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PUMA BIOTECHNOLOGY, INC.

For the period ended Mar 31, 2026. Filed May 7, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2026 · Filed May 7, 2026

PBYI$8.25-15.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-09-30; filed 2025-11-06.

0001437749-25-033633

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-03-31; filed 2026-05-07.

0001437749-26-015633

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 99 previous paragraphs and 85 current paragraphs.

39 unchanged; 29 reworded; 16 added; 30 removed; 1 previous and 1 current paragraphs rearranged.

Tables are not compared: 23 previous and 12 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (16)

Current report

On April 2, 2026, the U.S. government issued a proclamation under Section 232 of the Trade Expansion Act of 1962, imposing new tariffs on imported patented pharmaceutical products and APIs. Any potential impact of the proclamation on the Company is uncertain and under review.

Current report

Royalty revenue was approximately $2.9 million for each of the three months ended March 31, 2026 and 2025 as sales were relatively consistent to our international partners.

Current report

Cost of sales was approximately $10.4 million for the three months ended March 31, 2026, compared to approximately $10.6 million for the three months ended March 31, 2025. Cost of sales was relatively consistent year-over-year as sales of our product bottles were relatively consistent.

Current report

SG&A expenses increased approximately $0.8 million the three months ended March 31, 2026, compared to the same period in 2025, primarily attributable to the following:

Current report

On May 4, 2026, we paid $11.5 million under the Note Purchase Agreement, ahead of the scheduled maturity date of July 23, 2026. This payment reduced the principal balance outstanding under the Athyrium Notes to zero and terminated all of our remaining obligations under the Note Purchase Agreement, other than customary continuing indemnification obligations.

Current report

(4) Potentially dilutive common stock equivalents (stock options restricted stock units and warrants) were not included in this non-GAAP adjusted diluted net loss per share for the three months ended March 31, 2026, as these shares would be considered anti-dilutive.
Removed paragraphs (30)

Previous report

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 us. As of the date of these financial statements, we have evaluated the impact of the changes to Section 174 – Amortization of research and experimental expenditures on the valuation allowance release. We intend 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. Therefore, we have concluded that it remains reasonable to maintain the $7.0 million estimate for the valuation allowance release as of September 30, 2025 as the facts and circumstances supporting the deferred tax asset have not materially changed.

Previous report

Product revenue, net was approximately $51.9 million for the three months ended September 30, 2025, compared to $56.1 million for the three months ended September 30, 2024. This decrease in product revenue, net, compared to the three months ended September 30, 2024, was attributable toa decrease in product supply revenue to our international licensees (reduction in China sales), partially offset by an increase in domestic sales resulting from an 8%increase inbottles of NERLYNX sold in the U.S. market and an increase in net selling price. This increase in gross domestic sales was partially offset by greater deductions to gross revenue for variable consideration, primarily related to government chargebacks.

Previous report

Royalty revenue was approximately $2.6 million for the three months ended September 30, 2025, compared to approximately $24.4 million for the three months ended September 30, 2024. The decrease was primarily due to timing of sales made into China by our sub-licensee.

Previous report

Cost of sales was approximately $12.2 million for the three months ended September 30, 2025, compared to approximately $29.1 million for the three months ended September 30, 2024. The decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Previous report

SG&A expenses remained virtually unchanged for the three months ended September 30, 2025, compared to the same period in 2024, primarily attributable to the following:

Previous report

For the three months ended September 30, 2025, we recognized approximately $1.0 million in interest income, compared to approximately $1.3 million of interest income for the three months ended September 30, 2024. The decrease in interest income was primarily the result of lower investment balances and timing of investments.

Previous report

Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024

Previous report

Total revenue for the nine months ended September 30, 2025 was approximately $152.9 million, compared to $171.4 million for the nine months ended September 30, 2024. This $18.5 million decrease in total revenue was due to a decrease in royalty revenue of $21.9 million, partially offset by an increase in product revenue, net of approximately $3.4 million.

Previous report

Royalty revenue was approximately $8.7 million and $30.6 million for thenine months ended September 30, 2025 and September 30, 2024 respectively. Thedecrease in royalty revenue was primarily due to a decrease in sales to our international licensees (reduction in China sales).

Previous report

Cost of sales was approximately $35.0 million for thenine months ended September 30, 2025, compared to approximately $50.5 million for thenine months ended September 30, 2024. The decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Previous report

SG&A expenses were approximately $52.5 million for the nine months ended September 30, 2025, compared to approximately $63.5 million for the nine months ended September 30, 2024. SG&A expenses for the nine months ended September 30, 2025 and 2024 were as follows:

Previous report

SG&A expenses decreased by approximately $11.1 million for thenine months ended September 30, 2025, compared to the same period in 2024, primarily attributable to the following:

Previous report

R&D expenses were approxi mately $45.2 millionfor thenine months ended September 30, 2025, compared to approximately $39.8 million for the nine months ended September 30, 2024. R&D expenses for the nine months ended September 30, 2025 and 2024, were as follows:

Previous report

R&D expenses increased by approxim ately $5.5 million compared to thenine months ended September 30, 2024, primarily attributable to the following:

Previous report

For thenine months ended September 30, 2025, we recognized approximately $3.1 million in interest income, compared to approximately $3.5 million of interest income for thenine months ended September 30, 2024. The decrease in interest income was prima rily the result of lower investment balances and timing of investments.

Previous report

For the nine months ended September 30, 2025, we recognized approximately $0.9 million in other income, compared to approximately $0.6 million of other income for the nine months ended September 30, 2024. The increase inother income wasprimarily due to favorable exchange rates in Euro-denominated transactions.

Previous report

On October 26, 2023, we implemented a reduction in our workforce of approximately 5% across the Company. We incurred approximately $0.4 million in related costs, which included severance payments and insurance premiums. These costs were recorded in the fourth quarter of 2023. All payments related to this plan were paid as of June 30, 2024.

Previous report

Cash used in financing activities for the nine months ended September 30, 2024 was approximately $22.5 million. Of this amount, $22.7 million related to the payment of principal, as well as exit fees, on our debt with Athyrium, partially offset by approximately $0.2 million of proceeds from employee stock options exercised.

Previous report

The Athyrium Notes include affirmative and negative covenants applicable to us. The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage, and satisfy certain requirements regarding deposit accounts. The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions. We are also required to maintain minimum cash balances and achieve certain minimum product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis. As of September 30, 2025, we were in compliance with such covenants.

Previous report

In addition, we have based our estimate of capital needs 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, acquisitions of additional drug candidates and changes in regulation. Potential sources of financing include strategic relationships, public or private sales of equity or debt and other sources of funds. We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements. If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interests of our existing stockholders will be diluted. If we are not able to obtain financing when needed, we may be unable to carry out our business plan. As a result, we may have to significantly limit our operations, and our business, financial condition and results of operations would be materially harmed. In such an event, we will be required to undertake a thorough review of our programs, and the opportunities presented by such programs, and allocate our resources in the manner most prudent.

Previous report

(4) Non-GAAP adjusted basic net income per share was calculated based on 49,008,464 and 48,498,579 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.

Previous report

(6) Non-GAAP adjusted diluted net income per share was calculated based on 49,173,361 and 49,025,103 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.
Reworded paragraphs (29)

Previous wording

We currently market NERLYNX in the United States using our direct specialty sales force consisting of approxima tely 38 sales specialists. Our sales specialists are supported by an experienced sales leadership team consisting of several regional business leaders and a Vice President of sales, as well as experienced professionals in marketing, managed markets, access and reimbursement, research, and sales planning and operations. 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 September 30, 2025, NERLYNX has received approval for the treatment of certain patients with extended adjuvant or metastatic HER2-positive breast cancer in over 40 countries outside the United States. We are currently party to several sub-licenses in various regions outside the United States, including Europe, Australia, Canada, China, Southeast Asia, Israel, South Korea, Russia and various countries and territories in Central America, South America, Africa and the Middle East.

Current wording

We currently market NERLYNX in the United States using our direct specialty sales force consisting of approximately 35 sales specialists as of December 31, 2025. 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 March 31, 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.

Previous wording

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 of 2024.

Current wording

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.

Previous wording

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 September 30, 2025, no milestones had been accrued as the underlying contingencies were not probable or estimable.

Current wording

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 March 31, 2026, no milestones had been accrued as the underlying contingencies were not probable.

Previous wording

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 2025. 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 offerings of our common stock, proceeds from our credit facility and sales of our common stock in private placements. We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of September 30, 2025, and proceeds that will 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 and thus could have an adverse effect on our ability to satisfy the minimum revenue and cash balance covenants contained in the Athyrium Notes.

Current wording

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 March 31, 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 and thus could have an adverse effect on our ability to satisfy the minimum revenue and cash balance covenants contained in the Athyrium Notes.

Previous wording

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 nine months ended September 30, 2025 from our accounting policies at December 31, 2024, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

Current wording

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 three months ended March 31, 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.

Previous wording

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 nine months ended September 30, 2025 and 2024, 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.

Current wording

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 months ended March 31, 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.

Previous wording

We do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with the European Union 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.

Current wording

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

Previous wording

Total revenue for the three months ended September 30, 2025 was approximately $54.5 million, compared to $80.5 million for the three months ended September 30, 2024. This decrease in total revenue was due to a decrease in product revenue, net of approximately $4.2 million and a decrease in royalty revenue of $21.8 million.

Current wording

Total revenue for the three months ended March 31, 2026 was approximately $44.8 million, compared to $46.0 million for the three months ended March 31, 2025. This decrease in total revenue was due to a decrease in product revenue, net of approximately $1.1 million and a slight decrease in royalty revenue.

Previous wording

Product revenue, net was approximately $144.2 million for the nine months ended September 30, 2025, compared to $140.8 million for the nine months ended September 30, 2024. This increase in product revenue, net, compared to the nine months ended September 30, 2024, was attributable to anincrease in domestic sales resulting from a 3%increase inbottles of NERLYNX sold in the U.S. market and an increase in net selling price, partially offset by an increase in deductions to gross revenue for variable consideration, primarily related to government chargebacks.

Current wording

Product revenue, net was approximately $42.0 million for the three months ended March 31, 2026, compared to $43.1 million for the three months ended March 31, 2025. This decrease in product revenue, net, compared to the three months ended March 31, 2025, was primarily attributable toa greater deduction to gross revenue for variable consideration, primarily related to government chargebacks and payor mix, partially offset by an increase in selling price.

Previous wording

SG&A expenses were approximately $16.8 million for the three months ended September 30, 2025, compared to approximately $16.8 million for the three months ended September 30, 2024. SG&A expenses for the three months ended September 30, 2025 and 2024 were as follows:

Current wording

SG&A expenses were approximately $18.4 million for the three months ended March 31, 2026, compared to approximately $17.6 million for the three months ended March 31, 2025. SG&A expenses for the three months ended March 31, 2026 and 2025 were as follows:

Previous wording

R&D expenses were approxi mately$15.9 million for thethree months ended September 30, 2025, compared to approximately $12.6 million for the three months ended September 30, 2024. R&D expenses for the three months ended September 30, 2025 and 2024, were as follows:

Current wording

R&D expenses were approxi mately$19.8 million for thethree months ended March 31, 2026, compared to approximately $13.9 million for the three months ended March 31, 2025. R&D expenses for the three months ended March 31, 2026 and 2025 were as follows:

Previous wording

R&D expenses increased by approxim ately$3.4 million for the three months ended September 30, 2025, compared to the same period in 2024, primarily attributable to the following:

Current wording

R&D expenses increased by approxim ately$5.9 million for the three months ended March 31, 2026, compared to the same period in 2025, primarily attributable to the following:

Previous wording

For the three months ended September 30, 2025, we recognized approximately $1.5 million in interest expense, compared to approximately $3.1 million of interest expense for the three months ended September 30, 2024. The decrease in interest expense was primarily related to a lower debt balance as we began paying down our debt principal during the three months ended September 30, 2024.

Current wording

For the three months ended March 31, 2026, we recognized approximately $0.7 million in interest expense, compared to approximately $2.2 million of interest expense for the three months ended March 31, 2025. The decrease in interest expense was primarily related to a lower debt balance as we continue paying down our debt principal.

Previous wording

For the three months ended September 30, 2025, we recognized approximately $0.1 million in other income, compared to approximately $0.3 million of other income for the three months ended September 30, 2024. The decrease inother income wasprimarily due to unfavorable exchange rates in Euro-denominated transactions.

Current wording

For the three months ended March 31, 2026, we recognized approximately $0.1 million in other income, compared to approximately $0.4 million of other income for the three months ended March 31, 2025. The decrease in other income was primarily due to unfavorable exchange rates in Euro-denominated transactions.

Previous wording

The following table, which summarizes our liquidity and capital resources as of September 30, 2025 and December 31, 2024 and for the nine months ended September 30, 2025 and 2024, is intended to supplement the more detailed discussion that follows:

Current wording

The following table, which summarizes our liquidity and capital resources as of March 31, 2026 and December 31, 2025 and for the three months ended March 31, 2026 and 2025, is intended to supplement the more detailed discussion that follows:

Previous wording

Cash provided by operating activities for the nine months ended September 30, 2024 was $23.3 million and consisted of net income of approximately $11.0 million, adjusted for non-cash items of approximately $15.1 million, including stock-based compensation of $6.5 million, depreciation and amortization of $8.7 million and provision for credit loss of $0.1 million. Total changes in cash flows from operations were due to a decrease in working capital, primarily related to an increase in accounts receivable of approximately $6.7 million (primarily sales to China) and a decrease in accrued expenses and other of approximately $2.1 million, partially offset by a decrease in inventory of $4.4 million (primarily sales to China) and a decrease in prepaid expenses and other of $2.4 million.

Current wording

Cash provided by operating activities for thethree months ended March 31, 2026 was$15.4 million and consisted of net loss of approximately$3.8 million, adjusted for non-cash items of approximately $4.5 million, which included stock-based compensation of $1.9 million and depreciation and amortization of $2.6 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 $27.3 million, primarily due to royalty receipts related to China sales and an increase in accounts payable of $3.1 million, partially offset by decrease in accrued expenses and other of approximately $11.7 million related primarily to the payment of royalties, an increase in inventory of $3.2 million related to a receipt of raw material inventory, a decrease in operating lease assets and liabilities, net, of $0.6 million and a decrease of post-marketing commitment liability of $0.5 million.

Previous wording

Cash provided by operating activities for thenine months ended September 30, 2025 was$27.4 million and consisted of net income of approximately$17.7 million, adjusted for non-cash items of approximately $13.2 million, which included stock-based compensation of $5.3 million, depreciation and amortization of $8.3 million and provision for credit loss recovery of $0.4 million. Total changes in cash flows from operations were due to an increase in working capital, primarily related to an increase in accounts receivable of $1.2 million, an increase in inventory of $0.8 million, a decrease of post-marketing commitment liability of $1.7 million, a decrease in operating lease assets and liabilities, net, of $1.3 million and an increase in accrued expenses and other of approximately $0.3 million, partially offset by a decrease in prepaid and other expenses of $0.4 million and an increase in accounts payable of $0.9 million.

Current wording

Cash provided by operating activities for the three months ended March 31, 2025 was $3.6 million and consisted of net income of approximately $3.0 million, adjusted for non-cash items of approximately $5.0 million, which included stock-based compensation of $2.0 million, depreciation and amortization of $2.8 million and provision for credit loss of $0.2 million. Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accrued expenses and other of approximately $9.9 million, a decrease in operating lease assets and liabilities, net, of $0.4 million and a decrease of post-marketing commitment liability of $0.4 million and an increase in prepaid and other expenses of $0.8 million, partially offset by a decrease in accounts receivable of approximately $6.6 million and an increase in accounts payable of $0.5 million.

Previous wording

Cash used in investing activities for thenine months ended September 30, 2025 was approximately$9.2 million, compared to net cash used in investing activities of approximately$18.1 million for the same period in 2024. Cash used in investing activities for the nine months ended September 30, 2025 was primarily due to the purchase of available-for-sale securities of approximately $61.2 million, partially offset by the maturity of available-for-sale securities of approximately $52.1 million.

Current wording

Cash provided by investing activities for thethree months ended March 31, 2026 was approximately$2.5 million, compared to net cash provided by investing activities of approximately$1.5 million for the same period in 2025. Cash provided by investing activities for the three months ended March 31, 2026 was primarily due to the maturity of available-for-sale securities of approximately $27.3 million, partially offset by the purchase of available-for-sale securities of approximately $24.9 million.

Previous wording

Cash used in investing activities for the nine months ended September 30, 2024 was approximately $18.1 million, compared to net cash used in investing activities of approximately $11.0 million for the same period in 2023. Cash used in investing activities was primarily due to the purchase of available-for-sale securities of approximately $61.0 million, offset by the maturity of available-for-sale securities of approximately $42.9 million.

Current wording

Cash provided by investing activities for the three months ended March 31, 2025 was approximately $1.5 million. Cash provided by investing activities was primarily due to maturity of available-for-sale securities of approximately $14.1 million, partially offset by the purchase of available-for-sale securities of approximately $12.5 million.

Previous wording

Cash used in financing activities for the nine months ended September 30, 2025 was approximately $33.9 million, including $33.3 million related to the payment of principal and $0.7 million related exit fees, on our debt with Athyrium, partially offset by $0.1 million inproceeds from shares issued under employee stock plans.

Current wording

Cash used in financing activities for the three months ended March 31, 2026 and 2025 was approximately $11.3 million, including $11.1 million related to the payment of principal and $0.2 million related to exit fees, on our debt with Athyrium.

Previous wording

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 the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”).

Current wording

Interest on the Athyrium Notes was 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 the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”).

Previous wording

Following the effectiveness of the Third Amendment, the Athyrium Notes bear interest at an annual rate equal to the sum of (a) eight percent (8.00%) plus (b) the lesser of (i) the sum of (x) three-month term SOFR for an interest period of three months plus (y) 0.26161% (26.161 basis points) and (ii) three and one-half of one percent (3.50%) per annum. Interest is payable quarterly on the last business day of March, June, September and December each year. In the second quarter of 2024, we began paying the principal payments required to be made quarterly at 11.11% of the original face amount. The remaining balance will be paid at maturity. Each principal payment also includes a 2.0% exit payment. Each quarterly principal payment approximates $11.1 million, and each quarterly exit fee payment approximates $0.2 million. As of September 30, 2025, the effective interest rate for the loan was 12.99%.

Current wording

Following the effectiveness of the Third Amendment, the Athyrium Notes bore interest at an annual rate equal to the sum of (a) eight percent (8.00%) plus (b) the lesser of (i) the sum of (x) three-month term SOFR for an interest period of three months plus (y) 0.26161% (26.161 basis points) and (ii) three and one-half of one percent (3.50%) per annum. Interest is payable quarterly on the last business day of March, June, September and December each year. As of March 31, 2026, the effective interest rate for the loan was 12.99%.

Previous wording

As of September 30, 2025, the principal balance outstanding under the Athyrium Notes was$33.3 million and represents all of our debt. We are in compliance with all applicable covenants under the Athyrium Notes.

Current wording

As of March 31, 2026, the principal balance outstanding under the Athyrium Notes was $11.1 million and represented all of our debt. We were in compliance with all applicable covenants under the Athyrium Notes as of March 31, 2026.

Previous wording

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$53.5 million and approximately$40.9 million in marketable securities available at September 30, 2025. While our 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 September 30, 2025, 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.

Current wording

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$36.2 million and approximately$65.4 million in marketable securities available at March 31, 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 March 31, 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.

Previous wording

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 thethree and nine months ended September 30, 2025, stock-based compensation represented approximately 5.1% and 5.5% of our operating expenses, respectively, compared to 7.0% and 6.3% for the same respective periods in 2024, 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.

Current wording

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 (loss) income and net (loss) income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For thethree months ended March 31, 2026, stock-based compensation represented approximately 5.0% of our operating expenses, compared to 6.4% for the same respective 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.

Previous wording

Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income and

Current wording

Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted Net (Loss) Income and

Previous wording

GAAP Net Income Per Share to Non-GAAP Adjusted Net Income Per Share

Current wording

GAAP Net (Loss) Income Per Share to Non-GAAP Adjusted Net (Loss) Income Per Share

Previous wording

(3) Non-GAAP adjusted basic net income per share was calculated based on 50,339,456 and 49,881,181 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2025, respectively.

Current wording

(3) Non-GAAP adjusted basic net (loss) income per share was calculated based on 50,845,130 and 49,595,697 weighted-average shares of common stock outstanding for the three months ended March 31, 2026 and 2025, respectively.

Previous wording

(5) Non-GAAP adjusted diluted net income per share was calculated based on 50,929,893 and 50,334,553 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2025, respectively.

Current wording

(5) Non-GAAP adjusted diluted net income per share was calculated based on 49,906,341 weighted-average shares of common stock outstanding for the three months ended March 31, 2025.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

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.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

For the nine months ended September 30, 2025, we recognized approximately $5.5 million in interest expense, compared to approximately $9.8 million of interest expense for the nine months ended September 30, 2024. The decrease in interest expense was primarily related to a lower debt balance as we began paying down our debt principal during the nine months ended September 30, 2024.