Outlook Therapeutics reports Q3 2026 results, says FDA approved Lytenava

Outlook Therapeutics (NASDAQ: OTLK ) released third-quarter financial results and hosted an earnings call on Friday.

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The full earnings call is available at Summary Outlook Therapeutics secured FDA approval for Lytenava, the only FDA-approved ophthalmic formulation of bevacizumab for wet AMD, marking a significant milestone.

The company aims for Lytenava to generate over $500 million in peak annual sales by 2030, focusing on the U.S. retina market, with a pricing strategy competitive with biosimilars.

A $55 million public offering will support the U.S. commercial launch, with expected first-year net revenue of $50 million to $75 million post-launch.

European revenues improved with a 46% increase in unit sales, and the company plans strategic expansion in Europe and potentially Asia.

The company's leadership emphasized the importance of disciplined execution for the commercial success of Lytenava, with a focus on building a strong commercial and reimbursement infrastructure.

Full Transcript OPERATOR 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 operating 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 risks 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 to differ materially from those contemplated by such forward-looking statements are discussed in the periodic reports Outlook Therapeutics files with the Securities and Exchange Commission.

These documents are available in the Investor section of the Company's website and on the Securities and Exchange Commission's website.

We encourage you to review these documents carefully.

Additionally, certain information contained on 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 Jarr, 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 Jarr, President and Chief Executive Officer.

Please proceed.

UNKNOWN, CEO Thank you, operator, and good morning, everyone.

We are entering a defining new chapter for Outlook Therapeutics.

Only three weeks ago, the FDA approved Lytenava as the only FDA-approved ophthalmic formulation of bevacizumab 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 Lytenava to the world's largest retina market.

For over 20 years, bevacizumab 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 repackaged, off-label bevacizumab across millions of injections annually.

Until now, however, physicians in the United States did not have access to an ophthalmic formulation of bevacizumab that adheres to FDA standards from manufacturing to practice and is developed specifically for administration in the eye.

We are now changing that with the approval of Lytenava.

We are not introducing an unfamiliar molecule or asking physicians to rethink the important role Avastin plays in retina care.

We are providing an approved 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.