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Ironwood Pharmaceuticals Reports First Quarter 2022 Results; Maintains Full Year 2022 Financial Guidance - LINZESS (Iinaclotide) prescription demand growth increased 11% year-over-year; LINZESS U.S.

Key Takeaway: Pharmaceuticals Reports First Quarter 2022 Results; Maintains Full Year 2022 Financial Guidance LINZESS (Iinaclotide) prescription demand growth increased 11% year-over-year; LINZESS U.S. net sales of $232 million, an increase of 8% year-over-year - revenue of $98 million; U.S

Full Press Release Details

Pharmaceuticals Reports First Quarter 2022 Results; Maintains Full Year 2022 Financial Guidance
LINZESS (Iinaclotide) prescription demand growth increased 11% year-over-year; LINZESS U.S. net sales of $232 million,
an increase of 8% year-over-year -
revenue of $98 million; U.S. LINZESS collaboration revenue of $94 million -
GAAP net income of $39 million and adjusted EBITDA of $58 million;
ended Q1 2022 with $593 million in cash and cash equivalents -
Mass., May 5, 2022 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported
its first quarter 2022 results and recent business performance.
"Continuing the growth and momentum from 2021 when LINZESS exceeded
$1 billion in U.S. net sales and earned blockbuster status, we believe we are in a strong position to realize our vision of becoming the
leading U.S. GI healthcare company," said Tom McCourt, chief executive officer of Ironwood. "We continue to be excited by
the performance of LINZESS, which has delivered another quarter of double-digit prescription demand growth year-over-year. We believe
that our focused investments and commitment to reaching new patients will continue to drive demand growth moving forward. Beyond LINZESS,
we are making progress with our ongoing clinical trials and remain on track with the previously shared data readout timing. We are also
focused on strengthening our pipeline through the in-license or acquisition of innovative GI assets, which we believe will position our
company for continued growth."
First Quarter 2022 Financial Highlights1
(in thousands, except for per share amounts)
1Q 2022 1Q 2021
Total revenues $ 97,529 $ 88,845
Total operating expenses 39,683 43,447
GAAP net income 38,801 39,926
GAAP net income per share - basic 0.25 0.25
GAAP net income per share -diluted 0.21 0.25
Adjusted EBITDA 58,201 46,119
Non-GAAP net income 38,071 37,847
Non-GAAP net income per share - basic 0.24 0.24
Non-GAAP net income per share - diluted 0.21 0.24
First Quarter 2022 Corporate Highlights
U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) Three Months Ended March 31,
2022 2021
LINZESS U.S. net sales as reported by AbbVie $ 232,334 $ 215,399
AbbVie & Ironwood commercial costs, expenses and other discounts 61,016 57,511
Commercial margin 74 % 73 %
AbbVie & Ironwood R&D Expenses 8,166 9,474
Total net profit on sales of LINZESS 163,152 148,414
Full brand margin 70 % 69 %
First Quarter Financial Results
2022 Guidance
U.S. LINZESS Net Sales Growth Low single digits %
Total Revenue $420 to $430 million
Adjusted EBITDA 1 >$250 million
1 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 from GAAP net income. For purposes of this guidance, Ironwood has assumed that it will not incur material
expenses related to business development activities in 2022.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income and non-GAAP net income per share
to exclude the impact of net gains and losses on derivatives related to Ironwood's 2022 Convertible Notes that are required to be
marked-to-market, restructuring expenses, and the release of the company's valuation allowance
against the majority of deferred tax assets in the second quarter of
2021. 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 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, May 5, 2022 to discuss its first quarter 2022 results and recent business activities. Individuals interested in participating
in the call should dial (888) 330-2384 (U.S. and Canada) or (240) 789-2701 (international) using conference ID number and event passcode
4671230. 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 May 5, 2022 running through 11:59 p.m. Eastern Time on
May 19, 2022. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (647) 362-9199 (international) using conference ID number
4671230. The archived webcast will be available on Ironwood's website for 14 days beginning approximately one hour after the call
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,
We routinely post information that may be important to investors on
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
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
Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
Last updated: May 5, 2022