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Ironwood Pharmaceuticals Provides Update on FY 2021 Financial Guidance and Announces FY 2022 Financial Guidance - LINZESS Expected to Achieve Blockbuster Status with U.S. Net Sales in Excess of $1 B

Key Takeaway: Ironwood Pharmaceuticals Provides Update on FY 2021 Financial Guidance and Announces FY 2022 Financial Guidance LINZESS Expected to Achieve Blockbuster Status with U.S. Net Sales in Excess of $1 Billion in 2021 - - Initiates Board Authorized Share Repurchase Program in Q4 202

Full Press Release Details

Ironwood Pharmaceuticals Provides Update on
FY 2021 Financial Guidance and Announces FY 2022 Financial Guidance
LINZESS Expected to Achieve Blockbuster Status with U.S. Net Sales in Excess of $1 Billion in 2021 -
- Initiates Board Authorized
Share Repurchase Program in Q4 2021 -
Continued Double-Digit LINZESS Prescription Demand Growth in 2022 -
BOSTON, Mass., January 10, 2022
- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today provided
updated financial guidance for full year 2021 and announced financial guidance for full year 2022. The results were announced in advance
of the Company's presentation at the 40th Annual J.P. Morgan Healthcare Conference, which will take place on Wednesday, January 12,
2022 at 7:30 a.m. ET.
"Among the key highlights of 2021 was the progress we made across
our three strategic priorities which strengthened our organization and delivered strong operational performance," said Tom McCourt,
chief executive officer of Ironwood. "We expect to report solid financial results in 2021 and deliver our third consecutive year
of profits. Notably, we expect LINZESS to exceed $1 billion in U.S. net sales reaching blockbuster status, a significant accomplishment
for Ironwood. Additional highlights include advanced innovation through our expanded pipeline and development programs, and the initiation
of a share repurchase program of up to $150 million through December 2022."
"Looking ahead in 2022, we remain committed to further advancing
our strategic priorities, unlocking new opportunities for LINZESS and strengthening our pipeline with innovative GI assets. We expect
continued double-digit LINZESS prescription demand growth, further reinforcing its position as the #1 prescribed brand in the U.S. for
the treatment of adults with IBS-C or chronic idiopathic constipation. For 2022, we have also refined our mix of brand investment and
class-leading payer access, which we expect to result in low single digit LINZESS net sales growth, and we expect to deliver strong brand
margins. At the same time, we expect adjusted EBITDA growth well in excess of Ironwood revenue growth in 2022. Overall, we believe we
remain well positioned for long term growth and are focused on delivering patient benefit and shareholder value."
Updated Full Year 2021 Financial Guidance1
LINZESS U.S. net sales to exceed $1 billion in 20212, with LINZESS U.S. net sales growth, total Ironwood revenues,
and Ironwood adjusted EBITDA to be at the high end of our previously disclosed guidance ranges for full year 2021. The table below summarizes
Ironwood's revised full year 2021 guidance.
Ironwood now expects:
Previous 2021 Guidance (November 2021) Updated 2021 Guidance 1
LINZESS U.S. net sales growth 6% - 8% High end of 6% - 8%
Total revenue $390 - $410 million High end of $390 - $410 million
Adjusted EBITDA 3 >$210 million >$230 million
Update on Board Authorized Share Repurchase
Ironwood repurchased $27 million of shares
of the Company's common stock in the fourth quarter of 2021 under its board authorized share repurchase program of up to $150 million
through December 31, 2022.
Full Year 2022 Financial Guidance
For full year 2022, Ironwood expects
LINZESS U.S. net sales growth to be in the low single digits, total revenues to be between $420 million and $430 million and adjusted
EBITDA3 to be greater than $250 million. The table below summarizes Ironwood's full year 2022 guidance outlined above.
unaudited, preliminary and estimated amounts and may change as we receive final 2021 data and complete the preparation of our 2021 financial
net sales is unaudited, preliminary and based on estimates, and may change as we receive final 2021 data from AbbVie Inc. and as we and
AbbVie complete the preparation of our respective 2021 financial statements. LINZESS U.S. net sales are reported by AbbVie and LINZESS
costs incurred by each of us and AbbVie are reported in our respective financial statements.
3 Adjusted 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, from GAAP net income. For purposes of this guidance, we have assumed that
Ironwood will not incur material expenses related to business development activities in 2022. 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.
In 2022, Ironwood expects:
2022 Guidance
LINZESS U.S. net sales growth Low single digits
Total revenue $420 - $430 million
Adjusted EBITDA 3 >$250 million
J.P. Morgan Healthcare Conference Presentation
announced, Ironwood will present a corporate overview at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12,
2022 at 7:30 a.m. ET. The event is being held virtually and 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 for 14 days following the conference.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) 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). Under the guidance of our seasoned industry leaders, we continue
to build upon our history of GI innovation and challenge what has been done before to shape what the future holds. 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.
We routinely post information that may
Twitter 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. 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. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in
pediatric patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent
elevated GC-C agonism resulting in 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. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.
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
Last updated: Jan 10, 2022