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Sarepta Therapeutics, Inc (NASDAQ:SRPT)

Deutsche Bank BioFEST Conference Call

December 02, 2013 05:10 PM ET

Executives

Chris Garabedian - President and CEO

Analysts

Robyn Karnauskas - Deutsche Bank

Question-and-Answer Session

Robyn Karnauskas - Deutsche Bank

Thank you everyone, thank you for staying for the last talk of the day, I really appreciate it. My name is Robyn Karnauskas. For those of you who are looking to the webcast, I am one of the analysts at Deutsche Bank. And with us we have next Sarepta Therapeutics and we have the President and CEO, Chris Garabedian which I always probably mispronounce – always try really hard, Who’s had a very interesting year and so I thought that first of all those people listening on the webcast who want to ask a question feel free to email me, I am happy read anonymously and raise your hand, we'll bring a mic to you if you are in the audience.

So let me just start with, maybe just give a brief overview of what's happened over the last month as far as the FDA feedback and we can start from there.

Chris Garabedian

Well, obviously last month we communicated pre-meeting comments of a meeting that we requested with the FDA to talk about our confirmatory study design. As part of those pre-meeting comments the FDA provided unsolicited comments that we shared in great detail in our press release in subsequent conference call which basically stated that based on new information that they had reviewed in between our November 8th meeting and July meeting we had, that they were reconsidering some of their previous positions on dystrophin on the supportive six-minute walk data we had and had more commentary on our potential confirmatory design.

This was largely driven on two pieces of information; one was natural history data that they said was recently published and the second was largely the drisapersen failed study. Just to comment these pre-meeting comments are issued usually about 24 hours before the actual meeting takes place and it really represents a view before the company has an opportunity to respond or comment or try to address some of the issues concerns, issues that were raised.

So we expect that meeting minutes out of that November 8th meeting along with an extension of that meeting that was granted in a meeting in November that this will be culminated in meeting minutes that will be issued to us in December. We're not sure exactly the timing of that, we expected it will probably be consolidated from the two meetings we had in November into one meeting minute document and that will reflect kind of the totality of the conclusion of those meetings.

Robyn Karnauskas - Deutsche Bank

Have you had a meeting since the meeting, so you have had a meeting since the meeting in which you announced this?

Chris Garabedian

Yes, we did indicate on that call that they had already scheduled a subsequent meeting in November which did take place. And again what we're not clear on is if the meeting minutes will be issues 30 days from the first meeting or from the second meeting. So we have basically said that in December at some point we would have meeting minutes from those meetings.

Robyn Karnauskas - Deutsche Bank

How was the second meeting?

Chris Garabedian

Well I can't really comment, but just to comment on the process is it's a discussion and it’s a dialog and while you talk about a lot of things and there is a lot of good constructive dialog that takes place, we don't know the conclusion of that really until we get the formal meeting minutes confirming their view of what took place. But I would say that it was a productive, constructive meeting and we're both interested in working toward a resolution on finalizing a confirmatory study design.

They did grant us another meeting to take place in December which is a continued dialog of the confirmatory study design. So it's not clear exactly when we'll have final resolution on a study design but I will say that they are being very responsive. And obviously affording us three meetings in a span of a couple of months is notable in and of itself, but it's unclear when we'll have final resolution on the confirmatory study.

Robyn Karnauskas - Deutsche Bank

You mentioned that you are going to still debate with them on accelerated approval on the last conference call. Is that over now?

Chris Garabedian

I don't know if you used the term debate if I did.

Robyn Karnauskas - Deutsche Bank

You didn't use that term but there was another term you used.

Chris Garabedian

I think the question that was posed was, is the door completely shut? And based on the interactions we had with the FDA, we said we'll know the door is not completely shut. And that we will try to address some of the questions and concerns they raised that led them to come to the conclusion that an NDA would be premature and a shift in their position that they were open to it earlier, that while we address those issues, we will be working in parallel with them on a confirmatory study design.

So it's basically saying that we acknowledge their position, we don't think it necessarily should be the final word until we an opportunity to address some of the new data that they have raised, but we're not going to hold up our discussions around a confirmatory design in waiting for some different conclusion around an NDA filing.

And so it’s just to say the door is open on that but we're putting an effort into that but we're not holding up our discussion to try to get to resolution around a confirmatory study design.

Robyn Karnauskas - Deutsche Bank

But did that come up at all, did you or did the FDA bring that up at all in the last meeting?

Chris Garabedian

The last meeting was expressly to continue the dialogue around the confirmatory study. I believe I mentioned it on the previous call. But this was not to continue the discussion on the NDA filing. It was more around, we didn’t have time to discuss in greater detail the confirmatory study.

Robyn Karnauskas - Deutsche Bank

In the third meeting, again, did you plan to just focus on the December meeting, do you plan to focus on the design of the pivotal study?

Chris Garabedian

Yeah, I’d say the best way to describe these ongoing discussions with the FDA is the priority is to try to get resolution on a confirmatory study design. We both have an interest in coming to a resolution of that as quickly as possible. And so we will continue to discuss that. I think in parallel when we have the opportunity to discuss whether it’s six minute walk as our endpoint and being ending supportive of the totality of our clinical data for Dystrophin and the different ways to address that we think that will need to be addressed. But right now the priority is finalizing that confirmatory study.

Robyn Karnauskas - Deutsche Bank

And then talking about the confirmatory study, I mean, I listened to the BioMarin panel, and thought it was really interesting because they emphasized placebo controlled trials and there was a ton of data, a ton of clinical work to get that drug approved including a natural history study for a really significant disease. Where do you think the FDA is going to budge? Is it endpoints? Is it placebo?

Chris Garabedian

You know, it is hard to predict that. We proposed a study design, back in February. We provided a study synopsis and provided some preliminary, actually received some preliminary comments from the FDA, and nowhere to the degree that we received recently in the February pre-meeting comments. And we felt that the FDA was of the mindset that if the treatment benefit is robust enough that they were open to a non-placebo trial.

And we felt we had not only a robust treatment effect that we would expect, but we were proposing not only an untreated cohort, that would have the same inclusion criteria and then natural history would suggest, would behave similarly in terms of exon 53, exon 45, and exon 50. But also we had an abundance of natural history data that was recently published this year, even two year data, Nathalie Goemans and Elena Mazzone had two year data that we thought was not only supportive of our stability that we are seeing in our current study but also provided a good guide post for a comparison versus a open label study.

Now we have a third potential control of the GSK placebo arm which the over seven year olds declined 83 meters over 48 weeks. So we felt that the FDA had three different measures, the natural history literature with exon deletions, not the one they referred to which was the ataluren placebo arm. In untreated cohort with evidence that they performed similarly as exon 51 deletions, and now the GSK, why would they need a fourth placebo arm. But this is currently what they want us to explore.

So we’re trying to figure out if there is ways to provide flexibility around a placebo controlled study. They’ve proposed we can enroll new subpopulations and new endpoints. The only other way to reduce the sample size to make it more feasible for enrolment would be to have a discussion with them around treatment effect that is acceptable to powering the assumptions that go into that placebo control if we decide six minute walk is the endpoint that we want to stick with as a confirmatory study. So as you can see there are several issues that we are going to…

Robyn Karnauskas - Deutsche Bank

Doesn’t sound like they’re going to budge on the placebo?

Chris Garabedian

We are going to make our case. But we are also going to be open to considering ways that we can do a placebo control as well.

Robyn Karnauskas - Deutsche Bank

Okay. And you mentioned, you know, that it might be challenging for you because you don’t want, you don’t feel like you, in areas where you couldn’t sell the product, do a clinical trial. It’s the freedom to operate argument. Why can’t you enroll, except in UK, why can't you just to complete the trial, just enroll the trial?

Chris Garabedian

Our corporate policy right now is to adhere to the Helsinki Declaration which says, you don’t enroll patients in trials without a mechanism to provide access to them. This is not a cheap product to provide or produce. It’s not an oral small molecule that’s you know pennies to produce. So that’s something we have to consider seriously. This is something that we already dealt with to some degree in the UK when we did. This is prior to the patent opposition. We weren’t able to provide study drug. That was a real issue that we had to deal with as a company to not be able to provide study drug. And this is shortly after we were trying to do that, and we had the patent opposition hearing come through.

So I think we are exploring all possibilities including what it does look like to try to accelerate our ability to have freedom to operate. It’s premature to talk about specifics around that. But ultimately we’re putting everything on the table with how to make this feasible. The other thing to keep in mind is that, in an ideal situation we would want, you know exon skipping [endures] [ph] a person naïve, except the patient. In Europe many of the patients that GSK enrolled were picked up for their studies; in fact the majority of those patients were enrolled outside of the U.S. So we’re taking all that into account. We think the variability goes up when you go into new sites in new territories, and new geographies. So that would that maybe require a higher sample size. So these are all issues that would lend itself to a trade off and a consideration of which we’re open to having that discussion with the FDA.

Robyn Karnauskas

So this whole thing where you cannot do a clinical trial, I mean, Genzyme would go out to everywhere they can go to do clinical trials even if they weren’t offering the drug for free. So I don’t understand exactly why you can’t enroll?

Chris Garabedian

Well, I’m not aware that they went into territories that they weren’t planning to commercialize. My understanding with Genzyme is that they do it here for the Helsinki Declaration as well.

Robyn Karnauskas

Okay, so where exactly can you commercialize in Eastern Europe?

Chris Garabedian

Well, look, we don’t, on eteplirsen, right, we have a more limited patent scope. We increased that extension of that patent, or the, expanded the territories and the sequences that we have patent protection on when we licensed the second patent estate from University of Western Australia. So for subsequent exons, this presumably would be less of an issue for us than it is with eteplirsen. So it poses a little more of a challenge with this lead product with eteplirsen. But we’re going to continue to follow what happens with the program with drisapersen, right now as far as we know GSK or Prosensa has not discussed any termination of that program. And so we understand what that means if that program were terminated and the potential availability of that.

Robyn Karnauskas

But where can you not go, I am just trying to understand where you can’t go?

Chris Garabedian

We would have to have a mechanism to be able to commercialize the product, and in this rare disease field, there are - all territories don’t - can’t withstand a reimbursement.

Robyn Karnauskas

Well, okay, but I don’t understand because Genzyme has gone 80 countries. So where can’t you go?

Chris Garabedian

Our freedom to operate and our patent estate has very limited territory, patent protection as it relates to eteplirsen today.

Robyn Karnauskas

Okay but I mean where can’t you go?

Chris Garabedian

The U.S.

Robyn Karnauskas

Just the U.S.

Chris Garabedian

Okay, we don’t really want to comment on other territories right now because those are things that are part of our broader patent strategy and we just don’t comment on our freedom to operate in territories that we haven’t commented on publically to date.

Robyn Karnauskas

But I could find them on the patent. I can look up in your patent since you already filed them, right?

Chris Garabedian

Right.

Robyn Karnauskas

Okay. So then – so it’s the placebo discussion as far as enrolling or trials. What about opening up the argument, you can open up this trial and create some different endpoints for different patient populations? How are you feeling about that now?

Chris Garabedian

Well again part of the big question is validated endpoints, okay. Six-minute walk, we believe is the most validated endpoint in six-minute walk, it’s been used as a basis of approval in three neuromuscular conditions that are not the MD but akin to a neuromuscular progressive disease. It was used in the PTC Ataluren trial. It was used in the GSK and Prosensa trials. We believe there is a broad understanding and consensus among the industry that this is a validated marker for DMD. It’s the most well elucidated and documented endpoint in the literature.

There is more natural history on six-minute walk in DMD than any other endpoint out there. So when you start to introduce new endpoints in subpopulations, there is really not a large body of data to suggest what would you expect the decline to be and so then when you shrink the power populations, right, on new endpoints that are not validated or less validated in six-minute walk, it requires an extensive discussion and negotiation of what those assumptions are going to be. And so that’s something that the FDA has proposed but we would need to talk about what that would look like.

So they have talked about younger patients where six-minute walk is amenable or non-ambulant where six-minute walk is not amenable, so to produce a sketch of what that might look like, it would be saying let’s say we take four, five and six year olds and look at the Gower maneuver as the endpoint in four, five and six year olds because they’re still improving on six-minute walk. And let’s take seven to twelve year olds and six-minute walk is acceptable there and let’s take 13 to 15 year olds where they’re still having upper arm strength and mobility maybe there is an upper arm measure that we can combine and then if you take those who’ve lost the upper arms strength maybe pulmonary function or some other measure and the completely non-ambulant non-upper arm extremity function population.

So they proposed a mathematical combination of looking at some concoction of these types of endpoints, but you can see how it becomes difficult to figure it how to make assumptions on power and what to expect in an untreated arm versus a treated arm. But we’re having these discussions and the types of tradeoffs of sticking with six-minute walk test versus having a more broader population for enrollment to look at these other endpoints.

Robyn Karnauskas

So after the second meeting, how closer do you think - it feels like we’re leaning to, and my feel of this, feels like we’re leaning towards a placebo controlled trial in some capacity and that sounds like - that enrolling a broader population just sounds from your perspective very challenging?

Chris Garabedian

It remains challenging to figure out how we would come to an agreement but that’s something that is part of the discussion.

Robyn Karnauskas

You’re still having discussions around the broader population?

Chris Garabedian

Around what this confirmatory trial design looks like.

Robyn Karnauskas - Deutsche Bank

Okay. And then funding for this, remind me how much cash do you have?

Chris Garabedian

So, we entered the fourth quarter with 281 million on the balance sheet and that was with an operating loss of about 21 million. We reduced our operating loss guidance this year, calendar year, to 80 million to 90 million. And so we're comfortable with our cash position as we go into 2014. We're not providing guidance in 2014 at this time, but we've continued to scale up our manufacturing and we are prepared to start dosing our confirmatory study as we mentioned that's pushed out to the second quarter. To start dosing we think we can have resolution on a confirmatory trial design and still be able to start that study in the second quarter. So that's where we stand now and we're very comfortable with our cash position and our healthy balance sheet today.

Robyn Karnauskas - Deutsche Bank

But sounds like you could - have to raise money ahead of the outcome of the phase 3 given the delay and the potential size of the trial and timeline.

Chris Garabedian

Not necessarily. I mean the trial costs itself are not really the significant drivers of expenses. The drug cost is a large component of any trial. We've been producing midscale lots, that'll be coming offline. Soon we'll be able to have the testing done on that and the first quarter for potential drug release for that. So a lot of those expenses to start that trial were incurred this year on that drug supply, we need to continue to produce drug, right, to continue to dose those patients moving forward. But again the increase of a sample size from 60 was our assumption to a 100 or whatever it might be, in fact right now we're still at 60 in terms of treatment costs, would not be a significant driver.

Robyn Karnauskas - Deutsche Bank

What about the timeline? Because you still have to fund the company and it could take longer to enroll.

Chris Garabedian

Yeah, so that's something we don't have clarity on what that study design looks like, how easily it's going to be to enroll and what that timeline is to be able to complete enrollment and then ultimately have a readout presuming a 48 week study.

Robyn Karnauskas - Deutsche Bank

How many years can you go, say with a 100 patients? Say like what’s the limit that you could fund the company if you…?

Chris Garabedian

Well, I mean look, I can't, we don't have guidance for 2014 to provide at this point.

Robyn Karnauskas - Deutsche Bank

Got it.

Chris Garabedian

We can't give any kind of number of years to fund the company. But look, we're cognizant of the balance sheet, we think that there's going to be more clarity provided in the coming months that could provide you know the market with a better understanding of our path forward. And we are always looking opportunistically for the right times to shore up our balance sheet and raise more money but right now we feel 281 million going into the fourth quarter of this year is a healthy balance sheet.

Robyn Karnauskas - Deutsche Bank

Okay. I had a question from an investor. Why hasn't Sarepta released full data on other endpoints besides six minute walk, so just pulmonary function etc?

Chris Garabedian

Well, first we stated numerous times that the other endpoints did not show much meaningful supportive data to our six minute walk results. They were neither supportive nor unsupportive. And we only had through that first 36 weeks to show a comparison, so since that was noisy and we didn't have that benefit shown versus the placebo group, now what we have is all of the patients are producing dystrophin so we really are, would be looking at any other endpoints based on how are these boys doing relative to what would be expected in natural history over let's say a two year timeframe.

As I mentioned there's not a lot of good data out there on the natural history of these other endpoints to be able to compare these 10 ambulant patients to what a natural history. We have looked at this, there's some data out there. But at this point we're looking for the right medical conference and scientific venue to share any meaningful data. We have shared pulmonary on the Two Twins, and that's because we typically don't see a decline in pulmonary function until after boys lose ambulation and so we think it's the most relevant to look at that in the non ambulant because that's when we would typically start see that decline. So we can, as we've shown the stability on pulmonary function we think that's meaningful.

Robyn Karnauskas - Deutsche Bank

Why not just do non ambulatory study in placebo controlled non - pulmonary?

Chris Garabedian

Well again, we'd have to figure out how to power it on pulmonary function and again generally you don't see rapid declines in pulmonary function until potentially later in the non ambulant, that can vary but it’s a lot more variable than let’s say six minute walk and the progression that we see from let's say ages seven to 12.

Robyn Karnauskas - Deutsche Bank

Okay, are there any other questions on DMD? Anyone? Go ahead.

Unidentified analyst

Given that it’s difficult and challenging to find these patients, is there a possibility of a crossover trial design in DMD, where you can start with drug and then you can move these patients to placebo and then you can see the difference?

Chris Garabedian

Well, we would expect to start any study that includes placebo patients to be able to offer them drugs, right, you know that's something we did with our 24 week study and we would plan for in any subsequent study. One of the questions that was raised and is being discussed is, can you have a longer duration study and reduce the number of patients to make it more feasible to enroll but follow patients for a longer period of time?

So that's something that we could consider as well. The challenge there becomes, we know what happens to these boys, if you look at the GSK data and if you assume that all of the boys who went non-ambulant were not five or six but were seven or older, then about 20% of the patient in just 48 weeks lost ambulation in both the placebo and the drisapersen arm.

So to imagine going out to two years let's say, where you could have upwards of almost 40% of the boys lose the ability to walk, we think it will be a challenge to get through IRB but it's something we're putting on the table as a discussion also to be able to maintain a reduction of the sample size.

Unidentified Analyst

Thanks Robyn. How has the response from the patient advocacy community influenced the dialog that you have been having with the FDA? It seems like it's stronger than usual response and it may get even stronger than this.

Chris Garabedian

Look, there was a lot of communication from advocacy and parents I would say over the last six months and there were even meetings that took place between parents and advocate groups with even Janet Woodcock, Bob Temple that were published in blogs and tweets. We have always said we have to base it on what the FDA is communicating to us and the formal communications. So we try to be very careful not to try to extrapolate what moms or advocates might be hearing from the FDA directly and informally versus what we're hearing directly.

Clearly the FDA has made a decision to change the course of this program despite the communications to the advocates and moms. So if kind of told us that the community only has so much influence over the pathway that the FDA would consider because in this case they changed their course based on a natural history publication and based on the failed drisapersen study, and despite what the advocates may want in terms of access to this drug earlier.

I don't know if there has been any communication since the dialog and the press release and the conference call. I did get personal emails from many parents even across the globe expressing disappointment and honestly just questions like what does this mean for the follow on exon. It sounds like they are not accepting Dystrophin as a biomarker let alone the assays. So I had a lot of concern and questions coming from the community. Even had parents in our study who said does this mean you are going to take us off eteplirsen. So there is some misunderstanding of what the delay meant versus there was a failed competitor trial.

So we just try to be as communicative and transparent with the community as we’re with the investor community about what this means, what our path is moving forward and what we're trying to do. Look I have said all along that when you have parents who are believing the drug is working and are demanding the drug immediately that what we're trying to do is get the patients access to the drug and approval of eteplirsen as soon as we can, but we have to do that going through the right mechanisms and with the FDA’s support and [buy in] [ph].

So that's what we're still aiming to do and we're disappointed with this delay but we hope that we can work with them to provide a more expedient path than where we are right now.

Robyn Karnauskas - Deutsche Bank

I have another question from an investor. My question is, this goes back to the trust issue, so a lot of investors now maybe more skeptical about Sarepta. So what have you learned as the CEO from this experience and how will this change how you run the company over the next year?

Chris Garabedian

It comes with the territory to be in the seat, that you kind of get more credit when things go well and you get more blame when things go bad. And all I can say is we have tried our best to be very transparent with our intention. We have tried not to get ahead of ourselves, so we have never communicated our intention without getting the FDAs [buy in] [Ph] in advance. So for example, everybody was asking me for a long time, are you going to file an NDA, I said well first we have to ask the FDA if they'll even consider dystrophin as a surrogate before we can even answer that question. People may forget that but we only said we're going to submit an NDA until the FDA said they were open to it and we're willing to consider that.

So all along we have provided the caveats, the qualifications around all of our intentions and we did that again. Now unfortunately depending on how you look at it, FDA dialog is very material to this company and our pathway and trajectory. And so it makes what it would be under normal circumstances or many companies where run-of-the-mill discussions with the FDA that might be able to play out over longer periods of time, I think the market is seeing this play out real-time and they’re watching this process that can sometimes not be as smooth and clear and linear and it’s a negotiation, a discussion that evolves over time.

So the pre-meeting comments were an example of that. Many times pre-meeting comments can represent a more conservative or strident view, and sometimes meeting minutes can be more conciliatory or have a more open-minded view on things. But we don’t have the benefit of that. We had to issue something that was material. We pushed them to say “Are you sure you’re not suspending your comments until the meeting minutes?”, and they weren’t willing to go that far. So we had to disclose. Meeting minutes will come in December. If there is nothing new then we won’t disclose anything. If there’s something or a material change then we would obviously be obligated to disclose that.

But I think, honestly I mean, you try to, the lesson learned is maybe to remind everybody exactly about expectations and not let investor expectations run ahead of what the company is actually saying and what we are communicating. I think the other contributor in this case is there was a lot of communication outside of the company around this program. As I mentioned there were moms who were meeting with higher FDA officials and they were tweeting about it. And there were investors who were taking that information and sharing it with other investors, when we never showed a video that has appeared on Twitter, on one of our corporate presentations. So we’ve been very careful not to take what the moms had been saying and say “oh, look how great our drug is working.”, if that makes sense.

Robyn Karnauskas - Deutsche Bank

Okay. Last question - didn’t Glaxo enroll its Phase III? And if there is enough patients to commercialize this drug there should be enough to enroll the Phase III trial.

Chris Garabedian

So this is based on selecting the right patient population for the six minute walk endpoint. We’ve been very fortunate in that, we’re sitting here at a time where there is more natural history data on DMD and six minute walk, than it has ever been available. There has been more attempted studies on DMD and six minute walk than ever before especially with the recent drisapersen study. And so we’ve learned that for example if you include five and six year olds, it confounds the data because many of those improve and improve a great degree and can influence what the overall outcome is.

So we even started our Phase II study with seven years and above. Everybody is doing it. PTC is doing that now. Every data cut now is looking at the seven year and above. Then there is more and more data that says you need to select the baseline six minute walk very finitely. Many say you shouldn’t include anybody below 350. We think that’s pretty severe. But let’s say you exclude patients below 300. You don’t want to include too healthy of a patient because they won’t decline. So you cut out patients above 400 or above 450.

So when you start looking at a seven to 12 year old population for example, and you start looking at 300 to 450 on six minute walk baseline, and then there is other things like they can be cognitively impaired to be able to perform the test, as an example. If we were to exclude drisapersen exposed patients because of lingering toxicities or are there trace levels of Dystrophin that would confound a Dystrophin analysis, or would there be any immunogenicity that we’d concerned about, that would render Eteplirsen inactive. These are things of why companies exclude previously exposed patients with a similar mechanism of action.

When you start looking at who qualifies and you start with your 1,800 patients which is a nice number, but that includes from infant to 25 years, and it includes non-ambulant, it includes those patients who are more severe or less severe in the age group we’re studying. And so you start to cut the numbers and they get pretty thin in the available population. And so this is where it starts to become difficult. And GSK again, the large bulk of their studies, they recruited outside of the U.S. In the U.S. study, they were proposing to enroll 54, they stopped at 51. So it wasn’t easy or quick for them to find patients even in the U.S. So this is a really rare disease and it’s important when you start cutting the patient population for inclusion criteria, it gets to be a very, very rare subset.

Robyn Karnauskas - Deutsche Bank

Okay. All right, well, thank you very much.

Chris Garabedian

Thanks Robyn, I appreciate it.

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