Edited Transcript of ADMS earnings conference call or presentation 7-Nov-19 9:30pm GMT

As we approach year-end, we remain focused on our 2 priorities, which are driving commercial success for GOCOVRI and delivering top line Phase III data for an additional indication for GOCOVRI in multiple sclerosis patients with walking impairment. During the quarter, total GOCOVRI prescriptions continued sequential quarter-over-quarter growth, which provides a continuing foundation for our future commercial initiatives. I’ve spent a considerable percentage of my time in the patient and physician community. What I hear very strongly is GOCOVRI works and makes a significant impact on patients’ daily lives, and there’s a tremendous opportunity to realize its potential.

As Vijay will discuss, the commercial team has already taken several steps to increase GOCOVRI adoption. Progress is being made, and we’re committed to learning and adjusting our strategy to build sustainable value. While our primary focus is on increasing demand for GOCOVRI in Parkinson’s disease patients with dyskinesia, given the data we expect from our INROADS Phase III study in the second half of December, we are actively preparing to support our entry into the multiple sclerosis market. Rajiv will review the Phase III development program during his prepared remarks. We see a significant unmet need amongst MS patients with walking impairment and are excited about the potential for GOCOVRI if approved in this highly established market.

It’s important to note that Adamas focuses on large treatment effects to address significant unmet needs. Therefore, we will take a disciplined and rigorous approach to assessing the INROADS Phase III data to ensure we can deliver a meaningful impact to patients. We anticipate that our initial commercial focus will be on those who have tried and discontinued dalfampridine for whom there are limited treatment options. We look forward to seeing the top line data from our INROADS study prior to finalizing that strategy.

I’ll now turn the call over to Vijay, who you may remember started as our Chief Commercial Officer in June.

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [4]

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Thank you, Neil, and good afternoon, everyone. It is great to be speaking with you today. I will begin my comments with an overview of our performance in Q3 and then provide an update on the progress we’ve made on the strategic priorities I highlighted on the Q2 earnings call.

Total GOCOVRI paid prescriptions that exclude product from the free trial program rose to approximately 6,640 scripts, representing an increase of 8% versus Q2 of 2019 and 40% versus Q3 of last year. While we did not have a free trial program in place to help nonadopters gain clinical experience until the first quarter of this year, the growth in total paid prescriptions versus last year is encouraging. This growth continues to be driven by patients refilling GOCOVRI. Persistence remains strong and steady at approximately 55% to 60% at 6 months and 45% to 50% at 12 months, again, highlighting the value that GOCOVRI is bringing to patients.

Conversion rates from free trial to paid prescriptions also held steady between 45% to 50%, registering a modest increase in the latter part of the quarter, a topic I will elaborate on in a moment. There were approximately 710 new patient starts in Q3, which included both free trial patients and new paid prescriptions for patients who did not receive the free trial. This was generally consistent with previous quarters.

Our analysis of the quarter’s performance reveals that significant growth in prescriptions from new writers was offset by a slight decline in use amongst some established writers. We are addressing this by optimizing our sales force targeting to increase our share of voice in these high-prescriber offices and improving the operational effectiveness of our fulfillment process to enhance prescriber satisfaction.

We plan to grow new patient starts by focusing on breadth, the addition of new prescribers by leveraging the 4-week free trial program and depth, increasing use among current prescribers through optimization of sales force activity and enhancing the customer centricity of our fulfillment process.

Our interactions with thought leaders continue to reinforce the differentiated clinical profile of GOCOVRI. And we remain highly optimistic about our potential for helping Parkinson’s disease patients with dyskinesia and OFF. I want to highlight that there are no other FDA-approved medications indicated for the treatment of dyskinesia in patients with Parkinson’s disease, and medications that are approved for the treatment of OFF episodes generally increase dyskinesia. GOCOVRI is the only product clinically proven in 2 Phase III clinical trials to significantly reduce both dyskinesia and OFF, thereby increasing functional ON time for Parkinson’s patients on levodopa therapy.

On our Q2 earnings call in August, I highlighted 3 strategic priorities based on my initial assessment of our business. I am pleased to report that we have made notable progress in each of these areas. First, we are increasing the urgency to treat by educating health care practitioners to recognize the disruptive impact of dyskinesia, its relationship to OFF and its impact on the effective treatment of Parkinson’s disease. We have recently launched a digital disease awareness initiative specifically targeting health care practitioners treating a high number of Parkinson’s patients. This initiative is anchored on updated Web content and supplemented with new materials being delivered by our sales force. The campaign focuses on the impact that disruption caused by dyskinesia and OFF has on patients’ activities of daily living and on how many aspects of this disruption may not be obvious to physicians during a routine patient consultation unless prioritized for proactive discussion.

Second, we are improving the customer centricity of our fulfillment process to deliver one that is simple, reliable and transparent. Towards this end, we have conducted an end-to-end analysis of leakage points at our fulfillment center and instituted several changes in the quarter to address them. We are introducing a vastly simplified prescription form to reduce errors during submission. We have also created a team of GOCOVRI care coordinators to serve as a dedicated single point of contact and streamline communication for clinics and patients as they initiate treatment. This team, launched on October 1, is receiving positive feedback from customers. As a result of these initiatives, we have seen an early increase in the 90-day conversion rate in the last 4 weeks. Our sales force has also been trained to deliver education to clinics about our fulfillment process to increase transparency.

Third, we are increasing awareness of our 4-week free trial program. We have increased branded messaging of this program through digital marketing and in the new prescription form and have created new reminder resources for physician offices. We continue to evaluate all elements of this program to expand trial of the drug among nonadopters and to serve patients better.

While these 3 areas were prioritized for initial focus, we continue to examine every element of our strategy and execution. I look forward to sharing additional details about our strategic and operational plans in future calls.

I will now turn it over to Rajiv to review our INROADS trial.

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Rajiv Patni, Adamas Pharmaceuticals, Inc. – Chief Medical Officer [5]

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Thanks, Vijay. I’m happy to report that we remain on track to deliver top line data from our first Phase III trial in MS walking impairment INROADS by the second half of December 2019. This double-blind, placebo-controlled Phase III study will provide efficacy and safety data of 2 doses of GOCOVRI: 274 milligrams and 137 milligrams QHS or taken at bedtime.

The primary efficacy endpoint is the proportion of responders in each treatment group after 12 weeks of double-blind treatment. A responder is defined as a patient who experienced at least a 20% increase in walking speed from baseline as measured by the timed 25-foot walk test. Secondary endpoints include the Timed Up and Go, or TUG; the 2-minute walk test and the patient-reported outcome, the MSWS-12. The power assumption and the approach to control the type 1 error are standard for any pivotal trial.

It is important to recall that this development program consists of 2 placebo-controlled pivot studies: INROADS, which I just described; and a second placebo-controlled study, which will be similar to INROADS. Given the greater valuability of certain walking measures like the MSWS-12 compared to the timed 25-foot walk test, pooling of data from both placebo-controlled studies may be required. If INROADS is successful, we expect to initiate the second study in 2020. If data from both studies support a sNDA submission and approval, we would plan to launch GOCOVRI for this new indication in 2022.

We have thoughtfully defined success criteria for INROADS data. First and foremost, we need to ensure pristine data quality. That is, patients are not lost to follow-up, missing data are minimized and all database queries are answered satisfactorily prior to database lock. In this way, we will be confident in the reliability of our conclusions from the top line data.

The other success criteria include evidence of a dose response, an effect size on walking speed that is persuasive clinically and statistically and consistency across all walking efficacy measures. Lastly and equally important, the safety data should be on par with what we reported from the Phase II study.

Before I hand the call over to Chris, I will address a question we have recently received, “Why did we not study the effect of GOCOVRI on MS-related fatigue?” First, walking impairment in MS is an established market with patients in need. Walking impairment, as measured by the timed 25-foot walk test, is part of the multiple sclerosis functional composite, or MSFC. The FDA recognizes the timed 25-foot walk test as a registration efficacy endpoint since it is a direct measure of how a patient functions.

Second, a fatigue measure is not part of the MSFC, and there is, thus far, no precedent for a fatigue-related registration efficacy endpoint in MS trials. It is important to note that in our view, based on the literature, fatigue is multifactorial but primarily the consequence of living with MS-related disabilities, including walking impairment. As we reviewed at the 2019 AAN Congress, fatigue increases as the day progresses. In contrast, walking impairment remains constant throughout the day.

Third, I would like to emphasize walking impairment is a type of motor impairment. We have convincingly demonstrated that GOCOVRI reduces motor impairment in PD via its effect on OFF and dyskinesia. The Phase II MS data suggest a positive effect on motor impairment given the efficacy signal on walking speed.

With QHS dosing, the unique GOCOVRI PK profile is aligned with the temporal pattern of motor impairment in both PD and MS, that is, high amantadine concentrations are achieved in the morning and maintained through the day with low concentrations during the night. We look forward to the top line data from INROADS later this year.

With that, I will hand the call over to Chris.

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Christopher B. Prentiss, Adamas Pharmaceuticals, Inc. – CFO & Principal Financial Officer [6]

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Thanks, Rajiv, and good afternoon, everyone. First, I’d like to thank everyone here at Adamas for supporting me in my transition to this new role. I certainly look forward to working with the team to accomplish our key priorities and ensuring we meet the needs of our investors.

Now let’s discuss the results for the third quarter. Third quarter 2019 product sales were $13.9 million, a 9% increase over $12.7 million in second quarter of 2019 and a 31% increase over the same quarter last year. For the first 9 months of 2019, GOCOVRI product sales were $38.3 million compared to $20.7 million for the same period of 2018, an increase of 85%.

Regarding our overall operating results. Net loss for the third quarter was $27.6 million or a loss of $0.99 per share compared to a net loss of $33.2 million or a loss of $1.22 per share in the third quarter of 2018. R&D expenses were $6 million for the third quarter compared to $8.6 million for the prior quarter as our INROADS trial completed enrollment in the second quarter.

During the third quarter of 2019, SG&A expenses were $31.2 million compared to $25.2 million in the second quarter of 2019. This increase is primarily due to onetime charges related to the company’s CEO transition. Despite these onetime charges, we expect both R&D and SG&A to fall within our previous annual expense guidance.

Cash and investments as of September 30, 2019, were approximately $150 million. Overall cash burn for the third quarter was down slightly from prior quarters at approximately $18 million.

Finally, our shelf is expiring later this month. And as part of good financial housekeeping, we believe it is important to have an active shelf going forward. Therefore, today, we are filing a shelf registration consistent in amount with what we have previously had in place.

Let me now turn the call back over to Neil.

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [7]

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Thank you, Chris, Rajiv and Vijay. I’ll now open the line for questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Marc Goodman of SVB Leerink.

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Roanna Clarissa H. Ruiz, SVB Leerink LLC, Research Division – Associate [2]

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This is Roanna Ruiz on the line for Mark. I have a quick question on one of your comments earlier. I think you mentioned the ongoing prescribers offset growth in new prescribers. So I was curious, could you elaborate a bit on why ongoing prescribers might be lowering their use of GOCOVRI? Or is there any other color you can give around that?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [3]

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Anna, this is Neil. Thanks for the question. Maybe I’ll start off just quickly that our new patient starts were really stable and generally in line with previous quarters. When I think about the quarter in general, I think that we made tremendous progress towards listening, learning and adapting and executing on where we need to go.

I’ll maybe hand it over to Vijay to get into some of the specifics, but this was part of our Q3 strategy to be able to increase breadth. Vijay?

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [4]

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Thank you, Neil. Let me begin by reminding you on how we calculate and define new patient starts, right? New patient starts are the sum of patients receiving the free trial and patients who received paid new prescriptions without enrolling in the free trial. And this comes from a combination of new writers and current writers.

So in the third quarter, a major area of focus for our sales force was expanding our prescriber base. I’m pleased to report that we expanded that base significantly. There was an 18% growth in new prescribers in Q3 versus Q2. So we had a healthy growth in new prescribers starting to trial GOCOVRI. This was offset by a slight decline in some high-volume prescriber offices. Now why is that?

This is a highly promotionally sensitive space. There are multiple players in this space right now. It is relatively crowded. And Parkinson’s disease is complex, progressive. And in the routine visits of patients and discussions with physicians, the urgency to discuss dyskinesia and OFF is relatively low. So what we do to our sales force in these high-prescriber offices matters.

So that is why we have taken action to refine our sales force targeting to increase our relative share of voice in these clinics because we remain very optimistic and confident that we have a differentiated product profile. And our focus on these key areas of increasing the urgency to treat and improving our fulfillment and communicating that to physicians and educating them about the free trial will get us back to growth.

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Roanna Clarissa H. Ruiz, SVB Leerink LLC, Research Division – Associate [5]

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Got it. That’s helpful. And I just have one more question regarding streamlining the process for when patients move from their free drug program to paid prescriptions. Are there any metrics that you’re tracking to sort of evaluate success? And can you share some like color around those?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [6]

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Vijay?

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [7]

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We have done an end-to-end analysis of the process at our fulfillment center from when a prescription form is faxed in to when a patient receives drug. So there are multiple steps in the process that we have mapped out. And we have simplified each one of those processes in order to make it functionally easier for a physician’s office to see a drug get to patient.

We’re measuring this in a variety of ways. The cleanest way to measure it is the 90-day fulfillment rate in — a conversion rate in terms of free trial to paid prescription. Why 90 days? It takes that period of time for all prescriptions to work their way through the process. So as I said, we’re seeing an improvement in that 90-day conversion rate in the last few weeks of the quarter.

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [8]

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I might just add one thing on this. As Vijay talked about, the fact that he’s looked at the various leakage points across the fulfillment process, it’s important that we prioritize the largest areas of leakage quickly. To his point, in bringing the GCCs onboard that went live last month, that was a large part of the leakage we feel we could fix.

It doesn’t mean we’re over. We still see opportunities to be able to add additional tactics to our fulfillment process to improve it, but these were the big areas that we analyzed and are executing on now.

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Operator [9]

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And our next question comes from Josh Schimmer of Evercore ISI.

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Joshua Elliott Schimmer, Evercore ISI Institutional Equities, Research Division – Senior MD & Equity Analyst [10]

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Up until a couple of quarters ago, quarter-over-quarter script growth was much closer to 1,000. It’s recovered nicely from the second quarter to the third quarter. But do you think it is possible to get the script growth back into the 1,000 per quarter range? What might it take to do so? And how long might it take to do so?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [11]

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Vijay?

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [12]

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Let me begin with noting what you just said there. We have made notable progress in terms of our top focus areas in this quarter. The way that we approached it, and we set up the 3 key focus areas of increasing urgency to treat, improving fulfillment and increasing awareness and use of our free trial program was because we identified these as key barriers to increasing our demand. And therefore, we quickly instituted changes to address these barriers by focusing on the largest levers first.

So these changes, as you saw in my prepared remarks, have just been implemented. There are more coming in phases. The early signs of what we have implemented and the early reception to these changes have been largely positive. As Neil mentioned in his remarks, we are continuing to learn and adapt, execute as — we continue to execute as fast as we can, and we remain optimistic about our prospects over time. So that’s why our focus remains increasing breadth and depth. And I think the changes we’re starting to make will have impact over time.

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Operator [13]

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And our next question comes from David Amsellem of Piper Jaffray.

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David A. Amsellem, Piper Jaffray Companies, Research Division – MD and Senior Research Analyst [14]

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Just a couple. Sorry if I missed this, but what you said is the conversion rate now. And with the improvements, where do you expect it to be steady state realistically? So that’s number one.

Number two is in terms of sampling, how long do you think you’re going to be sampling? I mean is this going to be just a permanent feature of your commercial execution strategy?

And then lastly, what’s the average co-pay right now for patients? So just remind us on that.

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [15]

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Great. David, this is Neil. Maybe I’ll start with the conversion. It’s held steady at 45% to 50%. And again, a lot of what Vijay has talked about on executing our fulfillment process to simplify it, to make it more reliable, make it transparent, educate our field organization is coming through.

I was in the field last week with one of our top prescribers that are an MDS-er. And as I was leaving the office, the medical assistant said, “We really appreciate having a single point of contact.” That was after it only had been instituted for less than 3 weeks. So I think that there is some real benefits to us having the simplified format.

And the rest of the questions, I’ll hand over to Vijay to see if he can do a better job.

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [16]

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We — to add on to what Neil just talked about, a 90-day fulfillment rate, we have been tracking quite carefully to the previous question as well. And we see that tracking up steadily, and we’re very encouraged by the early signs that we see.

In terms of your question about the physical samples, I would say that this is not intended to be an unending program on the free trial aspect. I will remind you that our prescriber base still has a lot of room for growth. So our full unlocking of the potential of GOCOVRI depends on both depth among current writers but also breadth to get more new writers into the system trialing GOCOVRI. That is what the free trial program is intended to do. And we’re having good progress in increasing breadth of utilization, which we are very pleased to see. And we’ll keep the program in place as long as we see an opportunity for us to further increase spread.

Now you asked a question about the copays that we’re seeing come through. I’m pleased to report that from our latest data, of the patients that received GOCOVRI, 75% of the time, their out-of-pocket expenses are $25 or less. So we are very encouraged about that and pleased to see that. And we continue, of course, to remain committed to making GOCOVRI as broadly available to patients as possible.

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Operator [17]

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And our next question comes from Ken Cacciatore of Cowen and Company.

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Kenneth Charles Cacciatore, Cowen and Company, LLC, Research Division – MD & Senior Research Analyst [18]

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I may have an overly simplistic question. But was the — did you control the employees? Or were they your employees at the fulfillment center previously? And are they your employees now? I’m just trying to understand what might have been happening when they were not getting a form that seems correct. Like what was their motivation to get fixed? It seems like something was going wrong there, and I want to make sure that you’re in complete control of that process.

So you talked about a more simplistic form. Is that from a clinician standpoint? Because it seems like if a form had an issue when it came to one of your employees, everyone would work like heck to try to clarify it and get it done. So I just wanted to understand are you now in complete control of the fulfillment process.

And then also maybe OSMOLEX and their impact and their sampling, is that part of the problem? Or is that really not an issue at all?

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [19]

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Sure. So let me address the first question in terms of the fulfillment process. Our end-to-end analysis of the process revealed that every stage of the process had a different point of contact for a physician’s office and/or a patient, right? They were reaching different people, different people who are reaching out to them.

The GOCOVRI care coordinator team is a single dedicated point of contact to the physician as well as to the patient. These are employees of AllianceRx. However, they are fully dedicated to the GOCOVRI business, and we are very tightly coordinating with them. They essentially serve as the quarterbacks within the AllianceRx system to streamline the communication among the players who help with the various steps of the process so that to the customer, the communication is highly streamlined and there’s a resolution of issues that might pop up much quicker than we might have seen before.

To your question of competition. We do see presence of physical samples and activity by OSMOLEX. But let me begin with the fact that from our prepared remarks, what you heard was what physicians tell us. They continue to see GOCOVRI as a highly differentiated product. We have a very differentiated profile in that we’re the only ones with that FDA indication for the treatment of dyskinesia. We’re the only ones with a proven clinical benefit in both dyskinesia and OFF and an increasing ON time. And we’re the only ones with QHS bedtime dosing. So physicians continue to see us as highly differentiated. And we don’t see an impact right now of a competitive product in this space.

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [20]

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Ken, maybe I’ll add just one thing to that. When you asked the question around whether or not they’re ours, they were — are Adamas employees are not — they’re Adamas trained on the product. They’re aligned in terms of what our incentives are, on making sure that patients get product and simplifying the process of fulfillment.

So I think it’s a — and there’s a tight matrix to be able to ensure that these guys are delivering what we would want to deliver. So I want to make it clear that we feel like there’s a tight consistency between what they’re delivering and how we would deliver it ourselves. So…

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Operator [21]

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And our next question comes from Tim Lugo of William Blair.

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Timothy Francis Lugo, William Blair & Company L.L.C., Research Division – Co-Group Head of Biopharma Equity Research [22]

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Congratulations, Neil, on the first call. I guess quickly around the new prescribers as well as losing some of the top subscribers that previously have been prescribing with GOCOVRI. Do you think that’s going to lead to TRxs still growing at around the same rate we’ve seen in the past few quarters? And following on, on a previous question, where is it maybe that prescriptions are not growing sequentially in the 1,000s. However, they’re growing in the 100s and they’re just higher quality and therefore more sticky? I think maybe give me some more details around that.

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [23]

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Tim, I’m going to take a stab at the first one, which we talked about the fact that as part of growing this prescriber base away from just the depth on where we were, we really put a consistent effort in Q3 to being able to broaden that breadth of prescribers. An 18% increase is nothing to shake a stick at. I think the team did an outstanding job in doing that. And this is actually, I think, the first time where we’ve seen this type of increase in breadth. The opportunity when somebody has — that means we’re able to — that urgency to treat, that means we’re able to actually get that fulfillment going, and its free trial program is working.

So it’s kind of validating our current tactics. But when we now have that broad base, we can go deep now. So it allows for the TRx and Rx to improve.

So maybe I’ll switch to Vijay and he can get into some additional details.

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [24]

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Increasing demand is an utmost urgency for us. So let there be no misconception on that front. And we are therefore focused on increasing, as Neil said, both the breadth of prescriber base and the depth. And we are appropriately allocating our sales force targeting to ensure that both can happen. We saw a great success with the breadth aspect in Q3. We have some work to do on the depth aspect, and we are focused on that right now. And we firmly believe that our progress in the 3 key focus areas will get us there.

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Timothy Francis Lugo, William Blair & Company L.L.C., Research Division – Co-Group Head of Biopharma Equity Research [25]

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Okay. Could you maybe tie this back a bit to SG&A spend as well? Should we just continue to expect investment on the SG&A side as you’re deepening into these new prescribers? Or because it sounds like there might be some optimization, maybe just deeper into these new prescribers with around the same level of spend?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [26]

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So I’ll take a quick step, and we’ll see if we can get Chris engaged in this call. Vijay has done a great job on looking at the assessment of what we need to be able to accelerate growth in PD. We feel at this point we’re adequately sized. He’s moving, again, his targeting and refining his targeting as he’s going.

So I think we’re in pretty good shape. But I’ll hand it over to Chris on the SG&A side so you can actually have a voice here today, too.

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Christopher B. Prentiss, Adamas Pharmaceuticals, Inc. – CFO & Principal Financial Officer [27]

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Thanks, Neil. Obviously, PD is our key priority that we’re completely focused on. We’ve asked Vijay and the team to really continue to look at the priorities and the tactics that he wants to focus on. And we’re reallocating the resources we need to, to continue to focus on things that truly drive the business. But yes, make this our key priority, but yes, not overspend. So Vijay and team has done a really good job of just continuing to look at what’s important to drive the business.

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [28]

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And right now, where we are focused on is optimizing the marketing mix in terms of sales force targeting versus digital marketing to provide the necessary share of voice we need.

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Timothy Francis Lugo, William Blair & Company L.L.C., Research Division – Co-Group Head of Biopharma Equity Research [29]

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Okay. And maybe if I could sneak in one pipeline question. Thank you for your commentary around INROADS and kind of the — what you will view as a success.

However, the first point in terms of pristine data, it seems like you probably have a good idea about trial conduct as of now given it’s early November. Can you just maybe speak to the trial conduct and how confident you are that there will be pristine data set that we’ll get come December?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [30]

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Rajiv? Thank you. We’ll get you in here, too.

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Rajiv Patni, Adamas Pharmaceuticals, Inc. – Chief Medical Officer [31]

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So thanks for the question. We are very confident in the trial conduct. And as Neil mentioned, I say that based on our experiences with the PD program. So we will achieve high-quality data, which is step 1 in any Phase III data readout. We did it in PD. We will do it in MS.

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Operator [32]

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And our next question comes from Ram Selvaraju of H.C. Wainwright.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [33]

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So I just wanted to get some additional clarity regarding where the new patients are coming from and what the profile of the prescribers are that are bringing onboard those new patients. If you could elaborate on that, please? What’s the profile, in other words, of the prescriber base from which the new patients who are coming on to the product is?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [34]

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Vijay?

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [35]

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We see — thanks for the question, Ram. The mix of prescribers that we see are some new high-volume prescribers that have not prescribed previously, who are just trialing the drug for the first time as well as some prescribers who treat lower volumes of Parkinson’s disease patients. So we see a mix in terms of where we get the breadth from.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [36]

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Okay. And then with respect to the retention profile. If we think about what the original expectations were regarding GOCOVRI long-term retention dynamics at the time that the product was first introduced and we look at the profile that has emerged now, is this overall in keeping with what you originally anticipated? Or is it a new picture that has emerged? And in particular, I’m talking about those figures that you previously provided regarding the roughly 60% retention rate at 6 months and 45% to 50% at 12 months.

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Vijay Shreedhar, Adamas Pharmaceuticals, Inc. – Chief Commercial Officer [37]

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Yes. So to address that question, we are very pleased both from a persistency perspective and a compliance perspective in terms of how patients stay on the drug. So in terms of both those key metrics, we continue to see a continued highlighting of the value that patients see in the drug. They stay on the drug. So for a condition of this nature, we’re very pleased with what we’ve seen.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [38]

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Okay. And then the last question is pertaining to the INROADS indication. Given that there would be evidence supporting the use of GOCOVRI as an ameliorator of walking impairment, does this have any implications for potential explorations in indications beyond specifically MS? In other words, are there other related conditions in which positive impact on walking impairment would potentially be beneficial and point to the possibility of utility in those contexts?

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [39]

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Dr. Patni?

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Rajiv Patni, Adamas Pharmaceuticals, Inc. – Chief Medical Officer [40]

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Appreciate the question. And as I said in my prepared remarks about GOCOVRI and motor impairment, we have it in PD. We hope to demonstrate that in the first pivotal in MS. If 2 disease areas show an effect in motor impairment, it, of course, will make us think as a company, is there an additional population where we should study GOCOVRI.

And I say that because back to Neil’s opening comment, this is about maximizing patient benefit with where GOCOVRI can have a large effect size. So if we see it, then yes is the answer. We will seriously explore where else in a distinct patient population GOCOVRI could provide that patient benefit.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division – MD of Equity Research & Senior Healthcare Analyst [41]

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Great. And just one clarificatory point. You were talking previously about the possibility of pooling of data from the INROADS study and a putative confirmatory trial. But can you just clarify whether what you meant was just broadly speaking pooling of data to achieve statistical robustness? Or if what is implied was pooling with respect to certain prespecified subgroup analysis?

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Rajiv Patni, Adamas Pharmaceuticals, Inc. – Chief Medical Officer [42]

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What I meant — and I appreciate the request for clarity. Pooling of data with respect to certain secondary efficacy measures and in particular, the patient-reported outcome, the MSWS-12. PROs, in general, the MSWS-12 as an example, being a PRO, have inherently high variability. And the most straightforward way to deal with that is to pool data to just be more precise in the treatment effect point estimate.

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Operator [43]

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Ladies and gentlemen, this does conclude our question-and-answer session. I would now like to turn the call back over to Neil McFarlane for any closing remarks.

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Neil F. McFarlane, Adamas Pharmaceuticals, Inc. – CEO & Director [44]

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Thank you, Sonya. I want to thank everybody for the warm welcome that I’ve received since joining Adamas. We remain focused on our 2 top priorities: driving growth for GOCOVRI in Parkinson’s disease patients with dyskinesia and OFF; along with completing our INROADS Phase III study in the second half of December. We look forward to continuing the dialogue and providing updates at upcoming investor conferences and quarterly calls. Have a great afternoon.

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Operator [45]

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Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.