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Item 2. Management’s Discussion and Analysis

2026-04-30 compared with 2025-10-30 · 109 added, 115 removed, 85 unchanged (72% of the section changed)

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Our actual results could differ materially from those discussed in these forward-looking statements.

Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report entitled “Risk Factors.” These forward-looking statements speak only as of the date hereof.

Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this report titled “Risk Factors.” These forward-looking statements speak only as of the date hereof.

Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason.

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EXECUTIVE SUMMARY

We are a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs.

We developed a unique and innovative platform that enabled the discovery of new biological mechanisms and pathways to develop potent and efficacious therapies that minimize the side effects and drug-drug interactions frequently encountered with traditional, systemically absorbed medicines.

The first molecule we discovered and developed was tenapanor, a minimally absorbed, first-in-class, oral, small molecule therapy.

We are a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs.

We currently market two therapies from the active ingredient tenapanor, an NHE3 inhibitor that was discovered and developed by Ardelyx.

NHE3 is an antiporter expressed on the apical surface of the small and large intestines.

Tenapanor is a minimally absorbed, small molecule therapy.

We are committed to our mission of developing and commercializing innovative medicines that address unmet patient needs.

Our principal strategy is to continue our commercial momentum with our current products while advancing and expanding a portfolio of important medicines for patients with unmet medical needs.

Our priorities include (i) driving significant IBSRELA growth, (ii) maintaining XPHOZAH commercial momentum, (iii) further advancing our pipeline and portfolio and (iv) maintaining a solid financial foundation to support our future growth.

Tenapanor, branded as IBSRELA ® , is approved in the U.S.

for the treatment of adults with IBS-C.

We believe that IBSRELA can bring meaningful benefit to the approximately 13 million Americans who suffer from the symptoms of IBS-C,

many of whom continue to experience symptoms despite intervention with other therapies.

We are seeking to further expand the IBSRELA eligible patient population to include patients with CIC, and have initiated a Phase 3 clinical trial (ACCEL) evaluating tenapanor in adult CIC patients.

In January 2026, the Company dosed the first patient in ACCEL and has initiated all pre-identified sites.

The Company expects to complete enrollment by the end of 2026 with topline data read out in the second half of 2027.

IBSRELA is also being evaluated in multiple pediatric clinical trials which could potentially provide six months of additional patent life for tenapanor.

Tenapanor, branded as XPHOZAH ® , is approved in the U.S.

to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

We believe XPHOZAH can bring meaningful relief to adult chronic kidney disease patients on dialysis, the vast majority of whom have elevated levels of serum phosphorus and are unable to achieve target serum phosphorus levels with phosphate binders alone.

Continually elevated levels of serum phosphorus can result in severe cardiovascular health complications.

We are also developing a next-generation NHE3 inhibitor, RDX10531, which has demonstrated in preclinical models to have improved solubility and potency compared to tenapanor.

RDX10531 is currently being tested in IND-enabling studies.

If successful, RDX10531 has potential for broad applications across multiple therapeutic areas.

Effective as of April 28, 2026, we entered into the Sixth Amendment with SLR as collateral agent and the lenders party thereto, resulting in a collectively reduced interest rate under all term loans, including the term loans we have the future option to draw from, and an extended maturity date for the outstanding term loans.

For additional information, refer to Note 15.

Subsequent Events .

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.

We are committed to our mission of discovering, developing and commercializing first-in-class medicines that address unmet patient needs.

Our principal strategy is to maintain our commercial momentum with our current products while identifying additional assets that leverage our core capabilities, including clinical, developmental and regulatory expertise and commercial excellence while maintaining a solid financial foundation, to support our future growth.

Our priorities include:

(i) accelerating IBSRELA growth momentum;

(ii) executing our XPHOZAH strategy to grow utilization;

(iii) building a pipeline focused on areas of unmet patient need;

and (iv) continuing to deliver strong commercial and financial performance.

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.

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 under the AstraZeneca Termination Agreement.

On June 30, 2025, we entered into an amendment to our 2022 Loan Agreement (the Fifth Amendment), by and among the Company, as borrower, SLR, as collateral agent and the lenders party thereto.

The Fifth Amendment, among other things, (1) provided for the immediate draw of the principal amount of $50.0 million (the Term E Loan) on the closing date of the Fifth Amendment and (2) provides us with the option to draw an additional $100.0 million of committed senior secured term loans, consisting of two separate term loans, each in a principal amount of $50.0 million:

(a) the first of which is available at the Company’s election through June 30, 2026 (the Term F Loan) and (b) the second of which is available at the Company’s election through December 20, 2026 (the Term G Loan and, together with the Term F Loan, the Incremental Term Loans).

The interest rate for the Term E Loan is 4.00% plus a rate equal to 0.022% plus 1-month SOFR reference rate, subject to a SOFR floor of 4.7%.

The interest rate for each of the Incremental Term Loans, if drawn, will be 4.95% plus the 1-month CME Term SOFR reference rate as published by the CME Term SOFR Administrator on the CME Term SOFR Administrator’s Website, subject to a SOFR floor of 3.50%.

On the closing date of the Fifth Amendment, we paid (i) a fee of $0.3 million in connection with the funding of the Term E Loan, and (ii) a facility fee of $1.0 million with respect to the Incremental Term Loans.

On October 30, 2025, we announced that a development program had been initiated for RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas.

NHE3 is an antiporter expressed on the apical surface of the small and large intestines and is responsible for absorbing the majority of ingested sodium.

The Company plans to submit an IND in 2026.

RESULTS OF OPERATIONS

The results of operations 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.

See Part II, Item 7,

“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our 2024 Form 10-K to enhance the understanding of our financial metrics below.

The results of operations for the three months ended March 31, 2026 are not necessarily indicative of results to be expected for the entire year ending December 31, 2026, or for any other interim period or future year.

See Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” of our 2025 Form 10-K to enhance the understanding of our financial metrics below.

Below is a summary of our total revenues:

Three Months Ended

September 30, Change

2024 Nine Months Ended

September 30, Change

Three Months Ended March 31, Change 2026 vs.

($ in thousands)

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Product sales, net $ 93,373 $ 67,814 $ 25,559 38 %

Product supply revenue — 5,322 (5,322) (100) % 6,439 7,461 (1,022) (14) %

Licensing revenue 25 20 5 25 % 5,065 56 5,009 (a)

Non-cash royalty revenue related to the sale of future royalties 695 1,026 (331) (32) %

Product supply revenue 354 254 100 39 %

Licensing revenue 51 5,020 (4,969) (99) %

Total revenues $ 94,473 $ 74,114 $ 20,359 27 %

(a) Percent change is not meaningful.

Below is a summary of our product sales, net by product:

Three Months Ended

September 30, Change

2024 Nine Months Ended

September 30, Change

Three Months Ended March 31, Change 2026 vs.

($ in thousands)

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Product sales, net:

The increase in IBSRELA product sales, net in the three and nine months ended September 30, 2025 primarily reflected higher demand, driven by continued increase in awareness and prescriber experience, and to a lesser extent, higher net price.

The decrease in XPHOZAH product sales, net in the three and nine months ended September 30, 2025 primarily reflected lower demand and lower net price, both driven by the loss of XPHOZAH Medicare Part D reimbursement.

As of January 1, 2025, the Centers for Medicare and Medicaid Services officially transitioned oral only therapies for ESRD patients on dialysis, including XPHOZAH, into the ESRD Prospective Payment System.

This decrease was partially offset by continued growth in other channels.

The decrease in XPHOZAH product sales, net in the nine months ended September 30, 2025 included the release of $3.8 million of prior periods’ estimated product returns for XPHOZAH in the 2025 first quarter.

The increase in IBSRELA product sales, net in the three months ended March 31, 2026 primarily reflected higher demand, driven by continued increase in awareness and prescriber experience, and to a lesser extent, higher net price.

XPHOZAH product sales, net in the three months ended March 31, 2026 remained consistent with the prior year and reflected continued growth in other non-Medicare sales channels.

XPHOZAH product sales, net in the prior year included a $3.8 million favorable adjustment driven by a change in previously estimated product returns.

Product supply revenue:

Product supply revenue is primarily impacted by the timing of product supply shipments to our collaboration partners under our product supply agreements in support of non-U.S.

The product supply revenue was primarily attributable to Kyowa Kirin in the nine months ended September 30, 2025 and 2024.

Product supply revenue is primarily impacted by the timing of product supply shipments to our collaboration partners under our product supply agreements in support of the development and commercialization of our products ex-U.S.

by our collaboration partners.

The product supply revenue was primarily attributable to Fosun Pharma and Knight in the three months ended March 31, 2026 and 2025, respectively.

Licensing revenue:

Licensing revenue is primarily impacted by the timing of regulatory and commercialization milestone achievements from our collaboration partners, as well as sales-based royalties received from Knight.

The licensing revenue in the nine months ended September 30, 2025 was primarily attributable to a $5.0 million milestone earned during the 2025 first quarter under the terms of the Fosun Agreement, following 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.

Licensing revenue is primarily impacted by the timing of regulatory and commercialization milestone achievements as well as sales-based royalties received from our collaboration partners.

The licensing revenue in the three months ended March 31, 2026 was attributable to sales-based royalties received from Fosun Pharma and Knight.

The licensing revenue in the three months ended March 31, 2025 was primarily attributable to a $5.0 million milestone earned under the terms of the Fosun Agreement, following the NDA approval by China’s Center for Drug Evaluation of the NMPA for tenapanor in the control of serum phosphorus in adult patients with CKD on hemodialysis.

Non-cash royalty revenue:

Non-cash royalty revenue reflects royalties and commercialization milestones from Kyowa Kirin for sales of PHOZEVEL in Japan, which was launched in February 2024.

The increase in non-cash royalty revenue in the three and nine months ended September 30, 2025 included approximately $3.4 million related to a commercialization milestone earned during the 2025 third quarter under the terms of the Kyowa Kirin Agreement.

The payment will be remitted to HCR upon receipt in accordance with the HCR Agreement.

The decrease in non-cash royalty revenue in the three months ended March 31, 2026 reflected lower royalties received from Kyowa Kirin for sales of PHOZEVEL in Japan.

GTN Adjustments

Reconciliation of gross product sales to product sales, net is as follows:

Three Months Ended

September 30, Change

2024 Nine Months Ended

September 30, Change

Three Months Ended March 31, Change 2026 vs.

($ in thousands)

% 2025 2024 $ %

Gross product sales $ 146,618 $ 96,732 $ 49,886 52 %

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GTN adjustment percentage 36.3 % 29.9 %

The increase in GTN adjustment percentage in the three and nine months ended September 30, 2025 reflected the unfavorable payor mix shifts, primarily associated with loss of XPHOZAH Medicare Part D reimbursement.

The increase in GTN adjustment percentage in the nine months ended September 30, 2025 included the favorable impact of a change in prior periods’ estimate of expected returns of XPHOZAH, which occurred in the 2025 first quarter.

The increase in GTN adjustment percentage in the three months ended March 31, 2026 primarily reflected the prior year favorable impact of a change in previously estimated XPHOZAH product returns, an unfavorable channel mix and Medicare and Medicaid Inflation Rebate charges.

The activities and ending reserve balances for each significant category of GTN adjustments on product sales, net, which constitute variable consideration, were as follows:

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Credits/payments (7,753) (25,012) (12,475) (45,240)

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.

Below is a summary of our cost of goods sold, operating expenses, interest expense, non-cash interest expense related to the sale of future royalties and other income, net:

Three Months Ended

September 30, Change

2024 Nine Months Ended

September 30, Change

Balance as of March 31, 2026 $ 2,145 $ 39,413 $ 11,870 $ 53,428

(1) Adjustments to prior period provisions recorded in the current period were not material.

Costs and Expenses

Below is a summary of our costs and operating expenses, interest expense, non-cash interest expense related to the sale of future royalties and other income, net:

Three Months Ended March 31, Change 2026 vs.

($ in thousands)

2026 2025 $ %

Cost of product sales $ 2,662 $ 1,715 $ 947 55 % $ 8,247 $ 4,133 $ 4,114 100 %

Other cost of revenue 1,320 14,013 (12,693) (91) % 20,441 28,159 (7,718) (27) %

Total cost of goods sold $ 3,982 $ 15,728 $ (11,746) (75) % $ 28,688 $ 32,292 $ (3,604) (11) %

Cost of sales $ 4,811 $ 12,303 $ (7,492) (61) %

Research and development 20,188 14,938 5,250 35 %

Selling, general and administrative 102,267 83,222 19,045 23 %

Total operating expenses $ 101,679 $ 80,280 $ 21,399 27 % $ 299,493 $ 221,269 $ 78,224 35 %

Total costs and operating expenses $ 127,266 $ 110,463 $ 16,803 15 %

Interest expense $ (5,599) $ (4,191) $ (1,408) 34 %

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Other income, net $ 2,112 $ 2,326 $ (214) (9) %

Cost of Goods Sold

Cost of Sales

Three Months Ended March 31, Change 2026 vs.

($ in thousands) 2026 2025 $ %

Cost of product sales $ 2,875 $ 2,340 $ 535 23 %

The increase in cost of product sales in the three and nine months ended September 30, 2025 reflected higher product sales.

A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during the three and nine months ended September 30, 2025 was expensed as research and development expense in periods prior to the commencement of capitalization of inventory costs for each respective product.

The cost associated with inventory sold but previously expensed as research and development was $0.3 million and $2.0 million for the three and nine months ended September 30, 2025, and $2.2 million and $4.6 million for the three and nine months ended September 30, 2024, respectively.

The value of inventory on hand as of September 30, 2025 and December 31, 2024 that was previously expensed as research and development was approximately $12.3 million and $15.6 million, respectively.

Other cost of revenue 1,936 9,963 (8,027) (81) %

The decrease in other cost of revenue in the three and nine months ended September 30, 2025 primarily reflected the full recognition of the $75.0 million royalty obligation under the AstraZeneca Termination Agreement as of the 2025 second quarter, partially offset by costs related to product supply revenue.

Other cost of revenue related to the AstraZeneca Termination Agreement was zero and $12.7 million for the three and nine months ended September 30, 2025, and $10.0 million and $22.7 million for the three and nine months ended September 30, 2024, respectively.

Cost of sales $ 4,811 $ 12,303 $ (7,492) (61) %

The increase in cost of product sales in the three months ended March 31, 2026 reflected higher product sales.

A portion of the costs of IBSRELA and XPHOZAH units recognized as revenue during the three months ended March 31, 2026 was expensed as research and development expense in periods prior to the commencement of capitalization of inventory costs for each respective product.

The cost associated with inventory sold but previously expensed as research and development was $0.3 million and $0.7 million for the three months ended March 31, 2026 and 2025, respectively.

The value of inventory on hand as of March 31, 2026 and December 31, 2025 that was previously expensed as research and development was approximately $7.1 million and $10.9 million, respectively.

The decrease in other cost of revenue in the three months ended March 31, 2026 primarily reflected the full recognition of the maximum $75.0 million royalty obligation under the AstraZeneca Termination Agreement as of the end of the 2025 second quarter, partially offset by higher costs related to capacity expansion at our CMOs.

Other cost of revenue related to the AstraZeneca Termination Agreement was $8.8 million for the three months ended March 31, 2025.

Research and Development

Below is a summary of our research and development expenses:

Three Months Ended

September 30, Change

2024 Nine Months Ended

September 30, Change

Three Months Ended March 31, Change 2026 vs.

($ in thousands) 2026 2025 $ %

5 unchanged sentences

Total research and development expenses $ 20,188 $ 14,938 $ 5,250 35 %

The increase in R&D expenses in the three and nine months ended September 30, 2025 primarily reflected higher external R&D and other expenses associated with life cycle management, as well as the increase in employee-related expenses, driven by higher headcount to support medical engagement with scientific communities in the areas of gastroenterology and nephrology related to our marketed products.

The employee-related expenses included stock-based compensation expense, which decreased by $0.6 million in the three months ended September 30, 2025 and increased by $1.1 million in the nine months ended September 30, 2025.

The external R&D and other expenses consist primarily of expenses associated with life cycle management initiatives for tenapanor, including our CIC program.

The increase in external R&D and other expenses in the three months ended March 31, 2026 reflected increased clinical trial activities, including the initiation of the Phase 3 clinical trial evaluating tenapanor in adult CIC patients.

Selling, General and Administrative

The increase in selling, general and administrative expenses in the three and nine months ended September 30, 2025 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA and XPHOZAH.

The increases consisted of spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure.

In addition, these increases were attributable to increased headcount, including incremental stock-based compensation expenses of $4.2 million and $7.9 million in the three and nine months ended September 30, 2025, respectively.

The increase in selling, general and administrative expenses in the three months ended March 31, 2026 primarily reflected increased commercialization and administrative costs to support net sales growth of IBSRELA, consisting of external spending for disease awareness initiatives, patient affordability, access support and related patient awareness, as well as increased commercial infrastructure costs.

The increase was also attributable to increased headcount, including an incremental stock-based compensation expense of $3.1 million.

Interest Expense

The increase in interest expense in the three and nine months ended September 30, 2025 primarily reflected a higher outstanding loan balance resulting from the Term D Loan and the Term E Loan draws in October 2024 and June 2025, respectively.

The increase in interest expense in the three months ended March 31, 2026 primarily reflected a higher outstanding loan balance resulting from the Term E Loan draw in June 2025.

Non-Cash Interest Expense Related to the Sale of Future Royalties

The increase in non-cash interest expense related to the sale of future royalties in the three and nine months ended September 30, 2025 primarily reflected the increasing outstanding balance of the deferred royalty obligation attributable to the imputed interest accrued on the outstanding balance, partially offset by royalties received from Kyowa Kirin related to the sale of PHOZEVEL, which were remitted to HCR.

The decrease in non-cash interest expense related to the sale of future royalties in the three months ended March 31, 2026 primarily reflected the imputed interest accrued on the decreasing carrying value of the deferred royalty obligation and royalties received from Kyowa Kirin for sales of PHOZEVEL in Japan which were remitted to HCR.

Other Income, Net

Other income, net consists of interest income earned on our cash, cash equivalents and short-term investments and currency exchange gains and losses.

In the three and nine months ended September 30, 2024, other income, net also included the periodic revaluation of our previously outstanding 2022 Exit Fee related to our 2022 Loan Agreement that was settled in October 2024.

The decrease in other income, net in the three months ended March 31, 2026 reflected lower income on our investments resulting from lower interest rates throughout the period, partially offset by higher investment balances.

LIQUIDITY AND CAPITAL RESOURCES

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($ in thousands)

September 30, 2025 December 31, 2024 Change $ Change %

March 31, 2026 December 31, 2025 Change $ Change %

Cash and cash equivalents $ 31,209 $ 67,999 $ (36,790) (54) %

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We regularly assess our cash position and our working capital needs to execute our strategy.

We have historically funded our operations primarily from the sale of common stock, product sales, funds from our collaboration partnerships, funds from our loan agreements with SLR, as well as sale of future royalties to HCR.

We expect that we will increasingly rely on cash generated from operations to fund our operating plan while maintaining financial flexibility from our ability to source cash from future equity sales and debt financing.

In January 2023, we filed a registration statement on Form S-3, which became effective in January 2023, containing (i) a base prospectus for the offering, issuance and sale by us of up to a maximum aggregate offering price of $250.0 million of our common stock, preferred stock, debt securities, warrants and/or units, from time to time in one or more offerings;

and (ii) a prospectus supplement for the offering, issuance and sale by us of up to a maximum aggregate offering price of $150.0 million of our common stock that may be issued and sold, from time to time, under a sales agreement with Jefferies, deemed to be “at-the-market offerings” (2023 Open Market Sales Agreement).

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 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.

We have a loan and security agreement (as amended, the 2022 Loan Agreement) with SLR.

The 2022 Loan Agreement provides a total of $300.0 million, of which $200.0 million has been drawn and outstanding as of September 30, 2025, including $50.0 million of the Term E Loan drawn during the 2025 second quarter.

The additional available borrowings of $100.0 million consist of the Term F Loan and the Term G Loan, each in the amount of $50.0 million.

The Term F Loan and the Term G Loan may be drawn at the Company’s election by June 30, 2026 and December 20, 2026, respectively.

We have historically funded our operations primarily from product sales, sales of our common stock, funds from our loan agreements with SLR, funds from our collaboration partnerships, as well as the sale of future royalties and commercialization milestones to HCR.

We expect that we will increasingly rely on cash generated from our commercial operations to fund our operating plan while maintaining financial flexibility to source cash from future equity sales and debt financing.

Sources of Liquidity

In November 2025, we filed an automatic shelf registration statement on Form S-3ASR, which became effective upon filing, containing (i) a base prospectus, which covers the offering, issuance and sale from time to time in one or more offerings of our common stock, preferred stock, debt securities, warrants and/or units;

and (ii) a prospectus supplement for the offering, issuance and sale of up to a maximum aggregate offering price of $100.0 million of our common stock that may be issued and sold from time to time under the 2025 Open Market Sales Agreement, deemed to be “at-the-market offerings.” Pursuant to the 2025 Open Market Sales Agreement, Jefferies, as sales agent, may receive a commission of up to three percent of the gross sales price for shares of our common stock sold under the 2025 Open Market Sales Agreement.

As of March 31, 2026, there have been no sales of our common stock under the 2025 Open Market Sales Agreement.

We have a loan and security agreement (the 2022 Loan Agreement) with SLR.

The 2022 Loan Agreement provides a total of $300.0 million, of which $200.0 million has been drawn and is outstanding as of March 31, 2026.

The additional available borrowings of $100.0 million consist of the Term F and Term G Loans, each in the amount of $50.0 million.

The Term F and Term G Loans may be drawn at the Company’s election by June 30, 2026 and December 20, 2026, respectively.

Borrowing of our 2025 Form 10-K and Note 8.

Borrowing of this Quarterly Report on Form 10-Q for further discussion.

We believe our available cash, cash equivalents and short-term investments as of September 30, 2025 will be sufficient to fund our planned operations for at least a period of one year from the issuance of these financial statements.

We have based this estimate on assumptions that may prove to be wrong and we could utilize our available capital resources sooner than we currently expect.

In particular, our operating plan may change and we may require significant additional capital to fund our operations.

There are no assurances that our efforts to meet our operating cash flow requirements will be successful.

If our current cash, cash equivalents and short-term investments as well as our plans to meet our operating cash flow requirements are not sufficient to fund necessary expenditures and meet our obligations following the issuance of these financial statements, our liquidity, financial condition and business prospects will be materially affected.

Our future funding requirements will depend on many factors as described in Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q.

Borrowing of this Quarterly Report on Form 10-Q for further information on our long-term debt.

For additional information, refer to Note 15.

Subsequent Events .

Cash Flow Activities

The following table summarizes our cash flows:

Nine Months Ended September 30, Change 2025 vs.

Three Months Ended March 31, Change 2026 vs.

($ in thousands)

2 unchanged sentences

Net cash (used in) provided by investing activities (9,995) 2,851 (12,846) (451) %

(12,735) 23,302 (36,037) (155) %

Net cash provided by financing activities 5,442 1,482 3,960 267 %

Net (decrease) increase in cash and cash equivalents

$ (22,217) $ 25,959 $ (48,176) (186) %

Net decrease in cash and cash equivalents $ (36,790) $ (34,124) $ (2,666) 8 %

Cash Flows from Operating Activities

Net cash used in operating activities increased in the nine months ended September 30, 2025 primarily due to higher expenses to support our commercial growth, as well as higher disbursements for previously accrued royalties under the AstraZeneca Termination Agreement, pursuant to which the maximum royalty obligation of $75.0 million had been fully remitted as of September 30, 2025.

This increase was partially offset by cash inflows from higher product sales, net and timing of collection of our accounts receivable.

Cash flows from operating activities represent the cash receipts and payments related to all of our activities other than investing and financing activities.

Net operating cash flow is derived by adjusting our net loss for non-cash operating items and changes in operating assets and liabilities resulting from timing differences between the cash receipts and payments and when the transactions are recognized in our result of operations.

As a result, changes in net operating cash flow reflect, among other things, the timing of (i) cash collections from our Customers and (ii) payments made in the normal course of business such as payments to suppliers, including our CMOs, CROs and government agencies.

Net cash used in operating activities decreased in the three months ended March 31, 2026 primarily due to the timing of our payments and inventory purchases, partially offset by the timing of cash collections from our Customers.

Cash Flows from Investing Activities

Net cash used in investing activities increased in the nine months ended September 30, 2025 primarily due to the timing of our investment maturities and purchases.

Cash flows from investing activities include cash used for capital expenditures and purchases of short-term investments as well as net proceeds from asset dispositions and maturities of short-term investments.

Net cash used in investing activities increased in the three months ended March 31, 2026 primarily reflected higher short-term investment purchases.

Cash Flows from Financing Activities

Net cash provided by financing activities decreased in the nine months ended September 30, 2025 due to receipts from the Term E Loan, net of costs ($48.7 million) and the issuance of common stock under our equity incentive and stock purchase plans, which were lower than receipts from the Term C Loan, net of costs ($49.8 million) and the issuance of common stock under our equity incentive and stock purchase plans in the nine months ended September 30, 2024.

Cash flows from financing activities include net proceeds associated with our 2022 Loan Agreement, sales of our common stock with respect to the “at-the-market offering” programs and issuances of our common stock under our equity incentive plans.

Net cash provided by financing activities increased in the three months ended March 31, 2026 due to higher proceeds from the issuance of common stock under our equity incentive plans.

Funding Requirements

Based on our current operating model, we believe our available cash, cash equivalents and short-term investments as of March 31, 2026 will be sufficient to fund our planned operations for at least a period of one year from the issuance of these financial statements.

We have based this estimate on assumptions that may prove to be wrong and we could utilize our available capital resources sooner than we currently expect.

In particular, our operating plan may change and we may require significant additional capital to fund our operations.

There are no assurances that our efforts to meet our operating cash flow requirements will be successful.

Our future funding requirements will depend on many factors as described in Part II, Item 1A, “Risk Factors,” of this Quarterly Report on Form 10-Q.

Contract Obligations and Commitments

As of March 31, 2026, 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 discussed in Note 15.

Subsequent Events, effective as of April 28, 2026, we entered into the Sixth Amendment with SLR as collateral agent and the lenders party thereto.

Borrowing of our 2025 Form 10-K and Note 8.

Borrowing of this Quarterly Report on Form 10-Q for further information on our long-term debt.

We have entered into various operating leases for our offices.

As of March 31, 2026, our total undiscounted obligation for operating leases was $5.2 million, with maturities ranging up through July 2029.

Leases for further information on our operating leases.

We enter into a variety of contracts in the normal course of business.

These contracts generally allow us to terminate on notice, reschedule or adjust our requirements based on our business needs prior to the delivery of goods or performance of services.

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 2. Management’s Discussion and Analysis