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spk03: 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.
spk04: 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?
spk02: 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.
spk01: Thank you, Ron. Net global and Breesia revenue was essentially flat to Q2 2022. Last year in Q2 2022, recall that we made the initial shipment of a 7A Germany of $1.8 million. net Imperial revenue decreased 1.3 million or 7% from Q2 2022. SG&A decreased 8.3 million from Q2 2022 at 12.7 million in the first half of 23 from the first half of 2022. Cash decreased $10 million from Q2 2022. In addition to our US revenue, We reported $800,000 in Abresia ex-U.S. sales, $2.9 million in Vampiro royalties, and $800,000 in Norelis royalties, for a total of $4.5 million in additional ex-U.S. revenue for the second quarter. As Ron noted, we are updating our financial guidance for 2023. We expect Imbresa U.S. net revenue of between $34 and $38 million versus the original $38 to $42 million. We are reiterating our MPRA U.S. net revenue of between $65 and $70 million. Adjusted operating expenses guidance will be tightened to between $93 million and $98 million, an improvement from our original guidance of $93 to $103 million. We now expect our ending cash balance to be between $39 million and $42 million versus the original $43 million to $47 million. Although we were able to mitigate some of the inbreeding net revenue through improved SG&A and other balance sheet items, we do not expect to be cash flow neutral in 2023. And now I'll turn the call back over to Rod.
spk02: Thanks, Mike. So before summarizing our priorities moving forward, I want to acknowledge that we all would have preferred not to have us lower imbrogia guidance for the year, which in turn has necessitated lowering our cash flow projections somewhat. That's a miss, and we own it. Now, that said, we believe that the trends in the first half of the year have been highly positive. Our new imbrogia guidance still represents significant growth from last year. And we've been successfully accelerating Imbresia's U.S. trajectory, taking advantage of the new post-COVID environment with our new TV commercial and brand campaigns that I discussed earlier. We believe that these have gained a lot of traction since the beginning of the year. We've seen it especially in the increase in Imbresia new prescription requests in the first half, 42% over the first half of last year, and in the number of physicians who prescribed for the first time in 2023. We believe that these are key indicators for future growth. We're also maintaining the Empira brand, as we said, with continued flattening of the attrition curve. And we're exercising fiscal discipline. As Mike said, we're adjusting our guidance on OPEX for the year to 93 to 98 million, down from 93 to 103 million. And we're aiming to lower our costs further and implement additional efficiencies. Importantly, we continue to have open communications with Accorda's convertible debt holders so that we can arrive at collaborative approaches to servicing the company's debt, which is due at the end of next year. And finally, with respect to our Arcus technology, our team has shown the ability to create shelf-stable mRNA formulations now. as well as various proteins and peptides in addition to small molecules. And we're continuing to evaluate collaborations for creating important new inhaled therapies. And I'm going to turn this back to Mike for just a couple of seconds because I believe he needs to correct one of the numbers he mentioned.
spk01: Yes, thank you, Ron. I'm just stating the number that's clear on the tab or on the slide, our immune-task balance. It's expected to be between 39 million and 44 million. I said 42 by mistake. Thank you, Mike.
spk02: All right. Thank you all, and we'll now open the call to your questions.
spk04: Thanks, Ron. If there are people on the call who wish to submit a question, they should do so at this time. We have a couple of questions already. And the first question is, so you say you're encouraged about the trajectory of ambrosia going forward, and that you think sales will accelerate, but you just reduced your sales guidance downward. And the increases that you report in new prescription requests for the first half of the year are not reflected in your total prescriptions, net sales or cartons. So why do you expect the brand to grow?
spk02: Okay, let me unpack that a little bit. So as I said, yes, we have taken our guidance down, and even with the new guidance, that still represents a very nice increase over last year's sales. So we are seeing growth. The timing is such that it's not as aggressive as our projections had it originally. And as I said, we have to own our projections, and we have to continue to improve on that, and that's where we are. Now, in terms of the prescription request forms, the total prescriptions, you know, which reflect, which are ultimately reflected in our net revenue, total prescriptions The vast majority of that is made up of refills, not of new prescriptions. New prescriptions make up a small minority of the total prescriptions that we see over time. So when we see a bump, you know, first half of this year over first half of last year by 42%, That's quite gratifying. It means that we are getting our messages across, more physicians are prescribing it, expanding their view of who could benefit from the drug, more patients are asking for it, and so on. So that's real progress, given especially what we were working with and the challenges during the pandemic. It takes time for those new prescriptions to be totally reflected in the growth of the product and the growth of revenues. Because it starts out being a minority, but then as a sizable portion of those new patients begin to refill, then those refills now grow the total prescriptions that we see over time. So that's why I mentioned that the new prescriptions are a leading indicator. We're already seeing that Come into net revenue because we are increasing that revenue We expect that if this trend continues with our new prescriptions that we're going to see the total the totals in net revenue and total prescriptions accelerating from this point forward Thank you and The next question is are you looking to expand in Brescia in Canada and
spk04: And can you provide an update for further expansion in other European countries?
spk02: I guess what I would say to that is that we're not breaking out specific countries except to say that we are in discussions for other territories outside the U.S. around the world. And I think we'll leave it at that because we're in the middle of discussions and we We have said this before, and when we have a new deal ready, obviously we will publish it immediately, and we'll put that out immediately.
spk04: Okay, thank you. We don't have any other questions at this time, so Lauren, I'll turn it back over to you to wrap it up.
spk02: All right, well, thanks, Tierney, and thank you again, everyone, for joining us. We're looking forward to giving you the follow-up in the next quarter and beyond. Have a good evening, everyone.
spk04: Thank you.
spk03: Thank you. This concludes the Corda Therapeutics second quarter 2023 financial and business update. Thank you for your participation.
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