Core Insights - The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include non-endoscopic biomarker testing, such as Lucid's EsoGuard Esophageal DNA Test, as an acceptable alternative to invasive endoscopy for detecting esophageal precancer [1][2] Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company focused on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [3] - The EsoGuard Esophageal DNA Test is designed for early detection of esophageal precancer in at-risk patients and is performed using the EsoCheck Esophageal Cell Collection Device, which allows for a noninvasive office procedure [3] Industry Impact - The alignment of NCCN Guidelines with multiple gastroenterology society guidelines on Barrett's Esophagus (BE) screening is expected to positively influence commercial insurance policy coverage decisions, thereby expanding access to EsoGuard testing [2]

Financial Data and Key Metrics Changes - Net revenue for Q4 2024 was $24,000, down from $41,000 in Q4 2023 [32] - Total operating expenses for Q4 were $9.4 million, up 6% from $8.9 million in the same period last year [32] - Net loss for the quarter was $8.6 million compared to $7.9 million for the same period a year ago [32] - Cash, cash equivalents, and available-for-sale securities as of December 31, 2024, were approximately $68.2 million [33] Business Line Data and Key Metrics Changes - Research and development expenses decreased to $3.1 million from $3.9 million in Q4 2023, primarily due to reduced expenses related to the PRIME study [32] - Selling, general, and administrative expenses increased to $6.3 million from $5.0 million in Q4 2023, driven by spending on commercial activities [32] Market Data and Key Metrics Changes - The U.S. received a D+ grade from the March of Dimes for high preterm birth rates, indicating a significant market need for solutions [22] - Medicaid covers approximately 43% of births in the U.S., representing a substantial opportunity for the company to reduce costs for public health agencies [24] Company Strategy and Development Direction - The company aims to leverage the results of the PRIME study to drive awareness and adoption of its PreTRM test, focusing on building its evidence portfolio and seeking reimbursement [19][20] - Plans include expanding commercial operations in the U.S. and exploring international opportunities, particularly in Europe [20][26] - The company is focused on generating real-world evidence to support the adoption of its test and treat strategy [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for Medicaid to adopt the PreTRM test more quickly due to the current focus on cost reduction and improving clinical outcomes [51] - The company anticipates a pivotal year in 2025 for engagement with key stakeholders and adoption of its test following the publication of the PRIME study [35] Other Important Information - The company raised $57.5 million through a public follow-on offering to expand its commercial operations and secure a cash runway through 2028 [34] - The company is working on two products from its pipeline, targeting launches in the second half of 2025 [76] Q&A Session Summary Question: Can you elaborate on the three tenants of your plan to get into guidelines? - Management discussed plans for publishing more information, providing real-world evidence, and driving clinical community adoption to support the PreTRM test [40][41][46] Question: What are your plans regarding Medicaid and its coverage of the test? - Management highlighted the significant opportunity with Medicaid, emphasizing the potential for cost savings and the importance of focusing on states with high preterm birth rates [48][50][52] Question: How do you view the timeline for getting into guidelines? - Management indicated that while it is difficult to predict, there is potential for updates to guidelines within the next one to three years, especially with the upcoming publication of the PRIME study [61][62] Question: What is the expected cash runway based on current operating plans? - Management stated that the cash runway extends into 2028, with operating expenses projected between $30 million to $35 million for the year [64] Question: What are the commercial investments planned for 2025? - Management outlined plans to build a sales organization, enhance medical liaison efforts, and optimize the revenue cycle to drive adoption of the PreTRM test [70][73]

Financial Data and Key Metrics Changes - Total revenue for 2024 reached a record $55.6 million, marking a 6% increase from 2023, primarily driven by ASP expansion [31][32] - Adjusted EBITDA loss narrowed to approximately $10 million, showcasing a 40% improvement over 2023 [39] - Gross margin expanded to just under 60% in 2024 compared to 56% in 2023, with Q4 gross margin at about 62% [35][36] Business Line Data and Key Metrics Changes - The average selling price (ASP) for AVISE CTD increased to $411, up $75 from 2023 and $126 since 2022 [32][8] - Testing volume for 2024 was 123,000 AVISE CTD units, down 11% relative to 2023 [136] Market Data and Key Metrics Changes - The company anticipates a significant market opportunity in rheumatoid arthritis (RA), estimating an annual rate of connective tissue disease evaluations at around 2.5 million tests, with a conservative penetration estimate of about 5% [104] Company Strategy and Development Direction - The company is focused on enhancing its value proposition in the RA market with the launch of new biomarkers, which are expected to broaden the utility for clinicians [79][81] - Plans to expand sales territories from 40 to potentially mid-40s during 2025 to drive profitable growth [127] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, expecting strong revenue growth driven by both ASP expansion and volume [24] - The company aims to achieve positive adjusted EBITDA by Q4 2025, marking a key milestone in its turnaround strategy [40] Other Important Information - The company has made significant investments in capacity and technology to meet expected demand, including a $1.2 million investment in flow cytometry equipment [70] - The launch of new biomarkers is seen as a catalyst for both patient care and competitive differentiation in the market [20][22] Q&A Session Summary Question: Can you help us think about modeling for ASP going forward based on the new markers? - Management indicated that while they cannot provide precise guidance for 2025, the $90 incremental revenue from new markers is a reasonable approximation, with potential for ASP to trend upwards [48][49] Question: What is the adjusted EBITDA profitability target for Q4? - Management confirmed that adjusted EBITDA is a good proxy for free cash flow, with expectations for positive adjusted EBITDA in Q4 2025 [54] Question: What is the sensitivity improvement from the RA33 launch? - The new T cell biomarkers improve sensitivity for lupus diagnosis, capturing roughly 51% of previously undiagnosed patients, while RA markers are expected to capture 15-16% of seronegative patients [65][68] Question: How does the company plan to recover lost volume from physicians? - Management believes the business is recoverable and is focused on optimizing processes to facilitate smoother interactions with physicians [94] Question: What is the opportunity for the test to penetrate the RA market? - The company estimates the RA market opportunity at around 2.5 million tests annually, with a conservative penetration estimate of about 5% [104] Question: How will the company balance volume growth with profitability? - Management expects to see volume growth improve in 2025, with plans for sales expansion and a focus on enhancing the quality of the sales team [111][113]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [5] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Recent Offering - Lucid Diagnostics announced subscription agreements to sell 13,939,331 shares of common stock at a price of $1.10 per share, expecting gross proceeds of approximately $15.3 million [1]. - The offering is being managed by Canaccord Genuity as the sole placement agent, with the closing expected around March 5, 2025, subject to customary conditions [2]. Use of Proceeds - The net proceeds from the offering will be used for working capital and other general corporate purposes [2]. Regulatory Information - The securities are being offered under a registration statement on Form S-3, which was declared effective by the SEC on December 6, 2022 [3]. - A prospectus supplement will be filed with the SEC regarding the securities being offered [3]. Product Information - Lucid's EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer in at-risk patients, utilizing a noninvasive office procedure with the EsoCheck® Esophageal Cell Collection Device [5].

Financial Data and Key Metrics Changes - In Q4 2024, revenue totaled $119 million, representing a 21% year-over-year growth, while full-year revenue reached $446 million, reflecting a robust 23% year-over-year growth [9][32] - Testing revenue, which constitutes nearly 95% of the business, grew by 28% year-over-year [9] - The adjusted EBITDA margin for the full year was 20.6%, with cash generation exceeding $70 million [10][38] Business Line Data and Key Metrics Changes - Decipher testing revenue grew 44% year-over-year in Q4, with volume growth of 36% for the full year [10][33] - Afirma testing revenue increased by 4% year-over-year in Q4, with volume growth of 8% [16][33] - Prosigna revenue decreased by 18% year-over-year due to supply and manufacturing challenges [34] Market Data and Key Metrics Changes - The prostate cancer market is estimated to be approximately 40% penetrated, with the company holding over 65% market share, which increased by more than 500 basis points in 2024 [13] - The endocrinology market is about 65% penetrated, with growth projected in the low-single-digits [19] Company Strategy and Development Direction - The company aims for at least 80% market penetration across all indications, with Decipher being the only gene expression test recommended by the NCCN for personalized treatment decisions in prostate cancer [14] - The company is focusing on international expansion and launching tests as IVDs to meet patient needs outside the U.S. [25] - The NIGHTINGALE study for nasal swab testing has enrolled over 85% of the targeted 2,400 patients, with plans to demonstrate clinical utility [21][98] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of Decipher and Afirma, emphasizing the strong market opportunities and the importance of clinical evidence [55][92] - The company is navigating challenges related to its French subsidiary, which may impact timelines and operations [26][27] - Guidance for 2025 includes testing revenue of $470 million to $480 million, reflecting 12% to 15% year-over-year growth [42] Other Important Information - The company recorded a GAAP net income of $5.1 million in Q4 2024, with a significant tax benefit resulting in a negative effective tax rate [37][39] - The company is considering ceasing funding for its French operations, which may lead to bankruptcy proceedings if a buyer is not found [26][27] Q&A Session Summary Question: How does the company balance investment and margin improvement? - Management highlighted the importance of focusing on core products and long-term growth drivers while managing costs effectively [49][55] Question: What is the expected contribution of Afirma revenue growth? - The guidance for Afirma includes high-single-digit growth, primarily driven by volume rather than pricing [50][59] Question: Can you provide insights on metastatic revenue guidance? - Management indicated that the metastatic indication will have a more significant impact in the second half of the year, with a focus on proper launch and customer education [62][65] Question: What factors are contributing to Decipher's volume growth? - The NCCN guidelines and strong clinical evidence are key contributors to Decipher's growth, with ongoing efforts to generate more evidence [74][80] Question: What is the status of Prosigna and biopharma products? - Management clarified that Prosigna will continue, but its future is dependent on the outcome of the French entity's situation [83][86] Question: What are the potential upside levers for Decipher in 2025? - The company sees significant market opportunity with 60% of the market still unpenetrated, aiming for increased utilization and expansion into new accounts [91][92]