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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2014 - Q3
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Executives

Claudine Prowse – Vice President-Investor Relations George A. Scangos – Chief Executive Officer Tony Kingsley – Executive Vice President, Global Commercial Operations Paul J. Clancy – Executive Vice President, Finance and Chief Financial Officer Douglas E. Williams – Executive Vice President, Research and Development Alfred W.

Sandrock – Group Senior Vice President, Chief Medical Officer.

Analysts

Eric Schmidt – Cowen and Company Salim Syed – ISI Group Brian Abrahams – Wells Fargo & Company Geoffrey Porges – Sanford C. Bernstein Terence C. Flynn – Goldman Sachs Group Inc. Christopher Raymond – Robert W. Baird & Co. Matthew Harrison – Morgan Stanley Robyn S. Karnauskas – Deutsche Bank Securities Inc.

Ravi Mehrotra – Credit Suisse Ian Somaiya – Nomura Securities Co., Ltd. Matthew Roden – UBS Securities LLC Yaron Werber – Citigroup.

Operator

Good morning. My name is Tiffany and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Idec Q3 2014 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. (Operator Instructions) Thank you.

Claudine Prowse, VP, Investor Relations, you may begin your conference..

Claudine Prowse

Thank you, and welcome to Biogen Idec’s third quarter 2014 earnings conference call. 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.

Our GAAP financials are provided in tables one and two. Table three includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP better represents the ongoing economics of our business and reflects how we manage the business internally. We’ve also posted slides on our website that follow the discussions related to this call.

I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult our SEC filings for additional detail.

On today’s call, I’m joined by our Chief Executive Officer, Dr. George Scangos; Tony Kingsley, our Head of Global Commercial Operations; and our CFO, Paul Clancy; Doug Williams, our Head of R&D; and Al Sandrock, our Chief Medical Officer. Our traveling overseas will be available for Q&A. Now, I’ll turn the call over to George..

George Scangos

Okay, thanks Claudine and thanks to all of you for joining us today. Biogen Idec had another great quarter in which our products continued to perform well, and during which we achieved several key milestones.

Our underlying business remains strong as we enter into a period of anticipated growth, resulting from the introduction of several new therapies in MS and hemophilia. As Paul will review, third quarter financial performance was strong with 37% growth in revenues and 61% growth in diluted non-GAAP EPS year-over-year.

Our core multiple sclerosis franchise continued to capture share with an increasing number of patients using our therapies. We believe that our product portfolio of disease modifying MS products, including TECFIDERA, TYSABRI, AVONEX, and now PLEGRIDY truly differentiates Biogen Idec as a global leader in the treatment of MS.

TECFIDERA continues to gain market share in the U.S. and uptick has been strong in European countries, where it has been launched. TECFIDERA is the number one oral MS treatment in the U.S. and with many more launches to come around the world, we believe that it has the potential to be a market leader in many countries.

According to our estimates, TECFIDERA has treated over 100,000 patients globally within just 18 months of the U.S. launch, and only six months since EU approval.

This is an impressive milestone to reach and we believe that it reflects a broad recognition by physicians and patients that TECFIDERA is a unique product that offers strong efficacy with a favorable tolerability and safety profile along with the convenience of oral administration.

We would like to inform you that we have confirmed the case of PML in a patient being treated with TECFIDERA, who recently died from complications of pneumonia. Despite this project loss, we believe that the overall positive benefit risk profile of TECFIDERA remains unchanged.

The patient was treated with TECFIDERA for 4.5 years as part of the ENDORSE study. During the course of therapy, the patient experienced severe lymphopenia that lasted for over 3.5 years. Lymphopenia is a known risk factor for PML, and can be caused by a number of factors including treatments for MS, cancer, HIV.

The current TECFIDERA label includes warnings and precautions regarding lymphopenia. We’ve reported the case to the regulatory authorities and we’ll work with them to confirm that the language in our label provides patients and their physicians’ appropriate information regarding lymphopenia.

Moving on, AVONEX continues to be a very strong part of our business, and we believe that the Interferon franchise will continue to remain solid with the anticipated launch of PLEGRIDY in the U.S. With an attractive clinical profile and every two week subcu dosing, we believe that PLEGRIDY has the potential to be the leader in the Interferon class.

We’re optimistic about the future of TYSABRI as physicians continue to view this product as an important high efficacy treatment option.

We believe the high level of efficacy, the increasing understanding of the benefits of risk stratification, and the potential of TYSABRI and other indications such as SPMS and Stroke, all bode well for its long-term growth. We’ve now launched both of our hemophilia therapies, ALPROLIX and ELOCTATE, in the U.S.

Although, hemophilia is a new therapeutic area for Biogen, we believe that we’re well-positioned to succeed.

We’re the first-to-market with long-acting products and we bring tremendous expertise in Biologics Manufacturing and Process Sciences, and we’ve built a hemophilia organization comprised of many individuals with years of experience in the treatment of hemophilia for communicating the clinical benefit of ALPROLIX and ELOCTATE to physicians.

We continue to advance our R&D efforts. At last month’s ECTRIMS meeting, we highlighted our continued leadership in MS and ongoing commitment through advancing patient care. We presented several analyses of TECFIDERA’s positive real-world patient experience, as well as longer-term data from the ENDORSE study, demonstrating sustained patient efficacy.

ENDORSE data indicated a favorable overall safety profile, including data from some patients who were treated for up to 7.5 years.

Other presentations, including data reaffirming the powerful efficacy of TYSABRI, two-year data for PLEGRIDY demonstrating sustained efficacy and a compelling safety profile, full Phase III results for Daclizumab HYP, as well as supportive data for Anti-LINGO in acute optic neuritis.

Our pipeline continues to move forward, and we have strengthened our research and development capabilities even further by hiring a number of highly accomplished scientists. Chris Henderson has joined the Company as Head of Neurology Research.

Chris formerly was Professor of Neurology, Pathology, and Cell Biology, Director of the Stem Cell Initiative and Co-Director of the Motor Neuron Center at Columbia University Medical School. Richard Ransohoff also has joined as Vice President of Neuro-Immunology Research.

He previously was Director of the Neuroinflammation Research Center and Professor of Molecular Medicine at the Cleveland Clinic. Don Johns recently joined the Company to head our ALS initiative. Dr. John previously was Head of Neuroscience Translational Medicine at Novartis. And Olivier Danos recently joined Biogen Idec to head Gene Therapy Research.

He previously was Senior Vice President at Kadmon Pharmaceuticals and prior to Kadmon led the Gene Therapy Consortium at University College London. With these new hires, we’ve meaningfully strengthened our R&D capabilities in our areas of expertise and natural adjacencies. Now I’ll pass the call over to Tony..

Tony Kingsley

Thanks, George. Our commercial organization continued to execute and deliver strong results during the third quarter. Starting with MS, during the quarter Biogen Idec executed our MS franchise strategy, and as a result, we continued to grow our global MS market share. TECFIDERA’s launch trajectory in the U.S.

was sustained through the third quarter as this therapy continued to grow. TECFIDERA continue to capture share while attracting a broadening set of patients from the MS population. Year-to-date, our market research suggests that TECFIDERA is capturing approximately a third of all new patient starts and over 40% of patient switching therapies.

As a result, we estimate TECFIDERA’s market share in the U.S. ended the quarter in the high-teens. Outside of the U.S., the roll out of TECFIDERA continues and we’ve now secured reimbursement in 10 countries. In countries where TECFIDERA has been launched, patient uptake has been broad and strong.

TECFIDERA is now the number one prescribed oral MS therapy in Germany. TECFIDERA is also available in a number of other countries with limited reimbursement and we continue to expect to achieve full reimbursement across most of the major EU markets in 2015.

In a market where oral therapies are growing rapidly, our Interferon franchise saw 2% year-over-year revenue growth. Q3 revenues included AVONEX and early PLEGRIDY revenues from Europe. AVONEX continued to perform well within the Interferon therapies.

With our continued focus, we believe AVONEX has captured meaningful share of new patient starts and has exhibited strong performance within the evolving MS landscape. The PLEGRIDY launch in Europe is underway with the initial launch in Germany and Denmark.

Physician awareness of PLEGRIDY is high, and we believe the product’s efficacy and dosing make it an attractive option in the Interferon class. In Germany, we gained favorable reimbursement for PLEGRIDY. PLEGRIDY does not need to go through the AMNOG process and has been priced within the band of other Interferon 8018 therapies.

In the U.S., we are prepared for an early November launch of PLEGRIDY. We’ve completed sales force training, established contracts with specialty pharmacies, and prepared the financial and patient support programs for a successful launch. Now turning to TYSABRI. TYSABRI has continued to demonstrate strong performance.

Patient and physician demand for TYSABRI is solid as the therapy enjoyed its second consecutive quarter of positive net new patient adds. In the U.S. retention rates have improved the levels seen prior to the launch of TECFIDERA. We believe TYSABRI continues to be viewed by neurologist as a therapy of choice for patients requiring high efficacy.

In addition, we believe the TYSABRI has benefited from physicians’ improved understanding of patient management. The hemophilia launches are off to a solid start as we’ve said success is a new entrant as this market will require several things. Establishing Biogen Idec is a credible and committed partner to the community.

Activating early adopters among patients who see the benefits of the dosing schedule in prophylaxis regiments, educating hemophilia treatment centers and providing support services to ensure patients can get rapid access to products.

Our experience to date suggest we’re making good progress on all of these fronts and we believe, we can reinforce that positive experience to extend use over time to a broader set of patients. Starting with ELOCTATE, the patient and physician awareness for ELOCTATE is high in weeks into the launch.

We’re building strong relationships with customers in achieving our early goals of reach and frequency with hemophilia treatment centers or HTCs. As of the end of the quarter based on our data approximately 50% of all HTCs have prescribed ELOCTATE, suggesting broad interest in longer acting therapies across the market.

ELOCTATE is also widely available through specialty pharmacies and we’re pleased with the status of reimbursement at this stage. ALPROLIX is also seeing strong demand in broad interest from patients and physicians through the end of the quarter, approximately 55% of HTCs have prescribed ALPROLIX.

We believe that the early adopters initiating ALPROLIX have primarily been existing prophylactic patients and have been largely choosing the once weekly prophylactic dosing schedule. Acquiring additional patients with hemophilia will require sustained educational and promotional efforts, but we believe we have the ability to execute.

We continue to believe that reduced infusion frequency is the largest unmet need for the hemophilia community and then ALPROLIX and ELOCTATE have attractive product profiles to address this burden. Our goal is to become market leaders in the mid to long-term and we believe in the products and in our ability to execute.

So overall, we’re pleased with our performance. The commercial team is executing well. And we believe we are demonstrating the ability both to launch multiple therapies in parallel and drive continued growth in the base business. With that, I will turn the call over to Paul..

Paul J. Clancy

Thanks, Tony. Our GAAP diluted earnings per share were $3.62 in the third quarter. Our non-GAAP diluted earnings per share in the third quarter were $3.80. Walking down the P&L, I will start with revenues. Total revenue for the third quarter grew 37% year-over-year to approximately $2.5 billion. Global TECFIDERA revenue was $787 million in Q3.

In the U.S., TECFIDERA revenue was $638 million. Our best estimate at this time indicates that we ended the quarter with approximately 3.5 weeks of inventory in the channel, which includes specialty pharmacies and wholesalers. International TECFIDERA revenue was $149 million in the third quarter.

Germany represented approximately three quarters of our ex-U.S. TECFIDERA revenues. Interferon revenues including AVONEX and PLEGRIDY were $745 million. In the U.S., Q3 revenue increased 6%, compared to prior year to $482 million.

Outside of the U.S., Q3 AVONEX revenue was $260 million, a decrease of 6% compared to prior year due to increased oral competition. TYSABRI worldwide revenue net of hedging was $501 million in the third quarter, an increase of 25% over the same period last year. These results were comprised of $275 million in the U.S. and $226 million internationally.

There were number of items of note for TYSABRI. We’re now recognizing TYSABRI revenues at the full reimbursed price in Italy. In the U.S., there were 14 shipping weeks this quarter, compared to 13 in the same quarter last year, as TYSABRI ships on Tuesdays. And we benefited from the benefit of a timing of shipment in Brazil, a tender market.

Factoring in these items, TYSABRI still experienced double-digit revenue growth year-over-year. Moving to hemophilia, ELOCTATE revenue in the third quarter, first quarter on the market was $22 million. ALPROLIX revenue in Q3 was $25 million. Turning to our anti-CD20 franchise, RITUXAN and GAZYVA U.S. profit share was $271 million for the third quarter.

Royalties and profit share and sales of rituximab outside the U.S. were $20 million. The result was $291 million of net revenue from unconsolidated joint business. This amount includes an expense of approximately $21 million related to our share of changes in the recognition of the branded prescription drug fee in the quarter.

This fee was imposed to pharma companies as part of the Affordable Care Act. During the quarter, the IRS issued final regulations related to the drug fee which changed the recognition for accounting purposes from the period in which it is paid to when the sales occur.

The incremental charge this quarter represents the remaining expense for 2013 and year-to-date 2014 sales related to RITUXAN. Now turning to the expense lines on the non-GAAP P&L. Q3 cost of goods sold were $303 million or 12% of total revenue.

Q3 non-GAAP R&D expense was $416 million or 17% of revenues, which includes no new business development activity this quarter. Q3 non-GAAP SG&A expense was $569 million or 23% of total revenue. Included in this amount is an expense of approximately $90 million related to the previously mentioned Branded Prescription Drug Fee.

Our Q3 non-GAAP tax rate was approximately 25%. Weighted average diluted shares were $237 million, and we ended the quarter with approximately $3.2 billion in cash and marketable securities, of which 60% is in the U.S. In Q3, we incurred a $200 million liability as we reached $3 billion in cumulative sales of TECFIDERA and FUMADERM in the quarter.

As highlighted in our SEC filings, this relates to the TECFIDERA contingent payments, which are being recorded as an increase to goodwill, reported on the balance sheet when incurred and flowing through the cash statement when paid, but not impacting the income statement.

We expect to enter a period of meaningful TECFIDERA CVR payments to the former shareholders of Fumapharm. This brings us to our non-GAAP diluted earnings per share to a $3.80 for the third quarter, an increase of 61%. Now let me turn to our updated full year 2014 guidance.

We expect total revenue growth between 38% and 41% compared to prior year, unchanged from prior guidance. R&D expense is unchanged, yet expected to be at the low-end of the range of our previously communicated guidance between 20% and 21% of total revenues.

Our full year R&D forecast now includes approximately $50 million in the fourth quarter for business development opportunities, a decrease from prior guidance. This remains an important focus for the company and we continue to pursue high-quality early and mid-stage business development opportunities.

SG&A expense is expected to be approximately 22% to 23% of total revenue, unchanged from prior guidance. We anticipate non-GAAP EPS results between $13.45 and $13.55 and GAAP EPS to be between $12 and $12.10.

Our improvement in both GAAP and non-GAAP EPS is primarily due to our revised assumptions with respect to anticipated business development activity. I’ll turn the call over to George for his closing comments..

George A. Scangos

Neurology, Hematology and Immunology. We believe these guiding principles position us for long-term success. So in closing, I’d like to take this opportunity to thank our dedicated employees and the patients and physicians involved in our clinical development programs in helping us to make a deep difference to patients’ lives.

So thank you all for joining us this morning. And operator, we’ll now open up the call for questions..

Operator

(Operator Instructions) Your first question comes from the line of Eric Schmidt with Cowen and Company. Your line is open..

Eric Schmidt – Cowen and Company

Good morning and thanks for taking my question. Maybe for Tony or Paul, it’s on TECFIDERA. It looks like the growth on a quarter-on-quarter basis either absolute dollars or percentage basis, it looks a little bit lower in Q3 and, say over any of the last four, five prior quarters.

Was there anything sort of one-time nature that you want to call out or should we just assume that the drug is on a different sort of trajectory?.

Tony Kingsley

Thanks, Eric. It’s Tony. Nothing big on a one-time nature. Inventories are moderating, I think a little bit in the channel, and that’s always little, probably, difficult to predict exactly, but no look, we’ve always expected that TECFIDERA’s grow rate would moderate over time.

I think we’re seeing a natural case of that, but we’re very comfortable with the trajectory of the product right now. We’re very comfortable as we talked about the portion of new starts and switches that we’re getting. So nothing that’s significantly off plan from our standpoint, in fact I think we feel pretty good about the performance..

Operator

Your next question comes from the line of Mark Schoenebaum with ISI Group. Your line is open..

Salim Syed – ISI Group

Hey guys. This is Salim in for Mark. Thanks for all the information.

On the PML patient, George, can you just confirm if the patient had a history of being on TYSABRI, and then also I know you mentioned 100,000 patients have been treated with TECFIDERA, but how many of those patients have been on drug for same length of time that the PML patients, which I believe you said 4.5 years?.

George A. Scangos

Yes, okay. Look, this patient was not on TYSABRI, but this patient did have severe lymphopenia for 3.5 years, and we believe that the length of time on TECFIDERA is not the issue, the issue is related to lymphopenia, all right.

And so, we are treating this as a case that resolves from the lymphopenia, and there is a normal background rate of lymphopenia. There is a lymphopenia on the TECFIDERA label, a small fraction of the patients develop lymphopenia and that’s why a screening for the lymphopenia is on the label, it’s caused by lots of drugs..

Salim Syed – ISI Group

Okay..

Operator

Your next question comes from the line of Brian Abrahams with Wells Fargo. Your line is open. .

Brian Abrahams – Wells Fargo & Company

All right, thanks very much for taking my question. We’ve been getting feedback from physicians that PLEGRIDY could be an attractive option relative to other beta interferons.

So I’m just curious with respect to your marketing and commercial strategy to what extent are you going to be focused on trying to capture share from other interferons beyond AVONEX and how much weight do you think improvement, the improvements and convenience might happen since perhaps some of the pricing discounts going on from some of the competitors in that space? Thanks..

Tony Kingsley

Thanks Brian. It’s Tony. So look, we really like the product profile of PLEGRIDY, repeat the theory. Interferons as of last count still treat more than half of the patients in our markets. We think that’s declining for all the obvious reasons, but we think interferon remains an important part of the treatment set.

We think PLEGRIDY is the leading interferon and should take here from all the interferons that are on the market today. And I would point out when physicians look at it, they’re not going to look just at the convenience benefit, but they’re going to look at the total package of the efficacy and dosing schedule.

We think that’s a very attractive proposition. So, yes, we think we have the potential to take share of high frequency interferons..

Brian Abrahams – Wells Fargo & Company

Thanks..

Operator

Your next question comes from the line of Geoffrey Porges with Bernstein. Your line is open..

Geoffrey Porges – Sanford C. Bernstein

Thanks very much. Lots of questions, but perhaps the macro one, I’ll just go back to the issue of sequential growth. Paul, you top-lined if you net out the one-time items, it looks like sequentially it was about 3% and it’s been sort of in the 9% to 10% range for most of the past year.

Obviously that wasn’t going to be sustainable, but is this the new normal when you add up all the sort of bits and pieces and components of your revenue mix, is this what we should be thinking going forward?.

Paul J. Clancy

Geoff, as we move into 2015, we’ll use the end of the year call to give our expectations going into 2015, and obviously that will play into where we think 2016 goes as well. But I think that you’re painting a picture that’s probably less optimistic than we think. We certainly are in early stages in TECFIDERA for the European rollout.

The majority of European TECFIDERA sales are Germany. We’ve moved forward with reimbursement in a number of other markets, but ahead of us is a number of larger markets and most of those will be impacted as we go into 2015.

We think there is meaningful, still meaningful growth in TECFIDERA in the United States as we continue to penetrate docs and penetrate the marketplace. And certainly, we’re in very early days for the PLEGRIDY launch, which actually is ahead of us.

In the Unites States, it just started with a very small amount of sales in Europe and certainly in very early days in ELOCTATE and ALPROLIX that – well it’s hard to discern signal from noise early on, but the longer-term perspective that we have is that the marketplace will move to long acting hemophilia products, and we will play hopefully a meaningful role in that..

Operator

Your next question comes from the line of Michael Yee with RBC Capital Markets. Your line is open..

Unidentified Analyst

Hi, thanks. This is John on behalf of Michael Yee. On the TECFIDERA patient with PML, could you just remind us is this the first PML case in TECFIDERA and what was the JC virus status of the patient? Also going forward, how do you think this case maybe different or similar versus the prior experience with TYSABRI? Thank you..

George A. Scangos

Yeah, let me turn that question over to Doug Williams. Doug is in a different site..

Claudine Prowse

Operator, please unmute our colleagues overseas..

Operator

Your line is now open..

Douglas E. Williams

Can you hear me all right now, George?.

George A. Scangos

Yes, we can hear you, Doug. .

Douglas E. Williams

Okay, sorry about that technical difficulty. Yes, this is the first patient with PML on TECFIDERA that we’re reporting.

I think, as George pointed out, it’s important to note that this is a patient that as part of the ENDORSE study and was on drug for 4.5 years and for 3.5 of those years had severe lymphopenia, which we know is a risk factor for developing PML. And so, it’s an unfortunate circumstance that we believe is related to the lymphopenia.

Prolonged and severe lymphopenia is a risk factor. We have monitoring rules in our label right now for checking white count and we believe that that is the best way for physicians to manage patients going forward..

Operator

Your next question comes from the line of Terence Flynn with Goldman Sachs. Your line is open..

Terence C. Flynn – Goldman Sachs Group Inc.

Hi, thanks for taking that question. Maybe more just a high level one. So in the slides you guys had called out that a portion of the market growth since the launch of TECFIDERA was attributed to this increase in the commercially insured patients.

Just wondering what data led you to draw that conclusion and if you can try to quantify the benefit for us? Thank you..

George A. Scangos

Thanks, Terence. It’s an interesting point. Look, we think the market growth first and foremost is being – the increase is driven by oral to the marketplace. Specifically, TECFIDERA bringing back quitters in particular and slowing down even the number of those patients that exit the marketplace.

In addition to that, what we’ve noticed over the last call, five to seven years, is unemployment rates actually have in fact, play a role in this marketplace. So when unemployment rates in the United States specifically pop up to the high single-digits, we see the impact in a slightly delayed fashion.

And when they drift down, we see the impact of that as well. I mean, they’re modest impacts, but still meaningful.

And then the second impact is, as we came into 2014, we think we’ve gotten a little bit of a modest benefit from the Affordable Care Act, more patients being ensured in moving from essentially what was – patients that we supported on a free basis to those switching over to commercial. Thanks for the question..

Operator

Your next question comes from the line of (indiscernible) with Bank of America Merrill Lynch. Your line is open..

Unidentified Analyst

Hi, it’s actually Kathryn for (indiscernible). We’ll just have a question on LINGO. What do think is a clinically meaningful improvement in VEP until those back in 2020? And then what would expect of the placebo growth? And then how much detail do you expect to this in January versus a presentation at a conference next year? Thank you..

Paul J. Clancy

This is Paul. I was going to take it, but I’ll turn it to Al..

Alfred W. Sandrock

Hi, this is Al Sandrock. I don’t actually look on the MVP as a clinically meaningful end point to begin with. We powered the study for about a 30% affect on the latency, but I would look out it more as a biological measure and not necessarily one where we can look for clinical meaningfulness..

Operator

Your next question comes from the line of Chris Raymond with Robert Baird. Your line is now open..

Christopher Raymond – Robert W. Baird & Co.

Just a question on TECFIDERA life cycle management, I’m assuming you’re probably not going to want to be too descriptive of this. But we noticed a patent application that you guys filed in June describing a deuterium substitute a DMF compound.

And I guess it made us to think a bit, how might this fit into your life cycle management efforts around TECFIDERA and sort of if you could maybe talk generally about the attributes you think that that could make for a meaningful improvement over the currently approved compound obviously outside of the IP, but in terms of convenience, safety, and you know that kind of stuff, that would be very helpful..

George A. Scangos

Sure, but first of all great job of scanning the patent literature. Obviously the life cycle management for TECFIDERA is one of the key issues for us and we have a lot of work going on. That certainly is one aspect of it, but not certainly the only aspect.

And we haven’t gone into publicly all of the things that we’re doing and things we’re trying and certainly don’t, want to do that now and I think it’s in our interest. Obviously, if we tell you, we tell all our competitors as well. Look what would be the attractive life advantages, modest changes could be once a day, could be better tolerability.

I think the biggest change would be increased efficacy. And so, we’re working on all of those aspects..

Operator

Your next question comes from the line Matthew Harrison with Morgan Stanley. Your line is open..

Matthew Harrison – Morgan Stanley

Great, thanks for taking the question. I thought maybe now that you have the full Phase 3 on daclizumab. You haven’t talked about that aspect a lot and maybe you could talk about how you think that could fit in and how you might position that commercially? Thanks..

Tony Kingsley

Yes. Thanks, Matthew. It’s Tony. So Phase 3 data was obviously very encouraging.

We believe it has an attractive product portfolio that has a place in the market, doing lots of more detailed market research and positioning at this point to crisp that up, but we believe it has a nice efficacy; it has an MOA that is the interesting to many physicians that we talk to in once a month subQ injectable.

So the overall package is attracted and certainly something that makes sense for patients who require that level of efficacy. It could be a good switch to product for a lot of patients that are getting the efficacy that I need today. So more to come on that but we certainly think there’s a place where we believe that is a place for it on the market..

George A. Scangos

At this call, I’d just add additionally, we also often times think that this market is easy segments to split up, this we’re approaching 800,000 patients on disease-modifying therapies with lifelong disease that have lots of different heterogenous nature to the disease. So we think that actually plays well for Daclizumab..

Operator

Your next question comes from the line of Robyn Karnauskas with Deutsche Bank. Your line is open..

Robyn S. Karnauskas – Deutsche Bank Securities Inc.

Hi, guys, thanks for taking my question.

Just about hemophilia few things to your comments around, on the trends we’re seeing, [clearly] (ph) the 50% of the hemophilia treatment centers that are not (indiscernible) how do they just refer to 6% that are and how do you get access of those centers? And then why do you think you’re seeing some of the patients who are once-a-week versus to twice-week patients switch to longer halfway? And what do you need to do convert those patients do you think? Thank you..

Tony Kingsley

So, thanks Robyn, its Tony. Look I think I said first we’re pleased to have got the 50% or 50% plus of the hemophilia treatment centers. I think we’ve said this is largely a patient-driven market, meaning that’s kind of where the activation comes.

So as patients get interested in the proposition of the dosing regimen for treating disease prophylactically they are asking the hemophilia treatment centers. So we are in there talking to them, having conservations. We think as patients have good experience and as centers have good experience, it creates a virtuous cycle overtime.

And we believe we’re seeing some evidence of that as we go out and execute. So look, its early days, but the plan has been to do that, get the patients get their treatment centers provide good coverage and build that virtuous cycle overtime, but we believe we’re on a good path on that front.

In terms, of dosing frequency, I think, what I said on ALPROLIX, is we believe that most patients are choosing the once weekly, which is the label dose, it’s either once weekly or once every ten days. That is something that has made sense for the majority of patients. So I’d say that’s on plan..

Operator

Your next question comes from the line of Ravi Mehrotra with Credit Suisse. Your line is open..

Ravi Mehrotra – Credit Suisse:.

:.

George A. Scangos

Look where we – I assume you’re asking because of all the noise around Forward Pharma and their IPO. What we’ll say is we’re very comfortable with our IP situation, we’re certainly not going to litigate this in public. We’re very comfortable with where we are. And we’ll leave it at that..

Operator

Your next question comes from the line of Ian Somaiya with Nomura Securities. Your line is open..

Ian Somaiya – Nomura Securities Co., Ltd.

Thank you. I just want to follow-up on the questions on TECFIDERA. In the U.S., fairly rapidly you’ve got into roughly 20% market share. I just wanted to get maybe just your thoughts on how we should think about growth going forward, factors we should consider when modeling out sales going forward.

And similarly in Europe, the sales came in a little bit below our expectations and would you attribute more, more to that – which attribute at more to the timing of country introduction and to country rollout or was there sort of a bullish effect with the Germany introduction last quarter?.

Tony Kingsley:.

:.

:.

Paul J. Clancy

Yes, Ian just to add on Europe and I think these comments are probably a repeat from last quarter. We came into the Europe thinking Europe the pace of penetration would be underneath the pace of penetration that we saw at TECFIDERA in the United States. We’re very pleasantly surprising Germany to see actually that being on track or better.

And while Germany is that the Lion’s share of our ex-U.S. revenue right now, all the other countries that we’ve launched in Nordics, Canada, Australia, we’re seeing similar trends that we saw in Germany in terms of very strong update.

So the delayed launch actually has played and we’re effectively trying to do in every country is learn from the prior launches and execute even better, and I think we’re succeeding on that front..

Operator

Your next question comes from the line of Matt Roden with UBS. Your line is open..

Matthew Roden – UBS Securities LLC

Great. Thanks very much for taking the question. I just want to better understand the potential implications, if any, from that the case of PML. And we recognized that there is a background rate of PML in lymphopenic patients, including those with multiple sclerosis. We also know that TECFIDERA does lower lymphocyte count.

Do you think in light of what’s happened here would you prefer that severely lymphopenic patients not be on TECFIDERA? Do you expect that docs will reconsider use in lymphopenic patients? And lastly, do you expect that the regulators will update the label or will they wait for additional cases since there is a background rate in this population? Thanks..

George A. Scangos

Thanks. Those are good questions. Look, we’re certainly not in a position to make medical recommendation, right. For long lymphopenia like this patient experiences in known risk factor for PML, TECFIDERA does result in lymphopenia in a small fraction of the patients who take it. It’s for that reason that lymphocyte screening is on the label.

We have reported this case to the regulatory authorities. We’ll certainly, as we said in the prepared script, be discussing with them whether the language on the label is appropriate to inform patients and physicians. And what is done with lymphocyte results is, I think up to the physician that’s caring for those patients..

Operator

(Operator Instructions) Your first question comes from the line of Yaron Werber with Citi. Your next question comes from the line of Geoffrey Porges of Bernstein. Your line is open..

Geoffrey Porges – Sanford C. Bernstein

Thanks very much for letting me jump in with another question. I just want to follow-up on the discussion on ALPROLIX and ELOCTATE.

Could you give us a sense of what proportion of patients on each products, are existing prophylaxis patients for the switching over, what proportion new pro-fee patients and what proportion is used in demand? Look, I know the numbers are small, but it’d just be useful to see where the majority of the uptake is coming initially..

George A. Scangos

So I think, Geoff, it’s pretty clear that the vast majority is going to be existing pro-fee patients. That’s the group that we expected in both cases to buying the proposition of dosing frequency most attractive side, but I would say that’s the vast majority of it. There is probably a little bit on demand.

There are no signals yet that we’ve seen there. There is a meaningful conversion of bringing on demand patients into pro-fee. We’ve always said that’s probably something that happens over time. So, I would say vast majority is existing..

Operator

Your next question comes from the line of Ian Somaiya with Nomura Securities. Your line is open..

Ian Somaiya – Nomura Securities Co., Ltd.

And thank you again for letting me to ask a follow-up. George, you began the call just speaking to the new hires and I was just wondering if we should think about the growth within each of these new areas.

We should assume organic growth or do you think there are certain technologies out there that you sort of need to bring in-house to accelerate your efforts in the….

George A. Scangos

Yeah, those are good questions. Maybe I’ll turn that over to Doug Williams..

Douglas E. Williams

Sure, thanks George. Yes, I think you can look at those hires as somewhat of a mix of sort of building on our existing strengths. Don Johns would be a great example of that. Don is coming in to run the clinical trial programs in ALS. As we take those compounds into the clinic, he’ll be responsible for designing and executing those studies.

Chris Henderson is going to take over the research activities and neurology research.

So again that just strengthens what is already a very strong group and Chris will have the mandate to focus on new target discovery and validation to really help push ahead with new initiatives that we have in some of our core areas like Parkinson’s and Alzheimer’s..

:.

Operator

Your next question comes from the line of Yaron Werber with Citi. Your line is open. .

Yaron Werber – Citigroup

Thanks for squeezing me in. Question it’s for – I don’t know if Tony want to take it or Paul. Just relating to how do we think about TECFIDERA inventories, it sounds like its 3.5 weeks. I’m trying to get a sense what do you think is the normal range, especially given where you are sort of in the growth trajectory as a drug? Thank you..

Paul J. Clancy

Yes, good question, Yaron. The first thing I’d want to point out is it’s our best estimate. I think I had mentioned that, but that’s important. These things always wobble along product therapy, the size of TECFIDERA, it’s meaningful. So take it with a grain of salt.

We think that each quarter – the other thing (indiscernible) said on is that three and half week estimate is the combination of wholesalers and specialty pharmacies, which we’ve been trying to point out from the early days. We have good visibility on wholesalers.

There’s a limited number of them and that’s where our direct channel is and we have decent visibility in the specialty pharmacies. Over time, I would think that that will tighten up a little bit, as people early in the launch in particular specialty pharmacies, wanted to make sure they had plenty of product on hand.

So I think if anything over time, it tightens up a little bit to a tighter supply chain, which is normal for other therapies in particular rather overall therapies. And we’ll try to keep everybody apprised if that happens as it goes to the best knowledge that we have..

Operator

Your next question comes from the line of Matt Roden with UBS. Your line is open..

Matthew Roden – UBS Securities LLC

Great. Thanks very much. I wanted to ask somewhat of a similar question on TECFIDERA life cycle strategy. I have one on hemophilia. So it looks to us that you have a pretty nice opportunity here with ELOCTATE and ALPROLIX over the next couple of years.

But as you look out over the mid and long-term, obviously there are other parties working on not only competing long-acting factors, but there’s also other technologies being brought to bear.

I realize none of these other approaches are really de-risked, but the question is, given your leadership in this area whether we should expect to see additional innovation coming out of Biogen? And bigger picture, what’s your strategy for growing the franchise over the long-term? Thanks..

George A. Scangos

Sure.

Doug, you want to take that one?.

Douglas E. Williams

Yes, that’s related to hemophilia. I think we are continuing to innovate in that space. The first two products really represent the first two products.

We have other programs further back in research, one of which is a longer acting version of factor VIII that we presented some posters on, utilizes the XTEN technology, and we think that – if it does make it into the clinic will really sort of get us beyond that one and a half to two-fold half life extension threshold that everyone seems to be caught and all the long-acting factors.

For Hemophilia A, really in the sort of one and a half to two-fold half life extension range and this could actually double that from what we have seen. We’re also looking into gene therapy as a possibility to extend the franchise in hemophilia.

I think it’s sort of the general rule that when we move into an area and have programs and products that emerge from the pipeline, that we continue to innovate in those fields where we think that there’s opportunities to improve upon existing products.

So hemophilia is one area we’re doing that obviously MS, we continue to do that, that’s just sort of the natural part of the life cycle for any therapeutic area we’re in..

Operator

Your next question comes from the line of Eric Schmidt with Cowen and Company. Your line is open..

Eric Schmidt – Cowen and Company

Thanks for the follow-up. I guess I’ll ask the capital allocation question again, and I don’t know you’ve been getting asked from time-to-time. You’ve got over $3 billion on the balance sheet now, Paul. You’ve been saying that, I think, tuck in acquisitions have been your favorite use of cash.

But we haven’t seen any of those of late and you’ve now reduced the guidance for BisDev in the back half of this year.

So are you not seeing the opportunities? Are you changing strategy? What should we expect in the future?.

Paul J. Clancy

Thanks, Eric, for the question. Let me kind of address the second part of your question on the BisDev thing. The pipeline of business development activity, the strategic intense I think, I personally think our capabilities are at an all time high.

And you just never know when these things can turn into a deal, and as a result it gets a little bit bumpy quarter-to-quarter, early in the year obviously the Eisai transaction, the Sangamo transaction impacted the R&D line. Third quarter just didn’t really have anything.

And I think that’s continue way to expect it, it’s hard to then translate that into a guidance. So we all just have to be mindful of that. More broadly, we certainly still believe those bad word for it, but tuck-in acquisitions are a remark – it’s part and participle to the business that we’re in.

But it’s really all about the mission that we have and delivering outside has the potential to deliver outside shareholder value returns. We’ve seen that over the last ten plus years. As we move into 2015, we’ll probably open and look towards figuring out what’s the best way to return capital to shareholders as the cash flow continues to generate.

As I also pointed out just wanted to make sure, but it’s mindful of – we do expect to have meaningful CVR payments to the pharma owners of TECFIDERA, which is going to be captured into the cash flow statement, as well. So I think it’s kind of largely continued as we have and with a pretty decent intent to rebuild their early and mid-stage pipeline..

Operator

Your next question comes from the line of Chris Raymond with Robert Baird. Your line is open..

Christopher Raymond – Robert W. Baird

Hey, thanks. Just a follow-up here on TECFIDERA. So we’ve done some of our own work on discontinuation rate and at least from docs are telling us, it looks like it’s fairly flat and kind of consistent with what DEFINE and CONFIRM showed.

Can you guys maybe talk about the trends you’re seeing there? Are we right or is there some other sort of dynamic we should think about?.

Tony Kingsley

Yes, thanks, Chris. This is Tony. I think that’s consistent with what we’re seeing. As we’ve said before, the discontinuation rates, we expect to be similar to other in line therapies over time. We believe that physicians are learning to manage the GI and tolerability issues, but you’re still going to get some drop off of that.

So we believe that your analysis is probably in line with what we’re seeing..

Operator

Your next question comes from the line of Michael Yee with RBC Capital Markets. Your line is open..

Unidentified Analyst

Hi, thanks for the follow-up. This is John again on for Michal Yee. I don’t think this was addressed on today’s call, but for Anti-LINGO on the last earnings call, it was noted that the data from the optic neuritis studies will be expected in January of next year.

Just wanted to confirm, is that still the guidance? And as for top line announcement we can expect, it’s been a quite long since we’ve last seen a Biogen press release on a mid-stage proof-of-concept program.

So for the Anti-LINGO disclosure, how much data can we expect? Would it be something detailed with numerics from the multiple endpoints or just a simple short commentary whether a hit or the trends et cetera? Thank you..

George A. Scangos

Okay, sure. Yes, we’re still on track for January. As to the data that we’ll show, the goal here is to be as open as we can about the data without jeopardizing our ability to publish the data in peer review journal and have it accepted at a major meeting. Those are always the things that company is trying and trade off.

So I can’t tell you exactly what will be in the press release, but we will certainly be as explicit as we can with those caveats..

Operator

I would now like to turn the conference back over to our presenters..

George A. Scangos

Okay. Thank you all for the attention this morning and the time. And we’ll get back to work and so can all of you. Thanks..

Paul J. Clancy

Thank you..

Operator

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

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