Regeneron Pharmaceuticals Inc Wells Fargo 21st Annual Healthcare Conference

Yeah, I will take it from here.

Yeah. I appreciate you having us, Mohit.

Five years, it has flown by. A lot of successes that we have been able to report at this very conference, and excited to be back, so thank you.

Thank you. Before we begin, I just need to make a couple of forward-looking statement disclaimers.

I would like to remind you that remarks made today may include forward-looking statements about Regeneron, and each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in such statements. A description of material risks and uncertainties can be found in Regeneron's SEC filings. Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise. With that, I will just make a couple of opening comments, and then we will get to your questions, Mohit. Going back to the second quarter earnings report that we had in late July, I think we had a really strong financial performance that was driven by exceptional commercial execution.

Double-digit growth on the top and bottom lines, driven by EYLEA HD's outstanding performance in the U.S., DUPIXENT really setting a new high watermark globally in terms of revenues, as well as LIBTAYO. In fact, all three hit all-time high for quarterly sales for a quarter. Additionally, in the end of the second quarter, we finished repaying the Sanofi development balance.

Great. Going forward, we will be able to record our full share of the profits from DUPIXENT and KEVZARA as part of our Sanofi collaboration revenues.

So that should give us a little uplift going forward, and we are excited to finally get to that point. Looking ahead for the rest of 2026, we have some exciting pipeline catalysts, mainly around the C5 franchise. We have a PDUFA date for cemdisiran monotherapy for generalized myasthenia gravis, which is in November. Huge and growing market, and we think we have a differentiated product there, and are looking forward to hopefully launching that by the end of this year. We also have a pivotal data readout in paroxysmal nocturnal hemoglobinuria, which is another area where we are going to evaluate the combination of pozelimab and cemdisiran head-to-head against eculizumab or SOLIRIS.

We also have an interim readout for geographic atrophy that is looking at the combination that I just mentioned, as well as cemdisiran monotherapy. This will be kind of a peek at the data that will inform next steps for that program. We are currently enrolling a pivotal cohort, and this could inform powering as well as whether one arm performs better than another, and perhaps we can move forward with just two arms as opposed to three in our pivotal study. We also expect to have approval for the EYLEA HD prefilled syringe before the end of this year. We are working with multiple contract manufacturers on issues related to their facilities, as opposed to the product. So we hope that they can resolve them and the FDA can ultimately sign off on our application to get this important delivery mechanism into the market.

We are also reporting some early data in the metabolic portfolio, the siRNAs that we have been working on in MASH, as well as for an antibody that targets the NPR1 receptor and antagonizes it for postural orthostatic tachycardia syndrome, or POTS. Those are earlier-stage programs, but we are excited about both. We also anticipate initiating our pivotal studies for obesity and in type 2 diabetes with olerpeptide, which we in-licensed from Hansoh last year. Then finally, I think we are also working towards hopefully expanding our collaboration with Sanofi to go beyond DUPIXENT and potentially other assets. I am sure we will talk about a lot of these. I will leave it there.

Great Then we will jump into Mohit's questions.