Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) Q2 2020 Earnings Conference Call - Final Transcript

Jul 30, 2020 • 05:00 pm ET

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Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) Q2 2020 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Ladies and gentlemen, thank you for standing by and welcome to the Ultragenyx Second Quarter of 2020 Financial Results and Corporate Update Conference Call. [Operator Instructions] And without further ado, I would like to turn the conference over to Mr. Joshua Higa. Thank you. Please go ahead, sir.

Executive
Joshua Higa

Good afternoon and welcome to the Ultragenyx financial results and corporate update conference call for the second quarter 2020. We have issued a press release detailing our financial results, which you can find on our website at ultragenyx.com. I am Joshua Higa, Director of Investor Relations. Joining me on this call are Emil Kakkis, Chief Executive Officer and President; Shalini Sharp, Chief Financial Officer; Camiel Bedrosian, Chief Medical Officer; and Erik Harris, Chief Commercial Officer.

I'd like to remind investors that this call will include forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to the types of statements identified as forward-looking in our 2019 Annual Report on Form 10-K that was filed on February 14, 2020, our quarterly report on Form 10-Q that will be filed soon, and our subsequent periodic reports filed with the SEC, which will all be available on our website in the Investors section.

These forward-looking statements represent our views only as of the date of this call and involve substantial risks and uncertainties, including many that are beyond our control. Please note the actual results can differ materially from those projected in any forward-looking statement. For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, see our periodic reports filed with the SEC.

I will now turn the call over to Emil.

Executive
Emil D. Kakkis

Good afternoon and thank you everyone for joining us on today's call. I'll start our call with a general update on our progress and then turn it over to Erik, Shalini and Camille to provide more detailed updates on their respective areas.

The second quarter was highly productive for Ultragenyx. In a span of just two weeks in June, we received our third and fourth FDA approval in our first 10 years of the company. The first was for Crysvita for Tumor-Induced Osteomalacia or TIO, which is now the second indication with the product after its approval for XLH in 2018. The second was Dojolvi for Long-Chain Fatty Acid Oxidation Defect or LC-FAOD, a group of six distinct inborn errors of metabolism. These are the first approved treatments for either of these debilitating diseases. In both cases, we were able to secure full FDA approval based on our Phase 2 study, supplemented by data from expanded access programs. This significantly reduced the time to development for these therapies, for patients with no other FDA options.

Our established and approved products continue to perform well. Crysvita in XLH and Mepsevii continue to grow as we enter the third year post