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Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance - LINZESS (Iinaclotide) 2023 U.S. net sales of $1.1 billion, an increase of 7% year-over-

Key Takeaway: Ironwood Pharmaceuticals reported its fourth quarter and full year 2023 results, highlighting a 7% increase in LINZESS net sales to $1.1 billion. The company achieved revenue of $443 million with strong prescription demand for LINZESS, especially following its FDA approval for pediatric use. Ironwood anticipates continued growth with upcoming topline data from the STARS Phase III study of apraglutide for short bowel syndrome expected in March 2024, despite facing significant operating losses for the year.

Market Sentiment Analysis

POSITIVE FACTORS

  • 2023 U.S. net sales of LINZESS reached $1.1 billion, a 7% increase year-over-year.
  • The company received FDA approval for LINZESS for pediatric patients, expanding its market.
  • Positive outlook for apraglutide as a potential breakthrough therapy for short bowel syndrome.

CONCERNS & RISKS

  • GAAP net income showed a significant loss of $1,031,559 for the fiscal year.
  • Operating expenses are considerably high at $1,388,165 for 2023.

Full Press Release Details

Ironwood Pharmaceuticals Reports Fourth Quarter
and Full Year 2023 Results; Achieves 2023 Financial Guidance
- 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
BOSTON, Mass., February 15,
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 expenses 2 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 EBITDA 2 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
Fourth Quarter and Full Year 2023 Corporate Highlights
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 %
Fourth Quarter and Full Year 2023 Financial
2024 Guidance
U.S. LINZESS Net Sales Growth Low-single digits %
Total Revenue $435 to $455 million
Adjusted EBITDA 1 >$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:
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
Founded in 1998, Ironwood Pharmaceuticals
is headquartered in Boston, Massachusetts, and has an additional site in Basel, Switzerland.
routinely post information that may be important to investors on our website at www.ironwoodpharma.com.
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.

Frequently Asked Questions

What were Ironwood's 2023 net sales for LINZESS?

LINZESS achieved U.S. net sales of $1.1 billion in 2023, up 7% year-over-year.

How much revenue did Ironwood generate in 2023?

Ironwood reported a total revenue of $443 million for the year 2023.

What significant FDA approval did LINZESS receive in 2023?

In June 2023, LINZESS was approved for treating functional constipation in pediatric patients.

What is the expected revenue range for Ironwood in 2024?

Ironwood expects total revenue between $435 million to $455 million in 2024.

When will Ironwood provide topline data from the STARS study?

Topline results from the STARS Phase III study are expected in March 2024.

Last updated: Feb 15, 2024