Roche Holding Earnings Call Insights: Pipeline Details and Kadcyla Outlook

Roche Holding  (RHHBY) recently reported its first quarter earnings and discussed the following topics in its earnings conference call.

Pipeline Details

Timothy Anderson – Sanford C. Bernstein & Co., LLC: My questions, all have to do with the pipeline and different things that you’ve shown in the slides. On Slide 21, on your PD-L1 cancer compound, you talked about seeing – presenting efficacy data at ASCO from three Phase I studies. Can you say whether it’s reasonably possible that you’ll leapfrog straight into Phase III trials from here in the current year, essentially bypassing Phase II? Then a couple of Alzheimer’s question. You have two monoclonals in development, gantenerumab and crenezumab for Alzheimer’s. Is it realistic to think that you’re going to really push both of those through Phase III or at some point you’re going to choose just one of the other, because those trials are expensive and those compounds have a reasonable amount of similarities? Then on your base inhibitor, Slide 94 shows that you’re running quite a large Phase I trial that raises the possibility in my mind that maybe you could go straight into Phase III after the completion of that trial.

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Dr. Alan Hippe – Chief Financial and IT Officer: The first question I think is on PD-L1, whether we consider to directly going to Phase III?

Daniel O’Day – COO, Pharmaceuticals: So at this stage, we haven’t made any decision regarding that program. I think the best thing to do because we have to really audit the data at ASCO and to wait until ASCO. And I think after you take a look at the data there, we can have the discussion in more detail. But I would just say that we’re looking forward to presenting the data; it would be data on safety there, there will be some efficacy data as well in the indications that we mentioned and it will be a bit premature to decide how fast we can move those programs at this stage. You’ll also see some data there on biomarkers as well for PD-L1. The second question on neuroscience, I don’t know, if you want.

Dr. Alan Hippe – Chief Financial and IT Officer: Yeah in neuroscience we have (indiscernible) that we have already won combined Phase II, III trial ongoing and we expect data from crenezumab still this year. So, it will all be data driven very clearly. Depending on the data we get from crenezumab, we will make a decision of better to go forward with the second compound in Alzheimer and we might go forward with two if they are really differentiated. And we might go forward with one if one of the compounds is clearly superior. Your last question was on…

Daniel O’Day – COO, Pharmaceuticals: Again, we appreciate your enthusiasm. It’s still in Phase I right now. So far it’s bit early to determine how fast we could progress that or when we can progress that. But as most of these products is – once we get the data bring it in-house or make decisions. But of course we see very compelling signs. We certainly won’t be afraid if we move ahead quickly.

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Timothy Anderson – Sanford C. Bernstein & Co., LLC: I guess the reason I ask is that your Phase I trial is really as big as other company’s Phase II trials with their base inhibitor. So, it kind of looks like what you are running is really a Phase II trial that was the reason for the question?

Daniel O’Day – COO, Pharmaceuticals: I appreciate what you are saying here. So, let’s take a look at the data and it’s very compelling, I think, we could progress ahead we’ll have to take a look at it.

Dr. Alan Hippe – Chief Financial and IT Officer: But we have no indication either way. So, it’s really – it will be data driven.

Kadcyla Outlook

Steve Scala – Cowen and Company: First on Kadcyla, the product has had a fantastic rollout. How far along are you in establishing access in the U.S.? Secondly, follow-up on gantenerumab, in what venue might we see gantenerumab Phase II data and will we see efficacy endpoints in Phase II? Then the third question is, our analysis of the dispute over 7977 suggests Roche has a very credible argument. Would you tell us whether or not negotiations with Gilead are underway or if arbitration has commenced? Does Roche’s new information relate to prodrugs of 6130?

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Daniel O’Day – COO, Pharmaceuticals: Steve, I will take those. It’s Dan here. Thanks for the questions. Again, we are encouraged by the Kadcyla initial launch. But it’s early days. It has only been weeks. We are looking forward to having months behind us, but we’ve had some good reordering of the initial stock. I would just say probably that that indication of reimbursement and access in the U.S. is, as you know, the NCCN guidelines, which we do have now after a very short of period of time, 19 days and at the present time I think that is really, as you know, what insurers look to in the United States in terms of reimbursement. I think your second question was on gantenerumab. I just want to emphasize again that this has been transition from a Phase II to a Phase, if you like, Phase II/III or a label-enabling program. Therefore before it was transitioned to that and we have increased enrollment, we really don’t expect any substantial news on that compound until it reads out, which I believe if you remind me in 2015, yeah. We do have perhaps an interim that’s going to take a look at imaging and safety over the course of this year, but I want to put that into the proper context. We don’t expect to see an awful lot at that particular stage and certainly, nothing on efficacy accordingly. Then finally on 7977, your persistency, well, I appreciate that. I’d just say that we will really continue to stick to what’s in the public domain at this stage which is the Gilead 10-K. We have asserted our belief in the rights to 7977. It is now in a process which I’m not going to really speak to the details of what type of process we are in right now, but we will continue to pursue that process and the rights that we believe we have. I’m afraid I can’t say much more than that at this stage.

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