Kodiak Sciences Inc. (KOD) Earnings Call Transcript & Summary
January 11, 2021
Earnings Call Speaker Segments
Anupam Rama
analystWelcome everyone to the 39th Annual JPMorgan Healthcare Conference. My name is Anupam Rama. I'm one of the senior biotech analysts here at JPMorgan. I'm joined by Matt Bannon and Tessa Romero from the team. Our next presenting company is Kodiak Sciences, and speaking on behalf of the company, we have CEO, Victor Perlroth. Before I turn it to Victor, I just wanted to highlight for those listening on the webcast, you can submit a question by the Ask a Question feature in the portal, and I recommend everyone to do that. Victor?
Victor Perlroth
executiveHi, Anupam. Thank you. It's my pleasure to be here at the conference to present Kodiak as a company, our lead product, KSI-301 and its accelerating development plan and our ABC Platform with the deepening pipeline of medicines focused for retina diseases. Yes. I think we'll move forward with about a 15- or 20-minute presentation, and then we'll save time for questions. Let's move into the presentation, and let's go to Slide 3. So where is Kodiak today? At a high level, we're running 4 ongoing pivotal Phase III studies in 3 retinal indications, and we have another study, our GLOW study, in earlier diabetic retinopathy on the books, and we expect that to start shortly. And we're looking to bring these clinical studies into a single BLA filing expected in late 2022. At a high level, this slide is important to spend just a couple of minutes on to talk a little bit about where we are. Where are we with KSI-301 in terms of its clinical experience? Well, we have data now from well north of 1,500 injections in well north of 400 patients, representing many hundreds, 250-plus patient years of exposure in treatment-naive populations for wet AMD, DME and RVO diabetic macular edema, retinal vein occlusion. And our safety continues to be pristine. We're still tracking well with the current standard of care agents, LUCENTIS and EYLEA. And our efficacy, we have great efficacy, strong and appropriate improvements in vision and retinal anatomy in each of the indications studied. And our durability continues to be very strong, in fact, perhaps getting even stronger. We're seeing, at the 1-year point in our Phase Ib study in the treatment-naive patients in wet AMD, DME and RVO, that 2 out of every 3 patients are going 6 months or longer. That's really phenomenal and well beyond our expectation when we began our early designs around KSI-301 in the ABC Platform. So we have an optimized set of pivotal studies, our pivotal study program for KSI-301. The objective is to show a disruptive durability with the same efficacy and the same safety as EYLEA. So our DAZZLE wet AMD study is fully enrolled as of mid-December 2020. So with the 12-month endpoint, we'll be looking forward to top line data in probably just north of 12 months from today. Our RVO pivotal study, BEACON, is enrolling very well, and we have 2 pivotal studies in DME, GLEAM and GLIMMER, and those are also -- have begun enrolling as well. And data from all of those pivotals is expected in 2022. So the pivotal studies have been designed from the data in the Phase Ib. We've tightened somewhat the criteria for the disease activity assessments. We've shortened the durability intervals. We've increased statistical power, and we've maintained a similar 80-plus percent U.S. population treatment-naive as a base. And we've also selected uniquely the top dose, the 5.0 milligrams used from the information from the Phase Ib study. So we're very pleased with the pivotal study designs and also with our execution in the studies even through the pandemic, and are seeing very strong collaboration with our global clinical sites, with best practices shared as learned in March and April of last year, now shared broadly across the network of clinical sites and seeing extremely low missed visits, consistent with the fact that these retinal diseases are serious, and patients need to continue to go in to see the physician. So we're operating the company and investing with conviction. We're on track for a single BLA filing in the key indications, wet AMD, DME and RVO. And in a single BLA and then looking for the earlier NPDR, the nonproliferative diabetic retinopathy, which as I mentioned, the GLOW study in a supplemental, consistent with the lower severity of that disease and being a bit more cautious in the context of COVID and the pandemic. We're continuing to make important manufacturing investments aligned to the clinical opportunity with a commercial supply goal of millions of doses in the first year of launch and the ability to flex up dramatically even in the early years after launch, which really allows us the opportunity to take advantage of the potential of KSI-301 as a new late-stage and hopefully soon-to-be-disruptive medicine for patients. And based on the important validation of the ABC Platform that we see coming out of the safety, efficacy and durability with KSI-301, we continue to invest in our pipeline with our bispecific KSI-501 and new science emerging in our triplets, also all for retinal disease. So we're -- this year, especially the latter -- the first half of this year is really focused on clinical and manufacturing execution with KSI-301 and also towards earlier discovery and development in the pipeline. As we look to the latter half of this year, as we begin to stare at that top line data in the face, we begin to think more about being more of a pre-commercial and then in '22, thinking a little bit more about what it could mean for Kodiak to be a commercial company in the near term after the BLA. Moving to Slide 4. A reminder, right, Kodiak, how have we done today to where we are. It's through a patient application, dedication to science, discovery and development. It's to really focusing on medicines that we want to develop that have the potential to be disruptive in these high-prevalence diseases and really a singular focus in ophthalmology and retina. And those 3 pieces together have taken us to where we are today, and we're trying to stay true to that philosophy into those routes as we migrate from where we are today and look to the next several years. As we move into Slide 5. So with the success of KSI-301 to date, we see a powerful validation of our ABC Platform. The safety is pristine, the efficacy is great, and our durability is disruptive. So we want to be a leader in the redness space more broadly, and we see tremendous opportunity deeper in the pipeline as we look to other high-prevalence multifactorial diseases in retina. And to apply our ABC Platform, as I mentioned, to the KSI-501 or bispecific anti-IL-6 in the VEGF bioconjugate, which shares the same antibody structure by and large and shares the same biopolymer exactly as KSI-301. So we look forward to that molecule, and we hope that we're on schedule for an IND this year for KSI-501. And then, of course, we're deepening our science and our technology in the context of our ABC Platform to design and develop triplet medicines that can bring multimodality small molecule as well as biologic -- bioactives into single medicines for other diseases in retina that remain untreated, such as dry AMD and the retinal components of glaucoma. So as we look forward for Kodiak over the next 3, 5 and even 10 years, we are digging deep and following from the data that we're generating around the validation of the platform to try and become a company with a true pipeline. Moving on to Slide 7. In wet AMD, despite all of the discovery and the development and the sales of medicines of the anti-VEGFs, there's really still a problem of in theory versus in practice. So in theory, anti-VEGF medicines can maintain vision over many years when dosed per label. But in practice, they do not. If you look at Slide 8, without continuous high-intensity treatment with today's anti-VEGF biologics, vision loss can begin after only 3 months of anti-VEGF therapy. This pattern is seen globally and with all current medicines. Really, it appears that patients can really only come in to see the physician 5 or fewer times per year. So moving into Slide 9. What that means is for LUCENTIS and EYLEA and Avastin and other antibody-based medicines, there's a drug holiday that emerges in between administered doses, during which time the disease basically recurs and leads to slow incremental retinal damage or burnout. So on Slide 10, today's system for patients and physicians and health systems is inadequate. And a new class of drugs needs to be developed. We call those Generation 2.0. So on Slide 11, slowing down a little bit. So what profile -- for an anti-VEGF biologic, what profile may be required or would be required to meaningfully change the paradigm for patients, physicians and health systems? So LUCENTIS, EYLEA and Avastin are really tracking in the group down even below the bottom here of the table. But to break out what kind of profile would be required. Well, following from our Phase Ib data, Kodiak's KSI-301 is really in this 5- to 6-month predominant category, okay? And that means that in wet AMD, if we wanted to set a standard together with key opinion leaders in the field, a drug that could bring more than half the patients to 5 months in diabetes, DME, again, a drug that could bring more than half of patients to 5 months; and in RVO, which is currently a monthly indication, a drug that can double that to say, every 2 months; and in earlier diabetes could show compelling efficacy perhaps twice a year as a preventive agent. And if a drug can do that with just a small number of loading doses, let's say, 3 or fewer, and with an efficacy profile, great efficacy, which would mean in line with labeled regimens for LUCENTIS or EYLEA, that in the safety profile that was pristine or very close to that of LUCENTIS or EYLEA, that would really be disruptive. And that's, of course, what we're seeing in our Phase Ib study. And there's quite a lot of room to fall down, even if to a 4- or 5-month predominant profile or even to what would be an incremental improvement in the 3-month predominant profile. But a drug that could be in the 4 or 5 months or perhaps even in this 5- to 6-month predominant profile would have a tremendous amount of white space between its profile and that of the existing market agents, LUCENTIS and EYLEA and Avastin. So moving to Slide 12 and slowing down again a little bit. Here's a little bit of a preview into the durability data and to some of the data that we're going to be presenting at the Angiogenesis meeting, the retinal meeting in early February. So here at 1-year, we're able to show in treatment-naive patients for wet AMD, DME and RVO, that 2 out of every 30 patients are able to go 6 months or longer as a treatment-free interval after only 3 loading doses. So that says 2/3 or more at greater than or equal to 6-month treatment-free interval and more than 75% of the patients on a 4-month or greater treatment-free interval every year. And we also show within each disease, wet AMD, DME and RVO, the percentage of patients that are on 1 month, 2 month, 3 months, 4, 5 and 6 months because, of course, we remember that within each one of these diseases, it's really sort of a distribution of doses and of treatment intervals that are required within the population. And so by running our studies in treatment-naive patients and by running a broad view of patients for monthly, every 6 months or beyond, our view for KSI-301 is to be developing a medicine for everybody, right, for any patient with retinal vascular disease with, of course, the majority of them going well beyond 6 months, at 6 or beyond, in our Phase Ib study. And as I mentioned in our pivotal studies, of course, we've narrowed that somewhat, which is smart and consistent with running an appropriate pivotal program. On Slide 13, we take another snapshot of the safety that we're seeing in the Phase Ib study, which continues to be pristine as well, again, beyond our expectations, I would say. So in the Phase Ia/Ib, we've dosed 130 subjects. We've given 697 doses of medicine. We have over 160 patient-years of exposure, and a very, very pristine safety profile. So on Slide 14, just a quick view. How is it possible that we're able to continue to generate a very impressive data with the molecule? It really builds from the science of the underlying ABC Platform. And I think, over the course of the first half of this year and maybe through this year, we hope to dig in and describe a little bit more some of the underlying science for everybody. But of course, we have our antibodies with our protein engineering. We have our biopolymers with their engineering. We link those together to form the stable conjugates. And the overall science of the Biocon we get really built on the special nature of phosphorylcholine material that we use in the biopolymer, in which then becomes a conjugate that can demonstrate more than just the sum of its individual parts. On Slide 15, a quick reminder around KSI-301 versus LUCENTIS, Avastin and EYLEA. So KSI-301 is much larger than those molecules. We dosed at a higher formulation strength, bringing more molds of -- or more molecules of the anti-VEGF binding, 3.5x more than EYLEA on its labeled regimen and a much longer half-life, which translates over time into many logs of additional concentration in the anti-VEGF binding capacity versus the market leader, EYLEA. So on Slide 16, again, sort of a view of how this sort of preclinical science comes together, right, to form the bioconjugate medicine and its clinical properties, right? It's really more than 1 plus 1 equals 2. It's more than an antibody and a biopolymer. It's really more than the sum of its parts. The phenomenally long half-life, the unusual bioavailability to the retina despite the large size of the conjugate, a deeper potency of the conjugate versus our start of the antibody and versus the predicate agents, right? And yet acting very large in the eye, and then when it exits the eye into the circulation, acting very small and having rapid systemic clearance. So all of these elements can be understood through sort of an extrapolation and understanding up our phosphorylcholine biopolymer ABC Platform. And then kind of what's queued up here in the upper-right of the Slide 16 is sort of an artist's representation of KSI-301 as an antibody conjugate. But then kind of in the black here, this is an electron microscope average image of actually what KSI-301 is of KSI-301 itself. So we see the antibody. And then attached into site-specific manner down on the FC, we can see the visualization of the biopolymer shrouding the antibody, and delivering that special science, that special water structuring to create a conjugate that's really more than the sum of its parts and which can deliver as an optically clear liquid intravitreally injected biologic, a safety, efficacy and durability that can help bridge us and help bridge patients and physicians at the system to something new. So looking at Slide 18, a quick reminder of the pivotal study designs in wet AMD, DME, RVO and then earlier diabetes. We're very proud of the designs that we think the readouts from those studies can position KSI-301 very attractively. Looking at Slide 19, it's a reminder. So we're investing with conviction in our clinical development program as well as our manufacturing program. We're looking to be developing, manufacturing in the BLA that would be at scale, and that would allow us to capture and support an aggressive market uptake by KSI-301 into the market, even in the first years after launch. So trying to target the availability of drug for year 1 of perhaps 20% of the branded market, year 2, 1/3 of the branded market, and year 3, 40%. So those are aggressive numbers. I think there's commercial complexity in the space. Having said that, we believe that the profile of KSI-301 continues to be well differentiated, and we hope that there'll be a significant demand for the product to be able to deliver a special profile for patients. So on Slide 20, we bring ourselves to our 2022 vision, where DAZZLE can read out -- or we have a -- we're fully enrolled, and we're looking to read out for top line data in early 2022. Then BEACON, the RVO pivotal should read out a quarter later. And then we're looking for the 2 DME pivotals to read out one quarter after that. So a very busy 2022, starting early, and then in regular intervals through 2022, coming together into a single BLA filing consistent with our clinical and regulatory strategy to have one BLA for those 3 major indications by the end of 2022. Some more detailed view into the milestones on Slide 21, and Slide 22, a more granular view on our clinical studies. With that, I'll pause, and we can move into some questions. Thanks, Anupam.
Anupam Rama
analystGreat. Victor, do you want to introduce the broader team on the line here, and we can get started.
Victor Perlroth
executiveSure. We have John Borgeson, our Chief Financial Officer. Hi, John. And we have Jason Ehrlich, our Chief Medical and Development Officer. Thank you.
Anupam Rama
analystGreat.
Jason Ehrlich
executiveHi, everyone.
Anupam Rama
analystMaybe we'll just start out with a quick enrollment question for 301. DAZZLE is fully enrolled here. How are you thinking about the enrollment curve of GLEAM, GLIMMER and BEACON, given kind of we're still in an ongoing COVID pandemic?
Victor Perlroth
executiveYes, Jason?
Jason Ehrlich
executiveYes, sure. Thanks, Victor. Thanks, Anupam. So right, we started recruitment in BEACON, GLEAM and GLIMMER in the end of the third quarter. Maybe taking a step back into recruitment of DAZZLE, the wet AMD study, through the pandemic. One of the things I'm really proud that our team did is we really spent a lot of time working with our clinical trial sites in the U.S. and in Europe as the pandemic started to try to understand what was going to be required to help them continue to keep patients in the study and recruit patients as -- where it seemed appropriate to do so, going all the way back to March. And we collected a lot of interesting best practices, and then worked with our investigators to share best practices and ideas throughout our investigator community. And we continued to see very good patient retention in the studies, like low single-digit rates of missed visits on a monthly basis throughout the whole rest of 2020. And in fact, the summer of 2020, we had our strongest recruitment in DAZZLE on a monthly basis through the end of the recruitment period. So that was great to see. And then we're carrying that momentum forward into the new studies. The new studies, our strategy is that every site is recruiting in both the DME and RVO studies. So you can think that we have twice as many sites for BEACON as we do for GLEAM and GLIMMER, right, the 2 paired DME studies. So they're all off to a good start. We're working through all of the ex-U.S. CTAs as we work to bring Europe up online this quarter, and U.S. recruitment is off to a good start. So when we look to the other side of things, BEACON has a 6-month endpoint, a shorter endpoint, DME has a 1-year endpoint. So on the other side of things in 2022, we'd expect the DAZZLE readout first and then BEACON probably in the second quarter, and then the 2 DME studies probably sometime in the third quarter.
Anupam Rama
analystWe have a question from the e-mail portal here, which is, on your safety slide, it looks like you have disclosed one more ocular AE than previously reported. While not drug-related, maybe you can give any more color on that third ocular AE.
Victor Perlroth
executiveYes, Jason, do you want to talk a little bit about that?
Jason Ehrlich
executiveYes, sure. So that's -- the subretinal hemorrhage, you can say, something that can happen to wet AMD patients when they're ongoing treatment, even with anti-VEGF treatment on board. So that's one of the things that happens in wet AMD patients over time, even despite anti-VEGF therapy.
Anupam Rama
analystWe have another question from the portal, which is, at the Angiogenesis 2021 Meeting, will you be giving us BCVA and OCT data?
Victor Perlroth
executiveYes. So I think the objective for the Angiogenesis meeting is to have a full package of information for the Phase Ib study that includes vision, OCT, updated swim lanes and kind of final durability. There's still a couple of patients that have to come back for final visits. So that will be within the next few weeks, and we're looking forward to putting the full package together and having a real full update on the data for everybody.
Anupam Rama
analystI think Matt Bannon from the team has a question?
Matthew Bannon
analystYes. I had one question on manufacturing. Just wondering if we could get an update on the Lonza site specifically. I think completion is expected by end of 2021. So an update there would be helpful. And I guess kind of you mentioned how it should be comprehensive for the initial launch. But when you think about peak penetration, what do you think the manufacturing needs will be then? And are the 2 sites that you are working on now, will that suffice?
Victor Perlroth
executiveRight. Well, those are really good questions. Manufacturing for retina is a serious business, and you have to do it well and carefully. We make essentially 3 pieces: the antibody, which is a GMP intermediate; we make the biopolymer, which is a GMP intermediate; and we make the conjugate, which has to come together. All of those pieces, we've done technically well with multiple batches and resupplies in a GMP context. When we think about manufacturing capacity for the commercial market, as I said, our objective is to try and come in at scale, so that if there is really big demand for the product that we are essentially validating the commercial scale as part of the BLA kind of process. And so there are scale-ups required on the antibody, on the biopolymer and also on the conjugation, those 3 pieces. Having said that, technically, we think we're in good shape. We do have a global relationship with Lonza. We've been working with them since 2014, and that's been a strong relationship. One of the key pieces of the relationship on the bioconjugation side is the Lonza Ibex facility, and that will be the fundamental facility for some time for the manufacturing of our bioconjugate drug substance. And that facility will be designed to be able to supply well north of 15 million doses annually. So one way to think about, well, what could the potential demand be? I mean, obviously, that's a very high number. 15 million would be a very attractive medicine. That would mean we're really delivering on the unmet need in the indications of the population. Of course, you have like wet AMD, DME, RVO. Even within DME, there's the potential to go for a broader set of DME patients that would have like disease maybe outside of the fovea or the macula, and that aren't necessarily well treated today. There's the possibilities within DME for patients that have proliferative diabetic retinopathy to more aggressively be given anti-VEGF therapy. And then, of course, there's the possibilities to really open up commercially the earlier nonproliferative DR patients, right, that's sort of what we call the secondary prevention. So that would be phenomenal. And then, of course, we also have the possibility, if a drug like KSI were approved, would it -- for people to ask that question, well, is it really ethical to be forced to use Avastin on a monthly basis, right, if drugs that are in the 3-, 4-, 5- or even 6-month, right, treatment interval are approved and where that data has shown in pivotal studies. So we're looking optimistically, but we're trying to build facilities that have that flex-up capability where you don't need to change facilities to be at a commercial scale that is attractive. Now within the Lonza Ibex facility that you mentioned, for example, that's a good question. They're also doing a lot of work on some of the COVID vaccines within Lonza. And so whether the facility is going to be fully operational at the end of 2021 seems unlikely. But that shouldn't necessarily have an important impact on Kodiak's manufacturing. The key really is, are we going to be gearing up for batches out of that facility for their validation that we need in the context of our 2022 vision. And the answer currently is yes. The other answer to your question is that in the context of COVID, right, where there are competing clinical, but in this case, more competing manufacturing realities, Kodiak has to fight really hard to get the resources that we need in order to stay on track from a manufacturing scale-up standpoint. But our objective continues to be to work aggressively on the execution for manufacturing to be able to get to a point where we can be supplying an unreasonably large number of doses into the market, which we think will be important. If the drug continues to have the same safety, efficacy and durability profile, or even if it fell down substantially in the pivotals from what we've seen in the 1P, we still think it's a revolutionary drug for patients. And so, we're investing in our manufacturing capacity consistent with those core beliefs.
Anupam Rama
analystVictor, in 2020, we had multiple sort of Phase Ib presentations throughout the year for KSI-301. We've talked about Angiogenesis 2021 already. Should we expect a similar playbook in this year kind of heading into the 2022 DAZZLE results? And more specifically, any new additional analyses that you might point us to that might be interesting for us to watch out for?
Victor Perlroth
executiveWell, the key data we think kind of the Phase Ib will be the 52-week data that we're really putting together in the next few weeks as it finalizes for Angiogenesis, and we think that's going to be a full data package. At that time, we'll also do a cut of the swim lanes for all the patients for all the data that we have, and a number of patients go significantly beyond 52 weeks. Across all of the indications, RVO, we know was the earliest indication that had strong enrollment in the Ib and then DME and then the wet AMD. So even at Angiogenesis, we'll see substantive data that goes beyond 52 weeks. And so we think in some way, that kind of breaks the back of the study. And consistent with the design of the Phase Ib, which was sort of to extend and be a little bit loose, right, in terms of evaluating what the drug can do, and then in the pivotals, we kind of tightened it up a little bit. We do plan for another data update this year. We're thinking that it may be in the context of ASRS Meeting as well as AAO meetings, which I think are in the fall, the late fall. So we don't expect to be showing monthly or quarterly data. The core is showing the 52-week data in the Phase Ib, and then focusing on the execution of the pivotals and the drive towards the BLA. But that's a good question and the next fundamental update will be Angio. And then after that, our current thinking is to progress that, say, 6 months or so, maybe a bit more depending on the timing of the ASRS and AAO meetings. And that's still -- those meetings are still being slightly adjusted on our schedules. I think people are hoping that they can be in-person meetings.
Anupam Rama
analystAnd maybe just a final broader question here. We've talked about the profile of KSI-301 emerging, and we'll learn more at Angiogenesis as well. But how are you stacking up the profile that's emerging here for 301 against some of the other development agents out there, port delivery system, there's gene therapy development? Just broadly speaking, how do you think about that?
Victor Perlroth
executiveRight. Well, I think in the context of the journey of KSI-301 with the things that we control as well as the data that we're generating, we're very pleased with our own execution and the data that's being generated by our molecule, that's very favorable, obviously, for us. At the same time, I think the overall development of other molecules and other technologies, those data cards have also, by and large, to achieve and also very favorable for Kodiak and for KSI-301 and also for our platform. I think gene therapy is still far enough away into the future. I don't think there is a known credible plan or a path for gene therapy today based on the technologies and the data that we know about for it to be an important competitor in the timeframe that's relevant for like KSI-301. Whether it's intravitreal, with inflammation or whether it's subretinal with its surgical complexity, I think the suprachoroidal will be interesting to see. But fundamentally, there's -- the science isn't set there yet, and that's really not in a timeframe of relevance for KSI-301. I think the port system has a lot of questions around its safety and exactly what is the best patient population. In context of our medicines showing 2/3 of patients going 6 months or longer across all 3 indications, that's very powerful durability that really raises the bar in some way for the whole field and for all players, right? LUCENTIS, EYLEA and Avastin, their profiles are set, right? When you want to look at faricimab, I think we'll learn a lot more about faricimab this month, presumably in context of top line press release-type data in wet AMD. In terms of like how they want to talk a little bit about what types of durability intervals they're achieving, and some of that may depend a little bit on the overall study design as disclosed. I think the faricimab potential, to show superiority in DME, doesn't appear to have been achieved based on the date of release by Roche in December. We'll take a -- we'll learn a little bit more about its safety, and we'll also learn a little bit more about what "strong durability" in DME means. I think by and large, we'll be presenting at Angio first, and then I think the port delivery system will get presented. And then after that, we'll hear about wet AMD and then DME for faricimab. I think that's going to be a strong molecule, and Roche is a powerful franchise player in retina. They're going to commercialize faricimab, I think, aggressively. Nonetheless, there still appears to be tremendous white space between KSI-301 and its profile and all of those medicines that still seem to be grouped together. So we're pleased for KSI-301, and hoping, as a community, we can discover and develop the best medicines for patients.
Anupam Rama
analystMaybe one final question here about -- this is an unencumbered asset. How you're thinking about when you think about commercialization, partnering in Europe or rest of world or, I mean, what regions are you committing to sort of commercializing on your own?
Victor Perlroth
executiveYes. Well, for now, our focus is on the clinical and manufacturing execution towards the 2022 vision. That's really the focus, I would say, certainly for the first half of this year and maybe into the third quarter. As we begin to see that top line data readouts more in the face, and we begin to focus on being more precommercial and then commercial company, we'll have to answer those questions more directly. For now, we have almost $1 billion cash, and we have an accelerating molecule, and we have a lot to do. I think, with complexities related to potential changes in drug pricing in the United States and potentially MFN or other complexities, pricing control in ex-U.S. jurisdictions become increasingly more important to a franchise and to a molecule. So for now, we're very pleased to have global control in pricing. We wonder about what our strategy will be in Japan, which is the #2 or #3 market for anti-VEGFs globally. And we are continuing to enroll patients and expanding our presence from a clinical trial standpoint in Europe. And we, of course, have important manufacturing efforts already in Switzerland. So in some degree, we're a global company, but not with a commercial footprint. We're not going to probably make any important decisions imminently, and we'll keep our eye on that.
Anupam Rama
analystOkay. Well, I want to thank the Kodiak team, Victor, John, Jason, so much for taking the time to speak to us. And thank you so much for like a really productive session.
Victor Perlroth
executiveThanks, Anupam.
Jason Ehrlich
executiveGreat. Appreciate it.
John Borgeson
executiveThanks, Anupam.
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