Moderna, Inc. (NASDAQ:MRNA) Q2 2023 Earnings Call Transcript

Operator: Our next question comes from Luca Issi with RBC Capital.

Luca Issi: Maybe one, Jamey, if I can circle back on margins. I think your prior guidance implied 60% to 65% gross margin versus your new guidance today implies 47% gross margin at the midpoint. Can you just maybe expand a little bit more on what’s driving that change today? Maybe, Stephen, on flu, I think Sanofi argued that the lower immunogenicity for the B strain could actually be a class effect. So it’d be difficult for any of the mRNA players to actually have strong immunogenicity for B strain. Wondering what are your thoughts there. Thanks so much.

Jamey Mock: I’ll take the first question. So on margins, yes, you’re right. We were planning for 60% to 65%. I’d say it’s largely volume-driven, $1 billion of APAs pushing out 2024 as an example. We still have the cost for those fixed into our $3.5 billion to $4 billion in addition to other markets as well. So I think our volume expectation prior to this quarter was a little higher, some due to push-out, some just due to overall volume that we anticipate coming through here.

Stephen Hoge: And I’m aware of the argument that Sanofi made about a class effect. I’m not sure I see it the same way. I think we’ll look to the data to answer that question rather than conjecture. We’ll look forward to sharing where we are in the P303 Phase 3 study in the next quarter, and I’ll leave it at that.

Operator: Our next question comes from Edward Tenthoff with Piper Sandler. Your line is open.

Edward Tenthoff: My question is kind of a little bit of a longer-term strategic one. As COVID continues to evolve and then as you ultimately seek approval of 1010 and even RSV, what is the plan for combining these from a regulatory standpoint and then also a commercial standpoint? So, how do we get from where we are today with one approved, maybe two, three approved vaccines next year to one combo-approved or multiple combo-approved vaccines?

Stephen Hoge: As you know, as I said, we have six combo vaccines. We’ve got lots of clinical data out there, and we continue to look at new combinations. And if we’re in a situation that we expect to be in where we have a flu, RSV, and COVID approved as well as the second-generation COVID moving forward, you can rest assured we’ll be looking at multiple different combinations of those, trying to bring forward options that provide the greatest public health flexibility. Those studies, once we have the products approved, the monovalent vaccines, those studies are really just immune bridging studies, demonstrating that we can do the combination and achieve non-inferior immunogenicity and safety in those studies. They can be quite quick.

And they also don’t need to be run in the season, as you know. And so, our goal is going to be, as we’ve said throughout this year, is to complete the work to move towards approval, filing, and eventually, hopefully, approval of the three monovalent vaccines and quickly progressing into the pivotal Phase 3s for at least one and multiple combos. Our goal, again, is to be launching those in 2025 and beyond for the obvious reasons, they will improve compliance, deliver more value, and actually decrease the administration cost of healthcare. So the path is actually pretty clear from here, particularly given the strength of the RSV data and where we are in COVID, and we hope to be providing an update very shortly on flu that also provides a clear path for 2024 in the monovalent launches we’ve guided.

And then I think we’ll clarify very quickly that we’re starting the Phase 3s to allow the combo launches very shortly thereafter.

Edward Tenthoff: Just to clarify one point, if I may. When you said the pivotal Phase 3s, those would be immuno-bridging studies.