Apellis Pharmaceuticals, a prominent name in the biopharmaceutical industry, has been making waves with its new eye disease treatment.
On October 6, 2023, JP Morgan issued a noteworthy upgrade for the Apellis (APLS), changing its previous “Neutral” rating to “Overweight.” This upgrade suggests a bullish sentiment towards the stock’s future performance.
Alongside this rating change, JP Morgan also adjusted the price target for the stock, increasing it from $60 to $81. This adjustment in the price target signifies increased confidence in the stock’s potential to appreciate in value, aligning with their more positive outlook.
This US stocks upgrade and price target change reflect the evolving sentiment of the financial markets and can influence investor decisions and market dynamics.
Apellis’s Latest Stock Performance
On the last trading day, APLS stock closing price was $37.62 after starting a trading of $36.54, hitting a low of $36.48, and reaching a high of $40.67, indicating some volatility in the stock. Its earnings per share (EPS) over the trailing twelve months (TTM) stood at -5.84, suggesting a period of negative profitability. The company has a total market capitalization of $4.62 billion.
However, the company’s cash flow per share was $5.31, potentially indicating a strong cash position to support its operations. The book value per share was $2.94, indicating the net asset value of the company per share. Total of 3,215,786 shares changed hands on the day.
What Happened Recently?
The Launch of SYFOVRE®
Oct. 05, 2023, Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) provided an update on the launch of SYFOVRE®.
SYFOVRE® is a breakthrough therapy for the treatment of geographic atrophy secondary to age-related macular degeneration. It has experienced robust initial uptake since its launch. In just seven months, Apellis has distributed more than 100,000 vials of SYFOVRE® for both commercial use and clinical studies.
Demand for SYFOVRE®
The demand for SYFOVRE® has been steadily increasing on a week-over-week basis since August, with orders coming from both new and existing sites of care. This strong growth in demand demonstrates the significant unmet need and the strength of SYFOVRE’s product profile.
The Implementation of a Permanent J-Code
Understanding the J-Code
A significant development for SYFOVRE® is the implementation of a permanent J-code, which became effective on October 1. J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of Medicare Part B treatments, which must be administered by a healthcare professional.
Impact of the J-Code
The implementation of the J-code simplifies and streamlines the billing and reimbursement procedures, allowing for efficient claim processing. With this change, Apellis expects to build on the current trends and continue to bring SYFOVRE® to people living with this chronic disease.
Safety Concerns Around SYFOVRE®
Reports of Retinal Vasculitis
However, SYFOVRE® has faced some safety concerns. In July 2023, the company received reports of retinal vasculitis, or inflammation, following treatment with the injection. These events occurred between seven and 13 days after the initial administration of the drug.
Investigation and Monitoring of Retinal Vasculitis
In response, Apellis, along with the American Society of Retina Specialists’ Research and Safety in Therapeutics (ReST), examined the reported cases. Apellis has been closely monitoring and investigating the occurrences of retinal vasculitis.
Current Status of Adverse Events
As per the latest update, the company reported 10 confirmed adverse events and two suspected events. All these events occurred after the initial administration of SYFOVRE. The events of retinal vasculitis remain extremely rare, occurring at an estimated rate of 0.01% per injection.
Expansion Plans for SYFOVRE®
Regulatory Approvals
On a positive note, Apellis is seeking to launch SYFOVRE® in additional geographies. A regulatory application seeking approval of pegcetacoplan for the same indication as in the U.S. is currently under review in Europe and several other countries.
Expected Decisions
Decisions from the regulatory bodies in Europe are expected in early 2024, while those from other countries are anticipated in the first half of 2024. The successful approval and launch in additional geographies will add an incremental stream of revenues for Apellis.
Conclusion
Apellis Pharmaceuticals has shown impressive growth, driven by its innovative eye disease treatment, SYFOVRE®. With strong financial performance, a positive stock upgrade, and promising future prospects, the company is well-positioned for continued success in the biopharmaceutical industry.
