Gilead Sciences Earnings Call Insights: ADAP Purchases and HCV Treating Physician Patients

Gilead Sciences (NASDAQ:GILD) recently reported its first quarter earnings and discussed the following topics in its earnings conference call.

ADAP Purchases

Geoffrey Meacham – JPMorgan: Congrats on the LONESTAR data. I have one question; two parts, one for Kevin. Since COMPLERA and STRIBILD are becoming more meaningful, is there anything you can speak to in terms of the mix of purchases by ADAPs and other folks? And then, the second part of the single question is LONESTAR – for Norbert, anything notable on the safety side or on the one relapse in the…?

Kevin Young – EVP, Commercial Operations: It’s Kevin here. As described by Robin, and as we said upfront in our fourth quarter results, we did have significant purchase ahead of demand at year-end and that’s reflected in our comments in the first quarter. Now, of course, these purchases; that’s sub-wholesale level, sometimes smaller wholesalers; ADAP, VA tend to favor the very high volume antiviral products; so, primarily TRUVADA, followed by ATRIPLA and some VIREAD. So, you can see there was less effect and extremely good growth in our new single tablet regimens as you point out, COMPLERA and STRIBILD. But when people typically buy in, whether that be commercial buyers or whether that be federal buyers, they typically go for the large volume items that move very quickly, and hence, that’s first and foremost TRUVADA, and secondly, ATRIPLA.

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Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: So, Geoff, with regards to the other question, there was nothing really remarkable about safety. I think you know in the placebo-controlled study of sofosbuvir there was really – the safety was very similar to placebo and adding 5885 to that doesn’t change it in anyway. The other thing you asked is there anything remarkable? The answer is no. We just had one relapse. But I have to tell you, I again have to emphasize this is in my mind the first time that an oral regimen is tested in a severely difficult to treat population. We had both previous PI failures and cirrhotic patients, 22 of them, and if you just look at that cohort 12 weeks of treatment either with or without ribavirin cured 20 of them, one was a relapse and one was lost to follow-up. So, 21 out of 22 or 20 out of 22 depending on how you count, it’s pretty remarkable.

HCV Treating Physician Patients

Wesley Nurss – ISI Group: This is Wes sitting in for Mark. I had two commercial questions. The first one is, how many patients do you estimate, both in the U.S. as well as developed Europe that are diagnosed and under the active care of an HCV treating physician today? And my second question is, when you initially launch sofosbuvir you’ll have the indications into G1 population for 7977 plus PEG-riba. What’s your view on the uptake and do you expect patients to wait for the all orals or do you suspect that uptake for this regimen will be fast?

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Kevin Young – EVP, Commercial Operations: Wes, it’s Kevin here. We’re still honing the number of patients currently on the care from active HCV treated and I think that’s something that as we get towards launch that we can talk a little bit more about. It’s obviously a very, very key figure. I think we’re going to be able to get there with some more data that we are collecting. There isn’t a really high quality database in HCV like we’ve had for a number of years with Synovate or Ipsos as it’s called in HIV and we’re working quite hard to try and develop that. So we want to make the quality of the data is good before we really firm up that number. In terms of launching, the nice thing is that we’re going to be able to launch sofosbuvir with either a riba or a PEG-riba in three genotypes. I think there may be some opinion leaders who are really on the cusp and particularly involved in the clinical studies who might wait for the all oral but our sense is that 12 weeks with interferon is a great step change to what they have today. I think we expect that physicians will get on and treat their patients particularly when the need is high, when they have more advanced disease. So we certainly think that 12 weeks with PEG-riba is very attractive and we’re going to be fully promoting that as well. So it’s not as though Gilead is going to be holding back at all.

Norbert W. Bischofberger, PhD – EVP, R&D and Chief Scientific Officer: Mark, I would like to add something. We talked obviously to a lot of KOLs people that treat a lot of hepatitis C patients and they told us when you ask the patients, they will tell you that 12 weeks is very acceptable to them whereas if you tell them, it’s 24 weeks or possibly depending on what response get on therapy, even 48 weeks, that’s a lot less emotionally acceptable.

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