Lucid Diagnostics(LUCD)

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Lucid Diagnostics(LUCD) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:32
Financial Data and Key Metrics Changes - The company reported revenue of $800,000 for the first quarter, which fell short of expectations due to external headwinds and a greater concentration of testing through healthcare events [8][27] - The cash balance at the end of the first quarter was $25.2 million, which does not include the net proceeds from a recent public offering that raised approximately $16.1 million, bringing pro forma cash to over $41 million [23][11] - The non-GAAP net loss for the first quarter was $11.2 million, slightly higher than the trailing average of $10.8 million, with a non-GAAP net loss per share of $0.16 [29][28] Business Line Data and Key Metrics Changes - The company performed 3,034 EsoGuard tests in the first quarter, exceeding the target range of 2,500 to 3,000 tests [7] - The company doubled the number of contracts in its concierge medicine program and employer contracts in the first quarter [9][10] - The average allowable amount per test from adjudicated claims was approximately $13.62, with a median at the Medicare rate of $19.38 [32] Market Data and Key Metrics Changes - The company is experiencing delays in cash collections primarily from United Healthcare due to a national issue with a new claims processing system [27] - The percentage of Medicare volume is currently estimated at 10-15%, with a goal to increase this to 40% once Medicare coverage is secured [60][61] Company Strategy and Development Direction - The company is focused on driving commercialization of EsoGuard and enhancing long-term shareholder value, with a strong emphasis on securing Medicare coverage [5][6] - The company is actively engaging with regional commercial insurers to secure EsoGuard coverage and has seen positive developments with Highmark Blue Cross Blue Shield of New York [14][15] - The company is also targeting cash pay and contracted programs with concierge medicine practices and employers to diversify revenue streams [10][81] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the imminent Medicare coverage decision and believes it will significantly enhance commercialization efforts [38][40] - The company is preparing for a potential increase in test volumes and revenue once Medicare coverage is secured, while also managing cash burn effectively [70][82] - Management highlighted the importance of ongoing clinical studies to support expanded indications for EsoGuard, particularly in asymptomatic patients [44][46] Other Important Information - The company has secured a significant NIH grant for a larger study to replicate initial positive findings regarding EsoGuard's effectiveness in patients without GERD symptoms [46] - The company is actively involved in legislative efforts to promote biomarker testing coverage, although it acknowledges the challenges in translating state mandates into payer reimbursements [84][85] Q&A Session Summary Question: Impact of weather on Q1 volumes - Management indicated that there was no evidence that weather impacted volumes, noting a shift towards larger testing events which can create lumpier revenue [35][36] Question: Status of Medicare coverage discussions - Management confirmed ongoing engagement with the Medicare group and expressed confidence in the upcoming decision based on previous discussions [38][39] Question: Future studies related to EsoGuard - Management stated that additional data from the NIH study will be crucial for expanding clinical indications and market opportunities [41][46] Question: Trends in Medicare mix - Management noted that the current Medicare volume is lower than desired but plans to increase this significantly post-approval [60][61] Question: Marketing strategies for concierge medicine - Management explained that they are optimizing patient-facing materials and processes to effectively market EsoGuard within concierge practices [72][73] Question: Legislative efforts for biomarker testing - Management is actively engaged in legislative efforts to promote biomarker testing coverage but does not expect it to be a complete solution [84][85]
Lucid Diagnostics(LUCD) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:30
Financial Data and Key Metrics Changes - The company reported revenue of $800,000 for Q1 2025, which fell short of expectations due to external headwinds and a greater concentration of testing through healthcare events [8][28] - The cash balance at the end of Q1 was $25.2 million, which does not include the net proceeds from a recent public offering that added approximately $16.1 million, bringing pro forma cash to over $41 million [11][23] - The non-GAAP net loss for Q1 was $11.2 million, slightly higher than the trailing average, with a non-GAAP net loss per share of $0.16 [30] Business Line Data and Key Metrics Changes - The company performed 3,034 EsoGuard tests in Q1, exceeding the target range of 2,500 to 3,000 tests [7] - The company doubled the number of contracts in its concierge medicine program and employer contracts in the first quarter [9][10] - The quarterly test mix included larger testing events, which are more efficient but can lead to lumpier revenue recognition [37] Market Data and Key Metrics Changes - The company is experiencing delays in cash collections from United Healthcare due to a national issue with a new claims processing system, affecting revenue recognition [28] - Approximately 10-15% of the test volume is currently Medicare-related, with plans to increase this to 40% post-Medicare approval [60] Company Strategy and Development Direction - The company is focused on expanding its commercial efforts through concierge medicine and employer contracts while awaiting Medicare coverage [6][10] - The recent NCI-sponsored study showed EsoGuard's effectiveness in detecting esophageal precancer in patients without GERD symptoms, potentially expanding the target market by 70% [12][45] - The company is actively engaging with regional commercial insurers to secure EsoGuard coverage and has seen positive developments with Highmark Blue Cross Blue Shield [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about securing Medicare coverage soon, which is expected to accelerate commercialization efforts [19][41] - The company is well-positioned financially to navigate any delays in Medicare coverage due to recent capital raises [70] - There is a growing understanding in the GI community regarding the importance of screening asymptomatic patients, which could lead to expanded market opportunities [44][45] Other Important Information - The company has a robust pipeline of regional plans and is leveraging new clinical guidelines to drive positive policy coverage decisions [16][17] - The company is preparing for a comprehensive EsoGuard testing program in partnership with a major health system, which includes a concierge medicine component [9][63] Q&A Session Summary Question: Impact of weather on Q1 volumes and expectations for Q2 - Management indicated that weather was not a factor in Q1 volumes and expects to maintain similar volume levels until broader coverage is achieved [36] Question: Status of Medicare coverage discussions - Management confirmed ongoing discussions with the Palmetto GBA group and expressed confidence in the imminent decision regarding Medicare coverage [38][41] Question: Future studies and data investment for EsoGuard - Management highlighted the importance of the ongoing NIH study to replicate initial findings and support expanded indications for EsoGuard [42][48] Question: Trends in Medicare mix and expectations - The current Medicare volume is around 10-15%, with plans to increase this significantly post-approval [60] Question: Visibility for large testing events for the rest of the year - The company has a strong pipeline for large testing events, primarily driven by fire departments and self-insured employers [96]
Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Results
2025-05-14 12:20
Exhibit 99.1 Lucid Diagnostics Provides Business Update and Reports First Quarter 2025 Financial Results Processed 3,034 EsoGuard tests and recognized revenue of $0.8 million in 1Q25 Secured capital to extend runway well past key upcoming reimbursement milestones; ended 1Q25 with over $40 million in proforma cash Conference call and webcast to be held today, May 14, at 8:30 AM EDT NEW YORK, May 14, 2025 - Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention ...
Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Report
2025-05-13 20:58
Financial Performance - Revenue for the three months ended March 31, 2025, was $0.8 million, a decrease of 20% compared to $1.0 million for the same period in 2024[141] - Cost of revenue for the three months ended March 31, 2025, was approximately $1.6 million, down from $1.7 million in the prior year, reflecting a decrease of about 5.88%[142] - Sales and marketing expenses for the three months ended March 31, 2025, were approximately $4.1 million, a slight decrease of 2.38% from $4.2 million in the same period last year[142] - General and administrative expenses increased to approximately $6.2 million for the three months ended March 31, 2025, compared to $4.1 million in the same period of the prior year, reflecting a net increase of $2.1 million[143] - Research and development costs decreased to approximately $1.4 million for the three months ended March 31, 2025, down from $1.5 million in the prior year, primarily due to a $0.3 million decrease in manufacturing costs related to EsoCheck devices[144] - The amortization of acquired intangible assets was approximately $0.1 million for the three months ended March 31, 2025, compared to $0.4 million in the prior year, a decrease of $0.3 million due to certain assets being fully amortized[146] - The company experienced a net loss of approximately $26.9 million and used approximately $12.5 million of cash in operations during the quarter ended March 31, 2025[152] - Cash on hand at the end of the quarter was $25.2 million as of March 31, 2025[152] Funding and Capital Raising - The Company closed on the sale of 14,375,000 shares at $1.20 per share in April 2025, resulting in net proceeds of approximately $16.1 million for working capital[122] - The company closed on the sale of 13,939,331 shares of common stock at $1.10 per share on March 5, 2025, resulting in net proceeds of approximately $14.9 million[156] - On April 11, 2025, the company sold 14,375,000 shares of common stock at $1.20 per share, generating net proceeds of approximately $16.1 million[157] - The company raised gross proceeds of $21.975 million from the sale of 12.0% Senior Secured Convertible Notes due 2029 on November 22, 2024, with net proceeds of $18.3 million after repaying the March 2023 Senior Convertible Note[160] - The company has entered into a committed equity facility allowing for the purchase of up to $50 million of common stock, with $1.8 million raised as of March 31, 2025[158] Product Development and Research - The EsoGuard Esophageal DNA Test has 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%[119] - The Company plans to incur research and development expenses for the foreseeable future to support the development of existing products and new innovations[136] - An $8 million NIH grant was awarded for a five-year clinical study evaluating EsoCheck and EsoGuard for esophageal precancer detection among at-risk individuals without GERD symptoms[128] - EsoCheck is an FDA 510(k) and CE Mark cleared device that allows for non-invasive sampling of surface esophageal cells in a less than five-minute office procedure[120] Regulatory and Coverage Updates - A recent update to the NCCN Clinical Practice Guidelines now includes a section on Barrett's Esophagus (BE) screening, recommending non-endoscopic biomarker testing like EsoGuard as an alternative to invasive procedures[125] - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York, covering patients meeting established criteria for esophageal precancer testing[127] Accounting and Compliance - The company's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts[164] - There have been no material changes to the company's critical accounting estimates in the three months ended March 31, 2025[164] - As of March 31, 2025, the company had a payment obligation liability of $0.0 million, indicating no accrued obligations under the payroll and benefit expense reimbursement agreement or other operating expenses[163] Strategic Focus - The company is focused on the commercialization of EsoGuard and expanding insurance reimbursement coverage while developing additional products and services[150]
Will Lucid Diagnostics Inc. (LUCD) Report Negative Earnings Next Week? What You Should Know
ZACKS· 2025-05-07 15:05
Company Overview - Lucid Diagnostics Inc. (LUCD) is expected to report a quarterly loss of $0.09 per share, reflecting a year-over-year improvement of +57.1% [3] - Revenues for the upcoming quarter are anticipated to be $1.3 million, which is a 30% increase from the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 40% higher in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for Lucid Diagnostics aligns with the Zacks Consensus Estimate, resulting in an Earnings ESP of 0% [10][11] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likelihood of actual earnings deviating from consensus estimates, with a strong predictive power for positive readings [7][8] - Lucid Diagnostics currently holds a Zacks Rank of 2 (Buy), but this combination does not strongly indicate an earnings beat [11] Historical Performance - In the last reported quarter, Lucid Diagnostics was expected to post a loss of $0.15 per share but actually reported a loss of $0.19, resulting in a surprise of -26.67% [12] - The company has not beaten consensus EPS estimates in any of the last four quarters [13] Market Context - The upcoming earnings report for Lucid Diagnostics is scheduled for May 14, and the stock's movement will depend on whether the actual results exceed or fall short of expectations [2] - Other factors beyond earnings results may also influence stock performance, as stocks can decline despite an earnings beat or rise despite a miss [14][16]
Lucid Diagnostics to Hold a Business Update Conference Call and Webcast on May 14, 2025
Prnewswire· 2025-04-30 12:31
Core Points - Lucid Diagnostics Inc. will host a business update conference call and webcast on May 14, 2025, at 8:30 AM ET to discuss company operations and growth strategy [1] - The call will feature Lishan Aklog, M.D., the CEO, and Dennis McGrath, the CFO, who will present the first quarter 2025 financial results [1] - The conference call can be accessed via telephone or through the company's investor relations website [2] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [4] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [4] - Lucid's EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device are the first commercially available tools aimed at early detection of esophageal precancer [4]
NCI-Sponsored Study Shows Positive Data for Lucid Diagnostics' EsoGuard® Esophageal DNA Test in Patients Without Symptomatic GERD
Prnewswire· 2025-04-24 12:01
Core Insights - Lucid Diagnostics Inc. announced positive data from a National Cancer Institute-sponsored study showing that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer in at-risk patients without GERD symptoms, potentially expanding the target population and market opportunity [1][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 developing esophageal precancer and cancer [4] Study Findings - The study enrolled patients without GERD symptoms who met AGA recommendations for Barrett's Esophagus (BE) screening, demonstrating a 100% negative predictive value for detecting esophageal precancer [2] - The prevalence of BE in the study was found to be 8.4%, comparable to rates in symptomatic GERD patients [2] Market Opportunity - If the ongoing multicenter NIH-sponsored study replicates the promising results, the market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70%, potentially reaching a total of approximately $60 billion [3]
NCI-Sponsored Study Shows Positive Data for Lucid Diagnostics' EsoGuard® Esophageal DNA Test in Patients Without Symptomatic GERD
Prnewswire· 2025-04-24 12:01
Core Insights - Lucid Diagnostics Inc. announced positive data from a National Cancer Institute-sponsored study showing that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer in at-risk patients without GERD symptoms, potentially expanding its market opportunity [1][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 developing esophageal precancer and cancer [4] Study Findings - The study enrolled patients without GERD symptoms who met AGA recommendations for Barrett's Esophagus (BE) screening, demonstrating a 100% negative predictive value (NPV) for detecting esophageal precancer [2] - The prevalence of Barrett's Esophagus in the study was found to be 8.4%, comparable to rates in symptomatic GERD patients [2] Market Opportunity - If the ongoing multicenter NIH-sponsored study replicates the promising results, the market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70%, potentially reaching a total of approximately $60 billion [3]
Lucid Diagnostics Announces Pricing of Public Offering of Common Stock
Prnewswire· 2025-04-09 23:24
Core Viewpoint - Lucid Diagnostics Inc. has announced a public offering of 12,500,000 shares at a price of $1.20 per share, aiming to raise approximately $15 million for working capital and general corporate purposes [1][2]. Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [6]. Offering Details - The offering includes a 45-day option for underwriters to purchase an additional 1,875,000 shares at the public offering price [1]. - The gross proceeds from the offering are expected to be around $15 million, excluding any proceeds from the underwriters' option [2]. - The offering is expected to close on or about April 11, 2025, subject to customary closing conditions [2]. Underwriters - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [3]. Regulatory Information - The offering is made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022 [4]. - A prospectus supplement will be filed with the SEC, and the securities may only be offered by means of a written prospectus [4].
Lucid Diagnostics Announces Proposed Public Offering of Common Stock
Prnewswire· 2025-04-09 20:01
Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Offering Details - Lucid Diagnostics announced its intention to offer shares of common stock through an underwritten public offering, with plans to grant underwriters a 45-day option to purchase additional shares. Proceeds from the offering are expected to support working capital and general corporate purposes [1]. - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [2]. Regulatory Information - The offering is being made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022. A prospectus supplement will be filed with the SEC [3].