What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-08-07 compared with 2025-05-08 · 356 added, 160 removed, 1134 unchanged (31% of the section changed)

5 unchanged sentences

( unaudited )

March 31, 2025

June 30, 2025

December 31, 2024

7 unchanged sentences

Prepaid expenses, current

Restricted cash, current

Other assets, current

33 unchanged sentences

100,000,000 shares authorized;

49,615,174 shares issued and outstanding at March 31, 2025 and 49,105,834 issued and outstanding at December 31, 2024

49,892,725 shares issued and outstanding at June 30, 2025 and 49,105,834 issued and outstanding at December 31, 2024

Additional paid-in capital

13 unchanged sentences

( unaudited )

For the Three Months Ended March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Product revenue, net

$ 49,188 $ 44,395 $ 92,292 $ 84,674

Royalty revenue

3,248 2,688 6,151 6,175

Total revenue

52,436 47,083 98,443 90,849

Operating costs and expenses:

Cost of sales

12,301 10,658 22,857 21,386

Selling, general and administrative

18,047 24,972 35,651 46,722

Research and development

15,452 13,632 29,315 27,219

Total operating costs and expenses

45,800 49,262 87,823 95,327

Income (loss) from operations

6,636 ( 2,179 ) 10,620 ( 4,478 )

Other income (expenses):

Interest income

956 1,244 2,057 2,216

Interest expense

( 1,837 ) ( 3,372 ) ( 4,014 ) ( 6,731 )

410 156 769 247

Total other expenses, net

( 471 ) ( 1,972 ) ( 1,188 ) ( 4,268 )

Net income (loss) before income taxes

$ 6,165 $ ( 4,151 ) $ 9,432 $ ( 8,746 )

Income tax expense

( 310 ) ( 378 ) ( 603 ) ( 598 )

Net income (loss)

$ 5,855 $ ( 4,529 ) $ 8,829 $ ( 9,344 )

Net income (loss) per share of common stock—basic

$ 0.12 $ ( 0.09 ) $ 0.18 $ ( 0.19 )

Net income (loss) per share of common stock—diluted

$ 0.12 $ ( 0.09 ) $ 0.18 $ ( 0.19 )

Weighted-average shares of common stock outstanding—basic

49,700,217 48,292,414 49,648,246 48,240,835

Weighted-average shares of common stock outstanding—diluted

50,144,704 48,292,414 50,003,709 48,240,835

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

3 unchanged sentences

(in thousands)

For the Three Months Ended March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Net income (loss)

1 unchanged sentence

Other comprehensive income (loss):

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

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

( 3 ) ( 6 ) ( 20 ) ( 28 )

6 unchanged sentences

(in thousands, except share data)

For the Three Months Ended March 31, 2025

For the Three Months Ended June 30, 2025

Comprehensive

Balance at March 31, 2025

49,615,174 $ 5 1,409,026 ( 11 ) ( 1,311,912 ) 97,108

Stock-based compensation

— — 1,628 — — 1,628

Shares issued or restricted stock units vested under employee stock plans

277,551 — 130 — — 130

Unrealized loss on available-for-sale securities

— — — ( 3 ) — ( 3 )

— — — — 5,855 5,855

Balance at June 30, 2025

49,892,725 $ 5 $ 1,410,784 $ ( 14 ) $ ( 1,306,057 ) $ 104,718

For the Three Months Ended June 30, 2024

Comprehensive

Balance at March 31, 2024

48,214,663 $ 5 $ 1,400,982 $ ( 26 ) $ ( 1,349,979 ) 50,982

Stock-based compensation

— — 2,062 — — 2,062

Shares issued or restricted stock units vested under employee stock plans

245,457 — — — — —

Unrealized loss on available-for-sale securities

— — — ( 6 ) — ( 6 )

— — — — ( 4,529 ) ( 4,529 )

Balance at June 30, 2024

48,460,120 $ 5 $ 1,403,044 $ ( 32 ) $ ( 1,354,508 ) $ 48,509

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

PUMA BIOTECHNOLOGY, INC.

AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS ’ EQUITY

(in thousands, except share data)

For the Six Months Ended June 30, 2025

Comprehensive

Income (Loss)

Balance at December 31, 2024

49,105,834 $ 5 $ 1,407,000 $ 6 $ ( 1,314,886 ) $ 92,125

Stock-based compensation

— — 3,654 — — 3,654

Shares issued or restricted stock units vested under employee stock plans

786,891 — 130 — — 130

Unrealized loss on available-for-sale securities

Balance at March 31, 2025

For the Three Months Ended March 31, 2024

— — — ( 20 ) — ( 20 )

— — — — 8,829 8,829

Balance at June 30, 2025

49,892,725 $ 5 $ 1,410,784 $ ( 14 ) $ ( 1,306,057 ) $ 104,718

For the Six Months Ended June 30, 2024

Comprehensive

Balance at December 31, 2023

47,646,787 $ 5 $ 1,398,605 $ ( 4 ) $ ( 1,345,164 ) $ 53,442

Stock-based compensation

— — 4,439 — — 4,439

Shares issued or restricted stock units vested under employee stock plans

813,333 — — — — —

Unrealized loss on available-for-sale securities

Balance at March 31, 2024

— — — ( 28 ) — ( 28 )

— — — — ( 9,344 ) ( 9,344 )

Balance at June 30, 2024

48,460,120 $ 5 $ 1,403,044 $ ( 32 ) $ ( 1,354,508 ) $ 48,509

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

3 unchanged sentences

(in thousands)

For the Three Months Ended March 31,

For the Six Months Ended June 30,

Operating activities:

Net income (loss)

$ 8,829 $ ( 9,344 )

Adjustments to reconcile net income (loss) to net cash provided by operating activities:

1 unchanged sentence

Stock-based compensation

Provision for credit loss

Provision for credit loss recovery

( 149 ) ( 73 )

Changes in operating assets and liabilities:

1 unchanged sentence

Inventory, net

133 ( 1,969 )

Prepaid expenses and other

2 unchanged sentences

Operating lease assets and liabilities, net

( 919 ) ( 750 )

Accrued expenses and other

( 4,999 ) ( 13,716 )

Post-marketing commitment liability

( 1,074 ) ( 585 )

Net cash provided by operating activities

17,694 12,273

Investing activities:

Purchase of property and equipment

( 81 ) ( 20 )

Purchase of available-for-sale securities

( 34,420 ) ( 44,892 )

Maturity of available-for-sale securities

Net cash provided by (used in) investing activities

24,784 26,535

Net cash used in investing activities

( 9,717 ) ( 18,377 )

Financing activities:

Net proceeds from shares issued under employee stock plans

Payment of debt

( 22,220 ) ( 11,110 )

Payment of exit costs

( 444 ) ( 222 )

Net cash used in financing activities

( 22,534 ) ( 11,332 )

Net decrease in cash, cash equivalents and restricted cash

( 14,557 ) ( 17,436 )

Cash, cash equivalents and restricted cash, beginning of period

71,310 86,676

Cash, cash equivalents and restricted cash, end of period

56,753 69,240

Supplemental disclosures of non-cash investing and financing activities:

Property and equipment purchases in accounts payable

Supplemental disclosure of cash flow information:

Interest paid

$ 3,532 $ 5,814

Income taxes paid

$ 1,030 $ 922

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

21 unchanged sentences

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

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

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

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

5 unchanged sentences

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

The Company has reported net income of approximately $ 3.0 million and cash provided by operations of approximately $ 3.6 million for the three months ended March 31, 2025 .

The Company’s commercialization, research and development or marketing efforts may require funding in addition to the cash and cash equivalents and marketable securities totaling approximately $ 93.2 million at March 31, 2025 .

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

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

The Company has reported net income of approximately $ 8.8 million and cash provided by operations of approximately $ 17.7 million for the six months ended June 30, 2025 .

The Company believes that its existing cash and cash equivalents and marketable securities as of June 30, 2025 and proceeds that will become available to the Company through product sales and sub-license payments are sufficient to satisfy its operating cash needs, including amounts due under the Company’s Note Purchase Agreement with Athyrium Opportunities IV Co-Invest 1 LP (“Athyrium”) (see Note 9—Debt ), for at least one year after the filing of the Quarterly Report on Form 10 -Q in which these financial statements are included.

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

3 unchanged sentences

Additionally, the terms of the Company’s Note Purchase Agreement place restrictions on the Company’s ability to operate the business and on the Company’s financial flexibility, and the Company may be unable to achieve the revenue necessary to satisfy the minimum revenue and cash balance covenants as specified in the agreement.

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

In the opinion of management, the included disclosures are adequate, and the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary for a fair statement of our consolidated financial position as of March 31, 2025 .

Since its inception through June 30, 2025 , the Company’s financing has primarily consisted of proceeds from product, royalty and license revenue, public offerings of its common stock, private equity placements, and various debt instruments.

Such adjustments are of a normal and recurring nature.

The condensed consolidated balance sheet as of December 31, 2024 was derived from audited annual financial statements but does not contain all of the footnote disclosures from the audited annual financial statements.

The condensed consolidated results of operations for the quarter ended March 31, 2025 are not necessarily indicative of the consolidated results of operations that may be expected for the fiscal year ending December 31, 2025 .

The condensed consolidated results of operations for the quarter ended June 30, 2025 are not necessarily indicative of the consolidated results of operations that may be expected for the fiscal year ending December 31, 2025 .

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

14 unchanged sentences

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

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

For the Three Months Ended March 31,

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

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Cost of sales

1 unchanged sentence

General and administrative

6,538 13,969 12,718 23,938

Commercialization

2 unchanged sentences

Clinical research and development

7,679 5,094 14,093 10,880

Medical affairs

1,631 933 2,784 2,194

Other research and development (1)

5,506 6,978 11,010 12,592

Operating costs and expenses

1 unchanged sentence

Stock based compensation

1,628 2,062 3,654 4,439

Total operating costs and expenses

18 unchanged sentences

For the Three Months Ended

For the Six Months Ended

Options outstanding

7 unchanged sentences

A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share of common stock computations is as follows (in thousands, except share and per share amounts):

For the Three Months Ended March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

Net income (loss)

3 unchanged sentences

Net effect of dilutive common stock equivalents

444,487 — 355,463 —

Weighted average common stock outstanding for diluted net income (loss) per share

20 unchanged sentences

The Company expenses incremental costs of obtaining a contract when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less.

However, no such costs were incurred during the three months ended March 31, 2025 and 2024 , respectively.

However, no such costs were incurred during the six months ended June 30, 2025 and 2024 , respectively.

Reserves for Variable Consideration:

6 unchanged sentences

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

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

The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not likely occur in a future period for the estimates detailed below as of June 30, 2025 , and, therefore, the transaction price was not reduced further during the quarter ended June 30, 2025 .

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

42 unchanged sentences

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

As of March 31, 2025 , the total potential milestone payments that would be due to the Company upon achievement of all respective performance obligations under the sub-license agreements is approximately $ 579.8 million.

As of June 30, 2025 , the total potential milestone payments that would be due to the Company upon achievement of all respective performance obligations under the sub-license agreements is approximately $ 579.8 million.

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

30 unchanged sentences

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

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

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

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

21 unchanged sentences

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

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

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

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

12 unchanged sentences

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

As of March 31, 2025, the Company’s uncertain tax positions include a reserve for its research and development credits.

As of June 30, 2025 , the Company’s uncertain tax positions include a reserve for its research and development credits.

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

The Company is currently evaluating the provisions of the new law and the potential effects on its financial position, results of operations, and cash flows.

As of the date of these financial statements, the Company has not completed its assessment, and therefore no adjustments have been made.

Additional disclosures will be provided in future periods as the impact of the legislation is determined.

Financial Instruments:

6 unchanged sentences

The lease-related letters of credit will lapse at the end of the respective lease terms through 2 026.

At each of the periods ending March 31, 2025 and December 31, 2024 , the Company had restricted cash in the amount of approximately $ 2.1 million.

At each of the periods ending June 30, 2025 and December 31, 2024 , the Company had restricted cash in the amount of approximately $ 2.1 million.

Investment Securities:

20 unchanged sentences

Valuations derived from valuation techniques in which one or more significant inputs are unobservable.

Following are the major categories of assets measured at fair value on a recurring basis as of March 31, 2025 and December 31, 2024 , using quoted prices in active markets for identical assets (Level 1 ), significant other observable inputs (Level 2 ), and significant unobservable inputs (Level 3 ) (in thousands):

March 31, 2025

Following are the major categories of assets measured at fair value on a recurring basis as of June 30, 2025 and December 31, 2024 , using quoted prices in active markets for identical assets (Level 1 ), significant other observable inputs (Level 2 ), and significant unobservable inputs (Level 3 ) (in thousands):

June 30, 2025

Cash equivalents

2 unchanged sentences

19,474 — — 19,474

Corporate Bonds

Commercial paper

14 unchanged sentences

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

March 31, 2025

June 30, 2025

Cash equivalents

2 unchanged sentences

19,478 1 ( 5 ) 19,474

Corporate Bonds

Commercial paper

11 unchanged sentences

Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents, marketable securities, and accounts receivable, net.

The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at March 31, 2025 were approximately $ 64.4 million.

The Company does not believe it is exposed to any significant credit risk due to the quality nature of the financial instruments in which the money is held.

24 unchanged sentences

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

Of the total inventory amounts noted below, approximately $ 8.2 million is located at contract manufacturing organizations in Europe as of March 31.

Of the total inventory amounts noted below, approximately $ 7.9 million is located at contract manufacturing organizations in Europe as of June 30, 2025 .

The Company’s inventory balances are as follows:

March 31, 2025

June 30, 2025

December 31, 2024

14 unchanged sentences

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

No impairments were recorded during the three months ended March 31, 2025 and 2024.

No impairments were recorded during the three months ended June 30, 2025 and 2024 .

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

19 unchanged sentences

As the implicit rate on the Company’s leases are not readily determinable, the Company uses its IBR based on the information available at the commencement date in determining the present value of lease payments.

The Company’s average IBR for existing leases as of March 31, 2025 is 10.9 %.

The Company’s average IBR for existing leases as of June 30, 2025 is 10.9 %.

License Fees and Intangible Assets:

12 unchanged sentences

If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value.

In addition, the Company reached a commercial milestone by achieving aggregate worldwide net sales of $ 250.0 million in calendar year 2022, resulting in a payment to Pfizer of $ 12.5 million during the three months ended March 31, 2023.

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

The Company recorded amortization expense related to its intangible assets of approximately $ 2.4 million and $ 2.4 million for the three months ended March 31, 2025 and 2024 , respectively.

As of March 31, 2025 , estimated future amortization expense related to the Company’s intangible assets is approximately $ 7.3 million for the remainder of 2025 and $ 9.7 million for each year starting 2026 through 2029, and $ 2.4 million for 2030.

Recently Issued Accounting Standar ds:

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

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

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

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

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

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

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

13 unchanged sentences

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

March 31, 2025

June 30, 2025

December 31, 2024

Trade accounts receivable

$ 22,488 $ 26,362

Royalty revenue receivable

Total accounts receivable

$ 26,123 $ 32,373

Allowance for credit losses

( 213 ) ( 362 )

Total accounts receivable, net

$ 25,910 $ 32,011

Trade accounts receivable consist entirely of amounts owed from the Company’s customers related to product sales.

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

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

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

The Company recorded a credit loss expense of $ 0.2 million and $ 0.1 million for the three months ended March 31, 2025 and 2024, respectively.

The Company recorded a recovery to the provision for credit loss of $ 0.3 million and $ 0.2 million for the three months ended June 30, 2025 and 2024 , respectively.

The Company recorded a recovery to the provision of credit loss of $ 0.1 million for each of the six months ended June 30, 2025 and 2024 , respectively.

Note 4 — Prepaid Expenses and Other:

Prepaid expenses and other consisted of the following (in thousands):

March 31, 2025

June 30, 2025

December 31, 2024

3 unchanged sentences

Other clinical development

$ 5,674 $ 6,151

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

6 unchanged sentences

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

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

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

In July 2025, we amended our existing lease agreement for our Los Angeles office to extend the lease term from April 1, 2026 to August 31 2031.

We have an option to extend the lease for an additional five -year period.

The total future lease payments under the amendment are approximately $ 6.6 million.

A letter of credit will not be required with the extended lease and the current letter of credit of $ 1.0 million will be returned to the Company.

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

2 unchanged sentences

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

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

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

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

Total rent expense for both the three months ended March 31, 2025 and 2024 was approximately $ 1.2 million.

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

Total rent expense for the three and six months ended June 30, 2025 was approximately $ 1.0 million and $ 2.2 million, respectively.

Total rent expense for the three and six months ended June 30, 2024 was approximately $ 1.2 million and $ 2.4 million, respectively.

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

2 unchanged sentences

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

Variable lease p ayments not included in the lease liability were $ 0.2 million for both of the t hree months ended March 31, 2025 and 2024.

Supplemental cash flow information related to leases for the three months ended March 31, 2025:

Supplemental cash flow information related to leases for the six months ended June 30, 2025:

Operating cash flows used for operating leases (in thousands)

2 unchanged sentences

Weighted average discount rate

Future minimum lease payments as of March 31, 2025 were as follows (in thousands):

Future minimum lease payments as of June 30, 2025 were as follows (in thousands):

Total minimum lease payments

5 unchanged sentences

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

During the three months ending March 31, 2025, the Company signed another sublease agreement for the 12,429 square feet of the office space and the lease commencement date is April 1, 2025.

During the three months ending March 31, 2025, the Company signed another sublease agreement for the 12,429 square feet of the office space with a sublease commencement date of April 1, 2025.

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

1 unchanged sentence

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

As a result of the long-term sublease, the Company recorded an impairment expense on the ROU asset of approximately $ 0.6 million.

The Company recorded operatin g sublease income of $ 0.2 million for each of the three months ended March 31, 2025 and 2024, in oth er income (expenses) in the condensed consolidated statements of operations.

The f uture minimum lease payments to be received as of March 31, 2025 , were as follows (in thousands):

The Company recorded operatin g sublease income of $ 0.2 million for each of the three months ended June 30, 2025 and 2024 , and $ 0.5 million for each of the six months ended June 30, 2025 and 2024 , respectively, in other income (expenses) in the co ndensed consolidated statements of operations.

The f uture minimum lease payments to be received as of June 30, 2025 , were as follows (in thousands):

Note 6 — Property and Equipment, Net:

Property and equipment, net consisted of the following (in thousands):

March 31, 2025

June 30, 2025

December 31, 2024

Leasehold improvements

$ 3,779 $ 3,779

Computer equipment

3 unchanged sentences

accumulated depreciation

( 8,076 ) ( 7,868 )

Property and equipment, net

For each of the three months ended March 31, 2025 and 2024 , the Company incurred depreciation expense of $ 0.1 million and $ 0.1 million, respectively.

For the three and six months ended June 30, 2025 and 2024 , the Company incurred depreciation expense of $ 0.1 million and $ 0.2 million, respectively.

Note 7 — Intangible Assets, Net:

Intangible assets, net consisted of the following (in thousands):

March 31, 2025

June 30, 2025

December 31, 2024

Acquired and in-licensed rights

$ 102,500 $ 102,500

accumulated amortization

( 56,238 ) ( 51,369 )

Total intangible assets, net

For each of the three months ended March 31, 2025 and 2024 , the Company incurred amortization expe nse of $ 2.4 million and $ 2.4 million, respectively.

The estimated remaining useful life of the intangible assets as of March 31, 2025 is 5.0 years.

$ 46,262 $ 51,131

For each of the three and six months ended June 30, 2025 and 2024 , the Company incurred amortization expe nse of $ 2.4 million and $ 4.9 million, respectively.

The estimated remaining useful life of the intangible assets as of June 30, 2025 is 4.8 years.

Company reached a commercial milestone by achieving aggregate worldwide net sales of $ 250.0 million in calendar year 2022, resulting in a payment to Pfizer of $ 12.5 million during the three months ended March 31, 2023.

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

The Company recorded amortization expense related to its intangible assets of approximately $ 2.4 million and $ 4.9 million for the three and six months ended June 30, 2025 and 2024 , respectively.

As of June 30, 2025 , estimated future amortization expense related to the Company’s intangible assets is approximately $ 4.9 million for the remainder of 2025 and $ 9.7 million for each year starting 2026 through 2029, and $ 2.4 million for 2030.

Note 8 — Accrued Expenses:

Accrued expenses consisted of the following (in thousands):

March 31, 2025

June 30, 2025

December 31, 2024

Accrued royalties

$ 8,827 $ 10,169

Accrued CRO services

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Accrued manufacturing costs

$ 31,797 $ 36,898

Accrued other liabilities

$ 31,797 $ 37,019

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

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

Accrued compensation includes commissions and vacation.

Accrued compensation includes severance, commissions and vacation.

Note 9 — Debt:

Long term debt consisted of the following (in thousands):

March 31, 2025

June 30, 2025

Maturity Date

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Each quarterly principal payment approximates $ 11.1 million, and each quarterly exit fee payment approximates $ 0.2 million.

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

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

As of June 30, 2025, the effective interest rate for the loan was 12.99 %.

As of June 30, 2025, the Company may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

The Athyrium Notes include affirmative and negative covenants applicable to the Company.

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The Company is 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 March 31, 2025 , the Company was in compliance with such covenants.

As of March 31, 2025 , the principal balance outstanding under the Athyrium Notes was $ 55.6 million and exit fees were $ 1.1 million, representing all of the Company’s debt.

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

As of June 30, 2025 , the Company was in compliance with such covenants.

As of June 30, 2025 , the principal balance outstanding under the Athyrium Notes was $ 44.5 million and exit fees were $ 0.9 million, representing all of the Company’s debt.

The future minimum principal and exit payments under the Athyrium Notes as of June 30, 2025 are as follows (in thousands):

Debt Issuance Costs and Discounts:

Debt issuance costs and discounts consist of the following (in thousands):

March 31, 2025

June 30, 2025

December 31, 2024

Debt issuance costs and discounts (Athyrium Notes)

$ 5,410 $ 5,410

accumulated amortization

( 4,937 ) ( 4,454 )

Included in long-term debt

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Amortization of debt issuance costs is expensed using the effective interest method and is included in interest expense in the condensed consolidated statement of operations.

For both the three months ended March 31, 2025 and 2024, the Company recorded approx im atel y $ 0.2 million of interest expense in each period, related to the amortization of de bt issuance costs in the c ondensed consolidated statements of operations.

For the three and six months ended June 30, 2025 , the Company recorded approxi mately $0.1 million and $ 0.3 million of interest expense, respectively.

For the three and six months ended June 30, 2024 , the Company recorded approximately $ 0.2 million and $ 0.5 million of interest expense, respectively.

Note 10 — Stockholders ’ Equity:

Common Stock:

The Company issued no shares of common stock upon exercise of stock options during each of the three months ended March 31, 2025 and 2024 .

The Company issued 509,340 and 567,876 shares of common stock upon vesting of RSUs during the three months ended March 31, 2025 and 2024 , respectively.

The Company issued 55,882 and 0 shares of common stock upon exercise of stock options during the six months ended June 30, 2025 and 2024 , respectively.

The Company issued 731,009 and 813,333 shares of common stock upon vesting of RSUs during the six months ended June 30, 2025 and 2024 , respectively.

Authorized Shares:

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On June 18, 2024, the stockholders of the Company approved an amendment to the Company ’ s 2011 Plan, increasing the number of authorized shares of the Company’s common stock, par value $ 0.0001 per share, that may become issuable under the 2011 Plan by 3,000,000 shares and extending the period during which incentive stock options may be granted.

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

As of June 30, 2025 a total of 17,529,412 shares of the Company’s common stock have been reserved for issuance under the 2011 Plan.

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

As of March 31, 2025 , 4,446,428 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2011 Plan and 4,102,690 shares of the Company’s common stock are available for future issuance under the 2011 Plan.

The fair value of options granted to employees and nonemployees was estimated using the Black-Scholes Option Pricing Method (see Note 2—Significant Accounting Policies) with the following weighted-average assumptions used during the three months ended March 31, 2025 :

As of June 30, 2025 , 5,326,457 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2011 Plan and 2,975,277 shares of the Company’s common stock are available for future issuance under the 2011 Plan.

Dividend yield

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On July 15, 2021, the Board of Directors adopted an amendment to the 2017 Plan to increase the number of shares of the Company ’ s common stock reserved for issuance thereunder by 1,000,000 share s.

As of March 31, 2025 a total of 3,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 Plan.

As of March 31, 2025 , a total of 644,517 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 Plan and 1,127,046 shares of the Company’s common stock are available for future issuance under the 2017 Plan.

As of June 30, 2025 a total of 3,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 Plan.

As of June 30, 2025 , a total of 672,266 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 Plan and 1,069,130 shares of the Company’s common stock are available for future issuance under the 2017 Plan.

Stock-based compensation expense was as follows (in thousands):

For the Three Months Ended

For the Six Months Ended

Stock-based compensation:

Selling, general, and administrative

$ 235 $ 429 $ 545 $ 861

Research and development

46 ( 1 ) 93 177

Restricted stock units:

Selling, general, and administrative

757 1,006 1,682 2,024

Research and development

590 628 1,334 1,377

Total stock-based compensation expense

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( 84,954 ) 3.57

Outstanding at March 31, 2025

( 55,882 ) 2.33

Vested and expected to vest at March 31, 2025

( 218,246 ) 116.00

Outstanding at June 30, 2025

4,185,360 $ 22.64 4.6 $ 726

At March 31, 2025 , total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $ 1.5 million , which is expected to be recognized over a weighted-average period o f 1.4 years .

At March 31, 2025 , the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $ 5.8 million , which is expected to be recognized over a weighted-average period of 1.4 years .

The weighted-average grant date fair value of options granted during the three months ended March 31, 2025 and 2024 was $ 1.95 and $ 4.57 per share, respectively.

The weighted average grant date fair value of RSUs awarded during the three months ended March 31, 2025 and 2024 was $ 3.28 and $ 6.42 per share, respecti vely.

Vested and expected to vest at June 30, 2025

4,185,360 $ 22.64 4.6 $ 726

3,584,279 $ 25.80 3.8 $ 447

At June 30, 2025 , total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $ 1.0 million , which is expected to be recognized over a weighted-average period o f 1.2 years .

At June 30, 2025 , the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $ 5.0 million , which is expected to be recognized over a weighted-average period of 1.3 years .

The weighted-average grant date fair value of options granted during the six months ended June 30, 2025 and 2024 was $ 1.95 and $ 4.57 per share, respectively.

The weighted average grant date fair value of RSUs awarded during the six months ended June 30, 2025 and 2024 was $ 3.31 and $ 5.90 per share, respecti vely.

Restricted Stock Unit Roll Forward:

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( 731,009 ) $ 4.51

Nonvested shares at March 31, 2025

Nonvested shares at June 30, 2025

1,813,363 $ 4.09

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

The Company incurred expenses for employer matching contributions of approximately $ 0.5 million and $ 0.5 million for the three months ended March 31, 2025 and 2024 , respectively.

The Company incurred expenses for employer matching contributions of approximately $ 1.0 million and $ 0.9 million for the six months ended June 30, 2025 and 2024 , respectively.

Note 12 — Commitments and Contingencies:

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

No milestones were achieved as of March 31, 2025.

No milestones were achieved as of June 30, 2025.

Legal Proceedings:

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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.

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

On April 24, 2025, the Federal Circuit stayed the briefing schedule for the appeal pending consideration of the motion seeking leave to file an amicus curiae brief, and it is expected that a schedule for any remaining briefing will be set upon resolution of that motion.

That motion was granted on May 16, 2025.

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

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

Acebright China Litigation

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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 for examining evidence and debating merits of party arguments.

Aosaikang China Litigation

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The first instance decision may be appealed.

Hexal filed an appeal on June 6, 2025, Generics [UK] Limited filed an appeal on June 20, 2025 and Wyeth filed an appeal on June 30, 2025.

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 an extendible due date for the response of May 28, 2025.

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

MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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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 2025, NERLYNX has received approval for the treatment of certain patie nts with extended adjuvant and/or metastatic HER2-positive breast cancer in over 50 countries outside the United States.

We are currently party to several sub-licenses in various regions outside the United States, including Europe (excluding Russia and Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, and various countries and territories in Central America, South America, Africa and the Middle East.

As of June 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.

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.

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

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

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.

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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 March 31, 2025, and proceeds that will become available to us through product sales, royalties and sub-license milestone payments.

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, 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.

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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 three months ended March 31, 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.

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, 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.

Summary of Income and Expenses

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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, 2025 and 2024, our R&D expenses consisted primarily of clinical research organization (“CRO fees”);

During the three and six months ended June 30, 2025 and 2024, our R&D expenses consisted primarily of clinical research organization (“CRO fees”);

fees paid to consultants;

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

We are currently evaluating the provisions of the new law and the potential effects on our financial position, results of operations, and cash flows.

As of the date of these financial statements, we have not completed our assessment, and therefore no adjustments have been made.

Additional disclosures will be provided in future periods as the impact of the legislation is determined.

Results of Operations

Three Months Ended March 31, 2025 Compared to Three Months Ended March 31, 2024

Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024

Total revenue:

Total revenue for the three months ended March 31, 2025 was approximately $46.0 million, compared to $43.8 million for the three months ended March 31, 2024.

This increase in total revenue was primarily due to an increase in product revenue, net of approximately $2.8 million, partially offset by a decrease in royalty revenue of $0.6 million.

Total revenue for the three months ended June 30, 2025 was approximately $52.4 million, compared to $47.1 million for the three months ended June 30, 2024.

This increase in total revenue was due to an increase in product revenue, net of approximately $4.8 million and an increase in royalty revenue of $0.6 million.

Product revenue, net:

Product revenue, net was approximately $43.1 million for the three months ended March 31, 2025, compared to $40.3 million for the three months ended March 31, 2024.

This increase in product revenue, net, compared to the three months ended March 31, 2024, was primarily attributable to an increase in net selling price, partially offset by a decrease of approximately 3.0% in b ottles of NERLYNX sold in the U.S.

market, and a decrease of approximately 2.6% in related deductions to gross r evenue for variable consideration.

Product revenue, net was approximately $49.2 million for the three months ended June 30, 2025, compared to $44.4 million for the three months ended June 30, 2024.

This increase in product revenue, net, compared to the three months ended June 30, 2024, was attributable to a 4% increase in b ottles of NERLYNX sold in the U.S.

market and an increase in net selling price, partially offset by a slight increa se in deductions to gross revenue for variable consideration, primarily related to government chargebacks.

Royalty revenue:

Royalty revenue was approximately $2.9 million for the three months ended March 31, 2025 , compared to approximately $3.5 million for the three months ended March 31, 2024.

The decrease was primarily due to fewer international sales made by our sub-licensees.

Royalty revenue was approximately $3.2 million for the three months ended June 30, 2025 , compared to approximately $2.7 million for the three months ended June 30, 2024.

The increase was primarily due to increased international sales made by our sub-licensees.

Cost of sales:

Cost of sales was approximately $10.6 million for the three months ended March 31, 2025 , compared to approximately $10.7 million for the three months ended March 31, 2024.

The slight decrease was primarily due to the change in our annual standard cost adjustment (higher raw material costs), partially offset by higher cost of sales to sub-licensees and royalty expense .

Cost of sales was approximately $12.3 million for the three months ended June 30, 2025 , compared to approximately $10.7 million for the three months ended June 30, 2024.

The increase was primarily due to higher royalty expense and product costs resulting from increased worldwide net sales.

Selling, general and administrative expenses:

SG&A expenses were approximately $17.6 million for the three months ended March 31, 2025, compared to approximately $21.8 million for the three months ended March 31, 2024.

SG&A expenses for the three months ended March 31, 2025 and 2024 were as follows:

SG&A expenses were approximately $18.0 million for the three months ended June 30, 2025, compared to approximately $25.0 million for the three months ended June 30, 2024.

SG&A expenses for the three months ended June 30, 2025 and 2024 were as follows:

Selling, general, and administrative expenses

2 unchanged sentences

Payroll and related costs

Provision for credit loss

Provision for credit loss recovery

Professional fees and expenses

2 unchanged sentences

Stock-based compensation

SG& A expenses decreased by approximately $4.2 million for the three months ended March 31, 2025 , compared to the same period in 2024 , primarily attributable to the following:

SG& A expenses decreased by approximately $6.9 million for the three months ended June 30, 2025 , compared to the same period in 2024 , primarily attributable to the following:

a decrease in provision for credit loss of approximately $0.2 million primarily related to the payment history of a customer receivable;

a decrease in professional fees and expenses of approximately $7.4 million primarily related to legal fees associated with the AstraZeneca litigation in the prior year;

a decrease in travel and meetings of approximately $0.2 million primarily related to the cost of sales meetings;

a decrease in stock-based compensation expense of approximately $0.4 million, primarily due to newer awards at a lower grant price;

Partially offset by:

an increase of approximately $0.2 million related to an overdue receivable.

an increase in payroll and related costs of approximately $1.5 million primarily due to the severance costs related to the departure of our Chief Commercial Officer , increased headcount in our sales team as well as an increase in our healthcare insurance premiums.

Research and development expenses:

R&D expenses were approxi mately $13.9 million for the three months ended March 31, 2025, compared to approximately $13.6 million for the three months ended March 31, 2024.

R&D expenses for the three months ended March 31, 2025 and 2024, were as follows:

R&D expenses were approxi mately $15.5 million for the three months ended June 30, 2025, compared to approximately $13.6 million for the three months ended June 30, 2024.

R&D expenses for the three months ended June 30, 2025 and 2024, were as follows:

Research and development expenses

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Stock-based compensation

R&D exp enses increased by a pproxim ately $0.3 million for the three m onths ended March 31, 2025, compared to the same period in 2024, primarily attributable to the following:

R&D exp enses increased by a pproxim ately $1.8 million for the three m onths ended June 30, 2025, compared to the same period in 2024, primarily attributable to the following:

an increase in clinical trial expense of approximately $1.3 million, primarily due to increased alisertib study activity;

an increase in consultants and contractors expense of approximately $0.4 million, primarily due to increased alisertib stud y activity.

Partially offset by:

a d ecrease in stock-based compensation of approximately $0.1 million, primarily due to newer awards at a lower grant price.

Other income (expenses):

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Interest income:

For the three months ended March 31, 2025 , we recognized approximately $1.1 million in interest income, compared to approximately $1.0 million of interest income for the three m onths ended March 31, 2024 .

The i ncrease in interest income was primarily the result of improved investment management.

For the three months ended June 30, 2025 , we recognized approximately $1.0 million in interest income, compared to approximately $1.2 million of interest income for the three m onths ended June 30, 2024 .

The decreas e in interest income was primarily the result of lower investment balances and timing of investments.

Interest expense:

For the three months ended

March 31, 2025

June 30, 2025

, we recognized approximately $1.8 million in interest expense, compared to approximately $3.4 million of interest expense for the three m onths ended

March 31, 2024

June 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 June 30, 2024.

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For the three months ended

March 31, 2025

June 30, 2025

, we recognized approximately $0.4 million in other income, compared to approximately $0.2 million of other income for the three m onths ended

March 31, 2024

June 30, 2024

The increase in other income was primarily due

to favorable exchange rates in Euro-denominated transactions.

Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024

Total revenue:

Total revenue for the six months ended June 30, 2025 was approximately $98.4 million, compared to $90.8 million for the six months ended June 30, 2024.

This increase in total revenue was due to an increase in product revenue, net of approximately $7.6 million.

Product revenue, net:

Product revenue, net was app roximately $92.3 millio n for the six months ended June 30, 2025, compared t o $84.7 million for the six months ended June 30, 2024.

This increase in product revenue, net, compared to the six months ended June 30, 2024, was attributable to an increase in net selling price, partially offset by a decrease of approximately 1.0% in deductions to gross r evenue for variable consideration, primarily related fewer Medicaid charges.

Royalty revenue:

Royalty revenue was approximately $6.2 million for each of the six months ended June 30, 2025 and June 30, 2024.

Cost of sales:

Cost of sales was approximately $22.9 million for the six months ended June 30, 2025 , compared to approximately $21.4 million for the six months ended June 30, 2024 .

The increase was primarily due to higher royalty expense and product costs resulting from increased global sales.

Selling, general and administrative expenses:

SG&A expenses were approximately $35.7 million for the six months ended June 30, 2025, compared to approximately $46.7 million for the six months ended June 30, 2024.

SG&A expenses for the six months ended June 30, 2025 and 2024 were as follows:

Selling, general, and administrative expenses

For the Six Months Ended

(in thousands)

Payroll and related costs

Provision for credit loss recovery

Professional fees and expenses

Travel and meetings

Facilities and equipment costs

Stock-based compensation

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

a decrease in professional fees and expenses of approximately $11.0 million primarily related to legal fees associated with the AstraZeneca litigation in the prior year as well as some decrease in our insurance costs;

a decrease in stock-based compensation expense of approximately $0.7 million, primarily due to newer awards at a lower grant price;

Partially offset by:

an increase in payroll and related costs of approximately $1.2 million primarily due to the severance costs related to the departure of our Chief Commercial Officer , increased headcount in our sales team as well as increases in our healthcare insurance premiums

Research and development expenses:

R&D expenses were approxi mately $29.3 million for the six months ended June 30, 2025, compared to approximately $27.2 million for the six months ended June 30, 2024.

R&D expenses for the six months ended June 30, 2025 and 2024, were as follows:

Research and development expenses

For the Six Months Ended

(in thousands)

Clinical trial expense

Consultant and contractors

Stock-based compensation

R&D exp enses increased by a pproxim ately $2.1 million compared to the six m onths ended June 30, 2025, compared to the same period in 2024, primarily attributable to the follow:

an increase in clinical trial expense of approximately $1.6 million, primarily due to increased alisertib study activity;

an increase in consultants and contractors expense of approximately $0.6 million, primarily due to increased alisertib stud y activity;

Other income (expenses):

Other income (expenses)

For the Six Months Ended

(in thousands)

Interest income

Interest expense

Interest income:

For the six months ended June 30, 2025 , we recognized approximately $2.1 million in interest income, compared to approximately $2.2 million of interest income for the six m onths ended June 30, 2024 .

The decreas e in interest income was primarily the result of lower investment balances and timing of investments.

Interest expense:

June 30, 2025

, we recognized approximately $4.0 million in interest expense, compared to approximately $6.7 million of interest expense for the

m onths ended

June 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

months ended June 30, 2024.

Other income:

June 30, 2025

, we recognized approximately $0.8 million in other income, compared to approximately $0.2 million of other income for the

m onths ended

June 30, 2024

The increase in other income was primarily due

to favorable exchange rates in Euro-denominated transactions.

Liquidity and Capital Resources

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

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

Liquidity and capital resources (in thousands)

March 31, 2025

June 30, 2025

December 31, 2024

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Stockholders’ equity

Three Months Ended

March 31, 2025

March 31, 2024

Six Months Ended

June 30, 2025

June 30, 2024

Cash provided by (used in):

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These costs were recorded in the fourth quarter of 2023.

All payments related t o this plan were paid as of March 31, 2024.

All payments related to this plan were paid as of June 30, 2024.

Operating Activities:

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.

Cash provided by operating activities for the three months ended March 31, 2024 was $11.2 million and consisted of a net loss of approximately $4.8 million, adjusted for non-cash items of approximately $5.4 million, including stock-based compensation of $2.4 million, depreciation and amortization of $2.9 million and provision for credit loss of $0.1 million.

Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accounts receivable, net of approximately $23.1 million and an increase in accounts payable of approximately $2.1 million, partially offset by a decrease in accrued expenses and other of approximately $15.0 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.

Cash provided by operating activities for the six months ended June 30, 2024 was $12.3 million and consisted of a net loss of approximately $9.3 million, adjusted for non-cash items of approximately $10.2 million, including stock-based compensation of $4.4 million, depreciation and amortization of $5.8 million and provision for credit loss recovery of $0.1 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 approximately $19.8 million, a decrease in prepaid expenses and other of $1.4 million and an increase in accounts payable of approximately $6.6 million, partially offset by a decrease in accrued expenses and other of approximately $13.7 million and an increase in inventory of approximately $2.0 million.

Investing Activities:

Cash provided by investing activities for the three months ended March 31, 2025 was approximately $1.5 million, compared to net cash used in investing activities of approximately $19.1 million for the same period in 2024 .

Cash provided by investing activities for the three months ended March 31, 2025 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.

Cash used in investing activities for the three months ended March 31, 2024 was approximately $19.1 million.

Cash used in investing activities for the three months ended March 31, 2024 was primarily due to the purchase of available-for-sale securities of approximately $25.0 million, offset by the maturity of available-for-sale securities of approximately $5.9 million.

Cash used in investing activities for the six months ended June 30, 2025 was approximately $9.7 million, compared to net cash used in investing activities of approximately $18.4 million for the same period in 2024 .

Cash used in investing activities for the six months ended June 30, 2025 was primarily due to the purchase of available-for-sale securities of approximately $34.4 million, partially offset by the maturity of available-for-sale securities of approximately $24.8 million.

Cash used in investing activities for the six months ended June 30, 2024 was approximately $18.4 million, compared to net cash used by investing activities of approximately $22.1 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 $44.9 million, offset by the maturity of available-for-sale securities of approximately $26.5 million.

Financing Activities:

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

There was no cash provided by or used in financing activities for the three months ended March 31, 2024.

Cash used in financing activities for the three 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 exit fees, on our debt with Athyrium, partially offset by $0.1 million in proceeds from shares issued under employee stock plans.

Cash used in financing activities for the three months ended June 30, 2024 was approximately $11.3 million, including $11.1 million related to the payment of principal and $0.2 million related exit fees, on our debt with Athyrium.

Athyrium Note Purchase Agreement:

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The Athyrium Notes are secured by substantially all of our assets.

We incurred $1.9 million of deferred financ ing costs with the initial borrowing of the Athyrium Notes.

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

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”).

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Each quarterly principal payment approximates $11.1 million, and each quarterly exit fee payment approximates $0.2 million.

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

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

As of June 30, 2025, the effective interest rate for the loan was 12.99%.

As of June 30, 2025, we may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

The Athyrium Notes include affirmative and negative covenants applicable to us.

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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 March 31, 2025, we were in compliance with such covenants.

As of March 31, 2025, the principal balance outstanding under the Athyrium Notes was $55.6 million and represents all of our debt.

As of June 30, 2025, we were in compliance with such covenants.

As of June 30, 2025 , the principal balance outstanding under the Athyrium Notes was $44.5 million and represents all of our debt.

We are in compliance with all applicable covenants under the Athyrium Notes.

Current and Future Financing Needs:

We did not receive or record any product revenue until the third quarter of 2017.

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.

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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 $63.0 million and approximately $30.1 million in marketable securities available at March 31, 2025.

These efforts will require funding in addition to the cash and cash equivalents totaling approximately $54.7 million and approximately $41.4 million in marketable securities available at June 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.

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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, 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.

We believe that our existing cash and cash equivalents and marketable securities as of June 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.

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.

Po tential sources of financing include strategic relationships, public or private sales of equity or debt and other sources of funds.

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.

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The following table presents our net income (loss) and net income (loss) per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation.

For the three months ended March 31, 2025, stock-based compensation represented approximately 6.4% of our operating expenses, compared to 6.7% for the same period in 2024, in each case excluding cost of sales.

For the three and six months ended June 30, 2025 , stock-based compensation represented approximately 4.9% and 5.6% of our operating expenses, respectively, compared to 5.3% and 6.0% for the same respective periods in 2024 , in each case excluding cost of s ales.

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.

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(in thousands except share and per share data)

For the Three Months Ended March 31,

For the Three Months Ended June 30,

For the Six Months Ended June 30,

GAAP net income (loss)

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(2) To reflect a non-cash charge to operating expense for research and development stock-based compensation.

(3) Non-GAAP adjusted basic net income (loss) per share was calculated based on 49,595,697 and 48,189,256 weighted-average shares of common stock outstanding for the three months ended March 31, 2025 and 2024, respectively.

(4) 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.

(5) Potentially dilutive common stock equivalents were not included in this non-GAAP adjusted diluted net loss per share for the three months ended March 31, 2024, as these shares would be considered anti-dilutive.

(3) 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.

(4) Non-GAAP adjusted basic net loss per share was calculated based on 48,292,414 and 48,240,835 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2024, respectively.

(5) 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.

(6) 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 and six months ended June 30, 2024, as these shares would be considered anti-dilutive.

Off-Balance Sheet Arrangements

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements