Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Q4 2016 Earnings Conference Call - Preliminary Transcript

Feb 23, 2017 • 08:30 am ET

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Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Q4 2016 Earnings Conference Call - Preliminary Transcript

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Presentation
Operator
Operator

Thank you for joining the Intercept Pharmaceuticals 2016 Full Year Financial Results Conference Call. At this time, all participants are in listen-only mode. Following opening remarks, Intercept management will open the lines for a question-and-answer period. Please be advised that this call is being recorded at the company's request and a webcast of this call will be archived on the company's website for two weeks from today's date.

At this time, I would like to introduce Dr. Mark Vignola, Intercept Director of Investor Relations. Please go ahead.

Executive
Mark J. Vignola

Good morning and thank you for joining us on today's call. Before we begin, please remember we will be making certain forward-looking statements on today's call, including statements and forecasts regarding our future financial and operating performance; anticipated time lines for our development programs for obeticholic acid or OCA; market estimates relating to the indications we are pursuing in our regulatory, clinical and commercial plans, goals and estimates as well as other statements, which relate to future events. These statements are based on beliefs and expectations of management as of today.

Our actual results may differ materially from our expectations. Investors should read carefully the risks and uncertainties described in our reports filed with the SEC, including the Risk Factors section of our most recent Annual Report on Form 10-K and Intercept's other filings with the SEC. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise.

OCA is an investigational product that has not been approved for use by any regulatory authority in any indication other than primary biliary cholangitis or PBC. No conclusions can be drawn concerning the safety or efficacy of OCA in those indications at this time.

The format of today's call will include remarks from our CEO, Mark Pruzanski; our Senior Vice President and Head of U.S. Commercial, Richard Kim; our President of International, Lisa Bright; and our Chief Financial Officer, Sandip Kapadia. We'll then open up the call to take your questions. Rachel McMinn, our Chief Business and Strategy Officer is also available to answer your questions during the Q&A portion of the call.

We would like to note that we have slides associated with today's call. These can be accessed via the webcast and on the Events section of our IR website.

At this time, I'd like to turn the call over to our CEO, Dr. Mark Pruzanski.

Executive
Mark E. Pruzanski

Thank you, Mark. Good morning and thanks for joining us on today's call. 2016 was a truly momentous year for Intercept, marked by the U.S. and European approval of our first-in-class FXR agonist OCALIVA for PBC, a devastating disease with no therapeutic options for patients achieving an inadequate response to standard of care. We successfully transitioned to a commercial organization with our U.S. launch in June 2016 and recorded $18.2 million in net OCALIVA sales for the year, of which $13.4 million was booked in the fourth quarter. We made progress in our pioneering Phase 3 NASH trial,