– LINZESS® (linaclotide) U.S. net sales of $315 million in Q3 2025, an increase of 40% year-over-year; EUTRx demand growth increased 12% year-over-year –
– GAAP net income of $40 million and adjusted EBITDA of $82 million in Q3 2025; ended Q3 2025 with $140 million in cash and cash equivalents –
– Raises full-year 2025 LINZESS U.S. net sales guidance to $860 - $890 million; total revenue guidance to $290 - $310 million and adjusted EBITDA guidance to greater than $135 million –
– FDA approves LINZESS as the first drug for the treatment of children 7 years and older with irritable bowel syndrome with constipation (IBS-C) –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today reported its third quarter 2025 results and recent business performance.
“LINZESS delivered a strong third-quarter performance, driven by accelerated double-digit prescription demand growth combined with improved net pricing, which prompted us to raise our full-year 2025 financial guidance. Importantly, we expect our strong third-quarter revenue will result in substantial fourth-quarter cash flows, which will strengthen our financial position, enable us to reduce our debt and maintain compliance with debt covenants over the coming quarters,” said Tom McCourt, chief executive officer of Ironwood.
“As part of our ongoing commitment to patients, we continue to seek ways to expand the clinical utility of LINZESS. This month, the FDA approved LINZESS for the treatment of IBS-C in patients 7 years of age and older. We also remain focused on advancing the apraglutide program toward a confirmatory Phase 3 trial, with plans to align on a trial design with the FDA later this year. Pending that alignment, we expect to initiate a Phase 3 confirmatory study in the first half of 2026. In addition, we continue to review strategic alternatives to maximize shareholder value and look forward to providing an update on that process as appropriate,” added Tom McCourt.
Third Quarter 2025 Financial Highlights1
(in thousands, except for per share amounts)
|
| Q3 2025 | Q3 2024 | |
Total revenue 2 |
| $122,060 | $91,592 | |
Total costs and expenses |
| 46,576 | 65,956 | |
GAAP net income 2 |
| 40,080 | 3,646 | |
GAAP net income – per share basic 2 |
| 0.25 | 0.02 | |
GAAP net income – per share diluted 2 |
| 0.23 | 0.02 | |
Adjusted EBITDA 2,3 |
| 81,811 | 34,488 | |
Non-GAAP net income 2 |
| 41,933 | 3,869 | |
Non-GAAP net income per share – basic 2 |
| 0.26 | 0.02 | |
Non-GAAP net income per share – diluted 2 |
| 0.24 | 0.02 | |
1Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information.
2 Figures presented for the third quarter of 2024 include a $5.8 million increase to collaborative arrangement revenues as a result of an adjustment recorded for Ironwood’s estimate of LINZESS gross-to-net reserves as of September 30, 2024.
3 Adjusted EBITDA is calculated by subtracting restructuring expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation, from GAAP net income. The exclusion of stock-based compensation from Adjusted EBITDA represents an update to our definition of Adjusted EBITDA, effective in the first quarter of 2025. For comparison purposes, third quarter 2024 Adjusted EBITDA has also been updated to reflect this updated definition.
Third Quarter 2025 Corporate Highlights
Apraglutide
- Apraglutide is a once weekly, long-acting synthetic glucagon-like peptide-2 (“GLP-2”) analog with the potential to treat a range of rare gastrointestinal diseases where GLP-2 can play a central role in addressing disease pathophysiology.
- Ironwood is advancing apraglutide for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. Ironwood believes apraglutide has the potential to improve the standard of care for adult patients with SBS who are dependent on PS as the first and only GLP-2 to achieve a statistically significant reduction in weekly parenteral support volume with once-weekly administration.
- Ironwood is finalizing a confirmatory apraglutide Phase 3 trial design for patients with SBS who are dependent on PS and plans to align with the U.S. Food and Drug Administration (“FDA”) in the fourth quarter of 2025. Pending alignment with the FDA, Ironwood expects to initiate a confirmatory Phase 3 trial in the first half of 2026.
U.S. LINZESS
- Label Expansion: In November, the FDA approved LINZESS for the treatment of irritable bowel syndrome with constipation (IBS-C) in patients aged 7 years of age and older. In addition to expanding its clinical utility, this new indication establishes LINZESS as the first and only prescription drug approved for the treatment of IBS-C in patients 7-17 years old.
- Prescription Demand: Total LINZESS prescription demand in the third quarter of 2025 was 60.5 million LINZESS capsules, a 12% increase compared to the third quarter of 2024, per IQVIA.
- U.S. Brand Collaboration: LINZESS U.S. net sales are provided to Ironwood by its U.S. partner, AbbVie Inc. (“AbbVie”). LINZESS U.S. net sales were $314.9 million in the third quarter of 2025, a 40% increase compared to $225.5 million in the third quarter of 2024. Ironwood and AbbVie share equally in U.S. brand collaboration profits.
– Third quarter LINZESS U.S. net sales growth year-over-year was driven by improved net pricing and strong 12% demand growth in the quarter. As a reminder, gross-to-net rebate reserves in 2025 are based on rebates owed for units dispensed by channel in each applicable quarter. In its first quarter 2025 results, Ironwood stated that it expects gross-to-net rebate reserves based on units dispensed to impact quarterly phasing of 2025 LINZESS U.S. net sales and this dynamic led to a favorable year-over-year net price in the third quarter of 2025.
– LINZESS commercial margin was 76% in the third quarter of 2025, compared to 65% in the third quarter of 2024. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release.
– Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (“R&D”) expenses, was $233.1 million in the third quarter of 2025, a 67% increase compared to $139.6 million in the third quarter of 2024. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release.
- Collaboration Revenue to Ironwood: Ironwood recorded $119.6 million in collaboration revenue in the third quarter of 2025 related to sales of LINZESS in the U.S., a 35% increase compared to $88.9 million for the third quarter of 2024. Third quarter of 2024 collaboration revenue to Ironwood includes a $5.8 million positive adjustment to reflect Ironwood’s estimate of LINZESS gross-to-net reserves as of September 30, 2024. See the U.S. LINZESS Commercial Collaboration table at the end of the press release.
Corporate Updates
- Ironwood continues to progress its engagement with Goldman Sachs & Co. LLC to evaluate strategic alternatives for the Company and plans to provide an update as appropriate.
- In October, Ferring International Center S.A. filed a complaint in the U.S. District Court in the Eastern District of Texas against our wholly-owned subsidiary, VectivBio AG. While Ironwood believes these claims are without merit, it is engaged in settlement negotiations with Ferring to avoid the future cost, expense and distraction of litigation. Accordingly, the Company established an estimated litigation contingency reserve of $7.5 million, with the related charge recorded as part of the third quarter selling, general and administrative (“SG&A”) expenses.
Third Quarter 2025 Financial Results
- Total Revenue. Total revenue in the third quarter of 2025 was $122.1 million, compared to $91.6 million in the third quarter of 2024.
– Total revenue in the third quarter of 2025 consisted of $119.6 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and $2.5 million in royalties and other revenue. Total revenue in the third quarter of 2024 consisted of $88.9 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and $2.7 million in royalties and other revenue.
- Total Costs and Expenses. Total costs and expenses in the third quarter of 2025 were $46.6 million, compared to $66.0 million in the third quarter of 2024.
– Total costs and expenses in the third quarter of 2025 consisted of $21.9 million in selling, general and administrative (“SG&A”) expenses, $22.5 million in R&D expenses, and $2.2 million in restructuring expenses. Total costs and expenses in the third quarter of 2024 consisted of $36.1 million in SG&A expenses, $29.8 million in R&D expenses, and an insignificant amount in restructuring expenses.
– Third quarter 2025 SG&A expenses include an estimated $7.5 million litigation contingency reserve associated with the litigation referenced above.
- Interest Expense. Interest expense was $8.4 million in the third quarter of 2025, in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest expense was $9.4 million in the third quarter of 2024, in connection with Ironwood’s convertible senior notes and revolving credit facility.
- Interest and Investment Income. Interest and investment income was $0.9 million in the third quarter of 2025. Interest and investment income was $1.2 million in the third quarter of 2024.
- Other. Other income was insignificant in the third quarter of 2025 and pertained to a gain recorded for pension-related activities.
- Income Tax Expense. Ironwood recorded $27.9 million of income tax expense in the third quarter of 2025, the majority of which was non-cash, as Ironwood continues to utilize net operating losses to offset taxable income for federal purposes and in many states. Ironwood recorded $13.7 million of income tax expense in the third quarter of 2024, the majority of which was non-cash, as Ironwood continued to utilize net operating losses to offset taxable income for federal purposes and in many states.
- GAAP Net Income. GAAP net income was $40.1 million, or $0.25 per share (basic) and $0.23 per share (diluted) in the third quarter of 2025, compared to GAAP net income of $3.6 million, or $0.02 per share (basic and diluted) in the third quarter of 2024.
- Non-GAAP Net Income. Non-GAAP net income was $41.9 million, or $0.26 per share (basic) and $0.24 per share (diluted), in the third quarter of 2025, compared to non-GAAP net income of $3.9 million, or $0.02 per share (basic and diluted), in the third quarter of 2024.
– Non-GAAP net income excludes the impact of amortization of acquired intangible assets, restructuring expenses and acquisition-related costs, all net of tax effect. See Non-GAAP Financial Measures below.
- Adjusted EBITDA. Adjusted EBITDA was $81.8 million in the third quarter of 2025, compared to $34.5 million in the third quarter of 2024.
– Adjusted EBITDA is calculated by subtracting stock-based compensation, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs, from GAAP net income (loss). See Non-GAAP Financial Measures below.
- Cash Flow Highlights. Ironwood ended the third quarter of 2025 with $140.4 million of cash and cash equivalents, compared to $88.6 million of cash and cash equivalents at the end of 2024.
– The outstanding principal balance on the revolving credit facility was $385.0 million as of September 30, 2025.
– Ironwood generated $47.6 million in cash from operations in the third quarter of 2025, compared to $9.9 million in cash from operations in the third quarter of 2024.
- Ironwood 2025 Financial Guidance. Ironwood is raising its 2025 financial guidance and now expects:
| Prior 2025 Guidance (August 2025) | Updated 2025 Guidance (November 2025) |
U.S. LINZESS Net Sales | $800 - $850 million | $860 - $890 million |
Total Revenue1 | $260 - $290 million | $290 - $310 million |
Adjusted EBITDA2 | >$105 million | >$135 million |
– In the fourth quarter, Ironwood expects continued strong LINZESS prescription demand growth to be more than offset by reduced net price associated with unfavorable quarterly phasing of gross-to-net rebate reserves and increased Medicare Part D redesign impact as compared to third quarter of 2025.
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