Company Performance - Oncobiologics reported a quarterly loss of $0.44 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.42, but an improvement from a loss of $0.83 per share a year ago, indicating a year-over-year improvement in losses [1] - The company posted revenues of $1.51 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 40.98%, compared to zero revenues a year ago [2] - Over the last four quarters, Oncobiologics has surpassed consensus EPS estimates two times [2] Stock Performance - Oncobiologics shares have increased by approximately 12.7% since the beginning of the year, outperforming the S&P 500's gain of 10% [3] - The current Zacks Rank for Oncobiologics is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.33 on revenues of $5.78 million, and for the current fiscal year, it is -$1.89 on revenues of $6.42 million [7] - The outlook for the Medical - Biomedical and Genetics industry, in which Oncobiologics operates, is currently in the bottom 41% of over 250 Zacks industries, suggesting potential challenges ahead [8]

Core Viewpoint - Outlook Therapeutics reported a net loss of $20.2 million for the third quarter of fiscal year 2025, with initial revenue from the sales of LYTENAVA™ in Germany and the UK, marking the company's transition into a commercial entity [2][6][16]. Financial Performance - For the fiscal third quarter ended June 30, 2025, the company reported a net loss attributable to common stockholders of $20.2 million, or $0.55 per share, with revenue of $1.5 million from initial sales of LYTENAVA™ [2][3]. - The adjusted net loss for the same period was $15.8 million, or $0.44 per share, compared to an adjusted net loss of $19.2 million, or $0.83 per share, for the third quarter of 2024 [3][4]. - As of June 30, 2025, the company had cash and cash equivalents of $8.9 million [5]. Product and Market Update - LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD), being the first authorized ophthalmic formulation of bevacizumab in the EU and UK [7][13]. - The FDA has set a PDUFA goal date of August 27, 2025, for ONS-5010, which is expected to receive 12 years of regulatory exclusivity if approved [6][11]. - The company has entered into a strategic collaboration with Cencora to support the global commercial launch of LYTENAVA™ following regulatory approvals [9][10]. Clinical and Regulatory Developments - The resubmission of the Biologics License Application (BLA) for ONS-5010 was based on the efficacy and safety demonstrated in the NORSE EIGHT trial, with the FDA acknowledging the resubmission [11][12]. - The NORSE EIGHT trial evaluated ONS-5010 against ranibizumab, with a primary efficacy endpoint at 8 weeks [12]. Industry Context - Off-label repackaged bevacizumab is widely used in Europe and the U.S. for retinal diseases, with approximately 2.8 million and 2.7 million injections annually, respectively [8]. - ONS-5010/LYTENAVA™ has the potential to mitigate risks associated with the current off-label use of repackaged bevacizumab [8].

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retinal diseases [3] - The company is developing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), which is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD [3] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [4] - If approved, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4] Industry Event - Outlook Therapeutics will present at the 8th Annual OIS Retina Innovation Summit on July 29, 2025, in Long Beach, CA [1] - The presentation will be part of the Innovation Showcase, led by CEO Bob Jahr [1] - The Ophthalmology Innovation Summit aims to showcase novel therapies for unmet needs in ophthalmic diseases and vision disorders, facilitating connections among entrepreneurs, clinical leaders, and investment professionals [2]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [3] - The company has developed ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), which is the first ophthalmic formulation of bevacizumab to receive marketing authorization from the European Commission and MHRA for treating wet AMD [3] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK for the treatment of wet AMD [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [4] - If approved, ONS-5010/LYTENAVA™ would be the first approved ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [4] Leadership Insights - Bob Jahr, the newly appointed CEO, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, sharing his journey and excitement for the future of Outlook Therapeutics [2] - The on-demand video webcast of the conference is available on virtualinvestorco.com and the company's website [2]

Product & Regulatory Milestones - ONS-5010/LYTENAVA is the first and only approved ophthalmic formulation of Bevacizumab for wet AMD in the EU and UK[5] - The US FDA has accepted the resubmission of the BLA for ONS-5010 with a PDUFA goal date of August 27, 2025[28, 39] - The company received 10 years of market exclusivity in Europe covering 31 countries[6, 39] - LYTENAVA has a list price of £470 (approximately $618) in the UK[12] and €751.61 (approximately $857) in Germany[14] Market Opportunity & Commercialization - The total European anti-VEGF retina market is valued at $3.6 billion[9] - The total US anti-VEGF retina market is valued at $8.5 billion[29] - In Europe, 2.8 million injections of repackaged off-label bevacizumab are administered annually[8] - In the UK, the estimated market share of off-label repackaged bevacizumab is 5%, with 1.3 million anti-VEGF units per annum[12] - In Germany, the estimated market share of off-label repackaged bevacizumab is 50%, with 1.7 million anti-VEGF units per annum[15, 14] - The company projects potential for gross peak sales of over $600 million[16] Financial Status - As of March 31, 2025, the company had $7.6 million in cash[36] - The company's cash position does not include proceeds from a $13 million public offering that closed on May 27, 2025[37]

Company Overview - Outlook Therapeutics, Inc. is a biopharmaceutical company focused on enhancing the standard of care for bevacizumab in the treatment of retina diseases [9] - The company has launched LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) in Europe, specifically in Germany and the UK, for the treatment of wet age-related macular degeneration (AMD) [9] Leadership Appointment - Bob Jahr has been appointed as the Chief Executive Officer (CEO) of Outlook Therapeutics and will also join the Board of Directors [1][2] - Lawrence A. Kenyon will continue in his role as Chief Financial Officer (CFO) and remain a member of the Board of Directors [1] Executive Experience - Mr. Jahr brings over 20 years of experience in the biopharmaceutical industry, having led commercial teams across various therapeutic areas including rare disease, oncology, and hematology [3] - He has a proven track record of managing multiple billion-dollar assets and franchises [3] Strategic Importance - The appointment of Mr. Jahr is seen as timely due to the ongoing commercial launch in Europe and the potential for U.S. FDA approval in the coming months [2] - Mr. Jahr expressed excitement about joining the company at a pivotal time, emphasizing the potential of LYTENAVA™ to transform the global retina market [4] Inducement Grant - The Board of Directors approved an option for Mr. Jahr to purchase 800,000 shares of common stock as an inducement for his employment [6] - The option will be issued on July 1, 2025, with an exercise price equivalent to the closing price of the stock on that date, vesting over four years [7]

Summary of Outlook Therapeutics Conference Call Company Overview - **Company**: Outlook Therapeutics - **Ticker**: OTLK (trades on Nasdaq) [4] Recent Achievements - **Product**: Lightnova - **Regulatory Approvals**: Lightnova approved in the EU and UK; received positive recommendation from NICE for use in the UK [5][6] - **Launch**: Launched simultaneously in Germany and the UK in May 2025; first patients dosed in both countries [6] Market Landscape - **Industry**: Treatment of wet Age-related Macular Degeneration (AMD) - **Market Size**: The European market for wet AMD treatments is valued at approximately $3.6 billion annually, with 8 million anti-VEGF injections per year [9] - **Injection Distribution**: Germany accounts for 1.7 million injections, while the UK accounts for 1.3 million [10] Competitive Positioning - **Market Share**: Off-label bevacizumab holds a 33% market share in Europe, with Germany at 50% and the UK at 5% [11][12] - **Cost-Effectiveness**: Lightnova positioned as a cost-effective first-line treatment option for wet AMD [9][12] Pricing Strategy - **UK Pricing**: List price set at £470, the lowest among approved products; patient access scheme in place for competitive net pricing [16][18] - **Germany Pricing**: List price set at €751.61; negotiations for a post-launch price expected in early 2026 [20][19] Commercial Launch Strategy - **Market Access**: Focus on subnational access critical for success; rebate agreements in place covering 50% of the population in Germany, expected to increase to 90% by year-end [26] - **Team Experience**: Strong teams with extensive ophthalmology experience in both Germany and the UK [24] Physician Engagement - **Receptiveness**: Positive feedback from ophthalmologists regarding Lightnova; significant interest in an ophthalmic standard formulation of bevacizumab [13][14] - **Educational Efforts**: Focus on educating physicians about the ophthalmic formulation and clinical data supporting Lightnova [35][36] Future Expansion Plans - **Market Expansion**: Approved in 31 countries; focus on launching in Italy, Spain, France, Ireland, and the Nordics [44][47] - **Potential Partnerships**: Currently focused on maximizing Lightnova's potential independently, but open to partnerships if beneficial [48] FDA Approval Update - **BLA Submission**: BLA submitted to the FDA in February 2025; PDUFA goal date set for August 27, 2025 [50][51] - **Expectations**: Confident in the data provided to the FDA supporting approval for wet AMD treatment [75][76] Financial Outlook - **Liquidity**: Recent capital raised through a CMPO; sufficient funds to support operations through the PDUFA decision [58] - **Profit Margins**: Anticipated healthy profit margins, with a focus on minimizing dilution during financing [63] Conclusion - **Key Milestones**: Upcoming quarterly results expected in August, along with the FDA decision; preparations for further European launches ongoing [84][85]

Core Insights - Outlook Therapeutics, Inc. is participating in a Virtual Investor Lunch Break Event on June 25, 2025, at 12:00 PM ET [1] - Key executives will discuss the company's commercial strategy, upcoming milestones, and current activities during the event [2] - A live video webcast will be available on the company's website, with a replay accessible for 90 days [3] Company Overview - Outlook Therapeutics focuses on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg) to enhance the standard of care for retinal diseases [4] - LYTENAVA™ is the first ophthalmic formulation of bevacizumab to receive marketing authorization in Europe for the treatment of wet AMD [4] - The commercial launch of LYTENAVA™ has commenced in Germany and the UK [4] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, with a Biologics License Application (BLA) resubmitted to the FDA [5] - If approved, it would be the first ophthalmic formulation of bevacizumab for retinal indications, including wet AMD [5]

Core Viewpoint - Outlook Therapeutics has received acceptance from the Scottish Medicines Consortium (SMC) for LYTENAVA™ (bevacizumab gamma) to be used in NHS Scotland for treating wet age-related macular degeneration (wet AMD), marking a significant milestone for the company and enhancing treatment options for patients in Scotland [1][2]. Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to improve the standard of care for retinal diseases [7]. - LYTENAVA™ is the first licensed ophthalmic formulation of bevacizumab for treating wet AMD in the UK, with an initial 10 years of market exclusivity from the date of marketing authorization [1][4]. Clinical Development - The SMC recommendation was based on results from the company's clinical program for ONS-5010/LYTENAVA™, which includes three completed registration clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE [2]. - The product is currently commercially available in the UK for wet AMD treatment [2]. Strategic Collaborations - Outlook Therapeutics has formed a strategic collaboration with Cencora (formerly AmerisourceBergen) to support the global commercial launch of LYTENAVA™ following regulatory approvals, aiming for efficient distribution and market access [3]. Regulatory Status - LYTENAVA™ has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for treating wet AMD [4]. - In the United States, ONS-5010/LYTENAVA™ is still investigational, with a Biologics License Application (BLA) resubmitted to the FDA [8].

Core Viewpoint - Outlook Therapeutics has launched LYTENAVA™ (bevacizumab gamma) for the treatment of wet age-related macular degeneration (wet AMD) in Germany and the UK, marking a significant milestone as it is the first and only authorized ophthalmic formulation of bevacizumab for this condition in the European Union and UK [1][5][9] Company Overview - Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA™ to enhance the standard of care for retinal diseases [8] - The company has received centralized Marketing Authorization from the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for LYTENAVA™ [5][8] Product Launch and Market Strategy - The commercial launch of LYTENAVA™ in Germany and the UK is supported by a strategic collaboration with Cencora to facilitate market access and distribution [4] - The company aims to ensure success in these markets and is preparing for additional launches across Europe later in 2025 and throughout 2026 [2] Market Context - Off-label repackaged bevacizumab is widely used in Europe and the US, with approximately 2.8 million injections annually in Europe and 2.7 million in the US for retinal diseases [3] - LYTENAVA™ has the potential to mitigate risks associated with the current off-label use of repackaged bevacizumab [3] Regulatory Status - In the United States, ONS-5010/LYTENAVA™ is currently investigational, and a Biologics License Application (BLA) has been resubmitted to the FDA [6][8] - In certain EU member states, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold [6]