Acorda Therapeutics, Inc.

Welcome to Accorda Therapeutics' second quarter 2023 financial and business update. At this time, all participants are in a listen-only mode. There'll be a question and answer session to follow. Please be advised that this call is being recorded at the company's request. I'll now introduce your host for today's call, Tierney Sacavino with Accorda. Tierney, please go ahead.

Thank you, Lauren, 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. Today, during the Q&A, we'll take questions from some of the investors that have been written in. And I'll now pass the call over to our CEO, Ron Kohn. Ron?

Thanks, Tierney, and good afternoon, everyone. So Imbresia U.S. net revenue for the second quarter of 2023 was $8.3 million. That's a 12% increase over the same quarter in 2022. And this shows the pattern of U.S. net sales each quarter since launch. Now recall that we lost substantial business in the first quarter of 2022 due to the Omicron COVID surge. And that effectively set us back by approximately a year. We lost people permanently who had been on egregia that we weren't going to get back. Now, we have come back from that setback to the point where the second quarter of 2023 had the highest quarterly net sales of any Q2 since launch. We saw a similar pattern in total prescriptions, or TRX, They increased by 11% over the second quarter of 2022. And cartons dispensed to patients increased by 5% over Q2 2022. Now, looking at the first half of 2023 versus the first half of 2022, new prescription request forms increased 42% over the first half of 2022. And total prescriptions increased 11%, and cartons dispensed to patients increased by 9% over the same period. Now, new prescriptions are a key leading indicator of future performance, as patients refill and then increase the base of total prescriptions on a go-forward basis. We believe we're seeing the impact of the new sales and marketing programs that we launched this year, including our streaming television commercials. These have also been enabled by the receding of the pandemic challenges. We believe that full year Imbresa 2023 net sales will be lower than our guidance at the beginning of the year, and we're therefore updating our 2023 guidance to between $34 to $38 million from our original guidance range of $38 to $42 million. Now, that still represents substantial net sales growth this year over 2022, And if the growth in new prescription requests that we've seen in the first half continues, we expect to see continued acceleration in net sales going forward. Now, we recently launched a new consumer Ambrosia website and brand campaign. You can see this at Ambrosia.com. The campaign is called For the Fighters. It's based on extensive feedback that we've gotten from people with Parkinson's. and it recognizes the fighting spirit of the people who have Parkinson's and encourages them to augment their fight by considering whether an on-demand treatment for off-periods, such as ambrosia, is right for them. The campaign highlights that the return of symptoms or off-periods between regular doses of their medications may cause people with Parkinson's to avoid going out or make plans to miss important moments in their lives, such as those related to their family or friends, their interests, their exercise. And since the recent withdrawal from the market of Kymovi, which was one of the only two other on-demand therapies for Parkinson's off-periods, we believe it's even more important now for us to provide needed education and support for the Parkinson's community regarding the potential benefits of on-demand therapy. This campaign augments the TV commercial that we launched on over 50 streaming channels at the end of March. It's been doing extraordinarily well. It's had about 8 million views in just the four months since launch with widespread reports of patients who have seen it and subsequently have been asking their physicians about Imbresia and recall that this commercial is being targeted specifically to be viewed by people who have Parkinson's in the household or healthcare professionals who treat Parkinson's. Speaking of which, large numbers of healthcare providers have seen the commercial, and 165 have prescribed ambrosia for the first time in 2023 since either they or their patients saw it. Regarding Imbresa's performance outside the US, the launch in Spain is going very well and ahead of Esteve's projections. Uptake in Germany has been slower than Esteve's initial projections, and Esteve continues to report high levels of enthusiasm for the product in Germany. They've been addressing some issues that are unique to the German market, including deploying nurse educators to help train patients in person, and providing smaller boxes of ambrosia specifically to meet the needs for in-hospital distribution. Now, that's because uniquely in Germany, many Parkinson's patients there actually initiate their therapy in a short-term hospital stay and then are sent out to their regular doctors to continue therapy, but the needs of the hospital are for smaller packages of ambrosia, and we've been collaborating with the study to provide that. Chance Pharma expects to get an update from the Chinese regulatory authorities about the path to approval in late 2023 or early 2024. Now, that regulatory update will result in a milestone payment from Chance to Accorda of up to $6 million. We also received the upfront payment of $2.5 million in Q2 of this year. BioCost is working on the needed regulatory filings in Latin America. They're telling us the potential now for Imbresia approval. in up to five countries and at least one launch in 2024. We also continue to be in discussions with other companies for agreements in additional countries in the EU and around the world. Moving to Ampera. Ampera U.S. net revenue for the first quarter was $16.9 million. That's 7% decline over Q2 of 2022. And here you see Ampera's sales performance from the beginning of generic competition in Q4 of 2018. And as you see, the slope of the decline has continued to flatten into Q2 of 2023. We're reiterating our guidance for 2023 net sales of between $65 and $70 million. And we believe that sales will stabilize at approximately 60 million plus over the next several years based on the patterns to pay. We've continued to execute effectively on our strategy to maintain the MPIRA brand against the generic competition. Access remains high for MPIRA. Over 65% of covered lives can get access through their insurance. Our field sales team continues to call on MS specialists to ensure that they're aware of the support that we're continuing to provide for the brand. And one of the most encouraging signs of our success in maintaining the brand in the first half of 2023, 159 physicians prescribed branded Ampira who had not prescribed at all in 2022. and they wrote 195 new prescription requests for the brand. Now I'll turn the call over to our CFO, Mike Gesser, who will review the financials.