Outlook Therapeutics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Great. Thanks for having me here, Doug, and we are very excited here at Outlook Therapeutics with the milestone of the FDA approval of LYTENAVA. Really what the mission has always been is to bring the first ophthalmic FDA-approved bevacizumab to the treatment of wet AMD for the retina community. Really what's important there is bevacizumab is widely known and has been widely used in the treatments of retina and for wet AMD over the past 20 years. However, there's never been a specific ophthalmic version that has been FDA approved all the way from manufacturing, all the way to the patient side, specific for this treatment indication.

Really what we're looking to solve for is we're bringing something that is very familiar, that has great efficacy for patients and affordability, but also now knowing that you have the confidence and consistency of manufacture, safety, efficacy, FDA regulations, quality and consistency of supply, and more importantly, a commitment to the ophthalmology community that we're here to support them and their patients and also grow and build our company from there.

Yeah, that's a great question. I think first and foremost, there's consistency of supply and quality of supply. Which means that it is allowed to be repackaged, which is a repackaged bevacizumab that's actually manufactured for an oncology usage. That's then repackaged into syringes. Those syringes could have different particulates in them, different quality of sustainability, consistency. When they do that, you don't really know what you're getting each time. Luckily, it's effective and it's been something that they have used over years. I think most importantly is that supply chain is not guaranteed. For us, our manufacturing is all here in the U.S. That manufacturing is subject to FDA guidance and approval all the way in, as well as for quality.

That supply chain all the way through the 3PL, through the distributors to the practices is certainly regulated but also guaranteed for us. If there's any disruption in there, we own that. We take care of that. It's not something where they're having to go order and then reorder from somebody else from repackaged. More importantly, our commitment is for every patient every time. There have been challenges in the past where repackaged providers can pull out of the market. They decide to shift their business models to other areas that allow for compound or repackaging with no prior notice. That can really cause some disruption in the supply chain, but also too more consistently for patients that want the same product every time. I mean, these are important injections that are preserving vision into the back of the eye.

I think it's really important if I were a patient or if anybody in my family were, to make sure that they have that quality and that consistency throughout their treatment program.

Yeah. We're very happy with the label. The label's predominantly based off of our adequately well-controlled trial in NORSE TWO, which was a head-to-head against ranibizumab or LUCENTIS, and then confirmatory evidence from the NORSE EIGHT. Our trial is specific to wet AMD, and it allows for monthly dosing. Again, everything that we wanted in terms of the clinical trial program is reflected in the label. That's first and foremost. I also believe, too, what the label does provide us is to get into the practices and explain that we have the first and only ophthalmic version of bevacizumab for wet AMD. We can explain to the physicians and to the offices what exactly that means for them in terms of a benefit. Our label is not head-to-head against compounding or repackage. I think it's really important. The label is specific to against ranibizumab.

In our promotional campaign, we'll be really focusing on the safety and efficacy and the clinical benefit of treating with bevacizumab for wet AMD, number one. I think that's a really important piece of it. The other element to that is with the label is we can actually provide all the full round services at the offices and the practice that patients may need, whether it be hub services, co-pay assistance, payer services, et cetera, because we will be able to commercialize and support that all behind it. That has not been something that repackaged bevacizumab has been able to provide into the market before, which I think is very, very important, and what we hear from the customers is critically important in their offices in today's market.

Yeah. It allows us to be agile in that element. There's 2.2 million injections of repackaged bevacizumab roughly annually. The good news is this is a well-defined market. Wet AMD is well understood. Bevacizumab in the anti-VEGF class is well understood. Anti-VEGF overall as a treatment option for wet AMD is very well understood in this market. What that means is, in terms of our resources, we don't have to deploy out there 18 to 24 months before to shape a market, to explain a new MOA, or to discuss a concern about treatment undiagnosis or untreated patients. It is incredibly well-defined in that regard.

That enable us to focus our resources on what's really the most important part that I believe is coming into the market, making sure the offices and the physicians or practice managers are very comfortable ordering and procuring LYTENAVA, ensuring that we have the hub services so that they fully understand the payer landscape and the patient out-of-pocket cost, and that's where we can really put our support there. So that helps us really zero in and focus. The other part that we bring into as we've done our research, there are segments. There are some segments of this market that are willing to move very quickly because they're very dissatisfied or uncertain about repackaged bevacizumab, and they want an FDA-approved product. We can really focus on them out of the gate, and then we can grow and scale the organization in Q1 accordingly.

As you know, we're also in a buy and bill environment here, so we're doing all the correct things right now to submit for the HCPCS and the permanent J-code. That permanent J-code will be available in April of 2027. So again, that allows us and our resources as a small company to really go to make sure the first offices that order have a phenomenal experience. We support them very well, and we can build the momentum from there as we move through the first quarter toward that April 1st permanent J-code where we can start growing and scaling for broader offices and utilization because that permanent J-code is always sort of an adoption hurdle for some practices. Being a small company, I think number one, we know the bev consumers.