Acorda Therapeutics, Inc.
Q3 2017 Earnings Call Transcript

Published: 31 Oct 2017

[Operator:]

Welcome to the Acorda Therapeutics Third Quarter 2017 Update. At this time all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being taped at the company's request. I will now introduce your host for today's call, Felicia Vonella, Executive Director of Investor Relations at Acorda. Please go ahead.

[Felicia Vonella:]

Thank you. Before we begin, let me remind you that this presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that can cause actual results to differ materially. For more information on these and other risks, please refer to our filings with the SEC. I will now go ahead and pass the call over to Ron.

[Ron Cohen:]

Thanks, Felicia. Good morning, everyone. We reported AMPYRA net sales of $133 million for the third quarter of 2017; that is an increase of 3% over $120 million that we reported in the same quarter of 2016. We are reiterating our AMPYRA 2017 revenue guidance of $535 million to $545 million. AMPYRA's prescription growth has been in line with our expectations year-to-date in the low single-digits. The difference in consensus between our actual and consensus today were due to somewhat lower inventory levels and also some increases to our discounts and allowances. We are vigorously pursuing our appeal of the U.S. District Court decision that overturned four of our AMPYRA patents. We file our opening brief with the Federal Circuit Court of Appeals and the defendants have filed their opposing and cross appeal brief. We expect reply briefs to be filed this month November, I am sorry, this coming month, November 2017 followed by an oral argument which we believe most likely would be scheduled for early 2018. Both PhRMA and BIO have submitted amicus briefs in support of Acorda's appeal. This reflects the fact that our appeal raises issues going to the height of the patent systems incentive to innovate and are critically important to biopharmaceutical innovation in particular. We look forward to the opportunity to be heard by the appellate court. Moving to our late stage pipeline, in August we received a Refusal to File letter from the FDA regarding our NDA for INBRIJA. The letter specified two reasons for the RTF and also requested additional information that was not the basis for the RTF but which FDA indicated would have been raised as review questions in the ordinary review process. We've since had constructive dialogue with the FDA determined that we could resubmit the NDA without requesting a Type A meeting. We've taken time to strengthen the NDA with additional information that the FDA requested and we believe we have a strong package for a resubmission in the current quarter. Based on current guidelines we would expect the FDA to notify us within 74 days of the submission date regarding whether the submission has been deemed complete and accepted for full review. Our commercial preparations for the launch for INBRIJA continue. We are also in discussions with potential partners regarding INBRIJA outside the U.S. given our team's focus on the NDA submission or resubmission, we are revising the timing for our submission for the MAA or Marketing Authorization Application to the European Medicines Agency to the first quarter of 2018. We don't anticipate that that change in timeline will impact our ongoing partnering discussions or expectations for INBRIJA outside the U.S. and we remain confident in INBRIJA's promise as an important new therapy for people with off periods related to Parkinson's disease. We see tremendous long-term value in the solid clinical profile, strong IP, and what we believe is a more than $500 million peak net sales opportunity in the U.S. alone. Tozadenant is an oral adenosine A2A antagonist. It represents a potential first in class treatment for chronic maintenance therapy of Parkinson's Disease in the U.S. In a Phase 2b trial tozadenant reduced average daily off time by more than an hour relative to placebo and that was even in people already being treated with several other concurrent maintenance medications. We expect results from the pivotal Phase 3 trial in the first quarter of 2018 and as part of the Phase 3 program we also have initiated an open label long-term safety study in the second quarter of 2017. Toz would be complimentary to INBRIJA and if it's approved it represents a potential commercial opportunity in the U.S. that's greater than that of INBRIJA. Dave will now review select financials for the quarter.

[David Lawrence:]

Thanks Ron and good morning everyone. I want to take a minute to comment on a few key items of note in our third quarter 2017 financial results. This morning we announced a reduction to our 2017 SG&A expense guidance from 170 million to 180 million down to 160 million to 170 million. This reduction is related to a combination of operating efficiencies and a change in timing of certain expenses that will not be incurred in 2017. The asset impairment charge we took in the third quarter is a non-cash book adjustment to the carrying value of an intangible asset Selincro which was acquired as part of the Biotie acquisition. This impairment charge is a book adjustment only and has no impact on our operations or on our cash balance. We ended the quarter in a strong cash position with cash and equivalents of over $192 million. We continue to project our 2017 year-end cash balance to be in excess of 200 million. I will now turn the call back over to Ron.

[Ron Cohen:]

Thanks Dave. We are focused on three key priorities during the rest of this year and into 2018. First advancing our late stage Parkinson's programs INBRIJA and Tozadenant toward approval and commercialization. Second, maximizing the value of AMPYRA which includes our vigorous prosecution of the appeal in the federal circuit. And third, generating value through business development initiatives including monetization of existing royalty streams for AMPYRA and Selincro and exploring partnering and out licensing opportunities across our pipeline. We will now take your questions. Operator.

[Operator:]

[Operator Instructions]. And your first question comes from the Phil Nadeau with Cowen and Company. Your line is open.

[Phil Nadeau:]

Good morning, thanks for taking my questions. Ron a couple on the Refusal to File letter, I guess first, could you give us some more details about exactly what were those issues that caused the FDA to issue the Refusal to File?

[Ron Cohen:]

Yeah Phil, I think we had put that out in the original press release with respect to what the issues where. The first one had to do with the date when the manufacturing site would be ready for inspection and the second one was regarding the way in which the drug master production records were submitted and their desire for something a bit different than what we submitted.

[Phil Nadeau:]

So I guess I'm kind of asking on the second one was it simply formatting for the drug master file or is there missing information or questions about the actual content?

[Ron Cohen:]

You know we are not going into tremendous detail. It was -- let me put it this way, it was additional information that they wanted which we have and are putting in the resubmission. And we're highly confident that we have what they want.

[Phil Nadeau:]

And then secondly on the issues that didn't lead to the refuse to file but would have been reviewed questions later, can you give us some sense of what those topics concerned?

[Ron Cohen:]

No, because we have not gone into tremendous detail. These are review questions as the agency indicated. Some of that, I mean I will tell you some of them were of what we would call a technical nature, some of them were actual requests for questions about certain things. And there again we're confident that we can respond adequately to their questions.

[Phil Nadeau:]

Got it, okay, and then just last question on this, is the date when the manufacturing [ph] is ready for inspection. Was it simply they were looking for a date or was there something lost in translation between the quarter-end and the FDA in that question, it seems like almost a silly reason to give a refuse to file?

[Ron Cohen:]

Well I'm not going to characterize the reason. I guess what I'll say is that that was an extremely simple item to fix.

[Phil Nadeau:]

Got it, okay. And then just last question for me on AMPYRA, you gave two reasons for the different sources consensus, inventory destocking, and a change in discounts or allowances. Can you give us some sense of the impact of those two on the quarter?

[Ron Cohen:]

You now maybe the best thing I can do is point out that if you look let's say at one week of inventory across the Board that's worth about $10 million in net sales right there. So if you had a one week contraction in inventory across the spectrum that would be 10 million right there. So that gives you a sense of what the titles are. So between the contraction that we actually did see and it wasn't universal, there were certain pockets that were more than others and for various reasons who contracted their inventory across the year, so if you combine that with the adjustments in D&A that we saw it's pretty easy to get to the shortfall that is relative to consensus that we saw. Now having said that the fourth quarter is typically our biggest quarter for a number of reasons not least of which is that toward the end of the quarter we see that patients tend to take an extra prescription because they're heading into the New Year and they're going to reset the clock on their deductibles and their donut hole and so on. So you tend to see people kind of waking up and going oh my gosh, I had to get another prescription, it is the end of the year. You also see the pharmacies, similar looking ahead and saying well you know, there may be a price increase that's kind of typical, let's get ahead of it and get more orders in. So typically we see more orders in the fourth quarter and for that reason based on the best we can project we're still looking at our original range and maintaining our guidance on the original range even though we have had a shortfall because of the reasons that we pointed out.

[Phil Nadeau:]

Great, thanks for taking my questions.

[Operator:]

Your next question comes from the line of Tom Shrader with Stifel, your line is open.

[Thomas Shrader:]

Good morning, congratulations on another good quarter. I wanted to ask a question about the amicus briefs that I think is big enough that you can answer it. But these are huge issues and they seem compelling, if the courts were to take up this issue is that good for you or bad for you given that you have lost the previous round does this freeze your case or just what would happen if one of these cases were taken up? And then along these lines is this new work by BIO and PhRMA or have they filed these issues multiple times, just your thoughts on what's going on here and how different things would affect you, thanks?

[Ron Cohen:]

Okay, so you know Tom when you say if the courts take it up I'm not quite sure we are going with that because at least in this case where the court will consider it because it's part of our appeal. So it's -- we'll have an oral argument and the appellate court which will be a panel of three appellate judges will be reviewing all the arguments on both sides as they normally do and then coming to a verdict on that. Obviously we're aiming to get a verdict in our favor which is that even if they overturn the district court verdict or they remanded back to the district court for further consideration. What we're not aiming for obviously is that they uphold the verdict. With respect to the violent PhRMA briefs I'm not aware that they have filed anything like this before. It's specific to the issues that have arisen in our view because of the district court's verdict in which, well I mean you could read the brief. I don't want to characterize it, I am not being a lawyer. But the issues that are raised there go beyond our case alone. They actually go into the way in which patents and innovation, excuse me, patents are used to incentivize innovation and then how people can get patents to reward their innovation and incentivize them to commercialize it. So those issues are closely tied up in there again transcending just Acorda's case but going to the heart of these types of issues across the spectrum. Meaning all biopharmaceutical companies would have an interest in the outcome of that appeal.

[Thomas Shrader:]

Would your case wait on that appeal or does that -- would it just be totally independent?

[Ron Cohen:]

The amicus briefs are specific to our appeal. So BIO and PhRMA have not -- they didn't file in a vacuum. They didn't file on their own, they're actually filing specifically in support of our arguments on appeal. But that's what they are doing. And so they're putting in their own briefs essentially saying we're agreeing with Acorda's case here and arguments with respect to these issues and let -- we will fill it out in our own way and give you our arguments from the biotech industry's point of view and from the pharmaceutical industry's point of view.

[Thomas Shrader:]

Okay, okay, that's helpful but it is still a little complex but thank you.

[Operator:]

Your next question comes from the line of Cory Kasimov with J.P. Morgan. Your line in open.

[Cory Kasimov:]

Hey, good morning Ron. Thanks for taking the questions. I had two; one clinical one and then one follow up on the AMPYRA litigation. So first the clinical side with the Phase 3 Toz data in the relative near-term, can you talk about what your mind is key to demonstrate here from a I guess both a clinical meaningfulness standpoint but also strategically best to line the product with INBRIJA assuming that both ultimately make it to market and then I have the follow-up?

[Ron Cohen:]

Yes, so with respect to INBRIJA we see it as completely complimentary. That's one of the most attractive things about the way we use business development to build that portfolio assuming it works obviously because you would then have two products in the bag for the sales force where you go and you provide a range of solutions that complement each other. In one case you're providing -- in the case of Toz a novel mechanism, a new maintenance therapy that provides significant reductions in off time even in people who are already taking multiple maintenance medications and are still having issues which is very frequent as you know in Parkinson's disease. So that in itself is attractive, then you have INBRIJA which for people who still have off periods no matter what you do, you reduce the on off periods but they still have some off period now you have the ability to give them an on demand as it were, when they're going into an off period, when they're in an off period they have the ability to take that to supplement their daily maintenance therapy and hopefully get out of the off period quickly and then move on with their day. So those are complementary. With respect to Toz you know typically in the field the benchmark is around an hour of additional placebo adjusted off time reduction. That's typically the benchmark. Now is 0.9 hours acceptable, yeah probably but you know it's about an hour and that's typically what you see for most of the daily maintenance drugs that are out there in their clinical trials. To the extent that you are above an hour and remember that's an average right, so that means some people are getting an hour and a half, some people are getting two hours, some people are getting a half hour but that's an average. To the extent that you are above an hour the more you are above an hour the better off you are. So that if you're at let's say 1.3 hours or above, now you're talking about a message that will distinguish not just by mechanism but by actual outcome in the clinical trials. And that would be great if you saw that. Now what we saw in the phase 2b for 120 milligram dose was 1.1 hours of placebo adjusted reduction in off time. And we'll see what we see in a larger trial.

[Cory Kasimov:]

Okay, that's helpful and then quickly lets follow up on the next steps with AMPYRA litigation. I'm just curious is there a precedence or how long would you expect it to take for a verdict to be reached post the oral arguments?

[Ron Cohen:]

And my understanding is we don't know because it entirely depends on the court's docket at the time, how much they delved into the case, how much time they want to devote to reading the briefs and deliberating and all that. So it really is a mixed bag. Typically you would be thinking about months after but whether it's three months or six months or eight months we don't know.

[Cory Kasimov:]

Okay, great. Thanks for taking the questions.

[Operator:]

Your next question comes from the line of Paul Matteis with Leerink. Your line is open.

[Paul Matteis:]

Hey, thanks so much. Appreciate you taking my questions, I have a few. The first one Ron, I just wanted to clarify something about AMPYRA guidance, the fourth quarter is usually the best quarter as you said but we were looking back at it and the last couple years the year-over-year quarterly growth was 11% and 8%. To hit the bottom end of the guidance this year it's around 20%, so can you just comment are there any specific kind of onetime items you're expecting this quarter that you think are going to be a tailwind that will let you meet your guidance and then I have a couple quick follow ups, thanks?

[Ron Cohen:]

Yeah so, that is accurate. Your characterization is accurate. Our view is that there will be increased demand this year in the fourth quarter for various reasons. IF you think about it the inventory contractions that we saw, our inventory management historically was pretty tight anyway, it averaged about two weeks, it contracted below that in several places over the course of the year-to-date. And there were various reasons for that we believe and we believe that those reasons -- that based on those reasons we expect to see them make up for it in essence this quarter. So we do expect more than one normally would as a bounce back from that inventory contraction. Now again projections are what they are, that's the best projection we have based on all of our analysis to date. And we'll see if we're correct. But based on the analysis of those data and those trends we still believe that we can hit the range.

[Paul Matteis:]

Okay, thanks for the clarification and then just second on the write down of the Selincro royalty, why did you decide to write down the value of that now and does that have anything to do or correspond with ongoing discussions surrounding monetizing it? And then just lastly on CVT-301 I was wondering if you can comment on your expectations regarding whether or not there's going to be an FDA Advisory Committee? Thanks so much Ron.

[Ron Cohen:]

Okay, I'm going to let Dave take your question on the adjustment and then I'll come back on the other one.

[David Lawrence:]

Yeah, so when we looked at the asset we take a bunch of assumptions and do a revaluation of it. So the reassess market valuations that drive it based on the licensors plans for the asset. As you know we generate royalties on what they sell. The last we looked at it and their future plans changed and the market conditions and some other factors, we just decided it was the right time to take the write down.

[Ron Cohen:]

Yeah, and any other conversation than that, we can't comment on ongoing partnering or excuse me licensing discussions obviously. I mean we are in the middle of those discussions now. With respect to an ad com, I get asked that a fair amount. We have had -- this goes under the heading of absence of evidence is not evidence of absence. We've had zero indication in all of our conversations and correspondence with the agency that there would be an ad com. On the other hand they wouldn't -- it wouldn’t necessarily have come up based on where we are in the process. So it's really pure speculation on our part at this point. I will tell you based on what we know of the history of ad coms and when people -- when the FDA has ad coms we're not sure we see why there would be an ad com but having said that it's the FDAs prerogative and it's very hard to speculate on that.

[Paul Matteis:]

Fair enough, alright, thanks so much.

[Operator:]

Your next question comes from the line of Michael Yee with Jeffries. Your line is open.

[Michael Yee:]

Hey, good morning Ron, couple questions. On the partnership comments can you maybe talk a little bit about what type of partnership or broadly would it consider both INBRIJA plus the potential for Toz and if that's the case, if people are interested in that do you need to wait for the data, maybe just talk a little bit about the scenario trees with the potential partnership and how that might play out? And then as it relates to the INBRIJA developments next steps, have you actually had the Type B meeting, I guess you said it was Type A but maybe I am assuming it is Type B, I wish you had that meeting and walked through everything and therefore that's why you're confident you can file by the end of the quarter, maybe just talk a little bit about that as well? Thanks so much.

[Ron Cohen:]

Great Mike. Let me take the second question first. We have not had a Type A or Type B or Type C. We have been in dialogue with the division and based on that dialogue with the division where we determined that we did not need a Type A or Type B meeting and we did not need to take that time to get that scheduled and move the time lines back as a result because the communications were we believe clear and specific and gave us the guidance we needed with respect to what we need to put in the resubmission. So no formal meeting of those -- no Type meeting. So, that is one. So with respect to partnering scenario, that's harder to talk to. I would say that at this point we are engaging in discussions to get a sense of in essence the lay of the land primarily for well, for ex-U.S. Our intention is to keep -- in fact is to keep North America and so this would be ex-North America commercialization where at this point it would be much more difficult or challenging for us to try to go in alone in ex-North American territories. Now a deal could take many forms obviously and it could leave flexibility so that ultimately we could potentially have a piece of that and get into some of the more attractive markets like in the E.U. But we are not frozen in a rigid framework. We're exploring interest and a variety of frameworks so it's all in the exploratory phase of discussion. With respect to Toz I'm speculating here but I think it's safe to say that we're so close to the data relatively speaking that you could envision coming to terms in principle but then needing to actually have the data in order to finalize an agreement based on that.

[Michael Yee:]

Okay, thanks.

[Operator:]

Your next question comes from the line of Laura Chico with Raymond James. Your line is open.

[Laura Chico:]

Good morning and thanks for taking my question. I've got two; first, on INBRIJA and MAA that you are filing in the first quarter in 2018, I'm just wondering if you could elaborate a little bit here, was this really driven by partnering discussions or was this also perhaps after interactions with regulators, just a little clarity there? And also if you could help us frame perhaps ex-U.S. revenue expectations, I know you've been pretty clear about what you expect in the U.S. but kind of helping us understand what is the broader opportunity outside the U.S.?

[Ron Cohen:]

Okay, so if I'm understanding your question correctly and correct me if I am not, the move of the timeline by a quarter from fourth quarter to first quarter 2018 for the MAA submission has been driven entirely by the need to focus on the NDA resubmission here and the fact that we just need the resources on that and then we couldn't have the resources on both at the same time. So that's what's driving that. It's not being driven by anything new with respect to conversations with the EMA or anything of the kind. We have had those discussions and nothing has changed there. So that's not influencing it at all. With respect to the ex-U.S. markets, we have not commented on that yet because we ourselves have more work to go there and frankly we believe we will learn a lot in the ongoing conversations with potential ex-U.S. partners who live in those markets and know those markets really well and are providing very useful information that we add to our own projections. So we don't have projections ready to be publicized yet.

[Laura Chico:]

Okay, that's helpful and if I could just ask one quick follow-up, I think in previous years you've provided forward guidance for the company in January. I guess should we expect this to continue this year and perhaps if you could offer any color directionally at least in terms of how the operating expenses might move?

[Ron Cohen:]

Okay, well, so the best I can tell you is what we said earlier which is what I call the marquee piece of information at least from our perspective is what does the balance sheet look like at the end of next year. And under our scenario, under our current projections it's over 200 million exclusive of any of the monetizing activities we've been talking about. So just based on ordinary operations that -- and sales we believe we will have over 200 million at the end of next year. And that is assuming we don't win the appeal. So that assumes that AMPYRA goes generic in August 2018. So if we do win the appeal or it's remanded and there's a delay then that changes quite significantly on the upside. I think that's pretty much it.

[Laura Chico:]

Thank you.

[Operator:]

Your next question comes from the line of Ken Trbovich with Janney. Your line is open.

[Ken Trbovich:]

Thanks for taking the question. Ron, I was wondering if you could maybe address the issue on expectations for EMA and sort of the path there from a regulatory review timeline perspective. It just seems you just did a lot of noise associated with Brexit and the potential that that moving of the headquarters could delay review of applications, can you give us a sense as to whether or not that's a concern as you proceed with the efforts out license ex-U.S.?

[Ron Cohen:]

Yeah, we are following that Ken as you are and it's a developing story. I would say that it's fair to say that at this point I'm not aware that anyone in the industry has fully gotten their hands around it because the information just isn't there. So much of it is influx. So I'd have to say it is a potential concern that depending on how things go over there, there could be widespread delays in their process. I believe that -- I mean the MAA leadership is clearly aware of that -- not MAA, sorry the EMA leadership is clearly aware of that and they're doing their best to make sure that they have ongoing operations without disruption. It's a month-by-month thing at this point. All we can do is control what we control which is to submit the MAA on schedule and then hope that they prosecute it according to the usual timelines.

[Ken Trbovich:]

Sure, thanks and just one quick follow-up on the outlook for 2018, should we be factoring in channel inventory contraction in the first half from the channel just in light of the July date for the AMPYRA litigation?

[Ron Cohen:]

Yeah, so 2018 obviously is going to be an unusual year because of the litigation and the prospect of losing exclusivity at the end of July. That really is going to change a lot of the dynamics for next year so I don't have at this point anything specific to tell you about that. I can tell you that as a result of all of those variables that are coming up in 2018, the internal projections that we have made are based on what we believe to be the most conservative possible projections. So our belief is that if anything were to change it would be more likely that it would be on the up side and not based on the way we've done our projections. So that is the best we can do at this point because it's going to be an unusual year with respect to inventories and with respect to sales and with respect to everything, right, just because of that uncertainty that is looming the end of July.

[Ken Trbovich:]

Thanks, that makes sense. I appreciate it.

[Operator:]

Your next question comes from the line of Salveen Richter with Goldman Sachs. Your line is open.

[Salveen Richter:]

Thanks for taking my questions, can you quantify the impact to AMPYRA inventory levels in 3Q, is it one week or more and will these increases to discounts in allowances carry forward into 4Q? And then as it relates to the upcoming Toz Phase 3 results maybe you could just comment here how your molecule is differentiated from the prior A2A receptor antagonist studies that failed in pivotal trials and what gives you confidence here in your program?

[Ron Cohen:]

Well that's a lot Salveen in one bite. Let's see. Let me start with the AMPYRA inventory. What can I say about that that we haven't already said, it is our view that the inventory issues will bounce back in the fourth quarter. The contractions that we saw will be made up for in the fourth quarter, that is our view. The reference that we gave was just to illustrate what a week let's say of inventory means. A week of inventory means $10 million approximately. So that is just to give you a reference point for how much of a toddle do we need to make up the numbers. The second piece on D&A, there were some unusual items this year that we don't expect them to carry over into the fourth quarter. Now the second question I think you had was on Tozadenant, yeah we had discussed this. It's obviously a different molecule but it is the same mechanism. You may -- I think you were referring to Preladenant and frankly the other molecule that is out there is istradefylline which is HKN's [ph] drug which they've recently announced that they are going to submit an NDA for. They have it approved in Japan. I think if you look at the track record it is not a track record of relentless failure, it is a mixed track record. There have been trials across all these drugs that have been successful and there have been other trials that have not been successful. And in fact for istradefylline, those were successful enough in Japan that they got it approved in Japan. And now apparently based on talking to the FDA they're going to submit an NDA here. The Preladenant trial with Merck was the subject of an extensive post-mortem review in JAMA that the authors and the clinical investigators put together. We found it persuasive. Their conclusion was that the molecule was active and that the conduct of the trial had certain very serious flaws. And I won't go into all of the detail now. You can read the paper and we're happy to send it to you. But that was persuasive and we were impressed that the Biotie team and their advisors put together a trial that took into account all of those findings from the Preladenant study and build in features into the trial design and management and oversight of the trial to address those issues. Now how successful will that be, we will find out in the first quarter but I will say that if you just look at the tozadenant Phase 2b data it is a compelling data set and I don't think there's any way around that. You've got four different dose arms versus placebo, there is clear evidence of a dose effect, and essentially all of the outcome measures worked on a placebo adjusted basis. So, plus you had 1.1 hours of placebo adjusted reduction in off time at the 120 milligram dose which is the best that by a good margin, that's the best that's been reported for any of the drugs in this class. So put it all together we think it is a very strong profile for a Phase 3 product and we will obviously in a few months we'll find out exactly how it turns out.

[Salveen Richter:]

Thanks Ron and then if I could just follow for INBRIJA given the device component, should we expect a deviation from a normal FDA review cycle?

[Ron Cohen:]

I wouldn't expect it. We're expecting a 10 month review cycle.

[Salveen Richter:]

Thank you.

[Operator:]

[Operator Instructions]. Your next question comes from the line of Bill Tanner with Cantor Fitzgerald. Your line is open.

[William Tanner:]

Thanks for taking the questions. Ron I had a few maybe I will just do them sequentially so I don't dump them all on you. As it relates to the AMPYRA appeal you talked about potentially being overturned, being remanded just to be clear if it goes against Acorda, have you exhausted all of the opportunities?

[Ron Cohen:]

Alright, theoretically you could take it to the Supreme Court or I don't know if you could ask for an on bank, you could probably ask for an on bank review which would be the entire appellate court not just the three judges. So we could -- those are available, those are available routes. So I think first typically people ask for an on bank and then if they lose the on bank then they have the option of petitioning the Supreme Court if it's an important enough case.

[William Tanner:]

Got it, okay and then as it relates to 301 OUS I mean it sounds, is it fair to characterize that the company is in very early stages of engaging potential partners and I'm just curious then if that's the case and I'm assuming that the RTF is not -- has not really been a gating factor, I mean clearly any sophisticated company could be looking at the data and what not…?

[Ron Cohen:]

Correct, it has not been gating, yeah it has not been gating whatsoever.

[William Tanner:]

Okay, and then I guess a convention would be for potentially a partner maybe to want to file the regulatory application when you talk about a MAA in the first quarter, I guess that's presupposing that Acorda would likely file, it seems like it would be a stretch maybe to have something done by then such that a partner can actually do the filing?

[Ron Cohen:]

Yeah, again I'm speculating here, if conversations got to a point where they were really serious and you had a serious partner who said hey, we want to do this. Obviously we would have to take that into account and we'd come back and tell everyone. But that's speculating at this point. So we're pursuing parallel tracks. On the one hand we have to move forward as a company regardless of whether or not we might have a partnership. And that means we need to prepare to file an MAA in a timely way. If partnership discussions advanced to a point where they look real and attractive for the company then obviously we would take that into account.

[William Tanner:]

Yes and then I guess final question, so you'll see the Toz data in the first quarter, could you just remind us then assuming that the data are good what lies along sort of the critical path thereafter?

[Ron Cohen:]

So we started an open label and safety study in the second quarter and we need to accumulate sufficient safety experience and data from that. So that is going to require some time. At the moment I don't have it in my head though so I'll need to get that for you in terms of what we've said publicly on that. But that's going to be obviously the Phase 3 if it's successful is not the gating factor because we still have -- it's at least a year as far as I know. It is at least a year to accumulate the experience that we need there.

[William Tanner:]

So it is just more ICH guideline related stuff?

[Ron Cohen:]

Correct.

[William Tanner:]

Okay, alright, it's good. Thank you very much.

[Operator:]

There are no further questions and this concludes today's conference call. You may now disconnect.