Gilead Sciences, Inc. (NASDAQ:GILD)
William Blair 34th Annual Growth Stock Conference
June 10, 2014 11:50 ET
John Milligan - President, COO
John Sonnier - William Blair
John Sonnier - William Blair
I think we will go ahead and get started. I'm John Sonnier, one of the Biotechnology Analyst at William Blair. I appreciate all of you being at the conference and coming to the Gilead presentation. I need to tell you that please refer to our Web site at www.williamblair.com for all the appropriate disclosures. I do have an outperform reading on Gilead stock. We are pleased to have today the company's President and Chief Operating Officer, John Milligan to present the story and there will be a break out immediately following in LaSalle B. John?
Thanks John. Thanks for inviting us here. It's great to be back in my home town of Chicago. It's great to see a lot of familiar faces through the meetings today. And it's really great to be able to present on behalf of Gilead Sciences, all the progress that we have made over this year and provide with you some context for the future of the company. And with that, I of course need to put up my disclosure statement.
We will be making forward-looking statements during the course of this presentation. Our business of course biotechnology carries very many risks with it and I advice you to read our most recently filed SEC documentation with regard to those risks.
For those of you who don't know Gilead very well. And I realize this is a conference of many different kinds of companies here. Gilead is a company that is historically has been focused heavily in anti-viral particularly in the treatment of HIV. In HIV medications, you typically take three medications, sometimes four medications every day. And Gilead has a portfolio of eight different medications, three of which are called single tablet regimens. A single tablet regimen has three active ingredients, sometimes four ingredients in a single pill given once daily and this has transformed the treatment of HIV to the point of which it's gone from a short-term death sentence to a really a chronic illness or patients will be on not years, but decades of therapy and so that will – I will speak to further as we get into the HIV portion of this presentation.
But I want you to keep in mind that HIV is still a very important component of Gilead's past, it's an important component of our future. But I'm going to touch on it at the very end because of all the exciting things that are happening in other parts of our portfolio.
We also have the products for the treatment of liver diseases, of course, many of you have heard about Sovaldi, our recent treatment and care for hepatitis C as well as Viread for the treatment of chronic hepatitis B. We have products in cardiovascular disease. And our cardiovascular pulmonary franchise has actually topped $1 billion in sales last year as it becoming increasingly important part of what we do and it is increasingly important part of our pipeline as I will show on some slides coming up in just a few moments.
We have both Letairis for the treatment of pulmonary arterial hypertension and Ranexa for the treatment of cardiovascular disease and we continue to try to innovate around those projects and have many ongoing clinical studies. We are in diseases and respiratory disease such as Cayston for pseudomonas infection in cystic fibrosis patients and also Tamiflu, which we sell through our partner Roche.
And then finally, we have Ambisome. Ambisome is one of the oldest products in Gilead portfolio. It's still the most important product for the treatment of systemic fungal infections in transplantation patients in Europe and an important part of what we do.
I mentioned in our pipeline. Our pipeline has gotten so full, it takes 3 slides to go through it. I never thought that we would have these many things going this quickly. But the pipeline in fact is quite full. I mentioned some of our treatments for HIV. We continue to make new single tablet regimen featuring a molecule called TAF, I will talk about that later on which is a very potent low dose, once daily molecule that we think can be very important for the future of HIV treatment.
We have many products for the treatment of liver diseases including a fixed dose combination of two products one containing sofosbuvir, the active ingredient of Sovaldi with Ledipasvir, and I will talk about that in a moment what that means. But we continue to innovate bringing more products into our pipeline including pan-genotypic protease inhibitor. Pan-genotypic just means, it's actually active against all genotypes and there are six in HCV that has just entered the clinic as in Phase I study and could be important for continuing ways of innovation in the future.
We have treatments for hepatitis B including things that stimulates the innate or adaptive immunity and with HBV, we look to convert this from chronic care into a care like we have for HCV and are embarking on many programs through that. I won't have time to say anything further about it because of the length of this presentation. We have other diseases, for liver fibrosis we have a biological simtuzumab which could be useful for liver fibrosis for NASH and for diseases such as primary Sclerosing Cholangitis.
In oncology, we are looking at various different cellular pathways that we can knock out and have products such as Idelalisib, which is under review by FDA for the treatment of indolent non-Hodgkin's Lymphoma and lateral refractory CLL. I will talk about those later in the program.
And then in our cardiovascular disease, we have a number of programs that are ongoing, but I just want to highlight 6615 in this slide, which is a late sodium current inhibitor that came out of our research laboratories. It's very potent and very specific for the late sodium current channel. We had some early results in Phase I where we actually looked at patients who have something called LQT3. That's a long QT syndrome that occurs because of a genetic defect in the sodium channel and can cause sudden death in people. It's a common thing where you see young athletes die suddenly it's because they have this genetic abnormality.
And looking at patients who are continuously ultra monitored, we thought statistically significant decrease in the QT interval of the heartbeat, which lowers the risk dramatically for sudden death and could be a very important option for these patients in the future. Not many people have this. This is about 6000 patients across United States. But if this product is successful in this disease, it could also be successful in things like LQT2, which is a high prevalence and things like ventricular tachycardia/ventricular fibrillation and also hypertrophic cardiomyopathy.
So interesting molecule very early data, but really exciting opportunities for our cardiovascular portfolio. But again, that's all I'm going to be able to talk about because of the time constraints of this. So if you follow us at all, you know many of the conversations revolve around HCV and I will spend the majority of our time there talking about our HCV portfolio.
As many of you know, Sovaldi was approved last December by the FDA. This slide first of all is a little bit of a misstatement. We had about 30,000 patients treated in the first quarter of this year. So a very large number of patients coming onto treatment very early because of this severe unmet medical need. And frankly, a number that was higher than we had estimated in terms of adopting therapy. And it's higher than we thought because patients still need to get pegylated interferon and ribavirin. And in fact, when we look at those patients about 70% are getting that combination; they are Genotype 1 and getting pegylated interferon and ribavirin.
The fact that we shorten the duration to 12 weeks made a huge difference to patients and to doctors and their staff in terms of amount of time that difficulty of getting patients to these regimens. So we are seeing very high completion rates of therapies during the first quarter.
Likewise in Europe, we saw a rapid uptake of the product, even though we are on the market only in Germany and France. I think it's arguably one of the best launches in Europe because the roll-out takes longer to get pricing and reimbursement. We had very favorable placement of the EASL guidelines, which is important for how the medicine we use across the European Union and for the European discussions. And we are going through pricing and reimbursement discussions across the European Union right now.
For example, we are under nice review, but importantly we just got a rating of ASMR 2 in France. One is the highest rating very hard to get. Two means it's a highly innovative product and a very good rating for the value that we have for this product. And will help with our negotiations on pricing in France. And then importantly in Scotland, we just got viewed as being cost effective within the Scottish Healthcare System and the Scottish Healthcare System is typically one of the toughest to get that kind of designation. So I think it bodes very well for the remainder of the pricing and reimbursement negotiations across Europe.
There has been a lot talk about the cost per pill of Sovaldi, but I want to talk about the cost per regimen. A regimen is a number of medicines that it takes to fight the disease. And if you look at the cost of Sovaldi plus pegylated interferon plus ribavirin for 12 weeks, it cost just over $94,000.
If you look at the cost of care for other comparable medicines around the market either Telaprevir, which is typically used for 8 weeks plus 4-day weeks of PEG/RBV or Sofosbuvir, which can be used between 24 and 48 weeks. You see that both of those are in excess of $96,000 almost $97,000 on average between the two. So the cost of care for Sovaldi containing regimen is actually less than what the current standard of care with the – standard of care had been prior to the launch of Sovaldi. So we had felt that this is a very reasonable price based on the fact that its simpler, it's shorter and let's not forget the SVR rate, the rate of care is higher on this regimen than on the other regimen as well.
I think one of the issues that you have been hearing about is, just a number of patients coming into care. Let's look at the market dynamics across United States where we think there are slightly over 4 million people who are infected. Based on data that's out from the CDC and others, we think about 1.7 million of people are diagnosed so they know that they have HCV. Of those about 380,000 patients are under care.
But looking back at the last 12 months about 40,000 patients are treated across the entire United States. That's a reflection of the difficulty of the other medicines. That's a reflection of some of the restrictions on the kind of patients who can be treated because of the side effects and the difficulty of getting patients through.
As I mentioned earlier about 30,000 patients in the first quarter of this year has sort care. So which means there is a much higher number of patients could be treated. So the volume remains the issue, what we do about all these patients who suddenly can seek care and want to seek care because the disease can be managed much more easily than it could be before. And this will manifest itself even more when the fixed dose combination comes to market in the future we eliminate the need for PEG/RBV.
Turning to Europe briefly. I did mention the EASL guidelines. We are recommended across all HCV Genotype, so that is important. We are pan-genotypic polymerase inhibitor. We are also recommended across a broad range of different kinds of patients who have HCV. So we segment these into different kinds based on the severity of disease. So these are non-sustained virologic response, so these means patients who fail previous treatment, patients who have compensated cirrhosis that means the liver, disease is progressing very – in a very significant and badly toward prognostic way.
Patients who are waiting liver transplantation. Patients who have had liver transplantation and patients with other co-morbidity. So it's a very broad label across the rough wide range of patients. These guidelines were adopted rapidly and in fact the German guidelines came out very rapidly after the approval of Sovaldi because of the importance for their system.
And then finally, the last major market, I would like to talk about is Japan. Japan has a lower prevalence than it does in United States. But there are still over a million people infected. It has a higher diagnosis rate with almost 750,000 people diagnosed. But likewise, with the current medication, the very small number of patients get treated in any given year.
In addition to this, there is a difference in the dynamic of the HCV infection in Japan, which has a higher percentage of patients with Genotype 2 of which there are very few options. And the patient population is older. So we think there is a very interesting early opportunity for Gilead to treat Genotype 2 HCV in Japan. While we had very good discussions in fact with the regulatory authorities that accelerated our program by about a year over our expectations where we expected to be on the market in 2016 and it looks like it will be 2015 now.
We have now supportive data in Genotype 2 patients, I apologize for the sentence on the second bullet, it may not make sense. But we studied Sofosbuvir plus ribavirin for 12 weeks and patients with Genotype 2 infection and it's a very high SVR rate. These are rate that we presented two weeks ago at the Japan Society of Hepatology meeting. They were incredibly well received where we showed 97% of patients had an SVR12. 97% of patients taking Sofosbuvir plus ribavirin for 12 weeks were cured of their HCV. And these are predominantly older patients and you can see that it was a very good result whether it was treatment-naïve patients or treatment experienced patients.
So these data will be filed in the second half of this year, which will put us in a pricing and reimbursement negotiations in early part of next year.
The slide that I just showed, I can't see it the print. The slide I was going to show, it talks about the three ways of innovation. So I think there is – we talked about pegylated ribavirin being – and ribavirin being part of the – these are current therapy. They have severe side effects. They are difficult to take. You can imagine getting an injection once per week that makes you feel you have the flu for a few days that's difficult to do. It's easier to do for 12 weeks and 48, obviously, but we like to eliminate both of those components and the next wave of that is ledipasvir plus sofosbuvir.
The ledipasvir is called a NS5A inhibitor. It's a very potent product that can combine very nicely with sofosbuvir. So much like an HIV therapy where you need more than one medication, in HCV medication you need more than – in HCV treatment you need more than one medication. And it looks like two is sufficient for treatment for 12 weeks duration. So we have combined a potent NS5A inhibitor and a potent polymerase inhibitor to come up with a fixed dose combination of one till once day that can treat HCV without the need for ribavirin or pegylated interferon.
And these are three studies that we unveiled last year IN-1, IN-2, IN-3. In IN-1, we looked at a combination whether the duration of 12 weeks was better than 24, whether adding ribavirin improved anything and what we learned from the study was that in treatment-naïve patients, we can get very high SVR rates around 97%. We didn't need to dose as long as 24 weeks, 12 was sufficient. And we don't need ribavirin.
We also did a study called IN-2 in treatment experienced patients. And we found that again 12 weeks of therapy without ribavirin was sufficient to treat the vast majority of patients even those with levels of cirrhosis and have very good outcome.
And then we did a study called IN-3 where we explored 8 weeks versus 12 weeks. And we found that in treatment of naïve patients and those with low risk factors, we again got very high SVR rates with only 8 weeks of therapy using fixed dose combination.
And so as a result of that we filed these data with the FDA in February of this year. We were granted a priority PDUFA date that means the date on which the FDA must take action of October 10th of this year. We were also granted break through designation that allows the FDA flexibility and accepting more data and deviating from timelines.
And we are asking for label that will have both treatment-naïve and treatment experienced Genotype 1 patients and we were also asking for 8 or 12 weeks of therapy based on certain risk factors. And so those are the considerations that the FDA is looking through right now.
Likewise, we filed an MAA in Europe, which has now been fully validated that means it has been accepted. We were granted accelerated review by the EMEA based on the unmet medical needs. And likewise with the Japanese authorities we are doing a Genotype 1 study predominantly Genotype 1B in Japan. And we also have a recommendation on a clinical study which we have going and a recommendation on an accelerated approval pathway from the Japanese. And we would expect to file for approval for the Genotype 1 portion of this later this year. So Japan will be Genotype 2 earlier and the Genotype 3 – I'm sorry Genotype 1 later this year.
Okay. So that's the story in HCV. I want to now turn to oncology which is a growing franchise for Gilead.
We have been working on a number of different pathways and a number of different targets and thinking about how we could bring what we do well, which is combination therapy to oncology and possibly inflammatory diseases. And we have two different ways that we are tackling this problem. One is to look at intercellular signaling. So these are lot of the pathways that have been elucidated over the last decade based on the sequence of the human genome and the rapidity with which we can now sequence tumor tissue types to understand the biological pathways that drives certain tumors to grow in an uncontrolled fashion.
And we are focused currently on three different pathways, one is called PK – PI3K kinase delta and we have a molecule called the Idelalisib for the inhibition of this pathway. Another molecule called GS-9973 and that's for Syk tyrosine kinase, which is another pathway that drives, in this case both drive B-Cell proliferation and disorders.
And then momelotinib, which is a JAK1 or Janus kinase, JAK1/2 inhibitor which could be used in a number of disorders including myelofibrosis. And across our portfolio, we have time to go into in depth what you will see is a number of opportunities that we have to knockout different kinases that seem to drive the proliferation of cells. And importantly an opportunity to start to combine these to see if we can get synergy that is better activity than we would otherwise better depth of response – longer response and to do so without adding side effects. So that's our goal across the different pathways that we are looking at.
We are also looking at something called the extracellular matrix. And so we are using anti-bodies in this case and target specific enzymes that cause this matrix to grow in certain disease including different cancers that are called desmoplastic tumors. So you have this fibrous environment that seems to allow this – the tumors to grow better and to proliferate even in the phase of chemotherapy.
In preclinical studies if you knock this out using a molecule such as simtuzumab which is an antibody, you in fact make the tumor much more susceptible to chemotherapy. And this is something we are exploring.
So let's turn to Idelalisib, which is the most advanced through the molecules that we are working on. We have now filings in relapsed refractory CLL. We submitted our U.S. NDA in December of this year for relapsed refractory CLL and we were granted a PDUFA date of August 6th of this year. That was a filing that was based on the recommendation of independent data monitoring committee that we stop a study because the difference between the control ARM, which was rituxan and the active ARM, which was rituxan plus Idelalisib was highly statistically significant. And so we stopped that study based on that interim analysis. We also submitted the MAA in Europe on October 28th of last year for the same indication and in the United States we were granted breakthrough designation. So again, this allows the FDA flexibility in how they think about reviewing the product.
Prior to this, we had filed for relapsed refractory indolent non-Hodgkin's Lymphoma based on an open label Phase II study. Those data were submitted on September 11. This was not granted breakthrough designation for this based on the open label nature of the clinical study and was granted a PDUFA date again an action date of September 11th of this year. So we have two indications under review with the FDA based on a series of studies that we have now submitted.
As it's true in oncology, you often start with later stages of disease and then progress to earlier stages as you learn more as you gain confidence in your molecule and you build a market over time unlike other diseases where you might have a full indication when you come forward.
This will take time as we understand how to use it in different combinations and in fact we have a whole series of studies where we are looking at. The first line of indications we are looking to see if we can get down to minimal residual disease, which is a goal of some of the physicians out there. And we started to unveil some of these data at ASCO, which was held down here at McCormick Center basically just a week ago where there about 30,000 participants. We were able to pre-unveil some of our new data in our Phase III studies including our longer term analysis in CLL looking at previously untreated patients and previously treated non-Hodgkin's Lymphoma patients.
So we are building out a story of Idelalisib understanding how best to use it with the right duration is and what patient population it should be used in. And by the way, non-Hodgkin's Lymphoma is in fact a whole host of diseases and we are seeing more and more in this area that they are actually being segmented into different kinds of non-Hodgkin's Lymphoma because some molecules were better in this and certain kinds of non-Hodgkin's Lymphoma than others. It maybe a term that largely goes away in the future as we get more specific about what we are doing.
We also updated our Phase II of our second inhibitor. We had very good and pronounced effect using this inhibitor. And so in CLL and NHL, it's very clear there are multiple pathways that you can inhibit. There are some advantage and some kinds of tumors and some disadvantages and there is a possibility that the combination therapy could overcome some of these.
And behind the scenes in Gilead, we are doing a lot of work on the biology to help predict what is the right dosing regimen and what the right outcome could be based on different combination of products. And I have to say the biology is getting quite sophisticated in terms of predicting how that synergy might play out. So that we come to proper dosing across a wide range of opportunities and this is only catalyzing more research. So you will see more things coming into our pipeline in the not too distant future as we move forward in this area.
Okay. I want to turn to biologics real quickly. I talked about simtuzumab. It's a humanized monoclonal antibody to something called LOXL2. I'm not going into detail with that. What that means expect LOXL2 is associated with pathogenic fibrosis. And so we see for example in tumor is the high level of LOXL2 transcription. So the tumor environment is producing a lots of LOXL2 transcription. We see a significant protein expression in tumors. We know that in murine models of this, if we knock it out in primary and secondary xenograft cancer models that works very well.
We know in humans that it's very safe and well-tolerated up to 20 milligrams per kilogram that's a very high dose of an antibody. And we currently have clinical studies to evaluate it both in colorectal cancer and pancreatic cancer. I can say today, we have no human data that suggest it works because these studies aren't necessarily that comes along and their duration and we have a number of indications going forward. And I can show you here we have three different indications in oncology including myelofibrosis, we have three different indications that we are pursuing in liver disease including liver fibrosis primary Sclerosing Cholangitis and NASH, Non-Alcoholic Steatohepatitis. And then we have one big study in idiopathic pulmonary fibrosis we are looking at the effect of simtuzumab.
I can't say based on earlier experience in trying a study in IPF, we looked at in earlier molecule not related to simtuzumab that didn't have the right risk benefit. But going back and looking at those patients, we did serum samples across those patients as their disease progressed. And we have noticed that patients with high LOXL2 in their blood progressed faster than patients with low level.
So we established a threshold above which we are now enrolling patients into the study, so we should have faster progression. These studies largely will roll – will play our during the course of next year. So simtuzumab to me is a very interesting molecule. As I mentioned we have no data in human suggesting it works, in animal models its been spectacular and specific. And if it is successful it could help a lot of patients across the number of different indications.
So finally, I'm down to 5.5 minutes, so we are finally getting to our HIV talk which has been the focus of the company for so many years. I talked about single tablet regimens at the beginning of this talk. The benefits have been pretty clearly demonstrated across a number of different studies, in a number of different jurisdiction showing that you have improved patient convenience, you have to take a medicine every day that's hard to do. I know most patients have trouble getting through a seven day antibiotic regimen. If it's once a day, if its routine and if its safe and well-tolerated that adds to the compliance which matters in HIV. The more we take in medicine, the more benefit you get. If you take less then 95% of your medications your chance of getting resistance goes up once your resistant to one medication you quickly become resistant to others and then the treatment paradigm gets much harder to go through.
The single tablet regimen and a number of studies has been showing, even the short-term lead to better outcome and lower healthcare cost. Lower hospitalization is important. We see that. If you take your medications, if your CT4 count stays high you do much better and that's been documented both in European studies and U.S. studies now.
So I want to talk briefly about our two most advanced – our most recent I should say single tablet regimen; Stribild has four components in it. It's the first single tablet regimen to contain an integrase inhibitor, which is a relatively new mechanism in HIV. That integrase inhibitor called – boosted by a product we invented called cobicistat, which boosts the level so that it's all a once daily single tablet regimen.
In the first quarter this year, we had sales of just over $187 million. We are very pleased with the uptake, this is comparing Stribild to Isentress, an integrase inhibitor that was launched by Merck and we can see that we are at or above their launch trajectory and that was a very successful launch.
The European Commission approved our product in May of last year. And we have now launched in 19 countries across European Union. As I mentioned, it takes a longer time to launch across European Union. We have now been added some of the major guidelines including the British HIV association guidelines and we are very pleased with the trajectory in Europe as well, I will show you another slide in a moment about what I mean.
Other single tablet regimen is Complera in the United States; Eviplera was the name that we once used in the European Union for. It's a single tablet regimen that contains Viread FTC and Rilpivirine. Rilpivirine is a product that we got in a partnership with Janssen Pharmaceuticals a division of J&J; it provides a non-nucleoside RT inhibitor a very good once daily option for patients.
It's the number two most prescribed regimens across all treated patients in the United States. It's first quarter sales were $130 million and we have seen very, very good uptake in European Union where its about a year ahead of its rival in terms of its uptake in Europe now launched in greater than 20 countries across European Union including all big five countries where we have now got pricing and reimbursement.
So I'm thinking about the Gilead HIV franchise and looking at the top regimens. In the United States and what I have bolded here in blue are all the single tablet regimens. And you can see that in naïve patients, Stribild as number one, our newest product in all patients Atripla is number one that's our oldest single tablet regimen. But in each case, a top three regimens being used contain a single tablet regimen from Gilead. And if you look across the top five, our other product Truvada is contained in all those regimens. So we have all our products in the top five in treatment-naïve and in all treatment patients across the U.S.
In Europe, the story is similar but evolving Eviplera is number one in treatment-naïve patients. It's now moved up to number two in all patients I guess this is an older slide, I didn't touch that. Again, with Truvada being the backbone in all the rest of the patients. Across the European Union and the U.S., the Gilead products are the most preferred regimens used in most of the combinations.
So what does that mean for the future? What we think we can improve upon this, we are doing with the product called TAF, tenofovir alafenamide. It's a way to deliver tenofovir at a very low dose and so that means you can get higher concentrations of the active ingredient inside lymphoid tissue which is a side of infection. But you give the body much less exposure to Viread which is known to have side effects including a decrease in kidney function and also decrease in bone mineral density. And these are increasingly important as this HIV population is aging.
The average – I'm sorry, the median age for HIV patient is over 50 years old now. And naturally kidney function and bone decline with time. And we think that it could be a very important option not only for these aging patients, but for all patients as we move forward.
We are going forward with a very comprehensive group of studies. We have two Phase III studies that are ongoing in treatment-naïve patients. These are large highly-powered studies comparing Stribild to a TAF containing version of Stribild. These studies will read out at the end of this year, which will allow an early next year filing.
But in addition to that, we have other Phase III studies to address a number of population. The confidence we have in TAF is very high. We have never run these many studies this early in an HIV product. We have studies which will allow us to talk about the benefits of switching patients or will be able to talk about patients who have mild to medium renal impairment, something you just simply can't do with Viread. We will talk about adults on active failing treatment. We will talk about adults who switch from complex to multi-drug regimens to our new product. And we will have data in adolescents as well, which will give us the most comprehensive group of patients ever to talk about. I think is a really exciting opportunity for Gilead. And you will see more data on TAF in other combinations as we move forward including TAF Rilpivirine and TAF darunavir.
I think I have talked about everything that we want to talk about here and my light is flashing here. So I want to thank you for your attention. It's been a phenomenal start to the year for Gilead. We have much to do and much innovation to come and a lot of work ahead of us. But, I look forward to your support. I look forward to talking to you in future. And thank you for your attention here today.
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