Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) Q4 2022 Earnings Call Transcript

Reshma Kewalramani: Yes, sure. Liisa, let me tackle the IP questions and then I’ll turn it over to Stuart to talk about the CF epidemiology. The patent for TRIKAFTA goes out to at least 2037. And the reason, if you’re wondering, gosh, how is it so long from when we launched? It’s because of the rapid pace from when we had synthesized this molecule in the lab to when we got approval starting with the U.S., which is about three years, eight months or so. The vanzacaftor triple, we haven’t given a specific date, but it’s longer than the TRIKAFTA compound. And we have indeed identified potentiators and correctors behind vanzacaftor towards our goal of getting CF patients to sweat chloride levels in the carrier range. And those would be even longer than vanzacaftor. Let me turn it over to Stuart for CF epi.

Stuart Arbuckle: Yes, Liisa, so as you said, we updated our estimate for the number of people living with CF to 88,000 for North America, Europe, and Australia. That’s an increase from our previous estimate from a couple of years ago of 83,000. It’s really driven by three things, more patients coming forward for treatment, better data capture and more complete data capture in registries around the world. And perhaps most importantly, patients with cystic fibrosis are living longer due to improvements in the quality of care over the years, and also the availability of truly effective medicines. We see those trends occurring kind of across the globe in all of the regions that I mentioned, it’s not just in one part of the world. Those trends are consistent and I have to say we anticipate those trends will continue into the future.

Liisa Bayko: Great. Thank you very much.

Operator: The next question will come from David Risinger with SVB. Please go ahead.

David Risinger: Yes. Thanks very much. So my question is on VX-548. I guess first, could you talk about publication plans for detailed Phase 2 results in 2023? And if you are planning publications, what incremental points should we be expecting to focus on? And with respect to the commercialization scenarios, there’s one in which VX-548 is non-inferior to active control, and then another in which its superior to active control. So it would be helpful to just understand commercial opportunities in those two different scenarios. And then one final tidbit for Charlie, non-GAAP IPR&D was $116 million in 2022. What is the figure that’s incorporated in your guidance for 2023, please? Thank you.

Reshma Kewalramani: All right. Dave, you’ve given us three different questions here. Let me save the two related to VX-548 and let me ask Charlie to talk about the IPR&D.

Charlie Wagner: David, the guidance includes an estimate of $300 million for IPR&D, and that’s inclusive of the upfront for Entrada.

Reshma Kewalramani: Let me now move to VX-548. Dave, I’m going to tell you a little bit more about the publication strategy and the study design and I’m going to ask Stuart to tell you about the commercial potential and how we see it depending on the two scenarios that you laid out. VX-548 and the €“ this target in particular, NaV1.8 has been the Holy Grail NaV1.7 and NaV1.8 in the pain field for many, many years. And for that reason, because we are the first company to come forward with a highly specific and effective treatment that has shown effectiveness in Phase 2 across multiple pain models, not only with VX-548, but its predecessor molecule, the interest level in the community is very high. And our intent is to publish the full Phase 2 data abdominoplasty and bunionectomy in a high profile journal this year.