– LINZESS® (Iinaclotide) EUTRx prescription demand growth in Q3 2022 increased 10% year-over-year –
– Ironwood and its partner, AbbVie, plan to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a potential indication in functional constipation in pediatric patients aged 6-17 by the end of 2022 –
– GAAP net income of $50 million and adjusted EBITDA of $69 million; ended Q3 2022 with $574 million in cash and cash equivalents –
– Reiterates 2022 guidance of U.S. LINZESS net sales growth of low single digits %, total Ironwood revenue of $420 to $430 million and adjusted EBITDA of >$250 million –
BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported its third quarter 2022 results and recent business performance.
“As we approach the end of the year, I am excited about what we have done to support patients living with gastroenterology diseases and the progress made toward realizing our vision to become the leading GI company in the industry,” said Tom McCourt, chief executive officer of Ironwood. “I am pleased to share that the strong performance of LINZESS continues, and we delivered another quarter of double-digit year-over-year prescription demand growth. For the first time, LINZESS exceeded 1 million total prescriptions in a quarter, a remarkable achievement. We believe there is still a significant opportunity to reach appropriate new adult patients and drive additional prescription growth. We also continued to advance our pipeline programs, highlighted by the exciting positive topline data from the Phase III trial of LINZESS in pediatric patients aged 6 to 17 with functional constipation. The results of this study bring us one step closer to being able to potentially expand the clinical utility of LINZESS to this critical but underserved patient population, as there are currently no FDA approved prescription therapies for the treatment of functional constipation in pediatric patients. Looking ahead, we believe our capabilities in GI, strong balance sheet and disciplined capital allocation continue to position our company for growth.”
Third Quarter 2022 Financial Highlights1 (in thousands, except for per share amounts) | ||||
|
| 3Q 2022 | 3Q 2021 | |
Total revenues | $108,637 | $103,747 | ||
Total operating expenses | 40,164 | 38,576 | ||
GAAP net income | 50,317 | 55,845 | ||
GAAP net income per share – basic | 0.33 | 0.34 | ||
GAAP net income per share –diluted | 0.28 | 0.34 | ||
Adjusted EBITDA | 68,835 | 65,456 | ||
Non-GAAP net income | 50,166 | 53,608 | ||
Non-GAAP net income per share – basic | 0.33 | 0.33 | ||
Non-GAAP net income per share – diluted | 0.28 | 0.33 |
1. | Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information. |
Third Quarter 2022 Corporate Highlights
U.S. LINZESS
U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) | Three Months Ended September 30, | |
| 2022 | 2021 |
LINZESS U.S. net sales as reported by AbbVie | $261,131 | $252,650 |
AbbVie & Ironwood commercial costs, expenses and other discounts | 68,499 | 66,658 |
Commercial margin | 74% | 74% |
AbbVie & Ironwood R&D Expenses | 7,620 | 9,753 |
Total net profit on sales of LINZESS | 185,012 | 176,239 |
Full brand margin | 71% | 70% |
Pipeline Updates
Pediatric Program
IW-3300
CNP-104
Third Quarter Financial Results
Non-GAAP net income excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, and the release of the company’s valuation allowance against the majority of deferred tax assets in the second quarter of 2021. See Non-GAAP Financial Measures below.
| 2022 Guidance |
U.S. LINZESS Net Sales Growth | Low single digits % |
Total Revenue | $420 to $430 million |
Adjusted EBITDA1 | >$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, November 3, 2022 to discuss its third 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 November 3, 2022 running through 11:59 p.m. Eastern Time on November 17, 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), 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.
We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on Twitter and on LinkedIn.
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
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. |
Contraindications
Warnings and Precautions
Pediatric Risk
Diarrhea