XenoPort Inc XNPT
Q4 2012 Earnings Call Transcript
Transcript Call Date 03/11/2013

Operator: Good evening. My name is Terri, and I will be your conference operator today. 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. Thank you.

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

Jackie Cossmon - IR: Thank you, Terri. 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 related to future sales of and all commercialization and promotional plans and activities for Horizant, 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 partner, future sales of Regnite, the therapeutic and commercial potential of gabapentin 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 discussions 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 W. Barrett - CEO: 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 reacquisition of the rights to Horizant, and we've been busy preparing to commercialize Horizant starting May 1. Vince will describe our commercial preparation and plans, and then Bill will discuss the financials for the fourth quarter and what we expect financially going forward.

The reacquisition of Horizant represents an exciting opportunity for XenoPort and marks the important transition of the Company into a commercial entity. There remain substantial unmet medical needs in the treatment of moderate-to-severe primary restless legs syndrome, which we'll be referring to 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 1st.

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 determination 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 a large supply of API that will lead to reduced COGS for the foreseeable future. Vince will discuss our targeted 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 net sales. Sales in the third quarter were modest, but I should remind you that in the first year after the establishment of pricing for new prescription product in Japan, physicians are limited to writing prescriptions for two weeks, requiring patients to come back to the physicians’ 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 1,200 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 are also enrolling patients directly into the safety study and we are closed to completing that enrollment. We are in the process of completing entry of the data from the Phase 3 efficacy trial, locking the database, unblinding and conducting the statistical analysis. This process typically takes 8 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 are 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 the 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 I trial in October and initiated two additional Phase 1 studies. One is a multiple ascending dose study examining the safety and steady-state pharmacokinetics of ascending doses of formulation one dosed twice a day, and formulation two dosed 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 radiolabeled 829. We’ve also initiated 13-week toxicology studies for 829 in rodents and primates. All of these clinical and preclinical studies should be completed by mid-year. With these data in hand, we hope to speak to regulatory authorities about potential development paths for several indications, including relapsing-remitting MS, psoriasis, and potentially other neurology and dermatology indications, for which we are conducting medical and commercial diligence.

We are 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 are 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. Vice.

Vincent J. Angotti - EVP and Chief Operating Officer: Thanks, Ron, and good afternoon, everyone. As Ron mentioned, we believe that we’re taking a focused and disciplined approach to our initial commercialization efforts to intelligently deploy resources, confirm return on investment 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, prescriptions for restless leg 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 for the market share close to 85%. According to our estimates the overall neuropathic pain market experienced an annual growth rate of approximately 8% reaching 45 million prescriptions in 2012, with gabapentin reporting almost a 55% share. I will 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 market.

Horizant's prescription count in 2012 totaled about 50,000 total prescriptions. In the fourth quarter Horizant averaged approximately 4,900 prescriptions per month. During the course of 2012 the average size of the Horizant prescription 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 600 mgs twice per day. So a PHN prescription is worth twice that of an RLS prescription. However there has 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 continue to generate approximately 60% of all Horizant prescriptions. Through December of last year, the total number of unique Horizant prescriber since launch was close to 9,000, 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 30th of this year; XenoPort will assume all responsibilities for commercializing Horizant effective May 1st.

We spent considerable time analyzing the current and potential market for Horizant, including geographic distribution of sales, physician prescribing patterns and the payor environment. The goals have been to identify XenoPort’s optimal sales and marketing structure for Horizant for RLS and PHN, with the resources that we have available.

Accordingly, we plan to deploy 40 specialty sales representatives dedicated to Horizant on May 1st 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 the territories based on favorable managed care access to Horizant.

Finally, the CSO arrangement allows the 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 organizations, followed by the sales management team, who had been hired as XenoPort employees. In addition to this 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 a priority position within this team during a trial period from May through December of this year. These sales professionals will direct decile 8 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 personnel promotion.

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

During the process of establishing our wholesale with distribution arrangements as we believe will ensure smooth transition of the Horizant supply chain from GSK to XenoPort, our current assessment is that Horizant's managed markets access, which is largely the result of the (indiscernible) physicians 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 ads, our efforts will initially focus on the availability of tools for May 1st that may reduce co-pay levels for the patients at the point of purchase. Over time we will be evaluating contracting opportunities on select basis that could further expand Horizant access again concentrating resources on geographies with our personnel promotion.

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 as poor even amongst RLS experts. We expect to deploy this marketing resources largely in areas of the country where again we have sales representative coverage.

Finally, we are developing the medical affairs strategy, intended to raise disease awareness and to disseminate scientific knowledge about gabapentin enacarbil. These initiatives will include education regarding recent changes to RLS treatment guidelines. We plan to employ a small MSL team that will be predominantly aligned to the sales team 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 to focus our strategy should allow us to confirm the optimal mix of resources and active templates for potential future expansion.

I will 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 G. Harris - SVP of Finance and CFO: 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. 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. Just to be clear we have not included any assumptions regarding potential future partnerships.

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

Transcript Call Date 03/11/2013

Operator: Michael Yee, RBC Capital Markets.

Michael Yee - RBC Capital Markets: Two questions for the team, one on RLS and 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 am assuming that you are not giving any guidance in terms of – so what is defined as a successful launch and what point do you think there could be a breakeven business year? 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 obviously just recently presented data and has that changed your prioritization, how you're thinking what the next studies could be there?

Ronald W. Barrett - CEO: We are not providing guidance at this point. We understand why that's important, but there is 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 top line 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 are going to put our resources where we think we can generate business quickly obviously current sales of Horizant's are being driven by prescriptions. Beyond these territories, we are covering a large part of it, but not all of it. So, we think we should be measured by the performance where we are 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 trial, 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. 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 and beyond the Phase 1 studies that are ongoing.

Operator: Brian Abrahams, Wells Fargo Securities.

Brian Abrahams - Wells Fargo Securities: Thank you for all the clarity on the commercial plan, Vince. Just starting 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? Then I had a quick financial follow-up.

Vincent J. Angotti - EVP and Chief Operating Officer: 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 in-patient study because obviously this is the first time we have escalated the dose of 8 to 9, 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 8 to 9 to get to the same therapeutic level as the approved dose of BG-12. Why do we do that? For early or later in development, I think it 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.

Michael Yee - RBC Capital Markets: 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 happening attributable to the CSO and sales force build out versus increases in R&D as you advance 8 to 9? And I am also wondering, if that assumes a certain goal for Horizant sales or if you have more flexibility within that and you are 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?

Vincent J. Angotti - EVP and Chief Operating Officer: 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 component of it in terms of AP. We would expect our clinical spend to be kind of similar to what was incurred last year, but we are 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 are 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. 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. 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 for a lot of moving pieces and we’ll be continuing to monitor all these as we go forward.

Operator: Marko Kozul, 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 J. Angotti - EVP and Chief Operating Officer: So what we have 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 auth) are minimal related to the commercialized. That's why we are addressing it with the strategies related to alleviating some of these Tier 3 co-pays to a level at or below a Tier 2 typical co-pay moving forward. So, (prior auth), we don’t believe are a significant issue for this product.

Ronald W. Barrett - CEO: About 70% of the scripts are in commercial plans.

Vincent J. Angotti - EVP and Chief Operating Officer: Horizant scripts.

Ronald W. Barrett - CEO: Of Horizant scripts.

Marko Kozul - Leerink Swann: So 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?

Ronald W. Barrett - CEO: 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 1,200 mg a day of gabapentin enacarbil are effective in treating PHN. On a molar basis, that's equivalent to 600 mg 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 in our label peak-to-trough ratio is 1.5, so only a 50% difference in gabapentin levels throughout 24 hours for the patient. 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: I'll just change – 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 W. Barrett - CEO: 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 comordib 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 level of evidence review. Gabapentin enacarbil was the only alpha-2-delta product 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 order is treated.

Operator: Greg Wade, Wedbush Morgan.

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 G. Harris - SVP of Finance and CFO: 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: So what's the contract call for the dedicated team, what's the net on that?

William G. Harris - SVP of Finance and CFO: We're not going to that level of detail.

Ronald W. Barrett - CEO: Typical of sales reps, Vince could give you –

Vincent J. Angotti - EVP and Chief Operating Officer: Greg, I think how you have to think about it is, it's a syndicated sales team.

Ronald W. Barrett - CEO: No, no, this is dedicated.

Vincent J. Angotti - EVP and Chief Operating Officer: Not only dedicated team. So it's a typical specialty sales team build, so you're looking at fully loaded rep cost 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: There is nothing else in their bag, so you guys are responsible for all of that?

Vincent J. Angotti - EVP and Chief Operating Officer: Correct, that's a team dedicated to XenoPort. The only promoted product we have available is Horizant.

Gregory Wade - Wedbush Morgan: 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?

Vincent J. Angotti - EVP and Chief Operating Officer: 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, we have basically done as a range 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: The MSLs, how many of those folks do you have and are they contract or are they your people?

Ronald W. Barrett - CEO: So, we are building a small MSL team. We 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. Now that's where we are starting, 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: Just one last thing on the sales force, Vince your sales management, is that included within the 40 people that are…?

Vincent J. Angotti - EVP and Chief Operating Officer: It is not so, look what we have employed by XenoPort has been under control of 10 to 1 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: David Friedman, 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, it 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 W. Barrett - CEO: Sure. Yes. 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 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 run-in 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 3 to 8. There was a subjective spasticity disability requirement score and a baseline of 2 or higher, so this is moderate to severe spasticity. 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 W. Barrett - CEO: 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.