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spk04: Ladies and gentlemen, welcome to Accorda Therapeutics' second quarter 2022 financial and business update. At this time, all participants are in a listen-only mode, and 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 at Accorda. Tierney, please go ahead.
spk03: Thank you, Abby, 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 will take some questions from investors that they have written in when they registered for the call. I will now pass the call over to our CEO, Ron Cohen. Ron?
spk02: Thank you, Jenny. Welcome, everyone. We'll go right into the report. Starting with Imbresia, Imbresia net revenue for the second quarter of 2022 was $7.4 million. That's a 16% increase over Q2 of 2021. This also doubled our net revenue from the first quarter of 2022, which followed the buy-in that we saw in Q4 2021, and also a challenging Q1 due to the COVID Omicron surge at that time. We were also encouraged to see that new prescription forms increased progressively since the first quarter, and in July were 37% greater than in January, as the country has opened up even in the face of COVID. Regarding Ampira, Empira net revenue for the second quarter was $18.2 million. That's a 17% decline over Q2 2021, but a 22% increase over the first quarter of this year as, again, specialty pharmacy buy-in in the fourth quarter had a rollover effect into Q1. We're reiterating our guidance for 2022 net sales of Empira of between $68 and $78 million. Moving to our ex-U.S. revenue, Imbresa launched in Germany, which we were delighted to see in June, and we recorded $1.9 million in revenue from Esteve for the initial launch shipments under our supply agreement, and an additional $900,000 worth of drug was shipped in July. Esteve is reporting that feedback in the first two months of the launch in Germany has been enthusiastic with excellent uptake. And Esteve has benefited from our learnings in the U.S., which we transferred to them, particularly regarding the importance of training about proper inhalation technique. And we believe they're also benefiting by not launching into the onset of the pandemic. Esteve expects to launch in Spain in the first quarter of 2023. And our other partner, Biopass, is continuing to work toward launches of Embresa in the nine largest Latin America markets, including Mexico and Brazil. We're also in discussions for commercial Embresa partnerships in additional territories around the world. Regarding Ampira, which is the, I'm sorry, Vampira, which is the ex-U.S. version of Ampira that is marketed by Biogen, our obligation to healthcare royalty partners has been fulfilled. And the double-digit royalties for Vampira reverted to a quarter as of late June. We expect to see the full benefit of those royalties commencing again in Q3. And in addition, we are pleased that Biogen has now launched Vampira in China. Our CFO, Mike Gesser, will now review the financials. Mike?
spk01: Thanks, Ron. OpEx for 2022 is $2.5 million lower than our Q2 2021, and we are maintaining our 2022 OpEx guidance of $110 million to $120 million. The amendment to the Catalan supply agreement that was effective from July 1st, 2021 through June 30th, 2022 resulted in a $4.6 million in savings from the minimum commitment. As of July 1st, 2022, we have reverted back to the original contract conditions. Although we were aiming to be cashflow neutral by the end of the year, we now anticipate that that will occur in 2023. While we have seen a gratifying bounce back in our business from Q1, the Q1 shortfall had a bigger effect than we originally anticipated based on the buy-in in Q4 and the extremely large COVID surge during that quarter. Back to you, Ron.
spk02: We continue to focus on building long-term value through execution on the key goals you see here. First, continuing to drive Ambrosia's growth. We were encouraged to see that new prescription forms grew in the second quarter through July following the dip in Q1, which was associated, as you heard, with a large fourth quarter buy-in as well as the extreme Omicron wave at that time. Although COVID has not moved past the country, the country has clearly been moving past COVID. And as the effects of the pandemic continue to recede, we believe that people with Parkinson's are anxious to become more active again, especially since activity is an important part of managing their Parkinson's. We expect those trends to continue to positively impact Embresa's trajectory, and we've been implementing multiple new commercial programs to take advantage of that. Those programs include, for example, a new electronic or e-prescribing option, which reduces friction for physicians when prescribing Embresa. We've also added before and after videos to the Ambrosia website, Ambrosia.com. These compellingly demonstrate Ambrosia's potential benefits, and I encourage you all to visit the Ambrosia.com site to see them for yourselves. We're also gratified to have begun to receive initial revenues from our Ex-US-Embresa partnerships, and we're looking forward to additional launches from our existing partners, as well as additional partnerships for new territories moving forward. Regarding Ampera, while we expect the brand to continue to decline against generics over time, that decline has been flattening, and we've been encouraged by Ampera's durability to date We're continuing to provide our support programs, have our field force call on MS offices, and we're reiterating our net sales guidance of 68 to 78 million in 2022. We're also continuing to exercise fiscal discipline to control operating expenses. And as the Biogen royalties on the XUS sales of Vampira have reverted to a quarter, we'll receive the full value of these royalties commencing in the third quarter. We're also building on the Arcus technology platform, which has now been validated by the approval of Ambrosia in both the EUS and the EU. We're in discussions about potential collaborations with other companies who've expressed interest in formulating their novel molecules for pulmonary delivery with Arcus, and we've already been performing feasibility studies for a number of these opportunities. So with that, we will open up the line for questions. We have received a couple of questions per the announcement earlier, so I will I will read those. The first question is, please provide an update about the timing of breakeven cash flow. As Mike Gesser just shared in our presentation, we had been aiming to be cash flow neutral, to reach cash flow neutrality on a run rate basis by the end of this year due to the outsized impact in the first quarter of both the fourth quarter buy-in and the tremendous Omicron surge. We are now aiming for 2023, and we believe we will hit that in 2023. We'll narrow that more as we gather more data in the next couple of quarters. Second question is, FDA is slated to release product-specific guidance to develop a generic ambrosia later this year. How long do you envision a quarter can or will retain branded exclusivity on Ambrosia? And two, what are your lifecycle plans to blunt the impact of the brand? Are the patents strong enough to hold off generics? So a few points on that. First of all, FDA was actually scheduled to have issued the guidance last year. They have not yet done so. We are not aware of any hand to filers yet. But the broader point is we believe we have a strong patent portfolio that extends to 2032. In addition, the product is based on the Arctis technology, and we think the complexities of that technology, along with the patent portfolio and the fact that this is an inhaled drug which brings additional obligations for safety and so forth, that all of that will be helpful in defending the franchise going forward. Are there any other questions, operator?
spk04: I have no further questions at this time.
spk02: All right. So with that, thank you all for joining us, and we look forward to updating you in our third quarter call. Have a great evening.
spk04: And, ladies and gentlemen, this concludes the Accorda Therapeutics second quarter 2022 financial and business update. We thank you for your participation, and you may now disconnect.
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