Moderna, Inc. (NASDAQ:MRNA) Q4 2022 Earnings Call Transcript

Stephen Hoge: Sure. So, I will let Arpa take the second part of that question. First on frequency, it is not yet clear on how frequently people will need an RSV vaccine. It’s a seasonal virus, a seasonal epidemic of disease that shows up. Most of us have been exposed to RSV all over a dozen times over the course of our life. And what really happens from a biology perspective is as we get older, our ability to maintain high neutralizing titers to protect us goes down, and what we have is breakthrough disease and ultimately, a disease leads to substantial cost and morbidity and even some mortality in older adults. We do not €“ we have not yet had approved vaccines, and so what we don’t yet know is what’s the frequency of vaccination, is it going to be seasonal every year, or is it going to be less than seasonal every couple or few years.

But what’s pretty clear, based €“ from my perspective, based on the epidemiology of RSV infection, is that we do see RSV fairly regularly as adults, and unfortunately, over time, it breaks through more frequently, and so there probably will need to be repeated boosting to protect against RSV. At the end of the day, the initial recommendations will come from ACIP as well as from regulators around that frequency, and we will have to defer to them on how they want to administer and roll out the RSV vaccines, whether they want to follow a flu model, which would be annual to make sure that we get the broadest amount of protection, or that they want to initially roll out RSV vaccines and then follow over time for the durability of that efficacy.

At this point, none of us, none of the three products that have read out in Phase 3 have a clear answer on the durability of that efficacy, although we would expect it to wane as it does against natural RSV infection over time in those results. Arpa, do you want to take the next part of the question?

Arpa Garay: Sure. Yes. I can take the question on pricing. So overall, from a pricing philosophy perspective, Moderna is committed to pricing that reflects the value of our vaccines. In terms of what they deliver to patients, to societies and the healthcare systems, while also ensuring full access for patients regardless of their ability to pay. So, with that broader principle around pricing, we will be looking at the full recommendations that come out of ACIP as we get the filing and the ACIP recommendations to look at what the full value that could be provided back is based on things, as Stephen mentioned, around dosing frequency, and their pricing will be based on both value and access. I am not able to share any additional details on what sort of range that pricing might fall into, but it will be consistent with our overall pricing philosophy.

Operator: Thank you. Our next question comes from Ellie Merle with UBS. Your line is open.

Ellie Merle: Hey guys. Thanks so much for taking the question. Just another on flu, just €“ any more details on the titer level specifically that you saw or when we will get more details on the titer levels? And then how should we think about the importance of having titers above that 40 benchmark versus demonstrating non-inferiority. Like I guess what is the comparator vaccine titers in your Phase 3, did very well and were well above 40? How should we think about the implications then, say, you are at 30 or near 40, what that would mean from a regulatory standpoint as well as a commercial standpoint in interpreting the immunogenicity idea? Thanks.