Andrea Corcoran: Yes. Thank you, Jean-Pierre, and thanks, Max, for the question. So, I think as you’ve seen or will see when you have the chance to review the financial statements, we continue to exercise really discipline in our investments for both the COVID-19 program as well as the hep C program. Expenses are increasing but in a very measured way quarter-over-quarter for 2023. We would expect the same type of limited increase in 2024. The Phase 3 program for COVID will begin to wind down before the Phase 3 begins for hep C, but nonetheless, we will be preparing for commercialization, as you’ve said. So, there will be additional activities and that we will be funding at that point. So, the expenses for ’24 and ’25 are expected to increase, but in a very measured way.
Maxwell Skor: Great. Thank you.
Operator: And one moment for our next question. And our next question will be coming from Jon Miller of Evercore ISI. Your line is open, Jon.
Unidentified Analyst: Hi. This is Jessica on for Jon Miller. Thanks for taking our questions. I have two questions, if I may, one on COVID, one on the hep C front. So, for COVID, so you said SUNRISE-3 top line data expected in the second half of the year. So, how should we think about the various scenarios that can occur? Like how well does the market appreciate that preexisting immunity from infection and/or vaccination can affect placebo rates, possibly making the effect size smaller and maybe a direct comp to Paxlovid trial data may be limited? And then, also worst-case scenario, how should we think about the company direction in the bear-case scenario that the primary endpoint is not met? And then, I have a follow-up question. Thank you.
Jean-Pierre Sommadossi: Janet, do you like to address the question, please?
Janet Hammond: Thank you, Jessica. So, yes, I think everybody realizes that with vaccination and prior exposure to COVID-19, the severity of disease is frequently less severe, fortunately, than it was when we we’re going through, in particular, I think, the Delta wave and hospitalizations were at an all-time high. Our study is designed to show a delta in efficacy comparable to I think what Pfizer most recently reported in their outpatient study, where there was about a 50% — or in the 50%s difference between the active and the placebo groups. And so that’s what we’re expecting to see. I think particularly when you’re talking about high-risk patients and hospitalizations, that is still an important and meaningful difference. And of course, hospitalization and death are the worst outcomes. And so, if one can prevent those and reduce the severity of disease, I think that’s going to be really important.
Jean-Pierre Sommadossi: And just to add — go ahead, Janet. Sorry, go ahead.
Janet Hammond: No, I was just going to ask you if you wanted to follow on with Jessica’s other question around the scenario where we fail to achieve the primary end point.
Jean-Pierre Sommadossi: Yes, go ahead.
Janet Hammond: Okay. So, I think — I mean, certainly, I mean, it’s one of those things that is under consideration is if we’re unable to do that, are there further avenues to pursue in terms of looking for trends. And we have a Fast Track designation with the FDA to assess how to proceed. But we also have, as I think has been mentioned, two interim analyses where the DSMB will help us to make the decision not to proceed should we see that number of patients in what we are projecting would allow us to be successful. So, I think those are the scenarios that we’re certainly aware of and thinking about. But at the moment, things are moving forward well, and we look forward to presenting results and alerting you to update as we move forward.
Jean-Pierre Sommadossi: Thank you, Janet. And just what I wanted to add to the first question is I think it was — it’s very telling that the NIH actually recently reported that only 15% of high risk actually are taking Paxlovid, and actually — so 85% of high risk who should get an oral therapeutic drug. So, very likely many of the reasons of the limitation of Paxlovid. So, you can see that there is a huge opportunity for a best-in-class product, including even with the challenges that we face as Janet — and Jessica, you recognize in terms of number of low event, but we believe that the way this study has been built will maximize the results for the efficacy and safety of this drug. So, I understand you may have another question on HCV as well?
Unidentified Analyst: Yes. Thank you. So, on the hep C program, given the context that compliance with existing therapies is lacking with existing regimens, so there’s an unmet need here. And the patients you’re presumably going after are the ones that we know already are bad at compliance or else they’d be cured already. How do you guys plan to ensure for the Phase 3 that the protocol and clinical sites can optimize good drug adherence, especially since we’ve already seen that one patient in Phase 2 report here and who is thus unable to achieve SVR4?
Jean-Pierre Sommadossi: That’s a great question, Jessica. Arantxa, you spent quite some time on that. So Arantxa, you would like to address the question?
Arantxa Horga: Yes, it is a great question. I think in part, the compliance issues are just part of the nature of doing trials right now in hepatitis C. The population that we have that is in high unmet need right now. It’s a bit of a mix of the patients who are not taking drugs and they are just general patients, but also there is a very large population of patients that are ex-IV-drug users or IV-drug users, and those really benefit from short treatment durations. So I think by offering a short treatment duration, you’re already addressing some of the compliance issues because patients in general are very excited to take drugs at the beginning, but then sometimes they forget towards the end of the treatment. I think we have all experienced that.
So, the eight-week duration already helps. We, of course, have the regular measurements of checking with the patients, calling them, bringing them in. And what’s very important in Phase 3 is that we’re going to have a comparator. So, the issues with compliance will affect both arms equally because the patients are randomized. And there, you’re really going to see how the comparator is behaving in today’s kind of population, which includes these patients that are non-compliant in general.
