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

Phil Nadeau: Good afternoon. Thanks for taking our question and congrats on the progress. A question on the expense side from us, it does seem like the guidance for costs for 2023 is a bit heavier than we had anticipated and even excluding the Entrada upfront, it does seem like costs are growing a bit faster than revenue. So I’m curious, what are the push pulls in the guidance? What elements are you including in the guidance? Is there investment for pre-launch, more heavy investment in R&D? Just kind of looking for a little bit more color on what is causing the expenses to rise so much. Thank you.

Reshma Kewalramani: Well, I’m going to ask Charlie to take that one.

Charlie Wagner: Yes, Phil, thanks for the question. And just so you get an overall sense of where we’re thinking about things, given the strong and predictable performance in CF and the recent success of the advancing pipeline, with the number of first-in-class and best-in-class assets, including programs with significant near-term potential commercially. We see this as absolutely the right time to be investing in the business. If you look at 2023, specifically, over 70% of the planned increase in R&D and SG&A is expected in programs which are past POC and therefore meaningfully de-risked. Specifically, we’ve got trials for vanza and pain and AMKD and Type 1 diabetes. You’ve got the full year cost of the investments in commercial readiness for sickle cell and beta thal and we’re making commercial investments for pain as well.

Importantly, all of these programs are advancing rapidly and represent multi-billion dollar market opportunities. So from our perspective, it’s the right time to invest. And the good news is that if with our differentiated business model, we can deliver industry leading profitability while we’re investing for innovation and growth.

Phil Nadeau: Maybe one follow up, is there a long-term goal for either operating margins or R&D and SG&A as a percent of sales?

Charlie Wagner: No, we have not established a long-term goal.

Phil Nadeau: Great. Thanks for taking our questions.

Operator: The next question will come from Liisa Bayko with Evercore ISI. Please go ahead.

Liisa Bayko: Hi there. Could you just tell us a little bit more about VTCE-210 versus 211? I noticed before you were a little bit more focused on 210, now we’re talking about 211. And when what’s the right form for data for there, and what should we be expecting to see?

Reshma Kewalramani: Yes, sure. Liisa, this is Reshma. VCTX-211, a bit of a mouthful. Is the study that Vertex is now running in collaboration with CRISPR Therapeutics, it’s a hypo immune program for Type 1 diabetes where we are going to be assessing safety and efficacy. VCTX-210 was a safety study in terms of when you should expect data readouts and such. This study is just getting going. We haven’t called when we will be sharing results, but it is just getting going.

Liisa Bayko: Okay, great. And then just a quick question, two quick questions actually on regarding the CF franchise. Can you talk about the new 88,000 patients? Is that kind of equally distributed amongst the key world regions or are you seeing that more in certain areas than others? And then as for the long-term patents, how should we thinking about exclusivity for vanzacaftor, and then I noticed you even have a next-gen after vanzacaftor and maybe you could enlighten us about market exclusivity there. Thank you.