Kyntra Bio, Inc. (KYNB) Earnings Call Transcript & Summary

That is correct. So we have -- outside of China, where it's a 50-50 for different geographies, in some cases, through Astellas, in some cases, through AstraZeneca. We have royalties in the low 20s.

Okay. And could you tell us what's going on in Europe? When do you think that you can launch in Europe? How do you see the opportunity shaping up in the major markets there?

Yes. Clearly, we're working through the regulatory process in Europe. I think what we've guided towards is basically a decision by -- in Europe by the middle of the year. So that's what's expected. And we are -- Astellas is planning to basically launch after, of course, we get an approval. As you know, in Europe, each different market, while it's -- we talk about Europe, which different market has different reimbursement conditions. In some markets you can launch right away, like Germany, while you continue to negotiate the price, maybe the U.K.. In other markets, you really wait for -- to get that reimbursement before you actually fully launch. And those plans are basically in place.

Okay. And just to go back to the situation in China and Japan. Given what you are seeing in terms of the adoption of the HIFs, I mean, I know they're very markets. But fundamentally, people are the same and kidney failure is the same. So what does that suggest about the market in the U.S. and how it could evolve?

Clearly, and I think what we said in China is that we view just the CKD anemia opportunity for roxadustat, basically, with revenues north of $0.5 billion, right? Not $0.5 billion, but north of $0.5 billion. That's what we basically have said. That's -- now clearly, that's what we can achieve in China, I think one can do projections outside of China. Clearly, the opportunity is pretty massive. The one learning, I think, that we got in China, which I think is very important is we are -- we basically see -- I see an NDD opportunity that is coming faster than maybe I expected because, of course, in NDD, patients, sometimes, are not treated. So you need a little more time to build the market. And clearly, that's a great sign for us, right? As we think about what that opportunity could be in the U.S. and other markets. Because what we typically have said is that we view the DD as a fast uptake opportunity, and that's the case across the world. And NDD, while larger, much larger over time, we will -- we had expected that the uptake will be slower building it up. But already in China, NDD is 40% of our revenue roughly, which is much better than what we had expected when we launched the product.

Okay. And what about use -- relative use in PD versus hemodialysis? Are you finding that the product particularly resonates with individuals who either on home dialysis or peritoneal dialysis?

My -- we are seeing use everywhere. So whether it's peritoneal dialysis or whether it's in a dialysis center or -- as I just mentioned, in NDD. I think it's -- it is pretty clear that the peritoneal dialysis opportunity seems to be quite attractive for roxa, so we see significant news there. We see significant news also, of course, in incident dialysis because of the data. And also -- and as expected in patients that are hyper-responsive to ESAs, right? So those are the opportunities. In the U.S., as you know, the area of home dialysis is included, increasing. Right now, it's what is maybe roughly about 15% of the overall dialysis is conducted at home by increasing fast. And we think that the profile of roxadustat, I think it's a great profile as well for that setting.

Okay. Okay. Now can we just talk about other indications?

Yes. Just to add to that, we do have -- we do -- as you know, as part of our clinical trials, we included PD patients in our clinical trials, and our data was very impressive, very consistent with the overall data, very impressive data.

And can you pull that out and put that in a publication and put it in front of physicians?

Yes. Well, it has been already shared. In fact, there was -- a poster shared at ASM with some of these data, yes, and we intend to continue to mine our data and share our data and publish our data.

Okay. Great. Can we move to other indications? You're exploring MDS and CIA as well. Could you talk about the magnitude of those opportunities and what the path to market might be?

Yes. It's -- we are firmly pursuing those opportunities. In particular, MDS is a Phase III study, and we are expecting a readout in the first half of next year. So it's a very attractive opportunity. It's huge unmet needs. And right now, luspa is doing extremely well. So with -- that's encouraging. Keep in mind that we are pursuing both R positive and R negative patients, which makes -- and also, without regard to it's a failure and so forth. So the opportunity, as we see it, I think, is significantly larger for roxadustat in terms of number of patients. Clearly, the price point of luspa is different from the price that we have in CKD. We have not commented on pricing, of course, whether it's on CKD or in MDS. When it comes to CIA, the chemo-induced anemia opportunity. That opportunity, I think, in terms of size is almost comparable to the opportunity that I see in CKD anemia. Very, very significant opportunity. Clearly, we need to see the data from the Phase II study, and we'll be able to see it midyear of this year. So we're excited about that to be able to show the data in the second half of this year. And then I think work with the FDA to try to progress in our clinical trials. But we don't have -- we have not seen the data, and we need to see that before we can progress that particular indication, but the opportunity is very significant.

Okay. And just back to MDS. I mean, I think that you have said that you don't have an obvious way to price per indication. But your intention is to have one price in the market regardless of indication. Is that still your operating assumption?

No. I think what I would say -- I think what we said is clearly the price in CKD is very different from the prices that you see on MDS for therapies. No, I'm excluding. So very -- 2 very different price points. And any type of pricing that we would try to do, of course, to price by indications could be a challenge. But that's not something that we've discussed.

Okay, okay. And then in terms of your approach to MDS, is it your expectation that you will be superior to ESA in MDS as you were in CKD?

I think what we're looking for in MDS is basically to look at, so you know, transfusion independence, right? And we basically want to see, basically, rates that are -- for the product to be competitive, there are going to be somewhat comparable to what we shared already in some of our open blind data that are -- that could be comparable to what Losartan to basically showing. Because at the end of the day, I think this is a pretty serious condition, huge unmet needs. Products are going to be utilized, and we need to make sure that we have a therapy that is effective in that setting, which is very challenging. We feel good about our chances there, and we need to be thinking about, like you have suggested, is how to make sure that we capture as much of the value that this product's offering in that indication by thinking creatively about pricing and so forth.

Okay. So it sounds as though we could be starting to see the MDS revenue materialize sometimes next year and then CIA is still several years away. Is that a reasonable simplification.

Well, I think we have not provided any time what milestones other than the readout of MDS next year, right? And if you have a readout next year, I think from the readout, you need a submission. And so I -- revenue next year, I don't think it's due for MDS.

Okay.

I think what we've guided towards is basically when the riddle will happen. And I think, in the case of CIA, clearly, it is -- we need to look at the data, but we expect the data this year in the second half of this year. And then at that point in time, we will have a discussion with the FDA. As you know, in this particular population, the design of the trial matters. So we need to look at the data, have the discussion with the FDA, and then we'd be able to properly guide towards what we think would be an appropriate Phase III trial? And what could that mean for us to be able to get to the market?

Okay. A few minutes left, so I'd just like to quickly pivot to pamrevlumab. First, one of your competitors who would advance to Phase III very quickly recently had a disappointment in IPF. And I know that's totally different mechanisms of action and that sort of thing. But I'm curious about the confidence you have in your Phase II evidence compared to the confidence that you would have in the competitor's Phase II evidence. Is there something in your data, the data set, the size of the trial that cause -- that investors should refer to, to have more confidence in your Phase III in this indication than your competitors.

Yes. Clearly, when you look at our data in Phase II, and you look at the competitors' data that you're referring to in Phase II. I think this is -- I assume you're referring to the Galapagos product. Clearly, the effect size that we have was significantly larger than what they showed. Keep in mind, we met our primary endpoint. If I recall correctly, they did not meet their primary end point in Phase II. There -- so we were -- I really like our chances. I think the data set that we have, I think, is very, very compelling. So I have a high degree of conviction on our ability to show that the product works, we know that it's effective. We also need to show that it's going to be safe. And so far, I think we've seen that the product is very tolerable. So I have -- I feel very good about that problem. The challenge with -- has been because of COVID, in particular, has been enrollment. How, as a result of the Galapagos failure. I think what happens is now we have a number of sites that are now maybe available to us and accessible to us. So we've been already in discussions with many of those sites and also patients, right, that could be eligible to enroll in a trial. So the combination of both 2 things, I think, are important -- could be important for our enrollment, and we are executing in addition to everything else that we had, including expansion in other geographies like China, where we intend to recruit a sizable number of patients and so forth, it should really help our enrollment. So the key here is how well can we enroll and how quickly we can enroll. And we have a number of actions to try to accelerate that as much as possible, noting the challenges that the COVID pandemic has caused. And by the way, that's also improving, right? So we also see that improving. So there are a number of maybe tailwinds relative to where we've been in the last 12 months that I think is going to be very helpful.

Okay. And do you think that you will have an opportunity to update us on the guided timing for that result? Is there a possibility that, that could move forward with a change in the trajectory of enrollment?

Yes. So we have not guided on IPF. We've guided for every single other one of our trials. We expect to guide on IPF as soon as we have a little more clarity when it comes to the overall pandemic, and we see basically the -- basically, a narrower bracket in terms of the enrollment time line. We've discussed, both LAPC and DNB, where we basically have shared that we expect to basically report out in the second half of next year.

Okay. Last question then. As usual, FibroGen has tons of cash, and you're presumably still getting some more milestone payments in the relatively near future. And you kind of have a portfolio of programs that are coming to market. So how are you going to deploy that cash? What are your business development priorities?

Yes. It's a great question. We -- clearly, one of the key things, and I spoke this third leg of the stool, if you wish, about basically advancing our preclinical candidates. So we are making internal investments on areas where we have scientific expertise. But also, we're looking externally, of course, at areas that might be of interest to us. And as part of that, of course, oncology and fibrosis are key areas where we've looked, we are -- we try to be highly disciplined in our approach, that's why you have not seen a deal from us. It's not that we're not active or looking, but we want to make sure that the sign is to be compelling at the value also has to be right for us. But we're definitely interested. And I think we're going to need both. We're going to need to our internal pipeline, but we also will need to supplement that with external research.

Great. All right. Well, I've used up more time than we were even allotted. This is a very interesting time for FibroGen, Enrique. Thank you so much for your time today. Look forward to seeing you again soon, hearing about earnings and hopefully getting towards that PDUFA date. So good luck with everything.

Thank you very much, Geoff.

All right. Good to catch up. Thanks, Bye.