Summary of Lucid Diagnostics Conference Call Company Overview - **Company**: Lucid Diagnostics - **Founded**: 2018 - **Technology**: Focuses on detecting precancerous conditions for esophageal cancer, which is the second most deadly cancer [3][4] Industry Context - **Esophageal Cancer**: High mortality rate; early detection is crucial for prevention [4][5] - **Target Population**: Patients with heartburn and at least three out of six risk factors (e.g., over 50, white male, obese, smoker, family history) have about a 10% chance of having precancer [6] Core Technology and Testing Method - **Testing Method**: Non-invasive molecular test using a swallowable balloon capsule to collect samples from the lower esophagus [7][8] - **Performance Metrics**: - 99% negative predictive value [9] - 80% of patients can avoid invasive tests [10] - Approximately 40,000 tests performed to date [11] Financial and Coverage Insights - **Medicare Payment**: Established at $19.38 in 2021; ongoing efforts to secure coverage from Medicare and commercial payers [12] - **Current Testing Volume**: Approximately 2,756 tests in the latest quarter, a decrease from previous quarters due to waiting for coverage [14][15] - **Claim Denials**: About 83% of claims were denied in the quarter, primarily due to lack of medical policy coverage [20][21] Strategic Focus - **Coverage Strategy**: Engaging with payers to secure coverage; significant focus on building a clinical evidence package [12][19] - **Regional Plans**: Increased engagement with regional commercial plans, which are more willing to discuss coverage [24] - **Health System Partnerships**: Long-term partnerships with health systems to integrate testing into broader cancer prevention programs [25][26] Future Outlook - **Medicare Coverage Anticipation**: Expecting to secure Medicare coverage soon, which will allow for increased test volume and revenue growth [30][72] - **Market Opportunity**: Approximately 30 million patients recommended for screening, with 40-50% being Medicare age [30] - **Revenue Growth**: Anticipated solid revenue growth next year, with plans to ramp up operations post-Medicare approval [70][72] Competitive Landscape - **Comparison with Other Tests**: Lucid's test is positioned as more effective than sponge-based devices and blood tests for detecting precancerous conditions [82][88] - **Partnership Potential**: Opportunities for collaboration with other companies in the space to enhance market reach [81] Conclusion - **Growth Potential**: Lucid Diagnostics is poised for significant growth with the anticipated Medicare coverage and increasing commercial payer engagement, targeting a substantial market opportunity in esophageal cancer prevention [90][91]

Financial Performance - PAVmed's Q1 2025 revenue and management fee income was $3158 thousand, a decrease of $352 thousand compared to $3510 thousand in Q1 2024[23] - The company's operating expenses decreased significantly from $15046 thousand in Q1 2024 to $5454 thousand in Q1 2025, a reduction of $9592 thousand[23] - Net income for Q1 2025 was $18623 thousand, a substantial improvement of $37135 thousand compared to a loss of $18512 thousand in Q1 2024[23] - PAVmed reported an EBITDA of $19007 thousand in Q1 2025, compared to a negative EBITDA of $14813 thousand in Q1 2024, an increase of $33820 thousand[23] - Non-GAAP adjusted loss improved by $7705 thousand, from a loss of $8615 thousand in Q1 2024 to a loss of $910 thousand in Q1 2025[23] - Non-GAAP adjusted loss per share improved from $(099) in Q1 2024 to $(007) in Q1 2025, an increase of $092[23] Balance Sheet - PAVmed's cash position increased by $1515 thousand, from $1185 thousand in 4Q24 to $2700 thousand in 1Q25[22] - Equity method investments in Lucid increased by $21004 thousand, from $25637 thousand in 4Q24 to $46641 thousand in 1Q25[22] - Senior secured convertible notes decreased by $22500 thousand, from $29100 thousand in 4Q24 to $6600 thousand in 1Q25[22] - Preferred shares outstanding were 24480 thousand in 1Q25[22] - Shares outstanding increased from 112 million to 168 million, an increase of 56 million shares[22] Business Updates - Lucid Diagnostics' EsoGuard revenue for Q1 2025 was $08 million, with a test volume of 3034[17] - PAVmed strengthened its balance sheet by netting approximately $161 million in proceeds from an underwritten public offering of common stock[17]

Financial Data and Key Metrics Changes - The company reported a revenue of $800,000 for the last quarter, with a test volume of 3,034, which is at the upper end of the target range of 2,500 to 3,000 tests per quarter [9] - A significant balance sheet improvement was noted with a public offering netting $16,100,000, resulting in a pro forma cash position of $40,000,000 at the end of Q1, extending the runway well into 2026 [10] - The company achieved a large GAAP net income of $18,600,000 before non-controlling interest and preferred dividends, resulting in a positive primary EPS of $1.28 and a positive diluted EPS of $0.34 [22][23] Business Line Data and Key Metrics Changes - Lucid, the diagnostic subsidiary, is positioned to capitalize on a large clinical and market opportunity, with ongoing efforts to secure Medicare coverage [6][11] - Verus has restarted the development of a key implantable physiologic monitor, with favorable engagement from the FDA and a targeted filing for the first half of 2026 [12] - The incubator PMX is focusing on the PortIO implantable intraosseous device, with discussions ongoing with potential strategic partners [13] Market Data and Key Metrics Changes - The company is seeing momentum in new sales channels, particularly in concierge medicine and employer market contracts, which are expected to impact revenue in the second half of the year [10][11] - The company has a significant equity method investment balance of almost $47,000,000 reflecting a gain of $21,000,000 since year-end, representing an 82% increase in Lucid's stock price [18][19] Company Strategy and Development Direction - The company aims to diversify into the biopharma space, leveraging its infrastructure and management services model to pursue attractive biopharma assets [8][36] - The strategic vision includes expanding partnerships and exploring new opportunities while maintaining focus on existing subsidiaries like Lucid and Verus [53][54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning and ability to execute on strategic initiatives, highlighting the strong relationships with key cancer centers and the positive feedback from pilot programs [30][31] - The management team believes that the current market conditions will not hinder their ability to raise capital, citing successful recent financings [46][48] Other Important Information - The company has deconsolidated Lucid from its financial statements, which has impacted the historical understanding of its financials [16][21] - The company continues to explore additional assets and opportunities to diversify its portfolio, with a focus on maintaining operational independence among its subsidiaries [8][40] Q&A Session Summary Question: Feedback from the pilot program - Management received excellent feedback from the pilot program, meeting all pre-specified performance metrics and demonstrating clinical success [29][30] Question: Exclusive rights to the platform - There are no exclusive rights limiting broader commercialization; the agreement allows for a registry and initial implantable procedures at the cancer center [32][33] Question: Strategic rationale for biopharma expansion - The company is leveraging its infrastructure and management services to pursue biopharma opportunities, which align with its history of adapting to market needs [36][39] Question: Impact of market volatility on capital raising - Management indicated that market volatility has not affected their ability to raise capital, with successful recent financings demonstrating investor confidence [46][48]

Financial Data and Key Metrics Changes - The company reported a net income of $18.6 million for the first quarter, resulting in a positive primary EPS of $1.28 and a positive diluted EPS of $0.34 [23][24]. - A significant liability reduction of approximately $25 million was achieved, primarily from a reduction in convertible notes and accrued expenses [19][20]. - The company ended the quarter with $40 million in pro forma cash, extending its runway well into 2026 [11]. Business Line Data and Key Metrics Changes - Lucid, the company's diagnostic subsidiary, reported revenue of $800,000 with a test volume of 3,034, meeting the target range [10]. - Verus has restarted the development of a key implantable physiologic monitor after securing financing [12][14]. - The incubator PMX is focused on advancing technologies, particularly the PortIO device, with ongoing discussions with strategic partners [8][14]. Market Data and Key Metrics Changes - The company is seeing momentum in new sales channels, particularly in concierge medicine and employer market contracts, which are expected to impact revenue in the second half of the year [11][12]. - The company is awaiting a response from the MolDX program regarding Medicare coverage for EsoGuard, which is anticipated to be imminent [12]. Company Strategy and Development Direction - The company aims to diversify into the biopharma space, leveraging its infrastructure and management services model to capitalize on early-stage assets in oncology and cardiometabolic areas [9][39]. - The strategic focus includes expanding partnerships and exploring new assets that fit within the shared services model [10][39]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's positioning and ability to execute its strategic vision, highlighting the potential value creation from Lucid and Verus [51][52]. - The company is optimistic about leveraging its model and infrastructure to pursue significant opportunities in the near future [52][53]. Other Important Information - The company has deconsolidated Lucid from its financial statements, which will affect year-over-year comparisons in the upcoming quarters [16][22]. - PAVmed remains the largest shareholder of Lucid, holding approximately 29% of the common shares outstanding [20]. Q&A Session Summary Question: Feedback from the pilot program - Management received excellent feedback from the pilot program, with all pre-specified performance metrics met and enthusiasm from academic medical centers [31][32]. Question: Exclusive rights to the platform - There are local rights for advancing the platform, but no exclusivity that limits broader commercialization efforts [34][35]. Question: Rationale for expanding into biopharma - The company is leveraging its adjusted corporate structure and management services to explore opportunities in biopharma, particularly in early-stage assets that require clinical research [39][40]. Question: Impact of market volatility on capital raising - Management indicated that market volatility has not significantly affected their ability to raise capital, with successful financing in the first quarter [47][48].

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]

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 - Lucid Diagnostics的EsoGuard在2024年第四季度的收入为120万美元[12]，测试量为4042，环比增长45%[12] - Highmark Blue Cross Blue Shield in New York 建立了EsoGuard的积极商业保险覆盖政策[12] - NCCN临床实践指南更新，包括食管癌前病变筛查，与ACG等专业协会指南保持一致[12] Veris Health - 完成了一项私募融资，总收益约为240万美元[16]，Veris普通股的定价为3500万美元的税前估值[16] - 与俄亥俄州立大学詹姆斯癌症医院的试点项目延长至2025年4月[16] Financial Performance - 截至2024年第四季度末，公司持有的现金为118.5万美元[21]，高于第三季度的76.5万美元[21]，增加了42万美元[21] - 2024年第四季度的收入为1万美元[23]，低于2023年第四季度的104.9万美元[23]，减少了103.9万美元[23] - 2024年第四季度的运营费用为519.8万美元[23]，低于2023年第四季度的1743.3万美元[23]，减少了1223.5万美元[23] - 2024年第四季度的净利润为114.2万美元[23]，而2023年第四季度的净亏损为1740.8万美元[23]，增加了1855万美元[23]

Financial Data and Key Metrics Changes - The company generated $1,200,000 in revenue for the fourth quarter, reflecting a 15% increase compared to the same quarter last year [27][28] - Test volume exceeded 4,000 tests in the fourth quarter, representing a record quarterly test volume [7][28] - The quarterly burn rate was $10,100,000, lower than the average burn rate of $11,000,000 for the preceding four quarters [25] Business Line Data and Key Metrics Changes - The EsoGuard sales channels have seen significant advancements, with a focus on expanding coverage and reimbursement [6][9] - The concierge medicine cash pay program has signed 20 contracts within a few weeks of launch, indicating strong initial traction [8][20] Market Data and Key Metrics Changes - The company has submitted claims to 400 payers, with ongoing conversations with numerous commercial payers [94] - The NCCN guidelines now include a section on screening for esophageal precancer, which is expected to influence positive policy coverage decisions from commercial payers [10][70] Company Strategy and Development Direction - The company is focused on driving revenue through expanded sales channels, including direct contracting with employers and concierge medicine [14][19] - The recent positive insurance coverage policy from Highmark Blue Cross Blue Shield is seen as a precedent for future engagements with commercial payers [9][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for significant growth in test volume and revenue in the second half of the year, particularly with the expected Medicare coverage [22][60] - The company is confident in its ability to scale operations and target the Medicare population effectively once coverage is secured [59][61] Other Important Information - The company secured an $8,000,000 NIH grant to study EsoGuard for expanded indications, which could significantly increase the total addressable market [12][48] - The balance sheet was strengthened through long-term debt refinancing and a registered direct common stock offering, extending the runway well past key reimbursement milestones [11][24] Q&A Session Summary Question: How should we think about the volume metric going forward? - Management advised to remain conservative on test volume expectations, focusing more on revenue rather than just volume [36][37] Question: Why was the effective ASP lower than expected? - The lower ASP was attributed to the timing of payments rather than a direct reflection of payment rates [42][44] Question: Can you size the opportunity from the $8,000,000 NIH grant? - The opportunity is significant, potentially adding 20 million patients to the screening recommendations [48][50] Question: What happens if Medicare coverage is secured? - The company plans to aggressively target the Medicare population and expects to submit a backlog of claims [60][86] Question: How will NCCN inclusion help the company? - Inclusion in NCCN guidelines is expected to serve as a powerful tool in discussions with commercial payers [70][72]