Financial Data and Key Metrics Changes - TG Therapeutics reported full year 2024 U.S. revenues of 310million,exceedingguidanceandreflectinga250103.6 million, representing a 24% growth quarter-over-quarter and 160% growth year-over-year [25][36] - The company achieved a GAAP net income of approximately 23million,or0.15 per diluted share, for both the three and twelve-month periods ending December 31, 2024 [40] Business Line Data and Key Metrics Changes - BRIUMVI's total net product revenue for the fourth quarter was 107.3million,includingapproximately3.7 million from products sold to Neuraxpharm for the ex-U.S. launch [36] - The company reported total global revenue of approximately 329millionforthefullyear,predominantlyfromU.S.BRIUMVInetproductsales[36]MarketDataandKeyMetricsChanges−BRIUMVIisgainingmomentuminternationally,withsuccessfullaunchesinGermanyandotherEUcountriesbyNeuraxpharm[26]−Thecompanyisseeingstrongadoptionamonghigh−volumeinfusioncentersandacademicneurologists,contributingtoitsmarketsharegrowth[29]CompanyStrategyandDevelopmentDirection−ThecompanyplanstodevelopandcommercializeasubcutaneousformulationofBRIUMVI,whichcouldsignificantlyexpandmarketopportunities[19][33]−TGTherapeuticshasenteredapartnershipwithPrecisionBioSciencestodevelopazer−celforautoimmunediseases,indicatingastrategicexpansionbeyondMS[20]Management′sCommentsonOperatingEnvironmentandFutureOutlook−ManagementexpressedconfidenceinthecontinuedgrowthofBRIUMVI,withexpectationstomeetorexceedfullyearU.S.guidanceof525 million for 2025 [31] - The management highlighted the importance of ongoing clinical trials and the potential for new treatment options in the autoimmune disease market [21][33] Other Important Information - The company received three new patents for BRIUMVI, providing patent protection through 2042 [22] - Management noted that the gross-to-net ratio is expected to be in the 70% to 75% range, with fluctuations quarter-to-quarter [57] Q&A Session Summary Question: What are the biggest segments of growth for 2025? - Management indicated that growth is coming from a broad set of customers, particularly in academic hospitals, and that January and February were the best months for new enrollments [48][49] Question: What are the expectations for the subcutaneous trial design? - The subcutaneous trial design has not been finalized, but the target is to commence by mid-year [58] Question: How are you thinking about the size of the subcutaneous trial? - The trial size is expected to be similar to Ocrevus' subcutaneous studies, likely around 150 to 200 patients per arm, with a projected enrollment period of about 12 months [63] Question: What is the feedback on the ENHANCE trial data? - Feedback has been positive, with many physicians already switching patients to BRIUMVI without the introductory dose, indicating comfort with the safety profile [80] Question: How is the company approaching the myasthenia gravis opportunity? - Management believes there is potential for BRIUMVI in myasthenia gravis, but further exploration is needed before committing to a development program [86]
TG Therapeutics(TGTX)2025-03-03 20:24