PAVmed (PAVM) Q4 2024 Earnings Call March 25, 2025 02:49 PM ET Company Participants Matt Riley - Director - Investor RelationsLishan Aklog - Chairman & CEODennis McGrath - President & CFOMatthew Park - Equity Research Associate Conference Call Participants Jeremy Pearlman - Equity AnalystEdward Woo - Director of Research & Senior Analyst Operator Good morning, and welcome to PAVmed Fourth Quarter twenty twenty four Business Update Conference Call. At this time, all lines are in a listen only mode. Following ...

Financial Data and Key Metrics Changes - PAVmed reported a GAAP net income of approximately $1.3 million or about $0.12 per common share on a diluted basis for the fourth quarter [35] - The company achieved a non-GAAP loss of $688,000, offset by NIH grant proceeds of $900,000 [33] - The deconsolidation of Lucid Diagnostics resulted in a significant net income of $28.4 million before non-controlling interest, reflecting the elimination of Lucid's cumulative historical losses [31] Business Line Data and Key Metrics Changes - Lucid Diagnostics generated $1.2 million in revenue with a test volume of over 4,000 tests, representing a 45% growth quarter-on-quarter [11] - EsoGuard revenue was approximately $1.2 million, with record test volume of 4,042 tests, exceeding the target of 2,500 to 3,000 tests per quarter [11] - PAVmed's management service income from Lucid Diagnostics was $3.2 million for the quarter, reflected in other income [34] Market Data and Key Metrics Changes - Highmark Blue Cross Blue Shield in New York established the first positive commercial insurance coverage policy for EsoGuard, indicating progress in market acceptance [12] - The National Comprehensive Cancer Network updated clinical practice guidelines to include esophageal precancer screening, which may drive positive commercial insurance coverage decisions [12] Company Strategy and Development Direction - PAVmed completed a strategic transformation to solidify its position as a diversified commercial life sciences company with independently financed subsidiaries [9] - The company is focusing on advancing the implantable physiologic monitor and regulatory clearance submission by the end of this year or early next year [16] - PAVmed is actively seeking direct financing for PortIO and engaging with angel investors and strategic partners [17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's strong position following the restructuring and the successful completion of strategic initiatives [8] - The company anticipates significant milestones that will drive shareholder value, particularly through Lucid and Veris [82] - Management highlighted the importance of the upcoming FDA clearance for the implantable device, which is expected to enhance commercial potential [16] Other Important Information - PAVmed secured a private placement financing with gross proceeds of $2.4 million at a $35 million pre-money valuation for Veris Health [14] - The company received a $1.8 million NIH grant for Veris, which will support development activities [27] Q&A Session Summary Question: What will the contract with Ohio State look like? - The contract will be a comprehensive commercial and strategic partnership, with Ohio State committing to enroll a substantial portion of patients over the first year [44] Question: What is the timeline for FDA approval of the implantable device? - The submission is expected by the end of this year or early 2026, with a clear understanding of FDA requirements [48] Question: What discussions are happening with other institutions regarding Veris? - Conversations are ongoing with about a dozen cancer centers, but the focus remains on the Ohio State engagement and implantable advancement [56] Question: Are there competing products in the market for Veris? - The competitive landscape is favorable, with Veris' platform specifically designed for cancer patients, differentiating it from generic remote patient monitoring tools [74]

Nasdaq: PAVM, PAVMZ Q4 2024 Business Update March 25, 2025 LISHAN AKLOG, MD Chairman & CEO DENNIS MCGRATH President & CFO Nasdaq: PAVM Nasdaq: LUCD Early Detection of Esophageal Precancer D I A G N O S T I C S Privately Held Digital Cancer Care Platform & Smart Vascular Access Port D I G I T A L H E A L T H Privately Held Incubator for MedTech Technologies, including PortIO, EsoCure, and CarpX M E D T E C H PMX Privately Held TBD T B D TBD Privately Held TBD T B D TBD Disclaimer ▪ This presentation may cont ...

Financial Performance - Lucid Diagnostics recognized $1.2 million in EsoGuard Esophageal DNA Test revenue for Q4 2024, with a record of 4,042 tests processed, representing a 45% sequential increase and 84% annual increase [6]. - PAVmed's management service income from Lucid Diagnostics amounted to $3.2 million post-deconsolidation, reflected in Other Income [10]. - PAVmed's operating expenses for Q4 2024 were approximately $5.2 million, including stock-based compensation expenses of $0.7 million [10]. - GAAP net income attributable to common stockholders for Q4 2024 was approximately $1.3 million, or approximately $0.12 per common share on a diluted basis [10]. - Non-GAAP adjusted loss for Q4 2024 was approximately $0.7 million, or $(0.06) per common share [10]. - PAVmed's cash and cash equivalents as of December 31, 2024, were $1.2 million, projected to be approximately $3.6 million post-private placement [10]. Market Position and Product Development - The updated NCCN Clinical Practice Guidelines now include a section on esophageal precancer screening, enhancing EsoGuard's market position [6]. - An $8 million NIH grant was awarded to study EsoGuard for expanded indications, potentially increasing the total addressable market opportunity beyond $60 billion [6]. - Lucid Diagnostics markets the EsoGuard Esophageal DNA Test and EsoCheck Esophageal Cell Collection Device, the first tools for early detection of esophageal precancer [14]. - Veris Health secured approximately $2.4 million in private placement financing to advance the implantable physiological monitor through FDA clearance and commercial launch [6]. - Veris Health is developing an implantable physiological monitor to enhance personalized cancer care through remote patient monitoring [14]. Compliance and Regulatory Matters - PAVmed regained compliance with Nasdaq minimum bid price requirement, adding approximately $25 million to equity in Q1 2025 through debt restructuring [7]. - The company emphasizes the importance of regulatory authorities' satisfaction with clinical study designs and results for product clearance [18]. Risks and Challenges - PAVmed's future operations are subject to risks including stock price volatility, regulatory approval uncertainties, and market acceptance of its products [18]. - The company may face challenges in raising additional funding as needed for product development and commercialization [18]. - PAVmed and Lucid's management holds forward-looking statements that may differ from actual results due to various uncertainties [18]. - PAVmed and Lucid disclaim any obligation to publicly update or revise forward-looking statements based on changing expectations [18]. Contact Information - For more information, investors and media can contact Matt Riley at PAVmed and Lucid Diagnostics [19].

Core Viewpoint - PAVmed Inc. has made significant strides in stabilizing its corporate structure and balance sheet, positioning itself as a diversified commercial life sciences company with independently financed subsidiaries, particularly highlighting the achievements of Lucid Diagnostics and Veris Health [4]. Financial Results - For Q4 2024, PAVmed reported revenues of approximately $10,000, a decrease from $1,049,000 in Q4 2023. The total revenue for the year ended December 31, 2024, was $2,995,000, compared to $2,452,000 in 2023 [6]. - Operating expenses for Q4 2024 were approximately $5.2 million, down from $17.4 million in Q4 2023. For the full year, operating expenses were $47.5 million, compared to $71.2 million in 2023 [6]. - The GAAP net income attributable to common stockholders for Q4 2024 was approximately $1.3 million, or $0.12 per diluted share, compared to a loss of $1.98 per share in Q4 2023 [6]. - As of December 31, 2024, PAVmed had cash and cash equivalents of $1.2 million, which is projected to increase to approximately $3.6 million after a private placement in Q1 2025 [5]. Subsidiary Performance - Lucid Diagnostics has seen rapid uptake in concierge medicine contracts and has secured its first commercial insurance coverage policies, which are expected to drive future revenue growth [1]. - Veris Health has secured financing to advance its implantable physiological monitor through FDA clearance and commercial launch, indicating progress in its product development [1]. - The performance of Lucid, particularly with its EsoGuard product, is viewed as a key driver for PAVmed's long-term success and sustainability [4]. Corporate Developments - PAVmed completed a debt restructuring and deconsolidation of Lucid to regain Nasdaq compliance and strengthen its balance sheet [1]. - The company is set to hold a conference call and webcast to discuss its business updates and financial results, indicating a commitment to transparency with investors [2][3].

Clinical Evidence and Research - EsoGuard submitted a complete clinical evidence package to secure Medicare coverage, including six new peer-reviewed publications[348]. - EsoGuard demonstrated a 2.4-fold higher diagnostic yield for Barrett's Esophagus (BE) compared to expected yield from screening EGD alone, based on a cohort of 199 EsoGuard-positive patients[350]. - EsoGuard's sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively[352]. - Lucid received an $8 million NIH grant for a five-year clinical study evaluating EsoCheck and EsoGuard among at-risk individuals without GERD symptoms[354]. - Veris was awarded a $1.8 million NIH grant to optimize the Veris Cancer Care Platform for underserved cancer patients[356]. - EsoGuard is now referenced in the NCCN Guidelines as an acceptable alternative to invasive upper endoscopy for detecting esophageal precancer[349]. - A pilot program for the Veris Cancer Care Platform has been launched in collaboration with a National Cancer Institute-Designated Comprehensive Cancer Center[360]. - Research and development efforts will focus on the Veris Cancer Care Platform and other products in the pipeline as resources permit[394]. Financial Performance - Revenue for the year ended December 31, 2024, was $3.0 million, an increase of 20% compared to $2.5 million in the prior year, primarily driven by the EsoGuard Esophageal DNA Test[399]. - Cost of revenue decreased to $4.8 million in 2024 from $6.4 million in 2023, a reduction of 25% attributed to the limited inclusion of Lucid's results post-deconsolidation[400]. - The Company experienced net income before noncontrolling interests of approximately $28.4 million in 2024, while using approximately $33.6 million of cash in operations[414]. - Financing activities provided $31.3 million of cash during the year ended December 31, 2024[414]. - The Company ended the year with cash on-hand of $1.2 million as of December 31, 2024[414]. Stock and Shareholder Activities - The Company generated gross proceeds of $2.37 million from the sale of 2,574,350 shares of common stock and pre-funded warrants[361]. - The Company received shareholder approval to increase the total number of authorized shares from 50 million to 250 million on January 15, 2025[379]. - Lucid closed on the sale of 13,939,331 shares at $1.10 per share, generating net proceeds of approximately $14.5 million for working capital[380][381]. - The company raised a total of $18.16 million from the sale of 12,495 shares of Lucid Series B Preferred Stock at $1,000 per share and the exchange of existing preferred shares[422]. - The company issued approximately 11,634 shares of Lucid Series B-1 Preferred Stock, generating gross proceeds of $11.6 million, with a conversion price of $0.7228[424]. - The company realized gross proceeds of $21.95 million from the issuance of November 2024 Senior Convertible Notes, which were used to fully repay the Lucid March 2023 Senior Convertible Note[428]. - In the year ended December 31, 2024, the company sold 1,032,298 shares through its at-the-market equity facility for net proceeds of approximately $1.3 million[429]. - Cumulatively, the company issued 680,263 shares of common stock for net proceeds of approximately $1.8 million under a committed equity facility as of December 31, 2024[430]. - The company entered into an "at-the-market offering" for up to $6.5 million of its common stock, resulting in net proceeds of approximately $0.3 million from 230,068 shares sold as of December 31, 2024[431]. - The company issued 1,084,366 shares of common stock in satisfaction of approximately $1.4 million of principal repayments and $0.1 million of interest expense in 2024[415]. Compliance and Regulatory Matters - The Company regained compliance with Nasdaq's continued listing standard, maintaining at least $2.5 million in stockholders' equity[366]. - The Company achieved compliance through the exchange of $22.3 million in secured convertible notes for Series C Preferred Stock and a reduction in operating expenses due to the deconsolidation of Lucid[368]. - As of December 31, 2024, the company was in compliance with the Financial Tests, which require available cash to equal or exceed $8.0 million and market capitalization to be no less than $75 million[420]. - The company is subject to financial covenants under the Lucid March 2023 Senior Convertible Note, requiring available cash to equal or exceed $5.0 million and market capitalization to be no less than $30 million[427]. - The company has a Debt to Market Cap Ratio Test that should not exceed 30% based on the outstanding principal amount of notes and average market capitalization[420]. Expenses and Cost Management - The Company increased the monthly management services fee to Lucid from $0.83 million to $1.05 million[359]. - The Company anticipates a decrease in sales and marketing expenses due to the deconsolidation of Lucid, which will no longer be included in its operating results[391]. - Sales and marketing expenses decreased to approximately $11.6 million in 2024 from $17.6 million in 2023, a reduction of $6.0 million[401]. - General and administrative expenses were approximately $24.5 million in 2024, down from $30.9 million in 2023, reflecting a decrease of $6.4 million[401]. - Research and development costs fell to approximately $5.9 million in 2024 compared to $14.3 million in 2023, a decrease of $8.4 million[402]. Changes in Accounting Standards - The company adopted ASU No. 2023-07 for segment reporting, effective January 1, 2024, which did not materially impact its segment-related disclosures[441]. - The FASB issued ASU No. 2023-09 in December 2023, aimed at enhancing income tax disclosures, effective for annual periods beginning after December 15, 2024[443]. - ASU 2023-09 includes changes to rate reconciliation and income taxes paid information, but the company does not expect a significant impact on its consolidated financial statements[443]. - In October 2023, the FASB issued ASU No. 2023-06, which modifies disclosure requirements in response to the SEC's Disclosure Update and Simplification Initiative[444]. - The effective date for ASU 2023-06 amendments will align with the SEC's removal of related disclosures, with a potential removal of amendments if not enacted by June 30, 2027[444]. - The company is currently evaluating the potential impact of ASU 2023-06 on its consolidated financial statements[444]. Miscellaneous - The change in fair value of convertible debt resulted in approximately $0.5 million of income in 2024, compared to $6.0 million of expense in 2023[403]. - A gain on deconsolidation of Lucid Diagnostics was recognized at $72.3 million in 2024, with the value of the Company's shares in Lucid at $25.1 million[408]. - The outstanding principal balance of the September 2022 Senior Convertible Note was approximately $6.6 million after the exchange agreement[371]. - The conversion price for the September 2022 Convertible Note was reset to $1.068, with the maturity date extended to December 31, 2025[372]. - A deemed dividend of $7.5 million was recognized on the exchange of Lucid Series A and Series A-1 Convertible Preferred Stock for Series B Preferred Stock on March 13, 2024[412]. - The company does not have any off-balance sheet arrangements[446]. - There are no applicable quantitative and qualitative disclosures about market risk[447].

Core Viewpoint - PAVmed Inc. is set to host a business update conference call on March 25, 2025, where the CEO will discuss the company's operations and growth strategy, alongside the CFO presenting the fourth quarter 2024 financial results [1]. Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in the medical device, diagnostics, and digital health sectors [4]. - The company has two subsidiaries: - Lucid Diagnostics, which focuses on cancer prevention through the EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device, aimed at early detection of esophageal precancer [4]. - Veris Health Inc., which enhances personalized cancer care through remote patient monitoring and is developing an implantable physiological monitor to work with the Veris Cancer Care Platform [4]. Conference Call Details - The conference call will take place at 8:30 AM ET and will be accessible via a webcast on the company's investor relations website [2]. - U.S. callers can join by dialing 1-800-836-8184, while international listeners can call 1-646-357-8785, using the conference call name "PAVmed Business Update" [2]. - A replay of the conference call will be available for 30 days on the investor relations section of the company's website [3].

Core Insights - PAVmed Inc. and its subsidiary Veris Health Inc. completed a private placement financing of approximately $2.37 million, with Veris valued at around $35 million pre-money [1][2] - The financing will support the development of Veris' implantable physiological monitor, which aims to enhance personalized cancer care through early detection and reduced hospitalizations [2][4] Company Overview - PAVmed Inc. is a diversified commercial-stage medical technology company operating in medical devices, diagnostics, and digital health sectors [6] - Veris Health Inc. focuses on personalized cancer care through remote patient monitoring using implantable biologic sensors and connected external devices [2][3] Product and Technology - Veris Health's lead product, the Veris Cancer Care Platform, integrates remote physiological data collection, symptom reporting, telehealth capabilities, and electronic health record integration [3] - The platform includes a VerisBox™ for cancer patients, which transmits physiological data to a clinician portal and allows patients to report symptoms via a smartphone app [4] Strategic Importance - The financing is seen as a significant milestone for Veris Health, enabling advancement in its commercial strategy, including regulatory clearance and product launch [2] - The implantable physiological monitor is expected to enhance the clinical and commercial value of the Veris platform by providing remote data independent of patient compliance [4]

Core Points - PAVmed Inc. has regained compliance with Nasdaq's Continued Listing Standards for Primary Equity Securities, allowing its securities to continue trading on the Nasdaq Capital Market [1][2] - The company achieved compliance by increasing its stockholders' equity to over $2,500,000 through strategic initiatives, including the deconsolidation of its subsidiary Lucid Diagnostics and restructuring of its convertible debt [2] - PAVmed will be under a mandatory panel monitor for one year to ensure continued compliance with the stockholders' equity requirement [3] Company Overview - PAVmed Inc. operates in the medical device, diagnostics, and digital health sectors, with subsidiaries including Lucid Diagnostics and Veris Health [4] - Lucid Diagnostics focuses on cancer prevention through its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device, which are designed for early detection of esophageal precancer [4] - Veris Health is developing a digital health platform for personalized cancer care, utilizing remote patient monitoring and implantable biologic sensors [4]

Nasdaq: PAVM, PAVMZ Q3 2024 Business Update November 14, 2024 LISHAN AKLOG, MD Chairman & CEO DENNIS MCGRATH President & CFO Disclaimer ▪ 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 forwardlooking statements. ▪ Factors that might cause or contribute to such differences include, but are not limit ...