Gilead Sciences Earnings Call Insights: Stribild Progress, G3-7340 Studies

On Tuesday, Gilead Sciences Inc (NASDAQ:GILD) reported its third quarter earnings and discussed the following topics in its earnings conference call. Take a look.

Stribild Progress

Geoffrey Meacham – JPMorgan: Congrats on the quarter. Just got a couple for Kevin and then one for Norbert. For Kevin, I know it’s early on Stribild a bit, are you guys seeing uptick at the expense of PIs and how much of a driver do you think the switching studies will be with respect to share? Then for Norbert, you guys have talked about the 7977, 5885 combo study on last call and I wanted just to know if anything has changed and how you are thinking about the second pivotal study, what types of patients, what types of patients, what types of designs you think you will employ things like that?

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Kevin Young – EVP, Commercial Operations: Jeff, this is Kevin. We are pleased with the progress so far on Stribild. It is early days almost two months of launch. The sales you saw in Q3 were very much the inventory fill for the wholesale and that’s very similar to the amount we put out to year ago when we launched Complera. I think we’re particularly pleased with the access that we’ve got. It’s very much quicker than we have for Complera, the ADAP programs particularly have taken up Stribild and we almost have 505 which will be in procedure to have the fixed of the big five that ADAP programs have coverage of Stribild. Twice as many prescriptions for Stribild as Complera, so it’s running head of Complera, it’s running ahead of the uptick of Prezista. It’s more looking like an uptick of Isentress. So, I think overall we would consider I think the launch of Stribild more Atripla like and less Complera like. Obviously, you don’t have the bolus of conversions that Atripla had, but our sense is that’s probably a little bit more been used in the naive setting than in the switch setting. Other sense, and again it’s early, is that the uptick is probably coming at the expense of the protease inhibitors as per your comment earlier. So, it seems to be more have been used in the naive setting than switch. The switch data will help in having in the label will help, but the team, our expanded team is very much positioning this as the preferred regimen for upfront use in new patients as an alternative to – Atripla as an alternative to the boosted protease inhibitors.

Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: Now, Geoff, with regards to your question about the Phase 3 program, the big answer is, no, nothing has changed. As John mentioned, the first Phase 3 study, the first patient was dosed last week and just to underscore the rapidity of enrollment, we actually had to close the study for screening last week as well because we had enough patient in screening so that we can enroll the first 200. So, we’re going to take a look at this, the two 12-week arms sometime in the first quarter next year probably March and then we’ll make a decision as to what to – whether we’re going to continue to randomize patients in this study. Then with regards to the other study, keep in mind, we have other data coming in. The two data sets will be presented at AASLD, one of them is the 12-week arms of the Bristol-Myers’ daclatasvir 7977 combination and another one is the 7977/5885 ribavirin in genotype 1 naive patients in the ELECTRON study. Then we have a third arm in ELECTRON ongoing 7977/5885 ribavirin in genotype 1 null responders. We will take all this data into consideration and based on that design the second Phase 3 study, which would start pretty much at the latest around the same time as we’re going to reopen this current study for re-randomization and re-enrollment. But just briefly, this could be a very simple potentially one-arm study with a 12-week arm depending on the outcome. It could also include treatment experienced patients depending on what the data look like of the combination in the null responders with health gain. So I hope that answers the question. So it will all become clearer over the next two to three months what the nature and the design of that second Phase 3 study is going to be.

G3-7340 Studies

Matthew Roden – UBS: Congrats on the quarter. A question for Norbert on GS-7340. Is it reasonable for us to think about the potential to lower the incidence of renal adverse events with 7340 versus the standard of care? How many patients do you think would need to be treated and for how long to really start to tease out whether or not there is a difference here?

Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: So, Matt, that’s exactly what we’re hoping to be able to show. So, essentially 7340 is the same active ingredient as is in VIREAD, but it’s dosed at 1/10th the dose and now we say that unless you believe in homeopathy, it’s reasonable to assume that this compound has better, say, tolerability and safety and the two things in particular are BMD and creatinine clearance changes. Now, I personally think that BMD changes are easier to show because simply we saw about a 2% net BMD loss with VIREAD across a whole number of studies and if this compound is better, then it should be easier to show statistic. With regards to creatinine clearance, it really depends on the effect size and the variability, but we think in a Phase 3 study you should actually be able to show that and this will become clearer or by the way as John Martin said in his script, we should actually get the Phase 2 to final (20, with) Phase 2 data from the first study in a month or so and then it should become clearer what the powering will be for the Phase 3 study.

A Closer Look: Gilead Sciences Earnings Cheat Sheet>>