Supernus Pharmaceuticals, Inc. (SUPN) Q3 2017 Earnings Report, Transcript and Summary

Welcome to the Adamas Pharmaceuticals' Third Quarter 2017 Financial Results and Corporate Update Conference Call. All participants are in a listen-only mode. At the end of the company’s prepared remarks, we will open the call for questions and provide specific instructions. As a reminder, this call is being recorded. I would now like to turn the call over 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 I begin, I would like to remind everyone that the 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 statements which 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 most recent Form 10-Q and other SEC filings. I will now turn the call over to Greg.

Thank you, Ashleigh, and good afternoon, everyone. Thank you for joining us today. It's been a very event full and awarding quarter for Adamas as we continue on our mission to improve the lives of patients and their care partners, suffering from neurological diseases. We believe that neurological diseases represent an increasing healthcare burden and cost driver in the U.S. And we are committed to bringing medicines to people impacted by these conditions. Our time dependent biology approach is an idea, whose time has come. With the potential for large and durable clinical benefits. In this third quarter we saw the FDA approval of GOCOVRI, the first and only medicine approved to treat Dyskinesia and Parkinson’s disease patients receiving levodopa-based therapies. This medicine represents the most important proof point today of our time dependent biology approach and a major advance in treatment. Parkinson’s disease as the second largest neurodegenerative disease is particularly burdened some in cost way. In the U.S. medical and indirect cost for Parkinson’s disease were estimated to be approximately $14 billion in 2014, and by 2020 cost are estimated to increase over $20 billion a year. With that background, I am proud to report that GOCOVRI is now available for patients and their physicians through our distribution network with GOCOVRI Onboard. On this call today, Richard will update on how we're preparing for the full commercial launch of this innovative product in January 2018. Also in the quarter, we announced top line Phase 1b data from our ADS-4101 lacosamide program. ADS-4101 is in development for the treatment of partial onset seizures and patients with epilepsy. Consistent with our approach, we have understood the timing patterns of the disease and drug activity. And our advancements in medicine that allows the drug concentration to reach over two fold during the day time when seizures tend to occur, which we believe could generate increased efficacy without comprising tolerability. We expect to meet with the FDA in 2018 to discuss the potential Phase 3 program. In addition, we continue to execute on our plans for taking ADS-5102 forward into Phase 3 for multiple sclerosis walking with there are currently only one available drug which is believe to be effective in only a subset of MS patients. With look forward to initiating that Phase 3 program in the first quarter of 2018. Finally, we are ready to tackle new patient needs with now proven approach. The time is now and we are just embarking on the most rewarding phase of our mission. With that I’d like to turn the call over to Alf, to review our financials.

Thanks, Greg. For the full financial results for the quarter, I’d like to direct you to the press release and Form 10-Q that we've filed today. Let me make a couple of comments of our revenue expectations. Remember that our strategy is to make GOCOVRI available to physicians and patients in need during the fourth quarter throughout a full commercialization in January. As Greg mentioned, GOCOVRI is in our distribution channel and we have received and processed our first prescriptions. To be clear however, we do not expect revenues in the fourth quarter to be significant. The fourth quarter is about gearing up all aspects of our commercial infrastructure and preparation for launch with the deployment of our sales team in January. And these activities are progressing well. As a reminder, we are not giving revenue guidance for 2018, but for the 2018 revenue and expense framework that we provided at Investor day, I refer you to the slides on our website. Finally, moving to our cash position. We completed the quarter with $130.7 million of cash, cash equivalents and investments. In addition, we expect to receive in the fourth quarter the remaining $65 million in funding from HealthCare Royalty Partners as part of our $100 million royalty back financing. We announced last week that we had received a letter from the Office of Orphan Drug Products, recognized in the orphan drug exclusivity that we earned upon approval of GOCOVRI in August. And the FDA has also updated its orphan drug data base. We will receive the funding following the listing of GOCOVRI’s orphan drug exclusivity in the orange book, which we expect to happen shortly. This will provide approximately $195 million in cash resources on a pro forma basis, to fund the company as we prepare for full commercialization in January. With these funds we believe we will be sufficiently capitalize to launch and commercialize GOCOVRI, complete the Phase 3 clinical studies of ADS-5102 in multiple sclerosis walking and initiate a Phase 3 study of ADS-4101 in patients with epilepsy. I'll now turn the call over to Richard, who will discuss progress towards the January launch of GOCOVRI.

Thanks Alf. As Greg mentioned at the beginning of the call, we believe GOCOVRI is a major advance the people with Parkinson’s disease that can partners and for physicians trying to manage their patients' dyskinesia. Dyskinesia represents the turning point to people in that Parkinson’s disease journey. Social withdrawal, depression, pain, risk of injury, poor quality of life and increased care burden are all challenges born by these patients and their care partners. Dyskinesia is a consequence of levodopa-based therapy, the gold standard medicine use to treat the symptoms of Parkinson’s disease. And is characterize by involuntary movements during waking hours that are non-rhythmic, purposeless and unpredictable. These movements are distinct from traumas with Parkinson’s disease, and affect approximately a 150,000 to 200,000 people in the U.S. Prior to GOCOVRI people with Parkinson’s disease taking levodo-based therapy and their physicians face the challenge when treating Parkinson’s disease. As treating the all symptoms of rigidity and stiffness associated with Parkinson’s requires an increase in levodopa dose, but that in turn can lead to dyskinesia. Having a choice of either being dyskinesia or being off is a poor choice to anyone to have to make. To address this challenge, the patients have employed three alternative but on satisfactory strategies. They can reduce or split the dose of levodopa, the most common strategy but across places the patients at the risk of being OFF. Another alternative has been to add amantadine IR, but both positions and patients has been frustrated with the lack of efficacy, sleep disorder challenges and lack of durability of effect from this option. There is also an invasive surgical procedure the brain stimulation which involves the insertion of electrodes into the brain, but dyskinesia can still occur after surgery. With the approval of GOCOVRI, Parkinson’s disease patients now have an FDA-approved medicine, clinically proven specifically to treat that dyskinesia. GOCOVRI not only significantly reduces dyskinesia by about 30% compared to placebo, it also reduce its OFF time by 45%.Aand increase its functional time by about 4 hours a day, as measured by on time without troublesome dyskinesia. This means after the first time, physicians treating Parkinson’s patients don’t have to choose between managing dyskinesia, and treating OFF symptoms. Reacting to this product profile presented in market research, physicians reported they would use GOCOVRI and a little over half of their dyskinesia patients. They specify that they would use it in place of all three of the satisfactory dyskinesia management strategies that they currently use, as well as in patients who are currently not being treated at all for the dyskinesia. With this strong interest from physicians in GOCOVRI identified, let me now turn to the progress we have made in preparing for commercial launch since our last call. Our sales marketing, market access, and commercial operations teams are all now in place. Since this summer, we've been working with an outstanding senior leadership professional, Dean Hart, who is been providing leadership support to us and establishing our sales organization. Historically, Dean was responsible for establishing and running ASI USA sales organization where he launched Aricept for Alzheimer's into the neurology market. In addition, he also led Takeda pharmaceuticals' North American sales organization for many years, building that team from several hundred to several thousand professionals. More recently he is running consulting practice focused on optimizing sales organization performance which is how we initially engaged him. Dean is recently agreed to join Adamas as Senior Vice President Sales. A decision which finalizes the leadership team for the commercial organization on one which I and the entire management team at Adamas are thrilled with. You recall the immediately following approval we hired with the help of Dean’s success standing regional business directors. Since that time we have conducted a recruitment campaign to hire our 59 neurology account specialists. We were able to attract and phone screen over 1600 highly qualified applicants. And we have now filled almost all of the 59 positions with extraordinary talented people. Averaging 17 years the pharma industry experience, 9 years of neurology experience, and with more than 75% of the appointed neurology accounts specialists having specific movement disorder experience. We planned to have everyone on both the disease state and product training in early December, and planned to fully launch the recovery in January 2018. We have also begun outreach to payers and have scheduled clinical presentation with seven out of the top 10 payers in the country for later this year. The payers are particularly interesting in GOCOVRI as a first indication medicine for dyskinesia patients who they recognize are in need. We anticipate broad payer coverage for GOCOVRI. And will grow over the cost of 2018. We’re committed to ensuring access to GOCOVRI for people with Parkinson’s disease, who have dyskinesia. To that end, we’ve launched GOCOVRI Onboard. Our patient support service to provide benefit verification, reimbursement and financial supports, as well as product information for our patient population. GOCOVRI Onboard will be administered through a single specialty pharmacy point of care, to provide dedicated support to our patients in need. Although we’re not yet promoting GOCOVRI to positions, we’ve received our first script, which we’ve processed through our distribution network. And we’re very pleased with the way that the fulfillment and distribution channels are working. Finally, a quick word on manufacturing. I’m happy to say that we have enough drug, and finished in our supply chain to satisfy our anticipated demand well into 2019. With that, let me hand it over to Rajiv.

Thanks Richard and good afternoon. On the approval call in August 2017, I spent a time reviewing GOCOVRI’s newly approved prescribing information. Today I will provide some additional context and we’ll then provide an overview of our recently completed and upcoming medical conference presentations for the remainder of 2017. Since the approval, we’ve received numerous questions about GOCOVRI. And about how it is differentiated from existing treatment strategies for dyskinesia including the use of amantadine immediate release? Some had commented that GOCOVRI is simply a long acting amantadine. This is not the case. First, we did not extend the half-life of amantadine in the creation of GOCOVRI. As indicated in the labels, the half-life for both GOCOVRI and amantadine immediate release is approximately 16 hours. What we discovered is that the CNS related adverse reactions are associated with how quickly amantadine concentration initially rise in the blood and time of day, amantadine immediate release is taken. This limits the unit dose to 100 milligrams and the typical total daily dose to only 200 milligrams. Knowing this, we employed extended release technology to deliberately slow the initial rise in amantadine concentration. Coupled with bedtime administration, GOCOVRI was designed to achieve high sustained concentrations of amantadine from awakening and throughout the day, when dyskinesia symptoms frequently occurred. We confirmed the efficacy, safety and durability of the 340 milligram amantadine hydrochloride once daily dose in the Phase 3 program. As you recall, 340 milligrams of amantadine hydrochloride corresponds to 274 milligrams of amantadine. And second, based on our Phase 3 data, GOCOVRI can be used in a broad Parkinson’s disease population with dyskinesia. And is appropriate for all patients, irrespective of dyskinesia severity or dyskinesia duration. As part of our launch efforts, we’re deploying a six person medical science with the liaison team to educate the movement disorder neurology community on the role glutamate and the mechanism of modal complications, the temporal hazard of the disease as well as the totality of the GOCOVRI data. We’re very excited about the caliber of this team. They’re all highly qualified with many years of industry MSL experience in the CNS and movement disorder space. Now, on to the poster presentation, at the recent annual meeting of the American Neurological Association, we presented additional data on the treatment effect of GOCOVRI on a percentage basis. As you recall, the placebo corrected the treatment effect of GOCOVRI on the unified dyskinesia rating scale total score was approximately 30%. This large treatment is now further -- by the cumulative response curve on the percentage basis, which indicates that approximately 40% of GOCOVRI treated patients experienced at least a 50% reduction in the unified dyskinesia rating scale total score. At the Society for Neuroscience Meetings later this month, we have one poster where we will present the amantadine EC50 data in animal models of dyskinesia. The EC50 is the concentration of amantadine needed to reduce dyskinesia by 50%. Finally at the American Epilepsy Society Annual Meeting in early December, we have two posters on ADS-4101. Our high-dose once-nightly lacosamide investigational product. In these posters, we will present the single dose and multiple dose studies in healthy volunteers. In the third poster, we will present preclinical data that further support our discovery of the time dependence of laosamide. Namely back the rate of initial rise in lacosamide concentrations contributes to CNS adverse reactions. With that, I’ll turn the call back over to Greg.

Thanks, Rajiv. What Rajiv has just outlined, in addition to the approval of GOCOVRI is further evidence that the Adamas has created a scientific foundation and a resulting discovery engine built upon our understanding of time-dependent biology. With the upcoming commercial launch of GOCOVRI, we are fulfilling our corporate strategy of building a multi-product company that discovers, develops and commercialize medicines to treat chronic neurologic disorders. At Adamas, we always start with the end in mind, which is helping patients in need. For that reason we strive to deliver clinically differentiated medicines that provide large and durable clinical effects to improve the lives of people suffering from CNS disorders. These are large costly problems that need solving. We will continue to apply our knowledge and understanding of time-dependent biology to this end. We're very excited about moving forward with commercialization GOCOVRI and having it realizes its potential as a new medicine for physicians and a valuable treatment for patients in need . We look forward to keeping you update on our progress as we continue to deliver on our commitments to patients and their care partners. With that, I would like to open up the call for questions. Operator?

Thank you. [Operator Instructions] And our first question comes from the line of Ken Cacciatore from Cowen and Company. Your line is open.

Good afternoon guys. Just a couple of question around manage care, it sound like and may that's at the notes down that you have meetings set up with 7 out of top 10 or maybe you had meetings. I just didn't catch that? And the follow on to that would be can you give us a sense of how those kind of conversations are progressing maybe a little bit of context? And then also the product is available sounds like you are getting some scripts, can you just talk about general sense of the clinician awareness even ahead of your formal introduction early next year? Thank you.

Ken, it's Greg, thank you for that. I'm going to turn it over to Richard, handle those commercial questions. Richard?

Sure. So, I said that meetings were scheduled. So I'm going to differ on the sense of color about those clinical meetings. Obviously what we are doing in the initial instances, initial introductory phase through our grouping that we've retained banking to communicate with the payers about the availability of GOCOVRI. Those initial meetings are going well. And I just say we're coming up to the point where we have some feedback from the first clinical meetings. In terms of your second question, which was awareness related. The awareness of GOCOVRI is actually is split into two areas actually, you can split it into unaided awareness and then a prompted or raised awareness. In terms of unaided awareness it still relatively low of the brand GOCOVRI, it's in the sort of 10 maybe apatite 20% range. But unaided awareness is actually relatively high. People are aware of the fact but there is a product has been approved to treat dyskinesias in Parkinson’s. And when they asked, that do you know about a product called GOCOVRI, they will come back and say in the majority yes, I am aware of that product. So, prompted awareness in reasonably high, unaided awareness is still relatively low. And that’s inevitable given that we haven’t deployed the sales force at this stage to communicate detail about the brand.

Great, thank you.

Pleasure.

Thank you. And our next question comes from the line of Josh Schimmer from Evercore ISI. Your line is open.

Thanks so much for taking the questions. First a quick one on GOCOVRI, will you be allowing release of the prescription data 2 IMS?

Short and that is no.

Not be releasing, okay. And then...

So Josh, we will be reporting on a quarterly basis on our calls.

Okay, but we won’t be able to follow script data.

Correct.

Okay, for 4101 is there data that correlates lacosamide PK levels to seizure activity in individual patients, I know you had showed that for GOCOVRI and concentration effects correlation. Do you have something similar for lacosamide?

Josh, I’ll hand it over to Rajiv. But if you refer back to our Investor Day presentation the data from the UCB program was presented that showed in analysis of the population that in fact that dose response exist. Rajiv any?

No, it's exactly that. Greg, we presented those data from the UCB program where there was evidence that as a concentration increased, there was a larger effect on the frequency of seizure reduction.

Okay, I think what the 10-Q fillings as you planned to meet with the FDA post Phase 2 in 2018. Is there a Phase 2 trial plan for 4101 or what it maybe you can talk to that next step, before you got to the FDA?

We are preparing for end of Phase 2 meeting right now, Josh that will occur in early 2018. And upon that meeting we'll have a clear sense of what the final program design is that will take forward for Phase 3.

So to be clear the healthy volunteer data is going to account as the Phase 2 component?

To be clear, we have sufficient data to move from the healthy volunteer data into Phase 3, in our view right now. Phase 2 is obviously are to get a handle on dose response relationships. There was no substantial evidence to base anything on with amantadine hydrochloride in a dyskinesia population which is why we had to do a full Phase 2 dose response with GOCOVRI. In this case our view is there is adequate PKPD data to proceed, and are preparing for that into Phase 2 meeting as we speak.

Okay, thanks very much.

Thank you. And our next question comes from the line of David Amsellem with Piper Jaffray. Your line is open.

Thanks, just a couple. So first on GOCOVRI, can you talk about what you think will be this study state gross to net? And is your expectations change at all since your Analyst Day, given that you embarked on conversation with payers. My understanding is the product will be heavily contracted. So just give us a sense of how you expect that to play out? And then secondly in MS [indiscernible] you talked about, you alluded to competitor and payer are working in a subset of patients. I wanted to get your thoughts, preliminary at least on positioning of GOCOVRI versus and Ampyra at least in the context of the proof of concept data that you have already presented? Thanks.

Alfred should tackle that.

Yeah with regard to growth to that. First of all nothing has changed since the Investor Day presentation to affect our comments there. And you may remember we suggested that for this kind of product at this stage we throughout 25% to 35% that’s kind of the reasonable bracket for planning purposes. We don’t have any additional information at this point of to really form a more robust answer. And that will clearly take some time over the course of 2018 to evolve. So, as and when things evolve over the course of 2018. If there is something more specific to say, we'll comment on it. But I think for the time being that was the framework that we suggested investors focus on.

With regard to the second question David, on the MS. It is true there is a product approved that works in a sub population. In fact a program design was based upon that subpopulation response. Our expectation from our Phase 2a data and our understanding of the mechanism of action of amantadine in this indication strongly suggest that we'll have a broader response across all MSL patients. And so in a market where you'll have generic Ampyra present, I think the ADS-5102/ GOCOVRI exciting in this population as its breadth of response, its ability to improve a wide number of walking dimensions both fro Ampyra responders and non-responders. And so that's kind of the business, Rajiv anything to add on that?

Well comment from our Phase 2a study is to further expand on Greg's point is. When we look at the effect of ADS-5102/ GOCOVRIverses placebo, we saw approximately in our four weeks study, a 17% placebo corrected difference in walking speed. That's in the overall study population. And that just goes back to what we believe that ADS-5102 will have affect in a broad MS population based on that analysis, which we aim to confirm Phase 3.

Right. Thank you.

Thanks David.

Thank you. Our next question comes from the line of Tim Lugo with William Blair. Your line is open.

Thanks for taking the question. Can you talk about your interactions or maybe similar work your MSs have had with the patient assistance programs, focused on a Parkinson's patients. Given idea of how many patients might be in these programs. And then also I have heard some interest from neurologist who specialized in other movement disorders like ataxia. Do you have any plans for studying GOCOVRI in other movement disorders?

Tim, let me take the second half first. As you know, amantidine the molecule immediate release form has been studied in a whole host of populations through investigator studies over the years. Ataxia being one of the more interesting compelling once acute traumatic brain injury. But here are host of others that range from mood to hyperkinetic disorders to hypokinetic disorders. And beyond multiple sclerosis walking, we continue to assess. We're going to be interacting with the medical community that GOCOVRIis approved to get ideas and insights about directions we could take. So we're very exciting to embark on this next stage of the journey. With regards to patient assistance programs, not sure how they're coupled to the MSL, but let me let Richard describe what we're doing for patients who are in need in assistance.

Yeah, I think I'll take on a broad level first, and maybe this is what you headed Tim. But there's some broad feedback from marketplace that these patient assistance programs that they gain access to drug and support patients in getting access to drug can work well. But they often be frustrating both at the physician level and potentially sometimes at a patient level. So that is a lead for us in designing our program through a single specialty pharmacy, where the interaction is singular and uniform for both patients and physicians as well as payers by the way. In terms of the management of reimbursement of four patients. And also in terms of the follow-on distribution of products to the patient themselves that also acts as we designed to be a single point of interaction, rather potentially multiple points of interaction for the patient. We've also designed the treatment form which the physician uses in lieu of a prescription to establish the ability for the recovery on board to support patient reimbursement seeking for on behalf of patients as a single page form. It's easy to fill in and we've taken lot of input there from physicians to make sure that is a simple to use form. So I think we've design this patient interactions, patient assistance program well to meet the needs of both physicians and patients. And I hope that's responsive to the question that you've raised.

Tim was that what you're gone for?

Yeah, no that's definitely clarifying. I guess these strips that are coming through that, are those going through the GOCOVRIon board or are those, many physicians you’ve awareness of the product and writing their own scripts independently. Are you hearing any feedback whether the scripts going through reimbursement or being rejected by payers?

Yes, so, I consider it as the first part, which is positions of writing GOCOVRI, sometimes they're writing them on a prescription pad, is going to regional pharmacy and with picking them up and convert them to support through, they'll be onboard. It’s the only through our specialty pharmacy, the only mechanism to gain access to GOCOVRI, it’s not available through a retail pharmacy chain, for example. So, we’re seeing prescription coming, initially through retail. There is a need out there for GOCOVRI, and make their way to our specialty pharmacy. We’re also seeing that physicians are aware of gocovri.com, and they can use gocovri.com to access on treatment form, which gives very clear instructions, as it needs to go to, in order initiate the reimbursement support process for patients. And we’re seeing both of those aspects. And at this stage, it’s still early days, we've only have GOCOVRI available for a couple of weeks right now. But, so far, we’re managing them through the process of reimbursement support, I think efficiently in well.

Great, thanks for the color.

Thanks Tim.

Thank you. And our next question comes from the line of Irina Koffler from Mizuho. Your line is open.

Hi, thanks for taking the question. Can you talk about samples, or you guys sampling, and if so, are they monthly samples, or weekly samples. And then the second question I had was on the R&D expense this quarter. At the analyst day, you’d guided to $21 million to $23 million for 2017 but it looks like we’re going to run over that, just based on what you reported for this quarter. So, was there any accelerated works that you put forward on that anticipated spend?

Thanks Irina, Richard?

So, let me deal with the sampling issue. The short answer is no, we’re not be sampling. What we do have is a quick start program that is six patients as they work through reimbursement issues. And then we provide access to drug free of charge for a period, while those reimbursement issues are result. So, that’s fundamentally in lieu of our sampling program.

And with regard to the R&D spent Irina, as we probably are running a little bit ahead of that. There’s no specific big acceleration unlike that we’re probably running a bit ahead of the numbers that gave you in September.

Okay. And can I just clarify about the treatment form on the team, using in lieu of the prescription. Is that in electronic form to help with e-prescribing or is it something that just factored in?

It’s not an electronic form, no, and still took to format something that will go up with all of the electronic systems out there. It is a PDF form that is palatable with the bulk of the information which generally would apply to a physician's practices up, pre-filled document. And then you just required additional patient information and dosing information to be complete and some signatures. So, it’s an easy-to-use form, with effected moderate as a single page form, which was always had desire, it’s a very easy-to-use form, by physicians.

And Irina, it’s Greg. We just not vary at universally, but by the selection that we’ve made of a single specialty pharmacy partner, which is an affiliate of Walgreens. We feel like we’re going to be how to get there quickly, which is actually important to us as we move forward here and make GOCOVRI and all other products available to patients.

Thank you.

Thank you. And our next question comes from the line of Serge Belanger, from Needham. Your line is open.

Hi, good afternoon. Just a couple fair questions for a GOCOVRI. It sounds like you’ve started meeting with some of the payers and I assume these are commercial plants. What are your expectations to be on formulary with these commercial plans by January for the launch? And then any update on the Medicare billing process?

Okay. So, firstly, most pay of now both, adjudicate both Medicare and commercial plans. It’s just different parts of that business. So, when we meet with a payer, we’re meeting with them both in the half of both commercial and their Medicare plan. In terms of the commercial arena though, have adoption to formulary, typically that process is a 6 to 9 months review process. So, my guess is come January will still be very much in needing to go through supporting medical necessity safety for patient gaining reimbursement support through the mechanism, is a very Tried and trusted mechanism which is using to navigate appropriately. And we think we have do that through recovery on board. So, we are expecting probably the majority of former decisions that going to occur 6 to 9 months post hour, sort of initial in terms of the markets as probably sometime run in middle of 2018. On the Medicare side of things. Folks who have the Part D plan are of suppose to submit that 2009 formularies to CMS in April 2018.And once they have made a decision on that , including a product for 2019 formulary we would expect to have this implement into 2018 as early as possible since they're obviously moving towards that end point. And the reality as well even that the plan misses the April 18, 2019 formulary submission dates they will able to add recovery to that formulary any event, anytime during the cause of the year. So, we are targeting that April 2018 dates to get the majority of plans including GOCOVRI, on to the 2019, formulary submissions And we will anticipate the majority of those was start to adjudicate Part D request of reimbursement alongside of that 2019 formulary very quickly after the April date.

Okay. And then have your marketing materials have been approved thus far? And will they be approved by the launch in January. And I guess Rajiv hinted that there is still misunderstanding in the market that a GOCOVRI is not extended released submitted in, do you feel this could be add a clearly address in their marketing materials or other publication?

So, another comment process kind of approval process for the materials and what I will say is that the physician experience of Amanticidine IR [ph] is in general that its lack the desired efficacy to manage patients dyskinesias but it's inconvenient to use because it's not effective in the morning hours but it cannot be dosed after certain time in the day due to significant sleep related issues and it doesn’t have durability in usage. Against that there’s plenty of dates with our product in our label to support the fact it’s very effective but it's managed its patients early mornings coverage of dyskinesia, but because it's dosed to night, the sleep related side effects are minimized. And it certainly durability based on long term data. So, I feel comfortable and confident but that’s enough of our clinical comparison that we can substantiate in the minds of physicians. I don't know if you want to comment any further Rajiv?

The only thing I would add is from our publication side, we are very focused on ensuring that when one GOCOVRI is discussed in our publication, in our posters for conferences, we are very clear to what I said in our prepared comments about how we use extended release technology.

Okay. Thanks for taking the questions and congrats on an eventual quarter.

Thanks Serge. I appreciate that. Operator Thank you. And our next question comes from the line of Caroline Palomeque from Nobel Life Time Partners. Your line is open.

Hi, so I guess this question is for Richard as well. So when you discuss the potential adoption of GOCOVRI, which you mentioned is about 50%, with decision on. Is this a selection of the patients population that would need to the drive over the range particular concerns or faster decision had?

So in general it is a reflection of the population that needs the drug. This dyskinesia population is a challenging population to manage as I said previously. The terrible choice the physicians have to make between having that patients be underdosing levodopa or having in be dyskinesia by over dosing levodopa is a terrible dilemma both for the physician as well as for the patient. And it really don’t have a tool that they can use that adequately addresses that, GOCOVRI is the first time we have actually got a purposeful, meaningful tool to do it. The only patient population that I think within dyskinesia population that is probably a limitation is a truly really compromised by patient that would be counter indicated. And if we have sclerosis impairments as well there would be some concern, but other than that there is utility for a GOCOVRI and its population.

Okay, that’s helpful. Thanks.

Thank you.

Thank you. This concludes today’s Q&A session, and I will now like to turn the call back over to Dr. Went for closing remark.

Thank you listeners, I appreciate the time everyone has spent with us today. We look forward to interacting with you over the next couple of months and updating on our progresses. We continue the work here behind the scenes and then the formal introduction of GOCOVRI to the community in January. Thank you very much.

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