Chris Garabedian - CFO
Robyn Karnauskas - Deutsche Bank
Sarepta Therapeutics (SRPT) Presentation at Deutsche Bank dbAccess BioFEST December 4, 2012 7:50 AM ET
Good morning, everyone. Thanks for joining us so early in the morning. My name is Robyn Karnauskas. I’m the Deutsche Bank biotechnology analyst. And I’m really excited this morning to have Sarepta Therapeutics. And with us we have the president and CEO, Chris Garabedian.
For those of you who are listening on the webcast, my email address is email@example.com. So if you have any questions, I’ll be checking my Blackberry, and I’m happy to read those questions anonymously.
Thank you very much for coming this morning. We really appreciate it. First of all, I was thinking about questions for you all this morning. It’s been a very big year. And the one thing that came to mind was that you have a lot going on for a company that sort of rose to fame this year. You have a lot going on, and I think a lot of investors are very focused not only accelerated approval, but as well as manufacturing, execution, just the company.
And then I thought we’d also talk about just what about this company and the platform technology, and how do we think about this company more longer term? Because everyone’s very focused on accelerated approval, but I’d like to have a better sense of how you view the company longer-term.
With that, maybe we could start off with walking us through, step by step, just first on manufacturing. What do you need to do to get to a place where you have enough product for maybe a confirmatory study, and then under the scenario of what if you’re required to do another pivotal trial, does that vary at all. So, step by step, what needs to be done.
Thanks, Robyn. Thanks to Deutsche Bank for the invitation. It’s a pleasure to be here. On manufacturing, we’ve communicated a lot around timing and when certain activities will take place, and when we’ll be ready for a pivotal trial or confirmatory study.
So, first I’d say anytime you’re scaling up manufacturing, regardless of the compound, there’s complexity, there’s risk, there’s investment in time and resources. So we’re not unique in that regard. That happens with any technology. Morpholinos have not been scaled up before to the degree we’re doing it currently. We have had a lot of experience at small-scale production, both in house and working with contract manufacturers. And we’re very comfortable.
This process has worked very well. It has led to our broader Duchenne program, not just the current Phase IIB study, but obviously the previous studies that we conducted in the U.K. We also have conducted a full preclinical toxicology program. And that’s not an insignificant feat. For example, we completed a nine-month primate study where we went to doses as high as 320 mg/kg. So that’s a lot of drug to produce, even for that one study alone.
So we’re very comfortable with the process, and the purity of the compound, and the stability that we have at this smaller-scale production. We are in the process of scaling up for what we describe as mid-scale production. This is about five to six times what we’ve been doing at a small-scale production process.
So I highlighted the complexity, because I don’t want to suggest that everything is simple, but the drug chemistry itself, and the synthesis is not something that really provides a lot of technical challenges. This is an oligo. It really is a unique type of drug synthesis in that it’s not a biologic. It’s not a small molecule. It requires really a peptide manufacturing process. It’s closer to peptide manufacturing, but it’s not a peptide. So when people make the analogy to [Fuseon], that’s the wrong analogy.
We are an oligo, which means that we need to have each of the subunits. The ACTs and Gs that we produce, need to be linked to our backbone, which we’ve described is also differentiated from other oligos, which typically require linkage to a ribose backbone, a five-sided ribose ring, that’s linked by a phosphorothioate linkage. We have a six-sided morpholine ring at its base, which is linked through a phosphorodiamidate linkage.
These linkages are not difficult, but there’s many. This is a 30 [mer]. So when we talk about steps of the process, depending on who you talk to, they would not consider every one of those subunit linkages a step, because they’re fairly easy interactions to create. But there’s many of them, because we have a 30 [mer].
I just wanted to demystify the idea that this is a real difficult compound or molecule to synthesize. So we’re working contract manufacturers that have experience in the type of peptide scale up that is required for producing our drug, in a larger scale. And that is not as common, so we have a selected group that we’ve identified.
How many people do large scale oligo…?
There’s a handful. And we’ve had discussions, and we’re engaged with, or are working with, many of those companies. When people ask if a partner would bring a lot to the manufacturing efforts, not really, because the expertise that exists on morpholinos and the process of production exist within our company. That’s really the most experience that’s been done, is in our company. There’s a company that sells reagent morpholinos that also has experience, but in terms of GNP quality to produce a drug for clinical trials, a lot of that knowhow exists within our company.
So we understand the chemistry. We’ve been doing it at a small scale for a long time now. We have good stability data at the small scale batches. And so it’s really a question of putting the effort and the time that it takes to scale up production. And so there’s always risk in that, but we don’t think it’s a difficult challenge, or process. But it does take time.
And so what we’ve communicated pretty consistently is that our small scale effort has allowed us to continue our current Phase IIB, has supported preclinical efforts. We have these other exons that we’re developing for Duchenne, and we’re producing drug for those as well. And so for the larger, let’s call it clinical, campaign, which includes a confirmatory study, we’ve communicated that we need to get to a larger scale, or what we’re describing as midscale.
That is a process that includes tech transfer of those validated methods of the process that we’re using. It requires, sometimes, new equipment and set up by the manufacturers we’re working with. It requires the test runs, the validation, and at the end of the day, we need to have three batches that we would produce. And if we want to stick with one manufacturer, which is probably the right thing to do from a regulatory standpoint, then that’s done sequentially.
And then we have to put those on stability. And this is produced under CGMP conditions. And then once we have three-month stability with the last batch, we will compile that data, submit to the FDA. They need to review it. And then that’s typically a one to two month process. And then they would let us know that we can release the drug in dose in patients.
So what we’ve said is that we expect all of that to be completed, to start dosing a confirmatory study, by first quarter of 2014. We’ve also communicated that in a scenario where we have positive interactions with the FDA, and they seemingly support the idea that our current studies, to date, including our Phase IIB and the U.K. studies, and we had an IM study, all of which, by the way, have produced dystrophin.
So in terms of a biochemical proof of concept, we’ve done it now across three studies, our IM study, our U.K. study which was referred to as Study 28, and Study 201 and Study 202. We have biopsy confirmation of dystrophin produced at 24 weeks and now 48 weeks.
So we think there’s a compelling case that the drug is working, and it is producing dystrophin, which is the essential protein lacking in these patients. And again, that’s 38 patients in total that have been exposed to the drug, and the ones in our Phase IIB, at the highest doses ever tested - not only with morpholinos, but any RNA therapeutic - it’s 50 mg/kg per week. And we have exposure of over a year now of therapy in those patients. At the time we would file an NDA, we’d have likely around two years or more of exposure at the 50 mg/kg level.
So from that vantage point, we are waiting for the right signal that would suggest that we need to prepare for commercial demand. And we are already planning on turning the switch on, so to speak, if we get those positive signals to start large-scale production. And this is something that we do not believe we would need to wait for the midscale production to be complete, and have release of that drug. We could do this in parallel.
And we believe that because this is more akin to small molecule synthesis than it is biologics. With biologics there’s a lot of risk on scale up that you have really a different drug product at the end. And a lot of companies have gotten caught up in challenges on the CMC. This chemistry, we believe, is, relatively speaking, simpler to scale up, and really at the end of the day we need to show that the drug in the vials is the same. You know, the same active drug, the same purity profile, the same stability. And that’s something that we would be doing from small scale to midscale, to large scale.
What percentage of your company is focused on manufacturing? It seems like this is a big part of what you need to do for approval.
Again, we’ve had small scale production capability at our facility in Corvallis, Oregon. So we’ve had, I would say, a fair amount of staff dedicated to that. Across the Corvallis facility, it’s about half of our employee base, which is in excess of 100 employees currently. But not all of that is manufacturing. We have analytical R&D there. We have quality control, some quality assurance professionals. We have research biology there, and we have other staff support.
But overall, it’s been that effort that has been focused on the tech transfer. We still produce drug out of that facility, and it’s possible to create a GMP drug product. But we really need to shift to CMOs that can do it at larger scale, and that’s what we’ve been focused on this past year, and next year is really going to be a big year to make sure that our CMOs are up to speed and doing the right set up and are coming online to produce the quality of drug that we need.
So when I’ve seen other companies scale up, usually there’s always some small delay, or some mini-hurdle in some way. When I think about what you need to do, I guess the first question that comes to mind is how comfortable are you that you’ll be able to begin the scale up on time? Like, the beginning of the process. It sounds like once you begin it, like you’ve got all the machinery, you’ve got all the people in place, it sort of has a fair timeline.
Like you said, there’s a lot of moving parts in a business like this, and I am focusing a lot of attention on manufacturing. We have at least weekly, deep updates on the status of things. That’s because I get a lot of questions, and I have to communicate on this frequently. And oftentimes trading emails or conversations daily, just making sure we’re paying attention to the important things on the manufacturing front. So the guidance that I’ve provided is based on a belief that we can deliver on what I’ve suggested in terms of dosing to start in the first quarter of 2014.
Large scale, we haven’t really guided on when that drug supply would be coming online, and that’s something, when we have a clear idea, you’ll hear me communicate that more specifically. But that’s the reason. I just don’t want to be in a situation where I’m guiding, and then I have to change that guidance. So really we’re just talking about that we are preparing to turn the switch on to start that process.
Do you have to hire more people for large scale?
Yeah, we’re a growing enterprise. Presumably we would be hiring more people. But again, we’re relying primarily on contract manufacturers. Look, if I was on market cap of a couple billion, then we could really consider how we might try to build, instead of contract out. And that’s not something we would shy away from. It has to make sense, right? In terms of the risk profile of the company and how much supply we need. But right now, we think contract manufacturers are the way to go.
Got it. Okay, so if we think about a scenario where the FDA says, all right, all you have to do is the confirmatory trial, go ahead and file your application, under that scenario, if I understand it correctly, you’re going to do midscale, but you’d also start to begin hiring and actually working in large scale, and that would maybe be a bit of a delay. How much product would you have to do your confirmatory study, and then the additional stuff, like the stuff we don’t even talk about beyond the current product? Would you have to shut down the other stuff temporarily before you’re comfortable that you’ll have the capacity? I guess I’m asking how much wiggle room.
When we talk about capacity, this is not the only thing we’re working on, is eteplirsen. So we have government programs and commitments to those programs, and that is morpholino production and scale up in its own right. And that knowhow, and that expertise, can be easily adapted and adjusted to support Duchenne. But we have commitments. We have the other three collaborations around other exon skipping products in DMD alone, and those also need to be produced. And so that’s capacity. So when we talk about capacity, it’s not simply eteplirsen . It’s morpholino production capacity.
The other thing is that - and I try to remind people - we don’t know, until we scale up, exactly what those yields are going to be. So there’s a variable there that has a range of outcomes. And that’s where we’re providing guidance based on what we can reasonably expect based on the efficiencies of scaling up. This does not include any process improvements that might increase yield. We really have to do those batches to understand what the ultimate yield is.
And this is also an impact on cost of goods, right? So we could end up with higher yields than we’re anticipating, and that would provide not only a lower cost of goods, but it would provide more drug supply.
The other factor that I think is not insignificant is our discussions with the FDA are going to be centered around dose. The data that we’ve generated in the Phase IIB study suggests that there’s really not a dose response with the 50 mg versus 30 mg on dystrophin production, and that really is essentially what we’re trying to do. It’s a small sample.
The 50 mg from the 48-week data looked a little more promising than the 30 mg on six-minute walk, but 30 did better than placebo as well. So we’re not convinced that, on that small sample, that’s the right way to think about dose. And if 30 mg ends up being a dose that is acceptable for an accelerated approval filing, for example, that is going to produce more drug supply for patients out there, and studies, and the like.
So there’s a lot of factors. I know everybody wants to know exactly what that’s going to look like a year from now, or 18 months from now. And it’s really hard, at this stage of the cycle, to predict exactly what that’s going to look like.
So if you do get accelerated approval, or get the clearance to go forward and file for accelerated approval, what are the exact timelines? The FDA will have to review your manufacturing as part of the application. So you would just wait to file until you have the manufacturing? So you wouldn’t file until 2014?
We’re not guiding, first, whether or not we’re going to file on accelerated approval until we talk to the FDA. And then at that point, we need to better understand their views on manufacturing supply and readiness for the market. We know they have been flexible or had varied levels of support of different readiness stages of companies when they produce a drug. In some cases they like to see that you have sufficient supply.
We know that there have been scenarios where there are lotteries or restricted launches. We know that, I think, there may be a factor of how the ease of production, a small molecule where it would be very easy and very cost-efficient or cheap to produce large amounts of drugs. They may have more requirements than a drug that requires more investment and more, I guess, shelf cost, just to produce enough supply. That could be a costly endeavor, depending on that.
So that’s something we have to have a discussion with the FDA about, and we think that they’re going to be reasonable, and they’re going to be flexible. But we don’t know that until we have those meetings. So our first point of order is going to be have a clinical end of Phase II meeting in the first quarter that we have communicated on. Coming out of that, we’ll know exactly the feasibility of an accelerated approval, and then what the confirmatory trial and program is going to look like. And we’re going to have a good sense of the drug supply that we will need, not only for the clinical program, but if we will need to start preparing for the potential for a commercial approval.
And we would then come out of that meeting with a much better understanding of the questions we need to ask the FDA related to CMC, and we would expect that to follow shortly after our end of Phase II meeting on the clinical front. And that could be likely in the second quarter timeframe of next year, to have that CMC discussion.
So how do you begin anything, though, before the second quarter, as far as midscale, when you don’t know exactly what is required?
Well, we know what we need to do to produce more drugs. And so that process can continue on. And I often tell my staff that our job is to try to produce as much drug as possible, as soon as possible. Because there’s not a lack of interest or demand in this drug. So that is really our challenge.
And again, there’s two aspects to this. There’s the drug materials that go into the API production. It is an oligo, so we have subunits as well. And those subunits are a component and a cost driver of the final drug product as well. And these have different yields as well. They’re produced independently, then they’re attached to that backbone chemistry, and the final API is produced. So there are a lot of moving parts, and it’s really hard to provide specific guidance on that.
The other thing I would say related to an NDA filing, if we got a good signal of accelerated approval, that’s harder to predict when that would be, because it’s going to be very dependent on that discussion on CMC. You could see a scenario where we could file on our current process, but we would not have enough drug supply to provide the commercial market. So we have to look at the feasibility of an approved product where we don’t have enough drug supply to supply the market.
On a midscale scenario, and approval on a midscale batch production, we’d have to potentially explore the notion of a restricted launch, or a lottery. And then we would want to be able to have large scale production come on as soon as possible after that, and we would supplement any filing. Again, this is not guidance. These are just scenarios. Then we could envision supplementing that product approval, and midscale production process with the large scale, so that when that drug was finally able to come on, that we would start to be able to supply the full commercial demand.
So this is a question from an investor. What is the benefit to Sarepta of accelerated approval? If you get accelerated approval, you can’t really treat a lot of people. Potentially, you’re going to treat a few more people, but you can’t treat everyone. Would it be a distraction? Would it make some physicians upset? And why not just start scaling up your large scale right now no matter what?
That’s a good question. First of all, we may not need the large scale for a longer time if we don’t get the positive read from the FDA. So that’s why we’re planning for it and are prepared to turn the switch on as soon as possible so we don’t lose much time.
But the question about what does it gain, under a traditional approval scenario, we’d be looking at start dosing a pivotal study early ’14. We think enrollment would go pretty quickly. Let’s say by early to mid-15, we would have the results of that. We would prepare a filing sometime, let’s say, third quarter or second half of ’15, for an approval in late ’15, early ’16.
In the scenario under an accelerated approval, we would expect to have a drug supply for the market before that timeframe. And again, everybody’s trying to ask questions in a different way to figure out that we just don’t know what that timing is going to be, but I’m confident that it would be before when we would be ready to supply the market under a traditional approval.
The other thing is there’s been a lot of advocacy interest in this, and they’re a very vocal community, and they’re getting increasingly organized to be a voice at the table. And when you hear some of the stories… One notable story in the media is around a brother of a boy that’s in our study. To tell that parent that we can only supply… They would accept just if we had one extra patient that we could supply. That would make a world of difference.
So I think around the distraction and confusion, I think all of that can be managed with the right communication, the right setting expectations, being transparent with the FDA, with the community, with physicians. And when you see those things go wrong, it’s usually because there’s a lack of transparency or understanding of what’s causing the delay.
And I think we’d like this to be not just our problem, but the community’s problem. We’re open to getting as much help as we can to solve this problem. We think about it every day. We have consultants who help us with this. Anybody that I can bend their ear, on can they think of a better way. One of my board members says, hey, let’s look at this as a Manhattan Project.
If you think about the early days of biologics, there wasn’t a lot of knowhow. The yields weren’t that great. And over time, you had capacity increase, and cost of goods came down, and process improvements. We saw that happen year over year. And here we are with, we believe, a cutting-edge technology, with a novel chemistry that could be transformational in terms of its impact on medicine. And we’re at the early stages.
So this is the first one. We’re excited about it. We’re doing everything we can to do it the right way. But over the longer term I think this will all be worked out and we’re going to have plenty of capacity. And just think about it from a CMO standpoint. This is almost a guaranteed sale. If they can just figure out how to produce more of the drug, we’re going to be a buyer.
And then one question, before we get to a more long-term view of the company, any updated thoughts on when we could see the 62-week data?
I provided guidance on the last earnings call that we would be working with our CRO on the transfer of that data. We would analyze it, and we would determine the right venue to present that data. And so that is still the guidance on that. We’re not guiding more specifically than that.
We know there’s a lot of interest in the follow up data, but one thing that I think is important is that we really need to focus on our communication with the FDA. We need to translate the data set that we’ve produced to date. We have a 48-week data set that’s very robust, that was predefined as the primary endpoint in our study. And the time point that we have right now, that has both dystrophin production and six-minute walk data. We’re not going to have that again, moving forward on this study.
And so what we are going to try to avoid is, I’m sure a lot of investors would love us to just transfer our data set to them so they can do 50 different analyses on the data. That doesn’t necessarily help us on this program, in our communication with the FDA. And so we’re trying to minimize the distraction of our communication with the FDA. They read blogs. They read news reports. They’re not in a vacuum. And so we know every piece of data interpretation could impact and influence our dialog with the FDA. And we don’t want to compromise that.
Our job is in drug development, to get this drug on a fast track and try to get it approved as quickly as possible. And so although there’s a lot of investor interest in this, I think we will communicate what we feel is necessary to convey material information to the market. But really, we’re not obligated to provide much beyond that.
So could the FDA see it before Wall Street sees it? Or would you have to send it out [unintelligible] materials?
Well, the FDA, we always provide proprietary information to the FDA. Even meeting minutes are not public, per se. And we have to characterize and communicate things as best we know how that reflect what that information is saying. We have a full data set. This is probably the most robust set of data that I could even imagine from any 12-patient study. Obviously there’s a lot of data we have in house, but my job and the company’s job is to convey the information that reflects the totality of that data set. And that’s what we try to do.
We only have a few minutes, so I know there’s a lot of focus on accelerated approval, but if you’re an investor that says, you know, this is a good opportunity to get into the name, but I’m going to take a longer-term view. Say you don’t get accelerated approval, say it doesn’t really matter, because ultimately you could have a drug on the market that’s meaningful. Help me understand ways to value your base business and your technology, and timelines for when you think investors will get more comfortable that this is not just a [D&E] product.
First thing I’d say is that we have a lot of partnership interest as well. So while I think that we have FDA communication coming up, and accelerated approval, there also is the idea that we could potentially see a partner come through that could accelerate our program across the DMD pipeline.
An ex-U.S. partner?
An ex-U.S. partner, which could allow us to maintain a cash flow generating business ourselves, but would really be a big catalyst for the company to accelerate the broader program. So we are excited about the broader DMD program. The three collaborations we currently have on exon 53 now, it was announced this past week on exon 45 and exon 50, if you look at eteplirsen in the U.S., those three drugs alone are 3.5x the market opportunity when you take into account we have freedom to operate in Europe on those compounds and the U.S. market opportunity.
And those are all moving toward the preclinical data and getting ready for clinical that we’ve communicated would be filed in 2014 and could enter the clinic by the end of 2014. So that’s not an insignificant market opportunity, just in the DMD pipeline alone. And that does not account for the idea of a class approval where we could, again, more than double that opportunity upon class approval.
So that’s one. The technology, we believe the proof of concept is there now. We had great data on our infectious disease program against Marburg, with the delayed time to treat, in July, that shows with a novel chemistry, PMO-plus, that we have really unprecedented antiviral activity against the most lethal hemorrhagic viruses known to man.
So I think we’re very encouraged by that from proof of concept, and the DMD data, where we’re not only focused on translation suppression, as we are in the infectious disease programs, and where the RNA space has been historically over the last few decades, but really we can display switching now. We can turn on protein translation, as we’re doing with DMD.
When you take into account not only translation suppression but RNA modulation, splice switching, directed alternative splicing, where we can really apply this across a number of diseases where we understand the genetic basis of that disease. Obviously monogenic diseases are easier to target, like Duchenne. And this isn’t relegated only to rare genetic diseases. When we know that there’s a gene target that needs to be modulated - turned off or modulated some other way - we think we have a technology that’s very differentiated in the broader RNA space.
And so we’re already thinking about - and we’ve done some proprietary work internally we’ve not disclosed on - where are those next proprietary programs? Where can we provide the best proof of concept to establish partnerships across other therapeutic areas? And so I think in 2013 you’ll see a renewed focus on leveraging the technology platform to generate business development.
I think what this company’s been lacking for many years was that really compelling proof of concept. RNA, there’s been a lot of skepticism around this space, and there’s been a lot of failures, and a lot of trials and tribulations along the way. And I think at least our technology, now, has turned a corner, we believe, and has started to gain the attention that we needed to see to get the type of interest from pharma and big biotech partners that we’ve been looking for.
Your partner has more [unintelligible] compared to you with use of their drug. Is it the technology, or do you think there’s any risk when you go after different targets? You’re going to have different safety profiles.
No, I think it’s related to to backbone chemistry. And they have a very different backbone chemistry. Mipomersen just went to panel, and there was a lot of discussion around the side effect profile, even mutagenicity. And a lot of the same type of off-target effects we’re seeing with this type of backbone chemistry and similar to what our competitor has seen in their trials. Our current morpholino backbone that we’re using for DMD, again, we have a very favorable safety profile, including lab abnormalities that we haven’t seen signals of toxicity to date. And so we think we’re very differentiated.
Just like its backbone for DMD versus the other phosphorothioate chemistries, when we conjugate our morpholino, we see a different profile. And we know that from the first peptide that we brought into animals, we saw some renal toxicity. Well, we’ve focused all of our efforts internally on modifications that retain a good safety profile and a good therapeutic window.
And we think that we have a strong hold on the morpholino space with our PMO plus patents, which are positively charged [unintelligible] attached to our neutrally charged backbone, as well as we’ve done a lot of work on the peptide conjugated morpholinos, beyond what has been published internally and filed patents on that. And then what we call PMO X is a patent estate around all the modifications that are non-peptide that we can make to this chemistry.
So we think the future is bright for morpholinos, and we’ve focused a lot of our efforts on shoring up the IP estate around that, and figuring out what’s the best application from a disease standpoint.
And lastly, just because you have IP doesn’t mean you don’t infringe someone else’s IP. What are your thoughts on IP and freedom to operate in the U.S.?
We are very confident with our freedom to operate in the U.S. and in Europe, with the exception of the European patent opposition that came down last November, where we did not prevail on claims around exon 51 and exon 46. So that’s unfortunate. That was on our lead program, eteplirsen. But again, we understand the competitive landscape, and I think we need to convey that to a lot of people out there as well who have patents around certain sequences and claim that they have freedom to operate.
And we believe a lot of the real estate DMD was carved up many years ago around the sequences, and there were several groups that were doing microwalks along the genome. And there’s a very distinct set of sequences that these groups have, and we’ve licensed ours from the University of Western Australia, and we feel very confident in our freedom to operate based on that patent estate.
I know a lot of the original MS drugs were forced to license their patent, because their drug wasn’t on the market first. If you get to market first, can they be forced, even if they were deemed to cover your area, to grant a license?
It’s hard to comment on that. We know that this is a high unmet medical need. We know the advocacy voice is very strong, and we know that there’s a lot of interest in our product in particular. I hope it would not come down to that. I think there are other ways to make sure that we can get eteplirsen on the market in Europe, and we’re going to continue to explore, including an appeal of the patent ruling, which is still something that we could pursue and prevail on.
Thank you very much.
Thank you, Robyn.
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