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PAVmed(PAVM) - 2024 Q4 - Annual Report
PAVMPAVmed(PAVM)2025-03-24 21:22
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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 8millionNIHgrantforafive−yearclinicalstudyevaluatingEsoCheckandEsoGuardamongat−riskindividualswithoutGERDsymptoms[354].−Veriswasawardeda8 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 3.0million,anincreaseof203.0 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 4.8millionin2024from4.8 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 28.4millionin2024,whileusingapproximately28.4 million in 2024, while using approximately 33.6 million of cash in operations[414]. - Financing activities provided 31.3millionofcashduringtheyearendedDecember31,2024[414].−TheCompanyendedtheyearwithcashon−handof31.3 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 2.37millionfromthesaleof2,574,350sharesofcommonstockandpre−fundedwarrants[361].−TheCompanyreceivedshareholderapprovaltoincreasethetotalnumberofauthorizedsharesfrom50millionto250milliononJanuary15,2025[379].−Lucidclosedonthesaleof13,939,331sharesat2.37 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 14.5millionforworkingcapital[380][381].−Thecompanyraisedatotalof14.5 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 1,000pershareandtheexchangeofexistingpreferredshares[422].−Thecompanyissuedapproximately11,634sharesofLucidSeriesB−1PreferredStock,generatinggrossproceedsof1,000 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].−Thecompanyrealizedgrossproceedsof0.7228[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 1.3million[429].−Cumulatively,thecompanyissued680,263sharesofcommonstockfornetproceedsofapproximately1.3 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 6.5millionofitscommonstock,resultinginnetproceedsofapproximately6.5 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 1.4millionofprincipalrepaymentsand1.4 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 2.5millioninstockholders′equity[366].−TheCompanyachievedcompliancethroughtheexchangeof2.5 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 8.0millionandmarketcapitalizationtobenolessthan8.0 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 5.0millionandmarketcapitalizationtobenolessthan5.0 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 0.83millionto0.83 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 11.6millionin2024from11.6 million in 2024 from 17.6 million in 2023, a reduction of 6.0million[401].−Generalandadministrativeexpenseswereapproximately6.0 million[401]. - General and administrative expenses were approximately 24.5 million in 2024, down from 30.9millionin2023,reflectingadecreaseof30.9 million in 2023, reflecting a decrease of 6.4 million[401]. - Research and development costs fell to approximately 5.9millionin2024comparedto5.9 million in 2024 compared to 14.3 million in 2023, a decrease of 8.4million[402].ChangesinAccountingStandards−ThecompanyadoptedASUNo.2023−07forsegmentreporting,effectiveJanuary1,2024,whichdidnotmateriallyimpactitssegment−relateddisclosures[441].−TheFASBissuedASUNo.2023−09inDecember2023,aimedatenhancingincometaxdisclosures,effectiveforannualperiodsbeginningafterDecember15,2024[443].−ASU2023−09includeschangestoratereconciliationandincometaxespaidinformation,butthecompanydoesnotexpectasignificantimpactonitsconsolidatedfinancialstatements[443].−InOctober2023,theFASBissuedASUNo.2023−06,whichmodifiesdisclosurerequirementsinresponsetotheSEC′sDisclosureUpdateandSimplificationInitiative[444].−TheeffectivedateforASU2023−06amendmentswillalignwiththeSEC′sremovalofrelateddisclosures,withapotentialremovalofamendmentsifnotenactedbyJune30,2027[444].−ThecompanyiscurrentlyevaluatingthepotentialimpactofASU2023−06onitsconsolidatedfinancialstatements[444].Miscellaneous−Thechangeinfairvalueofconvertibledebtresultedinapproximately8.4 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 6.0millionofexpensein2023[403].−AgainondeconsolidationofLucidDiagnosticswasrecognizedat6.0 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 25.1million[408].−TheoutstandingprincipalbalanceoftheSeptember2022SeniorConvertibleNotewasapproximately25.1 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,withthematuritydateextendedtoDecember31,2025[372].−Adeemeddividendof1.068, 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].