SpringWorks Therapeutics(SWTX) - 2024 Q3 - Quarterly Report

Special Note Regarding Forward-Looking Statements This section details forward-looking statements, their inherent risks, and the company's disclaimer of obligation to update them - The report contains forward-looking statements concerning the company's ability to commercialize OGSIVEO, the timing and outcome of regulatory submissions for mirdametinib (with a PDUFA date of February 28, 2025), the success of clinical trials, and future financial performance[3] - Key risks and uncertainties that could affect future results include competition, intellectual property protection, manufacturing and supply chain capabilities, market acceptance of products, and global economic conditions[4] - The company clarifies that it assumes no obligation to update these forward-looking statements, and that industry and market data used in the report are based on third-party sources and internal estimates, which are inherently subject to uncertainty[5][6] PART I – FINANCIAL INFORMATION Financial Statements (Unaudited) This section presents unaudited condensed consolidated financial statements, including key financial results for the period ended September 30, 2024 Condensed Consolidated Balance Sheets Total assets decreased to $608.9 million as of September 30, 2024, driven by reduced cash and marketable securities Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $84,456 | $176,053 | | Total current assets | $435,111 | $500,912 | | Total assets | $608,878 | $725,788 | | Total current liabilities | $70,613 | $78,170 | | Total liabilities | $76,297 | $99,569 | | Total stockholders' equity | $532,581 | $626,219 | Condensed Consolidated Statements of Operations Q3 2024 saw $49.3 million net product revenue and a $53.5 million net loss, with a $180.8 million net loss for the nine months Statement of Operations Summary (in thousands, except per-share data) | Metric | Q3 2024 | Q3 2023 | Nine Months 2024 | Nine Months 2023 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $49,301 | $— | $110,493 | $— | | Total revenue | $49,301 | $— | $130,040 | $— | | Total operating costs | $107,238 | $83,999 | $326,829 | $244,550 | | Loss from operations | ($57,937) | ($83,999) | ($196,789) | ($244,550) | | Net loss | ($53,530) | ($79,437) | ($180,834) | ($230,782) | | Net loss per share | ($0.72) | ($1.27) | ($2.44) | ($3.70) | Condensed Consolidated Statements of Cash Flows Net cash used in operations was $146.1 million for the nine months ended September 30, 2024, resulting in a $91.6 million decrease in cash Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($146,099) | ($160,090) | | Net cash provided by investing activities | $50,400 | $193,959 | | Net cash provided by (used in) financing activities | $4,110 | ($2,432) | | Net (decrease) increase in cash | ($91,589) | $31,437 | Notes to Condensed Consolidated Financial Statements Notes detail the company's commercial transition, liquidity, and $19.5 million deferred revenue recognition from GSK agreement termination - OGSIVEO® (nirogacestat) was approved by the FDA on November 27, 2023, for adult patients with progressing desmoid tumors, marking the company's first commercial product[21] - As of September 30, 2024, the company had $498.1 million in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund operations for at least the next twelve months[23] - The collaboration agreement with GSK was terminated by GSK on June 6, 2024, leading to the recognition of all previously deferred revenue of $19.5 million as "Other Revenue" during the quarter ended June 30, 2024[51][82] Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) Management discusses financial condition and operational results, highlighting OGSIVEO's launch, mirdametinib's progress, and liquidity Overview The company is a commercial-stage biopharmaceutical firm with OGSIVEO launched and mirdametinib under FDA priority review - OGSIVEO® (nirogacestat) is the first and only FDA-approved therapy for adult patients with progressing desmoid tumors[66] - The NDA for mirdametinib for NF1-PN was granted priority review by the FDA with a PDUFA target action date of February 28, 2025, and an MAA has also been validated by the EMA[75] - The company is advancing a targeted launch for OGSIVEO, which generated $110.5 million in net product revenue in the first nine months of 2024, and is preparing for potential European launches in H1 2025[70][71] Results of Operations Operating results show new product revenue from OGSIVEO sales and increased operating expenses for commercialization and R&D Comparison of Operations (Q3 2024 vs Q3 2023, in thousands) | Metric | Q3 2024 | Q3 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $49,301 | $— | $49,301 | —% | | SG&A Expenses | $61,601 | $46,546 | $15,055 | 32% | | R&D Expenses | $42,296 | $37,453 | $4,843 | 13% | | Net Loss | ($53,530) | ($79,437) | $25,907 | (33)% | Comparison of Operations (Nine Months 2024 vs 2023, in thousands) | Metric | Nine Months 2024 | Nine Months 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenue | $130,040 | $— | $130,040 | —% | | SG&A Expenses | $179,553 | $137,715 | $41,838 | 30% | | R&D Expenses | $140,280 | $106,835 | $33,445 | 31% | | Net Loss | ($180,834) | ($230,782) | $49,948 | (22)% | R&D Expenses by Program (Nine Months, in thousands) | Program | 2024 | 2023 | | :--- | :--- | :--- | | Nirogacestat | $40,909 | $24,854 | | Mirdametinib | $39,055 | $21,468 | | Other | $19,979 | $5,665 | | Total program specific | $99,943 | $51,987 | Liquidity and Capital Resources The company has an accumulated deficit of $1.1 billion but asserts sufficient liquidity for the next twelve months - The company had an accumulated deficit of $1.1 billion as of September 30, 2024[107] - Management estimates its current liquidity position is sufficient to meet operating expenses for at least the next twelve months from the filing date of this report[108] - Net cash used in operating activities for the first nine months of 2024 was $146.1 million, a decrease from $160.1 million in the same period of 2023, reflecting increased revenue partially offset by higher operating expenses[109][110] Quantitative and Qualitative Disclosure About Market Risk No material changes to the company's market risks were reported since the 2023 Annual Report on Form 10-K - There were no material changes to the company's market risks since the 2023 Form 10-K[122] Controls and Procedures Management concluded disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - Management concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[123] - No changes in internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, internal controls were identified during the quarter[124] PART II – OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[126] Risk Factors No material changes to the company's risk factors were reported since the 2023 Annual Report on Form 10-K - There have been no material changes in the company's risk factors from those disclosed in the 2023 Form 10-K[127] Other Information Items (Items 2-6) This section covers standard disclosures, including no unregistered equity sales, no defaults, and no material changes to trading plans - The company reported no unregistered sales of equity securities, defaults upon senior securities, or mine safety disclosures[128] - No directors or officers adopted, materially modified, or terminated any Rule 10b5-1 trading plans during the third quarter of 2024[128] - The report includes a list of exhibits, including certifications by the CEO and CFO and XBRL data files[130]