Ironwood Pharmaceuticals (IRWD) Q2 2012 Earnings Call July 17, 2012 8:30 am ET Executives Meredith Kaya Michael J. Higgins - Chief Financial Officer, Chief Operating Officer, Principal Accounting Officer and Senior Vice President Thomas A. McCourt - Chief Commercial Officer and Senior Vice President of Marketing & Sales Mark G. Currie - Chief Scientific Officer and Senior Vice President of Research & Development James M. DeTore - Vice President of Finance and Administration Analysts Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division Graig Suvannavejh - Jefferies & Company, Inc., Research Division Raghuram Selvaraju Gregory R. Wade - Wedbush Securities Inc., Research Division Juan F. Sanchez - Ladenburg Thalmann & Co. Inc., Research Division Rachel L. McMinn - BofA Merrill Lynch, Research Division Mario V. Corso - Caris & Company, Inc., Research Division Irina Rivkind - Cantor Fitzgerald & Co., Research Division Presentation Operator
Some of the information discussed in today's call, particularly the information related to linaclotide, is based on information as of today, July 17, 2012, and contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those set forth in such statements. We do not undertake any obligation to update any forward-looking statements made during this call or contained in the accompanying slides as a result of new information, future events or otherwise. For a discussion of these risks and uncertainties, you should review the forward-looking statements disclosure in our press release, as well as the risks under the heading Risk Factors in our quarterly report on Form 10-Q for quarter ended March 31, 2012, and any of our future SEC filings.I would now like to turn the call over to Michael. Michael J. Higgins Thanks, Meredith, and thanks to everyone on the call for joining us this morning. Over the next several minutes, I'm going to walk through some recent highlights on linaclotide, our broader pipeline and our cash position. In previous quarterly updates, we have provided an in-depth discussion around our view of the linaclotide launch, including lessons learned from other successful launches. We will not be going through that level of detail this morning, so I refer you to those previous investor updates if you're interested in learning more. As you know, our NDA for linaclotide is presently under review at the FDA. In April, the FDA notified us and our U.S. partner, Forest Laboratories, that it had extended the review period for our NDA for 3 months. The PDUFA date for linaclotide is now in September. We and Forest are working with the FDA during the review process and continue to plan for a 2012 launch. The MAA for linaclotide submitted by our European partner, Almirall, is also currently under review. Almirall submitted the MAA to the European Medicines Agency in September 2011 for linaclotide for the treatment of IBS-C, and they continue to work closely with the MAA during the review process. We and Almirall are aligned in our vision for linaclotide and have been working to develop an off-market access strategy that addresses the local market conditions in Europe, particularly given the significant pricing pressures and reimbursement hurdles for pharmaceutical products. The primary objective of the strategy will be to fully leverage the opportunity for linaclotide and enable broad access to patients.
Our preparation for launch with our commercial partners, Forest and Almirall, are on track and continue to progress. Similarly, we are working closely with our global operations partners towards a high quality and nimble supply chain with redundancy in critical modes. This has been a steady strategic imperative for many years and we have made considerable investments towards this goal and will continue to do so. We believe our integrated teams, including our commercial and supply-chain partners, are fully prepared to launch upon approval.Astellas, our partner in Japan and other Asian territories, continues to advance linaclotide through clinical development. In the second half of this year, Astellas expects to begin enrolling patients in a Phase II trial with linaclotide in patients with IBS-C. Beyond our efforts in the U.S., Europe and Japan, we are also exploring opportunities in other parts of the world, such as South America and China, where we can enable access for linaclotide on a more global basis. There continues to be a lot of interest with several of these discussions continuing to progress nicely. In addition to our partnership discussions in China, we have been working to facilitate clinical development of linaclotide. And in May, we filed a Clinical Trial Agreement (sic) [Clinical Trial Application] with the State Food and Drug Administration for a Phase III trial with patients with IBS-C. We are excited to recently have been notified that the CTA was accepted for review. We believe there's a significant opportunity in China. However, keep in mind that the regulatory path to approval is long and our expectations are that we wouldn't reach commercialization for a number of years. Read the rest of this transcript for free on seekingalpha.com