Good morning. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Idec First Quarter 2011 Earnings Conference Call. [Operator Instructions] Thank you. I would now like to turn the conference over to Ms Kia Khaleghpour. Ma'am, you may begin the conference.
Thank you, Regina. Welcome to Biogen Idec's First Quarter 2011 Earnings Conference Call. I want to thank all the participants on the line for joining us at this early hour. While the timing isn't perfect, it is intended to accommodate the active agenda across the biotech sector.
Before we begin, I encourage everyone to go to the Investors section of biogenidec.com to find the press release and related financial tables, including a reconciliation of the non-GAAP financial measures that we'll discuss today. We have also posted slides on our website that follow the discussions related to today's call.
As usual, we'll start with the Safe Harbor statement. Comments made in this conference call include forward-looking statements that are subject to risks and uncertainties. Words such as believe, expects, may, plan, will and similar expressions are intended to identify such statements. Actual results could differ materially from our expectations, and you should carefully review the risks and uncertainties that are described in our earnings slides, earnings release and in the Risk Factors section of our most recent annual and quarterly reports filed with the SEC. We do not undertake any obligation to publicly update any forward-looking statements.
Today on the call, I'm joined by Dr. George Scangos, Chief Executive Officer of Biogen Idec; Dr. Doug Williams, Executive Vice President of Research and Development; Dr. Al Sandrock, Senior Vice President of Development; Dr. Francesco Granata, Executive Vice President of Global Commercial Operations; and Paul Clancy, Executive Vice President of Finance and Chief Financial Officer. Now I'll turn the call over to George.
Okay, thanks, Kia. And thanks to all of you for joining us this morning. We're off to a great start for 2011, and I'd like to begin today's call by taking a moment to recap some of the first quarter accomplishments and results. I'm particularly pleased with 3 areas where we continue to perform well. First, our current business is solid. As you'll hear in a few minutes, our products continue to do well, and our financial performance is strong. We're continuing our transformation into a lean, aggressive, focused organization. And as far as our R&D, I think the reinvigoration of R&D is underway. And that's evidenced by achieving a number of accomplishments this quarter.
So let me start with some of the R&D accomplishments. So last week, as you know, we were pleased to announce top line results from the DEFINE study. That's the first of 2 registrational trials for BG-12, our investigational oral compound for relapsing-remitting MS [multiple sclerosis]. There's been a lot of positive reaction to the results and the prospect of a potential new treatment option for people with MS. Since that announcement, we've received a lot of inquiries around 3 topics: First, the magnitude of the DEFINE clinical results; second, our economic commitments for BG-12; and third, the intellectual property protection for BG-12. So accordingly, I'd like to take the opportunity of the call here to provide some additional color in all of these areas.
So let me start with the data from DEFINE. The results for the BID and TID doses were generally similar and were all statistically significant versus placebo. Therefore for simplicity, today, I'm only going to discuss the BID results now for both the primary and secondary endpoints. And I'm going to read this slowly so that they have a chance to sink in.
For the primary endpoint, which was the reduction of the proportion of patients who relapsed at two years, the BID dose showed a decline of 49% versus placebo. The reduction in annualized relapse rate of the BID dose versus placebo was 53%. The reduction in the progression of disability as measured by EDSS [Expanded Disability Status Scale] was 38%. For the MRI measures, the reduction in the number of new or newly enlarging T2 hyperintense lesions was 85% and the reduction of galodinium (sic) [gadolinium] enhancing lesions was 90%.
These are top line results, and we don't yet have detailed safety information. But I can say that the initial data from the trial also showed that BG-12 demonstrated a favorable safety and tolerability profile consistent with what we've seen in the published Phase II study of BG-12. We're obviously very excited about these results, and we're looking forward to further analysis of the data from this study as well as the readout from our second Phase III trial, CONFIRMED, in the second half of the year.
As to the economic obligation for BG-12, we acquired the compound and Fumaderm in connection with our acquisition of Fumapharm AG in 2006. As part of this acquisition, we agreed to make an additional payment of $15 million upon the achievement of regulatory approval for BG-12 in MS in the EU or the U.S. We also agreed to make additional payments when the cumulative net sales of Fumapharm products reached $500 million, $1 billion and then each $1 billion increment thereafter up to $20 billion. A detailed explanation of the payment schedule is provided in the appendix of the slides for this call.
We've also gotten many questions about the intellectual property for BG-12. And so there are issued patents in both the U.S. and the EU that are relevant to BG-12. In the U.S., we're entitled to the five-year data exclusivity given to new chemical entities, and we own a patent covering the administration of dimethyl fumarate, or DMF, an active ingredient in BG-12, to treat MS and other autoimmune diseases. This patent expires in 2020, with a possible term extension to be determined.
In the EU, we have a patent covering our BG-12 formulation and the method of treating MS and other autoimmune diseases with the formulation that expires in 2019 and which may also be eligible for patent term extension in some countries. There's some uncertainty around achieving data protection in the EU. Specifically, we believe we're entitled to 8 years of data exclusivity and 2 years of market exclusivity because we believe BG-12 is a new active substance under EU law.
However, the CHMP [Committee for Medicinal Products for Human Use] has recently taken a position that a single active substance may not qualify for a new active substance status if it was one component of a previously approved multi-component product. Other companies have challenged this position in litigation that's still ongoing.
Fumaderm is approved for psoriasis in Germany and contains DMF, the active ingredient in BG-12, as well as additional monoethyl fumarate cells. We're closely watching this evolving landscape and we'll continue to address this issue. We believe we will be entitled to data exclusivity, and we'll aggressively make this point as we move the compound forward.
Lastly, at the end of last week, the FDA notified us that they've rescinded the fast-track designation for BG-12. This is not unexpected since there now is an oral treatment available. And I can say that if the CONFIRM data are similar to the DEFINE data, we'll certainly seek priority review upon NDA [Drug Application] filing.
Let me now turn to TYSABRI. As you know, we filed amendments with the EU and the U.S. to include anti-JC virus antibody status as a third factor to help stratify the risk of PML [progressive multifocal leukoencephalopathy] along with prior immunosuppressant therapy and duration of treatment, which are already in the label. And I'm happy to say that as we announced earlier this week, the CHMP recommended adding information about JC virus antibody status to the label in EU. The combination of the test, which is now available in the EU, and the inclusion of the antibody status on the label are very positive steps that will provide the tools that physicians and patients need to choose an appropriate MS therapy. We believe that these tools will allow the potential of TYSABRI to be unlocked and may lead to many more patients being able to have access to the benefits of TYSABRI with the risk that they'll be able to define and understand.
Concurrently, the CHMP also adopted a positive opinion for the 5-year renewal of the marketing authorization for TYSABRI. The FDA decision on our sBLA [supplemental Biologics License Application] filing for the inclusion of the anti-JC virus antibody status to the U.S. label continues to be expected in the second half of the year. Earlier last week, the FDA did approve additional data to be included in the U.S. TYSABRI prescribing information, outlining post-marketing incidence rate of PML by treatment duration. Importantly, the estimated incidence of PML for 1,000 patients for up to 24 infusions is now stated as 0.3; for 25 to 36 infusions, as 1.5; and for 37 to 48 infusions, as 0.9.
There were a number of other very positive events in our R&D programs recently, and Doug Williams will cover those in more detail in a few minutes. And I want to briefly now turn to our financial performance. Basically, our current business is very strong. We have 3 blockbuster products that are performing well despite the competitive landscape. We have good cash flow, and we finished the quarter with an overall strong financial performance. Overall revenues grew by 9% this quarter over Q1 2010 while product revenues grew by 10%. And our non-GAAP diluted EPS was $1.43, up 32% versus Q1 2010.
In summary, Q1 was a great kickoff to 2011 and finds Biogen Idec a leaner, more aggressive and more efficient organization that's focused on the highest payoff activities. Our R&D organization is reenergized and well underway to capitalize on some very promising opportunities. And our commercial organization is firing on all cylinders. I will now hand the call over to Doug Williams, our R&D head, who will update us on the R&D pipeline and the changes he's made to the R&D organization. Doug?
Thanks, George. This is a very exciting time at Biogen Idec, and it's a privilege to be part of a tremendous R&D team. Biogen Idec has great science and technology and a team of individuals committed to making the company the leading biotech enterprise in the industry. That's not to say there isn't work to be done to improve our productivity, but I believe that we have a solid base from which to build a world-class R&D capability.
As George mentioned, last week, we announced positive top line data results from DEFINE, the first Phase III study of BG-12 in relapsing MS. I'd like Dr. Al Sandrock to share with you some of the rationale for the design of the study. Al's done a tremendous job of leading this program, along with our talented internal team of dedicated neurologists and scientists. And with that, I'll pass the call off to Al.
Thank you, Doug. It certainly does feel great to share with our shareholders the progress we've made with our oral MS program, BG-12. It really was a team effort, a dedicated team of scientists, neurologists, clinical operations people, statisticians and many others that have contributed to this moment. As you recall, the DEFINE study was a 2-year, randomized, double-blind, multi-centered, placebo-controlled dose comparison study in over 1,200 relapsing-remitting MS patients. As George mentioned, both doses met the primary and all secondary endpoints with statistical significance compared to placebo.
In the DEFINE trial, 2 endpoints assessing relapses were included, the proportion of relapsing patients at 2 years as the primary endpoint and annualized relapse rate as the secondary endpoint. The second Phase III study of BG-12, CONFIRM, is also a 2-year, placebo-controlled dose comparison study, which includes glatiramer acetate as a reference comparator arm.
CONFIRM's primary endpoint is reduction of relapses at 2 years. Through the study endpoints for both DEFINE and CONFIRM, we will have a full spectrum of information regarding the effect BG-12 has on relapses. In addition, both trials were designed to measure the effects of BG-12 on EDSS, an extremely important endpoint for disability progression. Top line data release for CONFIRM continues to be expected in the second half of 2011, and we look forward to presenting more details from the DEFINE study in an upcoming medical meeting later this year.
BG-12 is the only compound currently in clinical trials for the treatment of MS that has been shown to activate the Nrf2 transcriptional pathway, a central mechanism of cellular defense against oxidative and metabolic stress. This pathway has shown anti-inflammatory properties in clinical trials and, experimentally, has demonstrated no protective effects. By increasing the activation of the Nrf2 pathway, BG-12 may prevent further cell damage and tissue loss in MS patients that can lead to symptoms of the disease. With that, I will pass the call back to Doug.
Thanks, Al. Let's move on to a discussion of the rest of our pipeline progress since our last earnings call. Last week, we shared important data on our neurology franchise at the American Academy of Neurology Annual Meeting where we demonstrated the strength and depth of our neurology pipeline with 55 company-sponsored platform and poster presentations. At AAN, we presented data on the efficacy of TYSABRI, where treated patients were more likely to have improved EDSS score over time versus a worsened score, lower annualized relapse rates and significant cognitive improvements in MS patients. AAN was also a great forum for us to present data on our TYSABRI risk stratification efforts. We discussed the role of prior immunosuppressant usage, TYSABRI treatment duration and anti-JCV antibody status in stratifying patients for their potential risk of PML. To date, based on an analysis of archived 3 PML samples from patients, 27 out of 27 TYSABRI-treated related PML cases have tested positive with the JCV antibody assay. We're committed to continuing to invest significant time and resources to evaluate additional risk factors for TYSABRI so that physicians and patients can make informed benefit-risk decisions.
Earlier this quarter, we made important progress on our JCV antibody risk stratification efforts. We obtained a CE mark for the JCV antibody assay in Europe. In the U.S., we're planning to make the assay available as a laboratory-developed test, or LDT. We expect to have the commercial assay under the CE mark broadly available in Europe by May and in the U.S. through the LDT process within the coming months. Francesco will provide you with additional details.
During the first quarter, we also made progress on all of our registrational trials. We continue to make good progress on advancing and developing our clinical pipeline. Updates on our neurology pipeline include, initiation of patient enrollment in EMPOWER, the global Phase III study of dexpramipexole for treatment of ALS or Lou Gehrig's disease. We've agreed with the FDA on a special protocol assessment, or SPA, for the design of this trial. We believe that dex [dexpramipexole] has the potential to provide a significant advancement for the treatment of patients suffering from ALS. Dex is a novel oral compound that's shown neuroprotective properties in multiple experimental and preclinical studies. In a 2-part Phase II study, dex showed a dose-dependent trend towards slowing functional decline as measured by the ALS Functional Rating Scale across treatment groups over a 12-week period and a trend toward improving overall survival over a 6-month period. Given the nature of the disease and the limited treatment options available, there's a pressing need for novel and effective therapies. Currently, there's only 1 approved treatment available to patients with at most a modest clinical benefit. We expect to fully enroll this trial by year end, with top line data available in 2013.
We expect to finish enrollment and advance the registrational study of PEGylated interferon by year end. With a 1-year treatment duration and annualized relapse rate as the primary endpoint, we expect top line data to be available in the first half of 2013. In the second half of this year, we expect to present top line data from SELECT, the first of two registrational trials for daclizumab. This drug targets the pathogenic activated T-cells in MS through a novel mechanism, and Phase II studies have shown solid efficacy and promising safety with the convenience of once-monthly subcutaneous dosing. We continue to work closely with the EMA [European Medicines Agency] during our appeal process for prolonged-release fampridine tablets to address their concerns with the goal of making this important medication available to MS patients in Europe. We'll update you when the procedure concludes. Additionally, we've withdrawn fampridine application from SwissMedic.
Finally, I'm pleased to say that we've received positive opinion from the CHMP and authorization from Health Canada for the AVONEX PEN. The PEN delivery will make for a better patient experience with AVONEX, one of the most trusted MS therapies available. The FDA required additional information in our filing, and we anticipate that the updated file will be approved in the first half of next year.
Moving on to our hemophilia programs. We continue to expect to complete enrollment in both B-LONG and A-LONG studies in 2011 and for data readout in 2012. Earlier this week, we also received FDA approval for RITUXAN in combination with corticosteroids as the new treatment for adults with Wegener’s Granulomatosis and Microscopic Polyangiitis, 2 severe forms of vasculitis. While these are relatively small indications, the need is significant, and it reflects the commitment that we and our partner, Genentech, have for following the science and developing the drug for as broad a group of patients as possible.
Along with substantial progress in our late-stage clinical programs, we've also taken steps to thoroughly evaluate our R&D organizational structure and our earlier-stage R&D portfolio and technology platforms. Our vision for the R&D organization is to make us the envy of the biotech industry in terms of pipeline depth and speed of advancement of our pipeline. Our performance over the last several years has not been at this level, and we took several steps in the last few weeks to restructure and create a solid base for future strengthening and growth. We've restructured our R&D group to more closely align resources with high-priority programs. Dr. Al Sandrock has been appointed as Senior Vice President of Development, with responsibly for clinical programs in neurology and immunology. This increased scope of responsibly for Al reflects a recognition of his accomplishments over the last several years and his skill as an architect of science-based development programs.
As part of these reviews, we phased out several early-stage programs in immunology and neurology and reallocated people and resources to other higher-priority projects. These were difficult but necessary decisions that needed to be made. These decisions were not necessarily based on the quality of science but on an assessment of whether the programs had sufficient differentiation and likely timing of market introduction to be competitive. All of the remaining Phase I and II candidates are potentially transformational drugs addressing unmet medical needs in areas of strength for Biogen Idec.
We have 4 very exciting Phase I and II programs that we prioritize and can fully resource. These include the anti-LINGO program for remyelination in all forms of MS, TWEAK for lupus nephritis, the anti-CD40 Ligand antibody for general lupus and neublastin for neuropathic pain. We decided to advance neublastin after further review of that data. We recently filed the IND [Investigational New Drug Application] for our anti-beta-amyloid antibody, known as BART, for treating Alzheimer's disease. All of these candidates have significant potential to address unmet medical needs with a high degree of differentiation. These program decisions also create some capacity to bring in potentially transformational drugs and new technologies from external sources. We'll also apply the same rigorous criteria for pursuing emerging external opportunities that are in line with our strengths in neurology, immunology, as well as hemophilia and hematology.
Our current progress in the changes we implemented over the last 2 months created a solid basis to grow the portfolio and position the R&D organization to achieve our aim of being the premier R&D company in the industry. With that, I'll now pass the call to Dr. Francesco Granata, our Executive Vice President of Global Commercial Operations.
Thank you, Doug. And good morning everyone. As George mentioned at the start of the call, our commercial performance started the year with a very positive momentum. Global AVONEX and TYSABRI patient share and unit growth was positive. For quarter 1, we achieved 10% global sales growth and 10% unit growth versus Q1 2010. Both AVONEX and TYSABRI performed well. These are the result of a stronger and more focused global commercial infrastructure. Because we have added more resources where they were needed and eliminated unnecessary layers of management, we believe that our journey to success is both structured and sustainable.
Starting with AVONEX. Our performance in the U.S. has continued to hold. We have now had 4 consecutive quarters of unit sales around the 166,000 to 170,000 range after several years of unit sales declines. And units has led quarter 1 2011 versus quarter 1 2010. For the first time in several years, despite the heavy competition in the market, I'm very pleased to report that AVONEX gained market share in the ABCRE market this quarter. Thanks to strong execution against the plans the commercial team began last year, we are making progress toward our near-term goal to put AVONEX back on a ABCRE market share growth trajectory. In the U.S., we further expanded the number of [indiscernible] in the field to increase share [indiscernible], focused the AVONEX and TYSABRI sales force to more efficient targeting and employed simple messaging focused on sustained disability impacts to maximize our efforts and address the evolving competitive landscape. In addition, the [indiscernible] that we put in place at the end of last year has now resulted in more awareness in key offices, increased conversion in prescription written to new patients starting therapy and improved patient compliance. We are also starting to see some improvement in the economic environment, which are allowing patients to move out of the free drug programs.
Outside the U.S., we are also seeing a very fast payback on our commercial structure investment. Where AVONEX unit demand grew by 14% as we held and started to improve share and the overall market continued to expand. In addition, our geographic expansion is paying off as we see quarterly revenue growth in the Asia-Pacific region of 31%. In Japan, market share is now in excess of 35%. And this is a milestone for the company, showing solid evidence that we could set up both a profitable and competitive business in Japan and set the stage for our future pipeline. Still the good news about AVONEX expanding the European Union and Canada, the commercial team is ready for a successful execution of the new offering to the market. This is a very important evolution for patients who are treating their MS with AVONEX. Data show that AVONEX PEN reduces injection pain and injection anxiety compared to manual injection. Through this new, convenient administration, AVONEX PEN has the possibility of improving patient independence and may even improve adherence.
Moving on TYSABRI performance. Quarter 1, 2011 worldwide in market, TYSABRI revenue was $349 million, an increase of 20% versus Q1 2010. And TYSABRI units increased 15% over Q1 2010 as well. We ended the quarter with 58,400 patients, an increase of 1,800 patients or 3% over Q4 2010. And we continued to gain market share despite more competition in the MS marketplace. Worldwide, net patient addition averaged 138 per week, up from 131 in quarter 4 2010. In the U.S., while we see moderating growth for new patients, we see increases in both new TOUCH forms submitted and patients graduated onto therapy this quarter versus the previous quarter, showing that demand of TYSABRI is strong. While STRATIFY 2 has impacted a number of patient discontinuation, it has had less impact than might have been expected given that more than half of the MS population will be expected to be JCV positive. There are now more than 20,000 patients who have been accrued into those certified trial. In those certified trial in the U.S. will suggest a tremendous amount of interest on the part of patients and physicians for more individualized care to this stratification.
Outside the U.S., the number of weekly net patient was strong this quarter. TYSABRI patients outside the U.S. grew by 6% and unit grew by 6% sequentially. In our emerging markets, TYSABRI also continues to grow. The launch of TYSABRI in India continues to grow as planned, and we achieved
an appropriate price in Brazil and Argentina, allowing for a 2-scale launch in these countries. As Doug mentioned, in the EU, the JCV commercial assay became available on a limited basis starting in March of this year through a partner lab. We have been working with a limited number of MS centers [indiscernible] to ensure the logistic of sample collection and delivery of assay result in working -- as a result is working smoothly. So far, the process has gone well. We expect broad availability of the commercial assay in the U.S., in the European Union sometime next month.
In the U.S., we are also finalizing plans to make the assay available to key diagnostic and reimbursement channels and expect broad commercial availability in the coming months. Our goal is to ensure that there are no barriers for patients and physicians to have access to the risks stratification tool they need to make an informed treatment decision. AVONEX and TYSABRI continue to hold their own even with competition from others. The overall market has modestly grown as a result of new entry and we expect orders to gain market share and meet the needs of a segment of the marketplace.
However, we believe that there is clearly room for both AVONEX and TYSABRI to continue to perform well and the safety and efficacy of both AVONEX and TYSABRI continue to make them a compelling option for patients. Strong, focused plan, along with strong local execution by the commercial teams around the world are paying off. And we've set the stage for a sustainable positive performance throughout the year. With that, I will now turn the call over to Paul Clancy, our Chief Financial Officer.
Thanks, Francesco. I'll start with our GAAP financials, which are provided in Tables 1 and 2 of the earnings release. Table 3 includes the reconciliation of the GAAP to non-GAAP results. The primary differences between our GAAP and non-GAAP results for the first quarter were $53 million related to the amortization of acquired intangibles and $17 million related to our restructuring. These were offset by $19 million of tax impact on these items. Our GAAP diluted earnings per share was $1.20 in the first quarter.
Now I'll move on to the non-GAAP P&L, which we believe better represents the ongoing economics of the business and reflects how we manage the business internally. Our non-GAAP diluted EPS was $1.43 for Q1, a 32% increase versus prior year. Total revenue grew 9% to $1.2 billion.
Q1 AVONEX worldwide product revenue was strong, growing 8% to $642 million. In the U.S. where AVONEX grew 11% to $387 million, inventory in the channel ended at just over two weeks, down from last quarter, which offset a slight favorable comparison with respect to shipping days. Internationally, AVONEX product revenue was $255 million, which was a 5% increase over Q1 2011 and benefited from some tender market sales in Russia. International AVONEX revenue includes a $7 million hedged loss in Q1.
As Francesco noted, TYSABRI worldwide in-market sales were $349 million in the first quarter, growing 20%. For Biogen Idec, we recorded TYSABRI product sales of $251 million in Q1, 15% increase over Q1 2010.
In the U.S., Q1 TYSABRI product revenue to Biogen Idec grew 21% to $73 million. Q1 international TYSABRI product revenue was $178 million, a 13% increase over prior year. The current quarter included a $1 million loss from hedging. Now moving on to the RITUXAN collaboration revenues. First, our share of the U.S. RITUXAN profits. U.S. RITUXAN sales were $722 million in the first quarter, up 5% versus prior year. Our profit share from that business was $222 million, up 11%. The profitability of the collaboration has been enhanced by the sales and marketing restructuring in late 2010.
Second, we received revenue on sales of RITUXAN outside the U.S. and in Q1, this was $32 million, down 18% as royalties from individual countries have expired. And third, in the first quarter, Biogen Idec was reimbursed $3 million for selling and development costs incurred related to RITUXAN. The result was $256 million of revenue from unconsolidated joint business for Q1, essentially flat with prior year.
Royalties were $26 million for the first quarter, a sequential quarter decline as we returned to a lower royalty tier from ANGIOMAX sales. We recorded $15 million of corporate partner revenue in the quarter, $11 million of this amount was due to a onetime cash payment received related to 2 discontinued oncology programs in connection with our restructuring initiatives.
Now turning to the expense line from the non-GAAP P&L. Q1 cost of goods sold were $103 million or 9% of revenues. Q1 R&D expense was $292 million or 24% of revenues. Q1 SG&A expense was $243 million, 20% of revenues, a reduction from our recent run rate as we're not incurring any meaningful expenses in this line related to the RITUXAN sales and marketing efforts. Continuing down the P&L, our collaboration profit sharing line totaled $74 million in expense for the quarter.
Other income and expense was a gain of $10 million in Q1. This includes a onetime $14 million gain on the liquidation of an investment which we viewed as no longer strategic. Our Q1 non-GAAP tax rate was approximately 27%, which is higher than previous quarters as our profit mix has shifted slightly more to the U.S. coming out of the restructuring last year. Let me also call attention to the noncontrolling interest line in the P&L. In Q1, we incurred a $10 million charge in NCI related to the ALS program Doug spoke of. Specifically, it amounted to $10 million for the successful initiation of the Phase III trial for dexpramipexole. In the first quarter our weighted average diluted shares were 245 million. During Q1, we repurchased 2.8 million shares for a total cost of $195 million. This was offset, however, by shares issued for equity-based compensation.
We ended the quarter with approximately $2.1 billion in cash and marketable securities, split approximately 60:40 between U.S. and outside the U.S. This brings us to our non-GAAP diluted earnings per share, which were $1.43 in Q1, representing a 32% increase over prior year.
We're maintaining our previously communicated guidance for full year 2011, which envisions the financial plan designed to capture the economic savings from the 2010 restructuring, optimize the performance of the core brands and invest behind a more focused pipeline, all to drive double-digit earnings per share growth in 2011.
Let me highlight a couple of financial modeling dynamics for the balance of the year. Over the last number of years, we've been capitalizing interest expense as a result of the continued build-out of our large-scale manufacturing plant in Denmark. It is likely in the near term we will look to mothball that plant if we determine that we don't need this capacity. The accounting impact of that decision will be to incur additional interest expense each quarter.
Additionally, we will incur a $15 million expense due to the initiation of IND on the BART program in the second quarter. This will be payable to Neurimmune and charged to the NCI line on the P&L. Now I'll hand the call over to George for his closing comments.
Thanks, Paul. This was quite a quarter. We've had good commercial results including increasing share for AVONEX in the ABCRE market for the first time in years and an increase in market share overall for TYSABRI, both of which led to a solid financial performance. We had very positive data for BG-12. We had a recommendation by the CHMP for an inclusion of JC virus antibody status as a risk factor for PML in the TYSABRI label in the EU. We had a positive CHMP opinion for the AVONEX PEN in the EU and marketing authorization from Health Canada. We had FDA approval for RITUXAN in Wegener’s Granulomatosis and Microscopic Polyangiitis, 2 severe forms of vasculitis. We dosed the first patient in the Phase III trial of dexpramipexole for ALS. And we continued our focus and our thoughtful resource allocation. All of that gives us a great start for 2011, and we're looking forward to a continued great year.
Let me just conclude by saying that these results are the result of a lot of hard work and dedication and talent of a lot of employees here at Biogen Idec. And I just want to acknowledge the contributions that those employees have made and thank them for everything they've done for the company. So with that, we'll close the call and open -- we'll close our remarks and open up the call for questions.
Thanks, George. Operator, we're ready to open the call for Q&A. [Operator Instructions] Operator, we're ready for your first question.
Our first question comes from the line of Geoff Porges with Bernstein.
Geoffrey Porges - Sanford C. Bernstein & Co., Inc.
Thanks guys for taking the questions. First of all, congratulations on the BG-12 data. That's very helpful. Just a quick question on TYSABRI. Could you tell us what proportion of patients on TYSABRI in the U.S. and Europe have already been tested for the JC virus? And then secondly, particularly in Europe, in those centers, what proportion of the new patient starts are coming from tested patients? Thanks.
Jeff, this is Paul. In quarters past, we're actually trying to keep the integrity of STRATIFY 2 trial in place. So we're actually not trying to disclose a lot of information on that. What I will tell everybody is STRATIFY 2 has had tremendous amount of interest. Obviously, between STRATIFY 1 and STRATIFY 2, we're at 20,000 patients enrolled, all of those in the United States. STRATIFY 1 is essentially 1,000, the balance of 19,000 is STRATIFY 2. So I mean, I think you can kind of get a sense for what is happening in the U.S. dynamics by that and put it against approximately the high 20,000 patients with respect to the number of patients inside the United States. Outside the United States, efforts are underway with respect to the gems [ph] but that is relatively small.
Geoffrey Porges - Sanford C. Bernstein & Co., Inc.
Our next question comes from the line of Eric Schmidt with Cowen.
Eric Schmidt - Cowen and Company, LLC
My congratulations also on BG-12 data. I was hoping you could address tolerability, specifically the dropout rate in Phase III and the compliance in label expansion defined? And then also, in the past, you kind of positioned this as an add-on to therapy. How are you now thinking about the role of BG-12 in the MS treatment paradigm?
Hi Eric, thanks for the question. We -- just turn to the Phase II data that's been published in Lancet. And as George noted, the results in Phase III are pretty comparable to what we saw in Phase II in terms of adverse events. And in the Phase II trial, roughly 10% of people discontinued due to adverse events, and they were flushing and upper GI-type symptoms. What we saw the Phase III trial is pretty comparable to what people are seeing nowadays in terms of dropout rates in Phase III trials. And I forgot the second part of your question.
The combination. Yes. Well, the combination study continues. It's good to have options. I think at this point, we're going to wait for the CONFIRM trial and evaluate all the different things we could do at that point with BG-12.
Our next question comes from the line of Mark Schoenebaum with ISI Group.
Mark Schoenebaum - ISI Group Inc.
First, I'd just like to say, Al, congratulations on this. I remember when you guys bought Fumapharm many years ago, people didn't believe in this in drug, and I was one of those. So congratulations.
Thank you, Mark.
Well, good to notice Al. We all do as well.
Mark Schoenebaum - ISI Group Inc.
Yes, I mean, that was a good call. I was wondering on the data, is there any way you can give us the actual numbers for ARR? That's Part A. Part B is maybe, Al, could you give some context about how these top line data that you reported today compare to other drugs on the market today? And also the data that you saw at AAN on Laquinimod. And then Part C is if BID worked as well as TID -- given all the data I've seen, there wasn't a lot of support for BID. Why wouldn't you try and cueday [ph]? Why don't you test the cueday [ph] at some point?
Wow, those were a lot of questions.
Mark Schoenebaum - ISI Group Inc.
But it was all a part of 1 question.
So the treatment effect, the reduction in annualized relapse rate compared to placebo was 53% with the BID dose of BG-12. And you're probably asking what the absolute annualized relapse rates are. I don't want to -- I mean, we're going to talk about this at a future meeting. I can tell you that when you see the results, they're pretty comparable with current sort of contemporaneous clinical trials in MS. So there are going to be no surprises there. In terms of comparison to other drugs, I hesitate to do that. There are no sort of head-to-head data. I told you what our relapse rate effect was compared with placebo, and you know what they are with the other drugs. So that's one common endpoint that you can use, perhaps, to get an idea. In terms of Laquinimod, the Phase III trial Laquinimod was positive on the primary endpoint. It was a fairly large study. And it showed statistically significant benefits using the primary endpoint, and I'm not going to say too much more about that. I think the trial was positive. In terms of cueday [ph], we did test cueday [ph] of BG-12 in the Phase II program. 120 milligrams once a day was less effective than the other two doses tested in the Phase II trial. And it was published in Lancet in 2009.
Our next question comes from the line of Rachel McMinn with Bank of America Merrill Lynch.
Rachel McMinn - BofA Merrill Lynch
Yes, thanks very much. I wanted to I guess clarify one thing on the primary endpoint and then also ask you a question regarding the next trial of BG-12. On the primary endpoint, when you say at 49% reduction versus placebo, is that an absolute or a relative number? And then on the BG-12 versus Copaxone study, I understand it’s a non-inferiority study, but just curious what percent difference you would need to see in order for the study to be superior? Thanks.
Well, so 2 questions. The primary endpoint was the proportion of patients who were relapsing. And it is relative to placebo. The 49% number that George gave you is relative to placebo. In terms of the -- what was the second question again?
The next trial.
The next trial.
Yes, the CONFIRM study, you mean. I think that the study was powered -- that arm was basically a power to give an idea about how similar the effects might be. It was not powered for non-inferiority or for superiority. And given the new data that we have, I'll have to go back and see what the power is to show superiority. I haven't done that calculation yet.
Our next question comes from the line of Robyn Karnauskas with Deutsche Bank.
Navdeep Singh - Deutsche Bank AG
It's Navdeep Singh in for Robyn. Congrats on the BG-12 data. Just a quick follow-up to maybe Mark's question. Anyway you can put the safety in terms of other drugs, in particular, maybe Laquinamod and Gilenya?
Let me give Al a break here. Maybe I can just jump in here. Laquinamod top line data, all we can tell you is the top line safety data, which is all that we have, actually, so far, and is consistent with what we saw in the Phase II trial. That's a published study in Lancet as Al said. So you can go back and look at that study. And there's nothing that jumps out looking at the top line data that makes this any different. We haven't -- these are recent data and we haven't fully analyzed everything yet, and so when we do, we'll publish that. But things look just like the Phase II so far.
It's important to say there's no safety signals in the data that we've analyzed thus far. We're still analyzing. And so far we're consistent with Phase II.
Our next question comes from the line of Gene Mack with Mizuho Security.
Gene Mack - Mizuho Securities USA Inc.
Thanks for taking the questions. Can you give us a sense of what the absolute reduction in relapses was, a? And then b, give us an update on what you’re thinking about in terms of the filing timeline for BG-12? Thanks.
Yes, as Al said, we are going to present the full data set at an upcoming meeting. Say terms of what the placebo rate was and what the treated arms were, we're going to reserve that for the meeting. You have the relative placebos. And the numbers we have, as Al said, are consistent with other recent trials that we've seen. So there won't be any big surprises there. In terms of filing date -- everybody seems to get in 2 questions in 1, good job. The filing date, we have the second trial to read out later this year. And of course, once we get that trial, assuming the data are consistent with what we are seeing now, we will file as quickly as possible, and we anticipate filing early next year.
Our next question comes from the line of Ravi Merogi (sic) [Mehrotra] with Crédit Suisse.
Ravi Mehrotra - Crédit Suisse AG
Thanks for taking my question. A question for Al. It looks like BG-12 has got a very interesting neuroprotective and atrophy profile. Could you remind us what basis that you have right now on what you could get going forwards? And more importantly, how you could leverage these into a label and commercially? Thank you.
Well, most of the data on neuroprotection comes from the animal experiment and in vitro experiments where we've demonstrated that you do see an activation of the Nrf2 pathway. And since that's a transcription factor in many of the genes that are regulated by Nrf2, we can see an increase in gene expression. When we're treating animals, we see anti-inflammatory effects. We also see protection of axon, as well as myelin from damage. And so we do believe that the drug does have very interesting neuroprotective properties, as well as anti-inflammatory properties. And we believe much of that emanates from the Nrf2 pathway activation.
Our next question comes from the line of Thomas Wei with Jefferies.
Thomas Wei - Jefferies & Company, Inc.
Thanks. I'll squeeze in 2 on BG-12. You didn't mention about brain atrophy, which one of your competitors has made a really big deal about. Should we assume that maybe that data isn't as strong for BG-12? And then also, can you just tell us whether or not the relapse rate reduction that you've seen here is consistent between the Indian and the non-Indian sites in the study? Thanks.
Well, our attention really was to just sort of stick to the top line results. We showed all the secondary endpoint results. Brain atrophy is one of the exploratory endpoints, one of many exploratory endpoints. We'll get to those next, and I would love to tell you about it. I would not assume that just because we didn't talk about it that the results aren't favorable. And in terms of looking at regional effects, we haven't -- that's a few steps down the line in terms of our analysis plan.
Our next question comes from the line of Mike Yee with RBC Capital Markets.
Michael Yee - RBC Capital Markets, LLC
Great, thanks. I offer my congratulations as well. With regards the BG-12, at least in Phase II, can you remind us how severe the flushing and GI is? Is it minor? More like irritation? Grade 1, 2? And then how does that change going into month 2? And is there any way to titrate BG-12 to reduce the tolerability? Could docs do that in the real world? Thanks.
Well, in terms of how minor they are, I mean, the vast majority of patients continue to take the drug even with these side effects. And in a way, these adverse events [indiscernible] for us. So they kind of go away on their own. And in fact, if you look at -- if you compare the incidence of these events between Phase I first month and the second month, you will already see quite a big reduction in the second month. And so -- and that was reported in the Phase II trial, and I can tell you so far, with our analysis of the Phase III program, we see something very similar.
Michael Yee - RBC Capital Markets, LLC
And the titration?
Not sure we need to do that. I mean, in a way, the titration is sort of done by taking the drug and the events kind of spontaneously diminish with time.
Our next question comes from the line of Yaron Weber with Citi.
Yaron Werber - Citigroup Inc
Actually, I want to sneak in 2 really quick questions. 1, any thoughts on formulation? Is there any way you can reduce the pill count maybe by coming up with a bigger tab or something like that? And then second, any thoughts about amending the combination study to go to BID from TID?
Well, we have no thoughts of amending the ongoing study. And George, do you want to handle the formulation?
Yes. Obviously, we're working on formulation and we do that all the time. We're very happy that the BID dose is very positive here. I think that was the key issue for us. And of course, we'll keep looking on the formulation as we go forward. And we have some interesting data. But we'll talk about that when we're ready.
The main intention of the combination study is to examine safety and tolerability. And in fact, that's the primary endpoint. And when you do that, it's always good to sort of look at the highest dose because if anything, when you go to a lower dose, that should improve. So since the main intention of safety and tolerability was just a quick look at efficacy by MRI, I think it makes sense to continue the trial as planned.
Our next question comes from the line of Geoff Meacham with JPMorgan.
Michael Ulz - JP Morgan Chase & Co
It's actually Mike in for Geoff. Thanks for taking the question. Just quick question for you on TYSABRI and discontinuation rates and kind of what you saw this quarter? And maybe you can put that in context to what you saw last quarter and sort of how you think about it going forward? Thanks.
Well, we have seen in the U.S., a increase in the discontinuation rate. We think that they are mainly driven by the fact that STRATIFY 2 physician get access to the JC virus status, and this has been driven more by the JC virus positive patients rather than as an external factor. We are seeing, however, in the last part of the quarter, some improvement in net patient adds, which together with the increasing TOUCH, a very solid TOUCH form and graduation, justify the continuing interest of the physician putting patients on therapy and also justify the fact that we've probably reached the point to STRATIFY 2 in which discontinuation has gone to stabilization.
Our next question comes from the line of Matt Roden with UBS.
Matthew Roden - UBS Investment Bank
Great. Thanks for taking the question. I want to add my congratulations on BG-12. The data are really impressive. The question was actually on hemophilia. What's your guys view on requirements for U.S. filing? Is there any chance or what are your expectations around potential synchronization of European filing guidelines with the U.S.?
I think based on the current guidance information from the EU, certainly, the pediatric study is a requirement for filing. We're making that assumption and planning for it. We're looking at ways to accelerate the initiation of the pediatric study to sync off, if you will, with the adult study so that we can file that as timely as possible in the EU. That's not a requirement in the U.S., so we will file on the basis of the adult data in the U.S. and conduct the pediatric studies once we're completed with that. That's sort of standard procedure. So that's the process going forward. We're still on target for accruing all of the patients in 2011 and being able to have a first look at data in 2012 and filing quickly thereafter as we can.
Our next question comes from the line of Jim Birchenough with Barclays Capital.
Jim Birchenough - Barclays Capital
Let me add my congratulations. Just another question on TYSABRI. In terms of thinking about what's happened in the U.S. with the reduction in new patient starts, do you expect the same dynamic in Europe initially upon launch of the JC virus assay? And also just wondering if you can quantify the opportunity for outflows versus inflows. We've got about 20,000 patients that are going to hit the 2-year mark over the next 12 months that could be candidates for outflows. I'm wondering if you can contrast that with how many new patients should come in that could benefit from the JC virus negative status? Thanks.
Yes. Let me correct one part of your statement, which is that we have not had a reduction in TYSABRI starts. We've had an increase in TYSABRI starts. And we monitor that very carefully in the U.S. with the TOUCH program. We've seen an increase in discontinuations. I would say it's very hard to quantitate [ph] this just talking theoretically now as more and more patients know their antibody status, you might expect positive patients who have been on for 2 years, some of them to come off. You might expect more negative patients to actually begin TYSABRI. And we think net-net over time, that will result in an increase in TYSABRI utilization. I think the one important thing that happened this quarter, which in most quarters would've been the focus of the most of the questions is that we actually did get approval from the EU to put JC virus antibody status as a risk factor on the label. Once that's on the label, once the test is available, both of which are the case now in Europe, then we can actually talk to physicians and talk to -- make it clear to physicians and patients what their individual risk is likely to be. And we think once that's the case, we can really achieve the potential of TYSABRI. So I think that is a huge positive event for TYSABRI in EU and hopefully, we'll have similar events for the U.S. later this year --
And if I may, the difference between the U.S. and Europe is that U.S. the patients has been involved through STRATIFY and the vast majority of patients were patients already in treatment with TYSABRI. So the test had been used mostly to take virus quality out when they reach the two-year landmark. While in Europe, the idea is that the test will be used to screen patients who have to go into therapy. This might allow more virus negative patients to go into therapy. Balancing probably the effect of the availability of the test on the JC virus positive.
Our final question comes from the line of Joel Sendek with Lazard Capital Markets.
Joel Sendek - Lazard Capital Markets LLC
Thanks a lot. I wanted to know if you can give us a little bit more detail about -- on fampridine on the appeal process, how it's going and when we might expect an answer? Thanks.
Yes. Look, it’s an ongoing regulatory process. We don't really want to comment on it. We are actively working on it. And we'll let you know when it's concluded. I think it's not appropriate to comment while it's still ongoing.
So that was our last question. Thank you for participating in today's call. You may now disconnect.
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