Biogen Inc (BIIB) 2005 Q3 法說會逐字稿

Good afternoon.

My name is Ramona, and I will be your conference facilitator.

At this time I would like to welcome everyone to the Biogen Idec third quarter 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 period. [OPERATOR INSTRUCTIONS].

I would now like to turn the call over to Ms. Elizabeth Woo, Vice President of Investor Relations.

Thank you, Ramona.

Welcome to Biogen Idec's earning conference call for the third quarter 2005.

Before we begin I'd urge everyone to go to the Investor Relations section of our Web site, Biogenidec.com, and printout the press release and accompanying tables.

This will make it easier to follow along when our CFO, Peter Kellogg, reviews the financial results and the reconciliation to nonGAAP financial measures discussed today.

I'll start with the Safe Harbor statement.

Comments made on this conference call include forward-looking statements regarding the Company's expectations regarding future financial results including the financial objectives of our recent restructuring, the potential for TYSABRI, the short and long-term growth of the Company, plans for the Company's commercial and pipeline products, and plans for external growth and pipeline growth.

Such statements are based on management's current expectations and are subject to risks and uncertainties which could cause actual results to differ materially.

In particular, careful consideration should be given to the risks and uncertainties that are described in our earning release and in the periodic reports Biogen Idec has filed with the Securities and Exchange Commission.

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

Today on the call I'm joined by Jim Mullen, CEO of Biogen Idec;

Burt Adelman, Executive Vice President for Development;

Peter Kellogg, CFO and Executive Vice President, Finance; and Bill Rastetter, Executive Chairman.

I now will turn the call over to Jim Mullen.

Thank you, Elizabeth.

Good afternoon, everyone.

And thank you for joining us.

We previously announced our strategic plan to reduce operating expenses to fund increased business development activities in order to accelerate long-term growth.

During the quarter, we have progressed against these goals by accomplishing the restructuring and by signing the partnership with PDL to jointly develop and commercialize three phase II antibodies.

Additionally, we achieved several key near term milestones, including completion of the extensive safety evaluation of TYSABRI, the submission of TYSABRI's regulatory filings for multiple sclerosis in the U.S. and Europe, and the submission of RITUXAN's regulatory filings for rheumatoid arthritis in the U.S.

Let me take this opportunity to focus a little more on the details of this restructuring.

We believe these initiatives will position the Company for long-term growth and enable us to deliver more for patients, shareholders and employees.

Over the years, Biogen Idec has enjoyed many accomplishments.

We have pioneered exciting new therapies that have helped paints suffering from MS, cancer, psoriasis, and in the near future, rheumatoid arthritis.

We've established an impressive global footprint with strengths in clinical trial design and execution, protein sciences and manufacturing.

We built a world-class commercial organization that can compete and win in specialty markets across the globe, against some of the biggest names in the industry.

And we project a solid balance sheet and cash flow over the next few years.

In the near term, our core business is strong led by sales of RITUXAN and AVONEX. n addition, our immediate growth prospects are promising, including RITUXAN in RA, TYSABRI in MS, and BG12 for psoriasis in Germany.

So again we've accomplished a great deal over the years and our near term fundamentals are strong.

We're moving forward more than a dozen candidates in the immunology portfolio and several programs in our oncology pipeline.

As good as we've been in the past and may have been -- may be over the next few years, we recognize the need to increase our long-term growth prospects by significantly augmenting the number of programs in our mid- to late-stage pipeline.

Over the last few months, we took an extensive look at the state of our business and made several important decisions.

We announced in early September Biogen Idec's long-term external growth strategy for the future.

The plan builds upon our near term strengths while driving growth in the midterm and beyond the current decade.

The central elements of this initiative are, first, the economic flexibility and more financial discipline, with the purpose, secondly, of reinvesting these savings for accelerated growth through external opportunities.

I'll add some detail around both of these points.

So firstly, economic flexibility and more financial discipline.

The starting point here is to get leaner and more disciplined.

We looked at every activity in the Company and the likelihood that it would create value in the future.

What could be consolidated either functionally or geographically, what could be reduced, eliminated, outsourced, or divested.

This analysis resulted in a work force reduction of 17% of our employees worldwide and the planned divestiture of our psoriasis product AMEVIVE, both tough discussions indeed, but these savings will allow for reinvestment in new opportunities.

Resizing our work force was the most difficult step, and one we wish we did not have to take.

But ultimately it's the right decision if we are to build for the future of our patients, shareholders, and our remaining employees.

Secondly, a decision to accelerate growth through external opportunities.

The purpose is to take the money we will save from restructuring and invest in our future by significantly enhancing our pipeline through external collaboration.

We expect to be able to earmark approximately $200 million a year for business development and external research opportunities starting in 2006, compared to approximately $50 million earmarked for business development in 2005.

Internally this statement brings much greater focus and urgency to accomplishing our business development goals.

Externally this is a strong signal to potential partners that we are motivated and have the capacity to execute on opportunities.

We feel that we've begun to execute on this external growth strategy in the third quarter as evidenced by the collaboration we closed with Protein Design Labs that encompass the joint development and joint commercialization of three phase II antibodies.

This partnership will expand our oncology presence in solid tumor, while potentially strengthening our position as the leader in the multiple sclerosis research and development.

This alliance enables both companies to share costs and risks of developing the products that may address large market opportunities, while leveraging our respective development, manufacturing and commercial strength.

It's our belief that this long-term growth strategy will reposition Biogen Idec to continue to deliver innovative and breakthrough products that will benefit patients as well as billed long-term shareholder value.

I'll now turn the call over to Burt Adelman, head of development.

Burt?

Thank you, Jim.

Good afternoon, everybody.

I'm going to take you through a quick trip of our pipeline, starting from our most advanced products with a brief look at some of our earlier products.

So let's of course begin with TYSABRI.

As I know you are all aware, we at Biogen Idec and our colleagues at Elan have now completed a rigorous safety evaluation of the majority of the patients who have been exposed to TYSABRI during the development of the product in MS, Crohn's and RA and during the brief period of time it was in the commercial space.

Although focused on the incidence of PML, progressive multifocal leukoencephalopathy, and other potential complications of immunosuppression, our study was intended to be comprehensive.

Today I can say with confidence that we have achieved this objective.

Now in summary, we found no new cases of PML, other than those previously reported and no other previously unrecognized pattern of adverse events.

These results apply to all patients from all studies, MS, Crohn's and RA.

Now as part of the safety review we assembled an independent adjudication committee sometimes referred to as the IAC, to help us evaluate clinical MRI and laboratory data, and we followed an evaluation protocol that we developed in collaboration with regulatory authorities both in the United States and Europe.

Very importantly, we collaborated with the National Institute of Health and the scientists there who have been instrumental in the conduct and interpretation of the JC virus assessments required for these evaluations.

We are uniquely indebted to our colleagues at the NIH, as we are indebted to many other colleagues who have helped over the period of time since we started this evaluation.

And we look forward to continued work, both with our colleagues at the NIH and around the world, in continuing to understand the relationship between immunosuppression and the potential risk of PML and other related disorders.

Now the complete evaluation, the complete report on these evaluations will be made available, I'm sure, in the near future in the scientific and medical literature.

Now as you also know, the encouraging results of these investigations have enabled us to submit to the FDA on September 26 an sBLA for TYSABRI use in MS.

Now a comment on why is this an sBLA rather than simply a request to go back into the commercial space?

And it's a very important distinction.

This is an sBLA because it contains the final two-year data from the phase III affirmed monotherapy trial.

And the SENTINEL add-on trial, in which we compared AVONEX to AVONEX plus TYSABRI.

The results of these trials support a request for inclusion of the effect of TYSABRI on the progression of disability.

So in fact we are asking in this sBLA for an expanded label than that which we originally had, so we now want to include the important effects of TYSABRI on preventing the progression of disability in patients with relapsing forms of MS.

Also in this sBLA, obviously, is the integrated safety assessment of the patients who were evaluated in this -- during this period of time that we've been out of the clinic and a revised label and risk management plan.

Now briefly, the purpose of the risk management plan is to ensure, first, that patients and physicians understand the benefits and risks of TYSABRI treatment for MS, and then to ensure that we have a process in place for rapid recognition of any new important safety signals once the product reenters the commercial space.

Now we expect to be informed about the acceptance of the file and whether or not we'll be granted priority review within 60 days after filing, which in this case will bring us towards the end of November.

So we await that information from the FDA.

At the same time, we are in active conversation with the FDA and European regulatory authorities to initiate redosing of patients with TYSABRI who have MS.

And that process is moving along and we should have additional information about that in the not too distant future.

Now just as importantly as our renewed interactions with the FDA with respect to the sBLA, now that we've completed the comprehensive safety evaluation we are again actively working with the CPMP in Europe to continue the review process of TYSABRI there, and things are moving along nicely.

Now from TYSABRI, I'll move to RITUXAN in particular the -- actually let me back up for one second, excuse me, and just add one comment on the RA results of TYSABRI.

As many of you know we were running a phase II trial with TYSABRI and RA.

Although that trial was stopped prematurely, we do believe that enough patients were treated and they were treated for a long enough time for there to be sufficient data to evaluate the results.

And we have concluded that the efficacy results of TYSABRI in RA are inadequate at this time to warrant continued development.

So we will present these results in detail at a future medical meeting, but we have made the decision not to continue development of TYSABRI in RA.

Briefly on AVONEX, we are very pleased to see in the July issue of Neurology three important articles in editorial that discuss the importance of neutralizing antibodies in the treatment of patients with MS receiving interferons.

Basically the conclusion of these articles in editorial is that neutralizing antibodies are important, that antibody levels tend to remain over time and that patients who have neutralizing antibodies appear to have significantly worse outcomes than those patients without neutralizing antibodies.

Now to move on to RITUXAN, RITUXAN in RA, many of your aware of the successful outcome of the of the REFLEX trial which was the phase III trial of RITUXAN for patients with rheumatoid arthritis who are inadequate responders to anti-TNF therapy.

As a result of that trial outcome we did file an sBLA for RITUXAN in this patient population.

We filed the sBLA at the end of August, and we'll be awaiting action of the FDA on that.

The phase III REFLEX trial results will be presented, I believe, at a plenary session of the American College of Rheumatology in San Diego, I believe on Wednesday, November 16, and we and our colleagues at Genentech will conduct an analyst meeting and conference call at the ACR following the oral presentation of the REFLEX results.

So we hope to talk to all of you about that at that time.

The DANCER study, which was the phase IIb study for Demart [ph] inadequate responders.

As many of you know, it was also successful and we along with our colleagues at Roche and Genentech are preparing to initiate a study program investigating RA -- investigating RITUXAN in RA patients who are inadequate responders to Demart therapy.

This trial program will be a global program and hopefully will be initiated toward the end of this year or early in 2006.

And we continue to be excited about the value of RITUXAN broadly in autoimmune indications and are investigating its use in lupus.

There's some clinical trial activities there, and multiple sclerosis and other areas.

Now RITUXAN in oncology, some important news there.

We have filed an sBLA for the front -- for use of RITUXAN in front line aggressive non-Hodgkin's lymphoma.

We filed that in August.

The FDA has granted priority review status.

We are obviously pleased by that because the assignment of priority review status demonstrates to us that the FDA recognizes the significant improvement in survival RITUXAN may offer patients with aggressive forms of lymphoma.

We also anticipate filing the combined RITUXAN indolent frontline and maintenance sBLA in the first half of '06.

Also on RITUXAN in oncology, our colleagues at Roche recently announced important new maintenance data in indolent non-Hodgkin's lymphoma from the European Organization For Research and Treatment of Cancer study.

I'm not going to go through the results here, but I will tell you that they have been accepted for presentation at the American Society of Hematology meeting this December, which I guess has been moved from New Orleans to Atlanta, so we all look forward to hearing those results there.

Not too long from now.

We're continuing our efforts in chronic lymphocytic leukemia with RITUXAN in U.S. and Europe.

A quick note on ZEVALIN, we have submitted to the FDA our protocol for incorporating ZEVALIN into the treatment of patients with diffuse large B-cells lymphoma, high-grade lymphoma, and we hope to initiate that study early in 2006.

That study is being conducted around the world in collaboration with our ZEVALIN partner, Schering AG.

The fumarate program, BG12, PANACLAR, as we've said in the past we have submitted that product to the German regulatory authorities for use -- approval for use in psoriasis.

It is under review.

And we hope to hear sometime early in '06.

Similarly, we are completing a comprehensive phase II MS study, and we'll have a view on the further development of PANACLAR in MS also some time early in '06.

So stay tuned.

We're obviously very excited about the BG12 program and the upcoming results.

With respect to our early pipeline, we've continued to move programs ahead in neurology, autoimmune disease and oncology.

We filed an IND in the third quarter for lymphotoxin beta inhibition in rheumatoid arthritis in Demart inadequate responders.

We expect to initiate phase II by year-end.

Our small molecule phase II program in Parkinson's disease with our colleagues at Vernalis should be -- begin accruing patients early until '06.

A number of our oncology programs are moving along in phase I trials.

Our anti-lymphotoxin beta receptor program, CB11, is accruing patients.

Our gene therapy adenovirus delivery of interferon beta is ongoing in an IV infusion study for patients with colorectal cancer, and we have a exciting collaborative study with investigators at the University of Pennsylvania looking at the use of that agent in patients with metastatic pleural effusions.

And internally, we are assessing our development plans for our anti-CD23 program in chronic lymphocytic leukemia and for the possibility of moving our anti-CD80 program forward into phase III in patients with non-Hodgkin's lymphoma.

Just to emphasize the point that Jim has already made, we are very excited about our collaboration with PDL.

It is certainly one of the more exciting recent collaborations in biotechnology.

It covers a spectrum of products in autoimmune and oncology areas, areas of great interest and expertise of both Biogen and PDL, and we are moving forward with all of these programs, Daclizumab, the antibody to IL2 is ongoing in multiple sclerosis.

The M200 antibody, an anti-angiogenic agent, is moving forward in a number of solid tumor indications, and the HuZAF, humanized antibody that targets gamma interferons, is being investigated across a number of potential autoimmune indications.

So we hope that this multi-product relationship with PDL will be the first of a number of similar programs that we are able to conclude in the next year through our very active BD efforts.

So thanks for your attention, and I'll now hand the call over to Peter.

Thank you, Burt.

Before I move on to the financials let me remind everyone that since the Biogen Idec merger in the fourth quarter of 2003, we have provided table three on our earning release as a reconciliation of the GAAP to nonGAAP financial results.

As I view the P&L operating performance of Biogen Idec, the bridging items that reconcile GAAP versus nonGAAP are listed in this table three, and these will allow you to follow the nonGAAP performance.

The main items excluded from operating nonGAAP this quarter are purchase accounting charges, as usual, of $88 million due to the quarterly purchase accounting impact on cost of sales and amortization of intangibles.

Secondly, severance and restructuring charges of $27 million due to the reduction in force and strategic changes announced in September.

And thirdly, impairment and loss on the sale of assets of $21 million driven primarily by the classifications of our NICO clinical manufacturing plant as an asset held for sale and marked down to its appraised value.

And additionally some related residual costs from the sale of the NIMO manufacturing plant.

Now because staff restructuring and asset disposals are non-operating, we have adjusted these charges from our nonGAAP P&L along with other normal purchase accounting elements.

Accordingly our nonGAAP EPS was $0.36 per share for the Q3.

We have included a number of charges in our nonGAAP P&L this quarter since they are operational in nature.

Included in the nonGAAP P&L this quarter are the following charges. $50 million in R&D associated with a $40 million up front payment to PDL, as well as $10 million in future payments; a $25 million operating charge due to ZEVALIN intangibles and inventory impairment which is broken out between cost of sales and SG&A which a I'll discuss later.

This is based on our annual long-range plan reevaluation of ZEVALIN expectations; and lastly, a $5 million write down of securities associated with Sunesis.

Now I'd like to walk through the P&L line, beginning with our third quarter total revenue, which was $596 million, a 10% revenue growth over the same period last year.

Now some of you may notice that revenue was down quarter-over-quarter, and I'd like to point out that Q3 revenue was higher than all previous quarters except for Q2 and we feel that Q2 was simply an exceptional quarter all around.

And the main driver for the drop in revenue quarter-over-quarter was AVONEX International, which I will address in more detail in a minute.

However, as you will see, the underlying business trends across the line are positive and very solid.

Now going through our product revenues beginning with AVONEX, the number one MS product worldwide, our third quarter worldwide product sales were $375 million, an 8% increase year-over-year.

In the U.S., the third quarter product sales for AVONEX were $235 million, up 5%.

And the U.S.

AVONEX remains the market leader with about 40% market share in the MS market.

On the international front, AVONEX in the third quarter had product sales of $140 million, up 15% versus prior year.

Now on a year-over-year basis, AVONEX's Q3 sales growth in local currency was 13%.

The foreign exchange impact in Q3 was roughly $3 million, or contributed about two points of growth.

Now on a quarter-over-quarter basis, as I mentioned earlier, a few unusual items affected sequential quarterly growth.

First, Germany, our largest market, had a softer quarter, in part due to some stronger Q2 sales that we now believe may have been driven by a price increase taken in May.

Secondly, as you are aware, the Euro actually softened in Q3 versus the dollar causing a $5 million down side based on currency versus the prior quarter.

Now remember, although ForEx helped on a year-over-year basis, on a quarter-over-quarter basis the impact was negative.

Finally our business model in Italy changed from a distributor to a consolidated joint venture.

Which changes revenue recognition from a sell-in structure to a sell-through model.

This results in a delay of revenue recognition on a one-time basis for certain units held by the distributor until they've been sold through the distributor to the market, creating a one-time softening of reported sales.

However, stepping back from all of this, perhaps the most important message throughout is that AVONEX continues to be the most used international MS therapy based on patient share.

We estimate our worldwide market share to be in the low 30s with Rebif and Betaseron following closely behind.

In addition, we continue to gain market share internationally and are growing slightly faster than the total MS market, which indicates clearly that the business is very strong and doing quite well.

Now moving down the P&L, in the third quarter, AMEVIVE product sales were $12 million.

In the third quarter ZEVALIN product sales were $5 million.

And royalties in the third quarter were $23 million.

Our RITUXAN collaboration revenues come next, which is titled revenue from unconsolidated joint business.

And that was $182 million, an increase of 14% year-over-year.

As we always discuss, this number has several elements.

First we receive our share of the U.S.

RITUXAN profits.

U.S.

RITUXAN sales were $456 million in the third quarter, and our Q3 profit share from that business was 129 million, up 9% versus prior year.

In Q3, although U.S.

RITUXAN revenue was up 16% year-over-year, this was somewhat offset by increased costs for regulatory filings and initial build up of the collaboration's R&D commercial infrastructure.

Now secondly, we receive royalty revenue on sales of Rituximab outside the U.S. and in Q3 this was $42 million, up 28% versus prior year driven by the impressive growth of MabThera internationally.

And third, we were reimbursed for selling and development costs incurred related to RITUXAN.

This was $11 million in Q3.

Now turning to the expense lines on the P&L, in Q3 our adjusted cost of sales were $78 million, and that's about 13% of revenues.

Now the reason why cost of sales are slightly higher in Q3 is because of some ZEVALIN impairment charges that I mentioned earlier.

Let's discuss this.

Each year, our long-range plan reevaluates our portfolio of products.

This year's analysis resulted in near term reduced expectations for ZEVALIN, resulting in a $25 million charge due to the impairment of ZEVALIN inventory and intangibles.

This charge is split between cost of sales and SG&A.

There'll be about $12 million charge if its imbedded in the numbers for cost of sales and about $13 million charge imbedded in the numbers for SG&A.

I would like to point out, however, that although ZEVALIN's growth expectations in the near future have declined, we are still interested in ZEVALIN's long-term potential as a consolidation therapy in the diffuse large B-cell lymphoma market, as Burt mentioned earlier, which is a longer term future growth driver, perhaps, for the Company.

In the third quarter, R&D was $207 million, 35% of revenue.

Now the R&D charges in Q3 did include the $50 million due to the PDL collaboration.

And as I mentioned earlier, this includes the up-front of $40 million and future payment liabilities totaling $10 million that were booked in Q3 because of the future certainty of these payments.

I'd also like to note that we had $10 million of TYSABRI high titre development and production expenses in Q3.

Now, only 1 million of this amount was for normal TYSABRI production. 9 million was related to high titre development work that would normally be charged to R&D anyway, so this is not really an unusual charge for Q3 in any way.

Our third quarter SG&A was 154 million, 26% of revenue, and as I just finished mentioning, that includes $13 million of the impairment of ZEVALIN intangibles.

The Q3 OIE was $11 million, and this includes a $5 million write down of marketable securities for Sunesis stock.

Our third quarter tax rate was 27%.

Now, on a tax basis the significant charges incurred for the PDL deal and restructuring caused our income in the U.S. to be much lower, driving our worldwide tax rate down for the quarter.

This brings our year-to-date tax rate to approximately 30%, which is the rate we anticipate for the full year.

These tax rate impacts are temporary for 2005, and we expect the tax rate in 2006 to return to the low 30s in terms of percent.

In the third quarter, diluted share outstanding that we use for nonGAAP EPS calculations were 344 million shares.

So this brings us to our Q3 adjusted EPS of $0.36 per share.

Now, I'd like to touch on a couple of final topics.

Clearly, this has been a year full of events that created numerous accounting impacts.

Given all these events, however, we thought it was important to remind you that we expect 2006 will be quite different.

As we look ahead to 2006, we expect and have modeled that first TYSABRI will be reintroduced in the U.S. in mid 2006 and launched in the EU in the second half of 2006.

We are assuming TYSABRI will be a modest contributor to 2006 revenue.

Remember, the U.S. revenue per unit for Biogen Idec is based on the transfer price to Elan while the EU revenue per unit is at market.

Also, we do not expect to have any cost of sales in 2006 based on the inventory write off taken in 2005.

This will improve the overall Biogen Idec gross margin in 2006.

Now secondly, we've assumed that RITUXAN in RA will be approved and launched by mid 2006 as well.

All other lines in the P&L are expected to remain consistent with current trends and that leads us to having operating expense that we would expect to be in the range of 1.4 to $1.5 billion, which includes $200 million allocated to business development as well as flow through expenses from the PDL deal.

Biogen Idec intends to spend the full $200 million in 2006 on BD activities, but, of course, it is hard to predict the timing of that spend.

Fourthly, we expect our tax rate to remain approximately in the low 30% range, as I mentioned earlier, and finally, as a result of these assumptions we are estimating 2006 EPS to be in the range of $1.95 to $2.10.

We are not giving detailed line by line guidance due to the number of moving parts in 2006, which I'm sure you can all well appreciate.

Please note that these estimates do not include the impact of FAS 123 R because we are still evaluating our long-term incentive program.

I will provide an update on this during our fourth quarter earnings call.

Also, we anticipate capital spending in 2006 to be much lower than this year.

We expect it to be in the range of 200 to 275 million.

So in summary, Q3 was a complex quarter where the Company has taken several bold decisions to redirect our future.

These actions triggered a number of charges from a financial standpoint, but we feel that our decisions position us well to achieve our 2006 goals and beyond.

The core businesses of Biogen Idec, AVONEX and RITUXAN, are strong.

We expect TYSABRI to be a future contributor to our growth as well, as we build the next stage of the Company.

Now I'd like to hand off to Bill Rastetter for his closing comments.

Bill?

Thanks, Peter.

Before we go to your questions I'd like to close on behalf of the entire team at Biogen Idec.

The thrust of our restructuring initiative is to plan for the future by reinvesting the money we will save to expand our pipeline, capitalizing both on internal and external opportunities.

What does success look like several years out, say in the 2010 to 2012 time frame?

Let me walk you through a brief glimpse of where we hope to go.

We expect to continue to be a global leader in neurology in general and MS in particular.

We expect that TYSABRI, with its strong efficacy profile, will be available as an important treatment option for patients.

We also hope to be on the brink of delivering a broad range of MS therapies to patients, including RITUXAN, Daclizumab, which you will recall we recently partnered as a part of the PDL deal, and the oral product, BG12.

Further backing development, we hope to have made considerable progress on the Nogo program for nerve regeneration, and the LINGO program for remyelination.

Both of these proteins offer significant promise to patients in potentially reversing the course of their disease.

In addition to MS, we hope to have made considerable progress in other areas of neurology.

There is considerable unmet need in Parkinson's disease, Alzheimer's disease, stroke and neuropathic pain.

In oncology, we see a market crowded with significant competition, but also one in which the unmet need for patients is truly staggering.

It is our goal to make the leap from being a top U.S. company in hematologic tumors to being viewed as a true global leader in oncology across the board -- from discovery to development to commercialization.

Oncology is an outstanding test for our culture of collaboration.

While success here involves moving our internal programs along, we must also grow and build through external partnerships.

A focus for '06 will be expanding our oncology R&D efforts, attracting top talent, developing early stage partnerships with academic centers, entering R&D collaborations with other companies, building opportunities in the solid tumor market and expanding our pipeline to include small molecules.

We will remain open as well to expanding into other major therapeutic areas.

Here, we'll stay focused on discovering, developing and commercializing significant products against high unmet medical need for global specialty markets.

These may include rheumatoid arthritis.

This is certainly an area where we hope to be a player.

We're obviously making good strides with RITUXAN, lupus, Crohn's disease and ulcerative colitis.

As a result of our efforts to collaborate at all levels of our pipeline, we will expect to see a doubling of products progressing through our pipeline in the 2010 to 2012 time frame, a vast network of research collaborations, what we call collaborative inquiring with top academic, government, teaching hospital, and bio tech and pharmaceutical companies, both in the U.S. and across Europe.

Our restructuring initiative was a first step towards achieving this vision for the 2010, 2012 period.

Now I'll turn the floor back to Elizabeth for your questions.

Operator, we are ready to take questions.

[OPERATOR INSTRUCTIONS].

Elise Wang, Citigroup.

Hi, thanks for taking my question.

I was wondering, Burt, perhaps you can elaborate on what are some of the key issues at this point either from the investigators or the regulatory authorities in regards to restarting the TYSABRI clinical study?

I don't think there are any key issues from the investigators.

I think there's a tremendous amount of enthusiasm from investigators and patients alike for us to be moving forward in any and all ways to bring the product back to patients.

And I don't -- we haven't heard anything from regulatory authorities, but I wouldn't anticipate a lot of issues.

If we have the confidence to be sending the sBLA back and to be able to reopen conversations with the EMEA about approval for the product to go into the commercial space, I think we have to have confidence that we understand how to use the product in the clinical trial area.

So I'm pretty upbeat about all that.

Mark Schoenebaum, Bear Stearns.

Hi.

This is actually Robin Karnouskis [ph] in for Mark.

He's on a plane.

Thank for taking my question.

I just was wondering if you could clarify -- you mentioned on the call that AVONEX sales were a little light because of FX charges and so forth, but what are we -- what should we expect going forward?

Should we expect growth to be flat or increasing market penetration in the EU?

What are your thoughts?

Hi, Robin, it's Peter.

First of all, we think that we would expect the international side to continue the trend that you would have seen -- and, of course, it did have -- the international business did grow 15% over prior year in the third quarter, so I just want to highlight that the business is still very strong.

It is growing faster than the market in total as well.

So it's gaining market share.

They've done a great job over there.

I think this is just sort of -- there was a couple of little differences.

One was ForEx as I mentioned.

The other was that we changed the structure of our relationship in Italy so it just caused us to for the inventory at that distributor to defer revenue -- to change the point where you recognize revenue.

So we expect the business to continued to do quite well.

We do think also the market continues to be penetrated.

Clearly in Europe in particular the position of neutralizing antibody competitively in the marketplace has been very effective, neutralizing antibodies are well understood.

Long-term therapy is highly valued.

So we think they're going to do very well.

The commercial team in Europe and around the world has done a great job developing the business over the last couple of years.

Likewise in the U.S.

I think the team's done very well.

The market share was very steady as we came through the third quarter.

The market growth overall, I think, has -- in fairness, has slowed a bit in the U.S.

And I think that as you go forward to next year, we're looking forward to continuing to hold our strong position with AVONEX but also get back into reintroducing TYSABRI, which we think -- if you look back at the launch experience of this year, one thing that you have to conclude is that while the U.S. market had -- growth overall had been slowing up to that launch, clearly, there is a lot of unmet need still out in the market.

A lot of patients lined and were very interested in getting back into therapy and trying TYSABRI, so we think the penetration in the U.S. market will improve as well with that relaunch.

Joel Sendek, Lazard Capital Markets.

Thanks.

I have a question about your guidance on business development expense next year.

Will that be likely to be in the R&D line, and why not amortize those expenses so that they won't be so lumpy next year?

Thanks.

Hi, Joel.

I think I'll take that one.

So I think in fairness most of those BD costs would be in R&D.

I think that's a fair assumption.

Secondly, in terms of amortizing them, well, I think that -- if we use the word amortize we're really talking about what the accounting treatment for the up front payments and most of these programs are in clinical stage, and so the proper accounting treatment would be for -- to be expensing them.

There are some instances that we could discuss off-line, perhaps, where you might take a large payment and capitalize and amortize it over the future useful life, but for the most part we're assuming that we're going to be bringing clinical products that we'd be expensing the -- up front.

Jason Kantor, RBC.

Thank you.

With regard to the TYSABRI filing, could you give us some sort of sense of what kind of rich production you want to put in there, what sort of methodologies you're asking doctors and patients to go through to lower the risk of -- or identify early potential PML patients?

Yes.

I mean, to the extent that I feel comfortable because obviously this is an area of great interest to the FDA and one that they've got their own group with expertise on and we'll get some feedback on our proposal.

But first and foremost, the issue is to ensure the drug is used in patients for whom it's indicated, patients with relapsing forms of multiple sclerosis.

Second of all is to ensure that -- that physicians and patients understand what the risks are with any and all drugs that act on the immune system with respect to anything from PML to risk for opportunistic infection.

So I think ensuring that patients and physicians understand the class of drug they're prescribing, understand who it's indicated for is first and foremost.

Then I think is basically to the remind people that the use of drugs that affect the function of the immune system in patients who have recognized disorders of immune function is probably something that people need to be advised about.

So you don't want to give the drug to someone with AIDS, probably, and you want to recognize other drug exposures or other historical facts in a given patient that might indicate that they are -- that they have a -- an altered immune system.

And I think -- so I think awareness and education and ensuring that that message is delivered is front and center in an effective risk management program.

Mike King, Rodman Renshaw.

Thank you for taking my question.

Just had a quick question on AVONEX inventories and price increases.

Were there any changes in inventories and any price increases before the quarter?

In Q3 there were -- I'm just double checking -- there were no price increases in Q3 for AVONEX.

The inventories remained the normal range in the channels in the U.S., which is -- we always say it's between one and two weeks.

So really in general the business is pretty straight forward in the U.S.

Internationally we don't really think there was a lot of change in inventories per se.

The one thing I did note was in Germany we feel that perhaps in Q2 we did have a price increase in Q2 in Germany, and -- but we don't have a lot of visibility because we're selling directly into pharmacies.

So perhaps some of the strong sales in Germany in Q2 were driven because of that price increase, but -- which might imply a slightly reduced level of inventories in Germany in Q3, but it's hard for us to have visibility of that.

Geoff Porges, Sanford Bernstein.

Thanks for taking my question.

Follow-up question on TYSABRI, there was suggestion [inaudible] peripheral blood borne [inaudible] PCR might be a more robust method for following -- for early detection of JC viremia in patients developing PML.

I'm just wondering if that work has been done on the affected patients, PBMCs, and what the result was?

And secondly, have you obtained the samples from the third patient that wasn't presented at the meeting and what were the serum and CSF JC virus finding prior to your clinical presentation and diagnosis in that patient?

Thanks.

So this is Burt.

I'm not going to comment specifically on some of those questions except to say we've been working with Gene Majors who is one of the world's experts on assay methodology for JC virus in the blood, plasma, urine, CSF, tissues.

We do use a PCR-based analysis.

The trick to good assays is the probe sequence that you use more so than whether you go to lymphocytes, monocytes, et cetera.

So I think we are using state-of-the-art technology and Gene and others involved in this will be discussing these results from this study and others in greater detail at various scientific meetings over the year.

With respect to any tests that we may be developing, there are no strategies to develop tests concurrent with the launch of the drug.

Testing is a research activity.

And with respect to patient number three, I don't think we know anything more than we've already told folks about that patient.

Craig Parker, Lehman Brothers.

Hi, Peter, sorry to turn this into accounting for dummies, but every time I think I understand your guidance and your expense recognition, I'm wrong.

So, the one-time expenses associated with the PDLI deal, that 50 million, is it -- am I right in believing that your R&D line would have been $50 million lower were it not for that recognition?

Correct.

And your cost of goods would have been $25 million lower were it not for the write off there?

No, let me just touch that one quickly.

The ZEVALIN impairment was split between cost of sales and SG&A.

So in the cost of sales line there was $12 million, and in the SG&A line there was 13.

And that's simply because some of it was inventory that we now believe based on the revised projections around the shelf dating issues, and then secondly, the remainder is writing off intangibles that related to patents as well as manufacturing technology that we have accessed.

So -- but they have a short life and so that's why the short term sales projection is what's critical.

Craig, I know that you're not in the world of accounting for dummies, but anyway, I apologize if that was confusing.

I hope that helps.

Bill Tanner, Leerink Swann.

Thanks.

Maybe a question for you, Peter.

You did mention that modeling, you guys are planning on TYSABRI launch in mid next year with a minimal contribution.

I'm assuming that you're assuming that the drug is going to be commercially available -- or to be sold, and not just on the compassionate use basis?

Correct.

That's correct.

We -- obviously, we have to assume something for modeling, so what we're doing right now is just saying, Look.

What are our expectations?

What's a reasonable thing to work with?

And so we have made those assumptions that in fact TYSABRI would be back in the market and sold in the U.S. in mid 2006 and then likewise launched in the European market, and obviously in Europe -- obviously you go country by country so take that with a grain of salt, but in the second half of 2006.

Quite frankly, we're early in the process, as you know where we are in terms of submitting data to the FDA and we have an ongoing discussion with the EMEA, so -- but this is our best estimate at this point, and that's what we felt was appropriate for our guidance.

Importantly, as I mentioned, we think that probably TYSABRI would be a modest contributor to revenue next year, and quite frankly, with the development costs that we expect, we don't think it's a big contributor to the bottom line.

So even if those dates change a little bit, I'm not sure that would dramatically change our outlook.

Eric Schmidt, SG Cowen.

Good afternoon.

Peter, I'm also having a little difficulty understanding the guidance for '06 in terms of expenses.

If I just do the exercise of taking out 50 million from R&D and 13 million from SG&A in Q3 '05, and then carry that kind of organic expense rate forward into '06, the assumption that the cost savings at least offsets the in-licensings that you're going to see, I'm coming up with dramatically lower expenses and higher earnings than you guided to.

So where's my math wrong?

Yes, no, that's a fair -- very fair question.

A couple additional items, though, that I think we've talked about that you should be incorporating into your thinking for expenses next year.

First, we will be launching -- we're assuming that we're going to be launching in RA for RITUXAN which would be a separate sales force on that side, and we'd be building that up as we finish up this year and going into next year.

So that's one additional cost.

Secondly, we would be relaunching TYSABRI in the U.S., which is a higher level of marketing and sales activity certainly than what you're seeing in the third quarter, where we're really completely shut down in terms of TYSABRI activity.

Additionally, we would be launching and marketing TYSABRI in the European arena, which would be a higher level of activity over there and very exciting activity obviously for those markets who have not even yet seen TYSABRI, so there'd be a lot of communication and information sharing would be critical.

Those would be three pieces.

And then finally, at this point, as Burt highlighted, we have no clinical trial activity going on for TYSABRI.

And so you have to figure that, Okay, right now we're at a pretty low run rate relative to the R&D clinical costs -- almost zero probably, for TYSABRI, but yet as we go back and we work with the agencies, clearly there'll be some requirements to continue dosing patients and monitoring them and all the things that you'd normally expect to have as part of the discussion with the agencies and that would increase our clinical costs as we go through next year for TYSABRI.

I think those would be the major drivers of why the OpEx would be -- I'm sorry, operating expense would be higher than maybe a Q3 trend per se.

So perhaps maybe I should have clarified that before, but I think that'll help get to the right outlook.

May-Kin Ho, Goldman Sachs.

Hi, a question on TYSABRI.

When you relaunch the product, assuming it's approved, how will you position it?

Because I imagine the risk is higher when it's used in combination with AVONEX, but knowing the risk profile, one would imagine this would be more appropriate for the more advanced patients or breakthrough patients?

Hi, May-Kin, it's Burt.

I'm not going to speculate at this point on the -- exactly what the usage and indication label will say.

We have identified some risks associated with TYSABRI that hadn't been anticipated in the original label.

But we do have to also say that now that we've completed this very comprehensive evaluation, we haven't discovered any more case of PML or any other unique insight into risks that we didn't know the day March 1 or so that we made the announcement.

So issue one is that the risk is out there, but pretty limited in terms of how many cases and how expansive the risk appears to be.

Second of all, what we do know is that this remains a remarkably effective drug with tremendous activity both on relapse rate, MRI, and disability progression.

So it's an important drug for patients with a life-long disabling serious disease.

I believe that the risk benefit profile of this drug still meets the needs of patients -- of a broad spectrum of patients with multiple sclerosis.

In terms of the specific usage statement, I'm just going to wait until we've completed our discussions with the FDA and EMEA.

Alex Hittle, A.G. Edwards.

Good afternoon.

I have a question about the business development expenses that you're talking about taking next year, the 200 million.

Along two lines.

One is what kind of expansion in the pipeline do you really see that turning into?

And second, how much of that 200 million is going to flow out the door, and how much of that 200 million is basically consumed by what must be sort of heightened due diligence efforts on the part of the staff that is currently employed at Biogen Idec?

Alex, let me just first answer part of it.

Maybe someone else will jump in as well.

But first of all to the question of what we expect the $200 million to be constituted of, it could be a couple things.

One is it could be up front payment or it could be if a program was brought in early in the year or mid year it could be the additional sharing of costs in that collaboration as we go through the year, or if it's an in-licensing the cost to actually step up and start carrying the cost of the clinical trial.

In terms of -- additionally, obviously, you have some due diligence and so forth, but I think that's not really a major cost relative to $200 million.

I mean, we obviously have very active due diligence efforts as we look at programs but it doesn't add up to that much probably.

So it's primarily the additional programs we'll be bringing in, with either up front milestones or new clinical costs that we'd be sharing as soon as we sign the deal and bring it in.

In terms of flowing out the door or not, it's a fair point in that once we bring a program in, obviously, we then start participating in the sharing of the cost, but we also start taking on some of the work, most likely -- not always, but most likely in some of the programs.

And so I'm not sure if that's what you meant by flowing out the door, but obviously, yes.

Some of that $200 million will represent additional costs, particularly let's say in Burt's area, or in the research area and manufacturing area as these groups step in and start getting involved in these programs.

That's not always the case.

I mean, in some cases our partner will be perhaps carrying the load for particular molecule and we may just be sharing the cost.

Other cases we may be stepping up and helping with the manufacturing, and the technical development,t or the clinical activity.

It's hard to tell until you actually get there.

This is Jim.

It's -- it's very hard to predict because with each deal it comes in a different shape and form, whether that's an in-licensing, a partnership or an acquisition.

So it's hard to predict going in.

It's likely to be lumpy as it goes through the year because it will flow when the deals get done, and those -- they happen when they happen.

They take some time to do.

And whether it's 200 or more or less, I think remains to be seen.

I think the main point around a number like 200 is that is a major statement to make internally to people to say this is one of our core parts of our strategy, and externally that we do have the -- we've got the money in terms of cash as well as P&L space to be active and a good partner.

Mark Karvosky, Piper Jaffray.

Hi.

Thanks for taking the question.

A question for Burt just on BG12.

Could you remind us of the design of the phase II trial?

And then, looking forward, what's the bar that's kind of been set to move this into phase III for MS?

Well, it's one of our typically well-designed comprehensive phase II dose ranging studies in multiple sclerosis with MRI and relapse rate as the important endpoints.

The bar to take this forward into phase III, I really don't want to discuss with you at this point except to say that obviously we understand this space pretty well.

I think we can estimate the unique value of an oral agent in this space as long as it has an efficacy and safety profile that we think is -- makes it useful to clinicians and patients.

So we'll be mixing all of that together along with what we anticipate as rigorous results from a well-constructed phase II trial.

Operator, we have time for about two more questions.

Steve Harr, Morgan Stanley.

Hi.

This is actually Kevin Peung [ph] filling in for Steve.

Two questions, both TYSABRI-related.

How much additional commercial infrastructure is needed overseas in Europe for a TYSABRI launch next year?

And second if you could provide any clarity surrounding I guess your current plans or current thoughts on filing TYSABRI in Crohn's disease?

Okay.

Why don't I take the first one, and Burt can take the second one if that's okay, Kevin.

So internationally obviously we do have an MS organization sales force, the whole organization established throughout Europe and so forth.

So there is obviously some leverage from that and that's clear.

Although we haven't really articulated yet to what degree we'd be adding resources, but you very well can expect that we would be adding infrastructure to support a launch of a whole new program like this, just to expand the presence and so forth.

So we haven't really broken that out yet.

Some of that might depend a little bit on kind of as we develop the strategy right now as we're going into the budget season and so forth, but there will be increases.

Perhaps as we get into the year and get closer to that launch point I can give you some breakdowns of that a little more clearly.

I think you can relate back to kind of how we launched in the U.S.

We did add significantly to the sales force presence in the U.S.

We had -- in the U.S. it was unique -- a little bit unique, we had infusion specialist organization as well.

That may not be as important going forward, but we will see.

And in Europe, obviously, it's a slightly different market, so that may not apply.

But there will be a ramp up, and obviously -- only part of the cost is the actual sales infrastructure.

There's also a lot of communication on a product like this at a launch where you have to make sure that people really do understand the label, the protocols, how to use the drug and obviously in the U.S. we've covered a fair bit of that, but that'll be to be renewed in the U.S. because it's based on the current review of the safety data and the two-year data.

But in Europe it'll be new, and so obviously that'll require a lot of communication and does -- that can be expensive as well for conference call calls and things.

Burt, any comments --?

Yes.

So very quickly on the Crohn's -- strategy around Crohn's.

Obviously we are working closely with our colleagues at Elan to figure out what to do here.

But in general I would say we will entertain conversations with regulatory authorities in the U.S. and Europe on the Crohn's data.

But what we don't want to do is in any way, shape or form slow down the already active review process for TYSABRI in MS in U.S. and Europe.

Our last question?

Bret Holley, CIBC World Market.

Yes, hi.

Burt, I have a question about TYSABRI and RA.

Did I hear you right that you were going to halt the in development in RA, and if so, when are we going to see that data, did you say.

Yes, so you heard me correctly.

We -- the -- our evaluation and our colleagues' at Elan's evaluation of the results from the truncated RA study is that, despite being truncated, we believe that the data are adequate to conclude at this time that activity in RA does not warrant further development.

Exactly when those results will be presented or published, I actually don't know.

I'm sure sometime within the year.

I don't mean between now and the end of '05, but I would say within a year cycle from the announcement of the results.

Thank you very much.

That was our last question.

Okay.

Thanks.

I appreciate everybody attending the conference and holding out for a little over an hour, and we look forward to talking to you in -- on the Q4 call and early next year.

Thanks.

Ladies and gentlemen, that concludes today's Biogen Idec third quarter earnings conference call.

You may now disconnect.