Acorda Therapeutics' (ACOR) CEO Ron Cohen on Q4 2018 Results - Earnings Call Transcript

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About: Acorda Therapeutics, Inc. (ACOR)
by: SA Transcripts
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Earning Call Audio

Acorda Therapeutics, Inc. (NASDAQ:ACOR) Q4 2018 Results Conference Call February 14, 2019 4:30 PM ET

Company Participants

Felicia Vonella – Executive Director-Investor Relations

Ron Cohen – Chief Executive Officer

Conference Call Participants

Cory Kasimov – JP Morgan

Ben Burnett – Stifel

Paul Matteis – Stifel

Sadia Rahman – Cantor Fitzgerald

Phil Nadeau – Cowen and Company

Michael Yee – Jefferies

Salveen Richter – Goldman Sachs

Silvan Tuerkcan – Oppenheimer

Edward Marks – HC Wainwright

Operator

Welcome to the Acorda Therapeutics Fourth Quarter Year-End 2018 Update. At this time all participants are in a listen-only mode. There will be a question-and-answer session to follow. Please be advised that this call is being taped at the company’s request.

I will now introduce your host for today’s call, Felicia Vonella, Executive Director of Investor Relations at Acorda. Please go ahead.

Felicia Vonella

Thank you, Gabriel. Before we begin, let me remind everyone that our presentation will contain forward-looking statements. Detailed disclosures can be found in our SEC filings, which are public, and we encourage you to refer to those filings.

I will now pass the call over to our CEO, Ron Cohen.

Ron Cohen

Thanks, Felicia, and good afternoon everybody. The FDA approval of INBRIJA on December 2018 was a major achievement by the company and its most important milestone last year. INBRIJA is indicated for the intermittent treatment of OFF episodes, also known as OFF periods and people with Parkinson’s taking carbidopa/levodopa. This is a major unmet need in the Parkinson’s community.

We’re particularly pleased by the fact that this was a first cycle approval given that INBRIJA is a novel drug device combination and targets a systemic condition by the inhaled route. And I’ll review more detail about INBRIJA and the launch later in this presentation. We were gratified that in January 2019, the results of the Phase III pivotal trial of INBRIJA were published in The Lancet Neurology, which is one of the most highly regarded neurology journals. This reflects both the quality of the study and the importance of its clinical results to people with Parkinson’s.

Moving to AMPYRA revenue was $64 million for the fourth quarter and $455 million for the full year 2018, sales declined significantly following introduction of generics to the market in September 2018 and we expect continued declines in 2019. We ended the year in a strong financial position with approximately $445 million on the balance sheet. This is sufficient to allow the company to be cash flow positive based on our long range projections.

Turning now to INBRIJA, we are pleased with our label. The label includes a graph of the primary outcome measure, the UPDRS Part III, which is a measure of motor function in Parkinson’s disease. The graph shows onset of action as early as 10 minutes statistical significance by 30 minutes and maintenance effect to 60 minutes, which was the long – the longest time point assessed. The approval is for a single dosage strength of 84 milligrams with no titration required.

Importantly, the open-label safety data, which went to one year, is also included indicating that there was no difference in the mean change in FEV1 pulmonary safety measure between the INBRIJA and observational cohorts.

Our commercialization strategy builds on our learnings and highly successful experience over the past nine years with AMPYRA. Our neuro specialty commercial organization is one of the most well regarded in the industry and they are highly motivated to be introducing a new therapy to a patient community with a major unmet medical need. We’re on track to put drug in the channel in the first quarter. Our first – our field sales and medical teams have been meeting with movement disorder specialists and their office staffs to educate them about INBRIJA’s clinical profile, proper use of the inhaler and our comprehensive patient support services.

We’re reviewing our prescription request forms also called PRFs with the physicians as part of the education and training process and we’ve also launched speaker programs. We’re finding strong receptiveness to INBRIJA as a novel on-demand treatment for OFF periods and have already received completed PRF forms. Our teams are implementing programs to engage people with Parkinson’s and their care partners as well. We’re working closely with the efficacy groups, several of which are shown here on the slide to help educate the community about INBRIJA. We’re also sponsoring community events including educational programs and have developed a welcome kit for first time users of INBRIJA.

And not least we’re also implementing a robust online presence for INBRIJA, including targeted digital advertising, a branded Facebook page websites to educate the Parkinson’s community about INBRIJA and electronic customer relationship management or ECRM tools for both consumers and healthcare providers.

The OFF periods are, as I’ve said, a significant unmet need in the treatment of Parkinson’s. OFF periods can occur regardless of what the daily maintenance medication regimen is and they usually occur unpredictably. This is due in large part of the highly variable absorption of levodopa through the oral route. OFF periods are often highly disruptive to people with Parkinson’s and INBRIJA allows self treatment of OFF periods when needed bypassing the oral route.

INBRIJA required over 20 years to develop from the time the inhaled ARCUS technology was invented at MIT in the lab of Bob Langer. The ARCUS technology transforms molecules into a unique dry powder that allows delivery of systemic doses of therapy through the lungs. INBRIJA is a major innovation. It is one of only three pulmonary delivered treatments approved for a non-pulmonary indication. The wholesale acquisition cost of INBRIJA will be $950 per carton, each carton contains 30 doses and one inhaler and we expect to have drug in the channel within the next few weeks.

One of our main priorities is to support access for people with Parkinson’s, who can benefit from INBRIJA appropriately. We’re working to reduce barriers to access as much as possible. We are going to provide copay mitigation for those who have commercial insurance. We’re making clinical presentations to insurance plans to gain formulary access as quickly as possible as we did with AMPYRA we’ll be seeking to establish win-win collaborations with the plans that benefit the patient.

We’re going to provide samples to allow patients and their physicians to assess the value of INBRIJA before the patient has to incur out of pocket copay or coinsurance costs. For those who rely on Medicare, there are legal constraints built into the system that prohibit copay assistance. We’re working within these constraints to help address these challenges for patients as much as possible. We will be also communicating with physicians and their office staffs, so they’re aware of which plans have coverage and how they can best help their patients get access. Our hub services will help patients understand their benefits and as much as possible, we will assist them in navigating the complex insurance landscape.

We also have a team of regional reimbursement directors in the field who augment our hub. They work directly with physicians offices to help with access issues, and we’re implementing a patient assistance program. This will include free drug to provide for those who are uninsured and meet income eligibility requirements.

In the U.S. we believe there are about 350,000 people with Parkinson’s who are experiencing off periods despite being on levodopa, carbidopa regimens and that peak sales for INBRIJA will exceed $800 million.

Moving to our 2019 guidance and priorities. This table outlines key financials for the fourth quarter and year-end. Most notably we ended the year with approximately $445 million in cash.

Our 2019 expense guidance was pre-announced at JP Morgan earlier this year. We expect R&D expenses for the full year 2019 to be $70 million to $80 million and SG&A expenses for the full year 2019 to be $200 million to $210 million. As we previously said we don’t expect to provide INBRIJA revenue guidance in 2019 as this is a launch year.

Moving to our priorities for 2019. First and foremost, to ensure a successful launch of INBRIJA, ensuring that as many people with Parkinson’s who may appropriately benefit are able to do so. We are also looking to obtain approval of our INBRIJA MAA application in Europe and expect the EMAs decision by the end of this year. And we are continuing to discuss collaborations on the ex-U.S. commercialization with potential partners.

The approval of INBRIJA has now validated the innovative ARCUS technology. We plan to apply the ARCUS platform to develop therapies for additional indications. Our most advanced program is for treatment of acute migraine, and we look forward to updating you on development milestones.

And finally, and not least, we will maintain our focus on controlling expenses and deploying resources so as to maximize shareholder value. Thank you all for your attention, and operator, we will now take questions.

Question-and-Answer Session

Operator

[Operator Instructions] Your first question comes from the line of Cory Kasimov with JP Morgan. Your line is open.

Cory Kasimov

Hi guys, good afternoon. Thanks for taking my questions. Couple of them for you. First one regarding the price. I’m curious with this price point, how many doses you’re expecting patients to use per day on average in the real world? And at that price point, what kind of range you would expect for out-of-pocket costs for Medicare patients in particular? And then I have one follow-up.

Ron Cohen

Right, so we are not going to get into tremendous detail, and certainly not on projecting, until we get – and we’ll see as we get through the launch. But what I can point you to is, if you start with our clinical data, the clinical data, depending on which trail you look at and where it took place, was anywhere from 1.3, 1.4 times a day on average to up to – or up to about two times a day on average depending on the trial, and we always discount off that and we advise people to discount off that because it’s a trial and people are getting free drug and care and so on. So there’s a different psychology at work and you usually will see less than that in the real world. So if that helps you, sort of, calibrate. And as we said, one carton is 30 doses, including the inhaler.

And then if you look at the label and the clinical trial, people were allowed to use the drug up to five times a day. And now the people who actually use it regularly five times a day are a minority. That’s a small minority. And again, I’d point you to the averages, which as we said, are 1.4 to 2 times a day in the trial, and we expect less than that in real life. But we’ll see as we go along.

In terms of Medicare, the out-of-pocket for a Medicare patient is a 33% coinsurance until they get through the donut hole, and there is just nothing that we can do about that. That is something for a larger discussion about how we do this with the people on Medicare in this country. As I said, we we’ll do our best to help patients as much as possible. If you look at our price point, Medicare even at that coinsurance and donut hole, and then looking out to, let’s say, a year’s worth of out-of-pocket, the out-of-pocket is heavily weighted upfront and then it drops to very little to almost nothing near the end.

So we have calculated that even with no support, the Medicare patient worse-case scenario would be about $10 a dose over the course of the year.

Cory Kasimov

Okay, that’s helpful and then my follow-up is that it seems like there’s a pretty diverse set of KOL opinions out there with regards to the outlook for INBRIJA. So I’m wondering what you think that says about the early potential of the product and maybe the level of education that’s still needed to build awareness in the market.

Ron Cohen

Yes, we are seeing zero surprises here. And we’re – as I said, we’re building on a huge amount of successful experience with the AMPYRA launch that we launched in 2010. And I have to say that, for almost any launch, you see a range of opinions before the drug actually gets out there and physicians are being educated and people are trying it and talking about it. So you’ll always see that. You see a wide variability in how familiar people actually are with the data versus how familiar they think they are with the data. And that’s a big toggle. That’s where the commercial organization and our medical organization do their work. And if I go back to 2010, that was a much bigger mountain to climb than we are seeing right now in all of our research.

Back then, people – there was no drug that had ever been indicated to improve walking in MS. People were – most of the KOLs were not familiar with the drug. Almost none of the patients were familiar with the drug no one knew what the data meant in two seconds and three seconds, and we were hearing all of this stuff, huge amounts of skepticism. And you see what we were able to do with that once you get out. If it’s a valuable drug and it benefits patients, we are going to make it a success. And right now, we’re actually seeing overwhelmingly that the distribution of enthusiasm versus scepticism is much further weighted towards enthusiasm than it was when we launched FAMPYRA.

Cory Kasimov

Okay. Thanks Ron. Good luck with the launch.

Ron Cohen

Thank you, Cory.

Operator

Your next question comes from the line of Paul Matteis with Stifel. Your line is open.

Ben Burnett

Hey, this is Ben Burnett on for Paul. Thanks for taking the question. I know you guys aren’t going to be providing guidance, but can you talk about what kind of patient metrics and how you’d be framing the launch over the next couple of quarters in terms of what you’re giving us beyond revenue? And then do you have any internal hurdles for success that you could provide?

Ron Cohen

So the answer to all of that is probably we’re going to provide net sales numbers obviously. And then as to the rest we are not committing to anything specific at this time. We are going to be – as you will we are going to be tracking the outside services, we track launches, we’re going to be getting a sense of how well and accurately they’re matching up with our numbers internally. And over time we will get a sense of that.

What we – I’m not committing to this, but just point you to the fact that with AMPYRA we did something very similar and then ultimately we were able to help people understand broadly how well, or not, or consistently, or not the outside services were capturing, the TRxs, and NRxs, and so on. And people were able to extrapolate and get a pretty good idea of where we were.

So can’t commit to anything right now, but we will be as forthcoming we think is helpful and as we can, going forward.

Ben Burnett

Got you. And then maybe one quick follow-up, you said it’s kind of been tilted more towards enthusiasm versus scepticism in AMPYRA’s launch. Can you maybe expand on that enthusiasm and then maybe what you’re hearing on the skeptical side?

Ron Cohen

Yes, I can tell you that in our own market research when we pulled a pretty good number, I’m trying to remember, it was something like, how many was it a 150 or so neurologists. And when we – this is a fairly recent study. And when we pulled them, 73% said that they were very or extremely likely to prescribe INBRIJA for their patients. So that gives you a sense of it. We also, by the way, in the same study we had about 150 or so people with Parkinson’s and 78% of them said that they were likely to discuss INBRIJA with their doctor when they found out what the description was. So I would say that that weights pretty heavily toward the enthusiasm side.

And by the way that matches what we’re getting back from the sales force right now. They’ve been out there for weeks in force, introducing themselves to the practices, particularly the movement disorder specialty practices and this mirrors what we’re getting back from their conversations.

Ben Burnett

Great, thanks.

Operator

Your next question comes from the line of Charles Duncan from Cantor Fitzgerald. Your line is open.

Sadia Rahman

Hi this is Sadia Rahman on for Charles. Thanks for taking my questions. I was wondering if you can go into a little more detail on how you view the INBRIJA market opportunity in the early stages of lunch? Can you discuss your marketing strategy regarding target patient subsets and also types of physicians or types of movement disorder specialists that you will focus on? And also how you are framing discussions with payers?

Ron Cohen

Okay. So that was kind of a long question. I lost the very beginning of what you were asking me there. Could you be – but it was something I couldn’t answer. So, we’re not going to project or speculate on the early stages of the launch. There are two kinds of projections there, lucky and wrong. And so we don’t really want to get into things that we can’t stand behind in the short run. We have about 10,000 healthcare professionals who account for about 70% of the Parkinson’s market prescriptions. We are targeting, in the early stages, we’re targeting the specialists, the high decile prescribers, the people who are the most expert in Parkinson’s disease. That is the movement disorder specialists. Those are the people, those are the neurologists who tend to see most of the, or disproportionately more of the Parkinson’s population.

So we are starting with them. And by the way, that also then plays into the referral nerve networks, right, because if they’re happy, then they spread that word among their referral networks and the rest of the community. So that’s what we’re starting with. We’re going to that segment. I think it’s probably a couple of thousand of those 10,000 that we’re really focusing on in the early stages of the launch. And then we’re going to branch out to the rest as we go along.

And as I mentioned in my presentation, in terms of the marketing we have multi-platform, multipronged marketing efforts that we really refined to a terrific degree with FAMPYRA and that we’re now transferring over. That’s going to be digital platforms, Facebook, web pages, digital advertising that’s targeted – digital targeted advertising, speaker programs, presentations at meetings, publications. I mean this is the full range of commercial activities to get the word out and get people educated.

With respect to the payers, what we are finding in our still early, early going, but we’ve met with quite a number of payers already. And the one thing that is clear that I would say differentiates it from our experience with FAMPYRA when we started with FAMPYRA is that we’re not getting any pushback on the unmet need. We are walking in and the immediate acknowledgement is we see that this is an important addition to the therapy for people with Parkinson’s, we understand that off periods are a real unmet need that’s important, so let’s move on to the next stage of the discussion.

So that’s a plus right there. And beyond that I really can’t characterize anymore because we’re going to be in discussions, negotiations. Our goal as it was with FAMPYRA successfully is to create as much win-win collaborations with managed care as we can. And ultimately both parties have in mind that the winner has to include the patient, right? So it has to be a win-win-win. The patient has to win, we have to win, the payers have to win, and we’re working to make that as possible as we can.

Sadia Rahman

Okay. And just following-up on that, among the healthcare professionals in your market research, do you see any differences in excitement for INBRIJA between the movement disorder specialists and maybe more of the community neurologists?

Ron Cohen

Yes. You know what I can’t – I don’t know the answer to that. We have not yet gotten out and forced to the vast majority of the community neurologists. As I said, the plan is that we’re executing on is to start with the movement disorder specialists and then branch out from there. So we’ll get more information on that as we continue with our plan.

Sadia Rahman

Okay. And one final question on the status of the reformulation of the migraine candidate, CVT-427. Can you outline the regulatory path forward for that, the timeline?

Ron Cohen

No, I cannot. No, I can’t. It’s early. As I said in our presentation, we will be providing milestone – or updates on milestones they occur. Right now, we’re working on three different molecules, all of which would be targeted toward migraine. And our goal is to select the one that has the best profile and move back into the clinic with that.

Sadia Rahman

Okay, thank you.

Operator

Our next question comes from the line of Phil Nadeau of Cowen and Company. Your line is open.

Phil Nadeau

Good evening, thanks for taking my questions and congrats on the progress. Ron, just – first a couple of clarifying questions. When you talk about a package having 30 doses, correct to conclude that that’s 60 capsules with two capsules per dose?

Ron Cohen

Correct, Phil.

Phil Nadeau

Got it, okay. And then second, do you have a sense of what the gross to net will be during the first year of launch?

Ron Cohen

No, we don’t. I mean, we’re certainly – certainly not enough to talk about it. We’re still working through all that. We have our own internal projections, but we’re not prepared to share those publicly yet.

Phil Nadeau

Okay, fair enough. And then third, on your sampling strategy, can you discuss how you’re going to sample INBRIJA? And maybe whether samples would be recorded as scripts or if it’s going to around the channels that we have?

Ron Cohen

No, they will not be recorded as scripts. These will be actual samples that will be distributed through the physicians’ offices. So we have – we actually have special sample kits that we are going to be providing to them.

Phil Nadeau

Great, okay. And then last question is on the payers. It may be too early to ask this. Do you have a sense of what requirements the payers will put in place to get reimburse for INBRIJA? So will you need a formal diagnosis of OFF episodes, if such a thing exists or will there be any step edits? What are your expectations?

Ron Cohen

Again, I don’t want to speculate on that because it’s a pretty big ecosystem with pretty wide ranges of approaches among payers and PBMs and so forth. So I think we’re going to wind up seeing a range of approaches. I would hope, especially given all of the public attention on this. Now, I would hope that everyone would come to the table bearing in mind that you don’t want to unreasonably restrict patients from getting something that can really help them. And that’s certainly our attitude and we certainly hope, and to some degree expect, that the folks on the other side of the table will be taking the same attitude.

Phil Nadeau

Fair enough. Thanks for taking my questions.

Operator

Your next question comes from the line of Michael Yee of Jefferies. Your line is open.

Michael Yee

Hey, Ron. Thanks for the question. Couple of questions for you. First, I guess, just housekeeping. Did you ever explain why the drug actually hasn’t launched yet? Is it just in terms of either what day or what the actual hold up is or anything like that? I guess, what’s the issue there? Just wondering, it’s been a while since you filed for approval.

Ron Cohen

Michael, there’s no holdup. It’s – this is a drug-device combination. It requires meticulous manufacturing. And you might recall that you, among others, were questioning early on whether we would even pass inspection on manufacturing and so on, which we did. And that’s because we paid meticulous attention to every detail of a complex process. So getting out to launch, you have to wait till you have the label so that you know how to label all of those capsule packages, which is what we’re in the process of doing.

So we’re making sure that our launch stock is exactly where we need it. We’re making sure that we have enough to supply out for the rest of the year and we’re right on track. So we are continuing to be on track for launching before the end of the quarter.

Michael Yee

Fantastic, fantastic. Second question was, when you talk about enthusiasm, I know was alluded to before, you talk about already seeing strong interest. Do you anticipate some form of pent-up demand? When you think about AMPYRA, there was sort of pent-up demand. That was also because people were quite familiar with the drug. I guess, how should we think about this? Is it slow and steady with sampling? I mean, maybe just give us some sort of shape of the curve for the first few quarters or for the year?

Ron Cohen

Yes, Michael, as I said earlier, we’re just not going to speculate on shape of the curve, even before the first drug is delivered to a patient out there. It’s a fool’s errand. And anyone who’s launching anything, there’s just no upside to that. We’ll all find out as we get out there. And I understand and appreciate that everyone wants to build it into their models and so forth. The reality is what it is. We can tell you what we’re seeing, which is that people are enthusiastic about it. There are going to be reimbursement challenges that we need to address and that’s going to take time. So it really just depends on all those moving parts. And we’ll find out within the quarter or two of actual drug in the channel where we are.

Michael Yee

Okay, understood. And then my last question is a strategic question, which is, you did allude to potentially thinking about European partnership. I mean, I guess, how do you think about the value proposition in Europe? And whether or not you would go ahead and do that the timing of that? And how we should think about that? And whether you would bring in other drugs as well?

So just I guess, strategically, are you trying to basically out licenses to Europe and partner it and then bring other stuff into the U.S. to become a full-fledged company? How should we think about that? Thanks. And happy Valentine’s Day.

Ron Cohen

Yes, happy Valentine’s Day. So you know what? We’re considering that whole spectrum that you just outlined, I think, very cogently. Clearly, to the extent that we – one of the big – we regard one of the greatest assets of the company to be our commercial and medical organization. And to the extent that we have additional commercial products that they can go out and optimize, that would be a good thing. So certainly, we are looking at that. In terms of Europe, it’s no secret that Europe is different from the U.S. with respect to reimbursement, with respect to pricing and so forth, and even with respect to just commercializing across multiple member states.

So we’re exploring with various potential partners a number of different ways of attacking those challenges. And right now, we don’t have a particular direction that we have 100% settled on. We’re still considering all of that. And the first order of business of course is to look for, hopefully, an approval in Europe by the end of the year, and we’ll take it from there.

Michael Yee

That makes sense. Thank you. I appreciate it, Ron.

Felicia Vonella

Gabriel, next question?

Operator

Your next question comes from the line of Salveen Richter from Goldman Sachs. Your line is open.

Salveen Richter

My question is could you help us understand the price differential between your price per carton and generic levodopa?

Ron Cohen

It’s not – actually in my view, that’s not a question that can be answered or even could be asked because there is – this is night and day. I mean, you’re not talking about the same thing. Generic levodopa is an oral – for the most part, is an oral maintenance regimen that people take by mouth three, four, five, sometimes six times a day, which has serious issues with variability and absorption, which is why OFF periods occur to begin with. So that is the state-of-the-art currently.

INBRIJA has a completely different indication. It is indicated to address OFF periods when they occur in an on-demand way, not in a regular maintenance sort of way. So it has nothing to do with generic or even branded or any other kind of oral maintenance therapy. It’s a novel approach that is meant to address the flaws that exist in current therapy, where, when it works, it works really well, but it often stops working at unpredictable times during the day and winds up upending these people’s lives and being incredibly disruptive to them.

So it’s – the other thing is, it’s an inhaled delivery system that is very high technology and very high innovative quotient that came out of Bob Langer’s lab, was featured on the cover of Science. And allows this to happen, it allows you to deliver L-dopa in a systemic way, but doing it through the lungs. So it’s just a completely different equation and has nothing to do with generic or any other kind of oral regime.

Salveen Richter

Thanks. And then with regard to the launch, will you provide us with details around the number of patients or doses associated with the sampling program and the free drug, just so we can get a sense of what the actual sales outlook would be in a quarter?

Ron Cohen

I’m sorry. Say it, again.

Salveen Richter

So just with regard to the sampling program and free drug, given they won’t come across as scripts, how will we get a sense in the quarter of patients associated – or patient use associated with the drug? Are you going to provide us patient numbers or doses?

Ron Cohen

So, no, we don’t expect to do that. As I said earlier, we will be reporting net sales on a quarterly basis. We will be tracking, as you will, the outside services, the [indiscernible] and so on. And getting a sense of how well or not they’re capturing the numbers that we see internally. And we will determine, as we go forward, what would be the most useful means of sharing information that would give you all some idea of how to interpret the metrics you’re seeing from those services. But right now, it’s premature to talk about that.

Salveen Richter

Okay. Thank you.

Operator

Your next question comes from the line of Jay Olson from Oppenheimer. Your line is open.

Silvan Tuerkcan

Hi, this is Silvan on for Jay. Thanks for taking my question and congrats on the quarter. You mentioned win-win agreements with managed care as you did with AMPYRA. Could you just tell us a little bit more about how that would look like for INBRIJA? Because I believe for AMPYRA, the drug was free until the patient responded. How could you construct something like that with carbidopa/levodopa use – users?

Ron Cohen

Yes. I think you’re referring to the First Step program that we implemented and that was very creative in its day and very well appreciated by managed care among others. So that was a different sort of program. And that was where patients were able to get two months of prescriptions on us free to determine whether or not they were responding to the drug. And for that particular drug, it took that long or within that period to be able to determine that.

And our pitch to managed care in that case was, when they respond, you should pay for it and not limit access. And if they don’t respond, they’re going to get off it and that’s going to be on our dime. And that was a great program, has been a great program.

This is a somewhat different metric here, it’s a different population, different drug. We have not determined yet if we will do something like that or not. We’re still considering a number of things, but what we are going to do, as we’ve said, is to provide samples. And we will have enough in a sample kit to allow the patient and the physician to determine whether it seems to be benefiting the patient and if so that it’s worth going and getting on a prescription. So we’re going to start with that and then we’re continuing to evaluate some of these other ideas.

Silvan Tuerkcan

Great. Thanks. And I just wanted to dig a bit deeper into the EU partnering process there. In your opinion, have deal, I mean, you may get approved by the end of the year, so up till now have deals not been good enough for you? Or what are partners waiting for it at this point in terms of the derisking and considering it’s approved in the U.S.?

Ron Cohen

Yes. I’m sure you will appreciate, that I just can’t go into that kind of detail at this point.

Silvan Tuerkcan

Great. Thanks. Thank you for taking my questions.

Operator

[Operator Instructions]

Your next question comes from the line of Raghuram Selvaraju from HC Wainwright. Your line is open.

Edward Marks

This is Edward Marks on for Ram. I’m just wondering, looking at AMPYRA, what do you anticipate likely to be the steady state number of purveyors, for generic dalfampridine? And how is that going to influence your pricing of AMPYRA?

Ron Cohen

Okay, so we can’t possibly speculate on that. All we can – and again, the – it is very difficult to project, what the degradation curve is going to be for a given drug when it goes generic. We have other ANDA filers or generics who could launch and who could enter the market at any time. And we have no way of predicting how many or when or so. So there’s just no way for us to do that with any kind of accuracy. So all we can say is that we are confident that sales will continue to decline for the brand over the coming year. We just can’t tell you specifically what that curve looks like at this point.

Edward Marks

Okay. Understood .And then focusing a little bit on INBRIJA. What is the – if you can briefly describe the process from receipt of the prescriptions to dispensing of the product? With a particular focus on who might be the specialty pharmacies within the network?

Ron Cohen

Right. Well, we’re not going to talk who they are. We’re under agreements with all of our specialty pharmacies. This is going to be a hub-and-spoke network, just as it was with AMPYRA, where we have our own patient services hub, and there is a network of specialty pharmacies, the hub will distribute the prescriptions to the appropriate specialty pharmacy. They will fill it and dropship the drug to the patient. So that’s what we have done with AMPYRA. That’s what we are going to be doing with INBRIJA.

The hub performs multiple functions for us and the patients. It does an initial every time a prescription comes in, they do an initial benefits investigation, so that helps smooth the process for the patient and the doctor’s office. They then farm it out to the specialty pharmacies, so that it is seamless going on in the background. If there are checkboxes that need to be checked for a given reimbursement party or a given insurer, they will inform the doctor’s office of that, they’ll inform the patient. We will supplement that with our regional reimbursement directors, who are Acorda employees, they’re out in the field.

And when there are specific issues that come up or questions, they supplement the hub. And they are in touch directly with the hub. They’re in touch directly with the physicians offices. And they help to hopefully smooth the communications and make sure that things are being processed as quickly and effectively as possible. So it’s a whole ecosystem that we have set up with the entire purpose is to make the whole reimbursement and prescription process as easy as possible for the patients and the physicians under whatever the circumstances are.

Edward Marks

Excellent, thank you for that detail. And one final question just on the pipeline. I’m looking mechanistically at CVT-427,wondering if it’s expected to have any therapeutic utility in patients who might have already failed at one prior triptan?

Ron Cohen

So just to maybe clarified that. First of all, we’re not calling it CVT-427 anymore. And actually, thank you for the opportunity to clarify for everybody. That was very specific to the zolmitriptan formation that we had in the clinic just for everyone’s recollection. The good news was, we showed that we got to maximal plasma concentration within an average of 11 minutes, so that was around what an injectable dose. So that was fantastic. The less good news, which is requiring the reformulation, was that in susceptible populations, we were seeing laboratory or diagnostic evidence of bronchoconstriction, enough that and we didn’t feel that we could move forward with that particular formulation.

What we are doing now as really belt and suspenders is we are looking at triptans and we are looking at a couple of other classes and molecule that we know we can formulate and we already know we can formulate them. And our goal is hopefully to be able to select one of them that performs the best in our preclinical testing, and move that back into the clinic. It will have a different number designator at that time.

Edward Marks

Excellent. Thank you for the clarity. And I appreciate the time with question.

Operator

There are no further questions at this time. I will now turn the call back over to the presenters.

Ron Cohen

All right. Great. Well, thank you everyone, for joining us, and we certainly look forward to keeping you posted as we launch INBRIJA. Bye, and have a great evening.

Operator

And this concludes today’s conference call. You may now disconnect.