Supernus Pharmaceuticals, Inc. (SUPN) Q1 2017 Earnings Report, Transcript and Summary

Welcome to Adamas Pharmaceuticals First Quarter 2017 Financial Results and Corporate Update Conference Call. All participants are in a listen-only mode. At the end of the company’s prepared remarks, we will open the call for questions and will provide specific instructions. As a reminder, this call is being recorded. I would now like to turn the call over to your host, Ashleigh Barreto, Investor Relations and Corporate Communications at Adamas. Please go ahead.

Thank you, operator and good afternoon everyone. Joining me on the call today are Dr. Greg Went, our Chairman and Chief Executive Officer; Bill Dawson, our Chief Financial Officer; and Dr. Rajiv Patni, our Chief Medical Officer. Before we begin, I’d like to remind everyone that this call will contain forward-looking statements which are subject to risks and uncertainties. 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 disclosed in greater detail on our most recent Form 10-Q and other SEC filings. I would now like to turn the call over to Greg. Greg?

Thank you, Ashleigh and good afternoon everyone. Let me start by thanking you all for joining us today on our first quarterly conference call. We will be conducting these calls on a quarterly basis going forward to keep you informed of our business progress and initiatives. This is a very exciting time at Adamas, as we prepare for the potential approval and U.S. launch of ADS-5102, an investigational extended release amantadine product administered once daily at bed time for the treatment [Audio Gap] people living in the U.S. today with Parkinson’s disease. Nearly all of those who are treated are on chronic levodopa therapy, considered the gold standard. Levodopa replaces the dopamine loss caused by the disease. Starting as early as six months from the initiation of the levodopa treatment, patients may begin to experience alternating periods of OFF Time and dyskinesia throughout their day. OFF Time refers to the periods of rigidity and stiffness where there is too little dopamine, whereas dyskinesia is defined as involuntary and uncontrolled movements when there is too much. Over time, approximately 90% of Parkinson’s patients develop dyskinesia and at any given time, there are approximately 150,000 to 200,000 patients in the U.S. fathered by dyskinesia. ADS-5102 is a big development platform, which is built upon our understanding of time dependent biological processes responsible for specific disease activities and drug response. Through our robust clinical program, ADS-5102 offers a new level of efficacy in treating dyskinesia and improving OFF Time in Parkinson’s patients as well as a manageable safety and tolerability profile. We achieved our goals for the development program which were to drive durable efficacy and maintain tolerability of the amantadine molecule in this new population. The NDA supporting ADS-5102 for the treatment of dyskinesia and Parkinson’s disease [Audio Gap] with Richard joining our executive team and leading our experienced commercial executives, I’m confident that we have the right team in place to successfully launch ADS-5102 and create significant value for all Adamas stakeholders. I will provide an update on our commercial plans later on today’s call, I would now like to turn the call over to Bill Dawson, our CFO to review the first quarter financial results and then to Dr. Rajiv Patni who will summarize the ADS-5102 clinical program. Bill?

Thanks, Greg and hello everyone. For the first quarter of 2017, Adamas reported a net loss of $16 million compared to a net loss of $13.8 million for the first quarter of 2016. Adamas recorded no revenue in the first quarter of 2017 [Audio Gap]. Additional costs associated with the ongoing open label safety study decrease prior year period as well. The decrease was offset impart by increased efforts to pre-commercial manufacturing [Audio Gap] in preparation for the anticipated approval and commercial launch of ADS-5102. We also incurred increased expenses related to clinical [Audio Gap] administrative expenses for the quarter were $9.1 million, up nearly 40% from last year’s first quarter G&A expense of $6.6 million. The increase in G&A expense was primarily due to cost associated with establishing commercial capabilities in preparation for the potential launch of ADS-5102 for dyskinesia in Parkinson’s disease. This included an increase in headcount related expenses and [Audio Gap]

Ladies and gentlemen, the conference will begin momentarily. Please remain on the line. Your conference will resume momentarily. You may begin.

Hello everyone. Welcome back to the call. We apologize for the technical issues that we’re having and I’d like to restart the conversation with Dr. Patni.

So as Greg mentioned, this is an exciting time for Adamas and for patients. As we look forward to the potential approval of ADS-5102 for the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease. ADS-5102 is a high dose amantadine, taken once daily at bedtime which allows amantadine concentrations to rise slowly at night to reach peak therapeutic levels in the morning and maintain them throughout waking hours. This is when patients need symptomatic relief from bothersome dyskinesia and Off Time. As a reminder, the ADS-5102 clinical development program for the treatment of dyskinesia in Parkinson’s consisted of four clinical trials, a Phase 2/3 dose finding study, two placebo controlled Phase 3 trials with study durations of three and six months and an ongoing two year open-label safety and efficacy study. The two pivotal Phase 3 studies were designed to evaluate the efficacy and safety of ADS-5102. The primary efficacy endpoint for both studies was the placebo corrected change from baseline in the Unified Dyskinesia Rating Scale total score at week 12. The scale evaluates dyskinesia based on both patient feedback and physician assessment. Key secondary efficacy endpoints were placebo corrected changes from baseline and on time without troublesome dyskinesia and Off Time as assessed by a standardized home diary. In both studies, ADS-5102 was added to an unchanged regimen of levodopa therapy and the duration of levodopa therapy ranged from 1 to 20 years. Recently, at the American Academy of Neurology Meeting, we presented a pre-specified pooled analysis of our Phase 3 studies. Treated patients compared to placebo demonstrated at 12 weeks, 30% placebo adjusted decrease in the Unified Dyskinesia Rating Scale total score, a 45% placebo adjusted decrease in Off Time representing a one hour per day placebo adjusted decrease in Off Time and a 40% placebo adjusted increase in on-time without troublesome dyskinesia which represents a 2.4 hour per day placebo adjusted improvement in on-time without troublesome dyskinesia. In the Phase 3 pooled analysis, the most common types of adverse drug reactions were consistent with the known amantadine safety profile and included visual hallucinations, dry mouth, dizziness, peripheral edema, falls, constipation, nausea, anxiety, decreased appetite, livedo reticularis [Audio Gap] of amantadine hydrochloride is equivalent to 137 milligrams and 274 milligrams of amantadine which on the doses that we anticipate will be reflected in the label upon approval, consistent with the updated U.S. Pharmacopeia salt policy. We also presented data from our ongoing open-label study at the Pan-American Parkinson’s Disease and Movement Disorder Congress in February. This analysis demonstrated continued safety and tolerability of ADS-5102 and a durable reduction from baseline in dyskinesia and Off Time symptoms for up to 64 weeks. Efficacy was assessed by the motor complication section of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale. At the upcoming International Congress of Parkinson’s Disease and Movement Disorder Society meeting in June, we plan to present our open-label safety and efficacy data out to 88 weeks. This analysis will also include data from two important sub-groups; Parkinson’s patients with persistent dyskinesia despite prior treatment with deep brain simulation as well as patients directly switched from immediate release amantadine. Through the robust clinical program, we believe we have demonstrated the favorable benefit safety profile for ADS-5102 and we are confident in the NDA package we submitted to the agency. The NDA review is on track and proceeding as expected. We have submitted the 120 day safety update and also have confirmation that an advisory committee meeting will not be required. We look forward to the potential approval in August. To summarize, ADS-5102 if approved, will be the first and only adjunctive treatment to levodopa that has demonstrated a sustained and durable reductions in both dyskinesia and Off Time for people with Parkinson’s disease. Based on these data, we believe ADS-5102 could enable physicians to treat their patients’ dyskinesia and Off Time episodes without compromising their underlying Parkinson’s disease treatment with levodopa. With that, I’ll turn the call over to Greg.

Thanks, Rajiv and again, I apologize for the technical challenges. The transcript will be available afterwards and you’ll get the full text of this. So with the August PDUFA date on the horizon, I want to talk about the pre-commercial activities that are underway here at Adamas. We see a significant opportunity for ADS-5102 in the Parkinson’s market as potentially the first and only FDA approved medication for the treatment of levodopa-induced dyskinesia with an important secondary benefit in reducing Off Time. This combined benefit for dyskinesia and Off Time totaling 2.4 placebo adjusted hours for a three to four hour improvement from baseline is an important improvement in functional time for Parkinson’s patients. Our market research confirms that physicians struggled to balance dyskinesia and Off Time in the context of treating Parkinson’s patients. Currently, without an approved medicine, most physicians attempt to manage dyskinesia and Parkinson’s patients by fractionating and adjusting levodopa doses and adding dopaminergic agents only approved for treating Off Time. This often leads to sub-optimal treatment of the underlying Parkinson’s symptoms. Our research shows that treating dyskinesia and people with Parkinson’s disease is a significant unmet need. Nearly two-thirds of surveyed neurologists are movement order specialists recognize efficacy as the biggest unmet need in treating dyskinesia and Parkinson’s. Less than 25% of surveyed physicians are satisfied with current management modalities such as levodopa dose adjustments. Additionally, our market research shows that ADS-5102 would significantly reduce the proportion of Parkinson’s patients with dyskinesia that go untreated. Based on these and other findings, we believeADS-5102, if approved, has the potential to change the Parkinson’s disease treatment paradigm so that physicians will not have to choose between dyskinesia and Off Time in managing their Parkinson’s patients. As with any new product launch and a new indication, it will require an educational effort and we look forward to engaging neurologist and movement disorder specialist utilizing our robust clinical data Rajiv described earlier. We are combining these and other insights into our commercialization and branding strategies as we look to launch and beyond. On the payer side, our research also indicates that payers appreciate the strong value proposition of ADS-5102. The payers recognize the substantial unmet need for this orphan population for whom there is no approved medication. We are looking forward to it being well received and covered in both commercial and Medicare Part D plans over time. To optimize this opportunity for the benefit of stakeholders, we will stay true to the efficient outsource model that has made us successful thus far. This means while we have in our building internal commercial capabilities and experienced leadership in such areas such as marketing, sales management and market access, we will also employ external infrastructure to advance our internal efforts. To this end, we will leverage a contract sales organization solely dedicated to promoting ADS-5102. Our current market research and ongoing field sizing work indicates that we should be able to cover approximately 6,500 physicians managing 90% of Parkinson’s disease patients with dyskinesia, with approximately 60 sales representatives. Adamas will recruit, select and manage these sales representatives who will be deployed at our direction. Similarly, we are striving to provide seamless access to ADS-5102 by distributing it through an exclusive specialty pharmacy partner. This approach will allows us to provide an integrated suite of access, patient education, data management and specialty distribution services for patients, caregivers, physicians, providers and payers. The use of both internal and external capabilities will enable us to be focused, efficient and nimble in the launch of ADS-5102. Finally, as I mentioned before, we are excited that Richard King has joined Adamas to lead the commercialization of ADS-5102. With Richard on board, we are confident that we, as a company, are well positioned to take advantage of the significant commercial potential of ADS-5102. So as you can see, we are making significant progress as we move closer to our anticipated approval in August. We’ll be providing additional updates on our commercial preparations and on our clinical development programs during future calls, so please stay tuned. I will now turn the call over to the operator for questions. Operator?

[Operator Instructions]. Our first question comes from Jason Butler with JMP. Your line is open.

Hi, thanks for taking the questions. First one, just maybe if you could give some perspective from treating physicians about how they view on time versus Off Time in terms of their focus and their desire to treat?

Jason, thanks for the question and for your patience on the call today. It’s interesting. In the absence of a drug to treat dyskinesia, Jason, the focus and the target to treat has been to treat Off Time. And I think our opportunity that lies ahead of us with the first and potentially only product for treating dyskinesia that also has a secondary benefit in Off, they’re recognizing that it’s going to be a new option. Their choices are going to be broader and we’ve gotten a great deal of positive feedback in terms of helping to manage with that struggle and allowing them to target the good on-time as the goal of their treatment.

Okay, great. And then, when you think about that initial target set of 6,500 docs, what proportion of those physicians do you think currently use immediate release amantadine? And can you maybe tell us what their prospective of ADS-5102 are from docs who do and don’t use immediate release amantadine right now?

That’s a good question, Jaosn. So let me start with the answers I have. ADS-5102 will be the first product approved for treating dyskinesia, yet it’s going to be supported by the dataset that Rajiv went through which is from six months controlled clinical studies with the 30% reduction in dyskinesia and the 45% reduction in Off, along with the two years of durable open-label safety data for both the dyskinesia and the Off. Absent that, the primary treatment modality is managing for the dyskinesia with levodopa dose adjustments, but we estimate from the work we’ve done, approximately 7% of patients are taking amantadine. The problem is when they do, it’s not durable and they don’t stay on it for very long. So, we’re really excited with the changes we’ve made to the timing of the amantadine molecule and ADS-5102 and in terms of how it will be received, I think it will be received as a new product by those who are unfamiliar with amantadine hydrochloride and by others, they will recognize the benefit in the benefit-tolerability ratio.

Okay, great. Thanks for taking the questions. I’ll jump back in the queue.

Thanks, Jason.

Thank you. Our next question comes from the line of Tyler Van Buren of Cowen & Company. Your line is open.

Hey good afternoon guys. Thanks for taking my questions.

Thanks, Tyler.

I guess in general just be curious to hear your thoughts on how the interactions with the FDA have been going with the 5102 review process so far?

I mean I’ll let Rajiv tackle that Tyler. Go ahead, Rajiv.

Thanks, Greg and thanks for the question, Tyler. So, the FDA interactions are going as planned. As I mentioned in my earlier comments, they’re reviewing the NDA package. We’re responding to queries and everything is on track.

Okay, that’s great to hear. And I know Greg you mentioned about the outsourcing of the sales force and I may have missed this some of it due to what appears to be kind of a systemic outage with a bunch of calls right now. But with respect to hiring the sales force and the additional commercial folks and kind of the phasing has been, maybe you could give us a little more granularity as opposed to what additional people you need to hire prior to approval and then upon approval, specifically how many reps, how much you expect from the cost and just any additional insights there?

Sure, happy to Tyler and now I know it’s not just our call from reports, appreciate that. We’ve been building the commercial team really since 2014. And with Richard joining as the Chief Operating Officer, he inherits a team with marketing, market access, distribution, manufacturing experience, regulatory people in place. So we’ve been running towards watching ADS-5102 for quite some time. Specifically, with regards to the sales force, we have elected to go with a – using a contract sales organization primarily because the ability to dial up and dial down and maintain nimbleness and flexibility is better. We will hire the senior sales folks and now that’s Richard’s here, that’s one of the responsibilities I can pass from me to him. Our plan is to have district level representatives be Adamas employees and really utilize our CSO partner to be able to help us rapidly recruit, manage and deploy those reps as our plans see fit. So that’s really where we are heading. And from a cost standpoint, it really has allowed us to manage expenses going into launch I think better, minimize internal infrastructure build which you know I love, but deploy the same high quality, same targeting under our direction post-approval as we would do in either case.

Okay, great. And just to -- that’s helpful and just the final question on pricing and some of the discussions, the more recent discussions you guys have had with payers. Is somewhere in the range of [indiscernible] and other branded product space kind of what we should be still be thinking and price for increased uptake? And how do you think about that with the potential of additional indications, clearly it looks like it’s pretty effective in MSK[ph]. So curious to get your thoughts there. And as well as any discussions with payers, is IR amantadine even involved in the discussions since it’s not even indicated and it doesn’t really have any data generated for the indication?

So Tyler, let me try and tackle each one of those. So you make some very good points and let me just start with… As we’ve gone out and engaged the payer community and we’ll continue to engage them under the new FDA guidelines that have been provided for us, we have found that the data that we present for ADS-5102 has been very well received. They are aware that LID occurs and limits the use of the gold standard therapy which is primarily a generic source of dopamine and levodopa. They recognize the reductions that Rajiv mentioned in LID time and Off Time, but we’re very emphatic about the recognition of the improvement from baseline in three to four hours of functional on time, that was a real important point in really understanding how much value that creates for the system. As we consider that and really bringing the LID product to the market Tyler, and the first product to treat that has ever shown a benefit in both LID and Off, meaning we can begin to remove the struggle from physicians. We’ve been looking at pricing really between the range of where the branded dopamine products are and where Nuplazid is priced right now as an adjunct in the Parkinson’s market. So that’s really where our pricing’s been focused and we have not been at this point receiving significant push back with regards to that given the size of the population or with regard to IR amantadine likely because of its relatively light use in this

Helpful. Thanks so much.

Thanks, Tyler.

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

Thanks for taking my question, and definitely would pass along that I hadn’t heard some of the earlier comments, as I’ve been juggling in multiple calls which has been going in and out as well. But I did hear about the contract sales force and Greg, can you give us a little bit more background for those of us who might have missed it, your thoughts behind using the contract sales force versus building within, what our expectations should be? And what are really the comparative launches that you looked at, because from our side, we have seen some disappointing side of 505(b)(2) ramps from contract sales forces, and if you can give us any help in modeling, will be appreciated.

Sure. So Tim, I appreciate the question and I’m sorry about the struggles today. Let me start with, I think a lot of this is about the data and I don’t think that this is a traditional 505(b)(2). As Rajiv just described, it is a very robust clinical package and the industry’s been trying to provide a product that would treat levodopa-induced dyskinesia for decades. They’ve been trying to provide a product that would not force doctors to choose between treating me off and making the dyskinesia work for decades. And so, from our standpoint, this product will be viewed on the merit to this data, it will be viewed as differentiated with a 30% reduction in LID and its correspondent reduction in Off Time. So that’s really first and foremost. So we treat this as a brand, first and only entering the Parkinson’s market and they are to be used adjunctively to levodopa and all other sources of dopamine that – choose to pursue to manage their Parkinson’s patients. The decision to go with the contract sales organization was really around comparing the cost and quality of having those employees directly employed by Adamas Pharmaceuticals and the speed and the nimbleness and the efficiency with which we could work with them, versus the cost and quality of doing it through a contract sales organization. And the contract sales organization model has evolved to the point that from a backend infrastructure standpoint, where you can direct and control the front end, it’s gotten to a point that for folks like Richard who’s been through this for the last 20 to 30 years, it’s just a different game than it was a long time ago. So like we were able to achieve with our CROs, like we are able to achieve with our CMOs a very active, engagement and management so that we are on the ground, directly engaged with our customers, I saw this as a similar type of a decision and was pleased when the team came forward with the recommendation.

Okay. And has there been anything that’s come up in your discussions with the agency which you think maybe has -- could show up in a label which maybe hasn’t been discussed to much extent to-date, and your interactions with investors, is there anything labeling wise that maybe we’ll see is novel. I know you obviously don’t have a label yet, but in your expectations?

Thank you for bridging to Rajiv for me. Rajiv, go ahead.

So, as I said earlier, the review is going as per plan. The FDA is reviewing the package. I think on label, we’ll contain the pre-specified primary endpoint data and we believe the key secondary endpoint data as well which is both the effects of ADS-5102 dyskinesia and Off Time.

And I guess, will there be any reference in the adverse events and safety data to known effects of amantadine?

As Greg mentioned, we are a 505(b)(2), but we’ve done a full drug development program, but yes is the answer. What we’ve seen in Phase 3 is consistent with what it has been described with immediate release amantadine.

Okay. That’s great to hear. And pending a successful review and an approval, what should we expect as we enter the managed care kind of the announcement so typically in the fall?

Well as you know, Tim, our PDUFA date is in August of 2017 and we are gearing up towards obviously in a pre-commercial phase right now, gearing up towards full commercialization in the fall. But as you know, the managed care works on a calendar system and we will be working through that. We’ve got an excellent, very experienced market access team who has been here since just after top-line data. They’ve been working on the value proposition with the payers, they’ve been out to conferences and as I mentioned earlier on the call, under the FDA’s new guidelines we’ll be able to start out - reach there ahead of approval. So, we’re excited about that engagement. We’re excited about the impact that data is going to have and where we’re positioned right now and we’ll be spending the fall building those relationships and building that case.

Okay. Thank you.

And our next question comes from the line of Serge Belanger of Needham & Company. Your line is open.

Hi. Good morning - good afternoon. Just a couple of questions for me. Greg, you mentioned that if approved, 5102 will be indicated for treating LID. Is there any desire to eventually get the label extension to treating Off Time, we’ve seen impressive and durable benefits throughout this Phase 3 program. Just wanted your thoughts on what will be necessary to get that label extension at some point?

Serge, it’s a good question. I think from a commercial standpoint, we need to wait and see what the label ends up reading, but as Rajiv walked through, we have a primary endpoint to find for dyskinesia. We hit on two key secondaries, one of which was Off Time and we’ll be making that decision really after the label negotiations are completed and we have a label.

Okay. And then can you give us an update on where EASE LID 2 is currently? And I guess when should we see additional data presentation?

Rajiv?

So, as I mentioned in my prepared comments, we reported 64 week data from EASE LID 2. The recent Movement Disorder meeting in Miami and the next update on EASE LID 2 will be at the movement disorder meeting in Vancouver in June. And at that meeting, we will have 88 week data and we will also present data from two important sub-groups. One sub-group being patients who were status – deep brain stimulation and the other sub-group being patients who were switched directly from immediate release amantadine.

Okay. And Greg, I don’t know if you mentioned this in your prepared comments, but given approval on the PDUFA date in mid-August, how quickly would you be able to launch the product?

We are planning right now to focus all of our energies on getting the product approved. We are highly focused on letting out the specifics around the launch plan and we’re going to update you later on specific timing for the launch. But we will be – we’re confident we’re going to be able to commercialize the product in 2017 and we’ll get back to specifics later in the year.

Okay. One last one for me, then I’ll get back in queue, on the epilepsy program, what can we expect the next step in -

Sure. Rajiv, you have some update just quickly on the epilepsy?

So we have an ongoing Phase 1 program. We’ll have data later this year and then based on those data, we’ll review those data internally with our – committee and then decide our next steps.

There’s an upcoming presentation on that data in epilepsy meeting here towards the end of May. So stay tuned.

Okay, great. Thanks.

Final question comes from the line of Kumar Raja of Nobel Capital. Your line is open.

Good afternoon. Thank you for taking my questions. So on the commercial product, how much of commercial product do you have on hand which has been already pre-expensed in R&D? And for the ADS-4101 program, what can we expect in the Phase 1 data is released? Obviously there is inter-parties review ongoing, how does the outcome of that influence the strategy going forward with this product?

Thank you very much for the question. With regards to the commercial supplies, yes, we’re in the stage of development review where we have commercial supplies for the launch of ADS-5102 in the U.S. So we’re feeling very confident about our ability to supply the market. With regard to the ongoing ADS-4101 studies, we have completed a single dose pharmacokinetic intolerability study which we’ll be reporting out on here in a few weeks time and the study that Rajiv mentioned is a steady state study designed to determine what strength and plasma level we can achieve at steady state with a comparable tolerability to the BID Vimpat a product which is on the market today. And I don’t see any impact of the events that you mentioned on that program. We really strive for clinical differentiation and we think our products can stand by themselves as they come to the market.

Okay. Thanks.

Thank you.

That concludes our Q&A portion. Ladies and gentlemen, thank you for participating in today’s conference. You may now disconnect.