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Gilead Sciences, Inc. (NASDAQ:GILD)

Robert W. Baird & Co. 2014 Health Care Conference

September 4, 2014 10:15 a.m. ET

Executives

John Milligan, PhD – President and Chief Operating Officer

Analysts

Brian Skorney – Robert W. Baird & Co.

Brian Skorney – Robert W. Baird

All right, good morning everyone. I’m one of Baird's senior biotech analysts, Brian Skorney. With me today, I have the management team of Gilead Sciences. This has now become the largest by market cap biotech company under my coverage, and I think in the whole sector and really has transformed several disease areas, particularly HIV and hepatitis C. Sitting to my left is John Milligan, the President of Gilead. Hopefully, we can start, John, maybe for -- I think most people in the audience are somewhat familiar, but maybe you can just give a quick overview of the areas that Gilead is focusing commercially and developing new drugs.

John Milligan

Yeah, sure. First of all thanks, Brian for having us here. It’s a terrific conference. I apologize for some of the disruptions that occurred this morning. Some of our friends from Act Up New York are out there. They are a passionate group who advocates on the part of patients and we appreciate the role they play in that. we hope for a constructive dialog with them on how to gain more access for HCV patients. But secondly, I wanted to say that as most of you know, Gilead is now one of the largest bio pharmaceutical firms. We have a very robust portfolio across many disease areas and we continue to innovate in the areas of HIV where we help to bring new medicines and new options for patients in the not too distant future as we roll out new data. we continue to innovate in HCV, not only with the launch of Sovaldi, but also with the launch of new combinations that will eliminate the need for interferon, shorten the duration of treatment and provide options for patients who don’t have any today with the hope of eventually eradicating this disease.

We’re providing new options for patients with the launch of Zydelig for patients who have CLL, so different forms of lymphomas. and we’re continuing to try to innovate in this area by providing combinations of drugs much like we have for HIV to try to provide long term cures or -- I’m sorry, long term therapy or potentially deeper cares than are available today. We have some innovative areas in the area of cardiovascular disease with some new data coming out on a combination of Ranexa and Dronedarone that shows that we can lower the incidence of atrial fibrillation. Those are exciting new data that came out. we have new products coming out that could provide options for patients with genetic long QT syndrome. So these are very interesting new things for us.

and then finally, we’re branching into biologics. we have two antibodies in development now, one called Simtuzumab, which is for the treatment of – or potential treatment of fibrotic diseases. It may also enhance the ability of chemotherapeutic agents to target certain tumor types. And so we’re very excited about the ongoing Phase 2 studies that we have there. And then we have a new antibody that targets -- it’s an old target in oncology that didn’t work out so well in the small molecule area. It’s MMP9, matrix metalloproteinase, and we have an antibody that targets that enzyme very specifically and in early trials it’s very promising for across a number of diseases.

so we have a wide range of things in our pipeline. I think our pipeline has never been broader or more robust than it is today and will provide us many opportunities to have conversations in the future as we progress this pipeline further. so we’re a company that is now diversified beyond antivirals into other areas and are hoping to grow and are hoping to grow and maintain those franchises the way we did in anti and antivirals. So that’s my brief overview, Brian.

Brian Skorney – Robert W. Baird

Great. so obviously I think people are very interested in Hep C and that’s been sort of the primary driver since the Sovaldi launch, it’s about a year ago now. And I guess this sounds like an absurd question to give your impression of the launch since it’s clearly been the best pharmaceutical drug launch ever. But what can you tell us about what you’re seeing in terms of the patients that are coming in using Sovaldi and maybe even more importantly, what patients aren’t going on Sovaldi at this point?

John Milligan

Yeah. so I’ll start with the impression of the launch. The launch has surprised me in a couple of different ways. Number one as we launched Sovaldi, we launched predominantly with a regimen called NEUTRINO in the label. NEUTRINO is a combination of Sovaldi plus interferon ribavirin for 12 weeks and we had very good results in the NEUTRINO studies. I had thought that the continuation of 12 weeks of interferon would still be somewhat of a barrier to patients coming into care and getting treatment, especially because the data for the oral regimen was known just a couple of weeks after we had approval last December. But despite that, the uptake has been very, very strong with a lot of patients going on that NEUTRINO regimen. And that NEUTRINO regimen has really been very popular in genotype 1 patients in particular, which is about 70% of the patient type.

We saw quite a bit of NEUTRINO use in the first quarter. As we got into the second quarter of the year, what we saw as a change in the regimens that were being used that surprised me quite a bit. A lot of patients, about 30% of patients were getting from Sovaldi plus a drug by Janssen Pharmaceuticals called Simeprevir. That combination is used entirely off label, although there were good Phase 2 data that were presented and a lot of doctors were advocating for the use of this combination regimen. so I was surprised because there weren’t data available in our label or J&J’s and I was also surprised that the payer system would accommodate that. But it’s been a very successful regimen in a number of patient. And so it’s very, very popular.

So those two things surprised me as well that the patient flow was much larger than I had anticipated at the beginning. So it is a larger patient flow. I had thought we would eventually get to this level, especially with the oral regimen. So it’s been more successful than we had anticipated at the beginning, although we knew it would be a very successful launch. You talked about what kind of patients. We are seeing a lot of patients who are new to treatment come on to therapy. About 60% of the patients who come onto therapy have a fibrosis score that’s on the lower end, F1 to F2, about 40% of patients. So the remaining 40% are F3 or F4 patients, so very -- a little bit of the opposite the way I thought. I thought we’d have more severe patients early on as well. And that’s been pretty consistent between quarter 1 so and quarter 2 so far.

Brian Skorney – Robert W. Baird

Great. And then obviously one of the big controversies to some extent has been pricing I think those of us close to the story recognize that this is actually -- there’s tremendous value especially compared to a lot of other pharmaceuticals out there that are much high priced, chronic, do not achieve a cure. I guess you have some insight into how payers have actually been responsive to Sovaldi. Obviously we hear some comments out of some of the PBMs that they’re looking for significantly lower price and potentially using competition to try to get that. What’s the separation between what’s seen in the lay process as an expensive drug versus what I think most people in the industry would recognizes as a fantastic value?

John Milligan

This is an interesting controversy in two ways, one about the price and then one about the benefit, which I was surprised especially at the benefit. I think it’s been clear for a long time what the great benefit is to patients who can be cured of HCV and somehow that has become a controversy again. But it’s obvious that once you are cured of a virus, the patient is much better off. There’s no doubt about that. Nobody really disputes that behind the scenes. We know that having HCV leads of course to greater levels of liver disease, including fibrosis, cirrhosis and liver cancer. We also know that they all cause mortality. The average patient dies about 15 years earlier than the patients who don’t have HCV. They have a higher incidence of MI. They have a higher incidence of diabetes. They have higher incidence of other cognitive disorders that put them in a haze. So you actually feel better when you get cured of this disease.

In the past it might not have been so clear that you’re cognitively doing better because the therapy itself maybe so much worse that by the time you felt better you forgot how bad you felt from the disease and ascribed all the bad feeling for the treatment itself for 48 weeks of interferon. What we’re seeing now is patients feel better and they noticeably feel better while on treatment because the side effects are so much less severe. And in the odd case of the oral, there’s barely any noticeable effect from a patient’s perspective. so it’s a very striking change for all these parameters. We know there’s a health benefit. We know that health benefit can go on for many, many years especially if you cure people early.

From the cost side, if you look at a Sovaldi regimen and the interesting thing is we try to get the press to talk about regimens, but of course that’s not a very interesting headline so they talk about the price per pill or the price per bottle or the price for a course of therapy. But a Sovaldi regimen with interferon and ribavirin for 12 weeks costs a little bit less than what Incivek was costing plus four, eight weeks of treatment with Peg/Riba at the WAC prices. so we were a little -- we basically priced it the same as existing regimens. And so I was surprised at the outcry for something that came in at exactly the same price.

Now, we didn’t take into account the fact that we cure more people than the Incivek regimen and we didn’t take into account the fact that it takes a lot of other medicines to get somebody to an Incivek regimen. We’ve seen some of these extreme cases where the total healthcare cost for a patient on Incivek can be close to $200,000. so that wasn’t taken into account, just simply the regime cost. and so that’s how we price Sovaldi. and I think that’s how we think about this disease. There is a price that was appropriate for other medicines and for medicine that’s better and safer and simple should also be appropriate.

Brian Skorney – Robert W. Baird

and when you are having payer discussions, whether it’d be with PBMs, insurers or even some of the legislators that have asked for some clarification on pricing, how much conversation do you wind up having around what may be a very quick demise of Sovaldi in favor of -- I don’t know what the branded name is, maybe in a couple of weeks we’ll find out. I think we should call it [inaudible], but the ledipasvir/sofosbuvir combination will offer an even greater benefit. How do we think about pricing that and how much of that combination has gone into discussions already to try to set an expectation?

John Milligan

Well, it’s difficult to talk about unapproved medicines from a pricing perspective because we simply cannot give the price. so I can tell you philosophically we don’t think about it much differently than the way I just described, that there’s an appropriate price for patients that’s similar to what today’s price is for the cost of each patient. We knew that most of the value that’s in the HIV medication -- I’m sorry, HCV medication is coming from Sovaldi. It is a very unique drug. it works against all genotypes. It is the one that has differentiated itself more than any other medicine for HCV. so we put most of the value into Sovaldi. As we have add ledipasvir to it, we will remove the Peg and Riba and that will achieve some cost savings, but we also of course drive some value to ledipasvir as well because it is a very important medication.

We will be providing the first single tablet regimen, the first once daily pill that you can take without anything else in order to provide a cure for HCV patients. In our iron studies, if you look across all the different patient types, we had between 95% and 100% cure rates in those patients. All those patients achieved SVR12. and so that was really an important finding that you could cure even higher percentages. Remember that NEUTRINO regimen is about 90%. So we were curing 9 out of 10 and now we’re pretty much 19 out of 20. We are doing a very good job of curing these patients.

The second thing we learned in the iron studies is that for certain patients, you can treat for only 8 weeks. That was an important finding. We weren’t certain if that would be true when we undertook these studies, but we thought it was important to explore the depths of how short the duration can be with a two drug combination and we found that for patients who have a viral load that’s below a certain threshold of 6 million international units per milliliter, it’s not copies of international units in this field, that those patients had very high cure rate. We saw 97% of patients who had 8 weeks of therapy, 96% in patients who had 12 weeks of therapy. so it says to me that for those patients who were having very high cure rate with only 8 weeks of therapy and I doubt that another four weeks of therapy would have made any difference to those patients.

We are going to be able to provide a natural price break to patients who are earlier in their disease and have lesser disease because they’ll take two bottles of the fixed dose combination of ledipasvir/sofosbuvir instead of three. Those prices will naturally come down because of that. I think that’s a good thing for the field and I think it’s a good thing for patients. It could open up a lot of patients to do therapies who simply wouldn’t have taken them before. We’ve looked across a number of databases. We think these are representative of the general population, but it’s hard to know what an undiagnosed population really looks like. Bu we think that could represent about 45% of patients based on our own clinical studies and some external databases that we’ve gone through to look at the viral load or where patients are in disease. Nearly half of patients might benefit from this eight week regimen which I think would be tremendous for them.

Brian Skorney – Robert W. Baird

So speaking of duration, one of the things I think some of your potential competitors have started looking more towards given that there’s really no way to beat sofosbuvir/ledipasvir on cures or safety is trying to target shorter durations. Any thoughts on how much of a lever do you think that could be in the future. I know Bristol and Merck are both looking at four weeks. You guys have looked at some six weeks and shown very good data. Is that -- will that be a meaningful competitive dynamic?

John Milligan

It’s something that’s worth exploring and the question is can you start the duration and can you short with -- what patient populations can you shorten the duration. We have unveiled data. We brought out data earlier this year of six week regimens where we looked at two different three drug combinations. These are small numbers of patients. But of those 40 patients we tested, we cured 39 of them with a three drug combination of only six weeks duration. This was a typically difficult patient population; African American patients do particularly poorly with interferon. By the way the interesting thing about ledipasvir/ sofosbuvir is that we have very high cure rates in a population that typical doesn’t do very with interferon with cure rates of about 50%. so I think that’s a huge advantage in that African American population. We did test this in a study with NIH. These are patients who were non-cirrhotic treatment naive so they didn’t have bad disease characteristics and we did get very high cure rates in those population.

These are data that we brought out earlier this year. So obviously we are doing additional exploratory studies looking at other three and four drug combinations and looking at durations between four and eight weeks across a wide range of patients from treatment naïve to treatment cirrhosis. We know we can do very well in six weeks. There’s been no data out that I’ve ever seen from any company or even our self that suggested four weeks’ worth. I don’t want to speculate too much on that. But I think we might be very close to the limit of where you can treat patients and get high percentages necessary to achieve approval today. Let’s not forget the bar to getting approval has gone way, way up. So 90% just isn’t going to cut it anymore. You’ve got to be north of 95% to have a shot at approval these days.

Brian Skorney – Robert W. Baird

And one of the things that a lot of people discuss is the potential for emerging market opportunities for Hepatitis C where a vast majority of patients, the patient prevalence is. Given how interesting dynamics of the US and early European launch have been, how should we think about emerging markets? Should we anticipate that it will be your standard flow of drugs sales? Or I know some other companies that talked about big stockpiles of curative regimens. What discussions are you having?

John Milligan

We’ve not had any discussion with any country about a stockpile. We have talked to a number of countries. We are trying to apply the same principals we did for HIV to HCV, which is a tiered pricing so that countries that have very low GDP and high prevalence of the disease, we give a very substantial discount to countries like Egypt which have over 15 million people infected have a very poor infrastructure for treatment. And we might be able to provide some relief to a government sponsored program where we treat at very low price. Similar to our access programs in the developing world for our HIV program where we are trying to do a similar thing in Pakistan. We will look at other countries differently of course depending on prevalence and GDP per capita. We do think that there can be some very substantial markets filled up in various parts of the world. It takes some time.

there’s 140 million people who have HCV around the world. There isn’t a lot of funding for this in many parts of the world. There isn’t a PEPFAR-like program. There isn’t global fund money like there is for HIV and other diseases. We’re learning and building out these things as we go through the process of trying to understand how we can best achieve our goal of access for people all over the world and maintaining our business as appropriate in each of those countries. in fact many of you know John Martin was supposed to be here today and he cancelled. I’m the replacement today. John was invited to meetings in Geneva to just take up this topic personally with a number of leaders from around the world. And so that’s where he will be today doing this work on behalf of the company. And so we are taking this very seriously and John and I are working very hard on this and I will fly over tomorrow to join him to have more discussions in this area.

Brian Skorney – Robert W. Baird

Great. So moving on to HIV which is another area that Gilead has profoundly changed the treatment paradigm, what are sort of the commercial opportunities that you’re seeing with your current offerings? How are you looking to expand in HIV? How do you see the competitive landscape playing out with one new or I guess the first new truly fixed combination that’s non-Gilead.

John Milligan

It’s a good question, Brian. So we’ll continue to grow our franchise through our offering of tablet regimens, Atripla, Complera and of course Stribild which we launched most recently and all those are doing very, very well. We are seeing that Eviplera, Complera -- Eviplera is the European name of Complera, both the US and United States are now the number one and number regimen in treatment naïve patients and all patients. We have set the bar high with new single tablet regimens. Stribild is working its way up the ladder very quickly. We are very pleased with the uptake of Stribild. We are getting reimbursement as it goes throughout Europe now for Stribild in all those countries. We are doing very, very well with those offerings. There is a new single tablet regimen from -- so just 8 years after the launch of Atripla, there is a competitors that has a single tablet regimen with ViiV's launch of larger Triumeq.

so we do have competition and we of course always welcome that. I think competition keeps us sharp. We have been developing our next generation of compounds and single tablet regimens focused on TAF, which is Tenofovir Alafenamide. TAF is a much more well targeted drug. It gets to the side of infection better. We give it at lower doses and in the stage 2 studies, we saw that it had fewer side effects in both bone and in kidney as a result of lower circulating levels of Tenofovir which is liberated from VIREAD and in all our single tablet regimens. This gives us an option to have a safer version of VIREAD in the market, which could be very important for a lot of patients who have now been on therapy a long time, have the disease a long time and are suffering the consequences of chronic inflammatory state due to having HIV and just the simple effects of aging.

The median age of any HIV patient is well over 50 years now and at some point VIREAD may not be appropriate for most of those patents because of declining kidney functions which occurs naturally. We think that TAF could be a very important component of long-term regimen for these patients. And as we offer a safer version we think it will be adopted in a wide group of patients. It’s our hope to launch not only our single tablet regimen of Stribild containing TAF; I don’t have a name for that one either yet Brian,

Brian Skorney – Robert W. Baird

I can come up with one.

John Milligan

If you can submit a name this will be helpful. But it also will replace Truvada with a TAF containing regimen will replace Complera and hope to offer other single tablet regimens because now with the dosing being so low, they’re low as 10 milligrams in some combination, we can actually accommodate enough space in a pill to make it allowable as a single tablet regimen and swallow-able because some of these tablets are in fact quite large. We think it’s a very exciting option. We are just at that very exciting point in drug development where we’re just about near the end of the trial. We expect to have data out in the next month or so from our pivotal studies and that will be really telling in terms of how a broader populations of patients fare relative to the small numbers in the phase 2 studies, which have historically been quite predictive of the outcome.

Brian Skorney – Robert W. Baird

Great and then moving on to oncology, which is an area that you were in a long time ago, you’re somewhat back in, or I’d argue very much back in with the recent approval of Idelalisib. talk about your strategy there because I think it’s one of the most interesting ones, especially since targeted therapy has really come to fruition over the last decade, but has also shown the liability of resistance, which I would argue Gilead may be the foremost expert on. How do you think about starting with Idelalisib and moving into the oncology field to kind of target the resistance issues that we’ve seen?

John Milligan

So this is the trade name, of the issues because Zydelig it’s easier to say. Zydelig was recently approved for certain lymphomas. It’s a very interesting molecule because it targets PI3 kinase delta, one of several targets that have been implicated in a variety of lymphoma and possibly some solid tumors. That’s something we’ll explore in the future. We have put together a portfolio of several different of these intracellular pathway inhibitors. These are generally kinase inhibitors that can target different parts of the pathways and some of the redundant pathways. One way you can become resistant is you become less reliable on the pathway that you’re targeting and more reliant on another pathway for proliferation. For example, we took SIK and put it together with the PI3 kinase cells and it showed that we had a very pronounced synergistic effect on0 lymphomas. The difficulty in this field much like it has been in other fields is you also can get synergistic toxicity. And so we are going through a series of studies right now with various intercellular pathway inhibitors, looking at lower doses to see if we can do -- we eventually started to do in HIV. You can lower doses because in combination you get a synergistic effect so that we can come up with a pronounced long term effect that works where there aren’t as many side effects.

And we’re doing some fascinating biology behind the scenes to try to understand what is the right dosing, what is the right combination of therapy so that we can carry out these things in various ways. I think the problem is we have too many intercellular pathway inhibitors. So we are trying to narrow it down just to focus on a few key combinations and key pathways in both lymphomas and also in some solid tumors where were we have really good evidence that these intercellular pathways are also useful.

So, as I mentioned we have SIK and PI3 kinase delta. We also have a JAK 1, 2 inhibitor and then we other inhibitors that we’re working on that are pre-clinical that are looking quite interesting. Those will come out in the clinic in 2015 and we’ll start to see these halfway inhibitors put together. so it’s our hope that we can achieve one of two goals and it may be different in different stages of the disease. Either have that single tablet combination that you can take for a long term to keep your disease in remission or we can drive you down to the point where you have very minimal residual disease, call it MRD negativity. So minimal residual disease negative that will allow you to come off therapy and then you can go with your life and then you will continue to get a checkup and if it comes back we could re-treat. That would be a theory with that. That could be a very important outcome for patients.

Brian Skorney – Robert W. Baird

Great, and then one of the question I always get is what’s the next hepatitis C? The two that jumped out to me that you guys are looking at in the early stages, hepatitis B which you’re very active in, but I think more and more people are looking at the potential for a curative market, we don’t know. I don’t know if it’s going to come any time soon, but love to hear your thoughts on that. And NASH certainly with the Intercept valuation move at the begin of the year, I know it’s another area you guys are very, very actively exploring. Are those the two areas that you would think if there’s another hepatitis C that this is the opportunity? If there’s other areas, what do you think those other areas might be?

John Milligan

Yeah, I would say among the areas. Those are very important opportunities for us and for other organizations working in these areas. So I’ll start with hepatitis B. The goal with hepatitis B is now finite therapy and we treat for a short duration and cure patients. Can we effectively get the immune system to take over its responsibility to keep the virus in check or to eliminate the virus. It’s a more difficult disease that HCV because the virus persists for very long periods of time inside cells. So we have been targeting two different ways to do this. One is through a therapeutic vaccine using something called a Tarmogen. That is something we are doing in collaboration with GlobeImmune and that’s an ongoing Phase 2 study. we’ll have some data out later this year or early into next year to let us know this is a viable strategy for trying to again kick start the immune system into taking over its responsibility.

We also have a TLR7 agonist that’s under investigation for the potential eradication of HPV. We have some very interesting data in a woodchuck model. Woodchucks get a diseases that’s very much like human hepatitis B, very difficult to cure, persistent covalently cocircular DNA in the cells of the liver. So it very much mimics the human disease and we have some cures in that woodchuck model. That’s something that’s not been seen before. So we’re exploring that very cautiously in this area to see if we can again come up with a series -- short treatment durations that will lead to a functional cure of hepatitis B. So that’s very important for us. Lots of other approaches out there I don’t know. I don’t quite have an opinion on other approaches right now. I think it’s sort of too early to know until you have long term data on safety in these areas.

You mentioned NASH, Non-Alcoholic Steatohepatitis, which is very important. It’s big. Maybe 7 million people in the United States have some form of NASH and growing. It’s seemingly an epidemic now because of the growing level of obesity in the country, which is very unfortunate and clearly there are things that are needed. We are studying Simtuzumab. That’s our antibody that targets LOXL2 for patients who have NASH. We are looking at a more severe form of NASH and for example we believe the Intercept studies explored, looking for example patients with burgeoning fibrosis, so later stage of the disease. Those studies are enrolled and ongoing. We will have data probably in the middle part of next year. But we’ll hit the 48 weekend point in a 96 week study to see if we can have a positive impact on patients with NASH using this antibody that knocks out some of the underlying causes, enzymes that cause fibrosis

so I think it’s an important area. I think it has the potential to be a fairly large area in this kind of disease. and I’m not -- the thing I’m not certain on is the pricing across the stages of the disease, what the exact potential is and it will depend quite a bit on the long term benefits that we can see in these different areas. but it is important to us. it is an area that we can continue to invest in. and not only NASH, but all fibrotic diseases have become quite interesting to us. so we have a number of ways to tackle that for small molecules now to the antibodies. and so you’ll see us continue to try to find ways to knock out these diseases which are quite debilitating and have no treatment options today.

Question-and-Answer Session

Brian Skorney – Robert W. Baird

I have just a couple of seconds. I’ll see if there’s any quick questions from the audience. I do have one question emailed to me and it’s a question I always get. what are you going to do with all the cash?

John Milligan

that was a surprise, Brian. We’re a very cautious company by nature. we are going to continue to invest in our pipeline of course. we are continuing to grow R&D. there are a lot of opportunities for us and we’ll need more people to be able to do that. we are enormously effective at outsourcing and using partners to help us and we’ll continue to do that. I see some opportunities for licensing this year where we could bring in some things which would augment certain franchises we have. in general we’re pretty well set in our pipeline. I like to think that we have -- I like the opportunities that we’re working on. I like the direction that we’re going. and with regard to capital structure, as Robin has signaled, we are going to continue to buy back our shares of stock and we’re going to continue then to evaluate the deployment of capital as we go through each year. and I will let you know if we make any changes to our current plan.

Brian Skorney – Robert W. Baird

Great, John. Thank you so much. Always a pleasure.

John Milligan

Thank you, Brian.

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