Acorda Therapeutics, Inc.

Welcome to Accorda Therapeutics' fourth quarter 2021 financial and business update. At this time, our participants are in a listen-only mode. There will be a question and answer session to follow. Please be advised that this call is being taped at the company's request. I will now introduce you to our host, Tierney Sacavino, Executive Vice President, Corporate Communications at Accorda. Please go ahead.

Thank you, Tania, 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 today's Q&A, we will first take calls from our analysts, and then we will take some questions that other investors have written in when they registered for the call. I will now pass the call over to our CEO, Ron Cohen. Ron?

Thank you, Tierney, and welcome, everyone. We'll dive right in. At the beginning of 2021, we established goals to address the company's challenges. And I'm happy to report that we executed on all of those goals, and these are summarized on this slide. We strengthened our balance sheet. We minimized our expenses and maintained fiscal discipline. We increased Embresa's trajectory. We executed two ex-U.S. commercialization partnerships, the launch in Brescia in Spain and Germany. We achieved the top of our guidance range for Ampera net sales in the face of generic competition. And we made important additions and changes to our leadership team and the board. And I will review those with you now in a bit more detail. So regarding strengthening Accorda's balance sheet, to do that, we sold our manufacturing operations to Catalan in early 2021 for approximately $74 million net. That, in turn, enabled us to pay the $69 million stub payment on our convertible debt, which was due in June, and that removed a significant overhang. We also received a $4.2 million tax credit from the CARES Act. Looking ahead to 2022, we expect that the double-digit royalty from Biogen on ex-U.S. sales of Vampyra will revert to Accorda in mid-2022. Note that this royalty has continued to appear as revenue in our financials, but with an accompanying expense as we passed on the payments to healthcare royalty partners with whom we, to whom we had sold the royalty extreme in 2017. We expect that obligation to end around the middle of this year and to have it revert back to a quarter. We also expect to receive revenue from ex-U.S. sales of Imbresia in 2022. Regarding our fiscal discipline, the sale of our manufacturing operations also reduced our operating expenses. And in addition, we implemented headcount and other expense reductions that we expect will reduce the company's annual operating expenses by about $60 million in 2022 over what they were in 2020. Based on our revenue and OPEX projections, we aim to be cash flow neutral on a run rate basis by the end of 2022 and to be cash flow positive in 2023. Now, in November, we announced an agreement with Esteve to commercialize Embresa in Germany. That's the largest pharmaceutical market in Europe, the fourth largest in the world. The court will receive a $5.9 million upfront payment. We'll also receive a significant double-digit percent of the selling price for supply of the product, as well as additional milestone payments based on met sales. And we also executed an agreement with Esteve to commercialize Imbresa in Spain. Esteve expects to launch Imbresa in Germany in mid-2022 and in Spain in early 2023. We're also in discussions quite actively with additional parties to commercialize Imbresa in other territories in Europe and the rest of the world. Moving to our leadership additions and changes, John Varian was appointed to Accorda's board in January of this year. John is an experienced biotech veteran. He's held both CEO and CFO roles and has experience on several biotech boards. Mike Gesser joined Accorda as CFO in November. Mike has held senior finance positions at both large and small companies, including Allergan. He's enhancing our ability to maintain our fiscal discipline, to increase the efficiency of the organization, and to continue to build shareholder value. Neil Beloff also joined Accorda as general counsel in November. Anil has extensive senior legal experience at biopharma companies such as Celgene, and he's also served at the Securities and Exchange Commission. And Lauren Sabella moved from Chief Commercial Officer to the role of Chief Operating Officer, while Kerry Clem, who had served as EVP of Sales and Market Access, was named our Chief Commercial Officer. I'll note that our ability to attract this high level of executive talent, notwithstanding the company's current challenges, is indicative of the opportunity that Acorda has to build shareholder value going forward. So moving to our commercial performance. In Brescia, net revenue for the full year 2021 was $29.6 million. That's a 22% increase over 2020. For the fourth quarter, net revenue was $10.4 million, and that's a 12% increase over Q4 2020. We were encouraged to see these increases in Brescia's trajectory, particularly in light of the continuing impact of COVID-19 on our business during the year. Empira net revenue for the full year 2021 was $84.6 million, and for the fourth quarter, net revenue was $22.5 million. We achieved the top of our guidance range for Empira sales in the face of ongoing generic competition. Moving to a bit more detail on ambrosia, as a reminder, ambrosia is inhaled levodopa. It's indicated to address the return of symptoms or what are called off periods that many people with Parkinson's experience in between doses of their regularly scheduled medication. Now, as I mentioned, the pandemic continued to pose headwinds for the launch in 2021. I'll give you some color on that. It manifested in a number of ways. In-person patient visits to offices continued to have declined overall from pre-pandemic levels. More patients did return to office visits after the initial precipitous decline in 2020. But those levels have waxed and waned with each successive new wave of COVID, most recently with the Omicron wave. In addition, many practices stopped accepting in-person visits by salespeople. That remains true now. Until very recently, we were not able to hold patient or physician speaker programs in person, and they still remain substantially lower than pre-pandemic levels, although we are beginning to rev back up with in-person programs, and what we have found is that everything related to marketing and educating about ambrosia is more effective in person, whether it's salespeople calling on the doctor in the office or having speaker programs where an actual physician can address a group of patients. It works better. Also, we've learned that people with Parkinson's disease in particular Many of them reduce their activity significantly outside their homes during the pandemic because they're in very high risk group. And thus they were less likely to report to their physicians their need for a therapy to treat their off periods. If you're sitting at home watching TV a lot rather than your usual outdoor activities, that's what you're going to do. So I think the good news here is that we expect these factors to largely reverse as the pandemic finally subsides. Hopefully we are seeing that happening now. We therefore see significant opportunities to accelerate the launch as that occurs, and particularly as people with Parkinson's become eager to resume levels of activity, exercise and so forth. Exercise and activity are one of the key ways that people with Parkinson's are encouraged to manage their PD, and ambrosia can be an important part of that for them as they reemerge from, let's call it the hibernation of the last two years, and are looking to catch up on that activity and exercise. Here are some additional metrics. Again, despite the COVID headwinds, our team was able to adapt creatively through digital means and otherwise, and we continued to see growth in Abresia compared to 2020. As I mentioned, we saw 22% annual growth in 2021 over 2020, with a 12% increase in net sales in the fourth quarter versus fourth quarter 2020. Now, bear in mind, The fourth quarter of 2020 had unusually large sales or outsized sales, largely due to factors related to our moving from several specialty pharmacies at that time and merging all of that into a single one. And during that transition, we saw even more excess ordering than we normally would see in the fourth quarter. We also saw a 14% increase in total prescriptions over Q4 2020. And I think the most important number here, the one that we follow the most closely, is we had a 24% increase in organic growth. That's measured by the actual number of cartons of ambrosia that patients received. That most accurately reflects demand because patients can get anywhere from one to five cartons in a single prescription. Note that in 2021, the average number of cartons per prescription actually went up from 2.5 to 2.8. Moving to Ampira. Overall net sales for 2021 were down by approximately 15% over 2020. But we were pleased to see the curve continuing to flatten. And if you look here, you see that sales in 2021 stabilized quarter over quarter. They were essentially the same, maybe a million or so apart from one quarter to the next. So that curve was relatively flat during the year. And while we continue to expect that there will be erosion over time and net revenue will continue to decrease over time, we believe we're seeing that the decrease has begun to stabilize or the rate has begun to stabilize. We believe that the durability of the product is due to a number of factors. First, our field sales team is continuing to call on MS specialists. They've maintained strong relationships there. We support the product. Physicians and patients remain loyal to the brand. And the support we've provided earns that loyalty, education. We continue to provide services. For example, our First Step program, in which commercially insured patients get their first two months of Ampira free. And then we mitigate their out-of-pocket copay costs for commercially insured patients, and we continue to provide physician and reimbursement support. Now, I'm going to turn this over to Mike Gesser, our CFO, who will provide you with an overview of the financials and 2022 guidance. Mike.