– 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 –
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
GAAP net income (loss)2 attributable to
Ironwood Pharmaceuticals, Inc.
3,189
3,189
(1,745)
(1,087)
1,813
1,813
(1,031,559)
(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 EBITDA2
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250227058847/en/
Company: Greg Martini Chief Financial Officer
gmartini@ironwoodpharma.com
Investors: Precision AQ (formerly Stern Investor
Relations) Stephanie Ascher Stephanie.Ascher@precisionaq.com
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