Full Press Release Details
Ironwood Pharmaceuticals
Provides Update on FY 2022 Financial Guidance and Announces FY 2023 Financial Guidance
submitted to U.S. FDA in December 2022 seeking approval of a new indication of LINZESS (linaclotide) for functional constipation
in children and adolescents 6 to 17 years of age -
high single-digit LINZESS EUTRx prescription demand growth in 2023 -
2023 adjusted EBITDA of greater than $250 million -
BOSTON, Mass., January 9, 2023
- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today provided updated financial
guidance for full year 2022 and announced financial guidance for full year 2023. The results were announced in advance of the Company's
presentation at the 41st Annual J.P. Morgan Healthcare Conference, which will take place on Wednesday, January 11, 2023 at 9:00
a.m. PT / 12:00 p.m. ET.
"Execution across our strategic
priorities last year is positioning Ironwood for growth in 2023 and beyond," said Tom McCourt, chief executive officer of Ironwood.
"In 2022, we are on track to deliver another year of strong profits and expect to end the year with approximately $650 million
of cash and cash equivalents on the balance sheet. Our performance continues to be driven by strong LINZESS prescription demand
growth and disciplined expense management. We're excited about the potential to expand the clinical utility of LINZESS based on
the recent sNDA submission in functional constipation for pediatric patients aged 6 to 17 years old, which, if approved, would make LINZESS
the first and only FDA approved prescription therapy for this patient population."
"Looking ahead in 2023, we remain
committed to further advancing our strategic priorities, unlocking new opportunities for LINZESS, and strengthening and progressing our
innovative GI portfolio. We expect to deliver high single-digit LINZESS demand growth and maintain class-leading formulary access, which
we believe will result in LINZESS net sales growth of between 3% to 5% in 2023. In addition, in 2023, we anticipate reaching new
clinical development milestones, including data in the second half of the year for CNP-104, and we expect to deliver greater than $250
million in adjusted EBITDA. Overall, we believe we are positioning the company well for long term growth and remain focused on
delivering patient benefit and shareholder value."
Updated Full Year 2022 Financial
below summarizes Ironwood's updated full year 2022 guidance.
| Previous 2022 Guidance (November 2022) | Updated 2022 Guidance 1 | |||
| LINZESS U.S. net sales growth 2 | Low single digits % | ~0% | ||
| Total revenue | $420 - $430 million | ~$411 million | ||
| Adjusted EBITDA 3 | >$250 million | ~$250 million |
2023 Financial Guidance
below summarizes Ironwood's full year 2023 guidance.
| 2023 Guidance | ||
| LINZESS U.S. net sales growth 2 | 3% - 5% | |
| Total revenue | $420 - $435 million | |
| Adjusted EBITDA 3 | >$250 million |
Guidance based on unaudited, preliminary and estimated amounts and may change as we
receive final 2022 data and complete the preparation of our 2022 financial statements.
2 2022 LINZESS U.S. net sales
is unaudited, preliminary and based on estimates, and may change as we receive final 2022 data from AbbVie Inc. and as we and AbbVie
complete the preparation of our respective 2022 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 and 2023. 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.
Healthcare Conference Presentation and Webcast Details
announced, Ironwood will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11,
2023 at 9:00 a.m. PT / 12:00 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 for 14 days following the conference.
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). 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.
routinely post information that may be important to investors on our website at www.ironwoodpharma.com.
About LINZESS (linaclotide)
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.
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
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.
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in
adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Common Adverse Reactions (incidence
2% and greater than placebo)
Please see full Prescribing Information
including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
LINZESS and CONSTELLA are
registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property