RIGEL PHARMACEUTICALS INC
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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Sep 30, 2026 · Filed Nov 5, 2026
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Notes to Condensed Financial Statements (Unaudited)
Rigel Pharmaceuticals, Inc.
Notes to Condensed Financial Statements
In this report, “Rigel,” “we,” “us” and “our” refer to Rigel Pharmaceuticals, Inc.
- Organization and Summary of Significant Accounting Policies
Description of Business
We are a biotechnology company dedicated to developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. We focus on products that address signaling pathways that are critical to disease mechanisms.
TAVALISSE® (fostamatinib disodium hexahydrate) is our first US Food and Drug Administration (FDA)-approved product and is the only approved oral spleen tyrosine kinase (SYK) inhibitor for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. The product is also commercially available in Europe and the United Kingdom (UK) (as TAVLESSE), and in Japan, the Republic of Korea (Korea), Canada, Israel, Brazil and Mexico (as TAVALISSE) for the treatment of chronic ITP in adult patients.
REZLIDHIA® (olutasidenib) is our second FDA-approved product and is indicatedfor the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. We in-licensed REZLIDHIA from Forma Therapeutics, Inc., now Novo Nordisk (Forma), with exclusive, worldwide rights for its development, manufacturing and commercialization, pursuant to a license and transition services agreement entered in July 2022.
GAVRETO® (pralsetinib) is our third FDA-approved product which we began commercializing in June 2024. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type rearranged during transfection (RET) and oncogenic RET fusions. GAVRETO is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. GAVRETO is also approved under accelerated approval based on overall response rate and duration of response, for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). We acquired the rights to research, develop, manufacture and commercialize GAVRETO in the US from Blueprint Medicines Corporation, now a Sanofi SA company (Blueprint), pursuant to an asset purchase agreement entered in February 2024.
VEPPANU™ (vepdegestrant) is our fourth FDA-approved product which we began commercializing on August 13, 2026. VEPPANU is an oral PROteolysis TArgeting Chimera (PROTAC) approved by the FDA for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. We in-licensed VEPPANU pursuant to a license agreement entered in May 2026 with Arvinas, Inc., Arvinas Operations, Inc., Arvinas Estrogen Receptor, Inc. (Arvinas) and Pfizer Inc. (Pfizer).
Our development pipeline includes R289, our dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor, which is being advanced in an open-label, Phase 1b study to determine the safety, tolerability and preliminary efficacy of the drug in patients with lower-risk myelodysplastic syndrome (MDS) who are relapsed, refractory or resistant to prior therapies.
To expand our evaluation of olutasidenib in other disease areas with IDH1 mutations, we have strategic development collaborations with the University of Texas MD Anderson Cancer Center (MDACC) and with Collaborative Network for Neuro-Oncology Clinical Trials (CONNECT).
Basis of Presentation
Our accompanying unaudited condensed financial statements have been prepared in accordance with United States generally accepted accounting principles (US GAAP), for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities Act of 1933, as amended (Securities Act). Accordingly, they do not include all the information and notes required by US GAAP for complete financial statements.
These unaudited condensed financial statements include only normal and recurring adjustments that we believe are necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year or any subsequent interim period. The balance sheet at December 31, 2025 has been derived from audited financial statements at that date but does not include all disclosures required by US GAAP for complete financial statements. Because certain disclosures required by US GAAP for complete financial statements are not included herein, these interim unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025.
Use of Estimates
The preparation of the accompanying unaudited condensed financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates.
Significant Accounting Policies
Our significant accounting policies are described in “Note 1 – Description of Business and Summary of Significant Accounting Policies” to our “Notes to Financial Statements” contained in Part II, Item 8, “Financial Statements and Supplementary Data” of our Annual Report on Form 10-K for the year ended December 31, 2025.
Liquidity
At September 30, 2026, we had approximately $99.3 million in cash, cash equivalents and short-term investments. We finance our operations primarily through sales of our products, and contract payments under our collaboration agreements, as well as through equity securities and debt financing.
Based on our current operating plan, we believe that our existing cash, cash equivalents, and short-term investments will be sufficient to fund our expenses and capital expenditure requirements for at least the next 12 months from the date of issuance of this Form 10-Q.
Recently Issued Accounting Standards
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures. This guidance enhances expense disclosure requirements for a public business entity’s expenses by mandating detailed information regarding types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) contained in income statement expense categories. This guidance is effective for our annual reporting for the fiscal year ending December 31, 2027, and interim reporting periods starting with the fiscal year ending December 31, 2028, though early adoption is available. This guidance may be applied prospectively to reporting periods after the effective date or retrospectively to all periods presented in the financial statements. We are currently evaluating this guidance and assessing the potential impact on our financial statements and disclosures.
In July 2025, the FASB issued ASU 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets, introducing a practical expedient for credit loss measurement on accounts receivable and contract assets. This guidance is effective for our annual reporting period for the fiscal year ending December 31, 2026, including interim periods within such reporting period, though early adoption is available. The adoption of this guidance did not have a material impact on our financial statements and disclosures.
In December 2025, the FASB issued ASU 2025-10, Accounting for Government Grants Received by Business Entities, which establishes the accounting and presentation for government grants received by a business entity. This guidance is effective for our annual reporting period for the fiscal year ending December 31, 2029, and related interim periods, though early adoption is available. Organizations may adopt this guidance using modified prospective, modified retrospective, or retrospective approaches. We are currently evaluating this guidance and assessing the potential impact on our financial statements and disclosures.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements to improve the guidance in Topic 270, Interim Reporting. The update provides clarifications aimed at improving interim disclosure requirement consistency and usability, incorporating a comprehensive listing of required interim disclosures and a new disclosure principle for reporting material events occurring after the most recent annual period. The amendments do not change the underlying objectives of interim reporting but are designed to enhance clarity in application. This guidance is effective for our interim reporting periods for the fiscal year ending December 31, 2028. We are currently evaluating the impact of adoption of this standard on our financial statements and disclosures.
In December 2025, the FASB issued ASU 2025-12, Codification Improvements, which addresses thirty-three issues, representing amendments to Accounting Standard Codification topics that clarify, correct errors or make minor improvements. The amendments make the Codification easier to understand and apply. The update is effective for us in our annual reporting period for the fiscal year ending December 31, 2027, and interim periods within such reporting period. Early adoption and retrospective application are permitted on an issue-by-issue basis. We are currently evaluating this guidance and assessing the potential impact on our financial statements and disclosures.
Other recently issued accounting guidance not discussed in this Quarterly Report on Form 10-Q are either not applicable or did not have, or are not expected to have, a material impact on us.
- Net Income Per Share
The following table sets forth the computation of basic and diluted earnings per share (in thousands except per share amounts):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| EPS Numerator: | ||||
| Net income | $13,185 | $27,900 | $39,129 | $98,959 |
| EPS Denominator—Basic: | ||||
| Weighted-average common shares outstanding | 18,710 | 18,038 | 18,557 | 17,912 |
| EPS Denominator—Diluted: | ||||
| Weighted-average common shares outstanding | 18,710 | 18,038 | 18,557 | 17,912 |
| Dilutive effect of stock options, RSUs and shares under Purchase Plan | 1,729 | 1,118 | 1,339 | 467 |
| Weighted-average shares outstanding and common stock equivalents | 20,439 | 19,156 | 19,896 | 18,379 |
| Net income per share | ||||
| Basic | $0.70 | $1.55 | $2.11 | $5.52 |
| Diluted | $0.65 | $1.46 | $1.97 | $5.38 |
The potential shares of common stock that were excluded from the computation of diluted net income per share for the periods presented because including them would have been antidilutive are as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Stock options | 319 | 1,166 | 579 | 2,223 |
| RSUs | 34 | — | 36 | 174 |
| Total | 353 | 1,166 | 615 | 2,397 |
- Revenues
Revenues disaggregated by category were as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Product sales: | ||||
| Gross product sales | $93,603 | $85,624 | $257,455 | $225,508 |
| Discounts and allowances | (21,314) | (21,557) | (63,228) | (58,943) |
| Total product sales, net | 72,289 | 64,067 | 194,227 | 166,565 |
| Contract revenues from collaborations and other: | ||||
| Release of cost share liability | — | — | — | 39,981 |
| Milestone revenue | — | — | 4,000 | 3,000 |
| Delivery of drug supplies, royalties and others | 8,601 | 5,395 | 20,184 | 14,934 |
| Total contract revenues from collaborations and other | 8,601 | 5,395 | 24,184 | 57,915 |
| Total revenues | $80,890 | $69,462 | $218,411 | $224,480 |
Revenue from product sales relates to sales of our commercial products to customers. For additional information regarding contract revenues from collaborations and other, see “Note 4 – Sponsored Research and License Agreements.”
Net product sales represent gross product sales less chargebacks, discounts and fees, government and other rebates, and returns. Of the total discounts and allowances from gross product sales presented in the table above for the nine months ended September 30, 2026 and 2025, $62.4 million and $53.6 million, respectively, were accounted for as additions to revenue reserves and refund liability, and $0.8 million and $5.3 million, respectively, were accounted for as reductions to accounts receivable (prompt pay discount and specialty pharmacy fees) and prepaid and other current assets (for certain prepaid fees) in the condensed balance sheet.
The following tables summarize activity in chargebacks, discounts and fees, government and other rebates, and returns included in revenue reserves and refund liabilities for each of the periods presented (in thousands):
| Chargebacks,Discounts andFees | Governmentand OtherRebates | Returns | Total | |
|---|---|---|---|---|
| Balance at January 1, 2026 | $12,519 | $10,389 | $4,808 | $27,716 |
| Provision related to current period sales | 50,502 | 15,683 | 1,885 | 68,070 |
| Adjustment related to prior period sales | (3,260) | (2,362) | — | (5,622) |
| Credit or payments made during the period | (49,672) | (12,356) | (1,327) | (63,355) |
| Balance at September 30, 2026 | $10,089 | $11,354 | $5,366 | $26,809 |
| Chargebacks,Discounts andFees | Governmentand OtherRebates | Returns | Total | |
|---|---|---|---|---|
| Balance at January 1, 2025 | $13,374 | $8,343 | $4,723 | $26,440 |
| Provision related to current period sales | 40,399 | 14,261 | 1,921 | 56,581 |
| Adjustment related to prior period sales | (307) | (1,287) | (1,357) | (2,951) |
| Credit or payments made during the period | (40,673) | (8,950) | (427) | (50,050) |
| Balance at September 30, 2025 | $12,793 | $12,367 | $4,860 | $30,020 |
Adjustment related to prior period sales reflect updates to estimates of variable consideration, including chargebacks, rebates, and returns, resulting from actual claims and other information obtained in the current reporting period.
The following table summarizes the percentages of revenues from each of our customers who individually accounted for 10% or more of the total net product sales and revenues from collaborations and other:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| McKesson Corporation | 44% | 48% | 46% | 39% |
| Cencora, Inc. | 22% | 23% | 22% | 17% |
| Cardinal Health, Inc. | 10% | 10% | 10% | * |
| OncoMed Specialty, LLC | 12% | — | 11% | — |
| Optime Care, Inc. | — | 11% | — | * |
| Lilly | — | — | — | 18% |
*Denotes less than 10%
- Sponsored Research and License Agreements
We conduct research and development programs independently and in connection with our corporate collaborators. We are currently a party to collaboration agreements with Grifols S.A. (Grifols) to commercialize fostamatinib for human diseases in all indications in Grifols territory which includes Europe, the UK, Turkey, the Middle East, North Africa and Russia (including Commonwealth of Independent States (CIS)); with Kissei Pharmaceutical Co., Ltd. (Kissei) to develop and commercialize fostamatinib in Japan, China, Taiwan and Korea, and olutasidenib in Japan, Korea and Taiwan; with Medison Pharma Trading AG (Medison Canada) and Medison Pharma Ltd. (Medison Israel and, together with Medison Canada, Medison) to commercialize fostamatinib in all indications, in Medison territory which includes Canada and Israel; with Knight Therapeutics International SA (Knight) to commercialize fostamatinib in all indications, in Knight territory which includes Latin America, consisting of Mexico, Central and South America, and the Caribbean; and with Dr. Reddy’s Laboratories (Dr. Reddy’s) to commercialize olutasidenib in Dr. Reddy’s territory which includes Latin America, South Africa, India, Australia, New Zealand, and certain countries in the CIS, Southeast Asia region and North Africa.
We are also a party to collaboration agreements, but do not have ongoing performance obligations with BerGenBio ASA, now Oncoinvent ASA (BerGenBio) for the development and commercialization of AXL receptor tyrosine kinase inhibitor, R428 (now referred to as bemcentinib (BGB324)), and with Daiichi Sankyo (Daiichi) to pursue research related tomurine double minute 2 (MDM2) inhibitor, DS-3032 (now referred as milademetan).
We were a party to a collaboration agreement with Eli Lilly and Company (Lilly), which included the development and commercialization of ocadusertib (previously R552), areceptor-interacting protein kinase 1 (RIPK1) inhibitor, which was terminated effective June 2026.
Under the above collaboration agreements, we have received, and may in the future receive, milestone payments contingent upon the achievement of specified events, as well as royalties on net sales of products commercialized by our partners. At September 30, 2026, the total potential future contingent payments under these agreements were approximately $652.1 million. This amount excludes terminated programs, including the termination of the Lilly agreement as discussed in detail below, and assumes the achievement of all applicable milestones under the existing agreements. Of this amount, $190.1 million relates to development and regulatory milestones and $462.0 million to commercial milestones. This estimate excludes any potential royalties that may become payable if our partners successfully commercialize licensed products. Milestone payments under these agreements are contingent upon our partners’ future efforts and the achievement of specified development, regulatory and commercial milestones.
We also have strategic development collaborations with MDACC and CONNECT to expand the evaluation of olutasidenib in other disease areas with IDH1 mutations.
Global Exclusive License Agreement with Lilly
In February 2021, we entered into a global exclusive license agreement and strategic collaboration with Lilly, which became effective in March 2021 upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), and was amended in September 2023, March 2024, and in August 2025 (collectively, the Lilly Agreement). Pursuant to the terms of the Lilly Agreement, we granted Lilly exclusive rights to develop and commercialize ocadusertib (previously R552) and related RIPK1 inhibitors in all indications worldwide. The collaboration was intended to develop and commercialize ocadusertib for the treatment of non-central nervous system (non-CNS) diseases, and additional RIPK1 inhibitors for the treatment of central nervous system (CNS) diseases.
Under the Lilly Agreement, we received a non-refundable and non-creditable upfront cash payment of $125.0 million in April 2021. In addition, for non-CNS diseases, we were eligible to receive up to $330.0 million in development and regulatory milestones and up to $100.0 million in sales milestones on a product-by-product basis, as well as tiered royalties on net sales ranging from the mid-single digits to the high-teens, subject to certain standard reductions and offsets. For CNS diseases, we were eligible to receive up to $256.0 million in development, regulatory and commercial milestones and up to $150.0 million in sales milestone payments, as well as tiered royalties on net sales up to the low-double digits.
Under the Lilly Agreement, we were responsible for 20% of the development costs for ocadusertib in the US, Europe, and Japan, up to a specified cap, and Lilly was responsible for funding the remainder of all development activities for ocadusertib and other non-CNS disease development candidates. In September 2023, we exercised our first opt-out right, and concurrently, our cost share obligation for ocadusertib development ended on April 1, 2024. Although we retained a right to opt back into co-funding to receive increased royalties, we notified Lilly in April 2025 that we would not exercise this option. As a result, we had no further development cost-sharing obligations. In connection with this decision, we released the $40.0 million remaining cost share liability and recognized the amount as contract revenues from collaboration in the second quarter of 2025.
On April 16, 2026, we received a written notice from Lilly of its decision to terminate the Lilly Agreement, which became effective June 15, 2026. Following termination, the rights previously licensed to Lilly under the Lilly Agreement reverted to us in accordance with the terms of the Lilly Agreement, and we do not expect to receive any future milestone payments or royalties thereunder.
Grifols License Agreement
We have an exclusive commercialization license agreement with Grifols entered in January 2019 with exclusive rights to commercialize fostamatinib for human diseases, and non-exclusive rights to develop fostamatinib in Grifols territory. There wasno deferred revenue related to the Grifols license agreement at September 30, 2026 and December 31, 2025.
Revenue recognized from the delivery of drug supplies pursuant to our commercial supply agreement with Grifols was $1.2 million and $4.3 million for three and nine months ended September 30, 2026, respectively, and $1.2 million and $4.9 million, for the three and nine months ended September 30, 2025, respectively.
We also recognize royalty revenue from Grifols, which is included within contract revenues from collaboration. Royalty revenue for thethree and nine months ended September 30, 2026 was$2.5 million and $6.2 million, respectively, and for the three and nine months ended September 30, 2025 was$1.9 million, and $5.0 million, respectively.
Kissei License Agreements
We have a collaboration and license agreement with Kissei entered in September 2024 to grant exclusive rights to Kissei to develop and commercialize olutasidenib in all human diseases in related Kissei territory. There wasno deferred revenue related to this collaboration and license agreement at September 30, 2026 and December 31, 2025. In the second quarter of 2026, we recognized$4.2 million of contract revenue from collaborations with Kissei, consisting of a milestone payment related to the marketing authorization application (MAA) submission for olutasidenib in Japan and sublicense revenue associated with Kissei's sublicensing of olutasidenib to a third party in Taiwan. The milestone and sublicense revenue were recognized when the related amounts became due and the related variable consideration was no longer constrained. Under the license and services agreement with Forma as discussed in “Note 5 – In-Licensing and Acquisition”, Forma is entitled to a specified portion of sublicensing revenue generated from olutasidenib. Accordingly, as a result of the milestone and sublicense payments received from Kissei, we recognized a$1.0 million sublicensing fee payable to Forma in the second quarter of 2026, recorded within cost of product sales.
We also have an exclusive license and supply agreement with Kissei entered in October 2018, amended in November 2022, October 2023, August 2024, September 2024 and October 2024, to develop and commercialize fostamatinib in all current and potential indications in related Kissei territory. At September 30, 2026 and December 31, 2025, the remaining deferred revenuewas related to the material right associated with discounted fostamatinib supply which amounted to $1.4 million. In the first quarter of 2025, we recognized$3.0 million of contract revenue from collaborations related to anon-refundable and non-creditable milestone payment from Kissei in connection with the approval of fostamatinib in Korea in January 2025.
Revenue recognized from delivery of drug supplies pursuant to our supply agreement with Kisseiwas$3.2 million and $6.7 million forthree and nine months ended September 30, 2026, respectively, and$1.8 million and $3.9 millionfor the three and nine months ended September 30, 2025, respectively.
Medison Commercial and License Agreements
We have exclusive commercial and license agreements with Medison entered in October 2019 for the commercialization of fostamatinib for chronic ITP in Medison territory. There wasno deferred revenue related to Medison commercial and license agreement at September 30, 2026 and December 31, 2025.
Revenue recognized from Medison, related to delivery of drug supplies and royalties was $0.3 million and $0.9 million, for the three and nine months ended September 30, 2026, respectively, and $0.2 million and $0.8 million for the three and nine months ended September 30, 2025, respectively.
Strategic Development Collaborations with MDACC and CONNECT
We have a strategic collaboration agreement with MDACC entered in December 2023 to evaluate olutasidenib in AML and other hematologic cancers. Under the agreement, as amended, we are obligated to provide study materials and up to $15.0 million in time-based milestone payments over thefive-year collaboration term, unless terminated earlier, including $1.0 million designated for clinical study enrollment support payable directly to a third-party vendor. Through September 30, 2026, we have provided $5.3 million in funding related to this collaboration agreement.
In January 2024, we announced our collaboration with CONNECT to conduct a Phase 2 clinical trial to evaluate olutasidenib in glioma. Under this agreement, we are obligated to provide study materials and up to $3.0 million in funding over thefour-year collaboration term.
Amounts paid under these research collaboration agreements are recorded as prepaid research and development to the extent payments are made in advance of services and are recognized as research and development expense as the services are performed.
- In-licensing and Acquisition
License Agreement with Arvinas and Pfizer
On May 11, 2026, we entered into a license agreement with Arvinas and Pfizer (together, the Licensors), which became effective on June 11, 2026 upon the early termination of the waiting period under the HSR Act. Pursuant to the license agreement, the Licensors granted us an exclusive, royalty-bearing license to develop, manufacture and commercialize VEPPANU (vepdegestrant) and vepdegestrant-containing products (the licensed products) worldwide.
Under the license agreement, we agreed to pay the Licensors a license fee of up to $85.0 million, including $70.0 million upfront payment which we paid in June 2026, and up to an additional $15.0 million payable upon the successful completion of certain transition activities. Of the potential transition payments, $2.5 million became payable upon the completion of a certain transition activity during the third quarter of 2026. This amount was included in accounts payable at September 30, 2026 and is expected to be paid in the fourth quarter of 2026. The remaining $12.5 million is subject to the successful completion of specified transition activities. In addition, the Licensors are eligible to receive up to $60.0 million in regulatory milestones upon achievement of specified regulatory approvals, and up to $260.0 million in commercial milestones upon achievement of specified net sales thresholds. We are also obligated to pay tiered royalties on annual net sales of licensed products ranging in percentages from the mid-teens to mid-twenties, subject to certain reductions and customary adjustments, and to share a portion of sublicense revenue with the Licensors at tiered rates that decrease based on the timing of execution of the applicable sublicense.
Under the license agreement, we will have the sole rights and will be primarily responsible for the development and commercialization of the licensed products worldwide, subject to certain transition activities to be performed by the Licensors. The license agreement includes customary diligence obligations for us to use commercially reasonable efforts to develop and commercialize the licensed products, including to seek regulatory approvals in specified major markets. The license agreement will remain in effect on a product-by-product and country-by-country basis until the expiration of the applicable royalty term for each licensed product in each country, after which the license becomes fully paid-up and perpetual. The license agreement may be terminated by either party under customary circumstances, including for material breach or certain insolvency events. In addition, the Licensors may terminate the license agreement if we cease all material development and commercialization activities for the licensed products for an extended period of time, subject to specified exceptions, or if we breach certain compliance-related obligations relating to anti-corruption and global trade controls. Upon termination of the license agreement prior to its expiration, the licenses granted to us will terminate and, at the Licensors’ request, the parties will negotiate in good faith an exclusive license from us to the Licensors under certain patent rights and know-how controlled by us covering the terminated licensed products. The license agreement contains customary provisions relating to, among other things, intellectual property, indemnification, confidentiality, and representations and warranties.
Pursuant to the license agreement, the Licensors will continue to be responsible for specified ongoing development, regulatory, manufacturing and transition activities. We are obligated to reimburse development costs incurred by the Licensors in connection with the ongoing studies, subject to an aggregate funding cap of $40.0 million and specified cumulative annual and quarterly funding caps through 2029. The related costs are recognized as research and development expense as the related services are performed. During the three and nine months ended September 30, 2026, we recognized $5.8 million and $7.3 million, respectively, of research and development expense related to these activities.
In connection with the license agreement, we also agreed to purchase certain VEPPANU drug product inventory and related materials from Pfizer. As contemplated by the license agreement, in July 2026, we entered into a manufacturing and supply agreement with Pfizer, which includes certain minimum purchase obligations. See related discussions in “Note 11 – Commitments and Contingencies - Purchase Commitments”.
We have concluded that the license agreement represents an asset acquisition of an intangible asset. Because the licensed products have received approval from the FDA prior to the execution of the license agreement, the acquired asset represents developed technology that is considered to have commercial viability. Remaining license fees payable upon the successful completion of certain transition activities as well as regulatory and commercial milestone payments will be capitalized as additional intangible assets in the period in which the corresponding milestone events are achieved and the payments become payable.
In connection with the license agreement, we capitalized approximately $73.1 million as intangible assets consisting of the upfront and transition payments and directly attributable transaction costs for the nine months ended September 30, 2026. The intangible assets are amortized on a straight-line basis over their estimated useful life of 15 years, which reflects the expected period over which the licensed products will generate economic benefits. Amortization expense is recognized within cost of product sales. Royalties will be recognized as cost of product sales in the period in which the related product sales occur.
Asset Purchase Agreement with Blueprint
We acquired the US rights to research, develop, manufacture and commercialize GAVRETO from Blueprint pursuant to an Asset Purchase Agreement entered in February 2024. The acquired assets from Blueprint include, among other things, applicable intellectual property related to pralsetinib in the US, including patents, copyrights and trademarks, as well as clinical regulatory and commercial data and records. Pursuant to the Asset Purchase Agreement, we agreed to pay a purchase price of $15.0 million, of which, $10.0 million was payable upon our first commercial sale of GAVRETO and an additional $5.0 million was payable on the first anniversary of the closing date of the agreement, subject to certain conditions. Blueprint is also eligible to receive up to $97.5 million in future commercial milestone payments and up to $5.0 million in future regulatory milestone payments. Blueprint is also entitled to tiered royalty payments on net sales of products containing pralsetinib (or related compounds) ranging from 10% to 30%, subject to certain reductions and offsets.
The total purchase price consideration amounted to $15.4 million, consisting of $15.0 million closing purchase price and $0.4 million of transaction costs. Of the total closing purchase price, $10.0 million was paid in July 2024, and the remaining $5.0 million was paid in June 2026. Because the closing purchase price consideration was contractually deferred and payable on separate dates after the acquisition date, we accounted for the arrangement, in substance, as seller-financed under ASC 230. The initial recognition of the deferred obligation was reported as a noncash investing and financing transaction at the acquisition date, and the subsequent cash payments of the closing purchase price were classified as financing activities in the condensed statements of cash flows.
We accounted for this transaction as an asset acquisition in accordance with ASC 805 Business Combinations(ASC 805) and recorded the total purchase consideration as intangible assets at the acquisition date. The intangible assets are amortized on a straight-line basis over an estimated useful life of 12 years, with amortization recognizedin cost of product sales. Royalties are also recognized in cost of product sales, as the related product sales occur.
License and Transition Services Agreement with Forma
We have a license and transition services agreement with Forma entered in July 2022, for an exclusive license to develop, manufacture and commercialize olutasidenib, a proprietary inhibitor of mutated IDH1 (m IDH1), for any uses worldwide, including for the treatment of AML and other malignancies. Under the terms of the license and transition services agreement, we paid an upfront fee of $2.0 million, and may be required to pay up to an additional $67.5 million upon achievement of specified development and regulatory milestones, and up to $165.5 million upon achievement of certain commercial milestones. Forma is also entitled to receive tiered royalties on net sales of licensed products at percentages ranging from the low-teens to mid-thirties, as well as a certain portion of sublicensing revenue, subject to certain standard reductions and offsets.
The transaction was accounted for as an acquisition of asset under ASC 730, Research and Development. Upfront payment of $2.0 million and milestone payments of $2.5 million incurred before regulatory approval of an indication associated with the acquired licensed asset were accounted for as acquired in-process research and development and expensed as research and development expense because the acquired asset had no alternative future use.
Following the FDA approval of REZLIDHIA and the first commercial sale in December 2022, we made milestone payments to Forma totaling $15.0 million. Because the milestone obligations arose upon or after regulatory approval, the payments were capitalized as intangible assets on our condensed balance sheet. The intangible assets are amortized on a straight-line basis over an estimated useful life of 14 years, with amortization recognizedin cost of product sales. Royalties are also recognized in cost of product sales, as the related product sales occur. Amounts payable to Forma based on sublicensing revenue are recognized in cost of product sales as the related sublicensing revenue is recognized.
- Stock-Based Compensation
Stock-based compensation for the periods presented was as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Selling, general and administrative | $3,862 | $2,961 | $11,813 | $8,172 |
| Research and development | 990 | 402 | 3,339 | 1,791 |
| Total stock-based compensation expense | $4,852 | $3,363 | $15,152 | $9,963 |
Pursuant to our 2018 Equity Incentive Plan (2018 Plan) and our Inducement Plan, as amended (Inducement Plan, and together with 2018 Plan, the Equity Incentive Plans), during the nine months ended September 30, 2026, we granted stock options to purchase 36,775 shares of common stock, with weighted-average grant-date fair value of $30.14 per share, and 723,658 RSUs, with a grant-date weighted-average fair value of $35.78 per share. In recent years, we have increased our use of RSUs, and beginning in 2026, RSUs represent the majority of our equity awards. Beginning in 2026, we also granted performance-based RSUs tied to the achievement of specified corporate performance milestones. These equity awards generally vest over athree-year period, except for performance-based awards, which vest upon the achievement of specified corporate performance milestones.
The fair value of the RSU is based on the market price of our common stock on the date of grant. The fair value of stock option awards is estimated on the grant date using the Black-Scholes option pricing model. The following table summarizes the weighted-average assumptions relating to stock options granted during the periods presented:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Risk-free interest rate | * | 3.9% | 3.8% | 4.3% |
| Expected term (in years) | * | 6.0 | 5.3 | 6.5 |
| Dividend yield | * | 0.0% | 0.0% | 0.0% |
| Expected volatility | * | 91.0% | 90.5% | 88.6% |
*No stock options granted during the period.
During the nine months ended September 30, 2026,304,233 stock options were exercised and 330,570 RSUs were released. During the nine months ended September 30, 2026,149,203 shares of common stock with an aggregate value of approximately $5.3 million were withheld in connection with the net share settlement of RSUs to satisfy employees’ minimum statutory tax withholding obligations upon vesting. The withheld shares were valued based on the closing market price of our common stock on the applicable vesting dates. Such share withholdings are treated as share repurchases for accounting purposes and are reflected as a reduction to additional paid-in capital.
At September 30, 2026, there were 3,214,717 stock options and 938,372 RSUs outstanding. Of these,83,125 stock options and 79,400 RSUs were performance-based awards for which achievement of the related corporate milestones was deemed not probable at September 30, 2026. Accordingly, none of the associated $4.6 million of grant date fair value has been recognized as stock-based compensation expense at September 30, 2026.
At September 30, 2026, there was approximately $25.7 million of unrecognized stock-based compensation expense, which is expected to be recognized over a remaining weighted-average period of 2.47 years. This amount relates to time-based stock options and RSUs, as well as performance-based stock options and RSUs for which achievement of the related corporate performance milestones was considered probable.
In May 2026, our stockholders approved an amendment to our 2018 Plan to, among other items, add an additional 500,000 shares to the number of shares of common stock authorized for issuance under our 2018 Plan. During thenine months ended September 30, 2026, our Board of Directors approved an additional 22,300 shares of common stock reserved for issuance under our Inducement Plan. At September 30, 2026, there were 1,210,282 shares of common stock available for future grant under our Equity Incentive Plans.
Employee Stock Purchase Plan
Our 2000 Employee Stock Purchase Plan (Purchase Plan) has 24-month offering periods. The prior offering period commenced on July 1, 2024 and ended on June 30, 2026, and the current offering period commenced on July 1, 2026 and is scheduled to end on June 30, 2028. At September 30, 2026, there was approximately $1.3 million of unrecognized stock-based compensation cost related to the Purchase Plan, which is expected to be recognized over a remaining weighted-average period of 1.20 years.
In May 2026, our stockholders approved an amendment to the Purchase Plan to, among other things, increase the number of shares of common stock authorized for issuance under the Purchase Plan by 360,000 shares. During thenine months ended September 30, 2026, employees purchased 60,649 shares under the Purchase Plan. At September 30, 2026,400,156 shares of common stock were available for future issuance under the Purchase Plan.
- Other Balance Sheet Components
Inventories
Inventories for the periods presented consist of the following (in thousands):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Raw materials | $7,335 | $4,514 |
| Work in process | 6,768 | 3,910 |
| Finished goods | 7,198 | 4,712 |
| Total | $21,301 | $13,136 |
| Reported as: | ||
| Inventories | $15,805 | $11,506 |
| Other assets | 5,496 | 1,630 |
| Total | $21,301 | $13,136 |
Non-current inventories included within other assets in the condensed balance sheet consist primarily of active pharmaceutical ingredient (API) classified as raw materials which have multi-year shelf life, as well as certain work in process and finished goods inventories that are not expected to be consumed within our normal operating cycle.
Advance payments to our contract manufacturers to manufacture APIs as well as APIs pending final release for commercial usage are classified as prepaid inventory and included within prepaid and other current assets in the condensed balance sheet. See prepaid and other current assets below for related details.
Prepaid and other current assets
Prepaid and other current assets for the periods presented consist of the following (in thousands):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Prepaid inventory | $5,435 | $11,849 |
| Prepaid research and development costs | 5,028 | 4,886 |
| Others | 6,493 | 5,207 |
| Total prepaid and other current assets | $16,956 | $21,942 |
Intangible assets
Intangible assets consist of the following (in thousands):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Intangible assets cost | $103,424 | $30,360 |
| Accumulated amortization | (8,838) | (5,612) |
| Intangible assets, net | $94,586 | $24,748 |
Amortization expense included in cost of product sales in the condensed statements of operations was $1.8 million and $3.2 million for thethree and nine months ended September 30, 2026, respectively, and $0.6 million and$1.8 million for thethree and nine months ended September 30, 2025, respectively.
At September 30, 2026, the weighted average remaining amortization period of outstanding intangible assets was 13.50 years. The following table presents the estimated future amortization expense of intangible assets at September 30, 2026 (in thousands):
| Remainder of 2026 | $1,806 |
| 2027 | 7,223 |
| 2028 | 7,223 |
| 2029 | 7,223 |
| 2030 | 7,223 |
| Thereafter | 63,888 |
| $94,586 |
- Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments
Cash, cash equivalents, restricted cash, and short-term investments for the periods presented consist of the following (in thousands):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Cash | $13,377 | $20,020 |
| Restricted cash | 57 | 57 |
| Money market funds | 12,787 | 14,509 |
| US treasury bills | 32,760 | 63,994 |
| Government-sponsored enterprise securities | 22,826 | 20,692 |
| Corporate bonds and commercial paper | 17,555 | 35,740 |
| $99,362 | $155,012 | |
| Reported as: | ||
| Cash and cash equivalents | $46,646 | $40,580 |
| Short-term investments | 52,659 | 114,375 |
| Restricted cash reported within other assets | 57 | 57 |
| $99,362 | $155,012 | |
Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands):
| At September 30, 2026 | AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | Fair Value |
|---|---|---|---|---|
| US treasury bills | $32,957 | $— | $(197) | $32,760 |
| Government-sponsored enterprise securities | 22,913 | 1 | (88) | 22,826 |
| Corporate bonds and commercial paper | 17,579 | — | (24) | 17,555 |
| Total | $73,449 | $1 | $(309) | $73,141 |
| At December 31, 2025 | AmortizedCost | GrossUnrealizedGains | GrossUnrealizedLosses | Fair Value |
|---|---|---|---|---|
| US treasury bills | $63,868 | $126 | $— | $63,994 |
| Government-sponsored enterprise securities | 20,663 | 30 | (1) | 20,692 |
| Corporate bonds and commercial paper | 35,714 | 28 | (2) | 35,740 |
| Total | $120,245 | $184 | $(3) | $120,426 |
Our short-term investments are classified as available-for-sale debt securities. Accordingly, we have classified these securities as short-term investments on our condensed balance sheets as they are available for use in the current operations. Accrued interest receivable, included within prepaid and other assets, was $0.4 million and$0.9 million at September 30, 2026 and December 31, 2025, respectively. At September 30, 2026 and December 31, 2025, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 246 days and 303 days, respectively. At September 30, 2026, available-for-sale debt securities classified as cash equivalents and short-term investments with a fair value of $51.7 million and $21.4 million had contractual maturities withinone year and after one year throughtwo years, respectively.
At September 30, 2026, a total of 68 individual securities had been in an unrealized loss position for 12 months or less, and the losses were determined to be temporary. We regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. We havenot recognized any credit losses at September 30, 2026 and December 31, 2025.
The following table shows the fair value and gross unrealized losses of our investments in individual securities that are in an unrealized loss position, aggregated by investment category (in thousands):
| At September 30, 2026 | Fair Value | Gross Unrealized Losses |
|---|---|---|
| US treasury bills | $31,768 | $(197) |
| Government-sponsored enterprise securities | 17,711 | (88) |
| Corporate bonds and commercial paper | 17,555 | (24) |
| Total | $67,034 | $(309) |
- Fair Value
The table below summarizes the fair value of our cash equivalents and short-term investments measured at fair value on a recurring basis, and are categorized based upon the lowest level of significant input to the valuations (in thousands):
| Assets at Fair Value at September 30, 2026 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Money market funds | $12,787 | $— | $— | $12,787 |
| US treasury bills | — | 32,760 | — | 32,760 |
| Government-sponsored enterprise securities | — | 22,826 | — | 22,826 |
| Corporate bonds and commercial paper | — | 17,555 | — | 17,555 |
| Total | $12,787 | $73,141 | $— | $85,928 |
| Assets at Fair Value at December 31, 2025 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Money market funds | $14,509 | $— | $— | $14,509 |
| US treasury bills | — | 63,994 | — | 63,994 |
| Government-sponsored enterprise securities | — | 20,692 | — | 20,692 |
| Corporate bonds and commercial paper | — | 35,740 | — | 35,740 |
| Total | $14,509 | $120,426 | $— | $134,935 |
- Debt
The following table summarizes loans payable, net (in thousands):
| September 30, 2026 | December 31, 2025 | |
|---|---|---|
| Revolving credit facility: | ||
| Principal outstanding | $8,000 | $— |
| Unamortized debt issuance costs | (764) | — |
| Revolving credit facility, net | $7,236 | $— |
| Term loan facility: | ||
| Principal outstanding | $— | $52,500 |
| Unamortized debt issuance costs | — | (206) |
| Principal outstanding, net | $— | $52,294 |
| Reported as: | ||
| Loans payable, net, current | $7,236 | $29,812 |
| Loans payable, net, non-current | — | 22,482 |
| $7,236 | $52,294 | |
We had a Credit and Security Agreement with MidCap Financial Trust (MidCap) entered into on September 27, 2019 and amended on March 29, 2021, February 11, 2022, July 27, 2022, and on April 11, 2024, which provided for a $60.0 million term loan credit facility (the prior Credit Agreement). Under the prior Credit Agreement, the term loans were scheduled to mature on September 1, 2027, and the interest-only period was through October 1, 2025. The term loans bore interest equal to the sum of one-month Secured Overnight Financing Rate (SOFR) plus an adjustment of 0.11448%, subject to a 4.00% applicable floor, plus applicable margin of 6.50%. A final payment fee of 4.25% of principal was due at maturity date. Under the prior Credit Agreement, we could make voluntary prepayments, in whole or in part, subject to certain prepayment premiums and additional interest payments. It also contained certain provisions, such as event of default and change in control provisions, which, if triggered, would have required us to make mandatory prepayments on the term loan. The obligations under the prior Credit Agreement were secured by a perfected security interest in all of our assets including our intellectual property.
On May 5, 2026, we repaid all outstanding term loan borrowings, including final payment fees, the applicable prepayment premium, and accrued interest, under the prior Credit Agreement with MidCap. Concurrently, we entered into a new credit agreement with MidCap providing for a revolving credit facility with a maximum borrowing capacity of $40.0 million, with an option to increase the facility to $60.0 million, subject to customary conditions (the new Credit Agreement). The revolving credit facility has afive-year term and bears interest at a rate equal to one-month SOFR, subject to a 2.00% floor, plus an applicable margin of 4.00%.
We evaluated this transaction under ASC 470-50, Debt—Modifications and Extinguishments, on a lender-by-lender basis. The portion of the prior term loan attributable to the continuing lender under the new revolving credit facility was accounted for as a debt modification. Accordingly, the related unamortized debt issuance costs and creditor fees of approximately $0.5 million continue to be amortized over the term of the new revolving credit facility. The remaining portion of the prior term loan was accounted for as a debt extinguishment, resulting in a loss on extinguishment of approximately $0.2 million during the second quarter of 2026. The loss was primarily related to the write-off of unamortized debt issuance costs, unaccrued final payment fees, and prepayment premiums attributable to the extinguished portion.
The availability under the revolving credit facility is subject to a borrowing base based primarily on eligible accounts receivable and inventory. Pursuant to the terms of the facility, substantially all of our accounts receivable collections are remitted to a lender-controlled lockbox account. Upon the occurrence of certain specified conditions, including an event of default, the funds in the lockbox account are required to be transferred to MidCap's payment account and applied to reduce outstanding borrowings under the facility. Subject to borrowing base availability and compliance with the terms of the agreement, we may re-borrow amounts under the revolving credit facility. Although the lockbox account is subject to contractual restrictions that require cash receipts to be applied to outstanding borrowings under those circumstances, we retain the ability to access liquidity through re-borrowings under the revolving credit facility, subject to borrowing base availability and covenant compliance.
The obligations under the revolving credit facility are secured by a first-priority security interest in substantially all of our assets, including our intellectual property. The revolving credit facility includes customary fees, including an unused commitment fee, administrative fee and prepayment premiums during the initial period.
At September 30, 2026, we had an outstanding borrowing of $8.0 million under the revolving credit facility, reflecting an initial $8.0 million borrowing in May 2026, and an additional $32.0 million borrowing in June 2026, and repayment of the $32.0 million in July 2026. The outstanding borrowings under the revolving credit facility were classified as a current liability on the condensed balance sheet. This classification reflects the nature of the facility, including its asset-based structure, borrowing base limitations, required application of certain cash receipts to outstanding borrowings, ongoing covenant compliance and provisions that may require repayment upon occurrence of certain events. The classification of borrowings under the revolving credit facility may change in future periods based on the facts and circumstances existing at each reporting date, including borrowing base availability, covenant compliance and our ability to maintain or refinance borrowings on a long-term basis. At September 30, 2026, the weighted-average interest rate on the outstanding borrowings under the revolving credit facility was 7.7%.
At September 30, 2026 and December 31, 2025, the carrying amounts of borrowings under our revolving credit facility and term loan facility, respectively, approximated fair value because management believes the applicable credit spreads were consistent with those available for similar borrowings at the respective dates. These fair values are classified as Level 2 within the fair value hierarchy.
The revolving credit facility contains customary covenants that, among other things, require us to deliver financial reports at specified times and maintain minimum liquidity and trailing twelve month product revenue. The minimum product revenue covenant is tested only during periods when the liquidity falls below specified thresholds. At September 30, 2026, we were not in violation of any covenants.
Interest expense includes amortization of the debt discount, accretion of the final fees, and losses on extinguishment attributable to the extinguished portion of the prior term loan. Interest expense was $0.3 million and $1.9 million, for the three months ended September 30, 2026 and 2025, respectively, and $2.5 million and $5.6 million for the nine months ended September 30, 2026 and 2025, respectively. Accrued interest of $0.1 million at September 30, 2026, was included in accounts payable, and accrued interest of $2.6 million at December 31, 2025, was included in other accrued liabilities in the condensed balance sheets.
- Commitments and Contingencies
Operating Leases
We lease our headquarters facility in South San Francisco, California under a lease agreement that expires in July 2027. Operating lease expense was $0.2 million and $0.5 million for each of the three and nine months ended September 30, 2026 and 2025, respectively. Cash paid for amounts included in the measurement of operating lease liabilities was $0.2 million and $0.1 million for the three months ended September 30, 2026 and 2025, respectively, and $0.5 million and $0.4 million for the nine months ended September 30, 2026 and 2025, respectively.
At September 30, 2026, the weighted average remaining term was 0.83 years, and future minimum lease payments were approximately $0.6 million.
Purchase Commitments and Obligations
In the ordinary course of business, we enter into agreements with contract manufacturers to manufacture our inventory products. These agreements generally include termination provisions that may require us to pay cancellation fees, which vary depending on the timing of termination and may equal up to the full value of the work order. In October 2024, we entered into an agreement with a third-party contract manufacturer to manufacture TAVALISSE, with deliveries expected from 2026 through 2029. At September 30, 2026, the contractual obligation not included in our financial statements related to an agreement that may potentially be subjected to cancellation fees was approximately $15.7 million. Of this amount, approximately $2.7 million is expected to be due in the remainder of 2026, and $8.6 million is expected to be due in 2027 and 2028. At September 30, 2026, we havenot incurred any cancellation fees under our agreements with contract manufacturers.
As contemplated by the license agreement with Arvinas and Pfizer, in July 2026, we entered into a manufacturing and supply agreement with Pfizer for the commercial manufacture and supply of VEPPANU. The agreement includes certain minimum purchase obligations on a take-or-pay basis, with expected purchases from 2026 through 2030. If we do not satisfy the applicable minimum purchase commitments within the required time periods, we may be required to make payments to Pfizer with respect to those commitments, as provided in the agreement. At September 30, 2026, the estimated contractual obligation not included in our financial statements related to this agreement was approximately $24.8 million. Of this amount, none is expected to be due in the remainder of 2026. Approximately $13.5 million is expected to be due in 2027 and 2028, with the remaining amount expected to be due thereafter through 2030.
Legal Contingencies
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not presently a party to any material legal proceedings that, if determined adversely to us, would have a material adverse effect on our business, financial condition, results of operations, or cash flows.
- Income Taxes
The following table presents provision for income tax for the periods presented (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Provision for (benefit from) income taxes | $4,224 | $(280) | $13,522 | $154 |
The quarterly provision for income taxes is determined by applying the estimated annual effective tax rate to the year-to-date pre-tax income, adjusted for any discrete items. The estimated annual effective tax rate is updated at the end of each reporting period.
The provision for income taxes for thethree and nine months ended September 30, 2026 primarily consisted of federal income tax expense of$3.7 million and $11.4 million, respectively, and estimated state income taxes of$0.5 million and $2.1 million, respectively. Prior to the fourth quarter of 2025, we maintained a full valuation allowance against our deferred tax assets. Although we do not expect to incur federal cash income taxes due to sufficient net operating loss (NOL) and research and development credit carryforwards, we recognized federal income tax expense based on the estimated impact of utilizing the deferred tax assets associated with such carryforwards. The total tax expense differs from the amount computed at the federal statutory rate primarily due to certain non-deductible expenses and state income taxes.
For thethree and nine months ended September 30, 2025, the benefit from or provision for income taxes, respectively, primarily related to estimated state income taxes, with the three-month benefit primarily reflecting an adjustment to those estimates. The tax expense differs from the amount computed at the federal statutory rate primarily due to the impact of the valuation allowance and state taxes.
- Segment Information
We view our operations and manage our business asone operating segment, and our chief operating decision maker (CODM) is our chief executive officer. The following table presents segment information for the periods presented (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Total Revenues | $80,890 | $69,462 | $218,411 | $224,480 |
| Less: | ||||
| Employee related expenses | 21,258 | 18,547 | 65,690 | 56,666 |
| Commercial related expenses | 9,444 | 6,303 | 23,568 | 18,915 |
| Outside clinical trial related expenses | 12,626 | 3,759 | 26,962 | 11,362 |
| Cost of product sales | 10,783 | 4,753 | 23,914 | 13,666 |
| Consultants and third-party services | 5,191 | 4,133 | 13,422 | 10,751 |
| Other segment items | 4,483 | 3,547 | 12,290 | 10,824 |
| Interest (income) expense and other, net | (304) | 800 | (86) | 3,183 |
| Provision for (benefit from) income taxes | 4,224 | (280) | 13,522 | 154 |
| Segment income | $13,185 | $27,900 | $39,129 | $98,959 |
There are no reconciling items or adjustments between segment income presented above and net income as presented in our statements of operations. The CODM does not review assets in evaluating the segment performance, accordingly, such information is not presented.
For details of revenues disaggregated by category, see “Note 3 – Revenues.”
Employee related expenses primarily consist of salaries, employee benefits, other employee related expenses and stock-based compensation expense. For additional details of stock-based compensation expense, see “Note 6 – Stock-Based Compensation.” Other segment items for the periods presented primarily consist of travel related expenses, business insurance, taxes and licenses, and subscription services.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.