What changed in this filing

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Item 1. Financial Statements

2025-10-30 compared with 2025-07-31 · 127 added, 89 removed, 383 unchanged (36% of the section changed)

3 unchanged sentences

(In thousands, except share and per share data)

September 30,

2025 December 31,

24 unchanged sentences

25,000,000 shares authorized;

no shares issued or outstanding at June 30, 2025 and December 31, 2024

no shares issued or outstanding at September 30, 2025 and December 31, 2024

Common stock, $ 0.001 par value;

125,000,000 shares authorized;

74,254,956 shares issued and 58,038,545 shares outstanding at June 30, 2025, and 73,372,696 shares issued and 57,156,285 shares outstanding at December 31, 2024

74,496,287 shares issued and 58,279,876 shares outstanding at September 30, 2025, and 73,372,696 shares issued and 57,156,285 shares outstanding at December 31, 2024

Additional paid-in capital 2,538,357 2,493,811

Accumulated other comprehensive income (loss) 2,051 ( 1,518 )

Treasury stock, at cost ( 16,216,411 shares at June 30, 2025 and December 31, 2024)

Treasury stock, at cost ( 16,216,411 shares at September 30, 2025 and December 31, 2024)

( 802,486 ) ( 802,486 )

5 unchanged sentences

Condensed Consolidated Statements of Operations

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands, except share and per share data)

8 unchanged sentences

Loss from operations ( 116,869 ) ( 102,811 ) ( 350,554 ) ( 300,700 )

Gain on sale of contingent payments — 889,136 — 889,136

Milestone payment from gain on sale of oncology business — 200,000 — 200,000

Interest income, net 13,369 13,059 43,969 30,068

Other income, net 67 1,651 1,843 4,864

Net loss $ ( 112,020 ) $ ( 96,118 ) $ ( 201,309 ) $ ( 177,667 )

Net loss per share - basic and diluted $ ( 1.93 ) $ ( 1.69 ) $ ( 3.49 ) $ ( 3.14 )

Weighted-average number of common shares used in computing net loss per share – basic and diluted 57,932,576 56,802,546 57,697,193 56,593,011

Net (loss) income before taxes ( 103,433 ) 1,001,035 ( 304,742 ) 823,368

Income tax expense — 53,120 — 53,120

Net (loss) income $ ( 103,433 ) $ 947,915 $ ( 304,742 ) $ 770,248

Net (loss) income per share - basic $ ( 1.78 ) $ 16.65 $ ( 5.27 ) $ 13.58

Net (loss) income per share - diluted $ ( 1.78 ) $ 16.22 $ ( 5.27 ) $ 13.38

Weighted-average number of common shares used in computing net (loss) income per share – basic 58,139,277 56,939,403 57,846,173 56,709,318

Weighted-average number of common shares used in computing net (loss) income per share – diluted 58,139,277 58,432,796 57,846,173 57,581,382

See accompanying Notes to Condensed Consolidated Financial Statements.

AGIOS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Comprehensive Loss

Three Months Ended June 30, Six Months Ended June 30,

Condensed Consolidated Statements of Comprehensive (Loss) Income

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands)

2025 2024 2025 2024

Net loss $ ( 112,020 ) $ ( 96,118 ) $ ( 201,309 ) $ ( 177,667 )

Other comprehensive income (loss)

Unrealized gain (loss) on available-for-sale securities 290 42 2,173 ( 604 )

Comprehensive loss $ ( 111,730 ) $ ( 96,076 ) $ ( 199,136 ) $ ( 178,271 )

Net (loss) income $ ( 103,433 ) $ 947,915 $ ( 304,742 ) $ 770,248

Other comprehensive income

Unrealized gain on available-for-sale securities 1,396 4,465 3,569 3,861

Comprehensive (loss) income $ ( 102,037 ) $ 952,380 $ ( 301,173 ) $ 774,109

See accompanying Notes to Condensed Consolidated Financial Statements.

19 unchanged sentences

Balance at June 30, 2025 74,254,956 $ 74 $ 2,521,545 $ 655 $ ( 350,233 ) ( 16,216,411 ) $ ( 802,486 ) $ 1,369,555

Unrealized gain on available-for-sale securities — — — 1,396 — — — 1,396

Common stock issued under stock incentive plan and ESPP 241,331 — 4,435 — — — — 4,435

Stock-based compensation expense — — 12,377 — — — — 12,377

Net loss — — — — ( 103,433 ) — — ( 103,433 )

Balance at September 30, 2025 74,496,287 $ 74 $ 2,538,357 $ 2,051 $ ( 453,666 ) ( 16,216,411 ) $ ( 802,486 ) $ 1,284,330

Common Stock Additional

16 unchanged sentences

Balance at June 30, 2024 73,091,490 $ 73 $ 2,464,284 $ ( 1,045 ) $ ( 1,000,316 ) ( 16,216,411 ) $ ( 802,486 ) $ 660,510

Unrealized gain on available-for-sale securities — — — 4,465 — — — 4,465

Common stock issued under stock incentive plan and ESPP 146,464 — 2,637 — — — — 2,637

Stock-based compensation expense — — 11,145 — — — — 11,145

Net income — — — — 947,915 — — 947,915

Balance at September 30, 2024 73,237,954 $ 73 $ 2,478,066 $ 3,420 $ ( 52,401 ) ( 16,216,411 ) $ ( 802,486 ) $ 1,626,672

See accompanying Notes to Condensed Consolidated Financial Statements.

1 unchanged sentence

Condensed Consolidated Statements of Cash Flows

Six Months Ended

Nine Months Ended

September 30,

(In thousands) 2025 2024

Operating activities

Net loss $ ( 201,309 ) $ ( 177,667 )

Adjustments to reconcile net loss from operations to net cash used in operating activities:

Net (loss) income $ ( 304,742 ) $ 770,248

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

Depreciation and amortization 3,911 4,286

5 unchanged sentences

Realized gain on investments — ( 168 )

Gain on sale of contingent payments — ( 889,136 )

Milestone payment from gain on sale of oncology business — ( 200,000 )

Changes in operating assets and liabilities:

12 unchanged sentences

Payments associated with license agreement ( 10,000 ) —

Proceeds from sale of contingent payments — 889,136

Proceeds from milestone payment from gain on sale of oncology business — 200,000

Purchases of property and equipment ( 3,196 ) ( 718 )

17 unchanged sentences

and its consolidated subsidiaries, and “our Board of Directors” refers to the board of directors of Agios Pharmaceuticals, Inc.

We are a biopharmaceutical company committed to transforming patients’ lives through leadership in the field of cellular metabolism, with the goal of creating differentiated medicines for rare diseases, with a focus on classical hematology.

With a history of focused study on cellular metabolism, we have a deep and mature understanding of this biology, which is involved in the healthy functioning of nearly every system in the body.

Building on this expertise, these learnings can be rapidly applied to our clinical trials with the goal of developing medicines that can have a significant impact for patients.

We accelerate the impact of our portfolio by cultivating connections with patient communities, healthcare professionals, partners and colleagues to discover, develop and deliver potential therapies for rare diseases.

We are a commercial-stage biopharmaceutical company dedicated to redefining the future of rare disease treatment.

We champion an inclusive culture that fosters bold innovation and collaboration, both within our teams and with the rare disease communities we serve.

By building deep connections and trusted partnerships with patients, advocates, and healthcare professionals, we advance our understanding of the unique priorities and needs of these communities.

These real-world insights, combined with our biological expertise, allow us to develop and deliver innovative medicines with the potential to transform lives.

We are located in Cambridge, Massachusetts.

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Additionally, we received marketing authorization in Great Britain for PYRUKYND® for the treatment of PK deficiency in adult patients under the European Commission Decision Reliance Procedure.

In December 2024, we announced that we submitted a supplemental new drug application, or sNDA, to the FDA for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia, which was accepted with standard review by the FDA and granted a Prescription Drug User Fee Act, or PDUFA, goal date of September 7, 2025.

Also in December 2024, we announced that we submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, and regulatory applications to the Kingdom of Saudi Arabia and United Arab Emirates health authorities for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia.

In addition, we are currently evaluating PYRUKYND® for the treatment of sickle cell disease, or SCD.

The FDA accepted the sNDA and granted a Prescription Drug User Fee Act, or PDUFA, goal date of September 7, 2025, which the FDA subsequently extended to December 7, 2025 following our submission of a proposed Risk Evaluation and Mitigation Strategy, or REMS, to mitigate the risk of hepatocellular injury that was described in the original sNDA filing.

The submission of the REMS is a major amendment to the PYRUKYND® sNDA, resulting in the three-month review extension.

The extension was not the result of new or additional efficacy or safety data requested by the FDA or submitted by us.

In December 2024, we also announced that we submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, and regulatory applications to the Kingdom of Saudi Arabia and the United Arab Emirates health authorities for PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia.

In August 2025, we announced that the Saudi Food and Drug Authority approved PYRUKYND® for the treatment of adult patients with non-transfusion dependent and transfusion-dependent alpha- or beta-thalassemia.

In October 2025, we announced that the Committee for Medicinal Products for Human Use, or the CHMP, of the EMA adopted a positive opinion for the new indication for PYRUKYND® in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia.

The European Commission will now review the CHMP’s opinion, with the final decision expected by early 2026.

In addition, we are currently evaluating PYRUKYND® for the treatment of sickle cell disease, or SCD and in pediatric patients with PK deficiency.

We are also developing (i) tebapivat, a novel PK activator, for the potential treatment of lower-risk myelodysplastic syndromes, or LR MDS, and SCD;

5 unchanged sentences

In accordance with the license agreement, we are responsible to pay up to $ 130.0 million in potential development and regulatory milestones, in addition to sales milestones as well as tiered royalties on annual net sales, if any, of licensed products, which may be subject to specified reductions and offsets.

In the three months ended June 30, 2025, we achieved a regulatory milestone that triggered a $ 10.0 million payment to Alnylam, which we recorded within research and development expenses in our condensed consolidated statements of operations.

In the nine months ended September 30, 2025, we achieved a regulatory milestone that triggered a $ 10.0 million payment to Alnylam, which we recorded within research and development expenses in our condensed consolidated statements of operations.

Sale of Oncology Business to Servier and Sale of Contingent Payments

18 unchanged sentences

Basis of Presentation

The condensed consolidated balance sheet as of June 30, 2025, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three and six months ended June 30, 2025 and 2024, and the condensed consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 are unaudited.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of June 30, 2025, our results of operations and stockholders' equity for the three and six months ended June 30, 2025 and 2024, and cash flows for the six months ended June 30, 2025 and 2024.

The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and six-month periods are also unaudited.

The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period.

The condensed consolidated balance sheet as of September 30, 2025, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three and nine months ended September 30, 2025 and 2024, and the condensed consolidated statements of cash flows for the nine months ended September 30, 2025 and 2024 are unaudited.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of September 30, 2025, our results of operations and stockholders' equity for the three and nine months ended September 30, 2025 and 2024, and cash flows for the nine months ended September 30, 2025 and 2024.

The financial data and other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and nine-month periods are also unaudited.

The results of operations for the three and nine months ended

September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period.

The condensed consolidated balance sheet data as of December 31, 2024 was derived from our audited financial statements, but does not include all disclosures required by U.S.

8 unchanged sentences

We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses.

As of June 30, 2025, we had cash, cash equivalents and marketable securities of $ 1.3 billion.

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $ 1.3 billion.

Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and marketable securities to be sufficient to fund current operations for at least the next twelve months from the issuance of the financial statements.

11 unchanged sentences

Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.

The following table summarizes our cash equivalents and marketable securities measured at fair value and by level on a recurring basis as of June 30, 2025:

The following table summarizes our cash equivalents and marketable securities measured at fair value and by level on a recurring basis as of September 30, 2025:

(In thousands) Level 1 Level 2 Level 3 Total

10 unchanged sentences

The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value.

After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2025.

There have been no changes to the valuation methods during the six months ended June 30, 2025, and we had no financial assets or liabilities that were classified as Level 3 at any point during the six months ended June 30, 2025.

After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of September 30, 2025.

There have been no changes to the valuation methods during the nine months ended September 30, 2025, and we had no financial assets or liabilities that were classified as Level 3 at any point during the nine months ended September 30, 2025.

Marketable Securities

Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities , and are recorded at fair value.

Unrealized gains and losses are included as a component of accumulated other comprehensive income (loss) in the condensed consolidated balance sheets and statements of stockholders’ equity, and a component of total comprehensive income (loss) in the condensed consolidated statements of comprehensive loss, until realized.

Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses , to determine if the impairment is credit-related or noncredit-related.

1 unchanged sentence

Realized gains and losses are included in investment income on a specific-identification basis.

There were no material realized gains or losses on marketable securities for the three and six months ended June 30, 2025 or 2024.

Marketable securities at June 30, 2025 consisted of the following:

There were no material realized gains or losses on marketable securities for the three and nine months ended September 30, 2025 or 2024.

Marketable securities at September 30, 2025 consisted of the following:

(In thousands) Amortized

25 unchanged sentences

Total marketable securities $ 1,457,302 $ 878 $ ( 2,396 ) $ 1,455,784

As of June 30, 2025 and December 31, 2024, we held both current and non-current investments.

As of September 30, 2025 and December 31, 2024, we held both current and non-current investments.

Investments classified as current have maturities of less than one year.

Investments classified as non-current are those that:

(i) have a maturity of greater

than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale.

As of June 30, 2025 and December 31, 2024, we held 123 and 213 debt securities, respectively, that were in an unrealized loss position for less than one year.

We did no t record an allowance for credit losses as of June 30, 2025 and December 31, 2024 related to these securities.

The aggregate fair value of debt securities in an unrealized loss position at June 30, 2025 and December 31, 2024 was $ 626.8 million and $ 768.1 million, respectively.

There were no individual securities that were in a significant unrealized loss position as of June 30, 2025 and December 31, 2024.

(i) have a maturity of greater than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale.

As of September 30, 2025 and December 31, 2024, we held 58 and 213 debt securities, respectively, that were in an unrealized loss position for less than one year.

We did no t record an allowance for credit losses as of September 30, 2025 and December 31, 2024 related to these securities.

The aggregate fair value of debt securities in an unrealized loss position at September 30, 2025 and December 31, 2024 was $ 288.9 million and $ 768.1 million, respectively.

There were no individual securities that were in a significant unrealized loss position as of September 30, 2025 and December 31, 2024.

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 do not consider these marketable securities to be impaired as of June 30, 2025 and December 31, 2024.

We do not consider these marketable securities to be impaired as of September 30, 2025 and December 31, 2024.

Inventory, which consists of commercial supply of PYRUKYND®, consisted of the following:

(In thousands) June 30,

(In thousands) September 30,

2025 December 31,

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Our building leases are comprised of office and laboratory space under non-cancelable operating leases.

These lease agreements have remaining lease terms of approximately three years and contain various clauses for renewal at our option.

These lease agreements have remaining lease terms of approximately two years and contain various clauses for renewal at our option.

The renewal options were not included in the calculation of the operating lease assets and the operating lease liabilities as the renewal options are not reasonably certain of being exercised.

1 unchanged sentence

The components of lease expense and other information related to leases were as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands) 2025 2024 2025 2024

1 unchanged sentence

Cash paid for amounts included in the measurement of operating lease liabilities 4,916 4,684 14,664 14,015

We have not entered into any material short-term leases or financing leases as of June 30, 2025.

In arriving at the operating lease liabilities as of June 30, 2025 and December 31, 2024, we applied the weighted-average incremental borrowing rate of 5.7 % for both periods over a weighted-average remaining lease term of 2.7 and 3.2 years, respectively.

As of June 30, 2025, undiscounted minimum rental commitments under non-cancelable leases were as follows:

We have not entered into any material short-term leases or financing leases as of September 30, 2025.

In arriving at the operating lease liabilities as of September 30, 2025 and December 31, 2024, we applied the weighted-average incremental borrowing rate of 5.7 % for both periods over a weighted-average remaining lease term of 2.4 and 3.2 years, respectively.

As of September 30, 2025, undiscounted minimum rental commitments under non-cancelable leases were as follows:

(In thousands)

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In July 2025, we entered into a long-term sublease agreement with a new tenant for the same space, which will begin in November 2025 with the term of the lease running through February 2028.

We recorded operating sublease income of $ 0.5 million and $ 1.6 million for the three months ended June 30, 2025 and 2024, respectively, and $ 1.8 million and $ 3.2 million for the six months ended June 30, 2025 and 2024, respectively, in other income, net in the condensed consolidated statements of operations.

We recorded operating sublease income of less than $ 0.1 million and $ 1.6 million for the three months ended September 30, 2025 and 2024, respectively, and $ 1.8 million and $ 4.8 million for the nine months ended September 30, 2025 and 2024, respectively, in other income, net in the condensed consolidated statements of operations.

We hold security deposits from our sublessee of approximately $ 0.1 million which is recorded within other non-current assets on our condensed consolidated balance sheet.

As of June 30, 2025, the future minimum lease payments to be received under the long-term sublease agreements were as follows:

As of September 30, 2025, the future minimum lease payments to be received under the long-term sublease agreements were as follows:

(In thousands)

2 unchanged sentences

Accrued expenses consisted of the following:

(In thousands) June 30,

(In thousands) September 30,

2025 December 31,

10 unchanged sentences

Product revenue, net, were as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands) 2025 2024 2025 2024

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We currently estimate product return and replacement liabilities using the expected value method, based on available industry data, including our visibility into the inventory remaining in the distribution channel.

The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the six months ended June 30, 2025:

The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2025:

(In thousands) Contractual Adjustments Government Rebates Returns/ Replacement Total

4 unchanged sentences

Payments/returns relating to sales in the prior years ( 202 ) ( 462 ) — ( 664 )

Balance at June 30, 2025 $ 123 $ 1,679 $ 745 $ 2,547

Balance at September 30, 2025 $ 111 $ 1,898 $ 880 $ 2,889

Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows:

(In thousands) June 30, 2025 December 31, 2024

(In thousands) September 30, 2025 December 31, 2024

Reduction of accounts receivable $ 108 $ 124

1 unchanged sentence

Total revenue-related reserves $ 2,889 $ 2,096

The following table presents changes in our contract assets during the six months ended June 30, 2025:

(In thousands) December 31, 2024 Additions Deductions June 30, 2025

The following table presents changes in our contract assets during the nine months ended September 30, 2025:

(In thousands) December 31, 2024 Additions Deductions September 30, 2025

Contract assets (1)

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In connection with the start of employment of our Chief Executive Officer and Chief Financial Officer in 2022, our Chief Commercial Officer in 2023, and our Chief Corporate Development and Strategy Officer in March 2025, our Board of Directors granted each of them equity awards in the form of stock options, RSUs and PSUs, which awards were made outside our equity incentive plans as inducements material to their respective entry into employment with us in accordance with Nasdaq Listing Rule 5635(c)(4).

As of June 30, 2025, the maximum number of shares reserved under the 2013 Plan, the 2023 Plan and the inducement grants described above was 12,661,855 , and we had 3,664,151 shares available for future issuance under the 2023 Plan.

As of September 30, 2025, the maximum number of shares reserved under the 2013 Plan, the 2023 Plan and the inducement grants described above was 12,501,715 , and we had 3,697,640 shares available for future issuance under the 2023 Plan.

Stock options

The following table presents stock option activity for the six months ended June 30, 2025:

The following table presents stock option activity for the nine months ended September 30, 2025:

Stock Options Weighted-Average

5 unchanged sentences

Expired ( 247,036 ) 106.25

Outstanding at June 30, 2025 6,424,575 $ 40.01

Exercisable at June 30, 2025 4,243,623 $ 44.21

Vested and expected to vest at June 30, 2025 6,424,575 $ 40.01

At June 30, 2025, there was approximately $ 35.8 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.57 years.

Outstanding at September 30, 2025 6,271,947 $ 39.58

Exercisable at September 30, 2025 4,232,483 $ 43.19

Vested and expected to vest at September 30, 2025 6,271,947 $ 39.58

At September 30, 2025, there was approximately $ 32.6 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.46 years.

Restricted stock units

The following table presents RSU activity for the six months ended June 30, 2025:

The following table presents RSU activity for the nine months ended September 30, 2025:

Stock Units Weighted-Average

4 unchanged sentences

Forfeited ( 108,350 ) 30.80

Unvested shares at June 30, 2025 2,096,123 $ 31.90

As of June 30, 2025, there was approximately $ 53.6 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 2.10 years.

Unvested shares at September 30, 2025 2,055,122 $ 31.98

As of September 30, 2025, there was approximately $ 47.0 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 1.94 years.

Performance-based stock units

The following table presents PSU activity for the six months ended June 30, 2025:

The following table presents PSU activity for the nine months ended September 30, 2025:

Stock Units Weighted-Average

3 unchanged sentences

Vested ( 83,027 ) 26.35

Unvested shares at June 30, 2025 477,006 $ 31.47

Unvested shares at September 30, 2025 477,006 $ 31.47

Stock-based compensation expense associated with these PSUs is recognized if the underlying performance condition is considered probable of achievement using our management’s best estimates.

As of June 30, 2025, there was no unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, and $ 15.0 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered not probable of achievement.

As of September 30, 2025, there was no unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, and $ 15.0 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered not probable of achievement.

2013 Employee Stock Purchase Plan

In June 2013, our Board of Directors adopted, and in July 2013 our stockholders approved, the 2013 Employee Stock Purchase Plan, or the 2013 ESPP.

We issued and sold 52,092 and 52,514 shares of common stock during the six months ended June 30, 2025 and 2024, respectively, under the 2013 ESPP.

We issued and sold 133,283 and 102,805 shares of common stock during the nine months ended September 30, 2025 and 2024, respectively, under the 2013 ESPP.

The 2013 ESPP provides participating employees with the opportunity to purchase up to an aggregate of 2,363,636 shares of our common stock.

As of June 30, 2025, we had 1,531,142 shares of common stock available for future issuance under the 2013 ESPP.

As of September 30, 2025, we had 1,449,951 shares of common stock available for future issuance under the 2013 ESPP.

Stock-based compensation expense

1 unchanged sentence

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(In thousands) 2025 2024 2025 2024

5 unchanged sentences

Expenses related to stock options and stock-based awards were allocated as follows in the condensed consolidated statements of operations:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands) 2025 2024 2025 2024

2 unchanged sentences

Total stock-based compensation expense $ 12,377 $ 11,145 $ 38,428 $ 31,944

Loss per Share

Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average shares outstanding during the period, without consideration for common stock equivalents.

Diluted net income (loss) per share is calculated by adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury stock method.

For purposes of the dilutive net income (loss) per share calculation, stock options, RSUs and PSUs for which the performance and market vesting conditions, respectively, have been deemed probable, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs with performance and market vesting conditions, respectively, that were not deemed probable as of June 30, 2025 are not considered to be common stock equivalents.

Net (Loss) Income per Share

Basic net (loss) income per share is calculated by dividing net (loss) income by the weighted-average shares outstanding during the period, without consideration for common stock equivalents.

Diluted net (loss) income per share is calculated by adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury stock method.

For purposes of the dilutive net (loss) income per share calculation, stock options, RSUs and PSUs for which the performance and market vesting conditions, respectively, have been deemed probable, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs with performance and market vesting conditions, respectively, that were not deemed probable as of September 30, 2025 are not considered to be common stock equivalents.

We utilize the control number concept in the computation of diluted earnings per share to determine whether potential common stock equivalents are dilutive.

The control number used is net loss from continuing operations.

The control number used is net (loss) income from continuing operations.

The control number concept requires that the same number of potentially dilutive securities applied in computing diluted earnings per share from continuing operations be applied to all other categories of income or loss, regardless of their anti-dilutive effect on such categories.

Since we had a net loss for all periods presented, no dilutive effect has been recognized in the calculation of loss per share.

Basic and diluted net loss per share was the same for all periods presented.

The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

Three Months Ended June 30,

Since we had a net loss for the three and nine months ended September 30, 2025, no dilutive effect was recognized in the calculation of loss per share and basic and diluted net loss per share was the same for those periods.

The following is a reconciliation of basic weighted-average number of common shares used in computing net (loss) income per share to diluted weighted-average number of common shares used in computing net (loss) income per share for the periods indicated:

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

Basic shares 58,139,277 56,939,403 57,846,173 56,709,318

Effect of dilutive securities

Stock options — 557,300 — 231,082

Restricted stock units — 927,149 — 626,208

Performance-based stock units — — — 11,793

Employee stock purchase plan shares — 8,944 — 2,981

Diluted shares 58,139,277 58,432,796 57,846,173 57,581,382

The following common stock equivalents were excluded from the calculation of diluted net (loss) income per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

Stock options 6,271,947 3,463,344 6,271,947 5,176,610

Restricted stock units 2,055,122 — 2,055,122 90,480

Employee stock purchase plan shares 81,191 3,139 81,191 4,393

Total common stock equivalents 8,408,260 3,466,483 8,408,260 5,271,483

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The following table contains additional information on our consolidated revenue and net loss, including significant segment expenses:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(In thousands) 2025 2024 2025 2024

3 unchanged sentences

Total selling, general and administrative expenses ( 41,274 ) ( 38,537 ) ( 128,670 ) ( 105,087 )

Gain on sale of contingent payments — 889,136 — 889,136

Milestone payment from gain on sale of oncology business — 200,000 — 200,000

Other segment items* ( 14,207 ) ( 56,704 ) ( 37,587 ) ( 75,511 )

Net loss $ ( 112,020 ) $ ( 96,118 ) $ ( 201,309 ) $ ( 177,667 )

*Other segment items primarily include cost of sales, other research and development expenses and interest income.

Subsequent Events

On July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was enacted in the United States, which includes significant changes to federal tax law and other regulatory provisions that may impact the Company.

We are currently evaluating the impact of the OBBBA on our financial condition and results of operations.

Net (loss) income $ ( 103,433 ) $ 947,915 $ ( 304,742 ) $ 770,248

*Other segment items primarily include cost of sales, other research and development expenses, interest income, and income tax expense.

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