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Will Pacira's (PCRX) Exparel Aid Growth Amid High Reliance?
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Pacira BioSciences, Inc. (PCRX - Free Report) has made steady progress with its flagship product, Exparel, which is a liposome injection of bupivacaine indicated for a single-dose administration into the surgical site to produce postsurgical analgesia.
Pacira’s top line mainly comprises product revenues from Exparel sales, other product sales and royalty revenues. Demand for Exparel has been strong since its launch in 2012. PCRX is also making efforts to expand the label of Exparel, which, upon potential approval, is likely to drive sales further.
In September 2022, Pacira announced positive top-line data from two phase III studies evaluating Exparel as a lower extremity nerve block.
One study evaluated Exparel as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty. The other study investigated Exparel as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy.
Both studies met their respective primary and secondary endpoints.
PCRX plans to submit a supplemental new drug application to the FDA seeking label expansion of Exparel to include sciatic nerve blocks in the popliteal fossa, as well as femoral nerve blocks in the adductor canal, in early 2023.
Also, in September 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) rendered a positive opinion on Exparel and recommended marketing authorization for the same to treat postsurgical pain in children aged six and above.
The CHMP recommended approval for Exparel as a field block to treat somatic post-operative pain from small to medium-sized surgical wounds in children aged six years and older.
A final decision from the European Commission on the marketing authorization application for the label expansion of Exparel is expected shortly.
Successful label expansion of Exparel into additional indications is likely to boost sales further in the days ahead.
Shares of Pacira have plunged 21% so far this year compared with the industry’s decline of 31.1%.
Image Source: Zacks Investment Research
This apart, Pacira’a other products, Iovera system and Zilretta, which were added to its portfolio following the acquisition of MyoScience, Inc. and Flexion Therapeutics, respectively, are also generating incremental sales.
However, Pacira’s top line mainly comprises contributions from Exparel sales. The company remains heavily dependent on Exparel for growth since the drug accounts for a significant chunk of its revenues. Exparel contributed approximately 94% of Pacira’s total revenues in 2021. Hence, a decline in Exparel sales is likely to adversely impact the company's top line in the future. Meanwhile, the COVID-19 pandemic is negatively impacting sales, which remains an overhang.
Loss per share estimates for KalVista Pharmaceuticals have narrowed 2.1% for 2022 and 9.9% for 2023 in the past 60 days.
Earnings of KalVista Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the other two occasions. KALV witnessed an earnings surprise of 2.93% on average.
Loss per share estimates for Harpoon Therapeutics have narrowed 7.2% for 2022 and 17.6% for 2023 in the past 60 days.
Earnings of Harpoon Therapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. HARP witnessed a negative earnings surprise of 6.84% on average.
Earnings estimates for United Therapeutics have been revised upward by 9.8% for 2022 and 8.3% for 2023 in the past 60 days.
Earnings of United Therapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. UTHR delivered an earnings surprise of 7.24% on average.
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Will Pacira's (PCRX) Exparel Aid Growth Amid High Reliance?
Pacira BioSciences, Inc. (PCRX - Free Report) has made steady progress with its flagship product, Exparel, which is a liposome injection of bupivacaine indicated for a single-dose administration into the surgical site to produce postsurgical analgesia.
Pacira’s top line mainly comprises product revenues from Exparel sales, other product sales and royalty revenues. Demand for Exparel has been strong since its launch in 2012. PCRX is also making efforts to expand the label of Exparel, which, upon potential approval, is likely to drive sales further.
In September 2022, Pacira announced positive top-line data from two phase III studies evaluating Exparel as a lower extremity nerve block.
One study evaluated Exparel as a single-dose femoral nerve block in the adductor canal for postsurgical regional analgesia in patients undergoing total knee arthroplasty. The other study investigated Exparel as a single-dose sciatic nerve block in the popliteal fossa for postsurgical regional analgesia in patients undergoing bunionectomy.
Both studies met their respective primary and secondary endpoints.
PCRX plans to submit a supplemental new drug application to the FDA seeking label expansion of Exparel to include sciatic nerve blocks in the popliteal fossa, as well as femoral nerve blocks in the adductor canal, in early 2023.
Also, in September 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) rendered a positive opinion on Exparel and recommended marketing authorization for the same to treat postsurgical pain in children aged six and above.
The CHMP recommended approval for Exparel as a field block to treat somatic post-operative pain from small to medium-sized surgical wounds in children aged six years and older.
A final decision from the European Commission on the marketing authorization application for the label expansion of Exparel is expected shortly.
Successful label expansion of Exparel into additional indications is likely to boost sales further in the days ahead.
Shares of Pacira have plunged 21% so far this year compared with the industry’s decline of 31.1%.
Image Source: Zacks Investment Research
This apart, Pacira’a other products, Iovera system and Zilretta, which were added to its portfolio following the acquisition of MyoScience, Inc. and Flexion Therapeutics, respectively, are also generating incremental sales.
However, Pacira’s top line mainly comprises contributions from Exparel sales. The company remains heavily dependent on Exparel for growth since the drug accounts for a significant chunk of its revenues. Exparel contributed approximately 94% of Pacira’s total revenues in 2021. Hence, a decline in Exparel sales is likely to adversely impact the company's top line in the future. Meanwhile, the COVID-19 pandemic is negatively impacting sales, which remains an overhang.
Zacks Rank & Other Stocks to Consider
Pacira currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the same sector are KalVista Pharmaceuticals, Inc. (KALV - Free Report) , Harpoon Therapeutics, Inc. and United Therapeutics Corporation (UTHR - Free Report) , all carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for KalVista Pharmaceuticals have narrowed 2.1% for 2022 and 9.9% for 2023 in the past 60 days.
Earnings of KalVista Pharmaceuticals surpassed estimates in two of the trailing four quarters and missed on the other two occasions. KALV witnessed an earnings surprise of 2.93% on average.
Loss per share estimates for Harpoon Therapeutics have narrowed 7.2% for 2022 and 17.6% for 2023 in the past 60 days.
Earnings of Harpoon Therapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. HARP witnessed a negative earnings surprise of 6.84% on average.
Earnings estimates for United Therapeutics have been revised upward by 9.8% for 2022 and 8.3% for 2023 in the past 60 days.
Earnings of United Therapeutics surpassed estimates in two of the trailing four quarters and missed on the remaining two occasions. UTHR delivered an earnings surprise of 7.24% on average.