Financial Performance - OGSIVEO generated net sales of $172.0 million in 2024, up from $5.4 million in 2023[549]. - The company recorded net product revenue of $172.0 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 $166.6 million[593]. - Total revenue for 2024 was $191,589 thousand, compared to $5,447 thousand in 2023, indicating a substantial growth[661]. - The net loss for 2024 was $258,131 thousand, an improvement from a net loss of $325,104 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 $325.1 million in 2023, and $277.4 million in 2022[671]. Cash and Securities - The company had cash, cash equivalents, and marketable securities of $461.9 million as of December 31, 2024, down from $662.6 million in 2023[558]. - Cash used in operating activities was $175.6 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 $461.9 million, down from $662.6 million as of December 31, 2023[680]. - The company’s accumulated deficit reached $1.2 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 $469.7 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 $200.5 million in 2024, an increase of $50.0 million or 33% compared to $150.5 million in 2023[593]. - Selling, general and administrative expenses were $256.7 million for the year ended December 31, 2024, a 30% increase from $197.6 million in 2023[593]. - The total equity-based compensation expense for 2024 was $109,140,000, compared to $94,534,000 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 $235 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 $725,788 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 $65,569,000 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 $17,943,000 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]. - 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].

Financial Performance - SpringWorks Therapeutics, Inc. achieved preliminary U.S. net product revenue of $61.5 million for Q4 2024 and $172.0 million for the fiscal year ended December 31, 2024[4] - The company's total preliminary cash, cash equivalents, and marketable securities amounted to $461.9 million as of December 31, 2024[4] Audit Status - The financial information provided is unaudited and preliminary, with ongoing audits that may result in changes[5]

Core Insights - SpringWorks Therapeutics reported strong financial results for the fourth quarter and full year 2024, achieving U.S. net product revenues of $61.5 million and $172.0 million for OGSIVEO® (nirogacestat) respectively [1][6] - The company received FDA approval for GOMEKLI™ (mirdametinib) for treating symptomatic NF1-PN in both adults and pediatric patients, marking a significant milestone in its product offerings [1][6] - As of December 31, 2024, SpringWorks had a cash position of $461.9 million, indicating a solid financial foundation for future growth [1][6] Financial Performance - OGSIVEO net product revenues were $61.5 million in Q4 2024 and $172.0 million for the full year 2024, a substantial increase compared to previous periods [6][19] - Selling, General and Administrative (SG&A) expenses rose to $77.1 million for Q4 2024 and $256.7 million for the full year, up from $59.8 million and $197.6 million in 2023, primarily due to commercial readiness activities for GOMEKLI and OGSIVEO [7][19] - Research and Development (R&D) expenses increased to $60.2 million in Q4 2024 and $200.5 million for the full year, compared to $43.7 million and $150.5 million in 2023, driven by higher external costs related to clinical trials and drug manufacturing [7][19] - The net loss attributable to common stockholders was $77.3 million, or $1.04 per share, for Q4 2024, and $258.1 million, or $3.48 per share, for the full year, showing improvement from the previous year's losses [7][19] Product Development and Pipeline - The company is advancing a diversified pipeline, including ongoing studies for nirogacestat in various indications, with initial data from a Phase 2 trial expected in the first half of 2025 [2][6] - A Marketing Authorization Application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with potential launch in Germany anticipated in mid-2025 [6][19] - GOMEKLI is now available through a specialty pharmacy network in the U.S., and an MAA for mirdametinib is also under review with the EMA [6][19] Strategic Outlook - The CEO expressed confidence in the company's ability to serve the desmoid tumor community and emphasized the importance of the recent FDA approval of GOMEKLI for expanding treatment options [2][6] - SpringWorks is committed to global expansion of its medicines and aims to develop important therapeutic advances for underserved patient populations [2][6]

Core Insights - SpringWorks Therapeutics has received FDA approval for GOMEKLI™ (mirdametinib), the first and only treatment for both adults and children with neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) [1][2][11] - The approval is based on positive results from the Phase 2b ReNeu trial, which demonstrated significant tumor volume reductions and a manageable safety profile [3][4][5] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with GOMEKLI being its second FDA approval in less than 18 months [2][21] - The company is also advancing a diverse portfolio of novel targeted therapy product candidates for solid tumors and hematological cancers [21] Product Details - GOMEKLI is an oral MEK inhibitor approved for patients aged 2 years and older with symptomatic NF1-PN not amenable to complete resection [11][21] - The drug is available in 1 mg and 2 mg capsules, as well as a 1 mg tablet for oral suspension, and is expected to be available through specialty pharmacies within two weeks [7][21] Clinical Trial Results - The ReNeu trial enrolled 114 patients (58 adults and 56 pediatric patients) and achieved a confirmed objective response rate (ORR) of 41% in adults and 52% in children [3][4] - The median best percentage change in target PN volume was -41% in adults and -42% in children, with 88% of adults and 90% of children showing a response lasting at least 12 months [3][5] Market Need - NF1 affects approximately 100,000 individuals in the U.S., with about 40,000 living with NF1-PN, highlighting a significant unmet need for effective treatment options [2][9] - Prior to GOMEKLI, there were no approved medications for NF1-PN, making this approval a critical advancement for patients [2][5] Regulatory Status - GOMEKLI was granted a rare pediatric disease priority review voucher by the FDA and has previously received Orphan Drug and Fast Track designations [4][5] - The Marketing Authorization Application for GOMEKLI is under review by the European Medicines Agency (EMA), with a decision expected in 2025 [8]

Core Insights - SpringWorks Therapeutics has received FDA approval for GOMEKLI™ (mirdametinib), the first and only treatment for both adults and children with neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) [3][5][17] - The approval is based on positive results from the Phase 2b ReNeu trial, demonstrating significant efficacy and a manageable safety profile [6][8][9] - The company has been granted a rare pediatric disease priority review voucher by the FDA, highlighting the importance of this treatment for the NF1-PN patient community [3][6] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer [27] - The company has developed GOMEKLI as the first FDA-approved medicine for NF1-PN, and it also markets OGSIVEO (nirogacestat) for adults with desmoid tumors [27] - SpringWorks is advancing a diverse portfolio of targeted therapy candidates for solid tumors and hematological cancers [27] Product Details - GOMEKLI is an oral MEK inhibitor approved for patients aged 2 years and older with symptomatic plexiform neurofibromas not amenable to complete resection [17][12] - The product is available in 1 mg and 2 mg capsules, as well as a 1 mg tablet for oral suspension [12] - GOMEKLI is expected to be available through specialty pharmacies and distributors in the U.S. within two weeks of approval [12] Clinical Trial Insights - The Phase 2b ReNeu trial enrolled 114 patients (58 adults and 56 pediatric patients) and met its primary endpoint with a confirmed objective response rate (ORR) of 41% in adults and 52% in children [7][8] - Tumor volume reductions were significant, with a median best percentage change of -41% in adults and -42% in children [8] - The trial also reported improvements in pain and quality of life for patients, indicating the treatment's potential to enhance overall well-being [8] Market Context - NF1 is a genetic disorder affecting approximately 100,000 individuals in the U.S., with a 30-50% lifetime risk of developing plexiform neurofibromas [5][14] - Prior to GOMEKLI, there were no approved treatments for NF1-PN, making this approval a significant advancement for the patient community [5][6] - The approval of GOMEKLI represents a critical new option for NF patients and their families, addressing a substantial unmet medical need [10][5]

– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile – – SpringWorks granted rare pediatric disease priority review voucher by the FDA – Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/8eb8effc-49a5-4b24-911f-d3e6dfa9c8 ...

STAMFORD, Conn., Jan. 30, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, February 20, 2025 to report its fourth quarter and full year financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To participate in the live confe ...

SpringWorks Therapeutics (SWTX) announced preliminary net product revenues for fourth-quarter and full-year 2024 for its sole marketed drug, Ogsiveo (nirogacestat). The drug is approved for treating adult patients with progressing desmoid tumors who require systemic treatment.The company also outlined some expected milestones related to its commercial portfolio and other pipeline candidates for 2025.Shares of SWTX were down 13.9% on Jan. 13 following the news announcement.In the past year, shares of SpringW ...

– Achieved $61.5 million and $172.0 million in preliminary fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively – – Ended 2024 with approximately $462 million in cash, cash equivalents, and marketable securities – – Additional updates across Company's commercial portfolio and investigational pipeline to be provided during J.P. Morgan Healthcare conference presentation today at 11:15 a.m. PT – STAMFORD, Conn., Jan. 13, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeu ...

Company Overview - SpringWorks Therapeutics (SWTX) shares increased by 6% to $41.20 in the last trading session, following a higher-than-average trading volume, contrasting with a 7.2% loss over the past four weeks [1] - The company's only marketed drug, Ogsiveo, approved for treating adult patients with progressing desmoid tumors, is experiencing strong initial uptake, contributing to the recent share price rally [2] Financial Performance - SpringWorks Therapeutics is expected to report a quarterly loss of $0.66 per share, reflecting a year-over-year increase of 54.2% [2] - Revenue projections for the upcoming quarter are $56.23 million, representing a significant increase of 931.8% compared to the same quarter last year [2] Market Trends - Trends in earnings estimate revisions are closely linked to near-term stock price movements, indicating potential strength in the stock [3] - The consensus EPS estimate for SpringWorks Therapeutics has remained unchanged over the last 30 days, suggesting that the stock's price may not sustain its upward movement without changes in earnings estimates [4] Industry Context - SpringWorks Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where Nurix Therapeutics, another company in the same sector, has seen a 1.7% decline in its stock price [4] - Nurix Therapeutics has a consensus EPS estimate of -$0.67 for its upcoming report, which is a 13% improvement from the previous year [5]