Form 8-K
8-K — IRONWOOD PHARMACEUTICALS INC
Accession: 0001104659-26-091625
Filed: 2026-08-06
Period: 2026-08-06
CIK: 0001446847
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
8-K — tm2622244d1_8k.htm (Primary)
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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):
August 6, 2026
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 August 6, 2026, Ironwood Pharmaceuticals, Inc.
issued a press release containing an update on its recent business activities as well as those for the quarter ended June 30, 2026.
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.
Exhibit No.
Description
99.1
Ironwood Pharmaceuticals, Inc. Press Release dated August 6, 2026
104
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL
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: August 6, 2026
By:
/s/ Ronald Silver
Name: Ronald Silver
Title: Interim Chief Financial Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2622244d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
FOR
IMMEDIATE RELEASE
Ironwood Pharmaceuticals
Raises 2026 Full-Year Financial Guidance Building on
Strong Second
Quarter Results
– Raises
full-year 2026 LINZESS® (linaclotide) U.S. net sales guidance to $1.15 - $1.20 billion, representing greater than
30% increase year-over-year; Raises total revenue guidance to $460 - $485 million and adjusted EBITDA guidance to
greater than $310 million –
– Q2 2026
LINZESS U.S. net sales of $282 million; $555 million year-to-date representing 44% year-over-year growth –
– Total
revenue of $113 million, GAAP net income of $51 million and adjusted EBITDA of $83 million in Q2 2026; repaid $200 million convertible
notes with cash on hand –
– Confirmatory
Phase 3 STARS-2 trial of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) now actively recruiting
patients –
BOSTON, Mass., August 6, 2026 —
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 2026 results and recent business performance.
“Throughout the first half of
the year, we have remained laser focused on meaningful execution of our three strategic priorities: maximizing LINZESS, advancing apraglutide,
and delivering sustained profits and cash flows,” said Tom McCourt, chief executive officer of Ironwood. “We are pleased
to report a second consecutive quarter of strong performance for LINZESS, fueled by improved net price and mid-single digit prescription
demand growth which supported our decision to raise our full-year 2026 financial guidance. We also repaid our $200 million convertible
notes during the quarter using cash on hand and remain committed to further debt reduction and strengthening our balance sheet through
year end.”
“Importantly, we initiated STARS-2
and are actively recruiting patients in this confirmatory Phase 3 trial of apraglutide with the goal that it will be the first long-acting
GLP-2 analog to market. Based on the positive Phase 3 STARS data and the confirmatory design of STARS-2, we are confident that apraglutide
has the potential to be a best-in-class therapy for people with short bowel syndrome with intestinal failure, a condition with significant
unmet need,” McCourt continued. “With Dr. Jeffrey Silber now serving as chief medical officer and head of research and
drug development, his proven clinical development leadership further strengthens our ability to advance apraglutide and bring it to patients
as quickly as possible.”
Second Quarter 2026
Financial Highlights1
(in thousands, except for per share
amounts)
Q2 2026
Q2 2025
Total revenue
$ 113,041
$ 85,239
Total costs and expenses
33,734
39,918
GAAP net income
51,291
23,599
GAAP net income – per share basic
0.31
0.15
GAAP net income – per share diluted
0.31
0.14
Adjusted EBITDA1
83,042
50,101
Non-GAAP net income
51,495
23,623
Non-GAAP net income per share – basic
0.31
0.15
Non-GAAP net income per share – diluted
0.31
0.14
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.
Second Quarter Corporate
Highlights
U.S. LINZESS
· In
May 2026, the U.S. Food and Drug Administration (FDA) approved the use of LINZESS in
pediatric patients 2 years of age and older with functional constipation (FC). LINZESS remains
the only FDA-approved prescription therapy for pediatric FC.
· Prescription
Demand: Total LINZESS demand in the second quarter of 2026 was 59.8 million LINZESS capsules,
a 4% increase compared to the second quarter of 2025, per IQVIA. Based on this performance,
we raised our U.S. LINZESS net sales guidance, which now reflects a mid-single digit percentage
demand growth.
· 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 $282.3 million in the second
quarter of 2026, a 14% increase compared to $248.0 million in the second quarter of 2025.
Ironwood and AbbVie share equally in U.S. brand collaboration profits.
2
· Q2
2026 LINZESS U.S. net sales growth year-over-year was driven by 4% demand growth and significantly
improved net price due to elimination of inflationary rebates and favorable time-phasing
of gross-to-net rebate reserves in the second quarter of 2026 relative to 2025.
· LINZESS
commercial margin was 78% in the second quarter of 2026, compared to 69% in the second quarter
of 2025. 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 $214.6 million in the second quarter of 2026, a 30%
increase compared to $164.9 million in the second quarter of 2025. See the U.S. LINZESS Full
Brand Collaboration table at the end of this press release.
· Collaboration
Revenue to Ironwood: Ironwood recorded $110.0 million in collaboration revenue in the
second quarter of 2026 related to sales of LINZESS in the U.S., a 28% increase compared to
$85.7 million for the second quarter of 2025. See the U.S. LINZESS Commercial Collaboration
table at the end of the press release.
Apraglutide
· Ironwood
initiated and is actively recruiting patients for STARS-2, (NCT07742735) a confirmatory Phase
3 clinical trial of apraglutide for patients with SBS-IF dependent on parenteral support
(“PS”), a severe chronic malabsorptive condition. STARS-2 is a 24-week global,
randomized, double-blind, placebo-controlled trial. The primary endpoint is relative change
from baseline in actual weekly PS volume. Secondary endpoints also to be measured at week
24 for the overall population include clinical response (defined as a 20% reduction in PS
volume), number of days of PS per week, and enteral autonomy.
· Apraglutide
is a once-weekly, long-acting synthetic glucagon-like peptide-2 (“GLP-2”) analog
with the potential to treat a range of rare GI diseases in which GLP-2 can play a central
role in addressing disease pathophysiology. Based on positive data generated from the STARS
Phase 3 trial, Ironwood believes apraglutide has the potential to be a best-in-class
therapeutic to improve the standard of care for adult patients with SBS who are dependent
on PS, as the first and only GLP-2 to achieve a statistically significant reduction in weekly
PS volume with once-weekly administration.
· In
May 2026, during the 2026 Digestive Disease Week (DDW) conference, Ironwood presented
data pooled from studies in the STARS clinical program - including the Phase 2 STARS
Nutrition study, STARS Phase 3 randomized placebo-controlled study, and the ongoing open-label
extension study STARS Extend. In this analysis, apraglutide showed a safety profile consistent
with previous studies. These findings build on the positive data previously announced in
2024.
3
Corporate Updates
· In
May, Ronald Silver, Ironwood’s Corporate Controller and Chief Accounting Officer,
was appointed as Interim Chief Financial Officer, following the resignation of Gregory Martini.
· In
July, Dr. Jeffrey Silber joined Ironwood as Chief Medical Officer and Head of Research
and Drug Development, following the retirement of Dr. Michael Shetzline. With broad
medical and scientific leadership expertise, Dr. Silber will lead Ironwood’s next
phase of R&D strategy and execution.
Second Quarter 2026
Financial Results
· Total
Revenue. Total revenue in the second quarter of 2026 was $113.0 million, compared
to $85.2 million in the second quarter of 2025.
· Total
revenue in the second quarter of 2026 consisted of $110.0 million associated with Ironwood’s
share of the net profits from the sales of LINZESS in the U.S., and $3.0 million in royalties
and other revenue. Total revenue in the second quarter of 2025 consisted of $85.7 million associated
with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., and
($0.5) million in royalties and other revenue.
· Total
Costs and Expenses. Total costs and expenses in the second quarter of 2026 were $33.7
million, compared to $39.9 million in the second quarter of 2025.
· Total
costs and expenses in the second quarter of 2026 consisted of $22.4 million in R&D expenses
and $11.3 million in selling, general and administrative (“SG&A”) expenses.
Total costs and expenses in the second quarter of 2025 consisted of $23.4 million in R&D
expenses, $16.8 million in SG&A expenses, and ($0.3) million in restructuring expenses.
· Interest
Expense. Interest expense was $7.2 million in the second quarter of 2026, in connection
with Ironwood’s convertible senior notes, which were paid at maturity in June 2026,
and revolving credit facility. Interest expense was $8.4 million in the second quarter of
2025 in connection with Ironwood’s convertible senior notes and revolving credit facility.
· Interest
and Investment Income. Interest and investment income was $1.6 million in the second
quarter of 2026 and $0.8 million in the second quarter of 2025.
· Other.
Other income was insignificant in the second quarter of 2026 and in the second quarter of
2025 and pertained to a gain recorded for pension-related activities.
· Income
Tax Expense. Ironwood recorded $22.4 million of income tax expense in the second
quarter of 2026, 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 $14.2 million of income tax expense in the second quarter of 2025, the majority
of which was non-cash, as Ironwood continued to utilize net operating losses to offset taxable
income for federal purposes and in many states.
· GAAP
Net Income. GAAP net income was $51.3 million, or $0.31 per share (basic and diluted)
in the second quarter of 2026, compared to GAAP net income of $23.6 million, or $0.15 per
share (basic) and $0.14 per share (diluted) in the second quarter of 2025.
4
· Non-GAAP
Net Income. Non-GAAP net income was $51.5 million, or $0.31 per share (basic and
diluted), in the second quarter of 2026, compared to non-GAAP net income of $23.6 million,
or $0.15 per share (basic) and $0.14 per share (diluted), in the second quarter of 2025.
· Non-GAAP
net income excludes the impact of amortization of acquired intangible assets, and net restructuring
expenses, all net of tax effect. See Non-GAAP Financial Measures below.
· Adjusted
EBITDA. Adjusted EBITDA was $83.0 million in the second quarter of 2026, compared to
$50.1 million in the second quarter of 2025.
· Adjusted
EBITDA is calculated by subtracting stock-based compensation, net restructuring expenses,
net interest expense, income taxes, depreciation and amortization, from GAAP net income.
See Non-GAAP Financial Measures below.
· Cash
Flow Highlights. Ironwood ended the second quarter of 2026 with $79.1 million of
cash and cash equivalents, compared to $215.5 million of cash and cash equivalents at the
end of 2025.
· The
outstanding principal balance on the revolving credit facility was $385.0 million as of June 30,
2026, with $165.0 million of remaining borrowing capacity available under the facility.
· Ironwood
generated $58.3 million in cash from operations in the second quarter of 2026, compared to
$15.1 million in cash from operations in the second quarter of 2025.
· Ironwood
had $112.7 million in accounts receivable as of June 30, 2026, primarily related to
second quarter 2026 collaboration revenues.
· Ironwood
repaid in full the $200 million aggregate principal amount of its 1.50% convertible senior
notes at their scheduled maturity in June 2026 using available cash on hand.
5
· Ironwood
2026 Financial Guidance. Ironwood is raising its 2026 financial guidance and now
expects:
Prior 2026
Guidance
(May 2026)
Updated 2026
Guidance
(August 2026)
U.S. LINZESS Net Sales
$1.125 to $1.175 billion
Driven by improved net price and low-single digit percentage demand growth
$1.15 to $1.20 billion
Driven by improved net price and mid-single digit percentage demand growth
Total Revenue1
$450 to $475 million
$460 to $485 million
Adjusted EBITDA2
>$300 million
>$310 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.
2 Adjusted EBITDA is calculated by subtracting stock-based compensation, net restructuring
expenses, net interest expense, income taxes, and depreciation and amortization from GAAP net income (loss). For purposes of this guidance,
we have assumed that Ironwood will not incur material expenses related to business development activities in 2026. 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 amortization of acquired intangible assets, and net restructuring expenses,
all net of tax effect. Non-GAAP adjustments are further detailed below:
· Amortization
of acquired intangible assets are non-cash expenses arising in connection with the acquisition
of VectivBio, which is 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.
· 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, net restructuring
expenses, net interest expense, income taxes, depreciation and amortization from GAAP net
income (loss). 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.
6
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, August 6th, 2026, to discuss its second quarter results and recent
business activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S.) or (646) 968-2525 (international)
using conference ID number and event passcode 3647053. 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, August 6, 2026, at approximately
11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on Thursday, August 20, 2026. To listen to the replay,
dial (800) 770-2030 (U.S. and Canada) using conference ID number 3647053. The archived webcast will be available on Ironwood’s
website for one 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 the treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). 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 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 and constipation
associated with IBS-C in adults and pediatric patients 7 years of age and older. LINZESS has also been shown to relieve constipation,
infrequent stools, hard stools, straining and incomplete evacuation associated with CIC in adult patients. LINZESS relieves constipation
in children and adolescents aged 2 to 17 years with functional constipation.
7
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 IBS-C in adults and pediatric patients 7 years of age and older,
CIC in adults and functional constipation (FC) in pediatric patients 2 years of age and older. 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 Grand
Life Sciences 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 irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older, chronic
idiopathic constipation (CIC) in adults, and functional constipation (FC) in pediatric patients 2 years of age and older.
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.
8
Warnings and Precautions
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 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 adult patients
with IBS-C or CIC treated with LINZESS 145 mcg or 290 mcg once daily, and in <1% of adult
patients with CIC treated with LINZESS 72 mcg once daily. In pediatric patients, diarrhea
was also the most common adverse reaction in clinical trials of patients 7 to 17 years of
age with IBS-C and 6 to 17 years of age with FC treated with LINZESS. In two double-blind
trials, diarrhea was reported in 4% of pediatric patients 6 to 17 years of age with FC treated
with LINZESS 72 mcg once daily, and 7% and 8% of pediatric patients 7 to 17 years of age
with IBS-C treated with LINZESS 145 mcg and 290 mcg once daily, respectively. In clinical
trials, severe diarrhea was reported in one pediatric patient with FC treated with LINZESS
72 mcg once daily and in one pediatric patient with IBS-C treated with LINZESS at a dose
higher than the recommended 145 mcg once daily dosage for IBS-C. If severe diarrhea occurs,
dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence
≥2% and greater than placebo)
· In
adult patients with IBS-C or CIC: diarrhea, abdominal pain, flatulence and abdominal distension.
· In
pediatric patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC: 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.
9
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; Ironwood’s ability to drive growth and profitability; the commercial potential
of LINZESS; Ironwood’s financial performance and results, and guidance and expectations related thereto; LINZESS prescription demand
growth, LINZESS U.S. net sales, total revenue and adjusted EBITDA in 2026; our commitment to further debt reduction and strengthening
our balance sheet and the timing to achieve thereof; anticipated recruitment in our STARS-2 trial; the goal of bringing the first long-acting,
once-weekly GLP-2 analog to market; and our belief that apraglutide has the potential to become a best-in-class, long-acting GLP-2 therapy
for people with SBS-IF. 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 statements. 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, 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 clinical programs and studies, including for apraglutide, 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 completed nonclinical studies and clinical trials may not be replicated in later trials
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 that apraglutide will not be approved by the FDA or other regulatory agencies; 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 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 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 apraglutide 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, 2025, and in our subsequent Securities and Exchange Commission filings.
10
Investors and Media:
Chris Stamm
Vice President, Investor Relations
and Communications
cstamm@ironwoodpharma.com
Investors:
Precision AQ
Stephanie Ascher
Stephanie.Ascher@precisionaq.com
11
Condensed
Consolidated Balance Sheets
(In
thousands)
(unaudited)
June 30,
2026
December 31,
2025
Assets
Current assets:
Cash and cash equivalents
$ 79,127
$ 215,456
Accounts receivable, net
112,732
46,745
Prepaid expenses and other current assets
7,342
11,977
Total current assets
199,201
274,178
Property and equipment, net
2,913
3,408
Operating lease right-of-use assets
8,443
9,340
Intangible assets, net
1,633
2,040
Deferred tax assets
69,064
103,433
Other assets
3,874
4,502
Total assets
$ 285,128
$ 396,901
Liabilities and stockholders’ deficit
Current liabilities:
Accounts payable
$ 911
$ 2,898
Accrued research and development costs
3,124
3,149
Accrued expenses and other current liabilities
25,534
33,239
Current portion of operating lease liabilities
3,285
3,252
Current portion on convertible senior notes
-
199,680
Total current liabilities
32,854
242,218
Operating lease obligations, net of current portion
8,581
9,870
Revolving credit facility
385,000
385,000
Other liabilities
20,536
21,648
Total liabilities
446,971
658,376
Total stockholders’ deficit
(161,843 )
(261,835 )
Total liabilities and stockholders’ deficit
$ 285,128
$ 396,901
12
Condensed
Consolidated Statements of Income (Loss)
(In
thousands, except per share amounts)
(unaudited)
Three
Months Ended
June 30,
Six
Months Ended
June 30,
2026
2025
2026
2025
Total revenues
$ 113,041
$ 85,239
$ 219,547
$ 126,382
Costs and expenses:
Research and development
22,421
23,373
44,361
50,805
Selling, general and administrative
11,313
16,795
23,346
41,055
Restructuring, net
-
(250 )
(40 )
18,309
Total costs and expenses
33,734
39,918
67,667
110,169
Income from operations
79,307
45,321
151,880
16,213
Other income (expense):
Interest expense and other financing costs
(7,203 )
(8,356 )
(16,344 )
(16,426 )
Interest and investment income
1,585
818
3,283
1,687
Other
42
39
84
76
Other income (expense), net
(5,576 )
(7,499 )
(12,977 )
(14,663 )
Income before income taxes
73,731
37,822
138,903
1,550
Income tax expense
(22,440 )
(14,223 )
(46,839 )
(15,337 )
GAAP net income (loss)
$ 51,291
$ 23,599
$ 92,064
$ (13,787 )
GAAP net income (loss) per share—basic
$ 0.31
$ 0.15
$ 0.56
$ (0.09 )
GAAP net income (loss) per share—diluted
$ 0.31
$ 0.14
$ 0.55
$ (0.09 )
13
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
June 30,
Six
Months Ended
June 30,
2026
2025
2026
2025
GAAP net income (loss)
$ 51,291
$ 23,599
$ 92,064
$ (13,787 )
Adjustments:
Amortization of acquired intangible assets
204
204
407
407
Restructuring expenses, net
-
(250 )
(40 )
18,309
Tax effect of adjustments
-
70
10
(4,533 )
Non-GAAP net income
$ 51,495
$ 23,623
$ 92,441
$ 396
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
June 30,
Six
Months Ended
June 30,
2026
2025
2026
2025
GAAP net income (loss) per share – basic
$ 0.31
$ 0.15
$ 0.56
$ (0.09 )
Adjustments to GAAP net income per share (as detailed above)
-
-
-
0.09
Non-GAAP net income (loss) per share – basic
$ 0.31
$ 0.15
$ 0.56
$ -
Weighted average number of common shares used to calculate net income (loss) per share — basic
164,405
161,723
163,930
161,350
14
A reconciliation between diluted net
income (loss) per share on a GAAP basis and on a non-GAAP basis is as follows:
Three
Months Ended
June 30,
Six
Months Ended
June 30,
2026
2025
2026
2025
GAAP net income (loss) per share – diluted
$ 0.31
$ 0.14
$ 0.55
$ (0.09 )
Adjustments to GAAP net income per share
(as detailed above)
-
-
-
0.09
Non-GAAP net income (loss) per share – diluted
$ 0.31
$ 0.14
$ 0.55
$ -
Weighted average number of common shares used to calculate net income (loss) per share — diluted
167,179
176,837
167,036
161,350
15
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
June 30,
Six
Months Ended
June 30,
2026
2025
2026
2025
GAAP net income (loss)
$ 51,291
$ 23,599
$ 92,064
$ (13,787 )
Adjustments:
Stock-based compensation
3,236
4,524
6,889
9,815
Restructuring expenses, net
-
(250 )
(40 )
18,309
Interest expense
7,203
8,356
16,344
16,426
Interest and investment income
(1,585 )
(818 )
(3,283 )
(1,687 )
Income tax expense
22,440
14,223
46,839
15,337
Depreciation and amortization
457
467
900
946
Adjusted EBITDA1
$ 83,042
$ 50,101
$ 159,713
$ 45,359
1 Adjusted EBITDA is calculated by
subtracting net restructuring expenses, net interest expense, income taxes, depreciation and amortization and stock-based compensation,
from GAAP net income.
16
U.S. LINZESS
Commercial Collaboration1
Revenue/Expense
Calculation
(In thousands)
(unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
LINZESS U.S. net sales as reported by AbbVie2
$ 282,309
$ 248,001
$ 554,834
$ 386,478
AbbVie & Ironwood commercial costs, expenses and other discounts3
62,987
76,886
127,614
143,793
Commercial profit on sales of LINZESS
$ 219,322
$ 171,115
$ 427,220
$ 242,685
Commercial Margin4
78 %
69 %
77 %
63 %
Ironwood’s share of net profit
109,661
85,558
213,610
121,343
Reimbursement for Ironwood’s commercial expenses5
384
125
657
3,108
Ironwood’s U.S. collaborative arrangements revenue
$ 110,045
$ 85,683
$ 214,267
$ 124,451
1 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 Year-over-year decrease
reflects impact of the reduction to Ironwood’s commercial expenses and corresponding reimbursement from AbbVie due to Ironwood’s
strategic reorganization announced in January 2025.
17
US LINZESS Full
Brand Collaboration1
Revenue/Expense
Calculation
(In
thousands)
(unaudited)
Three
Months Ended
June 30,
Six
Months Ended
June 30,
2026
2025
2026
2025
LINZESS U.S. net sales as reported by AbbVie2
$ 282,309
$ 248,001
$ 554,834
$ 386,478
AbbVie & Ironwood commercial costs, expenses and other discounts3
62,987
76,886
127,614
143,793
AbbVie & Ironwood R&D Expenses4
4,683
6,241
7,885
11,919
Total net profit on sales of LINZESS
$ 214,639
$ 164,874
$ 419,335
$ 230,766
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.
18
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