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Gilead Sciences, Inc. (NASDAQ:GILD)

March 07, 2012 4:30 pm ET

Executives

Susan Hubbard - Vice President of Investor Relations

Norbert W. Bischofberger - Chief Scientific Officer and Executive Vice President of Research & Development

Paul Sax -

Andrew Cheng - Senior Vice President of Development Operations

Analysts

Michael E. Ulz - JP Morgan Chase & Co, Research Division

Mark J. Schoenebaum - ISI Group Inc., Research Division

Matthew Roden - UBS Investment Bank, Research Division

Yaron Werber - Citigroup Inc, Research Division

Sapna Srivastava - Goldman Sachs Group Inc., Research Division

Brian Abrahams - Wells Fargo Securities, LLC, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

M. Ian Somaiya - Piper Jaffray Companies, Research Division

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Conference Call. My name is Stacey, and I will be your conference operator for today. [Operator Instructions] As a reminder, this conference call is being recorded today, March 7, 2012. I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations. Please go ahead.

Susan Hubbard

Thank you, Stacey. And good afternoon, everyone. Thank you for joining us today to discuss the 48-week results from Study 102, the pivotal Phase III study of our Quad drug head-to-head versus ATRIPLA. You can find the press release detailing the study results, as well as a link to the slides presented here today on our website at gilead.com.

We have Dr. Paul Sax with us today, the lead investigator from the study. Dr. Sax will recap the presentation he just gave here in Seattle at the Conference on Retroviruses and Opportunistic Infections. Dr. Sax's comments today will reflect his own conclusions, opinion and analysis and do not necessarily reflect Gilead's conclusions, opinions, and analyses. We're also joined today by our Executive Vice President of R&D, Norbert Bischofberger; and Andrew Cheng , our Senior Vice President of HIV Therapeutic and Development Operations. Dr. Sax, Norbert and Andrew will be available to take your questions following the presentation.

As a reminder, the purpose of this call today is to cover the details of the Study 102 results and answer any questions you have on the data from either Study 102 or 103. Because the Quad is still an investigational agent not yet approved by FDA, we're not in the position to comment on this call how the data may translate into prescribing information or uptake in the market.

We will also be making forward-looking statements regarding the Quad. These statements are subject to risks and uncertainties that may cause actual results to differ from those expressed in any forward-looking statements. These risks include the possibility that the FDA, the European Medicines Agency and other regulatory agencies may not approve the Quad and risks related to the anticipated timelines or any regulatory review and approval.

In addition, even if approved, physicians may not see the advantages of the Quad over other therapies. Description of these and other risks can be found on our latest SEC disclosure documents and recent press releases. In addition, please note that we undertake no duty to update or revise them.

I will now turn the call over to Norbert for opening comments.

Norbert W. Bischofberger

Thank you, Susan. As Susan mentioned, we're very pleased to have Dr. Paul Sax joining us today to present the 48-week results of Study 102. By way of introduction, Dr. Sax is the Director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston. He is an Associate Professor at Harvard Medical School and has been on the faculty for more than 14 years. Dr. Sax received his M.D. from Harvard Medical School in 1987. He fulfilled his residency in Internal Medicine at Brigham and Women's Hospital by continuing his postdoctoral education with fellowships at Harvard and the Infectious Disease Unit of the Mass [Massachusetts] General Hospital. Dr. Sax is board certified in internal medicine and infectious disease. Apart from his clinical and teaching work, Dr. Sax is also involved in many professional societies, such as the Mass Medical Society; the Infectious Disease Society of America; and the Massachusetts Infectious Disease Society. He serves on editorial boards of AIDS Clinical Care; Infectious Disease Special Edition; UpToDate; and Medscape. He is on the core faculty of the International AIDS Society-USA and the New England AIDS Education and Training Center.

Gilead has worked with Paul for more than 10 years and he is an investigator in many of our clinical studies.

I will now turn over the call to Paul to present the study results. Paul?

Paul Sax

Thank you very much, Norbert. So I'm going to go through the slide presentation that I just presented at the Retrovirus Conference. Slide #2 provides a bit of background. We know that the standard of care treatment right now, HIV therapy is the co-formulated non-inferior FTC efavirenz tablet, one pill a day, also called ATRIPLA. And also there's an investigational single-tablet regimen that includes the integrase inhibitor elvitegravir, the PK booster cobicistat and the nucleoside analog tenofovir and FTC. This is the so-called Quad. Phase II data, published last year demonstrated that these 2 approaches were comparable, which led to the Phase III data that I'll be presenting now.

Next slide shows the study design. It's a randomized double-blind placebo-controlled trial. Treatment-naïve HIV infected patients with any CD4 cell count and HIV RNA greater than 5,000 were enrolled and then randomized to receive either the Quad once daily or the efavirenz-based regimen [Audio Gap] daily. They also received matching placebos. It was protocol-specified stratification by HIV RNA. The randomization was one-to-one and the study was conducted at sites in the United States and Puerto Rico.

The primary endpoint, with the portion of patients to the HIV RNA less than 50 copies at week 48 using an FDA snapshot analysis and the intention to treat approach of analysis. There is a 12% non-inferiority margin for meeting their non-inferiority thresholds. And as Norbert mentioned, there's also a Study 103, which was done in parallel. This is the Quad comparing to a boosted atazanavir or boosted ritonavir regimen.

On the next slide, we see the baseline characteristics. 348 patients received Quad, 352 patients received ATRIPLA. The study population was well balanced overall. They're predominantly male. There was a significant proportion who are nonwhite. Approximately 1/3 had HIV RNA greater than 100,000 and the mean CD4 cell count was in the high 300s.

The next slide shows the study disposition through week 48. 917 patients were screened for the -- 700 were involved. The most common reason for screen failure was HIV RNA less than 5,000. In the Quad arm, 11% discontinued before week 48; in the ATRIPLA arm, 13%. And the reasons for discontinuation are roughly similar between the 2 study arms.

We'll now move on to the next slide to the primary results. At week 48, 88% of the Quad-treated subjects and 84% of the ATRIPLA-treated subjects had an HIV RNA below the limits of detection. On the right side of this slide, this one bit difference of 3.6% is plotted. You'll note that the lower bound of the 95% confidence interval is a minus 1.6. This is well within the minus 12 range of meeting non-inferiority threshold. So clearly, Quad was not inferior to ATRIPLA at week 48. Approximately equal numbers of patients had virologic failure, 7% in each treatment arm, and equal numbers had no week 48 data. Most of these were lost to follow-up.

We're going to look at the next slide, on the efficacy results based on protocol-specified baseline characteristics. This figure, the top line, is the overall results. Results that are to the right favor the Quad, results that are subluxed favor the ATRIPLA arm. The top line, as I said, is the overall and this is similar to the same data that I showed you in the previous slide. And then along the vertical axis, we have age, less than or greater than 40, sex, race, baseline HIV RNA from the H diff of 100,000 strata, baseline CD4 cell count and study drug adherence.

As you can see, the point estimates for each of these baseline characteristics tend to favor the Quad. Above 95% confidence intervals on these estimates tend to cross 0.

Looking at the next slide now, we see stratification based on HIV RNA less than or greater than 100,000 and CD4 cell count less than or greater than 350 cells. The focus on the middle 2 comparisons, the greater than 100,000 and the less than 350 cells, these are the harder-to-treat patients, and you'll see that the greater than 100,000 group, 84% of the Quad arm and 82% of the efavirenz arm showing virologic success. With the less than 350, again, very similar proportions, 83% and 84%. This is an area of vulnerability for some regimens as there's high viral load, but it clearly was not the case with Quad.

On the next slide, we have the immunologic response. At week 48, the Quad-treated subjects had gained 239 cells and the ATRIPLA-treated subjects had gained 206 cells. This is a statistically significant difference at P equals 0.009.

Then the next slide, looks at the resistance analysis. Patients who had a suboptimal virologic response, either never suppressing their viral load or rebounding and had an HIV RNA greater than 400 copies were eligible to undergo resistance analysis. Virologic failure of this magnitude was rare in both study arms, 4% in the Quad and 5% in the ATRIPLA arm. Among these patients who had virologic failure to this degree, half of them had evidence of resistance, 2% from Quad and 2% in ATRIPLA. Among the Quad-treated subjects, all 8 developed nucleoside resistance mutations, and 7 of the 8 developed resistance to the integrase inhibitor, most commonly the E92Q. Among the ATRIPLA arm, all 8 developed resistance to the NNRTIs, most commonly K103N, and 2 developed resistance to the nucleoside analogs.

This proportion of patients with resistance to the integrase inhibitor and the nucleoside analogs is similar to what was observed in the Phase III study comparing raltegravir or Isentress to ATRIPLA.

In the next slide, we look at common adverse events. Common in this table is defined as adverse events experienced by 10% or more of study subjects. Those that had an asterisk or other mark are statistically significant between study arms. Nausea occurred in 21% of the Quad-treated subjects and 14% in the ATRIPLA-treated subjects. This nausea was grade 1 nausea, meaning the mildest type, and led to study drug discontinuation in only one patient. Abnormal dreams, insomnia, dizziness and rash, all side effects known to be associated with efavirenz, a component of ATRIPLA, occurred more frequently in the ATRIPLA-treated subjects than in the Quad-treated subjects.

On the next slide, we have the study discontinuation due to adverse events. 4% of Quad and 5% of ATRIPLA-study subjects discontinued therapy. 1.4% of patients discontinued ATRIPLA due to rash or drug hypersensitivity. 1.4% of patients discontinued Quad due to renal abnormalities.

As you know, cobicistat is part of Quad and cobicistat has a small effect on serum creatinine through inhibition of creatinine tubular secretion. Among these patients who discontinued due to renal abnormalities, one had this minor elevation of serum creatinine and the study investigator elected to discontinue the patient. The other patients in this group developed what was characteristic tubular toxicity from tenofovir. On cessation of the study drug, the abnormalities reverted back to baseline.

In the next slide, we have grade 3 and 4 laboratory abnormalities. These are the more severe laboratory abnormalities. And as noted here, these occurred for more than 5 subjects in any treatment arm. Rates of these severe laboratory abnormalities were infrequent in both the Quad and the ATRIPLA arm.

This next slide shows the median change from baseline in serum creatinine and further delineates the cobicistat effect. The Quad-treated subjects at week 48 had a 0.14 milligram per deciliter increase in serum creatinine. The bulk of this increase occurred within the first 2 to 4 weeks of treatment and then stabilized. The Quad -- the ATRIPLA-treated subject had a 0.01 milligram per deciliter increase. The lines around these lines, vertical lines, are the interquartile ranges.

And then last, on the next slide, the median change from baseline in fasting lipids through week 48. The total cholesterol, LDL cholesterol and HDL cholesterol, all increased significantly more in the efavirenz or ATRIPLA-treated subjects than in the Quad-treated subjects. The total to HDL cholesterol ratio was not different and the triglyceride changes were not different as well.

So in the next slide, I summarize by noting that the Quad demonstrates in this study non-inferiority to ATRIPLA, and this is the first fully powered study comparing one tablet daily HIV regimens.

Virologic suppression rates were 88% versus 84% for Quad and ATRIPLA, respectively. Importantly, the non-inferiority in the virologic suppression was consistent across protocol-specified subgroups including HIV RNA greater than 100,000 copies. Quad was overall well tolerated with a similar rebound rate. Treatment discontinuations to ATRIPLA, fewer reports of abnormal dreams, insomnia, dizziness and rash, a higher rate of grade 1, but not higher grades than that nausea, and a median 0.14 milligram per deciliter increase in serum creatinine. There are 1.4% of patients discontinued Quad due to renal events and smaller increases with Quad in total cholesterol and LDL.

On the next slide, I mention briefly about Study 103. At this conference, Quad is also demonstrated to be non-inferior to atazanavir or ritonavir in the Phase III Study 103. Quad responses were 90% versus atazanavir response -- ritonavir response into the 87%. And in this study, 0.3% of subjects in both arms discontinued due to renal events.

The full results of these 2 studies, both Study 102 and Study 103, have been submitted for peer review publication. And health authority filings for the Quad have been submitted in Europe, Australia, Canada, Switzerland and in the United States.

So that brings me to the end of the presentation.

Susan Hubbard

At this point operator, we'll open up the call to the question-and-answer session.

Paul Sax

Thanks, Susan.

Question-and-Answer Session

Operator

[Operator Instructions] Your first question comes from the line of Geoff Meacham with JPMorgan.

Michael E. Ulz - JP Morgan Chase & Co, Research Division

It's actually Mike in for Geoff. Just curious if Dr. Sax could maybe comment on the nausea for the Quad. I know he's mentioned it was mostly grade 1, but what was kind of the distribution? Is it something that generally occurs?

Paul Sax

So mostly grade 1. In fact, the only area where there was a difference between the 2 study arms was grade 1. There was no difference between 2 study arms in higher grades of nausea, and only one patient discontinued due to the side effect.

Michael E. Ulz - JP Morgan Chase & Co, Research Division

And was that mostly seen when you started dosing, or is that something that was sort of persistent over time?

Paul Sax

It was seen when dosing was started and did not necessarily persist over time.

Operator

Your next question comes from the line of Mark Schoenebaum with ISI.

Mark J. Schoenebaum - ISI Group Inc., Research Division

Dr. Sax, given how apparently clean the data set looks, as you know, the FDA is -- plans to convene a panel. I was just wondering, from your perspective, what do you think might be discussed in a panel like that? I realize you can't speak for the FDA, but just when you look at the data, what kind of issues or questions do you think merit vetting by a panel of your peers?

Paul Sax

I really can't speak on behalf of the FDA. I have to say that's an excellent question, but I have not been involved in any FDA reviews. So I'll maybe ask some of my colleagues here.

Norbert W. Bischofberger

Yes, Mark, as you may know, we contacted the FDA when we heard about their plans for a panel meeting. And we asked them this question and they said there were no concerns about safety or efficacy. It had to do with the policy that these are 2 new drugs that are approved at the same time, and they felt it would be warranted to have a panel meeting. That's what we heard from the clinical reviewer at the FDA.

Operator

Your next question comes from the line of Matt Roden with UBS.

Matthew Roden - UBS Investment Bank, Research Division

Dr. Sax, I wonder if you could put on your clinical hat and speak for your colleagues, and what I wanted to ask is how do you think the clinical community, the HIV clinical community, will interpret the efficacy and safety data across both studies here? Do you think that they'll simply look at the non-inferiority and the comparable data and think that this is pretty much the same? Or do you think that people will say that there's several favorable trends here, both on efficacy and safety, and maybe this adds up to an overall better profile? How do you think that this will be received?

Paul Sax

Yes, I mean, based on the data, and again I'm speaking now as sort of HIV treater as much as an HIV researcher, this is clearly as effective virologically as the standard of care treatment. So no concerns there. It has certain favorable properties. We've known for a while that ATRIPLA or efavirenz in ATRIPLA has central nervous system side effects and the rates were significantly lower. We know that, that drug can cause rash and the rates are significantly lower. So I would say that in most patients, this would be a very favorable option. Each person's individual and each treating physician with each of the individual patient will make those decisions. But these results are very, very, very favorable overall.

Matthew Roden - UBS Investment Bank, Research Division

Does any one characteristic stick out to you as being differentiated?

Paul Sax

Probably on the favorable side is the fact that it doesn't have as much central nervous system side effects or rash. And then for fair balance, any drug that has booster in it, either ritonavir or cobicistat, will have more drug interaction, that's inevitable.

Operator

Your next question comes from the line of Yaron Werber with Citi.

Yaron Werber - Citigroup Inc, Research Division

So Dr. Sax, just give us maybe a little bit of a sense as to -- there's been a lot of concern back in the Phase II data about the potential for creatinine -- serum creatinine elevation, and now we know it really is related to inhibition of clearance. And it's visibly significant over the ATRIPLA arm, but if you look at the mean change from baseline at week 48, it's very little. So do you have any sense of -- and it looks like it's not cumulative, it looks like it plateaued. Do you think you're going to need to monitor the patients? And how much of a challenge is this going to be, if at all?

Paul Sax

Yes, one thing that is probably well known to you guys and certainly is to HIV treaters, is that it's standard of care for any patients on a tenofovir-based regimen, or any regimen for that matter, to have their blood test monitored on at least a twice-yearly basis and that includes measurements of renal function. So if one were to do that, and that's just standard of care, and one were to have a very small increase in serum creatine that you knew was a predictable result of a drug you were given, I wouldn't be concerned at this. And these data are actually reassuring. There is the small chance of tenofovir-related toxicity. And we know from both this study and from many, many other studies since the drug was first investigated and then approved in 2001, that there are certain patients who are greater risk for tenofovir toxicity, and those are the people who have baseline renal insufficiency or on other nephrotoxic drugs. So I would say that in the totality that these are reassuring data, and monitoring is still recommended.

Operator

Your next question comes from the line of Sapna Srivastava with Goldman Sachs.

Sapna Srivastava - Goldman Sachs Group Inc., Research Division

I was curious as to how would you use Quad once it's commercially available, both in front-line regimen and potentially which regimen do you think you could switch the patients away from, and at what time point do you put them on the Quad pill?

Susan Hubbard

Sapna, this is Susan. As we sort of said upfront, this is still an investigational drug and we don't have approval yet. We really don't want to speculate on where the first uptake's going to be once it's approved. So if you like to ask a question specifically around the data set, that would be great.

Sapna Srivastava - Goldman Sachs Group Inc., Research Division

I mean, I guess, just my view of the data set is like how would you compare this to the other data sets that we have seen for other regimens which include either integrase inhibitors or protease inhibitors and how should we think about them compared to those data sets?

Paul Sax

That part is -- we now have had the first line raltegravir data available for us for some time in the Stark Merck Study. And on the one hand, that drug, it was a major advance in HIV therapeutics when it was approved in 2007. It has many advantages. The disadvantage of Isentress -- of raltegravir, is that it has to be given twice daily and there's no co-formulation available right now. So for me to compare the 2, I would say they have -- appear to have very comparable and excellent efficacy, both drugs. But this treatment would be more convenient certainly.

Sapna Srivastava - Goldman Sachs Group Inc., Research Division

And just your thoughts on the protease inhibitors?

Paul Sax

So protease inhibitors tend -- well, we know from the Study 103, if you could just look at the Study 103 results, you see that, that Quad performed just as well as the boosted atazanavir, which is another preferred initial regimen. One thing that was seen in that study and in this study, which is a pleasant surprise, is that even though this drug does contain cobicistat as a booster, lipid changes were actually better than ATRIPLA in this study and just as good and a little bit better than the boosted atazanavir, so that's good news. With protease inhibitors, one of the major benefits of those regimens for initial therapy is that when treatment failure occurs, resistance does not seem to be a problem, and that's distinct to the protease inhibitor class and is not seen with any other treatment approaches, including ATRIPLA, including Quad, including Isentress, including Rilpivirin, none of those. So that will remain an advantage of protease inhibitors. But as you saw from the data, actual treatment failure and resistance is still pretty rare.

Operator

Your next question comes from the line of Brian Abrahams with Wells Fargo Securities.

Brian Abrahams - Wells Fargo Securities, LLC, Research Division

A question for Dr. Sax on the barrier to resistance. You mentioned the greater NRTI mutation seen on the Quad arms, both in your study and in Study 103. Just wondering how important is this with respect to thinking about potential next line options for those few patients who do fail treatment. Would this give you pause at all in using an integrase-based regimen on the frontline?

Paul Sax

This is one of the issues where protease inhibitor, as I just mentioned in the previous question, continue to have an advantage. And again, speaking about other drug developments that the drug development potentially, which has been publicly announced of a single pill darunavir, ritonavir, cobicistat and 7340 is an exciting one for that reason. There's still a role for a protease inhibitor-based therapy, but the reality is that most people in clinical care do take their medicines quite faithfully and have an extremely low risk of developing virologic failure and resistance, so they're the exception rather than the rule.

Norbert W. Bischofberger

Brian , can I just add something? You said it was also observed in Study 103, that's not the case. We did not do any virologic -- we had virologic failures, but there was no resistance in Study 103. Andrew, was that correct?

Andrew Cheng

On the atazanavir arm, there's no resistance, but we didn't -- there were people who developed integrase resistance.

Brian Abrahams - Wells Fargo Securities, LLC, Research Division

I was referring to the NRTI resistance specifically.

Andrew Cheng

I actually agree that the NRTI resistance as a consequence of treatment failure in integrase regimens have been consistently observed now both in these 2 studies as well as in the raltegravir studies.

Operator

Your next question comes from the line of Robyn Karnauskas with Deutsche Bank.

Robyn Karnauskas - Deutsche Bank AG, Research Division

I was wondering if you could comment on RNA curves over time and whether or not they appear to come together or separate over time because that wasn't in the presentation.

Paul Sax

So we do have information on trends of virologic suppression, and as this is an integrase-based regimen, virologic suppression was faster with the Quad than it was with the ATRIPLA arm, and I believe it was faster through week 12 or 24. It's clearly the first phase of the study it was faster, and then the curves came together over time and became virtually superimposed by week 48. And this is an observation that's been seen now in multiple integrase studies.

Robyn Karnauskas - Deutsche Bank AG, Research Division

And can you just also clarify the creatinine clearance? I mean, can you just characterize that a little bit more in a relative basis to other drugs?

Paul Sax

Yes. So we now have learned about several other drugs that have this property that impair creatinine -- tubular creatinine secretion, including, interestingly, other investigational antiretroviral agents such as the integrase inhibitor, the raltegravir, and then the recently approved NNRTI, Rilpivirin. Looks like most patients did about 0.1 milligram per deciliter, between 0.1 and 0.2. This is a relatively small amount, and I have to say in clinical practice, one would probably not notice it very much. Suffice to say that if someone is treating a patient with baseline renal abnormalities, especially if they're on a tenofovir-based regimen, one has to be more vigilant in monitoring.

Susan Hubbard

Operator, due to time, we do need to let Dr. Sax get back to the conference. We probably have time for one more question and then we'll need to conclude.

Operator

Your next question comes from the line of Ian Somaiya with Piper Jaffray.

M. Ian Somaiya - Piper Jaffray Companies, Research Division

So a question for Norbert on the chart related to efficacy by baseline HIV RNA and CD4 subgroup. Did your statistical plan allow you to measure for superiority because, obviously, there's a difference, a more meaningful difference in patients with lower viral load and a higher CD4 cell count at baseline?

Andrew Cheng

Let me see if I can understand the question. This is the farthest plot that shows the results by baseline, viral load, or is this the -- do you want to discuss the bar graphs?

M. Ian Somaiya - Piper Jaffray Companies, Research Division

The bar graph.

Andrew Cheng

Okay. So the bar graph, the less than 100,000, 90% response in Quad and 85% response in ATRIPLA. If you go to the previous slide, you can see how it does actually meet -- no, it almost does. It's still the 95% confidence interval for that difference crosses 0, so it's not statistically significant.

M. Ian Somaiya - Piper Jaffray Companies, Research Division

Okay. And just related to the creatinine elevations, I don't know if there are plans to -- what potential strategies could you use to probably potentially mitigate that? I don't know if there are potential changes to the cobicistat formulation, dosing of cobicistat, or some other factors that we could consider that might remove that side effect?

Norbert W. Bischofberger

No, Ian, there's nothing really we can do. We need cobicistat on board to inhibit the degradation of elvitegravir in the liver, particularly. And cobicistat has the side effect that it competes with creatinine secretion, so this is something that is not -- it's difficult to envision how you would remedy this. This is something we just have to deal with. But it's, as Paul pointed out, it's not a primary clinical concern and can be dealt with fairly in a straightforward way.

Susan Hubbard

Okay. Well, thank you certainly, Dr. Sax, for joining us today. We really appreciate that time to run through the data for us. And thank you, all, I'm sorry that the call's a bit brief, but we'd be happy to take your follow-on calls after we conclude.

Operator

We thank you for your participation in today's conference. This does conclude your presentation. You may now disconnect, and have a great day.

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