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BRISBANE, Calif. - Pacira BioSciences, Inc. (NASDAQ:PCRX), a company specializing in non-opioid pain therapies with annual revenues of $701 million and an impressive 64% gross margin, has reached a settlement in its patent litigation with Fresenius Kabi USA, LLC, Jiangsu Hengrui Pharmaceuticals Co., Ltd., and eVenus Pharmaceuticals Laboratories, Inc. regarding its product EXPAREL® (bupivacaine liposome injectable suspension).
As part of the settlement, Fresenius will be granted a license to sell volume-limited amounts of a generic version of EXPAREL in the United States starting at an undisclosed date in early 2030. These volume limits will start at a high-single-digit percentage of total U.S. market volumes and will gradually increase until reaching a high-thirties percentage in the final three years of the agreement. Additionally, beginning no earlier than 2039, Fresenius will have the right to sell an unlimited quantity of the generic product in the U.S. According to InvestingPro analysis, Pacira's stock appears undervalued compared to its Fair Value, suggesting potential upside from the current price of $22.92.
This settlement comes before the expiration of Pacira's last-to-expire Orange Book-listed patents for EXPAREL, which are due on July 2, 2044. The agreement is expected to provide clarity on EXPAREL's market exclusivity and is seen as a recognition of the strength of Pacira's intellectual property portfolio.
Frank D. Lee, CEO of Pacira, stated that the company is confident in its EXPAREL intellectual property portfolio and that the settlement appropriately acknowledges the patents' strength. With the litigation resolved, Pacira aims to focus on advancing its '5x30' strategy, which includes developing new treatments for chronic pain management. The company's strong financial health score of "GREAT" on InvestingPro, along with its impressive 44% stock price gain over the past six months, suggests investor confidence in this strategy. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
EXPAREL is an analgesic approved for various uses in postsurgical pain management, while Pacira's portfolio also includes ZILRETTA® for osteoarthritis knee pain and the iovera° device for drug-free pain control. The company is also developing a gene therapy, PCRX-201, for diseases like osteoarthritis.
The information in this article is based on a press release statement from Pacira BioSciences, Inc.
In other recent news, Pacira BioSciences has initiated a Phase 2 study for its gene therapy candidate PCRX-201, aimed at treating osteoarthritis of the knee. This trial, which plans to enroll about 135 patients, will assess the safety and efficacy of the therapy, with initial topline results expected before the end of 2026. Additionally, Pacira has adopted a majority voting standard for director elections in uncontested situations, signaling a shift towards enhanced corporate governance. Meanwhile, DOMA Perpetual Capital Management has nominated three candidates for Pacira's Board of Directors, citing a need for improved financial and legal expertise. DOMA, a significant shareholder, criticizes the current board's capital allocation strategy and suggests more shareholder-focused financial practices.
In a related development, Needham has raised its price target for Pacira shares to $32, maintaining a buy rating. This adjustment follows Pacira's strategic updates and its acquisition of GQ Bio, the original developer of PCRX-201, for $32 million. Pacira's 2025 revenue guidance is projected between $725 million and $765 million, aligning with analyst expectations. The company's "5x30" strategy and NOPAIN initiative are anticipated to drive growth, particularly in the latter half of the year. These developments underscore Pacira's ongoing efforts to enhance shareholder value and expand its portfolio.
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