PAVmed(PAVM)

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PAVmed(PAVM) - 2024 Q4 - Annual Results
2025-03-25 12:15
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].
PAVmed Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
Prnewswire· 2025-03-25 12:01
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].
PAVmed(PAVM) - 2024 Q4 - Annual Report
2025-03-24 21:22
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].
PAVmed to Hold a Business Update Conference Call and Webcast on March 25, 2025
Prnewswire· 2025-03-11 13:01
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].
PAVmed and Subsidiary Veris Health Complete Private Placement Financing
Prnewswire· 2025-02-24 13:31
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]
PAVmed Regains Compliance with Nasdaq Stockholders' Equity Requirement
Prnewswire· 2025-02-18 13:30
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]
PAVmed(PAVM) - 2024 Q3 - Earnings Call Transcript
2024-11-14 20:49
Financial Data and Key Metrics Changes - PAVmed reported a significant transformation in its financial structure due to the deconsolidation of Lucid Diagnostics, which resulted in a substantial reduction of the shareholder deficit from $18.6 million to a more stable position [12][15] - The company achieved a net income of $61 million for the third quarter, primarily due to the elimination of Lucid's cumulative historical losses, leading to a positive primary EPS of $6.43 and a diluted EPS of $1.44 [21][22] Business Line Data and Key Metrics Changes - Lucid Diagnostics reported record revenue in the third quarter, with a 20% increase quarter-on-quarter, and completed the ESOGUARD BE-1 clinical validation study [8] - Veris Health completed a pilot program with The Ohio State University, receiving a $1.8 million NIH grant to optimize its Cancer Care Platform [9] Market Data and Key Metrics Changes - The deconsolidation of Lucid allowed PAVmed to present a market value of $25.5 million for its 31.3 million shares in Lucid, which is expected to increase as Lucid's stock price rises [18] Company Strategy and Development Direction - PAVmed is positioned as a diversified commercial life sciences company with multiple independently financed subsidiaries, including Lucid Diagnostics and Veris Health, under a shared services model [7] - The company is actively pursuing new assets and technologies to enhance its portfolio, with a focus on innovative medical technologies addressing unmet clinical needs [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the successful restructuring efforts that have stabilized the company's financial footing and positioned it for growth [6][33] - The company anticipates that the funding efforts for Veris and PortIO will drive future operating expenses, with a baseline operating expense expected to remain steady until additional financing is secured [26] Other Important Information - PAVmed has entered into a term sheet with an angel fund for a direct investment in PortIO Corp at a pre-money valuation of $42 million, which is currently undergoing due diligence [17] Q&A Session Summary Question: Learnings from work with The Ohio State - The pilot program with The Ohio State University was successful, leading to discussions for a strategic partnership [25] Question: Future OpEx for PAVmed - Future operating expenses will depend on securing direct financing for Veris and PortIO, with a baseline expected to remain steady [26] Question: Veris program submission timeline - The submission to the FDA may be delayed into the early second half of 2025 due to financing delays [28] Question: Financing for PMX incubator - An angel network is engaged to raise $4 million for PortIO, with the diligence process nearing completion [29] Question: Competitive landscape for The Ohio State pilot - The cancer center has not previously engaged with a digital health platform specific for cancer, making PAVmed's offering unique in this context [31]
PAVmed(PAVM) - 2024 Q3 - Earnings Call Presentation
2024-11-14 20:26
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 ...
PAVmed(PAVM) - 2024 Q3 - Quarterly Results
2024-11-14 13:15
Exhibit 99.1 PAVmed Provides Business Update and Third Quarter 2024 Financial Results Lucid reports record quarterly EsoGuardrevenue and completes clinical evidence package for imminent submission to formally seek Medicare coverage Veris Health completes pilot program with The Ohio State's James Cancer Hospital and continues pursuit of financing to relaunch development of implantable monitor Ongoing initiatives position PAVmed to preserve Nasdaq listing Conference call and webcast to be held today, November ...
PAVmed Provides Business Update and Third Quarter 2024 Financial Results
Prnewswire· 2024-11-14 13:01
Core Insights - PAVmed Inc. has reported significant progress in its business operations, particularly through its subsidiaries Lucid Diagnostics and Veris Health, while also addressing compliance with Nasdaq listing requirements [4][6]. Business Update Highlights - PAVmed has completed a deconsolidation and is finalizing a debt restructuring to regain Nasdaq compliance [4]. - Lucid Diagnostics is preparing to submit a clinical evidence package to seek Medicare coverage for its EsoGuard test, which has shown commercial and clinical success [4][5]. - Veris Health has completed a pilot program with The Ohio State's James Cancer Hospital and is pursuing financing for its implantable monitor development [5][12]. Financial Performance - For Q3 2024, EsoGuard revenues reached $1.2 million, marking a 20% increase from Q2 2024, with a total of 2,787 tests performed [5]. - PAVmed reported operating expenses of approximately $12.6 million for Q3 2024, with a GAAP net income of approximately $64.3 million [7][9]. - The company had cash and cash equivalents of $0.8 million as of September 30, 2024, down from $19.6 million at the end of 2023 [7]. Subsidiary Developments - Lucid Diagnostics is expanding its direct contracting initiatives and has achieved a record number of tests performed in October 2024 [5]. - Veris Health received a $1.8 million NIH grant to enhance its Cancer Care Platform and is in discussions for long-term partnerships [5][12]. Nasdaq Compliance Efforts - PAVmed has until January 31, 2025, to regain compliance with Nasdaq by increasing stockholders' equity through a proposed exchange of $25 million in convertible debt for preferred equity [6].