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Outlook Therapeutics
Outlook Therapeutics (OTLK) investor relations material
Outlook Therapeutics Q1 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q1 2026 earnings summary17 Feb, 2026
Executive summary
LYTENAVA (bevacizumab gamma) launched commercially in Germany and the UK in June 2025, with unit sales more than doubling quarter-over-quarter following launches in Germany, the UK, and Austria.
Additional European launches are planned for Ireland and the Netherlands in 2026, and France, Italy, and Spain in 2027, with ongoing partnership discussions in other regions.
The company is seeking FDA approval for ONS-5010/LYTENAVA in the US but received a third Complete Response Letter (CRL) in December 2025, with the FDA requesting additional confirmatory efficacy data; a Type A meeting request was submitted to address this.
Net loss for the quarter ended December 31, 2025 was $23.1 million, compared to net income of $17.4 million in the prior year period.
There is substantial doubt about the company's ability to continue as a going concern due to insufficient cash to fund operations for the next year.
Financial highlights
Revenues, net for the quarter were negative $1.2 million, primarily due to a $1.1 million increase in returns reserve from lower-than-forecasted sell-through in the UK and administrative fees.
Research and development expenses decreased to $3.6 million from $9.7 million year-over-year, mainly due to lower clinical trial costs.
Selling, general and administrative expenses decreased to $8.6 million from $11.9 million, reflecting lower compensation and professional fees, partially offset by higher Europe launch expenses.
Net cash used in operating activities was $14.9 million; net cash provided by financing activities was $15.5 million, mainly from ATM equity sales.
Cash and cash equivalents stood at $8.7 million as of December 31, 2025, excluding $2.4 million in net proceeds from an at-the-market offering received after quarter-end.
Outlook and guidance
Additional financing is required to fund operations and commercialization efforts; management is evaluating licensing, partnerships, debt, and equity options.
Continued commercial expansion in Europe is expected, with launches in additional EU countries and ongoing efforts to secure partnerships in other global markets.
The company plans to focus on working with the FDA for a regulatory pathway and preparing for a potential US launch if approved.
Reconcile FDA's CRL effectiveness concern.
Prevent future short-dated product returns?
Cash runway with new confirmatory evidence costs?
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Next Outlook Therapeutics earnings date
Q2 202614 May, 2026
Outlook Therapeutics
Next Outlook Therapeutics earnings date
Q2 202614 May, 2026
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Frequently asked questions
Outlook Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing and launching innovative treatments for ocular diseases. The company is currently working on ONS-5010 / LYTENAVA™ (bevacizumab-vikg), aiming to make it the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal conditions such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO). The company is headquartered in Iselin, New Jersey, and its shares are listed on the Nasdaq.
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