Outlook Therapeutics, Inc. (OTLK): Business Model Canvas [Dec-2025 Updated]

You're looking at a biopharma, Outlook Therapeutics, Inc. (OTLK), sitting right at a major inflection point, and honestly, the numbers tell a tense story. This company is hinging its entire commercial future on the FDA's decision for its ophthalmic bevacizumab, LYTENAVA™, due by December 31, 2025, to finally offer a regulated alternative to risky compounded drugs for wet AMD. While they've begun generating revenue-posting $1.5 million in sales across the EU and UK in Q3 FY2025-the burn rate is steep, evidenced by a $20.2 million net loss that same quarter, leaving them with just $8.9 million in cash as of June 30, 2025. This Business Model Canvas cuts through the noise to show you exactly how Outlook Therapeutics, Inc. (OTLK) plans to execute its launch, who its key partners are for distribution, and what costs it must manage to survive past that critical regulatory date; read on to see the full blueprint for this make-or-break transition.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Key Partnerships

You're looking at the core external relationships Outlook Therapeutics, Inc. relies on to get LYTENAVA™ (bevacizumab gamma) to market, especially given their tight cash position as of late Q3 2025. These partnerships are critical because they allow Outlook Therapeutics to scale commercialization without straining internal resources, which is key when cash and cash equivalents stood at only $8.9 million as of June 30, 2025.

Cencora (formerly AmerisourceBergen) for US 3PL and Distribution

The strategic collaboration with Cencora, formerly AmerisourceBergen, is foundational for Outlook Therapeutics' global launch strategy. This agreement covers third-party logistics (3PL) services and distribution in the United States, should ONS-5010 receive FDA approval. Cencora's role extends to supporting the commercial launch of LYTENAVA™ across Europe, too. They provide end-to-end commercialization solutions, which is a big help for a company of this size.

Here's what Cencora is providing support for:

• Support for the launch in the EU, which was expected in early 2025.
• Support for the potential launch of ONS-5010 in the UK, expected in Q1 2025 pending approval.
• Support for the potential launch in the United States, expected mid-2025 pending FDA approval.

In Europe, Cencora's support package is quite broad, covering essential post-approval functions.

European Distributors for Commercial Launch in Germany and the UK

Outlook Therapeutics successfully transitioned into commercial operations in key European markets. LYTENAVA™ (bevacizumab gamma) commenced commercial launch in both Germany and the UK on June 2, 2025. This product is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD in the EU and the UK. The Scottish Medicines Consortium (SMC) also accepted LYTENAVA™ for use within NHS Scotland in June 2025.

The initial commercial success is reflected in the reported revenue for the fiscal third quarter ended June 30, 2025, which consisted of $1.5 million from these initial sales into Germany and the UK. This launch targets a market where approximately 2.8 million injections of repackaged off-label bevacizumab are administered annually.

Contract Manufacturing Organizations (CMOs) for ONS-5010/LYTENAVA™ Production

While Outlook Therapeutics is focused on commercialization, specific details regarding the current, active CMOs responsible for the late-2025 production of ONS-5010/LYTENAVA™ are not publicly detailed in recent filings. The company did terminate a development partner, MTTR, LLC, in January 2020, eliminating royalty rights for that entity. The manufacturing and controls information (CMC) was part of the resubmitted BLA to the FDA.

Regulatory Consultants to Navigate Complex FDA and EMA/MHRA Processes

Navigating the FDA and EMA/MHRA is a partnership function, often relying on specialized external expertise. The EMA granted centralized Marketing Authorization for LYTENAVA™ in the EU in May 2024, and the UK's MHRA approved it in July 2024.

The critical focus for late 2025 is the FDA process. Outlook Therapeutics resubmitted the Biologics License Application (BLA) for ONS-5010 in February 2025. Following a second Complete Response Letter (CRL) in August 2025, the FDA accepted the resubmission as a complete, Class 1 response on November 13, 2025. This acceptance set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025. If approved, ONS-5010 is expected to receive 12 years of regulatory exclusivity in the US.

Key regulatory milestones managed through this partnership structure include:

• Positive Committee for Medicinal Products for Human Use (CHMP) opinion from the EMA in March 2024.
• FDA acceptance of the BLA resubmission in November 2025.
• Targeted US launch of LYTENAVA™ in early 2026, pending the December 31, 2025 PDUFA date.

The US market relies heavily on off-label compounded bevacizumab, estimated at 2.7 million injections annually, which ONS-5010 aims to replace.

Finance: draft 13-week cash view by Friday.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Key Activities

You're hiring before product-market fit, so every operational activity needs to be tightly managed, especially when cash is lean. Here's the quick math on what Outlook Therapeutics, Inc. (OTLK) is actively driving as of late 2025.

Commercialization and market access for LYTENAVA™ in the EU and UK

Outlook Therapeutics, Inc. is executing the initial commercial rollout for LYTENAVA™ (bevacizumab gamma) following marketing authorization in the European Union and the United Kingdom. This activity is critical as it marks the company's transition to a commercial-stage entity.

The initial European commercial sales began in the second quarter of calendar year 2025, with revenue recorded from the UK and Germany.

• LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab in the EU and UK.
• The company received a positive reimbursement decision from NICE in the United Kingdom in December 2024.
• Market access in several EU countries is still contingent on securing local pricing and reimbursement approvals.
• A strategic collaboration with Cencora supports launch activities, including third-party logistics and distribution.

Key commercial and financial metrics related to the European launch for the fiscal third quarter ended June 30, 2025, are detailed below.

Managing the FDA's BLA review process for ONS-5010 (PDUFA date: December 31, 2025)

A primary key activity is managing the regulatory pathway for ONS-5010 in the United States, which involves responding to prior regulatory feedback and driving toward a final decision date.

The U.S. Food and Drug Administration (FDA) accepted the resubmission of the Biologics License Application (BLA) for ONS-5010, which addresses issues noted in a Complete Response Letter (CRL) received in August 2025. This acceptance is categorized as a complete, Class 1 response.

• The FDA set the Prescription Drug User Fee Act (PDUFA) goal date for a decision as December 31, 2025.
• The Class 1 designation triggered a 60-day review period from the date of resubmission.
• If approved, ONS-5010 will be branded LYTENAVA™ in the U.S. market.
• The application is expected to secure 12 years of regulatory exclusivity upon approval.

Manufacturing and supply chain management of the sterile ophthalmic formulation

Ensuring the quality and availability of the sterile ophthalmic formulation is a continuous operational requirement, especially following regulatory submissions.

The resubmitted BLA included updated information related to the product's production.

• The BLA resubmission package included additional Chemistry, Manufacturing, and Controls (CMC) information requested by the FDA.

Post-marketing surveillance and pharmacovigilance in launched territories

For the territories where LYTENAVA™ has launched, active monitoring of product safety is a necessary ongoing function.

The company utilizes its strategic partner to manage these responsibilities in Europe.

• Cencora provides launch support services in Europe, which explicitly includes pharmacovigilance.

Investor relations to secure financing and manage market expectations

Given the cash position and ongoing operational expenses, securing capital to fund the European ramp and U.S. regulatory process is a high-priority activity.

The company executed a public offering in May 2025 to bolster its working capital.

Financial status as of the end of Q3 FY2025 (June 30, 2025):

The May 23, 2025, underwritten public offering priced at $1.40 per unit (common stock plus accompanying warrant) was intended to provide funding for working capital and general corporate purposes.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Key Resources

ONS-5010/LYTENAVA™ (bevacizumab-vikg) drug product.

• Investigational in the United States for wet age-related macular degeneration (wet AMD).
• Biologics License Application (BLA) re-submitted to the U.S. Food and Drug Administration (FDA) in November 2025.
• FDA set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025 for the re-submitted BLA, classified as a complete, Class 1 response.
• Previously, the FDA set a PDUFA goal date of August 27, 2025 for a Class 2 review of an earlier BLA resubmission.

Intellectual Property (IP) protecting the ophthalmic formulation.

• Expected to receive 12 years of regulatory exclusivity in the United States upon approval.

European Commission and UK MHRA Marketing Authorizations.

• LYTENAVA™ (bevacizumab gamma) holds centralized Marketing Authorization from the European Commission in the EU.
• LYTENAVA™ (bevacizumab gamma) holds Marketing Authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA).
• Outlook Therapeutics, Inc. commenced commercial launch in Germany and the UK.
• Revenue from initial sales into Germany and the UK for the fiscal third quarter ended June 30, 2025 was $1.5 million.

Clinical trial data (NORSE EIGHT) supporting efficacy and safety.

Here's the quick math on the 12-week data comparing ONS-5010 to ranibizumab:

The trial demonstrated noninferiority to ranibizumab at week 12. Still, the pre-specified non-inferiority endpoint at week 8 was not met. Finance: draft 13-week cash view by Friday.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Value Propositions

You're looking at the core offering that Outlook Therapeutics, Inc. (OTLK) is bringing to the retinal disease space, centered entirely around its investigational product, ONS-5010, branded as LYTENAVA™ if approved in the US.

First FDA-approved ophthalmic bevacizumab for wet AMD

The primary value proposition hinges on achieving a regulatory first in the United States. Outlook Therapeutics is pursuing approval for ONS-5010, which, if the FDA grants it by the PDUFA goal date of December 31, 2025, will be the first FDA-approved ophthalmic formulation of bevacizumab specifically for wet age-related macular degeneration (wet AMD). This is a significant step, as the product already has Marketing Authorization from the European Commission and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Regulated, sterile alternative to compounded, off-label bevacizumab

In the US, the current standard of care for many patients involves the use of compounded, off-label bevacizumab, which inherently carries regulatory and sterility concerns because it lacks official FDA approval for this indication. Outlook Therapeutics offers a direct, regulated solution. LYTENAVA™ is designed as a cGMP produced alternative, meaning it adheres to current Good Manufacturing Practices, providing physicians and patients with a product that is manufactured under strict quality controls, unlike the repackaged, non-approved versions currently in use.

Potential cost-effective option in the anti-VEGF market

The product is positioned to be a cost-effective option within the broader anti-VEGF market, which is substantial. The US anti-VEGF market was valued at $5.23 billion in 2023, and the global anti-VEGF retina market is estimated at more than $15.9 billion worldwide. By offering an approved version of bevacizumab, which is already widely used off-label, Outlook Therapeutics aims to capture market share from higher-priced branded therapies like Eylea and Lucentis, while also providing a more secure option than the compounded product.

Enhanced safety profile compared to repackaged, non-approved alternatives

The value here is the assurance of quality and consistency. Being the first FDA-approved ophthalmic formulation means the product has met the agency's rigorous standards for safety and efficacy, specifically demonstrated in trials like NORSE EIGHT. This directly contrasts with the inherent risks associated with using non-approved, repackaged alternatives, which do not carry the same level of regulatory oversight for ophthalmic use.

Long-term market exclusivity (e.g., 12 years expected in the US if approved)

If the BLA is accepted and approved by the FDA, Outlook Therapeutics is expected to secure 12 years of regulatory exclusivity in the United States. This is a critical component of the business model, as it provides a significant competitive moat, effectively blocking biosimilar competition until approximately 2037. This exclusivity period is essential for recouping investment and establishing market presence before facing generic or biosimilar challenges.

To put the European and US market context into perspective, consider these figures:

The initial commercial traction in Europe further validates the proposition:

• LYTENAVA commenced commercial launch in Germany and the UK in June 2025.
• In the UK, the Scottish Medicines Consortium accepted LYTENAVA for use within NHS Scotland in June 2025.
• The National Institute for Health and Care Excellence (NICE) endorsed LYTENAVA in the UK in December 2024.

Financially, the company's current market capitalization as of late 2025 is approximately $56.86 million, while its EBIT margin is reported at -5973.7%, though the gross margin stands at 70.8%.

Finance: draft 13-week cash view by Friday.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Customer Relationships

You're focused on how Outlook Therapeutics, Inc. connects with the doctors who will prescribe LYTENAVA™ (bevacizumab-vikg) now that initial European sales are underway. The customer relationship strategy hinges on proving the value of an FDA-approved (or EU/UK authorized) ophthalmic formulation versus the long-standing off-label use.

High-touch engagement with retina specialists and ophthalmologists is the core driver. The company is actively engaging the medical community through scientific forums. For instance, CEO Bob Jahr presented on optimizing retinal disease treatment at the EURETINA Innovation Spotlight on September 3, 2025. This type of interaction is defintely key to building trust with the specialists who manage wet Age-related Macular Degeneration (AMD).

Direct sales force interaction in key launch markets (EU/UK) is being scaled, supported by a major distribution partner. Outlook Therapeutics has a strategic commercialization agreement with Cencora to support the global launch, which includes connecting to retina specialists and providers in the United States, should the BLA be approved. In the EU/UK, initial commercial sales began in the second quarter of calendar 2025, with $1.5 million in revenue reported from initial sales in Germany and the UK for the fiscal third quarter ended June 30, 2025.

Market access and reimbursement support for payers and providers is critical for adoption outside of the U.S. The company secured key payer wins that validate the product's economic value proposition. Specifically, the National Institute for Health and Care Excellence (NICE) endorsed LYTENAVA™ in the UK in December 2024, and the Scottish Medicines Consortium (SMC) approved its use in NHS Scotland in June 2025. This early European success provides a blueprint for future payer negotiations.

Educational programs on the benefits of an approved formulation are designed to shift prescribing habits away from the unapproved, off-label injectable. The target is substantial: the U.S. market alone has approximately 2.7 million annual off-label bevacizumab injections administered. In Europe, the market for off-label injections is around 3 million per year. Outlook Therapeutics expects to reach break even in Germany, its largest approved market, in early 2026.

Here's a quick look at the commercial and financial context supporting these relationship efforts as of late 2025:

The engagement strategy is clearly tiered. First, secure payer acceptance through health economics data, as seen with the NICE and SMC decisions. Second, use that success to drive adoption by retina specialists, supported by direct engagement like the EURETINA presentation. The collaboration with Cencora is the infrastructure layer, ensuring the product gets where it needs to go efficiently.

• Focus market: Germany, targeting break even in early 2026.
• Distribution support via Cencora for 3PL and pharmacovigilance.
• Addressing the liability risk associated with off-label use for providers.
• Presenting at EURETINA on September 3, 2025.

Finance: draft 13-week cash view by Friday.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Channels

You're looking at the distribution and access strategy for Outlook Therapeutics, Inc. (OTLK) as they transition into a commercial entity in late 2025. The channels are heavily weighted toward leveraging partners for logistics while building out a specialized direct sales presence contingent on US regulatory success.

The planned US direct sales force targeting retina specialists is directly tied to the Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025, for ONS-5010. This channel is designed to access the U.S. wet AMD market, estimated at $1.2 billion. Success here could translate to an estimated $120-240 million in annual revenue by 2030, based on capturing 10-20% of that market.

For logistics and distribution, Outlook Therapeutics, Inc. utilizes a key Third-Party Logistics (3PL) and specialty distributor relationship:

• Cencora (formerly AmerisourceBergen) is the strategic collaboration partner supporting the global commercial launch of LYTENAVA™.
• This partnership is designed to support market access and efficient distribution following regulatory approvals.

The European and UK commercialization efforts, which began in the second quarter of CY2025, are already generating revenue through established networks.

For drug administration within hospital and clinic settings, the initial European launch focused on securing reimbursement milestones, such as the NICE recommendation in the UK. The company reported an operating loss of $20.2 million in Q3 FY2025, reflecting the investment required to build out these commercial channels against trailing 12-month revenue of $1.51 million as of June 30, 2025. Outlook Therapeutics, Inc. also reduced its workforce by 23% to streamline operations supporting these launches.

International distribution partners beyond the initial EU/UK focus are being managed through the existing collaboration with Cencora for global support following regulatory approvals. The company is focused on ensuring success in Germany and the UK, with plans for additional launches across the region later in 2026.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Customer Segments

You're looking at the core groups Outlook Therapeutics, Inc. (OTLK) targets with LYTENAVA™ (bevacizumab gamma) and ONS-5010, especially now that the company has started generating revenue in Europe and is awaiting a key US decision.

Retina specialists and ophthalmologists treating wet AMD.

These are the frontline prescribers. Outlook Therapeutics, Inc. (OTLK) is positioning LYTENAVA™ as the first authorized ophthalmic formulation of bevacizumab, aiming to replace the current standard of care which heavily relies on off-label use. The market opportunity is substantial because retina specialists in the US have shown significant interest in an approved product; specifically, 85% of physicians showed interest in Bevacizumab in the context of the 1.75 million treated patients in the US anti-VEGF retina market. The company is also targeting the high volume of off-label use, which accounts for approximately 2.7 million injections annually in the United States and about 2.8 million injections annually in Europe as of mid-2025.

The customer segment is defined by their need for a reliable, regulatory-backed alternative to the current practice. For instance, the Q3 fiscal year 2025 revenue of $1.5 million came from initial commercial sales in Germany and the UK, showing the segment is beginning to adopt the authorized product.

Patients with wet Age-related Macular Degeneration (wAMD).

The patient population is large and growing, which is the fundamental driver for the entire market. In the United States alone, roughly 20 million Americans aged 40 and over have some form of AMD. Of those, approximately 1.49 million Americans are living with a late-stage, vision-threatening form of AMD, which includes wet AMD. Outlook Therapeutics, Inc. (OTLK) is focused on those who need treatment for wet AMD, a condition that causes 90 percent of legal blindness cases in the category.

The patient base is segmented by geography as the company rolls out its product:

• Patients in the European Union and United Kingdom, where LYTENAVA™ is already authorized.
• US patients, pending the Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, for ONS-5010.

Healthcare Payers (Medicare, private insurance) seeking cost-effective treatments.

Payers are a critical segment because they control access and reimbursement, and Outlook Therapeutics, Inc. (OTLK) is explicitly targeting them with an approved, potentially cost-effective option versus existing branded therapies. The US market is heavily influenced by Medicare; a 2025 study on Medicare Advantage members showed the prevalence of wet AMD ranged between 1.2% to 1.3%. The company's European success included a positive reimbursement decision from the National Institute for Health and Care Excellence (NICE) in the UK in December 2024, which directly addresses this segment's need for value.

The overall anti-VEGF retina market is estimated globally at $15.9 billion. Outlook Therapeutics, Inc. (OTLK) aims to capture share by offering an authorized product that mitigates risks associated with off-label use, which is a key financial consideration for payers. The company's first revenue generation in 2025, starting with $1.5 million in Q3 FY2025 from Europe, is the initial proof point for this segment.

Compounding pharmacies whose market share is targeted.

This segment represents the current source of the off-label bevacizumab that Outlook Therapeutics, Inc. (OTLK) seeks to displace. The company's product is positioned to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, which is what compounding pharmacies often supply for ophthalmic use.

The scale of the targeted off-label market is significant, representing a direct revenue opportunity for Outlook Therapeutics, Inc. (OTLK) upon regulatory success:

The company's revenue forecast for the fourth quarter of 2025 is $5.846M, which reflects the expected ramp-up in capturing this market share following European launches and anticipated US approval.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Cost Structure

You're looking at the cost side of the Outlook Therapeutics, Inc. (OTLK) business model as they transition from clinical development to early commercialization in late 2025. The structure is heavily weighted toward pre-revenue activities, which is typical for a company awaiting a major U.S. regulatory decision while managing initial European product sales.

Significant Research and Development (R&D) expenses continue to be a major cost driver, reflecting the ongoing commitment to clinical data generation and regulatory requirements for ONS-5010, which has a U.S. Prescription Drug User Fee Act (PDUFA) goal date set for August 27, 2025. For the fiscal third quarter ended June 30, 2025, R&D spending totaled $29.24 million. This investment supports the entire pipeline's advancement, including addressing any post-Complete Response Letter (CRL) requirements from the FDA.

The build-out for commercial readiness, even with initial European sales, results in high General and Administrative (G&A) costs, often reported as Selling, General, and Administrative (SG&A) expenses in their filings. For Q3 FY2025, these costs were $19.59 million. This figure covers the infrastructure needed to support the launch and distribution of LYTENAVA™ in Germany and the UK, and to prepare for a potential U.S. launch.

The overall financial performance for the period reflects these heavy investments. Outlook Therapeutics, Inc. (OTLK) reported a net loss attributable to common stockholders of $20.2 million for the fiscal third quarter ended June 30, 2025. This loss occurred despite recording $1.5 million in initial revenue from LYTENAVA™ sales into Germany and the UK during the same quarter. The operating loss for the quarter was $51.32 million.

Specific costs related to manufacturing and supply chain for ONS-5010 and legal and regulatory compliance for global approvals are embedded within the reported operating expenses, as specific line items for these categories are not separately itemized in the publicly available Q3 FY2025 highlights. The BLA resubmission for ONS-5010 occurred in February 2025, which would have incurred significant regulatory filing fees and associated legal/CMC (Chemistry, Manufacturing, and Controls) costs.

Here's a look at the primary components of the cost structure from the Q3 FY2025 results:

The cash position is also a critical factor in the cost structure, as it dictates the runway to cover these expenses. As of June 30, 2025, Outlook Therapeutics, Inc. (OTLK) held cash and cash equivalents of $8.9 million. This tight liquidity position means that managing the burn rate, which is heavily influenced by R&D and G&A spending, is paramount while awaiting the U.S. regulatory outcome.

The key cost elements driving the current operating profile include:

• Significant R&D spend for clinical and regulatory work.
• G&A/SG&A reflecting commercial preparation costs.
• Costs associated with the initial European LYTENAVA™ launch.
• Non-cash items impacting GAAP net loss figures.

Finance: review cash runway based on current burn rate by Monday.

Outlook Therapeutics, Inc. (OTLK) - Canvas Business Model: Revenue Streams

You're looking at the initial revenue generation phase for Outlook Therapeutics, Inc. (OTLK), which is a significant pivot from its prior pre-revenue status. The revenue streams are currently anchored in Europe but pivot heavily on the upcoming US regulatory decision.

Product sales of LYTENAVA™ in the European Union and the UK

The first commercial revenue for Outlook Therapeutics, Inc. was recorded in the fiscal third quarter ended June 30, 2025. This revenue consisted of initial sales of LYTENAVA™ (bevacizumab gamma) into Germany and the UK, where title to the product transferred to the distributor. The reported revenue for this period was $1.5 million. These initial sales mark the beginning of the transformation into a commercial company. The launch in the EU and UK was anticipated to commence in the second quarter of calendar year 2025.

Here's a quick look at the key financial metrics surrounding that initial revenue period:

The pace of revenue ramp-up in Europe is subject to country-specific pricing and reimbursement approvals that are still required in several EU countries.

Potential product sales of ONS-5010/LYTENAVA™ in the US (post-December 2025 PDUFA)

The primary catalyst for significant future revenue is the US market entry for ONS-5010, branded as LYTENAVA™ (bevacizumab-vikg). The U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025, for a decision on the resubmitted Biologics License Application (BLA). This review was designated as a Class 1 review, which implies a two-month review period from the date of resubmission. If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD in the United States. The US market for retinal disease treatment is estimated to require approximately 2.7 million annual injections. If approved, the product is expected to receive 12 years of regulatory exclusivity.

Licensing or distribution fees from international partners

Outlook Therapeutics, Inc. has established foundational partnerships to support its commercialization efforts outside the US. The company entered into a strategic commercialization agreement with Cencora, formerly AmerisourceBergen, to help with logistics and distribution in the EU. The initial sales in Germany and the UK were made where title transferred to the distributor, indicating a distribution-based revenue model in those initial territories.

Key partnership elements include:

• Strategic collaboration with Cencora for global commercial launch support.
• Initial sales structure involved transferring title to a distributor in Germany and the UK.
• Revenue from other international territories will depend on securing further regulatory approvals and subsequent distribution agreements.

Future sales for additional retinal indications (e.g., Diabetic Macular Edema)

The long-term revenue potential extends beyond the initial indication of wet Age-related Macular Degeneration (wet AMD). Outlook Therapeutics, Inc. is developing ONS-5010/LYTENAVA™ for other retina diseases.

The product candidate is indicated for retina disorders including:

• Diabetic Macular Edema (DME).
• Branch Retinal Vein Occlusion (BRVO).

Progression into these additional indications would represent future revenue expansion opportunities, contingent upon successful development and regulatory filings post-US approval.