Biogen Idec Earnings Call Insights: FUMADERM and BG-12 Factors

Biogen Idec Inc (NASDAQ:BIIB) recently reported its fourth quarter earnings and discussed the following topics in its earnings conference call.


Mark Schoenebaum – ISI Group: Congrats on a great year. As you know, it’s our job in the investment community to worry about the unlikely. So, with that in mind let me ask the following questions if you don’t mind. Could we maybe get your updated thoughts on the potential impact of the PML cases linked to FUMADERM in Germany on your BG-12 regulatory applications? Also I think there’s a recent blog post by Dr. Gold which seemed to suggest that – it seemed at least to suggest that some BG-12 patients he thought should be monitored – should other white blood cell counts monitored, so I would love to hear your thoughts on that. Finally what do you expect the FDA and EMA to do with the BG-12 pre-clinical kidney cancer signal that you disclosed many years ago? I remember you disclosing it many years ago, but which Teva referred to in its recent CP. Then I will get back in the queue. I really appreciate you entertaining my paranoid delusions.

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George A. Scangos – CEO: Let me just point out that it’s also our job to worry about unlikely events. But let me take those two things, one at a time and this is like the guest who won’t leave the party I guess. But anyway, look let me take the PML stuff first. We talked about this at JPMorgan. SO let’s first talk about BG-12. It’s been studied in 3,600 patients including a long-term extension study, zero cases of PML, no opportunistic infections, looks great. With FUMADERM in 180,000 patient (years) there’ve been three cases of PML and there’s one additional case that’s been reported in a patient taking formulated fumaric acid esters. So lump those together you get four cases in 180,000 patient (years). So the first thing to say is that is kind of the normal rate that you would expect to see in a population of patients with an autoimmune disease. There is nothing alarming about that. Two of those cases are heavily confounded, patients taking other drugs, having other risk factors for PML. Two of them, which I think are the two patients to which Dr. Gold alluded in his post last week were lymphopenic for sustained periods of time. Lymphopenia is also known to be a risk factor for PML. So the two cases reported last week are not new cases; they are two of the four cases that are already known. He mentioned that they are going to be published in a major medical journal. That’s true, but I’m just being glad you asked the question because we can make it clear here, those are not new cases, these were the old cases, and the rates are low. So that’s all there is I think to say about that. Now on the kidney issue, this came from a website that was being constructed for internal use only. Actually the information on that website were not completely accurate, they were not vetted completely by us, let alone even submitted to any regulatory agencies, let alone approved by any regulatory agencies and they were largely meant to be placeholders for the site, so we could substitute the official information and get the site up quickly after approval. The data on the site was accessed by Teva and the data were inappropriately used to file their citizen’s petition that they filed. The data are not new, they are old. We disclosed those data as you pointed out many years ago. The regulatory agencies have had them for years, for those reason that we did the renal monitoring during the clinical program and as you know from looking at the Phase 3 data there were no signs in the renal trail in humans. So, we feel very comfortable about the safety profile of BG-12 and about the risk-benefit profile of BG-12, and we are still aiming for an approval at the end of March. As I said before, we take these concerns now to be – I think the noise about them now is largely a question of competitive pressure, rather than anything else.

BG-12 Factors

Eric Schmidt – Cowen and Company: Maybe best for Paul, you laid out a lot of factors on BG-12 for us to think about in terms of how to model launch. When you look at the analyst models out there, maybe specifically consensus of about $330 million for the year, are you getting the sense that the streets thinking is aligned with your own, and if not where do you think there is a disconnect?

Paul J. Clancy – EVP and CFO: I think the – I’ve been working to try to do is just try to point out the fact that post the PDUFA delay last year, I think there were a fair amount of models that actually didn’t adjust for the fact that its nine months in the United States as opposed to 12 months. Then, I think the other key thing is that compliance for BG-12, we just actually don’t know. So, we’re kind of being a little bit cautious that looking at twice a day drugs as opposed to once a day drugs kind of the benchmark being – kind of Gilenya that there is a good chance that compliance coming out of the gates maybe a little bit lower. We’re going to be putting in place a lot of programs, pharmacy programs and alike, to make sure over the medium term that patients are taking the therapy appropriately. So, falling short a little bit of exactly answering your question on the number, the spot number, just want to really point that stuff out. It’s obviously a range. I think that we’ll know that as we get into it. We are very comfortable with the longer-term projections which also obviously is a range. But just for this year just wanted to try to really point a couple of those factors out.

A Closer Look: Biogen Idec Earnings Cheat Sheet>>