Felicia Vonella - Director of IR Ron Cohen - President and CEO David Lawrence - Chief, Business Operations and Principal Accounting Officer

Phil Nadeau - Cowen and Company Kevin Patel - Goldman Sachs Jay Olson - Oppenheimer Julian Harrison - H.C. Wainwright

Thank you, so much and good morning, everyone. Before we begin, let me remind everyone this presentation will contain forward-looking statements.

Our more detailed disclosures are found in our SEC filings, which are public, and we encourage you to refer to those filings. Let me now pass the call over to Ron Cohen.

Ron?

Thanks Felicia. And good morning, everyone.

Thanks for joining us. Highlights for the quarter included acceptance of our NDA for INBRIJA by the FDA.

With PDUFA date of October 5, 2018. INBRIJA is our investigational inhaled levodopa treatment for symptoms of OFF periods and people with Parkinson's disease who are taking Carbidopa and levodopa regimens.

And we also submitted a Marketing Authorization Application or MAA to the European Medicines Agency for INBRIJA at the end of March. Last week, we presented new data on INBRIJA at the Annual Meeting of the American Academy of Neurology.

We had four abstracts accepted for oral presentations, Dr. Stuart Isaacson and Bob Hauser presented Phase I safety and exploratory efficacy data for INBRIJA in early morning OFFs, which is Study 009 and Acorda's Dr.

Charles Oh [ph] presented long-term safety and efficacy data from Study 005 or extension study or excuse me long-term safety study. The presentations were well-received and indeed enthusiastically well-received.

Turning to AMPYRA. We reported revenue of $103 million in the first quarter, this was below analyst for - consensus of $129 million.

However, it was only slightly lower than our own internal forecast and that was primarily related to a modest expansion in inventories in the fourth quarter, although still within our contractual terms, which normalized by the end of the first quarter. Prescription demand in the first quarter was in line with our forecast as well and second quarter sales to-date and prescription demand is also in line with our internal forecast.

We are therefore we are innovating on net sales guidance for the full year of $330 million to $350 million. Regarding on our AMPYRA patent appeal, we've been assigned the date of June of June 7th for oral argument before the Federal Appeals Court and we are looking forward to the opportunity that argue our case in court.

This table summarizes the key financials for the quarter of note. We ended the quarter with $333 million in cash and our well capitalized for anticipated launch of INBRIJA.

Moving to our key milestones for 2018, most important is our PDUFA date for INBRIJA on October 5th, we're preparing for approval and launch potentially in the fourth quarter of this year. And as I noted previously, we'll also have oral argument for the AMPYRA patent appeal on June 7th, with a decision anticipated in the second half of the year.

We've completed and analyze the Phase I data for our remyelinating antibody, rHIgM22, this was a study in 27 people with acute relapse and multiple sclerosis and the studies primary objective was safety and tolerability of a single dose following a relapse. The data show that a single dose of rHIgM22 was not associated with any safety signals.

The study was not power to show efficacy. We had exploratory efficacy measures which showed no difference between the treatment groups.

And we're now considering the next steps for the program. So, our strategic priories for 2018 are to achieve approval and successful launch of INBRIJA to maximize the value of AMPYRA, including our vigorous prosecution of the appeal and continued financial discipline.

We will now open the line for your questions. Operator?

Hi, this is Andrew Tye [ph] in for Michael. Thanks for the questions.

Maybe a high level, if you win the AMPYRA appeal, do you think reason back to normal or what changes would you have to make and maybe if you lose than what happens, are you already fully prepared for this scenario? And I have a follow-up to that.

Yeah, so well the - our base case on which we based our projections has to assume as it does that there is a loss of exclusivity unless and until we win the appeal. Should we win the appeal, we would expect to continue to have exclusivity on AMPYRA for several more years and that would be an obviously a very good scenario and would allow us to accelerate development of pipeline and it would be a very good upside scenario in terms of our ability to build value and develop additional products.

Understood. And has the FDA's medical device decision reviewed the manufacturing facility that's making your drug device combo and if not, when would that happen, and do you - I guess do you consider that as a risk because you may have a relatively new facility?

Thanks.

Okay, so we don't comment on ongoing activities with FDA and during the NDA review unless there is something material, so really can't comment on an inspection question at all. In the normal - I will just say it's a general principle and normal course of an NDA one would expect at some point that there would be inspections by the FDA of our manufacturing facilities.

I do want to add a thought to your previous question, which is that of course we expect a precipitous decline in revenue if we were to have generic entry following the end of July and we are going to take appropriate steps as needed with regard to that and depending on the trajectory of the loss of revenue, we would adjust expenses as needed.

Thanks, Ron.

Yes. Hi, good morning.

This is actually Timor [ph] on for Laura Chico. And we had a question about your inventories, you mentioned expansion of customer inventories they are now back to normal, would you also characterize any potential impact or drawdown to your own inventory in the quarter and given the startup for the remainder of 2018, would you anticipate any fluctuations for current 2018?

I am sorry, I am not sure I understood your question about drawdown to our own inventories.

Sure, sure, I mean it looks like your inventories is down quarter-over-quarter about $10 million.

It's just a normal flow how we order depending on when batches come in. So, there was nothing unusual about what happened in the quarter to our inventories.

Okay, great. And then I guess my second question would be about your AMPYRA guidance.

So, we were wondering if you just walk us through the AMPYRA guidance assumptions for $340 million at the midpoint. I think looking back at historical sequential growth for 2Q over 1Q, you typically grow around 15% quarter-over-quarter and so that's just about $120 million assumption in back half in the second half of 2018 are there any growth drivers in 2Q that are we will be missing, could you elaborate anything else?

Thank you.

We really - we don't give quarter-by-quarter guidance, so what we can tell you is that again, I'll reiterate, we were very close to our actual numbers with our internal forecast for the first quarter. The second quarter prescription trends, inventories and sales are all in line with our internal forecast and we are therefore reiterating our guidance for the year.

Okay. Thank you very much.

Hi, this is Carmen [ph] on for Cory. Thanks for taking

I'm sorry we can't quite hear you.

Hi, can you hear me better?

Yes.

Hey, this is Carmen [ph] on for Cory. Thanks for taking the question.

So, on INBRIJA ahead of the potential launch in the fourth quarter. Have you initiated discussions with payers around pricing?

And if so, could you comment on their receptivity so far. And then in general, how are you thinking about pricing on INBRIJA?

Okay. So, I'm afraid I can't answer any of your questions because we just don't give that kind of guidance in advance, while we are in the stage where we're having discussion.

So, I can tell you that of course, we are having discussions, and we're having a lot of them. And we expect to have a lot more before launch.

That's all part of the process of coming to a price and a pricing strategy and the contracting strategy and so forth. So, the whole commercial team is vigorously involved in that.

I will take the opportunity to point out that, we have had an extensive amount of very successful experience in doing precisely that with AMPYRA. And both products share a lot in common in terms of being therapies that are addressing or aimed at addressing very important symptoms of chronic neurological diseases.

So, we have a lot of experience with that, a lot of successful experience. And we're using all of that knowledge and experience and applying it to our planning now.

So, we expect that by the time we get to launch, we'll be fully locked and loaded. And frankly, you almost never have a final determination on price until you actually have approval and your label.

And so, we would wait for that to give more color on it.

Okay, great. And then just one follow-up if I could.

What was kind of the reception of INBRIJA and AE and this year? Could you speak to kind of physician excitement to use the product?

Thanks.

Yes, it was enthusiastic. I think that's a fair characterization.

I was there, I had two full days of meetings with KOLs myself. We had a full team there, medical affairs having conversations, and the overall feedback was if I can summarize at this way, it was a very consistent with our market research, which is that we need this medicine off the periods are biggest single challenge with this patient population.

And we also we really like L-dopa. It's a gold standard therapy and the frustration with L-dopa is that the oral regimens are so inconsistent, and inconsistently absorbed and so forth.

We our own research has said that 89% of doctors say that that they will use the therapy like this. And from what I saw, and our team saw at AAN that is consistent with the market research.

Great. Thank you.

Good morning. Thanks for taking my questions.

First on the INBRIJA filing has the FDA suggested whether in ad com [ph] will be necessary?

We would have disclosed if there were an ad com if the FDA had suggested that. So, no, we have not heard that to this point from FDA.

Great. And then, second, I guess just back on your guidance.

So, to - this. But if you assume that in Q3, would have regulatory in the channel is going to be played out, so sales you won't have a full amount of sales.

It does seem tough to us to get to the bottom end of your guidance without a massive Q2. So, appreciating that you don't give quarter-by-quarter guidance.

What gives you confidence or what should we take as a reason at Q2 will be a particularly large impaired quarter?

Sale, I'm sorry. I can't give you more than I've given, which is that we have our own internal forecast.

Based on what we're seeing so far, the year as consistent with those forecast and by the way we do acknowledgement that it is more difficult to forecast in a year where one anticipates a potential loss of exclusivity that does make it more difficult because you have other assumptions you have to put in, but I can't go into another quarter-to-quarter basis I'm sorry.

Okay. Thanks for taking my questions.

Hi. Thanks for taking the question, could you provide details on your plans for INBRIJA's commercial sales force like stage and planning and will you be hiring more reps?

So, our current sales force is right-sized for the launch of INBRIJA and if we are successful on the appeal and we're able to keep our exclusivity on AMPYRA, we would need to increase the sales force to sell both products simultaneously so we would anticipate a 30-35% or so expansion of the sales force in that case but in the case where they were only selling INBRIJA they are right sized right now and so we have they would actually transition seamlessly from AMPYRA into INBRIJA.

Thanks for taking my question.

Good morning. Thanks for taking my question.

With regards to the European filing for INBRIJA is there any additional color you can provide with regards to the timeline there and also any update you can give us on your thoughts to that commercializing it yourself in Europe versus seeking out a partner and then any other potential filings in other ex-U.S. countries?

Right, so the MAA was submitted in late March it's currently undergoing what's called the validation by the EMA, the European Medicine's Agency. That's broadly speaking it's kind of like being accepted for filing by the FDA and we anticipate that the validation process will be completed around the end of May if it goes by typical timing.

If they do validate it, then the review procedure could take approximately another year give or take a few months depending on whether the clock stops and how many and so forth. With regard to selling abroad, we are looking at a number of options as we said earlier, we are exploring potential partnerships, ex-U.S.

not only in Europe but elsewhere in the world, we're exploring whether there is a role for us to expand ourselves into market and certain territories. We have not at this point applied anywhere else, that is something that we're evaluating in terms of where and when we would versus having a partner potentially do it and it depends on the territory such as Japan or some of the larger markets.

Okay, great. And then just a follow-up on the data you presented at AAN I appreciate the feedback.

You provided some physicians and attendance there is there any additional color you can provide with regards to anything you learned at AAN about how INBRIJA will fit into the treatment paradigm with regards to other potential rescue therapies such as sublingual echo marking [ph]?

Yes, we can. The thrust of the approach to INBRIJA is that this is L-dopa, which is the Gold standard therapy.

It is addressing what is recognized by the vast majority of clinicians in the space to be the number one and certainly one of the number one problems they have in treating people with Parkinson's disease which is that L-dopa is extremely effective and safe in general, but it is also poorly absorbed as subject to significant fluctuations during the day in terms of plasma levels with currently available oral therapies. In - and when the plasma level dropped below therapeutic level, the patient turns OFF which means they go back to their baseline disease state and now they can be in capacitated because they are trembling, and they are stiff, and they are falling, and their motor function is declining, and other things are declining as well.

So, this is seen correctly as a bridge between the oral doses where you have the random and unpredictable drops in plasma level. You inhale INBRIJA and fairly rapidly come back to a therapeutic level come out of OFF period and our study show that that effect lasted at least an hour.

So, enough time to bridge you between the times when your oral doses are kicking in. So, that is widely appreciated by - we're finding, it's widely appreciated by commissions, thinking of it as a way to optimize the impact of the gold standard therapy in Parkinson's disease.

Great, that's very helpful. Thanks for taking the quarters.

Hi, good morning. This is Julian on for Ram.

I was just curious about the past forward is rHIgM22, specifically or any additional safety study is necessary? And do you expect any changes to execute efficacy and randomization study?

Thank you.

We don't - we're still working on that, so I don't have a definitive advance if you. We don't expect - currently I don't expect and need for any more safety studies.

Obviously, this is a single - so far, we've only done single dose study here. So, we're talking about what the - what future studies might look like.

Okay. Thank you for taking my question.

Thanks for taking the question. Ron, I got few quick one, the first one is there anything on the tail for AMPYRA that we should be thinking about with regard to either an authorized generic or a potential lag before the decline occur simply because of the naturally distribution for AMPYRA?

We can't address anything specific with respect to that. I mean I think it's fair to say that no matter what we are expecting a precipitous decline in sales and this is no way to get around that.

Obviously, we'll do what we can with that and we'll brief you as if we get to that point, our goal is not to get that point obviously. We believe that our patents are valid and that we're going to argue that in the appeal.

But we are innovating our guidance, for the year and if there are changes as we go along we'll obviously alert everyone.

Okay. Thank you.

And then just with regard to INBRIJA, can you give us a sense, I know the R&D guidance and put to INBRIJA with some manufacturing cost. Should we be assuming that there is a portion of that that would be inventory, that would be salable post approval, or could you give us a sense of to what are you go risk for that?

I'm going to ask David to respond.

Yes, there would be any R&D expense, there is a portion of that is related to commercial inventory.

Okay. And then last question, just with regard to morning OFF I know that with the steady presented at AAN have regarding morning OFF and given that specifically significance that certainly suggested with their maybe some benefit there, is there any though as to going back and powering up the study and doing another, could you give us a sense us to how you going forward with that material?

Yeah, so we were encouraged by that study. Obviously, the reason for the study was safety to make sure that was no contraindication or reason not to let people use it in the morning.

And once we saw that the safety data were good, we opened up the expansion study in the lot of people to use it in the morning as well. And we were encouraged by the data you pointed out, which even though it was not a - it was by no means was it an efficacy study or powered for efficacy, we were encouraged by some of the trends that we saw in the data.

So, we are talking about what future studies might look like to look into that move deeply.

Okay. Terrific.

Thank you.

Great. Well, thank you everyone for joining us.

And we look forward to briefing you in the next quarter. Have a very great week.