The fundamentals that we see, Sami, is basically there’s been limited to no discontinuations because of the CHMP information. New patients continue to get scripts. Compliances actually remain very high and we’ve been able to maintain dose adjustments. We’ve had even patients that have gone from ambulatory to non-ambulatory and been maintained as well. And then to your question about geographic expansion outside, while some of the information has gone out to other countries. We’ve actually been able to continue to work with healthcare providers in other parts of the world and still continue to generate and see growth from Translarna in the quarter. So the simple answer, of course, is that we have not seen any discontinuations and the fundamentals remain strong.
And as I mentioned earlier in my talk, we’re not only very confident in what we did this quarter, but we’re very confident in how we’ll finish 2023. And we’ve actually raised guidance and our DMD guidance is now $565 million to $595 million, which includes Translarna growth in the fourth quarter. And combined, that would equal about 11% to 17% year-over-year growth for the DMD franchise compared to last year.
Samantha Corwin: Great, thank you.
Operator: Thank you. One moment please. Our next question comes from the line of David Lebowitz of Citi.
David Lebowitz: Thank you for taking my question. When looking at the Translarna European sales, could you please, or overseas sales, can you please give us a breakdown of what those sales are in Europe versus rest of the world? Also, could you give us insight as to what other geographies might have their opinion affected by the EU opinion?
Matthew Klein: David, thank you for the question. Let me start and start with your second part first. As we’ve talked about in the past, many of our largest markets outside of Europe have independent regulatory agencies that do their independent assessments and will continue to make their independent regulatory decisions independent of the CHMP and European authorization. In terms of revenue, we have said in the past that while many years ago, Europe would have been the primary source of our Translarna revenue, we’ve done a lot of work over the past years to diversify our business. I know, Kylie, do you want to go into a bit more detail about the breakdown of revenue?
Kylie O’Keefe: Yeah. Absolutely. As Matt was just saying, we’ve spent substantial effort and time over the last couple of years to geographically diversify the business. And this is the intent of evening out and sort of ensuring that we have contribution from a number of regions to total Translarna revenue. So where we stand today, we have a number of growth markets that have continued to grow over the last couple of quarters in last year. And this has allowed us to have a little less than half of EU revenue contribution to total revenue, and then the remainder being ex-US.
David Lebowitz: Sure, I mean, is there any way you can let us, I guess, zero in on what the particular number might be in the range of, just in case things don’t work out in Europe, we’re trying to understand what the implications might be going forward with respect to our projections.
Kylie O’Keefe: Yeah, so David, I think from that perspective, I think it’s roughly around 45% to 48%. But the one thing I would say, and what’s important to note is those European markets are some of our more mature markets. And so as you look over time, you would expect that the contribution to total revenue for more mature markets doesn’t have the growth trajectory as some of our newer and growth markets. And so while it currently sits around the 45% to 48%, currently you wouldn’t expect that number to remain flat over the coming years.
David Lebowitz: Got it. And with respect to expenses going forward, is there any way you can give us, I guess, some level of bandwidth on what to expect for 2024 and beyond when the restructuring is in full place?
Matthew Klein: Yeah. David, we announced the revised our OpEx guidance previously to $810 million to $860 million. And also, we then announced the subsequent cuts and how that would have an impact of additionally approximately 20% in January 2024. Obviously, we’ll give the updated our OpEx guidance at JP Morgan in January.
David Lebowitz: Thank you for taking my questions.
Operator: Thank you. One moment please. Our next question comes from the line of Kelly Shi of Jefferies. Your line is open.
Unidentified Analyst: Hi. This is Yun [ph] for Kelly. Thank you very much for taking the question. So the first question on Translarna, assume that you’re able to get the negative opinion reversed. Is there a deadline for you to eventually have to convert that conditional approval to full approval? And then on the pre-BLA meeting for AADC deficiency, on the comparability in terms of manufacturing, are there any specific assays that you have to develop before the meeting?
Matthew Klein: Yeah. Thank you very much for the question. So on your first question regarding the positive opinion, if we’re able to convert that to a positive opinion, the continued conditional marketing authorization in Europe. There’s typically not a fixed timeline to that. Typically, what goes along with the conditional marketing authorization in Europe is something called a specific obligation. And that specific obligation is typically some requirement to collect additional data to support the benefit and risk profile of the therapy. So there’s no timeline per se, but there would be a specific obligation that would require us to collect data. And obviously the shape or form of that and design of that data collection study would have some timeline likely tied to it.
