PBYI Filings — Puma Biotechnology, Inc.

PBYI Filings — Puma Biotechnology, Inc. - FilingSpy

10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗

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Original filing text

Management's Discussion and Analysis

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes thereto included in Item 1 in this Quarterly Report on Form 10-Q (this “Quarterly Report”). The following discussion should also be read in conjunction with our audited consolidated financial statements and the notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2025. Unless otherwise provided in this Quarterly Report, references to the “Company,” “we,” “us,” and “our” refer to Puma Biotechnology, Inc., a Delaware corporation, together with its wholly owned subsidiary. Overview We are a biopharmaceutical company that develops and commercializes innovative products to enhance cancer care and improve treatment outcomes for patients. We are currently commercializing NERLYNX, an oral version of neratinib, for the treatment of certain HER2-positive breast cancers. Additionally, in 2022, we in-licensed and became responsible for the global development and commercialization of alisertib. Alisertib is a selective, small-molecule inhibitor of Aurora Kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on Aurora Kinase A. Prior to our licensing alisertib from Takeda, alisertib was tested in over 1,300 patients who were treated across 22 company-sponsored trials resulting in a large, well-characterized clinical safety database. Based on information in this database, we believe alisertib has potential application in the treatment of a range of different cancer types, including hormone receptor-positive breast cancer, triple-negative breast cancer, and small cell lung cancer. We intend to pursue development of alisertib initially in small cell lung cancer and hormone receptor-positive breast cancer. NERLYNX is currently approved in the United States for two indications: the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy and for use 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. We currently market NERLYNX in the United States using our direct specialty sales force consisting of approximately 38 sales specialists as of June 30, 2026. Our sales specialists are supported by an experienced sales leadership team consisting of regional managers and directors, as well as a commercial team of experienced professionals in marketing, access and reimbursement, managed markets, marketing research, commercial operations and sales force planning and management. Outside the United States, we seek to enter into exclusive sub-license agreements with third parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved. As of June 30, 2026, NERLYNX has received approval for the treatment of certain patients with extended adjuvant or metastatic HER2-positive breast cancer in over 60 countries outside the United States. We are currently party to several sub-licenses in various 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. In September 2022, we entered into an exclusive license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to license the worldwide research and development and commercial rights to alisertib. Alisertib is an investigational, reversible, ATP-competitive inhibitor that is designed to be highly selective for Aurora Kinase A. Inhibition of Aurora Kinase A can lead to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. In clinical trials to date, alisertib has shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. We initiated the ALISertib in CAncer (ALISCA® -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we commenced the ALISCA™ -Breast1 Phase II trial (PUMA-ALI-1201) in November 2024. 33 Table of Contents Under the terms of the exclusive license agreement, we assumed sole responsibility for the global development and commercialization of alisertib. We paid Takeda an upfront license fee of $7.0 million in October 2022, and it is eligible to receive potential future milestone payments of up to $287.3 million upon our 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. We recorded in-process research and development expense of $7.0 million during the year ended December 31, 2022 in connection with the upfront payment related to the asset acquisition. As of June 30, 2026, no milestones had been accrued as the underlying contingencies were not probable. Our expenses to date have been related to hiring staff, commencing company-sponsored clinical trials, building out of our corporate infrastructure and, since 2017, the commercial launch of NERLYNX. Going forward, we anticipate significant expenses as we continue to develop alisertib in 2026. Accordingly, our success depends not only on the safety and efficacy of our drug candidates, but also on our ability to finance product development. To date, our major sources of working capital have been proceeds from product and license revenue, public and private offerings of our common stock, and proceeds from debt financings. We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of June 30, 2026, and proceeds that we expect to become available to us through product sales, royalties, and sub-license milestone payments. However, this intention is based on assumptions that may prove to be wrong. Changes may occur that would consume our available capital faster than anticipated, including changes in and progress of our development activities, the impact of commercialization efforts, acquisition of additional drug candidates and changes in regulation. Some of these developments have had and may continue to have an adverse effect on our revenue. Critical Accounting Policies As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2026 from our accounting policies at December 31, 2025, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. Summary of Income and Expenses Product revenue, net: Product revenue, net consists of revenue from sales of NERLYNX. We sell NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. We record revenue at the net sales price, which includes an estimate for variable consideration for which reserves are established. Variable consideration consists of trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, and other incentives. Product revenue also consists of product sales under sub-license agreements to our sub-licensees, who then sell into their respective international territories. License revenue: License revenue consists of consideration earned for performance obligations satisfied pursuant to our sub-license agreements. Royalty revenue: Royalty revenue consists of consideration earned related to product sales made by our sub-licensees in their respective territories pursuant to our sub-license agreements. Under our sub-license agreement covering China, the royalty rate payable to us is subject to reduction when the market share of generic versions of NERLYNX in China reaches a specified threshold. We are unable to predict with certainty when this threshold will be reached. However, we believe it is possible that the threshold could be reached, triggering the royalty rate reduction, in late 2026 or in 2027. 34 Table of Contents Cost of sales: Cost of sales consists of third-party manufacturing costs, freight, and indirect overhead costs associated with sales of NERLYNX. Cost of product sales also includes period costs related to royalty charges payable to Pfizer, the amortization of milestone payments made under our license agreement with Pfizer, certain inventory manufacturing services, inventory adjustment charges, unabsorbed manufacturing and overhead costs, and manufacturing variances. Cost of sales includes applicable license termination fees. Selling, general and administrative expenses: Selling, general and administrative expenses (“SG&A expenses”) consist primarily of salaries and payroll-related costs, stock-based compensation expense, professional fees, business insurance, rent, general legal activities, credit loss expense, and other corporate expenses. We expense SG&A expenses as they are incurred. Research and development expenses: Research and development expenses (“R&D expenses”) include costs associated with services provided by consultants who conduct and perform clinical services on our behalf and contract organizations for the manufacturing of clinical materials. During the three and six months ended June 30, 2026 and 2025, our R&D expenses consisted primarily of clinical research organization (“CRO fees”); fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D expenses as they are incurred. Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses, and supplies. Tariffs We do 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. On April 2, 2026, the U.S. government issued a proclamation under Section 232 of the Trade Expansion Act of 1962, imposing a 100% ad valorem duty, subject to specified exclusions, on the import of patented pharmaceutical products listed in the FDA’s Orange Book or Purple Book, as well as their associated APIs. A reduced 20% rate is available to companies with onshoring plans approved by the U.S. Secretary of Commerce, although this reduced rate is scheduled to increase to 100% over a four-year period. These tariffs become effective on July 31, 2026 for certain large companies and will become effective on September 29, 2026 for all other companies. The potential impact of the proclamation on the Company, including any indirect effect, remains uncertain and under review. Results of Operations Three Months Ended June 30, 2026 Compared to Three Months Ended June 30, 2025 Total revenue: Total revenue for the three months ended June 30, 2026 was approximately $56.5 million, compared to $52.4 million for the three months ended June 30, 2025. This increase in total revenue was due to an increase in product revenue, net of approximately $4.4 million, partially offset by a decrease in royalty revenue. Product revenue, net: Product revenue, net was approximately $53.6 million for the three months ended June 30, 2026, compared to $49.2 million for the three months ended June 30, 2025. This increase in product revenue, net, compared to the three months ended June 30, 2025, was primarily attributable to a 12.3% increase in domestic bottles sold and an increase in selling price, partially offset by a greater deduction to gross revenue for variable consideration, primarily related to higher Medicaid related deductions. 35 Table of Contents Royalty revenue: Royalty revenue was approximately $2.9 million and $3.2 million for the three months ended June 30, 2026 and 2025. The decrease in royalty revenue was due to lower sales by our international partners. Cost of sales: Cost of sales was approximately $12.5 million for the three months ended June 30, 2026, compared to approximately $12.3 million for the three months ended June 30, 2025. Cost of sales was slightly higher year-over-year as sales of our product bottles were higher. Selling, general and administrative expenses: SG&A expenses were approximately $17.5 million for the three months ended June 30, 2026, compared to approximately $18.0 million for the three months ended June 30, 2025. SG&A expenses for the three months ended June 30, 2026 and 2025 were as follows: Selling, general, and administrative expenses For the Three Months Ended Change (in thousands) June 30, $ % 2026 2025 2026/2025 2026/2025 Payroll and related costs $ 8,859 $ 9,064 $ (205) -2.3 % Provision for credit loss recovery — (362) 362 -100.0 % Professional fees and expenses 4,864 4,974 (110) -2.2 % Travel and meetings 1,522 1,357 165 12.2 % Facilities and equipment costs 310 1,132 (822 ) -72.6 % Stock-based compensation 1,179 992 187 18.9 % Other 813 890 (77 ) -8.7 % $ 17,547 $ 18,047 $ (500) -2.8 % SG&A expenses decreased approximately $0.5 million for the three months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following: ● a decrease in payroll and related costs of approximately $0.2 million, primarily due to the departure of an executive (and related severance costs), partially offset by higher employee payroll costs and higher sales commissions. ● a decrease in professional fees and expenses of approximately $0.1 million, primarily related to a $0.9 million reversal of a previously recorded legal accrual related to the AstraZeneca litigation, partially offset by an increase of $0.6 million in marketing and market access costs; and ● a decrease in facilities and equipment costs of approximately $0.8 million, related to reduced rent as we amended our Los Angeles office lease with less space and terminated our San Francisco office lease as of March 31, 2026. Partially offset by: ● a credit loss recovery related to the collection of accounts receivable in 2025 and no such credit loss recovery took place in 2026; ● an increase in travel and meetings of $0.2 million due to relatively insignificant fluctuations across multiple expense categories; and ● an increase in stock-based compensation of approximately $0.2 million, primarily related to our annual employee stock grants, and a higher stock price. 36 Table of Contents Research and development expenses: R&D expenses were approximately $18.9 million for the three months ended June 30, 2026, compared to approximately $15.5 million for the three months ended June 30, 2025. R&D expenses for the three months ended June 30, 2026 and 2025 were as follows: Research and development expenses For the Three Months Ended Change (in thousands) June 30, $ % 2026 2025 2026/2025 2026/2025 Clinical trial expense $ 7,837 $ 5,647 $ 2,190 38.8 % Internal R&D 9,318 8,076 1,242 15.4 % Consultant and contractors 966 1,093 (127) -11.6 % Stock-based compensation 774 636 138 21.7 % $ 18,895 $ 15,452 $ 3,443 22.3 % R&D expenses increased by approximately $3.4 million for the three months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following: ● an increase in clinical trial expense of approximately $2.2 million, primarily due to increased alisertib study activity; and ● an increase in internal R&D expense of approximately $1.2 million, primarily due to increased employee compensation, including the hiring of a new executive. Other income (expenses): Other income (expenses) For the Three Months Ended Change (in thousands) June 30, $ % 2026 2025 2026/2025 2026/2025 Interest income $ 831 $ 956 $ (125 ) -13.1 % Interest expense (180 ) (1,837 ) 1,657 -90.2 % Other income (expense) 9 410 (401 ) -97.8 % $ 660 $ (471 ) $ 1,131 -240.1 % Interest income: For the three months ended June 30, 2026, we recognized approximately $0.8 million in interest income, compared to approximately $1.0 million of interest income for the three months ended June 30, 2025. The decrease in interest income was primarily related to a lower cash balance and lower interest rates. Interest expense: For the three months ended June 30, 2026, we recognized approximately $0.2 million in interest expense, compared to approximately $1.8 million of interest expense for the three months ended June 30, 2025. The decrease in interest expense was primarily related to a lower debt balance as we paid down our debt principal in the three months ended June 30, 2026. Other income: For the three months ended June 30, 2026, we recognized approximately $0.0 million in other income, compared to approximately $0.4 million of other income for the three months ended June 30, 2025. The decrease in other income was primarily due to the termination of subleases as of March 31, 2026 and unfavorable exchange rates in Euro-denominated transactions. 37 Table of Contents Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025 Total revenue: Total revenue for the six months ended June 30, 2026 was approximately $101.3 million, compared to $98.4 million for the six months ended June 30, 2025. This increase in total revenue was due to an increase in product revenue, net of approximately $3.2 million, partially offset by a $0.4 million decrease in royalty revenue. Product revenue, net: Product revenue, net was approximately $95.5 million for the six months ended June 30, 2026, compared to $92.3 million for the six months ended June 30, 2025. This increase in product revenue, net, compared to the six months ended June 30, 2025, was primarily attributable to a 6.3% increase in bottles sold and an increase in selling price, partially offset by a greater deduction to gross revenue for variable consideration, primarily related to higher Medicaid related deductions. Royalty revenue: Royalty revenue was approximately $5.8 million and $6.2 million for the six months ended June 30, 2026 and 2025, respectively. The decrease of $0.4 million was due to lower sales by our international partners. Cost of sales: . Cost of sales was approximately $22.9 million for each of the six months ended June 30, 2026 and 2025. Cost of sales was relatively consistent with slightly higher year-over-year domestic sales, partially offset by lower sales to our international partners. Selling, general and administrative expenses: SG&A expenses were approximately $36.0 million for the six months ended June 30, 2026, compared to approximately $35.7 million for the six months ended June 30, 2025. SG&A expenses for the six months ended June 30, 2026 and 2025 were as follows: Selling, general, and administrative expenses For the Six Months Ended Change (in thousands) June 30, $ % 2026 2025 2026/2025 2026/2025 Payroll and related costs $ 17,971 $ 17,304 $ 667 3.9 % Provision for credit loss recovery — (149) 149 -100.0 % Professional fees and expenses 9,907 9,584 323 3.4 % Travel and meetings 2,888 2,748 140 5.1 % Facilities and equipment costs 1,405 2,341 (936 ) -40.0 % Stock-based compensation 2,318 2,227 91 4.1 % Other 1,481 1,596 (115 ) -7.2 % $ 35,970 $ 35,651 $ 319 0.9 % SG&A expenses increased by approximately $0.3 million for the six months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following: ● an increase in payroll and related costs of $0.7 million due primarily to increases in employee compensation; and ● an increase in professional fees and expenses of approximately $0.3 million, primarily related to an increase of $1.3 million to marketing and market access costs, partially offset by a $0.9 million reversal of a previously recorded legal accrual related to the AstraZeneca litigation. Partially offset by: ● a decrease in facilities and equipment costs of approximately $0.9 million, related to reduced rent as we amended our Los Angeles office lease with less space and terminated our San Francisco office lease as of March 31, 2026. 38 Table of Contents Research and development expenses: R&D expenses were approximately $38.7 million for the six months ended June 30, 2026, compared to approximately $29.3 million for the six months ended June 30, 2025. R&D expenses for the six months ended June 30, 2026 and 2025 were as follows: Research and development expenses For the Six Months Ended Change (in thousands) June 30, $ % 2026 2025 2026/2025 2026/2025 Clinical trial expense $ 16,666 $ 9,279 $ 7,387 79.6 % Internal R&D 18,601 16,636 1,965 11.8 % Consultant and contractors 1,892 1,973 (81) -4.1 % Stock-based compensation 1,531 1,427 104 7.3 % $ 38,690 $ 29,315 $ 9,375 32.0 % R&D expenses increased by approximately $9.4 million for the six months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following: ● an increase in clinical trial expense of approximately $7.4 million, primarily due to increased alisertib study activity; ● an increase in internal R&D expense of approximately $2.0 million, primarily due to increased employee compensation including the hiring of a new executive; and ● an increase in stock-based compensation of approximately $0.1 million, primarily due to the hiring of a new executive, our annual employee stock grants and a higher stock price. Other income (expenses): Other income (expenses) For the Six Months Ended Change (in thousands) June 30, $ % 2026 2025 2026/2025 2026/2025 Interest income $ 1,833 $ 2,057 $ (224 ) -10.9 % Interest expense (911 ) (4,014 ) 3,103 -77.3 % Other income (expense) 139 769 (630 ) -81.9 % $ 1,061 $ (1,188 ) $ 2,249 -189.3 % Interest income: For the six months ended June 30, 2026, we recognized approximately $1.8 million in interest income, compared to approximately $2.1 million of interest income for the six months ended June 30, 2025. The decrease in interest income was primarily related to lower cash balances and lower interest rates. Interest expense: For the six months ended June 30, 2026, we recognized approximately $0.9 million in interest expense, compared to approximately $4.0 million of interest expense for the six months ended June 30, 2025. The decrease in interest expense was primarily related to a lower debt balance as we paid down our debt principal in the three months ended June 30, 2026. Other income: For the six months ended June 30, 2026, we recognized approximately $0.1 million in other income, compared to approximately $0.8 million of other income for the six months ended June 30, 2025. The decrease in other income was primarily due to the termination of subleases as of March 31, 2026 and unfavorable exchange rates in Euro-denominated transactions. 39 Table of Contents Liquidity and Capital Resources The following table, which summarizes our liquidity and capital resources as of June 30, 2026 and December 31, 2025 and for the six months ended June 30, 2026 and 2025, is intended to supplement the more detailed discussion that follows: As of As of Liquidity and capital resources (in thousands) June 30, 2026 December 31, 2025 Cash and cash equivalents $ 36,537 $ 29,635 Marketable securities $ 57,366 $ 67,893 Working capital $ 95,247 $ 81,433 Current portion of long-term debt $ - $ 22,523 Stockholders’ equity $ 138,544 $ 130,340 Six Months Ended Six Months Ended June 30, 2026 June 30, 2025 Cash provided by (used in): Operating activities $ 17,040 $ 17,694 Investing activities 10,446 (9,717) Financing activities (22,675 ) (22,534 ) Net increase (decrease) in cash, cash equivalents, and restricted cash $ 4,811 $ (14,557 ) Operating Activities: Cash provided by operating activities for the six months ended June 30, 2026 was $17.0 million and consisted of net income of approximately $4.4 million, adjusted for non-cash items of approximately $8.9 million, which included stock-based compensation of $3.8 million and depreciation and amortization of $5.1 million. Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accounts receivable of $19.6 million, primarily due to royalty receipts related to China sales, partially offset by an increase in inventory of $7.8 million related to the purchase of raw material inventory, a decrease in accrued expenses and other of approximately $5.0 million related primarily to the payment of royalties and a $0.9 million reversal of a previously recorded legal accrual, a decrease in accounts payable of $2.0 million and a decrease of post-marketing commitment liability of $1.0 million. Cash provided by operating activities for the six months ended June 30, 2025 was $17.7 million and consisted of net income of approximately $8.8 million, adjusted for non-cash items of approximately $9.1 million, which included stock-based compensation of $3.7 million, depreciation and amortization of $5.6 million and provision for credit loss recovery of $0.1 million. Total changes in cash flows from operations were due to a slight decrease in working capital, primarily related to a decrease in accrued expenses and other of approximately $5.0 million, a decrease in operating lease assets and liabilities, net, of $0.9 million and a decrease of post-marketing commitment liability of $1.1 million, partially offset by a decrease in prepaid and other expenses of $0.5 million, a decrease in accounts receivable of approximately $6.3 million and a decrease in inventory of $0.1 million. Investing Activities: Cash provided by investing activities for the six months ended June 30, 2026 was approximately $10.4 million, compared to net cash used in investing activities of approximately $9.7 million for the same period in 2025. Cash provided by investing activities for the six months ended June 30, 2026 was primarily due to the maturity of available-for-sale securities of approximately $56.9 million, partially offset by the purchase of available-for-sale securities of approximately $46.4 million. 40 Table of Contents Financing Activities: Cash used in financing activities for the six months ended June 30, 2026 was approximately $22.6 million, including $22.2 million related to the payment of principal and $0.4 million related to exit fees, on our debt with Athyrium. Our Athyrium Note was paid in full as of June 30, 2026. Cash used in financing activities for the six months ended June 30, 2025 was approximately $22.5 million, including $22.2 million related to the payment of principal and $0.4 million related to exit fees, on our debt with Athyrium, partially offset by $0.1 million in proceeds from shares issued under employee stock plans. Current and Future Financing Needs: We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials, our R&D efforts, and our commercialization efforts. We may choose to begin new R&D efforts, or we may choose to launch additional marketing efforts. For example, we in-licensed alisertib from Takeda in 2022 and assumed sole responsibility for its global development and commercialization. These efforts will require funding in addition to the cash and cash equivalents totaling approximately $36.5 million and approximately $57.4 million in marketable securities available at June 30, 2026. While our condensed consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib. While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future. Our ability to obtain funding may be adversely impacted by uncertain market conditions, our success in commercializing neratinib, our success in developing alisertib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. We believe that our existing cash and cash equivalents and marketable securities as of June 30, 2026, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report. Non-GAAP Financial Measures In addition to our operating results, as calculated in accordance with Generally Accepted Accounting Principles (“GAAP”) we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net income and net income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three months ended June 30, 2026, stock-based compensation represented approximately 5.4% of our operating expenses, compared to approximately 4.9% for the same period in 2025, in each case excluding cost of sales. For the six months ended June 30, 2026, stock-based compensation represented approximately 5.2% of our operating expenses, compared to approximately 5.6% for the same period in 2025, in each case excluding cost of sales. Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures. 41 Table of Contents Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income and GAAP Net Income Per Share to Non-GAAP Adjusted Net Income Per Share (in thousands except share and per share data) For the Three Months Ended June 30, For the Six Months Ended June 30, 2026 2025 2026 2025 GAAP net income $ 8,189 $ 5,855 $ 4,436 $ 8,829 Adjustments: Stock-based compensation - Selling, general and administrative (1) 1,179 992 2,318 2,227 Research and development (2) 774 636 1,531 1,427 Non-GAAP adjusted net income $ 10,142 $ 7,483 $ 8,285 $ 12,483 GAAP net income per share—basic $ 0.16 $ 0.12 $ 0.09 $ 0.18 Adjustment to net income (as detailed above) 0.04 0.03 0.07 0.07 Non-GAAP adjusted basic net income per share $ 0.20 (3) $ 0.15 (4) $ 0.16 (3) $ 0.25 (4) GAAP net income per share—diluted $ 0.16 $ 0.12 $ 0.08 $ 0.18 Adjustment to net income (as detailed above) 0.03 0.03 0.08 0.07 Non-GAAP adjusted diluted net income per share $ 0.19 (5) $ 0.15 (6) $ 0.16 (5) $ 0.25 (6) (1) To reflect a non-cash charge to operating expense for selling, general, and administrative stock-based compensation. (2) To reflect a non-cash charge to operating expense for research and development stock-based compensation. (3) Non-GAAP adjusted basic net income per share was calculated based on 50,939,946 and 50,892,800 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2026, respectively. (4) Non-GAAP adjusted basic net income per share was calculated based on 49,700,217 and 49,648,246 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2025, respectively. (5) Non-GAAP adjusted diluted net income per share was calculated based on 52,596,589 and 52,278,925 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2026, respectively. (6) Non-GAAP adjusted diluted net income per share was calculated based on 50,144,704 and 50,003,709 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2025, respectively. Off-Balance Sheet Arrangements We do not have any “off-balance sheet arrangements,” as defined by SEC regulations. Contractual Obligations There have been no material changes outside the ordinary course of business to our contractual obligations and commitments as described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Legal Proceedings

Legal Malpractice Suit On September 17, 2020, the Company filed a lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in Eshelman v. Puma Biotechnology, Inc., et al. in the Superior Court of Mecklenburg County, North Carolina. The Company is alleging legal malpractice based on the defendants’ negligent handling of the defense of the Company in Eshelman v. Puma Biotechnology, Inc., et al. The Company is seeking recovery of the entire amount awarded in Eshelman v. Puma Biotechnology, Inc., et al. and all legal fees and expenses incurred in appealing from the judgment and retrying the damages phase of the trial. On November 23, 2020, the defendant filed an answer to the complaint denying the allegations of negligence. On August 19, 2022, the Company filed a voluntary dismissal of the legal malpractice action, without prejudice, to allow the Eshelman v. Puma Biotechnology, Inc., et al. to conclude before proceedings. On June 2, 2023, the Company re-filed the lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in Eshelman v. Puma Biotechnology, Inc., et al. in the Superior Court of Mecklenburg County, North Carolina. On August 22, 2023, the defendants filed motions to dismiss the case. These motions were presented at a hearing on February 20, 2024. The Superior Court Judge granted the motions to dismiss on March 20, 2024. 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. 43 Table of Contents Patent-Related Proceedings AstraZeneca Litigation On September 22, 2021, the Company filed suit against AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and AstraZeneca PLC for infringement of United States Patent Nos. 10,603,314 (“the ‘314 patent”) and 10,596,162 (“the ‘162 patent”) (Puma Biotechnology, Inc. et al. v. AstraZeneca Pharmaceuticals LP et al., 1:21CV01338 (D. Del. Sep. 22, 2021)). The Company’s complaint alleges that AstraZeneca’s commercial manufacture, use, offer for sale, sale, distribution, and/or importation of Tagrisso® (osimertinib) products for the treatment of gefitinib and/or erlotinib-resistant non-small cell lung cancer infringes the ‘314 and ‘162 patents. The Company is an exclusive licensee of the ‘314 and ‘162 patents under the Pfizer Agreement. Wyeth is a co-plaintiff. Plaintiffs seek a judgment that AstraZeneca’s product infringes the asserted patents and an award of monetary damages in an amount to be proven at trial. AstraZeneca AB and AstraZeneca Pharmaceuticals LP filed an answer and counterclaims on November 5, 2021, including claims challenging the asserted patents as not infringed and/or invalid, and accusing plaintiffs of unclean hands and patent misuse. The parties stipulated to dismiss AstraZeneca PLC as a defendant and Pfizer as a Counterclaim Defendant on December 10, 2021, which the Court so ordered on December 13, 2021. The Company filed its answer to AstraZeneca’s counterclaims on December 17, 2021, denying those claims. The case was reassigned to visiting Judge Matthew Kennelly of the Northern District of Illinois. A Markman Hearing was conducted on March 17, 2023, and the Court issued its claim construction decision on March 29, 2023. Fact discovery closed on May 19, 2023, and expert discovery closed on November 17, 2023. The Court denied the parties’ respective motions for summary judgment and Daubert motions, other than to clarify that Plaintiffs’ damages cannot extend to any time period before the asserted patents were issued. The Court granted AstraZeneca’s motion to dismiss the Company as a Plaintiff on constitutional standing grounds but denied the motion to dismiss Wyeth as a Plaintiff on constitutional standing grounds. On April 29, 2024, the Court granted AstraZeneca’s motion to dismiss AstraZeneca’s counterclaims against the Company, which removed the Company from the case. Wyeth remained in the case as a Plaintiff and counterclaim defendant. Under the Company’s worldwide exclusive license agreement with Pfizer, Inc. (the parent of Wyeth) as amended, the Company also maintains contractual rights to recover monetary damages in the AstraZeneca litigation, and those contractual rights are unaffected by the court’s March 18, 2024 and April 29, 2024 orders. A jury trial was held May 13-17, 2024. The jury found in favor of Wyeth and against AstraZeneca. In particular, the jury found that use of Tagrisso® according to each of the three FDA-approved indications infringes the asserted claims of the ‘314 and ‘162 patents, and that AstraZeneca induces that infringement. The jury further rejected AstraZeneca’s challenges to the validity of the patents, finding that they are not invalid. The jury awarded damages to Wyeth for past acts of infringement through December 31, 2023, in the amount of $107.5 million. A separate bench trial related to certain equitable claims and defenses raised by AstraZeneca was held before Judge Kennelly on June 20 and 25, 2024. On August 6, 2024, Judge Kennelly issued his ruling on the issues that were tried in the bench trial, finding for Wyeth and against AstraZeneca on all claims and defenses. 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 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. Briefing on these motions from both sides was completed on July 16, 2024. On August 14, 2024, Judge Kennelly ruled on AstraZeneca’s motion challenging the jury’s verdict, granting it in part and denying it in part. The Court granted AstraZeneca’s motion for judgment as a matter of law that the '314 and '162 patents are invalid under 35 U.S.C. § 112 for lacking enablement and adequate written description as to a particular claim limitation. In all other respects, the Court denied AstraZeneca’s motion. The Court entered its final and appealable judgment accordingly. The Company respectfully disagrees with the Court’s ruling regarding invalidity with respect to the particular claim limitation. 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. 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 and oral arguments were held on May 7, 2026. On July 9, 2026, the Federal Circuit affirmed the judgment of the Delaware District Court, holding the patent claims at issue invalid. The Company can request further review from the full Federal Circuit and the Supreme Court. 44 Table of Contents Acebright China Litigation On January 18, 2022, Shanghai Acebright Pharmaceuticals Group Co., Ltd. (“Acebright”) filed an abbreviated new drug application (“ANDA”) with the National Medical Products Administration in China (“NMPA”) seeking approval to market a generic version of the Company’s NERLYNX® (neratinib) tablet, 40mg in China. Acebright seeks approval prior to the expiration of three patents listed on the China Patent Information Registration Platform for Marketed Drugs (“Chinese Orange Book”), namely, Chinese Patent Nos. ZL201410082103.7, ZL201080060546.6, and ZL200880118789.3 (the “’789 patent” and collectively, the “NERLYNX® Patents”), alleging in a Type 4.2 patent declaration that its generic version of NERLYNX does not fall within the scope of the claims of NERLYNX® Patents listed in the Chinese Orange Book. The patent declaration of Acebright was published in the Chinese Orange Book on January 19, 2022. On March 2, 2022, the Company filed petitions with the China National Intellectual Property Administration (“CNIPA”) and requested administrative determination that Acebright’s generic neratinib tablet falls within the scope of the claims of NERLYNX® Patents listed in the Chinese Orange Book. The Company’s request for administrative determination was accepted by CNIPA on March 18, 2022. The Company has notified NMPA of the acceptance of the request for administrative determination for NMPA to institute a stay of Acebright’s ANDA for nine months. On July 11, 2022, CNIPA decided that claims 5 and 6 of Patent No. ZL200880118789.3 are not eligible for registration in the Chinese Orange Book on the ground that these two pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book. On September 9, 2022, CNIPA decided that the generic drug in Acebright’s ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No. ZL201410082103.7 and claims 1-4, 7 and 9-13 of Patent No. ZL201080060546.6. The three CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Acebright’s ANDA by NMPA. The Company has appealed each CNIPA administrative decision in January 2023 at the Beijing Intellectual Property Court (“BJIPC”). The three appeals were accepted by BJIPC on February 20, 2023. The Company also filed three civil complaints based on the three NERLYNX® Patents against Acebright with the BJIPC in July 2022 and requested court determination that Acebright’s generic neratinib tablet falls within the scope of the claims of NERLYNX® Patents. On May 6, 2023, the Company withdrew two civil lawsuits and two appeals in relation to Chinese Patent Nos. ZL201410082103.7 and ZL201080060546.6 at the BJIPC. On May 24, 2023, the BJIPC accepted the Company’s withdrawal request. On July 24, 2023, the Company withdrew the one remaining civil lawsuit and one appeal in relation to Chinese Patent No. ZL200880118789.3 at the BJIPC. On August 15, 2023, the BJIPC accepted the Company’s withdrawal request. On September 12, 2023, the NMPA approved Acebright’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20234141. On December 28, 2023, the Company filed a civil lawsuit against Acebright for infringement of the ’789 patent under Article 11 of the Chinese Patent Law before Jiangsu Nanjing Intermediate People’s Court. The Company’s complaint alleges that Acebright’s offer for sale of a generic version of the Company’s NERLYNX® product infringes the ’789 patent. The Company seeks a judgment that Acebright’s product infringes the ’789 patent and Acebright’s act of offer for sale shall be enjoined. On January 2, 2024, Jiangsu Nanjing Intermediate People’s Court accepted the civil complaint. An oral hearing was held on June 19, 2024, during which the Company amended its complaint to allege that Acebright making, selling and offering to sell the generic version of NERLYNX® infringes the ’789 patent. On July 24, 2024, the Company submitted a request to withdraw the lawsuit. 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 October 14, 2024, the Court accepted the complaint and designated case number (2024) Su 01 Min Chu 2192 to this case. On December 16, 2024, the Court conducted an evidence exchange hearing. 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 patent-in-suit, and Acebright did not infringe the NERLYNX® Patents. The Court also decided that the Company’s enforcement efforts were not malicious and did not amount to unfair competition. Aosaikang China Litigation On November 17, 2022, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (“Aosaikang”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®. The ANDA application No. is CYHS2202006. Aosaikang made Type 4.2 declarations against the four Orange Book Patents ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 and ZL201710057547.9, alleging that its generic version of NERLYNX does not fall within the scope of the claims of the Orange Book patents. Aosaikang also alleged that Patents ZL200880118789.3 and ZL201710057547.9 are not eligible for Chinese Orange Book listing. 45 Table of Contents On December 28, 2022, the Company submitted four Article 76 petitions against the Aosaikang ANDA with the CNIPA and requested administrative determination that Aosaikang’s generic neratinib tablet falls within the scope of the claims of the four Orange Book patents. On January 6, 2023, the CNIPA accepted the Company’s request for administrative determination in relation to Patent Nos. ZL201410082103.7 and ZL201080060546.6. Also on January 6, 2023, the CNIPA declined to accept the Company’s request for administrative determination in relation to Patent Nos. ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book. On January 28, 2023, the Company requested the NMPA to institute a nine-month stay against Aosaikang ANDA starting from the CNIPA’s acceptance of the Company’s request for administrative determination. On June 2, 2023, CNIPA decided that the generic drug in Aosaikang’s ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No. ZL201410082103.7 and claims 1-4, 7 and 9-13 of Patent No. ZL201080060546.6. The two CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Aosaikang’s ANDA by NMPA. On October 22, 2024, the NMPA approved Aosaikang’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20249180. Convalife China Litigation Convalife Pharmaceuticals (Shanghai) Co., Ltd (“Convalife”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®. The ANDA application No. is CYHS2202095. On December 23, 2022, Convalife made Type 4.2 declarations against the four Orange Book Patents ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 and ZL201710057547.9, alleging that its generic version of NERLYNX does not fall within the scope of the claims of the Orange Book patents. Convalife also alleged that Patents ZL200880118789.3 and ZL201710057547.9 are not eligible for Chinese Orange Book listing. On February 1, 2023, the Company submitted four Article 76 petitions against the Convalife ANDA with the CNIPA and requested administrative determination that Convalife’s generic neratinib tablet falls within the scope of the claims of the four Orange Book patents. On February 3, 2023, the CNIPA accepted the Company’s request for administrative determination in relation to Patent Nos. ZL201410082103.7 and ZL201080060546.6. Also on February 3, 2023, the CNIPA declined to accept the Company’s request for administrative determination in relation to Patent Nos. ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book. On February 24, 2023, the Company requested the NMPA to institute a nine-month stay against Convalife ANDA starting from the CNIPA’s acceptance of the Company’s request for administrative determination. On June 2, 2023, CNIPA decided that the generic drug in Convalife’s ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No. ZL201410082103.7 and claims 1-4, 7 and 9-13 of Patent No. ZL201080060546.6. The two CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Convalife’s ANDA by NMPA. On June 28, 2024, the NMPA approved Convalife’s ANDA to market a generic version of the Company’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20244222. Kelun China Litigation Hunan Kelun Pharmaceutical Co., Ltd. (“Kelun”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®. The ANDA application No. is CYHS2300221. On January 28, 2023, Kelun made Type 4.2 declarations against the four Orange Book Patents ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 and ZL201710057547.9, alleging that its generic version of NERLYNX does not fall within the scope of the claims of the Orange Book patents. Kelun also alleged that Patents ZL200880118789.3 and ZL201710057547.9 are not eligible for Chinese Orange Book listing. On March 13, 2023, the Company submitted four Article 76 petitions against the Kelun ANDA with the CNIPA and requested administrative determination that Kelun’s generic neratinib tablet falls within the scope of the claims of the four Orange Book patents. On March 21, 2023, the CNIPA declined to accept the Company’s request for administrative determination in relation to Patent Nos. ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of “patents of crystalline forms,” which are not eligible for listing in the Chinese Orange Book. On March 24, 2023, the CNIPA accepted the Company’s request for administrative determination in relation to Patent Nos. ZL201410082103.7 and ZL201080060546.6. On April 17, 2023, the Company requested the NMPA to institute a nine-month stay against Kelun’s ANDA starting from the CNIPA’s acceptance of the Company’s request for administrative determination. On September 14, 2023, the Company withdrew the two requests for administrative determination in relation to Chinese Patent Nos. ZL201410082103.7 and ZL201080060546.6 at the CNIPA. 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. 46 Table of Contents Demai Litigation Zhengzhou Demai Pharmaceutical Co., Ltd (“Demai”) filed an ANDA with NMPA in China seeking approval to market a generic version of the Company’s NERLYNX®. The ANDA application No. is CYHS2402776. On August 26, 2024, Demai made a Type 4.2 declaration against Orange Book Patent ZL201410082103.7, alleging that its generic version of NERLYNX does not fall within the scope of the claims of this Orange Book patent. On September 30, 2024, the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent No. ZL201080060546.6 and on October 8, 2024, the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent No. 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. On November 4, 2025, the NMPA approved Demai’s ANDA to market a generic version of Puma’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20255844. 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, the Company 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. Alfred E. 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. 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. On March 2, 2026, Hexal withdrew its request for oral proceedings, but remains a party to the proceedings. 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.

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