Acorda Therapeutics, Inc. (ACOR) on Q3 2022 Results - Earnings Call Transcript
Operator: Welcome to Acorda Therapeuticsâ Third Quarter 2022 Financial and Business Update. At his 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 recorded at the Companyâs request. I will now introduce your host for todayâs call, Tierney Saccavino at Acorda. Tierney, please go ahead.
Tierney Saccavino: Thank you, Harry, and good afternoon, everyone. Before we begin, 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. During the Q&A today, we will first take calls from our analyst, and then we may take questions from that other investors have written in when they registered for the call. I now pass the call over to our CEO, Ron Cohen.
Ron Cohen: Thanks Tierney, and welcome everyone. I will just start with a quick overview of todayâs call. On our agenda, we will be presenting the Q3 highlights and focus a good deal on INBRIJA and AMPYRA. Iâm also going to provide some summary of the long-term business plan, a high level summary of the plan that we released in detail last week. Mike Geer, our CFO will cover the financials and guidance, and I will touch at the end on our upcoming special meeting of stockholders this Friday. So starting with INBRIJA. INBRIJA net sales for the third quarter of 2022 were $7.85 million. That is a 1% increase over Q3 2021, and 104% increase over the first quarter of this year. Now, I recall our Q1 sales this year were severely reduced by both the Omicron surge and the extra large buy-in, in the fourth quarter of 2021. So we are very pleased to have seen sales rebound substantially through the third quarter. And this gives you an additional view. You can see here in INBRIJA net sales, total prescriptions and dispensed quarters in the first three quarters of 2022. And the circles of the bottom show you the percentage comparisons with the related 2021 periods. Now note the dramatic decline in Q1 2022 net sales percentage wise versus 2021. However, all of these metrics improve dramatically across the subsequent two quarters of this year. And that is providing momentum as we implement our new strategies and tactics to accelerate INBRIJAâs trajectory further. And Iâm going to touch on that a bit later on. Regarding INBRIJA XUS sales, recall that in June, we recorded $1.9 million in sales from ESTEVE for the initial launch shipments for Germany, and we received an additional $960,000 in the third quarter for Germany. ESTEVE reports high receptivity by patients and physicians in Germany, and they expect to launch in Spain in the first quarter of 2023. In addition, Biopas is continuing to work toward launches of INBRIJA in the nine largest Latin American markets, including Mexico and Brazil. We are also in continued discussions for INBRIJA partnerships in additional territories around the world, including in Asia and other EU territories. So moving to AMPYRA, AMPYRA net sales for the third quarter were $21.1 million. That was a 5% increase over Q3 2021. The rate of sales decline versus generics has slowed and we expected to continue to moderate. We are reiterating our guidance for 2022 net sales of between $68 million and $78 million. And on this slide, you see illustrated the continuing leveling of the decline in AMPYRA sales year-over-year since loss of exclusivity. With regard to AMPYRA XUS revenue, we received royalties of $2.6 million from Biogen, which markets AMPYRA, which is the XUS name of AMPYRA. So we received $2.6 million in the third quarter. These are double-digit tiered royalties. And we were also pleased that Biogen launched AMPYRA in China in May. I will now follow-up with highlights of the key elements of our long-term business plan to increase the value of the company. You see here an overview. Our plan is based on the key outcomes that you see here. First, we expect to be able to accelerate Andreâs growth in the US and we are also on track to expand into additional XUS markets. We will talk about that in a little more detail and upcoming slides. And while we expect that AMPYRA will continue to decline, the rate of decline has slowed over time, and we expected to continue to stabilize, still providing meaningful revenue over the next five years and beyond. And I will touch on that in additional slides. And especially with the courtâs recent arbitration award from Alchemies, we are well capitalized to execute this plan, and we expect to be cash flow positive in 2023. Finally at the end, I will touch on the need for shareholder approval of the Companyâs reverse stock split proposal that will be key to ensuring that the company is not delisted by NASDAQ in December. So, beginning with our plans for INBRIJA. Now, our commercial team has done an excellent job, establishing INBRIJA as the preferred on-demand treatment for people with Parkinsonâs Disease and off periods. And independent report shows that INBRIJA now has two thirds of the market for on-demand therapies and Parkinsonâs and our market research shows that healthcare professionals or HCPs are more comfortable with levodopa based treatments, which INBRIJA is and this is against the two other competitors in the market. But the key here is that only about 2% of the addressable population now, which is about 380,000 people with Parkinsonâs who take daily levodopa and experience off periods, only about 2% are currently receiving any on-demand therapy. Now, this represents a substantial opportunity for us to expand the market, and you can see that even a modest increase in penetration will result in significant value creation, right. Here are some of the new tactics that we are employing to achieve this. First we will be launching a new brand campaign this month, emphasizing the emotional impact of off periods on everyday activities for patients and their care partners. These are very underappreciated by many of the healthcare providers in the field. And we will be making that much more clear to them. And we will also be educating on the need for greater use of on demand treatments and that is going to be aided by three recently published peer reviewed paper and I will show you those references on the next slide. We are also increasing our investment in digital promotion. We are featuring a library of patient videos that personalize the impact of off periods on the person with Parkinsonâs and they also show the difference in people in an off period. And then as soon as ten minutes after they inhale INBRIJA, for those of you who would be interested in seeing them, I will give you some coordinates later about how you can see those. We have also introduced an e-prescribing platform. This reduces friction in the prescribing process so the prescriber can use, whichever platform they prefer rather than the more time consuming prescription request forms that have to be faxed in. And in the last few months that we have implemented this, we have already found that, the fulfillment rates and which is the percent of prescriptions that are actually resulting in drug being delivered to the patient has increased by about 30% using the e-prescribing options. So we are making this known to every prescriber that we visit and contact. And we are also continuing to work on improving patient access. We are now adding a cash payment option for example for uninsured and underinsured patients. These are the first pages of the three references I mentioned. Interestingly, they all come out in the last year or so. Each is authored by a group of leaders in the Parkinsonâs field, but they are independent papers and yet all three conclude that, there is a need for the field to adopt on-demand treatments substantially more than they are already. And we are making prescribers aware of these papers. This slide shows you still shots of two of the videos that we have. One is Jimmy on the left and Rachel on the right. These are I think one of the most powerful tools that we are now employing. They include these identical scenes left and right. On the left you will see the person with Parkinsonâs during an off period and then on the left, excuse me, on the left. And then on the right, 10 minutes after they have inhaled INBRIJA, the platform for this investor call doesnât allow for us to play video. So I encourage you to view these at inbrija.com I-N-B-R-I-J-A .com, or if you are a healthcare professional, you can also view them at INBRIJA-hcp.com. Now, we are also including these videos on Facebook feeds. This is a new program in the last very few months. This is specifically showing on the feeds of people with Parkinsonâs or an interest in Parkinsonâs and the videos run automatically. As soon as the person scrolls down to them, they start running. So you donât have to click on anything. They have already been seen by tens of thousands of viewers. Now regarding AMPYRA. An independent study reported that AMPYRA currently holds about 15% of the total -- market that is more than four years after it became available generically. Sales are at about 13% of our sales in 2017, which was the last full-year before AMPYRA lost exclusivity. We believe that AMPYRA sales over the next five years will level off at approximately 10% of the 2017 sales through 2027. Now, very interestingly note that about 200 doctors have already written prescriptions for branded AMPYRA in 2022, who had not written since the medication went generic in 2018. Now, we believe that this is due to a number of factors, the whole performance is due to a number of factors. First, physician and patient brand loyalty. And we are continuing to hear from both the healthcare providers and patients who value the support that we have always provided. And we are continuing to provide for branded AMPYRA. That includes our first step program, which gives the initial two months of AMPYRA free for commercially insured payment of patients, and we are mitigating down commercially insured co-pays to no more than $10 a month, which is often lower than what they would pay for generics. And we are also continuing to provide physician and patient reimbursement support. Access also remains high for AMPYRA about 70% of covered lives can get access to the medication. And our field team is continuing to call on MS specialists to ensure that they are aware of the various support programs that we are continuing to provide for the brand. Now our CFO, Mike Gesser, will now review the financials. Mike.
Michael Gesser: Thank you, Ron. INBRIJAâs net revenue was up over Q3 2021 by 14.1%, including outside the U.S. sales. Just the U.S. INBRIJA net revenue is up about 1% compared to Q3 2021, and peer revenue was up over Q3 2021 by 5.5%. SG&A was down from Q3 2021 by 22.3% as a result of our continued spending management effort. Cash of $34.2 million is aligned with our expectations, but I would like to point out does not include the cash from our settlement with Alchemies. That cash was received in October. Last month, an arbitration panel issued the final decision in the dispute between a court and Alchemies regarding the licensing of royalties relating to AMPYRA. At panelâs decision in the quarter was awarded $15 million plus a prejudgment interest of $1.5 million, as I said, were received in October. In addition, a quarter will no longer have to pay alchemy any royalties on net sales for license and supply of AMPYRA. We are free to use alternative sources for supply and we have already secured those sources. This award will allow us to obtain more competitive market rates for the supply of AMPYRA and significantly reduces our cost of goods going forward. Therefore, increasing the productâs value to the company and increasing that value meaningfully. We expect savings of $10 to $12 million in reduced cost of goods sold for AMPYRA in 2023 depending on volume, and that savings depending on volume continue in the future. As we release on October 27th, Acorda is providing financial guidance on many elements of the business in addition to the AMPYRA net revenue in OpEx that we have in the past. As Ron noted, we are holding our previous guidance for AMPYRA and we are also holding our previous guidance on OpEx. OpEx. As we have previously announced, the ending cash balance cash flow for 2022 includes the settlement for ALS of $16.5 million. In addition, we will not pay the December 2022 note interest in shares as we have announced. The cash of forecast going forward assumes that we pay the interest in cash. We continued to work on expanding our outside the U.S. INBRIJA sales, and that is also reflected here, although in clear net revenue continues to decline the face of generic competition, as Ron said, we believe that that curve is flattening and a decline is lessening. The AMPYRA royalty, which now we receive a 100% of the cash from since June. That outlook is based on information from our partner Biogen. The OpEx outlook is a result of our continued management expenses and shows in approximate $20 million from our 2022 guidance to our 2023 guidance. Along the lines of the actions we took in the past that we have been talking about. The cash guidance is a result of growing net revenue, the favorable impact of empiric cost to get sold from the (Ph) settlement and continued OpEx cost management. Ron.
Ron Cohen: Thanks Mike. So, to summarize on our business plan and long-term focus, we are continuing to focus on building long-term value through execution on the key goals we have discussed and that you see summarized here, accelerating and INBRIJAâs growth, maintaining AMPYRAâs strength continued financial discipline, and also leveraging the ARCA platform as we have discussed in the past. Now, before we go to your Q&A, I will touch on the special meeting of stockholders that is taking place this coming Friday, November 4th. In order to provide us with the runway that we need to allow us to execute on the business plan, we had a key proposal on the ballot for this meeting, proposal two, to give the board the ability to implement a reverse split of Acordaâs stock as needed. Now, this is critical to ensure that we donât become de-listed from NASDAQ in December because if that were to happen, we could be in default to our bond holders. That would make it quite difficult to execute the long-term business plan that we have shared. And we are asking shareholders to vote for Proposal Two to ensure that we are not delisted from NASDAQ. The three major proxy advisory firms have all recommended voting for these proposals. And in any case and in case any share shareholders who are eligible would like to vote, we are going to put up a slide with the ways you can vote while we open the call for your questions. Operator.
Operator: Thank you. We have a question here from the line of Raghuram Selvaraju of H.C. Wainwright. Ram please go ahead.
Raghuram Selvaraju: Hi thanks so much for taking my question. Why donât we focus first of all on the long-term revenue guidance. I wanted to better understand some of the principle drivers of your confidence in the longer term outlook for AMPYRA revenue, particularly in the years from 2025 to 2027, and the extent to which you believe there could be variance risks to those numbers?
Ron Cohen: Mike, do you want to take that?
Michael Gesser: Sure. Well, as we will continue to point out that, you know, forward looking statements do have risk of variability. The farther out you go, there is inherently that variability risk. However, I will say this about AMPYRA, it has been a rather well-performing drug and a well forecasted drug over the years. What we find is that, reduction of people who are on our drug typically do a cliff fall you could say between the end of one year and the beginning of another as they are moved off of our product onto a generic or forced off our product to a generic. And what we have seen is that drop slowing down as I said earlier. I think what we have done is, we have analyzed that curve. We have analyzed how we believe this drug will continue to perform as that curve flattens and we reach the parity that you see in many, many, many markets, where a generic is competing against a branded drug. The generic is light-branded drugs in the market if it sets the price, we are very conscious about our patients that take our drug and their need for our drug as opposed to generics. And we are fairly confident on this rate. The ranges that we provided you, they do contain a normal price increase from year-to-year and they do include a reduction in our taking population year-to-year.
Raghuram Selvaraju: Thank you, Ron. And as a follow on to that, can you maybe elaborate on also the makeup of the purchase prescribers who resumed prescribing AMPYRA and what might have factored into those decisions?
Ron Cohen: I donât have that available for you, Ram. But I will tell you that as part of our affirmative strategy and tactics, we have been adding the sales force call on more of the MS prescribers, because it became apparent that, there are many out there still who were actually not aware that we are still supporting the product, and that has been a disincentive to them to prescribe the brand versus the generic. I think you know, we built up a huge amount of goodwill and loyalty with all of the behaviors and programs that we had when it was branded. This was very appreciated by the field, very appreciated on behalf of their patients, and when we tell them, when we alert them that actually yes, we are still doing first step, we are still providing reimbursement support and so forth. We are still paying down co-pays. This goes a long way to encouraging them to start specifying DAW for the brand. And also by the way to pushing back on insurance companies, if they believe for whatever reasons that they prefer to have the brand for their patients.
Raghuram Selvaraju: Last question on AMPYRA. In the 2025 to 2027 timeframe, could you just give us a sense of how many generic competitors in that segment you expect to be on market, corresponding those volume from revenue projection?
Ron Cohen: You are talking about how many generics would be in the market during that period of time?
Raghuram Selvaraju: Yes, probably as a vote of a range.
Ron Cohen: Yes, I mean, I think right now. I believe we have five six and I donât have the exact number in my head. But I believe there are about six that are active in the market now. I donât know that, we expect that to change dramatically, but again, that is difficult to project because that is a matter for each generic company to decide whether they want to stay in the market or not. But right now, as far as we can tell we donât see it changing dramatically. By the way, I do want to say that in addition to the reps going to visit MS Docs more, we have increased media outreach as well, social media outreach and so on. So we are quite active there in promoting it. And what we have found is that when the doctors are made aware that we are still very much active from supporting them, supporting the brand, this goes a long way with them.
Raghuram Selvaraju: Okay. With respect to INBRIJA, I was just wondering if you could just describe a little bit more in detail some of the barriers to prescribing that the e-prescribing approach overcomes.
Ron Cohen: Sure. So the traditional way for prescribing, specialty drugs and certainly INBRIJA and even AMPYRA has been to have specialty pharmacies. And then you have principal forms that are - we call them prescription request forms or service request for PRFs. And those have to be filled in, and they are more time intensive than a regular prescription would be. And then they are actually faxed into a hub that then sends it to the specialty pharmacy or directly to a specialty pharmacy. So right away it is a departure from most of the prescriptions that the doctor or people in the office nurse practitioners, PAs are writing. So it adds friction right there. In addition, there is a more affirmative process going on here. In the system that we have set up, we are collaborating with an outside organization. That includes not just the e-prescribing software and platform, but a specialty pharmacy that is specifically geared to this kind of activity, because if we are going to one of the big major specialty pharmacies, we donât get a lot out of it other than data and then obviously fulfillment. But here you have the extra step where the specialty pharmacy itself is aware of the drug, they are aware of the prior authorization requirements of each given insurance company. And in many cases, they are able to address those prior authorizations without bothering the doctorâs office further or if the prior office such that they need the physicianâs office to do something, they will call them or the contact them and say, hey, we need you to do such and such. So that reduces friction, because without that, it is just kind of swirling all over the place. It is a busy practice and they donât really have the office, doesnât necessarily have the time to focus on these individual details. So this system and our particular e-prescribing system helps, and you can see the results with the about 30% improvement in fulfillment rates.
Raghuram Selvaraju: Great. Also one last question with respect to the possibility of affecting a reverse stock split, Iâm assuming that at this time Acorda has made no determination regarding the nature of the ratio, the split ratio. Is that correct?
Ron Cohen: That is correct. That is something that the board would have to take up.
Raghuram Selvaraju: Thank you.
Ron Cohen: Thank you, Ram. And by the way, I just wanted to just sort of roll back and clarify something just to make sure everyone understands that with respect to the Alchemy Arbitration award that was not - I want to make sure everyone understands it wasnât a settlement. It was a binding arbitration process, and the arbitrators made their decision and the award as Mike articulated it.
Operator: I will now pass the call back over to Tierney Saccavino for any additional remarks.
Tierney Saccavino: Okay. We have a few questions that were written in by shareholders when they registered, and I will just read them out. The first one is, I have been an investor for the last three years, I have a lot of confidence in the management team and the future of the company. There is no doubt that the share price doesnât reflect the real value of the company. Now, with an injection of another 16.5 million and that there is a risk of delisting, why doesnât the management declare a buy plan for the amount received in the award? In this case, you can immediately get the price to go much above a dollar, eliminating the risk of delisting.
Ron Cohen: Well, I appreciate the supportive comment, and I will say on a professional basis, in general, I think stock buybacks are a very useful tool. So Iâm sympathetic to that. Unfortunately, in our current case, we are not able to do share buybacks under the terms of our agreements with our bond holders. So, hopefully at some point in the future that all gets resolved, but right now we are just not able to do it.
Tierney Saccavino: The next question is, what are you doing to lower costs?
Michael Gesser: Yes, let me take this Ron.
Ron Cohen: Sure. Thanks Mike.
Michael Gesser: A couple of things. We are currently feeling the full effect of our actions over the last year by reducing OpEx by $20 million year-over-year from 2022 to 2023, as I talked about. And that is our continued platform to work against. Specifically we moved out of our 20,000 square foot facility in Ardsley to a 20,000 square foot facility in Pearl River, that full effect will be felt in 2023 and is reflected in numbers going forward. However, let me talk to about a couple of specific things. We are actively working on becoming more efficient in our internal processes, significantly changing our IT structure and platforms to a more modern cloud based approach to reduce cost and improve performance. That is going to be a significant reduction of cost for us. We are maximizing the value investment on our marketing programs, ensuring that a thoughtful and targeted approach to outreach will have long-term effects of both reducing out of pocket for those, as well as increasing revenue. We have continued to outsource several departments to maintain service level while saving costs. And finally, we are leveraging our existing capacity of both people and systems to support our outside the U.S. activity in both business development as well as support and delivery. That is increasing our economies of scale, but it is also increasing our economies of scale as we have been able to add that revenue stream with no significant additional operating expense costs. This is one of those answers as a finance guy I could probably talk all day, but I donât want to take away from some other questions and I hope that answered your inquiry. Tierney.
Tierney Saccavino: Okay. The next question is, inside our video Q&A, you mentioned on-demand is a fairly new modality. And in the past year, three papers have been published in peer reviewed journals. All concluding that this new modality is very important to Parkinsonâs disease, but is currently underutilized. Can you please direct us to the three articles were out for further reading?
Ron Cohen: So, yes, I donât know how to do that on the phone, but I will suggest to you if you just write to or e-mail to investor relations@acorda.com and no punctuation. It is just like one word investorrelations@acorda.com and ask and they will send you the citations. Now we are not able to send the actual papers out, because of copyright restrictions, but we can give you the citations so that you can look them up.
Tierney Saccavino: Okay. The next question is, any plan to split in the near future after a reverse split?
Ron Cohen: Any plan to split in the near future after reverse split? Well, I guess I guess the answer to that is that, the urgent immediate need is for the reverse split or at least the authority for the Board to do it, so that we donât get delisted in December. Now looking ahead longer-term, what we would like to do we want to do with the time that would buy us is to execute on the business plan that we have just discussed and that we put out in more detail last week. And we believe that, if we execute on that, we should build substantial value back in the company, and then the Board will look at the fact patterns as we go forward, and make decisions on whether and when a split would be a benefit to shareholders. Right now, I have to emphasize that the immediate issue is not the split, but a reverse split and that in the future, it is certainly something that the Board would continue to consider as part of its overall responsibilities.
Tierney Saccavino: Okay. The next question is, since we are cash flow positive, we retailers are hoping for no more dilution. Please let us know that if you are going to be cash flow positive and no more dilution in 2023.
Ron Cohen: Okay. So I believe that we covered this during the presentation and I will repeat it just to make sure. First of all, we expect to be cash flow positive in 2023, based on the plans that we have discussed today and also last week. With respect to dilution, we have said already publicly that we will not pay the upcoming interest payment on the debt in stock the one that is coming up this December. I believe Mike in the financials, you had a comment about what the financial projections encompass there, right?
Michael Gesser: Yes. The financial projections assume that we are going to pay the note interest in cash.
Ron Cohen: Right. Now, the only caveat I will put on that is that, obviously, the Board has to make decisions in real time depending on what is happening at the time. From where we are right now, we certainly hope that we donât pay it in cash in the future - excuse me, in stock, Iâm sorry, that we donât pay in stock in the future. And we can definitely say that right now, based on our assessment of where we are and our projections, we will not be paying it in stock for this coming payment.
Tierney Saccavino: Great. And the last question is, when will the reverse split take place?
Ron Cohen: That is something that is at the Boardâs discretion. So the Proposal Two on the proxy is to authorize the Board to effect the reverse split as needed in the Boardâs judgment. So the Board is going to take into account where we are. But bear in mind that our time line is fairly immediate because we will - let me put it this way. If the stock price is not above $1 for 10 consecutive trading days, then we will have run out the clock on delisting on the NASDAQ in December, and we would be facing delisting at that time. So between now and then, the Board will be assessing where we are, what the issues are and if needed and they have the authority given by Proposal Two, they would decide at that time whether to do the split then or not - a reverse split then or not.
Tierney Saccavino: Okay. That is the end of the questions that have been written from shareholders.
Ron Cohen: Alright. Well, we appreciate your joining us, everyone. Thanks, and we will see you for the next one. Have a good evening.
Operator: This concludes the Acorda Therapeuticsâ Third Quarter 2022 Financial and Business Update. Thank you for your participation.
