Ironwood Provides Second Quarter 2017 Investor Update

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology company, today provided an update on its second quarter 2017 results and recent business activities.

“Our performance in the first half of 2017 reinforces the potential for our commercial products and mid- to late-stage pipeline to efficiently grow large consumer-driven patient categories and help millions of patients for years to come,” said Peter Hecht, chief executive officer of Ironwood. “We expect LINZESS and DR1, if approved, to coexist as leading products and grow the IBS-C/CIC category into the 2030s. IW-3718, if approved, has the opportunity to build and grow the uncontrolled GERD market, and is a strong fit with our U.S. commercial capabilities. These assets, combined with DUZALLO, DR2 and our sGC stimulators, position us well to continue to deliver new medicines to patients and accelerate high-margin growth for our fellow shareholders.”

Second Quarter 2017 and Recent Highlights

Irritable Bowel Syndrome with Constipation (IBS-C) / Chronic Idiopathic Constipation (CIC)

• LINZESS. U.S. net sales, as reported by Ironwood’s U.S. collaboration partner Allergan plc, were $167.8 million in the second quarter of 2017, a 12% increase compared to the second quarter of 2016. Ironwood and Allergan share equally in brand collaboration profits.
  • Total LINZESS prescription volume in the second quarter of 2017 included over 28 million LINZESS capsules, a 19% increase in capsules compared to the second quarter of 2016, per QuintilesIMS.
    • Levels of inventory held in the channel were lower in the second quarter of 2017 compared to the second quarter of 2016, resulting in lower year-over-year growth in LINZESS net sales compared to LINZESS prescription volume. If inventory remains at these levels, we expect there will continue to be a gap between growth in LINZESS net sales and growth in LINZESS prescription volume for the balance of 2017.
  • More than 750,000 total LINZESS prescriptions were filled in the second quarter of 2017, a 15% increase compared to the second quarter of 2016, per QuintilesIMS.
  • Since the launch of LINZESS in December 2012, greater than 1.5 million unique patients have filled more than 8 million prescriptions, per QuintilesIMS.
  • Net profit for the LINZESS U.S. brand collaboration, including commercial and research and development (R&D) expenses, was $72.2 million in the second quarter of 2017, a 24% increase compared to the second quarter of 2016.
    • LINZESS commercial margin was 52% in both the second quarter of 2017 and of 2016.
  • Ironwood received a U.S. patent covering a component of LINZESS as well as formulations comprising linaclotide and this component. The patent extends the LINZESS patent portfolio into 2033.
• Linaclotide Delayed Release-1 (DR1). Ironwood and Allergan are evaluating DR1 in adult patients with IBS-C. The companies are engaging with the U.S. Food and Drug Administration (FDA) to discuss Phase III development plans, with Phase III IBS-C trials expected to begin in the second half of 2017.
• Linaclotide Delayed Release-2 (DR2). Ironwood and Allergan are evaluating DR2 for the potential to treat patients with disorders where lower abdominal pain is a predominant symptom, such as non-constipated subtypes of IBS. The companies plan to engage with the FDA to discuss advancing DR2 into Phase IIb dose-ranging clinical trials, expected to begin in 2018.

Uncontrolled Gout

• ZURAMPIC^® (lesinurad). In October 2016, Ironwood began commercializing ZURAMPIC in the U.S. for the treatment of hyperuricemia in patients with uncontrolled gout who are already taking a xanthine oxidase inhibitor (XOI), such as allopurinol or Uloric^® (febuxostat). ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia and should not be used as monotherapy.
  • ZURAMPIC U.S. net sales were $0.5 million in the second quarter of 2017.
  • Approximately 1,500 total ZURAMPIC prescriptions were filled in the second quarter of 2017, per QuintilesIMS.

• DUZALLO. The DUZALLO New Drug Application (NDA) for the treatment of hyperuricemia in patients with uncontrolled gout is currently under FDA review. If approved, DUZALLO is expected to be commercially available early in the fourth quarter of 2017 and would be the first fixed-dose, combination treatment of hyperuricemia in patients with uncontrolled gout.

Uncontrolled Gastroesophageal Reflux Disease (GERD)

• IW-3718. IW-3718 is a wholly-owned asset being developed for the potential treatment of uncontrolled GERD. In July 2017, Ironwood announced positive top-line data from a Phase IIb clinical trial of IW-3718 in adult patients with uncontrolled GERD. The trial met its primary endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump inhibitor (PPI) significantly reduced heartburn severity in patients by 58.0% compared to 46.0% in patients treated with a PPI alone. Further, 52.9% of patients treated with IW-3718 1500 mg plus a PPI achieved a clinically meaningful reduction in heartburn severity, based on patient-reported outcome measures. In the study, IW-3718 1500 mg plus a PPI also showed a 55.4% reduction in regurgitation frequency compared to 37.9% in patients treated with a PPI alone. IW-3718 1500 mg was well tolerated in the trial; the most common adverse event reported overall was constipation. Ironwood plans to have end of Phase II meetings with the FDA, after which the company expects to advance IW-3718 1500 mg into Phase III development in the second half of 2018.

Vascular and Fibrotic Diseases

• IW-1973. Ironwood expects to initiate Phase II trials of IW-1973 during the second half of 2017 in three disease states: heart failure with preserved ejection fraction, diabetic nephropathy, and resistant hypertension.
  • Data from two Phase IIa studies with IW-1973 in diabetic patients with hypertension are expected in the second half of 2017. The first study is designed to evaluate the effect of IW-1973 on endothelial function and explores its effects on biomarkers. The second study is a fourteen-day study designed to evaluate the tolerability and blood pressure effects of IW-1973.
• IW-1701. Ironwood is enrolling patients with Type II achalasia in a Phase IIa randomized, double-blind, placebo-controlled single-dose study of IW-1701. This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IW-1701 in these patients. Data from this study are expected in the second half of 2017.

Global Collaborations and Partnerships

• Ironwood continues to co-promote Allergan’s VIBERZI^® (eluxadoline) in the U.S. for adults suffering from IBS with diarrhea.
• Ironwood’s partner, Astellas Pharma Inc., is commercializing LINZESS for adults with IBS-C in Japan. Astellas also plans to submit a Supplemental New Drug Application with the Pharmaceuticals and Medical Devices Agency in Japan in the second half of 2017 for potential approval for the treatment of chronic constipation.
• Ironwood expects the China Food and Drug Administration to complete its review of the filing for approval to market linaclotide in China for adult IBS-C patients in the first quarter of 2018. Ironwood is partnered with AstraZeneca AB for development and commercialization of linaclotide in China.

Corporate and Financials