Outlook Therapeutics, Inc. (OTLK) Earnings Call Transcript & Summary

So welcome back, everyone, to another Virtual Investor Lunch Break segment. Today, we are featuring Outlook Therapeutics. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's segment. So from the Outlook Therapeutics team, I am very pleased to be joined by Lawrence Kenyon. He is Chief Financial Officer and Interim Chief Executive Officer. We also have Jeff Evanson. He is Chief Commercial Officer. And Jedd Comiskey, he is Senior Vice President and Head of Europe. Welcome, gentlemen.

Hey, Jenene.

Hi, Jenene.

So happy to have you all with us today. Before we get started, I just want to inform our audience that Outlook Therapeutics is publicly listed and trades on Nasdaq under the ticker OTLK. And during today's discussion, the company will be making forward-looking statements, and I encourage everyone to view the company's website at outlooktherapeutics.com for SEC filings and the latest information.

All right, so we are going to dive right in. Larry, this has truly been an exciting year for Outlook Therapeutics and the advancement of LYTENAVA. So to start us off, can you please walk us through the recent regulatory achievements, particularly in Europe and where you currently stand?

Thanks, Jenene, and thank you for inviting us to participate today. It really has been a very busy and exciting start to 2025. As you noted, there are a lot of great things happening in Europe for Outlook Therapeutics and LYTENAVA, and Jedd and Jeff will help fill in some of those details here today. But to recap, as everyone should be aware, LYTENAVA was approved in both the EU and U.K. last year and has received a positive recommendation from NICE for use in the U.K. In May of this year, we launched simultaneously in both Germany and the U.K., as we've previously announced. But I am pleased to report today that LYTENAVA is now in the channel in both countries and the first patients have already been dosed in both Germany and the U.K. We are very excited to have reached this important milestone. And even though it has only been just a few weeks, we believe that we're off to a very good start in Europe with many more updates to come for the remainder of this year. So I know that you have a lot of questions for us. Let's jump in.

Yes, absolutely. All right. So Jedd, I'm going to start with you here. Can you describe the current treatment landscape of wet AMD in Europe? And where do you see LYTENAVA fitting into this treatment paradigm? And can you also walk us through the market size and number of injections per year?

Absolutely. Thanks, Jenene. So I mean, the market in Europe is very similar to the market that we see in the U.S. in general. There's an off-label segment, so off-label compounded Avastin. And also, there's a branded segment, so there's faricimab, aflibercept, and ranibizumab, which are well-known molecules. So yes, a relatively crowded market, but we see, regardless of the market, we see LYTENAVA being positioned as a cost-effective first-line treatment option for patients with wet AMD. And there's a real need for a cost-effective treatment in the space. And in terms of the market, significant potential. It's worth USD 3.6 billion a year and it's growing as the population ages. And there's 8 million anti-VEGF injections a year. And I know we're going to focus in on Germany and the U.K. So just so you're aware, there's 1.7 million of those injections are in Germany every year, 1.3 million of those injections are in the U.K. So actually, those 2 markets represent around 1/3 of the overall potential in Europe, which makes them very important first launch markets.

Excellent. So Jedd, is off-label bevacizumab currently used in Europe? And if so, what is the market share?

Yes. So the overall market share in Europe is around 33%. So of those 8 million injections, just under 3 million of those injections are bevacizumab. But the market share from country to country ranges from 0%, all the way up to 80%. And in fact, Germany and the U.K. differ significantly. So in Germany, there's a 50% market share for off-label repackaged bevacizumab. And that's our target. We want to take a significant share of that market now that we have an on-label ophthalmic formulation of bevacizumab. In the U.K., it's lower. It's a 5% market share for off-label bevacizumab. And we want to take that share, but we also want to take a share of the branded market where we see ourselves, as I said, being positioned as a cost-effective, first-line treatment option in the U.K.

Excellent, Jedd. Thank you. Jeff, over to you. So as part of your market research, you must have had conversations with ophthalmologists. So how receptive are they to LYTENAVA? And have they shown excitement around it being available to use in their practice?

Yes. Thanks, Jenene. That's a really good question. And our research really started in 2019 and trying to understand just what our opportunity was based on creating an ophthalmic-standard bevacizumab. And so that very beginning, that first level of research that included Europe, but the U.S. as well, really reflected the need to have an ophthalmic-standard bevacizumab. And so you might ask, well, what does that mean? What are the differences between an ophthalmic standard and, let's say, an oncology standard? Well, there's different particulate levels required. We have much less available for the patients that get an injection in the eye, for example, compared to a parenteral, everything from the pH levels and -- but most importantly, one thing that has been well documented is, over time, supply disruption with off-label repackaged bevacizumab, including recently that time had pulled away from the market. The issues that the U.S. has faced and this had well documented, I think, apply also in Europe. And so when you ask a physician, if we give you an ophthalmic-standard bevacizumab, would you like it? Would you want it? Would you inject it? And we did get an overwhelming response initially, and that has continued throughout the years, even with the new entries of VABYSMO and others. So it's been really encouraging to see as we've taken this journey with our physician community and we have talked to hundreds of physicians. I mean at this point, we've talked to many of the key opinion leaders, and that consistency has really stood the test of time. So very encouraging for our opportunity.

Yes. I think one thing I'd add to that, Jenene, is that I think it's fair to say it's been kind of a long road for us, but we're just as, if not more, excited today about the opportunity than we were 5 years ago or 7 years ago when we started this adventure. So we think everything is shaping up nicely for us, both here in the U.S. as well as in Europe.

Excellent. All right. So moving to reimbursement. So where does LYTENAVA fit in terms of pricing compared to other branded products and biosimilars? And will you be competitive?

Yes, I'll start with that. So I'll start with the U.K. Our list price in the U.K. is GBP 470. That is the lowest price -- lowest list price of any of the other products available, any of the other approved products available on the market. We do have a confidential net price in place at a national level. It's called a patient access scheme in the U.K. So anyone who orders LYTENAVA can avail of that patient access scheme. And of course, that patient access scheme is designed to make us competitive at a net price level as well. I think we should touch on one of the big milestones that came towards the end of 2024 was the positive recommendation from NICE, which is the national payer body in England essentially, but one of the most respective payer bodies worldwide. And the basis of their assessment is what's known as a cost minimization. And basically, that's built on the assumption that we're as effective but less expensive than the other treatments. So by getting that recommendation from NICE where they say we're as effective as the other treatments available on the market, they're also saying that they see us as cost-effective or less expensive than those treatments. NICE is important because it gives us reimbursement at a national level in England and Wales. A few weeks ago, we had a positive recommendation from the SMC, which is the Scottish Medicines Consortium. So that means now that we have reimbursement in Scotland, but that's also taken on board by Northern Ireland. So all 4 countries within the United Kingdom, we have reimbursement, which is a really great achievement. Germany is slightly different in that you submit your HTA at the same time as launching. So we submitted our Health Technology Assessment on May 1. And very soon after that, we launched the product. When you launch and submit your HTA, you have a free price period in Germany. So our list price, which is listed is EUR 751.61, a very specific number. And it is the lowest list price of the commonly prescribed treatments. So one treatment has a lower list price and that's brolucizumab, which is brand name Beovu, which is rarely used because of some of the safety concerns that we're seeing a number of years back. So we'll start price negotiations in Germany in quarter 4 of this year. And then we should see a kind of post-negotiation list price in Germany coming into place in the early part of 2026. So that's where we're at.

Great. All right. So you mentioned you now have marketing authorization in both Germany and the U.K. So how are you approaching the commercial launch of LYTENAVA in each of those markets?

Yes, and obviously, every market is different. I already alluded to the fact that there's different levels of the uptake with respect to off-label repackaged bevacizumab in those markets. But before I talk about the differences and dive into the U.K. and Germany, there are a lot of commonalities. As I mentioned, our positioning is as a cost-effective, first-line, on-label treatment option. Subnational access is critical. So we just covered national access, but actually, regional and local access are critical to our success in both of those markets. And I think what's really important is that both markets are very concentrated. So a lot of the prescriptions come from a relatively small number of the overall centers that are in each country. And one thing I would like to highlight as well is our teams. What's common across our teams is that they have a lot of ophthalmology experience. So they have long-standing relationships with a lot of the top HCPs and other stakeholders in the market. So we have people from Apellis like myself, we have people from Bayer, we people from Alcon, we have people from Novartis. So we have a really, really strong team in place in both countries. I think just to look at Germany with respect to subnational access, so essentially, the drugs are reimbursed by the insurance funds, which are -- insurance companies, which are called sick funds in Germany. And we recognized very early on, the team recognized very early on that we would have to have rebate agreements in place with those insurance companies when we launched if we were to see any uptake of LYTENAVA. And I think what's really encouraging is that when we launched, we had rebate agreements in place with insurance companies that essentially covers 50% of the population. That's going to increase rapidly. And by the end of the year, we'll have 90% of the insured population in Germany covered with rebate agreements. So the team have done a tremendous job there. 20% of the market in Germany is hospital, which is very similar to the U.K. But actually, 80% is community-based, which I believe is similar to the U.S., but Jeff can correct me if I'm wrong. And that's a very unique market within Germany because in that market, all of the products that's used is compounded. So whether it's off-label bevacizumab, whether it's aflibercept, whether it's faricimab, everything goes through a compounding pharmacy and the vials are split. So we've worked hard to understand the dynamic of that market. And obviously, we've set rebates and set net prices that account for that dynamic within the marketplace. Yes, we have a full team on the ground in the field. We've got 5 key account managers. We have 1 in-field market access manager. We have 2 MSLs. We're covering the top accounts. We're going to expand the team and expand coverage over the coming months. So everything is in a good place in Germany. And then to switch to the U.K., I mentioned national reimbursement. After national reimbursement, step 2 is that you get regional reimbursement. So there's 42 regional health boards called integrated care boards, and you need to be on those regional formularies. So before we launched, we sent out a team to get us on to those formularies. And as of today, we're on 90% of those formularies. Step 3 is that you leverage that regional formulary status to get on to the local or hospital-level formularies. And that's what our team are working on now. And it's really only a step that you can take once you've launched the product. So we're working hard on that now and even in the last few weeks, we've seen really positive traction there. And final point on the U.K., it's a little simpler because it's only hospital-based and 80% of all the injections in the U.K. happen in 40 hospitals. So we've a team of 3 key account managers, 1 MSL and essentially a commercial lead who spends a lot of airtime in the field as well, covering those 40 hospitals. So also in a good place. And I think Jeff mentioned the positive feedback from customers. Everything we're hearing from the market in the last few weeks since we've launched has been very, very positive. So all very encouraging.

Excellent. So Jedd, you did discuss some of the differences between Germany and the U.K. and the approach. So are there specific nuances in each market that affect how you are approaching the launch?

Yes. I mean, I think it's really what I talked about is the commonality of subnational access, it's really just how the product moves through the markets and where the product is prescribed in the markets. I think the community-based dynamic in Germany and the fact that it moves through compounding pharmacies is a real nuance that we've worked hard to understand. And in fact, there's a company in Germany called ContraCare, who have been in the market for a very long time. And we've contracted with them to be our essentially wholesaler 1. So they manage all of our distribution in Germany. And it's not just about distributing the product, they have long-standing relationships with all of the key stakeholders, including the compounding pharmacies and they understand the market intimately. So that's been really, really beneficial for us. And then the U.K., as I said, it's really about what we do at a local level with the hospital-level payers now to make sure that we see uptake of the drug.

Excellent. I'm going to stick with you, Jedd, because I've got some follow-up questions here. So what educational efforts are in place to support physician onboarding and ensure appropriate use of LYTENAVA right at launch? And are there particular training programs, advisory boards or peer-to-peer outreach initiatives planned?

Well, luckily, LYTENAVA is really just like any other anti-VEGF. It's very, very straightforward. It's delivered in a vial. The right volume needs to be drawn up and delivered by intravitreal injection using common needle, common syringe that will be used for all intravitreal injections. So in terms of training physicians or even nurses in the U.K. on how to administer the product, there's no lift there. We don't need to teach them what they already know what to do, which is great, which means that the uptake and the implementation of LYTENAVA into the treatment pathway is relatively simple. I think Jeff talked about the fact that we have to differentiate from off-label bevacizumab. And obviously, we have to educate doctors on LYTENAVA, the label for LYTENAVA, the clinical data for LYTENAVA. So that's our focus. Our focus is those 2 things: one, to make sure they understand that we have the ophthalmic formulation of bevacizumab and what that means; and two, that we've got very compelling clinical data. Our product is just as good as any other products. And that's not just us that are saying that. NICE have said that in their recommendation. And what we have to do is just communicate through all channels. So obviously, we have teams in the field. One-to-one interactions are critical. We have national meetings. We had a launch meeting in Germany at a national congress in May. Similarly, in the U.K., there was a national congress in May that we used as our launch meeting. And we're doing a lot of local and regional meetings. The German team were only telling me yesterday, it's a bit like the U.S. You could go to an ophthalmology meeting at a regional or a local level every weekend. And that's exactly what the team are doing. They're going to all of the key events. And then everything else from digital to PR to medical education, all things that we're working through, targeting payers, health care professionals, patient groups and, of course, any relevant HCP associations. And we've run some very successful advisory boards. And the feedback has always been encouraging from those advisory boards. And the medical team have worked hard to build up a kind of a bank of KOLs that can advise us as we move forward with the launch.

And maybe, Jenene, I could just add a little bit from the global chair, including a U.S. point of view. The one encouraging thing here, too, as Jedd articulated, is that we have a unified position with this product across all geographies. And I think our work is really about getting patients to be started on this drug, and we call that start and stay. So for the wet AMD patients that are initially diagnosed, we're earning the right to be the first choice that a physician thinks of to prescribe for that patient. And that's been really nice for us as we think of the global teams, those that Jedd are building, but even look back to the U.S. ultimately should we get our approval. And that's been great because then we can have a brand position that is really reflecting on the data that Jedd mentioned among really good data that we generated in NORSE 2 study and along with our pricing strategy that I think will be differentiated from others, I would just say. And I think as we think of a pricing corridor, we do a lot of work to understand the ideal pricing corridor for products when we launch globally. And I think we're going to bring to the table something that's a little different than what others have done in markets like the U.S. versus Europe, for example. So we're really excited about that part and then continuing to build the confidence. The nice thing here is we don't have to educate about disease awareness. They know that. The patient -- talk about patient aggregation, they're seen by those that treat them with anti-VEGF. We're really specifically focused on the benefits of an ophthalmic bevacizumab, reflecting our data and then with our pricing strategy starting and staying on this product. So we're really excited about all those aspects.

Great. Thanks for that, Jeff. So if we think beyond Germany and the U.K., what is the time line and strategy for expanding into other EU markets?

Yes, I'll take that. So we're approved in 31 countries. The U.K., the EU 27 and then through EMA approval, you get Norway, Liechtenstein and I believe the final one is Iceland. Beyond the U.K. and Germany, we're focused on 10 more countries. And so obviously, Italy, Spain, and France are the other 3 large countries within Europe. And actually, when you combine the U.K. and Germany with those 3 countries, that's 80% of the total potential in terms of what we can achieve with LYTENAVA in Europe. So they're very, very important. Ireland is important because it's an easy tag-on to the U.K., and the U.K. team can look after that. And we'll also put the Nordics into the cluster with the U.K. So we'll start looking at the Nordics as well. And then just like Ireland, Austria is a very easy addition to -- for the German team, and we're already working towards launching in Austria as soon as possible. And finally, we're looking at the Netherlands. And the Netherlands is really interesting because we know for a fact that the centralized compounding of off-label repackaged bevacizumab can no longer occur from a legal perspective once we are available in the market. And the Netherlands isn't small. It's the seventh-largest market in Europe. So it's definitely one that we're pursuing and hoping to launch in early 2026 in that market as well. So that's really it. There's 31 countries, but there's U.K., Germany and 10 more that we're really focused on.

Excellent. All right. So Larry, over to you. So is there a potential for a commercial or a strategic partnership with a larger ophthalmology player once traction is demonstrated in Europe?

So great question, Jenene. But to be clear, I just want everybody to be aware that we are 100% focused on maximizing the potential of LYTENAVA in Europe. So our assumption for the moment is that we will be marketing the drug ourselves in all of these countries in Europe that Jedd mentioned, which are the -- where those are the countries where we want to be. However, partnering is always an option if a deal for a particular country or a group of countries makes sense and benefits our shareholders. So yes, there is today the potential to partner in Europe if it makes sense. But to be clear, we are planning for success in Europe using either option.

Excellent. All right, I have one more before we turn to our live Q&A. So I think it is important to mention before we finish this part of the segment that you did submit your BLA with the U.S. FDA for the potential approval in the United States. So can you provide an update on where things currently stand? And when do you expect to receive a decision back from FDA?

Yes, sure. We can't have a conversation without talking about the BLA here in the U.S. So yes, our BLA was submitted to the FDA in February of this year, and we have been granted a PDUFA goal date of August 27, 2025. So far, all indications are that the review is on track for a decision by that goal date this August. We continue to believe that we have provided the FDA with everything they need to support approval of LYTENAVA for use in the U.S. for the treatment of wet AMD. And we are looking forward to a potential positive outcome later this summer.

Excellent. All right, so let's turn to our live Q&A. So I know our audience has questions. I already have seen a few come through. So as a quick reminder, if you have a question, click on the Q&A button at the bottom of your screen, type in your question. And I know the team has been looking forward to taking them, so we will get to as many as time allows. All right. So our first question, can you talk about pricing both in Europe and the U.S.? And how Outlook plans to position the drug to gain share compared to existing options?

Yes. So I think we started that conversation already. We know what the list prices are in U.K. and Germany. I think it's fair to say from a European perspective, those are important markets, a; but b, that's where the high end of the price is to start. So we took that into consideration as we talked about internally our global pricing strategy. Country by country is going to differ a lot. So I don't think this is really the venue to go into those details yet because each pricing authority in each country has their own little niche that we're going to have to navigate through. But I think, and Jeff can speak more to this, it's important to note that all of this that we're doing in Europe and the U.S. has in mind what's going on here on the ground in the U.S. with current conversations with the administration. And the nice thing for us is that this fits nicely with our global pricing strategy that we started executing on a couple of years ago. So I think from that perspective, we're in pretty good shape. But happy to let Jeff and Jedd fill in any more details.

Larry, maybe I would add to just those comments that one of the things that's well studied for us is the pricing opportunity that we have, where we feel like we want to really complement the work that -- and the expectations of physicians, payers, and then also thinking about our patients. So one of the things we're trying to do is really find that ideal price that works in the U.S. but also works in Europe. And I think as Larry mentioned, with the most favored nation vernacular on how that plays out in this market specifically, I think it's unknown. But I think we will have a pricing strategy that will be considering that, I think would be the best way of saying it. But one of the things that we wanted to be sure that we had the right input. And so we are currently in the field, for example, in the U.S. We've been in the European markets as well with HTAs but with our payer community. And we want their thoughts about if we -- when launching, we feel that there is a certain value of this, and we want to hear though what they think the value of this is in the patient population. So it's been a well-studied topic, I think, is the best way of summarizing it.

Okay. Our next question, what is your liquidity situation and what additional funding will be necessary upon positive PDUFA finding?

Yes. So we -- our last cash position that we posted was at the end of March. Since then, we've raised a little bit of additional capital through a CMPO in May. That cash, we think, is definitely enough to get us through the PDUFA decision date and allows us to do everything we need to do to support Jedd in Europe as we continue to roll out the launch there. We're pursuing a number of different opportunities for financing options, assuming that we're going to get an approval in the U.S. And this is a range of different options that you would expect a small about-to-be or just barely commercial pharma company to be exploring, ranging from a number of nondilutive options to the typical pathway on an equity transaction. Our goal is to minimize the dilution as much as possible to fully support the launch of LYTENAVA in the U.S. And that's our working assumption right now is that we've got a plan for an approval, and that's what Jeff's put all together for us to map out how to be successful once we get that good news later this year.

Great. Our next question, is there an estimate on how many doses have been administered in Europe as of now?

We'll provide more details when we report our results for this fiscal quarter. But like I've said already, we've already -- we've got drug in the channel. There's drugs sitting at the wholesalers in the U.K. and Germany. That's real revenue today, and we'll be able to provide more color once we get to our regular quarterly report sometime probably in August.

Okay. Sorry, I'm just working through this. What kind of profit margin do you anticipate?

I'll take that question, too, guys. We haven't reported anything publicly on what the margins are going to be. So I'm not going to start here today on this call. But it's safe to say that these are healthy margins. The market here is well understood. You know what it costs to make these products pretty universally. So there's no real surprises there on the cost side. And everybody knows where these other drugs that have been approved price. Granted, there -- many of them are a lot higher than where we will wind up pricing in the U.S. without actually targeting a price on this call, but the margins are still very healthy and we see a huge opportunity both here in the U.S. and Europe with our margin potential.

Okay. Our next question, in which country will off-label use be prohibited with the commercialization of LYTENAVA? I don't know why that was a tongue-twister, sorry.

Well, I'm going to start that with, technically, in the U.S., that's a country, right out of the gate, that we believe use of off-label Avastin will no longer be allowed once we're available for sale here in the market. But I'll let Jedd walk into the recap on the European countries.

Yes. I think -- I mean, I mentioned the Netherlands. The Netherlands, it's clear that from a legal perspective, centralized compounding of Avastin essentially will not be prevented anymore. Germany is a gray area. I mean, one of the stakeholders summarized it to me very well not too long ago and said, it's always been illegal and it became more illegal when LYTENAVA became available in Germany. But it's not really easy to pinpoint the law that can kind of clean it up immediately. But what our launch has done in Germany, it's kind of raised a lot of questions and it shed a lot of doubt and people are really concerned that there really won't be a future for off-label bevacizumab as time goes on. What we don't want to do is we want to learn from what other companies have done in the past, and what we don't want to do is come in with And we want to work with the stakeholders to find a solution that works for everyone. And then Italy and Spain, there's definitely some legal question marks over what can be done with respect to off-label use once we launch. U.K. is not really a concern because the market share is so low. And France, there's pretty much no off-label use. So again, it's nothing of concern there.

Yes. I think it's important to note here that when we talk about the potential number of injections a year of off-label Avastin, in the U.S., it's around 2.5 million injections; Europe, similar number, 2.5 million injections. That's a huge number. Pick whatever price you want that we're talking about here in this range. And if we own the whole market, this is a huge company. But realistically speaking, we don't need to come anywhere near to owning the whole market. We just need to find those physicians and those countries where it makes sense to use an approved ophthalmic formulation of bevacizumab. We have that, and we think we'll get a significant percentage of that business. I think we have the added benefit that some of the issues that doctors have seen and patients have seen with using off-label Avastin could disappear by using an approved ophthalmic formulation of a GMP-produced product for use in the eye. So there's a better chance for starting to stay as well so maybe patients will stay on bevacizumab longer. So we think we've got a lot of opportunity here and we don't need 100% of the market. So even though compounding could coexist with us, it probably doesn't impact us too badly on our overall success.

Yes. And Larry, maybe I'd add to that. I agree and I think that from a positioning point of view, we're really, Jenene, trying to focus on adding something valuable in the market that they don't have today. And that's really where we're not trying to take anything away. We're trying to add something that will reduce the fiddle factors, the supply disruption that has been seen to silicon oil droplets to just even people pulling back from the market from an off-label point of view. So that maybe is point 1. The other part of this is that the nuance, one, we had German ad board last year, and I was really -- it was really remarkable what the physicians brought to our attention. So there's legal aspects that I think are on the minds of many. But I think even the nuance of, one, we're available, commercially available like we are in Germany and the U.K., the German physician community, we're thinking, I think we're going to need to inform consent patients if we choose off-label bevacizumab when an on-label version is available. And that was a really interesting point for us because there is a different way they may be thinking about it now that we're available, right? And I think that will play out even in the U.S. And so I just -- I think that was a really remarkable comment that we'll continue to, really, as Jedd mentioned, the groundswell of that thinking, I think, will convince people -- compel them to just choose our product.

100%.

Excellent, great add there. So okay, our next question is, do you think with the NORSE EIGHT data submitted, do you think the NORSE EIGHT data submitted to the FDA will support enough to get approval?

That's definitely what we believe. The hurdle that needed to be achieved based on the CRL we received was we needed to provide the FDA with a second adequate and well-controlled study that provides evidence of efficacy and safety. There is no doubt anywhere that 400 patients in that study is anything short of adequate and well controlled. There were no issues that popped up. It's a short study so there weren't a lot of dropouts. So there were no hang-ups there. Was the drug as safe as we've seen it in every other clinical trial we've run? Absolutely. No issues there. Efficacy, did we show efficacy? Absolutely. If you look at the data that we published, LYTENAVA gained 3 letters at day 30, 4 letters at day 60, and 5 letters -- 5.5 letters at day 90. You don't get improvement of vision with injections of saline, quite frankly. So the FDA has what it needs. There's definite evidence of efficacy. And I think the results are what they are at the critical 60-day endpoint for this particular study. We did not meet the endpoint, but that 60-day endpoint wasn't going to give us a label claim of any type because it's just not long enough. So even if we have met the endpoint, we wouldn't have been able to say we were not inferior to Lucentis. So we're still in that boat. We've never tried to say that we're not inferior to Lucentis at any time in the last 7 years. And we think we've given the FDA exactly what they asked for in terms of what they need to say yes. That part is out of our hands. We did everything we could. We ran the study. We showed the results. We gave it to the FDA, and now it's up to them. And they have the decision to make in 9 weeks.

Love responses with such conviction. So that's great. All right. Is there any plan to expand the label into other indications where anti-VEGF drugs are used such as DME or NPDR?

Yes. So we've said this in -- for years, we have SPAs in place approved by the FDA for diabetic macular edema as well as branch retinal vein occlusion. We think it's a good idea to potentially pursue those opportunities as well. But the biggest market by far is wet AMD for us. And we wanted to get that done first. And once, I'm going to be overly confident here, but once we get approved for wet AMD, then we can turn our attention to the other indications. But it's probably important for us to pursue those, but that's a decision we'll make once we've got another approval here and start to see the revenue coming in.

Right. All right. I was going to end with, because those are our questions that have come in, but any closing remarks, but I love this last question that's come in, it says, how can you convince investors in just a few words? I think that's a good one.

It is a very good one. So I tend to talk too much, but I think what you need to think about is what's out in front of us here for the rest of 2025. The key milestones kind of sum it up. It's just a matter of weeks now. We'll be reporting our first quarter results that will include LYTENAVA revenue. This should be sometime in mid-August. By the end of August, we're going to get an FDA decision. We think and I think I just made the point as to why we believe that we think we've got everything we need for an approval. But we can't control the FDA. And what else you're going to see in the rest of 2025 is we'll continue to finish the launch preparations and/or begin to launch in our wave 2 countries in Europe. And if everything goes well with the FDA, we'll be prepping for launch in the U.S. probably in early 2026, but hopefully, it can be a little bit earlier just depending on timing of a decision.

Excellent. Okay. Well, certainly an exciting time for Outlook Therapeutics and this does conclude our Virtual Investor Lunch Break featuring Outlook Therapeutics. And I'd like to extend a huge thank you to Larry, Jeff and Jedd for joining us today as well as our audience for your great questions as always. As a reminder, Outlook trades on Nasdaq under the ticker OTLK. And if you liked what you saw today, I encourage you to visit outlooktherapeutics.com for more information on the company and to sign up to follow the company to receive their alerts as well as follow their social channels to stay current on the latest information. And I do encourage you to do that because it's going to be an exciting next couple of months for the company. And you can also visit virtualinvestorco.com for a replay of today's segment as well as our latest events calendar. So gentlemen, thank you so much for joining us. Thanks again to our audience, and I do wish everyone a great rest of your day.

Thanks, Jenene, and thank you, everyone, for attending today. We appreciate it.

Thank you.

Thank you. Take care.

Bye-bye.