Acorda Therapeutics, Inc.

or in a listen-only mode. There will be a question and answer session to follow. I will now hand over to your host, Tierney Saccazino, Executive Vice President of Corporate Communications at Accorda to begin. Tierney, please go ahead when you're ready.

Thank you, Maxine, 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 all callers, during the Q&A session, we will only take calls from our analysts. I'm now going to pass the call over to our CEO, Ron Cohen. Ron?

Thanks, Tierney. Welcome, everyone. Get right into our report. I'm pleased to report that in Brescia, net revenue for the second quarter of 2021 was $6.4 million. That was a 36% increase over the second quarter of 2020. This was particularly encouraging in light of the continuing impact of the pandemic. Ampera net revenue for the second quarter was likewise encouraging at $21.8 million. We believe that the durability of Ampera brand since it went generic in September 2018 is due to the strategies that we deployed and that we're continuing to execute. Ampera is an important contributor to Accorda's financial stability and to our goal of becoming cash flow neutral on a run rate basis by the end of 2022. Moving to our Imbresa business and trajectory. As a reminder, Imbresa is inhaled levodopa. It's indicated to address the return of symptoms or off periods that many people with Parkinson's experience in between doses of their regularly scheduled medication. We saw encouraging signs of growth in ambrosia compared to the second quarter of 2020 as the pandemic began to recede. And as I mentioned, we had a 36% year-over-year increase in net sales. We also had a 16% increase in total prescriptions over Q2 2020. And importantly, we had a 22% increase in organic growth measured by dispensed cartons, which most accurately reflects demand. While we're pleased with the progress, the course of the COVID pandemic continues to make it difficult to predict how quickly physicians' offices will continue to open and how quickly at-risk populations will resume their office visits. We also announced our first ex-US commercialization agreement with Esteve Pharmaceuticals in Spain. Esteve has a successful track record of commercializing pharmaceutical products in the Spanish market, and this is an important milestone toward our goal of ex-U.S. commercial partnerships for Embresa. As part of the supply agreement, the quarter will receive a significant double-digit percent of gross sales in exchange for supply of the product. Esteve expects to launch Embresa in the fourth quarter of 2022. We're also in active discussions with additional companies for the rights to Ambrosia in other territories in Europe and the rest of the world. Moving to Ampera, Ampera net revenue increased 7% over the first quarter of this year and decreased only by about 15% over Q2 2020. We believe that the durability of this franchise is due to a number of factors. First, patients and their physicians remain loyal to the brand. We've earned that loyalty based on the education, support, and care that we've always provided and continue to provide for branded Ampera. And that includes our First Step program, in which commercially insured patients get their initial two months of Ampera free. And we also provide co-pay mitigation for commercially insured patients and physician and reimbursement support. And our field sales team is also continuing to call on MS specialists where they've maintained strong relationships. Moving to our financials and goals for 2021. The financials are summarized in this table and in more detail in our press release in 10Q. I want to note in particular that our cash of approximately $71 million at the end of Q2 is net of the $60 million payment that we made during the quarter to settle our short-term convertible debt. So moving to how we are building long-term value going forward. We've taken significant steps to position a quarter to build long-term value. We're focused on the following key factors. First, continuing to drive in breeches, commercial growth, the initiatives that we started in 2020 to enhance the patient experience are continuing to yield positive results as prescriptions and dispense cartons grew nicely in the quarter. We held over 100 virtual patient events in the first six months of 2021 and potentially will add in person events later this year, depending on the status of the pandemic. Our field tier team has returned to in person meetings with prescribers, and we believe that contributed materially to the increases in prescriptions in the second quarter. To the extent that the effects of the pandemic hopefully recede in the fall and beyond, we expect our field teams to gain increasing in person access to physicians offices and to see more patients returning to regular office visits. Importantly, as we mentioned, we've secured our first agreement to commercialize in Brescia outside the U. S. In Spain, and we're in active discussions with several parties for additional territories in Europe and the rest of the world. Regarding Ampera, while we expect the brand to continue to decline against generics over time, we've been very encouraged by the brand's durability to date, and we will maintain that as much as possible by continuing to provide our support programs and to have our field teams calling on MS offices. Another key factor in building value is to continue our fiscal discipline and continue to reduce expenses going forward We also expect to receive a total tax credit from the CARES Act this year of approximately $5 to $7 million, of which about $2 million has already been realized. In addition, we expect to have the royalties from Biogen on ex-U.S. sales of Vampira revert back to a quarter in the second half of 2022. As a reminder, these are double-digit tiered royalties on net sales. And also, by way of reminder, we're aiming to be cash flow neutral on a run rate basis by the end of 2022. We're also seeking to build on the Arcus technology platform. It's now been validated by the approval of Imbresia in the U.S. and EU, as well as by funding from the Gates Foundation, development of a pediatric inhaled surfactant product, We plan to discuss potential collaborations with other companies, some of whom have already expressed interest in additional potential indications for Arcus. We'll now open the call for your questions.