On Friday, H.C. Wainwright maintained a positive outlook on Outlook Therapeutics Inc. (NASDAQ:OTLK), reiterating a Buy rating and a $30.00 price target for the stock. The firm's endorsement comes in anticipation of regulatory approvals and the planned commercial launch of the company's product, Lytenava, in Europe and the UK.
Outlook Therapeutics recently received a favorable opinion from the Committee for Medicinal Products for Human Use (CHMP) for ONS-5010 (Lytenava/bevacizumab) in March, setting the stage for approval within the EU this quarter. The company has also submitted a Marketing Authorization Application (MAA) in the UK. The strategy involves introducing Lytenava in the EU and the UK starting in the first quarter of 2025, with initial launches in Germany and the UK, followed by expansion to France, Italy, and Spain in the fourth quarter of 2025.
The company has partnered with Cencora for the commercialization of Lytenava in the US, EU, and UK markets. The commercial launch plan includes assembling 10 sales and marketing teams in Germany and six in the UK. Despite the noted price compression in Europe's branded anti-VEGF market, off-label use of bevacizumab is prevalent, with approximately 3 million injections per year in the EU.
For the U.S. market, the NORSE EIGHT study, aimed at securing approval, is progressing as planned. The study has enrolled 30% of its target patient population and is expected to complete enrollment by the third quarter of 2024. Top-line data from the study should be available in the fourth quarter of 2024. With all clinical trial sites operational since April, the company believes the study's timelines are realistic. Successful completion of the NORSE EIGHT study could lead to a Biologics License Application (BLA) resubmission by the end of 2024. Outlook Therapeutics is actively engaging with the FDA to resolve any issues ahead of the study's completion.
InvestingPro Insights
While H.C. Wainwright maintains a bullish stance on Outlook Therapeutics Inc. (NASDAQ:OTLK), the company's financial metrics and market performance provide additional context for investors. According to InvestingPro data, Outlook Therapeutics has a market capitalization of approximately $180.57 million, indicating its size within the biotech sector. Despite the potential for Lytenava, the company's financial health shows some concerns, with a negative operating income of around $59.86 million over the last twelve months as of Q2 2024. This is consistent with the company's strategy of investing heavily in the development and regulatory approval process for its key product.
InvestingPro Tips suggest that the stock is currently in oversold territory based on the RSI, which could indicate a potential rebound or at least stabilization in the near term. However, it's important to note that analysts do not expect the company to be profitable this year, and the company suffers from weak gross profit margins. This information is crucial for investors who are considering the long-term profitability and sustainability of Outlook Therapeutics. Additionally, the company's share price has experienced a significant decline over the last year, with a 69.46% drop in total return, reflecting the market's reaction to the company's financial performance and outlook.
For investors seeking a deeper dive into the company's metrics and additional analysis, there are more InvestingPro Tips available, which can be accessed through the dedicated InvestingPro page for Outlook Therapeutics. To enhance your investing strategy with these insights, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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