SpringWorks Therapeutics(SWTX) - 2023 Q4 - Annual Results

Report Overview and Business Highlights Executive Summary In 2023, SpringWorks Therapeutics achieved its first FDA approval for OGSIVEO™ for desmoid tumors, generating $5.4 million in its initial partial quarter, and reported positive Phase 2b data for mirdametinib in NF1-PN, planning an NDA submission in H1 2024 - OGSIVEO™ (nirogacestat) generated net product revenue of $5.4 million in its first partial quarter after FDA approval on November 27, 2023[1] - Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for nirogacestat for the treatment of desmoid tumors[1] - Positive topline data from the Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN was presented, with a New Drug Application (NDA) submission planned for the first half of 2024[1] - The company ended 2023 with $662.6 million in cash, cash equivalents, and marketable securities[2] - 2024 focus includes the U.S. launch of OGSIVEO, filing the NDA for mirdametinib, expanding OGSIVEO's geographic reach, and advancing the emerging portfolio[3] Pipeline and Corporate Updates The company achieved FDA approval for OGSIVEO™, submitted it for EMA approval, and reported positive Phase 2b results for mirdametinib, planning an NDA submission, while advancing its emerging pipeline and strengthening its balance sheet OGSIVEO™ (Nirogacestat) OGSIVEO™ received FDA approval on November 27, 2023, for adult patients with progressing desmoid tumors, generating $5.4 million in its first partial quarter, with an MAA submitted to the EMA in February 2024 - Received U.S. FDA approval on November 27, 2023, for adult patients with progressing desmoid tumors[4] - Achieved $5.4 million in net product revenue in the first partial quarter of its U.S. launch, with payers representing over 98% of commercial lives providing reimbursement[4] - Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in February 2024[4] - Initial data from a Phase 2 trial in patients with recurrent ovarian granulosa cell tumors is expected in the second half of 2024[9] Mirdametinib The Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN demonstrated positive results, with confirmed objective response rates of 52% in pediatric patients and 41% in adult patients, leading to an NDA submission planned for H1 2024 Phase 2b ReNeu Trial Topline Data | Patient Cohort | Confirmed Objective Response Rate (ORR) | | :--- | :--- | | Pediatric | 52% | | Adult | 41% | - Mirdametinib was generally well tolerated, with most adverse events being Grade 1 or 2, primarily rash, diarrhea, and nausea/vomiting[9] - An NDA submission to the FDA for the treatment of children and adults with NF1-PN is on track for the first half of 2024[9] Emerging Pipeline & Corporate Updates The company is advancing its emerging pipeline, with plans to present additional data for brimarafenib in H2 2024 and initiate a Phase 1a trial for SW-682 in H1 2024, supported by a public offering and new patent issuances - The FDA cleared the IND application for SW-682, a TEA Domain inhibitor, with a Phase 1a trial in Hippo mutant solid tumors planned for H1 2024[9] - Strengthened the balance sheet with a public offering in December 2023, raising gross proceeds of approximately $316.2 million[9] - New patents were issued for OGSIVEO and mirdametinib, extending intellectual property protection for both products into 2043[9] Financial Performance Fourth Quarter and Full Year 2023 Financial Results Summary For Q4 2023, SpringWorks reported its first product revenue of $5.4 million from OGSIVEO, with increased operating expenses leading to a net loss of $94.3 million, and a full-year net loss of $325.1 million, while maintaining a strong cash position of $662.6 million Q4 & Full Year 2023 Financial Highlights (in millions) | Metric | Q4 2023 | Q4 2022 | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | :--- | :--- | | Net Product Revenues | $5.4M | $0 | $5.4M | $0 | | R&D Expenses | $43.7M | $37.9M | $150.5M | $146.1M | | SG&A Expenses | $59.8M | $40.5M | $197.6M | $134.6M | | Net Loss | $94.3M | $74.2M | $325.1M | $277.4M | | Net Loss Per Share | $1.44 | $1.19 | $5.15 | $5.21 | - The increase in SG&A expenses was largely attributable to commercial readiness activities to support the U.S. launch of OGSIVEO[14] - Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023[14] Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated statements of operations for 2021-2023 and selected balance sheet data for 2022-2023, detailing revenue, operating expenses, net loss, and key financial positions Condensed Consolidated Statements of Operations (in thousands) | | Year Ended December 31, | | | | :--- | :--- | :--- | :--- | | | 2023 | 2022 | 2021 | | Product revenue, net | $5,447 | $— | $— | | Total operating expenses | $348,460 | $280,674 | $173,468 | | Loss from operations | ($343,013) | ($280,674) | ($173,468) | | Net loss | ($325,104) | ($277,417) | ($173,910) | | Net loss per share | ($5.15) | ($5.21) | ($3.59) | Selected Balance Sheet Data (in thousands) | | As of December 31, | | | :--- | :--- | :--- | | | 2023 | 2022 | | Cash, cash equivalents and marketable securities | $662,588 | $597,006 | | Total assets | $725,788 | $630,242 | | Total liabilities | $99,569 | $72,050 | | Total stockholders' equity | $626,219 | $558,192 | Company Information and Disclosures About SpringWorks Therapeutics SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on precision medicine for severe rare diseases and cancer, with OGSIVEO™ as its first FDA-approved therapy - SpringWorks is a commercial-stage biopharmaceutical company focused on precision medicine for severe rare diseases and cancer[10] - The company's first FDA-approved therapy is OGSIVEO™ (nirogacestat), for adult patients with progressing desmoid tumors[10] Forward-Looking Statements This press release contains forward-looking statements regarding the company's business, development, and commercialization plans, which are subject to risks and uncertainties, advising readers to consult SEC filings for detailed risk discussions - The press release includes forward-looking statements concerning business plans, clinical results, regulatory submissions (e.g., mirdametinib NDA), and commercialization efforts for OGSIVEO[13][15] - Actual results may differ materially from expectations due to various risks and uncertainties[15] - For a detailed discussion of risks, investors should review the "Risk Factors" section in the company's Annual Report on Form 10-K for the year ended December 31, 2023[17]