Hello and welcome to Outlook Therapeutics' corporate update conference call and webcast. As a brief reminder, all participants are in a listen-only mode. If anyone requires operator assistance during the event, please press *0 on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the Federal Securities Law and are based on Outlook Therapeutics' current expectation and actual results could differ materially.
As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that can cause actual results to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Outlook Therapeutics files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Joining us on today's call from the Outlook Therapeutics leadership team are Bob Jahr, President and Chief Executive Officer; Lawrence Kenyon, Chief Financial Officer; and Dr. Jennifer Kissner, EVP, Medical, Clinical, and Regulatory Affairs. I would now like to turn the call over to Bob. Please proceed.
Good morning, and thank you all for joining us today. As you've seen from our announcement, we received a Complete Response Letter, or CRL, from the FDA regarding our BLA resubmission for LYTENAVA for the treatment of wet AMD. I want to be very clear here that this was not the outcome that we had hoped for, and we share the disappointment that many of you feel. At the same time, I want to emphasize this is not the end of the road for Outlook Therapeutics. The CRL identified only one deficiency that relates specifically to evidence of efficacy. In their letter, the FDA noted that while our pivotal NORSE TWO study met its primary endpoint and demonstrated that LYTENAVA was effective and well tolerated, the confirmatory NORSE ONE trial did not meet its primary efficacy endpoint under the criteria set by the agency.
As a result, the FDA concluded that there was not sufficient confirmatory evidence to support approval at this time. To be clear, the FDA did not state that another study is necessary. It is important to note that no other deficiencies were cited in the letter. There were no issues raised with safety, manufacturing, or with any other element with our BLA, and we believe that distinction matters. It means the foundation of our program is solid and that the path forward depends on addressing one defined issue. Again, while this outcome is very disappointing, we intend to meet with the FDA through a Type A meeting request in the near term to gain clarity on their expectations and to determine the best path forward in the U.S. Let me take a moment to explain why our mission remains so important.
Compounded bevacizumab has been used off-label as a first-line treatment for wet AMD for years, representing about 55% of the anti-VEGF market in the U.S. Compounded bevacizumab is not manufactured under the same rigorous conditions as FDA-approved biologics and has significant concerns around sterility, consistency, and regulatory oversight. Yet, despite those concerns, compounded bevacizumab continues to be widely used because of its efficacy, affordability, and accessibility. LYTENAVA was specifically designed to change this. It is the first ophthalmic formulation of bevacizumab that has been manufactured and packaged specifically for intravitreal use. That distinction ensures consistent dosing, reliable quality, and the oversight of a regulated product. Physicians and patients deserve this level of assurance, and that is why we are committed to continuing this process with the FDA. It is also important to highlight that our story is not defined by this single decision.
While the FDA has asked for more, we are already making progress globally. With marketing authorization in the European Commission and Medicines and Healthcare products Regulatory Agency in the UK, LYTENAVA is now commercially available in Germany and the UK, and we are absolutely moving forward with our commercial plans in these territories and look forward to participating in the EUR-RETINA Congress next week. LYTENAVA is now the first and only authorized ophthalmologist formulation of bevacizumab for wet AMD in Europe. That is a milestone achievement, not just for our company, but for patients and physicians in those markets. Importantly, we estimate that we have cash for at least the next quarter, and we will be laser-focused on cost cash conservation while we continue with our ongoing launch in Europe. Looking ahead, our priorities are clear.
We will engage directly with the FDA to define a path forward in the U.S. We will continue to expand our commercial footprint in Europe, ensuring that patients there can benefit from this important therapy, and we will remain focused and disciplined as a company, committed to our mission and to the patients who stand to gain from our work. To our shareholders, I want to thank you for your continued support and patience. To the physicians and patients who rely on bevacizumab, I want to reaffirm our commitment to pursuing LYTENAVA as a safe, consistent, on-label alternative in the United States. To our team, I want to thank you for your resilience and dedication throughout this process. To close, this was not the outcome we had hoped for today. It is not the end.
LYTENAVA has already begun to make a difference in Europe, and we will work with the FDA here in the United States for approval. I'll now turn it over to the operator for questions.
Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press *2 to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * keys. One moment, please, while we pull for your questions. Our first questions come from the line of Eddie Hickman with Guggenheim Securities. Please proceed with your questions.
Hey, good morning, guys. Obviously, disappointing result. I was wondering if you could provide any extra clarity on what your base case assumption for what you would need to do for another study is and how long that might take and what that might cost. Are there any changes to your operating plan in Europe given this news and refocusing efforts or cash across the Atlantic? Any help or details would help. Thanks.
Yeah, so I'll first tackle the first one. We will have to discuss with the FDA. They did not, they specifically said in the CRL, they did not call out that another trial was needed. We will have to wait till we engage with them on what the confirmatory information that they're looking for and if we possess it. That is still to be determined with most of what we've been able to share is what we know right now from the CRL. At this stage, we have not even discussed an additional trial design or cost or timeframe for that because that wasn't indicated to us in the CRL that that was necessary. More to come when we meet with the FDA. Regarding the operating model in Europe, we'd already, over the summer where we started first commercializing, been talking about how we want to scale and grow there.
Germany and the UK are the markets where the first patients have been treated. Within the UK, we plan to expand into Scotland and Ireland. Germany, which is the largest bevacizumab market, we're resourcing and going to expand our footprint in there to make sure that we have the right footprint with the commercial team to scale for that as we've gone through the reimbursement hurdles and we've got now broad access. We will start looking at the other countries such as Austria and the Netherlands. We will assess the other countries in terms of the timing to get approval and the timing for reimbursement.
We started to be doing that prior to the CRL and we'll just continue to do that and ramp most of our, as we said, we'll have laser focus on cash reserves, but what cash and reserves we have now will be really focused to drive the top line revenue growth in the European markets where we're approved and where we can expand to.
Gotcha. Appreciate that. Any ideas on what your estimates, at least in these initial countries in Germany, UK, Scotland, and Ireland, what the peak penetration or peak sales estimate could be or just in terms of what the opportunity might be given there's different usages of other anti-VEGFs in those different countries? I'm just wondering how we should think about the penetration across those countries.
Yes, as we've looked at our previous corporate deck, roughly Europe overall is around, you know, peak about a $600 million market. It will obviously take some time to penetrate to that market or to that peak sales. I don't think we've given any specific estimates. I'll turn it over to Larry by a country region, but we still look at Europe as a total market. Obviously, Germany is a very large bevacizumab market when you compare it to the UK. Each country represents a different opportunity. Also, depending upon how they are delivering the vial, if they're compounding it, that also makes a difference in what we can do in the forecast. I don't believe we've given any direct market share or forecast for those numbers yet. I'll turn it over to Larry, but we're not commenting on that at this time.
Yeah, thanks, Bob. That's right. We haven't broken everything down by country in our public statements. We've looked at Europe in total, and we haven't changed any of our estimates at this time for the total opportunity in Europe. We're still excited by that opportunity, and we continue to do what we need to to maximize the payout there.
Thanks for that call, guys.
Thank you. Our next questions come from the line of Danielle Gattalian with Chardan. Please proceed with your questions.
Yeah, hi. Good morning, guys. Thanks for taking the question. Bob, while you mentioned that the FDA did not explicitly request an additional study, what data do you have in hand that the FDA or that you haven't shared with the FDA to this point that you believe could support the potential approval?
I'll turn that over to Dr. Kissner to answer. I think that what I will address is, you know, what they're looking for is confirmatory of efficacy data. Looking at the NORSE 8 and the entire NORSE program, we will go back and we will assess with our stats, what data do we have there that will confirm what they saw in NORSE TWO. Our path to do that, you know, we're still waiting to talk to the FDA to see if they have some specific criteria that they want to meet too, but I'll turn it over to Dr. Kissner for providing some specifics on how we're thinking about that approach.
Thanks, Bob. Yes, we are evaluating this, and certainly we're going to have to get in front of the agency to find out exactly what they're looking for. Our data sets, as far as clinical trials are concerned, are already in front of the agency. It is a matter of how we're looking at that data or what exactly the agency is looking for, and then we'll be able to evaluate timing and what's necessary to provide it to them.
Okay, thank you. Just to follow up, in their CRL, did they acknowledge the positive 12-week data from NORSE TWO at all, or did they mainly focus on the primary endpoint?
They focused on the primary endpoint for that. They did acknowledge the NORSE TWO study as a positive, successful trial, but for NORSE EIGHT, they focused on the primary endpoints.
Got it. All right. Thank you very much.
Thank you. Our next questions come from the line of Doug Schau with H.C. Wainwright. Please proceed with your questions.
Hi, good morning. I'm just trying to understand, and I know this is very fresh, and you obviously haven't had a chance to interact with the agency, but if you could help us just sort of understand when you talk about alternative confirmatory evidence, what that could possibly be, just given the fact that at this point, you obviously, you know, they determined that, you know, NORSE ONE was not sufficient. I'm just sort of trying to see what additional evidence they could possibly find acceptable in place of NORSE ONE.
I think, as Jennifer said, thanks, Jennifer. Go ahead.
It's a good question. It's one that we are debating internally as well. In the regulations for the FDA, there are different types of confirmatory evidence that could be provided, but we won't know exactly what they're looking for. The CRL didn't specify, so we're going to have to get in front of the agency and get clarity on that.
Okay. A follow-up, if I can, just in terms of the European business, do you have a sense of what the run rate from a revenue standpoint you need to get that to be sort of break-even? Even just on the region, not necessarily at a corporate level.
I'll turn that over to Larry.
Sorry, I was going off mute. We haven't said that publicly yet, Doug. I think we've told everybody in relation to our most recent 10-Q that we filed, which had basically one month of revenue in it, that we'd be providing more details once we complete the current quarter. We'll be able to provide more guidance, or at least directionally how things are looking and what we need there. Overall, what we've said is that the European business gets to break even pretty quickly. We haven't changed any of those estimates. By itself, it doesn't take much for us to be break-even. It's probably early 2026 when that happens, depending on how much investment we make in other countries to ramp that up.
Okay. Larry, just as a follow-up, not to parse your words too much, but based on what you've seen so far in the calendar fiscal quarter, in the launch to date in the UK and Germany, you have no reason to sort of change expectations or think that you'll need more commercial infrastructure and so forth.
Yeah, we're making no changes to that at this point. We need to see the whole quarter. As of right now, we haven't made any significant changes to any of our planning for Germany. As we've said publicly before, our real focus here is on Germany. Bob Jahr mentioned it earlier in his opening remarks that Germany is a key market for us. We're looking forward to being successful there.
I'm just curious, what makes you prioritize Germany over the UK?
Part of it's just the size of the bevacizumab market. It's a large compounded bevacizumab market with over 55% of patients getting compounded bevacizumab there. Whereas in the UK, it's a good VEGF market, but bevacizumab has a lower market share. First, you have a market that's very comfortable using BEV in first-line treatment for wet AMD. Also, just by the size of the number of patients treated and the number of injections provided, Germany is a larger market than the UK.
Okay, thank you.
Thank you. Our next questions come from the line of Julian Harrison with BTIG. Please proceed with your questions.
Hi, good morning. Sorry to hear this news. I was interested in the near-term LYTENAVA ramp in Europe. I don't know to what extent you could comment on beyond what you've already said, but any additional details there would certainly be helpful and appreciated. The debt on your balance sheet, you know, how should we be thinking about that in the near term? Thank you very much.
I'll hand that over to Larry to touch base on the debt piece and then the ramp-up. I think we haven't commented on addressing that, but if we can add any more context, I'll defer to Larry.
Yeah, I think Julian kind of answered everything we can really on the ramp-up in Europe. We're marching towards the plan to get the peak revenues there. It's three to five years out from launch. We're just in the opening innings, if I can use a baseball analogy for Europe. More to come on that as we finalize our plans for the other countries. On the debt side, we've got probably about $30 million of convertible notes outstanding. There is some debt service associated with that. We're confident that we'll need to work with, that we'll be able to work with our lender on that. Obviously, we need to get through what the next steps here are in the U.S. In the short term, it's not a very big impact on us. In fact, we've actually had some conversions of our note recently.
I think the number is smaller than it was. I don't think that it's a hurdle for us in the short term at all. Just to be clear, the debt has a maturity date of July 1, 2026. That's something that we need to focus on. There's no immediate pressure for us from the note.
Thank you very much. Thank you. Our next questions come from the line of Kemp Dolliver with Brookline Capital Markets. Please proceed with your questions.
Thank you. Two questions. First, are you aware of any precedents with the FDA where you can leverage the real-world data in Europe to help address their data requirements?
Jennifer, I'll hand that over to you.
Sure. Good question. Real-world evidence is being accepted by the agency more and more. That is one of the possible avenues that we could go down, but we won't know until we get in front of them exactly what they're willing to accept as confirmatory evidence.
Thank you. Second question, apologies for being obtuse, but when you refer to having cash, adequate cash for the next quarter, are we talking about the December quarter or the September quarter?
Oh, thanks for the question. I'll hand that to Larry.
Yeah. Thanks, Kemp. We've got, we feel comfortable that we've got at least, you know, cash to get through the next three months. I don't want to be confusing people on quarters, but that's where things stand right now. As Bob noted, we're looking at the spending model as we speak and looking where we can conserve that even more and still support everything that we're doing in Europe, especially in Germany and the UK.
Great. Thank you.
Thank you. We have reached the end of our question and answer session. With that, that does conclude today's teleconference and webcast. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.