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Executives

Tierney Saccavino - Vice President of Corporate Communications

Ron Cohen, M.D. - Founder, Chairman, Chief Executive Officer

David Lawrence, M.B.A. - Chief Financial Officer and Principal Accounting Officer

Andrew R. Blight, Ph.D. - Chief Scientific Officer

Analysts

Matt Roden - J.P. Morgan

Joel Sendek - Lazard Capital Markets

Lawrence Neibor - Robert W. Baird & Co.

Philip Nadeau - Cowen & Co.

William Ho - Banc of America Securities

Acorda Therapeutics, Inc. (ACOR) Q3 2008 Earnings Call November 4, 2008 8:30 AM ET

Operator

Welcome to Acorda Therapeutics third quarter 2008 financial results conference call. (Operator Instructions). Now, I would like to introduce your host for today's call, Tierney Saccavino, Vice President, Corporate Communications, at Acorda Therapeutics.

Tierney Saccavino

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 could cause actual results to differ materially including delays in obtaining or failure to obtain FDA approval of Fampridine-SR, the risk of unfavorable results from future studies of Fampridine-SR, Acorda Therapeutics' ability to successfully market and sell Fampridine-SR, if approved, and Zanaflex capsules, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics' operations, and unfavorable results from its preclinical programs.

These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statement as a result of developments occurring after the date of this presentation.

I will now turn the call over to our CEO, Ron Cohen.

Ron Cohen

Welcome everyone. This morning, we reported our third quarter ’08 financial results. During the quarter, we made significant progress on the key initiatives that will drive a quarter’s growth, most notably on Fampridine-SR regulatory activities in both US and Europe. I’m going to give you an update on these initiatives, and them I’m going to turn the call over to Dave, who will provide you with the financial summary, and then we’ll open the call for questions.

We were pleased that the data from our second phase III clinical trial, the MS-F204 study were accepted as a late breaker at the World MS Congress in September in Montreal. Among the new analyses that were presented, the poster highlighted that the walking response rate for Fampridine-SR treated patients was higher than placebo across all MS subtypes and the walking response rates were similar between study participants who were being treated with immunomodulators as well and those who were not.

The poster presentation attracted a large audience. We brought more than 300 reprints to the meeting, they were gone within the first hour, and Dr. Andrew Goodman, our principal investigator at the University of Rochester who presented the data had a crowd around him throughout the session.

We also premiered a new exhibit booth at the conference. Its goal was to educate healthcare professionals about the pathophysiology of demyelination in MS and how that contributes to walking disability. I’m pleased to report that our booth was the most crowded and popular stop on the exhibit floor throughout the conference. Over 1600 people registered at the booth to receive additional educational materials and many many hundreds more visited the booth. The booth registrants alone represented about a third of the healthcare professionals at the conference. I invite you all to visit the website that is associated with this effort, www.msmobility.org, and that will give you a better sense of some of our pre-launch awareness building and education activities.

Seperately, data from our MS-F202 phase II trial was published in the October edition of Neurology, and we’re currently working with our scientific advisors to publish the phase III data in peer-reviewed journals.

Moving on to our regulatory update, we’re on track to file the NDA in the US in the first quarter of 2009. Given the current staffing pressures under which the FDA has been forced to operate, we are evaluating whether or not it would also be advantageous to request priority review, which would be requested at the time of NDA filing if we decide that it is advantageous.

With respect to Europe, the potential market for Fampridine-SR in the EU is sizable. There are approximately 630,000 people diagnosed with MS in Europe according to the Atlas of MS, and that is collaboration between the World Health Organization and the Multiple Sclerosis International Federation, and this represents the highest estimated incidence rate of MS of any geographic region.

As we noted in this morning’s press release, Acorda conducted scientific advice meetings with regulatory authorities in 4 key EU member states to discuss the Fampridine-SR clinical program. The discussion topics included the acceptability of the outcome measures used in our phase III clinical studies and the adequacy of the program to support submission of a marketing authorization application or MAA. Based on the feedback we receive, we plan to submit a centralized MAA filing in 2009 to the EMEA, which is the European Medicines Agency, after the NDA is filed in the US.

We’re continuing to evaluate options to maximize the value of the product in Europe. We’ve launched several additional initiatives including formal market research pricing and reimbursement analyses, and also outreach to physicians, advocacy groups, payers, and other stake holders in Europe. We will also be holding discussions with potential marketing and distribution partners to further assess the relative value of partnering in Europe versus other strategies.

Turning to our existing commercial product, Zanaflex continues to perform well. Gross sales this quarter were $13.7 million, up approximately 19% from Q3 2007 and our total shipments were $15.7 million. Based on sales through Q3, we continue to expect that Zanaflex commercial operations will be net cash flow positive in 2008 on an operating basis. Zanaflex is continuing to meet our strategic goal of supporting full commercial operations at Acorda and also providing us with the experience and infrastructure needed for a successful launch of Fampridine-SR if it’s approved.

And now, I will turn the call over to Dave for a financial update.

David Lawrence

In our press release this morning, we outlined our third quarter financial results for 2008. The company reported a net loss of $18.9 million for the quarter ended September 30, 2008, or $0.53 per diluted common share compared to a net loss of $8.5 million or $0.30 per diluted common share for the same quarter in 2007. Total operating expenses for the quarter ended September 30, 2008, were $29 million. Research and development expenses were $8.7 million, which includes costs related to our Fampridine-SR long-term extension studies, NDA preparation costs, and continued development of our pre-clinical pipeline products for potential IND filings in late 2009.

Sales general and administrative expenses for the quarter ended September 30, 2008, were $20.3 million and included the expenses related to Zanaflex promotional activities and Fampridine-SR pre-launch activities.

Other income expense included $1.2 million in interest income from our cash investment activities offset by $874,000 in interest expense primarily due to the Paul Capital Healthcare agreement.

The financing we completed in August enabled us to substantially strengthen our balance sheet. As of September 30, 2008, Acorda held cash, cash equivalents, and short-term investments of $263.2 million. We expect this to be sufficient to fund the company’s operations through 2010 based on our current projected revenue and spending levels.

I’ll now turn the call back over to Ron.

Ron Cohen

We’ll now open the call for your questions.

Question-and-Answer Session

Operator

(Operator Instructions). Our first question will come from the line of Matt Roden with J.P. Morgan.

Matt Roden - J.P. Morgan

I have a couple of questions on the European regulatory discussions. First, just to clarify, should we assume that no additional clinical trials would be required for filing an approval of Fampridine in Europe? Secondly, can you talk a little bit more about what led to your decision to file through the central route rather than the country-by-country basis? And then thirdly, can you narrow down a little bit in 2009 whether be it the first half or second half?

Ron Cohen

At this point, we don’t believe that we’ll need to conduct additional studies based on the meetings that we’ve had. Obviously, the final decision is going to be up to the EMEA as a whole, but based on where we are, we plan to file based on the trials that we have, which are, as you know, the 2 placebo controlled phase III trials primarily. With respect to how we arrived at this decision, we don’t generally get into specifics of our conversations with regulators. We discussed several topics with them as I mentioned in terms of the overall adequacy of the package that we have. Typically, as you know, a decentralized filing is used when you don’t necessarily plan to launch in every country. Typically, a centralized filing I would say is preferred if you do want to have the flexibility to launch throughout Europe, it’s a more efficient process, and if there is no apparent reason not to do it, typically companies will opt for centralized procedure, and based on our current information we think a centralized procedure is the way to go. We are not at this point prepared to give more specifics than to say that it’s in 2009, hopefully we’ll be able to narrow that down as we get into the New Year.

Operator

Our next question will come from the line of Joel Sendek with Lazard Capital Markets.

Joel Sendek - Lazard Capital Markets

Two questions, first you mentioned that you might request a priority review, I’m wondering why you wouldn’t.

Ron Cohen

Yes, I think Joel it’s a new environment right now at the FDA. We monitor these things as closely as we can as I think everyone else does in the industry, and it’s clear I think to everyone who has been watching that the agency has been under increasing stresses, mostly induced by staffing issues which in turn were induced by lack of funding until very recently. That puts a huge amount of pressure on the existing staff at the FDA, and we’ve seen that in terms of the output lately in terms of PDUFA dates and meetings being delayed or postponed and so forth. So, we’re reviewing whether or not priority review in this environment actually is going to be advantageous as opposed to, for example, possibly putting more pressure on an already stressed situation. That’s something we’re assessing and we’ll make the decision as we get to the filing, which is the time we would ask for priority review.

Joel Sendek - Lazard Capital Markets

Okay, so they might just create a PDUFA date that they can’t meet in which case you just create more problems for yourself?

Ron Cohen

I’m not going to put words in the agency’s mouth. I just want to say that we’re trying to be sensitive to the pressures that the agency is under, which is really induced by factors beyond their control as well. You might want to look on October 30th, just last week, Bloomberg ran a story about the numerous and unusual number of delays that have occurred in the regulatory process overall this year, and that’s just another harbinger of what we see happening at the FDA. So, that’s the long and short of it.

Joel Sendek - Lazard Capital Markets

And then my second question, you obviously are well capitalizing in that raise, had a great time over the summertime, but I’m wondering whether the financial crisis that we’ve looked through here might have an impact even on a company like yours which obviously has a very strong balance sheet in the sense that, does it impact your partnering strategy when you would be more likely to partner ex-US as a result of all these things that are going on?

Ron Cohen

If we decide to partner, it would not be based on a feeling of extraneous financial pressure. As you say, we financed with a good time, we are very well capitalized, and we don’t feel pressured to make a decision based on that. Hopefully, when we make that decision, it will be based on fundamentals and the long-term economic advantage to the company.

Operator

Our next question will come from the line of Lawrence Neibor with Robert W. Baird & Co.

Lawrence Neibor - Robert W. Baird & Co.

As you go through you pre-launch activities with Fampridine-SR, are you getting any feedback on pricing or reimbursement that you can share with us to tighten up the range you’ve talked about in the past and could you repeat the same answer for your initial talk on Europe?

Ron Cohen

I’m sorry, was that two questions or was that a question about Europe at the end?

Lawrence Neibor - Robert W. Baird & Co.

Right, two questions, pricing US, pricing Europe.

Ron Cohen

We’re not at a stage where we’re prepared to narrow the guidance that we have been giving although we are comfortable with the guidance we have been giving, and that is that, we’re focusing within the range of between $5000 up to $10,000 a year. We’re continuing to do our pricing research both here and in Europe. With respect to Europe, we don’t have anything specific to say except to point out that it’s clear that in the MS field, in any event, the reimbursement in Europe is at least on par with the reimbursement in the US for other products, and in some cases because of the exchange rate disparities, in dollar terms it might even be a little bit more. Now, that does not necessarily mean that that will be same case for Fampridine-SR. We’re studying that, and as you probably know, the pricing research gets very granular and it’s going to be talking place all the way well into next year. So, I don’t know that we’re going to have much more specific to say until we get further down the road, but based on the feedback we’ve gotten so far in the initial research, we’re quite comfortable that it’s somewhere in that range of $5000 to $10,000.

Lawrence Neibor - Robert W. Baird & Co.

And the second question would be, is there any possibility that you wouldn’t choose not to have a marketing or distribution partner for the EU market?

Ron Cohen

Sure, there is a possibility. We’re going through our process. We’ve completed our regulatory analysis, and we’ve announced today what the output of that is, that we plan to file an MAA next year in a centralized procedure. We are finishing up our market and initial pricing and reimbursement analysis, and then we’re going to be talking to interested parties, of which there are several, about what a partnership in Europe might look like so that we can evaluate the value of those sorts of deals against the go-it-alone strategy or something in between which might involve a co-promote in selective territories. So, all of that is still on the table as we go and complete our work.

Operator

Our next question will come from the line of Philip Nadeau with Cowen & Co.

Philip Nadeau - Cowen & Co.

My first question is on the filings, could you just update us on what remains to be completed before you can file in the US?

Ron Cohen

At this point, it’s blocking and tackling, Phil. There’s no one thing, it’s everything. So, as you know, it’s just a huge, a document is really not a big enough word, it is just a huge enterprise to put together all the pieces of the NDA and everyone here is working full steam to get it done, but there’s no particular element that I would point to. It’s just dotting all the I’s, crossing the T’s, and lots and lots of block and tackling.

Philip Nadeau - Cowen & Co.

And what about prior to the EU filings, you mentioned you don’t have to do any studies, is there any new analyses that needs to be done or is it simply taking what you’re filing in the US and putting it to the European format?

Ron Cohen

Yes, a couple of things, first, I just want to be clear, we have spoken with 4, we believe, influential member states, particularly knowledgeable in the MS and Neurology space in Europe, and based on the collective feedback, we believe we can go and file through a centralized procedure, I just want to make sure everyone hears that ultimately the EMEA is going to make the final determination. In terms of what we have to do to file the MAA, once the NDA is in, there are several areas in an MAA where the formatting is different and the way you construct the narrative is different. So, there’ll be a fair amount of re-formulating what we already have, but I don’t anticipate that there will be anything substantively new, and Andy Blight our Chief Scientific Officer is here. Andy, do you have any additional comment on what the MAA would require that’s not already in the NDA?

Andrew R. Blight

Yes, there are primarily region specific aspects of the CTD submissions that would have to be put together, and some of the elements of the NDA have to be modified into an MAA. It’s not a direct shift from one to the other, although it’s a common technical document, it’s not so common that you can simply take an NDA and put it in as an MAA. There are a lot of adjustments that have to be made for the European environment.

Ron Cohen

But is there anything substantive that we’re going to have to add?

Andrew R. Blight

No, it’s primarily an editing task.

Philip Nadeau - Cowen & Co.

And Ron on your comments that the EMEA will make the determination where you can file, do you now have to have a subsequent conversation with the EMEA, under what auspices would you get feedback from the EMEA, whether the filing is complete or not complete?

Ron Cohen

We’re going to go through a formal process now with EMEA. Based on the advice we’ve gotten from the individual member states, we’re comfortable doing that, but you always have to allow that once you get into the formal process, the unified EMEA may come back with something different than what you heard earlier. We think based on what we’ve heard from the 4 member states we’ve consulted with, we feel comfortable that we can go ahead and do this, but everyone just needs to be aware that that’s not the final arbiter. The final arbiter is once you get into formal process, the EMEA may come back with something that you didn’t anticipate.

Philip Nadeau - Cowen & Co.

Okay, that makes sense. At one point you had been suggesting that you would decide on European commercialization strategy by the end of the year, does that guidance still hold or is there some chance that you’d still be evaluating your options into 2009?

Ron Cohen

What holds is that we will have finished the research both on the market analysis front, pricing reimbursement front that we wanted to get done, as well as what we’ve announced today, which is the regulatory piece, which we felt was a critical piece. So, with that put to bed, the next step is really to talk in detail with some of these potential partners and get a sense of what the level of interest is, what the terms of a partnership might look like in reality versus what we might speculate it may look like. So, we’re going to go through that process. That’s going to obviously take a little while. I anticipate that that will take us past the end of the year, and in those conversations, I think once we have a sense of what that option looks like in detail, we’ll be prepared to make a decision.

Philip Nadeau - Cowen & Co.

And my last question is actually just a followup to Joel’s. You mentioned that you’re going to decide on whether to go with priority review or not, are you going to get any feedback from the FDA in that process or is it just going to you guys really making these off the FDA environment?

Ron Cohen

In the NDA process, there are conversations that you have with FDA routinely on a pre-NDA basis. So, we try to talk with them about a spectrum of topics where there may be uncertainty or where we’d like more clarity for filing the NDA. Priority review could well be one of those topics, but at the end of the day, that’s part of the analysis. We’re looking at views of some of our trusted advisors who have regulatory insight, just trying to gauge the current environment again and what the impact of that might be on a priority review filing versus letting it go on a standard review. Putting it another way, if we were to believe strongly that there was a strong chance that a priority review would put so much additional stress on an already stressed situation that it might be a net negative versus letting the agency have a little bit more leeway, then we might conclude that a standard review might well be more advantageous and we might get there more expeditiously on a standard review. Again, I’m not telling you we’ve come to a conclusion, but those are the things we’re thinking about.

Operator

And our next question will come from the line of William Ho with Banc of America Securities.

William Ho - Banc of America Securities

Congratulations on what turned out to be a very nice financing earlier this summer. My first question is did the EMEA accept the responder analysis that you did in the 203 and 204 studies as the FDA has in its SPA?

Ron Cohen

Okay, couple of things. I just want to make clear again that we did not seek advice from the EMEA per se but rather from the member regulatory bodies of 4 of what we think are key member states that belong to the EMEA, and again, we don’t talk about specifics of the conversation we have, however, broadly speaking, we did talk to them about our trial design, we talked to them about our outcome measures, we talked to them about the adequacy of the current trials and the current package to support a regulatory filing, and based on all of those conversations, we have concluded that we should go ahead and do a central filing next year, and we believe that we will not need any additional studies beyond what we’ve already done, and as you know, the two phase III trials are based on the primary outcome of the walking responder analysis.

William Ho - Banc of America Securities

And then finally, during the MS meeting in Montreal several conversations with commissions that I had seemed to indicate that there are significant numbers of MS patients who are taking other symptomatic treatments for MS both off label and out-of-pocket. What will be required for you to get Fampridine-SR finally reimbursed by third party payers, outside of the label of course?

Ron Cohen

Are those two different questions because I think I heard you say that MS patients were said to be taking off-label drugs and paying out of pocket?

William Ho - Banc of America Securities

Yes, I guess one of the concerns that doctors had was with respect to reimbursements, some of those other off-label symptomatic treatments that they’re taking are not being reimbursed, they are paying for out of pocket, and they thought that being reimbursed would be a big driver for uptick, so what would it take to get Fampridine reimbursed and paid for?

Ron Cohen

Reimbursement is obviously always or maybe the key driving factor for any drug that is launched for any indication. So, I don’t see it as being fundamentally different for Fampridine-SR than it would be for any drug in any other area or indication, and as part of our full pre-launch program, we’ve brought in some very good people from other companies with lots of experience, specifically in preparing third party payers, having those conversations in advance, preparing dossiers, doing the health economic studies to justify the benefit to patients, and we’re going through all that now, and we’re going to be intensifying that as we get through next year.

William Ho - Banc of America Securities

Any thoughts as to the ability to get reimbursement?

Ron Cohen

I’m not quite sure how to answer the question. Could you re-phrase the question?

William Ho - Banc of America Securities

Do you think you’ll be successful ultimately to get reimbursement for Fampridine?

Ron Cohen

We certainly hope so. We don’t see any particular road blocks right now, but that’s something that gets determined, first of all as we decide what our ultimate price point is going to be and that’s going to be based on this very issue, which is going out and talking to the third party payers, presenting our data, presenting health economic data, and so on. Let me also be clear that we’ll be aiming to get reimbursement for the labeled indication, and that is also going to be determined much closer to FDA approval when we actually have a much clearer sense of what the ultimate label is going to say. So, what happens is, you get a process that starts out more generically where you go to the payer, start the conversations based on the target product profile that you have, and then as we get closer and closer and we can cone down on what the ultimate label is actually going to say, we intensify those conversations, they become more specific. This is not fundamentally different again from any drug that is ever launched. It’s a very analogous process of getting the relationships with the payers, educating them as to the probable labeled indications, and also getting a sense of what price that they would support.

Operator

Our next question will come from the line of Lawrence Neibor with Robert W. Baird & Co.

Lawrence Neibor - Robert W. Baird & Co.

Your sales and marketing costs were up about 80% plus year-over-year, can you give us an idea of what portion of that was pre-launch spending for Fampridine-SR and perhaps an idea of what the pre-launch spending might be budgeted up to launch?

David Lawrence

As we’ve been guiding, our pre-launch activities in the SG&A expense line have continued to increase. If you look quarter over quarter this year you’ll see it’s been gradually increasing, and this quarter it’s taken a bit of a higher bump and it’s paying for all of the things that Ron was just speaking to around the pre-launch activities. The only guidance we’re giving at this point is that the cash in the bank will last through the end of 2010, but the SG&A line, the increases you’re seeing are primarily due to the S or the sales, which is pre-launch activity.

Ron Cohen

I just want to follow up on my previous answer to Will as well which is obviously as we talked to the third party payers we’re talking about reimbursing on label. So, I just want to make that clear, we’re not going to be promoting off-label. That part of the system we’re not going to be directly requesting reimbursement for off-label use.

Lawrence Neibor - Robert W. Baird & Co.

One final question please, given what you’ve announced this morning, could you give us some idea of the timing of your planned sales force expansion?

Ron Cohen

We’re going to monitor that Larry. We want to bring the new sales force in somewhere between, let’s say 3 to 6 months prior to the anticipated launch, closer to 3 if we can swing it. It becomes a bit of a dance because you have to anticipate when you might be getting an approval, hopefully we’ll get an approval. So, that becomes an issue of monitoring the progress with the FDA, what kind of feedback we’re getting back from them along the way, and trying to get our best educated guess based on reading those signs as to when a launch will probably be and then working back from there. I think on the current timeline, we will hope to bring them on board next year, but it won’t be in the beginning of the year.

Operator

Our next question is a followup question from the line of William Ho with Banc of America Securities.

William Ho - Banc of America Securities

I just wanted to clarify, I apologize if it didn’t come out so clear, my understanding with just talking from doctors that there really aren’t that many symptomatic treatments out there and that patients do take other drugs off label as symptomatic treatment, but it does seem to be a fairly large burden on them out of pocket, and so, just wondering and trying to get an understanding of your reimbursement process because I think that would ultimately be an advantage if you could reimburse.

Ron Cohen

Well again we plan to get as broad a reimbursement as possible on the drug. I should take the opportunity to just focus on the word symptomatic because I think it’s important. One of things we are educating away from with respect to Fampridine-SR is distinguishing it from other, what people call, symptomatic treatments. We think of Fampridine-SR as a new class of treatment, really a functional modifier because it is in fact modifying the actual function of the demyelinated nervous system, and as such, it is acting to reverse part of the pathophysiology of the disease itself, and that is distinct from a symptomatic therapy that is really treating a particular symptom usually regardless of what the disease or the etiology is. So, a good example would be Zanaflex. Zanaflex treats spasticity, painful spasms of the muscles regardless of whether it’s due to spinal cord injury or stroke or brain injury or MS or some other cause of painful spasms of the muscles. That’s a true symptomatic therapy. We see Fampridine-SR as a targeted therapy that reverses the conduction block in demyelinated axons, and that’s a fundamentally different and ultimately I think a more potent approach to these patients.

As for your point, some patients are taking compounded versions of Fampridine itself which are not FDA approved and they generally pay for those out of pocket. There are other drugs as you know that they take, that are not necessarily reimbursed. Our focus is going to be to again educate the payers about the potential for a first in class drug that restores or improves, I should say, walking ability a critical function in MS by modifying the function of the nervous system. We believe that that should commend a premium price and that it should be reimbursed. So, that’s what we’re going to be working on. Obviously, to the extent that there are co-pays involved in reimbursement and people have co-pays in their plans. Our belief is that in most cases, the co-pay would not exceed what they’re paying now or may be even be less than what they’re paying now for other off-label or compounded drugs.

Operator

And at this time, we have no further questions. I would now like to turn the call back over to Dr. Ron Cohen for closing remarks.

Ron Cohen

Thanks very much everyone for joining us. This concludes our conference call this morning, have a great week.

Operator

Thank you for your participation in today’s conference. This concludes your presentation. You may now disconnect.

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Source: Acorda Therapeutics, Inc., Q3 2008 Earnings Call Transcript
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