BioMarin Pharmaceutical (BMRN) Q2 2022 Earnings Call Transcript

For the period ending June 30, 2022

August 3, 2022 16:30 a.m. ET

Prepared Remarks

Questions and Answers

Call Participants

Prepared Remarks:

Operator

Welcome to the BioMarin Second Quarter 2022 Financial Results Conference Call. Hosting the conference call today from BioMarin is Traci McCarty, Group Vice President of Investor Relations. Please go ahead, Traci.

Traci McCarty

Thank you, Rob. Thank you, everyone, for joining us today. To remind you, this nonconfidential presentation contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including expectations regarding BioMarin's financial performance, commercial products and potential future products in different areas of therapeutic research and development. Results may differ materially depending on the progress of BioMarin's product programs, actions of regulatory authorities, availability of capital, future actions in the pharmaceutical market and developments by competitors and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, such as 10-Q, 10-K and 8-K reports.

On the call from BioMarin's management team today are J.J. Bienaime, Chairman and Chief Executive Officer; Jeff Ajer, Executive Vice President and Chief Commercial Officer; Hank Fuchs, President Worldwide Research and Development; Greg Guyer, Executive Vice President and Chief Technical Officer; and Brian Mueller, Executive Vice President and Chief Financial Officer.

I will now turn the call over to BioMarin's Chairman and CEO, J.J. Bienaime.

J.J. Bienaime

Thank you, Tracy and good afternoon, everyone. Thank you for joining us today on the call. So the first half of '22 is our strongest 6-month results to date with over $1 billion in combined total revenues from our record-breaking first and second quarters. VOXZOGO revenues of $34 million in the first half -- sorry, $54 million in the first half of the year contributed to these results and they were driven by continued rapid expansion of global commercial access for [indiscernible] achondroplasia. VOXZOGO growth led to today's increase in top and bottom line guidance for the full year, despite ongoing economic challenges, including considerable foreign currency exchange rate fluctuations and the strength of the dollar.

Turning now to some of the key highlights in the second quarter, all of which were first in our industry. In late June, we were thrilled to have received a positive CHMP opinion for Europe for ROCTAVIAN. We continue to expect European Commission approvals in the third quarter which will be opening access to thousands of people with severe [indiscernible] who are interested in a onetime infusion of ROCTAVIAN gene therapy. This will be the first gene therapy to treat any hemophilia recommended for approval in Europe. Jeff and his team are ready to launch ROCTAVIAN in the front, potential EC approval later this quarter. And in the U.S., we remain on track to resubmit the BLA by the end of September, the end of next month. Another first [indiscernible] approval of VOXZOGO in Japan for children of all ages with achondroplasia and no age restriction. This approval represents our largest commercial opportunity today in Japan and we look forward to working closely with the achondroplasia community there. We also received approval in Australia for children ages 2 years and older. These important additions to the global access footprint are expected to be meaningful cures with revenues throughout Japan beginning later this year. With BioMarin's financial outlook and robust global launch of VOXZOGO tracking to plan and ROCTAVIAN approval on the horizon in Europe, we are on our way to achieving the goal set forth at the start of the year.