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PUMA BIOTECHNOLOGY, INC.

For the period ended Sep 30, 2026. Filed Nov 9, 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.

Sep 30, 2026 · Filed Nov 9, 2026

PBYI$8.40+1.8%Stored close · as of Nov 9, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-06.

0001437749-26-026311

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

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-09.

0001437749-26-035912

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 89 previous paragraphs and 88 current paragraphs.

47 unchanged; 34 reworded; 6 added; 8 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 24 previous and 27 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 (6)

Current report

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. In October of 2026, the Company obtained new third-party market data indicating that the market share of generic versions of NERLYNX in China reached the specified threshold during 2025. To reflect this, the Company recorded a $2.1 million reduction to royalty revenue as a change in accounting estimate during the three months ended September 30, 2026. A reduced royalty rate will be applied to China sales going forward.

Current report

Royalty revenue was approximately$0.9 million and $2.6 million for the three months ended September 30, 2026 and 2025, respectively. During the three months ended September 30, 2026, the Company recorded a $2.1 million reduction to royalty revenue as a change in accounting estimate, reflecting the receipt of new third-party market data indicating that the market share of generic versions of NERLYNX in China reached a specified threshold during 2025.

Current report

Nine Months Ended September 30, 2026 Compared to Nine Months Ended September 30, 2025

Current report

Royalty revenue was approximately $6.7 million and $8.7 million for the nine months ended September 30, 2026 and 2025, respectively. During the nine months ended September 30, 2026, the Company recorded a $2.1 million reduction to royalty revenue as a change in accounting estimate, reflecting the receipt of new third-party market data indicating that the market share of generic versions of NERLYNX in China reached a specified threshold during 2025.

Current report

Cost of sales was approximately $38.1 million and $35.0 million for the nine months ended September 30, 2026 and 2025, respectively. Cost of sales was higher due primarily to higher product sales to an international partner.

Current report

SG&A expenses decreased by approximately $0.2 million for thenine months ended September 30, 2026, compared to the same period in 2025, primarily attributable to the following:
Removed paragraphs (8)

Previous report

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.

Previous report

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.

Previous report

Six Months Ended June 30, 2026 Compared to Six Months Ended June 30, 2025

Previous report

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.

Previous report

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.

Previous report

SG&A expenses increased by approximately $0.3 million for thesix months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following:
Reworded paragraphs (34)

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 2024.

Current wording

In September 2022, we entered into an exclusive license agreement with 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

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.

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 nine months ended September 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.

Previous wording

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.

Current wording

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. Revenue from product sales is recognized at the amount of transaction price the Company expects to be entitled to in exchange for transferring the products, which is net of estimates for variable consideration, including trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, and other incentives.

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 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.

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 and nine months ended September 30, 2026 and 2025, our R&D expenses consisted primarily of CRO 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

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.

Current wording

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 active pharmaceutical ingredients (“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 became effective on July 31, 2026 for certain large companies and 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.

Previous wording

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.

Current wording

Total revenue for the three months ended September 30, 2026 was approximately $55.1 million, compared to $54.5 million for the three months ended September 30, 2025. This increase in total revenue was due to an increase in product revenue, net of approximately $2.2 million, partially offset by a $1.7 million decrease in royalty revenue.

Previous wording

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.

Current wording

Product revenue, net was approximately$54.1 million for the three months ended September 30, 2026, compared to$51.9 million for the three months ended September 30, 2025. The increase was primarily attributable to a higher selling price and a $3.5 million increase in product supply revenue, primarily from sales to an international partner, partially offset by a 4.4% decrease in domestic bottles sold and higher deductions from gross revenue for variable consideration, primarily related to Medicaid.

Previous wording

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.

Current wording

Cost of sales was approximately$15.2 million for the three months ended September 30, 2026, compared to approximately$12.2 million for the three months ended September 30, 2025. Cost of sales was higher due primarily to higher product sales to an international partner.

Previous wording

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:

Current wording

SG&A expenses were approximately $16.3 million for the three months ended September 30, 2026, compared to approximately $16.8 million for the three months ended September 30, 2025. SG&A expenses for the three months ended September 30, 2026 and 2025 were as follows:

Previous wording

R&D expenses were approxi mately$18.9 millionfor thethree 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:

Current wording

R&D expenses were approxi mately$18.3 millionfor thethree months ended September 30, 2026, compared to approximately $15.9 million for the three months ended September 30, 2025. R&D expenses for the three months ended September 30, 2026 and 2025 were as follows:

Previous wording

R&D expenses increased by approxim ately$3.4 millionfor the three months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following:

Current wording

R&D expenses increased by approxim ately$2.4 millionfor the three months ended September 30, 2026, compared to the same period in 2025, primarily attributable to the following:

Previous wording

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.

Current wording

For the three months ended September 30, 2026, we recognized approximately $0.9 million in interest income, compared to approximately $1.0 million of interest income for the three months ended September 30, 2025. The decrease in interest income was primarily related to lower interest rates.

Previous wording

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.

Current wording

For the three months ended September 30, 2026, we recognized no interest expense, compared to approximately $1.5 million of interest expense for the three months ended September 30, 2025. The decrease in interest expense was related to the payoff of our debt principal in the second quarter of 2026.

Previous wording

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.

Current wording

For the three months ended September 30, 2026, other income was negligible, compared to approximately $0.1 million of other income for the three months ended September 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.

Previous wording

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.

Current wording

Total revenue for the nine months ended September 30, 2026 was approximately $156.4 million, compared to $152.9 million for the nine months ended September 30, 2025. This increase in total revenue was due to an increase in product revenue, net of approximately $5.4 million, partially offset by a $2.0 million decrease in royalty revenue.

Previous wording

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.

Current wording

Product revenue, net was approximately $149.6 million for the nine months ended September 30, 2026, compared to $144.2 million for the nine months ended September 30, 2025. This increase in product revenue, net, compared to the nine months ended September 30, 2025, was primarily attributable to a $2.9 million increase in product supply revenue, primarily related to sales to an international partner, a slight 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.

Previous wording

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:

Current wording

SG&A expenses were approximately $52.3 million for the nine months ended September 30, 2026, compared to approximately $52.5 million for the nine months ended September 30, 2025. SG&A expenses for the nine months ended September 30, 2026 and 2025 were as follows:

Previous wording

R&D expenses were approxi mately $38.7 millionfor thesix 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:

Current wording

R&D expenses were approxi mately $57.0 millionfor thenine months ended September 30, 2026, compared to approximately $45.2 million for the nine months ended September 30, 2025. R&D expenses for the nine months ended September 30, 2026 and 2025 were as follows:

Previous wording

R&D expenses increased by approxim ately$9.4 millionfor thesix months ended June 30, 2026, compared to the same period in 2025, primarily attributable to the following:

Current wording

R&D expenses increased by approxim ately$11.7 millionfor thenine months ended September 30, 2026, compared to the same period in 2025, primarily attributable to the following:

Previous wording

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.

Current wording

For the nine months ended September 30, 2026, we recognized approximately $2.7 million in interest income, compared to approximately $3.1 million of interest income for the nine months ended September 30, 2025. The decrease in interest income was primarily related to lower interest rates.

Previous wording

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.

Current wording

For the nine months ended September 30, 2026, we recognized approximately $0.9 million in interest expense, compared to approximately $5.5 million of interest expense for the nine months ended September 30, 2025. The decrease in interest expense was primarily related to a lower debt balance as we paid down our debt principal in May 2026.

Previous wording

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.

Current wording

For the nine months ended September 30, 2026, we recognized approximately $0.2 million in other income, compared to approximately $0.9 million of other income for the nine months ended September 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.

Previous wording

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:

Current wording

The following table, which summarizes our liquidity and capital resources as of September 30, 2026 and December 31, 2025 and for the nine months ended September 30, 2026 and 2025, is intended to supplement the more detailed discussion that follows:

Previous wording

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.

Current wording

Cash provided by operating activities for the nine months ended September 30, 2026 was $31.6 million and consisted of net income of approximately $10.4 million, adjusted for non-cash items of approximately $13.4 million, which included stock-based compensation of $5.9 million and depreciation and amortization of $7.6 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 $20.8 million, primarily due to royalty receipts related to China sales, partially offset by an increase in inventory of $6.0 million related to the purchase of raw material inventory, a decrease in accrued expenses and other of approximately $4.6 million related primarily to the payment of royalties and a $0.9 million reversal of a previously recorded legal accrual, and a decrease of post-marketing commitment liability of $1.5 million.

Previous wording

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.

Current wording

Cash provided by operating activities for the nine 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, partially offset by an increase in accrued expenses and other of approximately $0.3 million, a decrease in prepaid and other expenses of $0.4 million and an increase in accounts payable of $0.9 million.

Previous wording

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.

Current wording

Cash provided by investing activities for the nine months ended September 30, 2026 was approximately $0.7 million, compared to net cash used in investing activities of approximately $9.2 million for the same period in 2025. Cash provided by investing activities for the nine months ended September 30, 2026 was primarily due to the maturity of available-for-sale securities of approximately $83.1 million, partially offset by the purchase of available-for-sale securities of approximately $82.3 million.

Previous wording

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.

Current wording

Cash used in financing activities for the nine months ended September 30, 2026 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. Our Athyrium Notes were paid in full as of September 30, 2026.

Previous wording

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 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 to exit fees, on our debt with Athyrium, partially offset by $0.1 million in proceeds from shares issued under employee stock plans.

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 $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.

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 $41.5 million and approximately $67.0 million in marketable securities available at September 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 September 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.

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 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.

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 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 September 30, 2026, stock-based compensation represented approximately 5.8% of our operating expenses, compared to approximately 5.1% for the same period in 2025, in each case excluding cost of sales. For thenine months ended September 30, 2026, stock-based compensation represented approximately 5.4% of our operating expenses, compared to approximately 5.5% 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.

Previous wording

(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.

Current wording

(3) Non-GAAP adjusted basic net income per share was calculated based on 51,602,295 and 51,131,897 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2026, respectively.

Previous wording

(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.

Current wording

(4) 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.

Previous wording

(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.

Current wording

(5) Non-GAAP adjusted diluted net income per share was calculated based on 53,116,836 and 52,605,014 weighted-average shares of common stock outstanding for the three and nine months ended September30, 2026, respectively.

Previous wording

(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.

Current wording

(6) 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.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Cash used in investing activities for the nine months ended September 30, 2025 was approximately $9.2 million. 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.