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SpringWorks Therapeutics(SWTX) - 2023 Q2 - Quarterly Report
2023-08-02 10:36
PART I – FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and related management discussion for the period ended June 30, 2023 [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the period ended June 30, 2023, highlighting a decrease in total assets to **$517.3 million** and a net loss of **$151.3 million** [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This table presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2023, and December 31, 2022 Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $115,001 | $67,490 | | Marketable securities | $361,706 | $524,722 | | **Total Assets** | **$517,329** | **$630,242** | | **Total Liabilities** | **$65,888** | **$72,050** | | **Total Stockholders' Equity** | **$451,441** | **$558,192** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This table summarizes the company's revenues, expenses, and net loss for the three and six months ended June 30, 2023 and 2022 Statement of Operations Summary (in thousands, except per-share data) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $35,858 | $38,024 | $69,382 | $72,127 | | General and administrative | $46,994 | $30,987 | $91,169 | $58,353 | | **Total operating expenses** | **$82,852** | **$69,011** | **$160,551** | **$130,480** | | **Net loss** | **$(77,925)** | **$(69,050)** | **$(151,345)** | **$(130,851)** | | Net loss per share | $(1.25) | $(1.41) | $(2.43) | $(2.67) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table details the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2023 and 2022 Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(109,629) | $(87,759) | | Net cash provided by investing activities | $159,360 | $53,181 | | Net cash (used in) provided by financing activities | $(2,190) | $173 | | **Net increase (decrease) in cash** | **$47,541** | **$(34,405)** | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides additional details and context for the financial statements, including business overview, significant accounting policies, and financial position - The company is a clinical-stage biopharmaceutical firm with two late-stage product candidates: nirogacestat and mirdametinib. An NDA for nirogacestat for desmoid tumors was submitted and accepted for **priority review** by the FDA[30](index=30&type=chunk) - The PDUFA target action date for the nirogacestat NDA was **extended by three months** to **November 27, 2023**, to allow the FDA more time to review additional data analyses[30](index=30&type=chunk) - The company has a history of losses, with an accumulated deficit of **$721.3 million** as of June 30, 2023. However, management believes its cash, cash equivalents, and marketable securities of **$476.7 million** are **sufficient to fund operations for at least the next twelve months**[31](index=31&type=chunk)[32](index=32&type=chunk) - Stock-based compensation expense for the six months ended June 30, 2023, was **$46.4 million**, an **increase** from **$35.5 million** in the same period of 2022[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's business overview, financial results, and liquidity, focusing on clinical progress, increased General & Administrative expenses, and sufficient capital for the next year [Overview](index=19&type=section&id=Overview) This section provides a strategic overview of the company's clinical development programs and commercialization plans for its lead product candidates - The company's most advanced product candidate, nirogacestat, is under **priority review** by the FDA for the treatment of desmoid tumors, with an updated PDUFA target action date of **November 27, 2023**[75](index=75&type=chunk) - The second lead product candidate, mirdametinib, is in a potentially registrational Phase 2b trial for NF1-PN. Topline data is expected in **Q4 2023**, with a planned NDA submission in the **first half of 2024** if data is positive[78](index=78&type=chunk) - The company is actively preparing for the **commercial launch** of nirogacestat in the U.S., if approved, and plans to file for marketing authorization in the European Union in **2024**[76](index=76&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) This section analyzes the company's operating expenses, highlighting changes in research and development and general and administrative costs Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $35,858 | $38,024 | $69,382 | $72,127 | | General and administrative | $46,994 | $30,987 | $91,169 | $58,353 | - General and administrative expenses **increased by 52%** for Q2 2023 and **56%** for H1 2023 compared to the same periods in 2022. This **increase** was primarily driven by commercial readiness activities for the potential U.S. launch of nirogacestat, including hiring for sales, marketing, and commercial functions[94](index=94&type=chunk)[95](index=95&type=chunk)[101](index=101&type=chunk) - Research and development expenses **decreased by 6%** for Q2 2023 and **4%** for H1 2023 compared to the prior year periods, mainly due to lower external costs for drug manufacturing and clinical trials[92](index=92&type=chunk)[93](index=93&type=chunk)[99](index=99&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial position, cash flows, and ability to fund future operations - The company had an accumulated deficit of **$721.3 million** as of June 30, 2023. Management estimates that its current cash, cash equivalents, and marketable securities are **sufficient to fund operating expenses for at least the next twelve months**[104](index=104&type=chunk) - Net cash used in operating activities **increased to $109.6 million** for the first six months of 2023, compared to **$87.8 million** for the same period in 2022, driven by a higher net loss and changes in operating assets and liabilities[105](index=105&type=chunk)[106](index=106&type=chunk) - Net cash provided by investing activities was **$159.4 million** for the first six months of 2023, primarily from the net sale and maturity of marketable securities[107](index=107&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company reports that there have been **no material changes** to its market risks from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022 - There were **no material changes** to the company's market risks from those described in the 2022 Form 10-K[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2023, with **no changes** to internal control over financial reporting during the quarter - Management evaluated disclosure controls and procedures and found them to be **effective** as of the end of the reporting period[123](index=123&type=chunk)[124](index=124&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[125](index=125&type=chunk) PART II – OTHER INFORMATION This section covers legal proceedings, updated risk factors, and other standard disclosures [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) As of the report date, the company is **not currently involved in any material legal proceedings** - The company is **not currently involved in any material legal proceedings**[127](index=127&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section updates the company's risk factors, highlighting a **new risk factor** related to the financial services industry and its potential adverse impacts - A **new risk factor** has been added concerning adverse developments in the financial services industry, prompted by recent events like the failure of Silicon Valley Bank (SVB)[129](index=129&type=chunk) - Potential impacts from financial institution failures include **delayed or lost access** to deposits, **termination of cash management services**, and **impaired ability to secure financing**[131](index=131&type=chunk)[132](index=132&type=chunk) - The instability could also affect customers and suppliers, potentially leading to **payment defaults or disruptions** that would **materially harm** the company's business[133](index=133&type=chunk) [Other Items (Items 2-6)](index=29&type=section&id=Other%20Items%20(Items%202-6)) This section covers several standard disclosure items, reporting **no activity** for most, and listing the **index of exhibits** filed with the Form 10-Q - The company reported **no activity** under Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults Upon Senior Securities), Item 4 (Mine Safety Disclosures), or Item 5 (Other Information)[134](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk)[137](index=137&type=chunk) - Item 6 provides an **index of exhibits** filed with the report, including **required certifications** from the CEO and CFO[139](index=139&type=chunk)
SpringWorks Therapeutics(SWTX) - 2023 Q1 - Quarterly Report
2023-05-03 10:32
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 _____ ...
SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow
2023-03-02 18:19
Nirogacestat in Desmoid Tumors - The FDA accepted the NDA submission for Nirogacestat in desmoid tumors in Q1 2023 with Priority Review, with a PDUFA date of August 27, 2023 [61] - Desmoid tumor recurrence can be up to 77% following surgery [67] - In the Phase 3 DeFi trial, the objective response rate (ORR) for Nirogacestat was 41%, compared to 8% for placebo (p<0001) [90] - The Phase 3 DeFi trial demonstrated a 71% reduction in the risk of disease progression with Nirogacestat (hazard ratio: 029, p<0001) [140] - Among women of childbearing potential, ovarian dysfunction (OD) was observed in 75% receiving nirogacestat [119] Mirdametinib in NF1-PN - Topline data from the Phase 2b ReNeu trial in NF1-PN is expected in 2H 2023 [163] - NF1 patients have a ~30-50% lifetime risk of developing NF1-PN [151] - In the ReNeu trial, 50% of adult patients achieved an objective response by BICR [170] MAPK Portfolio - Approximately 25% of ER+ mBC patients progress on endocrine therapy [2] - Class 1 and 2 MEK mutants are sensitive to Mirdametinib in vitro [3] - BGB-3245 is active against resistance mutations that arise in BRAF V600 patients treated with approved BRAF inhibitors [270]
SpringWorks Therapeutics(SWTX) - 2022 Q4 - Annual Report
2023-02-28 11:39
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State of Other Jurisdiction of incorporation o ...
SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow
2022-11-04 18:07
Corporate Presentation November 2022 六 SpringW Forward-Looking Statements 2 Note: Unless otherwise indicated, the information presented herein is as of November 2022 and made publicly available on November 3, 2022. This presentation may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding t ...
SpringWorks Therapeutics(SWTX) - 2022 Q2 - Quarterly Report
2022-08-04 10:38
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2022 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 ______ ...
SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow
2022-06-08 17:42
Corporate Presentation May 2022 次 Spring\wੂ Forward-Looking Statements 2 Note: Unless otherwise indicated, the information presented herein is as of May 2022 and made publicly available on May 24, 2022. This presentation may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of ...
SpringWorks Therapeutics(SWTX) - 2022 Q1 - Quarterly Report
2022-05-05 11:03
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2022 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 100 Washington Blvd Stamford, Connecticut 06902 (Address of principal execut ...
SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow
2022-03-11 18:31
Corporate Presentation March 2022 次 Spring\W Forward-Looking Statements Note: Unless otherwise indicated, the information presented herein is as of February 2022 and made publicly available on March 4, 2022. This presentation may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our bus ...
SpringWorks Therapeutics(SWTX) - 2021 Q4 - Annual Report
2022-02-24 11:49
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State of Other Jurisdiction of incorporation o ...