Supernus Pharmaceuticals, Inc. (SUPN) Q4 2018 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Adamas Fourth Quarter 2018 Financial Results Conference. At this, time all participants are in a listen-only mode. [Operator Instructions] And now it is my pleasure to turn the call to Mike Biega [ph] of Investor Relations.

Thank you, Operator, and good afternoon everyone. 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 today. I'll now turn the call over to Dr. Greg Went, Our Chairman and Chief Executive Officer.

Thank you, Mike, and good afternoon everyone. Thank you for joining us today. I am here with Alf Merriweather, our Chief Financial Officer; and Dr. Rajiv Patni, our Chief Medical Officer As we reflect on our first quarter of commercialization of GOCOVRI, we are pleased to have closed out the year with $34 million in sales, and approximately 15,500 total prescriptions. More importantly, we brought the significant benefits of GOCOVRI to Parkinson's patient to reduce both dyskinesia and OFF time. As we look forward to 2019 with a strong year-end cash position, we are focused on the two most immediate drivers of value to patients and shareholders alike. First, we are focused on advancing the commercialization of GOCOVRI, and second, we continue to advance a potential additional indication for GOCOVRI for the treatment of walking impairment in patients with multiple sclerosis. As we disclosed earlier in the year, we expect to have top line data in the second-half of this year from our ongoing Phase 3 study in this population. Rajiv will provide more information on this opportunity later in the call. In 2018, we had a strong start to GOCOVRI commercialization. We are energized about both GOCOVRI's ability to positively benefit patient, and its robust market opportunity. In 2018, we met our overall goals introducing GOCOVRI as the first and only FDA approved medicine for the treatment of dyskinesia in patients with Parkinson's disease. In 2019, we expect to continue to expand the use of GOCOVRI by broadening prescriber adoption, and increasing positive prescriber and patient experience. Our confidence comes from the larger effect on reducing both dyskinesia and OFF time, resulting in a 45% increase in functional time, the rapid penetration of GOCOVRI in certain areas in which prescribers who understand GOCOVRI science are treating a broad spectrum of patients, and seeing firsthand GOCOVRI's impact on those patients. And once patients experience the benefit of GOCOVRI, they generally remain on the medicine. In 2018, patient persistence for GOCOVRI was nearly 60% at six months. This real-world strength and persistence is generally consistent with our clinical trial experience. We see these as conformation of both GOCOVRI's efficacy and its market potential. Since our last call, we completed extensive field research, and implemented changes to our commercial execution to expand the GOCOVRI experience. Firstly, we have evolved our promotional messaging. The revised messaging enables our neurology account specialists to more widely and more effectively communicate the scientific rationale for the clinical benefits of GOCOVRI. Specifically, we condensed our messages into a compelling and cohesive four-pillar GOCOVRI narrative that emphasis its demonstrative benefit in terms of less dyskinesia and less OFF without adjustments to levodopa dosing, its demonstrated efficacy and safety profile, the diurnal [ph] role glutamate hyperactivity plays in dyskinesia and OFF time, and finally, GOCOVRI's unique bed time dosing and administration allowing for PK coverage upon waking. In addition, we deployed new selling tools, including new disease state insights, patient profiles, patient video clips, and mechanism of disease and mechanism of action animations, all to better educate prescribers. Secondly, as we explained on our Q3 call, we were focusing execution efforts on the regional centers which treat a substantial portion of the 150,000 to 200,000 patients we are seeking to reach. We have equipped our neurology accounts specialist with tools to distinguish between those movement disorder specialists that use amantadine as a part of their treatment toolbox and those who don't. In certain regions, we are seeing strong adoption of GOCOVRI by the first group, who understand the challenge of treating both dyskinesia and OFF without worsening either, but slower adoption by the second group, many of whom use less levodopa as a means of managing or avoiding dyskinesia at the expense of more OFF time. Moreover, this group does not typically use amantadine immediate release, because in their experience it is associated with limited efficacy and/or poor tolerability. For this latter group, we believe based upon market research and confirm through field feedback that we need to more strongly emphasize the connection between dyskinesia and OFF time and the role glutamate hyperactivity plays in the occurrence of both as PD progresses. This education will help prescribers appreciate their patient's journey as well as GOCOVRI's unique ability to reduce both dyskinesia and OFF as an adjunctive non-dopaminergic therapy, so they don't have to leave their patients off. Importantly, our neurology accounts specialists are now better equipped to tailor information to prescribers based upon their approach to treating underlying Parkinson disease. We see educating those clinicians seldomly using amantadine as a substantial opportunity to expand the breadth of GOCOVRI prescribing. Finally, we have evolved our Quick Start program into a broader free trial program to allow more prescribers and patients to readily experience firsthand the benefits of GOCOVRI. This option will also potentially encourage trial of GOCOVRI in a broader array of patient with dyskinesia consistent with the population in which GOCOVRI was studied. We see as a proof point, our learning from 2018 that we needed to better educate prescribers about the appropriate use of GOCOVRI and the availability of the 68.5 milligram starting dose for patients with moderate to severe renal impairment. Many PD patients are elderly and less more likely to have renal impairment. Such patients not properly dosed on GOCOVRI could have, and in some cases, have had negative experiences on the medicine with the occurrence of adverse events. Accordingly, we armed our field team with specific messages around appropriate dosing, and added the 68.5 milligram dose as a reduced dosing option on our treatment front. We are already seeing a positive impact of this approved education. We believe that advancing prescriber education and positive experience of GOCOVRI through these and our other commercial efforts will drive the use of GOCOVRI going forward. We are excited about the potential of these approached which are live in the field today. Of course, we are still relatively early in our launch, actively learning, and we expect it to take a few quarters for these improved execution efforts to take effect. During this time, our results may continue to fluctuate quarter-to-quarter. As we look back on the latter part of 2018, we specifically note a slowing in the rate of total prescription growth quarter-to-quarter, which we see continuing into the first part of 2019. While seasonal phenomenon maybe playing some role in this, we are focused on the improved execution previously mentioned in order to expand GOCOVRI use and adoption in 2019 and beyond. Success for us for GOCOVRI is it to be widely considered the key adjunctive therapy for levodopa and other dopaminergic therapies, as a part of a treatment strategy to reduce both dyskinesia and OFF time for Parkinson's patients, thereby allowing prescribers to target functional time as their treatment goal. That in fact has started and our job now is to expand it. With that, I'll turn over the call to Alf. Alf?

Thanks, Greg, and thank you all for joining our call today. As we announced in January, through our first year of full commercialization, we recorded GOCOVRI product sales in the amount of $13.3 million for the fourth quarter, and $34 million for the full-year 2018. This was recorded on a solid method with revenue recognized typically upon delivery to our specialty pharmacy. For the fourth quarter, the approximate number of total paid prescriptions was 5,730, compared to 4,740 in the third quarter. Total prescriptions for the year were approximately 15,500. An important indicator of the performance of GOCOVRI is that persistence expressed as a percentage of patients who remain on drug after six months remained strong in 2018. Regarding expenses, I am pleased that we ended 2018 with full-year R&D and SG&A expenses of $39.3 million and $109.1 million respectively, below the low ends of our guidance ranges by approximately point $0.7 million and $6 million respectively. Regarding our overall operating results, net loss for the quarter was $28.9 million or loss of $1.6 per share in both cases reduced from the immediately preceding quarter. Overall use of cash for the quarter was $22 billion, about the same as in the third quarter. Cash and investments as of December 31, 2018, were $211 million, positioning us well to execute on the strategies discussed earlier in this call. Let me know turn to our outlook for 2019. We expect continued total prescription and revenue growth for the year based upon the benefits of GOCOVRI and the commercial initiatives to drive demand that Greg noted. Because we're still very early in the commercialization of GOCOVRI, we're not providing prescription or revenue guidance in 2019. During 2019, on a quarterly basis, there may be some unevenness in the trajectory over coming quarters, specifically, there are a number of seasonal factors that in fact can impact all pharmaceutical companies that may affect our results in the first quarter and potentially into the second quarter, including the Medicare Part D donut hole and New Year coverage and plan changes with deductible resets. In addition, our new free drug trial program while expected to benefit the amount of total prescriptions for the year could have a negative impact on pay prescriptions in the near-term. Turning to our operating expenses, we are providing the following full-year 2019 expense guidance. We expect R&D expenses of $35 million to $45 million, and SG&A expenses of $120 million to $130 billion respectively, including stock-based compensation. Such stock-based compensation expense for R&D and SG&A is expected to be approximately $3 million and $15 million respectively. I'll now pass the call for Rajiv to comment on progress in our development program for ADS-5102.

Thanks, Alf. I will begin by reviewing our 570-patient Phase 3 trial in multiple sclerosis, which is enrolling very well suggestive, we believe have of a strong interest on the part of both the MS physician and MS patient communities. We had targeted completion of enrollment by the end of 2019. And as we reported in January, we now expect completion of enrollment in the first-half of 2019 and top line data in the second-half of 2019. Since walking impairment is a central feature of MS progression and morbidity, and dalfampridine is the only FDA approved medicine to improve walking speed. The primitive walking impairment remains a significant unmet medical need. Additional medicines with different mechanisms of action are needed to improve walking speed and improve other aspects of walking such as functional mobility and walking distance. We are very excited about the pending data from this trial. I'm happy to announce the American Academy of Neurology, AAN, has accepted our abstract for presentation at their upcoming meeting in May 2019. In the Congress Poster, we will present the study design and baseline demographics. First, on the study design, I would like to remind you, we reviewed the design with the FDA at the end of Phase 2 meeting, and to emphasize that in the study we are evaluating the effect of ADS-5102 versus placebo on walking speed, as well as functional mobility and distance. Functional mobility, which involves balance and transfer, will be assessed by the timed up and go test. Distance will be assessed by the two-minute walk test. Taken together, these measures constitute complementary measures of walking or ambulation, coupled with the 12 item multiple sclerosis walking scale, we seek to generate robust data with ADS-5102 using both physician assessments and a patient reported outcome. There is one other study designed feature I would like to draw your attention to. We're enrolling patients with reduced walking speed, which by protocol is defined as the following. The patient completes a 25-foot walk in eight to 45 seconds. This broad population is composed of the expected two subgroups. Patients treated with dalfampridine in the past, that is the prior dalfampridine subgroup, and those who were never treated with dalfampridine in the past. That is the dalfampridine naive subgroup. In the baseline demographics page of The Case Report Form, investigators will provide the reason dalfampridine was discontinued in the prior dalfampridine subgroup. Thus far approximately 50% of the enrolled population was treated with dalfampridine in the past. This subgroup is reasonably sized as we expected. Moreover, the statistical analysis plan includes pre-specified subgroup analysis. Based on our Phase 2 data and of course subject to Phase 3 confirmation, we expect ADS-5102 to have a consistent treatment effect irrespective of prior dalfampridine use. In conclusion, our thesis on the potential role of ADS-5102 in walking impairment in patients with MS pending Phase 3 data remains unchanged: Number one, a relatively large treatment effect in a broad population using complementary measures of walking; number two, approximately 30% to 35% of patients experiencing at least a 20% improvement in walking speed; number three, a treatment option in dalfampridine failure. With that, I will turn the call back over to Greg.

Thanks, Rajiv. So, to summarize, we plan to continue to focus in 2019 on our two most immediate drivers of value, patients and shareholders alike, our current updated commercialization of GOCOVRI to benefit more Parkinson's patients and advancing the potential additional indication for GOCOVRI in multiple sclerosis. As to the latter, we look forward to seeing top line results of the Phase 3 study later in the year, and continuing to communicate with you about the commercial opportunity we see in this population, which we believe is substantial. Our experience commercializing GOCOVRI is preparing Adamas to effectively seize that opportunity as well. We remain committed to our mission to bringing the benefits of our time-dependent biology approach to an increasing number of patients with CNS disorders. I'd like to have my thanks to the entire Adamas teams for their contributions this quarter. And with that, I'll open the call up for questions. Operator?

Thank you. [Operator Instructions] And our first question is from David Amsellem with Piper Jaffray. Please go ahead.

Thanks. So, just a clarification question on 2019 and the outlook for GOCOVRI, so should I take your comments to mean that you are backing off your prior guidance that prescriptions or share would double? And I guess the second part of the question is, I guess, in the absence of guidance, are there any kind of guideposts that you could point us to regarding the trajectory of the product, particularly considering that you had provided certain clear markers regarding expectations last year? How should we think about that? Thanks.

David, thanks for your question. Listen, as we started with the third quarter call and reiterated today, our goal right now is to drive growth in TRx through the strategies I just described. We then implemented a number of these in the last few weeks at our National Sales Meeting, as we came off the call and really spend the fourth quarter developing the materials and the newer tools that we have rolled out to the field. So they are now all live in the field. As we look back from the end of last year, as I mentioned on the call, we did see a slower rate of increase in the TRx, and given that trend in the end of the fourth quarter and going into the first quarter, are not going provide any specific TRx guidance this year, or revenue guidance. So, we will continue to drive that growth through spreading the GOCOVRI message, broadening the GOCOVRI message around, and it's typical early -- still in launch, we are really not in a position right now to guide quarter-over-quarter for this year.

Okay. And then as a follow-up, so when you are talking about the OFF time benefits and emphasizing that as part of the overall detailing message, I guess, what I am struggling with here is that OFF time -- are -- the benefit is in the label, this is not new. So why wasn't that part the initial commercialization plan, and given that it's already in the label and that presumably, movement disorders specialists are aware of it, what kind of incremental benefit can you get out of that refined marketing message?

So, I think David -- and I think you have experienced this in many, many, many launches. It is a learning experience. And certainly we have done nothing to change the label for GOCOVRI. It was always positioned in Section 14 of the label. But what we have learned through the course of the three quarters of launch and additional research, it's just how to pull the messages together for our neurology account specialists to impact the broadest possible audience of physicians, in particular, those movement disorder specialists who are less familiar with amantadine, who may predominantly employee dopamine sparing and dopamine adjustment strategies in their treatment of Parkinson's. And as learn during the launch, there are ways that we can better tell that story, put that story in our NAS's -- in our Neurology Account Specialist's hands. We are also focusing on that just remarkable diary data sitting there in Section 14 that highlights the ability to reduce the OFF, the ability to increase the functional on time. So it's really refinement, learning from what works and what works at the top -- in the top neurology account specialist hands, and then beginning to apply those learnings towards the rest of the U.S. and rest of the territories.

I will jump back in the queue. Thanks.

Thank you. Our next question comes from Johnson Butler with GMP Securities. Please go ahead.

Hi, it's Roy [ph] on for Johnson. Thanks for taking the question. I just had one, if you could give us an update on the development plans for 4101? In 2019, your R&D expense guidance seems [indiscernible] Phase 3 start, that's the first question. Thanks.

So with regards to -- thanks for the question, Roy, in terms of 41, we continue to work on establishing the clinical supply and manufacturing infrastructure for the program. We continue to focus on a loss of exclusivity date for VIMPAT in the early part of 2022, and we will be providing updates as move that product forward into an announceable clinical study, but until then, we are going to minimize our comments.

Okay. I had one more on 4101, maybe you can't answer it, but was there anything unique in the FDA feedback to the program versus other adjunctive treatments -- epileptics? Thanks.

Thanks, Roy. The feedback that we are operating -- actually, Rajiv, why don't you handle that question?

Yes. As we have previously reported, the 4101 development program is centered on efficacy trial in the adjunctive setting in patients with refractory partial onset seizures.

Okay, thanks a lot.

Thank you.

Thank you. Our next question is from Tim Lugo with William Blair. Please go ahead.

Thanks for the question. Was the backing off of your prescription goals for 2019 driven by something which occurred in the past two months? And if so, should we be modeling some sort of reset in Q1? Can you also discuss your thoughts around GTN for the year? Shall we still expect high teens, low 20s?

Tim, thanks for the question. The answer to the first question is no, it's just based upon our ability to provide real -- real quarterly annual revenue guidance and TRx guidance, nothing in the last two months, but really what we are seeing right now and how we are focusing all of our energies on driving that right now. So given the stage we are in launch, given the quarter-over-quarter fluctuations, we are not going to be providing guidance until those items stabilize. In terms of GTN, Alf?

Yes. No change in our expectations too from what we previously said.

Okay, fair enough. And sequentially should we be expecting growth throughout the year in GOCOVRI in terms of just net product sales?

Tim, what we think the current trajectory, which is, it's just very difficult to model as you know, four quarters into a launch. We are pleased with where it is overall. The strategies we are implying right now are specifically intended to drive TRx and adoption into the areas where we are seeing lesser performance. We are very enthused by what we are seeing in some really core areas as adoption has occurred both broadly and deeply, but we still need to make progress, and we believe the tactics we are laying out are going to allow us to grow. And we will be monitoring it and reporting it to you very carefully as the next couple of quarters proceed.

But just one very specific sequential aspect in the Q4 to Q1 transition is affected by the things that we mentioned in our prepared remarks, in terms of the sort of Part D donut hole and insurance plan recess at the beginning of the year. Those certainly with every pharma company should be expecting to have an impact sequentially as you look into Q4 to Q1 on both revenue and potentially on prescriptions.

Okay, thanks. I will hop back in the queue.

Thank you, our next question comes from Ken Cacciatore with Cowen and Company. Please go ahead.

Hey, guys, thanks. Just a couple of questions here, just -- I am a bit confused maybe like some of the others, trying to understand, first, if you could at some point could give us new prescriptions, that would be helpful, because I want to ask about tolerability. It seems you are talking about fluctuations are slowing prescription growth, I'm just trying to understand, is there any issue with tolerability, and wanting to understand the retention of patients that's just one question maybe you can discuss it for us? And then maybe talk about some of the clinicians that are currently prescribing, are you seeing them writing more or you are seeing some of these clinicians writing less, just really confused by the commentary, at this point I would think clinician had touched the product that we wouldn't have a slowing, and you are not being able to give us a little bit more color on the go forward? Thank you.

Several questions there, Ken, Greg, thank you for those. Let me take the tolerability first. The tolerability we are seeing, we comment on the last call that we attributed some of the prescriber experience to tolerability concerns. And it really does show up in two places. One is physician adoption as they have their initial experience with GOCOVRI, and we observed and I commented on in my prepared remarks that if a physician did not properly account for the renal impairment state and dose put too higher, but initial dose of GOCOVRI, that could and we noticed that did lead to some negative physician experiences. As you recall, way back to the second quarter call, we talked about some of the trialing and the [indiscernible] experiences, and I would talk chuck [ph] some of those [indiscernible] not being favorable to that. So we made a change, we learned, we made a change, and we've seen a substantial increase in the utilization of the 68.5, just the pace based upon the messaging we rolled out in the fourth quarter. So, we think that one is receiving well right now. We think there's a better dialogue going on between our team and the offices to make that happen. The other major measure of tolerability is how do people persist on the product? And clearly, we are seeing a level of persistence, a level of durability that matches nearly our clinical trial experience with GOCOVRI, which is very much in contrast to what physicians are used to with add on treatments in this area. There's just -- the evidence is very strong. So it's really not -- that's not the phenomena we're working with. The phenomena that we are seeing and that we are driving hardest towards is where we have an understanding of the OFF dyskinesia axis and the benefit that GOCOVRI can provide, and it maybe the underlying scientific rationale. In those areas, where we see the greatest success, we are attempting to learn as much as we can from those -- what our sales force is doing in those areas, what's happening in those geographic areas, and really apply those learnings broadly to the rest of the country. And we're still in the process of doing that, Ken, and are focusing our energy right now on those lessons learned and bringing -- rolling out to the field those tools that we think will allow them to recognize better and message more successfully to drive that initial adoption. Finally, we have altered our free drug program, so that people can experience GOCOVRI prior to completing, just making it more readily-available prior to completing their coverage process, and we think that may and hopefully be a great driver here over the next couple of quarters to get the TRx's growing to where they need to grow for us to achieve our goals.

Okay. Thank you.

Thanks, Ken.

Thank you. And our next question comes from Tazeen Ahmad with Bank of America. Please go ahead.

Hi, thanks for taking my questions. So, just wanted to ask you a little bit more about your plans to allow free trial for full 28 days, would you allow patients to extend beyond that?

No, it's a 28-day program, Tazeen, at this time.

Okay. And then wanted to get your thoughts also on how you're thinking about the overall ramp. So if you're not giving guidance on specific numbers on script gross, where do you think you can guide us to where the growth could be? Is the growth going to come from doctors that have already been prescribing it or are you looking more to growth from new prescribers?

Great question that kind of ties into Ken's. Where we're seeing adoption that we're pleased with in those areas, what we're seeing is both a breadth of adoption in an area, as well as a dept of adoption, and physicians are continuing to prescribe GOCOVRI and we see them deepening that as is common in the launch of a new product. Where we need to be successful with the efforts that we're laying out that we've just introduced to the field in the last couple of weeks is in areas where the adoption is not as deep, where the number of experiences the physicians have had are not as significant as I'd like to be. And we believe from what we've seen that the market is every bit as big as we thought it was, based upon how the top areas are performing, but in those areas where we're not seeing that performance, we really need to get, you know, if you will, the fire started, get that deepening beginning, so that physicians and then neighboring physicians can see the impact that GOCOVRI can have both on their reduction in dyskinesia, but their ability to manage these patients more effectively through the improvements and reduction and OFF time as well.

Okay. And then the last question, Greg, is about your payments for your royalty-backed HDRP now. Can you give us some details about that? For example, when it's due and the amount that you're paying out?

Tazeen, it's Alf. We make payments, [indiscernible] and royalty on GOCOVRI revenues. There's also the first $15 million annually of Namzaric revenues that come in at 2022 to 2025 timeframe. So the cash payments are the royalty-based, revenue-based, which makes it very flexible structure. There's a coupon rate of interest that is paid out of the royalties that actually is picking the first nine quarters, so that interest is still being accumulating into principle for the time being. So, there is no fixed amortization schedule of that. Originally it had a term of 10 years non-recourse to the company. That's a very flexible revenue driven to the cash flows be paid over time, but to base on royalties not on a fixed amortization schedules. Any royalties in excess of interest goes to pay down the debt.

Okay. Thank you.

Thanks, Tazeen.

Thank you.

Thank you. Our next question comes from Marc Goodman with SVB Leerink. Please go ahead.

Yes. Hi, two things. First, is the more aggressive free drug trial program really the major change with respect to how you're more -- how you're viewing 2019 and how you don't want to provide guidance, and how things have changed a little bit with respect to prescriptions and paid prescriptions, I'm assuming because we're going to have prescriptions, it's just not going to be paid prescriptions, right? And then second question is can you talk about the milestones for this year with respect to IP, and what we're going to be looking for as the year progresses? Thanks.

Marc, thanks for both of those. Let's make sure I can remember them both. With regards to the contribution of the free trial program, we've been reporting only paid prescriptions since we brought GOCOVRI to the market. And so, there's no question that a part of our belief today is driven off of how would that program roll out, what percentage of prescriptions will use the free trial as a front-end to a paid prescription? And so that does affect our view point not of the long-term opportunity, we're taking this move because we believe based upon what we've seen that we need to -- in order to expand a physician experience with this drug, provide them this. We think it'll perform better than the Quick Start program that we had in place for the first 12 months of commercialization. And so, that definitely factors in to what Q1 from a revenue and from a total paid prescription is going to play out, because of how many -- what percentage of folks received 28-day is unknowable at this point, having…

And how long would that program be going on?

I don't have any comments, but it's going to go on as long as it works. So, as long as we can drive prescriber experience, we will continue to have it. We will evaluate it of course on an annual basis, but I will take a look at as it's going on. With regards to IP…

Well, hold on. Before we move on guys, I just want to make sure, just clear. So, the donut hole, everybody understands that, plan changes we all understand that, that's across the industry, and then your third comment was about the free drug trial program. So that really is the only thing that's a little bit different from how you would view the first quarter if we went back three months or four months. Is that fair to say or is there anything else?

Yes. Those are the -- those really are the major changes complemented with our efforts to drive TRx demand.

And that's also the reason why you mentioned that it may have some impact into 2Q, because you maybe keeping that program into 2Q as well?

It will be in place for this calendar year, and we will evaluate at the end of this calendar year for continuation next year.

Got it, okay.

And then, on the IP calendar, we obviously have two ongoing litigations, one with Osmotica, patent infringement and one Paragraph Four with Sandoz. Obviously not going to comment specifically on litigation, but the calendar is a mid-year marksman in the Osmotica litigation, and the marksman in the Sandoz litigation is in the first part of next year.

Thanks.

Thank you. Our next question comes from Ram Selvaraju with H.C. Wainwright. Please go ahead.

Hi, thanks very much for taking my questions. Can you hear me?

Yes. Hi, Ram.

So just very quickly a few things for all of you I guess, firstly, maybe the first set is for Alf. Could you give us a more clear breakdown of G&A versus sales and marketing spend as it pertains to the guidance you've given for 2019 and then could you also give us an update on what the full current headcount is along with the current estimated headcount, specifically in administrative positions please?

Ram, we don't break out our expense externally beyond SG&A. So I can't really give you much feel on the SG&A bucket, SG&A and R&D are the two categories that we report by. So I think if you look at the guidance, we're fairly consistent with last year. So, the pattern of spending isn't going to be significantly different. I'd say if anything the change will be in the commercial piece rather than the administrative piece, but there's going to be some movement in both. So can't really give you any specifics on that. And with regard to headcount, there is a -- we do disclose that in the 10-K by certain categories. So I'd refer you to that for those details.

Okay, thanks. With respect to the free drug program, I know several other people had asked about this, but maybe you could give us some more color on whether we should be thinking about it in terms of you using it as a potential response to OSMOLEX or not? And also if you have any color on how aggressively you're seeing Osmotica pushing OSMOLEX as a product at this point? That would be helpful.

So with regards to the –- thanks, Ram. With regards to the free drug trial program, we launched with a Quick Start program which allowed us to kick in free drug if the adjudication process on the claim had not progressed to completion by day five. We inaugurated the Quick Start and this was, I would say, a bit of a minority approach but it worked actually extraordinarily well in the areas that we had up tick for the first 12 months of the launch, but we did observe and we did listen to the field that those physicians officers who were so accustomed to samples and other forms, programs that would precede their reimbursement experience that we felt it prudent to put this in place and made that decision really without consideration and before considering anything with regards to the introduction of OSMOLEX. With regard to the introduction of OSMOLEX, we understand it has launched, we understand from our field that it is available but we're not really seeing a whole lot of data at this point, or getting a lot of feedback at this point that that product is a hindrance to the adoption of GOCOVRI.

Okay, that's very helpful. And then maybe a couple of questions for Dr. Patni, the dalfampridine experience subgroups that you alluded to in the context of the INROADS trial, I was just wondering hypothetically, if the INROADS trial reports positive data in this subgroup specifically, could you potentially use that as a way to offset or pre-empt or get around potential prior off requirements in MS. I'm just asking for hypothetical, I understand its conjecture at this point but would appreciate your perspectives on that since you mentioned that there's this subgroup in the trial.

Yes. So allow me to speculate. If in fact the trial demonstrates an effect on those measures of walking, that's similar or consistent in both those patients who were on dalfampridine and not on dalfampridine in the past, then I would posit that that would be a very useful point for the payer community. And that's precisely wide from my prepared commentary. This was a pre-specified subgroup analysis.

Perfect. And then just on ADS-4101, just because of the wording in your press release and your comments today, I was wondering if you could kind of either confirm or reject the hypothesis that if the impact loses exclusivity, the 44101 gets to the market. Does this or does this not destroy the rationale for the program per se?

Does not, meaning, we have always believed that the diurnal seizure pattern that we observed in our retrospective analysis of a large data set is real that by tuning out a tolerability component of the lacosamide pharmacokinetic profile, we could obtain higher doses at comparable tolerability or better tolerability at comparable doses, and that -- thirdly that VIMPAT upon the loss of exclusivity will grow just proportionately relative to other generic antiepileptic. So we will be in -- if we conduct as Rajiv as described, one of the first head-to-head clinical programs of a novel time dependent driven profile versus the current generic standard of care that it is a positive value proposition on its own merits.

Thanks very much.

.:

Thank you. Thank you. And our next question is from Serge Belanger from Needham & Company. Please go ahead.

Hi, good afternoon. Just two questions for me, first one is have you noticed any changes to GOCOVRI coverage started in January '19? And then the second one is just kind of backed away from some guidance parameters here for the start of the year, just wanted to know if the 20% to 30% peak market share that you've guided for in the past remains intact here.

Serge, thank you for both questions. The answer to first one is no, we have not noticed any differences in the beginning of the year with payer coverage, and we continue to monitor those carefully, so that we are maximizing access to GOCOVRI for our patients in need. So that's number one. On your second question, what…

The 20%, 30% peak.

Oh, the 20%, 30% peak. On the second, look, we believe very strongly and are seeing it in the areas in which adoption has occurred early and deeply that GOCOVRI can achieve a position as this ideal adjunctive to levodopa at the point patients enter this phase of the journey, where the threats or occurrence of dyskinesia begins to limit physicians use of all forms of dopamine, levodopa and other dopamine adjunctives. So we remain very excited about the long-term opportunity. I believe we've laid out in the call, the steps we are taking to educate physicians both in their understanding of this journey mechanistically, how the time dependency of this glutamate hyperactivity affects every day, and the progression of these patients, and it's our jobs here with the dataset we have in place and further enrichment down the road to really bring this to product where it belongs based upon the data that we've been able to generate for it, and that's really where we are driving for it's long-term. So we will continue to evaluate, how this grows quarter-over-quarter, and it's a sense over the next couple of years, and I think I have a better idea of where we're going to end up a couple years down the road here, but we remain excited and what we're seeing, and I think what folks are hearing on physician calls in those areas where adoption has occurred, and is continuing is suggestive of a very, very strong benefit that we're going to be able to see well into the future.

Thanks.

Thank you. And our last question is from Irina Koffler with Mizuho. Please go ahead.

Hi, thanks for taking the questions. I wanted to revisit prior guidance on the gross to net in the 25% to 35% range. So with this 28-day free drug program, are you going to jump into that range more quickly this year, and will you be able to stay in that range, or do you think you'll go above the higher end of it, and also, if you start contracting with Medicare Part D, would do you think you'll exceed the higher end of the range, or is it all still within this range contemplated? I think that's the first question. And the second question, can you comment on the number of prescribers you have now? I believe you had about 1,200 the last time you were reported, so correct me if I'm wrong on that, and just let us know where you are? Thank you.

So, Irina, on the gross to net, that 25% to 35% was always intended as a long-term framework, which would be at a point in time when likely we would have substantial contracting both on the Part D side and on the commercial side. So I think long-term, that's a framework laid out, I think where that ends up depends on the level of contracting that we get into, and we'll just have to wait and see. So that was a long-term thing, not a short-term thing. I think we indicated on the Q3 call that we expect it to be kind of in the high-teens to low 20s for this year, and that reflects the donut hole and all those issues that we saw last year, including the donut hole being a bit bigger this year than last year. So that's -- there's really no change in that gross to net framework for either near-term or long-term. And with regards to the number of prescribers, we ended up approximately 1,600 at the end of the year, Irina, and a lot of what we've talked on the call today is really ticking the subset of those who've got large practices and really driving the GOCOVRI message home and delivering a greater depth of prescribers in that area, in those centers, as well as increasing prescribers in 2019.

Okay, thanks.

Thank you.

Thank you. And ladies and gentlemen, this concludes our Q&A session for today. I would like to turn the call back to our CEO, Greg Went for any final remarks.

Thank you everyone for your time today. We look forward to seeing you at conferences over the spring, and are giving you an update on our continued progress on our next call in May. Thanks very much.

And with that, we thank you for participating in today's conference. This concludes the program, and you may all disconnect. Have a wonderful day.