Full Press Release Details
Ironwood Pharmaceuticals Reports Second Quarter
2025 Results; Maintains Full Year 2025
(Iinaclotide) U.S. net sales of $248 million in Q2 2025; EUTRx demand growth of 10% year-over-year -
to align with FDA on confirmatory Phase 3 trial design in Q4 2025 -
previously announced strategic alternatives review to maximize shareholder value -
BOSTON, Mass., August 7, 2025 - 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 second quarter 2025 results and recent business performance.
"In the second quarter, LINZESS delivered $248 million in U.S.
net sales with robust EUTRx demand growth of 10% year-over-year. Additionally, LINZESS net price was in-line with our expectations for
the quarter, further reinforcing our belief that we are on track to achieve our latest full year 2025 financial guidance. For apraglutide,
we have been finalizing a confirmatory Phase 3 trial design and plan to align with the FDA in the fourth quarter," said Tom McCourt,
chief executive officer of Ironwood. "In parallel, we continue to evaluate all paths to increase shareholder value. We have two
valuable assets, each of which we believe is worth more individually than our market cap today. We are actively progressing our strategic
alternatives review process and look forward to providing an update as soon as possible."
Quarter 2025 Financial Highlights1
(in thousands, except for per share amounts)
| Q2 2025 | Q2 2024 | |||||||
| Total revenue 2 | $ | 85,239 | $ | 94,396 | ||||
| Total costs and expenses | 39,918 | 69,419 | ||||||
| GAAP net income (loss) 2 | 23,599 | (860 | ) | |||||
| GAAP net income (loss) - per share basic 2 | 0.15 | (0.01 | ) | |||||
| GAAP net income (loss) - per share diluted 2 | 0.14 | (0.01 | ) | |||||
| Adjusted EBITDA 2, 3 | 50,101 | 36,479 | ||||||
| Non-GAAP net income 2 | 23,623 | 1,508 | ||||||
| Non-GAAP net income per share - basic 2 | 0.15 | 0.00 | ||||||
| Non-GAAP net income per share - diluted 2 | 0.14 | 0.00 |
1 Refer to the Reconciliation of GAAP Results to Non-GAAP
Financial Measures table and to the Reconciliation of GAAP Net Income (Loss) 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 second quarter of 2024
include a $17.0 million adjustment to collaborative arrangements revenue, driven by a $30.0 million increase to collaborative
arrangements revenue as a result of a gross-to-net change in estimate related to the year ended December 31, 2023, previously
recorded by Ironwood in the first quarter of 2024, which was reflected in LINZESS U.S. net sales as reported by AbbVie in the second
quarter of 2024. This was partially offset by a $13.0 million reduction to collaborative arrangements revenue in the second quarter
of 2024, to reflect Ironwood's estimate of LINZESS gross-to-net reserves as of June 30, 2024.
3Adjusted EBITDA is calculated by subtracting restructuring
expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation, from GAAP net income (loss).
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, second quarter 2024 Adjusted EBITDA has also been updated to reflect this updated
Corporate Highlights
Second Quarter 2025 Financial Results
| 2025 Guidance (August 2025) | |
| U.S. LINZESS Net Sales | $800 - $850 million High single digit prescription demand growth, more than offset by expected price erosion due to Medicare Part D redesign |
| Total Revenue 1 | $260 - $290 million |
| Adjusted EBITDA 2 | >$105 million |
1 Ironwood's U.S. collaborative arrangements
revenue includes reimbursement from AbbVie for a portion of Ironwood's commercial expenses related to sales of LINZESS in the U.S.
The FY2025 total revenue guidance accounts for the impact of the reduction to Ironwood's commercial expenses and corresponding
reimbursement from AbbVie due to Ironwood's strategic reorganization announced in January 2025.
2 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 purposes of this guidance, we have assumed that Ironwood will not incur material expenses related to business development
activities in 2025. Ironwood does not provide guidance on GAAP net income or a reconciliation of expected adjusted EBITDA to expected
GAAP net income because, without unreasonable efforts, it is unable to predict with reasonable certainty the non-GAAP adjustments used
to calculate adjusted EBITDA. These adjustments are uncertain, depend on various factors and could have a material impact on GAAP net
income for the guidance period. Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood's
GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood's
operating performance. These measures are also used by management to assess the performance of the business. Investors should consider
these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared
in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income (loss) and non-GAAP net income
(loss) per share to exclude amortization of acquired intangible assets, restructuring expenses, and acquisition-related costs, all net
of tax effect. Non-GAAP adjustments are further detailed below:
Ironwood also presents adjusted EBITDA, a non-GAAP measure, as well
as guidance on adjusted EBITDA. 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. The adjustments are made on
a similar basis as described above related to non-GAAP net income (loss), as applicable.
Management believes this non-GAAP information is useful for investors,
taken in conjunction with Ironwood's GAAP financial statements, because it provides greater transparency and period-over-period
comparability with respect to Ironwood's operating performance. These measures are also used by management to assess the performance
of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to,
measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be
comparable with non-GAAP information provided by other companies. For a reconciliation of non-GAAP net income (loss) and non-GAAP net
income (loss) per share to GAAP net income (loss) and GAAP net income (loss) per share, respectively, and for a reconciliation of adjusted
EBITDA to GAAP net income (loss), please refer to the tables at the end of this press release.
Ironwood does not provide guidance on GAAP net income or a reconciliation
of expected adjusted EBITDA to expected GAAP net income because, without unreasonable efforts, it is unable to predict with reasonable
certainty the non-GAAP adjustments used to calculate adjusted EBITDA. These adjustments are uncertain, depend on various factors
and could have a material impact on GAAP net income for the guidance period.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a biotechnology
company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases. Ironwood
is advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for short bowel syndrome patients who
are dependent on parenteral support. In addition, Ironwood has been a pioneer in the development of LINZESS (linaclotide), the
U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation
(CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years old. Building upon
our history of innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of diseases
and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals
is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland.
We routinely post information that may
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About LINZESS (Linaclotide)
LINZESS is the #1 prescribed brand in the U.S. for the
treatment of adult patients with irritable bowel syndrome with constipation ("IBS-C") or chronic idiopathic constipation
("CIC"), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and
overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools,
hard stools, straining, and incomplete evacuation associated with CIC. LINZESS relieves constipation in children and adolescents
aged 6 to 17 years with functional constipation. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients,
with a 72 mcg dose approved for use in CIC depending on individual patient presentation or tolerability. In children with functional
constipation aged 6 to 17 years, the recommended dose is 72 mcg.
LINZESS is not a laxative; it is the first medicine approved by the
FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine.
Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity
of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has
not been established.
In the United States, Ironwood and AbbVie co-develop and co-commercialize
LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA for the