Full Press Release Details
Ironwood Pharmaceuticals
Reports Fourth Quarter and Full Year 2021 Results; LINZESS (linaclotide) Achieves Blockbuster Status as U.S. Net Sales Exceed $1
- 2021 total revenue of $414 million,
driven primarily by $400 million in U.S. LINZESS
collaboration revenue -
- 2021 GAAP net income of $528 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 in Q2 2021 -
- 2021 adjusted EBITDA of $234 million;
ended 2021 with $620 million in cash and cash equivalents -
- Pursuing two areas of unmet medical
need with initiation of clinical studies for IW-3300 for the
treatment of visceral pain conditions, and CNP-104 for the treatment of primary
BOSTON, Mass., February 17,
2022 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported its
fourth quarter and full year 2021 results.
"The tremendous progress we made
against our strategic priorities last year puts Ironwood in a solid position as we begin a new year," said Tom McCourt, chief
executive officer of Ironwood. "I am proud to share that LINZESS has earned blockbuster brand status with more than $1 billion in
U.S. net sales in 2021, an extraordinary accomplishment for our company. I am also excited about what's to come in 2022, as we strive
to continue to execute on our key priorities of maximizing LINZESS growth via commercial innovation and lifecycle management, while also
seeking to strengthen our innovative GI pipeline and focusing on delivering sustained profits and generating cash flow."
"Bringing new treatments to GI patients remains a key priority
and our team has been working hard to advance our pipeline," said Mike Shetzline, chief medical officer, senior vice president and
head of research and drug development. "We are pleased to announce that we have initiated the IW-3300 clinical study, which will
evaluate the safety and tolerability of this potentially first-in-class treatment for visceral pain conditions. Combined with the initiation
of the CNP-104 clinical study by COUR for primary biliary cholangitis, we are energized about the progress of our pipeline."
Fourth Quarter and Full
Year 2021 Financial Highlights1
(in thousands, except for per share amounts)
| 4Q 2021 | 4Q 2020 | FY 2021 | FY 2020 | ||||||||||||||
| Total revenues | $ | 117,130 | $ | 116,680 | $ | 413,753 | $ | 389,523 | |||||||||
| Total costs and expenses | 60,538 | 65,296 | 181,494 | $ | 246,583 | ||||||||||||
| GAAP net income | 41,374 | 43,204 | 528,448 | 106,176 | |||||||||||||
| GAAP net income per share - basic | 0.25 | 0.27 | 3.26 | 0.67 | |||||||||||||
| GAAP net income per share - diluted | 0.25 | 0.27 | 3.21 | 0.66 | |||||||||||||
| Adjusted EBITDA | 56,950 | 65,952 | 233,738 | 160,678 | |||||||||||||
| Non-GAAP net income | 43,940 | 56,934 | 191,782 | 127,687 | |||||||||||||
| Non-GAAP net income per share - basic | 0.27 | 0.36 | 1.18 | 0.80 | |||||||||||||
| Non-GAAP net income per share - diluted | 0.27 | 0.36 | 1.16 | 0.79 |
Fourth Quarter and Full
Year 2021 Corporate Highlights
| U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) | Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| LINZESS U.S. net sales as reported by AbbVie | $ | 278,555 | $ | 278,320 | $ | 1,005,856 | $ | 931,211 | ||||||||
| AbbVie & Ironwood commercial costs, expenses and other discounts | 67,510 | 97,992 | 265,118 | 260,825 | ||||||||||||
| Commercial margin | 76 | % | 65 | % | 74 | % | 72 | % | ||||||||
| AbbVie & Ironwood R&D Expenses | 11,107 | 11,889 | 39,417 | 51,295 | ||||||||||||
| Total net profit on sales of LINZESS | 200,028 | 168,439 | 701,321 | 619,091 | ||||||||||||
| Full brand margin | 72 | % | 61 | % | 70 | % | 66 | % |
Fourth Quarter and Full
Year 2021 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, February 17, 2022 to discuss its fourth quarter and full year 2021 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 February 17, 2022 running through 11:59 p.m. Eastern Time on March 3, 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 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
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.