BeiGene , Ltd. (NASDAQ:BGNE), a biopharmaceutical company, has reached a settlement agreement with MSN Pharmaceuticals, Inc., resolving ongoing patent litigation concerning its cancer drug, BRUKINSA® (zanubrutinib).
The agreement, dated November 14, 2024, permits MSN to begin selling a generic version of BRUKINSA in the United States no earlier than June 15, 2037, with certain conditions allowing for a possible earlier or later market entry.
The dispute arose after MSN filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA), seeking approval to market a generic form of BRUKINSA and contesting several patents listed in the FDA's Orange Book.
These patents are related to BRUKINSA, a treatment for mantle cell lymphoma, among other indications. Notably, MSN did not challenge the composition of matter patent for BRUKINSA, which expires in April 2034.
As part of the settlement, both parties will submit the agreement for review by the U.S. Federal Trade Commission and the U.S. Department of Justice, as per regulatory requirements. Additionally, a joint stipulation has been filed to dismiss the lawsuit.
This settlement follows a similar resolution between BeiGene and Sandoz (SIX:SDZ) Inc., where patent litigation was dismissed by the United States District Court for the District of New Jersey. These developments conclude all patent litigation related to ANDA filings for generic versions of BRUKINSA by BeiGene.
The news comes as a significant step for BeiGene, ensuring market exclusivity for BRUKINSA well into the next decade. This exclusivity is critical for the company's revenue, as BRUKINSA is a key product in its oncology portfolio.
BeiGene is headquartered in the Cayman Islands and operates globally, with a significant presence in the pharmaceutical industry, particularly in the field of cancer treatments. The company's shares are traded on the NASDAQ Global Select Market under the ticker BGNE and on The Stock Exchange of Hong Kong Limited under the ticker 06160.
Investors and stakeholders in the pharmaceutical sector may view this settlement as an affirmation of BeiGene's intellectual property rights and its commitment to defending its product portfolio. The information contained in this article is based on BeiGene's recent SEC filing.
In other recent news, BeiGene, soon to be known as BeOne Medicines Ltd., has seen a series of noteworthy developments. The company announced a proposed name change, pending shareholder approval, to better align with its corporate identity. This rebranding will also involve a new ticker symbol, "ONC", on the NASDAQ Global Select Market.
In earnings and revenue results, BeiGene reported third-quarter earnings with a revenue of $1.1 billion, surpassing the consensus estimate of $980.5 million. This increase, a 28% improvement from the same period last year, was primarily driven by the robust sales of the cancer drug Brukinsa in the US and Europe. However, a narrower loss per share of $0.09 was reported, lower than the prior-year quarter's earnings per share of $0.15.
TD Cowen, a known analyst firm, raised its price target for BeiGene from $254 to $260, maintaining a Buy rating. This upgrade follows the successful performance of Brukinsa, which generated $690 million in quarterly revenue, exceeding both TD Cowen's and the consensus estimates. The company's pipeline is also progressing, with over ten new molecular entities slated to enter Phase 1 clinical trials by the end of 2024.
InvestingPro Insights
BeiGene's recent settlement agreement securing market exclusivity for BRUKINSA until at least 2037 aligns well with the company's strong market position and growth prospects. According to InvestingPro data, BeiGene boasts impressive revenue growth, with a 50.22% increase over the last twelve months as of Q3 2024, and a 39.54% quarterly growth in Q3 2024. This growth trajectory is supported by InvestingPro Tips, which indicate that analysts anticipate sales growth in the current year.
The company's gross profit margin of 83.67% underscores its efficiency in manufacturing and highlights the potential profitability of drugs like BRUKINSA. An InvestingPro Tip notes BeiGene's "impressive gross profit margins," which is crucial for sustaining research and development efforts in the competitive pharmaceutical industry.
Despite these positive indicators, it's worth noting that BeiGene is currently operating at a loss, with a negative operating income of $886.09 million over the last twelve months. This is reflected in the InvestingPro Tip suggesting that analysts do not anticipate the company to be profitable this year. However, given the recent legal victory and strong revenue growth, the company's long-term prospects remain promising.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for BeiGene, providing a deeper understanding of the company's financial health and market position.
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