AbbVie Earnings Call Nuggets: Growth Guidance and Drug Candidates
AbbVie (NASDAQ:ABBV) recently reported its first quarter earnings and discussed the following topics in its earnings conference call.
Jami Rubin – Goldman Sachs: Just a couple of questions. So on HUMIRA, sales were up 17% on an operational basis. Bill, you talked about tendering that could impact international sales, but still, your guidance for the full year of low double digit growth does assume, you know, decline in the pace of growth throughout the year. I’m just wondering if you could talk about why you expect such a slowdown or if it’s just too early in the year to make adjustments to your forecast? And secondly, if John Leonard is on the phone, I just wanted to ask a question on ABT-199, it sounds like you are making progress with the FDA in refining the trials so that you can remove the pause. But what gives you confidence that the tumor lysis syndrome is based on a dose response mechanism and not based on the drug mechanism itself? Thanks very much.
John M. Leonard, M.D. – SVP, Chief Scientific Officer: It’s John Leonard, I’ll go first. Just for everybody on the phone, to remind you, we had at the very end of last year some instances of tumor lysis syndrome in some of our early studies with ABT-199. We voluntarily paused enrollment in some of the studies that we were doing and with the FDA went on partial clinical hold for the CLL studies. In the last couple of months we’ve very carefully gone back retrospectively looking at all of those pictures to understand what might be the risk factors for TLS and now we’ve been working with the FDA, so let me give you a sense of exactly where we are. We’ve identified risk factors that we think are clearly related to the tumor burden itself. In other words, those patients had experienced any evidence of TLS, all had large tumor burdens associated with it. And with that we’ve taken that into consideration going forward. So, I’m pleased to report that many instances of multiple myeloma, non-Hodgkin’s lymphoma. We’ve resumed enrollment, so it’s actively going on and we’re in the very final stages of working with the FDA to resume enrollment in the CLL studies. Essentially what’s going on is some final work to refine the actual prophylactic regimen for handling some of the well-known side effects of TLS. I think to your question Jami, we’re pretty confident that one can step through dosing on an integrated fashion and have tumor die at a controlled rate and with well-known, well-characterized prophylactic measurements – or measures. We believe that we should be able to readily handle (TLS).
Richard A. Gonzalez – Chairman and CEO: Jami, this is Rick. So let me answer your HUMIRA question. Certainly, we’re off to a strong start. Now, one of the things that Bill pointed out in his remarks is we did have some tenders move from second quarter into first quarter, so first quarter is, you know, slightly up and we’ll see that reverse in second quarter. But all in all, still overall, if you looked at the average, we have very strong growth. We’re also only a quarter into 2013, so it’s probably a little early to change any projects that we have for the product. But I – suffice to say, we’re confident with the performance that we’ve projected for HUMIRA and we’ll just have to see how the rest of the year plays out.
David Risinger – Morgan Stanley: I have three questions on separate drug candidates. First, and, you know, I don’t think it’s worth going into a lot of detail because there would be too much ground to cover on HCV, but if you could hopefully just frame, as you see it, the timing of launch for your all-oral regimen and if you could position that relative to Gilead’s timing, that would be helpful in terms of the all-oral regimen. And then second, with respect to ABT-199, I’m just curious about whether there’s any risk of the lower dosing constraining the efficacy, yielding lower efficacy. And then finally, with respect to ABT-126, I noticed in the press release that you’re hoping to start Phase III trials next year. Could you just talk about the timing of news flow for ABT-126 for Alzheimer’s and also for cognition in schizophrenia? Thank you.
John M. Leonard, M.D. – SVP, Chief Scientific Officer: I’ve been scribbling notes with your questions. So ABT-126. Let me give you a sense of where we are David. We are doing Phase IIb work as we speak, and that’s meant to extend the proof-of-concept, call it IIa work that was done with modest sized studies and limited dosing. So what we wanted to do is more fully flush out with the efficacy curve might look like and with that characterize even higher doses that we were not in a position to test when we did our first study. Two different indications, you are correct, Alzheimer’s disease as well as cognitive disorders of schizophrenia or CIAS is it’s now called. With respect to the news flow, we will share the data from the first 2a study in Alzheimer’s disease in July at the Alzheimer’s meeting and our plans right now for the CIAS data would be in 2014. We haven’t chosen a venue yet, but as we have that, obviously we’ll share that with you. Let me move on to 199. It’s sort of an extension I think of Jami’s earlier question. The premise of your question I think is a little incorrect, if I understood it. I took it to imply that what we’re doing is giving lower doses on a continuous basis to patients and therefore at higher doses that we might want to get to may not be reached and therefore, efficacy might be constrained a bit. That’s not what we’re doing. Essentially what we’re doing is a walking up through lower doses and we’re convinced that as tumor dies the risk of tumor lysis syndrome will recede because there’s less material from the tumor to be dealt with and therefore you can get to those higher doses that have been associated with the outstanding activity that we’ve observed today. So it may take a little bit longer to get there, which is what we’ll be working out here as we go, but in terms of being able to deliver what we want to deliver for these patients, we’re very confident we’re going to be able to get there. And then finally HCV was the first question, launch timing. I mean, it’s no secret that we’re all working as fast as we can. It’s a very competitive space. We have an excellent team on that. They’re working flat out. We’ve communicated along the way that we would expect a very early 2015 launch. We’re confident that we will meet that and we’ll see where Gilead is with respect to that timing as well.