Biogen Idec Q4 2006 Earnings Call Transcript

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Biogen Idec (NASDAQ:BIIB)

Q4 2006 Earnings Call

February 15, 2007 8:30 am ET


Elizabeth Woo – Vice President of Investor Relations

James C. Mullen - President and Chief Executive Officer

Bob Hamm – Senior Vice President, Neurology Business Unit

Peter N. Kellogg - Executive Vice President, Finance and Chief Financial Officer

Dr. David Parkinson - Senior Vice President Oncology R&D

Dr. Al Sandrock- Senior Vice President of Neurology R&D

Christine Hasnin – Vice President of the Oncology Rheumatology Business Unit


Geoffrey Porges – Stanford Bernstein

Geoffrey Meacham – J.P. Morgan

Michael Aberman - Credit Suite

Gene Mack – HSBC Securities

Joel Sendek – Lazard Capital Markets

Mark Schoenebaum – Bear Stearns

William Tanner – Leerink Swann

Jason Kantor – R.B.C. Capital

May-Kin Ho – Goldman Sachs

Steve Bahar – Morgan Stanley



Hi, I would like to welcome everyone to the Biogen Idec fourth quarter and full year 2006 earnings 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. If you would like to ask a question during this time, simply press star and the number 1 on your telephone keypad. If you would like to withdraw your question, press star and the number 2 on your telephone keypad.

Thank you.

I will now turn the conference over to Miss Elizabeth Woo, Vice president of Investor Relations.

You may begin your conference.


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Elizabeth Woo

Good morning everyone, thanks for joining us today. Welcome to Biogen Idec earnings conference call for the fourth quarter and year end 2006.

Before we begin, I would urge everyone to go to the investor relations section of our website at and print out the press release and the accompanying table.

It'll make it easier to follow along when our CFO, Peter Kellogg reviews the financial results and the reconciliation to non-GAAP financial measures discussed today.

We're continuing the practice we introduced during our third quarter conference call of posting slides in our website that follow the topics on the call today.

I'll begin with the Safe Harbor statement. Comments made in this conference call include forward looking statements about the company's expectations regarding future financial results, including our financial guidance for 2007 and future growth rate, the launching potential of Tysabri in MS and Rituxan in RA, pricing and reimbursing for Tysabri, and plans for external growth and pipeline growth.

Such statements are subject to risks and uncertainties which could cause actual results to differ materially. In particular, careful consideration should be given to the uncertainties that are described in the earnings release and in the risk factor section of the company's quarterly report on form 10Q, for the fiscal quarter ended September 30th 2006 and other periodic and current report Biogen Idec has filed with the securities and exchanges commission.

The company does not undertake any obligation to publicly update any forward looking statements.

On today's call, we have Jim Mullen, CEO of Biogen Idec, Bob Hamm, Senior Vice President, Neurology Business Unit and Peter Kellogg, CFO and Executive Vice President, Finance.

I will now turn the call over to Jim.

James C. Mullen

Thank you Elizabeth, thank you everyone for joining us this morning. This is the Q4 and full year earnings call.

I want to put some context around the financial results and summarize the year that past as well as the year ahead.

We made some nice progress on the court road, we saw regular approvals for Rituxan and rheumatoid arthritis in both the US and Europe, and I think the launch has been very successful and it also demonstrates our ability to rapidly and effectively build sales and infrastructure in the new special therapeutic area.

In addition to that, we saw three new indications for Rituxan.

As everyone on this call is I'm sure aware, Tysabri was re-introduced to the US, approved for the first time in the EU, and I'm particularly proud of the dedicated team effort to bring Tysabri back. In the unwavering belief by the team that patients deserve a more application option.

And then finally, Avonex was introduced in Japan this year which is a part of our strategy to continue to increase our global footprint.

We also had a very strong momentum in the business development area. This was easily the most productive year in business development in our history. This follows the late 2005 restructuring which gave us the flexibility for greater investment in external opportunities on our pipeline you'll see in the press release, and press releases throughout the year, but I'll highlight just the larger of those deals.

So the acquisition of Primapharm and the acquisition of Conforma gave us the HSP90 platform licensing agreement with Mondobiotech and Aviptadil, licensing agreements and collaboration agreements with UCD and CDP323, which is an oral team inhibitor, the agreement with Alnylam which should work on JC virus and of course the acquisition of Syntonix which takes us into the hemophilia area. And of course with that and with the agreement with Mondobiotech we will enter into two more specialty areas.

We also made significant pipeline progress in the last 12 months. Just to emphasis three press releases we recently put out on BG-12 starting phase 312 in MS. Galiximab started the registration trial Lumiliximab starting registration trials in COL. So those have begun, all three of those.

And perhaps most importantly, we've added talent really throughout the organization. I'll just highlight two who I think you're all familiar with.

David Parkinson, who is leading out the oncology therapeutic area, has responsibility for all the R&D programs in oncology.

Cecil Pickett, who came to us as president of R&D, and I think that's significantly strengthens some of the senior leadership in our R&D area.

Cecil will join us on the Q1 call and he will also host a R&D day on May 17th where we will take you all for a pipeline product by product in greatly more detail.

I think 2005-2006 really demonstrated our ability as a company to navigate the choppy waters and still deliver long term financial results.

You saw the 11% revenue growth in 2006, 43% expansion of EPS on non-GAAP basis, and 34% on GAAP basis. Good performance on Avonex and of Rituxan of 14%, and a strong launch in rheumatoid-arthritis and Rituxan.

We are on track to achieve our 20% non-GAAP EPS compounded growth goal for the period 2006-2007. Through the end of 2006 we are at 23% compound and EPS growth and 13% on the revenue.

So, Peter will walk you through guidance for 2007 after he discusses the financial results for 2006.

And after a couple of choppy years, I think, we feel like we're right back on course. We’re on the market in the US and launching for the first time in Europe and I think you'll see from Peter's guidance, we're in good shape to hit our financial goals.

I want to make a couple of comments around Tysabri before I turn the call over to Bob Hamm, who'll take you into a bit more details.

We are as we turn over in the New Year, shipping the commercial focus to really begin spending time on the benefits.

To take you back, the first phase of this launch, the first six months, were preparing the foundation, educating on the touch program in the US and discussing the new label and the risk issues both in the US and Europe.

We have now initiated full force what we call phase two of the launch which is to emphasize and reinforce the efficacy message and continue to broaden up the use.

And just to remind everybody, we continue to believe that Tysabri will equip all of the other MS therapies over time as there's still significant room for growth in this marketplace. The patients need more efficacy, they want fewer side effects and they desire less frequent dosing and Tysabri competing for all these needs.

And as I'm sure you saw in the press release we're now approaching 10 000 patients on therapy.

Furthermore we are looking into indications for Tysabri, and we'll continue to talk about that as the year goes on.

Bob will fill you in on Tysabri and more of the details and metrics, and I know you're anxious to get to those metrics, but I want to read you excerpts from one letter I received which highlights the daily struggles of a MS patient and the quality of life benefits of Tysabri.

And this letter was written by Doctor Macalusso, Dr. Macalusso is a treating neurologist and also an MS patient taking Tysabri. And I quote, and I'm excerpting in the interest of time, but I'm going to read three excerpts.

"Tysabri has given me my life, many parts of my life back. It took away my daily headaches so now I can wholeheartedly look forward to tomorrow. It has reduced the swelling in my brain so now I can concentrate on what I want to do and not be bothered by the piece of paper that fell on the floor or the garbage truck that just passed while trying to read or write. I concentrate on the movie or TV show that I've been looking forward too and then be able to relate what I saw to someone with whom I want to share the happiness."

It goes on the letter and a little bit further along he says: "While the battle has not ended, the foe has been greatly disabled. And here's were your drug goes beyond the patient, I can play with my kids when they want, not when the disease wants to let them, and now maybe I can count for a more complete father, husband and doctor alternative”.

Bob Hamm

Thank you, Jim. I think it's important that before we get into the details on the metrics, to talk about what brought us to this point in time. And through the collaboration with the FDA, we established a touch program, embodying a risk map which was a complex and important tool to appropriately and systematically measure and understand Tysabri for the long term.

To that end it was very important that we systematically and consistently deliver all the information regarding such a program. And so we assembled a small team from Elon and Biogen Idec that would systematically go out to all the major centers and roll out the touch program to ensure that consistency.

So as we sit here today the initial roll out touch program has been completed for all the major centers and neurology practices representing more than 50% of the treated patients in the US which we believe to be a number of about 220,000 or so.

It's important to note that despite the fact that it's merely two years, or will be two years and two weeks since we voluntarily suspended Tysabri, the fundamental market conditions have not changed. As Jim related, patients are still seeking alternative existing products in the market place. The returning act of quitting therapy created momentum for Tysabri which should continue throughout 2007.

Patients are switching from all approved therapies. Recent US trends show Copaxone being cannibalized to the greatest extent. As a press release states, and Jim related, patients describe Tysabri as approaching 10,000 patients total. Almost 1,600 international patients are on therapy, nearly 5,000 patients on therapy in the US, and another 3,000 patients in the EU.

Also, I want to add that a global run rate of a little over 300 patients being added per week has been going on. And this is a number we hope of course will increase with the number of countries with reimbursement and a number of physicians prescribing our products throughout 2007.

So now I'll go into the metrics in a little more detail.

Let's start with international. Nearly 1,600 patients are being treated internationally, Germany representing the majority with 75% or so of patients being treated. In Germany net new patients have risen more than 30% per week since January 1st.

The Tysabri international launch began in July, 2006 in Germany and in Ireland. Launches initiated in nine international countries as of year-end 2006. Full reimbursement countries will likely roll out throughout the 2007 and into the 2008 time frame. Italy and Canada officially launched in January, Luxembourg and France are next countries to launch.

In all, 15 EU countries will be launched by the end of the year. This should provide significant breadth and use of Tysabri that should grow throughout 2007 and into 2008. Another way to look at the international picture is to state that as of today we are currently able to access about half of the relapsed remaining population in the EU, Canada, and Australia. So of course we'll grow as the other countries come up.

Turning to the US, as I've mentioned we have transitioned from the first days of the launch which was the systematic roll out of the touch program to ensure the physicians and patients were well informed about Tysabri. And by and large it has been very well received and very well executed.

And so now we're in the second phase of the launch providing fair balance in discussing the advocacy of the product represented by two of the largest trials ever conducted in mass and contained in our label.

Specific clinical results: two third relative reductions in relapse rate and 42% reduction in the risk of increased disability over two years.

Our results for Tysabri have helped explain why so many people with MS and physicians who treat MS wanted Tysabri as an option for treatment.

The relapse figure translates to an annual relapse rate of 0.23% which implies only one relapse for every four or five years. Another team metric is the MRI review and there we show 97% of patients had no relapsing at all for two years.

With regard to safety as we've indicated previously, we intend to provide periodic updates at medical meetings and then a poster presentation in safety has been accepted for the American Academy Neurology Meeting which is occurring at the end of April and early May.

Moving on to more US metrics now. Over 1,300 physicians have already submitted enrollment forms for their patients, representing nearly 8,000 patients. As mentioned, approximately 5,000 patients are currently being treated with Tysabri and over 700 infusion sites have infused patients. Approximately 30% of the patients are returning quitting patients. The remaining 70% are from existing therapies.

Recent trends have indicated that show more patients moving from Glytimerastate than other products. The measured roll out over 2003 and 2004 in the US has produced a launch dynamic for uptake in momentum that had to build over several months while the entire roll out of activities was accomplished.

And I'd like to add that despite the complexity and burden of the touch program, it has been largely well received and followed by physicians, people with MS, and other health care professionals who support MS treatment across the US.

This means, of course, as we increase the number of prescribers and the breadth of the prescribing population, momentum in numbers will again grow in a corresponding fashion. And it can't be emphasized enough that the underlying market conditions have not fundamentally changed in the past two years.

With more than 400,000 patients being treated today for MS and many thousands who have abandoned treatment for various reasons, it remains a broad interest by physicians and patients who are impressed by Tysabri's efficacy and convenient dosing regimen. And to emphasize again, reduction relapse by two thirds sustained over two years as demonstrated in clinical trials, 13 infusions per year versus more than 300 injections per year for some products makes it a very convenient choice for some patients.

On the reimbursement front, 95% of private paid patients have good access to Tysabri. 40% of private payer patients require no prior usage. 55% of private payer patients require prior use of one agent a physician can access in those accounts. They typically need to write a letter of medical necessity, a little more work of course. But most payers would not push back if a doctor felt it was important enough to start a patient on Tysabri.

Tysabri also has broad access within public payers. 100% Medicare patients have access to Tysabri per label. 88% of Medicaid patients have access with no prior usage or one prior agent. Given the importance of Tysabri in the MS world, it's clear the number of physicians in different therapeutic areas have interest in Tysabri's motive action beyond MS and trying to understand further Tysabri benefits.

Specifically, the crone's regulatory process continues in Europe and the US. These discussions help guide us with agencies for future indications. You may recall that we filed for crone's in the US at the end of last year. The agency has recently advised us that the filing has been accepted.

In MS, we also plan head to head trials and protocols that are being developed. And in Japan, we can expect to be dosing in clinical trial early in 2008. Furthermore, we are working with the launch to explore other indications such as Oncology. We're a team working with investigators who have expressed interest in pursuing Tysabri investigator sponsored trials as going on to Oncological indications for review.

Turning to Avonex, Avonex recent report milestone in 2006, more than $1 billion in sales in the US, market leadership continues after more than ten years in the US. With over $1.7 billion in revenue, Avonex remains the global leader in revenue and patients on therapy. Avonex was approved for use in Japan. So the message remains clear: start with Avonex due to its launcher. And it's more than ten years as the number one product over wide.

Turning to the MS future, as has already been said by Jim, there is a number of unanswered questions and needs in the market place that are not currently being met. One is the underlying biology and the need to look at more targeted efficacy for patients.

Second are the less frequent dosing and more convenient dosing which Tysabri offers and other injectibles. Finally, the need for oral compounds, and then ultimately products and other approaches that would lead to repair of damage already incurred or restore function in patients. And from diagnoses of these resolutions, we are amassing the highest quality portfolio compounds to address each of these unmet needs.

And so we start with the two approved products. Avonex beta-1a interferon which modulates the immune system and moving on is Tysabri which blocks immune cells moving from the bloodstream into tissues including across the blood-brain barrier.

In development, we have a half a dozen compounds in various stages of development which I'd like to touch on briefly. AG12 oral compound is more convenient to modulate the immune system. That's just begun phase three trials.

Rituxan antibody CD20, a marker on B cells, flags mature B cells for destruction. Proof of concept data was positive. Data is being presented at the AAN.

Tykliziman antibody IO2 receptor thought to block activation T cells and may have other effects and evasive combination trial with interferons that's present. We will be looking at the data in the coming months.

CDP323, another oral small molecule that targets cells for integrating validated pathway similar to Tysabri. It blocks migration of immune cells from bloodstream to tissues. We'll be starting phase two trials later this year.

And finally, Lingo, an antibody to Lingo pathway, blocking the anitipatory lingo pathway, may allow remobilization of axons and also NoGo which is exploring protein therapeutics in the NoGo receptor pathway. The aim there is to block inhibitory activity of regeneration of neurons.

So to summarize, we have today Avonex, which reduces relapses by a third. We have the number-one product for efficacy Tysabri, which reduces relapses by two-thirds. Both products also solve a progressive disability. And finally, we believe we have the best and broadest pipeline in MS compounds for the future.

I will now turn it over to the Biogen Idec CEO, Peter Kellogg, to discuss the financials.

Peter N. Kellogg

Thank you, Bob. Let me first remind everyone that we provide Table 3 of our Earnings Release as a reconciliation of the GAAP to non-GAAP financial results. The GAAP results are provided in Tables 1 and 2.

The main items excluded from the operating GAAP in Q4 were:

First, we adjusted for purchase-accounting charges. There was $60 million for the amortization of tangibles on the Biogen and Idec merger, as well as a little bit from the Conforma and Primapharm acquisitions.

Second, there was also a one time $28 million one-time charge to P&L, as we bought out a (inaudible) from Hermetica, our distributor. We anticipate this will be the last charge related to the consolidation of our Primapharm business.

Third, we adjusted the pre-tax impact of share-based expense recorded in the course of FAS123R, primarily employee stock options of $8 million. And this is spread across R&D in SG&A, and it represents about a penny impact on EPS this quarter.

And finally, we adjusted for a $16 million one-time gain from the sale of an older building in Cambridge, which we have long since outgrown.

Now, as normal, I will review the non-GAAP P&L operating performance of Biogen Idec, and then we will focus on our non-GAAP P&L driven by the reconciliation in Table 3.

We believe it is important to share this non-GAAP P&L with shareholders because we believe it enhances investors' understanding of the company's financial performance. And we use these non-GAAP financial measures to establish our own financial goals and to gain an understanding of the comparable financial performance of the company from year to year and quarter to quarter. And we always mention that non-GAAP financials should not be viewed in isolation or as a pure substitute for GAAP.

So, let's summarize how the year wrapped up. In 2006, we delivered 11% top-line and 43% non-GAAP EPS growth. Our full-year GAAP earnings were $0.63 per share, and after the adjustments shown in Table 3, our non-GAAP EPS was (inaudible) $0.25, well ahead of our guidance on the last earnings call, where we indicated that it would be above $2.20.

As an important note, in Q4 we wrote down $25 million, or $0.05 per share in net impairment charges against our equity investments, primarily recognizing the PDLI stock division at year end. Incorporating this $0.05 charge, our Q4 GAAP EPS was $0.32 per share, based on 343 million shares outstanding. After the adjustments shown in Table 3, our non-GAAP earnings per share for Q4 were $0.53 per share.

Now, let's walk through the fourth-quarter P&L results. In the fourth quarter, our total revenue was $708 million, a 12% revenue growth over the same period last year, and for the full year 2006 our total revenue was $2.7 billion, an the 11% revenue growth over last year.

The main drivers of the revenue results were Avonex sales, and our portion of Rituxan revenues recognized in revenue from unconsolidated joint ventures, which I'll address in more detail later. As you can see, the underlying business trends remain solid, and we believe they're well poised for additional expansion.

Going to our product revenues, let's start with Avonex, the number-one MS product world-wide.

In the fourth quarter, our world-wide Avonex product sales were $439 million, 6% increase over the prior year. On a full-year basis for 2006, Avonex world-wide product sales were $1.7 billion, an 11% increase over the prior year.

Now, looking at the US business alone, in the fourth quarter our Avonex product sales were $261 million, that's an 8% growth. And on a full-year basis for 2006, our US Avonex product sales were a little over $1 billion. So, a billion-dollar business in the US alone – Congratulations to Bob – and that's a 9% increase year-over-year.

Avonex in the US was fairly stable for the quarter. Our Q4 results were in-line with Q2, and modestly off from a strong Q3 for Avonex. As we've gone through the second half of 2006, our Q4 underlying patient demand has remained flat.

Wholesaler inventory levels in Q4 ended slightly below the prior quarter, modestly reducing sales in Q4. And we did take a 5% price increase in the US in February this year. However, even after this increase, Avonex remains the most affordable ABCR therapy for MS.

On the international front in the fourth quarter, Avonex product sales were $178 million, which is a 4% increase over last year. And on a full-year basis for 2006, our international Avonex sales were $685 million and that's a 13% increase year-over-year.

So net-net, our Avonex international performance remains quite strong. Our fourth- quarter Avonex sales in local currency were flat, while the full-year sales grew 13% in local currency. We continue to gain market share internationally in our direct markets, and are growing slightly faster than the total MS market.

In 2006 we saw Avonex patient growth of just under 10% year-over-year, slightly higher than the total patient market growth.

Now, let's turn to the new product, Tysabri. In the fourth quarter, Tysabri revenues worldwide were $18 million, and on a full-year basis for 2006, we recorded Tysabri revenues of $36 million. And as Bob highlighted, we're pleased by the progress of the Tysabri launch.

I'd just like to kind-of lay out also what the total end-user or end-market Tysabri sales were in the fourth quarter. So worldwide, they were $30 million, which is built on $20 million in the US, and $7 million internationally. And that means for the full year 2006, our end-market Tysabri sales were $38 million, including $28 million in the US and $10 million internationally.

Now, as we've discussed in the past, Biogen Idec records its revenue, all of the international revenue, and then on the US front, we record revenue for sales of our US shipments of finished products to Elon on a sell-true basis, and then Elon sells the product on to the market.

The other products on our P&L for the fourth quarter had $7 million of sales, and this includes Zevalin sales in the fourth quarter of $4 million, and Fumaderm sales of $3 million. And a couple of notes here that are important. First, we are still evaluating Zevalin's strategic options which does include possible divestment.

Secondly, Fumaderm sales were lower in Q4 than in Q3, due to the deferral of $3 million of revenue.

Now, in connection with the Fumaderm Fumedica distribution that I mentioned earlier, we expect Fumedica to work down their inventory levels until the distribution rights hand-over date, which is May 1st of this year, 2007.

Accordingly, we would not expect to record any revenue for Fumaderm in Q1, but we'd expect to see revenues continue or resume at a full market rate in Q2 when we take over the business.

Now, for the royalties in the fourth quarter, they were $26 million, and that's a number that's higher than prior quarters, and it's primarily due to Angiomax sales that reached a new royalty-rate tier step-up in the fourth quarter. And that tier step-up applies back to the first sales to the year, so we catch up on that royalty rate in the fourth quarter.

Our Rituxan collaboration revenues come next, and this is the line item titled “Revenue from Unconsolidated Joint Business”. This was $218 million, a 28% increase over prior year in the fourth quarter. As always, we discuss this number and the several elements that build it up.

First, we receive our share of the US Rituxan profits. US Rituxan sales, as reported by Dementec were $560 million in the fourth quarter, which was a 16% increase over prior year. And our Q4 profit-share from that business was $150 million, up 17% versus prior year.

Secondly, we received royalty revenue on sales of Rituxan outside the US, and in Q4 this was $52 million , up 24% versus prior year.

Third, we are reimbursed for selling and development costs incurred related to Rituxan. The reimbursement amount was $15 million in Q4, and this reflects our key role in commercializing Rituxan.

Now, turning to the expense lines for the non-GAAP P&L, our fourth-quarter costs of goods sold were $62 million. As a percentage of revenues, cost-of-goods sold in Q4 was a bit lower than prior quarters due to, quite frankly, fewer manufacturing write-offs compared to prior year, very good performance by our manufacturing team, and improved metrics as Rituxan revenue grows.

Our gross margin was about 90% for the full year 2006. And we believe this is the level that will likely be sustained during 2007.

In the fourth quarter, R&D was $197 million, 28% of revenue. Our underlying R&D expense is steadily increasing as our Pipeline grows and advances with programs such as BG12, Luxomat, Mumluxomat, LT-beta receptor, Declisimat, and HSP90.

Additionally, we remain committed to developing our pipeline through business development transactions, as demonstrated by completing six deals in less than a year. In 2006 we have spent approximately half of the $200 million that we allocated for consumer growth last year.

And we do like to remind everybody that, due to the inherently unpredictable timing of business-development activities, and the related expense that comes with that, we anticipate that our quarterly results may well be occasionally lumpy as we go through the future quarters. So, please don't pay too much attention to that in terms of recognizing ahead of time that we will be doing deals, and they will hit the quarterly P&L as they naturally fall.

In the fourth quarter, our SG&A was $182, now, SG&A is up versus prior year in the prior quarter, and our year-over-year increase is primarily driven by support of our growing core business, Tysabri commercial build up and our new Rituxan sales force, which Jim highlighted earlier. This was partially offset by the savings of no longer having an annuity sales force, which we did have last year. But keep in mind that we’re still launching Tysabri country by country in Europe throughout 2007.

Our fourth quarter collaboration profit-sharing was $4.4 million.

Now, I do want to highlight that this is a new line-item this quarter. And this is where we’re now reporting our net profit sharing payment with Elon related to our international Tysabri business.

In the third quarter we recorded this amount in SG&A. But we’ve now decided to break this out in order to fully give transparency of that exact number.

Now in the fourth quarter this was effectively sharing of the international laws, so the Elon reimbursed us and the number is negative. We don’t hope to see that in the future.

Q4 income from operations was $274 million and Q4 other income expense was $10.6 million. Now, the other income and expense was down significantly from prior year in the prior quarter. And as I mentioned in the beginning, this was primarily given by investment write-down and our equity portfolio year-end, in accordance with our investment accounting policy.

The net investment impairment was $25 million, as I mentioned earlier, including an $18 million impairment of our PDL BioPharma holdings. The total EPS impact was $0.05 per share.

In the fourth quarter our tax rate on the non-GAAP T&L was 30% and in 2004 our tax rate was improved by the renewal of the R&D tax credit. Now, as you may know, the R&D tax credit was originally introduced 25 years ago to boost spending for technological research.

This credit has always been temporary, with Congress renewing it each time it expired. The R&D tax credit expired at the end of 2005 and was only recently renewed in December 2006. And so therefore we retroactively applied the benefit of that from the full year in the fourth quarter.

The Q4 results for non-GAAP EPS calculations were 343 million shares which brings us to our Q4 non-GAAP EPS of $0.53 per share, a 10% increase over the year. And of course on a full-year basis, as I mentioned in the beginning, our non-GAAP EPS was $2.25, long ahead of our guidance in the third quarter, and a 43% increase for the year.

So in summary, and looking back at 2006, we are, as Jim mentioned in the beginning, now three years into the merger between Biogen and Idec. We are delivering on our goals set at the time, most notably achieving a three-year EPS compound growth rate of 23% so far, again with the target goal of 20% annual growth from 2003 to 2007.

So with that let’s move to guidance for 2007.

We expect our non-GAAP P&L…the total revenues will grow in the mid-teens, as a percentage over 2006 with Tysabri and Rituxan RA being key drivers of growth. Our non-GAAP margin structure should be pretty similar to 2006 with the exception of R&D, which should range between 27-29% of total revenues. This assumes a slightly higher level of new business development than in 2006. As a result, our non-GAAP EPS estimate in 2007 is in the range of $2.5-2.55. This implies achievement of our 20% EPS goal from the merger that Jim mentioned earlier.

The GAAP impact of stock options being expensed in 2007 is estimated to be in the range of $0.08-0.11. And finally our 2007 tablet expenditures are anticipated to be in the range of $250-300 million dollars.

That pretty much wraps it up, and now I’d like to hand off to Jim for closing comments. Jim?

James C. Mullen

Thanks, Peter. And I’ll be very brief with the close before we Q&A.

2007, the key drivers I think are certainly the performance on Tysabri and driving the performance of Tysabri in the US and the EU and continue to roll that out and talk about the benefits in very balanced fashion is our number one goal.

We’d like to also extend and continue the momentum we’ve seen on the business development side. We’ve seen a lot of interesting opportunities there to augment our pipelines that can help us in the near-term and the medium-term.

On our own pipeline, we are initiating several proof-of-concept trials, with Wolfotoxin Beta Receptor and RA, the Oral VLA4 inhibitor that we have in partnership with UCB, M200 and Renal Cell Carcinoma Ovarian and Non Small Cell Lung Cancer, those three trials, and that with partnership with PDL and the oral A2A Receptor Antagonist Parkinson’s disease, which is a licensed product for Grenalis.

Just to remind you all, I mentioned it earlier in the call, but we will have an R&D day hosted by Cecil Pickett on May 17th, and we hope to see as many of you there as possible. I think this pipeline has significantly advanced the organic pipeline, what we brought forth for research and momentum there. You’ll see a clearly impressive lineup of products.

And we need to do all that of course in the context, as we have in the last number of years, delivering in the financial results that build towards our long-term growth goals. So with that let me turn it to Elizabeth and we begin tune-up for the Q&A.

Question-and-Answer Session

Elizabeth Woo

Yes. I just want to advise... for the Q&A we have joining us Dr. David Parkinson, our Senior Vice President Oncology R&D, Dr. Al Sandrock, our Senior V.P. of Neurology R&D, and also Christine Hasnin, as V.P. of the Oncology Rheumatology Business Unit.

So, operator, we would like to open our calls to Q&A, and as our usual practice, I would like to ask those asking questions to limit themselves to one question per person. If you have follow-up questions, please re-enter the queue and ask your question later on. This practice allows as many people as possible to get their questions in.

So operator, please go ahead and take the first question.


At this time I would like to remind everyone, if you would like to ask a question, press # then the number 1 on your telephone keypad. We will pause for just a moment to compile

the Q&A roster.

Your first question comes from Geoffrey Porges of Stanford Bernstein.

Geoffrey Porges – Stanford Bernstein

Thank you very much for taking the question.

I’m sure there’d be lots of questions on Tysabri. I’d just like to ask a question on Rituxan.

There’s been a lot of talk about the step-down on the royalty or the revenue share in the future. I’m just wondering if you could give us a sense of when you’re planning for the occurrence of that, and how that might occur in a progressive fashion or one time...what sort of impact that could have? Thanks.

Peter N. Kellogg

Jeff, it’s Peter. I’ll take a first stab at that. That’s a function of when we have our first launch of one of our follow-up humanized programs. And obviously we are working on a number of different programs, a number of different indications. So it will be some time in the early part of the next decade, obviously, not near-term.

I mean, I just remind everybody that step-down occurs over a number of different years, you know, at minimum three, but it could be more. It’s just a question of how fast the sales of that new product ramp up. You know, we’ve disclosed that and that’s something that we’ve been talking about for some time.

You know, I think that one of the key features of that, that we are pretty excited about, furthering the CD20 program, expanding it. And obviously these additional new programs are being targeted for new indication. A lot of immunological indications obviously...with the original Rituxan is in RA right now, but we’re looking at MS and Lupus and other things.

So we would expect all franchises to benefit from the next-generation drug and to really expand. So, obviously, yes, we’re getting a slightly lower cut at the overall profit share in the US, but it’s of a much bigger market, hopefully, because this would be the next generation drug. That would be pretty exciting.

And I also remind you that obviously the new drugs would also have a very long intellectual-property life. They’ve been developed with a lot of investment in the last few years. So I think it’s kind of a, you know, it’s a mixed analysis you have to look at. But we’re pretty comfortable with all that. We’ve factored it into our long-range planning. It’s part of the franchise relationship, and, you know, I think we’re working with Gen Idec on that.

Geoffrey Porges – Stanford Bernstein

Thank you very much.


The next question comes from Geoff Meacham of J.P. Morgan.

Geoffrey Meacham – J.P. Morgan

Hi, and thanks for taking the question. A couple on Tysabri. Given the recent focus to promote the drug actively on efficacy in January, can you give us a sense of the rate of patient ads to touch since January? And then just a quick follow-up: if you can provide the average number of infusions in both regions: US and ex-US.

Bob Hamm

Yeah, this is Bob, thank you. On the question of the latest transit, as I mentioned, we’re running about 300 patients a week worldwide. I think another good measure is we conduct frequent market research. Our market research for January, which is a sampling of a couple of hundred physicians with different practice approaches indicates about 25% have been trained but have not been sent forms yet, but

70% expect to do so. And so we expect our prescriber base to grow and consequently we had hoped that we'd see an increase in the trends that I had talked about.

With respect to the number of infusions, I guess I'm...maybe someone else here has more clarity on what you're getting at. I don't quite know how to characterize that. We talked about the total number of patients and infusions that follow suit. The number of patients we're talking about are net of a small group that have actually just continued therapy so if you track the patients that gives you the infusions.

And I'd also comment that some of the discussion we've had about, you know, moving through the touch form training and the risk benefit communication, really a lot of the swing in momentum is occurring in January as we roll forward. So if you look at the Q4 Operating results, it's not really in there that much.

James C. Mullen

This is Jim. I'd like to have an expectation…there's not a lot of product in the downstream pipeline and because we and Elon are booking at the same time, I think you can sort of back up with a relatively modest time lag and figure out the number of infusions just from the revenue dollars.

Geoffrey Meacham – J.P. Morgan

Okay, thank you.


Your next question comes from Michael Aberman with Credit Suisse.

Michael Aberman - Credit Suite

Hey guys. Hey there?

James C. Mullen

Yep, yep.

Michael Aberman - Credit Suisse

Sorry, thanks. I wonder if you could comment…Genotech had mentioned that the arbitration was ongoing and I think they said it would be available within weeks on their conference call. Can you give us an update of where the arbitration stands for the next generation of CD20 and when you might see an outcome and how that could play out in terms of you moving forward with Rituxan or a novel agent, a novel CD20 for MS?

James C. Mullen

Sure, this is Jim. So I'm going to start in reverse order to the question. So the programs continue in the climb so that's probably the most important thing. Both 2A7 continues to move forward in clinic trials in version 114 and in the dispute overall its around decision making rights.

And as you can probably appreciate, with the number of molecules that Genotech has under development as well as the competitive circumstances that will change relatively rapidly over the next number of years. The strategy of how those get developed and how that all fits together commercially is important and frankly that's where a lot of debate is. And I wouldn't go further than that to say.

In terms of the arbitration, it is a very typical arbitration proceeding so there's one person chosen by us, one by Genotech, and to choose the third person, they listen to the first sets of motions at this point in time. And they're thinking about those you know it’s still very much in the preliminary stage at least from our viewpoint.

The only other thing that I would add , you know, our expectation is this is going to play out over a number of months and the pace of it is impossible to predict at least in my experience with arbitration.

The one thing I do want to, and I'm glad you asked the question, so in the category of no surprises, and you guys will see it in our 10K…Recently in the arbitration proceedings Genotech alleged for the first time, that the November 2003 transaction in which Idec acquired Biogen, it became Biogen Idec, constituted a change in control and that's of course an assertion that was strongly disagreed with.

The amended and restated collaboration agreement with Genotech provided that in the event that we do undergo a change of control, within 90 days Genotech may present an offer to us to purchase our rights for Rituxan. So again, first time that this has been asserted the 90 day window has passed about three years ago. So I don’t know exactly where that goes, but you will see it nevertheless disclosed in the pamphlet of the new item.

Michael Aberman - Credit Suisse

I know that this is follow up, I guess.

What could the outcomes be? Is there a win or a lose situation for you? What should we expect when this arbitration is over?

James C. Mullen

As I have said before, we have a relationship at the very broad collaboration relationship, with Genotech. It is going to go on for as long as there are sales of products. And therefore, we feel we need to have clarity on these decision rights and really that is why the arbitration is around, clarifying the decision rights of the two parties so that we can close up on that and operate as frictionless a relationship as possible for the rest of the sales as long as sales continue in any of these products. So I just view it as an investment in clarifying the future.

Michael Aberman - Credit Suisse

Thank you.


Your next question comes from Gene Mack with HSBC Securities.

Gene Mack – HSBC Securities

Thanks for taking my question. I was just wondering quickly when we might get data on Tysabri re-treatment for those patients who were stopped originally?

James C. Mullen

Fine, Gene, what we know of course from the touch program is a lot of details about the patient returning. What we don't really know in terms of the patients that were involved in the first launch, is all of those numbers, simply because they weren't required to be part of this discipline program at the first launch. And there wasn't a tracking method.

What we believe, what we know rather than what we believe, what we know is that about 30% of touch form (inaudible) for patients that were involved in the first launch. But again it's hard to reconcile those numbers given the lack of visibility during the first launch.

Gene Mack – HSBC Securities

Do you know anything about neutralizing antibodies at this point?

James C. Mullen

Uh no.

Gene Mack – HSBC Securities



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

Joel Sendek – Lazard Capital Markets

Thanks. I have a question about the business bill and spending guidance. I'm wondering how you got to the $100 million. Is that the leftovers from the $200 million budget for 2006? And is any variability in that $100 million spend for '07 embedded in the $250-265 guidance? So, in other words, if you spend more or less could you be outside the $250-265 million mark? Thanks.

Peter N. Kellogg

Okay. Let me take the corrected data. Of course, you know, we talked a year ago about this $200 million number as being the elbow room that we left ourselves on the P&L to really bring in business development. And that is very much, if you will, across the sum from business development deals what kind of impact would it have on the P&L.

Of course you saw the number of deals we did, the majority of the impact was actually on the balance sheet during the course of this year. However, because we are going to continue, and we do believe this is a core part of our business model, you know, we are going to leave ourselves a fair bit of elbow room to take advantage of external opportunities as we go forward.

Now the specifics of what goes into the $100 million that was consumed on the P&L. It is all of the current burn rate for those programs that were brought in plus all of the milestone payments, and any other payment that may go back and forth between the parties.

And those, of course, generally are pretty lumpy. At least the milestone payments via front payments tend to come very lumpy. It's all subject to negotiation. They're very hard to predict and they're idiosyncratic. They're just kind of whatever the feel is.

The ongoing burn rate obviously is a little easier to predict. But I think we're not going to call out necessarily the specific number that we've left in the budget going forward but more to tell you that, you know, we intend to continue in business development at the same kind of rates that you saw in 2006, and hopefully with at least that much success or more.

If we get to a deal or an opportunity that we think it's going to take us outside that band, then we'll be back talking to you in terms of the earnings then and you know of course you're going to want to know why that's good for you.

Joel Sendek – Lazard Capital Markets



Your next question comes from Mark Schoenebaum of Bear Stearns.

Mark Schoenebaum – Bear Stearns

Hi. Thanks a lot for taking my question. I appreciate it. Quick question.

I was intrigued by Jim's early remarks on a call about, I think you said you still expect to sort of eclipse all other MS therapies. Are you talking in terms of patients or dollars?

James C. Mullen

Uh, yes.

Mark Schoenebaum – Bear Stearns

So if you're talking in terms of patients giving placing that implies well over $3 billion? Is my math correct?

James C. Mullen

You know, let me put a broad context around this. So, you know, of course the big uncertainty in the market place, the big question that many of the neurologists and many of the patients are saying is what is going to be the full safety experience of Tysabri, as it gets into a broad number of patients.

And so, you know, we all have to stand back and see what that safety experience turns out to be. The safety program and some of the other programs that we’re conducting obviously give a much more precise insight into that as things unfold, and probably any other product that’s on the market, with the exception of Solidimy or something like that. So we’re going to have a great deal of insight into that.

Now, presuming that the safety profile... so, this is, you know, a critical assumption... safety profile that is not meaningfully different…by that I mean worse than what’s in the current label... I think people are going to get comfort as we go. I mean, and the comfort will come because of sheer numbers of patients as well as when and if we’ll see... and it’s in the label, so we expect to see additional cases of P&L, that we can understand much more precisely what the risk factors involved with P&L.

Now, if you look at where we are right now, somewhere in the middle part of the year, we will have administered more infusions for Tysabri than at the point time that the product was drawn from the market. You know, as we close out this year more patients will have been on for greater than a year, than at the point in time that the product was suspended from the market.

And you can march on from there to get to 18 months, two years data. So we are going to accumulate a lot of that experience in the next 12 months, and I think that based on that data, people will draw their own conclusions. But, assuming that it’s not meaningfully different or worse than the current label, I continue to believe that demand for this product is so strong, the need in this community is such, that the patient numbers will eclipse in the other individual products over time and as will revenue.

Mark Schoenebaum – Bear Stearns

Would that be this decade?

James C. Mullen

It could be...ramp rate is always hard to predict. But we’re going to move through,

The safety question gets answered, you know, by the end of 2008.

Mark Schoenebaum – Bear Stearns

Thanks. I appreciate it.


The next question comes from Bill Tanner with Leerink Swann

William Tanner – Leerink Swann

Thanks. The next question may be quite along the same lines for you, Jim, or maybe for Al. Sounds like there’s some, at least a couple of trials, one trial being conducted to look at the impact of Pherisis on removing or decreasing Tysabri in MS patients...maybe sounds like dated later this year.

I wonder where this goes from against a regulatory standpoint or from the perspective of how you guys see it being...were the data positive beneficial in terms of providing increased comfort for physicians to use the drugs?

James C. Mullen

Sure, Bill. We’re going to see how our conferencing capabilities work, and I’m hoping Al is actually on the line, sitting in San Diego. Al, are you on the line?

Dr. Al Sandrock

Yes, I am.

James C. Mullen

Oh, great. You want to handle that one?

Dr. Al Sandrock

Yeah. So the Pherisis program is one of several approaches we’re taking to see if we can reduce the disability that could result from P&L, should it occur. We will get information about whether or not we can effectively remove Tysabri. And we believe that a yearly constitution is the best way to deal with P&L and we hope to have an I&D in place, so that if people get P&L, they could be treated with Pherisis and perhaps some other approaches that we’re also examining.

Bill Tanner

And that would also include the interferon, I presume.

Dr. Al Sandrock


William Tanner – Leerink Swann



Your next question comes from Jason Kantor with R.B.C. Capital.

Jason Kantor – R.B.C. Capital

Hi, can you hear me? I was interested in this runway that you mentioned, the 300 patients per week. Where is that primarily coming from? Where do you think the growth in that is likely to come from? And how high do you think that number could get in 2007?

James C. Mullen

Well, let me take you first question. The patients to date are...the stats we receive today is what we’re getting in from information in Europe is that they’re coming from obviously the (inaudible) in terms of the current products, and about 31% are coming from other sources, such as returning quitters. We define a quitter as someone who has been off therapy for a minimum of like six months.

Then about 11% are coming from other products beyond the AVCR. Because in the last two years, obviously, physicians have tried to find other ways to fill the gap that the Tysabri withdrawal represented.

In terms of where the number grows to, again, I think it’s just a function of what we’ve talked about in terms of increasing countries coming up and the increasing prescriber base, as mentioned, the safety picture evolving over time.

Jason Kantor – R.B.C. Capital

But that 300 number was a world-wide new number of patients per week, or is that...

James C. Mullen

Yeah, that’s a global figure.

Jason Kantor – R.B.C. Capital

With the patients in the queue right now, what’s the, you know, how fast do you turn people through that queue? Is that speeding up and what is the current, you know...

James C. Mullen

That applies, of course, to the US and the Touch Program. What we’re seeing is an average of 19 days from Receive and Touch Program to infusion for folks. And that’s a credit to the pairs, who view the Touch Program, which controls the two things they’re most concerned about, once they’re convinced of the efficacy.

Number one is the inappropriate use of the drug, which the touch program largely eliminates through the discipline imposed. And secondly is the compliance of the product in the terms of how we track it and what not. That’s why the pairs are moving through pretty quickly on the main.

We expect to see that there are a reasonable number of neurologists that are currently on the sidelines right now in the US. There are the groups that I’ll reference that hadn’t prescribed but had indicated intent to prescribe relatively soon. And in Europe right now we’re really only into 50% of the market, so we would expect with the geographic expansion as well to start to see some expansion.

How high this goes I think is very difficult to predict. I think a lot of it has to do with trying to predict the confidence that people have and that’s going to get driven by factors that frankly we don’t control.

Jason Kantor – R.B.C. Capital



Our next question comes from May-Kin Ho of Goldman Sachs.

May-Kin Ho – Goldman Sachs

Hi. Can you talk a little bit about bio-similars, especially launch of the interferon?

James C. Mullen

May-Kin, we heard the beginning of that question about bio-similars. Can you repeat the second part?

May-Kin Ho – Goldman Sachs

Oh, sorry. I was just asking what you can tell about bio-similars for interferons and the potential launch of them in Europe and what are you doing to prepare for that.

James C. Mullen

Yeah, the bio-similars. Our expectation is that we will see one in the next couple of years. Initial plans and initial trials that were conducted were with the 22 micrograms that was trying to mimic that interferon. So they’ve got some more trial work to do, because that’s probably the one category that’s getting the most crowded out in the marketplace in terms of utilization. So from that perspective I don’t see an immediate or huge impact market.

In terms of what we’re doing to get prepared – most of that I’m not going to talk about for tentative reasons, the obvious ones are innovation, which, you know, Bob listed Tysabri and a long list of other products that we hope will change the whole paradigm in the game over time. We are also doing things with thebusiness and the products there to manage the life cycle of that product and those are initiatives that I cannot disclose for competitive reasons.

Elizabeth Woo

Operator, I’m seeing that we’ve gone past the hour. We’ll take one last question.


The final question from Steve Bahar from Morgan Stanley.

Steve Bahar – Morgan Stanley

Good morning. Can any of you guys address, on the accounting side, you said that part of your business you are going to include that in your financials?

But it seems that another important part of your ongoing business plans are the small acquisitions, you’re not including those in your financial statements. So how do you think through this and when would you consider putting these recurring charges into your ongoing business thoughts?

Peter N. Kellogg

Well, I think, just to clarify, when do buy a business, obviously the operating financials of the business rolls into our P&L. That's part of our ongoing activity. Generally, what we have been highlighting in Table 3, and extracting out of the non-GAAP P&L, are the purchase accounting charges. So that's primarily the up-front, in-process R&D charge that relates to the initial acquisition.

Frankly, the other thing that's in there is the amortization and tangibles, and a lot of these early stage companies that we're acquiring don't really have much to identify as a tangible because most of their work is really staged as in-process R&D.

So, the amortization and tangibles is basically most of what you'd see on our P&L there on the GAAP side is for the original Biogen and Idec merger, and its just the accounting basis for identifying the intangible related to Adamec, quite frankly, and amortizing that over time. So, that's an accounting convention, and we just haven't been including that in the non-GAAP performance.

And I think that, actually, as you look across the biotech industry, and in a lot of industries, you would see that that, you know, similar treatment is done as people think about communicating the ongoing financial performance of the company, so people can get a real sense of, you know, real cash-flow kind of items, real cash items, as opposed to accounting charges that are kind-of unique to that acquisition.

So, the primary charge that we see on an ongoing basis relates back to the Biogen Idec merger, that amortization of the (inaudible).

Steve Bahar – Morgan Stanley

I guess if you were to look across a broader swath of companies that could do frequent acquisitions of that size, you might see them in the P&L, and there is a cash charge obviously to making acquisitions with your cash.

James C. Mullen

Yeah, this is Jim. Most of the, well, all of those right to the (inaudible) are either intangible, right down, or is in-process R&D. And conceptually, if you think about how you guys value a company today, you are putting a value on that in-process R&D.

Just the accounting convention is, when we acquire it, we just have to write it all off. So, however you want to look at that, and then the premium that we may pay over whatever the current market value is, you know in the old-fashioned days, that would have just been stuck under good will. And then we would look at impairment over time. So, we are doing that, and that does flow down through the rest of the operating P&L.

Steve Bahar – Morgan Stanley

Great, thank you.

James C. Mullen

I think we have pretty-much gone over time.

Elizabeth Woo

Yeah, thanks to everyone for joining us on the call today. Operator, you can close out the call. Thank you.


Thank you for your participation. You may now disconnect.


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