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SpringWorks Therapeutics(SWTX) - 2024 Q4 - Annual Report

Financial Performance - OGSIVEO generated net sales of 172.0millionin2024,upfrom172.0 million in 2024, up from 5.4 million in 2023[549]. - The company recorded net product revenue of 172.0millionfortheyearendedDecember31,2024,comparedto172.0 million for the year ended December 31, 2024, compared to 5.4 million for the year ended December 31, 2023, reflecting a significant increase of 166.6million[593].Totalrevenuefor2024was166.6 million[593]. - Total revenue for 2024 was 191,589 thousand, compared to 5,447thousandin2023,indicatingasubstantialgrowth[661].Thenetlossfor2024was5,447 thousand in 2023, indicating a substantial growth[661]. - The net loss for 2024 was 258,131 thousand, an improvement from a net loss of 325,104thousandin2023[661].Thecompanyreportedanetlossof325,104 thousand in 2023[661]. - The company reported a net loss of 258.1 million for the year ended December 31, 2024, an improvement from a net loss of 325.1millionin2023,and325.1 million in 2023, and 277.4 million in 2022[671]. Cash and Securities - The company had cash, cash equivalents, and marketable securities of 461.9millionasofDecember31,2024,downfrom461.9 million as of December 31, 2024, down from 662.6 million in 2023[558]. - Cash used in operating activities was 175.6millionin2024,downfrom175.6 million in 2024, down from 222.8 million in 2023, indicating improved cash flow management[621]. - The company had cash, cash equivalents, and marketable securities totaling 461.9million,downfrom461.9 million, down from 662.6 million as of December 31, 2023[680]. - The company’s accumulated deficit reached 1.2billionasofDecember31,2024,comparedto1.2 billion as of December 31, 2024, compared to 895.0 million as of December 31, 2023[679]. - The company had no outstanding debt as of December 31, 2024[643]. Operating Expenses - Total operating expenses increased to 469.7millionfortheyearendedDecember31,2024,upfrom469.7 million for the year ended December 31, 2024, up from 348.5 million in 2023, representing a 35% increase[593]. - Research and development expenses rose to 200.5millionin2024,anincreaseof200.5 million in 2024, an increase of 50.0 million or 33% compared to 150.5millionin2023[593].Selling,generalandadministrativeexpenseswere150.5 million in 2023[593]. - Selling, general and administrative expenses were 256.7 million for the year ended December 31, 2024, a 30% increase from 197.6millionin2023[593].Thetotalequitybasedcompensationexpensefor2024was197.6 million in 2023[593]. - The total equity-based compensation expense for 2024 was 109,140,000, compared to 94,534,000in2023,indicatingayearoveryearincreaseofapproximately15.494,534,000 in 2023, indicating a year-over-year increase of approximately 15.4%[737]. Regulatory Approvals and Product Development - GOMEKLI was approved by the FDA on February 11, 2025, for treating NF1-PN, with commercialization starting in the same month[550]. - The FDA approved OGSIVEO in November 2023, leading to revenue generation from sales starting in December 2023[578]. - The company anticipates ongoing regulatory reviews for nirogacestat and mirdametinib, with decisions expected in 2025[551]. - The company began capitalizing inventory for OGSIVEO upon its FDA approval in November 2023[692]. Collaborations and Agreements - The company has entered into a license agreement with Rappta Therapeutics for a portfolio of PP2A activators, with an upfront payment of 13 million and potential future milestones totaling up to 235million[565].ThecompanyterminateditscollaborationagreementwithGSK,effectiveDecember3,2024,butwillcontinuetosupportongoingclinicaltrials[552].ThecompanyenteredintoseveralclinicaltrialcollaborationagreementstoevaluatenirogacestatincombinationwithBCMAdirectedtherapies[571].FutureOutlookThecompanyexpectstocontinueincurringsignificantexpensesrelatedtothecommercializationofOGSIVEOandGOMEKLI,aswellasongoingclinicaldevelopment[560].Thecompanyanticipatesachievingprofitabilityinthefirsthalfof2026,indicatingalongtermoutlookforfinancialrecovery[614].Thecompanyexpectsresearchanddevelopmentexpensestocontinueincreasingasitinvestsinproductcandidatesandpreclinicalprograms[583].AssetsandLiabilitiesTotalassetsdecreasedto235 million[565]. - The company terminated its collaboration agreement with GSK, effective December 3, 2024, but will continue to support ongoing clinical trials[552]. - The company entered into several clinical trial collaboration agreements to evaluate nirogacestat in combination with BCMA-directed therapies[571]. Future Outlook - The company expects to continue incurring significant expenses related to the commercialization of OGSIVEO and GOMEKLI, as well as ongoing clinical development[560]. - The company anticipates achieving profitability in the first half of 2026, indicating a long-term outlook for financial recovery[614]. - The company expects research and development expenses to continue increasing as it invests in product candidates and preclinical programs[583]. Assets and Liabilities - Total assets decreased to 587,276 thousand in 2024 from 725,788thousandin2023,indicatingareductioninoverallfinancialresources[659].Thecompanystotalaccruedexpensesincreasedto725,788 thousand in 2023, indicating a reduction in overall financial resources[659]. - The company's total accrued expenses increased to 86,012,000 in 2024, up from 65,569,000in2023,reflectingasignificantriseinaccruedcompensationandbenefits[736].Thecompanyspropertyandequipment,net,roseto65,569,000 in 2023, reflecting a significant rise in accrued compensation and benefits[736]. - The company's property and equipment, net, rose to 19,680,000 in 2024 from 17,943,000in2023,showinganincreaseofabout9.717,943,000 in 2023, showing an increase of about 9.7%[731]. Stock Options and Compensation - The company had 12,818,963 stock options outstanding, with a weighted average exercise price of 35.90 and an intrinsic aggregate value of 105,568,481[742].Thetotalunrecognizedcompensationexpenserelatedtounvestedstockoptionswas105,568,481[742]. - The total unrecognized compensation expense related to unvested stock options was 100.2 million, expected to be recognized over approximately 2.2 years[743]. - The total restricted stock awards compensation expense for the year ended December 31, 2024, was $2.2 million, with 11,101 unvested shares outstanding at year-end[744].