PTC Therapeutics, Inc. (NASDAQ:PTCT) Q1 2019 Earnings Conference Call Transcript
May 02, 2019 • 04:30 pm ET
Good day, ladies and gentlemen, and thank you for your patience. You've joined the PTC Therapeutics 2019 First Quarter Corporate Updates and Financial Results 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, this conference may be recorded.
I would now like to turn the call over to your host, Head of Investor Relations, Emily Hill. Ma'am, you may begin.
Thank you. Hello, good afternoon, and thank you for joining us to discuss our 2019 first quarter corporate updates and financial results. Joining me on today's call is our CEO, Stuart Peltz; our Chief Operating Officer, Marcio Souza; and our Principal Financial Officer, Christine Utter.
Before we start, let me remind you that today's call will include forward-looking statements based on current expectations. Please take a moment to review our slide on our simultaneous presentation, which contains our forward-looking statements.
Our actual results could materially differ from these forward-looking statements as any and such risks can materially and adversely affect our business and results of operations. 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 and annual report on Form 10-K filed with the Securities and Exchange Commission as well as the company's other SEC filings. We will disclose certain non-GAAP information during this call. Information regarding our use of GAAP and non-GAAP financial measures and a reconciliation of GAAP to non-GAAP is available for today's earnings release.
Before I hand the call over, I would like to point out that given the data from our SMA program will be presented next week at the American Academy of Neurology. We will not be making any comments on that program today.
With that, let me pass the call over to our CEO, Stuart Peltz.
Stuart W. Peltz
Thanks, Emily. Thank you for taking the time today to be on our call. PTC has had a very productive start to 2019. We continue to execute on our strategic vision. Importantly, Translarna was approved this week by the Brazilian regulators. This enables faster market expansion to DMD patients in Brazil. This is the largest independent regulatory authority, outside of the EMA to validate the risk-benefit of Translarna, which serves patients around the world.
Our current commercial sales continue to provide us with a strong base to help us grow the business. We continue to reiterate our DMD revenue guidance of $285 million to $305 million for the full year 2019. Over the next 12 months, we anticipate the launches of four new products, which will advance our strategic objective. Risdiplam for SMA, Tegsedi for hATTR, Waylivra for FCS and our gene therapy product for AADC deficiency. We also have a PDUFA date for expanding Emflaza's label to include DMD patients 2 to 5 years old. In addition, there is a potential for a U.S. approval of Translarna in 2020 based on