What changed in this filing

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Item 1. Financial Statements

2025-11-04 compared with 2025-08-05 · 165 added, 162 removed, 478 unchanged (41% of the section changed)

3 unchanged sentences

(In thousands)

June 30, 2025

September 30, 2025

December 31, 2024 (1)

38 unchanged sentences

(In thousands, except per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Product sales, net

6 unchanged sentences

Total costs and expenses

Income (loss) from operations

Income from operations

Interest income

Interest expense

Income (loss) before income taxes

Provision for income taxes

Net income (loss)

Net income (loss) per share

Weighted average shares used in computing net income (loss) per share

Income before income taxes

(Benefit from) provision for income taxes

Net income per share

Weighted average shares used in computing net income per share

See Accompanying Notes to Condensed Financial Statements

RIGEL PHARMACEUTICALS, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE INCOME ( LOSS)

CONDENSED STATEMENTS OF COMPREHENSIVE INCOME

(In thousands)

Three Months Ended June 30,

Six Months Ended June 30,

Net income (loss)

Other comprehensive income (loss):

Net unrealized income (loss) on short-term investments

Comprehensive income (loss)

Three Months Ended September 30,

Nine Months Ended September 30,

Other comprehensive income:

Net unrealized income on short-term investments

Comprehensive income

See Accompanying Notes to Condensed Financial Statements

20 unchanged sentences

( 1,319,006 )

Net change in unrealized gain on short-term investments

Issuance of common stock upon exercise of options

Stock-based compensation expense

Balance as of September 30, 2025

( 1,291,106 )

Accumulated Other

16 unchanged sentences

( 1,416,827 )

Net change in unrealized gain on short-term investments

Issuance of common stock upon exercise of options

Issuance of common stock upon vesting of RSUs

Stock-based compensation expense

Balance as of September 30, 2024

( 1,404,406 )

See Accompanying Notes to Condensed Financial Statements

2 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Operating activities

Net income (loss)

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

Adjustments to reconcile net income to net cash provided by operating activities:

Stock-based compensation expense

Gain on sale and disposal of fixed assets

Depreciation and amortization

10 unchanged sentences

Other accrued liabilities

Lease liability

Net cash provided by (used in) operating activities

Lease liabilities

Net cash provided by operating activities

Investing activities

1 unchanged sentence

Purchases of short-term investments

Capital expenditures

Payments for acquisition of intangible assets

Proceeds from sale of property and equipment

Net cash (used in) provided by investing activities

1 unchanged sentence

Net proceeds from issuance of common stock from equity plans

Closing purchase price payment related to asset acquisition

Cost share payments to a collaboration partner

5 unchanged sentences

Interest paid

Increase in right-of-use assets and lease liability

Increase in right-of-use assets and lease liabilities

Acquisition-related liabilities

18 unchanged sentences

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.

We continue to advance the development of R289, our dual interleukin receptor-associated kinases 1 and 4 (IRAK 1/4) inhibitor program, in an open-label, Phase 1b study to determine the tolerability and preliminary efficacy of the drug in patients with lower-risk myelodysplastic syndrome (MDS) who are relapsed, refractory or resistant to prior therapies.

We continue to advance the development of R289, our dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor program, 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.

We have strategic development collaborations with The University of Texas MD Anderson Cancer Center (MDACC) to expand our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations, and with Collaborative Network for Neuro-Oncology Clinical Trials (CONNECT) to conduct a Phase 2 clinical trial to evaluate olutasidenib in combination with temozolomide in patients with high-grade glioma (HGG) harboring an IDH1 mutation.

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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, 2024.

As of June 30, 2025, we had approximately $ 108.4 million in cash, cash equivalents and short-term investments.

As of September 30, 2025, we had approximately $ 137.1 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.

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Recently Issued Accounting Standards

In November 2024, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures.

In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-09, Improvements to Income Tax Disclosures , which enhance the annual disclosure requirements regarding the tax rate reconciliation and income taxes paid information.

This update is effective for our fiscal year ending December 31, 2025, and maybe adopted on a prospective or retrospective basis.

Early adoption is permitted.

We are currently evaluating the impact that the adoption of this guidance may have on our annual income tax disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures.

This new guidance improves the disclosures about a public business entity’s expenses by requiring more detailed information about the types of expenses (including purchases of inventory, employee compensation, depreciation and amortization) included within income statement expense captions.

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We are currently evaluating this guidance and assessing the potential impact on our financial statements and disclosures.

In December 2023, FASB issued ASU 2023-09, Improvements to Income Tax Disclosures , which enhance the annual disclosure requirements regarding the tax rate reconciliation and incomes taxes paid information.

This update is effective for our fiscal year ending December 31, 2025, and maybe adopted on a prospective or retrospective basis.

In July 2025, FASB issued ASU 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets , which provides a practical expedient to measure credit losses on accounts receivable and contract assets.

The ASU is effective for annual periods beginning after December 15, 2025, and interim periods within those annual reporting periods.

Early adoption is permitted.

We are currently assessing the impact of adopting this guidance but do not expect it to have a significant impact to our financial statements and disclosures.

We are currently evaluating the timing of the adoption and the impact of this guidance but do not expect it to have a significant impact to 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 (Loss) Per Share

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 June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

EPS Numerator:

Net income (loss)

EPS Denominator—Basic:

4 unchanged sentences

Weighted-average shares outstanding and common stock equivalents

Net income (loss) per share

The potential shares of common stock that were excluded from the computation of diluted net income (loss) per share for the periods presented because including them would have been antidilutive are as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Net income per share

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,

Stock options

Shares under Purchase Plan

Revenues disaggregated by category were as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Product sales:

4 unchanged sentences

Release of cost share liability

License revenue

Milestone revenue

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Revenue from product sales is related to sales of our commercial products to our customers.

For detailed discussions of our revenues from collaborations and government contracts, see “Note 4 – Sponsored Research, License Agreements and Government Contracts.”

For detailed discussions of our revenues from collaborations, see “Note 4 – Sponsored Research and License Agreements.”

Our net product sales include gross product sales, net of chargebacks, discounts and fees, government and other rebates and returns.

Of the total discounts and allowances from gross product sales for the six months ended June 30, 2025 and 2024, $ 36.5 million and $ 27.6 million, respectively, was accounted for as additions to revenue reserves and refund liability, and $ 0.9 million and $ 0.4 million, respectively, as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fees that were prepaid) in the condensed balance sheet.

Of the total discounts and allowances from gross product sales for the nine months ended September 30, 2025 and 2024, $ 53.6 million and $ 44.6 million, respectively, was accounted for as additions to revenue reserves and refund liability, and $ 5.3 million and $ 0.7 million, respectively, as reductions in accounts receivable (as it relates to allowance for prompt pay discount) and prepaid and other current assets (as it relates to certain chargebacks and other fees that were prepaid) in the condensed balance sheet.

The following tables summarize the activities in chargebacks, discounts and fees, government and other rebates and returns that were accounted for within revenue reserves and refund liability, for each of the periods presented (in thousands):

4 unchanged sentences

Credit or payments made during the period

Balance as of June 30, 2025

Balance as of September 30, 2025

Discounts and

2 unchanged sentences

Credit or payments made during the period

Balance as of June 30, 2024

Balance as of September 30, 2024

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:

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

McKesson Corporation

Cencora, Inc.

Optime Care, Inc.

Cardinal Health, Inc.

* Denotes less than 10%

Sponsored Research, License Agreements and Government Contracts

Sponsored Research and License Agreements

We conduct research and development programs independently and in connection with our corporate collaborators.

As of June 30, 2025, we are a party to collaboration agreements with Lilly to develop and commercialize ocadusertib (previously R552), a RIPK1 inhibitor, for the treatment of non-central nervous system (non-CNS) diseases and collaboration aimed at developing additional RIPK1 inhibitors for the treatment of central nervous system (CNS) diseases;

We are a party to collaboration agreements with Lilly to develop and commercialize ocadusertib (previously R552), a RIPK1 inhibitor;

with Grifols S.A.

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(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;

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;

Reddy’s Laboratories (Dr.

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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.

Further, we are also a party to collaboration agreements, but do not have ongoing performance obligations with BerGenBio ASA (BerGenBio) for the development and commercialization of AXL receptor tyrosine kinase i nhibitor, R428 (now referred to as bemcentinib (BGB324)), and with Daiichi Sankyo (Daiichi) to pursue research related to murine double minute 2 ( MDM2) inhibitor, DS-3032 (now referred as milademetan).

Further, 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 i nhibitor, R428 (now referred to as bemcentinib (BGB324)), and with Daiichi Sankyo (Daiichi) to pursue research related to murine double minute 2 ( MDM2) inhibitor, DS-3032 (now referred as milademetan).

Under the above existing agreements that we entered into in the ordinary course of business, we received or may be entitled to receive upfront cash payments, payments contingent upon specified events achieved by such partners and royalties on any net sales of products sold by such partners under the agreements.

As of June 30, 2025, total future contingent payments to us under all of the above existing agreements was approximately $ 1.5 billion, if all potential product candidates achieved all of the payment triggering events under all of our current agreements.

The total potential future contingent payments due to us under all existing collaboration agreements are approximately $ 1.1 billion, which amount reflects the impact of Lilly’s notice of intent to terminate the central nervous system (CNS) disease program in October 2025, as discussed in more detail below, and assumes that all potential product candidates achieve every payment-triggering milestone under our current agreements.

Of this amount, $ 179.5 million relates to the achievement of development events, $ 270.6 million relates to the achievement of regulatory events and $ 637.0 million relates to the achievement of certain commercial events.

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Global Exclusive License Agreement with Lilly

We have a global exclusive license agreement and strategic collaboration with Lilly (Lilly Agreement) entered in February 2021, which became effective in March 2021, upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, to develop and commercialize ocadusertib (previously R552) for the treatment of non-CNS diseases.

In addition, the collaboration is aimed at developing additional RIPK1 inhibitors for the treatment of CNS diseases.

We have a global exclusive license agreement and strategic collaboration with Lilly entered in February 2021, which became effective in March 2021 upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and was amended in September 2023 (first amendment), March 2024 (second amendment), and in August 2025 (third amendment) (collectively, Lilly Agreement).

The collaboration is to develop and commercialize ocadusertib (previously R552) for the treatment of non-central nervous system (non-CNS) diseases, and additional RIPK1 inhibitors for the treatment of CNS diseases.

Pursuant to the terms of the Lilly Agreement, we granted Lilly the exclusive rights to develop and commercialize ocadusertib and related RIPK1 inhibitors in all indications worldwide.

The parties’ collaboration is governed through a joint governance committee and appropriate subcommittees.

collaboration is governed through a joint governance committee and appropriate subcommittees.

Under the terms of the Lilly Agreement, we were entitled to receive a non-refundable and non-creditable upfront cash payment amounting to $ 125.0 million, which we received in April 2021.

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In addition, depending on the extent of our co-funding of ocadusertib development activities, we would be entitled to receive tiered royalty payments on net sales of non-CNS disease products at percentages ranging from the mid-single digits to high-teens, subject to certain standard reductions and offsets.

We are also eligible to receive milestone payments for CNS disease products consisting of up to $ 255.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, and up to $ 150.0 million in sales milestone payments on a product-by-product basis.

We would be entitled to receive tiered royalty payments on net sales of CNS disease products up to low-double digits, subject to certain standard reductions and offsets.

Under the terms of the Lilly Agreement, we were also eligible to receive milestone payments for CNS disease products consisting of up to $ 256.0 million in milestone payments upon the achievement of specified development, regulatory and commercial milestones, up to $ 150.0 million in sales milestone payments on a product-by-product basis, and tiered royalty payments on net sales of CNS disease products up to low-double digits, subject to certain standard reductions and offsets.

On October 1, 2025, we received a notice from Lilly of its intent to terminate the CNS disease program under the Lilly Agreement, which will become effective sixty ( 60 ) days following notification.

Following the termination of the CNS disease program, we do not believe we will be entitled to receive any future milestone and royalty payments associated with this program.

Under the Lilly Agreement, we were responsible for performing and funding initial discovery and identification of CNS disease development candidates.

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Pursuant to the terms of the Lilly Agreement, we have the right to opt-out of co-funding the ocadusertib development activities in the US, Europe and Japan at two different specified times and as a result receive lesser royalties from sales.

Under the Lilly Agreement, if the first opt-out right was exercised prior to September 30, 2023, we were required to fund our share of the ocadusertib development activities up to a maximum funding commitment of $ 65.0 million through April 1, 2024.

We accounted for this agreement under ASC 606 and identified the following distinct performance obligations at inception of the agreement:

(a) granting of the license rights over the non-CNS penetrant intellectual property (IP), and (b) granting of the license rights over the CNS penetrant IP which will be delivered to Lilly upon completion of the additional research and development efforts specified in the agreement.

We concluded that each of these performance obligations is distinct.

We based our assessment on the assumption that Lilly can benefit from each of the licenses on its own by developing and commercializing the underlying product using its own resources.

Under the Lilly Agreement, the first opt-out right was exercised prior to September 30, 2023, and we were therefore required to fund our share of the ocadusertib development activities up to a maximum funding commitment of $ 65.0 million through April 1, 2024.

We accounted for this agreement under ASC 606.

At the inception of the Lilly Agreement, given our rights to opt-out from the development of ocadusertib, we believed at the minimum, we had a commitment to fund the development costs up to $ 65.0 million as discussed above.

We considered this commitment to fund the development costs as a significant financing component of the contract, which we accounted for as a reduction of the upfront fee to derive the transaction price.

This financing component was recorded as a liability at its net present value of approximately $ 57.9 million using a 6.4 % discount rate.

Interest expense was accreted on such liability over the expected commitment period, adjusted for timing of expected cost share payments.

At the inception, we allocated the net transaction price of $ 67.1 million to each performance obligation based on our best estimate of its relative standalone selling price using the adjusted market assessment approach.

This financing component was recorded as a liability at its net present value of approximately $ 57.9 million using a 6.4 % discount rate and interest was accreted on such liability over the expected commitment period, adjusted for timing of expected cost share payments.

We allocated the net transaction price of $ 67.1 million to each performance obligation based on our best estimate of its relative standalone selling price using the adjusted market assessment approach.

The transaction price allocated to the non-CNS penetrant IP of $ 60.4 million was recognized as revenue upon delivery of the non-CNS penetrant IP to Lilly during the first quarter of 2021.

The transaction price allocated to the CNS penetrant IP of $ 6.7 million was recognized as revenue from the effective date of the Lilly Agreement through the eventual acceptance by Lilly in June 2022 using the input method.

There was no outstanding deferred revenue related to Lilly Agreement as of June 30, 2025 and December 31, 2024.

In September 2023, we provided our first-opt out notice to Lilly, and concurrently entered into a second amendment to the Lilly Agreement.

There was no outstanding deferred revenue related to Lilly Agreement as of September 30, 2025 and December 31, 2024.

In September 2023, we provided our first-opt out notice to Lilly, and concurrently entered into an amendment to the Lilly Agreement.

The amended Lilly Agreement provided, among others that if we exercise our first opt-out right, we have the right to opt-in to the co-funding of ocadusertib development, upon us providing notice to Lilly within 30 days of certain events as specified in the Lilly Agreement, and as a result receive greater royalties from sales.

3 unchanged sentences

As of December 31, 2024, the outstanding liability to Lilly reported within other long-term liabilities in the condensed balance sheets amounted to $ 40.0 million.

Although our cost share obligation for the ocadusertib development ended on April 1, 2024, the remaining cost share liability was not released in the periods prior to us providing the notice to Lilly not to exercise our opt-in right because we were not able to conclude that it was probable that a significant reversal of the amount of revenue, if recognized, would not occur until the likelihood of us exercising our opt-in right became remote, or when the opt-in right period lapsed.

Although our cost share obligation for the ocadusertib development ended on April 1, 2024, the remaining cost share liability was not released in the periods

prior to us providing the notice to Lilly not to exercise our opt-in right because we were not able to conclude that it was probable that a significant reversal of the amount of revenue, if recognized, would not occur until the likelihood of us exercising our opt-in right became remote, or when the opt-in right period lapsed.

On April 30, 2025, we provided notice to Lilly of our decision not to exercise our opt-in right following our evaluation of certain events specified in the Lilly Agreement.

Following this notification, we are no longer obligated to share in any future global development costs.

As such, we released the $ 40.0 million remaining cost share liability and recognized the amount as contract revenues from collaboration in the three and six months ended June 30, 2025.

As such, 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.

Grifols License Agreement

5 unchanged sentences

We accounted for this agreement under ASC 606, and recognized the corresponding revenue in the period we satisfied the performance obligations.

There was no outstanding deferred revenue related to the Grifols license agreement as of June 30, 2025 and December 31, 2024.

We have a commercial supply agreement with Grifols entered in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols order from us pursuant to and in accordance with the agreement.

For the three and six months ended June 30, 2025, we recognized revenue of $ 0.4 million and $ 3.7 million, respectively, related to the delivery of drug supply to Grifols.

No revenue was recognized related to delivery of drug supplies to Grifols during the three and six months ended June 30, 2024.

There was no outstanding deferred revenue related to the Grifols license agreement as of September 30, 2025 and December 31, 2024.

We have a commercial supply agreement with Grifols entered in October 2020 to supply and sell our drug product priced at a certain markup specified in the agreement, in quantities Grifols orders from us pursuant to and in accordance with the agreement.

Revenue recognized related to the delivery of drug supply to Grifols for the three months ended September 30, 2025 and 2024 was $ 1.2 million and $ 2.0 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 4.9 million and $ 2.0 million, respectively.

We recognize royalty revenue from Grifols included within contract revenues from collaboration.

Royalty revenue recognized for the three months ended June 30, 2025 and 2024 was $ 1.6 million and $ 1.1 million, respectively, and for the six months ended June 30, 2025 and 2024 was $ 3.1 million and $ 2.2 million, respectively.

Royalty revenue recognized for the three months ended September 30, 2025 and 2024 was $ 1.9 million and $ 1.3 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 5.0 million and $ 3.5 million, respectively.

Kissei License Agreements

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Under the agreement, we granted Kissei the license rights to fostamatinib in Kissei’s territory and are obligated to supply Kissei with drug product for use in clinical trials and pre-commercialization activities.

We are also responsible for the manufacture and supply of

fostamatinib for all future development and commercialization activities.

We are also responsible for the manufacture and supply of fostamatinib for all future development and commercialization activities.

We accounted for this agreement under ASC 606, and recognized the corresponding revenue in the period we satisfied the performance obligations.

As of June 30, 2025 and December 31, 2024, the remaining deferred revenue was related to the material right associated with discounted fostamatinib supply which amounted to $ 1.4 million .

No revenue was recognized during the three and six months ended June 30, 2025 and 2024 associated with the remaining performance obligation.

As of September 30, 2025 and December 31, 2024, the remaining deferred revenue was related to the material right associated with discounted fostamatinib supply which amounted to $ 1.4 million .

No revenue was recognized during the three and nine months ended September 30, 2025 and 2024 associated with the remaining performance obligation.

In April 2022, Kissei announced that an NDA for fostamatinib in chronic ITP was submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and in December 2022, Kissei announced that Japan’s PMDA approved the NDA.

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In January 2025, Kissei announced the Korean Ministry of Food and Drug Safety approved fostamatinib for the treatment of chronic ITP, which entitled us to receive a $ 3.0 million non-refundable and non-creditable milestone payment that we recognized as revenue in the first quarter of 2025.

Revenue recognized related to the delivery of drug supply to Kissei for the three months ended June 30, 2025 and 2024 was $ 0.4 million and $ 2.2 million, respectively, and for the six months ended June 30, 2025 and 2024 was $ 2.0 million and $ 4.5 million, respectively.

Revenue recognized related to the delivery of drug supply to Kissei for the three months ended September 30, 2025 and 2024 was $ 1.8 million and $ 3.0 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 3.9 million and $ 7.5 million, 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, pursuant to which, we received a $ 5.0 million upfront payment with respect to the agreement in Canada.

We accounted for this agreement under ASC 606 and identified the following combined performance obligations at inception of the agreement:

(a) granting of the license and (b) obtaining regulatory approval in Canada of fostamatinib in ITP.

However, under the agreement, we have the option to buy back all rights to the product in Canada within six months from obtaining regulatory approval for the treatment of auto immune hemolytic anemia in Canada.

We determined that the non-refundable upfront fee represented the transaction price, however, due to the buyback provision, we accounted this upfront payment as financing arrangement under ASC 606.

In 2022, management concluded that the likelihood of exercising the buyback option right was remote considering the top-line results from our Phase 3 trial of fostamatinib in warm auto immune hemolytic anemia (wAIHA) which showed that the trial did not demonstrate statistical significance in the primary efficacy endpoint, and the guidance received from the FDA.

As such, in accordance with ASC 606, we relieved the outstanding financing liability which included the upfront payment and accreted interest, and recognized such amount as revenue in 2022.

There was no outstanding deferred revenue related to Medison commercial and license agreement as of June 30, 2025 and December 31, 2024.

Revenue recognized from Medison related to delivery of drug supply and earned royalties for the three months ended June 30, 2025 and 2024 was $ 0.2 million and $ 0.1 million, respectively, and for the six months ended June 30, 2025 and 2024 was $ 0.6 million and $ 0.2 million, respectively.

We accounted for this agreement under ASC 606, and recognized the revenue in the period we satisfied the performance obligation .

There was no outstanding deferred revenue related to Medison commercial and license agreement as of September 30, 2025 and December 31, 2024.

Revenue recognized from Medison related to delivery of drug supply and earned royalties for the three months ended September 30, 2025 and 2024 was $ 0.2 million and $ 0.1 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 0.8 million and $ 0.2 million, respectively.

Knight Commercial License and Supply Agreement

1 unchanged sentence

Pursuant to such commercial license agreement, we received a $ 2.0 million one-time, non-refundable, and non-creditable upfront payment, with potential for up to an additional $ 20.0 million in regulatory and sales-based commercial milestone payments, and will receive twenty- to mid-thirty percent, tiered, escalated net-sales based royalty payments for products sold in the Knight territory.

We accounted for this agreement under ASC 606 and identified that the upfront payment was a consideration for granting Knight the license to commercialize fostamatinib for approved indication in the Knight territory, and no further material deliverables associated to such upfront payment.

As such, we recognized the upfront payment as revenue in 2022.

We accounted for this agreement under ASC 606, and recognized the revenue in the period we satisfied the performance obligation.

There was no outstanding deferred revenue related to Knight commercial and license agreement as of September 30, 2025 and December 31, 2024.

We are also responsible for the exclusive manufacture and supply of fostamatinib for all future development and commercialization activities under the agreement.

No revenue was recognized during the three and six months ended June 30, 2025 and 2024 from Knight.

No revenue was recognized during the three and nine months ended September 30, 2025 and 2024 from Knight.

Reddy’s Commercial License Agreement

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Reddy’s territory.

Pursuant to the commercial license agreement, we were entitled to receive a $ 4.0 million one-time, non-refundable and non-creditable upfront payment , which amount, net of applicable foreign withholding taxes was received in February 2025.

the commercial license agreement, we were entitled to receive a $ 4.0 million one-time, non-refundable and non-creditable upfront payment , which amount, net of applicable foreign withholding taxes was received in February 2025.

In addition, we are entitled to a potential for up to an additional $ 36.0 million in regulatory and sales-based commercial milestone payments, and will receive high teens- to thirty percent, tiered, escalated net-sales based royalty payments for products sold in Dr.

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Reddy’s, which revenue was recognized during the fourth quarter of 2024.

No revenue was recognized during the three and six months ended June 30, 2025 related to the commercial license agreement with Dr.

Government Contract

In August 2023, we were awarded up to $ 0.8 million by Biomedical Advanced Research and Development (BARDA), part of the Office of the Assistant Secretary for the Preparedness and Response at the US Department of Health and Human Services (DHHS), for our evaluation of fostamatinib in mitigating the impact of long-term respiratory distress.

No revenue was recognized during the three and six months ended June 30, 2025 and 2024 from this grant.

Through June 30, 2025, we have received $ 0.1 million of the award .

In August 2025, we entered into a supply agreement with Dr.

During the three and nine months ended September 30, 2025, we recognized $ 0.1 million of revenue related to delivery of drug supply to Dr.

Strategic Development Collaborations with MDACC and CONNECT

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Under the collaboration, we will provide MDACC the study materials and $ 15.0 million in time-based milestone payments as compensation for services to be provided for the studies, over the five-year collaboration term, unless terminated earlier as provided for in the agreement.

Through June 30, 2025, we provided $ 5.3 million funding to MDACC.

Through September 30, 2025, we provided $ 5.3 million funding to MDACC.

In January 2024, we announced our collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate olutasidenib in glioma.

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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.

The potential regulatory milestones include

full regulatory approval of pralsetinib (or related compounds) for the treatment of adult RET-fusion positive thyroid cancer, and maintenance of the current regulatory approval of pralsetinib for the treatment of adult RET-fusion positive thyroid cancer during the period beginning on February 22, 2024 and ending on the third anniversary of the first commercial sale of pralsetinib subject to certain conditions.

The potential regulatory milestones include full regulatory approval of pralsetinib (or related compounds) for the treatment of adult RET-fusion positive thyroid cancer, and maintenance of the current regulatory approval of pralsetinib for the treatment of adult RET-fusion positive thyroid cancer during the period beginning on February 22, 2024 and ending on the third anniversary of the first commercial sale of pralsetinib subject to certain conditions.

Subject to the terms and conditions of the Asset Purchase Agreement, Blueprint would be 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.

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Of the total closing purchase price, $ 10.0 million was paid in July 2024.

The remaining $ 5.0 million was outstanding and presented as acquisition-related liabilities in the condensed balance sheet as of June 30, 2025 and December 31, 2024.

The remaining $ 5.0 million was outstanding and presented as acquisition-related liabilities in the condensed balance sheet as of September 30, 2025 and December 31, 2024.

We classify the outstanding acquisition-related liabilities as current or non-current liabilities based on the period the amount is expected to be due as of the balance sheet date.

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Prior to the FDA approval of REZLIDHIA in December 2022, a certain regulatory milestone was met which entitled Forma to receive a $ 2.5 million milestone payment.

Because such milestone payment obligation was incurred prior to a regulatory approval of an

indication associated with the acquired licensed asset, we recorded such amount as research and development expense in the fourth quarter of 2022.

Because such milestone payment obligation was incurred prior to a regulatory approval of an indication associated with the acquired licensed asset, we recorded such amount as research and development expense in the fourth quarter of 2022.

On December 1, 2022, the FDA approved REZLIDHIA capsules for the treatment of adult patients with R/R AML with susceptible IDH1 mutations as detected by an FDA-approved test.

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Stock-based compensation for the periods presented was as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Selling, general and administrative

1 unchanged sentence

Total stock-based compensation expense

During the six months ended June 30, 2025, we granted stock options to purchase 619,572 shares of common stock with weighted-average grant-date fair value of $ 16.95 per share, and the grants generally vest over 3 years .

During the six months ended June 30, 2025, 140,126 stock options were exercised.

As of June 30, 2025, there were 3,846,358 stock options outstanding, of which, 168,564 are outstanding performance-based stock options wherein the achievement of the corresponding corporate-based milestones were assessed not probable as of June 30, 2025.

Accordingly, none of the $ 3.2 million grant date fair value for these awards has been recognized as stock-based compensation expense as of June 30, 2025.

During the nine months ended September 30, 2025, we granted stock options to purchase 633,417 shares of common stock with weighted-average grant-date fair value of $ 16.89 per share, and the grants generally vest over 3 years .

During the nine months ended September 30, 2025, 347,016 stock options were exercised.

As of September 30, 2025, there were 3,640,274 stock options outstanding, of which, 168,564 are outstanding performance-based stock options wherein the achievement of the corresponding corporate-based milestones were assessed not probable as of September 30, 2025.

Accordingly, none of the $ 3.2 million grant date fair value for these awards has been recognized as stock-based compensation expense as of September 30, 2025.

The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model.

The following table summarizes the weighted-average assumptions relating to options granted 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) for the periods presented:

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Risk-free interest rate

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Expected volatility

During the six months ended June 30, 2025, we granted 340,817 RSUs with a grant-date weighted-average fair value of $ 19.27 per share, and the grants generally vest over 3 years .

During the six months ended June 30, 2025, 143,691 RSUs were released.

As of June 30, 2025, there were 565,846 RSUs outstanding.

As of June 30, 2025, there was approximately $ 20.5 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 2.19 years, related to time-based stock options, performance-based stock options wherein achievement of the corresponding corporate-based milestones was considered as probable, and RSUs.

During the six months ended June 30, 2025, our Board of Directors approved an additional 23,350 shares of common stock reserved for issuance under our Inducement Plan.

During the nine months ended September 30, 2025, we granted 350,047 RSUs with a grant-date weighted-average fair value of $ 19.27 per share, and the grants generally vest over 3 years .

During the nine months ended September 30, 2025, 143,691 RSUs were released.

As of September 30, 2025, there were 569,106 RSUs outstanding.

As of September 30, 2025, there was approximately $ 17.3 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 2.04 years, related to time-based stock options, performance-based stock options wherein achievement of the corresponding corporate-based milestones was considered as probable, and RSUs.

During the nine months ended September 30, 2025, our Board of Directors approved an additional 42,925 shares of common stock reserved for issuance under our Inducement Plan.

In May 2025, our stockholders approved an amendment to our 2018 Plan to, among other items, add an additional 700,000 shares to the number of shares of common stock authorized for issuance under our 2018 Plan.

As of June 30, 2025, there were 1,396,042 shares of common stock available for future grant under our Equity Incentive Plans.

As of September 30, 2025, there were 1,407,956 shares of common stock available for future grant under our Equity Incentive Plans.

Employee Stock Purchase Plan

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The fair value of awards under our Purchase Plan is estimated on the date of our new offering period using the Black-Scholes option pricing model, which is being amortized over the requisite service periods.

As of June 30, 2025, there was approximately $ 0.2 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 0.81 years, related to our Purchase Plan.

During the six months ended June 30, 2025, there were 39,801 shares purchased under the Purchase Plan.

As of June 30, 2025, there were 144,373 shares reserved for future issuance under the Purchase Plan.

As of September 30, 2025, there was approximately $ 0.2 million of unrecognized stock-based compensation cost which is expected to be recognized over a remaining weighted-average period of 0.59 years, related to our Purchase Plan.

During the nine months ended September 30, 2025, there were 39,801 shares purchased under the Purchase Plan.

As of September 30, 2025, there were 144,373 shares reserved for future issuance under the Purchase Plan.

Other Balance Sheet Components

Inventories for the periods presented consist of the following (in thousands):

June 30, 2025

September 30, 2025

December 31, 2024

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Prepaid and other current assets for the periods presented consist of the following (in thousands):

June 30, 2025

September 30, 2025

December 31, 2024

4 unchanged sentences

Intangible assets consist of the following (in thousands):

June 30, 2025

September 30, 2025

December 31, 2024

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Intangible assets, net

Amortization expense recorded within cost of product sales in the condensed statements of operations for the three months ended June 30, 2025 and 2024 was $ 0.6 million and $ 0.6 million, respectively, and for the six months ended June 30, 2025 and 2024 was $ 1.2 million and $ 1.0 million, respectively.

The following table presents the estimated future amortization expense of intangible assets as of June 30, 2025 (in thousands):

Amortization expense recorded within cost of product sales in the condensed statements of operations for the three months ended September 30, 2025 and 2024 was $ 0.6 million and $ 0.6 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 1.8 million and $ 1.6 million, respectively.

The following table presents the estimated future amortization expense of intangible assets as of September 30, 2025 (in thousands):

Remainder of 2025

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Cash, cash equivalents, restricted cash, and short-term investments for the periods presented consist of the following (in thousands):

June 30, 2025

September 30, 2025

December 31, 2024

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Cash equivalents and short-term investments include the following securities with gross unrealized gains and losses (in thousands):

As of June 30, 2025

As of September 30, 2025

US treasury bills

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Corporate bonds and commercial paper

As of June 30, 2025 and December 31, 2024, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 117 days and 69 days , respectively.

As of September 30, 2025 and December 31, 2024, our cash equivalents and short-term investments had a weighted-average time to maturity of approximately 259 days and 69 days , respectively.

Our short-term investments are classified as available-for-sale 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.

As of June 30, 2025, a total of 40 individual securities had been in an unrealized loss position for 12 months or less, and the losses were determined to be temporary.

As of September 30, 2025, a total of 26 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 have no t recognized any credit losses as of June 30, 2025 and December 31, 2024.

We have no t recognized any credit losses as of September 30, 2025 and December 31, 2024.

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):

As of June 30, 2025

As of September 30, 2025

Gross Unrealized Losses

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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 as of June 30, 2025

Assets at Fair Value as of September 30, 2025

Money market funds

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The following table summarizes loans payable, net (in thousands):

June 30, 2025

September 30, 2025

December 31, 2024

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The outstanding loans payable as of the periods presented was related to our Credit and Security Agreement (Credit Agreement) with MidCap Financial Trust (MidCap) entered into on September 27, 2019 (Closing Date) and amended on March 29, 2021 (First Amendment), February 11, 2022 (Second Amendment), July 27, 2022 (Third Amendment), and on April 11, 2024 (Fourth Amendment).

The Credit Agreement provides for a $ 60.0 million term loan credit facility, which was fully funded as of June 30, 2025 and December 31, 2024.

The Credit Agreement provides for a $ 60.0 million term loan credit facility, which was fully funded as of September 30, 2025 and December 31, 2024.

Under the Credit Agreement, as amended, the term loans mature on September 1, 2027, and the interest-only period is through October 1, 2025.

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The obligations under the amended Credit Agreement are secured by a perfected security interest in all of our assets including our intellectual property.

Interest expense, including amortization of the debt discount and accretion of the final fees related to the Credit Agreement for the three months ended June 30, 2025 and 2024 was $ 1.9 million and $ 2.0 million, respectively, and for the six months ended June 30, 2025 and 2024 was $ 3.7 million and $ 3.9 million, respectively.

Accrued interest of $ 2.3 million was included within other accrued liabilities in the condensed balance sheet as of June 30, 2025.

The following table presents the future minimum principal payments of the outstanding loan as of June 30, 2025 (in thousands):

Interest expense, including amortization of the debt discount and accretion of the final fees related to the Credit Agreement for the three months ended September 30, 2025 and 2024 was $ 1.9 million and $ 2.1 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 5.6 million and $ 6.0 million, respectively.

Accrued interest of $ 2.6 million was included within other accrued liabilities in the condensed balance sheet as of September 30, 2025.

The following table presents the future minimum principal payments of the outstanding loan as of September 30, 2025 (in thousands):

Remainder of 2025

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The amended Credit Agreement contains certain covenants which, among others, require us to deliver financial reports at designated times of the year and maintain minimum unrestricted cash and trailing net revenues.

As of June 30, 2025, we were not in violation of any covenants.

As of September 30, 2025, we were not in violation of any covenants.

Commitments and Contingencies

3 unchanged sentences

In February 2025, we entered into a lease agreement with 611 Gateway Center LP (611 Gateway) to lease the same office space, which lease term commenced following the expiration of the sublease with Atara and will expire in July 2027.

Following our lease agreement with 611 Gateway, i n accordance with ASC 842, Leases , at lease measurement date, we recognized operating lease right-of-use asset and lease liability of approximately $ 1.2 million, which amount represents the present value of the future minimum lease payments over the term of the lease measured using our incremental borrowing rate.

Following our lease agreement with 611 Gateway, i n accordance with ASC 842, Leases , at lease measurement date, we recognized operating lease right-of-use asset and lease liabilities of approximately $ 1.2 million, which amount represents the present value of the future minimum lease payments over the term of the lease measured using our incremental borrowing rate.

The components of our operating lease expense were as follows (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Fixed operating lease expense

1 unchanged sentence

Total operating lease expense

Cash payments included in the measurement of operating lease liabilities for the three months ended June 30, 2025 and 2024 was $ 0.1 million and $ 0.2 million, respectively, and for the six months ended June 30, 2025 and 2024 was $ 0.3 million and $ 0.4 million, respectively.

The weighted average remaining term of our leases as of June 30, 2025 was 2.08 years.

The following table presents the future lease payments as of June 30, 2025 (in thousands):

Cash payments included in the measurement of operating lease liabilities for the three months ended September 30, 2025 and 2024 was $ 0.1 million and $ 0.2 million, respectively, and for the nine months ended September 30, 2025 and 2024 was $ 0.4 million and $ 0.6 million, respectively.

The weighted average remaining term of our leases as of September 30, 2025 was 1.83 years.

The following table presents the future lease payments as of September 30, 2025 (in thousands):

Remainder of 2025

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In October 2024, we entered into an agreement with a third-party contract manufacturer to manufacture TAVALISSE that is expected to be delivered starting in 2026 through 2029.

As of June 30, 2025, the contractual obligation not included in our financial statements related to an agreement that may potentially be subjected to cancellation fees of approximately $ 22.5 million, of which, $ 3.0 million is expected to be due in the remainder of 2025, and $ 10.5 million is expected to be due in 2026 and 2027.

As of June 30, 2025, we have no t incurred any cancellation fees under our agreements with contract manufacturers.

As of September 30, 2025, the contractual obligation not included in our financial statements related to an agreement that may potentially be subjected to cancellation fees of approximately $ 22.6 million, of which, $ 3.0 million is expected to be due in the remainder of 2025, and $ 10.5 million is expected to be due in 2026 and 2027.

As of September 30, 2025, we have no t incurred any cancellation fees under our agreements with contract manufacturers.

Legal Contingencies

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The litigation resulted from submission by Annora of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of TAVALISSE in the US.

Under the terms of the settlement agreement,

Annora will have a license to sell its generic product in the second quarter of 2032 or earlier under certain circumstances.

Under the terms of the settlement agreement, Annora will have a license to sell its generic product in the second quarter of 2032 or earlier under certain circumstances.

In accordance with the settlement agreement, the parties terminated all ongoing litigation between us and Annora regarding TAVALISSE patents pending in New Jersey.

For more information, see “ Part II, Item 1, Legal Proceedings” of this Quarterly Report on Form 10-Q.

The quarterly provision for or benefit from income taxes is based on applying the estimated annual effective tax rate to the year-to-date pre-tax income (loss), adjusted for any discrete items.

The quarterly provision for or benefit from income taxes is based on applying the estimated annual effective tax rate to the year-to-date pre-tax income, adjusted for any discrete items.

We update our estimate of our annual effective tax rate at the end of each quarterly period.

The provision for income taxes for the three and six months ended June 30, 2025 was primarily related to state income taxes.

We do not expect to owe federal income tax due to sufficient net operating loss carryforwards that were generated prior to the enactment of the Tax Cuts and Jobs Act (TCJA), as well as significant research and development credit carryforwards.

For the three and six months ended June 30, 2024, we did no t record a provision for income taxes due to our pre-tax book loss.

As of June 30, 2025, we continue to record a full valuation allowance on our deferred tax assets.

The benefit from or provision for income taxes for the three and nine months ended September 30, 2025 was primarily related to estimated state income taxes.

We do not expect to owe federal income tax due to sufficient net operating loss carryforwards, as well as significant research and development credit carryforwards.

For the three and nine months ended September 30, 2024, we did no t record a provision for income taxes based on the forecasted pre-tax book loss.

In July 2025, the One Big Beautiful Bill Act (OBBBA), formally titled “An Act to provide for reconciliation pursuant to title II of H.

14.” was signed into law.

The OBBBA introduces a wide range of provisions affecting business entities, including the establishment of certain permanent business tax measures.

Key provisions include a permanent and immediate deduction for domestic research and development expenditures, the restoration and permanent extension of 100% expensing for qualified equipment purchases, and restores the ability to add back depreciation and amortization expense when determining the limitation on interest deductions.

In accordance with ASC 740, Income Taxes , the effects of changes in tax laws are recognized in the period of enactment.

Accordingly, we accounted for the estimated impact of the OBBBA in our current period tax provision.

The enactment of the OBBBA did not have a material impact on our condensed financial statements for the three and nine months ended September 30, 2025.

As of September 30, 2025, we continue to record a full valuation allowance on our deferred tax assets.

The realization of deferred tax assets is dependent upon demonstrating sufficient positive evidence to conclude that it is more-likely-than-not that our deferred tax assets will be realized.

5 unchanged sentences

The following table presents segment information for the periods presented:

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

8 unchanged sentences

Interest expense, net

Provision for income taxes

Segment income (loss)

There is no reconciling items or adjustments between segment income (loss) presented above and net income (loss) as presented in our statements of operations.

(Benefit from) provision for income taxes

Segment income

There is 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 results and therefore such information is not presented.

2 unchanged sentences

For details of stock-based compensation expense, see “Note 6 – Stock-Based Compensation.” Other segment items for the periods presented primarily comprised travel related expenses, business insurance, taxes and licenses, and facility related expenses.

Subsequent Event

In July 2025, the US Congress approved, and President Trump signed into law, the One Big Beautiful Bill Act (OBBBA), formally titled “An Act to provide for reconciliation pursuant to title II of H.

14.” The OBBBA includes a broad array of measures affecting corporations and other business entities, including locking in a key set of business tax provisions.

These include incentives designed to promote innovation-driven investment, such as a permanent and immediate deduction for domestic research and development costs.

The legislation also locks in 100% expensing for qualified equipment purchases and makes permanent the deduction of up to 20% for qualified business income.

ASC 740, “ Income Taxes ”, requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation is enacted.

Consequently, we are evaluating the impact of the OBBBA on our financial statements and an estimate of the financial impact cannot be made at this time.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements