IRONWOOD PHARMACEUTICALS INC
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 10, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-11.
0001558370-25-011050
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001104659-25-108795
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 89 previous paragraphs and 92 current paragraphs.
51 unchanged; 33 reworded; 0 added; 1 removed; 4 previous and 8 current paragraphs rearranged.
Tables are not compared: 26 previous and 26 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Removed paragraphs (1)
Previous report
The decrease in collaborative arrangements revenue of $42.9 million for the six months ended June 30, 2025
Reworded paragraphs (33)
Previous wording
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the notes to those financial statements appearing elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024 which was filed with the U.S. Securities and Exchange Commission, or the SEC, on March 31, 2025, or the 2024 Annual Report on Form 10-K. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as those set forth under “Note Regarding Forward-Looking Statements,” in this Quarterly Report on Form 10-Q, under “Part I, Item 1A—Risk Factors” in our 2024 Annual Report on Form 10-K and under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.
Current wording
The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the notes to those financial statements appearing elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024 which was filed with the U.S. Securities and Exchange Commission, or the SEC, on March 31, 2025, or the 2024 Annual Report on Form 10-K. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as
Previous wording
LINZESS® (linaclotide), our commercial product, is the first product approved by the United States Food and Drug Administration, or U.S. FDA, in a class of GI medicines called guanylate cyclase type C agonists, or GC-C agonists, and is indicated for adult men and women suffering from irritable bowel syndrome with constipation, or IBS-C, or chronic idiopathic constipation, or CIC, and for pediatric patients ages 6-17 years-old suffering from functional constipation, or FC. LINZESS is available to adult men and women suffering from IBS-C or CIC in the U.S. and Mexico, adult men and women suffering from IBS-C or chronic constipation in Japan, and adult men and women suffering from IBS-C in China, and pediatric patients ages 6-17 with FC in the U.S. Linaclotide is available under the trademarked name CONSTELLA® to adult men and women suffering from IBS-C or CIC and pediatric patients ages 6-17 years old with FC in Canada, and to adult men and women suffering from IBS-C in certain European countries.
Current wording
LINZESS® (linaclotide), our commercial product, is the first product approved by the United States Food and Drug Administration, or U.S. FDA, in a class of GI medicines called guanylate cyclase type C agonists, or GC-C agonists, and is indicated for the treatment of irritable bowel syndrome with constipation, or IBS-C, in adults and pediatric patients 7 years of age and older, chronic idiopathic constipation, or CIC, in adults, and functional constipation, or FC, in pediatric patients ages 6-17 years-old. LINZESS is also available for the treatment of adults with IBS-C or CIC in Mexico, adults with IBS-C or chronic constipation in Japan, and adults with IBS-C in China. Linaclotide is available under the trademarked name CONSTELLA®for the treatment of adults with IBS-C or CIC and pediatric patients ages 6-17 years old with FC in Canada, and to adults with IBS-C in certain European countries.
Previous wording
To date, we have dedicated a majority of our activities to the research, development and commercialization of linaclotide, as well as to the research and development of apraglutide and our other product candidates. For the three and six months ended June 30, 2025, we recorded net income of $23.6 million and a net loss of $13.8 million, respectively. For the three and six months ended June 30, 2024, we recorded a net loss of $0.9 million and $5.0 million, respectively. As of June 30, 2025, we had an accumulated deficit of approximately $1.7 billion. We are unable to predict the extent of any future losses or guarantee that our company will be able to generate and maintain positive cash flows.
Current wording
To date, we have dedicated a majority of our activities to the research, development and commercialization of linaclotide, as well as to the research and development of apraglutide and our other product candidates. For the three and nine months ended September 30, 2025, we recorded net income of $40.1 million and $26.3 million, respectively. For the three and nine months ended September 30, 2024, we recorded net income of $3.6 million and a net loss of $1.4 million, respectively. As of September 30, 2025, we had an accumulated deficit of approximately $1.7 billion. We are unable to predict the extent of any future losses or guarantee that our company will be able to generate and maintain positive cash flows.
Previous wording
The majority of our revenues are generated from the sales of LINZESS in the U.S. We record our share of the net profits and losses from the sales of LINZESS in the U.S. less commercial expenses on a net basis and present the settlement payments to and from AbbVie as collaboration expense or collaborative arrangements revenue, as applicable. Net profits or losses consist of net sales to third-party customers and sublicense income in the U.S. less the cost of goods sold as well as selling, general and administrative expenses. Although we expect net sales to increase over time, the settlement payments between AbbVie and us, resulting in collaborative arrangements revenue or collaboration expense, are subject to fluctuation based on the ratio of selling, general and administrative expenses incurred by each party. In addition, our collaborative arrangements revenue may fluctuate as a result of the timing and amount of license fees and clinical and commercial milestones received and recognized under our current and future strategic partnerships as well as timing and amount of royalties from the sales of linaclotide in the European, Canadian, Mexican, Japanese, or Chinese markets or any other markets where linaclotide receives approval and is commercialized.
Current wording
sold as well as selling, general and administrative expenses. Although we expect net sales to increase over time, the settlement payments between AbbVie and us, resulting in collaborative arrangements revenue or collaboration expense, are subject to fluctuation based on the ratio of selling, general and administrative expenses incurred by each party. In addition, our collaborative arrangements revenue may fluctuate as a result of the timing and amount of license fees and clinical and commercial milestones received and recognized under our current and future strategic partnerships as well as timing and amount of royalties from the sales of linaclotide in the European, Canadian, Mexican, Japanese, or Chinese markets or any other markets where linaclotide receives approval and is commercialized.
Previous wording
Linaclotide. Our commercial product, LINZESS, is commercially available in the U.S. for the treatment of IBS-C or CIC in adults and for FC in pediatric patients ages 6-17 years-old. Linaclotide is also available to adult men and
Current wording
Linaclotide. Our commercial product, LINZESS, is commercially available in the U.S. for the treatment of IBS-C in adults and pediatric patients 7 years of age and older, CIC in adults, and FC in pediatric patients ages 6-17 years-old. Linaclotide is also available to adults suffering from IBS-C or CIC in certain countries of the world, including China, Japan, and in a number of European countries.
Previous wording
In addition, we and AbbVie have established a nonclinical and clinical post-marketing plan with the U.S. FDA to understand the safety and efficacy of LINZESS in pediatric patients. In August 2021, the U.S. FDA approved a revised label for LINZESS based on clinical safety data that had been generated thus far in pediatric studies. The updated label modified the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age. The boxed warning and contraindication previously applied to all children less than 18 years of age and less than 6 years of age, respectively. In June 2023, the U.S. FDA approved LINZESS as a once-daily treatment for pediatric patients ages 6-17 years-old with FC, making LINZESS the first and only FDA-approved prescription therapy for FC in this patient population. The safety and effectiveness of LINZESS in patients with FC less than 6 years of age or in patients with IBS-C less than 18 years of age have not been established. Additional clinical pediatric programs in IBS-C and FC are ongoing.
Current wording
In addition, we and AbbVie have established a nonclinical and clinical post-marketing plan with the U.S. FDA to understand the safety and efficacy of LINZESS in pediatric patients. In August 2021, the U.S. FDA approved a revised label for LINZESS based on clinical safety data that had been generated thus far in pediatric studies. The updated label modified the boxed warning for risk of serious dehydration and contraindication against use in children to those less than two years of age. The boxed warning and contraindication previously applied to all children less than 18 years of age and less than 6 years of age, respectively. In June 2023, the U.S. FDA approved LINZESS as a once-daily treatment for pediatric patients ages 6-17 years-old with FC, making LINZESS the first and only FDA-approved prescription therapy for FC in this patient population. In November 2025, U.S. FDA approved LINZESS for pediatric patients 7 years of age and older with IBS-C. Additional clinical pediatric programs in IBS-C and FC are ongoing.
Previous wording
CNP-104. Through the COUR Collaboration Agreement, we and COUR were developing CNP-104 for the treatment of PBC, a rare autoimmune disease targeting the liver. In the third quarter of 2024, we received from COUR the topline data from COUR’s Phase II Clinical study for the treatment of PBC. In September 2024, we notified COUR of our decision not to exercise the option to acquire an exclusive license to CNP-104. As a result, the COUR Collaboration Agreement has terminated, and we retain no rights and have no obligations related to CNP-104.
Current wording
the topline data from COUR’s Phase II Clinical study for the treatment of PBC. In September 2024, we notified COUR of our decision not to exercise the option to acquire an exclusive license to CNP-104. As a result, the COUR Collaboration Agreement has terminated, and we retain no rights and have no obligations related to CNP-104.
Previous wording
The following table sets forth our research and development expenses related to our product pipeline for the three and six months ended June 30, 2025 and 2024, respectively. These expenses relate primarily to compensation, benefits and other employee-related expenses and external costs associated with nonclinical studies and clinical trial costs for our product candidates. We allocate costs related to facilities, depreciation, share-based compensation, research and development support services and certain other costs directly to programs.
Current wording
The following table sets forth our research and development expenses related to our product pipeline for the three and nine months ended September 30, 2025 and 2024, respectively. These expenses relate primarily to compensation, benefits and other employee-related expenses and external costs associated with nonclinical studies and clinical trial costs for our product candidates. We allocate costs related to facilities, depreciation, share-based compensation, research and development support services and certain other costs directly to programs.
Previous wording
*Restructuring Expenses.*Restructuring expenses pertain to a workforce reduction initiative in connection with the VectivBio Acquisition as well as a workforce reduction in January 2025 consisting primarily of field-based sales employees. The workforce reduction and restructuring initiatives are more fully described in Note 11,Workforce Reductions and Restructuring.
Current wording
*Restructuring Expenses.*Restructuring expenses pertain to a workforce reduction initiative in connection with the VectivBio Acquisition, as well as workforce reductions in January 2025 consisting primarily of field-based sales employees and August 2025 consisting of certain positions supporting apraglutide commercialization efforts. The workforce reduction and restructuring initiatives are more fully described in Note 12,Workforce Reductions and Restructuring.
Previous wording
reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the condensed consolidated financial statements, and the amounts of revenues and expenses during the reported periods. We base our estimates on our historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from our estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
Current wording
Our discussion and analysis of our financial condition and results of operations is based upon our condensed consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make certain estimates and assumptions that may affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities at the date of the condensed consolidated financial statements, and the amounts of revenues and expenses during the reported periods. We base our estimates on our historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results may differ materially from our estimates under different assumptions or conditions. Changes in estimates are reflected in reported results in the period in which they become known.
Previous wording
During the three and six months ended June 30, 2025, there were no material changes to our critical accounting policies as reported in our 2024 Annual Report on Form 10-K.
Current wording
During the three and nine months ended September 30, 2025, there were no material changes to our critical accounting policies as reported in our 2024 Annual Report on Form 10-K.
Previous wording
Three and six months ended June 30, 2025 compared to three and six months ended June 30, 2024
Current wording
Three and nine months ended September 30, 2025 compared to three and nine months ended September 30, 2024
Previous wording
Collaborative arrangements revenue. The decrease in collaborative arrangements revenue of $9.2 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 was primarily related to a $5.7 million decrease in our share of net profits from the sale of LINZESS in the U.S., which was driven by decreased net price, partially offset by increased prescription demand. Additionally, the decrease in collaborative arrangements revenue was driven by an adjustment during the second quarter of 2025 to reduce cumulative collaborative arrangements revenue by $2.9 million due to an increase in estimated development costs in connection with the confirmatory Phase III trial needed to seek U.S. FDA approval for apraglutide.
Current wording
The decrease in collaborative arrangements revenue of $12.4 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily related to a $7.9 million decrease in our share of net profits from the sale of LINZESS in the U.S, resulting from decreased net price, partially offset by increased prescription demand. Additionally, the decrease in collaborative arrangements revenue was driven by a $4.0 million decrease in revenue recognized from the Company’s collaboration arrangement with Asahi Kasei Pharma Corporation. This decrease was largely driven by an adjustment during the second quarter of 2025 to reduce cumulative collaborative arrangements revenue by $2.9 million due to an increase in estimated development costs in connection with the confirmatory Phase III trial needed to seek U.S. FDA approval for apraglutide.
Previous wording
Research and development. The decrease in research and development expenses of $7.0 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 was primarily related to a $3.7 million decrease in external apraglutide costs, a $2.4 million decrease in costs associated with the COUR Collaboration Agreement, and a $0.8 million decrease in external costs associated with the IW-3300 development program.
Current wording
Research and development. The decrease in research and development expenses of $7.4 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was primarily related to a $3.7 million decrease in apraglutide costs and a $2.7 million decrease in costs associated with the IW-3300 development program.
Previous wording
The decrease in research and development expenses of $5.4 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily related to a $5.4 million decrease in external apraglutide costs, a $2.4 million decrease in costs associated with the COUR Collaboration Agreement, a $1.8 million decrease in external linaclotide costs, and a $1.2 million decrease in external costs associated with the IW-3300 development program, partially offset by a $4.8 million reduction to research and development expense recognized during the first quarter of 2024 in connection with the settlement of a license-related contract liability.
Current wording
The decrease in research and development expenses of $12.8 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily related to a $7.7 million decrease in external apraglutide costs, a $3.8 million decrease in costs associated with the IW-3300 development program, a $2.6 million decrease in costs associated with the COUR Collaboration Agreement, and a $2.0 million decrease in external linaclotide costs, partially offset by a $4.8 million reduction to research and development expense recognized during the first quarter of 2024 in connection with the settlement of a license-related contract liability.
Previous wording
Selling, general and administrative. Selling, general and administrative expenses decreased by $20.2 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024, primarily due to a $12.0 million decrease in compensation, benefits, and other employee-related expenses and a $5.0 million decrease in sales and marketing expenses, both resulting from the restructuring initiative during the first quarter of 2025, as well as a decrease of $2.4 million in professional services expenses.
Current wording
Selling, general and administrative. Selling, general and administrative expenses decreased by $14.2 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024, primarily due to a $15.1 million decrease in compensation, benefits, and other employee-related expenses and a $3.3 million decrease in sales and marketing expenses, both resulting from the restructuring initiatives during 2025, as well as a decrease of $1.8 million in professional services expenses. The decrease was partially offset by a $7.5 million legal contingency accrual recognized during the third quarter of 2025 (Note 4).
Previous wording
The decrease in selling, general and administrative expenses of $33.5 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 was primarily related to a $21.8 million decrease in compensation, benefits, and other employee-related expenses and a $7.5 million decrease in sales and marketing expenses, both resulting from the restructuring initiative during the first quarter of 2025, as well as a decrease of $1.6 million in professional services expenses.
Current wording
The decrease in selling, general and administrative expenses of $47.7 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily related to a $36.9 million decrease in compensation, benefits, and other employee-related expenses and a $10.8 million decrease in sales and marketing expenses, both resulting from the restructuring initiatives during 2025, as well as a decrease of $3.4 million in professional services expenses. The decrease was partially offset by a $7.5 million legal contingency accrual recognized during the third quarter of 2025 (Note 4).
Previous wording
Restructuring expenses. The decrease in restructuring expense of** $2.3 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 is due to employee severance, benefits and related costs for the VectivBio Acquisition-related workforce reduction. The increase in restructuring expense of $**15.8 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 is primarily due tothe workforce reduction in January 2025 consisting primarily of field-based sales employees. Workforce reduction and restructuring initiatives are more fully described in Note 11,Workforce Reductions and Restructuring.
Current wording
Restructuring expenses. The increase in restructuring expense of** **$2.2 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 is primarily related to the workforce reduction in August 2025, net of $0.4 million in adjustments related to the workforce reduction in January 2025.
Previous wording
Interest expense and other financing costs. Interest expense increased by $0.9 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 primarily due to an increase of $1.2 million in interest on the Revolving Credit Facility, resulting from a higher outstanding principal balance throughout the period. This increase was partially offset by a $0.5 million decrease in coupon interest expense associated with the 2024 Convertible Notes, which were fully repaid upon maturity in June 2024.
Current wording
Interest expense and other financing costs. Interest expense decreased by $1.0 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024, primarily due to a lower outstanding principal balance on the Revolving Credit Facility throughout the period.
Previous wording
Interest expense increased by $1.7 million for six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to an increase of $2.4 million in interest on the Revolving Credit Facility, resulting from a higher outstanding principal balance throughout the period. This increase was partially offset by a $1.1 million decrease in coupon interest expense associated with the 2024 Convertible Notes, which were fully repaid upon maturity in June 2024.
Current wording
Interest expense increased by $0.7 million for nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to an increase of $1.4 million in interest on the Revolving Credit Facility resulting from a higher outstanding principal balance throughout the period, partially offset by a $1.1 million decrease in coupon interest expense associated with the 2024 Convertible Notes, which were fully repaid upon maturity in June 2024.
Previous wording
Interest and investment income. Interest and investment income decreased by $0.6 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 due to a decrease in cash and cash equivalents balances and a decrease in interest rates.
Current wording
Interest and investment income. Interest and investment income decreased by $0.2 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 due to a decrease in cash and cash equivalents balances and a decrease in interest rates.
Previous wording
Interest and investment income decreased by $0.9 million for the six months ended June 30, 2025 compared to the six months ended June 30, 2024, primarily due to a decrease in cash and cash equivalents balances and a decrease in interest rates.
Current wording
Interest and investment income decreased by $1.1 million for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024, primarily due to a decrease in cash and cash equivalents balances and a decrease in interest rates.
Previous wording
Other. During the three and six months ended June 30, 2025, we recorded a gain of an insignificant amount for pension-related activities.
Current wording
Other. During the three and nine months ended September 30, 2025, we recorded a gain of an insignificant amount for pension-related activities.
Previous wording
Income taxes.* *For the three and six months ended June 30, 2025, we recorded income tax expense of $14.2 million and $15.3 million, respectively. For the three and six months ended June 30, 2024, we recorded income tax expense of $19.7 million and $28.9 million, respectively. Due to our ability to utilize our net operating losses to offset federal taxable income and taxable income in most states, the majority of our tax provision will be a non-cash expense until our net operating losses have been fully utilized.
Current wording
Income taxes.* *For the three and nine months ended September 30, 2025, we recorded income tax expense of $27.9 million and $43.3 million, respectively. For the three and nine months ended September 30, 2024, we recorded income tax expense of $13.7 million and $42.6 million, respectively. Due to our ability to utilize our net operating losses to offset federal taxable income and taxable income in most states, the majority of our tax provision will be a non-cash expense until our net operating losses have been fully utilized.
Previous wording
As of June 30, 2025, we had $92.9 million of cash and cash equivalents. Our cash equivalents include amounts held in money market funds, U.S. Treasury securities and commercial paper. We invest cash in excess of immediate requirements in accordance with our investment policy, which limits the amounts we may invest in certain types of investments and requires all investments held by us to be at least A- rated, with a remaining final maturity when purchased of less than twenty-four months, so as to primarily achieve liquidity and capital preservation objectives.
Current wording
As of September 30, 2025, we had $140.4 million of cash and cash equivalents. Our cash equivalents include amounts held in money market funds, U.S. Treasury securities and commercial paper. We invest cash in excess of immediate requirements in accordance with our investment policy, which limits the amounts we may invest in certain types of investments and requires all investments held by us to be at least A- rated, with a remaining final maturity when purchased of less than twenty-four months, so as to primarily achieve liquidity and capital preservation objectives.
Previous wording
We have financed our operations to date primarily through both the private sale of our preferred stock and the public sale of our common stock, debt financings, and cash generated from our operations. As of June 30, 2025, our debt is comprised of $200.0 million aggregate principal amount of convertible notes, due in June 2026, and $385.0 million aggregate principal amount outstanding under our Revolving Credit Facility, which we entered into in May 2023 to partially finance the VectivBio Acquisition. The Revolving Credit Facility provides for $550.0 million of borrowing capacity and includes a $10.0 million letter of credit subfacility. Refer to Note 8,Debt, to our condensed consolidated
Current wording
We have financed our operations to date primarily through both the private sale of our preferred stock and the public sale of our common stock, debt financings, and cash generated from our operations. As of September 30, 2025, our debt is comprised of $200.0 million aggregate principal amount of convertible notes, due in June 2026, and $385.0 million aggregate principal amount outstanding under our Revolving Credit Facility, which we entered into in May 2023 to partially finance the VectivBio Acquisition. The Revolving Credit Facility provides for $550.0 million of borrowing capacity and includes a $10.0 million letter of credit subfacility. Refer to Note 8,Debt, to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for information related to our debt obligations.
Previous wording
The following table summarizes cash flows from operating, investing, and financing activities for the three and six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes cash flows from operating, investing, and financing activities for the three and nine months ended September 30, 2025 and 2024:
Previous wording
Net cash outflows for the three months ended June 30, 2025 totaled $15.1 million and net cash inflows for the six months ended June 30, 2025 totaled $4.9 million, and were derived primarily from collaboration arrangements revenue related to sales of LINZESS in the U.S. Net cash inflows for the three and six months ended June 30, 2024 totaled $33.5 million and $78.5 million, respectively, and were derived primarily from collaboration arrangements revenue related to sales of LINZESS in the U.S.
Current wording
Net cash inflows for the three months ended September 30, 2025 totaled $47.6 million and net cash inflows for the nine months ended September 30, 2025 totaled $52.5 million, and were derived primarily from collaboration arrangements revenue related to sales of LINZESS in the U.S. Net cash inflows for the three and nine months ended September 30, 2024 totaled $9.9 million and $88.3 million, respectively, and were derived primarily from collaboration arrangements revenue related to sales of LINZESS in the U.S.
Previous wording
Cash used in investing activities for the three and six months ended June 30, 2025 was insignificant and pertained to the purchase of property and equipment. Cash used in investing activities for the three and six months ended June 30, 2024 was insignificant and pertained to the purchase of property and equipment.
Current wording
Cash used in investing activities for the three and nine months ended September 30, 2025 was insignificant and pertained to the purchase of property and equipment. Cash used in investing activities for the three and nine months ended September 30, 2024 was insignificant and pertained to the purchase of property and equipment.
Previous wording
Cash provided by financing activities for the three and six months ended June 30, 2025 was insignificant and was generated from employee stock purchases.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2025 was insignificant and was generated from employee stock purchases.
Previous wording
Cash used in financing activities for the three and six months ended June 30, 2024 totaled $49.4 million and $64.9 million, respectively. Cash used in financing activities during the six months ended June 30, 2024 was comprised primarily of a repayment of $200.0 million aggregate principal on the 2024 Convertible Notes upon maturity in June 2024, partially offset by $125.0 million of net borrowings under the Revolving Credit Facility and $10.8 million of proceeds from stock option exercises and employee stock purchases.
Current wording
comprised primarily of a $25.0 million repayment on the Revolving Credit Facility. Cash used in financing activities during the nine months ended September 30, 2024 was comprised primarily of the repayment of $200.0 million aggregate principal on the 2024 Convertible Notes upon their maturity in June 2024, partially offset by $100.0 million of net borrowings under the Revolving Credit Facility and $10.8 million from stock option exercises and employee stock purchases.
Previous wording
Under our collaboration with AbbVie for North America, total net sales of LINZESS in the U.S., as recorded by AbbVie, are reduced by commercial costs incurred by each party, and the resulting amount is shared equally between us and AbbVie. Additionally, we receive royalties from AbbVie based on sales of linaclotide in its licensed territories outside of the U.S. We believe revenues from our LINZESS partnership for the U.S. with AbbVie will continue to constitute a significant portion of our total revenue for the foreseeable future and we cannot be certain that such revenues, as well as the revenues from our other commercial activities, will continue to enable us to generate positive cash flows, or to do so in the timeframes we expect. We also anticipate that we will continue to incur substantial expenses for the next several years as we further develop and commercialize linaclotide in the U.S., develop** **and commercialize other product candidates, including apraglutide, and invest in building our pipeline through internal or external opportunities. We believe that our cash and cash equivalents on hand as of June 30, 2025, our expected cash inflows from operations, and our borrowing capacity on our Revolving Credit Facility will be sufficient to meet our projected operating needs at least through the next twelve months from the issuance of these financial statements. We have short-term and long-term debt obligations, including convertible notes that mature on June 15, 2026, which are disclosed in Note 8,Debt, to our financial statements included elsewhere in this Quarterly Report on Form 10-Q. There is no assurance we will have sufficient liquidity to meet our debt obligations when they become due.
Current wording
and AbbVie. Additionally, we receive royalties from AbbVie based on sales of linaclotide in its licensed territories outside of the U.S. We believe revenues from our LINZESS partnership for the U.S. with AbbVie will continue to constitute a significant portion of our total revenue for the foreseeable future and we cannot be certain that such revenues, as well as the revenues from our other commercial activities, will continue to enable us to generate positive cash flows, or to do so in the timeframes we expect. We also anticipate that we will continue to incur substantial expenses for the next several years as we further develop and commercialize linaclotide in the U.S., develop** **and commercialize other product candidates, including apraglutide, and invest in building our pipeline through internal or external opportunities. We believe that our cash and cash equivalents on hand as of September 30, 2025, our expected cash inflows from operations, and our borrowing capacity on our Revolving Credit Facility will be sufficient to meet our projected operating needs at least through the next twelve months from the issuance of these financial statements. We have short-term and long-term debt obligations, including convertible notes that mature on June 15, 2026, which are disclosed in Note 8,Debt, to our financial statements included elsewhere in this Quarterly Report on Form 10-Q. There is no assurance we will have sufficient liquidity to meet our debt obligations when they become due.
Previous wording
For a discussion of recent accounting pronouncements, refer to Note 2,Summary of Significant Accounting Policies, to our consolidated financial statements in our 2024 Annual Report on Form 10-K and Note 2,Summary of Significant Accounting Policies, appearing elsewhere in this Quarterly Report on Form 10-Q. We did not otherwise adopt any new accounting pronouncements during the three and six months ended June 30, 2025 that had a material effect on our condensed consolidated financial statements included in this report.
Current wording
For a discussion of recent accounting pronouncements, refer to Note 2,Summary of Significant Accounting Policies, to our consolidated financial statements in our 2024 Annual Report on Form 10-K and Note 2,Summary of Significant Accounting Policies, appearing elsewhere in this Quarterly Report on Form 10-Q. We did not otherwise adopt any new accounting pronouncements during the three and nine months ended September 30, 2025 that had a material effect on our condensed consolidated financial statements included in this report.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
those set forth under “Note Regarding Forward-Looking Statements,” in this Quarterly Report on Form 10-Q, under “Part I, Item 1A—Risk Factors” in our 2024 Annual Report on Form 10-K and under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.
Current report — wording carried from elsewhere
The majority of our revenues are generated from the sales of LINZESS in the U.S. We record our share of the net profits and losses from the sales of LINZESS in the U.S. less commercial expenses on a net basis and present the settlement payments to and from AbbVie as collaboration expense or collaborative arrangements revenue, as applicable. Net profits or losses consist of net sales to third-party customers and sublicense income in the U.S. less the cost of goods
Current report — wording carried from elsewhere
CNP-104. Through the COUR Collaboration Agreement, we and COUR were developing CNP-104 for the treatment of PBC, a rare autoimmune disease targeting the liver. In the third quarter of 2024, we received from COUR
Current report — wording carried from elsewhere
Collaborative arrangements revenue. The increase in collaborative arrangements revenue of $30.5 million for the three months ended September 30, 2025 compared to the three months ended September 30, 2024 was primarily related to a $30.8 million increase in our share of net profits from the sale of LINZESS in the U.S., which was driven by increased net price and increased prescription demand.
Current report — wording carried from elsewhere
The increase in restructuring expense of** **$18.0 million for thenine months ended September 30, 2025 compared to thenine months ended September 30, 2024 is primarily due tothe workforce reduction in January 2025.
Current report — wording carried from elsewhere
Workforce reduction and restructuring initiatives are more fully described in Note 12,Workforce Reductions and Restructuring.
Current report — wording carried from elsewhere
Cash used in financing activities for the three and nine months ended September 30, 2024 totaled $27.2 million and $92.1 million, respectively. Cash used in financing activities during the three months ended September 30, 2024 was
Current report — wording carried from elsewhere
Under our collaboration with AbbVie for North America, total net sales of LINZESS in the U.S., as recorded by AbbVie, are reduced by commercial costs incurred by each party, and the resulting amount is shared equally between us
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
women suffering from IBS-C or CIC in certain countries of the world, including China, Japan, and in a number of European countries.
Previous report — wording carried elsewhere
Our discussion and analysis of our financial condition and results of operations is based upon our condensed consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make certain estimates and assumptions that may affect the
Previous report — wording carried elsewhere
compared to the six months ended June 30, 2024 was primarily related to a $38.7 million decrease in our share of net profits from the sale of LINZESS in the U.S. The decrease reflects a change in AbbVie’s estimate of gross-to-net rebate reserves effective at the beginning of 2025 and is expected to impact the quarterly phasing of LINZESS U.S. net sales. Additionally, the decrease in collaborative arrangements revenue was driven by an adjustment during the second quarter of 2025 to reduce cumulative collaborative arrangements revenue by $2.9 million due to an increase in estimated development costs in connection with the confirmatory Phase III trial needed to seek U.S. FDA approval for apraglutide.
Previous report — wording carried elsewhere
financial statements included elsewhere in this Quarterly Report on Form 10-Q for information related to our debt obligations.