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Glaukos(GKOS) - 2024 Q3 - Earnings Call Transcript
GKOSGlaukos(GKOS)2024-11-05 04:03
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Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of 96.7million,representinga2496.7 million, representing a 24% increase compared to the same quarter last year [8] - The company raised its full year 2024 net sales guidance range to 3.77 billion to 3.79billion,upfromthepreviousrangeof3.79 billion, up from the previous range of 3.70 billion to 3.76billion[8]BusinessLineDataandKeyMetricsChanges−TheU.S.Glaucomafranchiseachievedrecordthirdquartersalesof3.76 billion [8] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record third quarter sales of 51.6 million, reflecting a strong year-over-year growth of 35%, driven by contributions from iDose TR and the iStent portfolio [11] - The procedural pharmaceutical franchise, iDose TR, is advancing with positive outcomes and feedback from trained surgeons, indicating its potential to reshape glaucoma management [13][18] - The international glaucoma franchise generated sales of 24.5million,withayear−over−yeargrowthof2124.5 million, with a year-over-year growth of 21%, supported by the new French CEPS agreement [20] - The Corneal Health franchise reported sales of 20.6 million, with a 5% year-over-year growth, including Photrexa net sales of 17.9million[21]MarketDataandKeyMetricsChanges−ThecompanynotedthatfiveofthesevenMACsissuedfinalMIGSLCDs,establishingcoverageforiStentinfinite,whichisexpectedtoenhancemarketaccess[11][12]−Theinternationalmarketisfacingpotentialheadwindsduetotrialingnewstandardsproductsasthecompanyenters2025[20]CompanyStrategyandDevelopmentDirection−Glaukosaimstoadvanceglaucomatreatmentbydrivingearlierinterventionandexpandingaccesstointerventionalglaucomatools[9][10]−ThecompanyisfocusedonincreasingreimbursementconfidenceandmarketaccessforiDoseTR,withplanstoexpandeffortsintothecommercialarenain2025[16][18]−Thecompanyisalsoinvestinginitspipeline,withafocusonEpioxa,anext−generationcornealcross−linkingtherapy,expectedtosupportanNDAsubmissionbytheendof2024[22][23]Management′sCommentsonOperatingEnvironmentandFutureOutlook−Managementexpressedconfidenceintheteam′sabilitytoexecuteanddriveclinicaladoptionofinterventionalglaucomatreatments,withafocusonestablishingconsistentprofessionalfeepayments[30][33]−Thecompanyanticipateschallengesintheinternationalmarketduetocurrencyfluctuationsandincreasedcompetition[39][98]−Managementremainsoptimisticaboutthepotentialforprofitabilityinthefuture,particularlyasiDosesalesrampup[91]OtherImportantInformation−ThecompanyissuedaNoticeofRedemptionfortheremaining17.9 million [21] Market Data and Key Metrics Changes - The company noted that five of the seven MACs issued final MIGS LCDs, establishing coverage for iStent infinite, which is expected to enhance market access [11][12] - The international market is facing potential headwinds due to trialing new standards products as the company enters 2025 [20] Company Strategy and Development Direction - Glaukos aims to advance glaucoma treatment by driving earlier intervention and expanding access to interventional glaucoma tools [9][10] - The company is focused on increasing reimbursement confidence and market access for iDose TR, with plans to expand efforts into the commercial arena in 2025 [16][18] - The company is also investing in its pipeline, with a focus on Epioxa, a next-generation corneal cross-linking therapy, expected to support an NDA submission by the end of 2024 [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the team's ability to execute and drive clinical adoption of interventional glaucoma treatments, with a focus on establishing consistent professional fee payments [30][33] - The company anticipates challenges in the international market due to currency fluctuations and increased competition [39][98] - Management remains optimistic about the potential for profitability in the future, particularly as iDose sales ramp up [91] Other Important Information - The company issued a Notice of Redemption for the remaining 57.5 million in principal amount of its convertible Senior Notes due 2027, which is expected to strengthen its capital position [24][25] - The FDA has agreed that the clinical data package for Epioxa is sufficient to support an NDA submission, indicating progress in the regulatory pathway [70][71] Q&A Session Summary Question: Can you discuss the learnings from the iDose launch? - Management highlighted the importance of clinical outcomes and reimbursement confidence as key factors for the successful adoption of iDose TR [29][30] Question: What are the expectations for iDose revenue in Q4 and 2025? - Management indicated that iDose TR sales are expected to continue growing, with a projected revenue of approximately $10 million in Q4 [35][36] Question: How is the reimbursement landscape evolving for iDose? - Management noted that while some MACs are paying in a normalized manner, others are still navigating the transition, which may impact reimbursement dynamics [75][76] Question: What is the outlook for Epioxa and its reimbursement pathway? - Management confirmed that Epioxa will be covered under an existing T-code and plans to apply for a J-code following its approval [87][88] Question: How does the company view its operating expenses and cash flow breakeven? - Management stated that while the focus is on achieving cash flow breakeven, there is potential for profitability in the coming quarters as iDose sales increase [91][92]