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Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Results; Achieves 2024 Financial Guidance - Announced positive data from open-label extension study demonstrating an increased numb

Key Takeaway: Ironwood Pharmaceuticals reported its fourth quarter and full year 2024 results, achieving a total revenue of $351 million and stable net income of $2 million. The company highlighted significant progress in the clinical development of apraglutide, with promising data from an open-label study showcasing increased patient benefit over time. Looking ahead, Ironwood is advancing its rolling NDA submission for apraglutide, aiming for completion by Q3 2025. The company also noted a year-over-year growth in prescription demand for its Iinaclotide product, though overall total revenue declined compared to the previous year.

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Full Press Release Details

Ironwood Pharmaceuticals
Reports Fourth Quarter and Full Year 2024 Results; Achieves 2024 Financial Guidance
positive data from open-label extension study demonstrating an increased
number of patients on apraglutide achieving enteral autonomy over time -
rolling NDA submission; on track to be completed in Q3 2025 -
(Iinaclotide) EUTRx prescription demand growth of 11% for full-year 2024 year-over-year -
Ironwood revenue of $351 million, GAAP net income of $2 million and adjusted EBITDA of $101 million -
BOSTON, Mass., February 27,
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 fourth quarter and full year 2024 results
and recent business performance.
"We believe that 2025 marks the
beginning of a transformation for Ironwood that will lay the foundation for growth, long-term value creation, and the delivery of new
medicines to rare disease and GI patients in need. We have taken strategic actions to position our organization for success, including
streamlining our business operations and advancing the clinical development of apraglutide, while maintaining disciplined financial stewardship
to drive cash flows, pay down our debt, and further strengthen our balance sheet," said Tom McCourt, chief executive officer of
initiated the rolling NDA submission for apraglutide, and we are working with urgency to complete the submission and prepare for potential
launch. Our confidence in apraglutide continues to grow, especially in light of the data we shared in January from the open-label
extension study. These results show a continued increase in clinical benefit over time, with 27 total apraglutide-dosed patients achieving
enteral autonomy. Given these compelling new long-term data, we plan to include additional extension study data in our NDA to deliver
a more robust, clinically differentiated, and comprehensive submission package. If approved, apraglutide would be the first and only
once-weekly GLP-2 therapy, reinforcing its potential to become a blockbuster drug and significantly expand treatment options for SBS
Fourth Quarter and Full Year 2024
Financial Highlights1
(in thousands, except for per share
Q4 2024 Q4 2023 FY 2024 FY 2023
Total revenue $ 90,545 $ 117,553 $ 351,410 $ 442,735
Total costs and expenses 2 57,328 79,964 256,560 1,388,165
GAAP net income (loss) 2 3,189 (1,745 ) 1,813 (1,031,559 )
GAAP net income (loss) 2 attributable to Ironwood Pharmaceuticals, Inc. 3,189 (1,087 ) 1,813 (1,002,239 )
GAAP net income (loss) - per share basic 0.02 (0.01 ) 0.01 (6.45 )
GAAP net income (loss) - per share diluted 0.02 (0.01 ) 0.01 (6.45 )
Adjusted EBITDA 2 33,775 39,895 100,600 (884,820 )
Non-GAAP net income (loss) 2 3,469 39 5,913 (973,788 )
Non-GAAP net income (loss) per share - basic 0.02 (0.00 ) 0.04 (6.27 )
Non-GAAP net income (loss) per share - diluted 0.02 (0.00 ) 0.04 (6.27 )
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
twelve months ended December 31, 2023 include a one-time charge of approximately $1.1 billion related to acquired in-process research
and development from the acquisition of VectivBio in the second quarter of 2023.
Fourth Quarter and Full Year 2024
Corporate Highlights
Apraglutide in SBS Advancing Through
Regulatory Submission and Review
Continued Strong Demand Growth for
Streamlined Organization Positioned
for Long-Term Success
Fourth Quarter and Full Year 2024
2025 Guidance (February 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 >$85 million
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.
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 by other companies.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income
(loss) and non-GAAP net income (loss) per share to exclude the impact, net of tax effects, of net gains and losses on derivatives related
to Ironwood's 2022 Convertible Notes that are required to be marked-to-market, amortization of acquired intangible assets, restructuring
expenses, and acquisition-related costs. 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 mark-to-market adjustments on
derivatives related to Ironwood's 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation
and amortization, and acquisition-related costs from GAAP net income. Beginning in the first quarter of 2025, adjusted EBITDA will be
calculated by also subtracting stock-based compensation expense. 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.
Conference Call Information
Ironwood will host a conference call
and webcast at 8:30 a.m. Eastern Time on Thursday, February 27, 2025 to discuss its fourth quarter and full year 2024 results
and recent business activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S. and Canada) or (646)
968-2525 (international) using conference ID number and event passcode 2530602. To access the webcast, please visit the Investors section
of Ironwood's website at www.ironwoodpharma.com. The call will be available for replay via telephone starting Thursday,
February 27, 2025, at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on Thursday, March 13,
2025. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international) using conference ID number 2530602.
The archived webcast will be available on Ironwood's website for 1 year beginning approximately one hour after the call has completed.
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.

Frequently Asked Questions

What were Ironwood's total revenues for full-year 2024?

Ironwood's total revenue for full-year 2024 was $351 million.

What is apraglutide's significance in Ironwood's pipeline?

Apraglutide could be the first once-weekly GLP-2 therapy, aiming to treat Short Bowel Syndrome (SBS).

What are the 2025 revenue guidance figures for Ironwood?

Ironwood's 2025 total revenue guidance is projected at $260 to $290 million.

How did Ironwood's adjusted EBITDA perform in 2024?

Ironwood's adjusted EBITDA for full-year 2024 was $101 million.

When will Ironwood submit the NDA for apraglutide?

Ironwood plans to complete the rolling NDA submission for apraglutide in Q3 2025.

Last updated: Feb 27, 2025