Ironwood Pharma (IRWD) Highlights 2015 Accomplishments; Offers Five-Year Operating Goals

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) detailed its strategy to build a top-performing commercial biotechnology company generating rapid, sustainable, high-margin growth. As part of this strategy, the Company outlined three- and five-year operational and financial goals, which include bringing new medicines to market, advancing several blockbuster opportunities into later-stage clinical development, and generating growing cash flows. These goals do not include the potential upside impact of any acquisitions, licensing or other corporate development transactions.

“Ironwood is one of the few companies in the biopharmaceutical industry to have successfully discovered, developed and commercialized a product that has become the branded prescription market leader in its category,” said Peter Hecht, chief executive officer of Ironwood. “Our flagship product LINZESS is well on its way to becoming our first blockbuster: in just its third year on the market, it generated approximately $450 million in 2015 U.S. net sales, annual growth of more than 50%, and is delivering rapidly expanding commercial margins. We are advancing potential blockbuster products for IBS-C/CIC, vascular/fibrotic diseases, and refractory GERD, and we believe the growing contribution from our commercial business and cash on hand are sufficient to fully fund our core business without the need to raise additional capital.”

2015 Accomplishments and Updates:

• Ironwood is advancing internally-developed programs in at least three important franchises: irritable bowel syndrome with constipation (IBS-C)/chronic idiopathic constipation (CIC), where LINZESS and linaclotide colonic release may represent a peak U.S. sales opportunity exceeding $2 billion (shared 50/50 with Allergan plc), with additional global potential; vascular and fibrotic disease, where multiple sGC stimulators may each represent a peak sales opportunity exceeding $1 billion; and refractory gastroesophageal reflux disease (GERD), where IW-3718 may represent a peak sales opportunity exceeding $2 billion.
• LINZESS U.S. net sales, based on estimates provided by Allergan, are expected to be approximately $450 million for the full year 2015, an increase of more than 50% compared to the full year 2014. LINZESS U.S. net sales are reported by Allergan, and final numbers will be provided during Ironwood’s Fourth Quarter 2015 Investor Update.
• Nearly 1 million unique patients have filled a LINZESS prescription since its launch in December 2012, according to IMS Health.

2017/2018 Operational and Financial Goals:

• Ironwood expects its current business to become cash flow positive during this period.
• At least three clinical programs targeting major opportunities are expected to be in later-stage clinical development by the end of 2018. These may include linaclotide colonic release for the treatment of IBS-C, IW-3718 for the treatment of refractory GERD, at least one sGC stimulator in an indication to be determined based on early-stage clinical data, a second formulation of linaclotide colonic release intended for the treatment of IBS-mixed and IW-9179 for the treatment of diabetic gastroparesis.
• At least two additional linaclotide launches are anticipated by the end of 2018, beginning with the 72 mcg dose of linaclotide in the U.S. in the first half of 2017.

By the end of 2020, Ironwood expects:

• To be generating rapidly growing cash flows.
• LINZESS annual net sales to be at least $1 billion.
• At least two additional product launches from Ironwood’s internal pipeline.
• At least five Phase III clinical programs ongoing.

“Ironwood’s proven expertise in R&D innovation, commercial performance and strategic partnering, performed by an incredibly talented team committed to financial discipline, have allowed us to build the bedrock of a successful commercial biotechnology company,” said Hecht. “We created a treatment for a significant unmet medical need in which patients are motivated to seek relief, and we are now pushing hard to repeat this success with the product candidates in our pipeline as we work to deliver on our commitment to sustainable, high-margin growth as one of the industry’s top-performing commercial biotechnology companies.”

Ironwood will provide further details on this strategy during its presentation at the 34th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2016 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time at the Westin St. Francis Hotel in San Francisco. The presentation will be followed by a question and answer session that will begin at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time.

A live webcast of Ironwood’s presentation and the question and answer session will be accessible through the Investors section of the company’s website at www.ironwoodpharma.com. To access the webcast, please log on to the Ironwood website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Ironwood’s website for 14 days following the conference.

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