Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) Q2 2023 Earnings Call Transcript

Salveen Richter: Just a follow-up on the acute pain program. Just can you help us understand, apart from — upon a positive data outcome here and given the target prescribers you mentioned, what needs to be done logistically to ensure a successful launch with regard to just the marketing aspect, the — whether there’s kind of any understanding that needs to be played out with regard to contracts and how the no pain law kind of falls into this? Just any idea of how you can ensure this plays out well.

Reshma Kewalramani: Sure. Salveen, I’ll ask Stuart to comment.

Stuart Arbuckle: Yes, Salveen, thanks for the question. I think there’s a couple of other things that are likely to be supportive of VX-548 in acute pain. One is, I think we are likely to see a number of the existing pain treatment guidelines, consider updates their guidelines once there is the availability of a safe and effective non-opioid medicine. In addition and you mentioned one of them, I think we are increasingly going to see policies change their focus. The policies that have been put in place in states and hospitals over the last few years for understandable reasons have largely all have been about restricting prescriptions, restricting who can prescribe for which patient types for what length of time. I think we are beginning to see the focus of those policy initiatives changed to being supportive of non-opioid pain medicines like VX-548.

And I think that that’s a very welcome systemic change which will potentially support the uptake of the VX-548 subsequent to it getting approved. So in addition to our own commercialization efforts, I think there’s a number of supportive at the launch.

Operator: Question is from Geoff Meacham with Bank of America.

Geoff Meacham: Just had a follow-up on exa-cel. I know you guys are focused today on regulatory and commercial as well. But when you think about the improved conditioning regimen, I wanted to know kind of what we should expect from that optimization of that? What are kind of the — what does success look like, I guess, for that? And what are the time lines, I think, that we’ll see some data for?

Reshma Kewalramani: Sure. Geoff, as we think about the busulfan based conditioning regimen which is what exa-cel will launch with, we see that as having a positive benefit risk profile for the approximately 32,000 people with the most severe forms of sickle cell disease and beta thalassemia. And with the improved or gentler conditioning, we see the opportunity to serve the full 150,000 people with sickle cell disease and beta thalassemia in Europe and the U.S. What this program looks like and we have an active set of programs internally, our partners at CRISPR are working on this problem, other academia and biotechs are working on this problem. And so I do see this as a problem that will be solved. It’s not a tomorrow solution but I see this happening in the coming months and years.

What we see is the opportunity to have a conditioning regimen that very specifically targets the compartment and the cells that are limited to those hematopoietic stem cells sparing all of the other cells. And in so doing, not have the side effects of busulfan, including the very significant cytopenias that you see with busulfan. So I do think that this is an area that we will see a solution for because we and others are working on it and because of the broad application and I do think you’ll see progress in the coming months and in our years. I don’t mean decades.

Operator: Our next question is from Robyn Karnauskas with Truist Securities.

Robyn Karnauskas: Sorry for the noise. I’m on board a plane and we’re departing. So the question is, what is the bar for neurotrophic mean? I know your previous study with your previous drug kind of looks similar to Lyrica. Maybe you could step that for us in a second. We’ve done some due diligence in the chemo-related peripheral neuropathy is a huge unmet need. I wanted to know whether you thought it might work in this population as well.