It doesn’t incorporate all data that are publicly available, notably the full and robust safety data set we have to REGENERATE. We presented this at AASLD in November 22. And frankly, it doesn’t present the new analyses that we shared at NASH-TAG in January 2023. So there’s kind of a lack of consistency in approach that we are recognizing and we’ll see how it goes from there. But we have some returns with the model.
Operator: Thank you. Our next question comes from the line of Jon Wolleben with JMP Securities. Your line is now open.
Jon Wolleben: Primarily wanted to ask about OpEx guidance. I’m wondering, how much incremental NASH SG&A is included there? And if it’s not fully included, how much more do you think would be necessary? And then I think, Andrew, you said that 2/3 of 2022 R&D was for NASH. I’m wondering if that’s the same proportion you expect for 2023.
Jerry Durso: Thanks, John. We are continuing to manage with, I think, the right intersection of ensuring we have the right investments as we prepare for NASH, but also paying a lot of attention to making sure that we’re managing our OpEx in a responsible way, Andrew, maybe you can go into how we’re thinking about the NASH investment in context of the guidance that you gave earlier.
Andrew Saik: Yes, sure. Thanks for the question, John. Yes, so probably the right way to think about it and the reason I gave sort of our continuing cost from last year, our last year spend was around $325 million when you don’t count the international operations that we sold in July. So, the way to think about it is the increase year-over-year is really 100% related to NASH launch then. So, you’ve got about $50 million to $60 million that we’ve targeted is prelaunch NASH. And that’s basically external, right? So, we’re looking at things like payers, we’re looking at pricing. We’re looking at disease education. We’re not adding a lot to infrastructure in the meantime until we get to our PDUFA date. So, it’s all going to be external spend that we could ratchet up or ratchet down sort of as we go.
With regard to R&D, we’re continuing to evolve our pipeline, as you know. So reverse is done, which means that our spend on NASH is going to be reduced this year relative to last year. Overall R&D spend will be slightly down but materially flat, but you’re going to see more like 50% NASH and 50% pipeline, if that helps.
Jon Wolleben: Very helpful.
Operator: Thank you. Our next question comes from the line of Joseph Stringer with Needham & Company. Your line is now open.
Joseph Stringer: Just wanted to get your updated thoughts on the pre-cirrhotic NASH market segmentation, and looking ahead, if OCA approved in NASH with your desired label, what types of NASH patients would you just getting on the drug for?
Jerry Durso: Yes. Thanks, Joe. Maybe I can start and Linda can chip in if she wants. I think, look, when we think about how we would best position OCA. We continue to be focused on the antifibrotic effect and the more advanced patients. And so I think that theme, what you’ve heard from me for a while continues to be what we’re getting back as we do these updated discussions with all of the stakeholders, the deep updated market research you would anticipate, we’re doing as we’re in this phase of preparation. So really, the advanced patient who is most likely identified through noninvasive means continues to be where we would zero in on both — it really is the patients that the physicians the payers and the patients themselves have the most amount of urgency towards seeking treatment.
