Acorda Therapeutics, Inc.

Good afternoon. Good evening. Welcome to the Accorda Therapeutics third quarter 2021 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, Tierney Sacavino from Accorda. Please go ahead.

Thank you, Felicia, 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. As a reminder to our callers, during the Q&A, we will only take calls from our analysts. And I will now pass the call over to our CEO, Ron Cohen. Ron?

Thank you, Tierney, and welcome, everyone. I'm pleased to open with late breaking news. This afternoon, we announced that we had executed an agreement with Esteve to commercialize Imbresa in Germany, which is the largest pharmaceutical market in Europe and the fourth largest in the world. Corda will receive a 5 million euro upfront payment from Esteve. will also receive a significant double-digit percent of the selling price for supplying the product and additionally milestone payments based on net sales. We previously announced an agreement with Esteve to commercialize Imbresa in Spain. Esteve is a prominent, highly successful pharmaceutical company in the EU, and these deals further validate Imbresa's importance as an innovative treatment for the many people with Parkinson's disease who suffer from off periods. Esteve expects to launch Imbresa in Germany in mid-2022. As a reminder, the GBA, which makes reimbursement assessments in Germany, has not required a benefit assessment prior to Imbresa's launch. We're in discussions with additional parties to commercialize Imbresa in other territories in Europe and the rest of the world. And I'm pleased to report that Imbresa net revenue for the third quarter of 2021 was $7.8 million. That's a 34% increase over the same quarter in 2020. And that was particularly encouraging in light of the continuing impact of the pandemic. And PIRA net revenue was likewise encouraging at $20 million. And PIRA remains an important contributor to shareholder value and to our goal of becoming cash flow neutral on a run rate basis by the end of 2022. I'm also very pleased to announce that we've added two seasoned biopharma executives to our leadership team. Mike Gesser has joined Accorda as CFO. Mike has held senior finance positions at both large and small companies, including Allergan. He will enhance our ability to maintain fiscal discipline, increase the efficiency of the organization, and to continue to build shareholder value. Neil Beloff has joined Accorda as General Counsel. Neil has extensive senior legal experience at biopharma companies such as Celgene, and he's also served at the Securities and Exchange Commission. We also announced that Burkhard Blanc, our chief medical officer, will be leaving his position with Accorda at the end of this year, but he will continue to advise the company in a consulting role. I want to thank Dr. Blanc for his years of service. Under his leadership, we secured marketing authorizations for Ambresia from both the FDA and the European Medicines Agency. We're also very pleased that Accorda will continue to benefit from his expertise in his new role as consultant to the company. So moving to Imbresa's trajectory. As a reminder, ambrosia is inhaled levodopa. It's indicated to address the return of symptoms or off periods that many people with Parkinson's experience in between their doses of regularly scheduled medications. As I mentioned, the pandemic has continued to pose headwinds for Imbresia's launch. This has manifested in a number of ways. First, although more patients are now visiting doctors than earlier in the pandemic, levels still haven't returned to the pre-pandemic norms overall. In addition, many practices remain closed to in-person visits by salespeople. And until very recently, we were also not able to hold patient or physician speaker programs in person. Also, for people with Parkinson's disease in particular, many had reduced their activities significantly, such that they've been less likely to report to their physicians their need for a therapy to treat their off periods. Now, all that said, we are seeing improvements in these trends as the pandemic subsides, and we expect that as long as it continues to subside, we will continue to do so. And despite those headwinds, Our team has been able to adapt creatively through digital means and otherwise, and we've continued to see encouraging signs of growth in Embresa compared to the third quarter of 2020. As I mentioned, we had a 34% year-over-year increase in net sales, We also had a 16% increase in total prescriptions over Q3 2020. And importantly, we had a 19% increase in organic growth, which we measure by the number of cartons that are dispensed to patients, which most accurately reflects demand. We've seen that as each of the four waves of the pandemic to date has receded, there have been corresponding upward trends in prescriptions for Ambresia. And again, we believe that when the pandemic fully recedes, we should see a further upward inflection in Ambresia's trajectory. And with regard to Ampera, net revenue decreased by about 28% over Q3 2020. And while we expect revenue to continue to decrease over time, we believe the rate of the decrease has begun to stabilize. Note that quarter-over-quarter sales in the first three quarters of 2021 have been fairly level. We believe that the durability of this product is due to a number of factors. First, patients and their physicians remain loyal to the brand. We've earned that loyalty based on education, support, and the care that we've always provided and continue to provide for branded Ampira. And that includes our First Step program in which commercially insured patients get their first two boxes or first two months of Ampira free. And we also provide copay mitigation for commercially insured patients, and we provide physician and reimbursement support. Our field sales team is also continuing to call on MS specialists where they've maintained strong relationships. Now, I'd like to now introduce our new CFO, Mike Gesser, to provide an overview of the financials. Mike?