Incyte Genomics Inc Wells Fargo 21st Annual Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- Incyte aims to maintain double-digit growth in its core business excluding Jakafi, targeting $3 to $4 billion by 2030, driven by product launches such as Opsalora, Nick Timvo, Monjuvi, and Zionis.
- The company has five key assets expected to drive 80 to 90 percent of its post-2029 recovery: 989 (a monoclonal antibody for MF and ET), letarsapart (a bleeding disorder treatment), a G12D inhibitor for front-line pancreatic cancer, a TGF beta by PD-1 bispecific for front-line MSS colorectal cancer, and povacitinib in immunology.
- The G12D inhibitor program is progressing with important data expected at ESMO, including combinations with chemotherapy and Erbitux, aiming to build a franchise in pancreatic and colorectal cancers with a U.S. TAM estimated at $7.5 to $10 billion.
- TGF beta by PD-1 bispecific is a higher-risk program targeting MSS colorectal cancer with promising single-agent activity and ongoing phase three studies, including combinations with chemotherapy and G12D inhibitor, with data expected at ESMO and further development plans into other tumor types in the first half of next year.
- 989 is advancing in phase three for myelofibrosis with conventional and potentially novel composite endpoints under discussion with the FDA, aiming to be first to market for calreticulin-mutated MF and ET, with a market opportunity north of $5 billion.
- Incyte is committed to expanding its hematology portfolio with next-generation calreticulin antibodies, T-cell engagers, and V617F inhibitors, with data expected in 2027 and beyond.
- The acquisition of letarsapart (VGA 039) targets Von Willebrand's disease with a novel protein S modulator approach, showing promising phase one data and a clear regulatory path, with pivotal trial data expected in early 2029.
- Povacitinib is under FDA review for hidradenitis suppurativa with expected approval in Q1 2027 and peak sales potential of at least $1 billion, with follow-up indications in vitiligo and prurigo nodularis planned.
- Incyte is focused on executing multiple product launches and expanding its franchises in hematology, GI oncology, and immunology to drive long-term growth.
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Transcript
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Good morning, everyone. Thanks for joining us for the next fireside discussion. My name's Derek Archila. I'm one of the senior biotech analysts here at Wells. I'm very excited to have the next company here, Incyte. From the company, we have Bill Meury, CEO, as well as Pablo Cagnoni, Global Head of R&D, if that's right. Gentlemen, a lot of changes at Incyte from last year when you started as CEO, Bill. Maybe just talk a little bit about a year in the seat, priorities, and then we can go through some of the key growth drivers here.
Yeah. Thanks, Derek. At the beginning of the year, we laid out a framework for how to think about the company, and I think there's really two simple parts to our plan, to our strategy. The first one is we have a core business ex-Jakafi, and how we should be judged on that core business is maintaining a double-digit growth rate for the next five years. By 2030, we think that core business, which sets the floor for Incyte in many respects, is going to be at $3 billion-$4 billion. Product launches is what will continue to drive our core business, and I think we are on track to do that. You see that each quarter as we report on the performance of OPZELURA and Niktimvo and MONJUVI and Zynyz. Then part two is really executing against the pipeline, and that will drive the recovery.
Our aim is to have a business post 2029 that can grow at a 15%-20% five-year CAGR. If you look at the unadjusted peak sales potential of the pipeline, you could see a business, we don't have to be perfect, but we have to be successful, that has about $8 billion-$10 billion in top-line potential. When you look at the pipeline, we have three therapeutic areas as you know, hematology, oncology, and immunology. There are five assets that I think have a high PTRS and will drive 80%-90% of that recovery. In hematology, we have 989, our monoclonal antibody for MF and ET, which is in phase III. We have latarcibart, which is a bleeding disorder, which we acquired at the beginning of the year.
In oncology, we have a G12D inhibitor, frontline PDAC, which is in phase III, and TGF-beta by PD-1 bispecific in frontline MSS CRC, which is also in phase III. Then, of course, we have povorcitinib in immunology. That's where our focus is right now, and this is an execution test. We have to convert phase III studies into FDA approvals and those approvals into revenue earnings and cash flow. It's a two-part story. Business development will be used to supplement what we have internally to start a therapeutics deal for latarcibart is, I think, a textbook example of a type of deal that makes sense for Incyte. We have a clear framework for doing deals. We have criteria. If a deal meets those criteria, we act quickly. If it doesn't, we're comfortable being patient. I think that framework makes a lot of sense for recovery.
Perfect. Good segue. Let's talk about these five growth assets that you're pointing to, and maybe starting with INCB000734 and G12D, just because ESMO's coming up and maybe, Bill Meury or Pablo Cagnoni, if you can set expectations on what we should be seeing in that data set and what gets you confident to build around and really invest around this, given a lot of the competition that's out there.
Pablo, go ahead. It's a really important program for us, as Bill highlighted, and I think ESMO will be a very important meeting for all of you to understand why we're so excited about 734.
What you're going to see are a couple of really important data sets. First, it's going to be a combination with two types of chemotherapy, gemcitabine and nab-paclitaxel and FOLFIRINOX, in patients with previously untreated pancreatic cancer. That's our lead indication. We haven't shown mature data in combination with chemotherapy, so this is going to be very important. Will be efficacy, will be a comprehensive update on the safety, including discontinuations, interruptions, dose intensity, et cetera, which I think everybody would like to see. The efficacy data is maturing very well. Importantly, we will not have yet a mature PFS, quite honestly, because we don't have enough events. Not enough patients have progressed.
But we'll have a landmark analysis that will give you an idea of the durability of these responses. So very important data set to de-risk the frontline phase III study that is ongoing in patients with pancreatic cancer in combination with chemo. That study is ramping up very quickly globally. It will have more than 150 sites open at its peak, and we're very optimistic on the enrollment rate and how that study's going. So that's the cornerstone, the foundational part of the G12D program. In addition to that, we will show data in combination with ERBITUX in patients with late-line colorectal cancer. If you remember, ERBITUX in those patients have a single-digit response rate. We're very enthusiastic about the data that we've seen in combination with our G12D agent. We'll show that data. We are having regulatory conversations with the agency to design a Phase III study in late-line colorectal cancer of our G12D in combination with ERBITUX.
A very important part as we continue to expand the franchise into a different tumor type. Two more important things, or three, that we are not going to show data yet but are important to keep in mind how the program is evolving. We are very interested in moving into adjuvant pancreatic cancer, a very important area for patients because it can drive a lot of benefit, and obviously an important part of the market. We have combined also with FOLFIRI and ERBITUX in frontline colorectal cancer. That will not be at ESMO, but it is evolving very well. The final point is we are going to give you an idea of the combination strategy.
We realize that G12D is combined well with other targeted agents, and that is also something we are building. You will see pancreatic and colorectal data, and you will get an idea of how we are expanding the program going forward.
I think a key takeaway in what Pablo Cagnoni just talked about is we should be judged when it comes to G12D, I think the data are very competitive, and you will see that at ESMO, is on systematic expansion, so that this moves from or transitions from a single asset story to a franchise. That type of breadth is how we extract as much value out of G12D as anything else.
Got it. I guess when you think about the need to be differentiated, as you said, you believe the data is very strong, and we know where that competitive benchmark is. But maybe talk to the development strategy as you outlined, Pablo Cagnoni, how you can differentiate around that, and ultimately maybe be first in areas.
How do you think the market evolves commercially, again, with the options that will be out there?
I think when I look at the KRAS G12D space, I think it's fair to say that there's two companies, us and our main competitor, that are ahead of the pack. Let's call it that, when it comes to executing frontline pancreatic cancer. I think when you see the data at ESMO, hopefully you will agree with us that I think getting into who is 2 percentage points higher or lower on response rates or nausea or I don't think it's a very productive use of time. I think you'll see that the two programs or the two drugs are basically comparable, and I think that's okay. In terms of who's going to finish first in pancreatic cancer, I think, again, we're neck and neck. The two studies are likely to finish pretty close to each other.
For us, the differentiation here is going to come by combination strategy. That's why we think colorectal cancer is very important because I think we have generated data that you'll see at ESMO that is fairly mature, showing that we can combine with ERBITUX, and we can really significantly improve the response rate of single agent ERBITUX in late-line colorectal cancer. Then taking that, which is in itself an important market, and moving that to frontline colorectal with ERBITUX and chemo is a really important area of growth for the program. That's the approach we're taking. Obviously, the combinations are going to come as well. The key for us in this point is to accelerate as much as possible colorectal cancer. We think it's a critical area of differentiation from our competitors.
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