Good day, ladies and gentlemen, and welcome to the Adamas Pharmaceuticals Second Quarter 2019 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session and instructions for how to participate will follow at that time.

[Operator Instructions] I would now like to turn the call over to Peter Vozzo from Westwicke Partners of Investor Relations for Adamas Pharmaceuticals. Please go ahead..

Thank you, Jimmy, 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 Greg Went, Chief Executive Officer..

Thank you, Peter, and good afternoon, everyone. Thank you for joining us today. I am here with Vijay Shreedhar, our new Chief Commercial Officer, Dr. Rajiv Patni, our Chief Medical Officer and Alf Merriweather, our Chief Financial Officer.

Our two priorities for Adamas in 2019 are driving towards commercial success by broadening and deepening GOCOVRI’s use in patients with Parkinson’s disease patients with dyskinesia and delivering top-line Phase 3 data for an additional indication for GOCOVRI in multiple sclerosis patients with walking impairment.

Turning to our second quarter, total GOCOVRI paid prescriptions which excludes patients from the free trial program rose to 6,160, up about 6% from Q1 2019. This growth continues to be driven by patients refilling GOCOVRI. New patient starts were up about 2% to 740 primarily from patients using the new free trial program.

While it’s early days for this program, the initial conversion to paid prescriptions is running at 40% to 50%. We look to improve utilization with better promotion of the program with our physicians and increase conversion by improving operational efficiencies with the process.

Patients refilling their prescriptions remains a key driver of GOCOVRI’s growth and provides a strong foundation for our future commercial initiatives. Persistence remains very solid with 55% to 60% of patients remaining on GOCOVRI at six months and 45% to 50% at 12 months.

Maintaining this level of persistence from 6 to 12 months is a strong indicator of the value that GOCOVRI is bringing to patients and these numbers are compelling.

For context, Rasagiline, commonly used and widely considered well-tolerated adjunctive treatment for Parkinson’s disease showed persistence rates of 49% and 37% at 6 and 12 months respectively in our recently presented poster.

Turning now to our development programs, our INROADS Phase 3 trial completed enrollment this quarter and is set to read out at the end of 2019. Vijay will walk you through the final enrollment details later on in this call. It’s important to note that this is an already established market.

Today, we believe there are approximately 270,000 multiple sclerosis patients with moderate to severe walking impairment. Of those patients, approximately 50,000 are receiving ongoing treatment with dalfampridine, another 100,000 have tried dalfampridine and discontinued it and the remaining 120,000 are dalfampridine naïve.

We anticipate that our initial commercial focus will be on those with tried and discontinued dalfampridine and we look forward to seeing the top-line data from our INROAD study prior to finalizing that strategy. Now, I am pleased to introduce Vijay Shreedhar, who joined us last quarter to lead our commercial efforts.

Vijay is a proven commercial leader who has grown multiple brands across multiple therapeutic areas of Amgen over the past decade. What is particularly impressive about Vijay is a strong scientific and broad business background. He has demonstrated success at Amgen and standing the commercial continuum from sales to marketing to brand management.

Vijay has used his skills to both launch and realize the value of some of Amgen’s key brands. I am delighted to have Vijay join us to lead our commercial team and help drive us forward. Over to you, Vijay. .

Thank you, Greg, and good afternoon, everyone. It is great to be speaking with you today. In the last two months or so that I have been at Adamas, I have been in listening and learning mode, interacting with a range of key stakeholders to develop a deep understanding of our business.

I have visited top movement disorder centers and urologists to observe practice considerations, attended the International Association of Parkinsonism and Related Disorder Congress to meet with thought leaders and gathered insights from the leading healthcare providers on our speaker bureau.

Additionally, I have visited our specialty pharmacy partner to assess the operational elements of our fulfillment and distribution process.

Internally, I have spoken individually and collectively to our entire sales and broader commercial teams to collect learnings and assess our organizational needs to fully unlock the commercial potential of recovery. These interactions have confirmed the optimism and excitement for the potential of GOCOVRI which drew me to Adamas in the first place.

I have been impressed to hear from many of the physicians and nurses who have clinical experience with GOCOVRI about the positive impact that the drug has on patients and caregivers lives. These healthcare practitioners see GOCOVRI as a drug with proven clinical data and a differentiated clinical profile as a result of these data.

The recently published individual patient-level analyses of the diary data from our pivotal Phase 3 program corroborate the prescribers’ feedback to me that GOCOVRI represents a paradigm shift because of its concomitant effect on dyskinesia and OFF.

Many of the clinicians I have interacted with have positive patient stories and are excited about the prospects for GOCOVRI moving forward. In short, the clinicians I have spoken with believe the drug works very well.

My interactions with our sales force have shown me both their commitment and passion to improve the lives of people affected by Parkinson’s disease and the depth and relevance of their experience in urology and with previous launches. However, my interactions have also highlighted that we have work to do.

There are three key areas where I will focus intensively in the weeks and months ahead. First, we need to do a better job in educating healthcare practitioners to recognize the disruptive impact of dyskinesia, its relationship to OFF and its impact on the effective treatment of Parkinson’s disease.

While prevalent in patients treated with levodopa, dyskinesia is still relatively poorly understood or appreciated by both prescribers and patients. It is often confused with tremors and the impact that it may have on many aspects of a patient’s daily life is not effectively highlighted.

Educating healthcare practitioners on these aspects and on how to systematically identify appropriate patients for consideration of GOCOVRI therapy offers an opportunity for enhancing patient care. Second, based on my recent observations, there is an opportunity to improve our operational effectiveness in the fulfillment process.

From the moment when a physician sends in a treatment form to when a patient gets the drug. I have noted some level of frustration among prescribers and we are working actively to address this and to improve the customer centricity of our overall fulfillment process to ensure that we create one that is simple, reliable and transparent.

Third, we need to better educate a wider audience about our 28-day, free trial program, which we hope will expand trial of the drug among non-adopters. We will look at every element of the program in order to make progress on this front.

While I am initially focused on these three areas, I continue to examine every element of our strategy and execution and I look forward to sharing additional details about our strategic and operational plans in future calls. All of the interactions that I have described have deepened my belief in the opportunity that initially drew me to Adamas.

I have heard how GOCOVRI has a significant on patients with Parkinson’s disease and have come to appreciate the impact it may have over time in other indications. I am particularly excited about the first of these other indications in MS walking and will turn the call over to Rajiv to discuss our progress. .

Thanks, Vijay. I am happy to report that enrollment is complete in our INROADS Phase 3 trial of ADS-5102 and MS patients with walking impairments. This is a significant milestone in our development program. We are on track to report top-line data in late Q4 2019.

This study is a three arm, randomized, double-blind placebo-controlled study of two-dose levels of ADS-5102. The primary efficacy endpoint is the proportion of responders in each treatment group. 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.

Key secondary endpoints include the mean change from baseline in walking speed, the Timed Up and Go or TUG, and the 2-minute walk test. The baseline demographics are noteworthy because these data provide a snapshot into the real world effectiveness of dalfampridine.

Approximately 50% of enrolled patients had received dalfampridine in the past and discontinued. This represents the dalfampridine discontinued subgroup. The other 50% of enrolled patients represent the dalfampridine naïve subgroup.

In the dalfampridine discontinued subgroup, the reason for discontinuation, prior to study entry was limited efficacy in 48% and adverse events in 21%.

Since the dalfampridine discontinued and naïve subgroups are each reasonably sized pre-specified analyses will provide an opportunity to characterize the treatment effect of ADS-5102 in both subgroups. Our thesis remains that the treatment effect will be consistent irrespective of prior dalfampridine use.

If the Phase 3 data for INROADS supports our thesis, and ADS-5102 has the potential to be a treatment option for the breadth of the MS population with walking impairment. We believe the initial unmet medical need is in patients who discontinue dalfampridine in the past due to limited efficacy and/or intolerability.

Our current estimate of the size of this population today is about 100,000 patients. We look forward to the readout of this trial late in fourth quarter of 2019, if successful, we expect to initiate a second pivotal study to support approval. If approved on this pathway and timeline, we would plan to launch GOCOVRI for this new indication in 2022.

I will now turn the call over to Alf. .

Thanks, Rajiv. In the second quarter of 2019, we recorded GOCOVRI product sales of $12.7 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 6,160 in the second quarter, compared to 5,820 in the first quarter of 2019, about 6% higher than the prior quarter. Gross to net was consistent with the prior quarter and our commentary on the last call.

Regarding our overall operating results, net loss for the quarter was $24.9 million or a loss of $0.90 per share, compared to a loss of $34 million or $1.26 per share in the second quarter of 2018. Cash and investments as of June 30, 2019, were $169 million, compared to $211 million at December 31, 2018.

Overall cash burn for the quarter was consistent with prior quarters at approximately $22 million. Let me now turn the call back over to Greg. .

Thanks, Alf, thanks, Rajiv and thanks, Vijay. I want to thank the whole Adamas team for their continued commitment to building sustainable business based upon the discovery, development and commercialization of our time-dependent medicines. As we reported in the press release earlier today, we announced that Alf will retire on December 31, 2019.

He will be succeeded by Chris Prentiss on November 1, the company’s current Senior Vice President of Finance and Chief Accounting Officer. I am deeply appreciative Alf for your contribution to Adamas’ growth and your role in mentoring Chris as your successor. I also appreciate your continued involvement to ensure a smooth transition.

Many of you will already know Chris from our interactions with you on the road. He has been a leader in our finance organization since he joined us in early 2015 and has played an integral role in building our financial infrastructure.

Finally, I am thrilled to have Vijay’s leadership as he reshapes and focuses our commercial efforts to better drive the adoption of GOCOVRI by physicians and patients. I am also excited for our INROADS top-line results in late Q4 which is successful. We expect it will add significant potential to GOCOVRI.

And with that, I’d like to open up the line for questions.

Operator?.

[Operator Instructions] Our first question comes from Marc Goodman with SVB Leerink. Your line is now open. .

Hi, this is Rudy on the line for Marc.

So, I am just wondering, first question is on the physician and the patient feedback so far for the free drug program, and you’ve noticed any notable changes on the treatment landscape on the dynamics? Second question is, we plan for the patient awareness campaign in Q1– I am just wondering can you more color on that program. Thanks. .

Thank you very much for the questions.

Vijay, do you want to tackle both of those?.

Sure, let me begin with the free trial program. The program is being perceived right now in terms of feedback as being one of the most generous among all of the peer set. It is a 28-day free trial program. The adoption among current users of GOCOVRI has been very robust.

And as I said, our goal moving forward to expand knowledge and awareness of that program and trial of that program among non-adopters and new patient types. In terms of your second question, we have initiated a program called the Go Getter patient education program. It is currently in market. It was fielded towards the end of May, beginning of June.

It is just a little early to seek to what that program is, but we will keep you posted in future calls. .

Thanks. That’s very helpful..

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

Thanks. So, just a couple. First on commercial consideration for GOCOVRI and in MS, are you expecting, it’s really for Vijay, are you expecting a step through toward dalfampridine in order to gain access to the product and I realize that you don’t have the data.

But talk about the – how restrictive do you think the payer landscape will be, vis-à-vis the dalfampridine, and then, number two, would you consider, partnering with another company for the commercial launch or you completely wedded for launching it on your own and if so, how many reps are you going to add to support the launch in MS gates? Thanks. .

Vijay?.

Yes, so, two-part question, I see. So the first question in terms of MS itself, it all depends on the clinical profile of the drug and what the clinical studies show us and what that readout is. We all eagerly anticipate towards the end of this year.

What I will comment on in the MS market is, was commented on in the prepared remarks is, a lot of learnings for us from where we are in the PD market and what we can apply to in the MS market. Now it is a well-established market for MS walking. It is a market which has seen specialty neurology drugs for a long period of time.

The patient demographics are younger, more motivated to seek help and to proactively talk to their physicians about new treatment options. So we expect a different and more active dynamic for how that drug launches in that market.

To your second question, we have done some preliminary analysis of where the account concentration and physician prescriber concentration is for MS, it does remain highly concentrated. So, we will keep you posted about our plans for the sales force. But currently, I believe we are right-sized for what we need to do. .

Okay. Thank you. .

Thanks, David. .

Thank you. And our next question comes from Tim Lugo with William Blair. Your line is now open. .

Hi this is [Indiscernible] on for Tim. Thanks for taking the questions.

Just a first one on your 40% to 50% conversion rate for the free drug program, I am wondering how many of those patients actually experienced a neuropsych adverse event? And whether or not, there is obviously more conversion from free drug to paid drug in patients that happen to have that experience? And then secondly, just in terms of the INROADS trial and now assessing dalfampridine discontinuations and naïve treatment, was that trial when you responded was it already powered to view those two groups on and off drug on your primary endpoint there and what are your pairing assumptions in general? Thanks.

.

Vijay, do you want to go first again?.

So, we have done an analysis of patients who received drug through the free trial program in order to understand where the gaps were in them converting to maintenance reps. The vast majority of patients actually drop-off because of operational considerations, right? There are prior authorizations that are still in process.

There are steps that a physician’s office needs to complete. There are steps that a patient themselves need to complete. That’s where we believe we can have the most impact, which is why one of the focus areas that I articulated with in terms of fulfillment focuses on the operational effectiveness to make it simpler and more transparent and reliable.

And actually the AEs are not one of the big reasons why they drop-off as far as we have seen in our initial analysis. Let me pass on to Rajiv. .

And on to the INROADS stay design, as I shared in my prepared remarks, the trial faced an FDA feedback at the end of Phase 2 meeting was to powered to compare active to placebo, an assumption of 33% inactive versus 20% placebo and equally important is that each sub-group I commented on reasonably sized, permitting us to characterize the effect on those patients who are treated with dalfampridine in the past versus were not.

.

Okay, useful. Thanks for the clarification and congratulations, Alf. .

Thank you. .

Thank you. And our next question comes from Ken Cacciatore with Cowen and Company. Your line is now open. .

Hi, thanks guys for the questions. Vijay, I know you are new and going through all the different parts of the operation.

But just wondering your view of OSMOLEX and its implications to the launch and is there any way in which we can avoid them or somehow have that impact mitigated? And then, secondly, can you get into a little bit deeper to this fulfillment issue with these number of patients that you are talking about new patients starting, it seems as if you could really give a white glove service, almost on an individual level to get them going.

So just confused as to what is happening in that somehow with this fewer patients were losing not properly processing paper work and getting the drug to them.

And then, lastly, can you just talk about the co-pay and the charities that are available to help – any sense of what’s going on with those and is the co-payment and that issue causing some problems as well? Thank you. .

Sure, so let me begin with the first part of your question, which was with regard to OSMOLEX.

Here is what I have learned in my listening towards the last couple of months as I’ve said in my prepared remarks, GOCOVRI really stands out as a differentiated drug in this space because of the clinical profile which has been demonstrated through a couple of clinical trials, right? So, the only drug to have clinical efficacy demonstration in a largest clinical trial, both on the dyskinesia side and secondarily on the OFF side and also in recent post talk analyses to show the increase in continuous on-time the reduction of disruptive episodes in a patient’s day.

So, really a remarkable clinical profile in how physicians characterize it to me. So, I think, the other competitors are in the market, but we don’t believe that they are making as many INROADS or having a significant on our presence in the marketplace. So, that’s your question one.

In terms of fulfillment, which was your second question, I think we are looking at various aspects of the process the steps in the process, the complexity of the process, the lack of – or I’d rather frame it as a white space that exists between a physician sending in a treatment form and then finally getting confirmation that their patient is on drug.

There are a lot of elements during this process where we could potentially look and improve our services and that’s where our focus is. So, the option that you proposed is on the table and we are looking at all options. The third question you had was about co-pay and charities.

I presume you are referring to foundations and where assistance to patients is being offered. We are continuing to see that patients are able to access our drug both on the commercial side and on the Medicare side and we are continuing to see that happen.

I think you raised the larger question in terms of cost of some specialty drugs and we are looking at various options to continue to drive access. .

Thank you. .

Thank you. And our next question comes from Tazeen Ahmad with Bank of America. Your line is now open. .

Hi, this is Bill on for Tazeen. So, I have two questions. First of all, GOCOVRI for LID has a pretty clear story around the time-dependent biology where you want to wake up with therapeutic levels on board to avoid the morning off.

How is the same time-dependent biology translate into MS walking where the – I don’t know, isn’t as clear? And then, for Vijay, you mentioned expanding the free drug program and getting more non-adopters to take it up.

In your listening tour, what have you heard from the non-adopters as their primary reason for not adopting GOCOVRI at this point? Thanks. .

Hey Bill, it’s Greg. Thanks for the question. I’ll take the first one and then I’ll see if Rajiv wants to add to it.

I think the reason why folks are familiar with the time-dependent hypothesis around dyskinesia and often Parkinson’s is because, we are well beyond our Phase 3 program where we’ve demonstrated it and we’ve talked about the underlying science to a much greater deal.

In the MS area, we began with a very similar understanding of the pathways that are involved in allowing people to move. We understood how those were coupled to our – patterns that crucially drove the hypothesis and we proved that program out beginning with pre-clinical studies moving it into animal models and moving it into human proof-of-concept.

So, as we look and see the data coming out here and have more confidence from completed Phase 3 programs we’ll begin to tell that story, the basic science story and the symptom coverage story in a more public forum. .

And the only thing I would add, Greg is, encourage you to see our poster from AAN where we began explaining to the community the time dependency of MS walking impairment for the first time. .

And Vijay, you have a second one for you..

Sure, I think that the question was about the reasons that are stated in terms of my listening towards in terms of non-adopters. They really boil down to two areas.

I think the first is what I alluded to in terms of the opportunity with educating physicians because I think what I’ve heard so far is confusion around dyskinesia, how does it manifest? Is it bothersome? That conversation that happens with patients, is that enough on a once every three to six months basis to identify the patients for consideration.

The relationship between dyskinesia and OFF and I think when they learn about our clinical profile more, that shows us as an opportunity for us to really talk about GOCOVRI and get them along the continuum.

The other reason that they talk about most often is cost and perceptions of cost and as we share some of our real data from the last year-and-a-half of experience, that seems to help them as well in terms of making that choice. .

Thank you. .

Thanks. .

Thank you. And our next question comes from Serge Belanger with Needham. Your line is now open. .

Hi, good afternoon. A couple questions for me. First on the payer landscape.

How satisfied are you with the current landscape? What else needs to be done there? And do you think it could be a driver for sales in the second half of the year?.

Vijay, do you want to take that?.

Sure. So, let me say upfront, right, we are committed to making GOCOVRI as broadly available to patients as possible. And we continue to see from what we have tracked in the first part of 2019 that prescriptions are being paid through the prior auth mechanism and coupled with the medical necessity for both commercial and Medicare plans.

We’ve seen no significant change in access in the first part of 2019. So I want to make sure that that folks you are aware. We continue to evaluate the payer landscape and we evaluate contracting as a means to drive access to simplify the prior auth process to reduce physician burden in terms of process.

But in the mean time, I think the greater area of focus for us would be educating them about dyskinesia and the value of GOCOVRI there.

The real simplification of our fulfillment process to make it simpler for the physicians practice and really making them aware of the free trial program to even trial the drug and those are the three areas we are going to focus on. .

Okay. And just looking on my notes, in terms of new patients, that number has been in the 700 range for the last few quarters.

Should we expect that to move up as the free program gets a little bit more implemented?.

So, I would say, are we satisfied with our number? No. We are continuously looking at ways for us to educate all stakeholders and improve that number. I think it’s a little early for me to speak to when that turnaround will happen. But that is definitely the goal is to get us on a trajectory of robust growth in that number. .

Thanks. And then I also want to offer my congrats to Alf. .

Thank you. .

Thank you. [Operator Instructions] Our next question comes from Ram Selvaraju with H.C. Wainwright. Your line is now open. .

Thanks very much for taking my questions. I just wanted to get some additional clarity on the 28 day sampling program.

Do you have a sense of how long do you expect to keep that in place if that’s going to be sort of core component of the sales and marketing strategy for GOCOVRI indefinitely? Or if you have a plan to sort of eventually seize it out or change in anyway? And if so, what might be the changes be that you would make? And then, I also wanted to ask if you are seeing any potential promotional impact from OSMOLEX ER? Obviously, that’s been kind of around for a while, but I don’t know whether you are actually seeing any promotional activities of that product coming up against you in the marketplace? If you could provide some color on that, that would be helpful.

.

To your latter question, your second question, the answer is no.

to the first question, I would say, in terms of the free trial program, the current plan is in the current format, to remind folks, the 28-day free trial where the drug is shipped directly to the patients, in that format, we plan to continue it through the end of the year as we have previously announced.

But part of what I am looking at right now is all of the various options open to us in addition to looking at the key metrics that come off of the current program we are looking and evaluating at various options, one obvious option is, do we go with one of the other ways of getting a free trial to a patient.

So, we are evaluating all options that I’ll keep you posted in the coming quarters. .

Okay.

And then, just do you have any further updates at this time on the status of the Qui tam lawsuit?.

I’ll take that. No, we don’t and we don’t, as, we don’t comment on ongoing litigation. .

Okay. Thank you. .

Thanks, Ram..

Thank you. I am showing no further questions in the queue at this time. I would now like to turn the call back to Greg Went for any closing remarks..

So, listen, I just want to thank everyone for participating today at the end of the summer and we look forward to seeing you at upcoming conferences and meetings that we have ahead of our next earnings call.

Thanks so much today and again, my thanks again to Alf for his service here, the team and as well as looking forward to having Chris on the next call. Thanks very much. .

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