Acorda Therapeutics, Inc.

Welcome to Accorda Therapeutics first quarter 2022 financial and business update. Please be advised that this call is being recorded at the company's request. I would now introduce you to our host, Tierney Sacavino, Accorda communications consultant. Tierney, please go ahead.

Thank you, Bethany, and good afternoon, everyone. Before we begin, let me remind everyone 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 Q&A, we will first take calls from our analysts, and then we will take some questions from other investors who have written in when they registered for the call. I'll now pass the call over to our CEO, Ron Cohen. Ron?

Thanks, Danny. Welcome, everyone. We'll dive right in. Embresa net revenue for the first quarter of 2022 was $3.5 million, a 26% decrease over the first quarter of 2021. This does not reflect our expectations for Embresa's performance for the rest of the year. We were pleased to see that as the Omicron wave waned from the beginning of the year, in Breesia sales rebounded significantly. In particular, whereas January and February sales were similar, March sales increased by approximately 85% over February and then continued to increase through April. So what happened? We believe the following factors affected the quarter's results. First, we typically see a decline in net sales in the first quarter over the fourth quarter of the prior year, and that's due to seasonal overstocking at the end of the year by patients and pharmacies, as well as by changing of insurance carriers at the beginning of each year. So we expect that. However, the declines were exacerbated this year due in large part to a significantly higher estimate for discounts and allowances that we have in Q1 2022 as compared to the estimate in Q1 2021. And in fact, gross sales were essentially the same in each period. We expect DNA rates to decline during the rest of this year. We also saw significantly fewer refills of the breeder prescriptions in Q one, and that was related to both the overstocking into four and the extreme spike in the national COVID cases that we saw in December to February, which we believe caused Parkinson's patients, who are among the most vulnerable, to reduce their activity levels, therefore reduce their usage of ambrosia to treat their off periods. We believe that the large rebound in net sales in March and April reflects both the depletion of the overstocking from Q4 and the subsiding of that major Omicron wave with patients becoming more active again. Also related to Imbresia, we are delighted to announce today that we've signed an agreement with Biopass Laboratories to commercialize Imbresia in the nine largest countries in Latin America, including Mexico and Brazil. Biopass is the leader in commercializing CNS therapies in Latin America. This is our third ex-U.S. commercialization agreement. We're also in active discussions with other companies for the rights to commercialize in Brescia and additional countries. By way of update, Esteve plans to launch in Brescia in Germany in June. And as a reminder, Germany is the largest pharmaceutical market in Europe. It's the fourth largest in the world. And we expect to begin to receive revenue from our supply agreement with Esteve in the current quarter by June. Moving to Ampira. Empira net revenue for the first quarter was $14.9 million, a 27% decline over Q1 2021. However, growth sales were reduced only by about 11% over Q1 2021, and that was consistent with our internal projections. Again, as with Ambregia, We had a higher estimated DNA for Ampira in Q1 2022 than in Q1 2021, and we expect the DNA to decrease over the remaining quarters of 2022. We're reiterating our guidance for 2022 net sales of Ampira of between $68 and $78 million. So to provide a bit more depth on Ambregia, As we noted previously, the net sales were 26% lower in Q1 22 versus 21. In addition, total prescriptions decreased by 12%. However, dispensed cartons, which we believe is the true indicator of demand, decreased by just 5%. And again, this does not reflect our expectations for Imbresa's performance for the rest of the year. We believe that the major Omicron spike in December to February was the major contributor to these declines. Very importantly, and really worth emphasizing again, we saw that 85% increase in net sales in March and then continued growth through April as that COVID spike subsided. The feedback we're hearing in the field is that people with Parkinson's are in fact anxious to return to their more normal levels of activity, and that motivates them to address their off periods more. Now, we've talked about the impact of COVID periodically on the launch of ambrosia. I want to provide some color here, some data to give you some color on that. This graph illustrates that new prescriptions for ambrosia have tracked with the average increases and decreases in in-person office visits during the various waves of COVID. This is our QVIA data. So you see that as office visits go up, prescriptions go up, as they go down, prescriptions go down, as you might expect, but then we can actually see it here. We don't have the data yet on office visits for Q1 2022. However, as I mentioned earlier, we also saw a decrease in daily utilization and refills in Q1 2022. as we experienced that record number of cases. There were over 20 million cases of COVID in January alone. That was over four times those of previous peaks. And hopefully, as that is subsiding, even with the more modest so far new waves, we will see improvements there. Moving to our financials and our goals for 2021, Mike, would you please go to the financials?