Full Press Release Details
Pharmaceuticals Reports First Quarter 2021 Results
LINZESS (Iinaclotide) U.S. net sales of $215 million,
an increase of 12% year-over-year -
revenue of $89 million, an increase of 11% year-over-year,
driven primarily by U.S. LINZESS collaboration revenue of $86 million -
GAAP net income of $40 million and adjusted EBITDA of $46 million;
ended Q1 2021 with $438 million in cash and cash equivalents -
full year 2021 financial guidance -
Mass., May 6, 2021 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today provided
an update on its first quarter 2021 results and recent business performance.
"We are off to a solid start to the year, as LINZESS continued
the strong momentum we saw in 2020," said Tom McCourt, president and interim chief executive officer of Ironwood. "Prescription
demand and new-to-brand prescription volume grew 12% and 24% year-over-year, respectively, which is a testament to the strength and resiliency
of LINZESS and the tremendous execution by our team. We ended the quarter with $438 million in cash and cash equivalents, positioning
us well to continue to invest thoughtfully into our business. As we look ahead, we are confident there is strong momentum in the business
and a strong sense of resolve in our ability to advance the treatment of GI diseases and redefine the standard of care for patients."
First Quarter 2021 Financial Highlights1
(in thousands, except for per share amounts)
| 1Q 2021 | 1Q 2020 | |||||||
| Total revenues | $ | 88,845 | $ | 79,943 | ||||
| Total costs and expenses | 43,447 | 66,716 | ||||||
| GAAP net income | 39,926 | 3,345 | ||||||
| GAAP net income per share - basic and diluted | 0.25 | 0.02 | ||||||
| Adjusted EBITDA | 46,119 | 13,936 | ||||||
| Non-GAAP net income | 37,847 | 6,811 | ||||||
| Non-GAAP net income per share - basic and diluted | 0.24 | 0.04 |
First Quarter 2021 Corporate Highlights
for the first quarter of 2020. See U.S. LINZESS Commercial
Collaboration table at the end of the press release.
| U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) | Three Months Ended March 31, | |||||||
| 2021 | 2020 1 | |||||||
| LINZESS U.S. net sales as reported by AbbVie | 215,399 | 192,822 | ||||||
| AbbVie & Ironwood commercial costs, expenses and other discounts | 57,511 | 56,082 | ||||||
| Commercial margin | 73 | % | 71 | % | ||||
| AbbVie & Ironwood R&D Expenses | 9,474 | 14,782 | ||||||
| Total net profit on sales of LINZESS | 148,414 | 121,958 | ||||||
| Full brand margin | 69 | % | 63 | % |
First Quarter Financial Results
Ironwood's 2022 Convertible Notes and restructuring
expenses from GAAP net income. See Non-GAAP Financial Measures below.
In 2021, Ironwood continues to expect:
| 2021 Guidance | ||||
| U.S. LINZESS Net Sales Growth | 3% to 5% | |||
| Total Revenue | $370 to $385 million | |||
| Adjusted EBITDA 1 | >$190 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 our 2022 Convertible Notes that are required to be marked-to-market
and restructuring expense. 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, May 6, 2021 to discuss its first 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
8067476. 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 6, 2021 running through 11:59 p.m. Eastern Time on May 20,
2021. To listen to the replay, dial (800) 585-8367 (U.S. and Canada) or (416) 621-4642 (international) using conference ID number 8067476.
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,
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 both
irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
Warnings and Precautions