What changed in this filing

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Item 9A. Controls and Procedures

2026-02-26 compared with 2025-02-27 · 267 added, 202 removed, 1308 unchanged (26% of the section changed)

21 unchanged sentences

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

We have adopted an insider trading policy applicable to our directors, officers and employees, that we believe is reasonably designed to promote compliance with insider trading laws and regulations and the Nasdaq stock exchange listing standards.

A copy of our policy is filed with this Annual Report on Form 10-K as Exhibit 19.1.

The other information required by this Item will be included in our 2025 Proxy Statement, which will be filed with the SEC, and is incorporated by reference herein.

We have adopted an insider trading and compliance policy applicable to our directors, officers and employees, that we believe is reasonably designed to promote compliance with insider trading laws and regulations and the NASDAQ stock exchange listing standards.

A copy of our policy is included with this Annual Report on Form 10 -K as Exhibit 19.1.

The other information required by this Item will be included in our 2026 Proxy Statement, which will be filed with the SEC in connection with our 2026 Annual Meeting of Stockholders within 120 days after December 31, 2025, and is incorporated by reference herein.

EXECUTIVE COMPENSATION

14 unchanged sentences

Consolidated Statements of Operations for the Years Ended December 31, 2025, 2024 and 2023

Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2024, 2023 and 2022

Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended December 31, 2024, 2023 and 2022

Consolidated Statements of Comprehensi ve Income for t he Years Ended December 31, 2025, 2024 and 2023

Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2025, 2024 and 2023

Consolidated Statements of Cash Flows for the Years Ended December 31, 2025, 2024 and 2023

10 unchanged sentences

Second Amended and Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware on June 14, 2016 (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 15, 2016 and incorporated herein by reference)

Fourth Amended and Restated Bylaws of the Company (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 18, 2023 and incorporated herein by reference)

Fifth Amended and Restated Bylaws of the Company (filed as Exhibit 3.1 to the Company’ s Current Report on Form 8-K filed with the SEC on June 24, 2025 and incorporated herein by reference)

Form of Common Stock Certificate (filed as Exhibit 4.1 to the Company’s Registration Statement on Form S-1/A filed with the SEC on February 1, 2012 and incorporated herein by reference)

3 unchanged sentences

Auerbach (filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on June 17, 2021 and incorporated herein by reference)

Description of the Company’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (filed as Exhibit 4.3 to the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2020 and incorporated herein by reference)

Description of the Company’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934

License Agreement, dated August 18, 2011, by and between the Company, as successor to Puma Biotechnology, Inc., and Pfizer Inc.

31 unchanged sentences

Form of Stock Option Grant Notice and Stock Option Agreement, issued pursuant to the 2017 Employment Inducement Incentive Award Plan (filed as Exhibit 10.2(k) to the Company’s Annual Report on Form 10-K filed with the SEC on March 1, 2019 and incorporated herein by reference)

Form of Restricted Stock Unit Award Agreement, issued pursuant to the 2017 Employment Inducement Award Plan

Form of Restricted Stock Unit Award Agreement, issued pursuant to the 2017 Employment Inducement Award Plan (filed as Exhibit 10.2(n) to the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2025 and incorporated herein by reference)

Office Lease by and between the Company and CA - 10880 Wilshire Limited Partnership, executed on December 7, 2011 (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on December 13, 2011 and incorporated herein by reference)

3 unchanged sentences

Fourth Amendment to the Office Lease, dated as of July 31, 2015, by and between the Company and CA - 10880 Wilshire Limited Partnership (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 9, 2015 and incorporated herein by reference)

Fifth Amendment to Office Lease, dated as of October 27, 2017, by and between the Company and DE PARK AVENUE 10880, LLC (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 7, 2025 and incorporated herein by reference)

Sixth Amendment to Office Lease, dated as of July 23, 2025, by and between the Company and DE PARK AVENUE 10880, LLC (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 7, 2025 and incorporated herein by reference)

Employment Agreement, dated January 19, 2012, by and between the Company and Alan H.

7 unchanged sentences

Form of Indemnification Agreement (filed as Exhibit 10.17 to the Company’s Registration Statement on Form S-1/A filed with the SEC on October 15, 2012 and incorporated herein by reference)

Amended Non-Employee Director Compensation Program, effective April 1, 2026

Amended Non-Employee Director Compensation Program, dated April 27, 2022 (filed as Exhibit 10.1 to the Company’s Current Report on Form 10-Q filed with the SEC on May 5, 2022 and incorporated herein by reference)

22 unchanged sentences

3 to the License Agreement, dated February 24, 2021, by and between the Company and Pierre Fabre Medicament SAS (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 6, 2021 and incorporated herein by reference)

Letter Agreement, dated February 13, 2020, by and between the Company and Jeff J.

Ludwig (filed as Exhibit 10.19 to the Company's Annual Report on Form 10-K filed with the SEC on March 1, 2021 and incorporated herein by reference)

Note Purchase Agreement, dated July 23, 2021, by and between the Company and Athyrium Opportunities IV Co-Invest 1 LP, as Administrative Agent (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 4, 2021 and incorporated herein by reference)

6 unchanged sentences

Seventh Amendment to Note Purchase Agreement and Third Amendment to Disclosure Letter, dated April 12, 2024, by and between the Company and Athyrium Opportunities IV CO-Invest 1 LP, as Administrative Agent (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 2, 2024, and incorporated herein by reference)

Eighth Amendment to Note Purchase Agreement and Fourth Amendment to Disclosure Letter, dated October 6, 2025, by and between the Company and Athyrium Opportunities IV Co-Invest 1 LP, as Administrative Agent (filed as Exhibit 10.1 to the Company’ s Quarterly Report on Form 10-Q filed with the SEC on November 6, 2025, and incorporated herein by reference)

Open Market Sale Agreement SM , dated November 4, 2021, by and between the Company and Jeffries LLC (filed as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 4, 2021 and incorporated herein by reference)

57 unchanged sentences

Consolidated Statements of Operations for the Years Ended December 31, 2025, 2024 and 2023

Consolidated Statements of Comprehensive Income (Loss) for the Years Ended December 31, 2024, 2023 and 2022

Consolidated Statements of Stockholders’ Equity (Deficit) for the Years Ended December 31, 2024, 2023 and 2022

Consolidated Statements of Comprehensive Income for the Years Ended December 31, 2025, 2024 and 2023

Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2025, 2024 and 2023

Consolidated Statements of Cash Flows for the Years Ended December 31, 2025, 2024 and 2023

5 unchanged sentences

We have audited the accompanying consolidated balance sheets of Puma Biotechnology, Inc.

and subsidiary (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations, comprehensive income, stockholders’ equity (deficit), and cash flows for each of the years in the three-year period ended December 31, 2024 and the related notes (collectively, the consolidated financial statements).

and subsidiary (the Company) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive income, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2025, and the related notes (collectively, the consolidated financial statements).

We also have audited the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

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Evaluating the key assumptions of forecasted patient buying and payment patterns underlying the estimate for provider chargebacks and government rebates involved especially challenging auditor judgment due to their measurement uncertainty.

We performed a sensitivity analysis in order to identify the key assumptions used to estimate the Company’s variable consideration.

These key assumptions relate to estimating which of the Company’s revenue transactions will ultimately be subject to a related provider chargeback or government rebate.

21 unchanged sentences

Prepaid expenses, current

Restricted cash, current

Other assets, current

15 unchanged sentences

50,031 36,898

Post-marketing commitment liability

Lease liabilities, current

Post-marketing commitment liability

Current portion of long-term debt

22,523 45,329

Other liabilities, current

Total current liabilities

81,253 96,111

Other liabilities, long-term

Lease liabilities, long-term

1 unchanged sentence

Long-term debt, net

21,719 65,659

Other liabilities, long-term

Total liabilities

7 unchanged sentences

1,414,074 1,407,000

Accumulated other comprehensive income (loss)

Accumulated other comprehensive income

Accumulated deficit

23 unchanged sentences

62,068 54,935 50,382

Acquired in-process research and development

Total operating costs and expenses

7 unchanged sentences

( 6,622 ) ( 12,452 ) ( 13,330 )

Legal verdict expense

1,027 862 759

Other income (expense)

862 759 ( 28 )

Total other expenses, net

2 unchanged sentences

$ 35,782 $ 24,100 $ 22,674

Income tax expense

Current income tax (expense)

( 1,426 ) ( 897 ) ( 1,083 )

Deferred income tax benefit

Deferred income tax (expense) benefit

( 3,245 ) 7,075 —

$ 31,111 $ 30,278 $ 21,591

Net income per share of common stock—basic

13 unchanged sentences

$ 31,111 $ 30,278 21,591

Other comprehensive income (loss):

Unrealized income (loss) on available-for-sale securities, net of tax of $ 0

Other comprehensive income:

Unrealized gain (loss) on available-for-sale securities, net of tax of $0

Comprehensive income

3 unchanged sentences

AND SUBSIDIARY

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share and per share data)

7 unchanged sentences

1,301,127 — — — — —

Shares issued under private investments in public equity, net of issuance costs of approximately $ 0.2 M

Unrealized loss on available-for-sale securities

— — — ( 4 ) — ( 4 )

Unrealized gain on available-for-sale securities

— — — — 21,591 21,591

Balance at December 31, 2023

4 unchanged sentences

1,459,047 — 150 — — 150

Unrealized loss on available-for-sale securities

Unrealized gain on available-for-sale securities

— — — 10 — 10

22 unchanged sentences

10,938 11,524 11,519

In-process research and development expenses

Stock-based compensation

6,944 8,245 10,247

Deferred income taxes

3,245 ( 7,075 ) —

Provision for credit loss recovery

( 362 ) ( 519 ) 881

Disposal of property and equipment

Loss on disposal of property and equipment

Loss on impairment of asset

14 unchanged sentences

13,154 ( 15,823 ) ( 7,583 )

Deferred tax assets

( 7,075 ) — —

Post-marketing commitment liability

5 unchanged sentences

( 71 ) ( 56 ) ( 140 )

Acquired in-process research and development

— — ( 7,000 )

Purchase of available-for-sale securities

4 unchanged sentences

— — ( 12,500 )

Net cash (used in) provided by investing activities

Net cash used in investing activities

( 36,188 ) ( 20,438 ) ( 19,125 )

1 unchanged sentence

Net proceeds from shares issued under employee stock plans

Gross proceeds from private investments in public equity

Issuance costs associated with private investments in public equity

Payment of debt

1 unchanged sentence

Payment of exit costs

Net cash (used in) provided by financing activities

( 888 ) ( 666 ) —

Net cash used in financing activities

( 45,198 ) ( 33,846 ) —

Net (decrease) increase in cash, cash equivalents and restricted cash

5 unchanged sentences

Supplemental disclosures of non-cash investing and financing activities:

Intangibles in accrued in-license rights

$ — — $ 12,500

Property and equipment purchases in accounts payable

15 unchanged sentences

The Company has one subsidiary, Puma Biotechnology, B.V., a Netherlands company.

This subsidiary was established for the purpose of legal representation in the European Union.

This subsidiary was established for the purpose of legal representation in the European Union (“EU”).

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.

All intercompany accounts and transactions have been eliminated.

The accompanying consolidated financial statements of the Company and its subsidiary has been prepared in accordance with generally accepted accounting principles in the United States (“US GAAP”).

The accompanying consolidated financial statements of the Company and its subsidiary have been prepared in accordance with generally accepted accounting principles in the United States (“US GAAP”).

The Company has incurred significant operating losses since its inception.

While the Company has reported net income, the Company cannot assure that it will continue to do so and will need to continue to generate significant revenue to sustain operations and successfully commercialize neratinib.

While the Company has previously reported net income, the Company cannot assure that it will continue to do so and will need to continue to generate significant revenue to sustain operations and successfully commercialize neratinib.

In 2017, the Company received U.S.

Food and Drug Administration (“FDA”) approval for its first product, NERLYNX® (neratinib)(“NERLYNX”), formerly known as PB272 (neratinib, oral), for the extended adjuvant treatment of adult patients with early stage HER2 -overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

Food and Drug Administration (“FDA”) approval for its first product, NERLYNX® (neratinib), formerly known as PB272 (neratinib, oral), for the extended adjuvant treatment of adult patients with early stage HER2 -overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

Following FDA approval in July 2017, NERLYNX became available by prescription in the United States, and the Company commenced commercialization.

In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2 -positive breast cancer who have received two or more prior anti- HER2 -based regimens in the metastatic setting.

In 2018, the European Commission (“EC”) granted marketing authorization for NERLYNX in the European Union (“EU”) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2 -overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy.

In 2018, the European Commission (“EC”) granted marketing authorization for NERLYNX in the EU for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2 -overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab-based therapy.

The Company is required to make substantial payments to Pfizer upon the achievement of certain milestones and has contractual obligations for clinical trial contracts.

The Company has entered into other exclusive sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in many regions outside the United States, including Europe (excluding Russia and Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, and various countries and territories in Central America, South America, Africa and the Middle East.

The Company has entered into other exclusive sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in many regions outside the United States, including Europe (excluding Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, Russia and various countries and territories in Central America, South America, Africa and the Middle East.

The Company plans to continue to pursue commercialization of NERLYNX in other countries outside the United States, if approved.

In September 2022, the Company entered an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”) to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of Aurora Kinase A.

In September 2022, the Company entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (“Takeda”) to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of Aurora Kinase A.

Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of Aurora Kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on Aurora Kinase A.

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The Company paid Takeda an upfront license fee of $ 7.0 million in October 2022 and Takeda is eligible to receive potential future milestone payments of up to $ 287.3 million upon the Company’s achievement of certain regulatory and commercial milestones over the course of the exclusive license agreement, as well as tiered royalty payments for any net sales of alisertib.

The Company recorded in-process research and development expense of $ 7.0 million during the year ended December 31, 2022, in connection with the up-front payment related to the asset acquisition.

As of December 31, 2025 , no milestones had been accrued as the underlying contingencies were not probable or estimable.

1 unchanged sentence

The Company’s commercialization, research and development or marketi ng efforts may require funding in addition to the cash and cash equivalents and marketable securities totaling approximately $ 97.5 million at December 31, 2025 .

The Company believes that its existing cash and cash equivalents and marketable securities as of December 31, 2024 and proceeds that will become available to the Company through product sales and sub-license payments are sufficient to satisfy its operating cash needs, including amounts due under the Company's Note Purchase Agreement with Athyrium, for at least one year after the filing of the Annual Report on Form 10 -K in which these financial statements are included.

The Company continues to remain dependent on its ability to obtain sufficient funding to sustain operations and continue to successfully commercialize neratinib in the United States.

The Company believes that its existing cash and cash equivalents and marketable securities as of December 31, 2025 and proceeds that will become available to the Company through product sales and sub-license payments are sufficient to satisfy its operating cash needs, including amounts due under the Company's Note Purchase Agreement with Athyrium, Opportunities IV Co-Invest 1 LP (“Athyrium”) (see Note 9—Debt ), for at least one year after the filing of the Annual Report on Form 10 -K in which these financial statements are included.

The Company continues to remain dependent, in part, on its ability to obtain sufficient funding to sustain operations and continue to successfully commercialize neratinib in the United States.

While the Company has been successful in raising capital in the past, there can be no assurance that it will be able to do so in the future.

The Company’s ability to obtain funding may be adversely impacted by uncertain market and economic conditions, the Company’s success in commercializing neratinib, unfavorable decisions of regulatory authorities or adverse clinical trial results.

The Company’s ability to obtain funding may be adversely impacted by uncertain market and economic conditions, including the Company’s success in commercializing neratinib and unfavorable decisions of regulatory authorities or adverse clinical trial results.

The outcome of these matters cannot be predicted at this time.

1 unchanged sentence

Since its inception through December 31, 2025 , the Company’s financing has primarily been proceeds from product, royalty, and license revenue, public offerings of its common stock, private equity placements, and various debt instruments.

The Company does not believe that tariffs imposed or proposed to be imposed by the United States, particularly with the EU and China, will have a material impact on our product costs or results of operations.

However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict.

The ultimate impact of any announced or future tariffs will depend on various factors, including what tariffs are ultimately implemented, the timing of implementation and the amount, scope and nature of such tariffs and potential exclusions from the application of those tariffs.

Note 2—Significant Accounting Policies

5 unchanged sentences

Management has determined that the Company operates in one reporting segment, which is the development and commercialization of innovative products to enhance cancer care.

We derive our global product, license and royalty revenue through the sales of NERLYNX®.

The Company derives its global product, license and royalty revenue through the sales of NERLYNX®.

The majority of our royalty revenue is derived from our sub-licensee sales into China.

The accounting policies of this operating segment are the same as those described below in Note 2–Significant Accounting Policies.

Our Chief Operating Decision Maker (“CODM”) is our President, Chief Executive Officer and Chairman of the Board, Alan Auerbach.

The CODM primarily uses our Consolidated Statement of Operations and related revenues, expenses and net income in evaluating the performance of the single operating segment and determining how to allocate resources of the Company as a whole, including our sales force and related marketing, research and development programs, including alisertib, and licensing strategy.

The Company's Chief Operating Decision Maker (“CODM”) is its President, Chief Executive Officer and Chairman of the Board, Alan H.

The CODM primarily uses our Consolidated Statement of Operations and related revenues, expenses and net income in evaluating the performance of the single operating segment and determining how to allocate resources of the Company as a whole, including its sales force and related marketing, research and development programs, including alisertib, and licensing strategy.

Consolidated revenue, expenses and net income are also used to monitor budget versus actual results.

The CODM does not typically review total asset amounts in evaluating the results of the operating segment.

In addition to the significant expense categories included within consolidated net income presented on the Company's Consolidated Statements of Operations, see below for disaggregated amounts that comprise operating expenses:

13 unchanged sentences

22,160 22,935 22,508

Acquired in-process research and development

Operating costs and expenses

4 unchanged sentences

$ 191,072 $ 199,502 $ 202,997

( 1 ) Other research and development expense include regulatory affairs, pharmacovigilance, quality assurance, chemical manufacturing and other costs.

( 1 ) Other research and development expense includes regulatory affairs, pharmacovigilance, quality assurance, chemical manufacturing and other costs.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented.

The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles ("GAAP") in the United States requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented.

Accordingly, actual results could differ from those estimates.

1 unchanged sentence

These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products.

Other significant estimates also include those related to legal and other expense accruals.

Other significant estimates include those related to the valuation of deferred income taxes, legal and other expense accruals.

Reclassifications

Certain prior year amounts in the Consolidated Statements of Cash Flows have been reclassified to correct an error in the prior year's presentation.

Specifically, for the year ended December 31, 2024, a change in deferred tax assets of $ 7.1 million was previously classified within "Changes in operating assets and liabilities." This amount has been reclassified to non-cash items within the operating activities section of the Consolidated Statements of Cash Flows.

This reclassification had no impact on the total net cash provided by (used in) operating activities, net income, or the Consolidated Balance Sheets for any period presented.

Net Income per Share of Common Stock

Basic net income per share of common stock is computed by dividing net income applicable to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by ASC 260, Earnings per Share .

For purposes of calculating diluted income per share of common stock, the denominator includes both the weighted average number of shares of common stock outstanding and the number of dilutive common stock equivalents, such as stock options, restricted stock units (“RSUs”) and warrants.

Basic net income per share of common stock is computed by dividing net income available to common stockholders by the weighted average number of shares of common stock outstanding during the periods presented, as required by Accounting Standard Codification ("ASC 260" ), Earnings per Share .

For purposes of calculating diluted net income per share of common stock, the denominator includes both the weighted average number of shares of common stock outstanding and the number of dilutive common stock equivalents, such as stock options, restricted stock units (“RSUs”) and warrants.

A common stock equivalent is not included in the denominator when calculating diluted earnings per common share if the effect of such common stock equivalent would be anti-dilutive.

The following potentially dilutive outstanding common stock equivalents were excluded from diluted net income per share because of their anti-dilutive effect:

For the Year Ended December 31,

Our potentially dilutive securities include potential common shares related to our stock options and RSUs granted in connection with the Puma Biotechnology, Inc.

2011 Incentive Award Plan and the Puma Biotechnology, Inc.

2017 Employment Inducement Incentive Award Plan.

Diluted earnings per share (“Diluted EPS”) considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential common shares would have an anti-dilutive effect.

Diluted EPS excludes the impact of potential common shares related to our stock options in periods in which the option exercise price is greater than the average market price of our common stock for the period.

The following potentially dilutive outstanding common stock equivalents for the respective periods were excluded from diluted net income per share because of their anti-dilutive effect:

For the Year Ended

Options outstanding

23 unchanged sentences

However, no such costs were incurred during the year ended December 31, 2025 .

For the year ended December 31, 2024 , fou r customers individually comprised approximately 28.4 %, 18.8 %, 14.1 % and 12.3 % respec tively, of the Company’s total product revenue.

For the year ended December 31, 2025 , five customers individually comprised approximately 27.3 %, 17.0 %, 16.4 %, 13.1 % and 10.

6%, respectively, of the Company’s total product revenue.

For the year ended December 31, 2024 , four customers individually comprised approximately 28.4 %, 18.8 %, 14.1 % and 12.3 % , respectively, of the Company’s total product revenue.

For the year ended December 31, 2022 , two major customers accounted for approximately 35 % and 20 %, respectively, of the Company’s total product revenue.

For the year ended December 31, 2023 , four customers individually comprised approximately 31.4 %, 17.2 %, 1 5.2% and 11.9 %, respectively, of the Company’s total product revenue.

Reserves for Variable Consideration

1 unchanged sentence

Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company’s sale of its products.

These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with ASU 2013 - 1, Balance Sheet (Topic 210 ):

Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities , or as a current liability.

2 unchanged sentences

The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period.

The Company’s analysis also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not occur in a future period for the estimates detailed below as of December 31, 2024 and, therefore, the transaction price was not reduced further during the year ended December 31, 2024 .

The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not likely occur in a future period for the estimates detailed below as of December 31, 2025 and, therefore, the transaction price was not reduced further during the year ended December 31, 2025 .

Actual amounts of consideration ultimately received may differ from the Company’s estimates.

2 unchanged sentences

The Company generally provides customers with discounts, which include incentive fees that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized.

The reserve for discounts is established in the same period that the related revenue is recognized, together with reductions to accounts receivables, net on the consolidated balance sheets.

The reserve for discounts is established in the same period that the related revenue is recognized, together with reductions to accounts receivable, net on the consolidated balance sheets.

In addition, the Company compensates its customers for sales order management, data, and distribution services.

13 unchanged sentences

The Company is subject to discount obligations under state Medicaid programs and Medicare.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets.

The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimates of future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period.

19 unchanged sentences

Since 2018, the Company has entered into sub-license agreements with certain sub-licensees in territories outside of the United States.

These sub-licensing agreements grant certain intellectual property rights and set forth various respective obligations with respect to actions such as development, pursuit and maintenance of regulatory approvals, commercialization and supply of NERLYNX in the sub-licensees’ respective territories.

These sub-licensing agreements grant certain intellectual property rights and set forth various obligations with respect to actions such as development, pursuit and maintenance of regulatory approvals, commercialization and supply of NERLYNX in the sub-licensees’ respective territories.

License fees under the sub-license agreements include one -time upfront payments when each sub-license agreement was executed and potential additional one -time milestone payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals or sales target thresholds, and potential double-digit royalties on sales of the licensed product, calculated as a percentage of net sales of the licensed product throughout each sub-licensee’s respective territory.

1 unchanged sentence

At this time, the Company cannot estimate if or when these milestone-related performance obligations might be achieved.

In September 2024, the Pharmacovigilance Risk Assessment Committee approved a change in existing post approval requirements for overall results and a reduction in sample size for the Pierre Fabre NERLYFE post-marketing study in Europe.

As of December 31, 2024, there is a post-marketing liability of $ 4.6 million, and the final costs of the study are being assessed.

Any adjustment to the liability will be recorded as license revenue as the original $ 9.0 million estimate in study costs were recorded as a reduction to license revenue.

Royalty Revenue

3 unchanged sentences

The Company’s payment terms range between 10 and 60 days.

Royalty Expenses

Royalties incurred in connection with the Company’s license agreement with Pfizer, as disclosed in Note 13–Commitments and Contingencies, are expensed to cost of sales as revenue from product sales is recognized.

Legal Contingencies and Expense

4 unchanged sentences

In determining whether a loss should be accrued, the Company evaluates, among other factors, the degree of probability of an unfavorable outcome and the ability to make a reasonable estimate of the amount of the loss (see Note 13 -Commitments and Contingencies).

Royalty Expenses

Research and Development Expenses

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Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions.

The Company’s accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs.

The Company’s accruals for clinical trials are based on estimates of the services received and efforts expen ded pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs.

As actual costs become known, the Company adjusts its accruals in that period.

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Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development costs.

Acquired In-Process Research and Development Expense

The Company has acquired, and may continue to acquire, the rights to develop new drug candidates.

Payments to acquire a new drug candidate are immediately expensed as acquired in-process research and development provided that the drug candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use.

Stock-Based Compensation

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The fair value of each option award is estimated on the grant date using the Black-Scholes Option Pricing Method.

As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatilities using its expected life, or approximately the past six years of publicly traded history.

The Company’s estimate of expected volatility is based on its average volatility using its expected life, or approximately the last six years of publicly traded history.

The risk-free rate for periods within the contractual life of the option is based on the U.S.

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RSUs are valued on the grant date and the fair value of the RSUs is equal to the market price of the Company’s common stock on the grant date.

RSU expense is recognized over the requisite service period in the statement of operations.

The RSU expense is recognized over the requisite service period.

When the requisite service period begins prior to the grant date (because the service inception date occurs prior to the grant date), the Company is required to begin recognizing compensation cost before there is a measurement date (i.e., the grant date).

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The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and other factors.

The RSU expense is “trued-up” upon the actual forfeiture of a RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates.

Compensation expense related to modified restricted stock units is measured based on the fair value for the awards as of the modification date.

The RSU expense is adjusted upon the actual forfeiture of an RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates.

Compensation expense related to modified RSUs is measured based on the fair value for the awards as of the modification date.

Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate.

Warrants (see Note 10–Stockholders’ Equity (Deficit) for further details) granted to employees and non-employees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period.

Warrants (see Note 10–Stockholders’ Equity for further details) granted to employees and non-employees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period.

When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method.

When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method.

As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatilities using its past nine years of publicly traded history.

The Company’s estimate of expected volatility is based on its average volatility using its past nine years of publicly traded history.

The risk-free rate for periods within the contractual life of the warrant is based on the U.S.

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ASC 740 also provides g uidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures.

As of December 31, 2024 , the Company’s uncertain tax positions include a reserve for its R&D credits.

As of December 31, 2025 , the Company’s uncertain tax positions include a reserve for its Research and Development credits.

On July 4, 2025, the “One Big Beautiful Bill” was signed into law, which includes significant changes to federal tax law and other regulatory provisions that may impact the Company.

As of the date of these financial statements, the Company has evaluated the impact of the changes to Section 174 – Amortization of research and experimental expenditures on the valuation allowance release.

The Company intends to deduct the capitalized costs over two years.

This deduction reduces the amount of net operating losses being utilized but results in a net zero change to the deferred tax asset balance.

In 2025, we released a portion of our valuation allowance related to our deferred tax assets in the amoun t of $ 3.8 million, w hich reduced our net income for the year.

Financial Instruments

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Restricted Cash

Restricted cash represents cash held at financial institutions that is pledged as collateral for stand-by letters of credit for lease and legal verdict commitments.

The lease related letters of credit will expire at the end of the respective lease terms through 2026.

Restricted cash represents cash held at financial institutions that is pledged as collateral for stand-by letters of credit for office leases.

The lease related letters of credit will lapse at the end of the respective lease terms through 2026.

At December 31, 2025 and 2024 , the Company had restricted cash in the amount of $ 2.1 million.

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The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities may be required prior to maturity to implement management’s strategies.

These securities are carried at fair value, with the unrealized gains and losses, reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit) until realized.

These securities are carried at fair value, with the unrealized gains and losses, reported as a component of accumulated other comprehensive inco me in stockholders’ equity until realized.

Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis.

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Measurement of Credit Losses on Financial Instruments , credit losses on available-for-sale securities are reported using an expected loss model and recorded to an allowance.

No material credit losses on available-for-sale securities were recognized in the years ending December 31, 2024 , Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method.

Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method.

Interest income is recognized when earned.

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$ 5,060 $ 18,710 $ — $ 23,770

Government securities

27,903 14,873 — 42,776

Corporate Bonds

— 6,865 — 6,865

Commercial paper

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$ 16,996 $ 38,102 $ — $ 55,098

Government securities

17,568 8,617 — 26,185

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$ 34,564 $ 52,280 $ — $ 86,844

The Company’s investments in commercial paper, corporate bonds and U.S.

The Company’s investments in commercial paper and U.S.

government securities are exposed to price fluctuations.

The fair value measurements for commercial paper, corporate bonds and U.S.

government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned.

government securities are based upon the quoted prices of identical and similar items in active markets multiplied by the number of securities owned.

The following tables summarize the Company’s short-term investments (in thousands):

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$ 23,772 $ — $ ( 2 ) $ 23,770

Government securities

42,739 37 — 42,776

Corporate Bonds

6,866 1 ( 2 ) 6,865

Commercial paper

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$ 55,096 $ 4 $ ( 2 ) $ 55,098

Government securities

26,186 $ 7 $ ( 8 ) 26,185

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The creditworthiness of its customers is continuously monitored, and the Company has internal policies regarding customer credit limits.

The Company estimates an allowance for credit loss primarily based on the credit worthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions.

The Company recorded $ 0.5 million credit loss recovery in the year ended December 31, 2024.

The Company recorded $ 0.9 million credit loss expense in the year ended December 31, 2023, and no such expense in the year ended December 31, 2022.

As of December 31, 2024 and 2023, accounts receivable from individual customers with balances due in exc ess of 10% of total accounts receivable totaled $ 22.9 million and $ 32.3 million, respectivel y.

The Company estimates an allowance for credit loss primarily based on the creditworthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions .

The Company recorded $ 0.4 million credit loss recovery in the year ended December 31, 2025, and $ 0.5 million in the year ended December 31, 2024.

As of December 31, 2025 and 2024, accounts receivable from individual customers with balances due in exc ess of 10% of total accounts receivable totaled $ 38.9 million and $ 22.9 million, respectively.

The Company’s success depends on its ability to successfully commercialize NERLYNX.

The Company currently has a single product with limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth.

The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future.

The Company currently has a single product and limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth.

The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of its lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future.

The Company relies exclusively on third parties to formulate and manufacture NERLYNX and its drug candidates.

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Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative expense as incurred.

Of the total inventory amounts noted below, approximately $ 4.5 million and $ 1.2 million was located at contract manufacturing organizations in Europe as of December 31, 2025 and 2024, respectively.

The Company’s inventory balances are as follows:

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If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would then determine the fair value of the long-lived asset and recognize an impairment loss for the amount in excess of the carrying value.

No impairments were recorded during the year ended December 31, 2024 and an impairment charge of $ 0.6 million was recorded during the year ended 2023 related to a sublease.

No material impairments were recorded during the years ended December 31, 2025 and 2024.

ASC Topic 842, Leases , as adopted in the first quarter of 2019, requires lessees to recognize most leases on the balance sheet with a corresponding right-of-use asset (“ROU asset”).

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Covenants imposed by the leases include letters of credit required to be obtained by the lessee.

The Company is required to remeasure the lease liability and make an adjustment in the following instances:

• The term of the lease has been modified or there has been a change in the Company’s assessment of a purchase option being exercised, in which case the lease liability is remeasured by discounting the revised lease payments using a revised discount rate;

• A lease contract is modified, and the lease modification is not accounted for as a separate lease, in which case the lease liability is remeasured by discounting the revised lease payments using a revised discount rate;

• The lease payments are adjusted due to changes in the index or a change in expected payment under a guaranteed residual value, in which cases the lease liability is remeasured by discounting the revised lease payments using the initial discount rate.

The incremental borrowing rate (“IBR”) represents the rate of interest the Company would expect to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.

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In September 2022, the Company entered into an exclusive license agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of Aurora Kinase A.

The up-front payment of $ 7.0 million was expensed as acquired in-process research and development as the drug candidate has not achieved regulatory approval for marketing and has no alternative future use.

The upfront payment of $ 7.0 million was expensed as acquired in-process research and development as the drug candidate has not achieved regulatory approval for marketing and has no alternative future use.

The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment may exist.

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In June 2020, the Company entered into a letter agreement with Pfizer relating to the method of payment associated with a milestone payment under the Company’s license agreement with Pfizer (see Note 13–Commitments and Contingencies).

The Company capitalized the mil estone payments as an intangible asset and is amortizing the asset to cost of sales on a straight-line basis over the estimated useful life of the licensed patent through 2030.

The Company capitalized the milestone payments as an intangible asset and is amortizing the asset to cost of sales on a straight-line basis over the estimated useful life of the licensed patent through 2030.

In addition, the Company reached a commercial milestone by achieving aggregate worldwide net sales of $ 250 million in calendar year 2022, resulting in a payable to Pfizer of $ 12.5 million as of December 31, 2022.

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As of December 31, 2025 , estimated future amortization expense related to the Company’s intangible asset was approximately $ 9.7 million for each year from 2026 through 2029, and $ 2.4 million for 2030.

Accounting Pronouncements Adopted During the Current Year

ASU 2023 - 09, Improvements to Income Tax Disclosures

On December 14, 2023, the FASB issued ASU 2023 - 09, Improvements to Income Tax Disclosures ( “ ASU 2023 - 09 ” ).

ASU 2023 - 09 amends ASC 740, Income Taxes to expand income tax disclosures and requires that the Company disclose (i) the income tax rate reconciliation using both percentages and reporting currency amounts; (ii) specific categories within the income tax rate reconciliation; (iii) additional information for reconciling items that meet a quantitative threshold; (iv) the composition of state and local income taxes by jurisdiction; and (v) the amount of income taxes paid disaggregated by jurisdiction.

The Company adopted ASU 2023 - 09 for the year ended December 31, 2025 on a prospective basis.

Accordingly, the expanded disclosures are provided for the year ended December 31, 2025, while prior period disclosures have not been retroactively adjusted and continue to be presented under the previous disclosure requirements.

As this update only impacts disclosures, its adoption did not have a material impact on the Company’s consolidated financial position, results of operations, or cash flows.

See Note 12 Income Taxes for additional information.

Recently Issued Accounting Standards

In October 2023, the FASB issued ASU 2023 - 06, Disclosure Improvements – Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative.

The ASU modifies the disclosure or presentation requirements of a variety of Topics in the Codification to align with the SEC’s regulations.

The ASU also makes those requirements applicable to entities that were not previously subject to the SEC’s requirements.

The ASU is effective for the Company two years after the effective date to remove the related disclosure from Regulation S- X or S-K.

As of the date these financial statements have been made available for issuance, the SEC has not yet removed any related disclosure.

The Company does not expect the adoption of ASU 2023 - 06 to have a material effect on its consolidated financial statements.

In December 2023, the FASB issued ASU 2023 - 09, Income Taxes (Topic 740 ):

Improvements to Income Tax Disclosures.

The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction.

ASU 2023 - 09 is effective for the Company’s annual reporting periods beginning after December 15, 2025.

Adoption is either with a prospective method or a fully retrospective method of transition.

Early adoption is permitted.

The Company is currently evaluating the effect that adoption of ASU 2023 - 09 will have on its consolidated financial statements.

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

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The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and related disclosures.

Accounting Pronouncements Adopted During the Current Year

Segment Reporting Disclosures

In November 2023, the FASB issued ASU 2023 - 07, Segment Reporting (Topic 280 ):

Improvements to Reportable Segment Disclosures.

The standard expands reportable segment disclosure requirements for public business entities primarily through enhanced disclosures about significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit (referred to as the “significant expense principle”).

We have adopted this standard for our fiscal year 2024 annual financial statements and interim financial statements thereafter and have applied this standard retrospectively for all prior periods presented in the financial statements.

See Segment Reporting in Note 2–Significant Accounting Policies above for further information.

Note 3—Accounts Receivable

Note 3—Accounts Receivable, Net

Accounts receivable, net consisted of the following (in thousands):

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Allowance for credit losses

( 362 ) ( 881 )

Total accounts receivable, net

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Royalty revenue receivable represents amounts owed related to royalty revenue recognized based on the Company’s sub-licensees’ sales in their respective territories in the years ended December 31, 2025 and 2024 .

For all accounts receivable, the Company recognized credit losses based on lifetime expected losses.

In determining estimated credit losses, the Company evaluated its historical loss rates, current economic conditions and reasonable and supportable forecasts of future economic conditions.

The Compan y recorded a recovery of credit loss expense of $ 0.5 million in year ended December 31, 2024.

The Company recorded $ 0.9 million credit loss expense in the year ended December 31, 2023, and no such expense in the year ended December 31, 202 2.

For all accounts receivable, the Company recognizes credit losses based on lifetime expected losses to selling and general administrative expense in the consolidated statements of operations.

In determining estimated credit losses, the Company evaluates its historical loss rates, current economic conditions and reasonable and supportable forecasts of future economic conditions.

The Compan y recorded a recovery to the provision for credit loss recovery of $ 0.4 million in the year ended December 31, 2025.

The Company recorded $ 0.5 million recovery to the provision for credit loss recovery in the year ended December 31, 2024 and a $ 0.9 million credit loss expense in the year ended December 31, 2023 .

Note 4—Prepaid Expenses and Other

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$ 6,476 $ 6,151

Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software, and prefunding of reimbursement claims.

Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software.

Other long-term prepaid amounts consist primarily of funding for commercial copay support programs.

Note 5—Property and Equipment

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Property and equipment, net

For the years ended December 31, 2024 , 2023 and 2022 , the Company incurred depreciation expense of $ 0.4 millio n, $ 0.4 million, and $ 0.6 million, respectively.

For the years ended December 31, 2025 , 2024 and 2023 , the Company incurred depreciation expense of $ 0.4 millio n for each of the years ended December 31, 2025 and 2024 .

Note 6—Leases

In December 2011, the Company entered into a non-cancelable operating lease for office space in Los Angeles, California, which lease was subsequently amended in November 2012, December 2013, March 2014, July 2015, and December 2017.

In December 2011, the Company entered into a non-cancelable operating lease for office space in Los Angeles, California, which was subsequently amended in November 2012, December 2013, March 2014, July 2015 and December 2017.

The initial term of the lease was for seven years and commenced on December 10, 2011.

As amended, the Company rents approximately 65,656 square feet.

The term of the lease runs until March 2026, and rent amounts payable by the Company increase approximately 3 % per year.

Concurrent with the execution of the lease, the Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $ 1.0 million.

The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, long-term on the accompanying consolidated balance sheets.

The term of the lease runs until March 2026.

In July 2025, the Company executed an additional amendment to its office space in Los Angeles, California to surrender certain suites effective March 31, 2026 and extend the lease term for the remaining 26,700 rentable square feet on the 17th floor for an additional five years and five months through August 31, 2031.

Base rent escalates annually and is abated from April 2026 through August 2026.

Lease payments also include variable charges for the Company’s proportionate share of building operating expenses and real estate taxes based on a 2026 base year.

The Company has the option to renew such lease for an additional five yea r term.

Management determined that the renewal option is not reasonably certain to occur.

Th e Company accounted for this amendment as a lease modification.

There was no change in the lease classification as a result of this modification and the Company continues to recognize such a lease as an operating lease.

The Company remeasured its ROU assets and operating lease liabilities using an updated incremental borrowing rate.

The change in ROU assets and operating lease liabilities related to this lease modification amounted to $ 4.1 million.

In June 2012, the Company entered into a long-term lease agreement for office space in South San Francisco, California, which was subsequently amended in May 2014 and July 2015.

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The Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $ 1.1 million.

The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, long-term on the accompanying consolidated balance sheets.

The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, current on the accompanying consolidated balance sheets.

The Company also leases copier equipment for use in the office spaces.

Components of copier lease expense include both fixed and variable lease expenses.

Total rent expense for years ended December 31, 2024 , 2023 and 2022 was approxi mately $ 4.9 mill ion for each year .

Fo r purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first obtains control of the facility, including any periods of free rent and any renewal option periods that the Company is reasonably certain of exercising.

The Company’s office and equipment leases generally have contractually specified minimum rent and annual rent increases are included in the measurement of the ROU asset and related lease liability.

Total rent expense for the years ended December 31, 2025 , 2024 and 2023 was approximately $ 4.5 million, $ 4.9 million and $ 4.9 million, respectively.

Fo r purposes of determining straig ht-line rent expense, the lease term is calculated from the date the Company first takes possession of the facility, including any periods of free rent and any renewal option periods that the Company is reasonably certain of exercising.

The Company’s office leases generally have contractually specified minimum rent and annual rent increases that are included in the measurement of the ROU asset and related lease liability.

Additionally, under these lease arrangements, the Company may be required to pay directly, or reimburse the lessors, for real estate taxes, insurance, utilities, maintenance and other operating costs.

Such amounts are generally variable and therefore not included in the measurement of the ROU asset and related lease liability but are instead recognized as variable lease expense in selling, general and administrative costs in the consolidated statements of operations when they are incurred.

Variable lease payments not included in the lease liability were $ 0.7 million and $ 0.5 million for the years ended December 31, 2024 and 2023, respectively.

Variable lease payments not included in the lease liabilit y were $ 0.5 million an d $ 0.7 million for the years ended December 31, 2025 and 2024, respectively.

The future minimum lease payments under ASC 842 as of December 31, 2025 were as follows (in thousands):

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In February 2019, the Company entered into a long-term sublease agreement for 12,429 square feet of the office space in Los Angeles, California.

Also, in August 2023 , the Company entered into a long-term sublease agreement for an additional 13,916 square feet of the office space in Los Angeles, California, which commenced in November 2023 .

As a result of the long-term sublease entered during 2023, the Company recorded an impairment expense on the right-of-use asset of approximately $ 0.6 million.

For both subleases, the term of the leases were to run until March 2026 and the rent amounts payable to the Company increase approximately 3 % per year .

The term of the lease ran until March 2026 and rent amounts payable to the Company increased approximately 3 % per year.

The February 2019 sublease was terminated in December 2024.

As a result, the Company received $ 0.7 million, which approximated the sublease rental payments on the remaining lease term.

The Company recorded sublease income of $ 1.4 million, $ 0.5 million and $ 0.5 million for the years ended December 31, 2024 , 2023 and 2022 , respectively, in other income (expenses) in the consolidated statements of operations.

In March 2025, the Company signed another sublease agreement for the 12,429 square feet of office space with a sublease commencement date of April 1, 2025.

In August 2023, the Company entered into a long-term sublease agreement for 13,916 square feet of the office space in Los Angeles, California, which commenced in November 2023.

The term of the lease runs until March 2026 and the rent amounts payable to the Company increase approximately 3 % per year.

The Company has recorded sublease income in other income (expenses) in the condensed consolidated statements of operations since November 2023.

The Company recorded operating sublease income of $ 0.7 million and $ 1.4 million for the years ended December 31, 2025 and 2024, respectively, in other income (expenses) in the consolidated statements of operations.

The future minimum lease payments to be received as of December 31, 2025 were as follows (in thousands):

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December 31, 2024

Accrued legal verdict expense

Accrued royalties

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Accrued variable consideration

14,215 10,829

Accrued bonus

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$ 50,031 $ 37,019

Included in accrued liabilities is approximately $ 7.7 million ($ 8.0 million net of imputed interest) as of December 31, 2023 that was related to Eshelman v.

Puma Biotechnology, Inc., et al.

On November 10, 2022, the Company announced the parties entered into a settlement agreement.

Pursuant to the settlement agreement, Dr.

Eshelman filed a Stipulation of Voluntary Dismissal with Prejudice on November 7, 2022, and the Company agreed to pay Dr.

Eshelman $ 16.0 million.

The settlement amount was paid in two separate payments.

The first payment of $ 8.0 million was paid in January 2023, and the second payment of $ 8.0 million was paid in October 2024.

Accrued variable consideration represents estimates of adjustments to product revenue, net for which reserves are established.

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Accrued CRO services, accrued other clinical development expenses, and accrued legal fees represent the Company’s estimates of such costs and are recognized as incurred.

Accrued compensation includes commissions and vacation.

Other accrued expenses consist primarily of grants, software and taxes.

Accrued compensation includes severance, commissions and vacation.

Long-term debt consisted of the following at December 31, 2025 (in thousands):

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The Athyrium Notes also require a 2.0 % exit payment to be made on each payment of principal.

The borrowings under the Athyrium Notes, together with cash on hand, were used to repay the Company’s outstanding indebtedness, including the applicable exit and prepayment fees owed to lenders under our prior credit facility with Oxford.

The Athyrium Notes are secured by substantially all of the Company’s assets.

The Company incurred $ 1.9 million of deferred financing costs with the borrowing.

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to Note Purchase Agreement dated as of September 16, 2022 ( the “Third Amendment”).

The Company incurred $ 1.9 million of deferred financing costs with the initial borrowing of the Athyrium Notes.

( the “Third Amendment”).

The modification of the Note Purchase Agreement pursuant to the Third Amendment did not meet the requirements of a debt extinguishment under ASC Topic 470 - 50 - Debt Modifications and Exchanges and no gain or loss was recognized.

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As of December 31, 2025, the effective interest rate for the loan was 12.99 %.

The carrying amounts of the Company’s debt approximate fair value because of the short‑term nature and near‑term maturity of the instruments.

As of December 31, 2025, the Company may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

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As of December 31, 2025, the Company was in compliance with such covenants.

As of December 31, 2024 , the principal balance outstanding under the Athyrium Notes w as $ 66.7 million, representing all of the Company’s debt.

As of December 31, 2025 , the principal balance outstanding under the Athyrium Notes w as $ 22.5 million, r epresenting all of the Company’s debt.

The future minimum principal and exit payments under the Athyrium Notes as of December 31, 2025 , were as follows (in thousands):

7 unchanged sentences

( 5,258 ) ( 4,454 )

Included in long-term debt

$ 956 $ 2,344

Included in current portion of debt

Debt issuance costs and discounts are financing costs related to the Company’s outstanding debt.

1 unchanged sentence

For the years ended December 31, 2025, 2024 and 2023 , the Company recorded app roximately $ 0.8 million, $ 1.4 million and $ 1.3 million, respe ctively, of interest expense related to the amortization of debt issuance costs, discounts and exit fees in the consolidated statements of operations.

Note 10—Stockholders’ Equity (Deficit)

The Company issued 64,118 shares of common stock upon exercise of stock options for the year ended December 31, 2024 and did not issue any shares of common stock in 2023 or 2022.

Note 10—Stockholders’ Equity

The Compan y issued 55,882 and 64,118 shares of common stock upon exercise of stock options for the years ended December 31, 2025 and 2024, respectively.

The Company did not issue any shares of common stock in 2023.

The Company issued 1,246,307 , 1,394,929 and 1,301,127 shares of common stock upon vesting of RSUs during the years ended December 31, 2025, 2024 and 2023 , respectively.

Auerbach, the Company’s President, Chief Executive Officer and Chairman of the Board purchased 2,360,295 shares of the Company's common stock for aggregate gross proceeds of approximately $ 7.5 million before deducting any offering expenses under two separate purchase agreements in the year ended December 31, 2022.

The first purchase took place on March 8, 2022 for 1,792,114 shares for a purchase price $ 2.79 per share and the second purchase took place on December 9, 2022 for 568,181 shares for a purchase price $ 4.40 .

Each purchase price was equal to the closing price of the Company’s common stock on NASDAQ on the date of each purchase.

Authorized Shares

The Company has 100,000,000 shares of stock authorized for issuance, all of which are common stock, par value $ 0.0001 per share.

In October 2011, the Company issued an anti-dilutive warrant to Mr.

In October 2011, the Company issued an anti-dilutive warrant to Alan H.

Auerbach, the Company's Founder and Chief Executive Officer.

The warrant was issued to provide Mr.

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Pursuant to the terms of the warrant, Mr.

Auerbach was able to exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $ 16 per share until October 4, 2021.

Auerbach may exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $ 16 per share until October 4, 2021.

On April 1, 2021, the Company's Board of Directors approved an amendment to the terms of the warrant by extending the term until October 4, 2026.

The amendment was approved by the Company's stockholders on June 15, 2021.

As a result of this amendment, the Company recorded additional stock-based compensation in the amount of $ 13.6 million which was included in selling, general and administrative expense for the year ended December 31, 2021.

The fair value of the additional stock-based compensation was estimated using the Black-Scholes Option Pricing Method (see Note 2 – Significant Accounting Policies) with the following assumptions as of June 15, 2021, the date of the modification.

Dividend yield

Expected volatility

Risk-free interest rate

Expected life in years

Stock Options and Restricted Stock Units

The Company’s 2011 Incentive Award Plan ( “2011 Plan”) was adopted by the Company’s Board of Directors on September 15, 2011.

The Company’s 2011 Incentive Award Plan ( “2011 Plan”), as amended, was adopted by the Company’s Board of Directors on September 15, 2011.

Pursuant to the 2011 Plan, the Company may grant incentive stock options and nonqualified stock options, as well as other forms of equity-based compensation.

6 unchanged sentences

As of December 31, 2025 , a total of 17,529,412 shares of the Company’s common stock have been reserved for issuance under the 2011 Plan.

As of December 31, 2024 , 4,701,229 shares of the Company’s common stock are issuable upon the exercise of outstanding awards granted under the 2011 Plan and 4,332,622 s hares of the Company’s common stock are available for future issuance under the 2011 Plan.

The Company awarded only “plain vanilla options” as determined by the SEC Staff Accounting Bulletin 107, or Share Based Payment .

All of the options awarded by the Company have been “plain vanilla options” as determined by the SEC Staff Accounting Bulletin 107 - Share Based Payment.

As of December 31, 2025 , 4,157,795 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting RSUs granted under the 2011 Plan and 3,668,856 s hares of the Company’s common stock are available for future issuance under the 2011 Plan.

The fair value of options granted to employees and non-employees was estimated using the Black-Scholes Option Pricing Method (see Note 2–Significant Accounting Policies) with the following weighted-average assumptions used during the years ended December 31:

4 unchanged sentences

Expected life in years

The Company’s 2017 Employment Inducement Incentive Award Plan ( “2017 Plan”) was adopted by the Company’s Board of Directors on April 27, 2017.

Pursuant to the 2017 Plan, the Company may grant stock options and restricted stock units, as well as other forms of equity-based compensation to employees, as an inducement to join the Company.

The Company’s 2017 Employment Inducement Incentive Award Plan ( “2017 Plan”), as amended, was adopted by the Company’s Board of Directors on April 27, 2017.

Pursuant to the 2017 Plan, the Company may grant stock options and RSUs, as well as other forms of equity-based compensation to employees, as an inducement to join the Company.

The maximum term of stock options granted under the 2017 Plan is 10 years and the awards generally vest over a three -year period.

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$ 6,944 $ 8,245 $ 10,247

Stock Option Rollforward

Stock Option Roll Forward

Activity with respect to options granted under the 2011 Plan and 2017 Plan is summarized as follows:

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( 1,186,317 ) 67.35

( 638,419 ) $ 146.47 — —

Outstanding at December 31, 2025

3 unchanged sentences

2,811,562 $ 17.95 4.9 $ 2,593

At December 31, 2024 , total estimated unrecognized compensation cost related to non-vested stock options granted prior to that date was approximately $ 0.9 million, which is expected to be recognized over a weighted-average period of 1.0 years.

On December 31, 2025 , total estimated unrecognized compensation cost related to non-vested stock options granted prior to that date was approximately $ 0.4 million, which is expected to be recognized over a weighted-average period of 1.1 years.

At December 31, 2025 , the total estimated unrecognized compensation cost related to non-vested RSUs was approximately $ 2.5 million, which is expected to be recognized over a weighted-a verage period of 1.3 years .

13 unchanged sentences

The Company is required to make matching contributions to the 401 (k) plan equal to 100 % of the first 3% of wages deferred by each participating employee and 50 % on the next 2% of wages deferred by each participating employee.

The Company incurred expenses for employer matching contributions of a pproximately $ 1.6 million, $ 1.6 million, and $ 1.5 million for th e years e nded December 31, 2024, 2023 and 2022 , respectively.

The Company incurred expenses for employer matching contributions of a pproximately $ 1.6 million for each of th e years e nded December 31, 2025, 2024 and 2023 .

Note 12—Income Taxes

12 unchanged sentences

193 ( 443 ) —

The provision for income taxes in the accompanying consolidated statements of operations differs from the amount calculated by applying the statutory income tax rate to income (loss) from continuing operations before income taxes.

Approximately $ 7.1 million of the $ 25.3 million change in valuation allowance is attributable to a partial valuation allowance release (see further discussion within the tax footnotes below).

Approximately $ 12.2 million of tax expense is due to stock-based compensation expense shortfall, the expiration of vested stock options, and non-deductible stock-based compensation.

Approximately $ 1.5 million of the tax benefits are due to R&D tax credits, net of a $ 0.4 million reserve related to unrecognized tax benefits for the method of allocation of expenses used in the R&D credit calculation.

The primary components of such differences are as follows as of December 31 ( in thousands):

Tax computed at the federal statutory rate

3,245 ( 7,075 ) —

$ 4,671 $ ( 6,178 ) $ 1,083

Reconciliation of Statutory Federal Income Tax Rate to the Effective Income Tax Rate

The Company has elected to prospectively adopt the guidance in ASU No.

2023 - 09, Income Taxes (Topic 740 ):

Improvements to Income Taxes Disclosures, or ASU 2023 - 09.

The following table is a reconciliation of the U.S.

federal statutory rate of 21 % to the Company's effective rate for the year ended December 31, 2025 in accordance with the guidance in ASU No.

federal statutory income tax

State and local income taxes, net of federal income tax effect (1)

Foreign tax effects

( 1,280 ) - 3.6 %

Change in valuation allowance

( 18,639 ) - 52.1 %

Non-taxable or non-deductible items

14,619 40.9 %

Section 162(m)

Other nontaxable or nondeductible items

Income tax expense

( 1 ) State taxes in Kentucky and Indiana comprise the majority (greater than 50% ) of the tax effect in this category.

As previously disclosed for the years ended December 31, 2024 and 2023, prior to the adoption of ASU 2023 - 09, the effective income tax rate differs from the statutory federal income tax rate as follows:

Tax computed at the federal statutory rate

$ 5,061 $ 4,488

Foreign taxes

1 unchanged sentence

( 1,532 ) ( 1,806 )

( 1,532 ) ( 1,806 ) ( 1,490 )

Prior year adjustment

4 unchanged sentences

$ ( 6,178 ) $ 1,083

Approximately $ 3.8 million of the $ 18.7 million change in valuation allowance is attributable to a partial valuation allowance release (see further discussion within the tax footnotes below).

Approximately $15.0 million of tax expense is due to stock-based compensation expense shortfall, the expiration of vested stock options, and non-deductible stock-based compensation.

Approximately $ 1.6 million of the tax benefits are due to R&D tax credits, net of a $ 0.4 million reserve related to unrecognized tax benefits for the method of allocation of expenses used in the R&D credit calculation.

Temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes give rise to the Company’s deferred income taxes.

10 unchanged sentences

Carryforward of disallowed interest

— 1,477 4,761

Accrued legal verdict

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The remaining change is attributable to a partial valuation allowance release of $ 3.8 million driven by forecasted earnings in 2026.

The remaining valuation allowance of $ 343.5 million reserves against deferred tax assets that are more likely than not to not be recognized, as the Company's forecasted profitability is uncertain beyond 2025 due to various risks which are further outlined in ITEM 1A.

RISK FACTORS.

The remaining valuation allowance of $ 324.8 million reserves against deferred tax assets that are more likely than not to not be recognized, as the Company's forecasted profitability is uncertain beyond 2026.

Management’s decision to release a portion of the valuation allowance was based on an assessment of both positive and negative evidence, as required under ASC 740.

3 unchanged sentences

Negative evidence that led to retaining a portion of the valuation allowance included:

Competitive pressure and risks of alternative treatments, potential impacting market share on our commercial product, NERLYNX.

Competitive pressure in the oncology market, including the risks of alternative treatments gaining market share or impacting pricing flexibility.

Ability to generate sustained profitability remains uncertain due to dependence on NYRLYNX as a primary commercial product

Future profits are contingent on the successful clinical development and approval of pipeline products

2 unchanged sentences

As of December 31, 2025, the remaining valuation allowance of $ 324.8 million continues to reflect management’s assessment of uncertainties related to the realization of certain net operating losses and R&D tax credit carryforwards, which remain subject to expiration or utilization limitations.

The decision to retain the remaining valuation allowance was based on inherent uncertainty in future taxable income.

The decision to retain the remaining valuation allowance was based on inherent uncertainty in forecasting taxable income beyond 2026.

The partial release of the valuation allowance decreased the effective tax rate by 9.07 %.

9 unchanged sentences

$ 3,045 $ 2,811 $ 2,522

Gross decreases - tax positions in a prior period

Gross decreases - tax positions in prior period

( 50 ) ( 143 ) ( 163 )

9 unchanged sentences

The Company’s tax years for 2012 and forward are subject to examination by the federal and California tax authorities due to the carryforward of unutilized net operating losses and research and development credits.

Income Tax Payments

Disclosed below is a summary of income taxes paid by jurisdiction pursuant to the disclosure requirements of ASU 2023 - 09 for the year ended December 31, 2025:

Federal income taxes paid (net of refunds)

State income taxes paid (net of refunds)

Foreign income taxes paid (net of refunds)

Total income taxes paid (net of refunds)

Income taxes paid (net of refunds) exceeded five percent of total income taxes paid (net of refunds) in the following jurisdictions:

Note 13—Commitments and Contingencies

22 unchanged sentences

In addition, the company reached a commercial milestone by achieving aggregate worldwide net sales of $ 250.0 million in calendar year 2022, resulting in a payable to Pfizer of $ 12.5 million as of December 31, 2022.

The commercial milestone payable is included in accrued in-licensed rights on the accompanying consolidated balance sheets and was paid in February 2023.

The commercial milestone payable was paid in February 2023.

The Company may trigger additional milestone payments in the future.

7 unchanged sentences

The Company paid Takeda an upfront license fee of $ 7.0 million in October 2022 and is eligible to receive potential future milestone payments of u p to $ 287.3 million upon the Company’s achievement of certain regulatory and commercial milestones over the course of the exclusive license agreement, as well as tiered royalty payments for any net sales of alisertib.

The Company recorded in-process research and development expense of $ 7.0 million in connection with the up-front payment related to the asset acquisition.

The Company recorded in-process research and development expense of $ 7.0 million in connection with the upfront payment related to the asset acquisition.

As of December 31, 2025 , no milestones had been accrued as the underlying contingencies were not considered probable.

35 unchanged sentences

The Company appealed this ruling to the North Carolina Court of Appeals.

On September 3, 2025, the Court of Appeals reversed the dismissal of the Company’s claim for legal malpractice and remanded the case to the Superior Court for further proceedings.

The defendants filed a petition for discretionary review of this decision by the North Carolina Supreme Court on October 8, 2025.

The Supreme Court has not decided whether to accept the case for review.

Patent-Related Proceedings

27 unchanged sentences

The Court found that AstraZeneca had not proved its claim that Wyeth’s asserted patents were invalid as indefinite, or that Wyeth had committed acts that would give rise to findings of unclean hands, implied waiver, or patent misuse.

AstraZeneca has filed a motion challenging the jury’s verdict and requesting a new trial.

Wyeth has filed a motion requesting supplemental damages for past infringement from January 1, 2024, through the date of judgment;

AstraZeneca filed a motion challenging the jury’s verdict and requesting a new trial.

Wyeth filed a motion requesting supplemental damages for past infringement from January 1, 2024, through the date of judgment;

pre-and-post judgment interest, and ongoing royalties through the remaining term of the patents.

7 unchanged sentences

Wyeth filed a notice of appeal on September 12, 2024, appealing the District Court’s judgment as a matter of law, as well as other rulings and opinions of the Court adverse to Wyeth.

Wyeth filed its opening brief on appeal to the Federal Circuit on December 18, 2024.

On December 18, 2024, Wyeth filed its opening brief.

On March 13, 2025, AstraZeneca filed its response brief.

On March 20, 2025, non-parties Regeneron Pharmaceuticals, Inc.

and Sanofi-Aventis U.S.

LLC filed a motion for leave to file an amicus curiae brief in the Federal Circuit.

The motion was granted on May 16, 2025.

On June 6, 2025, Wyeth filed its reply brief.

Briefing on the appeal is now complete, and the parties await further order from the Court.

Acebright China Litigation

30 unchanged sentences

On August 8, 2024, Jiangsu Nanjing Intermediate People’s Court accepted the withdrawal request.

On September 27, 2024, the Company filed an additional patent infringement claim against Acebright at Jiangsu Nanjing Intermediate People’s Court.

On September 27, 2024, the Company filed an additional claim of infringement of the ‘789 patent against Acebright at Jiangsu Nanjing Intermediate People’s Court.

On October 14, 2024, the Court accepted the complaint and designated case number ( 2024 ) Su 01 Min Chu 2192 to this case.

1 unchanged sentence

On January 10, 2025, the Court conducted a hearing of party experts on the evaluation of evidence.

On July 14, 2025, the Court conducted a hearing to examine evidence and debate merits of party arguments.

On September 28, 2025, the Court issued a first -instance decision, deciding that Acebright’s product does not fall within the scope of the ‘789 patent, and Acebright did not infringe the ’789 patent;

the Court also decided that the Company’s enforcement efforts were not malicious and did not amount to unfair competition.

Aosaikang China Litigation

49 unchanged sentences

On September 25, 2023, the CNIPA accepted the Company’s withdrawal request.

On September 9, 2025, the NMPA approved Kelun’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20255337.

Demai Litigation

6 unchanged sentences

ZL201410082103.7.

On February 13, 2025, the Company withdrew the lawsuits from BJIPC, filed an Article 76 petition with the CNIPA against the Demai ANDA and requested administrative determination that Demai’s generic neratinib maleate tablet falls within the scope of the claims of Nerlynx Patent No.

ZL201080060546.6.

On February 21, 2025, the CNIPA accepted the Company’s petition and started examination.

On March 18, 2025, the Company filed a request with the NMPA to set up a nine -month stay on Demai’s ANDA.

Hexal European Patent Opposition

An opposition was filed by Hexal AG (“Hexal”) on August 3, 2016 against European Patent No.

EP2416774 which was licensed from Pfizer in 2011, and which claims neratinib for use in a method for treating HER- 2/neu overexpressed/amplified cancer and improving IDFS, wherein the method comprises delivering neratinib therapy to HER- 2/neu overexpressed/amplified cancer patients following the completion of at least one year of trastuzumab adjuvant therapy, and wherein the neratinib therapy comprises treating the cancer patients with neratinib for at least twelve months.

An oral hearing was held on December 8, 2017, wherein the patent was maintained as granted.

Following an appeal filed by Hexal, the Board of Appeal of the European Patent Office rejected the claims as granted and all pending auxiliary requests during the oral hearing of September 2, 2021.

Before issuance of a decision, we withdrew approval of the text in which the patent was granted and all pending auxiliary requests, thereby revoking the patent and concluding the appeal.

One European divisional application, namely EP15188350.1, was granted with the European patent number EP3000467 on March 1, 2023.

Oppositions against EP3000467 were filed by Hexal on November 3, 2023, by Alfred E.

Tiefenbacher (GmbH & Co.

KG) on November 28, 2023 and by Generics (UK) Limited (“Generics”) on December 1, 2023.

EP3000467 is used as the basic patent for Supplementary Protection Certificate applications for the EMA-approved NERLYNX® product, 17 of which have been granted, three proceedings have been stayed, and 11 are in active prosecution.

The patentee response to the notice of opposition was filed on April 15, 2024, following which, all three opponents filed additional arguments in reply to the patentee’s submission.

On February 6, 2025, the Company filed its response to the summons to attend oral proceedings, including six auxiliary requests.

Tiefenbacher and Hexal filed their responses to the summons to oral proceedings on February 6 and 7, 2025, respectively.

Hexal filed a further brief on March 19, 2025.

Oral proceedings took place on April 9 and 10, 2025.

EP3000467 was upheld as amended after the first instance hearing based on Auxiliary Request 1, which covers the EMA approved indication for NERLYNX® as an extended adjuvant therapy for treating early stage hormone receptor-positive HER- 2 -overexpressed/amplified breast cancer.

The first instance decision may be appealed.

Hexal filed an appeal on June 6, 2025, Generics filed an appeal on June 20, 2025 and Wyeth filed an appeal on June 30, 2025.

On September 5, 2025, Wyeth filed its grounds of appeal, including nine auxiliary requests.

On the same day, Hexal filed its grounds of appeal.

Generics filed its grounds of appeal on September 4, 2025, and Alfred E.

Tiefenbacher filed its grounds of appeal on September 1, 2025.

On December 16, 2025, Alfred E.

Tiefenbacher withdrew its appeal.

Wyeth responded to the opponents’ grounds of appeal on January 12, 2026.

One European divisional application is pending in the same family, namely EP 23157078.8.

A response to the European Search Opinion (ESO) for this application was filed February 14, 2024.

The first office action was issued on January 28, 2025 with a response to the first office action filed on July 22, 2025.

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-K

Item 9A. Controls and Procedures