Biogen Idec (BIIB)
Q4 2011 Earnings Call
January 31, 2012 8:00 am ET
Kia Khaleghpour - Associate Director of Investor Relations
George A. Scangos - Chief Executive Officer and Director
Douglas Edward Williams - Executive Vice President of Research and Development
Tony Kingsley - Executive Vice President of Global Commercial Operations
Paul J. Clancy - Chief Financial Officer and Executive Vice President of Finance
Alfred Sandrock - Head of Neurology Research & Development
William D. Young - Chairman, Member of Corporate Governance Committee and Member of Science & Technology Committee
Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division
Robyn Karnauskas - Deutsche Bank AG, Research Division
Mark J. Schoenebaum - ISI Group Inc., Research Division
Matthew Roden - UBS Investment Bank, Research Division
Eric Schmidt - Cowen and Company, LLC, Research Division
Michael J. Yee - RBC Capital Markets, LLC, Research Division
Rachel L. McMinn - BofA Merrill Lynch, Research Division
Yaron Werber - Citigroup Inc, Research Division
Ravi Mehrotra - Crédit Suisse AG, Research Division
Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division
Thomas Wei - Jefferies & Company, Inc., Research Division
Joshua Schimmer - Leerink Swann LLC, Research Division
Charles Anthony Butler - Barclays Capital, Research Division
Previous Statements by BIIB
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Good morning. My name is Melissa, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Idec Fourth Quarter and Year-End Earnings Conference Call. [Operator Instructions] Ms. Kia Khaleghpour, Associate Director of Investor Relations, you may begin your conference.
Thank you, and welcome to Biogen Idec's fourth quarter 2011 earnings conference call. Before we begin, I encourage everyone to go to the Investors section of biogenidec.com to find the press release and related financial tables, including a reconciliation of the non-GAAP financial measures, that we'll discuss today.
Our GAAP financials are provided in tables 1 and 2. Table 3 include a reconciliation of the GAAP to non-GAAP results, which we believe that it represents the ongoing economics of our business and reflects how we manage the business internally. We have also posted slides on our website that follow the discussion related to this call.
As usual, we'll start with the Safe Harbor statement. Comments made in this conference call include forward-looking statements that are subject to risks and uncertainties. Words such as believe, expect, may, plan, will and similar expressions are intended to identify such statements. Actual results could differ materially from our expectations, and you should carefully review the risks and uncertainties that are described in our earnings slides, earnings release and in the risk factors section of our most recent annual and quarterly reports filed with the SEC. We do not undertake any obligation to publicly update any forward-looking statements.
Today on the call, I'm joined by Dr. George Scangos, Chief Executive Officer; Dr. Doug Williams, Executive Vice President of Research and Development; Tony Kingsley, Executive Vice President of Global Commercial Operations; and Paul Clancy, Executive Vice President of Finance and Chief Financial Officer.
We'll also be joined for the Q&A portion of the call by Dr. Al Sandrock, Senior Vice President of Development, Sciences and Chief Medical Officer. Now I'll turn the call over to George.
George A. Scangos
Okay, thanks, Kia, and good morning, everyone. We had a very productive fourth quarter and -- which concluded a really, I think, great year for Biogen Idec. Recall that in 2011, our goals were to deliver double-digit EPS growth, grow AVONEX and TYSABRI share while pursuing the serological assay and risk stratification to further unlock the value of TYSABRI, advanced or late stage pipeline and continue to drive cultural change. We delivered on all these goals and we've run a long way towards building a foundation for long term growth for Biogen Idec.
In 2011, our product -- total product revenues were up 11% year-over-year and non-GAAP diluted EPS ended the year at $5.90, a 15% increase over 2010. In 2011, our AVONEX commercial team substantially improved the business and AVONEX global sales reached $2.7 billion, a 7% increase year-over-year.
We introduced the AVONEX PEN to the European markets and Canada, thereby improving the administration for patients and reinvigorating physician interest and we filed for marketing authorization of the AVONEX PEN in the U.S.
TYSABRI in-market sales grew 23% year-over-year to reach $1.5 billion in 2011, and we hit key milestones that are important for unlocking the value of TYSABRI. First, the assay for JC virus antibodies was made broadly available in both the U.S. and the EU. Second, the TYSABRI product label was updated in both the EU and the U.S. to include JC virus antibody status as a risk factor for the development of PML.
There's been tremendous interest from the MS community in risk stratification and we believe that the large majority of TYSABRI patients now know their antibody status and that increasing numbers of patients considering TYSABRI are being tested as well.
Against long odds, we were able to convince the EMA to reverse their initially negative opinion for FAMPYRA and we obtained conditional EU marketing approval. We launched FAMPYRA in Germany in 2011 and plan additional launches this year.
Turning to R&D, our late-stage pipeline advanced substantially in 2011, led obviously by BG-12, but also including significant advances in many other portfolio compounds, both early and late. As you know, BG-12 data in 2 large clinical trials were very encouraging. These 2 clinical trials, with more than 2,600 patients, represent the largest data set for any new drug in relapsing-remitting MS to date. We're now focused on bringing this potentially major new therapy to patients with MS as soon as possible.