Invivyd, Inc. (NASDAQ:IVVD) Q4 2022 Earnings Call Transcript

Dave Hering: Yes, I’ll take the first question. And so our estimates that in 2022, the sort of overall market across vaccines, oral anti-virals, monoclonal antibodies was almost $100 billion. And yes, I think that a lot of folks are predicting that, that will come down. But it’s still an incredibly sizable market, monoclonal antibodies did $8 billion about in revenue in 2022, and that was with predominantly bebtelovimab and Evusheld. And Evusheld did $500 and some million in Q3 of last year. And what we see is with a similar indication, really targeting immune compromised vulnerable populations, they only touched really a fraction of that population, and we continue to work with €“ these groups talk to patient advocacy groups, speak with these individuals, and they still are really clamoring for products.

In particular, I spoke to a physician who works at the Mayo Clinic and said he had never been in a position that these types of patients come in and ask for products, and there is nothing available. And so based on that, we see the market for monoclonal antibodies continuing to be incredibly significant and a huge unmet need in this patient population. As it relates to your other question in terms of where regulators are and what the status is, we will provide updates, additional updates when we get them. We continue to be in dialogue with the FDA and other global regulators. And as I said, as soon as we have confirmed what that trial design will look like, we plan to provide that information.

Sidharth Mehta: Thank you.

Operator: Thank you. Our next question comes from the line of Matthew Harrison of Morgan Stanley. Your line is open.

Unidentified Analyst: Hi, this is an for Matthew. Thanks for taking our questions. I have two questions. One is €“ is there any update on adding kind of regulatory thresholds for new antibody therapy for COVID given the change of the pandemic setting. Could there be any flexibility in potential approval? The second is, do you have any updates on your potential progress on flu antibodies therapy development?

Dave Hering: Sure. No, thank you for the question. So on the first one, in terms of regards to thresholds, as you’re likely aware, at least in the U.S., none of the antibodies have been fully licensed and gone through BLA, they have all been authorized through EUAs and there currently are no monoclonal antibodies on the market. And so we have not seen any specific changes in thresholds. In particular, what we continue to look at is in-vitro data ahead of time and as what we’ve seen on VYD-222 is consistently strong activity against a variety of variants, including the most recent on .1.5 and so we see that, that is really important information as it relates to getting products into clinical trials, etcetera. And as I mentioned through the presentation, while the public health emergency is ending, that does not remove the potential for the FDA to utilize the EUAs. And so, we still see that as an open possibility for VYD-222 or our additional other candidates that we have in the pipeline.

As it relates to the flu component, I’ll turn it over to Lukas. You can provide an update on the status of what €“ of where we are with the flu program.

Lukas Dillinger: Yes. Thank you, Dave. So we’ve identified several interesting molecules in the flu program already. These molecules are currently being further characterized in in-vitro assays and other studies, and we will be releasing the data as soon as we have them available.

Unidentified Analyst: Okay, thank you.

Operator: Thank you. I’m showing no further questions at this time. I turn the call back over to Dave Hering for any closing remarks.