Acorda Therapeutics, Inc.

Welcome to Accorda Therapeutics second quarter 2022 financial and business 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 recorded at the company's request. I will now introduce your host for today's call, Tiani Sacavino at Accorda. Tiani, please go ahead.

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 analysts, and then we may take questions that other investors have written in when they registered for the call. I'll now pass the call over to our CEO, Ron Cohen.

Ron Cohen Thanks, Janie, and welcome, everyone. I'll just start with a quick overview of today's call on our agenda. We'll be presenting the Q3 highlights and focus a good deal on Ambrosia and Ampera. I'm 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 Gesser, our CFO, will cover the financials and guidance. And I'll touch at the end on our upcoming special meeting of stockholders this Friday. So starting with Imbresia, Imbresia net sales for the third quarter of 2022 were $7.85 million. That's a 1% increase over Q3 2021 and 104% increase over the first quarter of this year. 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're very pleased to have seen sales rebound substantially through the third quarter. And this gives you an additional view. You can see here in Brescia net sales, total prescriptions, and dispensed quarters in the first three quarters of 2022. And the circles at 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 improved dramatically across the subsequent two quarters of this year, and that's providing momentum as we implement our new strategies and tactics to accelerate Impreja's trajectory further, and I'm going to touch on that a bit later on. Regarding Imbresa ex-US sales, recall that in June, we recorded $1.9 million in sales from Esteve for the initial launch shipments for Germany. 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, Biopass is continuing to work toward launches of Ambrosia in the nine largest Latin American markets, including Mexico and Brazil. We're also in continued discussions for Ambrosia partnerships in additional territories around the world, including in Asia and other EU territories. So moving to Ampira. Empira 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 expect it to continue to moderate. We're reiterating our guidance for 2022 net sales of between $68 and $78 million. And on this slide, you see illustrated the continuing leveling of the decline in Ampira sales year over year since loss of exclusivity. With regard to Ampira ex-U.S. revenue, we received royalties of $2.6 million from Biogen, which markets Fampira, which is the ex-U.S. name of Ampira, So we received $2.6 million in the third quarter. These are double-digit tiered royalties. And we're also pleased that Biogen launched Vampira in China in May. I'll 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 Embresa's growth in the U.S., and we're also on track to expand into additional ex-U.S. markets. We'll talk about that in a little more detail in upcoming slides. And while we expect that Ampera will continue to decline, the rate of decline has slowed over time, and we expect it to continue to stabilize, still providing meaningful revenue over the next five years and beyond. And I'll touch on that in additional slides. And especially with the Corda's recent arbitration award from Alchemies, we're 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 company's 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 Embresa. Now, our commercial team has done an excellent job establishing ambrosia as the preferred on-demand treatment for people with Parkinson's disease and off periods. An independent report shows that ambrosia now has two-thirds of the market for on-demand therapies in Parkinson's, and our market research shows that healthcare professionals or HCPs are more comfortable with levodopa-based treatments, which ambrosia is, and this is against the two other competitors in the market. But the key here is, is that only about 2% of the addressable population now, which is about 380,000 people with Parkinson's who take daily levodopa and experience off periods, only about 2% are currently receiving any on-demand therapies. 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. Here are some of the new tactics that we're employing to achieve this. First, we'll 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. We'll also be educating on the need for greater use of on-demand treatments, and that's going to be aided by three recently published peer-reviewed papers, and I'll show you those references on the next slide. We're also increasing our investment in digital promotion. We're featuring a library of patient videos that personalize the impact of off periods on the person with Parkinson's. And they also show the difference in people in an off period and then as soon as 10 minutes after they inhale ambrosia. 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've 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've already found that the fulfillment rates, which is the percent of prescriptions that are actually resulting in drug being delivered to the patient, have increased by about 30% using the e-prescribing options. So we're making this known to every prescriber that we visit and contact. And we're also continuing to work on improving patient access. We're 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've all come out in the last year or so. Each is authored by a group of leaders in the Parkinson's field, but they're 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're 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're now employing. They include these identical scenes left and right. On the left, you'll see the person with Parkinson's during an off period. And then on the left, excuse me, on the left. And then on the right, 10 minutes after they've been hailed in Brescia. The platform for this investor call doesn't allow for us to play video, so I encourage you to view these at imbrija.com, I-M-B-R-I-J-A.com, or if you're a healthcare professional, you can also view them at imbrija-hcp.com. Now, we're also including these videos on Facebook feeds. This is a new program in the last very few months. Now, this is specifically showing on the feeds of people with Parkinson's or an interest in Parkinson's. And the videos run automatically. As soon as the person scrolls down to them, they start running. So you don't have to click on anything. They've already been seen by tens of thousands of viewers. Now, regarding Ampira, an independent study reported that Ampira currently holds about 15% of the total delphabridine market. That's 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 Ampira lost exclusivity. And we believe that Ampira 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 Ampira 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're continuing to hear from both the healthcare providers and patients who value the support that we've always provided and we're continuing to provide for branded Ampira. That includes our First Step program, which gives the initial two months of Ampira free for commercially insured patients. And we're 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're also continuing to provide physician and patient reimbursement support. Access also remains high for Ampera. 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're aware of the various support programs that we're continuing to provide for the brand. Now, our CFO, Mike Gesser, will now review the financials. Mike?