Outlook Therapeutics, Inc.

Hello everyone and welcome to the Outlook Therapeutics third quarter fiscal year 2026 corporate update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded 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, plans, or future projections. These are forward-looking statements and involve risk and uncertainties. As a result, you should not place undue reliance on any forward-looking statements, some of the factors that could cause actual results different materially from those contemplated by such forward-looking statements and discussed in the periodic reports Outlook Therapeutics files and Securities and Exchange Commissions. These documents are available in the investor sections of the company's website and on the Security Exchange Commission's website. We encourage you to review these documents carefully Additionally, certain information contained in the website relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research. While the adequacy, fairness, and accuracy of the completeness of or that any independent source has verified any information obtained from the third-party sources. Joining us on today's call from the Outlook Therapeutics Leadership Team are Bob Jahr, President and Chief Executive Officer, and Lawrence Kenyon, Executive Vice President and Chief Financial Officer. I would now like to turn the call over to Bob Jahr, President and Chief Executive Officer. 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 Light Nova is the only FDA-approved ophthalmology formulation of Bevacuzumab for the treatment of wet AMD in the United States. 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 Latin ABA to the world's largest retina market. For over 20 years, Bevacuzumab 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 Bevacuzumab across millions of injections annually. Until now, however, physicians in the United States do not have access to a bevacizumab formulation 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 wet NAVA. We are not introducing an unfamiliar molecule or asking physicians to rethink the important role that bevacizumab plays in retina care. We are providing an improved version of a treatment they have 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 continue 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. And 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 LightNava 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 us 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 discipline 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 LightNava to physicians and patients across the U.S. The commercial opportunity for Latin Ava 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-labeled repackaged Bevacuzumab across retinal indications in 2025. That includes approximately 2.2 million injections associated with wet AMD. These figures demonstrate two important points. First, betasuzumab already occupies a meaningful position within everyday operations at retina practices. Second, the market has established a clear need for affordable betasuzumab 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. Leitnava enters this market with a for their clear, differentiated proposition. Biosimilars are designed to compete with their respective branded reference products. Litinaba addresses a different and already established area of retina care, the widespread use of repackaged off-label bevacuzumab. This distinction matters. Litinaba is not simply another entrant within the existing branded category. It is the only FDA-approved ophthalmic formulation of bevacuzumab, 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 bevacuzumab 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. Decisions 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, while similars will provide additional choices. Our goal is to establish Lyte NAVA as an important FDA-approved option within that evolving treatment landscape. Based on our market research and customer segmentation and analysis of current betasuzumab utilization, We believe White Nava 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 Bevacis MAP will remain in the market. Achieving this target will require a strong execution, expanding partnerships with payers, appropriate access and reimbursement, reliable commercial supply, and sustained engagement with retina practices. It will also require us 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 Bevacuzumab and practices with significant current Bevacuzumab utilization to understand the characteristics of potential early adopters and prioritize our field engagements. Following approval, we have been refreshing at 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 build model. Successful adoption depends on more than physician awareness. Practicing 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 LightNava 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 light nava. Importantly, the label is grounded in NORS II, our adequate and well-controlled registration trial, and clearly reflects in the statistical significance and clinical meaningful improvement in visual acuity demonstrated in the study. In NORS II, 41.7% of patients treated with latinaba 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. We believe the strength in ORS2 results, together with latinaba's position as the only FDA-approved ophthalmic formulation of abacisumab for wet A&D, provides a clear and compelling clinical story. As we prepare to bring LightNava to the U.S. market, we have taken a thoughtful and research-driven approach to pricing. Our objective is to support broad access while balancing the needs of patients, retina practices, and payers. Patient affordability has been at the forefront of this work. We have carefully considered potential out-of-pocket costs and the financial barriers that can affect whether patients are able to begin and remain on treatment. We have also considered the operational realities of retina practices. because what not will be administered within a physician-directed, buy-and-bill environment, practice need a clear and workable path for product access and reimbursement. Importantly, our strategy has been informed by extensive research across the full range of stakeholders, including payers, providers, and patients. This has helped us better understand access expectations, potential barriers, and the factors likely to influence adoption. The anti-VEGF market is changing. including the growing availability of biosimilars and an increasing focus on value. We have taken that evolving environment into account. Without losing sight of LATNAVA's differentiated position as the only FDA-approved ophthalmic formulation of Bevacuzumab for wet AMD. Ultimately, our goal is to establish a pricing reimbursement approach that supports patient affordability, broad payer access, and practical adoption within retina practices. We believe this thoughtful approach will be important as we prepare for launch and work to make LightNava available to the physicians and patients who may benefit from it. To that end, we expect the WAP price for LightNava to fall below $500 per vial. Our target is to be competitive with biosimilars and other anti-VEGF therapies while appropriately reflecting LightNava's differentiated profile. A central part of that preparation is building a commercial organization designed specifically for the retina market. We currently plan to hire approximately 30 customer-facing commercial personnel who will be focused on engaging retina specialists in practices across the U.S. These individuals will be responsible for building awareness of light and other, educating customers on its approved profile, and supporting practices as they evaluate where the product may fit within their treatment approach. We also plan to hire approximately 20 field reimbursement personnel. This team will help practices understand access and reimbursement processes, navigate coverage requirements, provide clear insight into the impact of patient affordability, and address operational questions associated with adopting a newly approved physician administered product. We are intentionally placing support alongside customer engagement because we understand that clinical interest alone does not produce commercial adoption. Practices must be able to access, purchase, and receive appropriate reimbursement for the product. In parallel, we are expanding our medical affairs organization. Medical affairs will lead scientific exchange, respond to medical information requests, and support appropriate use in advanced evidence generation initiatives. Over time, we expect real-world evidence to become an increasingly important part of the Latinata story. We want to understand how the product is being used, which patients and physicians are selecting, and how it's performing in routine clinical practice. Across each of these functions, we are recruiting people with relevant expertise in retina, Specialty Launch Commercialization, Reimbursement, and Buy and Build Markets. We are also being disciplined in how we build. Our objective is not to create the largest organization. It is to create the right organization for the opportunity in front of us. We plan to align investment with our launch sequence, prioritize accounts where we believe adoption is most likely, and expand our capabilities as the market develops. The remainder of 2026 will be a period of commercial preparation, market engagement, and organizational build-out. We will be listening closely to retina physicians, practice administrators, payers, and other stakeholders. Their feedback will help inform our positioning, our resource allocation, and the pace of our commercial expansion. As we move into 2027, we expect to be in a stronger position to begin translating that foundation into broader adoption and commercial growth upon receipt of a permanent J-code expected in April of next year. Turning to Europe, we continue to make progress with the commercialization of LightNava across the region.

LightNava is available in Germany,