Outlook Therapeutics' Financial Results and Corporate Update: A Deep Dive into the Company's Progress

Outlook Therapeutics shares have kept pace with the market so far this year, rising 12.5% while the S&P 500 is up 11.7% and the S&P 500 Health Care Sector Index has gained 7.7%. The next indications about whether that can continue will come on Wednesday. Outlook Therapeutics is due to disclose its latest financial results before the start of trading. A conference call with analysts and investors is scheduled for 10 a.m. Eastern time.

Amid the ongoing development of its ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), Outlook Therapeutics has made significant strides in its regulatory and commercialization efforts. The company's success in achieving regulatory approval for LYTENAVA™ in the European Union (EU) and United Kingdom (UK) has proven the viability of its new model, focusing on the development and commercialization of innovative ophthalmic therapies.

Outlook Therapeutics' shares are up 12.5% since the start of 2024, while the S&P 500 is up 11.7%. The company's progress in the ophthalmic space has been notable, with its LYTENAVA™ product being the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the EU and UK. This approval has provided a competitive advantage and opened up new market opportunities for the company.



Here’s a snapshot of investors’ expectations and recent history:
- Analysts expect Outlook Therapeutics to report earnings of $0.05 per share, and sales of $1.2 billion, according to the FactSet consensus estimate.
- Outlook Therapeutics reported earnings of $0.03 per share for the fourth quarter of 2023 in February, falling short of the FactSet consensus estimates of $0.04 per share, and $950 million in sales.
- The Outlook Therapeutics earnings report comes after a difficult week for biopharma earnings. Bristol Myers Squibb, Merck, Amgen, and Eli Lilly all had disappointing results. AbbVie turned in a rare positive surprise among the large-cap biopharma firms.

Outlook Therapeutics' progress in the NORSE EIGHT clinical trial is crucial for the company's future prospects. The trial is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet AMD subjects. The primary endpoint is the mean change in BCVA from baseline to week 8. The trial's success is essential for the company's regulatory submissions and commercialization plans.

More than 359 subjects have been enrolled in the NORSE EIGHT trial as of the date of this release. The company remains on track for NORSE EIGHT enrollment completion in Q3 CY2024, with topline results expected to be reported in Q4 CY2024. The resubmission of the ONS-5010 BLA is planned for Q1 CY2025.



Outlook Therapeutics' strategic collaboration with Cencora (formerly AmerisourceBergen) has significantly contributed to its financial success in 2024. This collaboration, which was part of a multi-year planning process, aims to benefit all stakeholders, including retina specialists, providers, and patients. The integrated approach facilitated by this partnership enables the company to commercialize LYTENAVA™ (bevacizumab gamma) directly in the EU, the UK, and other regions outside of the US, as well as assess potential licensing and partnering options. Additionally, if approved by the FDA, the company plans to commercialize ONS-5010/LYTENAVA™ (bevacizumab-vikg) directly in the US. This strategic collaboration has been instrumental in the company's progress towards its anticipated commercial launches in Europe, which are planned to commence in the first half of CY2025.

The receipt of Marketing Authorization in the EU and UK for LYTENAVA™ has significantly impacted the company's market access and revenue potential. This authorization provides a competitive advantage and opens up new market opportunities. The company is also assessing potential licensing and partnering options, which could generate additional revenue through royalties or milestone payments. The anticipated commercial launch in the UK and Germany in the first half of 2025 will generate revenue from sales of LYTENAVA™ in these markets.

In conclusion, Outlook Therapeutics' financial results and corporate update highlight the company's progress in the ophthalmic space, with a focus on the development and commercialization of innovative therapies for wet AMD. The company's success in achieving regulatory approval for LYTENAVA™ in the EU and UK, along with its progress in the NORSE EIGHT clinical trial and strategic collaboration with Cencora, positions the company well for future growth and success. Investors should closely monitor the company's financial results and corporate updates to stay informed about its progress and potential investment opportunities.