BioMarin Pharmaceutical (BMRN) Q4 2012 Earnings Call February 21, 2013 5:00 PM ET
Operator
Good day, ladies and gentlemen, and welcome to the BioMarin pharmaceutical Inc. Fourth Quarter and Full Year 2012 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Eugenia Shen of Investor Relations. Ma'am, you may begin.
Eugenia ShenThank you. On the call today is a J.J. Bienaimé, BioMarin CEO; Dan Spiegelman, CFO; Hank Fuchs, Chief Medical Officer; and Jeff Ajer, Chief Commercial Officer.
This nonconfidential presentation contains forward-looking statements about the business prospects of BioMarin Pharmaceutical, 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.
And now I'd like to turn the call over to J.J. Bienaimé, BioMarin's CEO.
Jean-Jacques Bienaim - Chief Executive Officer and DirectorThank you, Eugenia. Good afternoon, and thank you for joining us on today's call. As we wrap up 2012 and set our sights on key 2013 milestones, I would like to share some thoughts of -- over the past and what is ahead for BioMarin. At BioMarin, our strategy is develop first-in-class or best-in-class therapies where we can make a big difference in the lives of the small number of patients suffering from rare or ultra-rare diseases. That strategy bore fruit in 2012. They set us for further growth in 2013 and beyond.
2012 was a milestone year for BioMarin on a number of important fronts. On the commercial side of our business, we reached the $0.5 billion revenue level. And with a direct commercial presence in 26 countries and products available in more than 40 markets worldwide, we expect to see revenues from our first-in-class commercial therapies to continue to grow. On the development side, we announced positive results for our Phase III Lumizyme study, and we expect to file for approval in the U.S. and EU over the next 2 months. We also announced positive results from our PEG-PAL Phase II study, and we plan on initiating a Phase III next quarter. Overall, we made continued progress on our rich development pipeline. And as a result, we expect to have 6 programs in the clinic this year, the most ever at BioMarin, and one of the richest pipelines for a company our size.
As we start 2013, we're excited about a potentially transformative event set with a number of key milestones coming up in the next few months. The filing of Vimizim VLA remains on track for later this quarter with a potential approval and product launch before year end in the U.S. Vimizim could be our largest product to-date and should put us on the road to reaching the billion-dollar revenue level over the next few years.
Before the end of this quarter, we would also have BMN-701 Phase I/II data and a program go/no go decision. As Hank will describe more fully, we have recently determined that if the data supports going forward with the further development of 701, we will be able to utilize a new cell line, which is much more productive than the current cell line. And with a new cell line, we could initiate a Phase II/III trial, the key component of our pivotal program before the end of this year, almost a full year earlier than we had previously anticipated.
Next quarter, we would also expect to present data on BMN-673 at ASCO, and we could be in a position to start a Phase III study before the end of the year. Finally, before we hit the halfway mark on '13, we expect to start a PEG-PAL Phase III study.
Operator
Good day, ladies and gentlemen, and welcome to the BioMarin pharmaceutical Inc. Fourth Quarter and Full Year 2012 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Eugenia Shen of Investor Relations. Ma'am, you may begin.
Eugenia ShenThank you. On the call today is a J.J. Bienaimé, BioMarin CEO; Dan Spiegelman, CFO; Hank Fuchs, Chief Medical Officer; and Jeff Ajer, Chief Commercial Officer.
This nonconfidential presentation contains forward-looking statements about the business prospects of BioMarin Pharmaceutical, 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.
And now I'd like to turn the call over to J.J. Bienaimé, BioMarin's CEO.
Jean-Jacques Bienaim - Chief Executive Officer and DirectorThank you, Eugenia. Good afternoon, and thank you for joining us on today's call. As we wrap up 2012 and set our sights on key 2013 milestones, I would like to share some thoughts of -- over the past and what is ahead for BioMarin. At BioMarin, our strategy is develop first-in-class or best-in-class therapies where we can make a big difference in the lives of the small number of patients suffering from rare or ultra-rare diseases. That strategy bore fruit in 2012. They set us for further growth in 2013 and beyond.
2012 was a milestone year for BioMarin on a number of important fronts. On the commercial side of our business, we reached the $0.5 billion revenue level. And with a direct commercial presence in 26 countries and products available in more than 40 markets worldwide, we expect to see revenues from our first-in-class commercial therapies to continue to grow. On the development side, we announced positive results for our Phase III Lumizyme study, and we expect to file for approval in the U.S. and EU over the next 2 months. We also announced positive results from our PEG-PAL Phase II study, and we plan on initiating a Phase III next quarter. Overall, we made continued progress on our rich development pipeline. And as a result, we expect to have 6 programs in the clinic this year, the most ever at BioMarin, and one of the richest pipelines for a company our size.
As we start 2013, we're excited about a potentially transformative event set with a number of key milestones coming up in the next few months. The filing of Vimizim VLA remains on track for later this quarter with a potential approval and product launch before year end in the U.S. Vimizim could be our largest product to-date and should put us on the road to reaching the billion-dollar revenue level over the next few years.
Before the end of this quarter, we would also have BMN-701 Phase I/II data and a program go/no go decision. As Hank will describe more fully, we have recently determined that if the data supports going forward with the further development of 701, we will be able to utilize a new cell line, which is much more productive than the current cell line. And with a new cell line, we could initiate a Phase II/III trial, the key component of our pivotal program before the end of this year, almost a full year earlier than we had previously anticipated.
Next quarter, we would also expect to present data on BMN-673 at ASCO, and we could be in a position to start a Phase III study before the end of the year. Finally, before we hit the halfway mark on '13, we expect to start a PEG-PAL Phase III study.
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