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Executives

Ronald W. Barrett – Chief Executive Officer

William G. Harris – Senior Vice President of Finance and Chief Financial Officer

Vincent J. Angotti – Chief Operating Officer

Jackie Cossmon – Investor Relations

Analysts

Michael Yee – RBC Capital Markets

Brian Abrahams – Wells Fargo Securities

Marko Kozul – Leerink Swann

Gregory Wade – Wedbush Morgan

David Friedman – Morgan Stanley

XenoPort, Inc. (XNPT) Q4 2012 Earnings Conference Call March 11, 2013 5:00 PM ET

Operator

Good evening. My name is Terry and I will be your conference operator. At this time, I would like to welcome everyone to the XenoPort Fourth Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions) Thank you.

I will now turn the conference over to Ms. Jackie Cossmon of XenoPort.

Jackie Cossmon

Thank you, Terry. Good afternoon and thank you for joining us on the call. Here with me today are Ron Barrett, our Chief Executive Officer; Bill Harris, our Senior Vice President of Finance and Chief Financial Officer; and Vince Angotti, our Chief Operating Officer.

Before we begin our discussion of today's news, I would like to note that the information to be discussed on this conference call and webcast, including answers to questions asked during this call will include forward-looking statements that involve risks and uncertainties, including all statements relating to future sales of and all commercialization and promotional plans and activities for Horizants, our current and future clinical development programs and clinical trials, the release of additional clinical trial data and the timing thereof, potential advantages of our product candidates, regulatory actions and submissions, our dependence on our collaborative partners, future sales of Regnite, the therapeutic and commercial potential of Gabapentin and Enacarbil and our product candidates and financial guidance.

XenoPort can give no assurance with respect to these statements and we assume no obligation to update them. For detailed information about the risks and uncertainties that could cause actual results to differ materially from those implied by or anticipated in these forward-looking statements, please refer to the Risk Factor section of our most recent SEC filings, including our discussion of inherent risks of clinical trials and regulatory matters. This webcast is a copyright of XenoPort.

At this time, I would like to turn the presentation over to Ron.

Ronald Barrett

Thanks, Jackie. Good afternoon and thank you all for joining us today. 2012 was an important year for XenoPort and has set up 2013 as a transformational year for the company. I’ll be summarizing our progress in 2012 and describing our development plans for 2013. An important event that occurred in November last year was the re-acquisition of the rights to Horizant and we have been busy preparing to commercialize Horizant starting May 1. Vince will describe our commercial preparations and plans and then Bill will discuss the financials for the fourth quarter and what we expect financially going forward.

The re-acquisition of Horizant represents an exciting opportunity for XenoPort and marks the important transition of the company into a commercial entity. There remains substantial unmet medical needs in the treatment of moderate to severe primary Restless Legs Syndrome which we’ll be referring as RLS and the management of Postherpetic Neuralgia which we’ll refer to as PHN. We look forward to educating key stakeholders about the value of Horizant starting May 1.

The commercial performance of Horizant since its launch in July of 2011 has not met our expectations, but rather than look backward at what we believe went wrong with GSK’s launch efforts, we are focusing on the opportunity soon to be in our hands for a product that is FDA approved for two indications. In our November call when we announced the return of Horizant, we discussed some of the key terms of the termination and transition agreement. These include the $40 million received from GSK, the avoidance of the cost of a large post-marketing RLS trial, studying lower doses of Horizant and enlarged supply of API that will lead to reduced cogs for the foreseeable future. Vince will discuss our target commercial plan intended to grow the Horizant business in a cost efficient manner while maintaining flexibility to expand our commercial efforts in the future.

Before I turn to our development programs, I’d like to say a few words about Regnite, which our partner Astellas launched in Japan in mid-July of last year. Today we reported our first royalty revenue from the sales of Regnite which occurred in the third quarter of last year. We receive a high teen royalty on med sales. Sales in the third quarter were modest, but I should remind you that in the first year after the establishment of pricing for our new prescription product in Japan, physicians are limited to writing prescriptions for two weeks, requiring patients to come back to the physician’s office frequently. We believe that this restriction has likely had some dampening effect on sales, but it will be lifted in May. So we believe we will begin to get a better sense of the opportunity for Regnite in the coming months. Astellas continues to invest in the program with approximately 1200 sales reps involved in promoting Regnite.

Now turning to our development programs. The last patient recently completed their final visit in our Phase 3 trial of AP for the treatment of spasticity in patients with multiple sclerosis. We ended up enrolling 228 patients in the study. Patients from this study can enroll in an open label safety study. We’re also enrolling patients directly into the safety study and we’re close to completing that enrolment.

We are in the process of completing entry of the data from the Phase 3 efficacy trial, locking the database on blinding and conducting the statistical analysis. This process typically takes eight to 10 weeks to get to the topline results. Therefore we will be releasing topline data by press release in the second quarter. Assuming positive results, we’re targeting the submission of a new drug application in the United States by the end of the year. Approval of the NDA for AP for spasticity would provide a second product for our neuroscience focused specialty sales effort. Our market research continues to confirm that the satisfaction with current oral spasticity agents and the high level of physician interest in AP.

We have made rapid progress in the development of XP23829, our Fumaric acid ester product candidate currently in Phase 1. We completed a formulation selection Phase 1 trial in October and have initiated two additional Phase 1 studies. One is a multiple ascending dose study examining the safety in steady state pharmacokinetics of ascending doses of formulation one dose twice a day and formulation two dose once a day in healthy subjects. Assuming FDA approval of BG-12 later this month, we may be able to introduce a BG-12 cohort into this study.

Last week we completed dosing of subjects in an additional Phase 1 study whose objective is to establish the metabolism and disposition of a single dose of radio labeled 829. We’ve also initiated 13 weeks toxicology studies for 829 in rodents and primates. All of these clinical and preclinical studies should be completed by midyear. With this data in hand, we hope to speak to regulatory authorities about potential development paths for several indications, including relapse in remitting MS, Psoriasis and potentially other neurology and dermatology indications for which we are conducting medical and commercial diligence.

We’re also in the process of scaling up the API and clinical trial formulation manufacturing. This effort is intended to put us in a position to begin efficacy studies in patients next year. So 2013 has already been and will continue to be a busy year for the development team within XenoPort. At the same time, we’re working hard to prepare to commercialize Horizant.

I’d like to now turn the call over to Vince who will discuss our preparation and plans. Vince?

Vincent Angotti

Thanks Ron. Good afternoon everyone. As Ron mentioned, we believe that we’re taking a focused, disciplined approach to our initial commercialization efforts to intelligently deploy resources, confirm return on investments and create a template for potential future expansion of our efforts.

First, let me update you briefly on the RLS and PHN markets. In 2012, prescription for Restless Legs Syndrome grew by a rate of slightly more than 4%, reaching a total of approximately 6.1 million prescriptions for the year. The short acting drug Regnite continued to dominate the market share close to 85%.

According to our estimates, the overall neuropathic pain markets experienced an annual growth rate of approximately 8%, reaching 45 million prescriptions in 2012, with Gabapentin reporting almost a 55% share. I’ll remind you that Horizant is indicated for PHN which is a small subset of the overall neuropathic pain market. It’s difficult to estimate the PHN only prescription markets.

Horizant’s prescription count in 2012 totaled about 50,000 total prescriptions. In the fourth quarter, Horizant averaged approximately 4900 prescriptions per month. During the course of 2012, the average size of Horizant prescriptions grew from about 38 tablets per prescription in January to about 42 tablets per prescription in December. We assume that this growth in the tablets per prescription was due to a gradual increase in mail order prescriptions during the course of the year. In June of 2012 Horizant was approved for Postherpetic Neuralgia, PHN at 600mg twice per day. So a PHN prescription is worth twice that of an RLS prescription. However, there’s been minimal promotional effort to date for this particular indication. In January of 2013, GSK took a 9% price increase, resulting in a current WACC price for Horizant of $3.81 per tablet or about $114 per month for RLS and $228 per month for PHN.

Specialty physicians continued to generate approximately 60% of all Horizant prescriptions. Through December of last year, the total number of unique Horizant prescribers since launch was close to 9,000, with about 80% of the prescriptions coming from a highly concentrated subset of only about 2,200 physicians. GSK will continue the promotion and distribution of Horizant through April 30 of this year. XenoPort will assume all responsibilities for commercializing Horizant effective May 1.

We spent considerable time analyzing the current and potential market for Horizant, including geographic distribution of sales, physician prescribing currents and the payer environment. The goal has been to identify XenoPort’s optimal sales and marketing structure for Horizant for RSL and PHN with the resources that we have available. Accordingly, we plan to deploy 40 specialty sales representatives dedicated to Horizant on May 1 in select territories around the country. The territories are based on current Horizant prescribers as well as sleep specialists, pain specialists treating PHN and neurologists who are high prescribers of RLS and PHN drugs. We also prioritized the selection of territories based on favorable managed care access to Horizant.

Finally, the CSO arrangement allows for flexibility as it relates to the size and duration of the sales team. As a note, our specialty sales representatives will be employed by contract sales organization. However the sale management team who have been hired are XenoPort employees. In addition to the specialty sales team, we intend to utilize approximately 40 part time primary care sales reps from an established PCP team provided by the CSO. Horizant will be sold in priority position within this team during a trial period from May through December of this year. These sales professionals will target eight to 10 PCP physicians for high prescribers of RLS or PHN drugs. Their deployment will predominantly overlap the geographies where XenoPort’s dedicated specialty reps are located allowing us to continue to maximize the potential return on our professional and patient marketing efforts in those areas where we have concentrated personal promotion.

We’ve engineered the terms of the CSO agreement for these primary care reps to minimize fixed costs to XenoPort. We’ll pay the CSO a portion of the detail fee and the CSO will participate in any incremental sales generated by this PCP sales force. We’ll monitor the effectiveness of these tactics throughout the year as we evaluate potential options to expand the Horizant business.

We’re in the process of establishing our wholesaler distribution arrangements that we believe will ensure smooth transition of Horizant’s supply chain for GSK to XenoPort. Our current assessment is that Horizant’s managed market access, which is largely the result of default positions, is similar to other recently launched branded agents indicated for RLS and PHN. Since we’re concentrating on territories with minimal restrictions in the form of prior authorizations or step edits, our efforts will initially focus on the availability of tools from May 1 that may reduce copay levels for the patient at the point of purchase. Over time we’ll be evaluating contracting opportunities on a select basis that could further expand Horizant’s access, again concentrating resources on geographies where there’s personal promotions.

In general, marketing materials utilized on May 1 and beyond will be XenoPort created tools, rather than those materials previously utilized by GSK. Marketing will focus on branded initiatives to raise awareness of Horizant which our research indicates is poor even amongst RLS experts. We expect to deploy these marketing resources largely in areas of the country where again we have sales representative coverage.

Finally, we’re developing a medical affairs strategy intended to raise the disease awareness and to disseminate scientific knowledge about Gabapentin and Enacarbil. These initiatives will include education regarding recent changes to RLS treatment guidelines. We plan to employ a small NSL team that would be predominantly aligned to the sales teams geographies.

In summary, our strategy is to cluster our sales and marketing investments in select areas of the country that we believe will lead to the best return on investment with the resources we have available. In parallel, the medical affairs effort will improve education to ensure a full understanding of the role of Horizant in the treatment of RLS and the management of PHN.

We intend to measure our success based on prescription growth in the specific geographies of focus. Our strategy should allow us to confirm the optimal mix of resources and active templates for potential future expansion. I’ll remind you that Horizant exclusivity is protected by a composition-of-matter patent that expires in 2022 with expected patent term expansions until 2025.

Now I will turn it over to Bill Harris for the financial update. Bill?

William Harris

Thanks, Vince. I'll spend a few minutes reviewing our financial results for the fourth quarter of 2012 and we'll then take your questions. I'd like to start with a brief update regarding Horizant. Pursuant to the termination and transition agreement with GSK, we were not responsible for any losses incurred under our previous agreement with GSK. In addition, we will not share any revenues or losses from the sales of Horizant during the transition period. Net sales of Horizant, as recorded by GSK, were $2.1 million and $6.5 million for the fourth quarter and year ended December 31, 2012 respectively.

Now turning to our financial results. The decrease in revenues for the fourth quarter compared to the same period in 2011 was due to the receipt and recognition of a $5 million milestone payment from GSK in the fourth quarter of 2011, partially offset by the receipt of a $0.1 million in Regnite royalty revenue in the fourth quarter of 2012. As a reminder, we are recognizing our Regnite royalties one quarter in arrears. So as Ron mentioned, this amount represents our royalty on third quarter 2012 net sales by Astellas, which began in mid-July.

Research and development expenses decreased for the fourth quarter of 2012 to $10.6 million compared to $12.5 million for the same period in 2011. This was primarily due to decreased personnel costs and decreased development activities for XP21279.

Selling, general and administrative expenses are relatively flat at $7.4 million for the fourth quarter of 2012, compared to $6.9 million for the same period in 2011. Also during the quarter we recognized a non-cash gain on litigation settlement of $20.5 million in connection with the resolution of our dispute and litigation with GSK, resulting in a profitable fourth quarter.

Net income for the fourth quarter of 2012 was $3 million compared to a net loss of $16.9 million for the same period in 2011. Net income per basic and diluted share was $0.07 for the fourth quarter of 2012 compared to a net loss per basic and diluted share of $0.48 for the same period in 2011.

In terms of cash, we ended the year with cash, cash equivalents and short term investments of $139 million. And finally turning to the matter of cash burn guidance, we expect a net use of cash for 2013 to be in the range of $100 million to $110 million. The increase in anticipated cash burn reflects increased investments in both AP, assuming a positive outcome on our Phase 3 trial and 829 in addition to comps associated with establishing commercial operations for Horizant. And just to be clear, we have not included any assumptions regarding potential future partnerships.

With that we will open the call to questions. Operator?

Question-and-Answer Session

Operator

(Operator instructions). Our first question comes from the line of Michael Yee with RBC Capital Markets.

Michael Yee – RBC Capital Markets

Two questions for the team, one on RLS and the launch or the re-launch of Horizant. Can you help us better understand internally or how you are thinking about what a successful re-launch would be, what metrics you are looking for? Obviously sales numbers are important, but I’m assuming you’re not giving any guidance in terms of – so what is defined as a successful launch and at what point do you think there could be a breakeven business year? And then the second question is on 829. I know there is data coming mid-year. How are you prioritizing Psoriasis versus MS? I know there was another Phase 3 drug that was just recently presented data and has that changed your prioritization, how you're thinking what the next studies could be there? Thanks.

Ronald Barrett

Sure. Thanks Mike. We’re not providing guidance at this point. We understand why that's important, but there are so many moving pieces on the Horizant launch. I think it's going to take us a while before we can provide any guidance with what the topline sales will be or when the product would breakeven. With regard to your question on how success should be measured, I think Vince touched on that. As Vince described, we're taking a very focused approach. We’re going to put our resources where we think we can generate business quickly. Obviously current sales of Horizant are being driven by prescriptions beyond these territories. We’re covering a large part of it, but not all of it. So we think we should be measured by the performance where we’re putting our resources and as we move forward that's the type of information we hope to be able to provide to investors.

With regard to your question on 829 and the development path, as I indicated in the second half of the year, we intend to go in and talk to the neurology products division within the FDA as well as the dermatology division. Obviously there is a complex set of issues related to each of these indications and I do recognize the point that you made that psoriasis could be a very attractive opportunity for this product given the history of uses of Fumaderm and also some work that was done with BG-12. It looks like the probability of success of Phase 2 or Phase 3 trials would be high. If you look at the efficacy level that's been achieved in past fumaric acid ester trials, we think it could present a competitive profile versus the other oral agents that are being developed.

We won't make a decision on that until we get all of our data and until we have these discussions with regulatory authorities. Meanwhile we continue to have discussions with potential partners. We think those partnerships could culminate in a deal at some time in the future. However, we think it's important for us to have a go it alone strategy. And we're putting our effort, while we're having these business decisions, into figuring out what the best path would be for us if we were to keep this further in development then beyond the Phase 1 studies that are ongoing.

Operator

Your next question comes from the line of Brian Abrahams with Wells Fargo Securities.

Brian Abrahams – Wells Fargo Securities

Thanks for taking my question and thank you for all the clarity on the commercial plan, Vince. Just to start off, a quick question on 829. You mentioned the potential incorporation of BG-12 into current multiple ascending dose study. Just wondering how that might look. Would that be more of a PK analysis? How are you guys thinking about the potential head-to-head tolerability assessments either within this study or future studies? And then I had a quick financial follow-up.

Vincent Angotti

So if BG-12 is approved and is available in a timeframe that makes sense, we have the ability to drop it into the current ongoing study, which is really focused on pharmacokinetics. It’s a small – each cohort is 12 subjects and so we are not going to get a lot of tolerability information from such study and it is also a in-patient study because obviously this is the first time we have escalated the dose of 829. So patients are retained within the Phase 1 unit for the entire dosing period. So we hope to get PK comparison out of this study. The question of whether we would do a head-to-head tolerability study is yet to be decided. Obviously we need to have the PK data first to understand how to adjust the dose of 829 to get to the same therapeutic level as the approved dose of BG-12. Whether we do that early or later in development I think is dependent on what our strategy is with regard to indication. And as I mentioned, there are scenarios in which we might do psoriasis first before MS. And so we don’t think we necessarily need to have that information to go into psoriasis.

Brian Abrahams – Wells Fargo Securities

Got it. And then just on the financials, can you give us any sense as to the year-over-year expected increase in cash burn? To what degree that we should think about that being attributable to the CSO and the sales force build out versus increases in R&D as you advance 829? And I’m also wondering if that assumes a certain goal for Horizant sales or if you have more flexibility within that and you’re sort of aiming to hit that cash burn and you might titrate up or down your investment in sales and marketing depending on where you are with Horizant relative to your goals?

William Harris

Sure. Let me try and take those one at a time. In terms of what’s driving the increase in our expected use of cash this year, clearly R&D is driving a component of it in terms of AP. We would expect our clinical spend to be similar to what was incurred last year, but we’re looking at a significant increase in investment in manufacturing for scale-up validation work. Soon we expect a successful trial. Also the cost associated with assembling and submitting electronic NDA is in there. In 829 we’re looking at increased investments in preclinical, clinical and manufacturing. So there are good component of the increase for R&D. Clearly the commercial piece is the other big nut and that’s not only the sales team, but also some of the internal compliance requirements for pharmacovigilance, global safety reporting, those types of things. And then on your second question, we do have internal targets for what we’re hoping to generate with Horizant. We’re obviously not speaking to those. And yes, we will continue to monitor how we’re doing there and our ongoing expenses on a real time basis. As Ron indicated, it’s kind of a transformational year with a lot of moving pieces and we’ll be continuing to monitor all these as we go forward.

Operator

Your next question comes from the line of Marko Kozul with Leerink Swann.

Marko Kozul – Leerink Swann

I wanted to start off with, for Horizant, how important do you think pre-authorizations are to driving use of the drug and how are you preparing to tackle that?

Vincent Angotti

It’s a good question. So what we’ve communicated in the past hasn't changed up to this point today. I will remind you that about 60% of the commercialized for access to this product have it available in a Tier 2 or Tier 3 unrestricted position. It's mostly in a Tier 3 position. So the prior authorizations are minimal related to the commercialized. That's why we’re addressing it with the strategies related to alleviating some of these Tier 3 copays to a level at or below a Tier 2 typical copay moving forward. So prior authorizations we don’t believe are a significant issue for this product.

Ronald Barrett

About 70% of the scripts are in commercial plans.

Vincent Angotti

Of Horizant scripts.

Ronald Barrett

Of Horizant scripts.

Marko Kozul – Leerink Swann

Terrific. And just a quick follow-up here. Other than being approved for RLS, how do you think about differentiation of Horizant say compared to Pfizer’s Lyrica? Thanks.

Ronald Barrett

Yes. So the profile that is in our label we think will be attractive to physicians and patients. Obviously the dynamics in the neuropathic pain PHN market are different from RLS. But what we have is a low dose. So 1,200mg a day of Gabapentin Enacarbil are effective in treating PHN. On a molar basis, that's equivalent to 600mg of Gabapentin. So that's getting a lot of efficacy from a low dose. We have the pharmacokinetic information with regard to gabapentin in our label. The fact that we have dose proportional exposure that we have a very flat pharmacokinetic profile, and in our label peak-to-trough ratio is 1.5. So only a 50% difference in Gabapentin levels throughout 24 hours for the patient. And importantly at that dose, we have a very low incidence of adverse effects. The incidence level has been similar to placebo for the two major class related side effects of dizziness and somnolence. So we think that that profile will be attractive to some patients and physicians and we'll be promoting those aspects of the product.

Marko Kozul – Leerink Swann

Ron, thanks. I'll just try and squeeze a quick one in here on organizations and their guidelines. Can you remind us which ones have already issued guidelines and which are the organizations you'd be looking for to maybe issue guidelines here in the near term, possibly AAN or others?

Ronald Barrett

Yeah. So the international Restless Leg study group issued – on their webpage they issued the summary of their treatment recommendations in which for the first time they are no longer recommending Dopamine Agonist as first-line treatment for our patient. So for those patients who have comordid sleep pain or anxiety or impulse control issues, alpha-2-delta class is the preferred first-line agent. That's a fundamental change from past practices. The American Academy of Sleep Medicine did a level of evidence review. Gabapentin and Enacarbil were the only alpha-2-delta products that achieved the high level of evidence. We are expecting – we've heard that the American Academy of Neurology is going to be releasing new treatment guidelines. The timing of that is a little uncertain, but they are working on it. So we think that very few people know about these treatment guidelines based on the market research that we've done. This will be an important part of our educational efforts, because it is a – as I mentioned, a fundamental change in the way this diorder is treated.

Operator

Your next question comes from the line of Greg Wade with Wedbush.

Gregory Wade – Wedbush Morgan

If you could just help us a little more with respect to the numbers. You've contracted with these contract sales organizations I guess, for 12 months. Is that right?

William Harris

So we've got a contract in place for the dedicated team. And then as we indicated, the 40 part-time primary care folks are in a trial period from May through December.

Gregory Wade – Wedbush Morgan

Okay. So what's the contract call for the dedicated team. What’s the net on that?

William Harris

We're not going to that level of detail.

Ronald Barrett

Typical of sales reps, Vince could give you –

Vincent Angotti

Greg, I think how you have to think about it is it's a syndicated sales team.

Ronald Barrett

No, no. This is dedicated.

Vincent Angotti

Yeah. Not on the dedicated team. So it's a typical specialty sales team build. So you're looking at fully loaded rep costs as you would normally see in many specialty sales team. We're about $200,000, $250,000 per rep fully loaded.

Gregory Wade – Wedbush Morgan

Okay. And there is nothing else in their bag? So you guys are responsible for all of that?

Vincent Angotti

Correct. That's a team dedicated to XenoPort. The only promoted product we have available is Horizant.

Gregory Wade – Wedbush Morgan

Okay, that’s helpful. Just was trying to get onto that. And then with respect to the 40 part-timers, what percentage of a part-time sales person would be a good guess in terms of their cost?

William Harris

So while I won't give you cost, I'll tell you how the part-time teams typically in this industry work for flex team. They usually work about 60% of the workload of a full time rep and in this particular case you also have to consider the fact that we have a slot. We are not taking the full time best sales representatives. So what we have basically done as arrange for targeted calls on a set of physicians with a T1 detail. The only thing to think about that is – and based on that T1 physician as we mentioned we put a portion of the cost of that detail at risk.

Gregory Wade – Wedbush Morgan

Right. And the MSLs, how many of those folks do you have and are they contract or are they your people?

Ronald Barrett

So we are building a small MSL team. We’ve hired the leadership position and we're working through the whether we reduce contract or not. We are – it's initially at the start going to have one MSL per area. Vince's team is going to have four areas for the 40 different sales reps. That's where we are start. Obviously when we get the AP read out, we'll make a decision if we want to expand the MSL team at that time.

Gregory Wade – Wedbush Morgan

Okay. Just one last thing on the sales force. Vince, your sales management, is that included within the 40 people that are…?

Vincent Angotti

It is not. So what we have employed by XenoPort has been a control of 10 to one as it relates to first line management. So your regional sales directors there will be four and a VP of sales. So it's not within the 40. It's an addition to it.

Operator

(Operator instructions). Your next question comes from the line of David Friedman with Morgan Stanley.

David Friedman – Morgan Stanley

I just – and I don't know how much you'll be able to disclose around this, but in Europe, coming AAN abstract for AP, it says in the spasticity for MS abstract that there would be efficacy in safety data presented at the meeting. Do you know given that your Phase 3 data looks like it's not for that meeting? Can you maybe just describe the patient population that you would be reporting efficacy data on?

Ronald Barrett

Sure. Yeah, the enrolment took a little longer than we had anticipated. So the results will not be ready for the AAN, but we are going to present the kind of baseline characteristics for the study. These are MS patients. They can have any form of MS. If they were on disease modifying therapy, they'd have to have been on that treatment stable and not have any relapses. I believe the criteria is for six months before entering our study. They have to have a max, an Ashworth score of 2 or greater after the running period for the study. Well, that's the same criteria that we used in our spasticity trial. With regard to other entry criteria, I'm just going to pull up my cheat-sheet here. So with regards to EDSS, the inclusion criteria, was three to eight. There was a subjective spasticity disability requirement score and a baseline of two or higher. So this is moderate to severe spasticity. And I think the rest of the - they had to wash off of any previous spasticity agents if they were previously taking a spasticity agent. So that's I think at a high level entry criteria for this study.

Operator

It does appear that we have no further questions at this time. Do you have any closing remarks?

Ronald Barrett

Yes. I'd like to thank you for participating in today's call and for those of you who are attending the AAN conference next week we will be presenting several posters, including the preclinical results for 829 and the results of our 829 Phase 1 trial. We hope to see you there. We look forward to updating you on our progress throughout 2013. Thank you very much. Bye.

Operator

Thank you for participating. That does conclude today's conference call. You may now disconnect.

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