The Pfizer Oxbryta withdrawal has drawn significant attention in the biotech space. Pfizer Inc. (NYSE:PFE) recently announced its decision to voluntarily withdraw all lots of its sickle cell disease (SCD) medication, Oxbryta (voxelotor), from markets where the drug is approved. This move marks a major shift in Pfizer’s approach to treating SCD and has raised questions about the therapy’s safety and financial implications for the company.
Why Is Pfizer Withdrawing Oxbryta?
Pfizer’s decision to withdraw Oxbryta is based on an assessment of clinical data showing that the benefits of the drug no longer outweigh its risks. Specifically, the data indicated an imbalance in vaso-occlusive crises (a common and painful SCD complication) and a higher-than-expected number of fatal events requiring further evaluation. Consequently, Pfizer has notified regulatory authorities and is discontinuing all clinical trials and access programs related to Oxbryta.
The withdrawal decision comes shortly after the European Medicines Agency (EMA) initiated a review of the drug following the concerning clinical data. Oxbryta was acquired as part of Pfizer’s 2022 purchase of Global Blood Therapeutics for $5.4 billion and had been approved by the U.S. FDA in 2019 under an accelerated pathway for patients aged 12 and older. Approval was later expanded to patients as young as four years old, and the drug was authorized for use in over 35 countries.
Financial Impact of Oxbryta Withdrawal on Pfizer
Despite the Pfizer Oxbryta withdrawal, the company’s financial outlook for 2024 remains unaffected. During the first half of the year, Oxbryta sales reached $176 million, marking a 19% year-over-year increase. However, these sales figures are modest compared to Pfizer’s other product lines. The company expects total revenues for 2024 to be between $59.5 billion and $62.5 billion, an upward revision from the previous guidance of $58.5 billion to $61.5 billion.
Adjusted earnings per share (EPS) are projected to be between $2.45 and $2.65, up from the previous guidance of $2.15 to $2.35. These figures include the dilution impact from Pfizer’s acquisition of Seagen (NASDAQ:SGEN), highlighting the company’s broader strategic focus on diversifying its portfolio.
Pfizer’s Position in the Market and Stock Performance
Pfizer stock has faced challenges in 2024, with shares rising only 0.4% year to date, trailing the broader industry growth of 22.5%. The Oxbryta withdrawal raises questions about Pfizer’s near-term prospects in the sickle cell treatment market, but it does not significantly impact the company’s financial health or broader revenue streams.
Competing Biotech Stocks Poised for Growth
Other biotech companies are capitalizing on growth opportunities within the SCD and broader biotech markets:
ADMA Biologics (NASDAQ:ADMA): ADMA has shown robust performance, with its earnings estimates rising over the last 60 days. The company’s year-to-date share price has surged by 331.2%, and it has reported a four-quarter average earnings surprise of 105.63%.
Bioventus (NYSE:BVS): The company’s earnings estimates for 2024 have increased from $0.27 to $0.40 per share in the past 60 days. Shares have jumped 120.5% year to date, and Bioventus reported an impressive average earnings surprise of 102.86% over the past four quarters.
Krystal Biotech (NASDAQ:KRYS): Krystal Biotech has seen its EPS estimates rise for both 2024 and 2025. Year-to-date, shares have climbed 44.7%, and the company has delivered a four-quarter average earnings surprise of 45.95%. Krystal Biotech is increasingly seen as a strong contender in the biotech market, with promising therapies in its pipeline.
Broader Biotech Market and Infrastructure Growth
The Pfizer Oxbryta withdrawal reflects the challenges pharmaceutical companies face in developing safe and effective treatments, but it does not diminish the overall growth potential in the biotech sector. With bipartisan support for U.S. infrastructure investment, there are expectations for significant opportunities within the biotech industry, especially companies engaged in therapies and technologies that could benefit from increased healthcare and life sciences funding.
Conclusion
While the Pfizer Oxbryta withdrawal signals a setback in the company’s sickle cell disease portfolio, it has a limited impact on Pfizer’s overall financial guidance and long-term strategic direction. With competitors like ADMA Biologics, Bioventus, and Krystal Biotech leading innovation in the biotech field, the sector remains ripe for growth. As Pfizer focuses on its broader portfolio, including the recently acquired Seagen, the withdrawal of Oxbryta underscores the company’s commitment to safety and effective therapies.
Featured Image: Freepik
