Ironwood Pharmaceuticals, Inc.
(NASDAQ: IRWD) today provided an update on its second quarter 2013 and recent business activities.
“The past six months have been a transformative period at Ironwood, thanks to the dedication and hard work of our team,” said Peter Hecht, chief executive officer of Ironwood. “The LINZESS launch is strong and tracking well across all leading indicators, and we and Forest are working closely together to drive all aspects of the launch. At the same time, together with Forest we are making progress in our efforts to maximize the commercial and clinical success of LINZESS by exploring ways to strengthen the existing label and seeking regulatory approval for LINZESS in additional populations and indications. During the second quarter, Almirall launched CONSTELLA in key European countries, and we continue to advance linaclotide in territories around the world along with our partners. We also continued to make progress with our other pipeline programs. We look forward to advancing our key value drivers and managing investments across our portfolio to maximize per share value for our fellow shareholders.”
Second Quarter 2013 and Recent Highlights
- LINZESS net product sales, as reported by Forest Laboratories, Inc., were $28.8 million in the second quarter of 2013.
- More than 125,000 LINZESS prescriptions were filled in the second quarter of 2013 and more than 200,000 LINZESS prescriptions have been filled since LINZESS launched on December 17, 2012, according to IMS Health.
- To date, more than 70% of high prescribing gastroenterologists and approximately 40% of high prescribing primary care physicians have prescribed LINZESS; approximately 1,000 physicians are writing their first LINZESS prescription each week.
- As of June 2013, approximately 80% of adult irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) patients with commercial insurance had unrestricted access to LINZESS and approximately 50% of patients with national commercial insurance plans have a copay of approximately $30 per month.
- Ironwood and Forest expect to report data in the third quarter of 2013 from a Phase IIIb clinical trial to further evaluate the effect of LINZESS on abdominal symptoms in patients with CIC.
- Ironwood and Forest continue to explore additional development opportunities to strengthen the clinical profile of LINZESS within its indicated population and to expand the product label for broader patient populations and indications, as well as to explore the potential for linaclotide-based combination products. The companies expect to initiate U.S. clinical trials in the pediatric population, as well as for the potential treatment of adult patients suffering from opioid-induced constipation, in the first half of 2014.
Linaclotide (Rest of World)
- Ironwood’s European partner, Almirall S.A., launched CONSTELLA in the U.K., Germany and the Nordic countries. Almirall will continue launching in additional European countries throughout the remainder of 2013 and 2014.
- The Scottish Medicines Consortium (SMC) published a health technology assessment of CONSTELLA advising payers in Scotland to provide access to CONSTELLA for moderate-to-severe IBS-C adult patients who have not responded adequately to or cannot tolerate other treatment options.
- CONSTELLA was approved by Swissmedic, the regulatory agency in Switzerland, for the symptomatic treatment of moderate to severe IBS-C in adults.
Research & Development
- Ironwood and AstraZeneca expect to begin enrollment in the Phase III clinical trial of linaclotide in adult patients with IBS-C in China in August 2013. The trial is expected to be completed in the first half of 2015.
- Astellas continues to enroll patients in a double-blind, placebo-controlled, dose-ranging Phase II clinical trial of linaclotide in adult patients with IBS-C in Japan. The trial is expected to be completed in the second half of 2013.
Corporate and Financials
- In addition to exploring additional linaclotide development opportunities, Ironwood is leveraging its pioneering understanding of linaclotide’s pharmacology and mechanism of action, guanylate cyclase-C (GC-C) agonists, cyclic GMP, and symptomatic diseases to advance other programs in its pipeline, which include early development candidates and discovery research efforts focused on gastrointestinal disease, central nervous system disorders, allergic conditions and cardiovascular disease.
Conference Call Information
- Total Revenues. Revenues were approximately $9.7 million in the second quarter of 2013. This consisted of $6.1 million in sales of active pharmaceutical ingredient (API), $1.7 million in the amortization of deferred revenue associated with consideration received from Ironwood’s collaborations with Astellas and AstraZeneca, and $1.9 million in milestone payments from Almirall as a result of the commercial launches of CONSTELLA in the U.K. and Germany. LINZESS net product sales are recorded by Forest and are not included in Ironwood’s total revenues (refer to the LINZESS U.S. Collaboration Expense Calculation at the end of this press release).
- Operating Expenses. Operating expenses were approximately $55.0 million in the second quarter of 2013. This consisted of $24.1 million of research and development expenses and $30.9 million of selling, general and administrative expenses.
- Interest Expense. Interest expense was $5.3 million in the second quarter of 2013 in connection with the $175 million debt financing executed in January 2013.
- Net Loss. Ironwood reported a net loss of $65.1 million, or $0.57 per share, in the second quarter of 2013.
- Cash Position. Ironwood ended the second quarter of 2013 with approximately $301 million of cash, cash equivalents and available-for-sale securities. Ironwood used approximately $80 million of net cash for operations during the quarter.
- Public Equity Offering. In the second quarter of 2013, Ironwood sold 11,204,948 million shares of its Class A common stock through an underwritten public offering at a price to the public of $13.00 per share. As a result of the offering, Ironwood received aggregate net proceeds, after underwriting discounts and commissions and other offering expenses, of approximately $137.8 million.
- Financial Guidance. Ironwood today reiterated its financial guidance for the Forest and Ironwood total 2013 sales and marketing expense for LINZESS to be in the range of $250 to $300 million. Ironwood also reiterated its guidance for 2013 non-linaclotide research and development expenses to be in the range of $60 to $75 million.
- Ironwood expects to host an Investor Day in the fourth quarter of 2013 to further discuss its corporate strategy, provide a full update on the LINZESS launch, discuss linaclotide opportunities in additional populations and indications, and discuss its R&D efforts.
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time, on Tuesday, July 23, to discuss its second quarter 2013 and recent business activities. Individuals interested in participating in the call should dial (877) 643-7155
(U.S. and Canada) or (914) 495-8552 (international) using conference ID number 14769645. To access the webcast, please visit the Investors section of Ironwood’s website at
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 today at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on July 30, 2013. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 14769645. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist approved by the FDA for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults. LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients. LINZESS should be taken at least 30 minutes before the first meal of the day.