Financial Data and Key Metrics Changes - Coherus reported Q4 2024 net product sales for UDENYCA at 46.3million,a2836.2 million in Q4 2023. For the fiscal year 2024, UDENYCA net sales were 206million,a62127.1 million in 2023 [24][10]. - LOQTORZI net revenue was 7.5millioninQ4,a2919.1 million [28][10]. - Cost of goods sold (COGS) decreased from 159millionin2023to118 million in 2024, primarily due to lower COGS from divested products and reduced inventory write-offs [53][54]. - Total GAAP R&D and SG&A expenses for 2024 were 261million,reflectingdecreasesinbothcategoriescomparedto2023[54][55].BusinessLineDataandKeyMetricsChanges−UDENYCA′smarketshareinQ4was15150 million to 200million[37][10].−TheNCCNupdatedguidelinesinNovember2024placedLOQTORZIinapreferredpositionformetastaticandlocallyrecurrentMPCpatients,whichisexpectedtodriveincreasedusage[34][10].CompanyStrategyandDevelopmentDirection−CoherusaimstomaximizerevenueswithLOQTORZI,expanditsindications,andadvanceitsproprietarypipeline[8][10].−Thecompanyhassuccessfullyaddresseditsbalancesheetdebtissueandexpectstohave250 million in cash post-transaction close, which will support development efforts through key data milestones in 2025 and 2026 [10][12]. - The divestiture of the UDENYCA franchise is a significant strategic change, with expectations to complete the transaction in late Q1 or early Q2 2025 [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the divestiture of UDENYCA, stating that there are no anticipated obstacles to its completion [64][10]. - The company is focused on enhancing investor appreciation of its value proposition post-transaction, particularly with a strong balance sheet and promising data on the horizon [12][10]. Other Important Information - The company has divested at least 800millioninassetsorcommitments,payingoff480 million in debt, and expects to maintain a strong financial position moving forward [17][10]. - The FDA authorization for selling final packaged products from a new contract manufacturer is the primary remaining condition for the UDENYCA divestiture [13][10]. Q&A Session Summary Question: Are there any hurdles expected with the UDENYCA divestiture? - Management sees no obstacles and believes the divestiture will proceed as planned, with all necessary reviews completed [64][10]. Question: Does the 250millioncashprojectionincludecostsavingsfromheadcountreduction?−The250 million projection is based on cash after the transaction, with a headcount reduction expected to decrease from 225 to 155 employees [67][70]. Question: Where is LOQTORZI currently being used? - LOQTORZI is being used in a mix of recurrent locally advanced and metastatic first-line patients, with expectations for increased usage due to updated guidelines [77][10]. Question: What is the FDA looking for regarding the second supplier's labeling and packaging? - The FDA requires validation runs and data review from the new contract manufacturer, which has been completed [82][10]. Question: What are the expectations for the CCR8-tori combo data? - The company anticipates robust data on immune cell ratios and T-reg depletion, which are critical for efficacy [122][10]. Question: How much off-label use of other PD-1s exists in the MPC market? - There is ongoing off-label use, particularly in community settings, and the company is actively working to increase awareness of LOQTORZI [131][10].
erus BioSciences(CHRS)2025-03-11 07:35