Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)  

Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX)

Q2 2010 Earnings Call Transcript

July 26, 2010 4:30 pm ET

Executives

Jonae Barnes – SVP, IR & Corporate Communications

Ron Renaud – CFO and Chief Business Officer

Doug Mayers – EVP and Chief Medical Officer

Jean-Pierre Sommadossi – Founder, Chairman and CEO

David Standring – EVP, Biology

Analysts

John Sonnier – William Blair & Company

Stephen Willey – Stifel Nicolaus

Howard Liang – Leerink Swann & Company

Liisa Bayko – JMP Securities

Brian Abrahams – Oppenheimer & Co.

Brian Skorney – ThinkEquity LLC

Operator

Good afternoon. My name is Bonnie and I will be your conference operator today. At this time, I would like to welcome everyone to the second quarter 2010 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. (Operator instructions) Thank you.

I would now like to turn the conference over to Jonae. Please go ahead.

Jonae Barnes

Good afternoon and welcome to Idenix’s conference call to discuss our second quarter and first half 2010 financial results. We will also provide a Research and Development update on the progress of our HCV candidates.

With me today are Jean-Pierre Sommadossi, CEO; Ron Renaud, CFO; Doug Mayers CMO; and David Standring, Executive Vice President, Biology.

Before we begin, let me review our Safe Harbor statement. Today's discussions contain 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 and 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 at www.idenix.com. While we may elect to update forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our estimates change. You should not rely on these forward-looking statements as representing our estimates as of any date subsequent to today.

The agenda for today’s call is as follows. Ron will review our financial results for the quarter and first half of 2010, Doug will then provide a Research and Development update for our HCV programs, and JP will summarize our first half 2010 achievements and highlight our upcoming milestones. We will then open the call for Q&A for which David will also be available.

I will now turn the call over to Ron

Ron Renaud

Thanks a lot, Jonae. Now, we know the stock was halted and believe there may have been some confusion with regard to how we recorded the recently received milestone payment from ViiV Healthcare. The preclinical operational milestone of $6.5 million from ViiV which we received in May was recorded as deferred revenue and is being recognized over the life of the agreement.

We believe this represents most of the difference between the consensus revenue estimates and what we are reporting today. Keep this in mind for future forecasting.

Moving to the second quarter which ended June 30, 2010, we reported total revenues of $1.3 million compared to total revenues of 2.4 million in the second quarter of 2009. We reported a net loss of $16.3 million or a loss of $0.23 per basic and diluted share for the second quarter ended June 30, 2010 compared to a net loss of $16.3 million or a loss of $0.28 per basic and diluted share for the second quarter ended June 30, 2009. For the six months ended June 30, 2010. We reported total revenues of $4 million. This compares to total revenues of 6.5 million for the six months ended June 30, 2009.

We reported a net loss of $32.5 million or a loss of $0.47 per basic and diluted share for the six months ended June 30, 2010 compared to a net loss of $29.2 million or a loss of $0.50 per basic and diluted share for the six months ended June 30, 2009.

Now, moving along to our 2010 financial guidance, Idenix ended the second quarter of 2010 with $51 million in cash and cash equivalents.

We anticipate that our current cash and cash equivalents together with the anticipated royalty payments associated with product sales of Tyzeka/Sebivo can fund operations into mid-2011. It is important to note that this guidance assumes no additional milestone payments, license fees, reimbursement for development programs, and no additional financing activities.

With that, I'll now turn the call over to Doug.

Doug Mayers

Thank you, Ron. It's been a busy summer so far and I am pleased to report that we are hitting all our clinical timelines. Let me start with an update of our most advanced program, IDX184 a liver targeted nucleotide polymerase inhibitor.

I am pleased to report that all patients have recently completed dosing in the 14 day Phase IIa clinical trial. This trial is evaluating 50 to 200-milligram daily doses of IDX 184 in combination of pegylated interferon and ribavirin in treatment naïve genotype 1-infected patients. Preliminary safety evaluation from this trial suggests that the side effect profile of IDX 184 in combination with pegylated interferon and ribavirin appears similar to that for treatment with pegylated interferon and ribavirin alone.

Data from this study have been submitted for presentation at the annual meeting of the American Association for the Study of Liver Diseases, AASLD which will be held at the end of October in Boston and if accepted, full data from this study, including the 150 and 200-milligram cohorts will be presented.

We will complete the data analysis over the coming weeks and anticipate sharing a top line summary of the data with the Street in September.

In the IDX 320 HCV protease inhibitor program, we are conducting a Phase I/II randomized, parallel arm, double blind placebo controlled study evaluating the safety and antiviral activity of IDX320 in 38 treatment naïve HCV genotype-1 infected patients.

This three day Proof of concept study is evaluating whether in vitro antiviral activity and promising PK profile observed in healthy volunteers is confirmed in HCV infected patients.

This study includes four doses of IDX 320 ranging from 50 to 400 milligrams once per day and one 200 milligrams twice daily dose. The once daily dosing cohorts have completed dosing and enrollment in the twice daily dosing cohort is underway.

Data from this study will be submitted will be submitted as a late-breaker to the upcoming AASLD meeting. Once the study is complete, we will submit the data to regulatory agencies and propose a 28 day Phase IIa dose ranging study of IDX320 plus pegylated interferon and ribavirin to evaluate the longer term safety profile of IDX320 as well as the rate of Rapid Viral Response or RVR at 28 days in order to determine the optimal dose for future studies.

Last quarter, we shared with you our plan to pursue a direct acting antiviral or DAA combination strategy. We are now laying the groundwork to implement this plan. In July we conducted a two week, Phase I, randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacokinetic drug-drug interactions between IDX320 and IDX184 in healthy volunteers.

We are currently analyzing the data from this trial. Today let me review the design of the study with you. Two cohorts were evaluated in the study with 10 subjects in each cohort randomized eight to active drug and two to placebo. Subjects in the first cohort received 400 milligrams once-daily of IDX320 plus placebo for the first week, subsequently adding 100 milligram once-daily of IDX184 in the second week. Subjects in the second cohort received 100 milligrams once-daily of IDX184 plus placebo for the first week, subsequently adding 400 milligrams once-daily of IDX320 in the second week.

Importantly, this study provides us a 14 day safety data for IDX320 as well as pharmacokinetic and safety data for the combination of IDX184 and IDX320. The clinical group is working diligently and over the coming weeks we anticipate completion of the full data analysis from the IDX184 Phase IIa study and the IDX320 Proof of concept Study in genotype-1 HCV infected patients as well as the IDX184 and IDX320 drug-drug interaction study in healthy volunteers.

We anticipate as previously mentioned that we will share a top line summary of these clinical data with the Street in the September time frame.

The three month preclinical toxicology studies for IDX184 will also be finished up this summer.

We will then be in a position to discuss with regulatory authorities our clinical development program plans for IDX320 and IDX184 and the combination clinical trials which will include the potential initiation of a 28 day Phase II combination study of IDX184 and IDX320 without interferon or ribavirin in HCV infected patients in the second half of the year.

We believe that the new paradigm in HCV treatment will ultimately be a combination of DAAs without interferon. The combination of IDX320 and IDX184 has the potential to be an important component of HCV treatment due to their distinct modes of action, complementary resistance profiles, and broad genotypic activity in in-vitro studies.

In addition, we are also continuing to develop classes of HCV antivirals such as non-nucleoside inhibitors and NS5A inhibitors as we believe it may take a triple DAA combination to eliminate interferon from HCV treatment regimens.

J.P. will update you in a minute on the status of our preclinical NS5A inhibitor program, but let me first review with you the progress of IDX375 or HCV non-nucleoside polymerase inhibitor.

During the second quarter we continued the Phase I clinical trial in healthy volunteers evaluating single and multiple doses ranging from 200 to 1200 milligrams per day. Assuming favorable PK and safety data we expected this Phase I study will be followed by a three day Proof of concept trial in treatment naïve genotype-1 HCV infected patients in the second half of 2010. An abstract from this program has been submitted to the upcoming AASLD meeting.

I would also like to mention that during the quarter, we presented data at the fifth International Workshop on Clinical Pharmacology of Hepatitis Therapy on June 23rd and 24th and the fifth International Workshop on Hepatitis C resistance in new compounds on June 24th and 25th.

Phase I clinical data on safety, tolerability and pharmacokinetics of both IDX320 and IDX375 were presented In addition, in-vitro and in-vivo resistance profile data on IDX184 and in-vitro resistance and cross resistance profiles of IDX320 were also presented.

The presentations from these workshops are posted on our website.

With that I will turn call over to J.P.

Jean-Pierre Sommadossi

Thank you, Doug. We are very pleased with the continued clinical advancement of our three Hepatitis C drug candidates as well as with the progress of our preclinical program NS5A inhibitor program which could play an important role towards achieving our ultimate goal of developing pan-genotypic direct acting antiviral HCV combination regimen.

We have three HCV drug classes now in the clinic and the fourth anticipated to enter clinical evaluation next year. We believe that Idenix alone or with potential partners will be well poised to evaluate HCV combination regimen in selective HCV infected population patient.

We are excited about the prospect of combining IDX184 and IDX320 to evaluate the antiviral activity and safety in HCV infected patients. The emerging profile of these direct candidates support our ultimate goal of developing an HCV combination where each component is dosed once daily and is potentially active against multiple genotypes.

I am also very pleased to report that we are on track to select by year end an NS5A inhibitor clinical candidate with potent, pan genotypic antiviral activity as well. We are currently evaluating the pharmacological properties of several leads in order to optimize the profile and actually an abstract which includes data from this late stage preclinical program has also been submitted to AASLD and if accepted we will give you additional detail for the meeting.

Our plan is to initiate IND-enabling studies by year end and subsequently conduct clinical trials next year with this new class.

Looking back on the first half of the year, we have already achieved many of our 2010 objectives and are excited to continue to advance our programs. As you can see, we are going to be very busy over the coming weeks, analyzing results from all of our HCV programs. AASLD shaping out to be a very busy scientific meeting for us with data from each one of our four HCV programs potentially being presented at this meeting.

And we look forward to sharing with you an update on those programs over the coming months.

In closing, I would like also to mention that in addition to our own achievements in the HCV clinical program, we are excited to report that ViiV Healthcare continues to advance IDX899 now known as GSK2248761, non-nucleoside reverse transcriptase inhibitor for the treatment of HIV Aids. ViiV Healthcare would be presenting scientific data for GSK2248761 at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy or ICAAC in Boston in September.

Three scientific presentations have been accepted and will include drug-drug interaction data in healthy volunteers and safety efficacy and PK data as well as resistance data in HIV-1 patients. We look forward to the initiation of the Phase IIb program by ViiV Healthcare.

That concludes our formal remarks and we will now open the floor to Q&A.

Operator, are there any questions?

Question-and-Answer Session

Operator

(Operator instructions) Our first question is from the line of John Sonnier of William Blair.

John Sonnier – William Blair

Hey, thanks for taking my question and congratulations on a lot of progress. Just a couple of questions. In the combination study I see you guys selected the 100-milligram once daily 184 and I'm trying to better understand that decision. Should we read into that in any way that I guess that100-milligram once a day is going to be the optimized dose for 184? In other words, have you seen an adverse event profile at higher doses that you don't like?

Doug Mayers

No, basically we talked to the agency – and remember we had little bit higher exposures in healthy volunteers previously so that 100 in healthy volunteers could look like 200 in patients. So in discussion we agreed to go 400 and 100. I wouldn't read anything into it at this point.

John Sonnier – William Blair

Well, based on – at the time that you designed the protocol for the combination study?

Doug Mayers

Yeah, basically, the combination study should cover us at any dose between 50 and 200 as we move forward.

John Sonnier – William Blair

Okay. And then I guess, I don't recall seeing as you are going to file the 320 data as a late breaker, should we read anything into that? Just remind us a little bit about the profile of that drug, its activity profile against resistance strains and other things. Anything you can tell us about 320 would be helpful.

Jean-Pierre Sommadossi

To summarize the preclinical data and actually, as Doug indicated, we should be in the position to definitely submit a late breaker abstract next week.

And actually, we are still awaiting the data. So that tells you – well – we going to commit to submit a late breaker, basically, regardless of the data. So it is a –

John Sonnier – William Blair

Okay.

Jean-Pierre Sommadossi

And David, can you summarize a little bit about the preclinical profile of the drug?

David Standring

Yes, so at the enzyme level we have very good activity against – potent activity against genotype one and genotype two, genotype four and at least reasonable activity against genotype three. Good activity against the genotypes in the (inaudible) system, it is 1, 1a1, b and 2a. And in terms of resistance profile, the signature mutation is D168 locus basically. And we have good activity against some of the mutants that have been selected in the clinic by other agents notably our 155k and some of the 156 variants as well. And some of this was presented at the recent replicon.

Doug Mayers

And just to remind you, we've also showed the healthy volunteer data at that meeting. And we basically had drug exposures that were multiple fold over the EC50 the virus with the half-life of 31 hours so we're very comfortable.

This will be a once a day drug for genotypes one, two, and four, and potentially a twice a day for the genotype three.

John Sonnier – William Blair

Okay, and just a final question on the – is the combination study in some ways perhaps a gating factor for the 184 partnership? In other words, do your partners want to see what that data looks like first? And maybe when you're answering that question, how should we think about Novartis playing into the 320 (inaudible) when we think about this at a higher altitude?

Jean-Pierre Sommadossi

Well, the answer – the quick answer is no. And—Ron is going to explain on that.

Ron Renaud

So John, as we've always said as we look to partner IDX184 we have always viewed 184 as a product that could be a backbone component of a big number of different potential combinations and we continue to view it that way. And the discussions that we've had with potential partners they – many of the potential partners see it that way as well. So absolutely not a gating factor in any of our discussions.

The other thing as we think about Novartis, it's the same thing. They still have the first option right on the pipeline. So, as it relates to 320 it is no different than any other product that comes up in the pipeline at this stage of the development.

As we move forward and the program moves to – progress through the completion of Proof of Concept, Novartis will then – we'll begin that process with them to get a decision on what their option is.

John Sonnier – William Blair

All right, thanks a lot.

Ron Renaud

You bet.

Operator

Thank you. And our next question comes from the line of Stephen Willey of Stifel Nicolaus.

Doug Mayers

Hi, Steve.

Stephen Willey – Stifel Nicolaus

Hi, thanks for taking the question and congrats in the quarter. Just a quick strategic question I guess. I noticed that you planned on moving 320 into a twenty-eight day, Phase IIa, in combination with standard of care. And I know in your development strategy from 184, you said that you had always felt that that fourteen-day data was kind of highly predictive of what you were going to see at day 28. So just wondering if that's something to kind of provide the agency going forward for the combo trial? Or if there's anything – that the way you're thinking about this drug?

Jean-Pierre Sommadossi

Well, the whole thing is – we will have data on the – first of all, we are reading in the crystal ball here. And we need the data, three day data, but also what we would like to have is a couple doses of twenty-eight days if there is any difference in terms of those rangings. But basically don't see more than that. That's all.

Stephen Willey – Stifel Nicolaus

So you don't feel just because I guess of the competitiveness of the PI arena relative to the nukes that you may need to throw a benchmark out there at day twenty-eight as opposed to, as opposed to the new class?

Jean-Pierre Sommadossi

No, I think, look, at the end of the day, all our long-term strategy is going to be based on the combination of direct acting agents. And actually, that will really dictate how we are going to develop our pipeline.

With that said, it's clear that we believe that we may get and grow much faster to delineate those that we are looking to move forward for longer term or combination already with a combination of peg/riba short term. But, that's basically what we are going to look. We are not going to look to go with large trials and with basically what has been done so far in terms of one drug plus peg/riba.

What we really are going to focus our strategy and, and really delineate for next year after our meeting with regulatory authorities, is really how we are going to move the combination of direct acting antiviral in general.

Stephen Willey – Stifel Nicolaus

And then just in thinking about deal structure on 184, we know what the terms were with Novartis. Is it safe to assume that, that you're kind of sticking to those same terms with respect to profit sharing rights and everything else?

Ron Renaud

Yeah, I mean, Steve, we haven't, we haven't really disclosed what our strategy is in terms of discussions with potential partners. Keep in mind that each of the potential partners bring a different set of assets or maybe not, to the table. So I think each of those discussions that we have are truly unique and the value proposition from the potential partner as well as what we bring to the table is different in each one of those discussions as well. So I think, for now, we'll, we'll keep that pretty – those cards pretty close to our chest and when we get a deal done, you guys will see everything.

Stephen Willey – Stifel Nicolaus

And then just one quick clarification question, you did say that you would be providing Street with top line data on the remaining dose cohorts 184 but also the 320 Proof of concept data?

Jean-Pierre Sommadossi

Correct.

Stephen Willey – Stifel Nicolaus

Okay. Thanks a lot.

Ron Renaud

You're welcome.

Operator

Thank you. Our next question comes from the line of Howard Liang with Leerink Swann.

Howard Liang – Leerink Swann & Company

Thanks very much and nice progress on the programs. On 184, are you done with dosing? Or are you going to higher doses still?

Doug Mayers

At this point, we don't intend to go to higher doses. We've completed the dosing and we're awaiting the final data from the 200 milligram cohort. But we think that we have adequate activity and that we'll move forward with one of the doses we've evaluated in this on-going study.

Howard Liang – Leerink Swann & Company

Okay. Great. Excellent. For the 184/320 combination study, what's the duration of dosing for initial trial?

Doug Mayers

The initial trial would be in genotype I treatment naïve patients. We're proposing to the (inaudible) design with one month of dosing we have – with both 184 and 320 followed by peg and riba. Our goal would be to evaluate combinations in this manner and then move the right combination into Phase – into a longer term Phase IIb study.

Howard Liang – Leerink Swann & Company

Okay, great. What – I know there's a ongoing study, three months I think, animal toxicology study for 184. Can you update on the status of that? And also is there a similar study for 320?

Jean-Pierre Sommadossi

As Doug indicated, we will basically have complete data some – in the early September time frame for these three months, 184. We already actually manufacturing about 1.5 kilo of IDX320 which will – of IDX320 which would be ready in the fall. And we will initiate three months for IDX320 tox in the fall with data in the second quarter of next year.

Howard Liang – Leerink Swann & Company

Okay, great. And what is known about the metabolism of 184 and 320? Is there reason to think whether there would be a direction?

Jean-Pierre Sommadossi

We have – as we mentioned, well, actually it has been quite some time now. 184 is mostly metabolized by a non-P450 system. We did not yet elucidated exactly what it is. But actually when we combine in-vitro with the return of as you know, which is a potent, probably the most potent P450 inhibitor, we have an inhibition of about 20 to 30%. So we see that – we may have at the most a P450 involvement of about 30% at most in the activation of IDX184.

We do know definitely, like any PI as you know, that P450 3A is the major root of metabolism for IDX320. So, that's basically what we know in term of in-vitro and cellular studies.

So we do not anticipate a major drug-drug interaction. But it's clear that you need to have the data when you have two – two drugs that at least one goes to some extent with P450 system, even if it's only 20 to 30% in that we have seen in the metabolism process.

Howard Liang – Leerink Swann & Company

Great, thanks very much.

Operator

(Operator instructions) Our next question comes from the line of Liisa Bayko with JMP Securities.

Liisa Bayko – JMP Securities

Hi, good afternoon. How are you doing?

Jean-Pierre Sommadossi

Great.

Liisa Bayko – JMP Securities

So just to clarify for IDX320, you're going to have that data and you're probably do the top line at the same time as you top line the IDX184 data? Is that the right way to think about it?

Jean-Pierre Sommadossi

Yes, Liisa.

Liisa Bayko – JMP Securities

Okay. And then can you talk a little bit more about the non-nuc? You're talking about the free acid form of the compound. Is that something different than you might use if you were to bring it forward?

Jean-Pierre Sommadossi

Sure. Doug is going to go over that.

Doug Mayers

Initially we moved forward with the choline salt form of the drug, and we found that it didn't have the stability properties, or the shelf life, that we'd want in a drug that we're going to take forward. So we shifted to the free acid form of the drug, which has a much better stability, much better shelf life. Essentially, as soon as you, as you take it by mouth it becomes 375. So it really doesn't make a huge difference beyond that. So this is just extending the doses to higher doses that we think we'll need to go with this molecule for treatment.

Liisa Bayko – JMP Securities

And then, for the combination study that you're doing right now, the one where you're analyzing the data, is that – when will we get data for that?

Jean-Pierre Sommadossi

In September time frame as well.

Liisa Bayko – JMP Securities

Okay. So, this is probably one call with a whole bunch of data.

Jean-Pierre Sommadossi

That's correct.

Liisa Bayko – JMP Securities

Would that be when the AASLD abstracts are released or before that?

Jean-Pierre Sommadossi

Look, we say September time frame, and we are not going to say beyond than that.

Liisa Bayko – JMP Securities

Okay, fair enough. And which –

Jean-Pierre Sommadossi

And we promise you'll have all the data for the three trials of the 184 data top line, 320 Proof of concept top line, and the drug-drug interaction 184/320 top line in September.

Liisa Bayko – JMP Securities

Okay. Great. And then one final question. Just to – maybe this is better for Ron. But in terms of the Tyzeka revenue, is that – it looks like it's changed since – it's come down considerably. Is that what we should expect on an ongoing basis? I just remember it was amortized.

Ron Renaud

Well – yes, what you're actually looking at in the P&L and the press release is the collaboration revenue related party. So there's some other things in that in the collaboration revenues besides the Tyzeka/Sebivo royalty. So what I would tell you is on a, on a quarter-to-quarter basis, the Tyzeka/Sebivo royalty was relatively flat.

Liisa Bayko – JMP Securities

Okay.

Ron Renaud

So remember, there's some revenue recognition in there from our relationship with Novartis that's also factored into that same line that will fluctuate based on accounting rules from quarter to quarter. But the Tyzeka/Sebivo royalty has stayed essentially flat.

Liisa Bayko – JMP Securities

Okay, great. Thanks a lot.

Ron Renaud

You bet.

Doug Mayers

Sure.

Operator

(Operator instructions) Our next question comes from the line of Brian Abrahams of Oppenheimer.

Brian Abrahams – Oppenheimer & Co.

Hi, thanks for taking my questions and my congrats as well on the continued progress. Question on the 184. Doug, I think you mentioned that the side effect profile that you've seen come out of the Phase IIa looks similar in combo with peg/riba as with peg/riba alone, which seems consistent with what you saw in the lower doses. Recognizing that you want to preserve all the details for us, albeit I was just wondering if you could speak generally as to whether or not there were any side effects that did appear to be dose related. Whether your saw any creatinine or triglyceride signals at all with the initial cohorts?

Doug Mayers

What I can tell you is, is that we don't have any side effects at this point that we believe are dose related. Remember, I'm still getting the 200 milligram data coming in, in early August. What I can tell you also is that – because I do track that these – we've had no further creatinine elevations since the 100 milligram cohort and any of the subsequent cohorts.

Brian Abrahams – Oppenheimer & Co.

Great. And then on 375, are you still expecting the Proof of concept data, it is going to start this quarter or might it flipping to next quarter? And should we expect that that proof of concept data will be at AASLD? Or that the – at the presentation might cover some of the healthy volunteer studies?

Doug Mayers

The AASLD will only be healthy volunteer studies. The proof of concept will be completed this year, but it will not be available at the time of AASLD.

Brian Abrahams – Oppenheimer & Co.

And how are you planning to present that data? Will it be top lined? Or will that be at (inaudible) next year?

Doug Mayers

I suspect it will be at (inaudible) next year.

Jean-Pierre Sommadossi

Yeah, yeah.

Brian Abrahams – Oppenheimer & Co.

Okay. And then just a follow-up –

Jean-Pierre Sommadossi

Brian, of course, we will not wait four or five months with data in hand. We will always give you some top line summary of the data early on. Okay?

Brian Abrahams – Oppenheimer & Co.

Got you. And then on the drug-drug interaction study, it's still ongoing now. Just wondering if there's any early read on the safety and PK, if what you're seeing at least initially looks consistent with that 20 to 30% interaction that you would might expect from the overlapping metabolism?

Doug Mayers

At this point, we don't have PK data. I think J.P. was giving you the outside potential for interaction. We actually – our in-vitro data suggests that it's much, much lower potential and that we will not see a drug-drug interaction with these two molecules. I don't have the PK data available to me at this point. I can tell you the safety profile has not provided us with any surprises.

Brian Abrahams – Oppenheimer & Co.

Okay. Great, no, that's very helpful. And then just lastly on 899. Just wondering if the Phase IIb is still expected to begin in the back half of this year? And whether or not Glaxo has started any drug-drug interaction studies with their integrase inhibitor? Thanks.

David Standring

Yeah, Brian, with regard to when they plan to start, they've, they've held the same message that they plan to start it in 2010. I think that hasn't changed from our perspective as well and, given that this is their program, it's in their hands. With regard to the drug-drug interaction, I'll let Doug speak to that.

Doug Mayers

Yes, I mean, basically we do anticipate that they are going to start the drug-drug interaction and the Phase IIb this year.

Brian Abrahams – Oppenheimer & Co.

Great. Thanks very much for taking all my questions.

Jean-Pierre Sommadossi

Sure.

Operator

Thank you, our next question comes from the line of Brian Skorney with ThinkEquity.

Brian Skorney – ThinkEquity LLC

Hello, good afternoon guys. Thanks for taking the question. Want to reiterate my congratulations on a very successful quarter.

Most of my questions have been answered. But I just maybe – just kind of take a bird's eye view of the combination study and what else is out there in the competitive environment. I know earlier, last week, Gilead announced that their combo PI non-nuc didn't really show the results that justify moving further, and as for your studies with just two drugs and then started exploring three drugs. Just wondering from your perspective what you would be looking for in the two drug combo study that you're planning to initiate later this year and next year as far as justifying moving into SVR based studies? Thanks.

Doug Mayers

I think it's important for us to do the two – the one-month two-drug combos just to get a good sense of what the activity, the safety, and the PK interaction profile is for the two-drug combination. We stated for a while now that we think it's going to take three drugs based on the viral burden, the amount of resistance that's generated in the patient. It's going to take three drugs.

Our goal will be to explore two drugs and then potentially three drugs, and it would be our goal to take a three drug combination without peg and riba for SVR. We would see taking the two drug combination forward with peg and riba to try and treatment – to treatment experienced patients.

Brian Skorney – ThinkEquity LLC

And how about as far as a three drug combination including just riba and not interferon? Any thoughts there?

Doug Mayers

It's our intention that we would look at three drugs and factorialize the riba across the design. At this point, we've not been – no one has shown that you can get rid of riba. So we would take three potent drugs that we think have good activity, and then half the patients would be given riba and half the patients would be given placebo to determine if we need the ribavirin to get SVR data.

Jean-Pierre Sommadossi

And that will be the 12-week studies, obviously.

Brian Skorney – ThinkEquity LLC

Great. Thanks so much, guys.

Jean-Pierre Sommadossi

You're welcome.

Operator

Our next question comes from the line of Howard Liang of Leerink Swann.

Howard Liang – Leerink Swann & Company

Thanks for taking a follow-up. Just a quick (inaudible) question. Are we still expecting a clinical milestone from GSK or ViiV for the HIV compound?

Ron Renaud

Yes, Howard, as we said, we expect milestones, financial milestones at every major inflection point of development of 899. So we haven't gone into many more details than that, but we clearly look forward to the initiation on the Phase IIb study.

Howard Liang – Leerink Swann & Company

Okay. Thank you.

Operator

Thank you. At this time, there are no further questions.

Jonae Barnes

Great, thank you for your time today and your interest in Idenix. In closing, I would like to mention that we will be presenting at two Investor conferences next week. They are the Wedbush Life Sciences Conference, and BMO Healthcare Conference. If you have any additional questions, please feel free to call.

Jean-Pierre Sommadossi

Thank you.

Jonae Barnes

Thank you.

Operator

Thank you. This concludes today's conference call. You may now disconnect.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: Idenix Pharmaceuticals, Inc. Q2 2010 Earnings Call Transcript
This Transcript
All Transcripts