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Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN)

38th Annual Deutsche Bank Health Care Conference

May 30, 2013 2:10 pm ET

Executives

Milind S. Deshpande - Chief Scientific Officer and President of Research & Development

Joseph Truitt - Chief Commercial Officer and Senior Vice President of Business Development

Analysts

Alethia Young - Deutsche Bank AG, Research Division

Alethia Young - Deutsche Bank AG, Research Division

So, it's Alethia Young, the alter ego to Robin Grenell [ph] who comes from the biotech team, the better looking alter ego, mind you. Yes, that just happened. So today, I am very lucky to have Achillion here who -- and secondarily, very lucky to have Milind Deshpande who is the now new CEO of Achillion. And I think he's taking the Maiden boys with the sell side right now with me, so this is fabulous. So with that, I'm going to leave it to Milind to have some points to the presentation and then we'll turn it into a fireside chat with the company. Milind?

Milind S. Deshpande

Thank you, Alethea. Thanks to Robin. Thanks for the opportunity to present at your conference. My name is Milind Deshpande, and I'm the 48-hour CEO of Achillion. It's my pleasure to be here and present to you the pipeline that we have developed in hepatitis C over the last 6 or 7 years. I'll keep the slide presentation fairly short just to give you an overview of the compounds and the key characteristics of the compounds that we are developing. And after that, we'll open up the floor for a fireside chat or Q&A.

Before I dive into the presentation, I would like to point out that in that presentation, I will be making some forward-looking statements. There are risks associated with the statements that I will be making and those risks have been fully disclosed in all our SEC filings.

I would like to open up my presentation with the management team that we have assembled at Achillion. And 2 of my colleagues, Mary Kay Fenton, who is the Chief Financial Officer, and Joe Truitt, who is our Chief Commercial Officer, are with me here today. I would also like to introduce to you David Apelian who just joined us as our Chief Medical Officer. David comes to us with a lot of experience in hepatitis. He was the project leader for the registrational trials of [indiscernible] while he was at Bristol-Myers Squibb Co. Prior to that, he worked on hepatitis at Schering Plough. And before he came to Achillion, he was the Chief Medical Officer of GlobeImmune.

We have multiple compounds with multiple different mechanisms that we are developing for treatment of hepatitis C. In the NS3 protease inhibitor program, we have sovaprevir, which is in late Phase II clinical trials. ACH-2684, which we've developed as a backup for sovaprevir. We completed Phase I trials and also this is an excellent NS3 protease inhibitor. But due to privatization, we are solely focusing on sovaprevir at this time.

We spent a lot of effort in developing the second generation NS5A inhibitor program, and ACH-3102 was the outcome of those efforts. This is truly a second generation NS5A inhibitor in terms of its resistance profile and 3102 also is currently in Phase II trials. Yesterday, we announced that we are progressing ACH-3422, which is a nucleoside NS5B polymerase inhibitor. And with the discovery of 3422, we now have 3 compounds with 3 complimentary mechanisms that we will move forward into clinical development.

As far as the combination development program that we currently have ongoing, we have sovaprevir in combination with ACH-3102, with and without ribavirin for treatment of genotype 1 HCV patients. And I'll briefly talk about the clinical trials that are currently ongoing with this combination. So if you look at the 3 compounds that are of keen interest to us in terms of developing a very robust combination treatment for HCV, our 3 compounds are pan-genotypic. They inhibit genotype types 1 through 6 of HCV. Our compounds provide a high barrier to resistance. And given the low fidelity in HCV application as well as the higher application grade, one of the key characteristics for a successful combination therapy is to provide high-barrier resistance and we have that in all 3 of our compounds. These compounds, we believe, will be additive to synergistic in combination for sovaprevir and ACH-3102. We have demonstrated safety and efficacy and a 12-week treatment regimen. And 3422 is still early, so we don't have any clinical data for 3422. But we'll do all the right things in terms of moving this compound into clinical development as far as safety is concerned. All 3 compounds are once-daily dosing and none of the agents require boosting with ritonavir.

This is a snapshot of the clinical trials that are ongoing as well as clinical trials that will be initiated towards the latter part of this year. The first trial that the trial that is currently ongoing is the 007 trial in genotype 1 treatment-naïve patients. And we are expanding this trial to include arms for 8 and 12 weeks of treatment duration with our trial designer. The Phase II program, overall, will have about 400 patients treated by third quarter of next year. And we anticipate initiating our registrational trials with the combination of sovaprevir and 3102 by -- towards the end of next year.

This is a little more detail on the study that is currently ongoing. Again, I won't deliver you the details of the study design but we are basically evaluating 2 doses of sovaprevir with one dose of 3102. Segment 1 is currently enrolling patients and we anticipate reporting RVR from segment 1, third quarter of this year and SVR, fourth quarter of 2013.

So moving onto ACH-3422, which is the compound that we announced today which is a nucleoside polymerase inhibitor. We are excited about this compound because this completes our portfolio in terms of having 3 important mechanisms in our portfolio for treatment of HCV. In terms of its chemical characterization, 3422 is a nucleotide prodrug of uridine analog. In terms of the virology, the compound is highly potent for inhibition of HCV. We anticipate that this compound will demonstrate tangent specific acuity [ph] as well as high-barrier resistance. 3422 is rapidly converted to the monophosphate in microsomes as well as in hepatocytes and the PK profile is actually, we have seen so far, suggests once-daily dosing. Again in terms of safety, early days but we were able to achieve very high stages of the drug in a 14-day tox study and we did not find any -- there were no significant findings at the highest dose testing.

The next few slides will just summarize some of the data that we have put together for 3422. And in -- on this slide, you will see the comparison of 3422 with sofosbuvir or GS-7977 which is currently in Phase III clinical trials. And what you'll see is that 3422 is maybe about 3 to 5 [indiscernible] more potent than sofosbuvir in genotype 1. And the activity of 3422 is very comparable against sofosbuvir in genotype 2. We do see a mild shift in EC50 values in the presence of SP82 [indiscernible] patients. And again, the flow chart is comparable to what we see with sofosbuvir .

3422 is very efficiently converted to its triphosphate. And again comparing the numbers for conversion of 3422 to its corresponding triphosphate, these numbers are very similar to the efficiency of sofosbuvir being converted to its corresponding triphosphate.

Again, very similar numbers for inhibition of NS5B polymerase. So this is a biochemical assay and the activity of the 2 drugs that we are comparing here is very similar. In terms of the therapeutic index as we compare EC50 to [indiscernible] toxicity, we see about a 304 [ph] difference between the EC 50 values and the lowest EC50 that was seen in the MG2 [ph] cell lines.

Achillion is a company that is very well capitalized. As of March 31, we reported $200 million in cash and equivalents. Debt obligations are fairly minimal. We have a total of 96.6 million shares outstanding. And this slide also shows our top 5 shareholders.

So in summary, our strategy for HCV drug development is to optimize treatment outcomes and treatment duration for all HCV patients. What we are looking at are high SVR rates in different genotypes and also in patients that have different stages of liver disease. Currently, we have a clinical trial ongoing with sovaprevir, 3102 and ribavirin for 12 weeks. And we will have the data rolling out from this trial starting end of summer. We are modifying the 007 protocols to evaluate the 8- and 12-week treatment regimens without ribavirin and the protocol amendments will be submitted to different regulatory authorities, again, by the end of summer. We continue to accelerate development program with keen focus on initiating Phase III studies with our drug combination in the second half of 2014. And with the augment of ACH-3422, we will be advancing that nucleoside polymerase inhibitor towards IND filing in first quarter of 2014.

So that's the quick overview of what we do. And I'll be glad to answer your questions.

Question-and-Answer Session

Alethia Young - Deutsche Bank AG, Research Division

I mean, at [indiscernible] first of all, a couple of administrative things. One, if you have a question for -- being webcast, you can just email me, alethia.young@db.com. It's spelled A-L-E-T-H-I-A. Or we have[indiscernible] Yorn, then you go to yorn.com/db. And just in general, I mean, I feel like it's not much of a change because you've been so involved in the process at the [indiscernible] level that, I mean, it seems like it's finally the culmination of a very appropriate title. So I can't think of anyone more deserving. Just to start it off there. I'm just curious, though. The rationale of portfolio expansion and on clinical expansion at this point right now, it seems that you guys, over the past month, had become -- have made some very aggressive announcements that should be received relatively very well. So I just wanted your thoughts on that.

Milind S. Deshpande

Regarding the addition of a nucleotide polymerase inhibitor in our portfolio. If you look at the drugs that are currently in development, I think these drugs will provide excellent treatment options to HCV patients. But the difference that we are going to see will be in the treatment duration across different HCV type -- HCV patients. So, clearly, even with the combination of a nucleotide and an NS5A inhibitor which does really well in treatment-naïve patients without cirrhosis. I think that our 12-week treatment duration, I think we will end up seeing differences in this. We average that at about maybe 10% to 15%. And if we fast forward and ask ourselves what is going to happen after this first wave of or direct acting on top of our regiments out on the market, I think the next step is going to be to optimize treatment regimen across all HCV patient populations and across all genotypes. And I think that treatment duration probably will be 12 weeks. In some patient populations, it might be 8 weeks.

Alethia Young - Deutsche Bank AG, Research Division

I have Joe Truitt here who's the Chief Commercial Officer, the man with the commercial plan, we'd like to call him. I guess, a question for you, Joe, and Milind. Just -- why not use NS5A? It seems -- why not do that?

Joseph Truitt

Yes, it's an excellent question and we've obviously thought about that, especially with the profile of ACH-3102. But our feeling is that our protease sovaprevir based on the profile and what's it's delivered so far through its Phase II studies, plus the ACH-3102 should make us highly competitive in what is considered the third week of evolution in direct-acting antivirals which will take place from some point around late 2014 through the 2016 time frame. And then what we're really focused on is -- and have been focused on commercially as well as on our discovery and business development efforts, is how can we get to really what we see as the end gain in HCV development, which we believe will be exactly what Milind described which is the optimization of a regimen in a fixed dose combination for a consistent duration across all genotypes and patient types. And we believe that protease NS5A nucleoside type of regimen is what will deliver that. And now we feel that with the nomination of 3422 that we actually have all of those assets under our control. So we may explore that doublet that you've described. But most likely, we'll just move right into the tripling. That's our current operating plan is to move right into the triple combination. I don't know, Milind, if you...

Alethia Young - Deutsche Bank AG, Research Division

So you guys are telling me there's another wave and have to see [indiscernible]...

Joseph Truitt

Wave 4.

Alethia Young - Deutsche Bank AG, Research Division

Wave 4 is out now?

Joseph Truitt

Yes. And I think you can -- I don't think it should be surprising. If you really look at the competitive landscape, there's a lot of companies moving early-stage assets forward still that are complementary or potentially complementary to the portfolios. And our assessment is that it will probably take no more than 3, but probably 3 direct-acting antivirals to deliver what we're describing.

Alethia Young - Deutsche Bank AG, Research Division

And so just another question like, what do you need for your combo to be competitive in Phase III? Like what's your baseline assumption?

Milind S. Deshpande

I think the treatment duration has to be 12 weeks. The SVR rates have to be greater than 85% and no issues in terms of safety and tolerability. Aside from that, a fixed dose combination that is a single tablet that patients can take once a day without boosting. Daclatasvir or ritonavir does cause some issue in terms of combination treatment. So I think as long as we have a 12-week treatment duration with SVR rates greater than 85%, no issues in safety and tolerability. It's one pill once a day without boosting other key factors.

Alethia Young - Deutsche Bank AG, Research Division

Do you think 85% is fine?

Milind S. Deshpande

Greater than 85%.

Alethia Young - Deutsche Bank AG, Research Division

At Phase III?

Milind S. Deshpande

Yes.

Joseph Truitt

Yes. I would point out because our research shows that whether you're talking to physicians or payers that it's very hard for them to differentiate because of the variability in clinical trials, plus or minus -- 10% is the range that they kind of look at. And you can probably expect that when you go into real world population, some diminishment of what you've seen from clinical trials just because of the nature of the real world patient from compliance and other things. So if we're in that range, we feel highly confident that we should be able to compete in the commercial markets.

Alethia Young - Deutsche Bank AG, Research Division

But the -- a couple of news-based questions. I guess, one hot topic always is like, I just want you to comment like on the validation of your IP process in nominating this nuke and like how comfortable you feel with the patents there because there seems to be a very interesting patent landscape in the world of nuke?

Milind S. Deshpande

Yes, well said. The IP landscape is interesting. The way we approach this problem was we made certain modifications to the basic cells, which is the uridine. And we also made some modifications to the sugar molecule. And it is the combination of these 2 modifications that we believe gave us the freedom to operate as well as start stability. In terms of how we evaluate whether we have intellectual property on a new given molecule, what we do is that, obviously, we have medicinal chemists who are very, very good at looking at a competitor patent, whether they are issued or published. So that's the first gaining factor. And then before we decide, we want to move forward with a particular chemo-type or a particular molecule. Usually, we get opinions from 2 independent law firms. We just submit the molecule or a class of compounds that we are interested in and ask them to render an opinion, whether or not they believe we have [indiscernible].

Alethia Young - Deutsche Bank AG, Research Division

And I guess -- it sounds a little vigorous. But I guess, one thing that I have to -- I know some of you guys. I have spent so much time with you guys, but it sounds like -- I'm not surprised that you've gone into the nuke landscape. But I think for others that have spoken to this morning, they find it a little bit surprising. Just -- can you give us a little bit of flavor about like your experience and like your team's experience in developing like a [indiscernible] classes?

Milind S. Deshpande

Yes. Our experience in, specifically nucleosides goes back to the development of -- and the side of the [indiscernible] which is a nucleoside reverse transcriptase inhibitor for HIV. We've worked on that compound for a number of years. And so there is internal expertise in, at least, doing the right strategies that need to be done with nucleosides. So there is a battery of immuno-rich assays that are typically associated with nucleosides on the safety side, on the biochemistry side, as well as on the profiling side. So we understand what assays need to be done to evaluate nucleosides and we relied on our experience going back to the development of Elvucitabine. So that's -- we have a fairly large database internally in terms of the assays, the outcomes, as well as clinical trials. We took the Elvucitabine to Phase II clinical trials. So there is internal expertise in looking at nucleosides. It really has been tough. And as you pointed out, the IP was the key issue for us. We have been working on this for the last, I would say, 3 to 4 years. And it was a tough proposition to identify proprietary compounds that also had good activity [ph] towards HCV. The main reason why we didn't talk about it is because we thought it was a very, very difficult problem.

Alethia Young - Deutsche Bank AG, Research Division

And so basically, if I'm to -- I'll be back to you. I mean, how [indiscernible] specifically. I mean, how confident are you in the patents here based on like the due diligence process?

Milind S. Deshpande

Again, as I said, we have obtained opinions from 2 independent law firms. These are very independent law firms in the intellectual property space. So we rely on their assessment. Internally, also, we have looked at the IP landscape very carefully. Never say never. So what I would say, at this point, is that we are comfortable at this time with our IP situation. And I've been in this business for more than 20 years and -- even in situations where before we started clinical trials, this was [indiscernible] a competitor packing published. So they could be submitting patents that will emerge. That could cause issues for us. But at this time, our assessment is that we are okay.

Joseph Truitt

And I would like to just comment. If this -- just what we did with the nucleoside is no different than what we've done with our protease inhibitors or NS5A. And if you just follow the logical path, our protease inhibitor patents had been issued. Our NS5A patent has published and, hopefully, is on it's way. And so it's just a -- we feel like we have a very solid process. We work with outstanding law firms that are not easy to get through. Many things have not gotten through that you never hear about. So as Milind said, we're very confident that we have a disciplined process to make sure that these assets will be owned by Achillion and our shareholders.

Alethia Young - Deutsche Bank AG, Research Division

And just looking at a little bit at the clinical profile. One, now that you're developing nukes, will you have access to a kind of Inhibitex like bond informations out there? And then secondarily, like just characterize for us, like the preclinical work that you have done, including cardiac and the preclinical work or any additional work that you plan to do around, obviously, the [indiscernible].

Milind S. Deshpande

Yes. So to your first question, would we have access to the BMS data, I have heard that if you are developing a nucleoside analog, you can access the data for the BMS inhibitors compound. I don't know that for sure. But as our compound moves forward, that's something that we will be very much interested in. In terms of our preclinical assessment for our safety for 3422, the key is to establish a high safety margin that is pushed for doses as high as you can in your nonclinical studies so that you really understand what the issues are with the compound. And that's what we will be doing.

Alethia Young - Deutsche Bank AG, Research Division

Okay. So maybe we'll just look to the upcoming catalyst with -- now as looking to be an interesting one, a big one for you guys with the PI NS5A study. I'm just curious when -- like what is your expectation for the trial? Like what would you view as good data?

Milind S. Deshpande

So ultimately, what we will be looking for is SVR and safety, tolerability. For SVR, again, if we get SVRs greater than 85%, I think that's a good outcome. In terms of safety and tolerability, it has to be really clear. There are no issues in terms of our clinical chemistries, our tolerabilities or so. That's what we will be looking for.

Alethia Young - Deutsche Bank AG, Research Division

You think -- we'll, I guess, you have the assets in house but to do it with the 2 drug combo and rival and get 85%, basically, it feels like, at some point in space, a few people want to see like north of 90%. I mean, is there -- do you think you could get that in other regimens? Or would you go for 3 drug combos to see if you could?

Milind S. Deshpande

Again, it depends on the patient population that you are looking at. So if you are looking straight at genotype 1 treatment-naïve patients, I think it's fair to expect greater than 90%. But as we look at the intricacies of clinical development, there are other factors that come into play. The IL28B status, the baseline mother load [ph] and we went through this. We needed the 12-week combinations to lead the 1625 [indiscernible]. So in these small trials, one patient can make a difference of 10%. So what we are really looking at is a patient -- the first trials -- the first group is 15 patients. So for some reason, if one patient drops out and we intend to treat [indiscernible], you are looking at -- your percent of difference in SVR rates is going to drop say, for example, from 95% to 85%.

Alethia Young - Deutsche Bank AG, Research Division

That's fair. That's right. So based on the portfolio you have today, did you guys feel like you need a partner? Or where are your views on partnering right now?

Milind S. Deshpande

Do you want to comment on it?

Joseph Truitt

Yes. And so our perspective is that based on what we've established at the portfolio with the in the second-generation protease inhibitor, second-generation NS5A and the nucleosides that we've announced here today, we feel that we have all the assets that are necessary to compete at the top level of any HCV combination. Of course, we have to execute and deliver on the data. But based on what we have, we don't feel that there's any need to go out and acquire any additional mechanisms or overlapping mechanisms to our portfolio. That being said, we're certainly still open to and interested in potential collaborations across a company with different assets because you never know what's going to be the exact best combination or what -- maybe some special population that might need addressing. So we feel pretty good about where we are but, certainly, open to those types of discussions with other companies. But don't expect any kind of licensing arrangements from us.

Alethia Young - Deutsche Bank AG, Research Division

All right. And then just -- maybe we'll talk about -- a little bit about more about timelines in the market. And one is, I've been asking around, I'm very curious what everyone, like the competitors, Gilead, their opinion is on when the standard of care will change and how that process works logistically. In the case that we never thought this was fairly changed with sofosbuvir, but perhaps that was of -- with the standard of care. But at some point, with sofosbuvir and -- or ritonavir or without or whatever you could see the standard of care changes, being more point but when do you think is kind of the drop dead moment? Or is there a drop dead moment?

Joseph Truitt

Yes. And so there seems to be some perception out there that you need to have your combination into Phase III before the first wave of genotype 1 or oral combinations are approved. So if that's the perspective, that's fine because we will have our combination in Phase III before that happens. But that being said, we're not sure that that's exactly correct. That the data, the new combinations approved, that the standard of care changes on that day. If the FDA issues approval, they don't necessarily issue guidelines. Guidelines are usually established by the professional associations. And our understanding is that from speaking to lots of folks about this is that it takes some time for the standard of care to transition into the established. So there will be a point where that does happen. But our view is that it doesn't happen on the day of FDA approval of the first combination. Because even if you think about it, there may be a couple of combinations approved right at that time point. So which one would be the standard of care? Who's to say that it's not ADNI versus Gilead versus BMS is over that period of 12 months when you'll have a number of approvals. So again, we'll get our combinations into Phase III to make sure that there is no issue. But on the other side of that, we're not sure that that's exactly correct. That on FDA approval, there's a change in the standard of care.

Alethia Young - Deutsche Bank AG, Research Division

Oh, oh, we got a question from Robin [indiscernible]. Just shout out. Get away from the mike, Robin. Come on.

Unknown Analyst

So just -- I have a question on that. Because a lot of investors are really going to believe -- they're not going to believe I think that you will have to have that. In their brains, I think they're going to still think you've had that. So how much do you -- how much buffer time do you have to get that Phase III going? And what are -- what is the risk to that time line being set back? What do you have to hit to get that Phase III in?

Milind S. Deshpande

We intend to start our Phase III program fourth quarter of 2014 and that gives us, I believe, 4 to 6 months before the approval of all sort of direct-acting antiviral replacements. The risk factors there are really not execution. So we have a [indiscernible] Phase II study going on. Right after that, we will start a study which we call Apollo-C, in which we will be treating 400 patients. And my intent is to convert that Phase II study into a Phase III registrational trial.

Alethia Young - Deutsche Bank AG, Research Division

Well, I would like to [indiscernible]. I guess, the biggest question that I get about Achillion and the call here is really on the size of the market and your ability to compete in a very large market. So I think people are sort of comfortable to add [indiscernible] some sort of triple times that, so perhaps you could show us something similar. But just talk a little bit about like how you see the market evolving. How you see yourselves competing if you were to go at it alone, perhaps maybe you may? But if you were, how do you see it happening? How many patients do you see coming on in the first couple of years and we all -- do we treat a million people in a year or something?

Joseph Truitt

So that's a lot of questions rolled into one. So let me start with -- so competitively, how would Achillion structurally compete? And so if we were to roll to FDA approval and commercialization and we were to commercialize and launch on a global basis, the reality of an Achillion-type company would be that we would probably look for commercial partners in different markets around the world, Asia, Europe, South America. But we would probably give a development and then pass off the time for commercialization. But for the United States market, we believe that this will remain a specialist disease, primarily hepatologist with some specialized GI, maybe some infectious disease. But a market that will be reasonably accessible by a small focused sales force and also, the fact that we would be leveraging specialty pharmacy for these type of a deliverance of the treatment. So from a commercialization perspective, it's very reasonable to build that kind of infrastructure and do that. I know plenty of companies that have done it. I've worked in companies where we've done it previously and it's a lot of work but not an impossible hurdle. On the perspective of market evolution and treatment, well, if you believe that the hepatologist will remain the main treaters and maybe an expansion into some GI and some IP, then the reality is there's a certain bandwidth of treatment that can be achieved in any given year. And I believe in our models, peak market years of treatment land sometime in the 2020 time frame and they range USA and EU at a little bit north of 300 -- about 300,000 patients. So and then the throughput kind of goes from there. But the idea of this model where all the patients will be rushing in mass into these offices to be treated, cured and then turned over, we just don't see that. And we've done all the patient flow models. We've done lots and lots of market research with all the folks that are in the chain of treatment. And that just doesn't seem like that's what's going to happen. So we think it will be a slow uptick of diagnosis and conversion. And there will be a bolus of treatment, but it'll happen in a more reasonable number and over a longer period of time. And in our models, we went up to 2029. We didn't go any further because that's when our patents expire. So that was the end of the model and it still is a pretty robust market.

Alethia Young - Deutsche Bank AG, Research Division

And I forgot to ask. But -- how's enrollment going on the NS5A study? Or -- do you feel like you're on track?

Milind S. Deshpande

Yes. The development is on track. We are getting very good feedback from the investigators, a lot of enthusiasm.

Alethia Young - Deutsche Bank AG, Research Division

All right. And is there anything that you're kind of picking up from the KOLs? Is that what they want you to do with your program that you're going to try to incorporate?

Milind S. Deshpande

Well, looking at the profile for ACH-3102 and the high-barrier resistant that it provides especially against genotype 1b, there are KOLs especially from Europe who are really asking us to develop a simple regimen with 3102 for our treatment of genotype 1b.

Alethia Young - Deutsche Bank AG, Research Division

Well, we're going to end 30 seconds early, and thanks Milind and Joe and congrats in the progress.

Joseph Truitt

Thank you.

Milind S. Deshpande

Thank you very much.

Milind S. Deshpande

Appreciate it.

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