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Ironwood Pharmaceuticals Maintains FY 2023 Financial Guidance and Announces FY 2024 Financial Guidance - Expects high-single digit percentage LINZESS EUTRx prescription demand growth in 2024 - - Exp

Key Takeaway: Ironwood Pharmaceuticals has maintained its financial guidance for FY 2023 and announced FY 2024 predictions, indicating high-single digit growth in LINZESS demand. The company expects over $150 million in adjusted EBITDA, reflecting its strong market position and growth potential in its GI development pipeline. Despite projections for continued growth, the company also acknowledges potential price erosion caused by Medicaid policies. The upcoming J.P. Morgan Healthcare Conference presentation is set for January 10, 2024, where more insights may be shared.

Market Sentiment Analysis

POSITIVE FACTORS

  • Ironwood expects high-single digit percentage growth in LINZESS prescription demand in 2024.
  • Projected adjusted EBITDA of greater than $150 million for 2024.
  • Strengthened GI pipeline with the addition of apraglutide, which is viewed as having blockbuster potential.

CONCERNS & RISKS

  • Anticipated mid to high-single digit price erosion due to Medicaid AMP cap removal may impact revenue.
  • Possible adjustments and uncertainties regarding GAAP net income and business development expenses could obscure financial projections.

Full Press Release Details

Ironwood Pharmaceuticals
Maintains FY 2023 Financial Guidance and Announces FY 2024 Financial Guidance
high-single digit percentage LINZESS EUTRx prescription demand growth in 2024 -
2024 adjusted EBITDA of greater than $150 million -
BOSTON, Mass., January 8, 2024 - Ironwood Pharmaceuticals, Inc.
(Nasdaq: IRWD), a GI-focused healthcare company, today announced financial guidance for full year 2024. The results were announced in
advance of the Company's presentation at the 42nd Annual J.P. Morgan Healthcare Conference, which will take place on
Wednesday, January 10, 2024 at 11:15 a.m. PT / 2:15 p.m. ET.
"We believe the significant progress we made across our strategic
priorities last year has strengthened our position to be the leading GI healthcare company," said Tom McCourt, chief executive
officer of Ironwood. "We are on track to deliver on our 2023 LINZESS U.S. net sales guidance, driven by continued strong prescription
demand and remain encouraged about the future growth potential of the brand. Furthermore in 2023, we strengthened our GI pipeline with
the addition of apraglutide, which we believe has blockbuster potential in short bowel syndrome requiring parenteral support, if approved."
"Looking ahead in 2024, we remain committed to maximizing LINZESS,
advancing our GI development pipeline and delivering profits and cash flows. We expect to deliver another year of high-single digit percentage
LINZESS demand growth and maintain class-leading formulary access, which we believe will result in low-single digit percentage LINZESS
U.S. net sales growth in 2024. In addition, we expect to deliver greater than $150 million in adjusted EBITDA in 2024. We are looking
forward to an exciting and potentially transformational year for Ironwood with several catalysts ahead of us, highlighted by the topline
data from our STARS Phase 3 study expected in March in SBS-IF and topline data from the ongoing Phase 2 study for CNP-104 expected
in the third quarter. We believe the advancement of our pipeline programs, combined with continued strong LINZESS demand growth, uniquely
position our company for success in our mission to be the leader in GI."
Full Year 2023 Financial Guidance and Full Year 2024 Financial
Ironwood is maintaining its previous FY
2023 financial guidance and is providing FY 2024 financial guidance.
FY 2023 Guidance (November 2023) FY 2024 Guidance (January 2024)
LINZESS U.S. net sales growth 6% - 8% Low-single digits % High-single digit prescription demand growth offset by mid to high-single digit price erosion primarily due to Medicaid AMP cap removal
Total revenue $435 - $450 million $435 - $455 million
Adjusted EBITDA 1 ~($900) million Reflects ~$1.1 billion one-time charge from acquisition of VectivBio >$150 million Excludes potential CNP-104 option exercise
J.P. Morgan Healthcare Conference Presentation
As previously announced, Ironwood
will present a corporate overview at the 42nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024
at 11:15 a.m. PT / 2:15 p.m. ET. A live audio webcast of Ironwood's presentation is accessible through the Investors
section of the Company's website at www.ironwoodpharma.com. To access the webcast, please log on to the Ironwood website
approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of
the webcast will be available on Ironwood's website after the event has completed.
EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to our 2022 Convertible Notes, restructuring expenses,
net interest expense, income taxes, depreciation and amortization, and acquisition-related costs from GAAP net income. For purposes of
the 2024 guidance, we have assumed that Ironwood will not incur material expenses related to business development activities in 2024. 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.
Full year 2023 adjusted EBITDA guidance reflects 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. Full year 2024 adjusted EBITDA guidance also excludes
any costs associated with a potential CNP-104 option exercise.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600
company, is a leading global 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 additional operations in Basel, Switzerland.
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.
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
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
Common Adverse Reactions (incidence 2% and greater than
Please see full Prescribing Information including Boxed Warning:
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
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 demand, development, commercial availability and commercial potential of linaclotide, including unlocking new
opportunities and maintaining class-leading formulary access for LINZESS, and the drivers, timing, impact and results thereof; the potential
indications for, and benefits of, linaclotide; 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 2023 and 2024; the commercial

Frequently Asked Questions

What is Ironwood Pharmaceuticals' FY 2024 guidance?

Ironwood expects FY 2024 total revenue of $435 - $455 million and adjusted EBITDA over $150 million.

What growth is anticipated for LINZESS in 2024?

LINZESS is projected to see high-single digit percentage prescription demand growth in 2024.

When will Ironwood present at the J.P. Morgan Conference?

Ironwood will present on January 10, 2024, at 11:15 a.m. PT/2:15 p.m. ET.

What is LINZESS used to treat?

LINZESS is indicated for treating irritable bowel syndrome with constipation and chronic idiopathic constipation.

Who markets LINZESS outside the U.S.?

AbbVie markets LINZESS in Europe, while Astellas and AstraZeneca partner in Japan and China, respectively.

Last updated: Jan 8, 2024