Idenix Pharmaceuticals' (IDIX) CEO Ronald Renaud Presents at 39th Annual Deutsche Bank Health Care Conference (Transcript)

May.10.14 | About: Idenix Pharmaceuticals, (IDIX)

Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX)

39th Annual Deutsche Bank Health Care Conference

May 07, 2014, 03:30 PM ET

Executives

Ronald Renaud - President and Chief Executive Officer

Douglas Mayers - Executive Vice President and Chief Medical Officer

Jacques Dumas - Executive Vice President and Chief Scientific Officer

Analysts

Alethia Young - Deutsche Bank

Alethia Young - Deutsche Bank

Alethia Young, one of the biotech analyst here at Deutsche Bank. Very happy to always have Idenix Pharmaceuticals here and I have the whole posse. And so we have Ron Renaud, to my first right, President and CEO; we have Doug Mayers, CMO; we have Jacque Dumas, Chief Scientific Officer. And maybe I'm lucky enough. This is Jacques' first foray into the fireside chat, perhaps.

Jacques Dumas

I think, it is.

Alethia Young - Deutsche Bank

Well, that's exciting. So with that, what we'll do is, we're going to do a fireside chat. And if you have any questions, you want to ask anonymously, feel free to e-mail me on my Blackberry, its alethia.young@db.com, A-L-E-T-H-I-A.

And so with that, I'm going to fire one off for Ron, and I guess it is, what are the three like most exciting things you've found from EASL? And just kind of help us think about where you think the space is going now.

Ronald Renaud

Yes. So I think the most important or maybe the most interesting thing we saw at EASL was the data that we had in our own press release. I think from our own perspective, having another nucleotide prodrug with potent activity across genotypes 1, 2, and 3, was very exciting for us. We press released that data during the course of that meeting.

But I think, broadly speaking, there was a more robust discussion about how to lower the duration of treatment. So just when we get comfortable with 12 weeks of therapy being kind of the mark for curing HCV, the discussion ramps up and it went well passed eight weeks in the discussion of six and we're even hearing as recently as yesterday, some groups trying to get down to four weeks. So that's a discussion that I think continues to be at the front of mind for folks developing regimens in the HCV-6.

And then I think the third thing that we probably heard the most around at EASL is just the payer environment. And I am not sure we came away from the EASL meetings with anything conclusive there, except to say that this is clearly a topic that's not going to go away anytime soon. We have to think and be thoughtful about how we look at the commercial approach for all of these regimens going forward and the pharmacoeconomic analysis that goes along with it.

But I think, clearly, we're getting to a place where we've got good regimens, good potent regimens that are safe. We're getting down to shorter durations. Patients are getting cured. And if you're a patient today with hepatitis C, it's probably the best time ever to be one of those patients. So it's getting better by the day.

Alethia Young - Deutsche Bank

So I'm going to spend the last half of the discussion talking about your new, but just in context of that, just how do you think about kind of what is going to take to get down to four to six weeks? Like what is needed in that ingredient package?

Ronald Renaud

Yes. So I'll take a quick stab at it, and then I'm going to let Doug take a try on that one, because Doug's got a lot more experience. He sat through a lot of the evolution of the HIV treatment paradigm and how that evolved. But I think clearly we're seeing some very interesting sub 12-week results with two drugs. We're seeing some with three drugs.

But I think that solidly and squarely get down to some regimen that consistently generates plus-90% SVR12 rates in my view, and you want to keep ribavirin out of the mix, it's going to require three direct-acting antivirals. And I think there is a lot of potential combinations out there that could happen, that could incorporate those three different DAAs.

I think really what the Holy Grail will be, can you get down to something that's short duration and is pan-genotypic? And perhaps even at very least fix those combinations, but maybe also in a one-pill once-a-day type situation. So I think those are very good goals to have. Doug, any additional thoughts on that?

Douglas Mayers

At this point, we believe that with two DAA combos, we can probably do eight and 12 with a good combination, eight for the easy to treat patients and 12 for the cirrhotic, more difficult to treat patients. We believe that was the three-drug combos. We can push it or whether we can get down to four is unclear, but I think probably the hope is to get down to four to six for the easy to treat patients and six to eight for the more difficult to treat patients. And if we can get it down to four weeks, its one prescription, the patients gets it, gets treated, goes home.

I think the fixed dose is important, especially to the patient, because they don't have the three pills to take, just one. And something interesting is I think that the competition originally was on potency and several of that are pretty potent that moved to safety, and safety is looking like there are several regimens that are equally safe. So my guess is the debate is now going to move to one-pill once-a-day convenience and to drug-drug interactions.

And we think that with the nuc-NS5A, we think we can do very well with 5816/Sofosbuvir, and with a right dose drug to make those combination, then we could get to studies 4, 6, 8 weeks in a reasonable time period, which also is a much quicker path to regulatory approval.

Alethia Young - Deutsche Bank

So I guess for everybody here, I'm just curious, how many people do you think actually can be treated like this year? And how do you think about kind of the next, this year and then the next two or three years? And then just kind of give us like how you think about the entire tale of those like opportunities?

Ronald Renaud

Well, I mean, I think we're starting to see the beginning of the discussion around this market taking a lot longer to meet the needs of the patient population than once was originally thought. I think it's very convenient to believe that the markets are going to go straight up and come straight back down. And we're going to cure all the patients with HCV and that's it and we'll move on to the next grievous illness.

I think it's going to take a lot longer than that. I think what we're seeing right now is a lot of the pent-up demand, patients that probably have the higher fibrosis scores or the more progressed patients getting treated. But patients that currently have low fibrosis scores, if not treated well, will eventually evolve into higher fibrosis scores and their disease will progress and those will become good candidates for treatment as we go along.

And I think the vast majority of patients that are quoted, and the number of the forecasts that are out there, a number of the forecasts that support some of the valuations for the compounds that are on the market today include patients that have yet to be diagnosed.

So in order for us to really see this play out, we're going to have to work very hard to continue to identify those patients, get those patients into a clinic and get those patients treated and get them genotype, get them treated. And that's going to take time. That's not something that's going to happen in the span of two or four quarters. This is going to take years to play out.

And that's just in the United States, where we have fairly advance way of identifying these patients. And as the commercial organizations work towards going out and screening, the government has screening initiatives in place, we'll get those patients into the clinic, and that's going to take two, three, maybe even four years. That's just the U.S., as I mentioned.

Once we get over into Europe and we get into some of the emerging countries where HCV as a percentage of some of these patient populations is much more dramatic, that's going to take a lot longer to play out. And so that's where having a very convenient, safe, potent pan-genotypic approach, is going to be critical.

But I think this market -- it's a market, that's going to be here for quite some time. We're seeing a very robust take-off with some of our competitors right now and we may see some ebbs and flows there. But I think overall it's going to continue to be very strong for, well into the foreseeable future.

Alethia Young - Deutsche Bank

How many people do you think actually really are kind of pent-up in the past two or three years?

Ronald Renaud

In the past two or three years, I don't know specifically what the actual number is on that. I don't think anybody can say with any kind of accuracy what the number is. I think we've seen estimates let's say, in the best year in the United States there were somewhere around the order of 150,000 to 175,000 patients treated. And that might have been with the advent of pegylated interferon and ribavirin. Maybe in the best year we saw those kinds of the patient numbers.

So if that's the case, and you still have a number of patients that are still eligible to get interferon, I mean I think in the advent now, where you regimen coming along that are interferon-free, why would anybody ever admit to being eligible for interferon?

I would absolutely say, that I can't tolerate it, I'm intolerant to interferon, put me on the orals. And I think what we're going to end up seeing is that pent-up demand blow right through that 150,000 patient number. Where it stops, I don't know. But it's probably a number of that's well in advance of what we've seen in the past.

Alethia Young - Deutsche Bank

Do you think that they'll blow through that number in one year, meaning like by the end of 2014 will you probably find 150,000 to 170,000 people?

Ronald Renaud

I don't know. That's a big number. I mean, I think the estimates or the numbers now are somewhere between 30,000 to 40,000, if I'm not mistaken. It might be a little bit more than that. So annualizing that, you start to get pretty close to that. I don't know if that's a number you can actually annualize or you don't see just kind of some aggregate build out of that number, which ends up taking it to something a little bit slower or lower than that. But I think when we really get going that number could be pretty high.

Alethia Young - Deutsche Bank

Do you think that if you could get down to like four weeks, that that timing would be an additional competitive advantage, meaning like if you could find these undiagnosed people and perhaps maybe it could be something that's used more in the general practice, unlike in specialty?

Ronald Renaud

I mean, it remains to be seen, because I think if you show up at the doctors office -- and I'll let Doug speak to this little bit more, but if you show up at the doctors office, and you're symptomatic and you show up and your liver function tests show something worrisome and you get an HCVR and it shows you have the virus, by and large today a lot of general practitioners will still refer that patient to the very least, for the GI doc, but more than likely to an HCV expert, a hepatologist.

If we really can get down to four weeks on a very regular basis and it's truly pan-genotypic, you start to take a lot of that guesswork out of it mean if it's only four weeks for genotype 1, then you're going to still have to get genotyped. Genotyping is not going to happen. I think by in large, not going to happen in the general practitioners office.

So there's a lot of nuances, a lot of intricacies that have to be considered before you really think about where four weeks takes everybody. But I think the bottomline is it's clearly more convenient and put you in a situation that you would truly be differentiating.

Alethia Young - Deutsche Bank

I know you probably can't talk a lot about it, but just kind of characterize some of the business conversations you've had, I mean there are clearly a few people who could need a nuc or either are probably working on or developing nucs?

Ronald Renaud

I mean I think broadly speaking there is one group that has a nuc on the market right now. It's not everybody knows how well that nuc, the launch, has gone for that. And I think we view everybody else in this space as potential collaborators. So at the outset of this discussion, we talked about how to get down to lower durations of treatment, whether it's eight, six or four weeks. And as we said, that's going to require three direct-acting antivirals to do that.

So for us with a nuc and an NS5A, clearly, we start thinking about what would be like to have, if we had a wish list. And there are protease inhibitors that are out there that are non-nucleoside inhibitors in the polymerase inhibitor camp.

And maybe some other approaches that we haven't quite contemplated. But for the one, the main one, the stream DAA is the non-nucs in the PIs, that's something we would be interested in. And as I said, if you don't have a nuc already then you're a potential collaborator.

Alethia Young - Deutsche Bank

Do you have a preference toward non-nucs or protease inhibitors?

Ronald Renaud

Not really. Our preference is towards, if we're going to short lien duration is towards an agent that is safe, that's potent. And what we really like to have is something that's pan-genotypic. And when you put all three of those things together and you lay out all the compounds that are available for potential partnership, it's pretty smallest.

Alethia Young - Deutsche Bank

Go ahead, Doug.

Douglas Mayers

I think the other piece is that barrier resistance does matter. And the data we've seen so far in nuc, NS5A, PI appears to be performing a little bit better stuff. So if you can get it, you want the third class to be potent, to have good barrier resistance and to play well with the other two drug regimen. So having the only other nuc available with clinical data to with a number of groups out there, they have drug to play out.

Alethia Young - Deutsche Bank

What's your sense on like kind of how expeditious people need to be? I mean I know in the case of J&J, many people kind of asked me like, what's their sensitivity of time? So I mean what do you feel we'll be looking at like a year from now, because I mean essentially we all are expecting Gilead to have the pan-genotypic combo in the market mid 2016, so you'll need to be in a study probably before?

Ronald Renaud

I think things are moving rapidly. And pieces on the proverbial chess board are moving almost on a daily basis. We heard about some new studies yesterday and I think there was some an NDA filed today. So there's always going to be moving parts here.

So with any kind of accuracy I don't think we can exactly predict, what's going to happen in a year from now, except that I think the leaders in the state will continued to get stronger. I think this focus on getting the shorter durations, is going to be at the front of mind.

I think what's going to be at the front of mind for everybody who is not a leader in the space is how to design these large pivotal trials? How we are going to control these studies? Are they going to have to be controlled study? So in other words, what will that control look like? We've got a number of regimens out there for example that will address genotype 1. Slightly different regimen there, depending on who the sponsor is for genotype 3 or genotype 4.

And so as we think about what a pivotal program will look like, I think it's very difficult from where we sit right now and know what that's going to look like. So we just have to continue to watch the landscape evolve just like everybody else has and make adjustments pretty much on the fly. In fact, even as we think about our Phase 2 program that we plan to initiate this summer.

We think about the arms that we would like in that study, but we also have to think about how we set ourselves up for pivotal program. And my sense is, we'll probably have, are thinking change on this a number of times before we really get going.

Alethia Young - Deutsche Bank

What's your current thinking there?

Ronald Renaud

Well, I mean I think it's a pretty straightforward one right now, where you would do eight and 12 week arms, with and without ribavirin, at least right out of the gate, start to focus on genotype 1, start also focusing on genotype 3, 4. And then where we start moving forward and getting to the shorter durations or bringing on a third direct acting antiviral I think remain to be seen.

So I think you're going to see a lot of people do electron like studies, where as you learnt from others as well as what you learnt from your own programs, as the trial evolves and you add arms and end up with some double-digit number of cohorts in a robust Phase 3 study.

I think what's going to be different for Idenix is, we don't have the luxury of bringing a small and Phase 2 program forward. I think to make up for time, we're going to have to do very robust, bigger-end studies to make sure that we build out the safety database and get a good patient experience across our compound in order to be comfortable going into pivotal program that we've got the requisite number of patients to make the regulatory authorities happy.

Alethia Young - Deutsche Bank

So you would look at six weeks perhaps maybe after completing the first eight and 12?

Douglas Mayers

I think at this point we were planning to focus on eight and 12, hopefully having eight riba-free for the two-DAA combo. And then if we can move it into three-DAA combos, look it to ultra-short, look at four, six and eight weeks in different patient population. So I think we'll tailor, that could change as data emerges. I mean this is based on all the data we have today. We clearly are going to do studies in which our combination is competitive with the best combination out there.

Alethia Young - Deutsche Bank

And I guess that's a good segue, but just a talk a little bit about your nuc and just simply kind of comparing what we've seen so far with the performance of sofosbuvir.

Ronald Renaud

Well, I think it's difficult to make direct comparisons. We're very pleased with what we've seen in the proof-of-concept program. We reported in the press release during the EASL meeting in genotype 1, a 4.2 reduction over the seven-day proof-of-concept study. And then patients that had genotype 2 and 3 HCV infection, we saw a 4.3 log reduction.

So from the best our ability, it's hard to make an apples-to-apples comparison, because I think the only other nuc that had sofosbuvir, did a proof-of-concept studies, but that was when it was 7851, it was a diastereomer.

And when they started separated out the isomers, they did in some individual studies in some arms, in some of their Phase 2 programs. And I think from what we can see from that at least on the 1A patients it compares very, very well. So we think we have a very competitive potent nucleotide prodrug to take forward and I am looking forward to getting that combine with our NS5A as quickly as we can.

Alethia Young - Deutsche Bank

So by the end of the year like what data will we have to kind of?

Douglas Mayers

I think we have our HELIX study, that's going on with Janssen. We've shown the two PI combinations, simeprevir, samatasvir and ribavirin at EASL. Our goal is to show the three drug combination of simeprevir, samatasvir, their non-nuc a little bit is for ribavirin in genotype 1 at AASLD to show some data of that study.

And that's an AbbVie-like combination, it could be pursued. But at this point, it's for us mainly to get 140 to 200 patient safety data before we combine the NS5A with one of our nuc. And it has done a great job at that. It's very safe. We've not seen any safe use or lab abnormalities, does not seem from clear ribavirin by itself. And so we got what we needed out of that study and we're getting ready to move into a new NS5A study this year.

Alethia Young - Deutsche Bank

How much safety do you have in that combination again?

Douglas Mayers

We've 140-plus patients of safety data and it's our intention to go up to 200 patients during the year.

Alethia Young - Deutsche Bank

And then just talking a little bit about kind of the nuc again, and its path forward, I mean as an individual asset. So how do you think about like bringing this asset back into the U.S. and the FDA environment? What do you need now? What are your updated thoughts on that?

Douglas Mayers

Well, at this point, our plan is to start our Phase 2 program in 240 patients, as Ron mentioned, outside the U.S. and we'll start in Canada, in Europe, Australia and New Zealand. Our goal is to have discussions with the FDA over the summer and see where they go.

We have a very clean safety profile, we have three months of toxin, we have good safety margins, we have good cytotox profile, we've done echocardiograms, cardiac biomarkers and histopath, have a very clean cardiac profile. And we have seven days of data now and actually two weeks of data in our DDI studies that shows the drug is safe and more tolerated.

So the question is going to be is that package acceptable to let us come back? And if it is, will it be in the U.S. in the fall and adding patients to our Phase 2 program at U.S. sites as well. If the agency wants to see 12 weeks of data, we'll be back in early 2015. But it's our clear intention to have a global program with the U.S., Europe and Asia, all participated in our Phase 2 program, which we hope to start second half of '15.

Ronald Renaud

And I think it's important to clarify on the issue is that we have not taking any of the data, not preclinical data or any clinical data to the FDA at this point on 21437. So the FDA is not seeing any data from this program. So basically when we do approach the regulatory authorities, this will be with a brand new data package.

And I think what was probably different than your standard IND package, which has a standard GLP preclinical tox program, is that now we'll be going to them with a healthy volunteer study and a proof-of-concept study. So hopefully that substantially adds to the confidence around the program. But we won't know, until we those discussions.

Alethia Young - Deutsche Bank

I don't want to leave you out in the cold there, Jacques, so a question for you on kind of nuc development in the future. So what are you thinking about for other follow-on compounds here in nuc space?

Jacques Dumas

So what we're working on right now in HCVR, we continue to our nuc activities. What we're trying to define is a complementary nuc, so it would be a nucleotide that would essentially rate different mutations, when exposed to the virus and would be complementary in this resistance profile to 437. Actually, we are well-position to do that. We have all the tools we need. They are in place. They are actually the same tools we used to put 437 and 459 into the clinic.

It is not an easy program to run, because you know, if you want to truly have a distinct resistance profile. You need radically different nucs. So you're going to have to go in terms of structural exploration to things that are truly in all the way different. But essentially that's what we're trying to do. We don't have an enormous amount of time. This is an effort that is our first priority right now and is somewhat limited in time, because as you can imagine, we cannot do HCV discovery forever, at some point we consider that.

We feel the kind of lines that stands, I mean nothing is exactly black and white. But the lines that stands, we have that we would like to have an IND before end of 2016 on a program like that. Although, again, it's not black and white, it's not a clip, but you will have to be just exceptionally good for us to risk launching something beyond 2020 and still have an impact.

Alethia Young - Deutsche Bank

And so since you've been the CSO for probably now a couple of months, just kind of talk about your vision and how you're taking things on a directional basis?

Jacques Dumas

I want to say that I'm having a lot of fun and I love this company. That's more on a personal note. Essentially what Idenix is really, really good at, we have a great compound library. We're working on two sites and we have capabilities in nuclear activities as well as tox prediction, the [ph] DMPK prodrug preparation and in predicting metabolism of nucleotides.

So we are really well tooled to do think other than HCV and actually in the history of the company, we've been doing HBV first, than HIV, and then came to HCV. So we're going to take that same platform at what we're really good at, and we're going to start applying it to other viruses as well as oncology. So for other viruses we already have a few screen campaigns done. And we talked about that at JPMorgan this year.

Right now, we're only talking about hits. We have very interesting restructures, but we are spending most of our time doing those HCV programs. So that's progressing in the background. We're trying to that through collaboration, a lot of collaboration.

And then for oncology, the product technology that we have is actually something that has not been applied to a larger extent in oncology. And so that they are also a thing that we'd love to talk about as soon as we have something interesting, we'll start presenting our programs. Right now, all this non- HCV is essentially in new generation and its progressing in the background of our HCV nucs program.

Alethia Young - Deutsche Bank

That kind of pivots too, you know Ron, when do you think you're going to start to kind of evolve the business into other diversify Idenix?

Ronald Renaud

I mean, as Jacques pointed out, we're very early days in the non-HCV program. And every single employee, still have to be absolutely committed to making sure we're successful in HCV first. So that is still the overarching goal. We want to get this Phase 2 combination study up and running.

We want to get these complementary nucs in a place where we feel very comfortable, that we have a chance to succeed there. And then I think we can continue to move things forward in the non-HCV space. So I think for the balance of 2014, it's still pretty much all HCV.

As Jacques pointed out a lot of this non-HCV work is going on in the background. That will start become more to the forefront I think in 2015. As long as we're successful in HCV, we'll be continuing to push that forward, march down towards at the end of Phase 2 and into pivotal programs there.

But then you start to think about different business questions for HCV in terms of what the pivotal trial has to look like and then what you're commercialization opportunities are looking like. Then you're also thinking of the long-term vision of the company is where do we want to go in the non-HCV spacing, where do we have the best chance to be successful. And I think those are questions we are asking now and hopefully we have better answers too next year.

Alethia Young - Deutsche Bank

And so maybe one last one or two questions. One, on the payer environment, what are you hearing and what kind of sensitivity is there? Is it just like you have to give them a 5% net discount, everyone kind of changes their behavior, what's your sense from speaking to people?

Ronald Renaud

I mean, as much as I would love to be in the lead position and launching in three HCV space today. I also acknowledge that this payer environment is very, very difficult and what we're seeing happen out there is, it's very noisy and it's very distracting, but at the same time, it's going to help us understand I think in pretty short order, as the company coming along after the leader, in terms of pricing strategy, how we need to approach it and what we need to be thinking about along the way.

I mean, the issues are fairly straightforward. It's a price and volume equation and can the payer system in the United States, can the payer system in North America, Western Europe, wherever, can it handle what's about to come down to play in the way of the number of patients that are going to benefit from these compounds.

I mean, no matter how you slice it, if you do the pharmacoeconomic analysis on this, we're curing patients. We are not talking about getting an extra, two-and-a-half weeks of overall survival, we're not talking about even getting an extra two months of overall survival, where in other therapeutic areas, that's where an incredible amount of money, we're talking about curing patients with HCV, where if they're not cured they are likely to progress to either end-stage liver disease or some type of hepatic cancer, some type of liver cancer.

And the cost to take care of those patients, which in a lot of cases is palliative effect, it ends up being multiple of what we are paying to cure HCV today. So I am not trying to justify it. I think what I'm pointing out is a problem that is complex.

It's going to require a lot of thought. And hopefully, when we get to the market, a lot of heavy-lifting would have been done and at the same time screen a few more patients and get those patients into the doctors office and get them ready to go on in Idenix regimen.

But it's a complex issue. We think about the payer. In fact, we're about to embark on our Phase 2 program this year. And we are already talking to payers, at this point, in our lifecycle. So this is something where we're giving a lot of thoughts to and spending a lot of time working on.

Alethia Young - Deutsche Bank

And maybe one last one, just where are your three strategic priorities now and kind of how they've changed over the past 12 months? It's a very dynamic environment.

Ronald Renaud

I mean the three strategic priorities is, the first one, and by far the most important is to get 437 and samatasvir into Phase 2 program and get that program moving, so that we can start answering some questions about where we're going to go in the pivotal program.

I think the second strategic is what Jacques outlined in the complimentary nuc program and figuring out how to best leverage, what's left I think of a nuc discovery timeline or even a new drug discovery timeline in HCV, that feels kind of like the door might be closing here over the next 12 to 18 months and how to best leverage what we have internally with well-over a decade of library building.

And then I think the third strategic imperative is, again, in Jacques' camp, and that is to figure out for the long-term of Idenix, where do we go beyond HCV, that best leverages our capability.

We have as Jacques pointed out, a terrific team of medicinal chemists. We've got a library that has largely been untouched, because of corporate collaborations that we've had in the past that we have since renegotiated, and now have full right to our compound library with a wide, wide bandwidth of freedom to operate there.

And so trying to understand what's in that library, how we can best leverage it and extract the most amount of value either on our own or with partners or collaborators, or what have you, it's going to take some time, but I think that its one of the more exciting things we're working on right now.

Alethia Young - Deutsche Bank

Well, great. Thanks guys for joining me today on the stage. Thanks.

Ronald Renaud

Thanks for having us.

Question-and-Answer Session

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