PAVmed (NasdaqCM:PAVM) Q3 2025 Earnings Call November 13, 2025 08:30 AM ET Company ParticipantsMatt Riley - Senior Director of Investor RelationsDennis McGrath - CFOLishan Aklog - Chairman and CEOConference Call ParticipantsAnthony Vendetti - AnalystOperatorGood morning and welcome to the PAVmed Lishan Aklog, 2025 Business Update conference call. At this time, all lines are in listen-only mode, and following the presentation, we will conduct a question-and-answer session. If at any time during this call you ...

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $6 million for the third quarter, which includes a non-cash loss of $4.4 million due to changes in the fair value of equity investments [23][24] - Non-GAAP loss for the quarter was $446,000, primarily reflecting incremental contractor development costs for the Veris implantable device [24][25] - Cash burn rate for the third quarter was $900,000, which included approximately $500,000 in outside contractor development costs for Veris [20][24] Business Line Data and Key Metrics Changes - Lucid's revenue for the quarter was $1.2 million, with test volume exceeding 2,800, consistent with the target range of 2,500-3,000 tests [10][11] - Veris launched the commercial phase of its strategic partnership with OSU, targeting 1,000 patients in the first year for enrollment in a registry [12][14] Market Data and Key Metrics Changes - The Medicare contractor meeting in September was successful, with experts endorsing Medicare coverage for EsoGuard, marking a significant milestone for Lucid [10][11] - PAVmed remains the largest shareholder of Lucid, owning approximately 23% of the common shares outstanding, although it no longer has voting control [21] Company Strategy and Development Direction - The company aims to stabilize its corporate structure and balance sheet, with plans to operate as a diversified commercial life sciences company with multiple independently financed subsidiaries [5][6] - PAVmed is pursuing additional technologies, including a partnership with Duke University for an endoscopic imaging technology for esophageal precancer [8][46] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's positioning to capitalize on Lucid's market opportunities and the potential for Medicare coverage [9][10] - The company is focused on expanding its commercial offerings and enhancing its value proposition through clinical support services and AI-based clinical decision tools [17][43] Other Important Information - The company has restructured its debt, exchanging about 80% of its outstanding debt for new Series C preferred equity [19] - The development of the Veris implantable device is progressing well, with a clear regulatory pathway established for FDA submission [34][38] Q&A Session Summary Question: Status of the implantable monitor development - Management confirmed that the development work has relaunched with a new manufacturing partner and that the clinical requirements for FDA submission are modest [33][34] Question: Timing for commercialization conversations with other cancer centers - Management indicated that they plan to start expanding commercial activities to other centers in the first quarter after gaining experience with OSU [40][41] Question: Exclusivity and timing of the endoscopic imaging technology agreement - Management stated that a definitive license agreement is expected soon, and the technology will be developed within a separate subsidiary of PAVmed [45][46]

Financial Data and Key Metrics Changes - The company reported a GAAP net loss of $6 million for the third quarter, which includes a non-cash loss of $4.4 million due to changes in the fair value of equity investments [23][24] - Non-GAAP loss for the quarter was $446,000, primarily reflecting incremental contractor development costs for the Veris implantable device [23][24] - Cash burn rate for the third quarter was $900,000, which included approximately $500,000 in outside contractor development costs for the implantable device [20][24] Business Line Data and Key Metrics Changes - Lucid's revenue for the quarter was $1.2 million, with test volume exceeding 2,800, consistent with the target range of 2,500-3,000 tests [9][10] - Veris launched the commercial phase of its strategic partnership with OSU, targeting 1,000 patients in the first year for enrollment in a registry [12][13] - The company has secured financing to support the development of the Veris implantable device, with a planned FDA submission in 2026 [12][13] Market Data and Key Metrics Changes - Medicare contractor meeting in September was successful, with experts endorsing Medicare coverage for EsoGuard, indicating a positive outlook for future revenue [10][11] - The company remains the largest shareholder of Lucid Diagnostics, holding approximately 23% of common shares, which reflects a significant influence despite no longer having voting control [21] Company Strategy and Development Direction - The company aims to stabilize its corporate structure and balance sheet, with ongoing efforts to build a diversified portfolio of independently financed subsidiaries [5][6] - Plans to expand the commercial offering of Veris beyond remote patient monitoring, incorporating clinical support services and AI-based clinical decision tools [17][40] - A licensing agreement for breakthrough endoscopic imaging technology is in the final stages, which will be developed under a separate subsidiary [8][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to complete restructuring efforts and reignite broader visions for innovation [27][28] - The company is optimistic about the prospects of new technologies and partnerships, including those with Duke University and UNC [8][28] Other Important Information - The company has transitioned to a new development and manufacturing partner for the implantable device, which is progressing well [32] - The regulatory strategy for the implantable device is clear, with minimal clinical data required for FDA submission [35] Q&A Session Summary Question: Status of the implantable monitor development - Management confirmed that development is progressing well with a new partner and that minimal clinical trials are required for FDA submission [31][32] Question: Commercialization conversations with other cancer centers - Management indicated that they plan to start commercialization discussions with other centers in the first quarter after initial volume at OSU [36][38] Question: Exclusivity and timing of the endoscopic imaging technology agreement - Management confirmed that a definitive license agreement is expected soon, with development work to begin immediately after signing [42][46]

2 LISHAN AKLOG, MD Chairman & CEO DENNIS MCGRATH President & CFO Disclaimer Nasdaq: PAVM Q3 2025 Business Update November 13, 2025 ▪ This presentation may contain certain forward-looking statements related to PAVmed Inc. or Lucid Diagnostics Inc. (the "Companies") that involve risks and uncertainties. ▪ Actual results and events may differ significantly from results and events discussed in forward- looking statements. ▪ Factors that might cause or contribute to such differences include, but are not limited ...

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]

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]

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].