BioMarin Pharmaceutical's CEO Discusses Q2 2012 Results - Earnings Call Transcript

BioMarin Pharmaceutical, Inc. (BMRN)

Q2 2012 Earnings Call

August 1, 2012 05:00 pm ET


J. J. Bienaime – Chief Executive Officer

Dan Spiegelman – Executive Vice President & Chief Financial Officer

Hank Fuchs – Executive Vice President & Chief Medical Officer

Steve Aselage – Executive Vice President & Chief Business Officer

Eugenia Shen – Investor Relations


Mike Yee – RBC Capital Markets

Salveen Richter – Canaccord Genuity

Yaron Werber – Citi

Chris Raymond – Robert W. Baird

Matt Lowe – JP Morgan

Joseph Schwartz – Leerink Swann

Phil Nadeau – Cowen & Co.

Alethia Young – Deutsche Bank

Tim Lugo – William Blair & Company

Ian Somaiya – Piper Jaffray

Matthew Harrison – UBS

Liana Moussatos – Wedbush Morgan

Kim Lee – ThinkEquity

Brian Abrams – Wells Fargo Securities

Stephen Willey – Stifel Nicolaus



Good day, ladies and gentlemen, and welcome to the Q2 2012 BioMarin Conference Call. My name is Chanel and I will be your operator for today. (Operator instructions.) Just as a reminder, today’s call is being recorded. I would now like to turn the call over to Ms. Eugenia Shen, Investor Relations. Please proceed.

Eugenia Shen

Thank you. On the call today is J.J. Bienaime, BioMarin’s CEO; Dan Spiegelman, CFO; Hank Fuchs, Chief Medical Officer; and Steve Aselage, Chief Business Officer.

This non-confidential presentation contains forward-looking statements about the business prospects of BioMarin Pharmaceuticals 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 in its 10(q), 10(k) and 8(k) report. And now I’d like to turn the call over to J.J., BioMarin’s CEO

J.J. Bienaime

Thank you, Eugenia, and good afternoon and thank you for joining us on today’s call. I have a few introductory comments before we welcome the newest member of our senior management team to the core of our call – Chief Financial Officer Dan Spiegelman who will review the financials for Q2 2012. Steve will then provide more detail on our commercial portfolio and Hank will provide an update on our R&D program before we open the call for questions.

We’re very pleased with the progress we’ve made today in both our commercial as well as our clinical programs. Starting with our commercial portfolio we generated almost $425 million in quarterly revenues for BioMarin-marketed products, and this is after a very strong Q1driven by continued growth from Naglazyme and Kuvan. Our core business is strong and continues to grow and support the majority of the development costs of our existing R&D pipeline.

Our cash balance was $524.6 million at the end of Q2 as compared to $288 million at the end of Q1 2012. At the end of May we raised $235 million of net proceeds from a public offering of common stock. The main purpose of this financing was to strengthen our balance sheet after spending $130 million in that year on a new manufacturing facility in Ireland and also for the repurchase of [Naglazyme 1T2]. We also wanted to raise money at an opportunistic time especially considering the uncertainty of the global markets.

As we enter the second half of the year we are nearing several significant clinical inflection points including the Phase III trials for GALNS, the Phase II trials for PEG-PAL, the Phase I/II trials for BMN-673 – our PARP inhibitors for solid tumors – and the Phase I trial in [healthy enroll] tiers for BMN-1 inhibitor or Achondroplasia; and also the Phase I/II trial for BMN-701 for Pompe Disease now anticipated in Q1 of next year.

Positive results for one or more of these patient-based trials could be transformative for the company. In particular, GALNS has the ability to quickly bring BioMarin to the next phase of maturity. There is an estimated worldwide population of approximately 3000 patients or 3x the MPS VI market size and all of which are theoretically eligible for treatment. And I’m happy to report that over 1200 patients have already been identified which is more than the entire MPS VI market served by Naglazyme, and combined with our exceeding worldwide commercial infrastructure that is highly leverage-able, that adds significant revenues and contributes substantially to our bottom line.

We continue to have confidence in the success of this program due to the clinical benefits seen in the Phase II extension study which Hank will elaborate on a little bit later, and the robust design of the Phase III trial. The Phase III trials include the enrollment of 176 patients. Selection criteria are baseline [walk] distance less than 325 meters which is [serious] to the design of the Naglazyme and Aldurazyme clinical trials; and no patients with planned surgical procedures during the 24-week duration of the trial. We’re also seeking the mean of two (inaudible) measurements at each time point which we expect to reduce variability in the primary endpoint based on our experience with Aldurazyme and Naglazyme.

Importantly we have two treatment arms in the study and can achieve statistical significance from AP value of 0.025 in either one of the treatment arms or 0.05 in each of the two treatment arms combined. We are further encouraged by the tremendous amount of support and encouragement from our patients and physicians, the [NTS IV Committee] and by the continuous patient benefit seen in the Phase II extension study including improvement in growth (inaudible).

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