– Data from open label extension study of
apraglutide demonstrate further increase in patients achieving
enteral autonomy –
– Initiated rolling NDA submission, now to
include long-term extension data given continued clinical
improvement over time, with submission completion expected in Q3
2025 –
– Organizational restructuring positions the
Company to realize the potential of apraglutide in SBS and
long-term success in GI and rare disease –
– Expects adjusted EBITDA excluding stock-based
compensation of greater than $85 million in 2025, driven by strong
LINZESS prescription demand growth and expense management to offset
pricing headwinds –
- Greg Martini named Chief Financial Officer
and Tammi Gaskins named Chief Commercial Officer to further
strengthen experienced leadership team in Ironwood’s next stage of
growth –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology
company developing and commercializing life-changing therapies for
people living with gastrointestinal (GI) and rare diseases, today
announced a streamlined strategic focus on advancing and realizing
the potential of apraglutide for the treatment of short bowel
syndrome (“SBS”) patients who are dependent on parenteral support.
In line with this strategic update, Ironwood will be reducing its
workforce by approximately 50%. This reorganization is intended to
position the company for long-term growth.
“Ironwood’s long track record of success stems from our ability
to be nimble as an organization by focusing on both significant
medical needs and financial performance. While LINZESS continues to
grow prescription demand, given the impact of ongoing pricing
pressures, we are taking steps to reduce Ironwood costs that are
predominantly associated with the brand. By doing so, we believe we
can continue to generate profits and cash flows and support the
successful development of apraglutide. LINZESS remains an important
part of our strategy, along with continued investment in
apraglutide for SBS patients who are dependent on parenteral
support, which we believe will deliver value to our stakeholders
and ultimately bring a new therapy to patients with great unmet
need,” said Tom McCourt, chief executive officer of Ironwood.
“We have made important progress by initiating our rolling new
drug application (“NDA”) submission and announcing new data from
our open label extension study, STARS Extend, demonstrating an
increased number of patients on apraglutide achieving enteral
autonomy over time. We plan to include the long-term extension data
in our NDA submission, in addition to the robust efficacy and
tolerability data from STARS, the largest Phase 3 clinical trial
ever conducted in SBS-IF patients. With these new data, we are even
more encouraged about apraglutide’s potential to help SBS patients
who are dependent on parenteral support,” said Mike Shetzline,
M.D., Ph.D, chief medical officer, senior vice president and head
of research and drug development at Ironwood.
"Our apraglutide launch planning is well underway. Under Tammi’s
leadership we have strong commercial capabilities to support the
future success of apraglutide, if approved. As a rare disease
therapy, this will require a very targeted promotional effort while
providing a robust patient hub service model,” Mr. McCourt
added.
“While the reduction in force is particularly difficult, these
changes are necessary to continue to progress apraglutide and
maintain our profitability and cash flow goals, to support
Ironwood’s long-term growth. I want to personally thank all the
employees affected by this restructuring for their dedication to
our mission and their many contributions to the company,” added Mr.
McCourt.
Recent Pipeline and Corporate Updates:
Apraglutide Open Label Extension Study, STARS Extend:
- The extension study data demonstrate that more patients weaned
off parenteral support with longer exposure to apraglutide.
- An analysis of long-term extension data also showed that 27
apraglutide-dosed patients achieved enteral autonomy, which is the
ultimate goal of SBS patients who are dependent on parenteral
support.
Strategic Reorganization:
- Reorganization is primarily driven by the elimination of
Ironwood’s field force.
- Ironwood also has decided to wind down the Phase 2 exploratory
study, STARGAZE, of apraglutide in Graft-versus-Host Disease to
further focus its resources and investments.
- 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.
- Ironwood expects to realize, as a result of the strategic
reorganization, 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.
Leadership Updates:
- Greg Martini has been promoted to Senior Vice President, Chief
Financial Officer. Greg joined Ironwood in 2017 and has served in
roles of increasing responsibility, most recently as Vice
President, Strategic Finance and Investor Relations since
2022.
- Tammi Gaskins has been appointed Senior Vice President, Chief
Commercial Officer. Tammi joined Ironwood in 2020 and has been
integral in shaping the apraglutide commercial launch plan and
driving the performance of LINZESS. Prior to joining Ironwood,
Tammi spent 20 years at AstraZeneca in various commercial
leadership positions across different therapeutic areas.
Full Year 2025 Financial Guidance: Ironwood is providing
FY 2025 financial guidance.
FY 2025 Guidance
(January 2025)
LINZESS U.S. net sales
$800 - $850 million
High single digit prescription
demand growth, more than offset by expected price erosion due to
Medicare Part D redesign
Total revenue 1
$260 - $290 million
Adjusted EBITDA 2
>$85 million
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.
Conference Call Information
Ironwood will host a conference call and webcast at 4:30 p.m.
Eastern Time on Wednesday, January 29, 2025 to discuss the recent
corporate updates. 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 at approximately 6:30
p.m. Eastern Time on January 29, 2025, running through 11:59 p.m.
Eastern Time on February 12, 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), an S&P SmallCap
600® company, 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, and has additional operations 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; Ironwood’s ability to generate
profits and cash flow and support the successful development of
apraglutide; the belief that LINZESS along with continued
investment in apraglutide will help to deliver value to
stakeholders and bring therapy to patients; Ironwood’s plan to
include long-term extension data in its apraglutide NDA submission
and the expected timing to complete the submission; Ironwood’s
financial performance and results, and guidance and expectations
related thereto; LINZESS U.S. net sales, total revenue and adjusted
EBITDA in 2025; Ironwood's expectations regarding the timing and
financial impact to be incurred in connection with the workforce
reduction, as well as the timing of the completion of all impacts
of the workforce reduction. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250129150325/en/
Company contact: Greg Martini
gmartini@ironwoodpharma.com
Investors: Precision AQ (formerly Stern Investor
Relations) Stephanie Ascher Stephanie.Ascher@precisionaq.com
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