Outlook Therapeutics, Inc. Common Stock 2026 Q3 Earnings Call

Please proceed. Thank you, operator, and good morning everyone.

We are entering a defining new chapter for Outlook Therapeutics. Only three weeks ago, the FDA-approved LYTENAVA is the only FDA-approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the U.S. Securing FDA approval is a transformational achievement for Outlook Therapeutics and an important development for the U.S. retina community. It significantly expands the commercial opportunity before us and positions the company to bring LYTENAVA to the world's largest retina market. For over 20 years, bevacizumab has played a central role in the treatment of retinal disease. Retina specialists know the molecule, have extensive experience using it, and continue to rely on the repackaged off-label bevacizumab across millions of injections annually.

Until now, however, physicians in the U.S. did not have access to ophthalmic formulation of bevacizumab that adheres with the FDA standards from manufacturing to the practice, and developed specifically for administration in the eye. We are now changing that with the approval of LYTENAVA. We are not introducing an unfamiliar molecule or asking physicians to rethink the important role that Beva plays in retina care. We are providing an improved version of a treatment they relied upon for years. Reaching this point required tremendous persistence and an extraordinary amount of work across our organization. The path to approval was not a straight line. We faced many challenges along the way. Each time, our team responded, completed the necessary work, and remained focused on our goal. This achievement belongs to everyone who helped make it possible. I want to begin by thanking our employees.

Many have dedicated years to this program and continued moving it forward through periods of uncertainty. Their expertise, resilience, and commitment to the retina community are the reasons we are here today. I also want to thank the clinical investigators, retina physicians, study coordinators, and clinical sites that participated in our development programs. Their expertise and partnership were essential throughout this journey. A thank you to the retina community for their support and guidance as we navigated the regulatory process. Most importantly, I want to thank the patients who participated in our clinical trials, along with their families and caregivers. Clinical research cannot advance without people willing to participate, and their contributions made the approval of LYTENAVA possible. We should take a moment to recognize what has been accomplished.

Securing FDA approval for a new biologic is an exceptional achievement, and everyone associated with Outlook Therapeutics should be proud of the role they played. At the same time, we should recognize that this is only the beginning of realizing our U.S. commercial opportunity. Our responsibility now is to convert this achievement into a successful and sustainable commercial launch. That will require the same determination and disciplined execution that brought us to this point. We have an FDA-approved product, a clearly defined market opportunity, and a molecule that is already deeply established in retina practice. Our focus is now on building the commercial foundation required to bring LYTENAVA to physicians and patients across the U.S. The commercial opportunity for LYTENAVA begins with the size and established nature of the U.S. retina market. The total U.S. anti-VEGF retina market is estimated at approximately $8.5 billion annually.

Within that market, it is estimated that there are approximately 3.6 million injections of off-label repackaged bevacizumab across retinal indications in 2025. That includes approximately 2.2 million injections associated with wet AMD. These figures demonstrate two important points. First, bevacizumab already occupies a meaningful position within everyday operations at retina practices. Second, the market has established a clear need for affordable bevacizumab treatment options. We believe this reinforces both the size and vitality of the retina market, and we believe that physicians will consider new therapies when those products offer a clear clinical, practical, or economic role within their practices. LYTENAVA enters this market with a clear differentiated proposition. Biosimilars are designed to compete with their respective branded reference products. LYTENAVA addresses a different and already established area of retina care, the widespread use of repackaged off-label bevacizumab. This distinction matters. LYTENAVA is not simply another entrant within the existing branded category.

It is the only FDA-approved ophthalmic formulation of bevacizumab, a molecule that retina specialists and patients already know and use extensively. Our opportunity is to provide physicians with a new treatment option that combines the familiarity of bevacizumab with the standards, oversight, and product consistency associated with an FDA-approved medicine. We also recognize that treatment decisions in retina are not driven by a single factor. Physicians consider efficacy, safety, durability, patient characteristics, reimbursement, acquisition economics, and their own clinical expertise. We are therefore not building our strategy around the assumption that one product will replace every other option. The anti-VEGF market is large enough to support multiple therapies serving different patient and practice needs. Branded innovation will remain important. Biosimilars will provide additional choices.

Our goal is to establish LYTENAVA as an important FDA-approved option within that evolving treatment landscape. Based on our market research and customer segmentation and analysis of current bevacizumab utilization, we believe LYTENAVA has the potential to generate more than $500 million in peak annual sales by 2030. That is our base case objective, not an assumption of immediate or universal adoption, and importantly assumes that repackaged bevacizumab will remain in the market. Achieving this target will require strong execution, expanding partnerships with payers, appropriate access and reimbursement, reliable commercial supply, and sustained engagement with retina practices. It will also require us to listen carefully to market and adapt as conditions evolve. We believe the opportunity is substantial, and we are approaching it with both confidence and discipline. Our immediate priority is building the infrastructure required for a successful U.S. launch.

The retina market is highly concentrated, which allows us to pursue a focused commercial model. A relatively defined group of retina specialists and high-volume practices account for a meaningful share of injections. That concentration creates an efficient opportunity, but it also means our execution must be precise. We have completed extensive customer segmentation and market analysis to identify practices currently dissatisfied with current compounded repackaged bevacizumab and practices with significant current bevacizumab utilization to understand the characteristics of potential early adopters and prioritize our field engagement. Following approval, we have been refreshing that work using the latest market information, including the evolving biosimilar environment. Our commercial strategy is built around the realities of the retina practice. These are physician-administered products operating within a buy-and-bill model. Successful adoption depends on more than physician awareness. Practice needs clarity around reimbursement, product acquisition, coding, inventory, and patient access.

That is why market access and reimbursement capabilities are central to our launch strategy. We are advancing payer engagement and preparing the infrastructure necessary to support coverage decisions. We are also planning for the submission of an application for a permanent HCPCS code by the end of the third quarter and anticipating a permanent J-code in April of next year. Commercial supply is another critical priority. We already have sufficient supply to support the launch later this year and are scaling the process required to provide a reliable commercial supply of LYTENAVA and coordinate product availability with our planned launch sequence. Reliability and constancy matter enormously to retina practices, where treatment scheduling, inventory management, and reimbursement are closely interconnected. We will continue to refine the timing and pace of our launch based on payer engagement, supply readiness, customer feedback, and the completion of key commercial capabilities.

Our approach is designed to support a measured, high-quality entry into the market and create a foundation that can scale as adoption grows. As we build that commercial foundation, we are equally focused on the strength of the clinical story we will bring to retina specialists. We are very pleased with the strong label approved for LYTENAVA. Importantly, the label is grounded in NORSE TWO, our adequate and well-controlled registrational trial, and clearly reflects the statistical significance in clinical meaningful improvement in visual acuity demonstrated in the study. In NORSE TWO, 41.7% of patients treated with LYTENAVA gained at least 15 letters at month 11, compared to 23.1% of patients treated with ranibizumab. These data will serve as the foundation of our marketing efforts and our engagement with retina specialists.