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Ironwood Pharmaceuticals Reports First Quarter 2025 Results - On track to achieve FY 2025 financial guidance; raised adjusted EBITDA guidance to greater than $105 million for 2025 - - LINZESS (Iinac

Key Takeaway: Ironwood Pharmaceuticals announced its first-quarter 2025 results, reporting continued strong demand for its LINZESS product, which saw an 8% growth compared to the previous year. The company has raised its adjusted EBITDA guidance to over $105 million for 2025. However, total revenue has dropped significantly compared to the same period last year, leading to a larger GAAP net loss. Ironwood is actively exploring strategic alternatives to enhance shareholder value amid these financial shifts.

Market Sentiment Analysis

POSITIVE FACTORS

  • Ironwood raised its adjusted EBITDA guidance to over $105 million for 2025.
  • LINZESS demand grew by 8% year-over-year, in line with expectations.
  • The company is actively pursuing strategic alternatives to enhance stockholder value.

CONCERNS & RISKS

  • Ironwood reported a significant GAAP net loss of $37,386 compared to $4,162 in Q1 2024.
  • Total revenue decreased from $74,877 in Q1 2024 to $41,143 in Q1 2025.

Full Press Release Details

Pharmaceuticals Reports First Quarter 2025 Results
- On track to achieve
FY 2025 financial guidance; raised adjusted EBITDA guidance to greater than $105 million for 2025 -
- LINZESS (Iinaclotide) EUTRx prescription
demand growth of 8% year-over-year; in line with full-year expectations -
strategic alternatives to maximize stockholder value -
BOSTON, Mass., May 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 first quarter 2025 results and recent business performance.
"LINZESS demand continues to be strong, and we remain on track
to meet our full-year 2025 guidance and further, recently raised our adjusted EBITDA guidance. We are making a concerted effort to maximize
stockholder value across all areas of the business, including advancing plans for a confirmatory Phase 3 trial for apraglutide and exploring
strategic alternatives," said Tom McCourt, chief executive officer of Ironwood.
First Quarter 2025 Financial Highlights1
(in thousands, except for per share amounts)
Q1 2025 Q1 2024
Total revenue 2 $ 41,143 $ 74,877
Total costs and expenses 70,251 63,857
GAAP net loss (37,386 ) (4,162 )
GAAP net loss - per share basic and diluted (0.23 ) (0.03 )
Adjusted EBITDA 3 (4,742 ) 21,142
Non-GAAP net loss (23,228 ) (2,933 )
Non-GAAP net loss per share - basic and diluted (0.14 ) (0.02 )
1 Refer to the Reconciliation of GAAP Results to Non-GAAP
Financial Measures table and to the Reconciliation of GAAP Net Loss to Adjusted EBITDA table at the end of this press release. Refer to
Non-GAAP Financial Measures for additional information.
2 Total revenue for three months ended March 31, 2025
reflects a change in estimate of AbbVie gross-to-net rebate reserves, which was refined to reflect rebates owed for units dispensed in
the first quarter of 2025. Ironwood does not expect first quarter LINZESS U.S. net sales results or this change in estimate to impact
the full-year results.
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, first quarter 2024 Adjusted EBITDA has also been updated to reflect this updated definition.
2025 Corporate Highlights
First Quarter 2025 Financial Results
2025 Guidance (May 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
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 and GAAP net income per share, respectively, and for a reconciliation of adjusted EBITDA to
GAAP net income, 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.
routinely post information that may be important to investors on our website at www.ironwoodpharma.com.
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
treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name
LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization
of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE

Frequently Asked Questions

What was Ironwood's adjusted EBITDA guidance for 2025?

Ironwood raised its adjusted EBITDA guidance to over $105 million for 2025.

How did LINZESS demand change year-over-year?

LINZESS prescription demand grew by 8% year-over-year, aligning with expectations.

What were Ironwood's total revenues in Q1 2025?

Ironwood reported total revenues of $41,143,000 for Q1 2025.

What is the purpose of Ironwood's strategic alternatives?

Ironwood is exploring strategic alternatives to maximize stockholder value.

What patient conditions does LINZESS treat?

LINZESS treats adults with IBS-C, CIC, and children aged 6-17 with functional constipation.

Last updated: May 7, 2025