Spark Therapeutics, Inc. (NASDAQ:ONCE) Q3 2018 Earnings Conference Call Transcript

Nov 06, 2018 • 08:30 am ET

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Spark Therapeutics, Inc. (NASDAQ:ONCE) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good morning, ladies and gentlemen, and welcome to the Quarter Three 2018 Spark Therapeutics, Incorporated Earnings Conference Call. At this time all participants are in listen-only mode. Later we will conduct a Question and Answer session and instructions will follow at that time. (Operator Instructions). As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Mr. Ryan Asay, Head of Investor Relations. You may begin your conference.

Executive
Ryan Asay

Thank you, Tom, and welcome, everyone, to the Spark Therapeutics Third Quarter 2018 Conference Call. With me, today, from the company are Jeff Marrazzo, Chief Executive Officer; Dr. Kathy High, President and Head of Research and Development; John Furey, Chief Operating Officer; Stephen Webster, Chief Financial Officer; and Federico Mingozzi, Chief Scientific Officer.

Please note that this conference call will include forward-looking statements regarding our products, programs and product candidates. Because such statements deal with future events and are subject to many risks and uncertainties, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 10-K and our quarterly reports on Form 10-Q that are filed with the U.S. Securities and Exchange Commission.

This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 6, 2018. Spark undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

This conference call is being webcast and will be archived on our website for approximately 1 week. Earlier this morning, we released financial results for the quarter ended September 30, 2018, and recent business progress. This news release is available on the Investors section of our website at sparktx.com.

I'd now like to introduce Jeff Marrazzo, Spark's CEO.

Executive
Jeffrey D. Marrazzo

Thanks, Ryan. Good morning, everyone, and thank you for joining us. On this morning's call, I will provide some introductory remarks before asking John to share an update on the launch of LUXTURNA and our progress in advancing our manufacturing platform; Kathy to provide commentary on our hemophilia A program; and Frederico to discuss our Pompe program, before Stephen reviews our third quarter financial results. I will then have some concluding comments before opening the call up to your questions.

During the third quarter, we continue to make important progress across our fully integrated gene therapy portfolio. With LUXTURNA, the launch execution in the United States continues to be strong and has recently achieved new milestones. John will provide the details shortly, but I'm pleased to share that last quarter, the first 2 patients were treated under the outcomes-based payment model we announced earlier this year, and the first government beneficiary was also treated.

In Europe, CHMP issued a positive opinion in September, and we expect formal approval for LUXTURNA by the European Commission as soon as this month. We also continue to make significant progress with both of our hemophilia programs.