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Acorda Therapeutics (NASDAQ:ACOR)
Q1 2019 Earnings Call
May. 02, 2019, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Welcome to the Acorda Therapeutics first-quarter 2019 update. [Operator instructions] 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, vice president of investor relations at Acorda. Please go ahead.

Felicia Vonella -- Vice President of Investor Relations

Thank you, Christa, and good morning, everyone. Before we begin this morning, let me remind you 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 -- Chief Executive Officer

Good morning, everyone. Thanks for joining us. By wide margin, the most important highlight of the first quarter was our commercial launch of INBRIJA, with drug in the channel as of February 28. INBRIJA is the first and only FDA approved inhaled levodopa for the intermittent treatment of OFF periods in adults with Parkinson's taking carbidopa/levodopa.

About 350,000 people with Parkinson's in the U.S. experience OFF periods despite being on levodopa/carbidopa regimens. These are characterized by return of Parkinson's symptoms, such as motor weakness, stiffness, tremor and other symptoms often unpredictably during a person's day. OFF periods occur when the person's maintenance regimen of Parkinson's drugs, usually, levodopa/carbidopa, drop below effective plasma levels.

OFF periods can last up to two hours or more depending on when the person's next dose kicks in, and many people with Parkinson's experience OFFs several times a day. OFF periods are considered by patients, their care partners and healthcare providers as among the greatest unmet medical needs in Parkinson's, and based on the description, I think you can get a sense of why. INBRIJA provides a novel treatment for on-demand use. Patients may use INBRIJA up to five times a day to help manage their OFF periods.

We expect that peak sales for INBRIJA in the U.S. will exceed $800 million. Now we're early in the INBRIJA launch, which effectively began in March when drug was available in the channel. Through March, we reported INBRIJA net revenue of $1.3 million.

Our total call audience is about 10,000 physicians, about 2,000 of whom are high-volume prescribers of levodopa/carbidopa and were focusing on these prescribers the most strongly. Through April, we've received approximately 2,000 prescription request forms, approximately 700 physicians have written prescriptions and approximately 45% have written more than one prescription. I'd like to note that we're providing these metrics now as we want to give you as much color as we can with the understanding that we're early in the launch, we won't necessarily be providing these exact metrics every quarter. Feedback from the field is reflecting what our market research has consistently shown over the last five years that both physicians and patients perceive INBRIJA as addressing a major unmet need in Parkinson's.

We expect that the trajectory will continue to accelerate as we reach agreements with the payers and PBMs for formulary placement, as our various marketing programs continue to rollout and as more and more prescribers experience the positive patient feedback that we're also hearing. We believe it will take the next two to three quarters or so before we have a strong sense of the trajectory of the launch. Lauren Sabella, our chief commercial officer, will follow with additional details on the launch. And before I turn the call over to Lauren, moving briefly to AMPYRA.

We reported AMPYRA net revenue in the first quarter of $41 million. We've been pleased by the level of branded sales, which are a result of our continued patient and physicians' support. Lauren?

Lauren Sabella -- Chief Commercial Officer

Thanks, Ron, and hi, everyone. First of all, I want to let you know that our commercial team is very enthusiastic about the launch of INBRIJA. The great majority of our current sales force has been here during the successful commercialization of AMPYRA, and we are applying our learnings from the success of AMPYRA over to the launch of INBRIJA. That being said, it is important to acknowledge that no two launches are identical, and there are going to be differences between both AMPYRA and INBRIJA.

And the reimbursement environment has also changed since the AMPYRA launch in 2010. Notwithstanding these differences, there are some fundamentals that every successful launch needs to get right. First, awareness levels need to be reached quickly by both the patients and the physicians, and we're monitoring this on a regular basis. The education process has to be consistent and repetitive, and we have to have the right brand positioning and messaging.

Physicians and patients need to have ample opportunity to trial the new medication in order for it to become a regular part of the doctor's treatment plan. Another key component to any successful launch is achieving formulary access. And in the interim, we have to support the physicians, their offices and the patients in navigating the reimbursement landscape. All of these fundamentals need to be executed with both focus and discipline.

As you're going to see on the next slide, we've a robust plan and includes a comprehensive collection of support services and resources. That will enable the physicians and the people with Parkinson's to have an early positive experience. So we've already implemented several launch activities, and there's more to come. This slide highlights some of the key activities and the audiences they're designed to reach.

For the physicians and the other healthcare professionals, the field sales and medical teams have been out there engaging since the beginning of the year educating on the clinical data and training on how to use INBRIJA. As a reminder, we are targeting about 10,000 doctors with a specific focus on about 2,000 high-level prescribers of levodopa/carbidopa, and our sales forces have visited over 90% of these high-level prescribers, an average of five times each to date, which is strong execution. We are augmenting awareness of the brand through digital promotion to physicians, as well as using journal ads. We launched an INBRIJA educational webinar series in February, and that offers a convenient way for physicians to learn about INBRIJA from a panel of national thought leaders.

At the beginning of April, we launched our speaker bureau. We have 120 neurologists who'll be conducting both peer-to-peer and patient programs at the local level. On April 1, we began providing INBRIJA's samples to the doctors' offices, and they come in a pack size of 16 doses. And in addition, just last week, we launched a free trial program for commercially insured patients.

That's similar to the AMPYRA First Step Program for both offices and institutions that have policies that don't allow sampling. This free trial program is accessed through the submission of our prescription form, and it provides one full carton of 30 doses. For the people with Parkinson's, we're building brand awareness through both targeted digital promotion and speaker programs. We're also engaging in all the community events, such as a Parkinson's walk and the local support group meetings to further educate on INBRIJA.

Our HUB is offering patient support throughout the prescription process, and that includes co-pay support for commercially insured patients. Even more importantly, it includes individualized education and information for the Medicare patients on both their initial out-of-pocket expense and on the reduction of that expense as they remain on INBRIJA through the course of the year. And the HUB will also give additional education, if needed, on the proper use of the inhaler. One program we're really excited about is our patient's starter kit.

And I'm going to review that on the next slide. Finally, and not least, we are having productive conversations with insurers to gain formulary status as quickly as possible. So we've developed a new patient starter kit that is sent to the patient once prescription is written. And in most cases, this is being delivered even before the prescription is filled.

All patients receiving this free trial program or prescription will receive a patient starter kit. What does this kid include? It has an animated self-playing demonstration video card, a charger, a magnetic card with contact information for the HUB and a convenient carrying case for the inhaler. You can see the video playing here. This has been very well received by both patients and physicians.

So on that note, I'm going to turn the call over to Dave, who will review the financials.

Dave Lawrence -- Chief Financial Officer

This table outlines key financials for the quarter. Our cash and cash equivalents balance at the end of the first-quarter 2019 was $343.2 million, compared to our 2018 year-end balance of $445.6 million, a decrease of $102.4 million. This decline in cash was due, in large part, to nonrecurring payments of approximately $45 million that were made in the first quarter, primarily related to AMPYRA inventory purchases. The impact of those payments can be seen in the reduction of our accounts payable, accrued expenses and other current liabilities on our balance sheet, which is included on our press release from this morning.

Orders for the AMPYRA shipments had to be placed in the third quarter of 2018 in anticipation of continued sales of branded AMPYRA. Payments for these orders were made in the first quarter of 2019. We do not expect to purchase additional AMPYRA inventory in 2019. For the remainder of 2019, the company expects cash expenditures to align with normal operating activities and continues to believe that it can become cash flow positive without raising additional capital based on our long-term projections.

I'll pass the call back to Ron to review our 2019 priorities.

Ron Cohen -- Chief Executive Officer

Thanks, Dave. Priorities in 2019, above all, are to ensure a successful launch of INBRIJA so that as many people with Parkinson's who can appropriately benefit are able to do so. We're also looking to obtain approval of our INBRIJA MAA in Europe and expect the EMA's decision by the end of the year. And we're continuing to discuss collaborations on ex-U.S.

commercialization with potential partners both in Europe and Japan. With the approval of INBRIJA, the ARCUS technology platform has now been validated, and we're applying the ARCUS platform to develop therapies for additional uses. Our most advanced program is for treatment of acute migraine, and we will update you on development milestones in the second half of the year. And finally, we'll maintain our focus on controlling expenses and deploying resources to maximize shareholder value.

Operator, we will now take questions. Thank you.

Questions & Answers:


Operator

[Operator instructions] Your first question comes from the line of Phil Nadeau from Cowen and Company. Please go ahead. Your line is open.

Phil Nadeau -- Cowen and Company -- Analyst

Good morning. Thanks for taking my questions. Just a few on the prescriptions that you mentioned, Ron. Do you have a sense what the current time is from writing a prescription to reimbursement for that prescription? And what's the conversion from the request that you're getting to filled scripts?

Ron Cohen -- Chief Executive Officer

Yeah. It's really too early, Phil, for us to comment on that. It's a moving -- it's a rapidly moving target. Week-over-week, we're seeing improvements in the timeline.

So it's -- let's say, for the last week, it's night and day from what it was in the beginning of March. So that's continuing to accelerate, and we expect that as we start getting our contracts in place and formulary placement, that's going to accelerate even more. So it really is -- there's no good way to give context for that until we get a little bit further into the launch.

Phil Nadeau -- Cowen and Company -- Analyst

And have you done any analysis of the prescriptions that we can all see the, like, IQVIA prescriptions? How accurate are they?

Ron Cohen -- Chief Executive Officer

Yeah. Again, very early. I mean I'll tell you for one thing, IQVIA -- one thing we do know is they are not picking up how many boxes are being written per prescription. So they're giving a number of prescriptions, and we already know that they're not actually picking up the number of boxes.

So what we've already said on the presentation is we've been averaging -- actually, I don't know if we said it or not, but if we haven't said it, right now, we're averaging more than one box per prescription. Now that may or may not continue. Again, it's early in the launch, but so far, we're averaging more than one box. They're not picking med up.

So we'll try to give more color as we get more data and we get a little bit more mature in the launch process.

Phil Nadeau -- Cowen and Company -- Analyst

Great. Thanks for taking my questions.

Operator

Your next question comes from the line of Paul Matteis from Stifel. Please go ahead. Your line is open.

Nate Tower -- Stifel Financial Corp. -- Analyst

Hey, this is Nate on for Paul. Thanks for taking the question. I just have a few quick ones. Maybe first, when you receive a prescription request form, is that going to turn into always in the near term a filled script? Or will it turn into a sample?

Ron Cohen -- Chief Executive Officer

OK. Thanks for the question. So Lauren, do you want to take that?

Lauren Sabella -- Chief Commercial Officer

Yeah. Sure. It's a great question. Great insight.

Right now, all of the prescription request forms that we have in, there was no free sample associated with it. So those are going to turn into prescription if in fact they make it all the way through the process. In the future, there will be an opportunity that a prescription request form will go -- in a commercial patient will go first to a free good and convert to a commercial prescription or not. And it's going to take time for us to understand what that conversion rate will be.

Nate Tower -- Stifel Financial Corp. -- Analyst

Sure. Makes sense. And then do you guys have a sense for how it's being used -- I know it's early, but how it's being used in terms of number of uses per day? Do you have any feel for that from physician or patient feedback?

Ron Cohen -- Chief Executive Officer

No. I mean, there's no way for us to have a sort of a global -- we hear anecdotes here and there. But at this point, we're just falling back on the clinical trial where we saw an average use of between 1.5 and 2.2 times a day, depending on which of the trials you've looked at. Even that we've said that our assumption is that in the real world, it's going to be less than that because people have to pay out of pocket, which they don't do in a clinical trial and so on.

That said, you never know. There are so many factors that go into it, and we expect we'll get a lot more information as the launch matures.

Nate Tower -- Stifel Financial Corp. -- Analyst

Awesome. I'll hop back into the queue. Thanks for taking the questions.

Operator

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

Michael Yee -- Jefferies -- Analyst

Thanks. Good morning, Ron. Two questions. One is, could you talk about an estimate as to how many patients you think are actually getting the free sampling? Do you think it's more or less than the 2,000 scripts requests that you've gotten? And then second question is on reimbursement.

How many people do you think get through on first pass? Or maybe just talk about how much back-and-forth there is with commercial pay and talk about how difficult it may or may not be to get through versus the coverage you've got. Maybe just talk a little bit more about reimbursement as you said you're working on that. Thanks.

Ron Cohen -- Chief Executive Officer

Yeah. Sure, Mike. So let me take your first question first on samples. Again, we -- there were no samples -- I think you're talking about the free month, right, as opposed to the actual samples?

Michael Yee -- Jefferies -- Analyst

Yeah.

Ron Cohen -- Chief Executive Officer

Is that right? Yeah. So just to level set --

Michael Yee -- Jefferies -- Analyst

I suppose.

Ron Cohen -- Chief Executive Officer

Yeah, there are two different programs here. One is what you think of is traditional samples where the doctor has them in the office and can give them out. And that's a sample kit of 16 doses, 1-6, 16 doses or 32 capsules. And that's for the doctor to give out, trial the patient when -- then hopefully prescribe as well.

For those institutions or offices that don't allow sampling, we've implemented just recently, last week, a First Step-type program where they can write the prescription to our hub, and they get a one-month box for free to try. And then hopefully, if they like it, that converts to a commercial prescription later, which was very successful in the AMPYRA program, as you know. So at this point, we don't have any way of knowing how many samples have been given out in doctors' offices. And in terms of the First Step-type program, we just started it last week.

So none of the numbers I gave reflect that program yet. That will be something going forward. Now with respect to -- does that answer your question there for that first part?

Michael Yee -- Jefferies -- Analyst

Yeah. So that clarifies that there's two different types of sampling, but we don't really know -- even though you probably sent the lot out, we don't actually know how many have been given to a patient, for example.

Ron Cohen -- Chief Executive Officer

Right. And in terms of the one-month prescription First Step type, hardly any, if any, have been written because we've just started that program last week, OK? So those are not in the numbers at all at this point. In terms of how many get through, it's way, way early to be able to tell that. What we can say is that for -- so in today's world as opposed to, let's say, when we launched AMPYRA nine years ago, in today's world, as I think you all know, you're not covered until you get your formulary status.

It used to be the opposite. It used to be that almost everything went through until you got your formulary status and then you had to deal with whatever each plan was putting in place to be on formulary. Now it's the opposite. You don't have automatic coverage until you get formulary status, and that takes months in many cases.

And we've said, I think, for the universe of plans and PBMs that we're dealing with, we expect we're going to be in series getting these in place throughout the rest of this year and even into next year. So that's on formulary status. So what do they do meanwhile? Meanwhile, there's an extra step where the physician or prescriber has to write a medical exception, and we have people in the field and the HUB who are handholding and walking the practices through that process to make it as painless and straightforward as possible for them to write those medical acceptance, and that's what they're doing, and we're seeing prescriptions get through on that basis, which is what we would expect. We're having productive discussions, I would say, very constructive discussions with the major insurers and PBMs.

As I mentioned, a number of the regional insurers have already put the drug on formulary. So we expect this to roll out over time. And as it does and as we get a more complete sort of landscape of formulary, we'll be able to get more data to you all about what's getting through and how fast and so on.

Michael Yee -- Jefferies -- Analyst

OK. That's sounds helpful. That sounds OK. I can get back to follow up.

Thanks.

Operator

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

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

Hi. This is Pete Stavropoulos on for Charles. I have one question on INBRIJA demand. Is INBRIJA demand being driven by a broad range of prescribers or those associated with clinical trial sites?

Ron Cohen -- Chief Executive Officer

Yeah. I'm going to give that over to Lauren. Lauren?

Lauren Sabella -- Chief Commercial Officer

Currently, about 75% of the prescription forms are coming in from that top 2,000 physicians, which is what we would have anticipated. We are making, as I mentioned, many calls on those physicians. They do see the bulk of the patients. And so that is where 75% of the prescription forms are coming from at this point in time.

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

All right. Thank you.

Operator

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

Unknown speaker

Thanks for taking our question. This is Andrea on for Salveen. Our first one is regarding how doctors are adopting INBRIJA in their treatment paradigm, if you could speak a little bit on that, where they're placing it and which particular patients. And then we have a follow-up.

Ron Cohen -- Chief Executive Officer

Yeah. Lauren?

Lauren Sabella -- Chief Commercial Officer

Yeah. Listen, it's really too early to really understand how they're going to place it in the treatment paradigm. As I mentioned, one of the reasons that you sample and we have the First Step Program is so that a lot of trial can happen. The physician needs to see how patients do on the medication.

That, together with the education by the sales force, will help them to understand better the patients that it is to be used in. We believe that this should be used in all patients that have OFF periods and that are on levodopa therapy, and that is approximately 350,000 patients in the U.S. market today.

Ron Cohen -- Chief Executive Officer

Yeah. I'll jump in here, and I will give you anecdote, which is not data, and the plural of anecdote is not data. But I do want to give you just a feeling for the kinds of things that we're hearing out there to put a little bit more context on it. So we got a report from one patient out there who was put on INBRIJA and then called the doctor's office, was told the doctor wasn't available because they were seeing patients, and the patient said, "I'll wait." So they waited on hold for about half hour before the doctor came to the phone.

Doctor came to the phone, and the patient said, "Doctor, I had to stay on the phone and wait for you. I need to tell you." Well, actually, I don't know if I can say this in public, but he said, "You changed my life." OK. Now the specifics around that I don't have, but clearly, you had a patient who was very motivated to give feedback to the doctor that they were pleased that the doctor had prescribed INBRIJA for them. Last week, I was presenting at a Parkinson's meeting actually, and there were just about 180 people or something in the audience.

And I was talking about the launch of INBRIJA briefly. And as I mentioned it, a woman in the back of the room shouted out, "It's great. I'm on it. It's great." And the whole place kind of laughed appreciatively.

I didn't know who she was. And after I got off, I went and talked to her, and she told me that she had been on the drug. She'd taken her third dose before she got to the event and was delighted with it. So those are the sorts of anecdotal things we're hearing.

They're completely consistent with everything we've seen throughout our market research for the last five years, talking to the doctors, talking to the patients. And as we go through the sampling process, as we go through the prescribing process and the doctors get more and more of that feedback, that also serves as a positive feedback loop and encourages additional acceleration to prescribing for others of their patients.

Unknown speaker

Great. Thanks for the color. And then maybe just one on AMPYRA. If you can provide any color on the number of generic entrants there are right now to the extent that you're aware.

Ron Cohen -- Chief Executive Officer

Yeah. Lauren? Hold on just a second.

Lauren Sabella -- Chief Commercial Officer

Yeah. I think at the current time, there are five generic entrants on the market.

Unknown speaker

OK. Great. Thanks again.

Operator

Your next question comes from the line of Ram Selvaraju from H.C. Wainwright. Please go ahead. Your line is open.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Hi. Thanks very much for taking my questions. So just some points of clarification. Could you elaborate a little bit on the timeline between the entry of a prescription into the system, the point at which you become aware that a prescription for INBRIJA has been written and the point at which product has actually dispensed? And also if you could comment at all on whether that 45% reordering or represcribing rate is both due to the fact that some doctors may not actually have had a need yet to file a reorder or to write a new prescription and/or whether some doctors have actually have long enough to write a new prescription and just haven't written one for whatever reason.

And then I just had a quick follow-up. Thanks.

Lauren Sabella -- Chief Commercial Officer

So I'll try to answer that second question first and that was when we talk about the 45%, what we're seeing is, of those 700 doctors, 45% of them have written a prescription for more than one patient. That's the metric that we're sharing. So I hope that clarifies it.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Yeah. No, the question was really along the lines of whether all of those doctors have actually had enough time to write a second prescription or whether some of those doctors have not yet actually gotten to the point where they would be eligible to write a second prescription because of the timeline that their patient may be on.

Lauren Sabella -- Chief Commercial Officer

So these physicians see patients every day. So yeah, there is time, but as with any launch, the physicians take the time to find correct patient upfront to start prescribing. And as they learn more about the medication and they gain more experience, they accelerate the number of patients that they normally prescribe the drug for.

Ron Cohen -- Chief Executive Officer

Right. And I'll just jump in and say that our goal here is that over time, the physicians or prescribers get to a point where this becomes standard of care, just the way when we introduced AMPYRA and nobody initially knew what to do with it. We said at that time, this is going to be a standard of care, and it became a standard of care for people with MS. This is one where it's a novel type of treatment that they haven't seen before.

It's a bridge between the patient's oral doses that compensates for the failures in that oral dose that occurs quite frequently and with increasing frequency as a person goes through their Parkinson's journey. So the goal is that the physicians get to a point based on experience and continued education where they understand that this is -- it's not actually a rescue medication. It is meant as part of the daily experience of patients who are having OFF periods and need to control them as their day goes through. So that just takes time.

It takes the feedback loops. It takes ongoing exposure to the messaging, answering questions, the doctor's own experience. And remember, it's only been two months that drug has been in the channel. And especially earlier on, it was slower just from the time they wrote a prescription to the time that the patient actually got it and was able to give feedback.

So it's really, really early. Over the next quarter and the quarter after that, we'll get a lot more robust data on all of these things, and we'll be able to give you more color, I'm sure.

Ram Selvaraju -- H.C. Wainwright -- Analyst

OK. Great. That's very helpful. And then just one follow-up was with respect to the inventory buydown.

Just two additional details that I was hoping to get. Firstly, the background to the actual inventory buydown decision, if you could elaborate on that. And then secondly, the reasons why you're giving us guidance that there won't be anymore.

Ron Cohen -- Chief Executive Officer

Yeah. I mean the key there is that we had a $100 million drawdown on the balance sheet in the quarter that we don't expect anything like that to be recurring over the year. That was largely due to nonrecurring items, and the bulk of that was the inventory payment. The inventory payment -- remember, the appeals court decision on genericization occurred in September of last year.

We have -- contractually, we have to order 90 days in advance on our inventory. So we couldn't afford to be in a position where we would stock out assuming we won the appeal, which was we think -- we thought a fair assumption. And as a result, we ordered for that contingency. Now obviously, we didn't win.

Sales dropped more, obviously, considerably. And that inventory that we ordered, the payment for it was in the first quarter of this year. So now we have that inventory. We don't expect to reorder this year.

As a consequence, we have enough to supply what we believe will be the demand for the rest of the year and somewhat into 2020. But we don't expect that that expense is going to come up again in 2019, and the quarterly expenses will revert to ordinary operating expenses, which is what we budget for. So we're actually on budget internally at this point. And all of the assumptions that we -- or projections we've made, including our expectation that we can get to cash flow positive based on our long-term projections of the INBRIJA launch and AMPYRA expenses and so on, that remains intact.

Nothing has changed.

Ram Selvaraju -- H.C. Wainwright -- Analyst

OK. So that basically means you can sell this inventory progressively going forward at some point, right?

Ron Cohen -- Chief Executive Officer

Absolutely. Yes.

Ram Selvaraju -- H.C. Wainwright -- Analyst

Yeah. OK. Thank you very much. Appreciate it.

Operator

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

Unknown speaker

Hi. Thank you. Appreciate you taking my question. This is Matt on for Jay.

And we just wanted to know what kind of metrics that you plan on providing to us on an ongoing quarterly basis that we could use to track the INBRIJA launch. And then my next question, if you may, was just an update on your plans to leverage the delivery technology for additional molecules in the pipeline. Thank you very much.

Ron Cohen -- Chief Executive Officer

OK. So we're still working through what metrics we think would be the most accurate and useful. So I don't have a specific answer for you. We gave you some metrics today based on the early stage of the launch.

We may or may not provide the exact same metrics going forward. We'll update you next quarter as we get more information, and we're going to try to be as helpful as possible to you all. With respect to the ARCUS delivery, as I mentioned, the lead program is for acute treatment of migraine. We have three different molecules, all of which are known to be effective that we have been able to formulate already.

So we know we can formulate them in ARCUS. We're now going through various preclinical types of testing so that we can select at least one for IMB and then moving it into clinical development. And we will -- we'll have more to say about that in the second half of the year in terms of the time lines. There are other programs -- I should add, there are other programs that are earlier.

For example, the Bill & Melinda Gates Foundation have given us substantial grants to develop an inhaled surfactant for premature infants who have respiratory distress syndrome as a substitute for the expensive and the bulky nebulizer technology. We've already shown that with the ARCUS technology, you can deliver those doses deep into the lungs with the equivalent of a normal baby's inhalation, which is really quite an advance. So we're looking at that and looking at other areas where that might be interesting. But that -- I'll just underscore, those are earlier stage.

The migraine program is more advanced, and that's the one we're going to be focusing on in particular this year and then beyond.

Unknown speaker

OK. Thank you very much. Appreciate that.

Operator

We have no further questions in the queue at this time. I will turn the call back over to the presenters for closing remarks.

Ron Cohen -- Chief Executive Officer

OK. Thanks, operator. Thanks, everyone, for joining us. We are -- I hope it comes across.

We are really excited about this launch. We are delighted by the early feedback we're hearing. And we're looking forward to updating you as we go forward. See you next time and have a great day.

Operator

[Operator signoff]

Duration: 38 minutes

Call participants:

Felicia Vonella -- Vice President of Investor Relations

Ron Cohen -- Chief Executive Officer

Lauren Sabella -- Chief Commercial Officer

Dave Lawrence -- Chief Financial Officer

Phil Nadeau -- Cowen and Company -- Analyst

Nate Tower -- Stifel Financial Corp. -- Analyst

Michael Yee -- Jefferies -- Analyst

Pete Stavropoulos -- Cantor Fitzgerald -- Analyst

Unknown speaker

Ram Selvaraju -- H.C. Wainwright -- Analyst

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