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Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX)

Promising Clinical Data Conference Call

April 7, 2014 08:00 AM ET

Executives

Teri Dahlman – Director of Corporate Communications

Douglas L. Mayers – EVP and CMO

Jacques Dumas – EVP and CSO

Ronald C. Renaud, Jr. – President and CEO

Analysts

Geoff C. Meacham – JPMorgan Securities LLC

Andrew Ross Peters – UBS Securities LLC

Alethia R. Young – Deutsche Bank Securities, Inc.

Geoffrey C. Porges – Sanford C. Bernstein & Co. LLC

Y. Katherine Xu – William Blair & Co.

Brian P. Skorney – Robert W. Baird & Co., Inc.

Koon C. Ching – Credit Suisse Securities LLC

Operator

Good day ladies and gentlemen and welcome to the Idenix Pharmaceuticals’ Conference Call. At this time all participants are in a listen-only mode, later we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder this call may be recorded.

I’ll now introduce your host for today’s conference, Teri Dahlman. You may begin.

Teri Dahlman

Thank you, good morning and welcome to Idenix’s conference call to discuss an update on the Company’s Nucleotide Prodrug program. With me today are Ron Renaud, President and Chief Executive Officer; Daniella Beckman, Chief Financial Officer; Jacques Dumas, Chief Scientific Officer; and Doug Mayers, Chief Medical Officer, who is joining us via phone.

Before we begin, I’ll review our Safe Harbor statements. Today’s discussion contains estimates and other statements that are forward-looking under the Private Securities Litigation Reform Act of 1995. Such estimates and statements are based on current expectations and assumptions that are subject to risks and uncertainties and involve a number of factors that could cause actual results to differ materially.

Additional information concerning these factors is contained in our filings with the SEC, which are available on the Investor section of our website. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates or assumptions change. You should not rely on these forward-looking statements as representing our estimates as of any date subsequent to today.

On today’s call, Doug will first review the clinical proof-of-concept data, we’re announcing for IDX21437, our lead nucleotide prodrug candidate. Jacq will review the preclinical profile of our nucleotide clinical candidates as well as our earlier-stage nucleotide discovery effort. And then Ron will wrap up the formal part of the call with closing remarks. We will then open the call for Q&A.

I’ll now turn the call over to Doug.

Douglas L. Mayers

Thanks Teri. I’m happy to provide you an update on the progress of IDX21437. This morning, we announced topline data from our seven-day proof-of-concept study. As a reminder, we initiated the proof-of-concept portion of the Phase I/II study in January in several countries outside the United States and enrolled 44 treatment-naïve genotype 1, 2 or 3 HCV-infected patients.

Genotype 1 patients were randomized to receive once-daily doses of placebo, 50, 150, or 300 milligrams of IDX21437 for seven days. Genotype 2 and 3 patients were randomized to receive once-daily doses of 50, 150, or 300 milligrams of IDX21437 for seven days.

In the study, IDX21437 was well-tolerated with no observed patterns of clinical or laboratory abnormalities. IDX21437 demonstrated potent pan-genotypic activity in a dose-dependent manner. In the eight genotype 1 HCV-infected patients receiving the 300 milligram dose of IDX21437, the mean maximal viral load reduction was 4.2 logs. The response was stellar between patients with genotype 1a and genotype 1b HCV-infection.

In the 10 genotype 2 or 3 HCV-infected patients receiving the 300 milligram dose, the mean maximal viral load reduction was 4.3 logs. The response was also somewhere between patients for genotype 2 and genotype 3 HCV-infection.

We are encouraged by these topline data for IDX21437, and we’ll present more detailed results in a presentation at the future scientific meeting. Based on these proof-of-concept results, we have selected 300 milligram dose of IDX21437 to be evaluated in a planned Phase II combination study of IDX21437 and samatasvir, our pan-genotypic NS5A inhibitor. The Phase II study is expected to initiate midyear.

As you may recall, samatasvir has now been evaluated in over 100 patients as part of the ongoing Phase II HELIX clinical program through our collaboration with Janssen. In this program, combination regimens including samatasvir have been found to be safe and well tolerated for up to 12 weeks of treatment.

We will provide the results of the IDX21437 proof-of-concept study, our three-month toxicology program, and the drug-drug interaction study of IDX21437 and samatasvir to the regulatory authorities. Based on this information, we plan to initiate a Phase II program including 200 to 300 patients for genotype 1, 2, or 3 HCV-infection resuming 8 or 12 weeks of the combination treatment with IDX21437 and samatasvir with and without ribavirin.

As this trial progresses and we review the interim data, we plan to expand the study to add additional exploratory arms. We’ll also initiate a dialog with the FDA to discuss next steps and potential timelines related to including U.S. sites in the clinical program. Assuming positive results for the Phase II clinical trial, we expect to move directly into pivotal trials in 2015.

I should briefly highlight, we’ve also completed the development of the co-formulated pill of IDX21437 and samatasvir supporting our ultimate goal of one-pill, once-daily, pan-genotypic regimen. We are excited about the progress of our nucleotide development program and look forward to sharing continued updates with you the second half of the year.

I’ll now turn the call over to Jacq.

Jacques Dumas

Thank you, Doug. As part of our broad nucleotide discovery program, we selected IDX21437, as a lead candidate based on its promising preclinical profile. As Doug has now discussed, this has been confirmed by the promising topline clinical data for IDX21437. Our extensive preclinical testing of IDX21437 demonstrated a clean safety profile including no cardiac, mitochondrial, or genotoxicity signals.

This along with potent antiviral activity across genotypes 1 through 6 and its high barrier to resistance supported the advancement of IDX21437 into the clinic. Further, the favorable safety profile was observed in the three-month tox program, including the absence of cardiac toxicity findings.

Later this week, we will present additional details on the preclinical profile of IDX21437 at the EASL meeting in London. Also, as part of our continuing nucleotide discovery efforts to develop multiple nucleotides for the treatment of HCV, I’m pleased to report that we also have chosen IDX21459 as a follow-on, uridine-based nucleotide prodrug candidate.

In preclinical study, IDX21459 had shown potent pan-genotype activity and a favorable safety profile with respect to cardiac, mitochondrial, and genotoxicity assessments. As a result of the preclinical data, we have initiated enrollment for the healthy volunteer portion of the Phase I study of IDX21459 in Europe. While the key goal is to combine IDX21437 with samatasvir for pan-genotypic regimen, we continue to identify additional nucleotides for HCV.

Our focus is on the discovery of a novel nuc with a distinct resistance profile from our clinical nucleotide candidates that can be part of a nuc-nuc combination strategy to treat HCV.

And I will now turn the call over to Ron.

Ronald C. Renaud, Jr.

Thank you Jacq. We are excited to have two nucleotide prodrug candidates in the clinic, and we are also very pleased with the positive data for IDX21437. As we have said before, our ultimate goal is to combine IDX21437 with samatasvir to develop an all world pan-genotypic combination for the treatment of HCV.

We believe our nuc, NS5A combination could play a meaningful role in the evolving HCV treatment landscape due to the scarcity of this assay combination, the potential to deliver the convenience of one pill, once-daily dosing, and the potential to be safe and potent with a high barrier to resistance and limited drug-drug interaction concerns.

With the initiation of the Phase II study of IDX21437 and samatasvir later this year, we will be one of the few companies within all world, pan-genotypic nucleotide-based combination approach in the clinic. We believe this regimen has the potential to play a significant role in advancing HCV care for the benefit of patients, physicians, and payers.

In addition, I want to point out another important development for the Company. As of today, you will notice that Idenix has a new logo and a new a look that you will across our communications, including our website. Our core strength has always been our science and our focus is to use our targeted nucleotide chemistry and prodrug technology to discover drugs that can help patients with Hepatitis C and potentially other life-threatening diseases.

Our targeted science for humanity campaign reflects our ability to be focused, nimble, and tenacious leveraging our targeted science to produce innovative drug therapies to fight diseases and to improve patient’s quality of life. We’re excited that this is reflected in our new look. We’ll hope you go to the new website launched today and check it out.

With that I’ll now open the call for Q&A. Operator, any questions?

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) Our first question comes from Geoff Meacham of JPMorgan. Your line is open.

Geoff C. Meacham – JPMorgan Securities LLC

Hi, good morning guys, thanks for taking the question and congrats on the data.

Ronald C. Renaud, Jr.

Thanks Geoff.

Geoff C. Meacham – JPMorgan Securities LLC

And so a couple ones. Are you close to reaching the MTD for IDX21437 or given the regulatory environment do you really not want to push the dose? And I have a couple follow-ups.

Ronald C. Renaud, Jr.

That’s a good question. Doug is actually out of the office, he is actually already over in the U.K., but I’ll let Doug take that question.

Douglas L. Mayers

I think at this point, look we wanted to normalize our dose to that of samatasvir in the clinic, and we dosed around that and we’re quite happy with our response of 300 milligrams, so we’re going to stick with that dose.

Geoff C. Meacham – JPMorgan Securities LLC

Okay. And then how are you thinking of the design of the samatasvir combo. I’m assuming at this point you guys won’t be looking at active comparator studies quite yet in Phase II, but that obviously could be something that that could play out in Phase III.

Ronald C. Renaud, Jr.

Yes, Doug – Geoff it’s a good question. I think at this point, the Phase II study will be pretty straight forward, you are right, no comparator arms, it will be a straight combination of IDX21437 and samatasvir to start, and as Doug mentioned in his prepared remarks, we will have the option to add additional trials and amend the study to look at exploratory arms.

I think it’s a little bit too soon to say what’s going happen in the pivotal program with regard to comparator arms as you know the landscape is evolving pretty rapidly. We haven’t seen comparator arms being used in the pivotal trials of late, so we’ll have to wait and see how this unfolds over the next 12 to 18 months, and as you can imagine we’ll be watching that closely.

Geoff C. Meacham – JPMorgan Securities LLC

Okay. Thank you.

Ronald C. Renaud, Jr.

You bet.

Operator

Thank you. Our next question comes from Katherine Xu of William Blair. Your line is open.

Ronald C. Renaud, Jr.

Good morning, Katherine.

Operator

Katherine, you might want to check your mute button. Katherine, if you have your question again, please re-queue we’ll go ahead and go on to the next. Our next question is from Matt Roden of UBS. Your line is open.

Andrew Ross Peters – UBS Securities LLC

Hi, guys it’s actually Andrew in for Matt. Congrats on the data this morning. Just a couple of quick questions. I guess the first on what just – what are the steps – what sort of data are you going to need to move the study into the U.S., have you met with the FDA, is it a pretty clear game plan from there, and then I have a quick follow-up.

Ronald C. Renaud, Jr

Okay thanks, Andrew. I’ll let Doug fill that one.

Douglas L. Mayers

Okay. So, at this point our plan is to take our three months tox program, our seven-day clinical data, and our drug-drug interaction studies were conducting. We’re going to open our Phase II program in overseas, as we did with our previous Phase I/II. And then we’re going to initiate a dialog with the agency, and we will discuss all the preclinical data and clinical data we have and determine whether we can come back in the fourth quarter in Phase II or whether they want to see 12 weeks of safety data in order to come back for Phase III, so, we’ll start the dialog mid-year and we’ll see where we go.

Andrew Ross Peters – UBS Securities LLC

Okay, thanks then, I may have missed this earlier, but on IDX21459, is the resistance profile similar to 437 or is it distinct and, how do you think about kind of a IDX21437 combo -- new combo or is that you’re looking to the earlier programs for that?

Ronald C. Renaud, Jr

I’m going to let Jacq fill that question.

Jacques Dumas

Yeah. Thank you. So, the IDX21459 resistance profile is not going to be very different from that of 437, but what we are working on right now in discovery setting, our compounds which we expect will have a completely different resistance profile, and these are the compounds that we would like to be able to combine in the nuc-nuc combination. That’s why we made clear that IDX21459 is a follow-on, it’s a follow-on compound and then that there is also a search right now for a complementary nucleoside with a distinct resistance profile.

Douglas L. Mayers

And Andrew, as we think through these as well, having a follow-on for IDX21437, I think provides us with in insurance policy, but it also provides us with an opportunity somewhere down the road if we have two nucleotide prodrugs, there are multiple opportunities if you think from a commercial perspective where you could launch two different nucleotides in two different geographies for whole host of competitive reasons, so this allows us some optionality as we move forward.

Andrew Ross Peters – UBS Securities LLC

Great. Congrats again on the data.

Ronald C. Renaud, Jr.

Thank you.

Operator

Thank you. Our next question comes from Alethia Young of Deutsche Bank. Your line is open.

Alethia R. Young – Deutsche Bank Securities, Inc.

Hey, guys. First of all, congrats on the data this morning, and I have two questions, but the first one is, I just kind of wonder how you’re thinking about the genotype 3 population now that you have some data in hand, and then I have a follow-up.

Ronald C. Renaud, Jr.

It’s a good question, Doug you want to take Alethia’s question on that.

Douglas L. Mayers

Sure, we’re very comfortable about genotype 3. As you know our NS5A had very, very good activity against genotype 3 and our nuc also has good activity. We’re seeing the same – around 4 logs activity for genotype 3 with the nuc, and about 3.5 logs with the NS5A, so we anticipate that it should be very potent. We’re just going to find out if we need to use riba or not to get the desired SVR rate that we want.

Alethia R. Young – Deutsche Bank Securities, Inc.

Great. And then on the Phase II, you’re going to have arms with and without riba, I assume. And then also what durations are you thinking about on Phase II? I might have missed that earlier. I joined the call a couple minutes --?

Ronald C. Renaud, Jr.

Doug?

Douglas L. Mayers

Yes, I mean, at this point we’re obviously learning from all of our competitors as they move forward. So at this point the genotype 1 arms are going to have IDX21437 and samatasvir for eight and 12 weeks without ribavirin, genotype 2 will have IDX21437 in riba versus IDX21437 we have samatasvir and riba for 12 weeks and genotype 3 will have IDX21437, samatasvir, within, without riba for 12 weeks. So we are basically each of the arms of what we know, from competitor arms and then we’ll get more aggressive in the fall.

Alethia R. Young – Deutsche Bank Securities, Inc.

Great, thanks congrats.

Operator

Thank you. Our next question comes from Geoff Porges of Bernstein. Your line is open.

Geoffrey C. Porges – Sanford C. Bernstein & Co. LLC

Thanks very much and congratulations everyone on the data.

Ronald C. Renaud, Jr.

Thank you Jeff.

Geoffrey C. Porges – Sanford C. Bernstein & Co. LLC

First, just a follow-up on the question about the genotype 1, 2, and 3, could you tell us what the – in the seven-day results what the differences where between I know the patients’ numbers are small. But could you tell us what the mains were of different genotypes?

Ronald C. Renaud, Jr.

Yes, so Geoff, we are not going to break that out there, as we pointed on the press release they are very similar, we’ve talked about a mean, maximum reduction of 4.2 to 4.3 across the genotypes so they were very similar across the genotypes as Doug pointed out, even between 1a and 1b and then 2 and 3.

So what we’ll say the granularity and the individual genotypes for wider distribution at a major medical meeting later this year.

Geoffrey C. Porges – Sanford C. Bernstein & Co. LLC

And the second question, Ron what do you thinking in terms of regimen for product treatment failures, so far you exposed just naïves. Do you have any data in product treatment failures, so when might we see that?

Ronald C. Renaud, Jr.

Yes, it is an interesting question I think, I’ll let Doug take the second part of it, but think about this Phase II study as we are going into treatment-naïve, but we’ll also have the opportunity as we said, to expand. And take on additional arms as we move forward to explore different durations and we may even look at different patient populations.

But in terms of the more difficult to treat patients clearly we want to have a regimen that treats as many people as simply as possible. But I think, what we are seeing is in – if you really want to get down to really, really short durations, we’re the most difficult to treat patient populations, it’s not unreasonable to expect that a third drug might be needed we are seeing some of our competitors do that.

So we’ll keep an eye open on that and we’ll move as we see fit, Doug I’m not sure if you want to add something to that?

Douglas L. Mayers

Yes, I think it was really good DAA combinations prior exposure to PEG rather doesn’t appeared to have an impact on response. So we would anticipate adding few experience patients and more importantly adding cirrhotic patients in the fall once we get our cirrho PK/PD done for our two drugs. So at this point, we will start out with treatment-naïve because we don’t have cirrhotic data moved into a cirrhotic population.

What we will go into those patients in the fall and we will add treatment experience patients in the fall. And at this point we think, it’s a really good regimen, you probably can do very well in all those populations with just two drugs.

Geoffrey C. Porges – Sanford C. Bernstein & Co. LLC

Great. And Ron, can I just ask one last question? Which is, so where do you stand on collaborating? You now have the two drugs in a single-pill formulation. So are you continuing, or will you continue to take either drug ahead with a partner? Or is nothing going ahead, at least on the J&J, side with samatasvir?

Ronald C. Renaud, Jr.

No, so in the HELIX program and our collaboration with the Janssen, HELIX-2 continues to move along or move along quite nicely and that’s with samatasvir they are non-nuc and they are protease inhibitor so that continues to move forward and we will watch that closely Geoff. I think, we’re very open to moving strategically with folks in terms of getting the best regimen to treatment as many patients.

So I think we are very going to be very open to trying to get the best regimen that we possibly can however we get that.

Geoffrey C. Porges – Sanford C. Bernstein & Co. LLC

Thanks, very much, I look forward to see you over in London.

Ronald C. Renaud, Jr.

Same here.

Operator

Thank you. Our next question comes from Ying Huang of Barclays. Your line is open.

Unidentified Analyst

Hi, it’s actually Katherine for Ying. Thanks for taking our questions. A couple of quick ones, first on the IP of IDX21437. Can you just kind of talk about that. And is there any interference to really add on that? And then secondly, sorry if I missed this earlier, how much animal toxicity data do you have on 437? Thank you.

Ronald C. Renaud, Jr.

The first question, we’re not going to comment on the intellectual property except to say that this is not part of the any of the ongoing litigations currently in place. And second of all, is I think Jacq may have pointed out in his prepared remarks, we’ve completed three months of toxicology on this – in two species and will have a poster on that this week’s EASL meeting.

Unidentified Analyst

Thanks.

Operator

Thank you. Our next question comes from Katherine Xu of William Blair. Your line is open.

Y. Katherine Xu – William Blair & Co.

Hi can you hear me?

Ronald C. Renaud, Jr.

We can now Katherine.

Y. Katherine Xu – William Blair & Co.

Great okay, good morning. So with regards to the dose, you are not pushing above 300 is it because you think the efficacy so far is in the same league [indiscernible] already. You don’t have to go or is there some therapeutic window issues, you don’t want to go out?

Ronald C. Renaud, Jr.

No, I don’t think it’s a therapeutic window as you mentioned [ph], I think, we are very happy with what we’re seeing at the 300 milligram dose, we call that the study was 50 mg, 150 mg and 300 mg. And so 300 mg is the data that looks to be most competitive with the other nucleotide that we’ve seen at this stage. So we’re comfortable with that and we think it’s a very safe and efficacious pills to take forward.

Unidentified Analyst

And have you had any updates on the interaction between simeprevir and samatasvir, since the beginning of the year?

Ronald C. Renaud, Jr.

Yes, you are talking about the data we sought from the HELIX-1 program and the Inverse Dose Response?

Y. Katherine Xu – William Blair & Co.

Yes.

Ronald C. Renaud, Jr.

Yes, we’re still working through that with Johson, I don’t know if any updates to speak of it at this point. I don’t Doug or Jacq, if you guys have anything you want to add there?

Jacques Dumas

We are going to present the DDI data from the post samatasvir and simeprevir at EASL, so that will be a poster.

Y. Katherine Xu – William Blair & Co.

Okay and then in terms of interaction and the related issues between the nuc and samatasvir, I just want to make sure that you don’t see anything or you don’t expect anything?

Ronald C. Renaud, Jr.

We absolutely do not expect interaction between samatasvir and IDX21437, they should not impact each other.

Y. Katherine Xu – William Blair & Co.

Thank you.

Operator

Thank you. Our next question comes from Brian Skorney of Robert W. Baird. Your line is open.

Brian P. Skorney – Robert W. Baird & Co., Inc.

Hey, good morning, guys. Congrats on the data. Just a couple of quick questions; most of mine had actually been answered. Just when we think about kind of moving beyond the 2'-methyl nucleosides, I wonder if you could just kind of give us your thoughts on how to move forward and how you're looking at other structures. Are they starting with the 2'-methyl structure and modifying that to get around the S282 [ph]? Or is it unique chemistry altogether?

Ronald C. Renaud, Jr.

So Brian we’re not going to comment on the chemistry or the structures or what we’re trying to do in our complimentary Nucleotide Prodrug Program, as you can imagine it’s a very competitive space and it doesn’t serve us well to disclose that.

Brian P. Skorney – Robert W. Baird & Co., Inc.

Got you. Then just in terms of the viral load reduction that you saw for IDX21437, could you give us the ranges that you saw in GT 1 and GT 2, 3?

Ronald C. Renaud, Jr.

No, as we said these are all very similar, there is fairly tight distributions at the 300 milligram arm and we’ll have the ranges when we presented at a major medical meeting. It’s very much in line with what we’ve seen, remember that I think with the other nucleotide prodrug that we’ve seen at least for the one that’s commercialized and you may have even referred to it and note a week or two ago that was specifically 1a data and I think you had quoted the 25th and 75th percent tile on that, we look just as, efficacious as the data seen in that poster.

Brian P. Skorney – Robert W. Baird & Co., Inc.

Got you. That’s helpful, and any chance we see the structure next week?

Ronald C. Renaud, Jr.

No chance at all.

Brian P. Skorney – Robert W. Baird & Co., Inc.

All right. Thanks, Ron.

Operator

Thank you, again. (Operator Instructions) Our next question comes from Ravi Mehrotra of Credit Suisse. Your line is open.

Koon C. Ching – Credit Suisse Securities LLC

Hi, this is actually Koon asking a question on behalf of Ravi. Congrats on the data. The two questions that I had are; what are the benefits of using a nuc-nuc combo that could not be obtained with other combos that people are currently studying? And then the second question is on the resistance profile for IDX21437. How does it compare to sofosbuvir, and how does it compare to other nucs that have entered the clinic in the past? Thanks.

Ronald C. Renaud, Jr.

Yes, so Doug, why don’t you take a first crack at that, I think you can probably cover both and then Jacq can jump in if he needs to.

Douglas L. Mayers

Okay, I think we feel the nuc-nuc, if we can do it offers a number of very unique advantages, the drugs will have a low milligram dose, they are easy to formulate, you can get it into one pill with a very high barrier to resistance and both nucs have high barriers to resistance. So potentially, if someone were to fail, they would fail without any resistance to have all other classes available to them for retreatment, and then the same thing, you could retreat anyone fails any of the other previous regimens with that type of a combination.

So if we can do it, it will be a very potent and a very high barrier to resistance pill, and as far as IDX21437 goes, we think it is – as far as we can tell completely competitive with any of the molecules out there, we see at this point, no significant differences or weakness that worry us at all.

Koon C. Ching – Credit Suisse Securities LLC

Okay. Thank you.

Operator

Thank you. I’m not showing any further questions in queue. I’d like to turn the call back over to management for any further remarks.

Teri Dahlman

Thank you. Thank you for your time today and your interest in Idenix. we look forward to an informative and productive week in London at the EASL meeting. Though we have two posters from our samatasvir program and one that Jacq mentioned from our IDX21437 program, we look forward to seeing many of you there. Please feel free to call us if you have any question.

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes today’s program. You may all disconnect. Everyone, have a great day.

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