Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) Q1 2019 Earnings Conference Call May 9, 2019 4:30 PM ET
Peter Vozzo - Westwicke Partners
Gregory Went - Co-Founder, Chairman & CEO
Alfred Merriweather - CFO
Rajiv Patni - Chief Medical Officer
Conference Call Participants
Joshua Schimmer - Evercore ISI
Marc Goodman - SVB Leerink
Timothy Lugo - William Blair & Company
David Amsellem - Piper Jaffray Companies
Stacy Ku - Cowen and Company
Irina Koffler - Mizuho Securities
Tian Sun - Needham & Company
Jason Butler - JMP Securities
Welcome to the Adamas Pharmaceuticals First Quarter 2019 Financial Results and Corporate Update Conference Call. [Operator Instructions]. As a reminder, this conference call may be recorded.
I would now like to turn the call over to Peter Vozzo from Westwicke Partners, Investor Relations for Adamas Pharmaceuticals. Please go ahead.
Thank you, Joelle, and good afternoon, everyone. Before we begin, I would 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 today with the SEC.
I will now turn the call over to Dr. Greg Went, Chief Executive Officer.
Thank you, Peter, and good afternoon, everyone, and thank you for joining us today. I'm here with Alf Merriweather, our Chief Financial Officer; and Dr. Rajiv Patni, our Chief Medical Officer.
At Adamas, we built our company around a single notion: that understanding timing patterns in CNS disorders can result in important new medications for patients and also create a sustainable business across multiple therapeutic areas.
In 2019, we are focused on 2 key priorities to achieve this: driving the growth of GOCOVRI for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy; and completing our Phase III study of ADS-5102 for walking impairment in patients with MS.
I'll start with our progress on GOCOVRI and Parkinson's disease. For the first quarter 2019, net product sales were $11.7 million. The approximate number of total prescriptions in the first quarter was 5,820, an increase from 5,700 in the fourth quarter of 2018, primarily from refills driven by strong patient persistence. Also, we continue to see high demand across the top quartile of our sales territories, accounting for almost half of our new patient starts. Overall, the number of new patients starting on GOCOVRI therapy in the first quarter was approximately 720, including 140 patients starting on GOCOVRI under our free trial program introduced in late February. This compares to approximately 760 new patients starts in the fourth quarter of 2018. This quarterly drop is due in part to expected and observed seasonal issues associated with the start of a new calendar year for commercial and Medicare Part D insurance plans that impacted January and February. New patient starts were highest in March and in April as we got later in the quarter and implemented the free trial program. Now our focus is on converting those new patient starts to paying GOCOVRI prescriptions.
Turning to our patients already on GOCOVRI. We saw refills increase in the first quarter, driving the overall increase in total prescriptions. This increase was largely seen in March, recovering from the fulfillment delays associated with the seasonal issues noted previously. This is a great achievement for our team, and we thank them for helping patients and customers successfully navigate through these seasonal challenges.
Persistence on drug remains strong, indicating that patients are having a positive experience. We continue to see a persistence rate of nearly 60% at 6 months. This compares to 45% to 50% for one of the better-tolerated adjunctive Parkinson's treatments, called rasagiline. Going forward, we continue to see opportunities to drive new patient starts by strengthening commercial execution. We are focused on applying our learnings as we build physician and patient awareness of dyskinesia and OFF and the benefits of GOCOVRI. These learnings apply to our physician-specific targeting and messaging, our education around dyskinesia and OFF episodes, our QHS dosing and dose adjustments and finally, our new free trial experience.
In addition, in early June, we are pleased to be launching a new patient and caregiver campaign that we mentioned previously. The GOCOVRI real go-getter campaign features real patients speaking about the impact of dyskinesia on their lives as well as their life before and after GOCOVRI. The campaign aims to educate patients and care partners about how adding GOCOVRI once at bedtime may result in patients waking up with less dyskinesia and OFF and reducing both throughout the day, which should also encourage more patients to speak to their doctors earlier to see if GOCOVRI is right for them.
Switching to our development programs. Enrollment continues in the INROADS Phase III study of ADS-5102 for walking impairment in patients with MS. Walking impairment is a common symptom that MS patients struggle with, affecting an estimated 225,000 patients in the U.S. We expect top line results from this Phase III study in the fourth quarter of 2019 and are excited about this new potential opportunity for GOCOVRI.
In summary, we believe that GOCOVRI has the potential to deliver benefit to significantly more Parkinson's patients suffering from dyskinesia and OFF, while ADS-5102 has the potential to deliver meaningful benefit to MS patients with walking impairment. We believe that meeting the unmet need of these 2 populations offers opportunities for significant near and long-term value creation.
Given the need to concentrate our resources on our top 2 priorities, we have deferred investment in ADS-4101, our earlier-stage development program in epilepsy. This will reduce overall R&D and SG&A expense levels and cash burn rate, thereby extending our cash runway. We believe this is the right path forward to build shareholder value and will give us the time we need to expand GOCOVRI's use and impact on patients' lives.
With that, I'll turn the call over to Alf to discuss the first quarter financial results.
Thanks, Greg, and thank you all for joining our call today. In the first quarter of 2019, we recorded GOCOVRI net product sales of $11.7 million. This was recorded on the sell-in method, with revenue recognized typically upon delivery to our specialty pharmacy. The approximate number of total paid prescriptions was 5,820 in the first quarter compared to 5,700 in the fourth quarter of 2018.
Gross to net was higher in Q1 compared to Q4 of 2018, due to Medicare Part D donut hole and other issues related to new insurance plan years, as Greg mentioned. Regarding our overall operating results. Net loss for the quarter were $29.7 million or $1.08 per share compared to $35 million or $1.35 in the first quarter of 2018. Cash and investments as of March 31, 2019, were $190.6 million compared to $210.9 million at December 31, 2018. Overall use of cash for the quarter was approximately $20 million.
Turning to our operating expenses. We have looked closely at our spending, particularly in relation to the deferral of investments in the ADS-4101 program described by Greg. Based on a full review of our operations, we're reducing our expense guidance for the year. For R&D, which was $10.2 million in the first quarter of 2019, we now expect full year expenses to be between $25 million and $35 million, reduced from our previous guidance of $35 million to $45 million.
For SG&A, which is $27.7 million in the first quarter, we now expect full year expenses to be between $105 million and $115 million, reduced from our previous guidance of $120 million to $130 million, resulting in our expected operating expenses for 2019 to be $130 million to $150 million.
Stock-based compensation expense associated with the R&D and SG&A in 2019 is expected to be approximately $2 million and $11 million, respectively, reduced slightly from our previous guidance. So excluding the approximately $13 million of non-cash stock-based compensation, our guidance for total operating expenses is between $117 million and $137 million compared to $137 million to $157 million previously.
I'll now pass the call to Rajiv to comment on our development progress and recent presentation on GOCOVRI.
Thanks, Alf, and good afternoon, everyone. I would like to update you on our Phase III trial of ADS-5102 in walking impairment in patients with MS as well as a recent presentation related to GOCOVRI and Parkinson's disease. Today, we are presenting the study design and preliminary pooled, blinded, baseline demographics of the ongoing MS Phase III study at the 2019 American Academy of Neurology Annual Meeting in Philadelphia. Before I go into the important details about the MS Phase III study, let me provide some background about walking impairment in MS.
Walking impairment can manifest in different ways: number one, slow walking speed; number two, difficulty with sitting, standing and turning; and number three, reduced walking distance or endurance. Published data suggests that walking impairment, unlike fatigue, remains a constant issue throughout the day, starting in the morning. There is currently only 1 FDA-approved drug, AMPYRA, or dalfampridine, to improve walking in patients with MS. In their pivotal trials, approximately 70% of AMPYRA-treated patients did not experience a consistent increase of any magnitude in walking speed during double-blind treatment. Hence, there remains a significant unmet need to treat walking impairment in MS, with an opportunity to address as many as 180,000 MS patients in need.
Let's now move on to our MS Phase III trial poster to be presented at AAN today. This study is a 3-arm, randomized, double-blind, placebo-controlled study of 2 dose levels of ADS-5102. The primary efficacy endpoint is the proportion of responders in each treatment group, where a responder is defined as a patient who experienced at least a 20% increase in walking speed from baseline. Key secondary endpoints include the mean change from baseline in walking speed, Timed Up and Go or TUG, and the 2-minute walk test.
The baseline demographics provide a snapshot into the real-world effectiveness of dalfampridine. Approximately 50% of enrolled subjects had received dalfampridine in the past. In this previously-treated dalfampridine subgroup, the reason for discontinuation from dalfampridine prior to study entry was: number one, no or lost efficacy in 49%; and number two, adverse events in 21%. We hope prespecified analyses of both the dalfampridine-naive and dalfampridine-experienced subgroups will provide evidence for the breadth of the MS population responding to ADS-5102. We look forward to the readout of this first MS Phase III trial in the fourth quarter of 2019. If successful, we plan to initiate a second pivotal study to support approval.
Before I move on to our second poster at AAN, let's recall that GOCOVRI is thought to work by reducing the amount of glutamate hyperactivity in a region of the brain that controls movement in patients experiencing episodes of dyskinesia and OFF. In so doing, one might further expect GOCOVRI to effectively widen the therapeutic window for dopaminergic management of Parkinson's disease.
Unlike the two pivotal placebo-controlled, double-blind trials where the background dose of dopaminergic therapies was held constant, this open-label study was meant to replicate the real-world treatment of patients with Parkinson's disease, since the investigators were committed to change the background dose of dopaminergic therapies. Patients in this study have progressed Parkinson's, meaning they are beyond their honeymoon period and experiencing unpredictable transitioning between good movement control, that is, good ON time; and poor movement control, that is, either dyskinesia or OFF.
Among the patients who took GOCOVRI for the entire 2-year trial period, 33% had their total daily levodopa dose increased, 16% had their dose decreased and approximately 52% had no change to their levodopa dose.
Among the patients with a levodopa dose increase, the mean increase was 372 milligrams over the baseline of 756 milligrams. Importantly, these levodopa dose increases were not associated with the worsening of the MDS-UPDRS Part IV score, which is a measure of dyskinesia and OFF. In fact, this score improved by an additional 1.7 units, driven by further decreases in both OFF and dyskinesia. This is particularly noteworthy since the baseline levodopa dose was already high. We interpret these findings, albeit with caution, to suggest the addition of GOCOVRI enabled the neurologists to increase their patients' dopaminergic therapy when their ability to do so previously had been dose-limited by poor movement control.
Consistent with our pivotal data, this analysis suggests that GOCOVRI is an effective adjunctive therapy in Parkinson's patients who have progressed beyond their honeymoon period, because they show GOCOVRI reduces both dyskinesia and OFF, leaving the patient in longer periods of good movement control and potentially widening the therapeutic window for dopaminergic therapy.
With that, I will turn the call back over to Greg.
Thanks, Rajiv. So to summarize, building off our first quarter progress, we are focused on the two most immediate drivers of value to patients and shareholders: increasing GOCOVRI new patient starts and advancing a potential additional indication for GOCOVRI in MS. Regarding GOCOVRI, we continue to see excellent persistence overall driving growth in refills and a recovery in new patient starts after an initial drop at the start of 2019. We continue to evolve our disease and product education to bring more physicians up to speed on the detrimental impact that dyskinesia and OFF can have on Parkinson's patients and the benefits of GOCOVRI.
As to ADS-5102 and MS walking, we look forward to seeing the top line results of this Phase III study in the fourth quarter of this year. We remain committed to our mission of bringing the benefits of our time-dependent biology approach to an increasing number of patients with CNS disorders.
And with that, I would like to open up the call for questions. Operator?
[Operator Instructions]. Our first question comes from Josh Schimmer with Evercore ISI.
Or a few questions, hopefully. First, can you provide any visibility into the difference for March and April versus the start of the year, how we might be thinking about growth going forward considering the fairly minimal quarter-over-quarter growth that we saw in Q1?
Josh, thanks for the question. I don't want to go any further into the second quarter beyond what we provided. But I think you can see with the reduction we're reporting in January and February, on the new patient start side, we were able to come pretty close making that up with March. So we feel good going into the second quarter. And with regards to the total Rx growth being driven primarily by refills, that rebounded nicely in March as well. So we think we've got the seasonal disruptions behind us.
Got it. And then what are the obstacles and what's the timing that you may estimate for converting patients on free GOCOVRI to paying customers?
The timing - the free drug program, as currently configured, lasts for 28 days. So we look forward to converting them, obviously, as quickly as possible within that period or immediately after that.
Is there a reason to think that some may not be able to convert and fall off therapy?
It does occur with these types of programs, so there is that possibility, but we're obviously working very hard to get the patients onto GOCOVRI and keep them on GOCOVRI. And by and large, that's been our experience with our - the program that we had in place last year and with last year, that people really like to be on GOCOVRI and go through a lot in order to stay on it.
Got it. And then I have a couple of other quick questions. Q1 softness seems to be a more common trend, at least from what I'm seeing, in the neurology setting. Is that accurate from your perspective? And if so, why might that be?
I think there's a lot more intelligent people on this phone call who know other segments than I, so I would leave it to them to speculate.
Okay. And then your - the valuation, you're now trading less than your cash position, which reflects both concerns regarding execution as well as communication and opacity. So what are you doing to address the latter?
What we could do to address the latter is to hold these calls. We're providing now, on this call and going forward, our new patient starts in addition to our total prescriptions, which gives, we believe, investors a way of really tracking our business. So to be able to track it consistently quarter over quarter over quarter. And to the former, we just need to execute on the promise of GOCOVRI and continue to bring new patients to it. Because the amazing thing about this product, as we hear from people and as we see in the numbers, when you're on it, by and large, you stay on it. And that just leads us to really have to focus on that experience, of getting physicians' experience with GOCOVRI and patients'.
And our next question comes from Marc Goodman with SVB Leerink.
Yes. Couple of questions. First, can you give us a sense of what the actual gross to net was in the quarter, and how you're thinking about it for the year, certainly relative to last year? And second question is talk about the free product program. You made a change. I was just curious if the feedback from the physician, patient community has been that this is more helpful, this is easy, it's working. Is there anything in the marketing messaging or the focus of the physician community that you kind of altered 3 or 4 months ago? Have you made any more changes? Are you feeling like you got the right message, you got the right targeting and you got the right - and now you've just got to get going?
Thanks, Marc. Alf, why don't you tackle the GTN first?
Gross to net, Marc, we started articulating, really last third quarter call, that we're expecting our gross to net, we give an indication of a range of high teens to low-20s for this calendar year. We have also been very clear in that time frame that we expected, for the reasons Greg described, the donut hole, et cetera, that the gross to net would be higher in Q1 and potentially into Q2 and then lower over the balance of the year. And that's exactly the pattern we saw last year, where it was high Q1 and to some extent, Q2, and then fairly low in the third and fourth quarter. That quarterly pattern we'd expect to be the same. And so for Q1, we were in that range that we talked about for the year, high teens to low-20s. Q2 will still likely still have some impact of the donut hole. And then Q3 and Q4, if the pattern continues as last year, would be reduced from there. The wild card would potential contracting, which hasn't been significant to this point, and we haven't any specific commentary there, but that will be a factor that could impact gross to net additionally going forward.
Alf, thanks. Marc, let me go on to your second one, which is the free trial and messaging. The initial feedback to the changes have been positive. We changed the program, which were free trial was occurring after the adjudication process began and put 28 days in front of that. And it has been well received and it's begun to be utilized, which in part allowed us to get to the same number - roughly the same number of new starts in Q1 as we had in Q4 of last year. It's going to take some time to see how that - what the conversion rates end up being with this program versus what we were doing last year into paid prescriptions. So we'll be looking at that carefully as we get through the end of the year.
But our experience to date, and part of why we made the change, has told us, that once people experience go GOCOVRI, they really want to stay on GOCOVRI, and it's just shown great persistence.
Your last question was are we doing any more changes to the messaging. And the answer to that is not beyond what we talked about on our last call. We got pretty well locked and loaded from the learnings from last year in terms of how we're talking about dyskinesia and OFF; how we're talking about it with neurologists and movement disorder specialists; and how we're talking about GOCOVRI QHS, dose adjustments. That has been working and resonating well in the community.
So we're just stably executing right now against what we laid out last quarter. I'll just finished off with we are going to have a new patient campaign coming up here that will be visible, the go-getter campaign. And we think that, based upon research last year, is an important component to activating the patient community who are really in desperate need of therapy.
And our next question comes from Tim Lugo with William Blair.
So last year, you were adding more than 1,000 scripts per quarter. In hindsight, how do you think of that growth? And do you think you'll be able to reach that level of growth again?
I think that growth was excellent, Tim, during the launch. Thank you for the question. And we're doing everything we can to return and potentially exceed a growth rate of 1,000 a quarter. And this point, as we look at the impact that dyskinesia has on patients, on treating their OFF, we feel that the market is there. And through these changes that we've implemented, and with our - what we have in place, that we can be successful at doing that. But we've got to start to see the new starting take hold, and that's what's going to drive the growth.
Okay. Can you at least directionally talk about growth quarter-over-quarter? I think you're pretty clear about the Q4 to Q1 and so hopefully, people aren't very surprised with the numbers you're putting up in terms of the growth. However, moving forward throughout the year sequentially, will you be seeing growth quarter-over-quarter for, let's say, Q2 to Q4? Or is this something that you're just not prepared to talk about?
We're not - I mean we obviously, Tim, haven't given any guidance on this year. We were overall pretty pleased with how we navigated through the seasonal disruptions that I was just speaking to. And it's too early to tell right how the rest of the year is going to play out. But we are working obviously very hard and monitoring very closely what these tactics are producing in terms of new starts and keeping people on drug. And second half of the year, I think we're going to have a lot more data in front of us to make that judgment call.
Okay. And I guess a broader question. There is a lot of almost discussion around pricing and how it works through the channel, and almost a vilification of specialty pharma distribution systems. What's your opinion right now on your current distribution system? And has any of the scrutiny around this model changed how you are able to market the therapy?
Tim, that's a great question. I think our approach to picking a - having a specialty distribution model in place was really to provide patients, their care partners and physicians with an experience which was seamless, was positive and provide a regular point of contact back with the patients in order to really make sure that they have a positive experience on GOCOVRI. And I don't think anything has changed in our observations in the last year about the ability to do that through a specialty distribution model versus a retail model. So we continue to be positive about the experience we believe our patients can have as a result. And that's really have been our focus as a company from - that's what drives us.
And our next question comes from David Amsellem with Piper Jaffray.
So first question is on expectations and this theme of transparency or on the flip side, opacity. So you withdrew your stated expectation or soft expectation for GOCOVRI for 2019 awhile back. I guess knowing what you know about the gross to net and where volumes are trending, are you willing to consider providing some sort of level of expectation, be it a soft - a soft sort of expectation or a hard range? And I mean is that something you'd consider as the year progresses? Second question is the payer landscape, and I wanted to get a sense from you regarding step edits and specifically how they've evolved, if at all, over the last few months?
Okay. First question, David, is an easy one. No, we don't intend to provide any guidance, given the - we're just coming out of Q1. The changes that we made at the end of last year and beginning of this year, we need to collect a few more quarters of data before we're in a position to do that. But to your point, I hope you have a lot of the information you need right now to improve your understanding of our business, through the new patient starts and having the total prescriptions numbers available from us on a quarterly basis.
With regard to the payer landscape, we have not seen a lot of significant changes quarter-over-quarter right now. We continue to see prescriptions being covered, we continue to see them being reimbursed by a prior auth. There really hasn't been any significant changes. So those prior auths are typically Parkinson's patients on levodopa with dyskinesia and in a significant number of plans, a prior experience with amantadine IR, which is not hard to imagine, since most people have tried it at some point in their treatment journey. So really no significant changes. It's the payer landscape we anticipated at launch and continue to work with.
And our next question comes from Stacy Ku with Cowen and Company.
I have two. First, I'm wondering your experience with the competitors so far. Are your sales reps having many discussions with clinicians about the benefits of GOCOVRI versus OSMOLEX? Do you have any insight into whether patients are trying both GOCOVRI and OSMOLEX free programs before they decide? And are the patients that use the GOCOVRI program generally sticking with it?
Great. Stacy, thanks for the question. We're obviously keeping an eye on OSMOLEX, but we're not going to comment a whole lot on it. It's out there, it's in the market. And I think just based upon the numbers we just reported, I think you can see that we're getting the new patient starts into the range, even coming out of the difficulties of the seasonal pushback, and we're maintaining persistence. So people who are on GOCOVRI are staying on GOCOVRI. They're not falling off to other treatment modalities in any significant numbers. So we're keeping our eye on it, we're keeping our heads down, we're continuing to execute with a whole host of competitors in the market.
Okay. And if I could just sneak in a follow-up on your last comment, do you think - first, I want to further clarify exactly what you think would be a good long-term persistence number. Do you think you can go higher than 60%? And do you mind reminding us what is exactly accounting for this 40% attrition rate?
Yes. So I'll be precise. The 60% - the about 60% is the percent of patients who remain on GOCOVRI therapy at 6 months, which represents a really quite a high number if you study these things in any market, including in the Parkinson's market. This didn't surprise us, given the shape of the persistence curves in our open-label study that Rajiv reported some of the data on, on today's call. There is an initial drop in persistence in those studies and in the real world, in the first 3 to 4 months. It then gets down to a plateau and is relatively flat in that study. So we will begin to report on additional persistence data further out as cohorts mature on subsequent calls, and we're really delighted with what we're seeing from a persistence standpoint. Rajiv, any...?
No. Just that, you commented about that other 40% in that open-label study is informative, because as Greg mentioned, the early discontinuations mostly in the first 3 months were because of expected side effects due to GOCOVRI, but the discontinuation, which ultimately led to the 40% over time, were due to other comorbidities and progression of underlying Parkinson's disease, which is what you would expect, and that's what we're seeing in the real world.
And our next question comes from Irina Koffler with Mizuho.
I think last quarter, you reported the number of prescribers, and I think it was 1,250. Can you provide an update on the number of prescribers? And just qualitatively, help us think about how you're doing in the experienced physicians that you're calling on versus the ones that need to be educated more on OFF and dyskinesias and ON?
Well, a bunch of questions in there, let me try to unpack them all and thank you for those, Irina. I think we did report on our last call or the fourth quarter, in the call in November, what the number of prescribers were at the time, but we have not continued to report on that. We have gotten to a number of prescribers that was some significant percentage of Parkinson's docs and have not updated that number. So I don't have that for you today. In terms of what we're seeing in physicians who are experienced versus not, Rajiv, would you like to tackle that in terms of impressions of how the different types of physicians are adopting GOCOVRI?
Yes. I think on the experienced neurologists, one, have they begun seeing the effects in their real-world population, both from how the patient is initially responding and then how they're able to stay on the medicine chronically, that's fueling the use of GOCOVRI in repeat patients and their practices. And I've visited, as I commented in our prior calls, many of these practices and that's the dynamic we're seeing.
In the physicians who are not experienced, to Greg's opening commentary, there, we've got to remind that neurology community that this is a medicine that is both treating dyskinesia and OFF, because what they are used to seeing are dopaminergic medications that only treat OFF. And so that's the education lift that were doing. But once that physician population begins to see that benefit on both dyskinesia and OFF, that's the trigger for them trying this medicine in initial cohort. And if a patient's responding, the patient's able to get medicine through their payer, the physicians in that cohort are then willing to continue this in other patients.
Okay. And if I can sneak in a follow-up on the epilepsy program. Is that on pause for this year? And you're still considering doing it maybe next year or is that kind of off the table?
Irina, thanks for the question. It's on a pause at the moment and really, we're deferring it to allow ourselves to focus on really, the 2 immediate priorities: GOCOVRI's launch in Parkinson's and the MS program. At such a time when we get to the point that we've got and achieved commercial success through those efforts, we will be able to evaluate 4101, and we continue to evaluate other opportunities that we can bring in to our time-dependent approach and fuel our growth down the road. But the immediate priorities are to be successful with what we have in hand right now.
And our next question comes from Serge Belanger with Needham & Company.
This is Tian on for Serge. I just had a question about the INROADS Phase III trial. In terms of the primary endpoint, are you only assessing the 274 milligram dose, or is the 137 also included? That wasn't clear based on the abstract that I saw earlier. And then the second trial that you are also planning to run, do you have a plan when that's going to start? And would it be similar to the first trial in terms of trial design?
Rajiv will handle both of those.
So your first question, yes, as per our statistical analysis plan and based on our end of Phase II meeting, we are going to be testing both doses. And it's typical for, when you have two doses in a pivotal, we'll approach the analysis plan hierarchically. So it's all prespecified and very typical. That's answer to question one. Question two, about that second pivotal, we would start it in 2020, and the design of that second pivotal will be informed largely by what we see in the first pivotal, because we'll have the data to properly size and design that second pivotal.
Okay. Got it. And you also have another open-label extension. Is that...
So yes. As you can imagine for a pivotal program, there is an extension trial to generate long-term safety data for the potential sNDA. So we have an open-label extension trial, it is ongoing. And patients that successfully complete this placebo-controlled trial, if they consent, they enter the open-label extension.
[Operator Instructions]. Our next question comes from Jason Butler with JMP Securities.
I had a quick follow-up on 4101 and then a couple of questions on GOCOVRI. So for 4101, has your view on how you think about potential partnerships for that program changed at this point? Or what is your - the level of priority or willingness to partner that program?
Jason, with regard to the 4101 program and clearly, this is a prioritization decision. The value of 4101 remains and remains to us in terms of the potential for superiority to VIMPAT, which we believe could be a great add-on as we go down the road and look to expand into epilepsy as a therapeutic area. So we would certainly remain interested and open to partnering with companies in that space as we go through this period of time.
Okay. Great. And then on GOCOVRI, and apologies if I missed this earlier, but in terms of - how should we think about the trend on the patients in the free trial - free start trial? How should we think about that going forward? And how does that play into your current expectations for managed care coverage?
Well, I'd say for the former, it's too early to judge, but we have to - obviously, the goal is to convert patients from submitting a treatment form, receiving a free trial and going on paid prescriptions. And we will be providing you information on both the numbers of new starts quarter-over-quarter on our future calls as well as be able to monitor TRx, total prescriptions, which is the outcome - that growth outcome of somebody actually converting over. And as numbers settle down, we'll have a better idea of judging how well that is succeeding in converting people onto GOCOVRI.
Okay. Great. And then just last question. Can you speak to any data or information you have about how physicians are managing a patient's other meds as they're treated with GOCOVRI and including L-dopa?
So I'm going to hand that to Rajiv. You may want to reiterate some of the points you made earlier.
No. I'd say it's a good question and one, I'd refer you to the poster that was presented yesterday at the AAN, which really is our best evidence set about how GOCOVRI is enabling changes to background medications. And just to reiterate my prepared comments, so we saw in patients that completed 2 years of GOCOVRI treatment, about 1/3 had their levodopa dose increased, about 16% had their levodopa dose decreased and about 1/2 had no change to the levodopa dose. What that means is, with the background of chronic GOCOVRI treatment, the neurology can modify the levodopa dose as he or she deems inappropriate. And pre-GOCOVRI, our view was and remains that, that was not permissible because of well-accepted complications of poor movement control, namely dyskinesia and OFF.
And how that plays into the real world, to my earlier comment to an earlier question, anecdotally, we are hearing amongst the movement disorder neurologic community, the expert community, that they are finding it easier to modify the dose of levodopa. And this goes back to this core principle of widening the therapeutic window to dopaminergic therapy. Because again, in our view, pre-GOCOVRI, you only widened one side of the window and now you actually can widen the window by both treating the OFF time, think about that as the lower pane of the window, as well as the dyskinesia, which is the upper pane of the window.
Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Greg Went for any closing remarks.
So thank you everyone for your time. We look forward to seeing you at upcoming conferences and continuing to report on our progress as we get to August and have another quarter behind us. Thanks very much.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program, and you may all disconnect. Everyone, have a wonderful day.