LOS ANGELES, CA - Puma Biotechnology, Inc. (NASDAQ:PBYI) faced a mixed outcome in its patent infringement lawsuit against AstraZeneca (NASDAQ:AZN) Pharmaceuticals LP, as a federal judge ruled on Tuesday that some of its patent claims were invalid, while others were upheld. This decision follows a jury verdict in May that favored Puma's co-plaintiff, Wyeth, awarding it $107.5 million in damages for past infringements by AstraZeneca.
The legal battle, which has been ongoing since September 22, 2021, centers on two patents held by Puma and exclusively licensed from Pfizer (NYSE:PFE), Inc. These patents, '314 and '162, relate to the treatment of non-small cell lung cancer resistant to certain medications. Puma alleged that AstraZeneca's Tagrisso® infringed on these patents.
The jury found AstraZeneca guilty of inducing infringement for all three FDA-approved uses of Tagrisso® and confirmed the validity of the patents against AstraZeneca’s challenges. However, the recent ruling by visiting Judge Matthew Kennelly of the Northern District of Illinois invalidated the patents based on lack of enablement and adequate written description for a specific claim limitation, under 35 U.S.C. § 112.
Despite the partial invalidation, the remaining findings, including the jury's verdict and the damages awarded for past infringement, stand. Wyeth has also moved for supplemental damages and ongoing royalties, while AstraZeneca seeks a new trial. Both parties completed briefing on these motions as of July 16, 2024.
Puma Biotechnology has expressed disagreement with the court's ruling on invalidity and is considering an appeal, which must be filed by September 13, 2024. This case is being closely watched as it may have implications for the pharmaceutical industry and patent law.
The information in this article is based on a press release statement from Puma Biotechnology, Inc.
In other recent news, Puma Biotechnology disclosed its second-quarter earnings for 2024. The company reported a net loss of $4.5 million, with total revenue reaching $47.1 million. A significant portion of this revenue, $44.4 million, came from the drug NERLYNX. Despite a drop in new patient starts and total prescriptions year-over-year, the company projects its net NERLYNX product revenue to range between $183 million and $190 million for 2024.
In addition to these developments, Puma Biotechnology has successfully obtained regulatory approvals for NERLYNX in Brazil and Saudi Arabia. Despite a 17% decline in ex-factory bottle sales of NERLYNX compared to the previous year, the company remains committed to maintaining a positive net income and continues to focus on NERLYNX sales trends.
InvestingPro Insights
In light of Puma Biotechnology's recent legal developments, investors are keenly watching the company's financial health and market performance. According to InvestingPro, Puma Biotechnology currently has a market capitalization of $133.16 million. Despite recent challenges, the company has been able to maintain a moderate level of debt and a high gross profit margin of 73.08% over the last twelve months as of Q2 2024. This suggests a strong operational efficiency, which could be a positive sign for investors looking for stable investments in the biotechnology sector.
One of the InvestingPro Tips indicates that analysts predict Puma Biotechnology will be profitable this year, which aligns with the company's recent profitability over the last twelve months. Additionally, the valuation implies a strong free cash flow yield, which could be appealing to investors seeking companies with the potential for good liquidity and financial flexibility. It is worth noting that the stock has experienced significant price fluctuations, with a one-week total return of -29.11% and a six-month total return of -61.16%, reflecting investor sentiment around the legal battles and market conditions.
For those interested in further analysis and additional InvestingPro Tips, there are 9 more tips available for Puma Biotechnology on InvestingPro's platform, which could provide deeper insights into the company's financial health and stock performance.
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