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Pacira (PCRX) Plummets as US Court Deems Exparel Patent Invalid
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Pacira BioSciences’ (PCRX - Free Report) shares plunged 47.7% on Aug 9, after the U.S. District Court for the District of New Jersey ruled that the company’s ‘495 patent for Exparel (bupivacaine liposome injectable suspension) is not valid.
An invalid patent means that the non-opioid pain management market would be flooded by generic versions of Pacira’s lead drug Exparel once it loses exclusivity, which will eat away from the drug’s commercial opportunity.
Please note that the company’s flagship product, Exparel, launched in 2012, is a long-acting local analgesic, which is currently approved for infiltration, fascial plane block and as an interscalene brachial plexus nerve block for postsurgical pain management.
The ruling came as part of Pacira’s ongoing litigations against eVenus Pharmaceutical Laboratories, which is looking to launch a generic version of Exparel in the United States. Consequently, PCRX filed a lawsuit against eVenus in 2021 in the U.S. District Court for the District of New Jersey, claiming that the abbreviated new drug application (ANDA) infringes upon the ‘495 patent for Exparel.
eVenus retaliated to the lawsuit alleging that the ‘495 patent is invalid and/or not infringed through the manufacture, sale or offer for sale of the product described in its 2021 ANDA submission.
Year to date, shares of PCRX have plunged 65.3% compared with the industry’s 3.4% decline.
Image Source: Zacks Investment Research
Pacira’s top line is highly dependent on revenues generated from Exparel sales. In the second quarter of 2024, the company recorded $137 million in net Exparel product sales, which accounted for 77% of the company’s total revenues for the quarter.
In the absence of a valid patent to protect Exparel against generic erosion, the top line will suffer enormously, as Pacira’s other marketed pain-management products, Zilretta and iovera, are yet to gain traction in the market.
Pacira is currently evaluating its legal options which include pursuing an appellate review at the U.S. Court of Appeals for the Federal Court as warranted.
Per Pacira, its Exparel franchise is well protected on multiple levels by its existing patents. Apart from the dispute regarding the ‘495 patent, three other infringement suits are currently underway, along with additional patents that are forthcoming.
In the past 60 days, the Zacks Consensus Estimate for Entrada Therapeutics’ 2024 loss per share has narrowed from 14 cents to 13 cents. The consensus estimate for 2025 loss per share has narrowed from $3.44 to $3.21 during the same period. Year to date, shares of TRDA have lost 7.1%.
Entrada Therapeutics beat earnings estimates in two of the last four quarters and missed twice, delivering an average earnings surprise of 42.18%.
In the past 60 days, the consensus estimate for Fulcrum Therapeutics’ 2024 loss per share has narrowed from $1.24 to 48 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.51 during the same period. Year to date, shares of FULC have jumped 31.3%.
Fulcrum Therapeutics beat earnings estimates in each of the last four quarters, delivering an average earnings surprise of 393.18%.
In the past 60 days, the consensus mark for Immatics’ loss per share has narrowed from $1.26 to $1.25 for 2024. During the same period, the Zacks Consensus Estimate for 2025 loss per share has narrowed from $1.49 to $1.41. Year to date, shares of IMTX have gained 9.5%.
Immatics beat earnings estimates in three of the last four quarters and met once, delivering an average earnings surprise of 32.57%.
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Pacira (PCRX) Plummets as US Court Deems Exparel Patent Invalid
Pacira BioSciences’ (PCRX - Free Report) shares plunged 47.7% on Aug 9, after the U.S. District Court for the District of New Jersey ruled that the company’s ‘495 patent for Exparel (bupivacaine liposome injectable suspension) is not valid.
An invalid patent means that the non-opioid pain management market would be flooded by generic versions of Pacira’s lead drug Exparel once it loses exclusivity, which will eat away from the drug’s commercial opportunity.
Please note that the company’s flagship product, Exparel, launched in 2012, is a long-acting local analgesic, which is currently approved for infiltration, fascial plane block and as an interscalene brachial plexus nerve block for postsurgical pain management.
The ruling came as part of Pacira’s ongoing litigations against eVenus Pharmaceutical Laboratories, which is looking to launch a generic version of Exparel in the United States. Consequently, PCRX filed a lawsuit against eVenus in 2021 in the U.S. District Court for the District of New Jersey, claiming that the abbreviated new drug application (ANDA) infringes upon the ‘495 patent for Exparel.
eVenus retaliated to the lawsuit alleging that the ‘495 patent is invalid and/or not infringed through the manufacture, sale or offer for sale of the product described in its 2021 ANDA submission.
Year to date, shares of PCRX have plunged 65.3% compared with the industry’s 3.4% decline.
Image Source: Zacks Investment Research
Pacira’s top line is highly dependent on revenues generated from Exparel sales. In the second quarter of 2024, the company recorded $137 million in net Exparel product sales, which accounted for 77% of the company’s total revenues for the quarter.
In the absence of a valid patent to protect Exparel against generic erosion, the top line will suffer enormously, as Pacira’s other marketed pain-management products, Zilretta and iovera, are yet to gain traction in the market.
Pacira is currently evaluating its legal options which include pursuing an appellate review at the U.S. Court of Appeals for the Federal Court as warranted.
Per Pacira, its Exparel franchise is well protected on multiple levels by its existing patents. Apart from the dispute regarding the ‘495 patent, three other infringement suits are currently underway, along with additional patents that are forthcoming.
Pacira BioSciences, Inc. Price and Consensus
Pacira BioSciences, Inc. price-consensus-chart | Pacira BioSciences, Inc. Quote
Zacks Rank & Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector include Entrada Therapeutics (TRDA - Free Report) , Fulcrum Therapeutics (FULC - Free Report) and Immatics (IMTX - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the Zacks Consensus Estimate for Entrada Therapeutics’ 2024 loss per share has narrowed from 14 cents to 13 cents. The consensus estimate for 2025 loss per share has narrowed from $3.44 to $3.21 during the same period. Year to date, shares of TRDA have lost 7.1%.
Entrada Therapeutics beat earnings estimates in two of the last four quarters and missed twice, delivering an average earnings surprise of 42.18%.
In the past 60 days, the consensus estimate for Fulcrum Therapeutics’ 2024 loss per share has narrowed from $1.24 to 48 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.51 during the same period. Year to date, shares of FULC have jumped 31.3%.
Fulcrum Therapeutics beat earnings estimates in each of the last four quarters, delivering an average earnings surprise of 393.18%.
In the past 60 days, the consensus mark for Immatics’ loss per share has narrowed from $1.26 to $1.25 for 2024. During the same period, the Zacks Consensus Estimate for 2025 loss per share has narrowed from $1.49 to $1.41. Year to date, shares of IMTX have gained 9.5%.
Immatics beat earnings estimates in three of the last four quarters and met once, delivering an average earnings surprise of 32.57%.