What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-10-30 compared with 2025-08-04 · 94 added, 91 removed, 482 unchanged (28% of the section changed)

3 unchanged sentences

(in thousands, except share and per share amounts)

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Current assets

28 unchanged sentences

500,000,000 shares authorized;

240,765,516 and 238,015,825 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

242,971,838 and 238,015,825 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital 1,100,664 1,058,548

Accumulated deficit ( 946,532 ) ( 885,340 )

Accumulated other comprehensive (loss) income ( 38 ) 57

Accumulated other comprehensive income 124 57

Total stockholders’ equity 154,280 173,289

4 unchanged sentences

(in thousands, except share and per share amounts)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

12 unchanged sentences

Total operating expenses 101,679 80,280 299,493 221,269

Loss from operations ( 14,395 ) ( 13,630 ) ( 50,744 ) ( 38,308 )

Income (loss) from operations 4,668 2,233 ( 46,076 ) ( 36,075 )

Interest expense ( 5,796 ) ( 3,357 ) ( 14,343 ) ( 9,039 )

8 unchanged sentences

Net loss $ ( 969 ) $ ( 809 ) $ ( 61,192 ) $ ( 43,781 )

Unrealized losses on available-for-sale securities ( 56 ) ( 81 ) ( 95 ) ( 325 )

Unrealized gains (losses) on available-for-sale securities 162 286 67 ( 39 )

Comprehensive loss $ ( 807 ) $ ( 523 ) $ ( 61,125 ) $ ( 43,820 )

3 unchanged sentences

(in thousands, except shares)

Three Months Ended June 30, 2025

Three Months Ended September 30, 2025

Common Stock Additional Paid-In Capital

Accumulated Deficit

Accumulated Other Comprehensive Income/(Loss)

Accumulated Other Comprehensive (Loss) Income

Total Stockholders’ Equity

Shares Amount

Balance as of March 31, 2025 239,201,256 $ 24 $ 1,072,118 $ ( 926,484 ) $ 18 $ 145,676

Issuance of common stock for services 87,256 — 315 — — 315

Balance as of June 30, 2025 240,765,516 $ 24 $ 1,085,108 $ ( 945,563 ) $ ( 38 ) $ 139,531

Issuance of common stock under employee stock purchase plan 162,859 — 703 — — 703

Issuance of common stock upon exercise of options 860,811 — 2,111 — — 2,111

1 unchanged sentence

Stock-based compensation — — 12,742 — — 12,742

Unrealized losses on available-for-sale securities — — — — ( 56 ) ( 56 )

Unrealized gains on available-for-sale securities — — — — 162 162

Net loss — — — ( 969 ) — ( 969 )

Balance as of June 30, 2025 240,765,516 $ 24 $ 1,085,108 $ ( 945,563 ) $ ( 38 ) $ 139,531

Six Months Ended June 30, 2025

Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income/(Loss)

Balance as of September 30, 2025 242,971,838 $ 24 $ 1,100,664 $ ( 946,532 ) $ 124 $ 154,280

Nine Months Ended September 30, 2025

Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income

Total Stockholders’ Equity

6 unchanged sentences

Stock-based compensation — — 36,517 — — 36,517

Unrealized losses on available-for-sale securities — — — — ( 95 ) ( 95 )

Unrealized gains on available-for-sale securities — — — — 67 67

Net loss — — — ( 61,192 ) — ( 61,192 )

Balance as of June 30, 2025 240,765,516 $ 24 $ 1,085,108 $ ( 945,563 ) $ ( 38 ) $ 139,531

Three Months Ended June 30, 2024

Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Loss

Balance as of September 30, 2025 242,971,838 $ 24 $ 1,100,664 $ ( 946,532 ) $ 124 $ 154,280

Three Months Ended September 30, 2024

Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive (Loss) Income

Total Stockholders’ Equity

Shares Amount

Balance as of March 31, 2024 233,959,744 $ 23 $ 1,023,610 $ ( 872,722 ) $ ( 20 ) $ 150,891

Issuance of common stock for services 40,549 — 257 — — 257

Balance as of June 30, 2024 235,401,398 $ 23 $ 1,036,244 $ ( 889,176 ) $ ( 101 ) $ 146,990

Issuance of common stock under employee stock purchase plan 226,297 — 1,189 — — 1,189

Issuance of common stock upon exercise of options 663,358 1 1,507 — — 1,508

1 unchanged sentence

Stock-based compensation — — 9,133 — — 9,133

Unrealized losses on available-for-sale securities — — — — ( 81 ) ( 81 )

Unrealized gains on available-for-sale securities — — — — 286 286

Net loss — — — ( 809 ) — ( 809 )

Balance as of June 30, 2024 235,401,398 $ 23 $ 1,036,244 $ ( 889,176 ) $ ( 101 ) $ 146,990

Six Months Ended June 30, 2024

Balance as of September 30, 2024 236,890,431 $ 24 $ 1,048,073 $ ( 889,985 ) $ 185 $ 158,297

Nine Months Ended September 30, 2024

Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income (Loss)

9 unchanged sentences

Net loss — — — ( 43,781 ) — ( 43,781 )

Balance as of June 30, 2024 235,401,398 $ 23 $ 1,036,244 $ ( 889,176 ) $ ( 101 ) $ 146,990

Balance as of September 30, 2024 236,890,431 $ 24 $ 1,048,073 $ ( 889,985 ) $ 185 $ 158,297

The accompanying notes are an integral part of these condensed financial statements.

2 unchanged sentences

(in thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Operating activities

22 unchanged sentences

Purchases of property and equipment ( 1,131 ) ( 418 )

Net cash provided by investing activities 37,774 20,961

Net cash (used in) provided by investing activities

( 12,735 ) 23,302

Financing activities

2 unchanged sentences

Net cash provided by financing activities 53,952 57,276

Net increase in cash and cash equivalents 25,113 20,420

Net (decrease) increase in cash and cash equivalents

( 22,217 ) 25,959

Cash and cash equivalents at beginning of period 64,932 21,470

27 unchanged sentences

The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto included in our 2024 Form 10-K.

The results for the three and six months ended June 30, 2025 are not necessarily indicative of results to be expected for the entire year ending December 31, 2025, or for any other interim period or future year.

The results for the three and nine months ended September 30, 2025 are not necessarily indicative of results to be expected for the entire year ending December 31, 2025, or for any other interim period or future year.

Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for definitions of terms used throughout the document.

8 unchanged sentences

2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures .

The amendments in this ASU provide more transparency about income tax information through improvements to income tax disclosures, primarily related to the rate reconciliation and income taxes paid information.

For public business entities, the amendments in this ASU are effective for annual periods beginning after December 15, 2024.

Early adoption is permitted on a prospective basis for annual financial statements that have not yet been issued or made available for issuance.

The Company anticipates that the adoption of ASU 2023-09 will result in modifications to its income tax disclosures.

The ASU provides additional transparency within the income tax disclosures, primarily related to the rate reconciliation and income taxes paid information.

The Company anticipates that the adoption of ASU 2023-09 will result in modifications to its income tax disclosures, including an enhanced effective tax rate reconciliation using both percentages and currency amounts, broken out into defined categories, with certain reconciling items further disaggregated by nature and jurisdiction to the extent those items exceed a specified threshold.

In addition, the Company will disclose income taxes paid, net of refunds received disaggregated by jurisdiction if the amount is at least five percent of total income taxes paid, net of refunds received.

The new disclosure requirements will be included in the Company’s Form 10-K for the fiscal year ending December 31, 2025 and will be applied retrospectively.

In November 2024, the FASB issued ASU No.

2024-03, Income Statement (Topic 220) - Reporting Comprehensive Income - Expense Disaggregation Disclosures, Disaggregation of Income Statement Expenses , which requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements.

2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.

Early adoption is permitted and is effective on either a prospective basis or retrospective basis.

The new disclosure requirements are effective for the Company’s annual periods beginning January 1, 2027, and interim periods beginning January 1, 2028, with early adoption permitted, and may be applied either prospectively or retrospectively.

The Company is in the process of evaluating the impact of this new guidance on its disclosures.

1 unchanged sentence

The following table summarizes our cash, cash equivalents and short-term investments:

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Gross Unrealized Gross Unrealized

14 unchanged sentences

Realized gains or losses have not been significant and are included in other income, net, in the condensed statements of operations and comprehensive loss.

Unrealized losses as of June 30, 2025 and December 31, 2024 were not material.

All of the short-term available-for-sale securities held as of June 30, 2025 and December 31, 2024 had contractual maturities of less than one year.

We determined that none of our available-for-sale securities were other-than-temporarily impaired as of June 30, 2025 and December 31, 2024, and no investment was in a continuous unrealized loss position for more than one year.

Unrealized losses as of September 30, 2025 and December 31, 2024 were not material.

All of the short-term available-for-sale securities held as of September 30, 2025 and December 31, 2024 had contractual maturities of less than one year.

We determined that none of our available-for-sale securities were other-than-temporarily impaired as of September 30, 2025 and December 31, 2024, and no investment was in a continuous unrealized loss position for more than one year.

Therefore, we believe that it is more likely than not that the investments will be held until maturity or a forecasted recovery of fair value.

Based on our procedures under the expected credit loss model, including an assessment of unrealized losses in our portfolio, we concluded that any unrealized losses on our marketable securities were not attributable to credit and, therefore, we have not recorded an allowance for credit losses for these securities as of June 30, 2025 and December 31, 2024.

See “Cash and Cash Equivalents” and “Short-Term Investments” captions of Note 2.

9 unchanged sentences

The following table sets forth the fair value of our financial assets that are measured or disclosed on a recurring basis by level within the fair value hierarchy:

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

(in thousands) Total

10 unchanged sentences

Fair Value of Debt

The principal outstanding under our term loans is subject to a variable interest rate and therefore, we believe the carrying amount of the term loan approximates fair value as of June 30, 2025 and December 31, 2024.

The principal outstanding under our 2022 Loan Agreement is subject to a variable interest rate and therefore, we believe the carrying amount of the term loan approximates fair value as of September 30, 2025 and December 31, 2024.

Borrowing for a description of the Level 2 inputs used to estimate the fair value of the liability.

The carrying value of the deferred royalty obligation related to the sale of future royalties approximates its fair value as of June 30, 2025 and December 31, 2024 and is based on our current estimates of future royalties and commercialization milestones expected to be paid to us by Kyowa Kirin over the life of the agreement.

The carrying value of the deferred royalty obligation related to the sale of future royalties approximates its fair value as of September 30, 2025 and December 31, 2024 and is based on our current estimates of future royalties and commercialization milestones expected to be paid to us by Kyowa Kirin over the life of the agreement.

Deferred Royalty Obligation Related to the Sale of Future Royalties for a description of the Level 3 inputs used to estimate the fair value of the liability.

Inventory consisted of the following:

(in thousands) June 30, 2025 December 31, 2024

(in thousands) September 30, 2025 December 31, 2024

Raw materials $ 27,622 $ 30,792

5 unchanged sentences

Total $ 129,358 $ 91,184

Prepaid commercial manufacturing with third-party CMOs not included in inventory was $ 12.7 million and $ 16.4 million as of June 30, 2025 and December 31, 2024, respectively.

There were no prepayments expected to be converted into inventory after 12 months as of June 30, 2025 and December 31, 2024.

Prepaid commercial manufacturing with third-party CMOs not included in inventory was $ 8.1 million and $ 16.4 million as of September 30, 2025 and December 31, 2024, respectively.

There were no prepayments expected to be converted into inventory after 12 months as of September 30, 2025 and December 31, 2024.

Disaggregation of total revenues by nature is as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands)

8 unchanged sentences

Total product sales, net was as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands)

8 unchanged sentences

Gross product sales from Customers accounting for more than 10% of total revenues were as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

2 unchanged sentences

Cardinal Health 25.5 % 12.4 % 23.9 % 14.6 %

McKesson Corporation 20.7 % 13.0 % 19.7 % 13.9 %

Cencora (formerly AmerisourceBergen Drug Corporation)

17.3 % 13.8 % 18.6 % 15.9 %

McKesson Corporation 20.7 % 14.0 % 19.1 % 14.7 %

(1) The total of the above percentages exceeds 100% as the numerators used in the calculations represent gross product sales for each Customer, as opposed to product sales, net as presented in our condensed statements of operations and comprehensive loss.

9 unchanged sentences

Credits/payments ( 15,615 ) ( 59,740 ) ( 25,390 ) ( 100,745 )

Balance as of June 30, 2025 $ 1,519 $ 21,001 $ 9,543 $ 32,063

Balance as of September 30, 2025 $ 1,854 $ 29,630 $ 11,709 $ 43,193

(1) Provisions included approximately $ 3.8 million of favorable adjustment in the 2025 first quarter, resulting from changes in prior periods’ estimated product returns for XPHOZAH.

COLLABORATION AND LICENSING AGREEMENTS

We out-license to external partners for the development of tenapanor and commercialization of tenapanor outside of the U.S.

We out-license to external partners for the development and commercialization of tenapanor outside of the U.S.

We recognize revenue from our agreements with Kyowa Kirin, Fosun Pharma and Knight as licensing revenue, product supply revenue or non-cash royalty revenue related to the sale of future royalties.

2 unchanged sentences

The following table summarizes total revenues by collaboration partner:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands) 2025 2024 2025 2024

9 unchanged sentences

$ 4,789 $ 809 $ 7,195 $ 1,776

The following table presents changes in our current and non-current deferred revenue balances, which are all attributable to Kyowa Kirin:

The following table presents changes in our current and non-current deferred revenue balances, which are primarily attributable to Kyowa Kirin:

(in thousands) Current Non-Current Current Non-Current

4 unchanged sentences

Reclassify amounts to be recognized in the next twelve months — — 4,086 ( 4,086 )

Deferred revenue balance as of June 30, $ 6,280 $ 12,295 $ 10,829 $ 9,613

Significant developments and updates related to our collaboration and licensing agreements in the six months ended June 30, 2025 and 2024 are discussed below.

Deferred revenue balance as of September 30, $ 6,581 $ 13,699 $ 7,272 $ 12,770

Significant developments and updates related to our collaboration and licensing agreements in the nine months ended September 30, 2025 and 2024 are discussed below.

In February 2024, Kyowa Kirin announced the launch of tenapanor, marketed as PHOZEVEL ® , for patients with CKD with hyperphosphatemia in Japan.

In the three months ended March 31, 2024, we began to recognize non-cash royalty revenue related to the sale of future royalties, which was remitted to HCR in accordance with the HCR Agreement.

Following the launch, we began to recognize earned royalties and commercialization milestones from sales of tenapanor in Japan, which are remitted to HCR in accordance with the HCR Agreement.

The first commercialization milestone was achieved in the 2025 third quarter, triggering a ¥ 500.0 million payment to us under the terms of the Kyowa Kirin Agreement, or approximately $ 3.4 million at the currency exchange rate as of September 30, 2025.

This milestone was recorded as non-cash royalty revenue related to the sale of future royalties and will be remitted to HCR upon receipt.

In February 2025, we announced the approval of an NDA for tenapanor for the control of hyperphosphatemia in adult patients with CKD undergoing hemodialysis by China’s Center for Drug Evaluation of the NMPA.

This approval triggered a $ 5.0 million milestone to us under the terms of the Fosun Agreement, which was recorded as licensing revenue on our condensed statement of operations and comprehensive loss when earned during the 2025 first quarter and was received in April 2025.

In connection with the AstraZeneca Termination Agreement, we recognized royalty expense as other cost of revenue in our condensed statements of operations and comprehensive loss of $ 3.8 million and $ 12.7 million in the three and six months ended June 30, 2025, and $ 7.9 million and $ 12.6 million in the three and six months ended June 30, 2024, respectively.

As of June 30, 2025, we have fully recognized the $ 75.0 million royalty obligation.

In connection with the AstraZeneca Termination Agreement, we recognized royalty expense as other cost of revenue in our condensed statements of operations and comprehensive loss of zero and $ 12.7 million in the three and nine months ended September 30, 2025, and $ 10.0 million and $ 22.7 million in the three and nine months ended September 30, 2024, respectively.

As of the 2025 second quarter, we had fully recognized the $ 75.0 million royalty obligation, which had been fully remitted as of September 30, 2025.

DEFERRED ROYALTY OBLIGATION RELATED TO THE SALE OF FUTURE ROYALTIES

We and HCR have an agreement in which HCR agreed to pay up to $ 20.0 million in exchange for royalty payments and commercial milestone payments that we may receive under our Kyowa Kirin Agreement.

We and HCR have an agreement in which HCR agreed to pay up to $ 20.0 million in exchange for royalty and commercialization milestone payments that we may receive under our Kyowa Kirin Agreement.

Deferred Royalty Obligation Related to the Sale of Future Royalties of our 2024 Form 10-K for further discussion on the nature, purpose, significant rights and obligations of the parties, as well as our accounting policies regarding the HCR Agreement.

A summary of financial information related to the HCR Agreement is as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

($ in thousands)

8 unchanged sentences

( 3,379 ) ( 1,009 )

Deferred royalty obligation balance as of June 30, $ 27,761 $ 23,104

Deferred royalty obligation balance as of September 30, $ 28,626 $ 24,372

The following table presents our long-term borrowing under the 2022 Loan Agreement:

(in thousands) June 30, 2025 December 31, 2024 Interest rate

(in thousands) September 30, 2025 December 31, 2024 Interest rate

Term A Loan $ 27,500 $ 27,500 7.95 % + 0.022 % + SOFR (subject to a floor of 1.0 %)

24 unchanged sentences

In addition, the 2022 Loan Agreement contains subjective acceleration clauses to accelerate the maturity of outstanding principal amount in the event that a material adverse change has occurred within the business, operations or financial condition of the Company.

As of June 30, 2025, the Company believes that the likelihood of the acceleration of the maturity due to subjective acceleration clauses is remote.

The total unaccreted final fee was $ 7.1 million and $ 5.4 million as of June 30, 2025 and December 31, 2024, respectively.

As of June 30, 2025, our total future payment obligation related to the outstanding balance of the term loans, excluding interest payments, was $ 209.9 million, which is due on July 1, 2028.

As of September 30, 2025, the Company believes that the likelihood of the acceleration of the maturity due to subjective acceleration clauses is remote.

The total unaccreted final fee was $ 6.5 million and $ 5.4 million as of September 30, 2025 and December 31, 2024, respectively.

As of September 30, 2025, our total future payment obligation related to the outstanding balance of the term loans, excluding interest payments, was $ 209.9 million, which is due on July 1, 2028.

The following table provides additional details of our facility leases presented in our condensed balance sheets:

($ in thousands)

Facilities June 30, 2025 December 31, 2024

Facilities September 30, 2025 December 31, 2024

Right-of-use assets $ 5,152 $ 2,380

5 unchanged sentences

The lease costs, which are included in operating expenses in our condensed statements of operations and comprehensive loss, were as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands)

2 unchanged sentences

Cash paid for operating leases $ 279 $ 1,229 $ 1,666 $ 3,594

The following table summarizes our undiscounted cash payment obligations for our operating lease liabilities as of June 30, 2025:

The following table summarizes our undiscounted cash payment obligations for our operating lease liabilities as of September 30, 2025:

(in thousands)

10 unchanged sentences

Pursuant to the 2023 Open Market Sales Agreement, Jefferies, as sales agent, may receive a commission of up to 3.0 % of the gross sales price for shares of common stock sold under the 2023 Open Market Sales Agreement.

In the six months ended June 30, 2025, we completed no sales pursuant to the 2023 Open Market Sales Agreement.

As of June 30, 2025, we have completed sales pursuant to the 2023 Open Market Sales Agreement, resulting in the issuance of 16.8 million shares of our common stock and receipt of gross proceeds of $ 70.0 million at a weighted average sales price of approximately $ 4.17 .

In the nine months ended September 30, 2025, we completed no sales pursuant to the 2023 Open Market Sales Agreement.

As of September 30, 2025, we have completed sales pursuant to the 2023 Open Market Sales Agreement, resulting in the issuance of 16.8 million shares of our common stock and receipt of gross proceeds of $ 70.0 million at a weighted average sales price of approximately $ 4.17 .

EQUITY INCENTIVE PLANS

1 unchanged sentence

Stock-based compensation expense recognized for stock options, RSUs and our ESPP is recorded as operating expenses in our condensed statements of operations and comprehensive loss, as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands)

3 unchanged sentences

Total $ 12,742 $ 9,133 $ 36,517 $ 27,518

A summary of our total unrecognized stock-based compensation expense, net of estimated forfeitures, as of June 30, 2025 is as follows:

A summary of our total unrecognized stock-based compensation expense, net of estimated forfeitures, as of September 30, 2025 is as follows:

Unrecognized Compensation Expense

5 unchanged sentences

Stock Options

A summary of our stock option activity and related information for the six months ended June 30, 2025 is as follows:

A summary of our stock option activity and related information for the nine months ended September 30, 2025 is as follows:

Number of Shares

4 unchanged sentences

Options forfeited or canceled ( 3,857 ) $ 6.78

Balance as of June 30, 2025 29,790 $ 5.51

Exercisable as of June 30, 2025 16,282 $ 5.41

Balance as of September 30, 2025 30,143 $ 5.52

Exercisable as of September 30, 2025 17,039 $ 5.42

Restricted Stock Units

A summary of our RSUs activity and related information for the six months ended June 30, 2025 is as follows:

A summary of our RSUs activity and related information for the nine months ended September 30, 2025 is as follows:

Number of RSUs

4 unchanged sentences

Forfeited ( 1,611 ) $ 6.00

Non-vested restricted stock units as of June 30, 2025 12,976 $ 5.80

Non-vested restricted stock units as of September 30, 2025 13,824 $ 5.72

Employee Stock Purchase Plan

During the six months ended June 30, 2025, we issued approximately 0.2 million shares of our common stock under the ESPP.

During the nine months ended September 30, 2025, we issued approximately 0.4 million shares of our common stock under the ESPP.

The shares were purchased by employees at an average purchase price of $ 4.46 per share, resulting in proceeds to us of approximately $ 1.7 million.

Issuance of Common Stock for Services

During the six months ended June 30, 2025, we issued 0.1 million shares of our common stock to members of the board of directors who elected to receive stock in lieu of their cash fees under our Non-Employee Director Compensation Program.

During the nine months ended September 30, 2025, we issued 0.1 million shares of our common stock to members of the board of directors who elected to receive stock in lieu of their cash fees under our Non-Employee Director Compensation Program.

SEGMENT REPORTING

4 unchanged sentences

Detailed information regarding our single operating segment’s significant revenues, expenses and operating loss is as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands) 2025 2024 2025 2024

8 unchanged sentences

15,057 11,610 38,260 29,091

Selling expenses (2)

55,361 41,402 170,113 118,094

General and administrative expenses (2)

General and administrative (2)

14,897 13,673 42,505 33,202

3 unchanged sentences

Total operating expenses 101,679 80,280 299,493 221,269

Consolidated loss from operations ( 14,395 ) ( 13,630 ) ( 50,744 ) ( 38,308 )

Consolidated income (loss) from operations 4,668 2,233 ( 46,076 ) ( 36,075 )

Other reconciliation items (4)

2 unchanged sentences

(1) Other revenues includes revenues from our collaboration partnerships, including licensing revenue, product supply revenue and non-cash royalty revenue related to the sale of future royalties.

(2) Research and development, selling and general administrative expenses herein do not include certain allocated items, such as stock-based compensation expenses.

(3) “Other segment expenses” primarily consists of allocated facilities, information technology and employee costs of approximately $ 3.2 million and $ 7.9 million for the three and six months ended June 30, 2025, and $ 4.6 million and $ 8.3 million for the three and six months ended June 30, 2024, respectively.

(2) Research and development, selling and general and administrative expenses herein do not include certain allocated items, such as stock-based compensation expenses.

(3) Other segment expenses primarily consists of allocated facilities, information technology and employee costs of approximately $ 3.2 million and $ 11.1 million for the three and nine months ended September 30, 2025, and $ 3.9 million and $ 12.2 million for the three and nine months ended September 30, 2024, respectively.

(4) Other reconciliation items includes interest expense, non-cash interest expense related to the sale of future royalties, provision for income taxes and other income, net.

2 unchanged sentences

Diluted net loss per common share is computed giving effect to all potential dilutive common shares, including common stock issuable upon exercise of stock options, unvested restricted stock units and ESPP shares issuable pursuant to the current purchase period.

As we had net losses for the six months ended June 30, 2025 and 2024, all potential common shares were determined to be anti-dilutive during those periods.

As we had net losses for the nine months ended September 30, 2025 and 2024, all potential common shares were determined to be anti-dilutive during those periods.

The following table sets forth the computation of net loss per common share:

(in thousands, except per share amounts)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

4 unchanged sentences

The total numbers of securities that could potentially dilute net income per share in the future that were not considered in the diluted net loss per share calculations because the effect would have been anti-dilutive were as follows:

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

(in thousands) 2025 2024 2025 2024

31 unchanged sentences

Both Appellees and Appellants filed a final brief on April 10, 2025.

Oral argument in the case has been scheduled for September 25, 2025.

Oral argument in the case was heard on September 25, 2025.

On August 16, 2024, a complaint was filed against us in the U.S.

9 unchanged sentences

Plaintiffs filed a response on May 13, 2025.

Defendants filed a reply to plaintiffs’ response on June 23, 2025.

Defendants filed a reply in support of their motion to dismiss on June 23, 2025.

There is no hearing currently scheduled on the motion to dismiss, and the Court has not yet issued a decision on the motion.

We believe the plaintiffs’ claims are without merit.

7 unchanged sentences

From time to time, we may be involved in legal proceedings arising in the ordinary course of business.

As of June 30, 2025, there is no litigation pending that would reasonably be expected to have a material adverse effect on our results of operations and financial condition.

As of September 30, 2025, there is no litigation pending that would reasonably be expected to have a material adverse effect on our results of operations and financial condition.

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