At this time I would like to welcome everyone to the Biogen Idec first quarter 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) Claudine Prowse, VP Investor Relations, you may begin your conference.
Welcome to Biogen Idec’s first quarter 2014 earnings conference call. Before we begin, I encourage everyone to go to the investor’s section of www.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 which we believe better represents the ongoing economics of our business and reflects how we manage the business internally. We have also posted slides on our website that follow the discussion 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, EVP of Global Commercial Operations; Dr. Doug Williams, EVP of Research and Development; and our CFO Paul Clancy. Now, I’ll turn the call over to George.
George A. Scangos
Biogen Idec had an excellent start to 2014 with successful milestone accomplishments and solid financial performance. We secured approval for TECFIDERA in the EU, launched in Germany, and some other countries. ALPROLIX was approved for hemophilia B in the US and Canada. We continued to move two of our late-stage pipeline candidates, ELOCTATE for hemophilia A and PLEGRIDY for MS, through the registration processes towards anticipated approvals this year. We strengthened our pipeline through new collaborations with Eisai and Sangamo in areas that fit within our strategic therapeutic focus, and first quarter financial performance reflected 51% growth in revenues and 25% growth in non-GAAP EPS year-over-year.
So, this month marks the one-year anniversary of the US introduction of TECFIDERA. It’s introduction has dramatically shifted the US market for MS therapy. We’ve seen an expansion of the MS market and within that TECFIDERA is the number one oral MS therapy in the US, achieving over $1 billion in revenue during the first year of launch. We launched TECFIDERA in initially European countries, beginning in February and already there appears to be broad interest among physicians and patients. Based on the continued strong demand in the US and the encouraging early signs in the EU, we believe that TECFIDERA’s attractive product profile positions it well for the long run.
The approval and anticipated launch of ALPROLIX marks an important milestone for our company as we expand into the hemophilia market. ALPROLIX is the first hemophilia B therapy to reduce bleeding episodes with prophylactic infusions at least a week apart. We believe that this therapy has the potential to change the standard of care in hemophilia and significantly improve patients’ lives. As we’ve done for so many years in multiple sclerosis, our goal is to bring a diligent patient centric approach to addressing the hemophilia community. Our keen focus on patients permeates everything that we do from our direct interactions with patients, to our assistance programs, to our continuing R&D efforts. We remain focused on making decisions that are right for patients.
Last month, the FDA extended the PDUFA date of PLEGRIDY, our subcutaneous peginterferon beta-1a candidate for relapsing forms of MS to allow additional time for review of the application, while obviously not the news we were hoping to hear, a three-month PDUFA extension is not uncommon, particularly for applications involving MS therapies. We look forward to the potential launch of PLEDGRIDYin the second half of the year.
We’ve continued to make strides to expand our global presence beyond Europe and the US. In Japan, we obtained marketing approval for TYSABRI and filed a marketing application for ELOCTATE. Japan is the second-largest pharmaceutical market in the world with attractive dynamics, and it is an important long-term priority for the company.
So in summary, I think we’re off to a great start for 2014, and I’ll turn the call over to Doug.
Douglas E. Williams
We’re excited about the approval of ALPROLIX. ALPROLIX is a recombinant DNA derived long-acting coagulation Factor IX concentrate indicated in the US for both adults and children with hemophilia B. In the US, ALPROLIX is indicated for the control and prevention of bleeding episodes perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Starting dosing regimens for prophylaxis are 50 international units per kilogram once weekly or 100 IUs per kilogram once every 10 days. Dosing can be adjusted based on individual response.
The safety and tolerability information including in the US label is consistent with data from the Phase 3 Study. The most common adverse reaction observed were headache and oral paresthesia. In summary, we’re pleased to have obtained what we believe is an attractive and differentiating product label for ALPROLIX.
Earlier this month, we along with our partner Sobi, announced topline results from the ELOCTATE Kids A-LONG Phase 3 study in pediatric patients with hemophilia A. These data demonstrated that twice weekly prophylactic dosing with ELOCTATE maintained low bleeding rates in children. We believe these results support the potential for ELOCTATE to address a significant need for children with hemophilia A by providing prolonged intervals between scheduled prophylactic infusions to protect against bleeding episodes.
The tolerability, safety, and relative half-life were consistent with those observed in previous clinical studies and no inhibitors were detected. These data support applications for pediatric indications globally and are a necessary step to obtaining marketing authorization in Europe. The ALPROLIX Kids B-LONG study remains ongoing with data expected in the first half of 2015.
Transitioning to our neurology programs, we continue to generate new data to support our products and better understand our pipeline candidates. At next week’s American Academy of Neurology Meeting, we’ll be presenting important new data for several of our programs. Specifically, we’ll present TECFIDERA data that demonstrates strong efficacy in various patient subgroups including those with more active disease. Results from the TECFIDERA managed study show that GI symptoms experienced by some patients are often transient in nature.
For PLEGRIDY, we’ll present post-hoc analysis from year one of the advanced study demonstrating a higher proportion of patients taking PLEGRIDY to achieve freedom from measured disease activity. We’ll also present final two year data providing further support for this product candidate’s efficacy and safety profile.
Finally, new TYSABRI data demonstrate its efficacy benefits in patients switching to TYSABRI versus maintaining the use of alternative therapies. This quarter, we also completed a number of transactions that provide Biogen Idec with access to promising new clinical candidates. Our collaboration with Sangamo BioSciences is focused on an innovative gene editing technology with the potential to treat sickle cell disease and beta-thalassemia.
Our agreement with Eisai expands our efforts to develop disease modifying therapies for Alzheimer’s disease. In recent years, meaningful advances have increased our understanding in both trial design and target selection for Alzheimer’s disease. The optimal therapeutic approach for AD remains uncertain, and we believe it’s prudent to evaluate multiple therapeutic methods for treating the disease. With the Eisai transaction, we’ve gained access to two-mid stage clinical candidates for AD, a small molecule BACE1 inhibitor and a monoclonal antibody targeting beta-amyloid. Combined with BIIB037 and our anti-tau program in preclinical testing, we now have four potential Alzheimer’s disease candidates with three different mechanisms.
Looking forward, we also anticipate data from several clinical studies including the Phase 3 Daclizumab HYP DECIDE study in relapsing MS patients. Rather than a placebo controlled study design, the DECIDE study sets a higher standard with a compelling two to three head-to-head design versus interferon beta treatment. The primary endpoint is the reduction in annualized relapse rate. We remain on track for obtaining DECIDE data around the middle of this year.
I’ll now pass the call over to Tony.
During the quarter we continued to grow total MS patient share across our franchise. Starting with TECFIDERA, performance in the US remains strong and the global introduction is under way. After one year on the market, over 65,000 patients have been treated with TECFIDERA globally. In the US, we continue to be pleased with how broadly neurologists have adopted TECFIDERA. As of Q1 approximately 7,000 physicians have written TECFIDERA in the US and we’re also encouraged by deeper usage among writers as approximately 75% of all TECFIDERA prescribers have written multiple subscriptions.
According to our market research TECIFDERA is the leading therapy for newly diagnosed MS patients. One year into the US launch we believe TECIFDERA is continuing to stimulate higher switch rates. While we anticipate the patient start and switch dynamics to remain strong, we continue to believe that the overall market growth rates will moderate towards historical levels during 2014.
Outside of the US, we believe TECIFDERA is also performing well in other launch markets. In both Canada and Australia, our market research suggest the TECIFDERA is outpacing the other orals on the market when comparing the initial months of launch. In Germany, we’re encouraged by the early signs. In addition to driving strong execution on promotion and education, we’re actively engaging with reimbursement authorities across multiple markets. Australia gained full year reimbursement in December and we expect to gain government reimbursement in Canada later this year.
In year up we have secured full reimbursement, in [doorway] and Scotland. Our local market access teams are executing well and we continue to expect the series of reimbursement decisions across European markets in the latter half of the year.
AVONEX continued to perform well globally in the first quarter. In the US as the injectable class continues to decline, the demand for AVONEX is softening as we anticipated. But within the injectable class we believe AVONEX is emerging as the interferon of choice. Outside the US we are maintaining strong AVONEX promotional efforts in advance of anticipated TECIFDERA launches and we remain committed to maintaining strong relative position for AVONEX among the platform therapies as that segment of the market declines. We continue to believe the convenience remains the key differentiator for this segment.
Moving onto TYSABRI, in the US demand for TYSABRI remains solid as physicians continue to choose this therapy for patients requiring higher efficacy treatment. We’re also encouraged by a recent uptick in patient retention rates. Importantly, in patients who have discontinued TYSABRI, approximately 70% have stayed within our franchise during the first quarter. In Europe we believe that as TECIFDERA is launched across individual markets TYSABRI may experience similar dynamics that we saw in the US. Overall, we continue to believe in TYSABRI as a leader in the high efficacy segment.
Now turning to our new hemophilia business. We’re currently in launch mode for ALPROLIX in the US and anticipate having patients on commercial therapy starting in early May. Based on NHF guidelines, traditional hemophilia B therapy requires prophylactic infusions two or more times a week. Given the clarity of our label, we believe our value is very clear for the majority of patients. 50 international units per kilogram will cover a patient for a week, or 100 IUs per kilogram starting every 10 days and adjusting the dosing based on individual response. Our market research suggests that reducing infusion frequency is the largest unmet need for this community and we expect ALPROLIX will directly address this burden.
With the approval of ALPROLIX in the US, we are focused on two immediate objectives: first, to initiate comprehensive education to physicians, payers, and advocacy groups; and second, to facilitate access to patients starting on ALPROLIX. Our commercial team is actively establishing contracts with specialty pharmacies, finalizing the supply chain, and establishing the financial and patient support programs which we believe will enable a smooth launch.
We believe that patients and physicians are anticipating the entry of long acting therapies to the market and we are excited to be first. Our commitment is to transform the care of people with hemophilia and facilitate expanded use of prophylactic treatment. A successful launch will require extensive promotional and educational efforts and our commercial organization is executing on this strategy. Our goal is to become market leaders in the mid to long term and we believe in the product and our ability to execute.
Overall, I’m very pleased with the performance of the commercial organization. Across an expanding portfolio of therapies we are demonstrating strong execution and good results. I’ll now pass the call to Paul.
Paul J. Clancy
Our GAAP diluted earnings per share were $2.02 in the first quarter and our non-GAAP diluted earnings per share were $2.47. Before I walk through the P&L there are a number of items to remember with respect to the year-over-year comparisons. These include: the TYSABRI asset purchase which impacted revenue and COGS; the RITUXAN arbitration charge in Q1 last year; and an unusually low effective tax rate from Q1 2013. Also, this quarter’s results were impacted by $118 million R&D expense related to our Eisai transaction as Doug reviewed. This agreement impacted EPS in the quarter by approximately $0.35.
Now, walking down the P&L I’ll start with revenues. Total revenue for the first quarter grew to approximately $2.1 billion. First quarter AVONEX worldwide revenue was $761 million. In the US, Q1 AVONEX revenue decreased 3% to $476 million and outside the US Q1 AVONEX revenue was $285 million. TYSABRI worldwide revenue net of hedging was $441 million in the first quarter. These results were comprised of $234 million in the US and $207 million internationally.
Global TECFIDERA revenue was $506 million in Q1. US TECFIDERA was $460 million. We ended the quarter with approximately five weeks of inventory in the channel which includes specialty pharmacies and wholesalers. We estimate that US TECFIDERA revenue includes an incremental inventory build of approximately $45 million versus the end of last year. International TECFIDERA revenue was $46 million in the first quarter with Germany being the primary contributor. We estimate approximately $10 million to $15 million of Germany sales in Q1 were related to inventory build.
Turning to our anti-CD20 franchise, RITUXIN and GAZYVA US profit share was $275 million for Q1. Royalties and profit share in sales of RITUXIN outside the US were $22 million. The result was $297 million of net revenue from unconsolidated joint business.
Now turning to the expense lines of the non-GAAP P&L. Q1 non-GAAP cost of goods sold were $279 million or 13% of revenue. The increase year-over-year was primarily driven by TYSABRI contingent payments and royalties. Q1 non-GAAP R&D expense was $527 million or 25% of revenue. The increase year-over-year was primarily driven by our recently announced agreement with Eisai where we recorded a $118 million R&D charge. This amount consisted of a $100 million upfront payment and $18 million reflecting the value of options for certain programs and geographic rights.
Q1 non-GAAP SG&A expense was $509 million or 24% of revenue. We continue to make significant investments associated with TECFIDERA and the upcoming hemophilia launches. Our Q1 non-GAAP tax rate was approximately 27%. Weighted average diluted shares were 238 million and we ended the quarter with almost $2 billion in cash and marketable securities of which approximately 70% is within the United States.
This brings us to our non-GAAP diluted earnings per share which were $2.47 for the quarter, an increase of 25%. Now, turning to our updated full year 2014 guidance. We now expect total revenue growth between 26% and 28% an increase from prior guidance owing to AVONEX and TYSABRI buoyance compared to our prior expectations. Our 2014 guidance continues to exclude the impact of a settlement with AIFA as the timing of the final approval of this agreement remains uncertain.
R&D expense is expected to be between 20% and 22% of sales unchanged from prior guidance. Our full year R&D forecast continues to earmark approximately $200 million for new early stage business development opportunities of which the Eisai transaction is included in this amount. SG&A expense is expected to be approximately 22% to 23% of total revenue also, unchanged. We anticipate non-GAAP earnings per share results between $11.35 and $11.45 and GAAP EPS to be between $9.85 and $9.95.
Now, over to George for his closing comments.
George A. Scangos
In closing, we’re off to a strong start for the year and looking forward we have several crucial milestones and activities that require our intense focus. First, expanding TECFIDERA into new markets as we seek to serve more patients with MS. We’re launching three additional products ALPROLIX for hemophilia B and other potential launches this year including ELOCTATE for hemophilia A and PLEGRIDY for relapsing MS. We’re advancing the next wave of new potential medicines. In the coming 12 to 18 months we anticipate a number of data readouts including Phase 3 results for Daclizumab HYP in relapsing MS and for TYSABRI in SPMS, as well as, early and mid stage data for a number of compounds in the pipeline including LINGO.
Continuing to focus on innovation we believe that Biogen Idec scientific acumen and robust pipeline program give us the opportunity to not only expand our leadership position in MS but also contribute to new treatment options for patients with other series diseases. These activities are at the very core of our mission and require determination and perseverance. We believe that our team is ready to meet these objectives and we look forward to providing updates on our progress throughout the year.
I’d like to thank the patients and physicians who are involved in our clinical development program and our employees who are dedicated to making a positive impact on patient’s lives, and all of you, for joining us this morning. Operator, we can now open up the call for questions.
(Operator Instructions) Your first question comes from the line of Ravi Mehrotra – Credit Suisse.
Ravi Mehrotra – Credit Suisse
Congrats on the progress, especially TECFIDERA’s launch. It's obviously not Sovaldi launch, but it is okay. My question regards biomarkers in MS, can you just remind us of the work you’ve done or are doing to look at the potential of biomarkers to predict response rates for treatment selection in MS patients? Specifically, on LINGO, is there any clinical data historical or ongoing to support the hypothesis that LINGO expression where activation is increased in MS patients? Just a very quick follow on, on the hemophilia, how should we think about gross-to-net revenues?
Douglas E. Williams
I’ll take the first two and then let either Tony or Paul handle the gross-to-net question. Biomarkers, obviously that’s very important part of the ongoing research activities here. There’s really two major questions that we’re trying to approach with the biomarker activity that’s part of our clinical trial program. One is really trying to characterize patients who have either a more or lesser, in terms of aggressiveness, disease course to really try to match them up with certain therapies that may have greater activity and a higher level of disease activity, so for instance, with TYSABRI-like molecule in patients with more aggressive disease.
So, we’re looking at things like RNA profiling, we’re looking at all the laboratory tests that are collected in these patients, we’re looking at MRI activity, clinical relapses, EDSS progression, and really looking across those data sets to try to see whether or not there’s a signature and that signature can be one or more of those parameters that I just named that correlate with a greater level of disease activity. That information, at the time of diagnosis, may help physicians choose the appropriate therapy for their patients at the time of diagnosis.
The sort of bigger question we’re trying to get at with respect to our own portfolio of drugs is, can in fact we use similar types of algorithms to predict patients who will have a greater or lesser response to our therapies or potentially may experience a safety event that we want to steer them away from. So, all of our studies have very extensive sampling embedded in them now, that’s true of our MS studies, it’s actually true of all of our clinical studies now, probably not unlike all of our compatriot companies out there as well. Again, the idea here is to try to match up the appropriate patient with the appropriate drug either in terms of the best response to therapy or steering them away from a potential safety event.
A lot of work still to be done, but I think there’s progress being made and you can expect that we’ll have data reading out over the course of the next months and years that will be presented at major medical meetings to describe what we’ve been finding.
With respect to LINGO, a lot of the hypothesis around the use of LINGO is based on some data from several years back that was based on autopsy specimens from patients with MS showing that in lesions there were in fact pre-myelinating oligodendrocytes, so the cells that are capable of re-myelination are actually present in the lesions, but they are blocked from maturing by one or more factors. LINGO is clearly one of them based on the experimental data that we’ve accumulated.
I don’t know that there is specific data in autopsy specimens that show an increased level of LINGO versus what’s present in sort of normal brain tissue but it’s clearly present. If you think about what’s happening, we’ve got essentially a targeted delivery of the drug because of the breakdown of the blood/brain barrier in and around those lesions. So, where we’re going to be able to reverse the inhibition of myelination and allow the maturation of those oligodendrocyte precursor cells is specifically in the area where the blood/brain barrier has broken down.
You can see this very clearly happening in the animal models, so our expectation is that’s what’s going to happen in the human situation as well; and the targeted delivery of the anti-LINGO molecule releasing the block on myelination and hopefully a sufficient level of re-myelination taking place to show clinical benefit in these patients.
On your question about channel discount, look it’s steady state. Our research suggests that the gross-to-net in the hemophilia space tend to run higher, probably meaningfully higher than what we’re used to seeing in MS. There’s really two big pieces to that. One is the channel, so you have specialty pharmacies, specialty distributors, and home health. The second is there’s a meaningful portion of the patients that go through 340B designated hemophilia treatment centers. We’re going to have to see how that evolves, it will depend a lot on the mix of the patients, and I just think we’ll have to look over the next handful of quarters. I think mix will be a big driver.
Your next question comes from Michael Yee – RBC Capital Markets.
Michael Yee – RBC Capital Markets
You just launched TECFIDERA in Europe and I’m just trying to understand, based on your feedback so far or your research, whether you think there’s different demand dynamics in sort of the three different pools: newly diagnosed versus switchers versus the quitter pool versus say the US, and are there differences there that we should consider obviously other than price versus the US? Then just as a follow up to that, you’ve mentioned now multiple times in slides and your 10-K about BIIB061, so as I think about the trajectory and longevity of your oral franchise that you’re working on, can you say anything about that drug as to whether it’s remyelinating or anything about BIBB061 that would keep down the suspense?
On Europe look, I think I’ve said before we continue to believe in the product and are looking forward to launching it. We highlighted a couple of differences in general in Europe which were third oral to market. The other orals [inaudible] more traction perhaps less clear in participation by the community given the uncertainty and the regulatory delays. Like we said before, that’s going to take hard work. We’re working hard.
If I look at Germany, we’re getting great execution, we’re getting reach and frequency, we’re getting access to customers and we’re seeing interest and we’re getting patients on therapy so we’re encouraged by the signs in Germany. In terms of talking about the trajectory and the mix across pools it’s probably a little early to make that call. As I think you know, in Germany the data is more lag driven IMS basis, we’re looking at shipments and various things like that so probably a little early to make a more specific mix but I think the message is getting access to customers and seeing interest and encouraged by the early signs.
Douglas E. Williams
BIIB061 that is an oral remyelinating drug in much the same way disease modifying therapies are moving towards an oral platform approach, we see the same thing happening in the remyelinating space. So, as LINGO is the biologic and is the first generation of what we hope will be a successful remyelination franchise, BIIB061 is working through a different mechanism which we’re not prepared to disclose at this point but does very much the same thing that LINGO does in the experimental models so we’re quite excited about initiating the clinical program with the molecule.
Your next question comes from Mark Schoenebaum – ISI Group.
Mark Schoenebaum – ISI Group
A couple of questions, one maybe for Paul, I just thought I’d take this opportunity, you guys choose to include the upfront R&D payments in your non-GAAP EPS numbers. A couple of other companies out there don’t do that, I’m just wondering why it? It creates volatility on a quarter like this. That’s an old school CFO question so I appreciate it. Then also, if they’re already BG-12 contingent payments that were made in the quarter, would it be possible for you to tell us what they were? Then Doug, how does the base inhibitor from Eisai differ from Merck or AZ’s drug which I think are already in Phase 3 so you guys are pretty far behind I guess and I’m just wondering why you think you still have got a shot at being competitive?
Paul J. Clancy
The delineation we generally make is purchase accounting items are in our GAAP P&L but not in our non-GAAP P&L so that has been a practice. Essentially what we view as these upfronts and milestones are part in parcel to the business, they come in lumps as we saw in this quarter, as we’ve seen in last quarter but it’s essentially part and parcel to the business but we do make that kind of delineation.
Mark Schoenebaum – ISI Group
Did you make a cash payment to Fumaderm in the quarter?
Paul J. Clancy
We did. It was a cash payment that was earned in the fourth quarter and paid out technically in the first quarter of 2014.
Mark Schoenebaum – ISI Group
Do you have the amount?
Paul J. Clancy
Gosh, off the top of my head I don’t. I believe it was $25 million.
Douglas E. Williams
With respect to the base compound, we did very extensive diligence on the compound before we licensed it in and actually thought the profile was very favorable from a safety perspective with the caveat that there’s still a ways to go on development to really understand that completely. I would say the same thing is true with both the Merck compound and the AZ compound, nobody has actually gotten there yet so the opportunity is still very much there. We like the profile of the compound. We also like the ability, potentially, if the compound is successful in the clinic to start thinking about combinations between the base inhibitor and one or both of our anti-beta amyloid antibodies or potentially the anti-tau antibodies. So, we’re looking at this from sort of a portfolio approach in addition to just the individual compound which we like the profile as we saw it.
Your next question comes from Eric Schmidt – Cowen & Company.
Eric Schmidt – Cowen & Company
I was a bit surprised that AVONEX is doing so well within the interferon class. What do you scribe that to? Is there some kind of beneficial franchise effect going on there with TECFIDERA? Then for Paul, was there also an R&D upfront to Sangamo in the quarter?
A very good question. I think the short answer is yes, I think TECFIDERA has probably taken disproportionally from the high dose high frequency interferon’s relative to AVONEX. I think that makes sense when you take into account those tend to be more [switch two] products relative to AVONEX. So, if TECFIDERA gets in front of that switch I think you’re seeing a positive manifest. But, I would also add with an increased focus on promotion we think we’re putting some very good effort to see the continuation of the story behind AVONEX so a little of each.
Paul J. Clancy
Eric, there was a Sangamo payment in the first quarter that was for $20 million, upfront payment. That was actually in our original press release with Sangamo. The Eisai, if you recall, the financial terms weren’t disclosed until today just because of the partnership at the time.
Your next question comes from Geoff Porges – Sanford C. Bernstein.
Geoff Porges – Sanford C. Bernstein
Just a follow up on first of all the Eisai, Paul could you confirm whether if the products are successful you will report the revenue or whether that will simply be a profit sharing that reports below the line? Then further to the $200 million that you allowed for BD activity, with what you’ve spent in the first quarter should we assume there’s only 50 to 80 left for the balance of the year? Then lastly, with your step up in your revenue guidance and keeping the expense guidance the same it certainly applies that your expenses are going to be higher than you previously anticipated. Is that the right way to look at it and should we be expecting this higher level of SG&A spend to be the baseline going forward?
Paul J. Clancy
All good questions. With respect to the first part of the question, Eisai essentially is about $118 million of the $200 earmarked and so what is the balance is exactly as you noted and we obviously had an eye towards the Eisai deal when we set up the original guidance. We actually continue to work on business development transactions but I mean, quite frankly, the pipeline was far more advanced right before the Eisai transaction than it is right now. I think it’s much closer to an earmark. I don’t know if it will be 100, or 60, or 80, but we’ll update people along the way as we go.
The Eisai transaction is essentially a 50/50 split with the exception of certain geographies that are really dependent on Eisai. Specifically, the Japan geography of whether or not they want to bring that into the collaboration or not. From a perspective of development 50/50 with a respect from a commercialization and 50/50 in terms of profits assuming one or two of the products get to market. We haven’t yet determined who would be taking the lead on different geographies and I think at this point in time that would probably guide our revenue model. So, it’s a little bit early to tell how the geography lands in the P&L but it is in essence a 50/50.
Then you’re last part of the question yes, I think you’re right is that implicit is a little bit of increase. It’s probably in the $30 million, $40 million, $50 million range for SG&A spending. We have consciously over the last 12 months in this year made the decision on SG&A spending not to be penny wise and pound foolish. We’re kind of at an unprecedented period of time in what we’ve gone through in 2013 in launching TECFIDERA in the US. We’re very excited to be launching TECHFIDERA in Europe after a lot of hard work in the back end of the year and the same thing on hemophilia.
I think that what we’re doing right now is making sure we really appropriately fund all these launches and as we move into 2015 we’ll take a much more critical eye towards really trying to get SG&A leverage which we’ve talked about. I can’t really exactly tell you the amount at this point but we’re going to be taking a much more critical eye. So, I think we pivot mentally from really thinking hard about making sure we fund these critical launches to kind of pivoting towards looking to making sure we’re not over funding and over expensing on the items in the P&L.
Your next question comes from the line of Matt Roden – UBS.
Matt Roden – UBS
Tony, you mentioned the five weeks of inventory for TECFIDERA, we understand that weekly demand is still growing but are we getting to the point in the launch in the US that we need to think about normalization of that inventory as we think ahead to second quarter and second half of the year? Then also, you guys have recently commented on the pricing approach for ALPROLIX which on a net basis looks to be about parity, just wondering if we should assume you’ll adopt the same philosophy with ELOCTATE as well?
Paul J. Clancy
I’ll take the first part of that. I think that’s overall correct is that we will probably likely see not as much increase in terms of inventory in the channel. We keep a watchful eye on that. We are a bit of a player in that but certainly what’s most important is to make sure the specialty pharmacies have product for the patient and the wholesalers don’t have any kind of excessive product. I think if you just look at the run rate I think there may be a little bit of upward inventory over the next few quarters but I think it certainly moderates in terms of the impact.
On the ALPROLIX pricing as you know, the math can get complicated but I think your read of the basic intent is right. No comment at this point how that might translate to [other CPD].
Your next question comes from Geoff Meacham – JP Morgan.
Geoff Meacham – JP Morgan
A high level question for you Tony, when you look at US TECFIDERA you’ve obviously been in the market for the year, what types of MS patients are coming on today and how does that compare to when you launched? Then a question for Doug, I know it’s tough on the LINGO opportunity to say specifically, I don’t know if there’s a lot of data out there, but how does a compromised blood/brain barrier correlated to disease severity, or say progression, or say relapse frequency, things like that that try to correlate that outcome to the clinical benefit or worsening?
Look, I think the interesting thing is there’s not a dramatic change in the [inaudible] and it speaks a little bit more to the start the product got off too. As I think we pointed out early days, we got a meaningful portion of newly diagnosed pretty much out of the gate and captured a nice portion of the switch pool at a broad level. I think those dynamics are still true today. There’s probably a little shift in the switch pool in terms of the nature of what patients were getting and what reasons between tolerability and efficacy but it’s actually a little bit more the same.
The only other wrinkle I’d add to it, which is interesting, is we think TECFIDERA is keeping people from leaving the market. The market has a group of people that quite therapy every year and a group of people that return, what our research suggests is that there are fewer patients who might have quit the market absent this alternative who are staying in the market and I think that’s encouraging.
Douglas E. Williams
As far as the LINGO question and the relationship with the blood/brain barrier, what happens when there’s a new lesion that develops, a relapse if you will, is that you get local breakdown of the blood/brain barrier. That’s because the release of all the inflammatory mediators that takes place locally. The point I was alluding to is that because of that localized impact on the blood/brain barrier you’re going to get a relatively higher concentration of the drug in those lesions at the time the barrier breaks down which is not to say that you’re not going to get drug to other older lesions, that should happen as well and in fact, the Phase 1 data confirms that we are getting sufficient quantity of drug to match the sort of IC90 level in the animal models in patients with MS in their cerebral spinal fluid.
So, we know we’re getting drug into the brain in quantities that sort of match up with what we saw to be efficacious in the animal models, but on a relative basis, just because of the physiology of the blood/brain barrier with a new lesion, you’ll get relatively more delivered locally to a new lesion.
Your next question comes from Terence Flynn – Goldman Sachs.
Terence Flynn – Goldman Sachs
First on just the top line raise, I was wondering if you can give us anymore color behind the drivers there? Is that solely TECFIDERA or anything else you’re seeing? Then the kind of follow up question to Eric’s on AVONEX’s resiliency on the US, is there anything different on the European side that we should consider as we think about that franchise and its resiliency in Europe?
Paul J. Clancy
The color on the raise that I give you, and this is versus our expectations and our kind of original guidance, is around the buoyance seen in AVONEX and TECFIDERA. So, it isn’t per say that we see a different forecast on TECFIDERA. I think the US in TECFIDERA is kind of marching along our expectations is really five to six weeks into Europe and to Germany. So it’s a little early to call for that on TECFIDERA. But, what we have seen kind of just one quarter in is just AVONEX and TECFIDERA not being as impacted as much in the last 90 to 120 days.
On AVONEX the answer actually differs market-by-market. There are some markets where we have higher dose high frequency interferon have lower share, etc., so I think it’s going to be the sum of Europe is the sum of a bunch of different parts. We believe similar to the US that AVONEX should do as well or better on a proportional basis as the injectables proportion of the market declines. Again, that will differ market-by-market on average, that remains our belief but we’ll have to see as TECFIDERA rolls out across market-to-market what the individual impacts are.
(Operator Instructions) Your next question comes from Matthew Harrison – Morgan Stanley.
Matthew Harrison – Morgan Stanley
Just two quick ones for me, one on TECFIDERA in Europe you told us you’ve gotten reimbursement in Norway and Scotland and that you expect reimbursement in a bunch of other geographies. I was wondering if you might be willing to help us think about what those geographies are. Then second, on TYSABRI the sequential growth in the US looks when I looked over the last couple years, what you saw this quarter was actually the second worst and the first worst was sort of when TECFIDERA launched? So I’m just wondering if you can help us in terms of units? I’m just wondering if you can help us think about what was going on there and was it TECFIDERA driven or something else?
So we haven’t laid out a very specific schedule of what sequence we think the countries will get reimbursement in. As you know, it’s multiple independent events. We’ve said a lot of these markets it’s a kind of 12 to 18 month timeframe and the generalization is the northern European markets tend to move on a little faster pace, the southern European markets then move on a little slower pace. But we think towards the end of the year and around the turn of the year we’ll start to see some meaningful reimbursement decisions if you look at where [inaudible] national reimbursement processes typically goes on a timeline.
Paul J. Clancy
I would want to point out there’s a little bit of noise in the last five quarters that you kind of see even on the graph in the earnings slide deck and what I’d point out is in Q1 and Q2 of last year there was inventory movement that arose out of the transaction. So Q1 actually kind of moved revenue up by about $25 million or $26 million and as a result Q2 was depressed by that amount in the United States. I believe it’s in one of the footnotes.
Then, as it relates to Q1 2014 the one thing I would point out is that just the uniqueness of the way we ship TYSABRI, Q1 2014 actually had 12 shipping weeks versus all the prior quarters last year had 13 shipping weeks and it’s just a function of we essentially ship on Tuesdays. It’s essentially a function of the number of Tuesdays in a quarter so it’s quite peculiar.
Now, if you rise above all that, when we look at our patient data, when we look at our discontinuations, when we look at our patient adds we still believe there’s still a fair amount of homework to get TYSABRI moving in the right direction but we believe those metrics are moving in the right direction. Discontinuations were meaningfully impacted through the second and third quarter last year as many patients moved to TECFIDERA but we’re seeing discontinuations come back to a more normal level and we’re seeing actually patient adds coming into the TYSABRI franchise that is solid performance.
Your next question comes from the line of Yaron Weber – Citi.
Yaron Weber – Citi
I’ve got a couple of quick questions. One, Tony, just housekeeping we’re hearing that the TECFIDERA drop out due to the typical GI is around 15% to 20%. I think it was around 10 initially, it sounds up it went up a little bit, is that what you’re seeing? Then secondly, I don’t know if it’s for Doug or for [inaudible], but it’s a question on LINGO. When you’re looking at your primary end point whether it’s optic neuritis, the fore field [inaudible] potential or in MS where you’re using this neurofunctional neurocongnitive decline or stability in three or more months. My question is how validated are these end points in terms of your ability to adequately power against the control arm? Just help me understand a little bit how validated have you been on the studies just so we really kind of understand what to expect?
The short answer to your question is I don’t think we have any strong signal that GI is moving up or down. We’re obviously monitoring that on a regular basis through a whole bunch of different data sources and no signal that there’s a meaningful trend in one direction or the other.
Douglas E. Williams
With respect to the endpoints, I think the endpoints that we’ve chosen to use are well validated endpoints. I mean, certainly not only visual [inaudible] potential, it gives you a hard number in terms of nerve conduction velocity but also the low contrast visual acuity endpoint in that study is one that’s been used for other drugs for registrational purposes. So the endpoints I believe are hard. I don’t think we’ve released the power calculation but suffice to say that these studies are large enough and well powered enough for us to feel comfortable about whether or not we will make a go no go decision based on the data that comes out.
I should also point out that the other endpoint in the MS study is ESS progression as well so we’re looking at well validated tried and true endpoints in these studies on the basis of which to make our decision to go to Phase 3.
Your next question comes from Brian Abrahams – Wells Fargo.
Brian Abrahams – Wells Fargo
On the Alzheimer’s front you’re looking primarily at imaging endpoints with 037 and clinical endpoints with 2401 so I’m wondering how do you put all that information together to determine which antibody to move forward with, in what population you might proceed. Then real quick, I’m just wondering if you’re expecting any shifts in US reimbursement dynamics in the MS space given some of the concerns out there for pricing for other specialty drug classes?
Douglas E. Williams
With respect to the two different antibodies in Alzheimer’s disease, you’re correct that there is a straight cognition endpoint with the Eisai molecule. We’ve also built that in as exploratory endpoints in the BIIB037 study so the primary endpoint of the study is based on imaging as you point out but we’ve also built in [FDG PET] as sort of the surrogate for improvement in synaptic activity. We consider that to be sort of a surrogate clinical endpoint but we’re also looking at cognition and we hope to see a trend in cognition in that study as well. So, there are a number of endpoints that will help drive the decision making with respect to BIIB037 including both imaging and clinical endpoints as well.
Paul J. Clancy
On the second part of your question I mean no real additional color to provide. Certainly, we’re cognoscente that it could be a challenging environment. In multiple sclerosis the patient mix is kind of 80% private. At this point we’re very comfortable with our formulary status so we’ll just have to continue to see where the landscape takes us.
Your next question comes from Robyn Karnauskas – Deutsche Bank.
Robyn Karnauskas – Deutsche Bank
The first question, on LINGO I know that it’s a six month trial and I’ve heard from some physicians that some patients can recover faster than that especially with steroids so what are your thoughts on whether or not you’ll be able to see a difference between the treatment control arm giving the time element and how quickly LINGO might be able to act? The second question, what percentage of hemophilia treatments [inaudible] trial and what percentage of patients do you think would be the people who would switch first to new therapy?
Douglas E. Williams
With respect to LINGO, you’re correct that there are some patients that do respond to steroid therapy and show an improvement. The natural history studies that have been done looking at the kinetics of that improvement were taking into account when we actually powered the study to hopefully see a treatment effect in LINGO versus placebo. So, remember this is a placebo control trial that is randomized. It is on top of standard of care and so we took the natural history data into account when we designed the study both in terms of duration and in terms of the design of the endpoints.
Paul J. Clancy
On the trail question on hemo, we’re a little bit searching each other for that answer so I don’t think we have it handy but what I would point out is a couple of things. It was only about 120 or 125 patients and in fact, it was a worldwide trial and part of the rationale in a worldwide trial with the worldwide approval but also because we just needed to get to sites around the world in order to get to those patient numbers. Fundamentally we don’t believe the gating issue on launch is going to be the dynamic that you’re poking at. I think we just fundamentally believe that there’s a big unmet need in the marketplace for longer acting factors and that will probably carry the weight.
Your next question comes from Ying Huang – Barclays Capital.
Ying Huang – Barclays Capital
First of all, we know that there’s potential the FDA could approve a generic version of [COPAXONE] in May. I was wondering your thought on the impact on the pricing for the whole MS therapy class? Then secondly, on your collaboration with Eisai here for the [inaudible], it looks like there’s encouraging [CFF beta level] lowering which is also [inaudible] but then how much faith do you have that there is a correlation between that and then the clinical endpoint in the trials? For example the [inaudible]?
We’ve said before our expectation and our business plan does assume that there will be generic [COPAXONE] in the market this year. Obviously, there remains some uncertainty around that but we plan for it. Short term, we think the impact is on branded [COPAXONE] itself. We’ve also said it adds pressure to the overall market over time because it becomes an additional option that payers can use but we think it’s a very tough thing for payers to force a step out or switch to generic.
Douglas E. Williams
With respect to the base inhibitor, as far as the target itself there is some pretty strong genetic evidence that the enzyme itself is an important target in Alzheimer’s disease. That’s based on some recent data from an Icelandic cohort showing that patients who had a specific mutation in an around the [cleavage] site where the base one enzyme clips, those patients had about a 40% reduction in the amount of beta amyloid peptide that they produced and that was completely protective for those patients if they had that mutation even in the face of ApoE4, that was a protected mutation. So, 40% seems to be the target at least in terms of lifelong inhibition of the enzyme. The [inaudible] data from Phase 1 shows that you can dose escalate the compound and get to levels of inhibition sort of north of 90% at safe doses.
So, we think that we have a compound that’s capable of blocking the enzyme at levels that are sufficient to be meaningful and with respect to the ADAS-cog endpoint it is an accepted endpoint for clinical trials and we think it’s probably the most sensitive and most validated measure to use for these studies. The target is good, the endpoint is good and appropriate and we’ll wait to see the data.
I will now turn the conference back over to our presenters.
George A. Scangos
Thank you all for your attention today, for all the questions, and we can now all get back to work. Thanks.
This concludes today’s conference call. You may now disconnect.
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