SpringWorks Therapeutics(SWTX) - 2021 Q3 - Quarterly Report

PART I – FINANCIAL INFORMATION Item 1. Financial Statements (unaudited) The unaudited financial statements for Q3 2021 show a net loss of $117.8 million, an increase from $56.8 million in Q3 2020, with total assets decreasing Condensed Consolidated Balance Sheets As of September 30, 2021, total assets decreased to $495.3 million from $576.2 million, primarily due to reduced cash and marketable securities, while total liabilities increased and equity decreased Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $93,852 | $147,089 | | Marketable securities (Current & Long-term) | $386,791 | $414,731 | | Total assets | $495,275 | $576,191 | | Accrued expenses | $24,344 | $14,885 | | Total liabilities | $28,597 | $19,133 | | Total stockholders' equity | $466,678 | $557,058 | Condensed Consolidated Statements of Operations For the nine months ended September 30, 2021, net loss increased to $117.8 million from $56.8 million, driven by a significant rise in R&D and G&A expenses Statement of Operations Highlights (in thousands, except per-share data) | Metric | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Research and development | $72,332 | $36,597 | | General and administrative | $45,340 | $20,946 | | Total operating expenses | $117,672 | $57,543 | | Loss from operations | ($117,672) | ($57,543) | | Net loss | ($117,838) | ($56,846) | | Net loss per share, basic and diluted | ($2.43) | ($1.35) | Condensed Consolidated Statements of Cash Flows Net cash used in operating activities increased to $81.6 million for the nine months ended September 30, 2021, while investing activities provided cash, reversing prior year's usage Cash Flow Summary (in thousands) | Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($81,561) | ($47,257) | | Net cash provided by (used in) investing activities | $27,411 | ($196,051) | | Net cash provided by financing activities | $913 | $512 | | Net decrease in cash and cash equivalents | ($53,237) | ($242,796) | Notes to Condensed Consolidated Financial Statements The notes detail the company's clinical-stage operations, accumulated deficit of $236.4 million, and $480.6 million in cash, sufficient for twelve months, alongside key expenses - The company is a clinical-stage biopharmaceutical company with a portfolio including late-stage candidates nirogacestat and mirdametinib[31] - As of September 30, 2021, the company had an accumulated deficit of $236.4 million and cash, cash equivalents, and marketable securities of $480.6 million, expected to fund operations for at least the next twelve months[32][33] - In May 2021, the company made an $11 million upfront payment for an exclusive worldwide license to a portfolio of TEAD family inhibitors, recorded as R&D expense[52] - Total stock-based compensation expense for the nine months ended September 30, 2021 was $26.6 million, a significant increase from $7.0 million in the same period of 2020[69] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's focus on rare diseases and cancer, highlighting lead candidates, increased operating expenses, and a net loss of $117.8 million, with sufficient cash to fund operations through 2022 - The company is advancing two lead product candidates: nirogacestat for desmoid tumors (Phase 3 DeFi trial) and mirdametinib for NF1-PN (Phase 2b ReNeu trial)[75][76] - Recent developments include a license agreement for a TEAD inhibitor portfolio, and clinical collaborations with Seagen, St Jude, MSK, and Dana-Farber to evaluate nirogacestat and mirdametinib in various combinations and indications[81][82][84][85][86] - The company believes its cash, cash equivalents, and marketable securities of $480.6 million as of September 30, 2021, will be sufficient to fund operations through at least 2022[90][111] Results of Operations For the nine months ended September 30, 2021, R&D expenses increased by 98% to $72.3 million, and G&A expenses rose 116% to $45.3 million, driven by various cost increases Comparison of Nine Months Ended September 30, 2021 and 2020 (in thousands) | Item | 2021 | 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $72,332 | $36,597 | $35,735 | 98% | | General and administrative | $45,340 | $20,946 | $24,394 | 116% | | Total operating expenses | $117,672 | $57,543 | $60,129 | 104% | | Net loss | ($117,838) | ($56,846) | ($60,992) | 107% | - The increase in R&D expense for the nine months ended Sep 30, 2021 was driven by higher internal costs ($13.3M), a nonrefundable upfront payment for the TEAD inhibitor program ($11.0M), and increased external costs for drug manufacturing and trials ($11.2M)[106] - The increase in G&A expense was primarily due to hiring additional personnel, increased stock-based compensation, and a $4.7 million increase in IT, consulting, and professional services[108] Liquidity and Capital Resources The company has an accumulated deficit of $236.4 million and used $81.6 million in cash from operations, but its $480.6 million in liquidity is expected to fund operations through 2022 - As of September 30, 2021, the company had $480.6 million in cash, cash equivalents, and marketable securities[218] - Net cash used in operating activities was $81.6 million for the nine months ended September 30, 2021, compared to $47.3 million for the same period in 2020[113] - Future funding requirements depend on factors including clinical trial progress, regulatory outcomes, commercial-scale manufacturing costs, and potential in-licensing activities[117][124] Quantitative and Qualitative Disclosure About Market Risk The company's primary market risk is interest rate sensitivity on its $480.6 million cash and marketable securities, which are high-quality, short-term investments, limiting material impact from rate changes - The company is exposed to market risks, primarily interest rate sensitivities, on its portfolio of cash, cash equivalents, and marketable securities totaling $480.6 million[131] - The company aims to preserve capital and ensure liquidity by investing in high-quality, highly liquid debt securities with short-term maturities, minimizing the impact of interest rate fluctuations[131] Controls and Procedures Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[133] - No material changes to the company's internal control over financial reporting occurred during the quarter[134] PART II. OTHER INFORMATION Legal Proceedings The company is not currently a party to any material legal proceedings, though it may be involved in various claims in the ordinary course of business - As of the report date, the company is not a party to any material legal proceedings[136] Risk Factors The company faces numerous risks, including heavy dependence on lead product candidates, uncertainties in clinical development, reliance on third parties, intellectual property issues, and the need for additional capital Risks related to research and development The company's success depends heavily on its lead candidates, with risks including clinical trial failures, non-predictive interim data, patient enrollment delays, and challenges in developing combination therapies - The business is highly dependent on the success of its lead product candidates, nirogacestat and mirdametinib, where failure to complete clinical development or obtain regulatory approval would materially harm the business[147] - Interim "topline" and preliminary data from clinical trials may change as more data becomes available and are not necessarily predictive of final results[153] - The company plans to develop its product candidates in combination with other therapies, and safety or supply issues with these combination products could delay or prevent development and approval[156] Risks related to our reliance on third parties The company relies on third parties for preclinical studies, clinical trials, and all manufacturing, creating risks related to quality control, supply interruptions, and regulatory compliance - The company relies on third parties (CROs, investigators) to conduct preclinical studies and clinical trials, and their failure to perform could prevent regulatory approval[166] - The company depends on third-party manufacturers for all preclinical and clinical supplies and has not yet arranged for commercial-scale manufacturing, where non-compliance could halt development[173][177] - Existing and future collaborations are important, but partners have significant discretion and may not perform as expected, potentially delaying or terminating programs[181][182] Risks related to our intellectual property The company depends on licensed intellectual property, including from Pfizer, where license termination or non-compliance with obligations would severely harm the business - The company is dependent on intellectual property licensed from third parties, including Pfizer, for its lead product candidates, where termination of these licenses would severely harm the business[187] - Failure to comply with obligations under its patent license agreements could result in the loss of important rights[191] Risks related to government regulation The company's Orphan Drug Designation may not be maintained, and manufacturing in China and India exposes it to risks from trade disputes, political unrest, or operational disruptions - The company has Orphan Drug Designation for nirogacestat and mirdametinib but may be unable to maintain it or the associated market exclusivity benefits[193] - Manufacturing of lead product candidates in China and India exposes the company to risks from trade wars, political unrest, and operational disruptions that could adversely affect its business[199] Risks related to managing our business and operations The company faces challenges in managing organizational growth, building commercialization capabilities, and successfully in-licensing new product candidates, with operations concentrated in two locations - The company will need to grow its organization and may experience difficulties managing this growth, including recruiting and integrating new personnel[200] - The company has no history of commercializing products and is investing significantly to build these capabilities, with no assurance of success[204] - The growth strategy depends on in-licensing or acquiring new product candidates, which is a competitive and uncertain process[205] Risks related to our financial position and need for additional capital The company has a history of significant net losses and will require substantial additional capital, which may cause dilution or require relinquishing valuable rights - The company has incurred significant net losses since inception ($236.4M accumulated deficit as of Sep 30, 2021) and anticipates these will continue[211][212] - The company will require additional capital to fund operations, and failure to obtain it could force delays or discontinuation of development programs[218] - Raising additional capital may cause dilution to stockholders, restrict operations, or require relinquishing rights to technologies or product candidates[220] Risks related to our common stock The company does not intend to pay dividends, and significant control by principal stockholders, along with anti-takeover provisions, could limit stockholder influence and judicial forum choices - The company does not intend to pay dividends, so any returns will be limited to the appreciation of the stock's value[223] - Principal stockholders and management own approximately 51.9% of the stock (as of Sep 30, 2021) and can exert significant control over matters requiring stockholder approval[224] - Bylaws designate the Court of Chancery of Delaware and the U.S. District Court for the District of Connecticut as exclusive forums for certain legal disputes, which could limit stockholders' ability to choose a favorable judicial forum[228] Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the period - None[389] Exhibits This section provides an index of exhibits filed with the Form 10-Q, including certifications by officers and XBRL data files - The exhibit index lists all documents filed with or incorporated by reference into the report, including officer certifications and XBRL data[394]