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Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Welcome to Acorda Therapeutics' Third Quarter 2023 Financial and Business Update. [Operator Instructions] 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 Saccavino with Acorda. Tierney, please go ahead.
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 from some investors have written in when they registered for the call. I'll now pass the call over to our CEO, Ron Cohen. Ron?
Thank you, Tierney. Welcome, everyone. We'll dive right in, starting with INBRIJA 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 3 quarters of 2023 versus the first 3 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 3 quarters of this year, they're actually up 38% over the first 3 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 a desired result. We're maintaining our guidance of $34 million to $38 million for INBRIJA in the U.S. 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 4% over Q3 of 2022 and by 6.5% for the first 3 quarters of 2023 versus the first 3 quarters of 2022. And TRx or total prescription trends since launch. We see a similar pattern. These increased by 10% over the third quarter of 2022 and for the first 3 quarters by 11% versus the first 3 quarters of last year. The INBRIJA 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 the health care professionals who treat Parkinson's disease. So 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 been -- has had over 9.3 million views. And very importantly, 270 physicians prescribed INBRIJA 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.getinbrija.com, that's get i-n-b-r-i-j-a.com. For INBRIJA ex-U.S., as we announced last week, our partner, Biopas has filed for the approval of INBRIJA in 6 countries now in Latin America. They expect to have up to 5 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 9 countries that they have licensed for. The launch in Spain to date has exceeded Esteve's initial projections. INBRIJA 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 that 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 enthusiastic. 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, but -- and actually, in most of Europe, they don't have it. But in Germany, when a patient is having their medications adjusted or new medications coming on, they do that in the hospital. So we have had a need to develop a smaller box of INBRIJA due to cost reasons and the economics of the whole hospital process. So we have now shipped smaller boxes of INBRIJA 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, Esteve 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 INBRIJA successfully requires some training and education upfront. And this is -- from their perspective, it helps them because they have limited time in the clinic for training and so on, and this is 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. So moving to AMPYRA. AMPYRA U.S. 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 calculation. But as you see here, the decline was just 17%. If you look at the first 3 quarters of 2023 over the first 3 quarters of '22 -- 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 million 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. So we've continued to execute effectively on our strategy to maintain the AMPYRA brand against the generics. Access remains high. Over 65% of covered lives can get access to branded AMPYRA through their insurance. And our field sales team is continuing to call on the MS specialist 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 3 quarters of this year, 210 physicians prescribed branded AMPYRA 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?
Yes. Thank you, Ron. Net global INBRIJA 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 to the same quarter last year and $12.5 million or 15.6% below year-to-date September to 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 work towards cash flow neutral for the company. In addition to our U.S. revenue, we recorded $1.4 million in INBRIJA ex-U.S. sales, $2.5 million in FAMPYRA 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 INBRIJA U.S. net revenue of between $34 million and $38 million. We expect AMPYRA U.S. net revenue of between $65 million 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 Ron.
Thanks, Mike. So to summarize our priorities for building shareholder value. First, on INBRIJA, as we noted, we've seen sales increase this year with a 15% increase for the first 3 quarters over the first 3 quarters of last year. We believe that our promotional programs are having the desired impact. And we've seen this especially in the 38% increase in INBRIJA new prescription requests for the first 3 quarters of this year versus the first 3 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 AMPYRA brand, as we 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 million to $98 million from the original $93 million 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?
We have a few writing questions here. Here is the first one. When can we expect the company to be cash flow positive?
Well, we typically -- and again, will this year, we typically give our projections for the year at the year-end call. So that will 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.
Second question is, what measures are being taken to better forecast to improve performance? And what way is management being held accountable?
So in terms of projections, I'm assuming that the questioner is referring more to INBRIJA because I'll just remind people that we have had an excellent -- a really outstanding record of accurately projecting AMPYRA ever since, I would say, the first year or 2 after launch and launch was in 2010. So we've been very consistently on target with our projections for AMPYRA. The difficulty -- but with INBRIJA, that has not been the case in the last few years. And the difficulty there, which I think we've discussed at some prior calls, is that having -- 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 the first 2, 3 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. And 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 modules. And I expect that we will get better and better as we go along here in a more normal environment. With regard to accountability, if you look back and if you followed us or you want to check the previous proxies and 10-Ks, I believe you will find that the Board has been very attended to making sure that management is held accountable for performance to goals and to shareholder value and that they -- 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 will 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.
And here is the last writing question that I have, which is how is the company planning to address the 2024 notes?
Well, I touched on that toward the end of the presentation. We must -- what we have had an open -- I think an open relationship with our convertible bondholders. I think it's been a constructive relationship throughout. And 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. .
Okay. And that is the last written question. So operator, we can go ahead and close out the call.
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.
That concludes the Acorda Therapeutics' Third Quarter Financial and Business Update. Thank you for your participation. You may now disconnect your line.