Outlook Therapeutics (OTLK 14.09%), a biopharmaceutical company focused on ophthalmic treatments, released its third quarter fiscal 2025 results on August 14, 2025. The company posted its first-ever commercial revenue from European sales of LYTENAVA (bevacizumab gamma), reaching $1.5 million (GAAP) and matching analyst expectations. Non-GAAP adjusted loss per share improved to $0.44, while the company’s adjusted net loss narrowed to $15.8 million. However, cash reserves (GAAP) were $8.9 million. The quarter represented a clear shift as Outlook Therapeutics moves from the clinical stage to commercial operations, but ongoing U.S. regulatory approval and capital needs remain in focus.
| Metric | Q3 FY2025(Ended June 30, 2025) | Q3 FY2025 Estimate | Q3 FY2024(Ended June 30, 2024) | Y/Y Change |
|---|---|---|---|---|
| EPS (Non-GAAP) | ($0.44) | ($0.35) | ($0.83) | 47.0 % |
| EPS (GAAP) | ($0.55) | ($0.89) | 38.2% | |
| Revenue (GAAP) | $1.5 million | $1.5 million | $0.0 million | N/A |
| Adjusted Net Loss Attributable to Common Stockholders | ($15.8 million) | ($19.2 million) | 17.7 % | |
| Cash and Cash Equivalents | $8.9 million | N/A | N/A |
Source: Analyst estimates for the quarter provided by FactSet.
About Outlook Therapeutics and Recent Focus Areas
Outlook Therapeutics develops treatments for eye diseases, specializing in medicines delivered by intravitreal injection—directly into the eye—for retinal conditions. Its lead commercial product, LYTENAVA (bevacizumab gamma), is an ophthalmic formulation of the cancer drug bevacizumab, repurposed in an authorized version for eye use. The product launched in Germany and the United Kingdom in the latest quarter, signaling the company’s first step into sales and revenue generation after years in clinical development.
The company’s focus has shifted to launching commercial operations, securing regulatory approvals, and supporting product access in Europe and, potentially, the United States. Key factors for ongoing success include growing sales of LYTENAVA, managing cash and expenses carefully, and obtaining regulatory clearance in new markets, especially the U.S. where revenue opportunity is significant.
Quarter Highlights and Developments
The third quarter brought a clear milestone for Outlook Therapeutics: it became a commercial-stage company with the first sales of LYTENAVA in Europe. These initial sales into Germany and the UK totaled $1.5 million (GAAP), matching company and analyst expectations. LYTENAVA is currently the only approved ophthalmic bevacizumab treatment for wet age-related macular degeneration (wet AMD) in the European Union and UK. Prior to this, bevacizumab use in eye care there relied on non-approved, repackaged versions.
The commercial launch follows strategic partnerships with distributor Cencora and early patient use in both Germany and the UK. The company notes, “first patients have already been dosed” confirming product adoption is underway. Revenue contribution remains small for now, but marks a starting point for further European expansion. However, the company clarified that in several EU countries, pricing and reimbursement approvals are still required before sales can proceed, which could affect future growth pace.
Adjusted net loss attributable to common stockholders improved nearly 18% compared to the same quarter last year, dropping from $19.2 million to $15.8 million (non-GAAP). General and administrative costs increased from $8.4 million in Q3 FY2024 to $9.7 million.
Looking Forward
The most significant near-term milestone is the pending U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) decision, scheduled for August 27, 2025, on the company’s application for LYTENAVA (bevacizumab-vikg) in the United States. If approved, this would allow Outlook Therapeutics to enter a U.S. market estimated at approximately 2.7 million annual injections for retinal disease treatment.
The company did not provide detailed financial guidance for the coming quarter or year. Investors should watch for cash burn rates, updates on additional European launches, and the success or delays in the U.S. regulatory process.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
