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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to
Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
February 27, 2025
IRONWOOD PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
| Delaware |
|
001-34620 |
|
04-3404176 |
| (State
or other jurisdiction |
|
(Commission
File Number) |
|
(I.R.S.
Employer |
| of incorporation) |
|
| |
Identification Number) |
| 100 Summer Street, Suite 2300 |
|
|
|
|
| Boston, Massachusetts |
|
|
|
02110 |
| (Address of principal |
|
|
|
(Zip code) |
| executive offices) |
|
|
|
|
(617)
621-7722
(Registrant’s telephone number,
including area code)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
| Class A common stock, $0.001 par value |
IRWD |
Nasdaq Global Select Market |
Indicate by check mark whether the
registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Item 2.02 Results of Operations and Financial Condition.
On February 27, 2025, Ironwood Pharmaceuticals, Inc.
issued a press release containing an update on its recent business activities as well as those for the quarter and year ended December
31, 2024. A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The press release is being furnished pursuant to
Item 2.02 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall
such document be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act except
as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Ironwood Pharmaceuticals, Inc. |
| Dated: February 27, 2025 |
By: |
/s/
Gregory Martini |
| |
|
Name: Gregory Martini |
| |
|
Title: Senior Vice President, Chief Financial Officer |
Exhibit 99.1
FOR
IMMEDIATE RELEASE
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
number of patients on apraglutide achieving enteral autonomy over time –
– Initiated
rolling NDA submission; on track to be completed in Q3 2025 –
– LINZESS®
(Iinaclotide) EUTRx prescription demand growth of 11% for full-year 2024 year-over-year –
– 2024
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
Ironwood.
"We have
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
patients.”
Fourth Quarter and Full Year 2024
Financial Highlights1
(in thousands, except for per share
amounts)
| |
|
Q4 2024 |
|
|
Q4 2023 |
|
|
FY 2024 |
|
|
FY 2023 |
|
| Total revenue |
|
$ |
90,545 |
|
|
$ |
117,553 |
|
|
$ |
351,410 |
|
|
$ |
442,735 |
|
| Total costs and expenses2 |
|
|
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
| · | Ironwood
is advancing apraglutide, a next-generation, synthetic glucagon-like peptide-2 (“GLP-2”)
analog 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 with once-weekly administration, if approved. |
| – | Data
from the apraglutide open label extension study, STARS Extend, demonstrated that more patients
weaned off PS with longer exposure to apraglutide, with 27 total apraglutide-dosed patients
achieving enteral autonomy. |
| – | Ironwood
has initiated the rolling new drug application (“NDA”) to the U.S. Food and Drug
Administration (“FDA”) for apraglutide for the treatment of adult patients with
SBS who are dependent on PS, with submission completion expected in Q3 2025. |
Continued Strong Demand Growth for
U.S. LINZESS
| · | Prescription
Demand: Total LINZESS prescription demand in the fourth quarter of 2024 was 56 million
LINZESS capsules, a 12% increase compared to the fourth quarter of 2023, per IQVIA. Total
prescription demand was 212 million LINZESS capsules for the full year 2024, a 11% increase
compared to the full year 2023, 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 $223.0 million in the fourth
quarter of 2024, a 19% decrease compared to $274.4 million in the fourth quarter of 2023,
and $916.3 million for the full year 2024, a 15% decrease compared to $1,073.2 million for
the full year 2023. Ironwood and AbbVie share equally in U.S. brand collaboration profits. |
| – | LINZESS
commercial margin was 64% in the fourth quarter of 2024, compared to 77% in the fourth quarter
of 2023. LINZESS commercial margin was 66% for the full year in 2024 and 73% for the full
year in 2023. 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 $135.2 million in the fourth quarter of 2024, a 33%
decrease compared to $202.5 million in the fourth quarter of 2023. Net profit for LINZESS
U.S. brand collaboration, net of commercial and R&D expenses, was $570.9 million for
the full year 2024, a 24% decrease compared to $749.9 million for the full year 2023. See
the U.S. LINZESS Full Brand Collaboration table at the end of this press release. |
| · | Collaboration
Revenue to Ironwood: Ironwood recorded $88.4 million in collaboration revenue in the
fourth quarter of 2024 related to sales of LINZESS in the U.S., a 22% decrease compared to
$114.0 million for the fourth quarter of 2023. Fourth quarter of 2024 collaboration revenue
to Ironwood includes a $7.2 million positive adjustment to reflect Ironwood’s estimate
of LINZESS gross-to-net reserves as of December 31, 2024. Ironwood recorded $340.4 million
in collaboration revenue for the full year 2024 related to the sales of LINZESS in the U.S.,
a 21% decrease compared to $430.5 million in 2023. See the U.S. LINZESS Commercial Collaboration
table at the end of the press release. |
Streamlined Organization Positioned
for Long-Term Success
| · | In
January 2025, Greg Martini was promoted to Senior Vice President, Chief Financial Officer,
and Tammi Gaskins was promoted to Senior Vice President, Chief Commercial Officer. |
| · | In
January 2025, Ironwood announced a streamlined strategic focus on advancing and
realizing the potential of apraglutide in SBS to position the company for long-term growth.
This reorganization included a reduction of Ironwood’s workforce by approximately 50%,
primarily driven by the elimination of the Ironwood field force. Ironwood expects to incur
restructuring charges of approximately $20 to $25 million, which are anticipated to be incurred
primarily in the first half of 2025. As a result of the strategic reorganization, Ironwood
expects to realize approximately $55 to $60 million of annual operating expense savings,
resulting in $40 to $45 million benefit to annual profits, net of impact to collaborative
arrangements revenue. |
Fourth Quarter and Full Year 2024
Financial Results
| · | Total
Revenue. Total revenue in the fourth quarter of 2024 was $90.5 million, compared to $117.6
million in the fourth quarter of 2023. Total revenue for the full year 2024 was $351.4 million,
compared to $442.7 million for the full year 2023. |
| – | Total
revenue in the fourth quarter of 2024 consisted of $88.4 million associated with Ironwood’s
share of the net profits from the sales of LINZESS in the U.S. and $2.1 million in royalties
and other revenue. Total revenue in the fourth quarter of 2023 consisted of $114.0 million
associated with Ironwood’s share of the net profits from the sales of LINZESS in the
U.S. and $3.6 million in royalties and other revenue. |
| – | Total
revenue for the full year 2024 consisted of $340.4 million associated with Ironwood’s
share of the net profits from the sales of LINZESS in the U.S. and $11.0 million in royalties
and other revenue. Total revenue for the full year 2023 consisted of $430.5 million associated
with Ironwood’s share of the net profits from the sales of LINZESS in the U.S. and
$12.2 million in royalites and other revenue. |
| · | Total
Costs and Expenses. Total costs and expenses in the fourth quarter of 2024 were $57.3
million, compared to $80.0 million in the fourth quarter of 2023. Total costs and expenses
for the full year 2024 we $256.6 million, compared to $1,388.2 million for the full year
2023. |
| – | Total
costs and expenses in the fourth quarter of 2024 consisted of $33.3 million in selling, general
and administrative (“SG&A”) expenses, $23.9 million in R&D expenses and
$0.1 million in restructuring expenses. Total costs and expenses in the fourth quarter of
2023 consisted of $38.7 million in SG&A expenses, $35.7 million in R&D expenses,
$5.0 million in acquired in-process research and development, as well as $0.6 million in
restructuring expenses. |
| – | Total
costs and expenses for the full year 2024 consisted primarily of $144.0 million in SG&A
expenses, $110.0 million in R&D expenses and $2.6 million in restructuring expenses.
Total costs and expenses for the full year 2023 consisted primarily of $1.1 billion in acquired
in-process research and development relating to the acquisition of VectivBio, $158.3 million
in SG&A expenses, $116.1 million in R&D expenses and $18.3 million in restructuring
expenses. |
| · | Interest
Expense. Interest expense was $8.9 million in the fourth quarter of 2024 and $33.0 million
for the full year 2024, in connection with Ironwood’s convertible senior notes and
revolving credit facility. Interest expense was $8.4 million in the fourth quarter of 2023
and $21.6 million for the full year 2023, in connection with Ironwood’s convertible
senior notes and revolving credit facility. |
| · | Interest
and Investment Income. Interest and investment income was $0.8 million in the fourth
quarter of 2024 and $4.5 million for the full year 2024. Interest and investment income was
$1.2 million in the fourth quarter of 2023 and $19.0 million for the full year 2023. |
| · | Income
Tax Expense. Ironwood recorded $21.9 million of income tax expense in the fourth quarter
of 2024 and $64.5 million of income tax expense for the full year of 2024, 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 $32.1 million of income
tax expense in the fourth quarter of 2023 and $83.5 million of income tax expense for the
full year of 2023, 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 (Loss) Attributable to Ironwood. GAAP net income attributable to Ironwood
was $3.2 million, or $0.02 per share (basic and diluted) in the fourth quarter of 2024, compared
to GAAP net loss of $1.1 million, or ($0.01) per share (basic and diluted) in the fourth
quarter of 2023. GAAP net income for the full year 2024 was $1.8 million, or $0.01 per share
(basic and diluted), compared to GAAP net loss of $1 billion, or ($6.45) per share (basic
and diluted), for the full year 2023. |
| · | Non-GAAP
Net Income. Non-GAAP net income was $3.5 million, or $0.02 per share (basic and diluted),
in the fourth quarter of 2024, compared to non-GAAP net income of an insignificant amount,
or ($0.00) per share (basic and diluted) in the fourth quarter of 2023. Non-GAAP net income
for the full year 2024 was $5.9 million, or $0.04 per share (basic and diluted), compared
to non-GAAP net loss of $973.8 million, or ($6.27) per share (basic and diluted), for the
full year 2023. |
| – | Non-GAAP
net income (loss) excludes the impact of mark-to-market adjustments on the derivatives related
to Ironwood’s 2022 Convertible Notes, 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 $33.8 million in the fourth quarter of 2024, compared to
$39.9 million in the fourth quarter of 2023. For the full year 2024, adjusted EBITDA was
$100.6 million, compared to ($884.8) million for the full year 2023. |
| – | 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 loss.
See Non-GAAP Financial Measures below. |
| – | Note:
Beginning in the first quarter of 2025, adjusted EBITDA will be calculated by also subtracting
stock-based compensation expense. |
| · | Cash
Flow Highlights. Ironwood ended 2024 with $88.6 million of cash and cash equivalents,
compared to $92.2 million of cash and cash equivalents at the end of 2023. |
| – | In
the fourth quarter of 2024, Ironwood repaid $15.0 million of the outstanding principal
balance on its revolving credit facility. The outstanding principal balance on the revolving
credit facility was $385.0 million as of December 31, 2024. |
| – | Ironwood
generated $15.2 million in cash from operations in the fourth quarter of 2024, compared to
$35.8 million in cash from operations in the fourth quarter of 2023. Ironwood generated
$103.5 million in cash from operations for the full year 2024, compared to $183.4 million
for the full year 2023. |
| · | Ironwood
2025 Financial Guidance. Ironwood continues to expect: |
| | |
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 Revenue1 | |
$260 - $290 million |
| Adjusted EBITDA2 | |
>$85 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.
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:
| · | The
gains and losses on the derivatives related to Ironwood’s 2022 Convertible Notes were
highly variable, difficult to predict, and of a size that could have a substantial impact
on the company’s reported results of operations in any given period. |
| · | Amortization
of acquired intangible assets are non-cash expenses arising in connection with the acquisition
of VectivBio and are considered to be non-recurring. |
| · | Restructuring
expenses are considered to be a non-recurring event as they are associated with distinct
operational decisions. Restructuring expenses include costs associated with exit and disposal
activities. |
| · | Acquisition-related
costs in connection with the acquisition of VectivBio are considered to be non-recurring
and include direct and incremental costs associated with the acquisition and integration
of VectivBio to the extent such costs were not classified as capitalizable transaction costs
attributed to the cost of net assets acquired through acquisition accounting. |
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.
We
routinely post information that may be important to investors on our website at www.ironwoodpharma.com.
In addition, follow us on X and
on LinkedIn.
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
LINZESS® (linaclotide) is indicated
for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults and
functional constipation (FC) in children and adolescents 6 to 17 years of age. It is not known if LINZESS is safe and effective in children
with FC less than 6 years of age or in children with IBS-C less than 18 years of age.
IMPORTANT SAFETY INFORMATION
WARNING:
RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in
patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult
oral dose of linaclotide caused deaths due to dehydration. |
Contraindications
| · | LINZESS
is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. |
| · | LINZESS
is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. |
Warnings and Precautions
| · | LINZESS
is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased
fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism,
which was associated with increased mortality within the first 24 hours due to dehydration.
There was no age dependent trend in GC-C intestinal expression in a clinical study of children
2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal
expression in children less than 2 years of age to assess the risk of developing diarrhea
and its potentially serious consequences in these patients. |
Diarrhea
| · | In
adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the
pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was
similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and
290 mcg LINZESS-treated patients and in <1% of 72 mcg LINZESS-treated CIC patients. |
| · | In
children and adolescents 6 to 17 years of age, diarrhea was the most common adverse reaction
in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe
diarrhea was reported in <1% of 72 mcg LINZESS treated patients. If severe diarrhea occurs,
dosing should be suspended and the patient rehydrated. |
Common Adverse Reactions (incidence
≥2% and greater than placebo)
| · | In
IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension. |
| · | In
FC pediatric patients: diarrhea. |
Please see full Prescribing Information
including Boxed Warning:
https://www.rxabbvie.com/pdf/linzess_pi.pdf
LINZESS® and CONSTELLA® are
registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property
of their respective owners. All rights reserved.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance
on these forward-looking statements, including statements about Ironwood’s ability to execute on its mission; Ironwood’s
strategy, business, financial position and operations; our financial performance and results, and guidance and expectations related thereto;
LINZESS prescription demand growth, LINZESS U.S. net sales growth, total revenue and adjusted EBITDA in 2025; our belief that 2025 will
mark the beginning of a transformation for Ironwood to lay the foundation for growth, long-term value creation, and the delivery of new
medicines to GI and rare disease patients in need; our plan to include the open-label extension study data in our rolling apraglutide
NDA submission and the expected timing to complete such submission; apraglutide’s potential to become a blockbuster drug and significantly
expand treatment options for SBS patients; and our belief that 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 with once-weekly administration, if approved. These forward-looking
statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements.
Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those
expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development
and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development
of linaclotide, apraglutide, IW-3300, and our other product candidates; the risk of uncertainty relating to pricing and reimbursement
policies in the U.S., which, if not favorable for our products, could hinder or prevent our products’ commercial success; the risk
that healthcare reform and other governmental and private payor initiatives may have an adverse effect upon or prevent our products’
or product candidates’ commercial success; the risk that apraglutide will not be approved by the FDA or other regulatory agencies;
the risk that clinical programs and studies, including for linaclotide pediatric programs, apraglutide and IW-3300, may not progress
or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment,
manufacturing, economic or other reasons; the risk that findings from our ongoing and completed nonclinical studies and clinical trials
may not be replicated in later trials or further data analyses and earlier-stage clinical trials may not be predictive of the results
we may obtain in later-stage clinical trials or of the likelihood of regulatory approval; the risk of competition or that new products
may emerge that provide different or better alternatives for treatment of the conditions that our products are approved to treat; the
risk that we are unable to execute on our strategy to in-license externally developed products or product candidates; the risk that we
are unable to successfully partner with other companies to develop and commercialize products or product candidates; the efficacy, safety
and tolerability of linaclotide and our product candidates; the risk that the commercial and therapeutic opportunities for LINZESS, apraglutide
or our other product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional
patent protection for linaclotide, apraglutide and other product candidates, that patents for linaclotide, apraglutide or other products
may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that we
are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the risk that the development
of any of our linaclotide pediatric programs, apraglutide and/or IW-3300 is not successful or that any of our product candidates does
not receive regulatory approval or is not successfully commercialized; outcomes in legal proceedings to protect or enforce the patents
relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating
results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors
or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; developments
in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices
as between Ironwood and AbbVie; the risk that our indebtedness could adversely affect our financial condition or restrict our future
operations; and the risks listed under the heading “Risk Factors” and elsewhere in our Annual Report on Form 10-K for
the year ended December 31, 2023, and in our subsequent Securities and Exchange Commission filings.
Company contact:
Greg Martini
Chief Financial Officer
gmartini@ironwoodpharma.com
Investors:
Precision AQ (formerly Stern Investor Relations)
Stephanie Ascher
Stephanie.Ascher@precisionaq.com
Condensed Consolidated
Balance Sheets
(In thousands)
(unaudited)
| | |
December 31, 2024 | | |
December 31,
2023 | |
| Assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 88,559 | | |
$ | 92,154 | |
| Accounts receivable, net | |
| 81,886 | | |
| 129,122 | |
| Prepaid expenses and other current assets | |
| 11,973 | | |
| 12,012 | |
| Total current assets | |
| 182,418 | | |
| 233,288 | |
| Property and equipment, net | |
| 4,495 | | |
| 5,585 | |
| Operating lease right-of-use assets | |
| 11,028 | | |
| 12,586 | |
| Intangible assets, net | |
| 2,860 | | |
| 3,682 | |
| Deferred tax assets | |
| 144,576 | | |
| 212,324 | |
| Other assets | |
| 5,923 | | |
| 3,608 | |
| Total assets | |
$ | 351,300 | | |
$ | 471,073 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Accounts payable | |
$ | 2,127 | | |
$ | 7,830 | |
| Accrued research and development costs | |
| 6,924 | | |
| 21,331 | |
| Accrued expenses and other current liabilities | |
| 26,907 | | |
| 44,254 | |
| Current portion of operating lease liabilities | |
| 3,189 | | |
| 3,126 | |
| Current portion on convertible senior notes | |
| - | | |
| 199,560 | |
| Total current liabilities | |
| 39,147 | | |
| 276,101 | |
| Operating lease liabilities, net of current portion | |
| 12,304 | | |
| 14,543 | |
| Convertible senior notes, net of current portion | |
| 198,988 | | |
| 198,309 | |
| Revolving credit facility | |
| 385,000 | | |
| 300,000 | |
| Other liabilities | |
| 17,106 | | |
| 28,415 | |
| Total stockholders’ deficit | |
| (301,245 | ) | |
| (346,295 | ) |
| Total liabilities and stockholders’ deficit | |
$ | 351,300 | | |
$ | 471,073 | |
Condensed Consolidated
Statements of Income (Loss)
(In thousands,
except per share amounts)
(unaudited)
| | |
Three
Months Ended December 31, | | |
Twelve
Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| Total revenues | |
$ | 90,545 | | |
$ | 117,553 | | |
$ | 351,410 | | |
$ | 442,735 | |
| Collaborative arrangements revenue | |
| 90,545 | | |
| 117,553 | | |
| 351,410 | | |
| 442,735 | |
| Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
| Research and development | |
| 23,925 | | |
| 35,676 | | |
| 109,955 | | |
| 116,085 | |
| Selling, general and administrative | |
| 33,330 | | |
| 38,667 | | |
| 144,012 | | |
| 158,314 | |
| Restructuring | |
| 73 | | |
| 621 | | |
| 2,593 | | |
| 18,317 | |
| Acquired in-process research and development | |
| - | | |
| 5,000 | | |
| - | | |
| 1,095,449 | |
| Total
costs and expenses1 | |
| 57,328 | | |
| 79,964 | | |
| 256,560 | | |
| 1,388,165 | |
| Income (loss) from operations | |
| 33,217 | | |
| 37,589 | | |
| 94,850 | | |
| (945,430 | ) |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Interest expense and other financing
costs | |
| (8,915 | ) | |
| (8,423 | ) | |
| (33,035 | ) | |
| (21,629 | ) |
| Interest and investment income | |
| 778 | | |
| 1,194 | | |
| 4,468 | | |
| 18,971 | |
| Gain on derivatives | |
| - | | |
| - | | |
| - | | |
| 19 | |
| Other income (expense), net | |
| (8,137 | ) | |
| (7,229 | ) | |
| (28,567 | ) | |
| (2,639 | ) |
| Income (loss) before income taxes | |
| 25,080 | | |
| 30,360 | | |
| 66,283 | | |
| (948,069 | ) |
| Income tax expense | |
| (21,891 | ) | |
| (32,105 | ) | |
| (64,470 | ) | |
| (83,490 | ) |
GAAP
net income (loss)1 | |
| 3,189 | | |
| (1,745 | ) | |
| 1,813 | | |
| (1,031,559 | ) |
| Less: GAAP net loss attributable to noncontrolling interests | |
| - | | |
| (658 | ) | |
| - | | |
| (29,320 | ) |
| GAAP net income (loss) 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 | ) |
1 Figures presented for the twelve months
ended December 31, 2023 include a one-time charge of approximately $1.1 billion related to acquired IPR&D from the acquisition of
VectivBio in the second quarter of 2023.
Reconciliation
of GAAP Results to Non-GAAP Financial Measures
(In
thousands, except per share amounts) (unaudited)
A reconciliation between net income
(loss) on a GAAP basis and on a non-GAAP basis is as follows:
| | |
Three
Months Ended December 31, | | |
Twelve
Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| GAAP
net income (loss)1 | |
$ | 3,189 | | |
$ | (1,745 | ) | |
$ | 1,813 | | |
$ | (1,031,559 | ) |
| Adjustments: | |
| | | |
| | | |
| | | |
| | |
| Mark-to-market adjustments on the derivatives related to convertible
notes, net | |
| - | | |
| - | | |
| - | | |
| (19 | ) |
| Amortization of acquired intangible assets | |
| 207 | | |
| 207 | | |
| 822 | | |
| 418 | |
| Restructuring expenses | |
| 73 | | |
| 621 | | |
| 2,593 | | |
| 18,317 | |
| Acquisition-related costs | |
| - | | |
| 1,173 | | |
| 1,146 | | |
| 40,718 | |
| Tax effect of adjustments | |
| - | | |
| (217 | ) | |
| (461 | ) | |
| (1,663 | ) |
| Non-GAAP
net income (loss)1 | |
$ | 3,469 | | |
$ | 39 | | |
$ | 5,913 | | |
$ | (973,788 | ) |
A reconciliation between basic net income
(loss) per share on a GAAP basis and on a non-GAAP basis is as follows:
| |
|
Three
Months Ended
December 31, |
|
|
Twelve
Months Ended
December 31, |
|
| |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
| GAAP
net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – basic |
|
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
0.01 |
|
|
$ |
(6.45 |
) |
| Plus: Net income
(loss) per share attributable to noncontrolling interests – basic |
|
|
- |
|
|
|
(0.00 |
) |
|
|
- |
|
|
|
(0.19 |
) |
| Adjustments to GAAP net income per share (as detailed above) |
|
|
- |
|
|
|
0.01 |
|
|
|
0.03 |
|
|
|
0.37 |
|
| Non-GAAP net income (loss) per share – basic |
|
$ |
0.02 |
|
|
$ |
(0.00 |
) |
|
$ |
0.04 |
|
|
$ |
(6.27 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average
number of common shares used to calculate net income (loss) per share — basic |
|
|
159,895 |
|
|
|
156,014 |
|
|
|
159,083 |
|
|
|
155,435 |
|
A reconciliation between diluted net
income (loss) per share on a GAAP basis and on a non-GAAP basis is as follows:
1 Figures presented for the twelve months ended December
31, 2023 include a one-time charge of approximately $1.1 billion related to acquired IPR&D from the acquisition of VectivBio in the
second quarter of 2023.
| | |
Three
Months Ended December 31, | | |
Twelve
Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| GAAP net income (loss) attributable to Ironwood
Pharmaceuticals, Inc. per share – diluted | |
$ | 0.02 | | |
$ | (0.01 | ) | |
$ | 0.01 | | |
$ | (6.45 | ) |
| Plus: Net income (loss) per share attributable to noncontrolling interests –
diluted | |
| - | | |
| (0.00 | ) | |
| - | | |
| (0.19 | ) |
| Adjustments to GAAP net income per share (as detailed above) | |
| - | | |
| 0.01 | | |
| 0.03 | | |
| 0.37 | |
| Non-GAAP net income (loss) per share – diluted | |
$ | 0.02 | | |
$ | (0.00 | ) | |
$ | 0.04 | | |
$ | (6.27 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted
average number of common shares used to calculate net income (loss) per share — diluted | |
| 160,419 | | |
| 156,014 | | |
| 160,084 | | |
| 155,
435 | |
Reconciliation
of GAAP Net Income (Loss) to Adjusted EBITDA
(In thousands)
(unaudited)
A reconciliation of GAAP net income
(loss) to adjusted EBITDA:
| | |
Three
Months Ended December 31, | | |
Twelve
Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| GAAP
net income (loss)1 | |
$ | 3,189 | | |
$ | (1,745 | ) | |
$ | 1,813 | | |
$ | (1,031,559 | ) |
| Adjustments: | |
| | | |
| | | |
| | | |
| | |
| Mark-to-market
adjustments on the derivatives related to convertible notes, net | |
| - | | |
| - | | |
| - | | |
| (19 | ) |
| Restructuring expenses | |
| 73 | | |
| 621 | | |
| 2,593 | | |
| 18,317 | |
| Interest expense | |
| 8,915 | | |
| 8,423 | | |
| 33,035 | | |
| 21,629 | |
| Interest and investment income | |
| (778 | ) | |
| (1,194 | ) | |
| (4,468 | ) | |
| (18,971 | ) |
| Income tax expense | |
| 21,891 | | |
| 32,105 | | |
| 64,470 | | |
| 83,490 | |
| Depreciation and amortization | |
| 485 | | |
| 512 | | |
| 2,011 | | |
| 1,575 | |
| Acquisition-related costs | |
| - | | |
| 1,173 | | |
| 1,146 | | |
| 40,718 | |
| Adjusted
EBITDA1 | |
$ | 33,775 | | |
$ | 39,895 | | |
$ | 100,600 | | |
$ | (884,820 | ) |
1
Figures presented for the twelve months ended December 31, 2023 include a one-time charge of approximately $1.1 billion related
to acquired IPR&D from the acquisition of VectivBio in the second quarter of 2023.
U.S. LINZESS
Commercial Collaboration1
Revenue/Expense
Calculation
(In thousands)
(unaudited)
| | |
Three
Months Ended December 31, | | |
Twelve
Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| LINZESS
U.S. net sales as reported by AbbVie2 | |
$ | 222,961 | | |
$ | 274,356 | | |
$ | 916,281 | | |
$ | 1,073,210 | |
| AbbVie &
Ironwood commercial costs, expenses and other discounts3 | |
| 80,527 | | |
| 62,903 | | |
| 313,338 | | |
| 286,045 | |
| Commercial profit on sales of LINZESS | |
$ | 142,434 | | |
$ | 211,453 | | |
$ | 602,943 | | |
$ | 787,165 | |
| Commercial
Margin4 | |
| 64 | % | |
| 77 | % | |
| 66 | % | |
| 73 | % |
| | |
| | | |
| | | |
| | | |
| | |
| Ironwood’s share of net profit | |
| 71,217 | | |
| 105,727 | | |
| 301,472 | | |
| 393,583 | |
| Reimbursement for Ironwood’s commercial expenses | |
| 9,961 | | |
| 8,260 | | |
| 38,922 | | |
| 36,875 | |
| Adjustment for Ironwood’s estimate of LINZESS gross-to-net
reserves | |
| 7,200 | | |
| - | | |
| - | | |
| - | |
| Ironwood’s
U.S. collaborative arrangements revenue5 | |
$ | 88,378 | | |
$ | 113,987 | | |
$ | 340,394 | | |
$ | 430,458 | |
1
Ironwood collaborates with AbbVie on the development and commercialization of linaclotide
in North America. Under the terms of the collaboration agreement, Ironwood receives 50% of the net profits and bears 50% of the net losses
from the commercial sale of LINZESS in the U.S. The purpose of this table is to present calculations of Ironwood’s share of net
profit (loss) generated from the sales of LINZESS in the U.S. and Ironwood’s collaboration revenue/expense; however, the table
does not present the research and development expenses related to LINZESS in the U.S. that are shared equally between the parties under
the collaboration agreement. Please refer to the table at the end of this press release for net profit for the U.S. LINZESS brand collaboration
with AbbVie.
2
LINZESS net sales are recognized using AbbVie’s revenue recognition accounting policies
and reporting conventions. As a result, certain rebates and discounts are classified as LINZESS U.S. commercial costs, expenses and other
discounts within Ironwood’s calculation of collaborative arrangements revenue.
3
Includes certain discounts recognized and cost of goods sold incurred by AbbVie; also includes
commercial costs incurred by AbbVie and Ironwood that are attributable to the cost-sharing arrangement between the parties.
4
Commercial margin is defined as commercial profit on sales of LINZESS as a percent of total
LINZESS U.S. net sales.
5
Figures presented for the three months ended December 31, 2024 include a $7.2 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 December 31, 2024.
US LINZESS Full
Brand Collaboration1
Revenue/Expense
Calculation
(In
thousands)
(unaudited)
| | |
Three
Months Ended December 31, | | |
Twelve
Months Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| LINZESS
U.S. net sales as reported by AbbVie2 | |
$ | 222,961 | | |
$ | 274,356 | | |
$ | 916,281 | | |
$ | 1,073,210 | |
| AbbVie &
Ironwood commercial costs, expenses and other discounts3 | |
| 80,527 | | |
| 62,903 | | |
| 313,338 | | |
| 286,045 | |
| AbbVie &
Ironwood R&D Expenses4 | |
| 7,242 | | |
| 8,980 | | |
| 32,065 | | |
| 37,250 | |
| Total
net profit on sales of LINZESS | |
$ | 135,192 | | |
$ | 202,473 | | |
$ | 570,878 | | |
$ | 749,915 | |
1
Ironwood collaborates with AbbVie on the development and commercialization of linaclotide
in North America. Under the terms of the collaboration agreement, Ironwood receives 50% of the net profits and bears 50% of the net losses
from the commercial sale of LINZESS in the U.S. The purpose of this table is to present calculations of the total net profit (loss) generated
from the sales of LINZESS in the U.S., including the commercial costs and expenses and the research and development expenses related
to LINZESS in the U.S. that are shared equally between the parties under the collaboration agreement.
2
LINZESS net sales are recognized using AbbVie’s revenue recognition accounting policies
and reporting conventions. As a result, certain rebates and discounts are classified as LINZESS U.S. commercial costs, expenses and other
discounts within Ironwood’s calculation of collaborative arrangements revenue.
3
Includes certain discounts recognized and cost of goods sold incurred by AbbVie; also includes
commercial costs incurred by AbbVie and Ironwood that are attributable to the cost-sharing arrangement between the parties.
4
Expenses related to LINZESS in the U.S. are shared equally between Ironwood and AbbVie under
the collaboration agreement.
v3.25.0.1
Cover
|
Feb. 27, 2025 |
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Feb. 27, 2025
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| Entity File Number |
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|
| Entity Registrant Name |
IRONWOOD PHARMACEUTICALS, INC.
|
| Entity Central Index Key |
0001446847
|
| Entity Tax Identification Number |
04-3404176
|
| Entity Incorporation, State or Country Code |
DE
|
| Entity Address, Address Line One |
100 Summer Street
|
| Entity Address, Address Line Two |
Suite 2300
|
| Entity Address, City or Town |
Boston
|
| Entity Address, State or Province |
MA
|
| Entity Address, Postal Zip Code |
02110
|
| City Area Code |
617
|
| Local Phone Number |
621-7722
|
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dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
| Name: |
dei_DocumentPeriodEndDate |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:dateItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
| Name: |
dei_DocumentType |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:submissionTypeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
| Name: |
dei_EntityAddressAddressLine1 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 2 such as Street or Suite number
| Name: |
dei_EntityAddressAddressLine2 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- Definition
+ References
+ Details
| Name: |
dei_EntityAddressCityOrTown |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCode for the postal or zip code
| Name: |
dei_EntityAddressPostalZipCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the state or province.
| Name: |
dei_EntityAddressStateOrProvince |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:stateOrProvinceItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityCentralIndexKey |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:centralIndexKeyItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionIndicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityEmergingGrowthCompany |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
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|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
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| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
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| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
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|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
Ironwood Pharmaceuticals (NASDAQ:IRWD)
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Ironwood Pharmaceuticals (NASDAQ:IRWD)
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