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Executives

Ronald C. Renaud, Jr. – President and Chief Executive Officer

Analysts

Robyn Karnauskas – Deutsche Bank

Idenix Pharmaceuticals, Inc. (IDIX) Deutsche Bank 37th Annual Healthcare Conference Call May 7, 2012 3:30 PM ET

Robyn Karnauskas – Deutsche Bank

Next, we have Idenix Pharmaceuticals, and we have the President and CEO, Ron Renaud, future Hep C/Cystic Fibrosis Company. So for those of you who want to ask questions anonymously, please either e-mail me or you can go onto the new website called yorn.com/hc, and ask the questions anonymously, and then I really won’t know who you are.

So with that, I’ll turn over to Ron.

Ronald C. Renaud, Jr.

Thanks, Robyn. And I think the way we’ll do this is, I may go through slides here for about 10 or maybe 15 minutes, and then I think we’ll open it up to Q&A. So before I begin, just a reminder, the requisite reminder that this is a presentation that includes forward-looking statements about Idenix, and the details about the risk factors and uncertainties are detailed in our SEC filings.

So with that, let’s spend a little bit of time talking about what’s going on at Idenix today. As most of you in the room know, we are a company focused on the development of next-generation antivirals with a singular focus on developing drugs for hepatitis C.

Our lead program is an unencumbered, unpartnered HCV nucleotide polymerase inhibitor that we currently called IDX184, which is in Phase IIb clinical testing. I’ll talk a little bit about recent data we’ve had from that program, and that where we’re going with that program.

We also have an NS5A inhibitor currently in Phase I, currently in proof-of-concept testing. We had some early data, one-day data on that we recently press released at the EASL meeting in Barcelona.

And then, I’ll spend a little bit of time talking about what’s probably going to end up as maybe the most robust discovery program we’ve ever run at Idenix in terms of nucleotide prodrug with the lead candidate coming from that program IDX19368, which is the next-generation nuc that we’re hoping to file an IND on in the not too distant future.

So I know for a lot of folks in this room that are very familiar with the HCV space. These aren’t going to come as a surprise. We have tiers of what’s important for developing an optimal direct-acting antiviral regimen. Some of these are very obvious, right? You want to have potency. You know here that we have greater than an 80% SVR. This is on an intent-to-treat basis. When we think about greater than 80%, we think about this on an intent-to-treat basis as far as the package insert is concerned.

I know we’re seeing a lot of early data right now that better than 90%, but really what we are looking for potency in very large scale Phase III pipeline and clinical trials, and we want to see this activity, potency against (inaudible) relapses and sporadics as well as the high barrier to resistance.

Clearly, we want safety, all-oral, these are pretty obvious. Convenience is also going to be important and ease of administration. We still believe this is a game that can be played in less than 12 weeks. We think that HCV patient are going to be able to go to their physicians in the not too distant future. Interferon will not be part of the mix, and that HCV will be able to be cured in 12 weeks or less. What we think really one of the most important things, and really what can set Idenix apart from the rest of the group is having a regimen that is truly pan-genotypic.

So actually have a regimen that doctors don’t need to think about what genotype it is or what the dose needs to be based on the genotypic. It can be pan-genotypic, one regimen that can be applied against any patients that’s infected with HCV. So this is important as we think about our program going forward.

So I mentioned a little bit about IDX184, here is the snapshot of the study designed from our ongoing Phase IIb 12-week program. This is a 12-week randomized study, we’re looking at two doses 50 mg and 100 mg, both of these are in combination with pegylated interferon and ribavirin. This is a study that we started last year. Hopefully, this is the last study we ever do with pegylated interferon and ribavirin. We have no plans for running anymore studies with peg/riba, but this is the study that we began in the middle of last year. And then, its response guided with extensions for 12 of 36 weeks depending on how they’re randomized.

Our target enrollment is 60 patients, and as we announced recently, the second cohort of 30 patients are fully enrolled, and we expect to have complete SVR data sometime in 2013.

What I’ll talk about a little bit today is, as I mentioned here that second cohort of 30 patients are fully enrolled, I’ll talk about the first cohort of 30 patients and the data we have from that program, and that puts us here.

I think first and foremost, given some of the concerns around nucleoside and nucleotide prodrugs, we’ve seen safety in the IDX184 program that is consistent with the non-safety profile of pegylated interferon and ribavirin. So we’re very happy with so far the safety profile we’ve seen with IDX184 in this ongoing Phase IIb study.

And from antiviral activity perspective, we’re also very impressed with what we’ve seen so far. In the 50 mg group n of 16, we had patients at a medium time of 22 days undetectability and RVR rate of 63%, and a 12-week for the cEVR, we saw 81% of the patients in the 50 mg group get undetectable.

In the 100 mg group, we saw those patients get to undetectability a week earlier with RVRs at 73% and cEVRs at 93%. and this was particularly exciting, because if you think about some of the other compounds that are out there and see how it stacks up, at 12-week cEVR, 100 mg once a day of IDX184 looks just as good as just about anything that we’ve seen out there.

TMC435 is probably recognized as one of the more potent protease inhibitors out there. 7128 or mericitabine is a first generation nucleoside, it’s not a nucleotide, it’s a nucleoside, and I think that may get probably the most attention in our space right now, it’s 400 mg once a day of PSI-7977, which is now in the hands of Gilead. So this stacks up very well. we think we’ll be very, very competitive, a lease right now from the data we see on top of pegylated interferon and ribavirin.

So moving forward into our NS5A program. IDX719 is the lead candidate there, a little bit of cutoff; you’re not missing anything in terms of the picture there. But what we’re excited about here is the broad pan-genotypic activity that we’ve seen preclinically, 2 to 24 (inaudible) is across the genotypes.

preclinically, we did not see any significant safety signals, and we believe there’s a potential for low milligram doses and QD dosing in human, and we believe that the NS5A, and I think this is fairly typical to a lot of the NS5As, low potential for drug-drug interaction. and I think what we’re excited about when I talk about the data is, if you look at lot of the NS6As that are out there, there’s a lot of claims around being pan-genotypic.

in the replicon, we’ve seen across a number of the different drug classes, a lot of pan-genotypic activity, but what that ultimately materializes to in the clinic has been very different.

For us, the preclinical data predicted very, very nicely what we saw in the clinic. And this is a one-day study that we did. So a lot of us say, as you do healthy volunteers – these studies get designed to do healthy volunteers to get your PK and PD data, and what we did was try to get a quick early snapshot of what 719 looks like in patients infected with HCV. and you can see here, in genotype 1 patients that 1 mg; we had already seen it 1 mg nearly two log maximal viral load reduction. As we went to 5 and 10, we were getting very impressive viral load reductions in genotype 1 patients.

Moving up to 25, was where we started looking genotypes 1, 2 and 3 and a 25 mg, we were able to capture the genotype 1s and genotype 3 pretty nicely, you can see here 0.4 in genotype 2, not so impressive. And for us to define true pan-genotypic activity, if we assume that genotype 1 is the base, you want to see the same activity in the other genotypes as you see at genotype 1. So it’s not just having significant activity, you want to see a equal potent activity across all of the genotypes.

At 50 mg, nearly three logs in genotype 1 and remember these are still small numbers, but still impressive results, 3.2 logs in genotype 2 and 3.7 log at genotype 3, and at 100, 3.5 logs across the genotypes 3.3 and genotypes 3.

What was also impressive is, we’re measuring PK/PD, so in some of these patients, we saw a significant viral load reduction as early as eight hours after the first. So we’re quite impressed with the potency in the pan-genotypic activity of 719.

and actually before I leave it, the importance also here is, at a 100 mg, we’re thinking about what we’ve talked about in the first slide, having the ability to combine these compounds. Right now our nuc IDX184, our lead program is the 100 mg, right now, the dose cohort that we like the most is a 100 mg. So if we were to put these two together, right now, we’re still only talking about 200 mg, this is something that could be very amenable to co-formulation and the Proof of Concept Study in genotypes 1, 2, 4 was started in April and is accruing very, very nicely.

And then lastly, I’ll talk a little bit about our novel nucleotide prodrug discovery program, 19368 as I mentioned is the first candidate out of that very robust discovery program. What we’ve done over the span of about the last year and a half is really try to understand what goes into making the best nucleotide prodrug. So we’ve tried to understand the components of the nucleotide prodrugs whether it’s the prodrug itself, it’s the sugar part of the molecule or the base itself.

and we’ve looked at all of these components and [hence] taking detail and identified some very promising compounds in-vitro where we’ve seen triphosphate production, which is important for procuring the virus where we’ve seen the levels of triphosphate production that we’ve never seen in any clinical candidates. So we’re excited about this.

368 generates very high triphosphate levels. we’re in the process of wrapping up the IND enabling studies and plan to file the IND by mid-year and we probably have another somewhere on the order of half dozen too maybe even as much as two dozen potential clinical candidates.

We clearly won’t bring all those forward into the clinic, but with some very, very some candidates that’s what we probably recognized them as true third generation nucleotide prodrugs.

We just reported our numbers last week. We finished the quarter, I think the most important part of this is, we finished the quarter with $105.3 million, and what’s important about the cash balance is, as you can see here, we’ve got a number of what we think our value driving inflection points. That cash balance is going to be enough to help us execute on all of these programs here and move these programs to the next what we think are the next value driving inflection point.

And I think with that we can start the Q&A.

Question-and-Answer Session

Robyn Karnauskas – Deutsche Bank

Great. Does anyone have questions from the audience to begin with? Okay, obviously fair amount (inaudible).

Ronald C. Renaud, Jr.

Sure. So the question third, as I’m assuming this is been webcast.

Robyn Karnauskas – Deutsche Bank

Repeat the question.

Ronald C. Renaud, Jr.

Yes, so the question is where are we finding a partner for the protease inhibitor, a combination study of IDX184. I would characterize our discussions as we’re way deep in those discussions to happen very much in real time. What we’re trying to do is make sure, we digest all the information in front of us. We want to combine 184 with 840’s inhibitor or a number of protease inhibitor that they are going to give 184 the best chance to succeed.

Keeping in mind that the focus and the objective of those next studies are to build up the safety data base as well as to continue to build up on the potency discussion, it’s very important that whether it’s one PI or two PIs or three PI that we decide to work with, the PI that we do choose gives us a very, very good chance to succeed. So we’ve committed to making sure those studies start by the middle of this year, and our guidance on that doesn’t change. Any other questions?

Robyn Karnauskas – Deutsche Bank

Maybe a follow-up on that and just kind of ask about, how many people you expect to kind of enroll in the combination study, how many was the critical mass for the Phase II database there?

Ronald C. Renaud, Jr.

Yeah, so the question around the number of patients required, so what we did in the fall of 2011 was to start a manufacturing campaign somewhat at risk to manufacturing up drug for 600 patients worth of study material to run in 2012. So right now that campaign has been run, we have the material, so we have enough capacity to do 600 patients so that could be three 200 patient study, it could be two 300 patient studies or it could be one study that looked at any number of patients.

So I think we’re well positioned from a drug supply standpoint to do any number of those studies and any kind of combination there. And then in terms of a safety data base, I don’t think there are any real hard fast numbers there. I think what you wanted to do is, we want to be in a situation as I mentioned part of our strategy, it’s put IDX184 also with our NS5A inhibitor IDX719. So we want to be in a situation where once we put those two drugs together, we’ve got enough safety build up on the IDX184 side that if we’re marching down the path where we haven’t seen 719 out beyond three days and we hit a bump in the round, we can absolutely say with complete certainty it wasn’t 184 because we got this well established safety database to make sure that we can do that safely.

So my guess is that we can get to three or four may be 500 patients in combination that will be more than enough and if we have good data with one of those PIs that could certainly be enough to drive a registration pathway.

Robyn Karnauskas – Deutsche Bank

So it would be dozen, probably a dozen of two 300 patients in the PI combination study.

Ronald C. Renaud, Jr.

Well it’s not necessarily any one study, it’s going to be the number 184 patients. So we’d like to have probably better than 300 additional patients on the study, and all the studies put together.

Robyn Karnauskas – Deutsche Bank

And what do you think was between boosted versus and unboosted PI in combination with your new?

Ronald C. Renaud, Jr.

Yeah, so it’s a good question around boosted versus non-boosted. I mean, if you look at the Abbot data, some very impressive data with a boosted protease inhibitor in combination with a non-nuc that was, a) I am not even sure with the one law drug with about a 50% RVR, so it just goes (inaudible) some things with the combination if we get the combination right. And you don’t see that same kind of data with, b) return of your boosted PI Roche.

Now that may be because of what they combined with, it’s hard to say, but we don’t have any fundamental opposition to a ritonavir boosted PI. I think commercially down the road that may be difficult when you have other regiments generating 80 plus percent of CR rays that may not contain a return of your boosted CI. But for our purpose, if they mean generating data like I say we’re not fundamentally opposed to it.

Robyn Karnauskas – Deutsche Bank

Okay, and so you were looking at maybe more than one PIs potentially?

Ronald C. Renaud, Jr.

We would like to do that because they would give us multiple opportunities and we can take the one where we hopeful get the best results towards registration. The other thing I mentioned on the return of your boosted protease inhibitors and I think even on my peer making comments about the commercial difficulty that might be out there in a couple of years time having a return of your boosted PI.

But if you talk to the key opinion leaders, they’re very positive on the return of your boosted protease inhibitors. They don’t really have any versions with them. I think the way that maybe, some folks that aren’t so close to the data you may have on. So when we talk to the KLOs and we try to get their view on prioritizing what PIs we should work with, I’ll tell you there was a return of your boosted PIs usually show up pretty high surprisingly.

Robyn Karnauskas – Deutsche Bank

What’s the top kind of whistlers for the resistance?

Ronald C. Renaud, Jr.

As far as attributes, I think resistance is a part of potency though, it’s always important. But resistance is a significant part.

Robyn Karnauskas – Deutsche Bank

What model were that (inaudible).

Ronald C. Renaud, Jr.

We are going to keep that list close to our chest for now.

Robyn Karnauskas – Deutsche Bank

I guess just maybe taking a step back and just kind of it’s still pretty important to be on the market, 2015, 2016 is…

Ronald C. Renaud, Jr.

Yeah.

Robyn Karnauskas – Deutsche Bank

I know you guys are on the same page with that, can you just kind of walk us through many combinations like how you expect to get there and very painfully detail them in simple ways?

Ronald C. Renaud, Jr.

Yeah, so how do we get to the market in 2015, I think we have a very clear pathway of getting there. It starts with combining 184 with protease inhibitor. And like I said, if we can do that with two different compounds or even three different compounds and then pick the one that we have the best data on and start down the registration pathway sometime in 2013 that very easily gets us to the marketplace in 2015. And while we’re doing that 719 comes up in the background in combination with 184, that’s the study that we’re going to start by the end of this year.

So 184 are nuc, our lead nucleotide prodrug and 719 starts probably sometime in the fourth quarter. We think that puts really only one group out there ahead of us, and that’s (inaudible). So we think there is going to be others going to try, they’re going to have a new kind of PI, but we offers things with a lot of heavy width and that have to be done around the industry to figure out what’s the combination of these drugs are looking like, how they pick their dose for their nucs, or how they pick the dose for the NS5A. So we see a very, very clear pathway that’s making up a lot of lots ground this year.

And so as we move down the pathway with 184 in the PI, we’re coming up right behind it with 184 and NS5A that maybe more or like the 2016 timeframe. And then we’re also as I mentioned in the slide deck, we’re also going to have another nucleotide prodrug that comes on to the clinic this year were our proof of concept from that program by the end of this year and depending on what that data looks like if we really – if it pans out the way we seen pre-clinically and if they are very low dose, highly potent nucleotide prodrug, we’re going to swap that at the same time and we’ll figure out how to combine that with our NS5A program.

So that we’re really life cycling the HCV portfolio as much as possible, so that we have as many chances to be in this marketplace where as long as we can possibly be in the market place.

Robyn Karnauskas – Deutsche Bank

May be I’ll just put the 719, I find it incredibly interesting to do activity or maybe you can talk about how 719 differs from 52 and 5885, so Gilead and Bristol combination?

Ronald C. Renaud, Jr.

Well, I mean you saw some of the preclinical Replicon data there, I mean, I think for starters this was some of the most potent replicon data we’ve seen in where as much as people trust Replicon data, I think for us it’s really played out well, to the [2 to 24 peak more] is probably as much potency as you’re ever going to see in the NS5A class. And so we’ve seen some pretty impressive potencies for the NS5A’s across the board, but how that materialize in terms of pan-genotypic activity has been, I think somewhat disappointing. And I think even from the competitors, we have yet to see any body. I don’t know, if I’m right on this, but I don’t think I have seen any other clinical data from an NS5A program showing true pan-genotypic activity besides what we just released back a couple of weeks ago. So I think we really have a very well differentiated NS5A and I am very much looking forward to getting the proof of concept study done and getting that in combination with 184 by the end of this year.

Robyn Karnauskas – Deutsche Bank

Just curious, but why did you choose to do a one day or three day like when I just started with the three day?

Ronald C. Renaud, Jr.

Well remember, so the one day really what you almost every body have to start up whether it’s a PK and PD, you’re doing a healthy volunteer study. So everybody have to do the healthy volunteer. What we chose to do was to add HCV infected patients to our healthy volunteer study. So it gives us a very nice early look at not only the PK and PD, but what the antiviral activity is. And then it allows us I think in a much more facilitated ways to establish our dose and we don’t with anytime doing this. We would have been doing the healthy volunteer studies anyway. So this goes right into the ongoing Phase III proof-of-concept study right now that that’s currently I think it’s more than half enrolled. It’s moved very, very quickly.

Robyn Karnauskas – Deutsche Bank

And the readout on that is in the second quarter?

Ronald C. Renaud, Jr.

Yeah, we’ll have a readout on that. I don’t want to say the second quarter. I want to say sometime in the middle of the year, but I think given where we are with the NS5A program, it would be our hope to get the data presented at the AASLD meetings. So I think we’re going to be pretty close with on that data. Hopefully get it presented at AASLD, because you know if you presented or you disclose in advance, it’s very tough to get those abstracts accepted.

Robyn Karnauskas – Deutsche Bank

Anybody in the audience have any question? I’m wondering, just a big picture question for you sort of, if a product reaches the market with a viable regimen, how do you think the regulatory [affairs] will change for companies that follow?

Ronald C. Renaud, Jr.

Well, it’s a great question. I mean we’re getting a pretty good roadmap of that right now with the two commercially available protease inhibitors. Those are now considered the standard of care. So as people start to run there pivotal Phase III studies, they’re going to have to run a month against telaprevir, boceprevir plus peg/riba.

Timing wise, I’d love to do those studies until the calls from home, I mean those I think are easy comparison studies to do. My guess is as we see some of these studies begin to move forward in the all oral’s, whoever gets across the finish line first, I think if you’re running a study, at the same time you may get grandfathered in right. You’ll have that study that’s ongoing, that’s not unique to any therapeutic area. If the study is ongoing, you’ve been given an agreement by the FDA and how the study design should look then you’ll have to run that study out.

But I think for the first group that get a direct acting antiviral regimen across the finish line and it’s got a good SVR rate. It’s going to very, very quickly became the standard of care and that’s where I think the hurdles we’re going to get very, very high. Because then you’re going to be run non-inferiority studies and those get to the very, very big studies and my guess is these drugs aren’t going to be cheap.

Robyn Karnauskas – Deutsche Bank

So given that that’s probably going to happen and how is that influencing your business strategy, because it may cause some sort of pull back, sometimes on some safety trials that may make other company to see more aggressive for combining? So how is that it influencing Idenix and your business strategy?

Ronald C. Renaud, Jr.

Yeah, it’s a good question. I mean I think where we are in a timeline, as I mentioned we don’t feel like we’re that far behind in fact, we feel like as far as the next-generation regimens are concerned, we are as almost this far in front of anybody is. So we’re going to keep a very, very close eye on that the one or two folks that we think are right in front of us, but we think we’re all going to be running those same pivotal studies right around the same time.

So I don’t think we’re far enough behind, where we’re going to have to really worry about a different standard of care coming, squeezing into our studies that the people right directly in front us are running, as long as we keep pace with the folks that are right in front of us. I think we’re going to have the same crack out of this everybody else.

Robyn Karnauskas – Deutsche Bank

Are there enough KOLs to go around?

Ronald C. Renaud, Jr.

That’s a different KOLs, I don’t know. Look, it’s interesting, good data we get, a lot of interest from the KOLs and the 719 data or NS5A compound. I don’t think we’ll have any problem in combination with 184 during those studies just about anywhere. Our Chief Medical Officer, Doug Mayers wants to do them.

Robyn Karnauskas – Deutsche Bank

Maybe also quick one on Novartis, can you just characterize how that relationship is going with 719?

Ronald C. Renaud, Jr.

Yeah, so Novartis owns 31% of the outstanding shares of Idenix. They have an option right on every compound that we develop. On 184, they passed on that option back in 2009. On 719, we’re in the midst of, as I said the proof-of-concept study, and if the POC that actually drive the decision point.

So once we finish the proof-of-concept study, we pull the other the pre-clinical data, a clinical data and then we pull together a series of financial models, market models, financial expectations, and we have 45 days from the time we finish the last patient on the POC to give that data to Novartis. And then once we give that to them, they have 90 days to make a decision on whether or not they would like to exercise their right on the compound.

Now big in-license and NS5A inhibitor recently that was a decision they made, it wasn’t one based on looking at our data because everyone in this room has much information on our NS5A program as they do. So they didn’t get any preferential look at it before they did that transition. If they exercise their option on 719, I can tell you, their financial terms that are far more significant than the licensing deal that they just did for the one they in-license, I think that’s first important point.

Second important point is, if they exercise their right, we still have 50% of the co-marketing and co-selling in the United States. We have 50% of the co-marketing and co-selling in the EU Big Five. We get a royalty on the rest of the world. The way the contract works is Idenix also the development rights. So we’re in responsible for developing the compound, the clinical development, we manufacture the drug. So I mean it’s still a very – we would view it as a win-win situation for us.

Robyn Karnauskas – Deutsche Bank

Okay. Maybe I’ll just ask another one about the patents and I think that’s going to be interesting sago that’s going to play out next year in all the classes. So just maybe characterize for us, you patent is stayed for your new – for your NS5A?

Ronald C. Renaud, Jr.

Yeah, you haven’t known me very long, but Robyn’s know me for a long time. I’m not going to say anything about the IT. What I will say is the interference is ongoing as most people know we’ve been named the senior party here. So the burden of proof is on the junior party here, and I think we’ll just leave it as that. I think for folks who want to watch the blow-by-blow and play-by-play, the USPTO does a very, very good job, and putting the documents up there and leaving very little to the imagination, so I’ll leave it to that.

Robyn Karnauskas – Deutsche Bank

Got it.

Robyn Karnauskas – Deutsche Bank

Any question?

Robyn Karnauskas – Deutsche Bank

You mentioned that the KOLs aren’t bothered by the boosted PIs and some of the doctors I have talked to say they are, I’m just wondering on your end, what is the biggest misconception you think that investors have versus like your experience with KOLs. There’s one thing that definitely came out [as usual] for us that there is different ways of thinking between investors, some investors and some physicians?

Ronald C. Renaud, Jr.

Yeah, there are some very big differences in thinking. But I would say, I think to just put it simply, I think HCV is a very difficult space, I mean when you see Robyn and I didn’t want to touch HCVs with a ten foot pole. I’d say six, seven years ago, it’s very difficult to try to make sense, I’m on the inside now…

Robyn Karnauskas – Deutsche Bank

I still don’t cover Idenix…

Ronald C. Renaud, Jr.

And it’s still a tough space to watch. But what I would say is that I think to the investment community, one of the misperception is folks want these compounds and these regimens been into very nice unique little boxes.

So a nuc, you just take a nuc and a PI and an NS5A and that should generate some level of RVR, some level of SVR and you move forward. and I think what folks are starting to learn, I think the big difference is, it’s about the regimen, but the individual drugs are important. It’s not, you can’t just take a class of compounds and drawn together and say okay, this should work. I think we’re learning that there is a lot of unique property to these compounds that come to bear on the regimen.

As I mentioned, look at the Abbott regimen. you’ve got a non-nuc with a very low barrier to resistance, a very low RVR and low potency and it’s part of a 95% SVR whereas you have some other compounds and other classes where you have much better potency and don’t contribute to an SVR rate that’s very similar.

So I think it shows you exactly how difficult it is. I think we just have as an industry, we just have to generate the data, and I think for the timelines to do that are always going to be a little bit longer than what the investment community is comfortable with. And we just have to live with that and keep folks appraise of where we are. but at the end of the day, its data have to drive everything, and it’s got to be substantial data, it can’t just be six patients here or eight patients here. I think what the KOLs are really starting to clamor for is robust clinical trials.

I think that we had one investor said it was that, they want to see us study that has more patients than presentations. So we’re hearing things like that from the KOLs and I think that was pretty apparent that at the recent ACE meeting.

Robyn Karnauskas – Deutsche Bank

From your strategic, when you think about Idenix strategically, how do you avoid the situation of Vertex’s NOE, you’ve got a drug on the market for x number of years, you want to have a drug in the market to capture the entire length of time is still around?

Ronald C. Renaud, Jr.

Yep.

Robyn Karnauskas – Deutsche Bank

So how are you thinking about that? and second, if you realize at some point, you can’t get there, when do you sort of explore different strategic alternatives that would diversify the company away from it?

Ronald C. Renaud, Jr.

Yeah. I mean, I think you always – I mean the strategy wise you’re always thinking about what’s making sure that you’re in the game for a long time. However, you have to be there, you have to be thinking about that, this phase is moving on a weekly basis. So we think about this on an hourly basis and I think as I laid out, for us, it’s not just about one getting one program across the finish line. It’s about getting the lead program, IDX184 across, doing that in combination.

So if you think about U.S. strategically, that’s why we didn’t we filled our own PI program. and we felt like there were enough PIs out there that we would be able to pick from, and not expand our own internal resources focused on it, in the event that something went wrong, that would be money down a hole that we can’t afford to lose.

So we knew there would be enough PIs out there to work with. We’ll work on that strategy, and if that takes us down a registration pathway, we’ll then also have the NS5A coming up behind it, a next generation nuc. my sense is, we’ll have more than just 368 on the nucleotide prodrug side. my guess is next year, you’ll see us put in 1, 2, maybe 3 new novel nucleotide prodrugs that continue to try to improve on potency, convenience, low dosage formulation, everything to try to get this regimen as potent and as low dosage and as pan-genotypic as possible.

So I think unlike maybe someone that has just one product across the finish line, and then came to the game late with a bunch of other combination approaches, we’re thinking about that already. So that, we’ll have these combinations coming one right after another, right after another as 184 already crosses the finish line.

Ronald C. Renaud, Jr.

Great. Any questions?

Robyn Karnauskas – Deutsche Bank

I have one last one for you.

Ronald C. Renaud, Jr.

Okay.

Robyn Karnauskas – Deutsche Bank

What are your thoughts on nuc-nuc combo, and like what will take you across that finish line?

Ronald C. Renaud, Jr.

Yeah. That’s a really good question, and I think we’ve thought a lot about nuc-nuc combos, because it was fashionable, talk about nuc-nuc combos a year ago, and we didn’t believe in that kind of a nuc-nuc combo. I think as we think about putting two nucleotide prodrugs together, you got to think about compensating for each other’s resistance profiles, you want to have very potent compounds.

and so we think putting compounds that look a lot alike together isn’t going to accomplish that. and we saw some of that data; we saw some of that nuc-nuc data last year where one drug didn’t look much different than two on top of each other.

So I think part of what David has done with the nucleotide prodrug strategy over the last year and a half is, really try to understand what makes the best qualities of a nucleotide prodrug and we’ve learned a lot of things about the prodrug. We’ve also learned a lot of things about the bases and sugars.

And so we’re going to have compounds that come up, that are completely different than anything that anybody has seen. these aren’t going to be things that look like IDX184 or other nucleotide prodrugs that are in the clinic. these are going to be true novel nucleotide prodrugs that we think will have the qualities that will certainly support a real nuc-nuc strategy. It’s far down the road, and it’s something we’re thinking about it’s not the overarching strategy that we’re focused on getting 184 and 368 and 719 forward. but we think we have the genesis of what could be a very, very compelling nuc-nuc strategy going forward.

Robyn Karnauskas – Deutsche Bank

Great, thank you very much.1

Ronald C. Renaud, Jr.

Thank you.

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