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Pulse Biosciences(PLSE) - 2024 Q2 - Earnings Call Transcript
PLSEPulse Biosciences(PLSE)2024-08-12 22:50
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Financial Data and Key Metrics Changes - Cash and cash equivalents totaled 26.2millionasofJune30,2024,comparedto26.2 million as of June 30, 2024, compared to 58.7 million as of June 30, 2023, not including the 60millionfromtherightsofferingclosedinJuly2024[24]−CashusedinQ22024was60 million from the rights offering closed in July 2024 [24] - Cash used in Q2 2024 was 8.7 million, down from 10millioninthesameperiodlastyearand10 million in the same period last year and 9.5 million in Q1 2024 [25] - Total GAAP costs and expenses increased by 1.5millionto1.5 million to 11.7 million compared to 10.2millionintheprioryearperiod,primarilyduetoanincreaseinnon−cashstock−basedcompensation[25]BusinessLineDataandKeyMetricsChanges−Thecompanyisfocusedonthreeproductlines:softtissueablation,epicardialsurgicalablation,andendocardialcatheterablation,withsignificantprogressreportedineacharea[11][22]−Initialclinicalresultsforsofttissueablationofbenignthyroidnoduleshavebeenpromising,withthefirstU.S.procedurescompletedfollowingFDAclearance[13][14]−ThecardiacsurgicalsystemforatrialfibrillationhasreceivedbreakthroughdevicedesignationfromtheFDA,emphasizingitspotentialbenefits[18]MarketDataandKeyMetricsChanges−Thebenignthyroidnodulemarketisestimatedtohaveasmanyas1.3millionpeopleworldwide,representingasignificantopportunityforthecompany′snano−PFAtechnology[33]−ThecompanyplanstoexpanditsclinicalstudiesinEurope,addingtwoprestigiousclinicalsitestogatheradditionaluserexperiencesandclinicaloutcomes[21]CompanyStrategyandDevelopmentDirection−Thecompanyaimstocommercializedevicesforsofttissueablation,epicardialsurgicalablation,andendocardialcatheterablation,focusingoncompellingclinicaldatatosupportregulatorypathways[8][10]−Thestrategyincludespursuingspecificlabeledindicationsforregulatoryapproval,whichwillenhancemarketingandclinicianadoption[10][30]Management′sCommentsonOperatingEnvironmentandFutureOutlook−Managementexpressedconfidenceinthepotentialofnano−PFAtechnologytotransformtreatmentoptionsacrossvariousmedicalapplications,highlightingtheimportanceofrigorousclinicalandregulatorypathways[5][22]−Thecompanyanticipatesthatthecashonhandwillsupportoperationsinto2026,evenwithoutexercisingwarrantsfromtherightsoffering[34]OtherImportantInformation−ThecompanycompletedarightsofferingfundraisinginJuly,whichwasoversubscribedandprovidedgrossproceedsof10.2 million in the prior year period, primarily due to an increase in non-cash stock-based compensation [25] Business Line Data and Key Metrics Changes - The company is focused on three product lines: soft tissue ablation, epicardial surgical ablation, and endocardial catheter ablation, with significant progress reported in each area [11][22] - Initial clinical results for soft tissue ablation of benign thyroid nodules have been promising, with the first U.S. procedures completed following FDA clearance [13][14] - The cardiac surgical system for atrial fibrillation has received breakthrough device designation from the FDA, emphasizing its potential benefits [18] Market Data and Key Metrics Changes - The benign thyroid nodule market is estimated to have as many as 1.3 million people worldwide, representing a significant opportunity for the company's nano-PFA technology [33] - The company plans to expand its clinical studies in Europe, adding two prestigious clinical sites to gather additional user experiences and clinical outcomes [21] Company Strategy and Development Direction - The company aims to commercialize devices for soft tissue ablation, epicardial surgical ablation, and endocardial catheter ablation, focusing on compelling clinical data to support regulatory pathways [8][10] - The strategy includes pursuing specific labeled indications for regulatory approval, which will enhance marketing and clinician adoption [10][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of nano-PFA technology to transform treatment options across various medical applications, highlighting the importance of rigorous clinical and regulatory pathways [5][22] - The company anticipates that the cash on hand will support operations into 2026, even without exercising warrants from the rights offering [34] Other Important Information - The company completed a rights offering fundraising in July, which was oversubscribed and provided gross proceeds of 60 million [22] - Paul LaViolette has been appointed Co-Chairman of the Board, bringing extensive experience in scaling cardiology medtech franchises [23] Q&A Session Summary Question: Feedback on initial cardiac surgical cases and regulatory pathway - Management noted that initial procedures were efficient, and the device performed well, with excitement from clinicians involved [29] - The regulatory pathway will focus on a PMA application for atrial fibrillation treatment rather than a 510(k) submission [30][31] Question: Market opportunity for benign thyroid nodules - Management highlighted the significant number of patients with benign thyroid nodules and the advantages of nano-PFA in providing a non-invasive treatment option [32][33] Question: Capitalization for concurrent studies in 2025 - Management indicated that while cash burn will increase with the active phases of studies, current cash reserves are expected to last into 2026 without warrant exercises [34]