– LINZESS® (Iinaclotide) 2023 U.S. net sales of
$1.1 billion, an increase of 7% year-over-year, driven by EUTRx
prescription demand growth of 10% year-over-year –
– 2023 Ironwood revenue of $443 million, driven
primarily by $430 million in U.S. LINZESS collaboration revenue
–
– Continues to expect topline results from the
STARS Phase III study of apraglutide in patients with short bowel
syndrome with intestinal failure (SBS-IF) in March of 2024 –
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today reported its fourth quarter and full year
2023 results and recent business performance.
“In 2023, we made important progress toward realizing our vision
to become the leading GI healthcare company in the industry,” said
Tom McCourt, chief executive officer of Ironwood. “In its 11th year
on market, LINZESS had another terrific year as the leading
prescription treatment for adults with IBS-C or chronic idiopathic
constipation, with prescription demand increasing a robust 10%
year-over-year. In June of 2023, LINZESS received FDA approval for
functional constipation in pediatric patients ages 6 to 17,
becoming the first and only prescription therapy for this patient
population. In addition, we strengthened our GI pipeline with the
addition of apraglutide. We believe apraglutide has the potential
to improve the standard of care for patients with short bowel
syndrome dependent on parenteral support, if approved, as the only
once-weekly GLP-2 therapy, and achieve $1 billion dollars in peak
net sales. Looking ahead in 2024, we remain focused on maximizing
LINZESS, advancing our GI pipeline and delivering sustained profits
and cash flows. We are excited about the continued strong LINZESS
performance and the key pipeline catalysts ahead of us, highlighted
by the topline data from our STARS Phase 3 study expected in March
and topline data from the ongoing Phase 2 study for CNP-104
expected in the third quarter, which we believe can propel
Ironwood’s next phase of growth and create value for patients and
shareholders in the years to come.”
Fourth Quarter and Full Year 2023 Financial Highlights1
(in thousands, except for per share amounts)
Q4
2023
Q4
2022
FY
2023
FY
2022
Total revenues
$117,553
$107,199
$442,735
$410,596
Total operating expenses2
79,964
38,836
1,388,165
160,259
GAAP net income (loss)2
(1,745)
48,867
(1,031,559)
175,065
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc.2
(1,087)
-
(1,002,239)
-
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share – basic
(0.01)
0.32
(6.45)
1.13
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share – diluted
(0.01)
0.27
(6.45)
0.96
Adjusted EBITDA2
39,895
68,703
(884,820)
251,755
Non-GAAP net income (loss)2
39
48,885
(973,788)
174,883
Non-GAAP net income (loss) per share –
basic
(0.00)
0.32
(6.27)
1.13
Non-GAAP net income (loss) per share –
diluted
(0.00)
0.27
(6.27)
0.96
1.
Refer to the Reconciliation of GAAP
Results to Non-GAAP Financial Measures table and to the
Reconciliation of GAAP Net Income to Adjusted EBITDA table at the
end of this press release. Refer to Non-GAAP Financial Measures for
additional information.
2.
Figures presented for FY 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 2023 Corporate
Highlights
U.S. LINZESS
- Prescription Demand: Total LINZESS
prescription demand in the fourth quarter of 2023 was 50 million
LINZESS capsules, a 10% increase compared to the fourth quarter of
2022, per IQVIA. Total prescription demand was 191 million LINZESS
capsules for the full year 2023, a 10% increase compared to the
full year 2022, 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 $274.4 million in the
fourth quarter of 2023, a 5% increase compared to $260.3 million in
the fourth quarter of 2022, and $1,073.2 million for the full year
2023, a 7% increase compared to $1,002.1 million for the full year
2022.
- Ironwood and AbbVie share equally in U.S. brand collaboration
profits. See the LINZESS U.S. Commercial Collaboration table at the
end of the press release. – LINZESS commercial margin was 77% in
the fourth quarter of 2023, compared to 74% in the fourth quarter
of 2022. LINZESS commercial margin was 73% for the full year in
each of 2023 and 2022. See the U.S. LINZESS Full Brand
Collaboration table below and 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
$202.5 million in the fourth quarter of 2023, compared to $183.8
million in the fourth quarter of 2022. Net profit for the LINZESS
U.S. brand collaboration, net of commercial and R&D expenses,
was $749.9 million for the full year 2023, compared to $695.7
million for the full year 2022. See U.S. LINZESS Full Brand
Collaboration table below and at the end of this press
release.
- Collaboration Revenue to Ironwood:
Ironwood recorded $114.0 million in collaboration revenue in the
fourth quarter of 2023 related to sales of LINZESS in the U.S., a
9% increase compared to $104.8 million for the fourth quarter of
2022. Ironwood recorded $430.5 million in collaboration revenue for
the full year 2023, an 8% increase compared to $398.8 million in
2022. See U.S. LINZESS Commercial Collaboration table at the end of
the press release.
U.S. LINZESS Full Brand
Collaboration
(in thousands, except for percentages)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
LINZESS U.S. net sales as reported by
AbbVie
274,356
$260,327
1,073,210
$1,002,143
AbbVie & Ironwood commercial costs,
expenses and other discounts
62,903
66,879
286,045
272,757
Commercial margin
77%
74%
73%
73%
AbbVie & Ironwood R&D Expenses
8,980
9,684
37,250
33,684
Total net profit on sales of LINZESS
202,473
183,764
749,915
695,702
Full brand margin
74%
71%
70%
69%
- In January 2024, Ironwood announced publication in The Lancet
Gastroenterology & Hepatology of new linaclotide Phase III data
in children and adolescents aged 6-17 years with functional
constipation. The data highlighted additional efficacy endpoints
from the company’s pivotal Phase III trial, which formed the basis
of the June 2023 U.S. Food and Drug Administration (FDA) approval
of linaclotide for the treatment of functional constipation in this
population. Additional details can be found here.
- In October 2023, Ironwood presented new data at the 2023 North
American Society for Pediatric Gastroenterology, Hepatology &
Nutrition (NASPGHAN) Annual Meeting reinforcing the impact of
linaclotide on functional constipation in children and adolescents
ages 6-17 years-old. The data demonstrated that linaclotide reduces
the need for rescue medications in this patient population and
further characterized the efficacy and safety profile of
linaclotide as the only FDA-approved prescription therapy for this
population. Additional details can be found here.
Pipeline Updates
Apraglutide
- Ironwood is advancing apraglutide, a next-generation, synthetic
glucagon-like peptide-2 (“GLP-2”) analog for short bowel syndrome
with intestinal failure (“SBS-IF”), a severe malabsorptive
condition. Ironwood believes apraglutide has the potential to be
the new standard of care for the treatment of short bowel syndrome
dependent on parenteral support, also known as short bowel syndrome
with intestinal failure, based on its potency and pharmacologic
properties. Ironwood is conducting a Phase III clinical trial,
STARS, designed to evaluate clinical benefit for both SBS-IF stoma
and colon-in-continuity (“CIC”) patients with the unique
convenience of weekly dosing. Topline results are expected in March
of 2024.
- In October 2023, Ironwood presented positive final data from
the company’s Phase II STARS Nutrition program during United
European Gastroenterology (UEG) Week. This multicenter, open-label
study of nine patients was designed to evaluate the safety,
pharmacokinetics, and efficacy of apraglutide on intestinal
absorption in adult patients who have SBS-IF and CIC. Additional
details can be found here.
- Ironwood is also conducting an exploratory Phase II clinical
trial, STARGAZE, to evaluate apraglutide in patients with
steroid-refractory acute Graft versus Host Disease (aGvHD), a
life-threatening condition that occurs when immune cells from the
donor attack a recipient’s healthy cells after an allogeneic
hematopoietic stem cell transplant. Enrollment is completed and
data is expected for the STARGAZE Phase II clinical trial in the
first quarter of 2024.
CNP-104
- Ironwood has a collaboration and license option agreement with
COUR Pharmaceuticals Development Company, Inc. (“COUR”). This
agreement grants Ironwood an option to acquire an exclusive license
to research, develop, manufacture and commercialize, in the U.S.,
products containing CNP-104 (“CNP-104”), a tolerizing immune
modifying nanoparticle, for the treatment of primary biliary
cholangitis (“PBC”), a rare autoimmune disease targeting the liver.
If successful, CNP-104 has the potential to be the first approved
disease modifying therapy for PBC.
- COUR is currently conducting a clinical study with CNP-104
evaluating the safety, tolerability, pharmacodynamic effects and
efficacy of CNP-104 in PBC patients, with topline data expected in
the third quarter of 2024.
IW-3300
- Ironwood is currently advancing IW-3300, a guanylate cyclase-C
agonist being developed for the potential treatment of visceral
pain conditions, such as interstitial cystitis / bladder pain
syndrome (“IC/BPS”) and endometriosis. Ironwood is continuing the
Phase II proof of concept study in IC/BPS.
Fourth Quarter and Full Year 2023 Financial Results
- Total Revenues. Total revenues in the fourth quarter of
2023 were $117.6 million, compared to $107.2 million in the fourth
quarter of 2022. Total revenues for the full year 2023 were $442.7
million, compared to $410.6 million for the full year 2022.
- Total revenues 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 revenues in the fourth quarter of 2022
consisted of $104.8 million associated with Ironwood’s share of the
net profits from the sales of LINZESS in the U.S. and $2.4 million
in royalties and other revenue.
- Total revenues 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 royalties
and other revenue. Total revenues for the full year 2022 consisted
of $398.8 million associated with Ironwood’s share of the net
profits from the sales of LINZESS in the U.S., and $11.8 million in
royalties and other revenue.
- Operating Expenses. Operating expenses in the fourth
quarter of 2023 were $80.0 million, compared to $38.8 million in
the fourth quarter of 2022. Operating expenses for the full year
2023 were $1,388.2 million, compared to $160.3 million for the full
year 2022.
- Operating expenses in the fourth quarter of 2023 consisted of
$38.7 million in selling, general and administrative (“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. Operating expenses in the fourth
quarter of 2022 consisted of $28.4 million in SG&A expenses and
$10.4 million in R&D expenses.
- Operating expenses for the full year 2023 consisted primarily
of approximately $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. Operating expenses for
the full year 2022 consisted primarily of $116.0 million in
SG&A expenses, and $44.3 million in R&D expenses.
- Interest Expense and Other Financing Costs. 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
expense recorded in the fourth quarter of 2023 included $7.6
million in cash expense and $0.6 million in non-cash expense.
Interest expense recorded for the full year 2023 included $19.3
million in cash expense and $2.1 million in non-cash expense.
- Interest expense was $1.5 million in the fourth quarter of 2022
and $7.6 million for the full year 2022, in connection with
Ironwood’s convertible senior notes. Interest expense recorded in
the fourth quarter of 2022 included $1.1 million in cash expense
and $0.4 million in non-cash expense. Interest expense recorded for
the full year 2022 included $5.7 million in cash expense and $1.9
million in non-cash expense.
- Interest and Investment Income. Interest and investment
income was $1.2 million in the fourth quarter of 2023 and $19.0
million for the full year 2023.
- Interest and investment income was $5.4 million in the fourth
quarter of 2022 and $9.5 million for the full year 2022.
- Gain (Loss) on Derivatives. Ironwood recorded a loss on
derivatives of an insignificant amount in the fourth quarter of
2022, as a result of the change in fair value of its note hedge
warrants. For the full year 2022, Ironwood recorded a gain on
derivatives of $0.2 million. Ironwood’s note hedge warrants
terminated unexercised upon expiration in April 2023.
- Income Tax Expense. 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 continues to utilize net operating
losses to offset taxable income for federal purposes and in many
states. Ironwood recorded $23.4 million of income tax expense in
the fourth quarter of 2022 and $77.4 million of income tax expense
for the full year of 2022, 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 loss was $1.1 million, or ($0.01) per share (basic and
diluted), in the fourth quarter of 2023 compared to GAAP net income
of $48.9 million, or $0.32 per share (basic) and $0.27 per share
(diluted), in the fourth quarter of 2022. GAAP net loss for the
full year 2023 was $1.0 billion, or ($6.45) per share (basic and
diluted), compared to GAAP net income of $175.1 million, or $1.13
per share (basic) and $0.96 per share (diluted), for the full year
2022.
- Non-GAAP Net Income (Loss). Non-GAAP net income was an
insignificant amount, or ($0.00) per share (basic and diluted), in
the fourth quarter of 2023, compared to non-GAAP net income of
$48.9 million, or $0.32 per share (basic) and $0.27 per share
(diluted), in the fourth quarter of 2022. Non-GAAP net loss for the
full year 2023 was $973.8 million, or ($6.27) per share (basic and
diluted), compared to non-GAAP net income of $174.9 million, or
$1.13 per share (basic) and $0.96 per share (diluted), for the full
year 2022.
- Non-GAAP net income 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 $39.9 million in
the fourth quarter of 2023, compared to $68.7 million in the fourth
quarter of 2022. For the full year 2023, adjusted EBITDA was
($884.8) million, compared to $251.8 million for the full year
2022.
- 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. See Non-GAAP Financial Measures below.
- Cash Flow Highlights. Ironwood ended 2023 with $92.2
million of cash and cash equivalents, compared to $656.2 million of
cash and cash equivalents at the end of 2022.
- In the fourth quarter of 2023 and in the full year of 2023,
Ironwood repaid $25.0 million and $100.0 million, respectively, of
the outstanding principal balance on its revolving credit facility
used to partially finance the VectivBio acquisition. The
outstanding principal balance on the revolving credit facility was
$300.0 million as of December 31, 2023.
- Ironwood generated $35.8 million in cash from operations in the
fourth quarter of 2023, compared to $79.2 million in cash from
operations in the fourth quarter of 2022. Ironwood generated $183.4
million in cash from operations for the full year 2023, compared to
$273.8 million for the full year 2022.
- Ironwood 2024 Financial Guidance. In 2024, Ironwood
continues to expect:
2024 Guidance
U.S. LINZESS Net Sales Growth
Low-single digits %
Total Revenue
$435 to $455 million
Adjusted EBITDA1
>$150 million
Excludes potential CNP-104 option
exercise
1 Adjusted EBITDA is calculated by
subtracting restructuring expenses, net interest expense, income
taxes, depreciation and amortization, and acquisition-related costs
from GAAP net income. For purposes of the 2024 guidance, Ironwood
has assumed it will not incur material expenses related to business
development activities in 2024 and excludes any costs associated
with potential CNP-104 option exercise. 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 and non-GAAP net income
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.
Included in restructuring expenses are 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. The adjustments are
made on a similar basis as described above related to non-GAAP net
income, 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 and non-GAAP net income 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 15, 2024 to discuss its fourth
quarter and full year 2023 results and recent business activities.
Individuals interested in participating in the call should dial +1
(888) 596-4144 (U.S. and Canada) or (647) 495-7514 (international)
using conference ID number and event passcode 1057375. To access
the webcast, please visit the Investors section of Ironwood’s
website at www.ironwoodpharma.com at least 15 minutes prior to the
start of the call to ensure adequate time for any software
downloads that may be required. The call will be available for
replay via telephone starting at approximately 11:30 a.m. Eastern
Time on February 15, 2024, running through 11:59 p.m. Eastern Time
on February 29, 2024. To listen to the replay, dial (800) 770-2030
(U.S. and Canada) or (647) 362-9199 (international) using
conference ID number 1057375. 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 leading gastrointestinal (GI) healthcare company
on a mission to advance the treatment of GI diseases and redefine
the standard of care for GI patients. We are pioneers 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. Ironwood is
also advancing apraglutide, a next-generation, long-acting
synthetic GLP-2 analog being developed for rare gastrointestinal
diseases, including short bowel syndrome with intestinal failure
(SBS-IF) as well as several earlier stage assets. Building upon our
history of GI innovation, we keep patients at the heart of our
R&D and commercialization efforts to reduce the burden of GI
diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in
Boston, Massachusetts, and has an additional 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.
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; 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 2024; the
commercial potential of apraglutide, including its peak sales
potential; Ironwood’s anticipation of reaching new clinical
development milestones in 2024 and the timing of data related
thereto, and the belief that Ironwood is positioned well for long
term growth. 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, CNP-104, IW-3300, and our 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, IW-3300 and CNP-104, 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 and clinical studies may not be
replicated in later studies; 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 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 or our product candidates are not as we
expect; decisions by regulatory and judicial authorities; the risk
we may never get additional patent protection for linaclotide and
other product candidates, that patents for linaclotide 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, CNP-104 and/or IW-3300 are 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 we are unable to
manage our expenses or cash use, or are unable to commercialize our
products as expected; 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, 2022, in our Quarterly Reports on Form 10-Q for the
quarters ended June 30, 2023 and September 30, 2023, and in our
subsequent Securities and Exchange Commission filings.
Condensed Consolidated Balance
Sheets
(In thousands)
(unaudited)
December 31,
2023
December 31, 2022
Assets
Cash and cash equivalents
$
92,154
$
656,203
Accounts receivable, net
129,122
115,458
Prepaid expenses and other current
assets
12,012
7,715
Restricted cash
-
1,250
Total current assets
233,288
780,626
Restricted cash, net of current
portion
-
485
Accounts receivable, net of current
portion
-
14,589
Property and equipment, net
5,585
6,288
Operating lease right-of-use assets
12,586
14,023
Intangible assets, net
3,682
-
Deferred tax assets
212,324
283,661
Other assets
3,608
847
Total assets
$
471,073
$
1,100,519
Liabilities and Stockholders’
Equity
Accounts payable
$
7,830
$
483
Accrued research and development costs
21,331
5,258
Accrued expenses and other current
liabilities
44,254
16,700
Current portion of operating lease
liabilities
3,126
3,065
Current portion on convertible senior
notes
199,560
-
Note hedge warrants
-
19
Total current liabilities
276,101
25,525
Operating lease liabilities, net of
current portion
14,543
16,599
Convertible senior notes, net of current
portion
198,309
396,251
Revolving credit facility
300,000
-
Other liabilities
28,415
9,766
Total stockholders’ equity (deficit)
(346,295
)
652,378
Total liabilities and stockholders’
equity (deficit)
$
471,073
$
1,100,519
Condensed Consolidated
Statements of Income
(In thousands, except per
share amounts)
(unaudited)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
Revenues
Collaborative arrangements revenue
$
117,553
$
107,199
$
442,735
$
410,596
Total revenues
117,553
107,199
442,735
410,596
Operating expenses:
Research and development
35,676
10,446
116,085
44,265
Selling, general and administrative
38,667
28,390
158,314
115,994
Restructuring expenses
621
-
18,317
-
Acquired in-process research and
development
5,000
-
1,095,449
-
Total operating expenses
79,964
38,836
1,388,165
160,259
Income (loss) from operations
37,589
68,363
(945,430
)
250,337
Other income (expense):
Interest expense and other financing
costs
(8,423
)
(1,526
)
(21,629
)
(7,598
)
Interest and investment income
1,194
5,446
18,971
9,501
Gain on derivatives
-
(18
)
19
182
Other income (expense), net
(7,229
)
3,902
(2,639
)
2,085
Income (loss) before income taxes
30,360
72,265
(948,069
)
252,422
Income tax expense
(32,105
)
(23,398
)
(83,490
)
(77,357
)
GAAP net income (loss)
(1,745
)
48,867
(1,031,559
)
175,065
Less: GAAP net income (loss) attributable
to noncontrolling interests
(658
)
-
(29,320
)
-
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc.
$
(1,087
)
$
48,867
$
(1,002,239
)
$
175,065
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share—basic
$
(0.01
)
$
0.32
$
(6.45
)
$
1.13
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share—diluted
$
(0.01
)
$
0.27
$
(6.45
)
$
0.96
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,
2023
2022
2023
2022
GAAP net income (loss)1
$
(1,745
)
$
48,867
$
(1,031,559
)
$
175,065
Adjustments:
Mark-to-market adjustments on the
derivatives related to convertible notes, net
-
18
(19
)
(182
)
Amortization of acquired intangible
assets
207
-
418
-
Restructuring expenses
621
-
18,317
-
Acquisition-related costs
1,173
-
40,718
-
Tax effect of adjustments
(217
)
-
(1,663
)
-
Non-GAAP net income (loss)1
$
39
$
48,885
$
(973,788
)
$
174,883
____________________________________
1 GAAP and non-GAAP net loss for 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.
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,
2023
2022
2023
2022
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share – basic
$
(0.01
)
$
0.32
$
(6.45
)
$
1.13
Plus: GAAP net income (loss) attributable
to noncontrolling interests – basic
(0.00
)
-
(0.19
)
-
Adjustments to GAAP net income (loss) per
share (as detailed above)
0.01
-
0.37
-
Non-GAAP net income (loss) per share –
basic
$
(0.00
)
$
0.32
$
(6.27
)
$
1.13
Weighted average number of common shares
used to calculate net income (loss) per share — basic
156,014
153,337
155,435
154,366
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
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share – diluted
$
(0.01
)
$
0.27
$
(6.45
)
$
0.96
Plus: GAAP net income (loss) attributable
to noncontrolling interests – diluted
(0.00
)
-
(0.19
)
-
Adjustments to GAAP net income (loss) per
share (as detailed above)
0.01
-
0.37
-
Non-GAAP net income (loss) per share –
diluted
$
(0.00
)
$
0.27
$
(6.27
)
$
0.96
Weighted average number of common shares
used to calculate net income (loss) per share — diluted
156,014
185,188
155,435
186,312
Reconciliation of GAAP Net
Income 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,
2023
2022
2023
2022
GAAP net income (loss)1
$
(1,745
)
$
48,867
$
(1,031,559
)
$
175,065
Adjustments:
Mark-to-market adjustments on the
derivatives related to convertible notes, net
-
18
(19
)
(182
)
Restructuring expenses
621
-
18,317
-
Interest expense
8,423
1,526
21,629
7,598
Interest and investment income
(1,194
)
(5,446
)
(18,971
)
(9,501
)
Income tax expense
32,105
23,398
83,490
77,357
Depreciation and amortization
512
340
1,575
1,418
Acquisition-related costs
1,173
40,718
Adjusted EBITDA1
$
39,895
$
68,703
$
(884,820
)
$
251,755
____________________________________
1 GAAP net loss and adjusted EBITDA for
twelve months ended December 31, 2023 includes 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.
U.S. LINZESS Commercial Collaboration1
Revenue/Expense
Calculation
(In thousands)
(unaudited)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
LINZESS U.S. net sales as reported by
AbbVie2
$
274,356
$
260,327
$
1,073,210
$
1,002,143
AbbVie & Ironwood commercial costs,
expenses and other discounts3
62,903
66,879
286,045
272,757
Commercial profit on sales of LINZESS
$
211,453
$
193,448
$
787,165
$
729,386
Commercial Margin4
77
%
74
%
73
%
73
%
Ironwood’s share of net profit
105,727
96,724
393,583
364,693
Reimbursement for Ironwood’s commercial
expenses
8,260
8,048
36,875
34,074
Ironwood’s collaborative arrangement
revenue
$
113,987
$
104,772
$
430,458
$
398,767
____________________________________
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.
US LINZESS Full Brand Collaboration1
Revenue/Expense
Calculation
(In thousands)
(unaudited)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2023
2022
2023
2022
LINZESS U.S. net sales as reported by
AbbVie2
$
274,356
$
260,327
$
1,073,210
$
1,002,143
AbbVie & Ironwood commercial costs,
expenses and other discounts3
62,903
66,879
286,045
272,757
AbbVie & Ironwood R&D
Expenses4
8,980
9,684
37,250
33,684
Total net profit on sales of LINZESS
$
202,473
$
183,764
$
749,915
$
695,702
____________________________________
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 R&D 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/20240215798096/en/
Investors: Greg Martini, 617-374-5230
gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395 mroache@ironwoodpharma.com
Media: Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com
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