacks Rank of 2 (Buy), suggesting it is positioned for outperformance in the market [4] Performance Metrics - Over the past week, LUCD shares increased by 10.58%, while the Zacks Medical - Instruments industry declined by 2.74% [6] - In a longer timeframe, LUCD's monthly price change is 17.76%, significantly outperforming the industry's 0.67% [6] - Over the past quarter, LUCD shares rose by 12.5%, and over the last year, they gained 55.56%, compared to the S&P 500's increases of 7.25% and 16.06%, respectively [7] Trading Volume - LUCD's average 20-day trading volume is 1,341,620 shares, indicating a bullish sign with rising stock prices and above-average volume [8] Earnings Outlook - Recent earnings estimate revisions show one upward revision for the full year, raising the consensus estimate from -$0.41 to -$0.35 [10] - For the next fiscal year, one estimate has moved upwards with no downward revisions, indicating positive sentiment [10] Conclusion - Considering the performance metrics and earnings outlook, LUCD is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [12]
Lucid Diagnostics (NasdaqCM:LUCD) Earnings Call Presentation
2025-09-18 11:00
Company Overview - Lucid Diagnostics Inc is a commercial-stage cancer prevention company focused on esophageal precancer screening[4] - The company's mission is to prevent esophageal cancer deaths in at-risk patients through a comprehensive precancer screening solution[6] - Lucid's solution includes EsoCheck for esophageal cell collection and EsoGuard Esophageal DNA Test for detecting epigenetic changes[24, 32] Market Opportunity - The total addressable U S market for EsoGuard is approximately $60 billion, targeting ~30 million at-risk GERD patients recommended for screening[8, 52] - The Medicare payment for EsoGuard is approximately $1,938 per test[52] - The company boasts over 90% gross margin per test[53] Clinical and Financial Performance - EsoGuard has a 96% sensitivity for detecting esophageal cancer and precancer[39] - Since launch, approximately 36,000 cumulative EsoGuard tests have been performed[79] - The company's pro forma cash as of 2Q25, including September CMPO, is $58.1 million[81] Esophageal Cancer Context - Esophageal cancer has a low 5-year survival rate of 13%[14] - The incidence of Esophageal Adenocarcinoma (EAC) has increased by 573% from 1975 to 2020[16] - Approximately 16,250 estimated U S deaths from esophageal cancer in 2025[17]
Lucid Diagnostics Appoints Danielle Scelfo as Senior Vice President, Market Access & Government Affairs
Prnewswire· 2025-09-16 12:01
Core Insights - Lucid Diagnostics Inc. has appointed Danielle Scelfo as Senior Vice President of Market Access & Government Affairs to enhance market access infrastructure and accelerate commercial coverage expansion for its EsoGuard Esophageal DNA Test [1][2] - The company is at a critical juncture, aiming to expand patient access to the EsoGuard test, with Medicare coverage anticipated following a positive MolDX CAC meeting [2][3] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of esophageal precancer and cancer [3] - The EsoGuard test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients [3] Leadership and Experience - Danielle Scelfo brings over 25 years of experience in market access, reimbursement, and government affairs, having held senior roles in various diagnostics companies [2][3] - Her previous positions include Vice President at ClearNote Health and leadership roles at CareDx, Hologic, Adaptive Biotechnologies, and Genomic Health [2]
Lucid Diagnostics Inc. (LUCD) Investor Conference Call (Transcript)
Seeking Alpha· 2025-09-08 20:31
Group 1 - The conference call is hosted by Lucid Diagnostics, featuring remarks from the Senior Director of Investor Relations and the CEO [2][3] - The discussion will cover various topics including the September 4 contractors Advisory Committee meeting, reimbursement strategies, and regulatory milestones [3] - The PAC meetings are advisory and do not establish coverage determinations, indicating the nature of the discussions [3] Group 2 - The company emphasizes that forward-looking statements are based on current expectations and may differ materially from actual outcomes [2][4] - Important factors affecting actual results are detailed in SEC filings, including risk factors in the most recent annual and quarterly reports [4]
Lucid Diagnostics (NasdaqCM:LUCD) Update / Briefing Transcript
2025-09-08 13:30
Summary of Lucid Diagnostics Conference Call Company Overview - **Company**: Lucid Diagnostics (NasdaqCM: LUCD) - **Industry**: Medical diagnostics, specifically focusing on esophageal cancer detection through the EsoGuard test Key Points and Arguments 1. **Positive Outcome of MOLDEX CAC Meeting**: The recent Contractor Advisory Committee (CAC) meeting was overwhelmingly positive, with broad clinician support for EsoGuard, exceeding expectations [4][5][6] 2. **Clinical Need and Evidence**: There is a strong clinical need for EsoGuard, supported by a robust body of clinical evidence. Medical experts unanimously agreed that Medicare should cover the test for detecting precancerous conditions [5][6][8] 3. **EsoGuard's Performance**: EsoGuard has a 99% negative predictive value, making it a reliable rule-out test for esophageal precancer and cancer. The test is designed to avoid unnecessary endoscopies for the majority of patients [16][20][24] 4. **Consensus on Clinical Validity**: The test performs well across various conditions, including short-segment Barrett's esophagus, which is critical as a significant portion of the target population has this condition [22][24] 5. **Unmet Screening Needs**: Only about 10% of eligible patients currently undergo screening for esophageal cancer, compared to 40-50% for colorectal cancer. Increasing this percentage could save thousands of lives annually [51][54] 6. **Patient Compliance**: EsoGuard has shown to improve patient compliance for follow-up endoscopies, with 85% of patients referred for endoscopy actually undergoing the procedure [32][33] 7. **Guidelines and Support**: Major gastroenterology societies support non-endoscopic testing like EsoGuard, which aligns with established guidelines for managing patients with precancerous conditions [36][38] 8. **Next Steps for Coverage**: The publication of a draft Local Coverage Determination (LCD) is expected, indicating a move towards Medicare coverage for EsoGuard. This is seen as a significant milestone for the company [44][46][49] Additional Important Insights 1. **Real-World Clinical Experience**: Primary care physicians and gastroenterologists shared their positive experiences with EsoGuard, emphasizing its utility in practice and the ease of incorporating it into patient care [39][40][61] 2. **Addressing Endoscopy Deserts**: The discussion highlighted the challenges faced by patients in rural areas who lack access to endoscopy services, underscoring the need for non-invasive testing options like EsoGuard [27][64] 3. **Future Opportunities**: There is potential for expanding the use of EsoGuard to asymptomatic patients, supported by ongoing research and grants [58][60] 4. **Marketing and Implementation**: The company has been actively marketing EsoGuard to primary care physicians, emphasizing its non-invasive nature and the importance of early detection in high-risk populations [59][61] This summary encapsulates the key discussions and insights from the Lucid Diagnostics conference call, focusing on the company's strategic direction, clinical evidence, and the potential impact of EsoGuard in the medical diagnostics landscape.