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Executives

Eric S. Hoffman – Investor Relations

James C. Mullen – Chief Executive Officer, President & Director

Al W. Sandrock, Jr.– Senior Vice President Neurology R&D Organization

Robert A. Hamm – Chief Operating Officer

Paul J. Clancy – Chief Financial Officer & Executive Vice President Finance

Analysts

Rachel McMinn – Bank of America Merrill Lynch

Eric Schmidt – Cowen & Company

Analyst for Yaron Werber – Citi

Joshua Schimmer – Leerink Swann, LLC

Mark Schoenebaum – Deutsche Bank Securities

Michael Aberman – Credit Suisse

Geoffrey Meacham – JP Morgan

[Unidentified Analyst]

Jim Birchenough – Barclays Capital

[Megan Ho]

Joel Sendek – Lazard Capital Markets

Biogen Idec, Inc. (BIIB) Q4 2009 Earnings Call February 9, 2010 8:30 AM ET

Operator

At this time I’d like to welcome everyone to the fourth quarter 2009 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks there will be a question and answer session. (Operator Instructions) Mr. Hoffman you may begin your conference.

Eric S. Hoffman

Welcome to Biogen Idec’s fourth quarter and full year 2009 earnings conference call. Before we begin, I encourage everyone to go to the investor’s section of BiogenIdec.com to find the press release and related financial tables including a reconciliation of the non-GAAP financial measures we’ll discuss today. We’ve also posted slides on our website that will outline the topics discussed on today’s call.

As usual we’ll start with the Safe Harbor statement. Comments made in this conference call include forward-looking statements about our expected future results, our organization, operational and financial activities and goals, the market potential of TYSABRI and other products, the potential market for our products and pipeline advancements and regulatory actions.

These statements are subject to risks and uncertainties that could actual results to differ materially from expectations. You should carefully review the risks and uncertainties that are described in our earnings release and in the risk factors section of our most recent annual and quarterly reports filed with the SEC. We do not take any obligation to publically update any forward-looking statements.

Today on the call I am joined by Jim Mullen, CEO of Biogen Idec; Dr. Al Sandrock, VP of the Neurology R&D Organization; Bob Hamm, our Chief Operating Officer; and Paul Clancy, CFO and Executive Vice President of Finance. I’ll now turn the call over to Jim Mullen.

James C. Mullen

I’m pleased to report that in 2009 Biogen Idec once again delivered strong financial and operational results. For the full year 2009 total revenue increased 7% to $4.4 billion. Non-GAAP diluted EPS increased 13% to $4.12 and the business generated $1.1 billion in cash. The 13% non-GAAP EPS growth marks six consecutive years of double digit EPS which increases date back to the merger between Biogen and Idec in 2003.

On the operational side, I’m also pleased to announce a very successful year. With $1.1 billion of in market net sales in 2009, TYSABRI is officially a blockbuster. I’m especially proud of this accomplishment when you take a step back and consider the voluntary market withdrawal in 2005. Think about this, a product that was taken off the market is now generating a $1 billion in annual revenue and is still growing.

Furthermore, we made significant progress in our understanding of PML risk and opportunities to stratify that risk and I attribute these accomplishments to both TYSABRI’s advocacy, positive risk benefit profile and a very committed team of Biogen Idec employees who are justifiably proud of their accomplishments but at the same time are aware that there is still more work to be done.

During 2009, we also took steps to extend the durability of our core Interferon franchise. The therapy is now protected until 2026 by virtue of newly issued method of use patents. In addition, we advanced PEGylated Interferon has the potential to reinforce AVONEX’s advantage and improve on convenience. With an eye on reinvigorating our efforts to restore AVONEX’s market leadership, in Q4 we also announced some new additions to our commercial leadership team. Bob Hamm will talk about these new leaders later.

Biogen Idec’s MS pipeline is deeper and more complete than ever before. We now have first in class or best in class therapies that has the potential to address a full spectrum of patient needs. Our strategy has been to slow, stop and reverse MS and we’ve assembled a collection of products and development programs designed to do just that.

During 2009 our R&D organization filed for European and Canadian regulatory approval of Fampridine. Well ahead of plan and we initiated two pivotal trials, three Phase II trials, two Phase I trials and four R to D transition, all while continuing to manage 90 trials for 31 compounds with over [14,000] patients in more than 45 countries.

Finally, we have a strong balance sheet and nearly $100 million in cash flow monthly. This is allowing us the flexibility to both return cash to our shareholders and continue to invest in future growth both internally and externally. Before I turn the call over to Al Sandrock for an update on R&D, let me address a topic I am sure you are interested in, the board’s search for my successor.

The board has formed a CEO search committee headed by director Brian Posner which also includes Chairman Bill Young and Directors Alex Denner and Bruce Ross. The committee is working diligently with a leading search firm Spencer Stuart. The process is underway but as you can understand, beyond that we’re not going to comment on this call today.

I’ll now hand the call over to Dr. Al Sandrock, our Senior Vice President Neurology Research & Development.

Al W. Sandrock, Jr.,

I’d like to begin by welcoming some new additions to the neurology R&D and medical affairs teams at Biogen Idec. You’ve probably already seen the announcements but let me take a moment to tell you about each person. Dr. Richert, joins us from the National Multiple Sclerosis Society where he served as Executive Vice President for Research and Clinical Programs for the past five years. Prior to that John was at Georgetown University where he was Professor and Chair in the Department of Microbiology and Immunology, Professor of Neurology and Founder of the University’s MS clinic.

Dr. Frederick Munchauer joins us from the State University New York at Buffalo School of Medicine where he was the Irvin & Rosemary Smith Professor in the Department of Neurology and Chair of the Department of Neurology. Dr. Nancy Richert, an expert in neuro imaging joins us from the National Institute of Neurologic Disorders & Stroke where she served as a Staff Clinician in the Neuroimmunology Branch and Dr. Doug Kerr an expert on transverse myelitis and MS joins us from Johns Hopkins where he was Associate Professor of Neurology.

We are extremely excited to add these distinguished leaders of the multiple sclerosis community to the Biogen Idec team. I’d like to begin now with an update of our pipeline starting with one of my favorite programs. I’m very pleased to report that in January we initiated a Phase I trial of our fully human anti-LINGO-1 monoclonal antibody. This is especially exciting for us because most of the biology of LINGO-1 was elucidated in Biogen Idec’s own research laboratories.

It has been known for some time that when myelin, the insulation around nerve fibers is damaged by diseases such as multiple sclerosis, neurons often lose the ability to transmit nerve impulses. It was also known that the ability of the human central nervous system to repair myelin was limited. As reported in such publications as Nature Medicine and Nature Neuroscience our scientists found that treatment with anti-LINGO-1 antibody promoted the remyelination of damaged nerve fibers when tested in various animal models of demyelination.

Although current MS therapies can slow disease progression, none are designed to directly affect this repair process. As such, anti-LINGO-1 antibody represents a novel therapeutic approach in multiple sclerosis.

Another new technology that we advanced in to development last quarter was our bispecific antibody targeting TNF-alpha and TWEAK. With this novel bispecific antibody design which was also pioneered by Biogen Idec scientists we can simultaneously bind TNF-alpha and TWEAK with high affinity while retaining many of the desired properties of traditional [monoclonal] antibodies including a long circulating half life and ease of production. Simultaneous inhibition of the TNF-alpha and TWEAK pathways offers the pathways offers the potential to more effectively block inflammatory pathologies and autoimmune diseases.

Now, and update on our blood factor programs. In December with our partner Swedish Orphan Biovitrum, we announced that our Factor VIII product for hemophilia A moved in to clinical trials making ours the only long acting Factor VII compound in clinical trials. In January, we announced that our Factor IX product for hemophilia B moved in to a registrational trial making ours the first long acting Factor IX compound to reach this milestone.

The case for innovating in hemophilia is strong where the only treatment options are those with relatively short half lives requiring between 100 and 150 infusions per year. Our product substantially increases the half life which offers the hope that hemophilia patients would need to receive 50 or fewer infusions per year. We will present the results of our Phase I II Factor IX study in an upcoming medical meeting.

As you may already know Biogen Idec regularly reviews and adjusts its pipeline as scientific, market or regulatory conditions change. In accordance with this process we reviewed the data for a ADENTRI and determined that the results are not supportive of continuing either the oral or the IV program. The efficacy and safety data from our TRIDENT trials analyzed to date suggest a beneficial effect on symptoms without a positive impact on clinical morbidity or mortality outcomes. These results are consistent with recent Phase III results from Rolofylline program in the QT compensated heart failure.

Now, let me take a moment to provide an update on TYSABRI. When we reintroduced TYSABRI in July of 2006 you will recall that we set out to answer three questions about PML in TYSABRI treated patients: who was at risk; what is the risk; and how can we mitigate the risk? With the start of the new year I thought it would be a good time to revisit the progress that we have made in answering these questions.

I’ll begin with what we know about the risks. During our Q3 earnings call I announced that we had initiated conversations with regulators worldwide about updating the TYSABRI product label as we began to believe that the risk of PML increases with the length of time on therapy. In the US we updated the label to include language stating that in patients treated with TYSABRI the risk of developing PML increases with longer treatment duration and that for patients treated for 24 to 36 months the risk is generally similar to the rate seen in clinical trials.

There is limited experience beyond three years. As recently as last Friday, February 5th the FDA reaffirmed that it believes that the clinical benefits of TYSABRI continue to outweigh the potential risks. On January 21st the European Medicines Agency announced that they had finalized a review of TYSABRI and the risk of PML. The Agency’s Committee for Medicinal Products for Human Use, concluded that the risk of developing PML increases after two years of use of TYSABRI although this risk remains low.

The Committee also reaffirmed its position that TYSABRI’s benefits continue to outweigh its risks for patients with highly active relapsing remitting multiple sclerosis for whom there are few treatment options available. We expect that the TYSABRI label in the EU will be revised to reflect the Committee’s conclusions.

We continue to explore avenues for stratifying risk. One key area of focus is on the development of a serological assay to detect the presence of JC virus antibodies. We are currently planning to initiate a clinical study to determine whether antibody negative patients are at lower risk for PML. Our aim is to make these studies widely acceptable to TYSABRI patients worldwide.

Risk mitigation efforts have also continued. When TYSABRI was introduced the expectation was that PML was usually fatal. This assumption was largely based on outcomes seen in the HIV Aids population. It is still too early to draw firm conclusions but so far survival rates have been approximately 75%. We believe that clinical vigilance combined with rapid action including the ability to shut off the activity of Natalizumab by timely does suspension and plasma exchange have contributed to improved outcome.

We will continue to put considerable resources in to PML research to further refine ways of identifying ways of who is at risk for this rate event and to provide other approaches that could improve patient outcomes. A final note on TYSABRI’s efficacy, based on the data coming from our clinical trials the real world observations from various studies and registries around the world as well as the uplifting stories we hear from many patients, we believe strongly in the benefit that TYSABRI can offer many patients with multiple sclerosis.

While PML seems to get all the headlines, we think TYSABRI’s efficacy is a story that also needs to be reinforced. To that end, last month we announced our decision to launch a head-to-head trial of TYSABRI versus Copaxone and Rebif, a trial we call Surpass. Surpass has a target enrollment of 1,800 patients at 230 sites worldwide. As such, it will be the largest well controlled comparative trial of MS treatments ever undertaken.

As you know, many neurologists currently switch patients from one ABCR therapy to another and they do this without any clinical trial evidence that has evaluated the utility of this approach. The Surpass study will be the first trial to provide Class I data on whether patients who are not doing well on first line therapies are better off if they switch to TYSABRI versus waiting to switch or switching among the ABCR therapies. We expect the study to be completed in 2013.

I will now pass the call over to Bob Hamm, our Chief Operating Officer.

Robert A. Hamm

In the fourth quarter AVONEX, TYSABRI and RITUXAN generated combined worldwide revenue to Biogen Idec of $1.1 billion or 5% year-over-year with continued growth in our core MS business offsetting a modest decline in RITUXAN revenues. For the year, this product totaled $4.2 billion which represents 7% growth versus 2008. As Jim mentioned, TYSABRI has achieved blockbuster status in its fourth year, exceeding $1 billion in sales with 30% growth in both end market sales and patients. Our durable AVONEX franchise now in its 14th year in the market, delivered 5% revenue growth.

In January, we installed new commercial leadership, Dr. Francesco Granata joined Biogen Idec to lead our global commercial organization and our global medical affairs team. Dr. Granata is a trained MD who previously held executive commercial leadership positions at Schering-Plough, Pharmacia and Pfizer. Joining Dr. Granata as head of the US business is Tony Kingsley, an entrepreneurial leader who previously held senior operational management positions at Hologic and Cytyc. Together Francesco and Tony’s focus during 2010 will be on reenergizing our US AVONEX business and continuing to drive TYSABRI adoption.

I will now provide more detail on each franchise individually. TYSABRI finished 2009 with over 48,000 patients on therapy worldwide. In the US the number of patients grew by 21%. Outside the US the number of patients grew by 40%. The higher growth rate outside of the US was in part fueled by geographic expansion. During 2009 we launched TYSABRI in seven countries bringing the total number of countries where TYSABRI is sold to 45.

AVONEX is currently available in over 70 countries so we still have plenty of room to continue to expand. We anticipate making TYSABRI available in five or six additional countries in Latin America and central Europe during 2010. No doubt much of the interest in TYSABRI is due to its efficacy. Having demonstrated a 42% to 54% reduction in disability progression, a 68% reduction in relapse rate an five times as many patients free of disease activity versus placebo.

Doctors and patients appear to be taking TYSABRI efficacy into account when weighing TYSABRI’s benefits and risks. In Q4, we updated TYSABRI’s label information to include a duration effect following two years of treatment. Response to this news so far appears to be measured. Worldwide, TYSABRI grew by an average of 867 patients net per month during Q4 which is somewhat lower than during the second and third quarters but still about 24% above the same period prior year.

We have yet to see a meaningful change in discontinuation trends. As of December, we estimate that less than 10% of US neurologists had ever prescribed TYSABRI drug suspension and less than 5% of TYSABRI patients were currently on a drug suspension. For patients with few options other than TYSABRI, the risk of PML even after 24 months remains low while the risk of debilitating MS progression without TYSABRI is high.

Potential competitors to TYSABRI are on the horizon and for competitive reasons I am not going to go in to detail on our commercial preparation for these nation therapies. But I can say this, we are quite confident in the appeal TYSABRI’s benefit risk equation has for many MS patients. In fact, advances in MS therapy such as TYSABRI are changing the way that many patients view and manage their disease.

In January, we launched a customized yoga program called My MS Yoga for people with MS. This program was developed with a top MS specialist Dr. Elliot Frohman and world renowned yoga instructor Baron Baptiste. The video features TYSABRI patients who are all proactively managing their disease through exercise and treatment. This program has had significant pickup in the national and local media including a high profile piece on Good Morning America Health. In the first three weeks since launch, over 4,600 patients have visited MyMSYoga.com to learn more about the program and over 1,200 patients have taken advantage of the free My MS Yoga DVD.

Now, an update on AVONEX; the franchise generated $586 million in global revenue during the fourth quarter of 2009 and $2.3 billion for the year, both an increase of 5% year-over-year. With approximately 137,000 patients on therapy worldwide and 16 years of remaining patient live AVONEX continues on as a strong and durable foundation to our market leading franchise in neurology.

RITUXAN Q4 revenue to Biogen Idec with $257 million, down 15% year-over-year. This decline was driven primarily by the continued expiration of royalties on revenues outside of the United States, off 44% versus 2008. Also in the US our Q4 profit share declined by 7%. As Roche reported last week, this was due to a reduction in wholesaler inventory. For the year RITUXAN revenue to Biogen Idec were $1.1 billion, down 3% year-over-year due to a 24% decline in royalties on sales outside the US.

Now, looking towards the future, let’s turn to our next anticipated product launch in MS. As Jim mentioned, we filed for regulatory approval for Fampridine in December, ahead of schedule, in Europe and Canada. In the US Fampridine is developed and commercialized by Acorda Therapeutics. The FDA recently approved the drug as AMPYRA extended release tablets. It is the first therapy indicated in the US to improve walking in patients with MS.

This was demonstrated by an increase in walking speed. Biogen has established a focused team that is initiating launch preparations for expected approval outside the US in the first half of 2011. Much of our neurology sales and marketing infrastructure is already in place given our market leading position in most countries outside the US.

Fampridine will fit very nicely in to that infrastructure. Our commercial efforts are primarily focused on pharma economic research at this stage. In parallel our supply chain team is preparing to enable appropriate compassionate use programs and named patient supply. Biogen Idec is excited to bring this new therapy to MS patients outside of the US.

Fampridine demonstrates efficacy in people with all four major types of MS: relapsing remitting; secondary progressive; progressive relapsing; and primary progressive and it can be used alone or with existing MS therapies. In short Fampridine’s launch outside the US provides us an opportunity to offer therapies to an even broader community of MS patients, a goal that fits wholly with our mission to create new standards of care in neurology through our global, commercial and medical capabilities.

With that, I will now turn the call over to Mr. Paul Clancy, our Chief Financial Officer.

Paul J. Clancy

I’ll review our 2009 fourth quarter and full year financial performance. Additionally, I’ll provide our 2010 financial guidance. Our GAAP financials are provided in tables one and two of the earnings release. Table three includes a reconciliation of GAAP to non-GAAP results. The primary differences between the GAAP and non-GAAP results for the quarter were $56 million related to the amortization of acquired intangibles and $7 million for employee stock options offset by a $24 million tax impact on these items. Our GAAP diluted earnings per share was $1.06 in Q4 and $3.35 for the full year.

Now, I’ll move on to the non-GAAP P&L operating performance for Biogen Idec which we believe better represents the ongoing economics of the business and it reflects how we manage the business internally. Our non-GAAP diluted EPS was $1.20 for Q4 and $4.12 for full year 2009. In the fourth quarter we benefitted by $0.12 earnings per share due to onetime discreet tax benefits that I’ll detail later in the call.

Now, let’s move through the fourth quarter and full year results in a bit more detail. Total revenue for the fourth quarter 2009 was $1.1 billion, 5% growth over fourth quarter 2008. Revenue for the full year 2009 totaled approximately $4.4 billion which represents a 7% growth over full year 2008. Q4 2009 product revenue was $827 million a 13% growth over Q4 2008. Full year 2009 product revenue totaled $3.2 billion an 11% growth over full year 2008.

Going through our product revenues I’ll begin with AVONEX. Q4 AVONEX worldwide product revenue was $596 million a 5% increase over Q4 2008. Worldwide AVONEX revenue for full year 2009 totaled approximately $2.3 billion, also a 5% growth. US AVONEX product revenue in the fourth quarter was $352 million a 3% increase over Q4 2008.

US AVONEX revenue for the full year totaled $1.4 billion which represents a 10% growth over full year 2008. US AVONEX inventory ended at just over two weeks in the fourth quarter unchanged from the third quarter. In Q4 2009 unit sold in the US declined approximately 7% as compared to Q4 2008. This was offset by price increases. On a sequential basis Q3 to Q4 US AVONEX units declined by approximately 1%.

Q4 international AVONEX product revenue was $244 million a 9% increase over Q4 2008. On a sequential basis, AVONEX international revenues increased by 6% as compared to Q4 driven by higher volume. Foreign exchange net of hedge accounted for 2% of the increase. International AVONEX revenue for the full year 2009 totaled $917 million, a 1% year-over-year decline. The full year international AVONEX revenue was unfavorably impacted by foreign exchange and hedging which reduced revenue by $88 million or approximately 10%. This is offset by unit increases of approximately 6% and favorable price and mix impact of 2%.

Q4 TYSABRI worldwide product sales were $216 million for Biogen Idec, a 39% increase over Q4 2008. TYSABRI worldwide revenue for full year 2009 totaled $776 million for Biogen Idec, a 32% increase over full year 2008. In the US in market TYSABRI sales totaled $137 million for the fourth quarter.

Q4 US TYSABRI product revenue for Biogen Idec was $62 million. US end user end market TYSABRI sales for the full year 2009 totaled $509 million, a 21% increase over 2008. Biogen Idec booked $232 million for full year 2009. Q4 international TYSABRI product revenue was $154 million, a 49% increase over Q4 2008. International TYSABRI revenue for full year 2009 totaled $544 million a 39% year-over-year increase. Foreign exchanged reduced international TYSABRI revenue by approximately $29 million for full year 2009 or 5%. Q4 Fampridine revenue was $14 million.

Now, I’ll move on to the RITUXIN collaboration revenue from unconsolidated joint business. We recorded $257 million in revenue for the quarter representing a decrease of 15% on a year-over-year basis. Revenue for the full year decreased 3% to $1.1 billion as compared to full year 2008. Our RITUXIN revenues are broken down in to three components, first our share of the net US RITUXIN profits. Net US RITUXIN sales were $658 million in the fourth quarter down 3% versus prior year and as Bob noted was partly due to destocking in the channel.

Our Q4 2009 profit share from that business was $192 million down 7% versus prior year. Full year 2009 US RITUXIN sales were $2,666,000,000 up 3% as compared to full year 2008. Our profit share from that business was $774 million up 5% as compared to full year 2008. Year-over-year profit share benefitted from price increases and lower operating expenses in the collaboration.

Second, we receive revenue on sales of RITUXIN outside the US and in Q4 this was $46 million, down 44% versus Q4 2008 as royalties from individual countries have expired. Revenue on sales of RITUXIN outside the US for the full year was $256 million down 24% as compared to full year 2008. We expect for 2010 rest of world revenues from RITUXIN to be approximately $120 to $130 million dependent on exchange rates.

Third, in the fourth quarter we were reimbursed $18 million for selling and development costs incurred related to RITUXIN. For the full year 2009 we were reimbursed $66 million. Royalty revenue were $41 million for fourth quarter 2009 and $124 million for the year.

Now, turning to the expense lines on the non-GAAP P&L; Q4 COGS were $100 million or 9% of revenues. Q4 R&D expense was $279 million and 24% of revenues. R&D spend for the full year totaled $1.3 billion, approximately 29% of revenues and an increase of 20% on a year-over-year basis. This was owed largely to the $110 million payment we made to Acorda Therapeutics in the first half of 2009.

Q4 SG&A expense was $236 million, a 5% increase year-over-year. This represents 21% of revenues. Drivers of the year-over-year increase included investments to support the MS franchise and the ongoing geographic expansion of our commercial operations. Continuing down the P&L our collaboration profit sharing line totaled $63 million in expense for the quarter.

Other income and expense in the quarter was a gain of $6 million driven by net interest income and realized gains on strategic investments.

Let me now share the progress we’ve made with respect to our share purchase program. On our last earnings call we announced that in October 2009 the board of directors had authorized a share repurchase program of up to $1 billion of common stock intended to reduce our shares outstanding with the objective of returning cash to shareholders. This program was in addition to the previously approved $20 million share repurchase program authorized in October 2006 which has always been earmarked for share stabilization.

In the fourth quarter of 2009 we made solid progress on our share repurchase programs purchasing 14.8 million shares of stock at a total cost of approximately $694 million. Repurchases have continued in the first quarter of 2010 through February 5th whereby we’ve repurchased an additional 5.4 million shares for a total cost of $289 million. Net-net since October 2009 through February 5, 2010 we’ve purchased approximately 20.2 million shares for a total cost of $983 million.

Our cash and marketable securities position remains strong. We ended the year at 2.5 billion of cash and marketable securities. Our Q4 non-GAAP tax rate was approximately 24% which benefitted from multiple discreet events. Specifically in the fourth quarter we effectively resolved previously outstanding tax audits across multiple years on both the federal and state level.

For the full year 2009 our tax rate was approximately 27% reflecting these benefits offset by the negative impact from the Acorda transaction being entered in to by an ex-US affiliate. As we look in to 2010, I expect the non-GAAP tax rate to be in the 28% to 29% range. This does not include the R&D tax credit which currently has not been reinstated. This brings us to our Q4 non-GAAP diluted earnings per share which were $1.20 and our full year non-GAAP EPS of $4.12 representing a 13% increase over full year 2008.

Now, I’d like to provide our 2010 guidance. Revenue growth in 2010 is expected to be in the mid single digits. This includes the expected decline in RITUXIN rest of world revenues. Core operating expenses growth is expected to be in the low single digits. R&D expense is expected to be approximately 24% to 27% of revenue excluding any new business development expense.

SG&A expense is expected to be approximately 20% to 22% of revenue. The high end of this range reflects investments we may be making in our brands in light of the competitive landscape. GAAP earnings per share is expected to be above $3.71. Non-GAAP diluted EPS is expected to be above $4.55 striving towards another double digit earnings growth year. We expect capital expenditures in the range of $170 to $200 million.

So in conclusion 2009 was a solid top and bottom line result. Our total revenue grew by 7% for the full year, product revenue grew by 11%. TYSABRI surpassed $1 billion in sales and our non-GAAP earnings per share grew by 13%. Our cash flow was strong and we made solid progress against our $1 billion share repurchase plan returning cash to shareholders.

Now, I’ll hand the call over to Jim for his closing comments.

James C. Mullen

In summary, 2009 business and pipeline performance positioned the company for continued success in 2010 and beyond. The organization delivered mid teens non-GAAP earnings growth, drove the ongoing growth of TYSABRI patients and revenues, filed new products for regulatory approval, advanced two programs in the registrational trials and broadly drove what’s an increasingly exciting pipeline.

We have consistently delivered double digit earnings growth since the merger between Biogen and Idec in 2003 and we’ve positioned the company to remain competitive well in to the future. With that, Eric let’s now open it up to Q and A.

Eric S. Hoffman

Operator, please open it up for Q and A. We ask that you limit yourself to one question and then reenter the queue for follow up. Please state your name and company affiliation. We’re ready for the first question

Question-and-Answer Session.

Operator

(Operator Instructions) Your first question comes from Rachel McMinn – Bank of America Merrill Lynch.

Rachel McMinn – Bank of America Merrill Lynch

I’m wondering if you can comment a little bit on your R&D choice, particularly on Surpass, how we should be thinking about the $1.2 billion spend for next year, if I have the math kind of in the right ballpark. How much of that is really related to Surpass and TYSABRI investment versus other programs in the pipeline?

Paul J. Clancy

Rachel, you’ve got the math plus or minus pretty close. Surpass is a very meaningful investment as well as a number of the other TYSABRI investments that we have planned for 2010. That of course is shared with Elan from a collaboration standpoint. I think the way we think about R&D broadly is that there are a number of activities that are putting upwards pressure on the R&D line. TYSABRI lifecycle initiatives certainly moving PEG along in the registration trial, a number of the other late stage programs and that kind of being offset by some of the program decisions we’ve made over the last few months that have been noted on the third quarter call and the fourth quarter call. I hope that kind of gives you a little bit of a ballpark to work with.

Rachel McMinn – Bank of America Merrill Lynch

I’m just wondering if you can clarify it all? It’s a big investment but you’re not willing to really put percentages around it?

Paul J. Clancy

You’re saying the specific amount on Surpass? The other thing I’d just point out also is that as Al had noted, it’s a multiyear investment with the trial kind of concluding in the 2013 time period.

Operator

Your next question comes from Eric Schmidt – Cowen & Company.

Eric Schmidt – Cowen & Company

Just looking for an update on ocrelizumab and MS? I guess you recently got the Phase II data in house, maybe you could characterize what you see in there and what your plans are for a Phase III or potential pivotal trial?

James C. Mullen

I’ll take the first crack at that and Al is here with me. I guess what we would do is characterize the MS results on ocrelizumab similar to the RITUXIN results ocrelizumab but at the same stage, certainly interesting results worthy to continue to progress the trial in to Phase III. I think the specifics of that program are yet to be determined with our partner. I don’t know if Al you’ve got any additional comments?

Al W. Sandrock, Jr.,

I don’t have much to say. We’re going to be presenting the results this year at a major medical meeting.

Eric Schmidt – Cowen & Company

Could I ask if you could quantify the destocking that you saw in RITUXIN in Q4?

Paul J. Clancy

Eric, our best estimate is that the business which generally has about 15 days of inventory destocked to about down to in the range of 12 to 13 days of inventory. So our estimate is that on the top line for the collaboration that had an impact of $10 to $15 million.

Operator

Your next question comes from Analyst for Yaron Werber – Citi.

Analyst for Yaron Werber – Citi

I have a question about your guidance, can you elaborate a little bit on what your assumptions are for competitive breadth in the MS space and how that factors in to your guidance and what could be upside and downside scenario to that?

Paul J. Clancy

I’ll kind of take team this a little bit with Bob. We absolutely, as we described in the past fully expect kind of the two oral products to be moving along and get approved. Pragmatically speaking, the impact of that is a little bit more potentially on the sales and marketing for the given 2010 as opposed to the revenue line. As I had noted in our guidance, we’re contemplating investments in sales and marketing. Plans are underway, plans are a little ahead of activities right now to defend our MS franchise which is extremely important over the long haul. So I’d say it is embedded in our guidance for 2010 and plans are underway both to defend the product as well as make smart investments in the sales and marketing front.

Robert A. Hamm

I would just add that for patients with MS, unfortunately it’s not just about [inaudible] administrations, it’s about the course of their disease and the safety profiles of the individual drugs so much is yet to be learned about that but it’s really outcomes the patients are looking for.

Operator

Your next question comes from Joshua Schimmer – Leerink Swann, LLC.

Joshua Schimmer – Leerink Swann, LLC

On TYSABRI, I was just wondering what the design of the studies you are considering to analyze the various predictors of PML? In those studies how do you plan to control for any potential drop out of patients who turn out to have a high risk factor?

James C. Mullen

As you point out, the denominator may change in terms of these two strata but if the risk decreases then we should – if most of the people are in a lower risk category then the overall risk of PML should go down and the number of cases should go away or diminish. So if that’s the case then we will have answered the question. I think the denominator will need to be adjusted according to the number of people who stay in the strata that we’re studying.

Joshua Schimmer – Leerink Swann, LLC

What is the design of the study and what will you specifically be measuring or following?

James C. Mullen

If we’re talking about the serological assay study, it’s basically simply a blood draw where we take the blood, store it. We actually have a couple of studies, in one study we will verify that the findings we got from our strata samples is the same. We will match it up with urine JC Virus. In the other study we’ll collect blood and see whether or not when patients develop PML they were antibody positive at that prior time point or not.

Joshua Schimmer – Leerink Swann, LLC

Is it just the antibody? What are the JC virus specific T cell function assays or the viral protein assays that you’ll also be monitoring? Do you only check those if patients are positive or do you test everyone and see who gets PML?

James C. Mullen

Those will be separate studies done in a focused way in conjunction with some registries and other studies going on in Europe and elsewhere we will look for additional biomarkers. They will include cellular assays as you indicate that test immune response, they’ll also look for mutation in JC virus. If we get a technology we can use to measure mutations and so forth but there are some studies that are going to be underway for example in Germany that we intend to collaborate with the investigators who are doing those studies.

Operator

Your next question comes from Mark Schoenebaum – Deutsche Bank Securities.

Mark Schoenebaum – Deutsche Bank Securities

I was just wondering actually to maybe build on Josh’s question, this is more of a question maybe for Bob, I’m not sure who it is appropriate for but on this whole topic of the JCV serologic assay do you guys expect this assay to materially affect TYSABRI prescribing behavior in 2010 or 2011? Can you help set expectations for those of in the investment and analyst community please?

Robert A. Hamm

Well, I think the simple answer is what kind of industry are we in and we run experiments and outcomes can be pro, con or neutral and with that information treating physicians will make further decisions. So to prejudge and outcome or think that is going to mean something is premature.

Mark Schoenebaum – Deutsche Bank Securities

Can you just give an update on PEG enrollment and time lines for the hemophilia program? Then for Paul, why is cap ex up so much year-on-year for 2010?

Al W. Sandrock, Jr.,

PEG enrollment is on track. We expect to complete enrollment in approximately a year or so plus or minus a few months. It’s always difficult to get enrollment exactly right but it’s going very well so far.

James C. Mullen

The hemophilia programs, obviously the Factor XIII program just got started, that’s a Phase I program so those predictably in this disease area, those go relatively slowly as you go through a bunch of up dosing cohorts. You need to finish each cohort before going to the next so think of that as kind of going on for the remainder of the year to get to sort of Phase I results. The Factor IX program, we have a multicenter international trial ongoing. It’s not lots and lots of patients because it will be less than 100 patients required for that registration trial.

Nevertheless, it’s a pretty competitive area for recruiting patients. On the optimistic side maybe we can be done something this year or early next year. So that’s probably as good as we can peg it right now, no pun intended on the PEG. On cap ex, cap ex is up just because Paul is usually conservative on the upside and then I grind it down through the remainder of the year.

Paul J. Clancy

Mark, it also is in we in the last 12 months have made significant organizational changes in our IT leadership. That resulted in a little bit lighter spending in 2009 as that organization was kind of getting geared up in the organization and we expect very good investments around IT are going to be made in 2010. It’s almost like a little bit of a catch up year.

Operator

Your next question comes from Michael Aberman – Credit Suisse.

Michael Aberman – Credit Suisse

Can you just give us your guidance for 2010, what share count you assume for that? Then also if I could ask you to update the RA or ocrelizumab plans?

Paul J. Clancy

With respect to share count Michael, as we’ve talked in the past the progress as it relates to the share repurchase program we’ll kind of pace that and communicate that on each of the earnings call. But certainly as I noted today we brought in 20 million shares over the last call it two to three months.

Michael Aberman – Credit Suisse

Where are you now in terms of share count, 270?

Paul J. Clancy

We ended the year around 276 in terms of December 31, 2009. Then, with respect to authorization, we actually will tap out of the authorization once we complete the $1 billion share repurchase program.

Robert A. Hamm

In terms of the ocrelizumab RA trials there’s two trials that remain to be read out both in the first half of this year. One trial is called script, it’s an 800 patient trial in TNF inadequate responders. The other one is a trial called FILM in which the enrollment had to be halted but the patients that were enrolled prior to the halt will be evaluated. That trial is called FILM, it’s a methotrexat-naïve trial so both of those will be read out in the first half of the year.

Michael Aberman – Credit Suisse

Can you remind us why it was halted?

Robert A. Hamm

Because of the opportunistic infections that occurred predominately in Asia.

Operator

Your next question comes from Geoffrey Meacham – JP Morgan.

Geoffrey Meacham – JP Morgan

I guess more of a strategic question, you guys are putting cash flow to work obviously with the buyback but your pipeline could take a few years to play out so my question is are you guys content with single digit revenue growth or are you more willing to do marketed product kind of deals going forward?

Paul J. Clancy

Geoff, I think the way we’ve described is not terribly different in the past in terms of capital deployment. We absolutely would love to capture opportunities to create value through products, both pipeline products as well as ideally marketed product but we’d be disciplined that it’s really what we’re trying to solve for is creating shareholder value not simply kind of moving the revenue growth numbers a little bit up or down.

So we’re in an enviable position that we ended the year with $2.5 billion of cash. 2010 looks like another robust year with respect to cash flow generation and we will continue to be challenged with this strategic question of looking for opportunities to create value and doing that in a disciplined way and if not returning cash to shareholders in a disciplined way as well.

Geoffrey Meacham – JP Morgan

A follow up, on the AVONEX what’s the strategy to monetize going forward, to the extent that you can comment?

Robert A. Hamm

Actually, no comments to really make on that right now. The patent takes us out to 2026, it covers interferon beta but nothing really to report and when we do have something we’ll obviously update the community.

Operator

Your next question comes from [Unidentified Analyst].

[Unidentified Analyst]

A quick question on the PLM cases, Al can you just give us a sense of the last three cases I think from 28 to 31 what the duration of exposure was? I just want to throw another one on ocrelizumab, could you remind us of the step down in royalty, what the actually kicks in from RITUXIN and what proportion of the RITUXIN revenue will kick in? Is it going to be across the board or just for the autoimmune use where you have to carve it out?

Al W. Sandrock, Jr.,

In terms of the duration of treatment I actually don’t know the exact numbers but my recollection is they were on the upper end, the two to three year timeframe for these three additional cases.

James C. Mullen

I think we’re going to have a formal update out in the middle of the month so you’ll be able to get that. But, I think the simplest way to think about it is it’s no real change in the profile but you’ll have that information. On ocrelizumab, the step down occurs at certain end market revenue numbers and it’s all revenues, it’s not cut by indication so I think the first traunch, do you have that detail in front of you now?

Paul J. Clancy

I don’t, I apologize, it’s one of the things I don’t have but it’s itemized in our Qs and Ks. But essentially it’s a step down that triggers at approximately, if I recall, $150 million and then $350 million stepping down first to 38% then to 35% and then down to 30% profit share. It as Jim said, affects the whole franchise.

The other thing I would just note is we can have the [inaudible] work with everybody. Ocrelizumab right now is embedded in our R&D expense just because it is a new product. That will upon approval we envision that to actually flip back in to the unconsolidated joint business.

Operator

Your next question comes from Jim Birchenough – Barclays Capital.

Jim Birchenough – Barclays Capital

It may be a little early but I was just wondering if you could characterize the impact of the label amendment in terms of the new patient starts in to the new year? Is it stable, declining still, starting to reverse itself? Then just as a follow up, in terms of patients where you’re seeing drug holidays, can you characterize those patients? Do they tend to be beyond three years and how long are they typically of therapy?

Robert A. Hamm

I guess Jim the best way to think about it is it’s too early to tell, on your first question. Your second question really varies by treating physicians and again, it’s a little too early to tell. The label information really is not new Al, is it?

Al W. Sandrock, Jr.

No, we announced the last earnings call that the US label was going to indicate that the risk goes up with duration of treatment and at the 24 to 36 month mark it was roughly similar to what was seen in the clinical trials. There’s nothing new. The FDA announcement last Friday reiterated the benefits outweigh the risks and there’s no further label changed anticipated.

Robert A. Hamm

I think a lot of physicians are sort of taking a measured approach because there is a trepidation about taking people directly off therapy and not having other options for them so I think increased vigilance and the drug suspensions are mostly physicians taking a very thoughtful approach towards their patients’ outcomes.

Jim Birchenough – Barclays Capital

I guess what I’m trying to get at is as we look at the back half of the first quarter and the first part of the first quarter whether new patients starts are stable or if we should expect a further decline based on what you’re seeing right now?

Robert A. Hamm

It’s too early to tell I would say.

James C. Mullen

Jim, it’s always hard to say because the back half of December there’s nothing much happening because people just don’t start a lot of new patients in that holiday season. I think we’ll have a better read as we come to the end of Q1.

Operator

Your next question comes from [Megan Ho].

[Megan Ho]

First a follow up on the Factor IX question, Jim you had indicated that it will be done late this year early next year. When you say done do you mean enrollment or actually the entire study? What kind of safety follow up would you need for that?

James C. Mullen

I’m going to ask Al if he can answer on the safety follow up. Presumably, they’re going to want to see people on dosing for a year like they do every other biologic. Of course, it’s not going to be your typical patient numbers so my guess will be we need once we finish we’ll end up with the usual file it, the safety update there under review and that will wrap around the one year follow up on the remainder of the patients.

Exactly how quickly that accrual goes I think it’s just too early to say. I can say that the very early accruals in the Phase I trials were difficult but of course now you actually have real data and people get excited about it so I hope that really influences the accrual rate and plus we’re in a lot more centers internationally for the registration trial.

[Megan Ho]

So when you said it would be done by late 2010 early ’11, is that enrollment?

James C. Mullen

That’s enrollments we were talking about. I’ll ask Eric and the IR team to maybe pull together some more specific information on that so that we can get that back out to you. I’m not trying to be evasive I just don’t know what it is off the top of my head.

[Megan Ho]

Then another question on Fampridine, now that we know the pricing in the US can we assume that is basically a global pricing strategy? Obviously the patient population is pretty broad and I’m not trying to kind of ask you for a forecast but kind of thinking about the patient population and knowing the pricing could this be a product the size of AVONEX?

James C. Mullen

Good question. We’ll all be anxiously watching how the launch goes here in the US. The pricing in the US is of course set by Acorda, the pricing outside the US is our responsibility and we’re doing all the pharma co economic research and preliminary discussion to figure out where is the right price point in the EU. We’re not going to really talk about that in any detail because frankly there’s nothing good that can happen with regulators and pricing authorities by talking about price before you’re ready.

The other part of your question is well what’s the population? Certainly one of the things that eventually – I was probably the internal skeptic and I kept looking at this data and looking at this data but it became clear that the impact appreciated by patients goes beyond the primary endpoint. It’s not what’s going to be in the label but I think as Acorda and we expand out the trials and additional things, hopefully we can tease that kind of clinically relevant data. Then the last point is there certainly is strong technical rational to consider this product in other disease areas where nerve conduction is also a problem and there are a fair number of those. So I think you’ve got a big opportunity in MS and a bigger opportunity potentially in some other similar diseases. Al do you have anything to add?

Al W. Sandrock, Jr.,

If you look at how neurologists are using the compounded versions, people are using it for other things besides walking ability and there’s nothing about the biology of this drug that suggests it should only work on ambulation because any [inaudible] nerve fiber track should respond or at least has a theoretical change of responding to fampridine so not just the pathways involved in ambulation but other pathways as well.

Operator

Your next question comes from Joel Sendek – Lazard Capital Markets.

Joel Sendek – Lazard Capital Markets

Jim, one thing you mentioned is that since the merger Biogen and Idec you’ve grown EPS by 10% or at least 10% every year and I know you don’t give long term guidance but can you give us some sense of your confidence of your ability to do that beyond 2010?

James C. Mullen

A good question and I would love to make promises for the next CEO so that he can throw me under the bus as the previous administration but let’s go back to some of the rational for the merger at the time and I think it was evident to Bill on the one side and me on the other side that neither one of us had a pipeline that could really deliver unless we just got lucky and we needed to broaden and build the pipeline fairly quickly.

With the merger obviously we expanded out our therapeutic area expertise as well as we became much more competitive on BD and half this pipeline that you look today came through some kind of BD whether it’s a collaboration, licensing or an all out acquisition. What happens over the next one year or so as fampridine comes to the market as we see the oral competitors I guess we’ll all see that play out but I personally would be pretty optimistic that the pipeline that we’ve assembled and we have a lot of compounds in Phase II and registration trials are really going to deliver a new leg of growth here starting in the next couple of years.

Exactly what the next one or two years I think matters a lot less than watching how that pipeline progresses as well as frankly the competitive environment and of course that’s what we’ve always been focused on. I don’t want to commit the next guy to exactly what it should look like but I think we’ve got things that can certainly drive revenue growth, continue to drive shareholder value and that will show up on the earnings line as well.

Thank you very much everybody. I appreciate it and I’m sorry that we ran over our slot a little bit.

Operator

This concludes today’s conference. You may now disconnect.

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Source: Biogen Idec, Inc. Q4 2009 Earnings Call Transcript
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