Biogen IDEC, Inc. Q4 2007 Earnings Call Transcript

Feb. 6.08 | About: Biogen Inc. (BIIB)

Biogen Idec Inc. (NASDAQ:BIIB)

Q4 FY07 Earnings Call

February 06, 2008, 08.30 AM ET

Executives

Elizabeth Woo - VP, IR

James C. Mullen - President and CEO

Bill Sibold - Sr. VP

Cecil Pickett - President, Research and Development

Paul J. Clancy - EVP and CFO

Analysts

Joel Sendek - Lazard Capital

Eric Schmidt - Cowen & Company

Steven Harr - Morgan Stanley

Geoff Meacham - J.P. Morgan

Michael Aberman - Credit Suisse

Bill Tanner - Leerink Swann

Geoffrey Porges - Sanford C. Bernstein

Jim Birchenough - Lehman Brothers

Jason Kantor - RBC Capital Markets

Mike King - Rodman & Renshaw

May-Kin Ho - Goldman Sachs

Yaron Weber - Citi

Maged Shenouda - UBS

Operator

Good morning. My name is Dennis and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Idec fourth quarter 2007 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] Thank you.

I will now turn the call over to Ms. Elizabeth Woo, Vice President, Investor Relations. Please go ahead Ma’am.

Elizabeth Woo - Vice President, Investor Relations

Thanks Dennis. Thank you all this morning for joining us on today's Biogen Idec's earnings conference call for the fourth quarter and full-year 2007. Before we begin, I would encourage everyone to go to the investor relations section of our website, biogenidec.com and print out the press release and related financial tables. You will find these particularly useful when our CFO Paul Clancy reviews the financial results and the reconciliation to non-GAAP financial measures discussed today. We have also posted slides on the website that outlined the topic discussed on today's call.

As usual we will start with the Safe Harbor statement. Comments made in this conference call includes forward-looking statements about the company's expectations regarding future financial results, including our 2008 financial guidance, our longer-term operational and financial goals, the sales potential of TYSABRI and plans for external growth and pipeline advancements. Such statements are subject to risks and uncertainties, which could cause actual results to differ materially from expectation. In particular careful consideration should be given to the risks and uncertainties that are described in our earnings release and in item 1A of the company's report of the Form 10-K and 10-Q and in other periodic internal reports, Biogen Idec files with the SEC.

The company does not undertake any obligation to publicly update any forward-looking statement. In addition, because we have recently received a Board of Director’s nomination and by our amendment proposal from one of our shareholders we are obliged to inform you this and to be sure that our stockholders have access to all the information they might need around this process. Today on the call I’m joined by Jim Mullen, CEO of Biogen Idec, Bill Sibold, Senior Vice President, US Neurology Business Unit, Cecil Pickett, President of Research and Development and Paul Clancy, Chief Financial Officer and Executive Vice President of Finance.

I'll now turn the call over to Jim Mullen.

James C. Mullen - President and Chief Executive Officer

Thank you Elizabeth. Good morning everyone. We are extremely proud of our accomplishments in 2007. Our revenues grew 18% and non-GAAP earnings grew by 22% and we achieved our full-year growth targets and as you know late last year we outlined our growth targets for the next few years. We’ve really advanced and expanded our pipeline significantly and 2008 is shaping up to be another strong year with many meaningful clinical data readouts.

So let me just expand on a couple of the accomplishments. AVONEX worldwide sales approached $1.9 million in 2007, which represented a 9% year-over-year growth, RITUXAN worldwide in-patient sales for 2007 exceeded $4.5 billion, and revenue from the related joint business topped $900 million, up 14% year-over-year. TYSABRI exceeded the fourth quarter run-rate exceeding $0.5 billion in market revenues and importantly in terms of corner out profitability in Q4. Between AVONEX and TYSABRI MS, franchise share of 40% continuous to expand and Bill Sibold the Senior Vice Present US Neurology will take you through commercial update for TYSABRI. So going into 2008, we expect to meet steady progress towards our goal of 100,000 patients on TYSABRI by year-end 2010.

I'll take you to slide 8. The financial performance for 2007 was very robust and we finished with a very strong fourth quarter and I think that’s despite some of the uncertainty events in the fourth quarter. We did keep everybody focused on the mission, delivered a very strong quarter both on the topline and the bottom line. Total revenue for the full-year of 2007 was almost $3.2 billion and that's 18% year-over-year increase and non-GAAP EPS was up 22%. We essentially achieved our long-term growth goals set out at the time of merger four years ago where we indicated our goal was 15%, topline company growth rate 20%, non-GAAP bottom line company growth rate, actuals are 14.4% on the topline and 22.4% on the bottom line.

Now over that same full year period the stock price has increased at the company growth rate of 12% and that's only surpassed by two companies in our peer group [inaudible]. Our 2008 plan is in line to achieve the 2010 growth goals that I’ve outlined late last year, 50% company growth rate on the topline and 20% company growth on the bottom line. Paul is going to walk you through the guidance for this year later on in the call.

Couple of comments about the pipeline, our pipeline advanced nicely. We now 15 products in Phase II and beyond and in 2008 we will see quite a number of clinical results, Cecil will walk you through that as well.

At the R&D day in May, we reviewed our pipeline review and the feedback was quite positive that the quality and quantity portfolios impressive for company of our size. Significant R&D investment has yielded a robust pipeline with three novel compounds and registrational trials, BG-12, galiximab, and lumiliximab, and two more entering those registrational trials this year was about in ADENTRI. So along with a number of other meaningful data readouts this is going to be a very exciting year for clinical data.

We have built this pipeline with a balanced approach of organic development and business development and business development continues to be an important part of our strategy as it has been over the last four years. By pursuing this strategy, we've already manned the pipeline with more than 10 compounds over the past few years, which is inclusive of three acquisitions; Conforma, Syntonix, and Fumapharm. In Q3 we closed another business development deal with Cardiokine for the end of Phase II of lixivaptan program and in Q4 we signed a deal with Neurimmunie to develop antibodies for Alzheimer’s.

I'll take you to slide 11 now. Obviously, we have significant financial capacity to conduct business development and acquisitions. Our approach to acquisitions has been highly disciplined. We look for strategic fit, add attractive valuations, valuations that allow us to generate significant returns to shareholders. In late 2006 and in early 2007 we concluded that there were no significant acquisition target that met [ph] tests our strategic fit and attract valuations and we therefore returned $3 billion to shareholders in a Dutch auction. We are continually evaluating companies for acquisition and periodically assessing our capital structure. We do occasionally see smaller acquisition targets that could be executed for cash and accommodated into our current business forecast. At this time, our valuation of the acquisition market for large companies there are no companies meets the dual test of strategic fit at attractive valuations.

Now, I want to finish the introduction with a little review of the sale process conducted through the fourth quarter. I went through a very detailed description of the process at the J.P. Morgan Conference in January but I'd like to take this opportunity to review some key points again and why management and the Board and the company's advisors concluded was an appropriate action for the company to explore the level of strategic interest in Biogen Idec and to reemphasize the few key points about the process.

We began the process for the following reasons. We had received expressions of interest, first, second after the MedImmune and AstraZeneca transaction. There was a prevailing view within the market, the big pharma companies were very interested in acquiring biotech companies like Biogen Idec. The timing of our process was ultimately triggered by Mr. Ikon’s offer and our investors which include Mr. Ikon [ph] and many others strongly encouraged us to do so.

The management and the Board felt we should test the pieces in a comprehensive objective way to see whether it could result in a transaction that will result in greater returns to shareholders than the plan that we have described. Our Board in consultation with management and advisors developed an executed sale process that was professional, objective, and thorough and was designed to the illicit the highest possible value for the company's shareholders.

We engaged through investment banks that we’re already with them there with company's business. These two investment banks happened to be the same two that executed the MedImmune and AstraZeneca transaction. These bankers provide to contact a range of potentially interested buyers close to 20 in all to solicit interest, our advisors ran a classic two-step process designed to encourage as much interest as possible in the company at the highest possible price and our bankers were fully incentivized to get a deal there. We provide the interested parties with the opportunities for thorough due diligence. There has been much said about the process but it really boils down to a discussion about sequence of events.

We ran a process that dealt with the largest value drivers first and the smallest ones last. Despite the [inaudible] about this or that decision around the process all of which was done in concert with our financial advisors and other advisors. The basic fact remains that no company put a bid on the table. I think it's clear that for those few major pharmas who could afford the acquisition of our size perceived risk profile of TYSABRI at this time is simply too great.

As a result company is moving forward because that’s what is best for Biogen Idec and our shareholders. We’re executing a comprehensive strategic plan for growth that does not rely in any single event or single approach but the compass is driving the core business, discipline, and M&A and prosecuting the pipeline. As the circumstances evolved, the Board and management will continue to explore all our opportunities with goal of maximizing value for all of our shareholders and I think as demonstrated by Q4 and the full-year 2007, the future Biogen Idec is extremely great.

I’ll now turn the call over to Bill Sibold, who runs our U.S. Neurology business. Bill has been with the company for six years most recently as VP, Neurology SBU, prior to that assignment, Bill was Managing Director of Australia. Bill?

Bill Sibold - Senior Vice President

Thanks Jim. Let me start off by reminding everyone that Biogen Idec has the Number 1 prescribed MS Therapy today, AVONEX, the product that has established a new level of efficacy TYSABRI which has been shown to delay the progression of disease and reduce relapses by two thirds and [inaudible] pipeline of MS compounds for the future. These strengths have translated into a strong Q4 and a strong 2007.

In 2007, our global neurology business reached approximately $2.1 billion in revenue with about $600 million of that coming in the fourth quarter. This is up 20% for the full year versus 2006 and up 30% for the quarter versus the prior year. In 2007, our MS franchise continued to gain share. In the U.S. our share is now about 40% of the overall market. AVONEX remains the product to start with in most cases and TYSABRI is the product for patients needing more efficacy. Our franchise is very well positioned for the future and will continue to grow.

Looking specifically at products, AVONEX remains the world's most prescribed MS therapy with over 135,000 patients worldwide. In 2007, we had a significant milestone with AVONEX as we surpassed the 1 million patient earmark. With $1.9 billion in revenue in 2007, up 9% from 2006 and over $500 million in Q4 revenue, up 15% year-over-year AVONEX remains the foundation of our global MS business.

In Q4, we saw revenue growth in the U.S. of 6% year-over-year; internationally AVONEX revenue grew 26% in Q4 '07 year-over-year. In 2008 AVONEX will celebrate its 12th anniversary on the market. Market research indicates that AVONEX is the therapy option that positions most associates with patients who lead an active daily lifestyle, which is important given that MS tends to strike dose between the ages of 20 and 50.

With this long-term efficacy profile, proven track record with physicians and patients and number 1 physician, AVONEX remains the product to start with. AVONEX is well positioned to continue to its success based on its ability to disrupt disease not patient’s life.

Now TYSABRI. TYSABRI is approved in over 30 countries and has been on the market in the U.S for 18 months. It continues to grow Biogen Idec’s share and the overall MS market with 405 [ph] new patients to the Biogen Idec franchise and 105 [ph] patients either returning quitters or naïve patients. The global market share is now approximately 5% for TYSABRI and one of five patients either returning quitters or naive patients. The global market share is now approximately 5% for TYSABRI. Neurologists are growing increasingly comfortable with TYSABRI's benefit risk profile.

As of late December, there were over 21,000 patients on therapy worldwide in the commercial and clinical trial setting. About 12,900 of the patients were in the U.S. with over 2,500 physicians prescribing here. This is twice the number of physicians that were prescribing in the U.S. at the beginning of 2007 and this number continues to grow at a strong steady pace. About 7,500 of the 21,000 patients were from international markets. While Germany and France continue to be the largest contributors, Spain, Italy, Sweden, Canada, and Switzerland are also significant contributors to TYSABRI's growth. Additionally, as of mid-December, over 6,300 patients had been on therapy for longer than one year.

TYSABRI continues to build momentum in 2008 and will celebrate its two-year launch anniversary in July. Already in January, CMS issued TYSABRI a permanent J code and the FDA approved TOUCH online, which is in the process of being rolled out. TOUCH online will provide substantial benefits to our prescribers and infusion sites such as real-time access to patient data, reduce paper transactions and phone calls, and reduced administrative burden.

According to research, TYSABRI is already the most switch-to product in MS. Over 50% of MS patients who switch do so because they are unsatisfied with the efficacy of their existing therapy. The majority of the remainder switch because of tolerability concerns. TYSABRI is extremely well positioned to capture both of these switcher segments and regarding switching dynamics, glatiramer acetate, with its 365 injections per year continues to be the single largest source of TYSABRI patients.

Growth in 2008 will be driven by increasing the breadth and depth of TYSABRI’s physicians. Those physicians already prescribing TYSABRI indicate strongly that they intend to increase their prescribing in 2008 and many of those who have not yet prescribed tell us they plan to do so in the next 12 months. Growth in 2008 will also be driven by the continuing geographic rollout. Additionally, we will see full-year benefit in 2008 of those countries such as France that launched in 2007.

It is clear that neurologists and patients are increasingly choosing TYSABRI given its significant impact on clinically meaningful and relevant endpoints, including relapses and disability progression. With its market share currently growing at the fastest rate of any MS therapy, we are confident that TYSABRI will achieve the previously stated goal of 100,000 patients on therapy by year-end 2010.

Of course, we will also extend our leadership position beyond 2008 with our robust pipeline that includes four products in Phase II. These products are BG-12, RITUXAN, and our CD20 franchise, oral VLA-4 inhibitor, and daclizumab. We are also expanding indications with TYSABRI. As Biogen Idec and Elan announced in January, TYSABRI has been approved by the FDA for Crohn's Disease. Our partner, Elan, is leading the commercial effort in Crohn's and we expect to launch by the end of February. Approximately 500,000 people in the U.S. have Crohn's Disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.

Approximately 30,000 to 40,000 Crohn's patients in the U.S. are on a biologic therapy now with this number expected to grow rapidly over the next few years. Currently, there is no medical or surgical cure for the Crohn's disease. The unmet need remains high in Crohn's disease and TYSABRI provides an important option for these patients.

In conclusion, with the number one prescribed MS therapy today, AVONEX, a product that has established a new level of efficacy TYSABRI and the best and broadest pipeline of MS compounds for the future, Biogen Idec is the leader in multiple sclerosis. We recognize that MS patients need more options since MS is a chronic disease and it is unlikely only one drug will be appropriate over the course of the disease. From diagnosis to disease resolution, we are massing the highest quality portfolio compound to address the unmet needs of our patients in 2008 and beyond.

I will now hand the call over to Dr. Cecil Pickett, President of Research and Development.

Cecil Pickett - President, Research and Development

Thank you, Bill and good morning everyone. Today, I'll report on our recent accomplishments and upcoming data readouts. First I'll provide a review of the recent positive regulatory events and data readouts. Then I'll provide an update of some of our R&D accomplishments for the quarter. And then finally, I will close by reminding you of the upcoming data readouts, which we are expecting by the end of 2008.

Starting with recent positive regulatory events and data readouts, we've had a very successful several months. First, our sBLA for TYSABRI to treat Crohn's disease was approved by the FDA on January 14. TYSABRI is now also approved for inducing and maintaining clinical response and remissions in patients with moderate-to-severe Crohn's disease with evidence of inflammation who have had an inadequate response to conventional therapies and inhibitors of TNF.

Stain was successful of regulatory outcomes. We also had good news on RITUXAN. On January 25, we and our collaborators received FDA approval for RITUXAN sBLA on slowing progression of structural damage in TNF inadequate responder RA patients. We believe these are among the first clinical data on slowing structural damage in this patient population and are pleased to have the label now reflect this additional important benefit of RITUXAN in these patients.

Continuing with RITUXAN and also on January 25, we and our collaborators announced positive topline results from the Phase III serine study investigating the safety and efficacy of RITUXAN in the earlier disease setting of DMARD and adequate responding RA patients. This is the first Phase III study demonstrating that RITUXAN improved symptoms of RA in patients who has not previously been treated with a biologic therapy and provide further support for B-cell therapy in RA.

Also during the fourth quarter, we received positive results from the RITUXAN Phase III SUNRISE study investigating controlled retreatment of patients who are inadequate responders to TNF therapies. In this study, patients with active disease, 24 to 40-weeks following an initial course of RITUXAN were randomized to receive either a second course of RITUXAN or placebo.

The primary endpoint was achieved with significantly more patients achieving an ACR20 after 48 weeks with RITUXAN treatment followed by a retreatment with RITUXAN as compared to retreatment with placebo. A preliminary review of the safety data has revealed no new safety signals. We and our collaborators look forward to sharing the full results from both these RITUXAN studies with the medical community and the FDA.

Staying on RA for the moment, but moving to a novel molecule, I will mention baminercept alpha or LT beta R-Ig. On November 9, we presented as a poster the baminercept alpha Phase IIa results at the American College of Rheumatology Meeting. The data suggests clinically meaningful improvements in ACR scores in patients with RA on baminercept alpha compared with placebo.

We view the results as highly encouraging and two Phase IIb RA trials are currently enrolling. A 380 patient DMARD-IR dose ranging trial at 120 patient TNF-IR trial, the primary endpoint for both trials is ACR 50 at three months and we expect to have a readout by year-end 2008. We believe there is a potential for a dosing advantage as one of the doses we are testing is a once-a-month subcutaneous dose.

Next, I will mention some of our R&D accomplishments for the quarter. We continue to make good progress on enriching and advancing our pipeline. We are advancing and developing our late-stage clinical pipeline. We currently are accruing patients to our three ongoing pivotal registration programs with novel molecules, namely Lumiliximab in CLL, Galiximab in Non-Hodgkin's Lymphoma and BG-12 in relapsing remitting MS. In addition, we expect to initiate two more pivotal programs during 2008 with lixivaptan in hyponatremia and ADENTRI in acute decompensated congestive heart failure.

Related to one of these late-stage programs, in January, the EMEA's Committee for Orphan Medicinal Products adopted a positive opinion recommending Lumiliximab as an orphan medicinal product for the treatment of Chronic Lymphocytic Leukemia. We expect the European Commission to adopt the recommendation this month.

Next, we and our collaborators completed enrollment in the RITUXAN Image [ph] study in Q4. The primary endpoint is the change in structural damage as measured by joint X-rays at 52 weeks in early RA patients. Results from these studies are of particular interest due to the potential of impacting the course of disease by initiating B-cell mediated therapy in early RA patients. In addition, we filed INDs for TYSABRI in multiple myeloma and Anti-Cripto DM4 for solid tumors and expect to initiate human trials soon.

We also continue to execute our external growth strategy. In November, we announced an agreement with Neurimmune around a novel, fully human antibody for the treatment of Alzheimer's disease focused on antibodies that bind to beta amyloid. Neurimmune will identify candidate antibodies using proprietary technology and will be responsible for the development and commercialization of the products. We believe we have a solid pipeline that is progressing well with a good balance of both risk and potential return represented.

Now I will touch on data readouts. With three data readouts under our belt already in the last four months, we are expecting to see data from at least seven more clinical trials by the end of 2008. I will start by outlining anticipated readouts from new indications for RITUXAN. In the first half of 2008, we anticipate results from OLYMPUS, the RITUXIN Phase II/III study in primary progressive MS. The primary endpoint for this study is the time-to-disease progression as measured by the expanded disability status scale at 96 weeks.

Also in the first half of 2008, we anticipate results from EXPLORER, the Phase III RITUXAN study in SLE. The British Isle Lupus Assessment Group scale or BILAG will be used to assess SLE disease activity in this study. We chose this scale because it has been shown to be comprehensible, reliable, sensitive to change, and effective in capturing the waxing and waning nature of lupus. Whether patients in the study have achieved and maintained a major or partial clinical response will be assessed at 52 weeks.

A second lupus trial is also very near complete enrollment, the RITUXAN lupus nephritis study called LUNAR, the primary endpoint for LUNAR is renal response at 52 weeks. We also expect to see Phase II readouts in 2008 from a number of novel molecule programs, including Phase IIb data on baminercept alpha in RA, our Heat Shock Protein 90 Inhibitor and volociximab in solid tumors, BIIB14 for Parkinson's Disease and long-acting factor IX in hemophilia B.

So in conclusion, I am very impressed with the caliber of our R&D team and as you have heard, 2008 will be a very active year on the R&D front. We will have on average four times as many patients in clinical trials throughout 2008 as compared to 2007. In addition, the remainder of 2008 remains poised to be a year of results and we are as eager as you to see the data. For a company this size, we have an outstanding pipeline, which includes both novel molecules potentially addressing large markets, as well as line extensions.

So with that, I will hand the call over to Paul Clancy, our CFO.

Paul J. Clancy - Executive Vice President and Chief Financial Officer

Thank you, Cecil. I will use this call to review our quarterly and full-year financial performance. Additionally, I will provide greater detail for our 2008 financial guidance. The GAAP financials are provided in tables 1 and 2 of the earnings release. Table 3 is a reconciliation of the GAAP to non-GAAP financial results.

So let's begin with our GAAP to non-GAAP reconciliation. In accordance with Regulation G, we have provided table 3, which breaks out the adjustments by major driver. The main adjustments excluded from the non-GAAP operating expenses in Q4 were, first, we adjusted $107 million in purchase accounting charges for in-process R&D and the amortization of intangibles for the transactions outlined in table 3. Second, we adjusted $34 million in pre-tax other income due to the consolidation of Neurimmune. Third, we adjusted $9 million in pre-tax employee stock option expenses; $5 million of this adjustment is in SG&A, while the remaining $4 million in R&D. And fourth, we had a $16 million tax impact of the items I just mentioned.

Now, I will move on to the non-GAAP P&L operating performance. We believe it's important to share this non-GAAP P&L with shareholders because it better represents the ongoing economics of our business, it reflects how we manage the business internally and forms the basis of our management incentive programs. In Q4, while we delivered $0.67 diluted EPS on the GAAP P&L, after the adjustments shown in table 3, our non-GAAP diluted EPS was $0.89. For full-year 2007, GAAP EPS was $1.99 and non-GAAP EPS was $2.74.

Now let's move through the fourth quarter non-GAAP P&L results in a bit more detail starting with revenue. Q4 total revenue was $893 million, which represents 26% growth over the same quarter in prior year. Revenue for the full year totaled approximately $3.17 billion, which represents an 18% growth over full-year of 2006. Key drivers of this year-over-year increase include the increasing penetration of the TYSABRI business and the continued growth of the AVONEX and RITUXAN franchise. For the fourth quarter, Biogen Idec’s MS franchise revenue grew by an impressive 30% over prior year. With the launch of TYSABRI, we continue to grow the MS market as new patients and former quitters joined the market.

Going through our product revenues, I'll begin with AVONEX, the Number 1 worldwide MS product. Q4 AVONEX worldwide product revenue was $503 million, which represents a 15% increase over the same period last year. Worldwide AVONEX revenue for the full-year totaled almost $1.9 billion representing a 9% year-over-year growth.

AVONEX U.S., Q4 US AVONEX product revenue was $279 million, which represents a 7% increase over Q4 2006. U.S. AVONEX revenue for the full-year 2007 totaled approximately $1.1 billion representing a 6% year-over-year growth rate. AVONEX U.S. inventories remained relatively steady at historical levels and essentially unchanged from quarter-end to quarter-end.

Now moving to AVONEX International. Q4 International AVONEX product revenue was $224 million, which represents an increase of 26% on a year-over-year basis. International AVONEX revenue for the full-year 2007 totaled $783 million representing a 14% year-over-year growth rate. The quarterly increase in our international AVONEX business was driven by increases in unit sold and favorable foreign-exchange rates.

Favorable FX moments accounted for 10% of the growth for the quarter and 9% for the year. Also of note, international revenues benefited from one-time $8 million German VAT rebate in the fourth quarter. Direct markets, which make up almost 90% of our international revenue continue to perform well and increased year-over-year by almost 32% in the fourth quarter.

Now, moving to TYSABRI. Q4 TYSABRI worldwide product sales were $90 million. TYSABRI revenue for the full-year of 2007 totaled $230 million for Biogen Idec. TYSABRI in-patient revenue totaled $129 million in Q4 thus exiting the year at over $500 million run rate. As Bill highlighted, TYSABRI continues to make strong progress.

TYSABRI Q4 financial highlights include U.S. end-market or end-user or in-market TYSABRI sales totaled $76 million, which represents a 31% quarter-over-quarter increase. Biogen Idec booked $37 million of this amount. International end-user for in-market TYSABRI sales totaled $53 million, which is a 51% increase from the prior quarter.

Now, moving to other product revenue. Q4 ZEVALIN product sales were $3 million. In August of 2007 Cell Therapeutics announced that it would take Biogen Idec’s $10 million in upfront cash for the rights to ZEVALIN plus up to an additional $20 million in future milestone payments and ongoing royalties on sales. We closed this deal late in the fourth quarter of 2007. The $10 million upfront payment will be recognized in our operating results over the term of our supply agreement. Also Q4 FUMADERM revenue was $9 million.

Now moving on to the RITUXAN collaboration revenues, which is referred to as revenue from unconsolidated joint business. We recorded $254 million in revenue for the quarter, which represents an increase of 17% on a year-over-year basis. Revenue for the full year increased 14% to $926 million. This number has several elements. First, we receive our share of the U.S. RITUXAN profits. As reported by our partner Genentech, U.S. RITUXAN sales were $596 million in the fourth quarter, up 6% versus prior year. And our Q4 profit share from that business was $171 million, up 14% versus prior year. I should note that this includes a $10 million payment associated with Roche opting into the relapsing-remitting MS development plan.

Second, we received royalty revenue on the sales of rituximab outside the U.S. And in Q4 this was $69 million, up 33% versus prior year. Third, we reimbursed $14 million for selling and development costs incurred related to RITUXAN. As indicated by our partner Genentech, total U.S. RITUXAN sales approached $2.3 billion for the year, a 10% increase over 2006. Genentech further indicated that full-year RITUXAN sales in the U.S. included $240 million to $260 million of sales in the immunology setting. This represents an 80% to 90% growth over 2006, driven by increased patient share in the anti-TNF setting.

Now moving to royalties. Q4 royalties were $33 million for the quarter and $102 million for the year. Our quarter-over-quarter growth rate was driven in large part by our royalty stream from ANGIOMAX. Let me provide a bit more detail. The Medicines Company pays Biogen Idec a royalty on ANGIOMAX sales, which increases as we exceed sales targets during the year. If we pass through one of these sales targets, the new higher royalty rate is applied to total sales since the beginning of the year. We exceeded one of these targets in Q4, which resulted in a stepped-up royalty payment in the fourth quarter and retroactively applied to sales from January 1.

Now turning to the expense lines on the non-GAAP P&L. Q4 COGS were $88 million or 10% of revenue. During Q4, we benefited by selling the remaining TYSABRI inventory, which had been fully written off when we removed TYSABRI from the market in 2005. As we move into 2008, all future TYSABRI sales will be at a full cost associated with production.

Q4 R&D expense was $226 million or 25% of revenues. R&D spend for the full year totaled $911 million, which was about 29% of full-year revenue and increased 30% on a year-over-year basis. The increase in R&D spend is very much a function of our robust development pipeline, both due to the advancement of our internal programs as well as the continued successful execution of our business development strategy.

Q4 SG&A expenses were $188 million representing 21% of revenues. And this was a 4% year-over-year increase. SG&A spending was flat on an absolute dollars basis and declined as a percentage of revenue when compared to Q3. As we mentioned during last earnings call we initiated a major TYSABRI marketing effort in the U.S. and Europe last year. As revenue has continued to grow we are benefiting from increasing leverage of these investments.

Continuing down the P&L, our collaboration profit-sharing line totaled $14 million in expense for the quarter. As a reminder this line represents Biogen Idec's payment of 50% of the profits outside the U.S. to Elan and the reimbursement of the third party royalties incurred by Elan outside the U.S. We expect this number to continue to grow in the coming quarters reflecting the growing profitability of our international TYSABRI business.

Q4 other income and expense was $2 million expense, a significant change to our '08 lines in the same period last year is the impact of our $3 billion share repurchase. Q4 tax rate on a non-GAAP basis was 29%, our full-year non-GAAP tax rate is 28%. This includes the $15 million Q2 reduction in tax liabilities associated with the IRS audits for fiscal years 2003 and 2004. This brings us to our Q4 non-GAAP diluted EPS of $0.89 and our full-year non-GAAP EPS of $2.74.

Now, I'd like to conclude by providing more detail for 2008 guidance. We expect the annual revenue to increase 15% to 20% over 2007 as TYSABRI continues to penetrate the market. Non-GAAP R&D is expected to be 26% to 28% of total revenue and non-GAAP SG&A is expected to be 21% to 23% of total revenue.

In total the combination of R&D and SG&A expenses for the year should be in the range of $1.9 billion to $2 billion. Major drivers of this year-over-year increase include a number of commercial investments including the TYSABRI Crohn's launch and geographic expansion of our international neurology commercial infrastructure. Additionally, the continued advancement of our pipeline, both from the maturation of our organic programs and the execution of our business development strategy which as you know is very much deal dependent.

While we expect R&D as a percent of revenue will be lower than our 2007 levels, we are planning on a greater than 4 times increase in the number of patients in clinical trials when comparing 2007 to 2008. Additionally, I have excluded our collaboration profit line from our $1.9 billion to $2 billion expense guidance for 2008. I should note that we do expect this express line to grow in line with the TYSABRI uptake outside the U.S.

I'd like to note that we expect to see the impact of several investments on OpEx in the first half of 2008. These investments include the temporary shutdown of our large-scale manufacturing facility as we initiate the TYSABRI high-titre production process, upfront commercial activities associated with the TYSABRI Crohn's disease launch, and over $10 million in development of milestones in Q1 the largest of which is an $8 million payment related to Neurimmunie deal.

Our non-GAAP tax rate is expected to be between 28 %and 30%, included is an assumption that the R&D tax credit legislation will be renewed, as you know the R&D tax credit was originally introduced 25 years ago to boost spending for research. The credit has always been temporary with Congress renewing it each time it expired. The R&D tax credit expired at the end of 2007 and we expect it to be renewed and applied to the full year. Should this legislation be renewed later in the year, it may impact our quarterly tax rate for the first quarters of the year.

Non-GAAP diluted EPS is expected to be in the range of $3.20 to $3.35, which represents a 17% to 22% year-over-year growth rate. GAAP EPS is expected to be in the range of $2.23 to $2.38. Overall, our full-year 2008 guidance provides strong topline and bottom line growth and is an important stepping stone in achieving our longer-term operating and financial goals. So, in conclusion, 2007 was a year of strong results. Our topline revenue grew 26% for the quarter and 18% for the full year. Our non-GAAP EPS grew at 68% for the quarter and 22% for the year.

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

James C. Mullen - President and Chief Executive Officer

Thanks, Paul. In 2008, we will continue to execute upon the key drivers of business performance. The first of which is to continue to grow the MS franchise and that's going to be driven primarily by increasing depth and breadth of TYSABRI usage both in the U.S. and internationally. Importantly, by year-end, a couple thousand patients will have been on commercial therapy for two years, which will provide prescribers with a better understanding of the impact of duration on TYSABRI's safety profile.

Second major focus area is moving our pipeline programs forward with a number of important data readouts on late-stage programs over the coming months. In the first half of this year, we expect topline results for RITUXAN primarily for progressive MS and lupus to become available. Positive results in these indications have the potential to be significant drivers of future growth for RITUXAN's autoimmune franchise.

In summary, I think we are moving into 2008 with a very strong momentum and we are confident we can achieve our 2010 goals just as we have over the past four years. With that, Elizabeth, let's open up for Q&A.

Elizabeth Woo - Vice President, Investor Relations

Thank you. Operator, we're ready now to open up the call to Q&A. We’d ask participants on the call to limit themselves to one question and then re-enter the queue for follow-up. Please state your name and company affiliation. So Denis we can now take the first question.

Question and Answer

Operator

Thank you. The first question will come from line of Joel Sendek with Lazard Capital.

Joel Sendek - Lazard Capital Markets

Hi, thanks a lot. On the pipeline, I'm wondering if you could give us some update on the enrollment for the registration trials on lumiliximab, and galiximab and I didn't see in the slides when that data might come out presumably it's '09, if you can give us an update there? Thanks.

James C. Mullen - President and Chief Executive Officer

Yeah. Lumiliximab enrollment is going very well, patient accruals going extremely well. We anticipate a clinical readout in more than likely, the first quarter of '09, somewhere in that timeline. Galiximab I think I have mentioned previously what galiximab that enrollment initially was slow to take off. Over the past few months though it has increased quite significantly. So now we are very pleased with the overall patient accrual on galiximab.

Joel Sendek - Lazard Capital Markets

And the data there?

James C. Mullen - President and Chief Executive Officer

I think it's 2010.

Joel Sendek - Lazard Capital Markets

Thank you.

Operator

Your next question will come from the line of Eric Schmidt with Cowen & Company.

Eric Schmidt - Cowen & Company

Yeah congratulations on a strong fourth quarter. My question is on AVONEX pricing, I'm not sure who to direct this to, but could someone please comment on whether the pricing environment of the U.S. remains… it’s actually wide open and whether we should expect '08 price hikes that are I guess on where what we've seen in 2007, also interested in whether U.S. pricing has changed at all over the last 12 months… ex-U.S. pricing as well?

James C. Mullen - President and Chief Executive Officer

Sure, I’ll handle that, and as you know by policy, we don't really comment on forward-looking pricing. The pricing…. you’ve seen what the pricing happened in the U.S., there may be, I think the environment is still actually fairly good in the U.S., in particular given where we are relative to the other products, ex-U.S., I think overall by our mix, our pricing is probably up a little bit on average, but that's really a mix question because the pricing hasn’t really changed much in international market on a market-by-market basis.

Eric Schmidt - Cowen & Company

Thank you.

Operator

Your next question will come from the line of Steve Harr with Morgan Stanley.

Steven Harr - Morgan Stanley

The ex-U.S. numbers were up significantly more sequentially than FX would suggest in the $8 million from Germany. Was there any change in inventory or any other special items that might have accounted for that?

Paul J. Clancy - Executive Vice President and Chief Financial Officer

Steve, no significant change in inventory that we can see. As you know we don't have as a tighter visibility as we do in the U.S. And as a result, we are not able to kind of provide that. But we didn't see any significant change in inventory. So I think it’s just, the business has done very well and kind of the marketing messages are really holding firm and we are benefiting from kind of slowly but surely geographic expansions including Eastern Europe and other places around the world.

Steven Harr - Morgan Stanley

Thank you.

Operator

Your next question will come from the line of Geoff Meacham with J.P. Morgan.

Geoffrey Meacham - J.P. Morgan

Hi, guys. Thanks for taking my question. Question for you on TYSABRI, can you talk little bit about the fourth quarter drivers in Europe particularly and are you seeing greater traction in U.K., Italy, these are the countries I think that rolled on second half? And then, just a quick follow-up to that is there any early feedback, where these patients were coming from in Europe, is it similar to the U.S.?

James C. Mullen - President and Chief Executive Officer

Sure. Geoff. This is Jim. I will take that. In every one of the markets, I think you've heard me use this analogy before so did the same store sales, places where we been launched for six months, we see pattern much as we are seeing in the U.S. increasing breadth in prescribing and increasing debt, and the more they use it in an account, the more than they want use it. Pretty much a similar pattern and of the markets that rolled out in the latter part of the year with France and Italy, while we always hear a lot about the U.K. because of nice, the U.K. is typically a laggard market because even with a nice green light as we have now with TYSABRI, you still have to go NHS region by region to the 22 regions to make sure that there is actual reimbursement at the local level in funding. So that's going pretty well. Did you have any other to try to add to that?

Geoffrey Meacham - J.P. Morgan

The question about where the patients are coming from, is it…?

James C. Mullen - President and Chief Executive Officer

Oh, yeah. I'm sorry, the patients, as you know, we've said pretty consistently four or five in the U.S. are new to franchise. It’s actually a little higher than outside the U.S. and again a lot of switching mostly from… in larger market share from [inaudible] but there is a little less penetration in the market. So there is probably new… there's a bigger chunk of newer patients as well.

Geoffrey Meacham - J.P. Morgan

Okay. Thanks.

James C. Mullen - President and Chief Executive Officer

Yeah.

Operator

Your next question will come from the line of Michael Aberman with Credit Suisse.

Michael Aberman - Credit Suisse

Hi, guys, thanks. Congratulations on a good quarter. Can you comment there is a report in New England Journal this week about a couple of cases melanoma and the potential for capacity added to label, have you had any discussions with the FDA about melanoma risk of TYSABRI?

Cecil Pickett – President, Research and Development

No, we have not any discussions with the agency about melanoma risk. I think it's important to sort of put those two cases in some kind of context with regard to our clinical trial experience. I think overall the occurrence in our clinical trials of malignancies are similar in TYSABRI treated and placebo groups. There has been… there has been a single case of melanoma during placebo controlled clinical trial experience in a male patient but that patient had a lesion present at first dose. So I think it's something that we will certainly monitor. As I think I've said before, I think our risk management program on TYSABRI through touch is an incredible risk management program probably one of the best in the industry and we'll continue to monitor safety and update the label as appropriate.

Operator

Your next question will come from the line of Bill Tanner with Leerink Swann.

William Tanner - Leerink Swann

Thanks for taking the question. Jim, just a question for you, I guess with contemplated changes in the Board that the sale process might be revisited and kind of based on your comments at the beginning of the call about what may have been the sticking issue about discomfort about TYSABRI, I guess the question is what is the likelihood of a different outcome and secondly how do you sort of view this potentially, having to renew this process in terms of any disruption to the company, it sounds like the last iteration was somewhat painless. So I was just curious your thoughts on those process?

James C. Mullen - President and Chief Executive Officer

Well, somewhat painless is probably an overly optimistic description of the last process. So, look one of the issues that we need to deal with is when you’ve got topline growth rates and bottom line growth rates and this is… how do we keep people focused on the bowl [ph] and how we recruit great talent to continue the momentum in the business. Certainly a lot of distractions around that aren't helpful for that or for business development. What I say is look that the initial pieces has been thoroughly tested for the time being. We as a Board management, continued to remain open to all of the opportunities to maximize the shareholder value. But I don't think the right way to run the business is to have for anybody's sake, there are permanent for sales line out on the front lawn. So, I think we have to get back to the business focus on prosecuting going forward and if the circumstances and conditions change we will address those at that time.

William Tanner - Leerink Swann

Okay, I guess our med payments in terms of employee turnover, but that seems not be… much of a problem last time?

James C. Mullen - President and Chief Executive Officer

Well, employee turnover is… it's a lagging indicator. So, while… the third and fourth quarter were pretty solid. I'm actually more interested in what happens in the first six months of this year because every headhunter use that as a opening to call everybody in the place. So it's a little hard to judge what the impact of that is just at this time. I think that remains to be seen.

William Tanner - Leerink Swann

Okay, thank you.

James C. Mullen - President and Chief Executive Officer

You're welcome.

Operator

Your next question will come from the line of Geoffrey Porges with Sanford Bernstein.

Geoffrey Porges - Sanford C. Bernstein

Yes, thanks. Just a follow-up a little bit Jim. Could you… you made some quick comments about the M&A and you looked to rounded opportunities and something that were… not a good strategic fit or not appropriately priced. Does that reflect your current sentiment and strategic intent or what kind of things do you think it would be worthwhile to add to your current portfolio of products and capabilities?

James C. Mullen - President and Chief Executive Officer

Well, I guess first off, I mean, we're always interested in with the financial strength that we had, we're always interested at adding important products and they come in different forms, Neuroimmune was an interesting opportunity to get in the Alzheimer’s space and we took advantage of that, always interested in later-stage opportunities. Of course, we're focused in oncology, neurology sort of the autoimmune diseases, in cardiology I'd say those are the four places we continue to look for product.

From the capabilities point of view, anything that could augment our R&D abilities and small molecules, we might be interested in. We got a good strength in biologics but small molecules is not yet strong as biologics backbone. And things that help us continue to globalize the business would also be interesting. But we're going to stay disciplined to things that meet the strategy that we really think at the valuations that they can be acquired, give us an opportunity to see a significant step up in value and that's partly dependent on what phase it's in, if it's very early on we go to see big opportunities, if it's a later stage product it will be sort of more two ex-kind of step-up opportunities that we're going to look for.

At this moment in time, in terms of acquisitions that would require us to take…. use either equity or take on more debt, I just don't see any right at this moment that need both the dual test of strategic fit and attractive valuations. There are things that are strategically interesting and we’ll go in detail and we will continue track those, both in large and small. But at this point in time, my view really hasn't changed from where it was about a year ago. There aren’t big targets out there that are both interesting and attractive evaluation.

Geoffrey Porges - Sanford C. Bernstein

Thanks very much.

Operator

Your next question will come from the line of Jim Birchenough with Lehman Brothers.

Jim Birchenough - Lehman Brothers

Hi guys. Just wondering if you could provide any comment on sizing the primary progress of MS market as well as the Lupus market that could be come available if trials are successful? And whether the capacity is adequate on the manufacturing side to deal with any surge there?

James C. Mullen - President and Chief Executive Officer

This is a RITUXAN question. The primary progressive of MS, it’s thought that primary progressive forms of MS are perhaps about 10% to 50% of the total numbers of patients. So think of that has 150,000 patients plus/minus between North America and Eastern and Western Europe. So, now having said that there is very little healthy patients out. So I think if you were to see some positive results for RITUXAN particularly given the utilization that you've already seen in RA, you might see a fairly significant uptake for that product in that space.

With respect to Lupus, we think that that is a pretty large opportunity. There is 425,000 diagnosed SLE patients in the U.S. Again not allowed to help them other than sort of the old line immunosuppressants and we do know that based on some of the safety surveys and things we've done around RITUXAN that there is some amount of label use already. In Lupus, I think there is some experiences and believe there. I think that's an opportunity with strong trial results that could be cite like an MS opportunity to be honest, kind of a multibillion dollar opportunity but it’s still dependent on what the outcomes look like.

And as you know Lupus has been a particularly difficult place to do clinical trials and get a positive outcomes. Having said that, you got to like the odds of a products like RITUXAN, it’s got a track record both in the oncology setting that's more recently in the autoimmune setting. So I think that's pretty interesting.

On the production side, I am not… it’s probably a better question for Genentech, but really not a word that we have got any significant limitations and ability to manufacturers to supply in those markets. And if need be Biogen Idec could performs some of that but we have not been requested to do so.

Jim Birchenough - Lehman Brothers

Okay. Thanks.

Operator

Your next question will come from the line of Jason Kantor with RBC Capital Markets.

Jason Kantor - RBC Capital Markets

Hi, and thanks for taking my call. I wanted to go back to this question about M&A that you might have been looking out and passed on. How much of your guidance for 2010 is dependent on completing any kind of new acquisition, or are your basing that entirely on what you have today?

James C. Mullen - President and Chief Executive Officer

The 2010 top and bottom line is coming from the three major products you can touch today, RITUXAN, AVONEX, and TYSABRI. We may see, one or more of these other products get launched in the tail end of that, but its not going to have any significant impact for this three-year time frame. So from that perspective 0% of that topline is dependent on business development…. any business development activities.

Jason Kantor - RBC Capital Markets

Okay. So, then it is more highly dependent on this Lupus and primary progress of MS data that's coming up?

James C. Mullen - President and Chief Executive Officer

Well, I'm not sure I would characterize it that way. I mean, we think it would be RA, we have gotten a… we expect to get an approval label there in the [inaudible]. I think we're hopeful in Lupus, we are hopeful in the primary progressive, but I don't think those are absolute must haves to continue grow that business. In TYSABRI we do expect… we continue to be very bullish about the 100,000 patients. The majority of that coming from MS, but we do expect decent contribution from Crohn’s as well.

Jason Kantor - RBC Capital Markets

And is --

James C. Mullen - President and Chief Executive Officer

Sorry, go ahead, Jason.

Jason Kantor - RBC Capital Markets

Is there an assumption for the RITUXAN profit share that there is any kind of decrease with Genentech in that timeframe?

James C. Mullen - President and Chief Executive Officer

Well, the assumption that we continue to build into our long-term models is the one that you guys have all modeled out there, but the step down as the practical matter probably doesn't occur in this timeframe, because it depends on volociximab coming to the market or the next CD20 products, and that's probably not in the 2010 timeframe.

Jason Kantor - RBC Capital Markets

Thank you.

James C. Mullen - President and Chief Executive Officer

Yes.

Operator

Your next question will comes from the line of Mike King with Rodman & Renshaw.

Michael King - Rodman & Renshaw

Hi, good morning and thanks for taking my question. I guess, can I… you guys give some nice color on the ex-U.S. sales of AVONEX, but I guess I’m still little unclear about what happened in the U.S. since script seemed to decline on a quarter-on-quarter basis. So I'm wondering if you could perhaps address any… I know Eric Schmidt asked about price increases. Could you go over price increases again, as well as any inventory change that may have take place in the quarter? Thank you.

Paul J. Clancy - Executive Vice President and Chief Financial Officer

Yeah. Sure, Mike. No inventory changes from a quarter-to-quarter basis and essentially our inventory levels have remained very much in a tight band of what we have done over the last number of quarters. The business certainly did benefit from couple of price increases that were taken later in the second half of the year, those are pretty well disclosed out there. So it did benefit from that, but we also did see… from a unit prospective, a level of buoyancy that was kind of indicated some positive trends.

Operator

Your next question will come from the line of May-Kin Ho with Goldman Sachs.

May-Kin Ho - Goldman Sachs

Hi, I just have a question on Neurimmune. What do you see in the antibody program there that's shading versus other programs outlined?

Cecil Pickett - President, Research and Development

Yes, this is one of the... this is one of the few antibodies that recognize a conformational from of Ab [ph] data that is found in plaques in Alzheimer's patients versus recognizing circulating Ab data. So we feel that recognizing Ab data in plaques is a much more meaningful form of Ab data that contributes to Alzheimer's disease and hence that was our influence in this antibody, potentially there are some safety advantages, but it really is focused on the conformational form Ab data that’s seen in plaques.

Elizabeth Woo - Vice President, Investor Relations

Operator, we will take one or two more questions.

Operator

Thank you. The next question will come from the line of Yaron Weber with Citi.

Yaron Weber - Citi

Yes, hi. I just have some quick housekeeping question, can you give us a sense to what the FX impact was in the quarter and year-to-date? And then also just a question on COGS can you give us little bit of sense, what should we expect in COGS on '08 or maybe just help us understand a little bit, how much of benefit you have been getting from using inventories that you have written off in the past?

Paul J. Clancy - Executive Vice President and Chief Financial Officer

Yes, this is Paul. In specific to the AVONEX sales, the favorable foreign exchange improvements accounted for about 10% of the growth in the quarter and about 9% of the growth for the full year, that would be the FX impact. With respect to the cost, we certainly in the fourth quarter benefited from essentially having some of the TYSABRI inventory using some of the TYSABRI inventory that was previously written off. Going forward that won't be the case… we’ve kind of gone through all of that product and going into the Q1 we will actually see some burden on the P&L for TYSABRI COGS. I think the way we think about it is that the cost of goods sold or the gross margin percentage line will materially change from a year-to-year basis.

Yaron Weber - Citi

And just a follow-up. When you say 10% growth in AVONEX, I guess what I am confused about, are you talking about year-over-year or quarter-over-quarter, or would assume it's year-over-year?

Paul J. Clancy - Executive Vice President and Chief Financial Officer

Year-over-year for the quarter…. for the given quarter.

Yaron Weber - Citi

Thank you very much.

Paul J. Clancy - Executive Vice President and Chief Financial Officer

Yes.

Operator

And this morning's final question will come from the line of Maged Shenouda with UBS.

Maged Shenouda - UBS

Sure thanks. Most of my questions have been answered, but just a small item. What is the breakpoint for the step up in ANGIOMAX royalties?

Paul J. Clancy - Executive Vice President and Chief Financial Officer

It is actually a number of breakpoints. We actually don't disclose those breakpoint. I think, if you looked at the ANGIOMAX sales what they did in the year, we pushed right through kind of midway through the fourth quarter.

Maged Shenouda - UBS

Thank you.

Elizabeth Woo - Vice President, Investor Relations

Thank you everyone for joining us on the call today.

Operator

Ladies and gentlemen, this does concludes the Biogen Idec fourth quarter 2007 earnings conference call. You may now disconnect.

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