Welcome to the Adamas Pharmaceuticals' First Quarter 2018 Financial Results and Corporate Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn over the call to your host, Ashleigh Barreto, Director of Investor Relations and Corporate Communications at Adamas. Please go ahead.

Thank you, Operator, and good afternoon, everyone. Joining me on the call today are Dr. Greg Went, our Chairman and Chief Executive Officer; Alf Merriweather, our Chief Financial Officer; Richard King, our Chief Operating Officer; and Dr. Rajiv Patni, our Chief Medical Officer. Before we begin, I'd like to remind everyone that this call will contain forward-looking statements, which are subject to risks and uncertainties. Any statements regarding future events, results or expectations are forward-looking statements. Please note that these forward-looking statements reflect our opinions only as of the date of this call. We undertake no obligation to revise or update these forward-looking statements in light of new information or future events. Information concerning factors that could cause actual results to differ materially from those contained in or implied by such forward-looking statements are discussed in greater detail in our Form 10-Q filed with SEC. I'd now like to turn the call over to Greg.

Thank you, Ashleigh and good afternoon everyone. And thank you for joining us today. When I founded Adamas 15 years ago, my goal was to build an organization that could discover and bring to market a new generation of medicines that yield large and meaningful clinical benefits to lessen the burden of chronic neurological diseases on patients, caregivers and society. We had a simple idea that developing medicines based upon understanding timing patterns and biological systems and how they manifest in human disease may be just as impactful to patients as developing new chemical entities. We call this our time depended biology approach. The patient experiences with the disease always been our starting point and focus, which has what has made this quarter so gratifying as we hear stories about how GOCOVRI is helping patients in changing lives. GOCOVRI is the first and only FDA approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy with or without concatenate dopaminergic medications. The success of GOCOVRI will be the most important near-term proof point of our time depended biology approach. Although we are very early in the commercialization of GOCOVRI, we have already seen a significant number of physicians writing GOCOVRI and we're hearing more and more from patients, as well as their physicians about positive patient experiences on the medicine. Richard will be providing additional color on the launch later in the call. In addition to launch of GOCOVRI in the Parkinson's disease market, our development pipeline continues to advance with the enrollment of patients in our Phase 3 trial ADS-5102 for multiple sclerosis patients with walking impairment. Finally, I'm very pleased to announce today that we received positive feedback from the FDA which will allow our ADS-4101 program to advance directly into pivotal Phase 3 trial. ADS-4101 is an investigational modified release high-dose lacosamide capsule in development for the treatment of partial onset seizures in patients with epilepsy. As you will recall, lacosamide is the active ingredient of VIMPAT, a blockbuster antiepileptic. We feel ADS-4101 provides Adamas with an opportunity to address a significant unmet need for improved seizure control with manageable tolerability. The goal of our development program is to demonstrate the ADS-4101 improves efficacy with comparable tolerability at 600 mg once daily versus the impact 200 mg twice daily and/or has comparable efficacy with improved tolerability at 400 mg once daily versus VIMPAT 200 mg twice daily. Rajiv will discuss this program further later in the call but we are extremely pleased with the feedback. With that, I would like to now turn the call over to the team to walk through our Q1 progress starting with Alf from the financials.

Thanks Greg, and thank you for joining our Q1 2018 conference call. I'm pleased to report that in our first quarter of full commercialization we recorded $2.6 million in product sales from GOCOVRI. This is recorded on the selling method with revenue recognized typically upon delivery to our specialty pharmacy. For the first full quarter after launch, the total number of fulfilled prescriptions was 1608. This number does not include drug provided QuickStart or patient assistance program. Also as of March, 31 the total number of prescriptions has increased to 550 from 100 at December 31, 2017. While we are very early in our launch, we're very pleased with these indicators of launch progress. Gross and net adjustments were within the range of our expectations for the quarter. Research and development expenses were $7.2 million during the quarter reflecting completion of the EASE LID 2 study, the two-year Phase 3 open label study of GOCOVRI and work in our key pipeline programs. We expect R&D spend to increase over the balance of the year as we enroll patients in the Phase 3 trial for MS walking and prepare for the Phase 3 program in epilepsy. With respect to selling, general and administrative expense, these were $26.4 million for the quarter. This reflects the cost of our sales force and other commercialization costs in our first full quarter of commercial activity. As far as overall operating results, net loss for the quarter was $35 million or $1.35 per share and our cash used in operations for the quarter was $24.8 million. Our cash and investments as of March 31 were $286.7 million. With these funds we are well capitalized to execute on the launch of GOCOVRI, as well as the advancement of the Phase 3 trials at MS walking and epilepsy. With that, I'll pass the call over to Richard for a review of GOCOVRI launch progress.

Thank you, Alf. With the approval and launch of GOCOVRI, Parkinson's disease patients now have an FDA approved medicine clinically proven specifically to treat dyskinesia. In two Phase 3 trials, GOCOVRI not only significantly reduces dyskinesia but it also reduced off. Together this produced an increase in functional time from baseline of about four hours a day as measured by on time without troublesome dyskinesia. This means that for the first time, physicians treating Parkinson's patients with levodopa don't have to choose between managing dyskinesia and treating off symptoms. With a strong data in hand, let me turn to the progress we've made in launching GOCOVRI since our last call. In these early days, the best assessments of progress of a launch in my book is measured by what we call evaluation of awareness, trial and usage. That is the awareness of the availability of the newly approved product, the trial of that new product by the prescribing population, and ongoing usage by and feedback from physicians and patients. In terms of awareness, we measure this by surveying physicians to ask them about their unaided or unprompted awareness of products that have recently been approved or are available and also their aided awareness of products based on selection from a list that is presented to them. We did such an exercise in December 2017 prior to the launch of GOCOVRI and again in March of 2018. In each survey we asked approximately 130 neurologists about their awareness of GOCOVRI. In December 2017, unaided awareness of GOCOVRI was 13% and aided awareness was at 53%. By March following the introduction of GOCOVRI, physician awareness had risen to 56% for unaided awareness and was at 95% for aided awareness. In a very short period of time therefore, GOCOVRI has reached very high…

Thanks Richard, and good afternoon. We continue to demonstrate our commitment to patients through our discovery and development activities, as well as through the education of the medical community and our approach, products and product candidates. I would like to start by providing an update on the ADS-4101 development program. ADS-4101 is our modified release high-dose lacosamide capsule in development for the treatment of partial onset seizures in patients with epilepsy. As Greg announced, the FDA agreed with our proposed Phase 3 program to run a single pivotal forearms study comparing 400 mgs and 600 mgs of ADS-4101 to placebo, as well as the active comparative impact dosed at 200 mgs twice a day. We expect to initiate this study in 2019. If we are successful with our pivotal study, ADS-4101 would be noteworthy. Why? Because of our understanding of the impact of the rate of rise in lacosamide concentrations on CNS tolerability, the 400 mg and 600 mg doses had a potentially improved tolerability profile compared to the impact. Also the maximum approved dose of ADS-4101 would be 600 mgs once daily versus the maximum approved dose of impact which is 200 mgs twice daily thereby conferring greater efficacy. ADS-4101 is a very exciting product candidate, our first epilepsy and represents our most compelling effort to-date to confirm our time dependent biology approach with a pivotal placebo controlled head-to-head trial. I will now turn to ADS-5102 in multiple sclerosis walking. As Greg mentioned, we enrolled the first patient in late March. I'm extremely proud of our team for this accomplishment. As with dyskinesia and Parkinson's disease, we believe that dysregulation of the NMDA receptor and glutamate signaling has been associated with the symptoms of Male Speaker 1:. We believe that ADS-5102 could improve motor function in MS patients with…

Thanks Rajiv. Thank you, Richard and Alf and my thanks to the entire Adamas team for their efforts this quarter. As I said earlier, it is still early in the GOCOVRI launch but we are pleased with the level of acceptance and the use of GOCOVRI across physicians, patients and payers. Stories like the ones Richard recounted inspire us. Our development team continues to advance product candidates into new patient populations like multiple sclerosis and epilepsy. We are also pleased with the growing awareness of how timing patterns affect, how patients feel, how they function and how they live. With that, I'd like to open up the call to questions. Operator?

[Operator Instructions] Your first question comes from the line of David Amsellem with Piper Jaffray. Your line is open.

So had a couple of commercialization and payer related questions. So first I guess for either Greg or Richard. What's your view these days on contracting and I'm sure you get asked us a lot I know I have asked a lot. But wanted to get your sense of your willingness to more aggressively contract given that you may have another competitor, I guess cause a competitor if you will enter the market. So I guess I'll stop there and want to get your thoughts there? Thanks.

Richard you want to take it?

So from a contracting perspective, we’re always ready to identify ways in which we can enhance the ability to patients to get access to GOCOVRI. To-date we have found that we can get that access to patients reason be e stayed forwardly, suddenly we're seeing the overwhelming majority of prescriptions filled I noted earlier on and we are seeing support for the reimbursement of prescriptions whether they are Medicare or commercial prescriptions across the pay universe. But we always remain willing and able to the contract if that is the relevant way to go.

Can I ask you similar related question it may be a bit of a backward looking question but are you surprised regarding the extent to which you are seeing patient having to be step through immediate release amantadine. And I guess maybe another way of asking this is, as you look to broaden the patient audience and presumably get access to patients who are naïve to amantadine. Does that inform in any way your willingness to contract more aggressively?

So, let me just try and pickup on the first point you mentioned stepping through IR you mentioned, I'm not aware of any plan that has a hard step for us through IR amantadine. I am aware of plans that have – I’m interested as to whether IR amantadine has been tried before in patients and has been shown B2B ineffective or not well-tolerated, we've seen that. But I'm unaware of any plan which is a formal step through IR amantadine.

And just to reiterate, as you know amantadine does not have an indication for treating dyskinesia has not shown the type of clinical benefits that we have demonstrated for GOCOVRI. It is tried by a lot of physicians because they have nothing to treat this patient population with. But patients don't stay on it for a very long period of time either in controlled studies or in the studies that we've published of real-world use. And so it leaves a physician having had a experience with amantadine IR but with very few patients who are on it chronically.

May be just to sneak in just a quick follow-up to that, is the population of your LID patients who have been on a course of IR amantadine, is that would you characterize that as a sizable chunk or even significant majority of your LID audience?

Yes it’s difficult to nail it down because you're looking longitudinally over a hosted data sets but certainly I would say somewhere it’s least - it’s around the 50% mark and may be higher than that, it’s difficult trying to get an exact number but I would say that there is good number of patients who have IR experience and we’re not seeing as a limitation to get access to GOCOVRI and the ultimate outcome.

Your next question comes from Josh Schimmer of Evercore ISI. Your line is open.

Looks like you're seeing more scripts per prescriber since your prior update looks like it’s gone from about two to three. You're also adding new prescribers at a rate of around - looks like 35 per week or so. Are these trends that you think are sustainable or are these just to reflect some early pent-up demand an interest in the community?

Thanks for the question Josh, I’m going to have Richard take that.

So, very good question Josh. I think - we’re seeing increasing numbers of new prescribers as we know to come from a hundred at the end of - coming into the first quarter 150 as we exit the first quarter. So we are seeing steady build of prescribers that’s encouraging, that's obviously as our sales team gets to talk with them, gets to share with them some of the background and information on GOCOVRI. In terms of the movement of on the average number of prescriptions per prescriber from 2 to 3, my sense is that we're still in the early days of the launch. We’ll wait to see how that kind of pans out, I would anticipate it is going to continue to increase. Certainly there is a population of dyskinesia patients per prescriber which is significantly sized in this target audience that we’re visiting so there is plenty of scope and room to continue to move that up and time will tell as we continue to commercialize.

Any additional color on the ANDA filing that appeared on the FDA website a few weeks back?

Only that it wasn't really a surprise to us. I think any product that has a type of a promise that GOCOVRI is going to generate a tension from generics. And we will respond in due course, just remind we have orphan exclusivity on this product for seven years and multiple orange book listed patents that extend up to 2030 plus additional pending patents that extend beyond that. So we will be aggressively defending our IP on that and updating as appropriate.

And then two more questions one is very quick one, is 4501 dosed at before bed similar to GOCOVRI or is it different kinetic profile or [indiscernible] profile?

It’s a different profile but it's dosed before bed as well. Rich any…

The plan Josh is bedtime dosing.

So I mean, I guess is the idea similar to GOCOVRI that peak levels occur in sleep to mitigate side effects and so that tolerability and efficacy can be sustained during the day?

So yes, that we can obtain safety and tolerability during the day and it’s also to ensure that the high sustain concentration both to your point during the day, as well as during the night.

And then last question, based on your early markers of success with GOCOVRI how are you thinking about the way this informs either your near-term or long-term planning. Greg I know you've got a lot of things that that you're looking to do with GOCOVRI and beyond, are the early markers informing or changing your strategy for projects and programs?

It’s been very gratifying as I said Josh the notes that come back both from physicians and directly our IR team. But it's too early to have anything that is coming back affect how we think about GOCOVRI and other products at this point so.

Your next question comes from Irina Koffler with Mizuho. Your line is open.

Wanted to follow up on the epilepsy program and the plan for overcoming the patent that is in place right now by UCB and the timing for your program as how it coincides with that, I wanted to understand more about that. And also was hoping you could provide a couple of compounds that we could look to where a new agent came along with more convenient dosing that then displaced an older one or took up some market share or other ones that didn't work as successfully so maybe just give us some background on that.

Great compound questions Irina. If I forget one of them please forgive me. With regards to the first question which is the intellectual property timing, the loss of exclusivity for VIMPAT would appear to occur in early 2022. So during this period of time as we’re developing the product which we are able to do and leading up to that point in time we’re have developed the product. But the product is approved prior to that and really depends on how long prior to that, there are couple of options we can pursue in terms of bringing the product to the market. But at this point it's too early to determine exactly what that pathway would be. But their exclusivity is in place and intact we believe to the first quarter of 2022. With regards to examples, where you change the time dependency and really drive an increased adoption of a product, I would just say they aren’t a whole lot because we’ve been pioneering this approach for the last decade and half. Richard oversaw one early in his career of course with Niaspan and whether there's some couple of Niacin products on the market that weren’t doing particularly well and the launch of that created a much greater use of that product. In the amphetamine area getting the PK profile right for stimulants drove an increase in the utilization not so much due to convenience, but just a better outcome for the patients and of course we believe we’re watching that occur very nascent early days with the active amantadine hydrochloride and providing it in a manner that it really can untap its full potential. So we’re going to continue to do these or couple of examples I gave in the past that motivated us early on, but generally you need to do something much different than convenience to create a real significant change in patient and physician adoption.

If I could have a follow-up on another IT question which is, you have this PK curve for GOCOVRI and do you have IT around this curve, if there was another amantadine product that had either a similar curve or fell on a piece of a curve maybe you could just talk through that item?

So we have a fairly wide array of patents covering the shape of profiles of amantadine and other molecules and the benefits that those confer and Rajiv discussed one of the posters that we presented at AAN which tells a portion of that story. Those patents which relate to the GOCOVRI curve of course are listed in our orange book and need to be certified to by any generic company. But that's not our complete portfolio so that we have other inventions related to the shape maybe called activity a response that we will continue to defend as we brings this product to patients.

[Operator Instructions] Your next question comes from Geoff Porges with Leerink. Your line is open.

This is Gerard on for Geoff. Congrats on a very solid first quarter of launch. My questions are first of all, could you give a little bit detail about the concentration of the current prescriptions and what I mean by that is, are there 15 to 20 docs accounting for 40% of the scripts or is it relatively spread evenly. And could you also comment on transfer repeat prescribers and then lastly I guess for Alf, do you think this gross margin is what you think will persist going forward? Thanks.

Richard you want to pick up the first two.

So in terms of concentration of current prescriptions, I mentioned in the comments that we've got some physicians who have already moved a good number of their dyskinesia patients to GOCOVRI and we got a good number of physicians who are still early in that trial final phase of the product and have got a patient that they are seeing how they progress before they make a decision to move them on and go to a broader number of patients. I think I wouldn't call it either concentrating on not at this stage where we’re doing what I think the majority of products do as they come into marketplace. You got an adoption sequence that is based on the nature of the individual physician as much as anything else. Some physicians are all in early, they are early adopters of any product. Some physicians are more measured, they're trying to solve a particular problem and they take that solution to a problem to a test vehicle to decide how to handle and manage it. And I think we’re right in the middle of that. So I think it’s too early to call either concentrated or otherwise, we’re exactly why I would anticipate we would be for the end of the first quarter and seeing physicians move through from trial into more sustained usage. In terms of trends for repeats, we’re not commenting on that at this stage, it’s still too early to kind of talk about that. We again with our product that we launched and made available at the end of October than formally launched in January and here we are at the end of the first quarter conference call, it’s too early to provide any commentary that would make sense at that stage, Gerard but suffice to say we are seeing we feel occuring.

And Alf just quick comment on the…

Yes, on the gross margin. Gerard as it’s very, very normal for a new launch our gross margin is impacted by the fact that we have materials that were expensed to R&D prior to approval that’s normal accounting process. So, we had material that we procured inventory built up anticipation of the approval last August and also a second manufacturing site that was approved back in January. So, a significant amount of material because the previous expensed gross margin at the time. So you should expect that to continue for certainly this year and into next year and then it would be a more normal sort of margin for this kind of product.

Your next question comes from Tim Lugo with William Blair. Your line is open.

This is Ashiq Mubarack on for Tim. Thanks for taking my question and congrats on the quarter, looks really good. I wanted to ask quickly about your prescriptions the 1608 number. I wanted to know if that included any off label use or if you’re seeing any off label use now and can you comment on how many unpaid scripts there were during the quarter. And then my second question was on the OSMOLEX product which I think they recently released pricing which puts it may be around 5400 a year. What do you think of that price point, did that surprise you at all and I would love your general thoughts there? Thanks.

Richard, I mean why don’t you try to answer those.

So in terms of the 1608 prescriptions and their nature. The overwhelming majority of our prescriptions are captured under the description of dyskinesia with Parkinson's disease. Inevitably we see some prescriptions that are not consistent with that indication but the overwhelming majority are Parkinson's disease, dyskinesia. From a OSMOLEX perspective let me kind of first take a moment just to make sure folks think of OSMOLEX. OSMOLEX obviously is approved as a once daily version of amantadine immediate release which is the reference part against which they are approved. The product has no new clinical data that we are aware of setting nothing that’s expressed in the labeling that’s been approved for the product. And certainly specifically there is no data that we’re aware of in dyskinesia. Contrast that for a second with GOCOVRI where PK profile is designed to marry with the timing of dyskinesia in Parkinson's disease for patient's, the indication is specific for dyskinesia. The data is lots of it is available to support using in Parkinson's dyskinesia. And we’re now getting really strong and positive feedback from both physicians and patients relative to their experience. I think that the challenge for OSMOLEX will be whatever the price point is, that the comparison will be to amantadine IR in the first instance and whether that price point is worth paying for the convenience of a once daily version of amantadine IR. So, that would be the commentary I would give you.

Could you - I don’t know if you mentioned this but are you able to quantify how many unpaid scripts are out there under your starter programs, any idea what they look like?

So I will tell you that we obviously have two programs a QuickStart Program that get early access to patients who are waiting to see what happens with their insurance. We have also a Patient Assistance Program both of those are modestly used, very modestly used and generally we’re seeing reimbursement for prescriptions happen quickly which means that there is no need for the majority of patients for access to QuickStart Program.

Thank you. And I’m showing no further questions at this time. I’d like to turn the call back over to Greg Went for closing remarks.

So thank you everybody for your time today. A very exciting quarter for us and again I want to thank the folks at Adamas for delivering. We look forward to seeing you at upcoming conferences and reporting on our continued progress on our next call in August. Thanks very much.

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you all may disconnect. Everyone have a wonderful day.