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spk04: Welcome to Accorda Therapeutics third quarter 2023 financial and business update. At this time, all participants are in listen-only mode. 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'll now introduce your host for today's call, Tierney Sacavino with Accorda. Tierney, please go ahead.
spk01: Thank you, Cole, 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 the Q&A, we will take questions that some investors have written in when they registered for the call. I'll now pass the call over to our CEO, Ron Cullen. Ron?
spk03: Thank you, Tierney. Welcome, everyone. We'll dive right in, starting with Ambrosia U.S. net sales for the third quarter. They were $8.1 million, and that was a 4% increase over the same quarter in 2022. And in this slide, you see the net sales trends since launch. Note that the growth in the first three quarters of 2023 versus the first three quarters of 2022 is actually 15%. The smaller increase, Q3 over Q3, is related in part to just lumpiness in pharmacy buying patterns across quarters each year, and also to some different adjustments to projected discounts and allowances in the respective quarters. We've also continued to see an increase in new prescription request forms Those were up 32% over Q3 of 2022, and for the first three quarters of this year, they're actually up 38% over the first three quarters of 2022. We believe that that is highly encouraging for the growth of the brand and also indicates that the various programs that we've been putting in place over the last year or so have been having the desired results. we're maintaining our guidance of 34 to 38 million dollars for embresa in the u.s uh for 2023 as per our q2 call if we go to the next slide these are the dispensed cartons and you see that q3 increased by four percent over q3 of 2022 and by 6.5 percent for the first three quarters of 2023 versus the first three quarters of 2022. And TRX, or total prescription trend since launch, we see a similar pattern. These increased by 10% over the third quarter of 2022, and for the first three quarters by 11% versus the first three quarters of last year. The Imbresia TV commercial that we discussed earlier this year has been performing very well. It is airing on about 50 streaming services, and those include Hulu, the Disney Channel, Paramount+. It's directed specifically to households that have self-identified as being impacted by Parkinson's disease, and also to healthcare professionals who treat Parkinson's disease. In contrast to a typical broadcast or cable commercial, this is highly targeted to the audiences that need to have this information. And since we launched the commercial in April of this year, the commercial has had over 9.3 million views. And very importantly, 270 physicians prescribed ambrosia for the first time in 2023 after they saw the commercial. If you'd like to see the commercial, you can watch it at www.getimbregia.com. That's getimbregia.com. For Imbregia XUS, as we announced last week, our partner Biopox has filed for the approval of Imbregia in six countries now in Latin America. They expect to have up to five approvals in 2024, and they expect to file in Chile by the end of this year, and in Brazil and Mexico in 2024, which will be all nine countries that they have license for. The launch in Spain to date has exceeded Esteve's initial projections, and Brizio has now surpassed Apomorphine as the leading on-demand treatment there, and feedback from physicians continues to be highly encouraging. Now, the launch in Germany has been slower than Esteve originally anticipated. Esteve continues to report high levels of enthusiasm for the product in Germany, and in fact, I personally was in Germany last week meeting with some 50 key opinion-leading Parkinson's doctors from both Germany and Spain, and I can verify that based on my conversations there, there was indeed a high degree of enthusiasm. But Esteve has had to adjust its marketing to account for Germany's unique reliance on in-hospital stays to initiate therapy for many patients. We don't have that system here, and actually in most of Europe they don't have it. But in Germany, when a patient is having their medications adjusted or a new medication coming on, they do that in the hospital. So we we have had a need to develop a smaller box of embresia due to cost regions and the economics of the whole hospital process. So we have now shipped smaller boxes of embresia to Esteve for distribution to patients in hospitals. And based on my conversations last week with the physicians as well as Esteve's market research, That's going to make it more affordable and easier for physicians to initiate therapy there. Also, very importantly, SEVE has now deployed nurse educators. Nurses actually visit and train the patients at home, and they are expanding that program right now. The physicians find that very important and very useful because they're aware that using ambrosia successfully requires some training and education upfront. And this is, um, from their perspective, it helps them because they have limited time in the clinic for training and so on. And this was a great adjunct for them. So we're looking forward to seeing the results of that as that continues to roll out in China. Chance Pharmaceuticals is expecting an update from the regulatory authorities there late this year or early next year. So we will report on that when we get that information. And we also have ongoing conversations or discussions with multiple other companies for agreements in additional territories in the EU and the rest of the world. Moving to Ampira. And PIRA US net revenue for the third quarter was $15.7 million. That was a 26% decline over Q3 over 22. I'm going to show you another slide regarding that, but it's related to the fact that revenue in the third quarter of 2022 was unusually high. And it was, in fact, it was the highest of any quarter of 2022. And also it was partly due to adjustments in our gross to net calculations. But as you see here, the decline was just 17%. If you look at the first three quarters of 2023 over the first three quarters of 2022, and that compensates for some of the lumpiness we see quarter over quarter. So we're maintaining our guidance for 2023 net sales of between $65 and $70 million. We believe that sales will continue to decline, as we've said, but stabilized at approximately 60 million plus over the next several years. And we've continued to execute effectively on our strategy to maintain the Ampera brand against the generics. Access remains high. Over 65% of covered lives can get access to branded Ampera through their insurance. And our field sales team is continuing to call on the MS specialists to make sure that they're aware that we are continuing our support programs for the brand, which are extensive. One of the most encouraging signs of our success in maintaining the brand is that in the first three quarters of this year, 210 physicians prescribed branded Empira who had not prescribed it in 2022. and that resulted in 303 new prescription requests for the brand. Our CFO, Mike Gesser, will now review the financials with you. Mike? Yeah, thank you, Ron.
spk05: Net global and breeder revenue was up 6.7% in Q3 over Q3 2022, and 12.3% over year-to-date September to prior year-to-date September. SG&A was essentially flat the same quarter last year and $12.5 million or 15.6% below year-to-date September the prior year, year-to-date September, showing our continued commitment to lower our operating expenses. Q3 2023 cash was $600,000 behind the Q3 2022 ending balance the same period as we worked towards cash flow neutral for the company. In addition to our U.S. revenue, we reported $1.4 million in Ambrosia ex-U.S. sales, $2.5 million in Vampira royalties for a total of $3.9 million in additional U.S. revenue for the third quarter. As Ron noted, we are reiterating our financial guidance for 2023. We expect Ambrosia U.S. net revenue of between $34 and $38 million. We expect imperial U.S. net revenue of between $65 and $70 million. Adjusted operating expense guidance is expected to be between $93 million and $98 million. And our ending cash balance is expected to be between $39 million and $42 million. And now I'll turn the call back over to Rob.
spk03: Thanks, Mike. So to summarize our priorities for building shareholder value, First, on Ambresia, as we noted, we've seen sales increase this year with a 15% increase for the first three quarters over the first three quarters of last year. We believe that our promotional programs are having a desired impact. And we've seen this especially in the 38% increase in Ambresia new prescription requests. for the first three quarters of this year versus the first three quarters of last year. And we believe that's going to be a leading indicator for future growth of the brand. We're continuing to maintain the Antira brand, as we've discussed, with a flattening of the attrition curve. And we've also been exercising fiscal discipline. Last quarter, we adjusted our guidance on OPEX for the year downward to 93 to 98 million from the original 93 to 103 million. And we're continuing to work to implement additional efficiencies to lower operating expenses further. Very importantly, we are continuing to have open communications with the quarter'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 as you might well expect, We expect these conversations to increase in depth and frequency. Finally, with respect to our Arcus inhaled technology, our team has shown the ability to create shelf-stable mRNA formulations, as well as various proteins, peptides, in addition to small molecules using the inhalable powder technology. And we are continuing to evaluate collaborations with other companies for creating important new inhaled therapies. With that, we will open the call to questions. Tierney?
spk01: Thank you. We have a few write-in questions here. Here is the first one. When can we expect the company to be cash flow positive?
spk03: Well, we typically, and again, will this year, We typically give our projections for the year at the year-end call. So, that'll be after the end of this year when we've got our budgets complete and we have our projections complete. So, we'll be updating you all at that call.
spk01: Thank you. Second question is, what measures are being taken to better forecast and improve performance In what way is management being held accountable?
spk03: So, in terms of projections, I'm assuming that the questioner is referring more to Ambregia because I'll just remind people that we have had an excellent, really outstanding record of accurately projecting Ampera Ever since I would say the first year or two after launch and launches in 2010 so we've been very consistently on target with our projections for Ampira. The difficulty, but within Brescia that has not been the case. And in the last few years and the difficulty there, which I think we've discussed some prior calls is that having launched, we launched into an extremely aberrant set of circumstances, mainly the pandemic. And that throws a monkey wrench into the usual metrics because you have a situation where for the first two, three years, we had patients not seeing their doctors, doctors not actually being in the office, people switching to video. We did not have the access to train the physicians and the other professionals in the office to train the patients except online, which is fine, but it's not a substitute for being there in person. And so it was difficult. It was difficult to factor all that in. It's been challenging. I will say that over the last year or so, conditions have normalized or more or less normalized. And now we're able to get data within a more typical environment that we're feeding into our projection uh modules and i expect that we will get better and better as we go along here in a more normal environment uh with regard to accountability uh if you look back and if you followed us or you want to check uh you know the previous proxies and pancakes i believe you will find that the board has been very attentive to making sure that management is uh held accountable for performance to goals and to shareholder value, and that they use incentive compensation quite strongly, quite firmly to ensure that we're being rewarded if we are doing, if we're meeting goals or exceeding goals, and that the opposite is true if we're not. So that's been the track record. I'll also remind everyone that the entire management team owns stock in the company. And so to the extent that our performance is reflected in the stock price or the value of the company, that's also incentivizing. And to the extent that it's not, that is also holding us accountable.
spk01: Thank you. And here is the last question. writing question that I have, which is, how is the company planning to address the 2024 notes?
spk03: Well, you know, I touched on that toward the end of the presentation. We must, well, we have had an open, I think, an open relationship with our convertible bondholders. I think it's been a constructive relationship throughout. we are going to sit down and have the right conversations with them about how we can collaboratively arrive at the best solution for the stakeholders in the company.
spk02: Okay, thank you.
spk01: And that is the last write-in question. So, operator, we can go ahead and close out the call.
spk03: All right, well, let me just thank everyone for joining us, and we look forward to seeing you at the year-end call where we'll have more information to give you.
spk04: That concludes the Accorda Therapeutics third quarter financial and business update. Thank you for your participation. You may now disconnect your line.
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