Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q3 2018 Earnings Conference Call - Final Transcript

Oct 24, 2018 • 04:30 pm ET

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Sarepta Therapeutics, Inc. (NASDAQ:SRPT) Q3 2018 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good day ladies and gentlemen and welcome to the Sarepta Therapeutics Third Quarter 2018 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program Ian Estepan, VP, Chief of Staff and Corporate Affairs. Please go ahead.

Executive
Ian Estepan

Thank you, Jonathan, and thank you all for joining today's call. Earlier today we released our financial results for the third quarter of 2018. The press release is available on our website at www.sarepta.com. Joining us on the call today are Doug Ingram, Sandy Mahatme, Bo Cumbo; Dr. Gilmore O'Neill, Dr. Louise Rodino-Klapac. After our formal remarks we'll open the call up for Q&A.

(Forward-Looking Cautionary Statements)

For a detailed description of applicable risks and uncertainties we encourage you to review the company's most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission, as well as the company's other SEC filings. The company does not undertake any obligation to publicly update it's forward-looking statements including any financial projections provided today based on subsequent events or circumstances.

With that let me turn the call over to our CEO, Doug Ingram who will provide an overview of our recent progress. Doug?

Executive
Douglas S. Ingram

Thank you, Ian. Good afternoon and thank you all for joining Sarepta Therapeutics third quarter 2018 results and corporate update conference call. Before I comment on the quarter I am pleased to announce that Dr. Gilmore O'Neill has taken on an expanded role as Senior Vice President, Research and Development as well as his previous Chief Medical Officer role.

The structure will ensure that we have a seamless alignment across research through clinical development and approval as we accelerate our plans. As noted previously Dr. O'Neill is with us this evening as is doctor Dr. Louise Rodino-Klapac our Head of Gene Therapy. And now as we will discuss this evening we've had a very productive quarter. Once again posting strong sales growth for EXONDYS 51 while we continue to advance our RNA platform and build our gene therapy center of excellence engine with a sense of purpose. Starting with our RNA platform.

We had another strong quarter of sales with EXONDYS 51 standing at $78.5 million and tracking toward our full year guidance of $295 million to $305 million. I'm very pleased with the execution focused approach of our commercial and medical affairs teams as reflected in our performance.

We are focused on identifying all patients who could benefit from EXONDYS 51 and working to remove any barriers that stand in their way. One of those barriers has been some misunderstanding about the FDA's accelerated approval pathway and the obligation to make therapies available.

We were pleased to see the centers for Medicare and Medicaid services or CMS clarify some issues and correct misconceptions regarding the obligation of State Medicaid's to make access available