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Ironwood Pharmaceuticals Reports Strong Second-Quarter 2021 Results, Raises Full-Year Guidance - LINZESS (Iinaclotide) U.S. net sales of $259 million, an increase of 18% year-over-year - - Total rev

Key Takeaway: Ironwood Pharmaceuticals Reports Strong Second-Quarter 2021 Results, Raises Full-Year Guidance - LINZESS (Iinaclotide) U.S. net sales of $259 million, an increase of 18% year-over-year - of $104 million, an increase of 16% year-over-year, driven primarily by U.S. LINZESS co

Full Press Release Details

Ironwood Pharmaceuticals Reports Strong Second-Quarter
2021 Results, Raises Full-Year Guidance
- LINZESS (Iinaclotide)
U.S. net sales of $259 million,
an increase of 18% year-over-year -
of $104 million, an increase of 16% year-over-year,
driven primarily by U.S. LINZESS collaboration revenue of $100 million -
of $391 million, includes a $338 million non-recurring income tax
benefit related to the release of the valuation allowance against the
majority of the company's deferred tax assets -
ended Q2 2021 with $493 million in cash and cash equivalents -
Mass., August 5, 2021 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported
financial results for second quarter 2021 and raised full year 2021 financial guidance.
Commenting on the results, Tom McCourt, chief
executive officer of Ironwood, said: "Continued exceptional execution behind a sound strategy resulted in another outstanding quarter
for Ironwood. Building on the momentum of LINZESS and its impressive growth, we remain in a position of strength and confident in our
future growth prospects. I am proud of our experienced leadership team and employees who continue to maintain laser focus on our strategic
priorities in order to deliver important medicines to patients and value to our shareholders."
Second Quarter 2021 Financial Highlights1
(in thousands, except for per share amounts)
2Q 2021 2Q 2020
Total revenues $ 104,031 $ 89,432
Total costs and expenses 38,933 56,719
GAAP net income 391,303 25,204
GAAP net income per share - basic 2.42 0.16
GAAP net income per share - diluted 2.39 0.16
Adjusted EBITDA 65,212 33,353
Non-GAAP net income 56,387 25,671
Non-GAAP net income per share - basic 0.35 0.16
Non-GAAP net income per share - diluted 0.34 0.16
Second Quarter 2021 Corporate Highlights
U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) Three Months Ended June 30,
2021 2020
LINZESS U.S. net sales as reported by AbbVie 259,252 218,945
AbbVie & Ironwood commercial costs, expenses and other discounts 73,439 53,812
Commercial margin 72 % 75 %
AbbVie & Ironwood R&D Expenses 9,173 13,417
Total net profit on sales of LINZESS 176,640 151,716
Full brand margin 68 % 69 %
U.S. Promotional Partnerships
Second Quarter Financial Results
Ironwood is raising its 2021 financial guidance due to the
growth in U.S. LINZESS prescription demand. The Company now expects:
Prior 2021 Guidance Updated 2021 Guidance
U.S. LINZESS Net Sales Growth 3% to 5% 6% to 8%
Total Revenue $370 to $385 million $390 to $410 million
Adjusted EBITDA 1 >$190 million >$210 million
1 Adjusted EBITDA is calculated by subtracting net interest
expense, income taxes, depreciation, amortization, mark-to-market adjustments on derivatives related to Ironwood's 2022 Convertible
Notes and restructuring expenses from GAAP net income.
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 expense, and the release of the Company's valuation allowance against the majority of deferred
tax assets. 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 net interest expense, income taxes, depreciation, amortization,
mark-to-market adjustments on derivatives related to Ironwood's 2022 Convertible Notes and restructuring expenses 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, August 5, 2021 to discuss its second quarter 2021 results and recent business activities. Individuals interested
in participating in the call should dial (833) 350-1432 (U.S. and Canada) or (647) 689-6932 (international) using conference ID number
and event passcode 2598317. 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 August 5, 2021 running through
11:59 p.m. Eastern Time on August 19, 2021. To listen to the replay, dial (800) 585-8367 (U.S. and Canada) or (416) 621-4642
(international) using conference ID number 2598317. The archived webcast will be available on Ironwood's website for 14 days beginning
approximately one hour after the call has completed.
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 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 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age
have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of guanylate cyclase-C ("GC-C")
agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients
less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious
consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
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
Last updated: Aug 5, 2021