SEC Form 10-Q filed by SpringWorks Therapeutics Inc.
$SWTX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
____________________________________________________
FORM 10-Q
____________________________________________________
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025
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
__________________________________
(Exact name of registrant as specified in its charter)
__________________________________
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
(203 ) 883-9490
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
_________________________________________
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| x | Accelerated filer | ¨ | |||||||||
| Non-accelerated filer | ¨ | Smaller reporting company | |||||||||
| Emerging growth company | |||||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The number of outstanding shares of the Registrant’s Common Stock as of May 2, 2025 was 75,322,696 .
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, these forward-looking statements can be identified by the use of words such as “may”, “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
•our proposed acquisition by Merck KGaA, Darmstadt, Germany including our expectations regarding the anticipated occurrence, manner, timing and completion thereof and its effects on our relationships with employees, customers, suppliers, other business partners or governmental entities;
•our ability to continue commercializing OGSIVEO® (nirogacestat), including our ability to successfully maintain commercial manufacturing and supply chains for OGSIVEO, and our expectations regarding the size and growth potential of the commercial markets for OGSIVEO;
•our ability to continue commercializing GOMEKLITM (mirdametinib), including our ability to successfully establish and maintain commercial manufacturing and supply chains for GOMEKLI, and our expectations regarding the size and growth potential of the commercial markets for GOMEKLI;
•the timing and outcome of our regulatory submissions and interactions, including the decision on the Marketing Authorization Application, or MAA, for nirogacestat for patients with desmoid tumors that we received validation for in February 2024 by the European Medicines Agency, or EMA, the Committee for Medicinal Products for Human Use’s opinion on such MAA and the decision on the MAA filing for mirdametinib for patients with neurofibromatosis type 1-associated plexiform neurofibromas, or NF1-PN that we received validation for in August 2024 by the EMA, as well as our interactions with other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies;
•the success, cost and timing of our product development activities and clinical trials, the initiation and completion of any other clinical trials and related preparatory work, the expected timing of the availability of results of our clinical trials;
•the fact that topline or interim data from our clinical studies may not be predictive of the final or more detailed results of such study or the results of other ongoing or future studies;
•our ability and our partners’ ability to enroll and successfully complete clinical trials of our product candidates for additional uses, and in combination with other agents;
•the potential attributes and benefits of our product candidates;
•our plans to commercialize any of our product candidates that achieve approval either alone or in partnership with others;
•the period over which we anticipate our existing cash, cash equivalents and marketable securities, will be sufficient to fund our operating expenses and capital expenditure requirements;
•the potential for our business development efforts to maximize the potential value of our portfolio;
•our ability to identify, in-license or acquire additional product candidates;
•the ability and willingness of our third-party collaborators to continue research and development activities relating to our product candidates, including those that are being developed as combination therapies;
•our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product;
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•the potential benefit of orphan drug exclusivity, Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, and Rare Pediatric Disease designation for nirogacestat, mirdametinib and any other of our product candidates that may receive one or more of these designations;
•our ability to compete with companies currently marketing or engaged in the development of treatments for desmoid tumors, NF1-PN and other oncology and rare disease indications;
•our expectations regarding our ability to obtain and maintain intellectual property protection or market exclusivity for our product candidates and the duration of such protection;
•our ability and the potential to successfully manufacture our product candidates for preclinical studies, clinical trials and, if approved, for commercial use, the capacity of our current contract manufacturing organizations, or CMOs, to support clinical supply and commercial-scale production for product candidates and approved products, and our potential election to pursue additional CMOs for manufacturing supplies of drug substance and finished drug product in the future;
•the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
•the rate and degree of market acceptance of our product candidates, if approved;
•regulatory developments in the United States and foreign countries;
•our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;
•the success of competing products that are, or may become, available;
•risks associated with global political changes and global economic conditions, including changes in tariff policy being implemented by the current U.S. presidential administration, inflation or uncertainty caused by political violence and unrest, including ongoing global and regional conflicts;
•our ability to attract and retain key scientific, medical, commercial and management personnel;
•our estimates regarding expenses, future revenue, future profitability, capital requirements and need for additional financing;
•our financial performance; and
•developments and projections relating to our competitors or our industry.
Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events and future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described under Part II, Item 1A, Risk Factors and elsewhere in this Quarterly Report. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
We may from time to time provide estimates, projections and other information concerning our industry, the general business environment, and the markets for certain diseases, including estimates regarding the potential size of those markets and the estimated incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events, circumstances or numbers, including actual disease prevalence rates and market size, may differ materially from the information provided. Unless otherwise expressly stated, we obtained this industry information, business information, market data, prevalence information and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources, in each case, from sources we consider to be reliable, and in some cases applying our own assumptions and analysis that may, in the future, prove not to have been accurate.
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SPRINGWORKS THERAPEUTICS, INC.
FORM 10-Q
FOR THE QUARTER ENDED March 31, 2025
INDEX
| Page | |||||
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
SpringWorks Therapeutics, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
| March 31, 2025 | December 31, 2024 | ||||||||||
| (in thousands, except share and per-share data) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Marketable securities | |||||||||||
| Accounts receivable, net | |||||||||||
| Inventory | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
| Long-term marketable securities | |||||||||||
| Property and equipment, net | |||||||||||
| Operating lease right-of-use assets | |||||||||||
| Equity method investment | |||||||||||
| Restricted cash | |||||||||||
| Other assets | |||||||||||
| Total assets | $ | $ | |||||||||
| Liabilities and Stockholders’ equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued expenses | |||||||||||
| Operating lease liabilities, current | |||||||||||
| Total current liabilities | |||||||||||
| Operating lease liabilities, long-term | |||||||||||
| Total liabilities | |||||||||||
| Commitments and contingencies | |||||||||||
| Stockholders’ equity: | |||||||||||
Preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated deficit | ( | ( | |||||||||
Treasury stock, at cost ( | ( | ( | |||||||||
| Accumulated other comprehensive (loss) income | |||||||||||
| Total stockholders’ equity | |||||||||||
| Total liabilities and stockholders’ equity | $ | $ | |||||||||
See accompanying unaudited notes to condensed consolidated financial statements
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SpringWorks Therapeutics, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
| Three Months Ended March 31, | |||||||||||
| (in thousands, except share and per-share data) | 2025 | 2024 | |||||||||
| Revenue: | |||||||||||
| $ | $ | ||||||||||
| Total revenue | |||||||||||
| Operating costs and expenses: | |||||||||||
| Cost of product revenue | |||||||||||
| Selling, general and administrative | |||||||||||
| Research and development | |||||||||||
| Total operating costs and expenses | |||||||||||
| Loss from operations | ( | ( | |||||||||
| Interest and other (expense) income: | |||||||||||
| Interest and other (expense) income, net | ( | ||||||||||
| Total interest and other (expense) income | ( | ||||||||||
| Equity method investment loss | ( | ( | |||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Net loss per share, basic and diluted | $ | ( | $ | ( | |||||||
| Weighted average common shares outstanding, basic and diluted | |||||||||||
See accompanying unaudited notes to condensed consolidated financial statements
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SpringWorks Therapeutics, Inc.
Condensed Consolidated Statements of Comprehensive Loss (Unaudited)
| Three Months Ended March 31, | |||||||||||
| (in thousands) | 2025 | 2024 | |||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Changes in other comprehensive income (loss): | |||||||||||
| Unrealized gain (loss) on marketable securities, net | ( | ||||||||||
| Total changes in other comprehensive income (loss) | $ | $ | ( | ||||||||
| Comprehensive loss | $ | ( | $ | ( | |||||||
See accompanying unaudited notes to condensed consolidated financial statements
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SpringWorks Therapeutics, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited)
| Three Months Ended March 31, 2025 and March 31, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Common | Treasury | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total | |||||||||||||||||||||||||||||||||||||||||||||
| (in thousands, except share data) | Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | ( | $ | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||
| Equity-based compensation expense | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Forfeitures of restricted stock awards | ( | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| Restricted stock units vested | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of stock options | — | |||||||||||||||||||||||||||||||||||||||||||||||||
| Shares of common stock used to satisfy tax withholding obligations | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | ( | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | ( | $ | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||
| Equity-based compensation expense | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Restricted stock units vested | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Exercise of stock options | — | |||||||||||||||||||||||||||||||||||||||||||||||||
| Shares of common stock used to satisfy tax withholding obligations | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income, net of tax | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2025 | $ | $ | ( | $ | $ | $ | ( | $ | ||||||||||||||||||||||||||||||||||||||||||
See accompanying unaudited notes to condensed consolidated financial statements
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SpringWorks Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended March 31, | |||||||||||
| (in thousands) | 2025 | 2024 | |||||||||
| Operating activities | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation and amortization expense | |||||||||||
| Non-cash operating lease expense | |||||||||||
| Equity-based compensation expense | |||||||||||
| Equity method investment loss and impairment | |||||||||||
| Changes in operating assets and liabilities | |||||||||||
| Accounts receivable, net | ( | ||||||||||
| Inventory | ( | ( | |||||||||
| Prepaid expenses and other current assets | ( | ||||||||||
| Other assets | ( | ( | |||||||||
| Accounts payable | ( | ||||||||||
| Accrued expenses | ( | ( | |||||||||
| Lease liability | ( | ( | |||||||||
| Net cash used in operating activities | $ | ( | $ | ( | |||||||
| Investing activities | |||||||||||
| Capital expenditures | ( | ( | |||||||||
| Equity method investment | ( | ||||||||||
| Purchases of marketable securities | ( | ||||||||||
| Proceeds from sale and maturity of marketable securities | |||||||||||
| Net cash provided by investing activities | $ | $ | |||||||||
| Financing activities | |||||||||||
| Treasury stock | ( | ( | |||||||||
| Proceeds from stock option exercises | |||||||||||
| Net cash used in financing activities | $ | ( | $ | ( | |||||||
| Net (decrease) increase in cash and cash equivalents | ( | ( | |||||||||
| Cash and cash equivalents including Restricted cash, beginning of period | |||||||||||
| Cash and cash equivalents including Restricted cash, end of period | $ | $ | |||||||||
| Supplemental non-cash disclosure | |||||||||||
| Milestone payment for first commercial sale of GOMEKLI included in accrued expenses as of March 31, 2025 | $ | $ | |||||||||
See accompanying unaudited notes to condensed consolidated financial statements
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SpringWorks Therapeutics, Inc.
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. Nature of Operations
SpringWorks Therapeutics, Inc., together with its wholly-owned subsidiaries, collectively, the Company, is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. The Company has a differentiated portfolio of small molecule targeted oncology assets, including two approved products and several clinical and preclinical candidates at various stages of development, and is advancing programs in rare tumor types as well as highly prevalent, genetically defined cancers. The Company currently commercializes its two approved products, OGSIVEO® (nirogacestat) and GOMEKLITM (mirdametinib), in the United States. OGSIVEO was approved by the United States Food and Drug Administration, or FDA, on November 27, 2023 for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. GOMEKLI was approved by the FDA on February 11, 2025 for the treatment of adult and pediatric patients two years of age and older with neurofibromatosis type 1, or NF1, who have symptomatic plexiform neurofibromas, or PN, not amenable to complete resection.
The Company has incurred losses and negative operating cash flows since inception and had an accumulated deficit of $1.2 billion and $1.2 billion, and working capital of $274.1 million and $280.5 million, as of March 31, 2025 and December 31, 2024, respectively. In December 2023, we began to generate revenue from sales of OGSIVEO in the United States and in February 2025, we began to generate revenue from sales of GOMEKLI in the United States. For the three months ended March 31, 2025, the Company recorded net product revenue of $49.1 million from the sales of OGSIVEO and GOMEKLI.
The Company had cash, cash equivalents and marketable securities of $382.7 million and $461.9 million as of March 31, 2025 and December 31, 2024, respectively. Based on the Company’s cash, cash equivalents and marketable securities as of March 31, 2025, management estimates that its current liquidity will enable it to meet operating expenses through at least twelve months after the date that these financial statements are issued.
Agreement and Plan of Merger
2. Basis of Presentation
The Company’s unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and Article 10 of Regulation S-X of the Securities and Exchange Commission, or SEC, and should be read in conjunction with the Company's consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 20, 2025. The condensed consolidated financial statements presented in this Quarterly Report on Form 10-Q are unaudited; however, in the opinion of management, such financial statements reflect all adjustments, consisting solely of normal recurring adjustments, necessary for a fair presentation of the results for the interim periods presented.
Use of Estimates
Summary of Significant Accounting Policies
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The Company’s significant accounting policies are described in Note 3 to the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 20, 2025. There have been no significant changes in the Company’s significant accounting policies from those disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 20, 2025.
Recently Adopted and Recently Issued Accounting Pronouncements
There were no recently adopted accounting pronouncements that had a material impact on the Company's financial statements.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, to provide more detailed income tax disclosure requirements. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation as well as information on income taxes paid. The disclosure requirements should be applied on a prospective basis, with the option to apply it retrospectively. The effective date for the standard is for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company does not expect ASU 2023-09 to have a material impact on the Company's financial statements.
3. Marketable Securities
The following table summarizes the Company’s available-for-sale marketable securities as of March 31, 2025 and December 31, 2024:
| As of March 31, 2025 | |||||||||||||||||||||||
| (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||
| Marketable securities: | |||||||||||||||||||||||
| Short-term investments: | |||||||||||||||||||||||
| U.S. government securities | $ | $ | $ | $ | |||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Long-term investments: | |||||||||||||||||||||||
| U.S. government securities | ( | ||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | ||||||||||||||||||
| As of December 31, 2024 | |||||||||||||||||||||||
| (in thousands) | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||||||||
| Marketable securities: | |||||||||||||||||||||||
| Short-term investments: | |||||||||||||||||||||||
| U.S. government securities | $ | $ | $ | $ | |||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||
| Long-term investments: | |||||||||||||||||||||||
| U.S. government securities | ( | ||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total | $ | $ | $ | ( | $ | ||||||||||||||||||
The Company’s marketable securities are available-for-sale securities and consist of high-quality, highly liquid debt securities including corporate debt securities, U.S. government securities, and commercial paper.
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The Company’s securities classified as short-term marketable securities mature within one year or less of the balance sheet date. Marketable securities that mature greater than one year from the balance sheet date are classified as long-term. As of March 31, 2025, the Company did not hold any investments with maturity dates greater than five years.
As of, and for the three months ended March 31, 2025, the Company did not have any allowance for credit losses or impairments of its marketable securities.
4. Fair Value Measurements
The fair value of the Company’s financial assets measured on a recurring basis are classified based upon a fair value hierarchy consisting of the following three levels:
Level 1 — Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets, or liabilities.
Level 2 — Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the instrument.
Level 3 — Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
The fair value hierarchy is based on inputs to valuation techniques used to measure fair value that are either observable or unobservable. Observable inputs reflect assumptions market participants would use in pricing an asset or liability based on market data obtained from independent sources while unobservable inputs reflect a reporting entity's pricing based upon their own market assumptions.
As of March 31, 2025 and December 31, 2024, the Company's financial assets and liabilities measured at fair value on a recurring basis consisted of the following:
| As of March 31, 2025 | |||||||||||||||||||||||
| Fair Value Hierarchy | |||||||||||||||||||||||
| (in thousands) | Total | Level 1 | Level 2 | Level 3 | |||||||||||||||||||
| Financial instruments carried at fair value (asset position): | |||||||||||||||||||||||
| Cash equivalents: | |||||||||||||||||||||||
| Money market funds | $ | $ | $ | $ | |||||||||||||||||||
| Short-term investments: | |||||||||||||||||||||||
| U.S. government securities | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Long-term investments: | |||||||||||||||||||||||
| U.S. government securities | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
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| As of December 31, 2024 | |||||||||||||||||||||||
| Fair Value Hierarchy | |||||||||||||||||||||||
| (in thousands) | Total | Level 1 | Level 2 | Level 3 | |||||||||||||||||||
| Financial instruments carried at fair value (asset position): | |||||||||||||||||||||||
| Cash equivalents: | |||||||||||||||||||||||
| Money market funds | $ | $ | $ | $ | |||||||||||||||||||
| Short-term investments: | |||||||||||||||||||||||
| U.S. government securities | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Commercial paper | |||||||||||||||||||||||
| Long-term investments: | |||||||||||||||||||||||
| U.S. government securities | |||||||||||||||||||||||
| Corporate debt securities | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
As of March 31, 2025 and December 31, 2024, the Company’s financial assets measured at fair value on a recurring basis using a market approach included cash equivalents, which consist of money market funds, and marketable securities, which consist of high-quality, highly liquid available-for-sale debt securities including corporate debt securities, U.S. government securities, and commercial paper.
The Company’s money market funds are readily convertible into cash and the net asset value of each fund on the last day of the quarter is used to determine fair value. The U.S. government securities are classified as Level 1 and valued utilizing quoted market prices. The Company’s corporate debt securities, and commercial paper are classified as Level 2 and valued utilizing various market and industry inputs.
The Company considers all highly liquid instruments that have maturities of three months or less when acquired to be cash equivalents. The carrying amounts for cash equivalents, accounts payable, and accrued expenses approximate fair value due to their short-term maturities.
5. Collaboration, Licensing and Variable Interest Entities
MapKure
In June 2019, the Company announced the formation of MapKure LLC, or MapKure, an entity jointly owned by the Company and BeiGene Ltd., or BeiGene. BeiGene licensed to MapKure exclusive rights to brimarafenib (BGB-3245). During March 2025, the Company and BeiGene made the decision to wind-down MapKure and cease further investment in the joint venture following a review of the totality of data generated across clinical trials of brimarafenib. Concurrently with this decision, the MapKure joint steering committee, which includes the Company, elected to discontinue the Phase 1b combination trial of brimarafenib with panitumumab, a monoclonal antibody targeting Epidermal Growth Factor Receptor, or EGFR, in colorectal and pancreatic cancer patients with known MAPK pathway mutations. As a result, and following the recent terminations of other monotherapy and combination studies, there remain no ongoing programs under development by MapKure. As of March 31, 2025, the Company’s ownership interest in MapKure was 39.7 %.
The Company recognized an equity loss of $1.7 million and $1.0 million for the three-month periods ended March 31, 2025 and March 31, 2024, respectively. In addition, based on the decision to wind-down MapKure, the Company fully impaired the carrying value of the investment of $2.5 million, and included the Company’s portion of funding to support wind-down activities, estimated at $2.4 million. This resulted in a total impairment charge of $4.9 million, which is included in Interest and other (expense) income, net. These commitments are expected to replace the $6.2 million due from the Company at each of the second and third closings previously established by the Series C preferred unit purchase agreement.
6. Accrued Expenses
Accrued expenses consists of the following:
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| March 31, | December 31, | |||||||||||||
| (in thousands) | 2025 | 2024 | ||||||||||||
| Accrued compensation and benefits | $ | $ | ||||||||||||
| Accrued research and development | ||||||||||||||
| Accrued milestone | ||||||||||||||
| Accrued other | ||||||||||||||
| Total accrued expenses | $ | $ | ||||||||||||
GOMEKLI was approved by the FDA on February 11, 2025 for the treatment of adult and pediatric patients two years of age and older with neurofibromatosis type 1, or NF1, who have symptomatic plexiform neurofibromas, or PN, not amenable to complete resection. Upon the first commercial sale of GOMEKLI in February 2025, a milestone payment of $6.0 million is due to Pfizer, which has been accrued and included in accrued expenses as of March 31, 2025. This milestone payment is due 180 days after the milestone is met and is expected to be paid in the third quarter of 2025.
7. Commitments and Contingencies
The Company enters into contracts in the normal course of business for clinical trials, preclinical studies, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice and therefore the Company believes that non-cancelable obligations under these agreements are not material.
Additionally, the Company has excluded milestone or royalty payments or other contractual payment obligations as the timing and amounts of such obligations are unknown or uncertain.
Contingencies
From time to time, the Company may be involved in disputes or regulatory inquiries that arise in the ordinary course of business. When the Company determines that a loss is both probable and reasonably estimable, a liability is recorded and disclosed if the amount is material to the financial statements taken as a whole. When a material loss contingency is only reasonably possible, the Company does not record a liability, but instead discloses the nature and the amount of the claim, and an estimate of the loss or range of loss, if such an estimate can reasonably be made.
As of March 31, 2025, there was no litigation or contingency with at least a reasonable possibility of a material loss.
8. Equity-Based Compensation
2019 Equity Incentive Plan
The Company's 2019 Stock Option and Incentive Plan, or 2019 Equity Incentive Plan, provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards and dividend equivalent rights to the Company’s officers, employees, directors and other key persons (including consultants). The number of shares available for issuance under the 2019 Equity Incentive Plan is cumulatively increased each January 1, through and including January 1, 2030, by 5 % of the number of shares of Common Stock outstanding on the immediately preceding December 31 or such lesser number of shares as determined by the compensation committee of the Company’s board of directors.
As of March 31, 2025, there were 5,046,965 shares available for issuance in connection with future awards under the 2019 Equity Incentive Plan.
Equity-Based Awards
During the three months ended March 31, 2025, the Company granted 1,139,369 stock option awards to its officers, employees and directors under the 2019 Equity Incentive Plan.
During the three months ended March 31, 2025, the Company awarded 1,208,258 restricted stock units to its officers, employees and directors under the 2019 Equity Incentive Plan.
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During the three months ended March 31, 2025, 11,101 restricted stock awards previously issued to employees of the Company were released, 708,468 restricted stock units vested and 89,972 stock options were exercised. As of March 31, 2025, there were 8,913,890 stock options vested and exercisable.
Performance Stock Units
On January 10, 2025, the Company’s officers were granted 229,813 performance based restricted stock units (the target amount) that are subject to a total shareholder return, or TSR, market condition based on the Company’s relative TSR percentile rank compared to companies in the NASDAQ Biotechnology Index during the three-year performance period, and are eligible to be earned and vested from 0 % to 150 % of the target amount.
Equity-based compensation expense included in the condensed consolidated statements of operations for each of the periods presented is as follows:
| Three Months Ended March 31, | |||||||||||
| (in thousands) | 2025 | 2024 | |||||||||
| Research and development | $ | $ | |||||||||
| Selling, general and administrative | |||||||||||
| Total equity-based compensation expense | $ | $ | |||||||||
As of March 31, 2025, the unrecognized compensation expense related to unvested stock options, restricted stock units and performance stock units was $116.5 million, $84.8 million and $17.1 million, respectively, which is expected to be recognized over a weighted-average remaining period of approximately 2.40 years, 2.14 years and 2.08 years, respectively.
9. Net Loss per Share
Since the Company had a net loss in each of the periods presented, basic and diluted net loss per share are the same. The table below provides potentially dilutive securities not included in the computation of the diluted net loss per share for the periods ended March 31, 2025 and March 31, 2024 because to do so would be anti-dilutive:
| As of March 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Common stock options issued and outstanding | |||||||||||
| Restricted stock units subject to future vesting | |||||||||||
| Performance stock units subject to future vesting | |||||||||||
| Restricted stock awards subject to future vesting | |||||||||||
| Total potentially dilutive securities | |||||||||||
10. Segment Reporting
The Company has one reportable segment relating to developing and commercializing life-changing medicines.
The Company's chief operating decision maker, or CODM, is its chief executive officer. When evaluating the Company’s financial performance, the CODM reviews total revenues, total expenses and expenses by function and the CODM makes decisions using this information on a company-wide basis.
The table below is a summary of the segment net loss, including significant segment expenses by function:
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| Three Months Ended March 31, | |||||||||||
| (in thousands) | 2025 | 2024 | |||||||||
| Revenue | $ | $ | |||||||||
| Less segment expenses: | |||||||||||
| Cost of product revenue | |||||||||||
| Commercial | |||||||||||
| General and administrative | |||||||||||
| Development and discovery | |||||||||||
| Medical | |||||||||||
| Total operating and segment expenses | |||||||||||
| Interest and other (expense) income, net | ( | ||||||||||
| Equity method investment loss | ( | ( | |||||||||
| Segment and consolidated net loss | $ | ( | $ | ( | |||||||
11. Subsequent Events
On April 27, 2025, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Merck KGaA, Darmstadt, Germany, a German corporation with general partners (“Parent”), and EMD Holdings Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), pursuant to which Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly owned subsidiary of Parent.
At the effective time of the Merger, each share of common stock of the Company (other than (i) shares owned by Parent, Merger Sub or any other wholly owned subsidiary of Parent, the Company or any wholly owned subsidiary of the Company, in each case not held on behalf of third parties, immediately prior to the effective time of the Merger and (ii) shares that are held by any person who is entitled to demand and properly demands appraisal of such shares pursuant to, and who complies in all respects with Section 262 of the Delaware General Corporation Law) will automatically be cancelled and converted into the right to receive an amount in cash equal to $47.00 , without interest and subject to applicable withholding taxes.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of the financial condition and results of operations of SpringWorks Therapeutics, Inc. should be read in conjunction with the condensed consolidated financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q, or Quarterly Report, and our consolidated financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, or 2024 Form 10-K, filed with the Securities and Exchange Commission, or SEC, on February 20, 2025. Unless the context otherwise requires, all references to "we," "us," "our," "SpringWorks," or the "Company" refer to SpringWorks Therapeutics, Inc., together with its subsidiaries. This discussion and analysis contains forward-looking statements based upon current expectations that involve risks and uncertainties. We caution you that forward-looking statements are not guarantees of future performance, and that our actual results of operations, financial condition and liquidity, and the developments in our business and the industry in which we operate, may differ materially from the results discussed or projected in the forward-looking statements contained in this Quarterly Report. We discuss risks and other factors that we believe could cause or contribute to these potential differences elsewhere in this Quarterly Report, including in Part II, Item 1A. “Risk Factors” and under “Special Note Regarding Forward-Looking Statements.” In addition, even if our results of operations, financial condition and liquidity, and the developments in our business and the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments in future periods. We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Overview
We are a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and commercializing life-changing medicines for underserved patient populations suffering from devastating rare diseases and cancer. We have a differentiated portfolio of small molecule targeted oncology assets, including two approved products and several clinical and preclinical candidates at various stages of development, and are advancing programs in rare tumor types as well as highly prevalent, genetically defined cancers. Our strategic approach and operational excellence across research, translational science, and clinical development have enabled us to successfully launch two products, investigate additional product candidates across various clinical trials, and enter into multiple shared-value partnerships with industry leaders to expand our portfolio. From this foundation, we are continuing to build a differentiated, fully-integrated, commercial-stage biopharmaceutical company intensely focused on understanding patients and their diseases in order to develop transformative targeted medicines.
Pending Transaction with Merck KGaA, Darmstadt, Germany
On April 27, 2025, the Company, entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Merck KGaA, Darmstadt, Germany, a German corporation with general partners (“Parent”), and EMD Holdings Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), pursuant to which Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly owned subsidiary of Parent. At the effective time of the Merger, each share of common stock of the Company (other than (i) shares owned by Parent, Merger Sub or any other wholly owned subsidiary of Parent, the Company or any wholly owned subsidiary of the Company, in each case not held on behalf of third parties, immediately prior to the effective time of the Merger and (ii) shares that are held by any person who is entitled to demand and properly demands appraisal of such shares pursuant to, and who complies in all respects with Section 262 of the Delaware General Corporation Law) will automatically be cancelled and converted automatically into the right to receive an amount in cash equal to $47.00, without interest, subject to applicable withholding taxes.
The Merger is subject to customary closing conditions, including the affirmative vote of holders of at least a majority of the outstanding shares of the Company’s common stock entitled to vote on the adoption of the Merger Agreement at a meeting of Company stockholders duly called and held for such purpose, the expiration of the applicable waiting periods (and any extension thereof) under the Hart-Scott Rodino Antitrust Improvements Act of 1976 and a certain foreign antitrust and competition law, each as amended, and other customary closing conditions. The Merger Agreement contains customary termination rights for the Company and Parent. If the Merger Agreement is terminated by the Company under specific circumstances, it will be required to pay Parent a termination fee of $145.6 million in cash.
Our Products and Product Candidates
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OGSIVEO® (nirogacestat), our first commercial product, was approved by the United States Food and Drug Administration, or FDA, on November 27, 2023. OGSIVEO is a novel, oral, selective gamma secretase inhibitor that is the first and only FDA-approved therapy for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.
The FDA approval of OGSIVEO was based on the results from the Phase 3 DeFi trial, which were published in the March 9, 2023 edition of the New England Journal of Medicine. DeFi was a global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors. The study randomized 142 patients to receive 150 mg of nirogacestat or placebo twice daily. OGSIVEO met the primary endpoint of improving progression-free survival, or PFS, demonstrating a statistically significant improvement for nirogacestat over placebo, with a 71% reduction in the risk of disease progression (hazard ratio (HR) = 0.29 (95% CI: 0.15, 0.55); p< 0.001). Median PFS was not reached in the OGSIVEO arm and was 15.1 months in the placebo arm. Confirmed objective response rate, or ORR, based on RECIST v1.1 was 41% with OGSIVEO versus 8% with placebo (p<0.001); the complete response rate was 7% in the OGSIVEO arm and 0% in the placebo arm. The median time to first response was 5.6 months with OGSIVEO and 11.1 months with placebo. PFS and ORR improvements were in favor of OGSIVEO regardless of baseline characteristics including sex, tumor location, tumor focality, treatment status, previous treatments, mutational status and history of familial adenomatous polyposis. OGSIVEO also demonstrated early and sustained improvements in patient-reported outcomes, including pain, desmoid tumor-specific symptoms, physical/role function and overall health-related quality of life.
OGSIVEO exhibited a manageable safety and tolerability profile. The most common adverse events (>15%) reported in patients receiving OGSIVEO were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea. Warnings & Precautions include diarrhea, ovarian toxicity, hepatotoxicity, non-melanoma skin cancers, electrolyte abnormalities and embryo-fetal toxicity.
Long-term efficacy and safety data from DeFi were presented at the Connective Tissue Oncology Society, or CTOS, 2024 Annual Meeting on November 16, 2024. These results, utilizing an August 2024 data cutoff date, showed that longer-term treatment with OGSIVEO was associated with further reductions in tumor size, increase in ORR with additional complete responses, sustained improvement in desmoid tumor symptoms, and no new safety signals compared to the April 2022 primary data cut. In March 2025, we submitted the long-term efficacy and safety data from DeFi to a peer-reviewed journal, with publication anticipated by the end of 2025.
OGSIVEO is the first and only FDA-approved treatment indicated specifically for desmoid tumors. Nirogacestat is recommended as a National Comprehensive Cancer Network, or NCCN, Category 1, Preferred treatment option for desmoid tumors in the NCCN Clinical Practice Guidelines in Oncology, or NCCN Guidelines®, for Soft Tissue Sarcoma. Additionally, a June 2024 review of the current management of desmoid tumors from the Desmoid Tumor Working Group, or DTWG, highlighted nirogacestat’s role as the first approved medicine for the disease and its incorporation into the desmoid tumor treatment algorithm.
We are advancing a commercial strategy focused on reinforcing OGSIVEO's position as the systemic standard of care for adult desmoid tumor patients. For the three months ended March 31, 2025, we recorded net product revenue of $44.1 million from sales of OGSIVEO in the United States.
We are also seeking to expand the reach of OGSIVEO to additional geographies. In February 2024, we received validation for a Marketing Authorization Application, or MAA, from the European Medicines Agency, or EMA, for the treatment of adults with desmoid tumors. We anticipate the Committee for Medicinal Products for Human Use, or CHMP, of the EMA will adopt an opinion on the MAA in the second quarter of 2025. Pre-commercial preparations are underway ahead of expected launch in the second half of 2025. Beyond the United States and Europe, we continue to advance our efforts to bring OGSIVEO to the market in additional territories, such as Japan.
GOMEKLITM (mirdametinib), our second commercial product, was approved by the FDA on February 11, 2025. GOMEKLI is an oral, small molecule mitogen-activated protein kinase kinase, or MEK, inhibitor, indicated for the treatment of adult and pediatric patients two years of age and older with neurofibromatosis type 1, or NF1, who have symptomatic plexiform neurofibromas, or PN, not amenable to complete resection. With the approval of GOMEKLI, we received a rare pediatric disease priority review voucher from the FDA.
A milestone was met upon the first commercial sale of GOMEKLI in February 2025, and a milestone payment of $6.0 million is due to Pfizer, which has been accrued and included in accrued expenses as of March 31, 2025. This milestone is expected to be paid in the third quarter of 2025.
The FDA approval of GOMEKLI was based on the results from the registrational Phase 2b ReNeu trial in adult and pediatric patients with NF1-PN. In November 2023, we announced positive topline results from the ReNeu trial, and we presented
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additional data from the ReNeu trial at the American Society of Clinical Oncology, or ASCO, Annual Meeting in June 2024. The results of the ReNeu trial were subsequently published in the Journal of Clinical Oncology in November 2024. The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the United States. The primary endpoint was confirmed objective response rate, or ORR, defined as ≥ 20% reduction in target tumor volume as measured by MRI and assessed by Blinded Independent Central Review, or BICR. As of the data cutoff date of September 20, 2023, 52% (29/56) of pediatric patients and 41% (24/58) of adult patients had BICR confirmed objective responses within the 24-cycle treatment period (cycle length: 28 days). An additional pediatric patient and two additional adult patients achieved confirmed objective responses after Cycle 24 in the long-term follow up phase of the trial, where patients continue to receive GOMEKLI treatment. Median (range) best percent change from baseline in target tumor volume was -42% (-91% to 48%) and -41% (-90% to 13%) in the pediatric and adult cohorts, respectively; among study participants with a confirmed objective response on GOMEKLI, 52% of children and 62% of adults achieved a >50% reduction in tumor volume. As of the data cutoff, the median duration of treatment was 22 months in both the pediatric and adult cohorts; the median time to onset of response was 7.9 months in pediatric patients and 7.8 months in adult patients. Median duration of response was not reached in either cohort. Pediatric and adult patients in the ReNeu trial also experienced statistically significant improvements from baseline in worst tumor pain severity, pain interference, and health-related quality of life, as assessed across multiple patient-reported outcome, or PRO, tools. Children and adults with NF1-PN in the ReNeu trial reported early, sustained, and clinically meaningful reductions in worst tumor pain severity and pain interference over the course of GOMEKLI treatment.
GOMEKLI exhibited a manageable safety and tolerability profile. The most common adverse events (>25%) reported in adult patients receiving GOMEKLI were rash, diarrhea, nausea, musculoskeletal pain, vomiting, and fatigue; in pediatric patients, the most common adverse events (>25%) were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction, and nausea. Warnings & Precautions include ocular toxicity, left ventricular dysfunction, dermatological adverse reactions, and embryo-fetal toxicity.
GOMEKLI is the first and only FDA-approved treatment indicated for both adult and pediatric patients with NF1-PN. We believe that GOMEKLI represents a differentiated and potentially best-in-class option for NF1-PN. In March 2025, the NCCN Guidelines® for Central Nervous System Cancers were updated to recommend mirdametinib as an NCCN Category 2a systemic therapy option for the treatment of adult and pediatric patients two years of age and older with NF1 who have symptomatic PN not amenable to complete resection.
We are advancing a targeted launch strategy focused on positioning GOMEKLI as the standard of care for both adult and pediatric NF1-PN patients. To support commercialization of GOMEKLI, we have assembled a U.S. commercial field organization of 35 territory business managers plus regional business directors. For the three months ended March 31, 2025, we recorded net product revenue of $4.9 million from sales of GOMEKLI in the United States.
We are also seeking to expand the reach of GOMEKLI to additional geographies. In August 2024, we received validation for an MAA from the EMA for the treatment of adult and pediatric patients with NF1-PN. We expect to receive a regulatory decision on mirdametinib from the EC and launch our product, if approved, in 2025. Beyond the United States and Europe, we continue to evaluate additional territories in which to potentially bring GOMEKLI to the market.
We are also seeking to expand the opportunity set for nirogacestat and mirdametinib in additional rare oncology indications and more prevalent, genetically defined cancers. Additionally, we are advancing a portfolio of early-stage product candidates in areas of high unmet need.
We completed the primary analysis from a Phase 2 trial evaluating nirogacestat as a monotherapy in adult patients with recurrent ovarian granulosa cell tumors, or GCT, a subtype of ovarian cancer. In April 2025, we submitted the results from the Phase 2 trial to a peer-reviewed journal, with publication anticipated by the end of 2025.
In hematologic malignancies, we are evaluating novel combination regimens of nirogacestat alongside B-cell maturation antigen, or BCMA, directed therapies for the treatment of multiple myeloma. We have entered into several, non-exclusive clinical collaboration agreements with industry partners to evaluate nirogacestat in combination with multiple different BCMA-directed therapies. Each partner is responsible for the conduct and expenses of a clinical trial to evaluate the combination of nirogacestat with its respective BCMA agent in multiple myeloma. To date, we have generated clinical data across several modalities that support nirogacestat’s ability to potentiate BCMA and enhance activity of BCMA targeted therapies at clinically achievable doses. Several Phase 1 studies are currently ongoing through our collaborators.
In genetically defined metastatic solid tumors, our current clinical-stage efforts center on the mitogen activated protein kinase, or MAPK, pathway. We are evaluating mirdametinib for the treatment of solid tumors harboring MAPK aberrations, including
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for the treatment of pediatric and young adult patients with low-grade gliomas. Data from the Phase 1 portion of an ongoing Phase 1/2 clinical trial being conducted by St. Jude Children’s Research Hospital study were presented at the Society of Neuro-Oncology Annual Meeting in November 2024 and showed encouraging clinical activity in patients with recurrent or progressive pediatric low-grade glioma. The Phase 2 portion of the study is ongoing and enrolling patients.
In June 2019, we announced the formation of MapKure, LLC, an entity jointly owned by us and BeiGene. BeiGene licensed to MapKure exclusive rights to brimarafenib, a novel, investigational, oral, selective small molecule inhibitor of monomeric and dimeric forms of activating BRAF mutations. In March 2025, we and BeiGene made the decision to wind-down MapKure and cease further investment in the joint venture following a review of the totality of data generated across clinical trials of brimarafenib. Concurrently with this decision, the MapKure joint steering committee, which includes the Company, elected to discontinue the Phase 1b combination trial of brimarafenib with panitumumab, a monoclonal antibody targeting Epidermal Growth Factor Receptor, or EGFR, in colorectal and pancreatic cancer patients with known MAPK pathway mutations. As a result, and following the recent terminations of other monotherapy and combination studies, there remain no ongoing programs under development by MapKure. Future financial commitments are expected to support wind-down activities, which are expected to conclude in early 2026 and are expected to be substantially less relative to the previously contemplated funding requirements as prescribed in the Series C preferred unit purchase agreement.
We intend to continue to build our portfolio with assets that have strong biological rationales and validated mechanisms of action. Our early-stage pipeline includes SW-682, an investigational oral, small molecule TEA Domain, or TEAD, inhibitor that we in-licensed from Katholieke Universiteit Leuven and the Flanders Institute for Biotechnology in 2021. In June 2024, we initiated a Phase 1a trial of SW-682 in Hippo-mutant solid tumors; patient enrollment and dosing is ongoing.
Additionally, in January 2025, we announced an exclusive worldwide license agreement with Rappta Therapeutics Oy, or Rappta, pursuant to which we in-licensed a portfolio of novel small molecule activators of protein phosphatase 2a, or PP2A, complexes. The primary compound covered by the license agreement is SW-3431, formerly known as RPT04402, an investigational, potentially first-in-class, PP2A activator. We expect to file an IND for SW-3431 in aggressive subsets of uterine cancer, including uterine serous carcinoma and uterine carcinosarcoma, with the FDA by the end of 2025.
We are also pursuing development of discovery programs that represent potentially first-in-class and best-in-class product candidates designed to address tumors where no or limited treatment options exist. We continue to invest in our R&D infrastructure in a focused manner in order to support both our drug discovery capabilities and our translational medicine activities for development programs. We also plan to continue exploring shared-value partnerships to maximize the potential of our therapies to transform the lives of oncology patients.
Components of our results of operations
Product revenue, net
In November 2023, the FDA approved OGSIVEO for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. In February 2025, the FDA approved GOMEKLI for the treatment of adult and pediatric patients two years of age and older with NF1 who have symptomatic PN not amenable to complete resection. In December 2023, we began to generate revenue from sales of OGSIVEO in the United States and in February 2025, we began to generate revenue from sales of GOMEKLI in the United States. We record product revenue net of estimated discounts, chargebacks, rebates, product returns, and other gross-to-net revenue deductions.
Operating costs and expenses
Cost of Product Revenue
Our cost of product revenue includes the cost of goods sold, amortization expense for commercial milestones and royalty expense. Our cost of goods sold consists of raw materials, third-party manufacturing costs to manufacture the raw materials into finished product, freight and other costs associated with sales of commercial products.
Selling, general and administrative expenses
Selling, general and administrative expenses consist primarily of salaries and related costs, including equity-based compensation, for personnel in executive, finance, corporate, commercial, business development and administrative functions. Selling, general and administrative expenses also include consulting services, legal fees relating to patent and corporate matters; professional fees for accounting, auditing and tax services; insurance costs; administrative travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.
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We anticipate that our selling, general and administrative expenses will increase in the future as we increase our headcount to expand operations to support the organization, including commercialization efforts.
Research and development expenses
Our research and development expenses consist of expenses incurred in connection with the development of our product candidates. These expenses include:
•employee-related expenses, which include salaries, benefits and equity-based compensation for our research and development personnel;
•fees paid to consultants for services directly related to our research and development programs;
•expenses incurred under agreements with third-party contract research organizations, investigative clinical trial sites, academic institutions and consultants that conduct research and development activities on our behalf or in collaboration with us;
•costs associated with discovery biology and medicinal chemistry efforts and with preclinical and clinical trials;
•costs associated with the manufacture of drug substance and finished drug product for preclinical testing and clinical trials;
•costs associated with technology and intellectual property licenses; and
•an allocated portion of facilities and facility-related costs, which include expenses for rent and other facility-related costs and other supplies.
External costs for research and development expenses are tracked on a program-by-program basis. Expenditures for clinical development, including upfront licensing fees and milestone payments associated with our product candidates, are charged to research and development expense as incurred. These expenses consist of expenses incurred in performing development activities, including salaries and benefits, materials and supplies, preclinical expenses, clinical trial and related clinical manufacturing expenses, depreciation of equipment, contract services and other outside expenses. Costs for certain development activities, such as manufacturing and clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using either time-based measures or data such as information provided to us by our vendors on actual activities completed or costs incurred.
We expect our research and development expenses to increase for the foreseeable future as we continue to invest in activities related to developing our product candidates and our preclinical programs, and as certain product candidates advance through clinical development, including SW-682, which is being studied in Hippo-mutant solid tumors in a Phase 1a trial, and SW-3431, which is in preclinical development for rare uterine cancers. The process of conducting the necessary clinical trials to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of any of our product candidates.
Interest and other (expense) income
Interest and other (expense) income consists primarily of interest income and other income/expense, including impairment charges. Interest income consists of interest earned on our cash, cash equivalents and available-for-sale marketable securities.
Equity method investment loss
The equity method investment loss represents our share of the losses from the MapKure investment, which is accounted for using the equity method of accounting.
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Results of Operations
Comparison of the three months ended March 31, 2025 and March 31, 2024
The following table summarizes our results of operations for the three months ended March 31, 2025 and March 31, 2024:
| Three Months Ended March 31, | ||||||||||||||||||||||||||
| (in thousands) | 2025 | 2024 | $ Change | % Change | ||||||||||||||||||||||
| Revenue: | ||||||||||||||||||||||||||
| Product revenue, net | $ | 49,087 | $ | 21,006 | $ | 28,081 | 134 | % | ||||||||||||||||||
| Total revenue | 49,087 | 21,006 | 28,081 | 134 | % | |||||||||||||||||||||
| Operating costs and expenses: | ||||||||||||||||||||||||||
| Cost of product revenue | 3,527 | 1,202 | 2,325 | 193 | % | |||||||||||||||||||||
| Selling, general and administrative | 76,501 | 60,113 | 16,388 | 27 | % | |||||||||||||||||||||
| Research and development | 49,595 | 53,622 | (4,027) | (8) | % | |||||||||||||||||||||
| Total operating costs and expenses | 129,623 | 114,937 | 14,686 | 13 | % | |||||||||||||||||||||
| Loss from operations | (80,536) | (93,931) | 13,395 | (14) | % | |||||||||||||||||||||
| Interest and other (expense) income: | ||||||||||||||||||||||||||
| Interest and other (expense) income, net | (998) | 7,571 | (8,569) | (113) | % | |||||||||||||||||||||
| Total interest and other (expense) income | (998) | 7,571 | (8,569) | (113) | % | |||||||||||||||||||||
| Equity method investment loss | (1,653) | (1,025) | (628) | 61 | % | |||||||||||||||||||||
| Net loss | $ | (83,187) | $ | (87,385) | $ | 4,198 | (5) | % | ||||||||||||||||||
Revenue
In November 2023, the FDA approved OGSIVEO for the treatment of adult patients with progressing desmoid tumors who require systemic treatment. For the three months ended March 31, 2025, we recorded net product revenue of $44.1 million from sales of OGSIVEO in the United States.
In February 2025, the FDA approved GOMEKLI for the treatment of adult and pediatric patients two years of age and older with NF1 who have symptomatic PN not amenable to complete resection. For the three months ended March 31, 2025, we recorded net product revenue of $4.9 million from sales of GOMEKLI in the United States.
Cost of Product Revenue
Our cost of product revenue includes the royalties associated with sales of OGSIVEO and GOMEKLI in the United States, amortization expense for commercial milestones and cost of goods sold.
Selling, general and administrative expenses
Selling, general and administrative expenses increased by $16.4 million to $76.5 million for the three months ended March 31, 2025 from $60.1 million for the three months ended March 31, 2024, an increase of 27%.
The increase in selling, general and administrative expenses included a $8.3 million increase in consulting and professional services and a $8.1 million increase in internal costs. The increase in consulting and professional services was largely attributable to commercial readiness activities to support the U.S. launch of GOMEKLI, as well as commercial activities supporting the continued U.S. commercialization and European pre-launch preparations for OGSIVEO. The increase in internal costs was attributable to the growth in employee costs associated with increases in the number of personnel, including an increase in equity-based compensation expense, driven by the growth of our commercial organization, which included establishing certain sales support, marketing, and commercialization functions to support the U.S. launch of GOMEKLI.
Research and development expenses
Research and development expenses decreased by $4.0 million to $49.6 million for the three months ended March 31, 2025 from $53.6 million for the three months ended March 31, 2024, a decrease of 8%.
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The decrease in research and development expenses was primarily attributable to a decrease of $2.7 million in internal costs driven by equity-based compensation expense, and a decrease of $1.3 million in external costs related to licensing fees, drug manufacturing, clinical trials, other research, and consulting and professional services.
We track research and development expenses on a program-by-program basis to the extent such spend is attributable to a specific program. Our research and development expenses by program for the periods presented were as follows:
| Three Months Ended March 31, | ||||||||||||||||||||
| (in thousands) | 2025 | 2024 | $ Change | |||||||||||||||||
| Program specific costs: | ||||||||||||||||||||
| Nirogacestat | $ | 14,906 | $ | 13,700 | $ | 1,206 | ||||||||||||||
| Mirdametinib | 13,422 | 16,155 | (2,733) | |||||||||||||||||
| Other | 6,034 | 9,583 | (3,549) | |||||||||||||||||
| Total program specific costs | 34,362 | 39,438 | (5,076) | |||||||||||||||||
| Non-program specific costs | 15,233 | 14,184 | 1,049 | |||||||||||||||||
| Total research and development expenses | $ | 49,595 | $ | 53,622 | $ | (4,027) | ||||||||||||||
Interest and other (expense) income
The decrease in interest and other (expense) income was driven by a decrease in interest income, net, of $3.3 million and MapKure investment total impairment charge of $4.9 million, for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.
Liquidity and Capital Resources
On April 27, 2025, we entered into the Merger Agreement with Parent and Merger Sub, providing for the acquisition of the Company by Parent. Under the terms of the Merger Agreement, we have agreed to various covenants and agreements, including, among others, agreements to conduct our business in the ordinary course of business between the execution of the Merger Agreement and the closing of the Merger. Outside of certain limited exceptions, we may not take certain actions without Parent’s consent, including (i) acquiring businesses and disposing of significant assets, (ii) incurring expenditures above specified thresholds, (iii) incurring debt, (iv) issuing additional securities or (v) repurchasing shares of Company’s common stock. We do not believe these restrictions will prevent us from meeting our ongoing costs of operations, working capital needs or capital expenditure requirements. Under the terms of the Merger Agreement, we may be required to pay Parent a termination fee of $145.6 million if the Merger Agreement is terminated under certain circumstances specified in the Merger Agreement. Moreover, we have incurred, and will continue to incur, significant costs and expenses in connection with the pending transaction. We must pay a material portion of these costs and expenses whether or not the transaction is completed. Payment of any such fees, costs or expenses may require us to use available cash that would have otherwise been available for general corporate purposes or other uses.
Sources of Liquidity
We have incurred operating losses and experienced negative operating cash flows since our inception and anticipate that we will continue to incur losses for at least the near future, until we reach profitability, which we currently anticipate achieving in the first half of 2026. Our net loss was $83.2 million and $87.4 million for the three months ended March 31, 2025 and March 31, 2024, respectively. We had an accumulated deficit of $1.2 billion and $1.2 billion as of March 31, 2025 and December 31, 2024, respectively. Based on our cash, cash equivalents and marketable securities balances as of March 31, 2025, management estimates that our liquidity position will enable us to meet operating expenses through at least twelve months after the date that this Quarterly Report is filed. Our marketable securities consist of high-quality, highly liquid available-for-sale debt securities including corporate debt securities, U.S. government securities, and commercial paper.
Cash Flows
The following table provides information regarding our cash flows for the three months ended March 31, 2025 and March 31, 2024:
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| Three Months Ended March 31, | ||||||||||||||
| (in thousands) | 2025 | 2024 | ||||||||||||
| Net cash used in operating activities | $ | (68,759) | $ | (78,930) | ||||||||||
| Net cash provided by investing activities | 73,393 | 21,463 | ||||||||||||
| Net cash used in financing activities | (10,609) | (552) | ||||||||||||
| Net (decrease) increase in cash and cash equivalents | (5,975) | (58,019) | ||||||||||||
| Cash and cash equivalents including Restricted cash, beginning of period | 70,375 | 176,666 | ||||||||||||
| Cash and cash equivalents including Restricted cash, end of period | $ | 64,400 | $ | 118,647 | ||||||||||
Net Cash Used in Operating Activities
Net cash used in operating activities was $68.8 million for the three months ended March 31, 2025, which was driven by a net loss of $83.2 million, and a net decrease from changes in operating assets and liabilities of $23.7 million, partially offset by equity-based compensation expense of $29.9 million, equity investment loss and impairment of $6.6 million, non-cash operating lease and depreciation and amortization expense of $1.6 million. Net cash used in operating activities was $78.9 million for the three months ended March 31, 2024, driven by a net loss of $87.4 million, and a net decrease from changes in operating assets and liabilities of $24.2 million, partially offset by equity-based compensation expense of $30.5 million.
Net Cash Provided by Investing Activities
Net cash provided by investing activities for the three months ended March 31, 2025 was driven by the sale and maturities of available-for-sale debt securities of $73.4 million. Net cash provided by investing activities for the three months ended March 31, 2024 was driven by the sale and maturities of available-for-sale debt securities of $103.9 million, partially offset by purchases of available-for-sale debt securities of $73.6 million and our investment in MapKure of $8.2 million.
Net Cash Used in Financing Activities
Net cash used in financing activities for the three months ended March 31, 2025 consisted of stock repurchased to satisfy employee tax withholding obligations upon vesting of restricted stock awards of $12.9 million, partially offset by proceeds from stock option exercises of $2.3 million. Net cash used in financing activities for the three months ended March 31, 2024 consisted of stock repurchased to satisfy employee tax withholding obligations upon vesting of restricted stock awards, partially offset by proceeds from stock option exercises.
Funding Requirements
Our primary use of cash is to fund operating expenses, including our research and development programs, as well as our commercialization activities and corporate operations. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable, accrued expenses and prepaid expenses.
Our future funding requirements will depend on many factors, including the following:
•costs to launch, promote and support commercialization of OGSIVEO and GOMEKLI, and the level of commercial success achieved by OGSIVEO and GOMEKLI;
•the initiation, progress, timing, costs and results of clinical trials for our product candidates; including any unforeseen costs we may incur as a result of clinical trial delays due to ongoing global and regional conflicts, or other causes;
•the clinical and preclinical development and manufacturing plans we establish for our product candidates;
•the number and characteristics of product candidates that we develop or in-license;
•the cost of identifying and evaluating potential product candidates for acquisition or license, including the cost of preclinical activities or clinical activities;
•the terms of any collaboration or licensing agreements we may choose to enter into;
•the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA, and other comparable foreign regulatory authorities;
•the cost of filing, prosecuting, defending and enforcing our patent claims and other intellectual property rights;
•the cost of defending intellectual property disputes, including patent infringement actions brought by third parties against us or our product candidates;
•the effect of competing technological and market developments;
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•the cost and timing of completion of commercial-scale outsourced manufacturing activities;
•the establishment of sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products on our own or jointly with third parties; and
•the degree of commercial success achieved following the successful completion of development and regulatory approval activities for a product candidate.
Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical studies.
Until such time, if ever, as we can generate sufficient product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, current ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Effects of Inflation
Although our operations are influenced by general economic conditions, we do not believe that inflation has had a material impact on our business, financial condition, or operating results during the periods presented.
Contractual Obligations
During the three months ended March 31, 2025, there were no material changes to our contractual obligations and commitments from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations” in Part II Item 7. of our 2024 Form 10-K.
Critical Accounting Policies and Use of Estimates
This discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts and the related disclosures in the financial statements and accompanying notes. These accounting policies involve critical accounting estimates because they are particularly dependent on estimates and assumptions made by management about matters that are uncertain at the time the accounting estimates are made. We base our estimates on historical experience, known trends and other market-specific or relevant factors that we believe to be reasonable under the circumstances, the results of which form the basis of making judgments; however, because future events and their effects cannot be determined with certainty, actual results may differ from those estimates, judgments or assumptions, and such differences could be material. On an ongoing basis, we evaluate our estimates, judgments and assumptions, and adjust those estimates, judgments and assumptions when facts or circumstances change. Changes in estimates are recorded in the period in which they become known. Although we believe that these estimates are reasonable, actual results could differ.
We describe our significant accounting policies in Note 3, Summary of Significant Accounting Policies, of the notes to the financial statements included in our 2024 Form 10-K. We discuss our critical accounting estimates in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, in our 2024 Form 10-K. There have been no changes in our significant accounting policies or critical accounting estimates during the three months ended March 31, 2025.
Item 3. Quantitative and Qualitative Disclosure About Market Risk
There were no material changes to our market risks from those described in Part II Item 7A. Quantitative and Qualitative Disclosures About Market Risk in our 2024 Form 10-K.
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Item 4. Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective at a reasonable assurance level in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms; and (ii) accumulated and communicated to management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely discussions regarding required disclosure. We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. Other Information
Item 1. Legal Proceedings
As of the date of this Quarterly Report on Form 10-Q, we are not a party to any material legal proceedings. In the future, we may be involved in various claims and legal proceedings relating to claims arising out of our operations. The outcome of litigation cannot be predicted with certainty and some lawsuits, claims or proceedings may be disposed of unfavorably to us, which could materially affect our financial condition or results of operations.
Item 1A. Risk Factors
In addition to the other information contained elsewhere in this report and below, you should carefully consider the risks and uncertainties described in “Part I, Item 1A—Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, or 2024 Form 10-K, filed with the Securities and Exchange Commission, or SEC, on February 20, 2025, which could materially and adversely affect our business, prospects, financial condition and results of operations. New risk factors can emerge from time to time, and it is not possible to predict the impact that any factor or combination of factors may have on our business, prospects, financial condition and results of operations. The risk factors disclosure in our 2024 Form 10-K is qualified by the information that is described in this Quarterly Report on Form 10-Q. The risks described below and in our 2024 Form 10-K are not our only risks. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or future results. Other than the risk factors listed below, there are no material changes to the Risk Factors described in our 2024 10-K.
Risks Related to the Pending Transaction with Merck KGaA, Darmstadt, Germany
We may not complete the pending transaction with Merck, KGaA, Darmstadt, Germany within the time frame we anticipate, or at all, which could have a material adverse effect on our business, financial condition, results of operations, and/or stock price.
On April 27, 2025, we entered into the Merger Agreement with Merck, KGaA, Darmstadt, Germany (“Parent”) and EMD Holdings Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), pursuant to which Merger Sub will merge with and into the Company (the “Merger”), with the Company surviving the Merger as a wholly owned subsidiary of Parent.
The completion of the Merger is subject to the satisfaction or waiver of certain customary closing conditions, including (i) the adoption of the Merger Agreement by the affirmative vote of holders of at least a majority of the outstanding shares of our common stock entitled to vote on the adoption of the Merger Agreement at a meeting of stockholders duly called and held for such purpose, (ii) the expiration or termination of any applicable waiting periods, and the receipt of approvals, under U.S. and a certain foreign antitrust and competition law, (iii) the absence of any governmental order or law that makes consummation of the Merger illegal or otherwise prohibited, (iv) the accuracy of the other party’s representations and warranties, subject to certain customary materiality or de minimis standards set forth in the Merger Agreement, (v) compliance in all material respects with the other party’s obligations under the Merger Agreement, and (vi) no Material Adverse Effect (as defined in the Merger Agreement) having occurred since the date of the Merger Agreement.
The Merger Agreement contains termination rights, including, among others, (i) if the consummation of the Merger does not occur on or before October 27, 2025, subject to extension by either party to January 27, 2026 in certain circumstances related to obtaining regulatory clearances and (ii) subject to certain conditions, if we wish to terminate the Merger Agreement to enter into a definitive agreement with respect to a Superior Proposal (as defined in the Merger Agreement). In connection with the termination of the Merger Agreement under specified circumstances, including the termination by Parent in the event of a change of recommendation by our board of directors to enter into an Alternative Acquisition Agreement (as defined in the Merger Agreement) providing for a Superior Proposal, we would be required to pay Parent a termination fee of $145.6 million.
If the pending Merger is not completed within the expected time frame or at all, we may be subject to a number of material risks, including to the extent that the current market price of our common stock is positively affected by a market assumption that the Merger will be completed. We could be required to pay Parent a termination fee of $145.6 million if the Merger Agreement is terminated under specific circumstances described in the Merger Agreement. The failure to complete the Merger also may result in negative publicity and negatively affect our relationship with our stockholders, employees, collaborators, distributors, vendors, suppliers, regulators, and other business partners. We may also be required to devote significant time and resources to litigation related to any failure to complete the Merger or related to any enforcement proceeding commenced against us to perform our obligations under the Merger Agreement.
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The announcement and pendency of the transaction with Parent could adversely affect our business, financial condition, and/or operating results.
Our efforts to complete the Merger could cause substantial disruptions in, and create uncertainty surrounding, our business, which may materially adversely affect our results of operation and our business. Uncertainty as to whether the Merger will be completed may affect our ability to recruit prospective employees or to retain and motivate existing employees and, while the Merger is pending, such existing or prospective employees could experience uncertainty about their future with the Company. A substantial amount of our management’s and employees’ attention is being directed toward the completion of the Merger and thus is being diverted from our day-to-day operations. Uncertainty as to our future could adversely affect our business and our relationship with collaborators, distributors, vendors, suppliers, regulators and other business partners. For example, vendors, suppliers, collaborators, distributors, and other counterparties may react unfavorably, including by delaying or deferring decisions concerning their business relationships or transactions with us, or seeking to change or terminate their existing business relationships with us. Changes to or termination of existing business relationships could adversely affect our results of operations and financial condition, as well as the market price of our common stock. The adverse effects of the pendency of the Merger could be exacerbated by any delays in completion of the Merger or termination of the Merger Agreement.
While the Merger Agreement is in effect, we are subject to restrictions on our business activities.
While the Merger Agreement is in effect, we are subject to restrictions on our business activities, generally requiring us to conduct our business in the ordinary course, and subjecting us to a variety of specified limitations absent Parent’s prior consent. Outside certain limited exceptions, these limitations include, among other things, restrictions on our ability to acquire other businesses and assets in excess of a specified limit, dispose of our assets, make investments, enter into certain contracts, repurchase or issue securities, pay dividends, incur capital expenditures in excess of a specified limit, take certain actions relating to intellectual property, amend our organizational documents, and incur indebtedness. These restrictions could prevent us from pursuing strategic business opportunities, taking actions with respect to our business that we may consider advantageous and responding effectively and/or timely to competitive pressures and industry developments, and we may have to forgo certain opportunities we might otherwise pursue, and may as a result materially and adversely affect our business, results of operations and financial condition.
In certain instances, the Merger Agreement requires us to pay a termination fee to Parent, which could require us to use available cash that would have otherwise been available for general corporate purposes.
Under the terms of the Merger Agreement, we may be required to pay Parent a termination fee of $145.6 million if the Merger Agreement is terminated under specific circumstances described in the Merger Agreement. If the Merger Agreement is terminated under such circumstances, the termination fee we may be required to pay under the Merger Agreement may require us to use available cash that would have otherwise been available for general corporate purposes and other uses. For these and other reasons, termination of the Merger Agreement could materially and adversely affect our business operations and financial condition, which in turn would materially and adversely affect the price of our common stock.
We have incurred, and will continue to incur, direct and indirect costs as a result of the pending Merger.
We have incurred, and will continue to incur, significant costs and expenses, including fees for professional services and other transaction costs, in connection with the pending Merger. We must pay a material portion of these costs and expenses whether or not the Merger is completed. There are a number of factors beyond our control that could affect the total amount or the timing of these costs and expenses, any of which could materially and adversely affect our business, prospects, financial condition, and results of operations.
Lawsuits may be filed against us and the members of our board of directors arising out of the proposed Merger, which may delay or prevent the proposed Merger.
Complaints may in the future be filed against us, our board of directors, Parent, any of Parent’s boards of directors and/or others in connection with the transactions contemplated by the Merger Agreement. The outcome of litigation is uncertain, including the amount of costs associated with defending these claims or any other liabilities that may be incurred in connection with the litigation of these claims, and we may not be successful in defending against any such future claims. Lawsuits that may be filed against us, our board of directors, Parent, or any of Parent’s boards of directors could delay or prevent the consummation of the Merger, result in significant costs, and divert the attention of our management and employees from our day-to-day business which could affect our operations and otherwise adversely affect us financially.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
Rule 10b5-1 Trading Plans
During the three months ended March 31, 2025, none of the Company’s directors or officers adopted terminated
Item 6. Exhibits
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EXHIBIT INDEX
| Exhibit Number | Description | |||||||
| 3.1 | ||||||||
| 3.2 | ||||||||
| 3.3 | ||||||||
| 4.1 | ||||||||
| 4.2 | ||||||||
| 4.3 | ||||||||
| 4.4 | ||||||||
4.5* | ||||||||
10.1** | ||||||||
31.1** | ||||||||
31.2** | ||||||||
| 32.1† | ||||||||
| 32.2† | ||||||||
| 101.INS | Inline XBRL Instance Document. | |||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | |||||||
| 101.CAL | Inline XBRL Taxonomy Calculation Linkbase Document. | |||||||
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |||||||
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | |||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |||||||
| 104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | |||||||
_____________________________________________
*Schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company hereby agrees to furnish supplementally a copy of any omitted schedule to the Securities and Exchange Commission upon request.
**Filed herewith.
†This certification will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, except to the extent specifically incorporated by reference into such filing.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| SPRINGWORKS THERAPEUTICS, INC. | ||||||||
| Date: May 9, 2025 | By: | /s/ Saqib Islam | ||||||
| Saqib Islam | ||||||||
| Chief Executive Officer | ||||||||
| Date: May 9, 2025 | By: | /s/ Francis I. Perier, Jr. | ||||||
| Francis I. Perier, Jr. | ||||||||
| Chief Financial Officer | ||||||||
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