1. -- Expanding EXPAREL utilization continues to drive growth with average daily sales at 109% of August 2020 --

    -- More than nine million patients treated with EXPAREL as of August 2021 --

    PARSIPPANY, N.J., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales. EXPAREL® (bupivacaine liposome injectable suspension) net product sales increased 15 percent to $41.4 million for the month of August 2021, compared with $36.1 million for the prior year. Net product sales of iovera° increased 13 percent to $0.9 million for the month of August 2021, compared with $0.8 million…

    -- Expanding EXPAREL utilization continues to drive growth with average daily sales at 109% of August 2020 --

    -- More than nine million patients treated with EXPAREL as of August 2021 --

    PARSIPPANY, N.J., Sept. 15, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales. EXPAREL® (bupivacaine liposome injectable suspension) net product sales increased 15 percent to $41.4 million for the month of August 2021, compared with $36.1 million for the prior year. Net product sales of iovera° increased 13 percent to $0.9 million for the month of August 2021, compared with $0.8 million for the prior year. EXPAREL average daily sales for the month of August 2021 were 109 percent of August 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 22 in August 2021 and 21 in August 2020.

    "We continue to solidify our leadership position in opioid-sparing pain management with EXPAREL now having treated more than nine million patients since launch with penetration increasing across all target market segments," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "EXPAREL utilization continues to significantly outpace the recovery of the elective surgery market, which is facing additional pandemic-related challenges this summer with regional surges in delta variant cases, staffing shortages, and surgical fatigue from care teams addressing significant procedure backlogs. We expect these variables to subside and the fourth quarter to reflect improving market dynamics."

    "From a competitive standpoint, we have not experienced impact from new market entrants and EXPAREL remains extremely well positioned given its broad efficacy label that spans infiltration, field blocks and brachial plexus nerve block. In addition, a pristine safety profile and proven ability to reliably facilitate surgical migration to outpatient sites of care continue to be hallmarks of EXPAREL adoption across pediatric and adult settings. Looking ahead, we remain confident in our ability to achieve our five-year objectives and deliver topline annual growth in the high teens with operating margins that exceed 50 percent by the end of our planning period," continued Mr. Stack.

    The company's net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

    To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the third quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. Since its launch, EXPAREL has been used in over nine million patients.   The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL and iovera°; the rate and degree of market acceptance of EXPAREL and iovera°; the size and growth of the potential markets for EXPAREL and iovera° and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL and iovera°; the ability to successfully integrate any future acquisitions into the company's existing business and the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Kristin Capone, (973) 588-2108
    kcapone@coynepr.com

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  2. PARSIPPANY, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference at 7:00 AM ET on Monday, September 13, 2021. Pre-recorded audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome…

    PARSIPPANY, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference at 7:00 AM ET on Monday, September 13, 2021. Pre-recorded audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

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  3. PARSIPPANY, N.J., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $40.9 million and $1.0 million, respectively, for the month of July 2021. EXPAREL average daily sales for the month of July 2021 were 117 percent of July 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 21 in July 2021 and 23 in July 2020.

    "The continued growth of EXPAREL reflects its accelerating deployment…

    PARSIPPANY, N.J., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $40.9 million and $1.0 million, respectively, for the month of July 2021. EXPAREL average daily sales for the month of July 2021 were 117 percent of July 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL selling days were 21 in July 2021 and 23 in July 2020.

    "The continued growth of EXPAREL reflects its accelerating deployment as the opioid-free local analgesic of choice given its enduring efficacy, excellent safety profile and proven ability to reliably facilitate surgical migration to outpatient sites of care," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Following record-level revenue in the second quarter, EXPAREL demand remains strong leaving us confident in our ability to achieve our five-year goals of top line growth in at least the high teens and operating margins that exceed 50 percent."

    The company's net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

    To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the third quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL and iovera°; the rate and degree of market acceptance of EXPAREL and iovera°; the size and growth of the potential markets for EXPAREL and iovera° and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL and iovera°; the ability to successfully integrate any future acquisitions into the company's existing business and the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

    Investor Contact:

    Susan Mesco, (973) 451-4030

    susan.mesco@pacira.com

    Media Contact:

    Coyne Public Relations

    Kristin Capone, (973) 588-2108

    kcapone@coynepr.com



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  4. PARSIPPANY, N.J., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 Wedbush PacGrow Healthcare Virtual Conference at 10:20 AM ET on Tuesday, August 10, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable…

    PARSIPPANY, N.J., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 Wedbush PacGrow Healthcare Virtual Conference at 10:20 AM ET on Tuesday, August 10, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.





    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

    Primary Logo

    View Full Article Hide Full Article
  5. -- EXPAREL average daily sales at 178% of the prior year second quarter --
    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the second quarter of 2021.

    Second Quarter 2021 Financial Highlights

    • Total revenues of $135.6 million
    • GAAP net income of $19.1 million, or $0.43 per share (basic) and $0.42 (diluted)
    • Non-GAAP Adjusted EBITDA of $50.3 million

    "We made terrific progress in the first half of 2021 with strong sales momentum in the second quarter and continuing in recent weeks," said Dave Stack, chairman and chief executive…

    -- EXPAREL average daily sales at 178% of the prior year second quarter --

    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the second quarter of 2021.

    Second Quarter 2021 Financial Highlights

    • Total revenues of $135.6 million
    • GAAP net income of $19.1 million, or $0.43 per share (basic) and $0.42 (diluted)
    • Non-GAAP Adjusted EBITDA of $50.3 million

    "We made terrific progress in the first half of 2021 with strong sales momentum in the second quarter and continuing in recent weeks," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Record revenue in the second quarter significantly ramped our bottom line, allowing us to achieve our highest-ever adjusted EBITDA for a quarter. Market dynamics remain highly favorable and leave us confident that we will deliver robust topline growth, improved margins, and accelerating earnings for the remainder of 2021, leaving us well-positioned to achieve the goals laid out within our five-year plan."

    Second Quarter 2021 Financial Results

    • Total revenues were $135.6 million in the second quarter of 2021, versus the $75.5 million reported for the second quarter of 2020.
    • EXPAREL net product sales were $130.1 million in the second quarter of 2021, versus the $73.0 million reported for the second quarter of 2020.
    • Second quarter 2021 iovera° net product sales were $3.8 million, versus the $1.4 million reported for the second quarter of 2020.
    • Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.0 million in the second quarter of 2021, versus the $0.8 million in the second quarter of 2020.
    • Second quarter 2021 royalty and collaborative licensing and milestone revenues were $0.7 million, versus the $0.3 million in the second quarter of 2020.
    • Total operating expenses were $100.7 million in the second quarter of 2021, compared to $82.7 million in the second quarter of 2020.
    • Research and development (R&D) expenses were $12.6 million in the second quarter of 2021, compared to $13.6 million in the second quarter of 2020. R&D expenses included $4.6 million and $6.1 million of product development and manufacturing capacity expansion costs in the second quarters of 2021 and 2020, respectively.
    • Selling, general and administrative (SG&A) expenses were $50.8 million in the second quarter of 2021, compared to $43.3 million in the second quarter of 2020.
    • GAAP net income was $19.1 million, or $0.43 per share (basic) and $0.42 (diluted), in the second quarter of 2021, compared to a GAAP net loss of $7.3 million, or $0.17 per share (basic and diluted), in the second quarter of 2020.
    • Non-GAAP net income was $35.3 million, or $0.80 per share (basic) and $0.77 (diluted), in the second quarter of 2021, compared to non-GAAP net income of $5.0 million, or $0.12 per share (basic and diluted), in the second quarter of 2020.
    • Adjusted EBITDA was $50.3 million in the second quarter of 2021, compared to $8.5 million in the second quarter of 2020.
    • Pacira ended the second quarter of 2021 with cash, cash equivalents and short-term investments ("cash") of $646.6 million. Cash provided by operations was $30.1 million in the second quarter of 2021, compared to cash used in operations of $15.6 million in the second quarter of 2020.
    • Pacira had 44.1 million basic and 45.6 million diluted weighted average shares of common stock outstanding in the second quarter of 2021.

    See "Non-GAAP Financial Information" below.

    Recent Business Highlights

    • FDA approval of enhanced EXPAREL manufacturing process. In July 2021, the U.S. Food and Drug Administration (FDA) approved the company's enhanced manufacturing process for EXPAREL, which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.



    • Patent granted for EXPAREL. In June 2021, the United States Patent and Trademark Office issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, "Manufacturing of Bupivacaine Multivesicular Liposomes," claims composition of EXPAREL prepared by an improved manufacturing process and will have an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) in July 2021.



    • Distribution agreement with Eurofarma in Latin America. In June 2021, Pacira announced a distribution agreement with Eurofarma Laboratories S.A. (Eurofarma) for the development and commercialization of EXPAREL in Latin America. Under the terms of the agreement, Eurofarma obtained the exclusive right to market and distribute EXPAREL in 19 countries including Argentina, Brazil, Colombia, and Mexico.

    Financial Guidance

    The company's net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise. In order to provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company reports average daily growth rates for EXPAREL to normalize for differences in the number of selling days per reporting period. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. 

    Today's Conference Call and Webcast Reminder

    The Pacira management team will host a conference call to discuss the company's financial results and recent developments today, Tuesday, August 3, 2021, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9991311. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 9991311. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    Non-GAAP Financial Information

    This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense and adjusted EBITDA, because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

    These measures supplement the company's financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2021 and to help make managerial decisions. In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL and iovera°; the rate and degree of market acceptance of EXPAREL and iovera°; the size and growth of the potential markets for EXPAREL and iovera° and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL and iovera°; the ability to successfully integrate any future acquisitions into the company's existing business and the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

     

    1Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    (Tables to Follow)

    Pacira BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     June 30,

    2021
     December 31,

    2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$105,774  $99,957 
    Short-term investments540,821  421,705 
    Accounts receivable, net68,357  53,046 
    Inventories, net65,264  64,650 
    Prepaid expenses and other current assets12,363  12,265 
    Total current assets792,579  651,623 
    Long-term investments  95,459 
    Fixed assets, net153,302  136,688 
    Right-of-use assets, net71,252  74,492 
    Goodwill99,547  99,547 
    Intangible assets, net92,588  96,521 
    Deferred tax assets98,599  106,164 
    Equity investment and other assets17,966  14,019 
    Total assets$1,325,833  $1,274,513 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$12,179  $10,431 
    Accrued expenses52,163  70,974 
    Lease liabilities5,644  7,425 
    Convertible senior notes (1)153,681  149,648 
    Contingent consideration5,026  14,736 
    Income taxes payable  114 
    Total current liabilities228,693  253,328 
    Convertible senior notes (2)321,708  313,030 
    Lease liabilities68,235  71,025 
    Contingent consideration12,332  13,610 
    Other liabilities7,697  3,832 
    Total stockholders' equity687,168  619,688 
    Total liabilities and stockholders' equity$1,325,833  $1,274,513 

    (1) Relates to our 2.375% convertible senior notes due 2022. These notes are classified as current at June 30, 2021 and December 31, 2020 because the note holders can convert any time on or after October 1, 2020.

    (2) Relates to our 0.750% convertible senior notes due 2025 that are not currently convertible.

    Pacira BioSciences, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    Net product sales:       
    EXPAREL$130,059   $73,046   $244,736   $174,315  
    Bupivacaine liposome injectable suspension991   775   1,784   1,981  
    Total EXPAREL / bupivacaine liposome

    injectable suspension net product sales
    131,050   73,821   246,520   176,296  
    iovera°3,813   1,395   7,081   3,665  
    Total net product sales134,863   75,216   253,601   179,961  
    Collaborative licensing and milestone revenue125      125     
    Royalty revenue602   289   891   1,228  
    Total revenues135,590   75,505   254,617   181,189  
            
    Operating expenses:       
    Cost of goods sold35,248   22,305   66,597   52,037  
    Research and development12,573   13,620   28,453   29,440  
    Selling, general and administrative50,813   43,342   99,335   88,122  
    Amortization of acquired intangible assets1,967   1,967   3,933   3,933  
    Acquisition-related charges (gains), product

    discontinuation and other
    146   1,418   2,019   (2,290) 
    Total operating expenses100,747   82,652   200,337   171,242  
    Income (loss) from operations34,843   (7,147)  54,280   9,947  
            
    Other (expense) income:       
    Interest income224   1,323   639   2,911  
    Interest expense(7,023)  (5,456)  (13,994)  (11,477) 
    Other, net(2,396)  3,969   (2,554)  (136) 
    Total other expense, net(9,195)  (164)  (15,909)  (8,702) 
    Income (loss) before income taxes25,648   (7,311)  38,371   1,245  
    Income tax (expense) benefit(6,567)  42   (8,921)  (356) 
    Net income (loss)$19,081   $(7,269)  $29,450   $889  
            
    Net income (loss) per share:       
    Basic net income (loss) per common share$0.43    $(0.17)  $0.67   $0.02  
    Diluted net income (loss) per common share$0.42    $(0.17)  $0.64   $0.02  
    Weighted average common shares outstanding:       
    Basic44,145   42,221   43,989   42,126  
    Diluted45,592   42,221   45,779   42,861  

    Pacira BioSciences, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Information

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    GAAP net income (loss)$19,081   $(7,269)  $29,450   $889  
            
    Non-GAAP adjustments:       
    Milestone revenue(125)     (125)    
    Acquisition-related charges (gains), product

    discontinuation and other
    146   1,418   2,019   (2,290) 
    Stock-based compensation10,461   9,222   20,571   18,070  
    Amortization of debt discount5,744   3,660   11,401   7,254  
    Amortization of acquired intangible assets1,967   1,967   3,933   3,933  
    Loss (gain) on investment2,476   (3,979)  2,585   (8) 
    Tax impact of non-GAAP adjustments(4,488)     (10,048)    
    Total Non-GAAP adjustments16,181   12,288   30,336   26,959  
            
    Non-GAAP net income$35,262   $5,019   $59,786   $27,848  
            
    GAAP basic net income (loss) per common share$0.43   $(0.17)  $0.67   $0.02  
    GAAP diluted net income (loss) per common share$0.42   $(0.17)  $0.64   $0.02  
            
    Non-GAAP basic net income per common share$0.80   $0.12   $1.36   $0.66  
    Non-GAAP diluted net income per common share$0.77   $0.12   $1.31   $0.65  
            
    Weighted average common shares outstanding - basic44,145   42,221   43,989   42,126  
    Weighted average common shares outstanding - diluted45,592   42,937   45,779   42,861  
            
    Cost of goods sold reconciliation:       
    GAAP cost of goods sold$35,248   $22,305   $66,597   $52,037  
    Stock-based compensation(1,465)  (1,284)  (2,917)  (2,503) 
    Non-GAAP cost of goods sold$33,783   $21,021   $63,680   $49,534  
            
    Research and development reconciliation:       
    GAAP research and development$12,573   $13,620   $28,453   $29,440  
    Stock-based compensation(1,329)  (1,357)  (2,435)  (2,544) 
    Non-GAAP research and development$11,244   $12,263   $26,018   $26,896  
            
    Selling, general and administrative reconciliation:       
    GAAP selling, general and administrative$50,813   $43,342   $99,335   $88,122  
    Stock-based compensation(7,667)  (6,581)  (15,219)  (13,023) 
    Non-GAAP selling, general and administrative$43,146   $36,761   $84,116   $75,099  

    Pacira BioSciences, Inc.

    Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA (Non-GAAP)

    (in thousands)

    (unaudited)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2021 2020 2021 2020
    GAAP net income (loss)$19,081   $(7,269)  $29,450   $889  
            
    Interest income(224)  (1,323)  (639)  (2,911) 
    Interest expense (1)7,023   5,456   13,994   11,477  
    Income tax expense (benefit)6,567   (42)  8,921   356  
    Depreciation expense2,931   3,023   5,815   5,877  
    Amortization of acquired intangible assets1,967   1,967   3,933   3,933  
    EBITDA37,345   1,812   61,474   19,621  
            
    Other adjustments:       
    Acquisition-related charges (gains), product discontinuation

    and other
    146   1,418   2,019   (2,290) 
    Stock-based compensation10,461   9,222   20,571   18,070  
    Milestone revenue(125)     (125)    
    Loss (gain) on investment2,476   (3,979)  2,585   (8) 
    Adjusted EBITDA (Non-GAAP)$50,303   $8,473   $86,524   $35,393  

    (1) Includes amortization of debt discount

    Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) includes GAAP to non-GAAP adjustments that reflect how the Company's management analyzes its financial results. The adjusted EBITDA figures presented here are unlikely to be comparable with adjusted EBITDA disclosures released by other companies. 



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
            
    Media Contact:
    Coyne Public Relations
    Kristin Capone, (973) 588-2108
    kcapone@coynepr.com

    Primary Logo

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  6. -- New 200-liter suite doubles capacity to meet growing EXPAREL demand --

    -- Patent covering enhanced manufacturing process extends proprietary position to January 2041 --

    PARSIPPANY, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the company's enhanced manufacturing process for EXPAREL® (bupivacaine liposome injectable suspension) which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter…

    -- New 200-liter suite doubles capacity to meet growing EXPAREL demand --

    -- Patent covering enhanced manufacturing process extends proprietary position to January 2041 --

    PARSIPPANY, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the company's enhanced manufacturing process for EXPAREL® (bupivacaine liposome injectable suspension) which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.

    "This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Launching this new manufacturing site marks an important milestone for Pacira that will allow us to double our capacity to meet the growing demand for EXPAREL, while simultaneously improving our gross margins and extending our market exclusivity into 2041."

    In June 2021, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, "Manufacturing of Bupivacaine Multivesicular Liposomes," claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) in July 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL and iovera°; the rate and degree of market acceptance of EXPAREL and iovera°; the size and growth of the potential markets for EXPAREL and iovera° and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL and iovera°; the ability to successfully integrate any future acquisitions into the company's existing business and the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

     



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
            
    Media Contact:
    Coyne Public Relations
    Kristin Capone, (973) 588-2108
    kcapone@coynepr.com

    Primary Logo

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  7. PARSIPPANY, N.J., July 29, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced new data on the ability of the iovera°® system to reduce pain, opioid consumption, and length of stay (LOS) following total knee arthroplasty (TKA). The findings show that patients receiving preoperative iovera° as part of a multimodal pain management protocol reduced both opioid intake and in-hospital pain while optimizing outcomes during the 6-week recovery period after TKA. The results of the study, A Multimodal Pain Management Protocol Including Preoperative Cryoneurolysis for Total Knee Arthroplasty to Reduce Pain, Opioid Consumption, and Length of Stay, were published in Arthroplasty Today.

    This retrospective analysis utilized…

    PARSIPPANY, N.J., July 29, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced new data on the ability of the iovera°® system to reduce pain, opioid consumption, and length of stay (LOS) following total knee arthroplasty (TKA). The findings show that patients receiving preoperative iovera° as part of a multimodal pain management protocol reduced both opioid intake and in-hospital pain while optimizing outcomes during the 6-week recovery period after TKA. The results of the study, A Multimodal Pain Management Protocol Including Preoperative Cryoneurolysis for Total Knee Arthroplasty to Reduce Pain, Opioid Consumption, and Length of Stay, were published in Arthroplasty Today.

    This retrospective analysis utilized data from patients who underwent TKA by a single surgeon at one center. Patients who received iovera° before TKA were compared with a historical control group including patients who underwent TKA without iovera°. Both groups received a similar perioperative multimodal pain management protocol. The primary outcome was opioid intake at various time points from hospital stay to 6 weeks after discharge. Additional outcomes included pain, length of stay (LOS), and range of motion. The study population included a total of 267 patients, with 169 patients in the iovera° group and 98 patients in the control group.

    Results showed that patients undergoing TKA who received iovera° compared to those who did not demonstrated a significant:

    • Decrease in daily opioid consumption, as the iovera° group had 51% lower daily morphine milligram equivalents (MMEs) than the control group (47 vs 97 MMEs; ratio estimate, 0.49 [95% confidence interval (CI), 0.43-0.56]; P<.0001)
    • Decrease in mean and maximum pain scores (P<.0001)
    • Decrease in average hospital LOS (P<0.0001), with 17% of patients having an overall LOS of 2 or more days, compared with 99% of patients in the control group (P<.0001)
    • Greater range of motion, as indicated by greater flexion degree at discharge (P<.0001)

    "Our analysis underscores the benefits of optimizing pain control in the perioperative period with the addition of iovera° to a multimodal TKA pain protocol," said Dr. Joshua Urban, M.D., orthopedic surgeon at OrthoNebraska and lead author on the study publication. "This approach allows patients to take fewer opioids during hospitalization and the 6-week recovery period, reduce their hospital LOS, decrease readmission rate and face fewer postoperative complications."

    Results of this study are consistent with findings from clinical trial and retrospective data that indicate a multimodal pain management protocol with preoperative iovera° treatment of the superficial genicular nerves reduced opioid consumption without increasing pain for up to 12 weeks after TKA compared with a standard multimodal pain management protocol.1,2

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.3 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Company Contact:

    Pacira BioSciences, Inc.

    Susan Mesco, (973) 451-4030

    susan.mesco@pacira.com

    Media Contact:

    Coyne Public Relations

    Kristin Capone

    (973) 588-2108

    kcapone@coynepr.com

    _____________________

    1 V. Dasa, G. Lensing, M. Parsons, et al., Percutaneous freezing of sensory nerves prior to total knee arthroplasty Knee, 23 (2016), p. 523

    2 W.M. Mihalko, A. Kerkhof, J.L. Guyton, et al., Cryoneurolysis prior to total knee arthroplasty reduces postoperative pain and opioid use, Orthop Proc, 101-B (2019), p. 69

    3 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.



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  8. PARSIPPANY, N.J., July 20, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will report its second quarter financial results before the open of the U.S. markets on Tuesday, August 3, 2021. Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

    To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9991311. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will…

    PARSIPPANY, N.J., July 20, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will report its second quarter financial results before the open of the U.S. markets on Tuesday, August 3, 2021. Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

    To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9991311. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 9991311. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    About Pacira

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Investor Contact:
    
    Pacira BioSciences, Inc.
    Christian Pedetti, (973) 254-4387
    Christian.Pedetti@pacira.com 

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  9. -- EXPAREL average daily sales at 178% of the prior year for the second quarter and 120% of the prior year for the month of June --

    PARSIPPANY, N.J., July 13, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net revenue of $135.6 million for the second quarter of 2021. The company's total revenues include net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera°, which were $130.1 million and $3.8 million for the second quarter of 2021 and $45.8 million and $1.4 million, respectively, for the month of June 2021. EXPAREL average daily sales were 178% and 120…

    -- EXPAREL average daily sales at 178% of the prior year for the second quarter and 120% of the prior year for the month of June --

    PARSIPPANY, N.J., July 13, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net revenue of $135.6 million for the second quarter of 2021. The company's total revenues include net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera°, which were $130.1 million and $3.8 million for the second quarter of 2021 and $45.8 million and $1.4 million, respectively, for the month of June 2021. EXPAREL average daily sales were 178% and 120% of the prior year levels for the second quarter and month of June 2021, respectively.  The company reports average daily growth rates for EXPAREL to normalize for differences in the number of selling days per reporting period. The number of EXPAREL selling days were 22, 20, and 22 for the months of April, May, and June, respectively, in both 2021 and 2020. 

    "We are encouraged by the continued robust growth in EXPAREL sales with the second quarter of 2021 coming in at record levels despite the barrier of COVID-19 for many elective surgery procedures. As conditions normalize in the second half of 2021, we anticipate increasing opportunity for EXPAREL expansion," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The surgical market is accelerating its transition to outpatient settings, facilitated by our wealth of clinical data and experience to support EXPAREL-based regional approaches across a growing number of complex surgical settings. Additionally, interest in iovera° continues to mount with our educational and commercial programs highlighting its ability to deliver drug-free pain control that endures for several months. Throughout the balance of the year, we will continue to build on our established momentum as the industry leader of non-opioid pain management and regenerative health solutions."

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. EXPAREL sales in the second quarter of 2020 were significantly disrupted when the COVID-19 pandemic was at its peak and elective surgeries were largely prohibited. Elective surgery restrictions began to lift on a state-by-state basis in April 2020 and EXPAREL average daily sales returned to year-over-year growth in June 2020.

    In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the second quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the cost and timing of an early termination payment to DePuy Synthes Sales, Inc.; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

     



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Kristin Capone, (973) 588-2108
    kcapone@coynepr.com

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  10. PARSIPPANY, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that it has entered into a distribution agreement with Eurofarma Laboratories S.A. (Eurofarma) for the development and commercialization of EXPAREL® (bupivacaine liposome injectable suspension) in Latin America.

    "Through this distribution agreement with Eurofarma, Pacira is significantly expanding its global footprint in one of the fastest growing international markets. This partnership is a key achievement in our global expansion strategy and supports our mission to bring EXPAREL to patients around the world who are in need of a safe…

    PARSIPPANY, N.J., June 22, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that it has entered into a distribution agreement with Eurofarma Laboratories S.A. (Eurofarma) for the development and commercialization of EXPAREL® (bupivacaine liposome injectable suspension) in Latin America.

    "Through this distribution agreement with Eurofarma, Pacira is significantly expanding its global footprint in one of the fastest growing international markets. This partnership is a key achievement in our global expansion strategy and supports our mission to bring EXPAREL to patients around the world who are in need of a safe and effective opioid alternative for managing postsurgical pain and reducing length of stay," said Max Reinhardt, president ROW for Pacira BioSciences. "The Eurofarma team has considerable experience introducing and marketing innovative medical products throughout Latin America and we are confident they will be an ideal partner in this region."

    "This new partnership reflects the tireless work to improve the patient surgical experience and to reduce reliance on opioids in Latin America. By partnering with Pacira, Eurofarma benefits from access to the best-in-class asset in postsurgical pain," says Martha Penna, vice president of innovation at Eurofarma.

    Under the terms of the agreement, Eurofarma obtains the exclusive right to market and distribute EXPAREL in 19 countries in Latin America, including Argentina, Brazil, Colombia, and Mexico. In addition, Eurofarma will be responsible for regulatory filings for EXPAREL in these countries. Pacira will receive royalties based on Eurofarma's future commercialization of the product and is also eligible to receive milestones payments that are triggered by the achievement of certain regulatory and commercial events.

    Jones Day is acting as legal advisor to Pacira in connection with the transaction.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About Eurofarma Group

    The Eurofarma Group has been operating in the pharmaceutical industry since its establishment in Brazil in 1972, producing and marketing innovative healthcare products and services to improve patient's quality of life.   Eurofarma is a diversified company with leading operations in segment of Prescription Drug and growing participation on the segments of Oncology, Hospital-based therapeutics, among others. Eurofarma has adopted a dual growth strategy of in-licensing of innovative brands and geographic expansion in Latin America.

    The Eurofarma Group has operations in 20 countries with an industrial park in Brazil and plants in six Latin American countries. The Group employs over 7,600 staff across the continent.



    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
            
    Media Contact:
    Coyne Public Relations
    Kristin Capone, (973) 588-2108
    kcapone@coynepr.com

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  11. -- EXPAREL average daily sales for May 2021 were 162% of May 2020 --

    -- EXPAREL momentum continues with average daily sales for May 2021 at 105% of April 2021 --

    PARSIPPANY, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $41.2 million and $1.0 million, respectively, for the month of May 2021. EXPAREL average daily sales for the month of May 2021 were 162 percent of May 2020 and 105 percent of April 2021. Sales in May 2020 were negatively impacted by significant restrictions that…

    -- EXPAREL average daily sales for May 2021 were 162% of May 2020 --

    -- EXPAREL momentum continues with average daily sales for May 2021 at 105% of April 2021 --

    PARSIPPANY, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $41.2 million and $1.0 million, respectively, for the month of May 2021. EXPAREL average daily sales for the month of May 2021 were 162 percent of May 2020 and 105 percent of April 2021. Sales in May 2020 were negatively impacted by significant restrictions that were in place for elective procedures due to the COVID-19 pandemic.

            

    "EXPAREL sales continue to significantly outperform the elective surgery market recovery, with May marking our fourth consecutive month of sequential growth in average daily sales. This growing demand is driven by the increasing entrenchment of EXPAREL as the cornerstone of reliable regional-based enhanced recovery after surgery protocols that successfully facilitate the safe transition of procedures to outpatient settings, as well as the expanding use of EXPAREL in non-elective procedures, such as cesarean sections and cardiovascular surgeries. Our iovera° customer base continues to rapidly expand as our educational and commercial programs highlight the value of this novel, cold technology for drug-free pain control that endures for several months, further solidifying Pacira as a market leader in opioid-sparing pain management," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the second quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the cost and timing of an early termination payment to DePuy Synthes Sales, Inc.; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com 
    
    Media Contact:
    Coyne Public Relations
    Kristin Capone, (973) 588-2108
    kcapone@coynepr.com

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  12. -- Study did not demonstrate statistical significance for primary endpoint of pain reduction from 0 to 96 hours for EXPAREL versus bupivacaine HCl --

    PARSIPPANY, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced topline results from its Phase 3, randomized, double-blinded, active-controlled…

    -- Study did not demonstrate statistical significance for primary endpoint of pain reduction from 0 to 96 hours for EXPAREL versus bupivacaine HCl --

    -- EXPAREL achieves highly statistically significant reductions in pain and total opioid consumption from 24 to 96 hours versus bupivacaine HCl (p<0.01) --

    -- EXPAREL also hits statistical significance for area under the curve cumulative pain scores from 12 to 96 hours versus bupivacaine HCl (p<0.02) --

    PARSIPPANY, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced topline results from its Phase 3, randomized, double-blinded, active-controlled, multicenter STRIDE study. EXPAREL administered as combined sciatic (in popliteal fossa) and saphenous (in adductor canal) nerve blocks did not demonstrate statistical significance for the study's primary endpoint of reduction in cumulative pain scores from 0 to 96 hours as measured by the area under the curve versus bupivacaine HCl. EXPAREL did achieve statistical significance versus bupivacaine HCl for secondary endpoints of reducing cumulative pain scores from 24 to 96 hours post-surgery (p<0.001) and total opioid consumption from 24 to 96 hours post-surgery (p<0.01). EXPAREL also achieved statistical significance versus bupivacaine HCl for area under the curve cumulative pain scores from 12 to 96 hours (p<0.02). The EXPAREL group achieved and maintained mild pain at 36 hours (Least Square Mean NRS 3.0) while bupivacaine HCl was in the moderate range (Least Square Mean NRS 4.7).

    There were no clinically relevant safety issues observed in STRIDE, specifically no reports of falls and no serious adverse events observed in the study.

    Next Steps

    • STRIDE offers important insights into the critical position of EXPAREL as the cornerstone of multimodal protocols to achieve both early onset and prolonged pain management goals.
    • The company will complete a full analysis of the STRIDE study and plans to discuss these highly informative data and next steps with the U.S. Food and Drug Administration (FDA).
    • Pacira plans to submit the full results from the Phase 3 STRIDE study for presentation at future scientific conferences and for publication in a peer-reviewed journal.

    "In the absence of preoperative multimodal therapy, the study demonstrated the advantages of EXPAREL versus bupivacaine from 24 hours and beyond. The findings from this study are valuable and demonstrate the ability of an EXPAREL long-acting lower extremity nerve block to provide significant pain relief that extends to 96 hours. These data also add to the significant body of evidence supporting the excellent safety profile of EXPAREL," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The market is in need of additional approaches to safe and effective opioid-sparing pain management as the surgical suite remains a key gateway to opioid misuse and abuse. We look forward to discussing these important findings with FDA and defining the next steps for broadening the EXPAREL label to include lower extremity nerve blocks."

    About STRIDE

    This Phase 3, multicenter, randomized, double-blind, active controlled, 3-arm study evaluated 120 subjects undergoing lower extremity surgeries after receiving ultrasound-guided combined sciatic (in popliteal fossa) and saphenous (in adductor canal) nerve blocks. Subjects were randomized (1:1:1) to one of the following three treatments arms administered in an equally divided dose to the two nerves:

    • EXPAREL: Subjects received 20 mL (266 mg) EXPAREL mixed with 20 mL saline
    • EXPAREL + bupivacaine HCl: Subjects received 20 mL (266 mg) EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl
    • Bupivacaine HCl: Subjects received 40 mL (100 mg) 0.25% bupivacaine HCl

    The study's primary endpoint was the area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.25% bupivacaine HCl. Secondary endpoints included total postsurgical opioid consumption from 0 to 96 hours comparing EXPAREL to bupivacaine HCl and the AUC of the NRS pain intensity scores from 24 to 96 hours post-surgery comparing EXPAREL to bupivacaine HCl.  

    Prior to each procedure, patients in this study received mild sedation with 1 to 2 mg of midazolam intravenously (IV) before the block was administered. For all arms, the total volume (40 mL) was split such that 20 mL was administered as the sciatic nerve block and 20 mL was administered as the saphenous nerve block. Following the procedure, medications including acetaminophen or nonsteroidal anti-inflammatory drugs were used for the initial treatment of postsurgical pain. Rescue opioid medication was available upon request.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the cost and timing of an early termination payment to DePuy Synthes Sales, Inc.; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com 
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com 

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  13. PARSIPPANY, N.J., May 25, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 Jefferies Virtual Healthcare Conference at 9:30 AM ET on Tuesday, June 1, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension…

    PARSIPPANY, N.J., May 25, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 Jefferies Virtual Healthcare Conference at 9:30 AM ET on Tuesday, June 1, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

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  14. PARSIPPANY, N.J., May 18, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 17/156,400 related to EXPAREL® (bupivacaine liposome injectable suspension). The allowed application, "Manufacturing of Bupivacaine Multivesicular Liposomes" claims composition of EXPAREL prepared by the company's 200-liter commercial-scale manufacturing process. A Notice of Allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed. The USPTO then…

    PARSIPPANY, N.J., May 18, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application Serial Number 17/156,400 related to EXPAREL® (bupivacaine liposome injectable suspension). The allowed application, "Manufacturing of Bupivacaine Multivesicular Liposomes" claims composition of EXPAREL prepared by the company's 200-liter commercial-scale manufacturing process. A Notice of Allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed. The USPTO then grants the patent upon payment of the patent issuance fee. The new patent will have an expiration date of January 22, 2041.

    "This new patent marks the first deliverable from our comprehensive patent strategy and adds yet another layer of market exclusivity that extends our proprietary position for EXPAREL into the 2040s," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The comprehensive nature of the allowed claims underscores the deep multivesicular liposome manufacturing expertise that Pacira has accumulated over more than 25 years. Over the last six years, we have invested more than $100 million to create, design and commercialize a more efficient method for making EXPAREL, exceeding the U.S. Food and Drug Administration's (FDA) rigorous standards for safety and bioequivalence. Our innovative manufacturing processes for EXPAREL are a core competency that we are committed to safeguarding globally."  

    "Our growing intellectual property portfolio provides significant barriers of entry, protects us from would be competitors, and gives us confidence in long-term market leadership for EXPAREL as the only non-opioid, single-dose, long-acting local analgesic that is FDA-approved for infiltration, field block and brachial plexus nerve block," continued Mr. Stack.

    Pacira intends to submit the patent for listing in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) after securing FDA approval of its 200-liter manufacturing process. The FDA is currently reviewing the company's supplemental New Drug Application (sNDA) for this manufacturing process, which offers enhanced efficiencies. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 6, 2021 for the sNDA.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the cost and timing of an early termination payment to DePuy Synthes Sales, Inc.; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  15. PARSIPPANY, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 RBC Capital Markets Global Healthcare Conference at 10:20 AM ET on Tuesday, May 18, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable…

    PARSIPPANY, N.J., May 12, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 RBC Capital Markets Global Healthcare Conference at 10:20 AM ET on Tuesday, May 18, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

    Primary Logo

    View Full Article Hide Full Article
  16. PARSIPPANY, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $43.1 million and $1.5 million, respectively, for the month of April 2021. EXPAREL average daily sales for the month of April 2021 were 449% of April 2020, when the COVID-19 pandemic was at its peak and elective surgeries were largely prohibited.

    "We continue to be very encouraged by the robust and expanding demand for EXPAREL and ioverao as the market embraces the significant advantages of opioid-sparing pain control," said…

    PARSIPPANY, N.J., May 11, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $43.1 million and $1.5 million, respectively, for the month of April 2021. EXPAREL average daily sales for the month of April 2021 were 449% of April 2020, when the COVID-19 pandemic was at its peak and elective surgeries were largely prohibited.

    "We continue to be very encouraged by the robust and expanding demand for EXPAREL and ioverao as the market embraces the significant advantages of opioid-sparing pain control," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Long-acting EXPAREL-based blocks are being established as institutional protocol and revolutionizing regional anesthesia by reliably enabling earlier discharge and surgical migration to outpatient sites of care. Our ioverao commercial initiatives are taking hold and driving a significant increase in our customer base as healthcare providers recognize the value of this innovative cold therapy as an opioid-free, drug-free option for long-term pain management."

    "The Pacira Innovation and Training Center of Tampa is driving demand for new and existing EXPAREL and ioverao users through best-practice education and training. Looking ahead, given these highly favorable market conditions, as well as EXPAREL utilization consistently outpacing the recovery of the elective surgery market, we believe there is a tremendous amount of growth ahead as the COVID crisis resolves and the elective surgery market normalizes," added Mr. Stack.

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the second quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue

     
    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the cost and timing of an early termination payment to DePuy Synthes Sales, Inc.; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  17. -- EXPAREL average daily sales at 115% of the prior year first quarter--
    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., May 04, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the first quarter of 2021.

    First Quarter 2021 Financial Highlights

    • Total revenues of $119.0 million
    • GAAP net income of $10.4 million, or $0.24 per share (basic) and $0.23 (diluted)
    • Non-GAAP Adjusted EBITDA of $36.2 million

    "2021 is off to a terrific start with notable progress taking place across all areas of our business," said Dave Stack, chairman and chief executive officer of Pacira BioSciences…

    -- EXPAREL average daily sales at 115% of the prior year first quarter--

    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., May 04, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the first quarter of 2021.

    First Quarter 2021 Financial Highlights

    • Total revenues of $119.0 million
    • GAAP net income of $10.4 million, or $0.24 per share (basic) and $0.23 (diluted)
    • Non-GAAP Adjusted EBITDA of $36.2 million

    "2021 is off to a terrific start with notable progress taking place across all areas of our business," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The launch of EXPAREL for pediatric patients is going exceptionally well and already garnering a high level of receptivity and enthusiasm from key opinion leaders at the top children's hospitals. We continue to see expanding utilization of EXPAREL-based nerve and field blocks as a cornerstone of low- or no-opioid protocols that enable accelerated recovery and surgical migration to the outpatient setting, as evidenced by EXPAREL consistently outpacing the elective surgery market. In addition, commercial enhancements for iovera° are taking hold and driving a substantial increase in sales and ordering accounts."

    "The Pacira Innovation and Training Center of Tampa is addressing the market's significant demand for effective, long-acting opioid-sparing pain management strategies through a robust offering of live and virtual programs for both EXPAREL and iovera°. Looking ahead, we remain well-positioned to continue to deliver strong top- and bottom-line growth as the COVID crisis recedes and the elective surgery market normalizes," concluded Mr. Stack.

    First Quarter 2021 Financial Results

    • Total revenues were $119.0 million in the first quarter of 2021, versus $105.7 million reported for the first quarter of 2020.
    • EXPAREL net product sales were $114.7 million in the first quarter of 2021, versus $101.3 million reported for the first quarter of 2020.
    • First quarter 2021 iovera° net product sales were $3.3 million, versus $2.3 million reported for the first quarter of 2020.
    • Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $0.8 million in the first quarter of 2021, versus the $1.2 million in the first quarter of 2020.
    • First quarter 2021 royalty revenues were $0.3 million, versus the $0.9 million in the first quarter of 2020.
    • Total operating expenses were $99.6 million in the first quarter of 2021, compared to $88.6 million in the first quarter of 2020.
    • Research and development (R&D) expenses were $15.9 million in the first quarter of 2021, compared to $15.8 million in the first quarter of 2020. R&D expenses include $4.7 million and $6.6 million of product development and manufacturing capacity expansion costs in the first quarters of 2021 and 2020, respectively.
    • Selling, general and administrative (SG&A) expenses were $48.5 million in the first quarter of 2021, compared to $44.8 million in the first quarter of 2020.
    • GAAP net income was $10.4 million, or $0.24 per share (basic) and $0.23 (diluted), in the first quarter of 2021, compared to GAAP net income of $8.2 million, or $0.19 per share (basic and diluted), in the first quarter of 2020.
    • Non-GAAP net income was $24.5 million, or $0.56 per share (basic) and $0.53 (diluted), in the first quarter of 2021, compared to non-GAAP net income of $22.8 million, or $0.54 per share (basic) and $0.53 (diluted), in the first quarter of 2020.
    • Adjusted EBITDA was $36.2 million in the first quarter of 2021, compared to adjusted EBITDA of $26.9 million in the first quarter of 2020.
    • Pacira ended the first quarter of 2021 with cash, cash equivalents, short-term and long-term investments ("cash") of $625.0 million. Cash provided by operations was $12.1 million in the first quarter of 2021, compared to $6.2 million in the first quarter of 2020.
    • Pacira had 43.8 million basic and 46.0 million diluted weighted average shares of common stock outstanding in the first quarter of 2021.

    See "Non-GAAP Financial Information" below.

    Recent Business Highlights

    • Investment in Spine BioPharma. In April 2021, Pacira announced a $3.0 million investment in Spine BioPharma in the form of a convertible note. The investment will support the advancement of Spine BioPharma's lead candidate, Remedisc™, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7.0 million investment predicated upon Spine BioPharma achieving certain prespecified milestones.
    • FDA approval of EXPAREL in pediatric patients 6 years of age and older. In March 2021, the U.S. Food and Drug Administration approved the expansion of the EXPAREL label to include its use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.

    Financial Guidance

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.

    Today's Conference Call and Webcast Reminder

    The Pacira management team will host a conference call to discuss the company's financial results and recent developments today, Tuesday, May 4, 2021, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8238109. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8238109. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    Non-GAAP Financial Information

    This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense and adjusted EBITDA, because such measures exclude acquisition-related (losses) gains, product discontinuation and other; stock-based compensation; amortization of debt discount; amortization of acquired intangible assets, loss on investment, and the tax impact of non-GAAP adjustments.

    These measures supplement the company's financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2021 and to help make managerial decisions. In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, including adjusted EBITDA.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

     

    1Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.



    Pacira BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     March 31,

    2021
     December 31,

    2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$66,699  $99,957 
    Short-term investments523,364  421,705 
    Accounts receivable, net52,583  53,046 
    Inventories, net64,606  64,650 
    Prepaid expenses and other current assets12,995  12,265 
    Total current assets720,247  651,623 
    Long-term investments34,971  95,459 
    Fixed assets, net144,822  136,688 
    Right-of-use assets, net72,888  74,492 
    Goodwill99,547  99,547 
    Intangible assets, net94,554  96,521 
    Deferred tax assets104,467  106,164 
    Equity investment and other assets16,053  14,019 
    Total assets$1,287,549  $1,274,513 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$9,110  $10,431 
    Accrued expenses50,239  70,974 
    Lease liabilities5,503  7,425 
    Convertible senior notes (1)151,647  149,648 
    Contingent consideration14,864  14,736 
    Income taxes payable721  114 
    Total current liabilities232,084  253,328 
    Convertible senior notes (2)317,338  313,030 
    Lease liabilities69,666  71,025 
    Contingent consideration12,355  13,610 
    Other liabilities5,288  3,832 
    Total stockholders' equity650,818  619,688 
    Total liabilities and stockholders' equity$1,287,549  $1,274,513 

    (1) Relates to our 2.375% convertible senior notes due 2022. These notes are classified as current at March 31, 2021 and December 31, 2020 because the note holders can convert any time on or after October 1, 2021.

    (2) Relates to our 0.750% convertible senior notes due 2025 that are not currently convertible.

    Pacira BioSciences, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended
     March 31,
     2021 2020
     Net product sales:   
    EXPAREL$114,678  $101,269 
    Bupivacaine liposome injectable suspension792  1,206 
    Total EXPAREL / bupivacaine liposome injectable suspension net product sales115,470  102,475 
    iovera°3,268  2,270 
     Total net product sales118,738  104,745 
     Royalty revenue289  939 
    Total revenues119,027  105,684 
        
    Operating expenses:   
    Cost of goods sold31,349  29,732 
    Research and development15,879  15,819 
    Selling, general and administrative48,522  44,780 
    Amortization of acquired intangible assets1,967  1,967 
    Acquisition-related loss (gains), product discontinuation and other1,873  (3,708)
    Total operating expenses99,590  88,590 
    Income from operations19,437  17,094 
        
    Other (expense) income:   
    Interest income415  1,589 
    Interest expense(6,971) (6,022)
    Other, net(157) (4,104)
    Total other expense, net(6,713) (8,537)
    Income before income taxes12,724  8,557 
    Income tax expense(2,355) (398)
    Net income$10,369  $8,159 
        
    Net income per share:   
    Basic net income per common share$0.24  $0.19 
    Diluted net income per common share$0.23  $0.19 
    Weighted average common shares outstanding:   
    Basic43,833  42,032 
    Diluted45,966  42,785 

    Pacira BioSciences, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Information

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended
     March 31,
     2021 2020
    GAAP net income$10,369  $8,159 
        
    Non-GAAP adjustments:   
    Acquisition-related loss (gains), product discontinuation and other1,873  (3,708)
    Stock-based compensation10,110  8,847 
    Amortization of debt discount5,657  3,594 
    Amortization of acquired intangible assets1,967  1,967 
    Loss on investment108  3,971 
    Tax impact of non-GAAP adjustments(5,560)  
    Total Non-GAAP adjustments14,155  14,671 
        
    Non-GAAP net income$24,524  $22,830 
        
    GAAP basic net income per common share$0.24  $0.19 
    GAAP diluted net income per common share$0.23  $0.19 
        
    Non-GAAP basic net income per common share$0.56  $0.54 
    Non-GAAP diluted net income per common share$0.53  $0.53 
        
    Weighted average common shares outstanding - basic43,833  42,032 
    Weighted average common shares outstanding - diluted45,966  42,785 
        
    Cost of goods sold reconciliation:   
    GAAP cost of goods sold$31,349  $29,732 
    Stock-based compensation(1,452) (1,219)
    Non-GAAP cost of goods sold$29,897  $28,513 
        
    Research and development reconciliation:   
    GAAP research and development$15,879  $15,819 
    Stock-based compensation(1,106) (1,186)
    Non-GAAP research and development$14,773  $14,633 
        
    Selling, general and administrative reconciliation:   
    GAAP selling, general and administrative$48,522  $44,780 
    Stock-based compensation(7,552) (6,442)
    Non-GAAP selling, general and administrative$40,970  $38,338 

    Pacira BioSciences, Inc.

    Reconciliation of GAAP Net Income to Adjusted EBITDA (Non-GAAP)

    (in thousands)

    (unaudited)

     Three Months Ended
     March 31,
     2021 2020
    GAAP net income$10,369  $8,159 
        
    Interest income(415) (1,589)
    Interest expense (1)6,971  6,022 
    Income tax expense2,355  398 
    Depreciation expense2,884  2,854 
    Amortization of acquired intangible assets1,967  1,967 
    EBITDA24,131  17,811 
        
    Other adjustments:   
    Acquisition-related loss (gains), product discontinuation and other1,873  (3,708)
    Stock-based compensation10,110  8,847 
    Loss on investment108  3,971 
    Adjusted EBITDA (Non-GAAP)$36,222  $26,921 

    (1) Includes amortization of debt discount

    Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) includes GAAP to non-GAAP adjustments that reflect how the Company's management analyzes its financial results. The adjusted EBITDA figures presented here are unlikely to be comparable with adjusted EBITDA disclosures released by other companies.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
            
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  18. PARSIPPANY, N.J., April 21, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will report its first quarter financial results before the open of the U.S. markets on Tuesday, May 4, 2021. Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

    To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8238109. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be…

    PARSIPPANY, N.J., April 21, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will report its first quarter financial results before the open of the U.S. markets on Tuesday, May 4, 2021. Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

    To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8238109. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8238109. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    About Pacira

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Investor Contact:
    
    Pacira BioSciences, Inc.
    Christian Pedetti, (973) 254-4387
    Christian.Pedetti@pacira.com

    Primary Logo

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  19. NEW YORK, April 20, 2021 /PRNewswire/ -- Spine BioPharma, LLC, a company committed to developing non-opiate, non-surgical therapies for the treatment of pain and disability from chronic low back pain caused by degenerative disc disease, today announced a $3 million investment by Pacira Biosciences in the form of a convertible note. The investment will support the further development of Remedisc, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7 million investment predicated upon achieving certain prespecified milestones.

    Pacira's investment follows on the closing of Spine BioPharma's recent Series A financing round, led by Viscogliosi Bros. with participation by Vulcan Capital and…

    NEW YORK, April 20, 2021 /PRNewswire/ -- Spine BioPharma, LLC, a company committed to developing non-opiate, non-surgical therapies for the treatment of pain and disability from chronic low back pain caused by degenerative disc disease, today announced a $3 million investment by Pacira Biosciences in the form of a convertible note. The investment will support the further development of Remedisc, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7 million investment predicated upon achieving certain prespecified milestones.

    Pacira's investment follows on the closing of Spine BioPharma's recent Series A financing round, led by Viscogliosi Bros. with participation by Vulcan Capital and others. Marc Viscogliosi, CEO of Spine BioPharma, stated, "We are delighted to welcome two investment partners that bring significant biopharma expertise, relationships, and scale to our ambitious mission of changing the lives of millions of patients suffering from chronic low back pain. Remedisc represents a unique, best-in-class, first-in-class therapeutic that can provide a non-opiate, non-surgical treatment option to these patients."

    Remedisc is a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1), which is often highly expressed in the degenerated discs of patients with lower back pain. Abnormal TGFβ1 signaling is associated with the degradation of extracellular matrix components that maintain the structural integrity of healthy spinal discs. TGFβ1 is also reported to stimulate the expression of nerve growth factor leading to an increase in sensory neurons and discogenic pain. Intradiscal injection of Remedisc in patients with degenerative disc disease was developed as a first-in-class regenerative approach to treating chronic back pain and disability, preventing progression of disc degeneration through TGFβ1 modulation.

    Spine BioPharma expects to file an Investigational New Drug Application with the U.S. Food and Drug Administration seeking approval of a Phase 2/3 multicenter, randomized controlled study of Remedisc later this year.

    Troutman Pepper is acting as legal advisor to Spine BioPharma in connection with the transaction.

    About Degenerative Disc Disease

    266 million individuals around the world have Degenerative Disc Disease, or DDD, and its associated Chronic Low Back Pain each year. DDD of the lumbar, or lower, spine is a significant cause of disability in the world and a tremendous expense to the healthcare system. It is associated with a variety of clinical symptoms, including, weakness, low back pain and disability of varying levels of severity. There is currently no treatment for the underlying cause of DDD and current approaches are aimed at managing pain through a variety of approaches that include physical therapy, chiropractic care, over the counter medications like non-steroidal anti-inflammatory drugs (NSAIDS) or prescription opioids.  or patients with moderate to severe pain that persists chronically, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefit.  Given the substantial costs, pain, and disability associated with DDD, and the current lack of an approved disease-modifying agent, a therapy that could relieve pain and increase function with the potential to mediate the progression of DDD or achieve a regenerative effect could revolutionize the standard of care.

    About Spine BioPharma

    Spine BioPharma specializes in non-surgical therapies that will reduce pain, restore function and slow or stop pathological spinal disease progression without the use of  opioids. Spine BioPharma's lead candidate, Remedisc™, is a first-in-class, therapeutic for the treatment of degenerative disc disease, offering clinical benefits of pain relief, restoration of function and potential prevention of disease progression. To learn more about Spine BioPharma, visit www.spinebiopharma.com.

    About Pacira Biosciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    Cision View original content:http://www.prnewswire.com/news-releases/spine-biopharma-announces-investment-by-pacira-biosciences-301272300.html

    SOURCE Spine Biopharma, LLC

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  20. -- Supports clinical advancement of lead candidate, Remedisc, for degenerative disc disease --

    PARSIPPANY, N.J., April 20, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced a $3 million investment in Spine BioPharma in the form of a convertible note. The investment will support the advancement of Spine BioPharma's lead candidate, Remedisc™, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7 million investment predicated upon Spine BioPharma achieving certain prespecified milestones.

    "We are excited to support Spine BioPharma as they share…

    -- Supports clinical advancement of lead candidate, Remedisc, for degenerative disc disease --

    PARSIPPANY, N.J., April 20, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced a $3 million investment in Spine BioPharma in the form of a convertible note. The investment will support the advancement of Spine BioPharma's lead candidate, Remedisc™, a first-in-class therapeutic for the treatment of degenerative disc disease. Pacira will make an additional $7 million investment predicated upon Spine BioPharma achieving certain prespecified milestones.

    "We are excited to support Spine BioPharma as they share our commitment to offering patients non-opioid pain relief. We are particularly interested in this regenerative medicine as it has the potential to address the underlying cause of degenerative disc disease and avoid more invasive procedures or surgical intervention," said Ron Ellis, DO, senior vice president of corporate strategy and business development at Pacira BioSciences. "Importantly, this investment advances our mission to address unmet needs that improve the patient experience with a diversified portfolio of novel non-opioid and regenerative health solutions along the neural pain pathway."

    Remedisc is a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1), which is often highly expressed in the degenerated discs of patients with lower back pain. Abnormal TGFβ1 signaling is associated with the degradation of extracellular matrix components that maintain the structural integrity of healthy spinal discs. TGFβ1 is also reported to stimulate the expression of nerve growth factor leading to an increase in sensory neurons and discogenic pain. Intradiscal injection of Remedisc in patients with degenerative disc disease was developed as a first-in-class regenerative approach to treating chronic back pain and preventing progression of disc degeneration through TGFβ1 modulation.

    Spine BioPharma expects to file an Investigational New Drug Application with the U.S. Food and Drug Administration seeking approval of a Phase 2/3 multicenter, randomized controlled study of Remedisc later this year.

    Perkins Coie LLP is acting as legal advisor to Pacira in connection with the transaction.

    About Degenerative Disc Disease

    266 million individuals around the world have Degenerative Disc Disease, or DDD, and its associated Chronic Low Back Pain each year. DDD of the lumbar, or lower, spine is a significant cause of disability in the world and a tremendous expense to the healthcare system. It is associated with a variety of clinical symptoms, including, weakness, low back pain and disability of varying levels of severity. There is currently no treatment for the underlying cause of DDD and current approaches are aimed at managing pain through a variety of approaches that include physical therapy, chiropractic care, over the counter medications like non-steroidal anti-inflammatory drugs (NSAIDS) or prescription opioids. For patients with moderate to severe pain that persists chronically, treatment plans include epidural steroid injections, nerve blocks, radiofrequency ablation or surgical intervention. Clinical outcomes vary and often do not provide predictable benefit. Given the substantial costs, pain, and disability associated with DDD, and the current lack of an approved disease-modifying agent, a therapy that could relieve pain and increase function with the potential to mediate the progression of DDD or achieve a regenerative effect could revolutionize the standard of care.

    About Spine BioPharma

    Spine BioPharma specializes in non-surgical therapies that will reduce pain, restore function and slow or stop pathological spinal disease progression without the use of opioids. Spine BioPharma's lead candidate, Remedisc™, is a first-in-class, therapeutic for the treatment of degenerative disc disease, offering clinical benefits of pain relief, restoration of function and potential prevention of disease progression.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
            
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  21. PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL® (bupivacaine liposome injectable suspension) is not an effective analgesic. The articles, included in its official medical journal, Anesthesiology, were published in print and on the ASA website under the summary headline, "Liposomal Bupivacaine Is Not Superior to Standard Local Anesthetics." This headline appeared on the cover of the publication's February 2021 print issue.

    The Complaint establishes that the ASA published…

    PARSIPPANY, N.J., April 14, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today filed a lawsuit against the American Society of Anesthesiologists (ASA) and various other defendants seeking pecuniary damages and the retraction of three articles that create the false and misleading impression that EXPAREL® (bupivacaine liposome injectable suspension) is not an effective analgesic. The articles, included in its official medical journal, Anesthesiology, were published in print and on the ASA website under the summary headline, "Liposomal Bupivacaine Is Not Superior to Standard Local Anesthetics." This headline appeared on the cover of the publication's February 2021 print issue.

    The Complaint establishes that the ASA published articles that were not only scientifically unsound, but that also failed to disclose that certain authors were accepting payments from competing pharmaceutical or drug device manufacturers. Inaccurate or incomplete financial disclosures are a violation of ethical standards established by the medical and scientific research communities and raise serious questions regarding the objectivity of the published work.

    "EXPAREL has been used in more than 8 million U.S. patients and is backed by scores of published studies that demonstrate safe and effective, long-lasting pain control, including decreased opioid requirements, improved patient outcomes, and the migration of surgical cases to outpatient sites of care," said Dave Stack, Chief Executive Officer and Chairman of Pacira. "While pain trials are notoriously difficult to execute, and mixed evidence can be identified for all studied analgesics, the three Anesthesiology articles overwhelmingly overlook the positive body of literature that exists for EXPAREL."

    Mr. Stack continued, "We cannot allow this misrepresentation of the clinical effectiveness of EXPAREL to continue to be promoted in the journal and on the website of the American Society of Anesthesiologists, at the risk of confusing stakeholders along the patient care continuum about the value of EXPAREL compared to current treatment modalities. Requests for discussion with the ASA and the editor of Anesthesiology were repeatedly dismissed. This left us with no choice but to take legal action in order to ensure this false and misleading information is not inappropriately cited as an accurate reference in other scientific manuscripts and cannot be used to limit access to patients and providers who require low- and no-opioid care."

    EXPAREL is the only long-acting local analgesic approved for infiltration, field block and interscalene brachial plexus nerve block in adult patients, and the FDA recently approved it as the first and only long-acting local analgesic approved with established safety for local infiltration in children aged six and over.

    The product is separately reimbursed by the Centers for Medicaid and Medicare Services when used to treat Medicare surgical patients in the ambulatory surgery center environment, a policy that most major commercial payers have also adopted.

    Background on the Complaint

    Pacira seeks to address three issues in its complaint:

    1. The published meta-analysis is deeply flawed: Meta-analyses should only be conducted when the studies included are similar in terms of procedure type, patient population, and outcomes evaluated—this analysis combined a variety of administration techniques which included a variety of off-label uses with the largest subgroup being penile block for penile prothesis implant procedures, for which Pacira does not promote or provide educational support, and employed widely rejected methodologies. When proper methodologies are applied, the results are favorable to EXPAREL
    2. Key financial and commercial conflicts were not disclosed: Financial and commercial disclosures allow transparency related to any potential bias in the publication process. Three authors and the editor-in-chief failed to disclose previous or current and ongoing relationships—either between themselves or their employers—with manufacturers who make products that could or would compete with EXPAREL, including over $14 million in research funding involving competing treatment modalities.
    3. Educational tools on the ASA website—including a continuing medical education (CME) course and a podcast—restate as a fact, the flawed conclusions of the Anesthesiology articles: Guidelines clearly state the importance of avoiding any commercial bias in CME materials in order to ensure the highest level of scientific credibility.

    Pacira seeks a preliminary injunction requiring the ASA to remove materials containing these misleading statements from its website in order to prevent the continued spread of misinformation. Pacira will also file a motion for expedited discovery to enable it to obtain crucial documents exposing the ASA's unconscionable conflicts of interest and anti-EXPAREL bias.

    The company's motion for a preliminary injunction, which will be filed subsequent to the complaint, will be supported by several key declarants and experts, including William Rayburn, MD, former president of the Society for Academic Continuing Medical Education and former Associate Dean of Continuing Medical Education and Professional Development at the University of New Mexico School of Medicine, and Thomas Trikalinos, MD, PhD, Director of the Center for Evidence Synthesis in Health at Brown University.

    The case, Pacira v. American Society of Anesthesiologists, was filed in the United States District Court for the District of New Jersey. Pacira is represented in this lawsuit by Latham & Watkins LLP. Copies of the pleadings and declarations are available at www.pacira.com/legal/ASAComplaint.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting.

    In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

    Company Contact:

    Pacira BioSciences, Inc.

    Susan Mesco, (973) 451-4030

    susan.mesco@pacira.com

    Media Contact:

    Coyne Public Relations

    Alyssa Schneider, (973) 588-2270

    aschneider@coynepr.com



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  22. PARSIPPANY, N.J., April 07, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $114.7 million and $3.3 million, respectively, for the first quarter of 2021. The company also reported preliminary unaudited net product sales of EXPAREL and iovera° of $44.3 million and $1.5 million, respectively, for the month of March 2021. EXPAREL average daily sales were 108%, 103%, and 137% of the prior year levels for the months of January, February and March, respectively.

    "The first quarter of 2021 was marked…

    PARSIPPANY, N.J., April 07, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $114.7 million and $3.3 million, respectively, for the first quarter of 2021. The company also reported preliminary unaudited net product sales of EXPAREL and iovera° of $44.3 million and $1.5 million, respectively, for the month of March 2021. EXPAREL average daily sales were 108%, 103%, and 137% of the prior year levels for the months of January, February and March, respectively.

    "The first quarter of 2021 was marked by significant progress as highlighted by the U.S. regulatory approval of EXPAREL in the pediatric setting and its growing utilization across a wide range of long-acting regional blocks for low or no opioid postsurgical pain control," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The surgical paradigm continues its rapid progression out of the hospital as EXPAREL-based enhanced recovery after surgery protocols redefine best practice and drive surgical migration to the outpatient setting."

    "The COVID-19 pandemic has accelerated this transition, which we expect will be permanently embedded in healthcare systems given the improved patient outcomes, satisfaction rates and economic advantages of outpatient care. These positive market dynamics, along with EXPAREL growth continuing to outpace the recovery of the elective surgery market, leave us very well-positioned for robust long-term growth once the COVID-19 crisis recedes and elective surgeries normalize," added Mr. Stack.

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.

    The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the first quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  23. -- EXPAREL is the first and only FDA-approved long-acting local analgesic for children aged six and over
    -- Conference call tomorrow at 8:30 a.m. ET --

    PARSIPPANY, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric…

    -- EXPAREL is the first and only FDA-approved long-acting local analgesic for children aged six and over

    -- Conference call tomorrow at 8:30 a.m. ET --

    PARSIPPANY, N.J., March 22, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include use in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. With this approval, EXPAREL is the first and only FDA approved long-acting local analgesic for the pediatric population as young as age six.

    "The current standard of care for managing moderate-to-severe pain in children is opioids, which often come with unwanted severe and possibly life-threatening side effects in this vulnerable patient population," said Dave Stack, Chairman and Chief Executive Officer at Pacira. "In line with our corporate mission to provide an opioid alternative to as many patients as possible, we are grateful for the opportunity to give clinicians and patients a new, safe and effective option for achieving long-lasting non-opioid pain control in children without the need for an indwelling catheter and pump."

    Since initial approval in 2011, more than 8 million patients have been treated with EXPAREL. With approximately one million pediatric procedures per year where opioids, catheters and pain pumps are the mainstay of postsurgical pain control, there is an urgent unmet need for opioid alternatives.

    "There has been a significant gap in our pain control armamentarium as it relates to the ability to safely and effectively provide long-lasting non-opioid pain control for the pediatric surgical population," said Christopher Tirotta, MD, Chief of Anesthesiology at Nicklaus Children's Hospital and an investigator in the pivotal PLAY study. "Traditional local anesthetics have not provided a duration of pain control that matches the time course of the most significant postsurgical pain, which has necessitated the reliance on opioids in an attempt to manage pain. With the addition of EXPAREL as an FDA-approved non-opioid option to provide prolonged pain control we are better equipped to treat our pediatric patients while reducing opioid exposure, and ultimately improving outcomes."

    The sNDA was based on the positive data from the Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg. The PLAY study enrolled 98 patients to evaluate safety and the pharmacokinetics of EXPAREL for two patient groups: patients aged 12 to less than 17 years and patients aged 6 to less than 12 years. Per FDA guidance, the primary objectives of the PLAY study were to evaluate the pharmacokinetics and safety of EXPAREL.

    "Moderate-to-severe postsurgical pain is experienced by 40% of hospitalized children, and every scoliosis patient I treat surgically. Over and under treated pain in pediatric patients is a significant cause of morbidity after surgery," said Peter Newton, MD, Chief of the Division of Orthopedics & Scoliosis at Rady Children's Hospital-San Diego and Clinical Professor at UC San Diego School of Medicine. "Opioids are responsible for 50% of postsurgical respiratory failure events in children, and often cause unpleasant side effects delaying a patient's recovery after surgery. This FDA approval is a remarkable victory for pediatric patients and their families and paves the way for opioid-minimizing pain management protocols in children undergoing surgery."

    Tomorrow's Conference Call and Webcast Reminder

    The Pacira management team will host a conference call to discuss the contents of this press release tomorrow, Tuesday, March 23rd, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 1185087. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 1185087. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL is not recommended to be used in patients younger than 6 years old for single-dose infiltration, or in patients younger than 18 years old as an interscalene brachial plexus nerve block, or in pregnant women. EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

    Investor Contact:

    Susan Mesco, (973) 451-4030

    susan.mesco@pacira.com

    Media Contact:

    Coyne Public Relations

    Alyssa Schneider, (973) 588-2270

    aschneider@coynepr.com



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  24. -- EXPAREL average daily sales at 103% of the prior year for the month of February 2021 --

    PARSIPPANY, N.J., March 09, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $35.6 million and $0.7 million, respectively, for the month of February 2021. EXPAREL average daily sales were 103 percent of the prior year for February 2021.

    "We are off to a terrific start for the year, with February EXPAREL sales surpassing a very strong comparative month in 2020 amid recent severe weather-related shutdowns…

    -- EXPAREL average daily sales at 103% of the prior year for the month of February 2021 --

    PARSIPPANY, N.J., March 09, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $35.6 million and $0.7 million, respectively, for the month of February 2021. EXPAREL average daily sales were 103 percent of the prior year for February 2021.

    "We are off to a terrific start for the year, with February EXPAREL sales surpassing a very strong comparative month in 2020 amid recent severe weather-related shutdowns in key markets and ongoing COVID-19 related challenges. EXPAREL growth continues to significantly outpace the recovery in the elective surgery market as utilization increases across a wide range of anesthesia-driven regional blocks and enhanced recovery after surgery protocols shift more complex, painful elective surgeries to the outpatient setting. We also continue to see a strong uptake in regional blocks for non-elective procedures given the market's critical need for opioid-sparing approaches. Looking ahead, Pacira remains well-positioned to deliver robust top- and bottom-line growth as we further entrench EXPAREL as the leader in non-opioid postsurgical pain management and advance iovera° in key orthopedic settings," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the first quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  25. PARSIPPANY, N.J., March 03, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 Barclays Global Healthcare Conference at 10:55 AM ET on Tuesday, March 9, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension…

    PARSIPPANY, N.J., March 03, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2021 Barclays Global Healthcare Conference at 10:55 AM ET on Tuesday, March 9, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

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  26. — Reports record full-year 2020 revenue of $429.6 million  —

    — Anesthesia-driven regional approaches expanding and driving strong EXPAREL growth —

    — Conference call today at 8:30 a.m. ET —

    PARSIPPANY, N.J., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the fourth quarter and full-year of 2020.

    "Our nation's opioid crisis has escalated under the shadow of the COVID-19 pandemic, as isolation and lack of access to healthcare has exacerbated mental health challenges, particularly addiction. I am delighted to report that EXPAREL-based protocols are expanding opioid-sparing pain…

    — Reports record full-year 2020 revenue of $429.6 million  —

    — Anesthesia-driven regional approaches expanding and driving strong EXPAREL growth —

    — Conference call today at 8:30 a.m. ET —

    PARSIPPANY, N.J., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the fourth quarter and full-year of 2020.

    "Our nation's opioid crisis has escalated under the shadow of the COVID-19 pandemic, as isolation and lack of access to healthcare has exacerbated mental health challenges, particularly addiction. I am delighted to report that EXPAREL-based protocols are expanding opioid-sparing pain management for a variety of procedures where historically poor postsurgical pain management fueled such addictions. Despite these challenging times, we have quickly adapted to a virtual world and delivered record revenues for 2020," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Looking ahead to the balance of the year, we remain steadfast in our commitment to providing an opioid alternative to as many patients as possible and redefining the role of opioids as a rescue medication while enabling the migration to hospital outpatient and ambulatory surgery centers for elective surgery."

    2020 Full-Year and Fourth Quarter Financial Highlights

    • Full-year revenues of $429.6 million and fourth quarter revenues of $131.0 million.
    • Full-year GAAP net income of $145.5 million or $3.41 per share (basic) and $3.33 (diluted).
    • Fourth quarter GAAP net income of $14.5 million or $0.33 per share (basic) and $0.32 (diluted).
    • Full-year non-GAAP Adjusted EBITDA of $112.6 million and fourth quarter non-GAAP Adjusted EBITDA of $42.9 million.

    Recent Business Highlights

    • Equity investment in GeneQuine Biotherapeutics.

      In January 2021, Pacira announced an equity investment in GeneQuine Biotherapeutics GmbH. Under the terms of the agreement, Pacira made an initial investment of €2.0 million with an additional €4.0 million investment predicated upon GeneQuine achieving certain prespecified near-term milestones related to its lead gene therapy product candidate, GQ-303. Up to €2.5 million of the total Pacira investment will be in the form of a convertible note. In addition, Pacira is entitled to appoint one member to GeneQuine's board of directors. GeneQuine Biotherapeutics is a privately held biopharmaceutical company advancing a gene therapy platform for the treatment of osteoarthritis (OA) and other musculoskeletal disorders. GeneQuine's product candidates are next-generation gene transfer vehicles that are highly efficient in entering joint cells to confer multi-year gene expression.



    • European Commission approves EXPAREL for the treatment of postsurgical pain. In November 2020, the European Commission  granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults. The European Commission approval was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use. These studies include: lower extremity nerve block, upper extremity nerve block, and infiltration studies in hard and soft tissue surgeries. The European Commission decision is applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein. Commercial planning is underway, with an anticipated launch in the second half of 2021.

    Fourth Quarter 2020 Financial Results

    • Total revenues were $131.0 million in the fourth quarter of 2020, a 7% increase over the $122.4 million reported for the fourth quarter of 2019.
    • EXPAREL net product sales were $125.3 million in the fourth quarter of 2020, a 7% increase over the $116.9 million reported for the fourth quarter of 2019.
    • Fourth quarter 2020 iovera° net product sales were $2.4 million, a 25% decrease versus the $3.2 million reported in the fourth quarter of 2019.
    • Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $2.0 million in the fourth quarter of 2020, compared to $1.7 million in 2019.
    • Fourth quarter 2020 royalty revenue was $1.2 million compared to $0.6 million in 2019.
    • Total operating expenses were $112.2 million in the fourth quarter of 2020, compared to $120.7 million in the fourth quarter of 2019.
    • Research and development (R&D) expenses were $15.3 million in the fourth quarter of 2020, compared to $19.7 million in the fourth quarter of 2019. The company's R&D expenses include $5.2 million and $8.7 million of product development and manufacturing capacity expansion costs in the fourth quarters of 2020 and 2019, respectively.
    • Selling, general and administrative (SG&A) expenses were $52.8 million in the fourth quarter of 2020, compared to $54.2 million in the fourth quarter of 2019.
    • GAAP net income was $14.5 million, or $0.33 per share (basic) and $0.32 (diluted), in the fourth quarter of 2020, compared to a GAAP net loss of $4.9 million, or $0.12 per share (basic and diluted), in the fourth quarter of 2019.
    • Non-GAAP net income was $38.8 million, or $0.89 per share (basic) and $0.87 per share (diluted), in the fourth quarter of 2020, compared to non-GAAP net income of $23.8 million, or $0.57 per share (basic) and $0.56 per share (diluted), in the fourth quarter of 2019.
    • Adjusted EBITDA was $42.9 million in the fourth quarter of 2020, a 48% increase over $29.1 million in the fourth quarter of 2019.
    • Pacira had 43.5 million basic and 44.7 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2020.

    Full-Year 2020 Financial Results

    • Total revenues were $429.6 million in 2020, a 2% increase over the $421.0 million reported in 2019.
    • EXPAREL net product sales were $413.3 million in 2020, a 1% increase over the $407.9 million reported in 2019.
    • Full-year iovera° net product sales were $8.8 million, a 12% increase over the $7.9 million reported in 2019. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.
    • Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $4.5 million in 2020, compared to $3.2 million in 2019.
    • Full-year royalty revenue was $3.0 million compared to $2.1 million in 2019.
    • Total operating expenses were $383.3 million in 2020, compared to $410.5 million in 2019.
    • Research and development (R&D) expenses were $59.4 million in 2020, compared to $72.1 million in 2019. The company's R&D expenses include $23.5 million and $29.7 million of product development and manufacturing capacity expansion costs in 2020 and 2019, respectively.
    • Selling, general and administrative (SG&A) expenses were $193.5 million in 2020, compared to $200.8 million in 2019.
    • GAAP net income was $145.5 million, or $3.41 per share (basic) and $3.33 per share (diluted) in 2020, compared to a GAAP net loss of $11.0 million, or $0.27 per share (basic and diluted) in 2019.
    • Non-GAAP net income was $96.6 million, or $2.26 per share (basic) and $2.21 per share (diluted), in 2020, compared to non-GAAP net income of $70.7 million, or $1.70 per share (basic) and $1.67 per share (diluted), in 2019.
    • Adjusted EBITDA was $112.6 million in 2020, a 26% increase over $89.2 million in 2019.
    • Pacira had 42.7 million basic and 43.7 million diluted weighted average shares of common stock outstanding in 2020.

    See "Non-GAAP Financial Information" below.

    Financial Guidance

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19 to reinstate financial guidance.

    Today's Conference Call and Webcast Reminder

    The Pacira management team will host a conference call to discuss the company's financial results and recent developments today, Thursday, February 25, 2021, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4864607. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com. 

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4864607. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    Non-GAAP Financial Information

    This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense and adjusted EBITDA, because such measures exclude acquisition-related charges, product discontinuation costs and other expense; stock-based compensation; amortization of debt discount; loss on early extinguishment of debt, amortization of acquired intangible assets; an income tax benefit and a step-up in basis of inventory in connection with the acquisition of MyoScience, Inc., (gain) loss on investment and other non-operating income and the reversal of a deferred tax valuation allowance.

    These measures supplement Pacira's financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2021 and to help make managerial decisions. In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, including adjusted EBITDA.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com

    About EXPAREL

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

     

    1Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Pacira BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     December 31,

    2020
     December 31,

    2019
    ASSETS   
    Current assets:   
         Cash and cash equivalents$99,957  $78,228 
         Short-term investments421,705  213,722 
         Accounts receivable, net53,046  47,530 
         Inventories, net64,650  58,296 
         Prepaid expenses and other current assets12,265  10,781 
              Total current assets651,623  408,557 
    Long-term investments95,459  64,798 
    Fixed assets, net136,688  104,681 
    Right-of-use assets, net74,492  38,124 
    Goodwill99,547  99,547 
    Intangible assets, net96,521  104,387 
    Deferred tax assets106,164   
    Equity investments and other assets14,019  10,971 
              Total assets$1,274,513  $831,065 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
         Accounts payable$10,431  $12,799 
         Accrued expenses70,974  70,427 
         Lease liabilities7,425  4,935 
         Convertible senior notes (1)149,648   
         Contingent consideration14,736  18,179 
         Income taxes payable114  1,333 
              Total current liabilities253,328  107,673 
    Convertible senior notes (2)313,030  306,045 
    Lease liabilities71,025  40,938 
    Contingent consideration13,610  19,963 
    Other liabilities3,832  1,502 
    Total stockholders' equity619,688  354,944 
              Total liabilities and stockholders' equity$1,274,513  $831,065 

    (1) Relates to our 2.375% convertible senior notes due 2022. These notes are classified as current at December 31, 2020 because the note holders can convert any time on or after October 1, 2021.

    (2) Relates to our 0.750% convertible senior notes due 2025 that are not currently convertible.



    Pacira BioSciences, Inc.

    Consolidated Statements of Operations

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended Year Ended
     December 31, December 31,
     2020 2019 2020 2019
     Net product sales:       
          EXPAREL$125,309  $116,939  $413,338  $407,877 
          Bupivacaine liposome injectable suspension2,029  1,685  4,459  3,153 
          Total EXPAREL / bupivacaine liposome injectable

          suspension net product sales
    127,338  118,624  417,797  411,030 
          iovera°2,426  3,221  8,817  7,896 
     Total net product sales129,764  121,845  426,614  418,926 
     Royalty revenue1,210  579  3,033  2,100 
          Total revenues130,974  122,424  429,647  421,026 
            
    Operating expenses:       
         Cost of goods sold35,298  31,904  117,328  106,712 
         Research and development15,331  19,653  59,421  72,119 
         Selling, general and administrative52,831  54,223  193,516  200,782 
         Amortization of acquired intangible assets1,966  1,967  7,866  5,703 
         Acquisition-related charges, product discontinuation and other6,765  12,965  5,166  25,230 
              Total operating expenses112,191  120,712  383,297  410,546 
    Income from operations18,783  1,712  46,350  10,480 
            
    Other (expense) income:       
         Interest income693  1,667  4,629  7,376 
         Interest expense(7,062) (5,997) (25,671) (23,628)
         Loss on early extinguishment of debt    (8,071)  
         Other, net279  (923) 2,852  (4,976)
              Total other expense, net(6,090) (5,253) (26,261) (21,228)
    Income (loss) before income taxes12,693  (3,541) 20,089  (10,748)
         Income tax benefit (expense)1,821  (1,347) 125,434  (268)
    Net income (loss)$14,514  $(4,888) $145,523  $(11,016)
            
    Net income (loss) per share:       
         Basic net income (loss) per common share$0.33  $(0.12) $3.41  $(0.27)
         Diluted net income (loss) per common share$0.32  $(0.12) $3.33  $(0.27)
    Weighted average common shares outstanding:       
         Basic43,503  41,784  42,671  41,513 
         Diluted44,730  41,784  43,682  41,513 



    Pacira BioSciences, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Information

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended Year Ended
     December 31, December 31,
     2020 2019 2020 2019
    GAAP net income (loss)$14,514  $(4,888) $145,523  $(11,016)
            
    Non-GAAP adjustments:       
    Acquisition-related charges, product discontinuation and other6,765  12,965  5,166  25,230 
    Stock-based compensation10,896  9,189  39,920  33,650 
    Loss on early extinguishment of debt    8,071   
    Amortization of debt discount5,570  3,530  18,254  13,746 
    Amortization of acquired intangible assets1,966  1,967  7,866  5,703 
    Income tax benefit in connection with acquisition      (1,828)
    Recognition of step-up basis in inventory from acquisition      220 
    Release of valuation allowance on deferred tax assets(2,041)   (126,613)  
    Loss (gain) on investment and other non-operating income, net1,161  1,023  (1,618) 4,981 
    Total Non-GAAP adjustments24,317  28,674  (48,954) 81,702 
            
    Non-GAAP net income$38,831  $23,786  $96,569  $70,686 
            
    GAAP basic net income (loss) per common share$0.33  $(0.12) $3.41  $(0.27)
    GAAP diluted net income (loss) per common share$0.32  $(0.12) $3.33  $(0.27)
            
    Non-GAAP basic net income per common share$0.89  $0.57  $2.26  $1.70 
    Non-GAAP diluted net income per common share$0.87  $0.56  $2.21  $1.67 
            
    Weighted average common shares outstanding - basic43,503  41,784  42,671  41,513 
    Weighted average common shares outstanding - diluted44,730  42,612  43,682  42,370 
            
    Cost of goods sold reconciliation:       
    GAAP cost of goods sold$35,298  $31,904  $117,328  $106,712 
    Stock-based compensation(1,539) (1,174) (5,589) (4,665)
    Recognition of step-up basis in inventory from acquisition      (220)
    Non-GAAP cost of goods sold$33,759  $30,730  $111,739  $101,827 
            
    Research and development reconciliation:       
    GAAP research and development$15,331  $19,653  $59,421  $72,119 
    Stock-based compensation(1,267) (1,342) (5,211) (5,114)
    Non-GAAP research and development$14,064  $18,311  $54,210  $67,005 
            
    Selling, general and administrative reconciliation:       
    GAAP selling, general and administrative$52,831  $54,223  $193,516  $200,782 
    Stock-based compensation(8,090) (6,672) (29,120) (23,871)
    Non-GAAP selling, general and administrative$44,741  $47,551  $164,396  $176,911 



    Pacira BioSciences, Inc.

    Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA

    (in thousands)

    (unaudited)

     Three Months Ended Year Ended
     December 31, December 31,
     2020 2019 2020 2019
    GAAP net income (loss)$14,514  $(4,888) $145,523  $(11,016)
            
    Interest income(693) (1,667) (4,629) (7,376)
    Interest expense (1)7,062  5,997  25,671  23,628 
    Income tax (benefit) expense (2) (3)(1,821) 1,347  (125,434) 268 
    Depreciation expense3,095  3,124  12,042  13,873 
    Amortization of acquired intangible assets1,966  1,967  7,866  5,703 
    EBITDA24,123  5,880  61,039  25,080 
            
    Other adjustments:       
    Acquisition-related charges and product discontinuation, net6,765  12,965  5,166  25,230 
    Stock-based compensation10,896  9,189  39,920  33,650 
    Loss on early extinguishment of debt    8,071   
    Recognition of step-up basis in inventory from acquisition      220 
    Loss (gain) on investment1,161  1,023  (1,618) 4,981 
    Adjusted EBITDA (non-GAAP)$42,945  $29,057  $112,578  $89,161 

    (1) Includes amortization of debt discount

    (2) Includes an income tax benefit in connection with the April 2019 acquisition of MyoScience, Inc.

    (3) Includes the reversal of a deferred tax valuation allowance during the year ended December 31, 2020

    Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) includes GAAP to non-GAAP adjustments that reflect how the Company's management analyzes its financial results. The adjusted EBITDA figures presented here are unlikely to be comparable with adjusted EBITDA disclosures released by other companies.

     



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com 
               
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com 

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  27. PARSIPPANY, N.J., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will report its fourth quarter and year ended December 31, 2020 financial results before the open of the U.S. markets on Thursday, February 25, 2021. Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

    To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4864607. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate…

    PARSIPPANY, N.J., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will report its fourth quarter and year ended December 31, 2020 financial results before the open of the U.S. markets on Thursday, February 25, 2021. Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

    To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4864607. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4864607. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    About Pacira

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patients' journeys along the neural pain pathway. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Investor Contact:
    
    Pacira BioSciences, Inc.
    Christian Pedetti, (973) 254-4387
    Christian.Pedetti@pacira.com 

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  28. PARSIPPANY, N.J., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $34.9 million and $1.1 million, respectively, for the month of January 2021. EXPAREL average daily sales were 108 percent of the prior year for January 2021.

    "We are pleased to kick off the year with solid year-over-year EXPAREL growth in January 2021, especially as January 2020 was a particularly strong month for EXPAREL sales. Despite the ongoing challenges from COVID-19, weekly EXPAREL growth rates continued to outperform the elective surgery market compared…

    PARSIPPANY, N.J., Feb. 10, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $34.9 million and $1.1 million, respectively, for the month of January 2021. EXPAREL average daily sales were 108 percent of the prior year for January 2021.

    "We are pleased to kick off the year with solid year-over-year EXPAREL growth in January 2021, especially as January 2020 was a particularly strong month for EXPAREL sales. Despite the ongoing challenges from COVID-19, weekly EXPAREL growth rates continued to outperform the elective surgery market compared to pre-COVID baseline levels. Importantly, we continue to see the successful migration of complex elective surgeries to 23-hour sites of care, where EXPAREL allows physicians to achieve long-acting, non-opioid pain control using a wide range of regional blocks. The pandemic has created a critical need for expedited recovery and discharge, making EXPAREL-based Enhanced Recovery After Surgery Protocols more relevant than ever in non-elective procedures such as cesarean section, oncology, and cardiovascular surgeries, where EXPAREL utilization continues to expand. Looking forward, Pacira remains well-positioned as the market leader in opioid-sparing postsurgical pain management, as we help to redefine the role of opioids as a last resort rescue medication," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    The company's 2021 product sales continue to be negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the first quarter or full year 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  29. PARSIPPANY, N.J., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today announced that the company will lead an equity investment in GeneQuine Biotherapeutics GmbH. Under the terms of the agreement, Pacira will make an initial investment of €2.0 million with an additional €4.0 million investment predicated upon GeneQuine achieving certain prespecified near-term milestones related to its lead gene therapy product candidate, GQ-303. Up to €2.5 million of the total Pacira investment will be in the form of a convertible note. In addition, Pacira is entitled to appoint one member to GeneQuine's board of directors.

    "Our equity investment in GeneQuine…

    PARSIPPANY, N.J., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today announced that the company will lead an equity investment in GeneQuine Biotherapeutics GmbH. Under the terms of the agreement, Pacira will make an initial investment of €2.0 million with an additional €4.0 million investment predicated upon GeneQuine achieving certain prespecified near-term milestones related to its lead gene therapy product candidate, GQ-303. Up to €2.5 million of the total Pacira investment will be in the form of a convertible note. In addition, Pacira is entitled to appoint one member to GeneQuine's board of directors.

    "Our equity investment in GeneQuine represents a significant opportunity to participate in the development of what we believe is an exciting disease-modifying gene therapy for osteoarthritis. GeneQuine is conducting preclinical work to support the initiation of human studies in approximately two years. In addition to our confidence in this transaction as a sound investment, we enthusiastically look forward to the maturation of data and for further opportunity to participate in GeneQuine's successful preclinical program and entry into the clinic. Importantly, this investment is consistent with our mission to advance innovative pain management and regenerative health solutions," said Ron Ellis, DO, senior vice president of corporate strategy and business development at Pacira BioSciences.

    GeneQuine Biotherapeutics is a privately held biopharmaceutical company headquartered in Hamburg, Germany that is advancing a gene therapy platform for the treatment of osteoarthritis (OA) and other musculoskeletal disorders. GeneQuine's product candidates are next-generation gene transfer vehicles. These gene therapy vectors are highly efficient in entering joint cells to confer multi-year gene expression. Safety of this platform has been demonstrated in several species and is currently being evaluated in an ongoing Phase 1 study.

    GQ-303 and its analogs are currently in preclinical development as a treatment for OA. These helper-dependent adenoviral gene therapy vectors express proteoglycan 4 (PRG4), a protein that plays an important physiological role in regulating OA through lubrication and decreased pain, inflammation and cartilage degeneration. After intra-articular injection, the vector enters joint cells and turns them into factories to produce sustained therapeutic levels of PRG4 to restore joint homeostasis and provide long-lasting improvement in joint function and pain relief, which has been demonstrated in several in vivo OA models.  

    Perkins Coie LLP is acting as legal advisor to Pacira in connection with the transaction along with Vogel Heerma Waitz as local advisor.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.



    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  30. -- EXPAREL average daily sales at 109% of the prior year for the fourth quarter and 111% of the prior year for the month of December --

    PARSIPPANY, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net revenue of $429.6 million for 2020, a 2.0% increase compared with net revenue of $421.0 million reported for 2019. The company's total revenues include net product sales of EXPAREL and iovera°, which were $125.3 million and $2.4 million for the fourth quarter of 2020 and $46.5 million and $0.6 million for the month of December 2020, respectively. EXPAREL average daily sales were 112 percent, 103 percent…

    -- EXPAREL average daily sales at 109% of the prior year for the fourth quarter and 111% of the prior year for the month of December --

    PARSIPPANY, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net revenue of $429.6 million for 2020, a 2.0% increase compared with net revenue of $421.0 million reported for 2019. The company's total revenues include net product sales of EXPAREL and iovera°, which were $125.3 million and $2.4 million for the fourth quarter of 2020 and $46.5 million and $0.6 million for the month of December 2020, respectively. EXPAREL average daily sales were 112 percent, 103 percent, and 111 percent of the prior year for the months of October, November, and December, respectively.

    "We are pleased with the solid performance EXPAREL delivered in 2020, with the fourth quarter and full-year 2020 posting record product sales despite ongoing pandemic-related challenges. EXPAREL weekly sales growth continues to outperform the elective surgery market, which we attribute to its critical role in reducing or eliminating the need for opioids and enabling the shift of complex surgical procedures to the 23-hour stay environment. EXPAREL utilization also continues to grow in non-elective procedures, such as cesarean section, oncology, and cardiothoracic surgeries. As we look forward to 2021, the deployment of COVID-19 vaccinations should further support the recovery of elective surgery volumes. EXPAREL remains well positioned for more robust growth as it plays a critical role in revolutionizing the practice of regional anesthesia and enables the ongoing migration of procedures to the ambulatory setting." said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    2020 Full Year & Fourth Quarter Revenue Highlights

    • Fourth quarter net product sales of EXPAREL/bupivacaine liposome injectable suspension were $127.3 million in 2020, compared to $118.6 million in 2019.
    • Fourth quarter EXPAREL net product sales were $125.3 million in 2020, compared to $116.9 million in 2019. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $2.0 million in 2020, compared to $1.7 million in 2019.
    • Full-year EXPAREL net product sales were $413.3 million in 2020, compared to $407.9 million in 2019. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $4.5 million in 2020, compared to $3.2 million in 2019.
    • Full-year iovera° net product sales were $8.8 million in 2020, compared to $7.9 million in 2019. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.
    • Fourth quarter royalty revenue was $1.2 million and full-year was $3.0 million in 2020; compared to $0.6 million and $2.1 million in 2019, respectively.

    The company's 2020 product sales were negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's fourth quarter and full-year 2020 financial results. Pacira expects to report its complete financial results for the fourth quarter and full-year 2020 in the first quarter of 2021.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

    Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.


    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com

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  31. PARSIPPANY, N.J., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 39th Annual J.P. Morgan Healthcare Conference at 7:30 AM ET on Wednesday, January 13, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome…

    PARSIPPANY, N.J., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 39th Annual J.P. Morgan Healthcare Conference at 7:30 AM ET on Wednesday, January 13, 2021. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, the company acquired the iovera⁰ system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.



    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

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  32. -- EXPAREL average daily sales at 103% of the prior year for the month of November 2020 --

    PARSIPPANY, N.J., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $38.1 million and $0.8 million, respectively, for the month of November 2020.

    "We are pleased to report our sixth consecutive month of year-over-year growth for EXPAREL in the face of ongoing challenges from the COVID-19 pandemic. Sales for the final two days of November were meaningfully below the daily average for the month, which we believe to be attributable…

    -- EXPAREL average daily sales at 103% of the prior year for the month of November 2020 --

    PARSIPPANY, N.J., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $38.1 million and $0.8 million, respectively, for the month of November 2020.

    "We are pleased to report our sixth consecutive month of year-over-year growth for EXPAREL in the face of ongoing challenges from the COVID-19 pandemic. Sales for the final two days of November were meaningfully below the daily average for the month, which we believe to be attributable to the Thanksgiving holiday. Such anomalies aside, market indicators remain favorable as EXPAREL growth rates are significantly exceeding those of the elective surgery market versus pre-COVID baseline levels. This outperformance reflects the increasing use of EXPAREL within 23-hour sites of care and within non-elective procedures, such as cesarean section, oncology, and cardiovascular surgeries. We expect these favorable market dynamics to continue as we drive stronger growth in a post-pandemic world. EXPAREL not only helps enable the shifting of complex, painful procedures to outpatient settings but is well entrenched as the forerunner in opioid-sparing postsurgical pain management," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    The company's 2020 product sales have been negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the fourth quarter or full year 2020.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

    Investor Contact:

    Susan Mesco, (973) 451-4030

    susan.mesco@pacira.com 

    Media Contact:

    Coyne Public Relations

    Alyssa Schneider, (973) 588-2270

    aschneider@coynepr.com 

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.



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  33. PARSIPPANY, N.J., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2020 Piper Sandler 32nd Annual Virtual Healthcare Conference at 11:30 AM ET on Tuesday, December 1, 2020. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL®…

    PARSIPPANY, N.J., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2020 Piper Sandler 32nd Annual Virtual Healthcare Conference at 11:30 AM ET on Tuesday, December 1, 2020. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, the company acquired the iovera⁰ system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    Company Contact:

    Pacira BioSciences, Inc.

    Christian Pedetti

    (973) 254-4387

    Christian.pedetti@pacira.com



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  34. --Approval based on four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery--

    --EXPAREL is the first long-acting non-opioid option for field block and brachial plexus or femoral nerve block approved in Europe--

    PARSIPPANY, N.J., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NADSAQ: PCRX), the leading global provider of non-opioid pain management options, today announced that the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.

    "We are pleased to see…

    --Approval based on four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery--

    --EXPAREL is the first long-acting non-opioid option for field block and brachial plexus or femoral nerve block approved in Europe--

    PARSIPPANY, N.J., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NADSAQ: PCRX), the leading global provider of non-opioid pain management options, today announced that the European Commission has granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.

    "We are pleased to see news of the European Commission's approval of EXPAREL and look forward to the opportunity to bring a safe and effective opioid alternative to surgical patients across Europe," said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences. "Europe has long been at the forefront of enhanced recovery after surgery – or ERAS – models of care. With the European Commission's broad approval for EXPAREL across a wide variety of surgical settings and administration techniques, we see a well-defined position for EXPAREL to play an integral role in further optimizing postsurgical protocols and accelerating postoperative recovery."

    The European Commission approval was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use. These studies include:

    • Lower Extremity Nerve Block Study: This study assessed the safety and efficacy of EXPAREL as a femoral nerve block in patients undergoing total knee arthroplasty. Results demonstrated that EXPAREL resulted in a significant reduction in cumulative pain scores over 72 hours compared to placebo. A higher percentage of patients who received EXPAREL were pain-free, consumed fewer opioids and reported higher satisfaction with their pain control compared with placebo.
    • Upper Extremity Nerve Block Study: This study assessed the safety and efficacy of EXPAREL as an interscalene brachial plexus nerve block in patients undergoing total shoulder arthroplasty or rotator cuff repair. Results demonstrated that EXPAREL significantly improved pain control and reduced opioid consumption through 48 hours compared with placebo and a standardized pain management protocol alone.
    • Hard Tissue Infiltration Study: This study assessed the safety and efficacy of EXPAREL administered via infiltration in patients undergoing bunionectomy. Results demonstrated that EXPAREL significantly reduced pain and opioid consumption compared with placebo over the first 24 hours following surgery than patients administered placebo.
    • Soft Tissue Infiltration Study: This study assessed the safety and efficacy of EXPAREL administered via infiltration in patients undergoing hemorrhoidectomy. Results demonstrated that EXPAREL significantly reduced pain compared to placebo at all time points, including a 30 percent reduction in the cumulative pain scores at 72 hours. Patients who received EXPAREL consumed significantly fewer opioids than patients administered placebo.

    The European Commission decision is applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein. Commercial planning is underway, with an anticipated launch in the second half of 2021. EXPAREL was initially approved in the United States for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Since its launch, EXPAREL has been used in over seven and a half million patients.

    About Pacira BioSciences

    Pacira BioSciences, Inc. is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    Company Contacts:

    Investors:

    Susan Mesco, (973) 451-4030

    Pacira BioSciences, Inc.

    Susan.Mesco@pacira.com

    Media:

    Alyssa Schneider, (973) 588-2270

    Coyne Public Relations

    aschneider@coynepr.com



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  35. PARSIPPANY, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $40.7 million and $1.0 million, respectively, for the month of October 2020.

    "While we are beginning to see encouraging signs of recovery, the COVID-19 pandemic continues to hinder the number of procedures performed in the elective surgery market. Despite these headwinds, EXPAREL has enjoyed five consecutive months of year-over-year growth, demonstrating the market's overwhelming need for opioid-sparing postsurgical pain management. Importantly, EXPAREL…

    PARSIPPANY, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net product sales of EXPAREL® (bupivacaine liposome injectable suspension) and iovera° of $40.7 million and $1.0 million, respectively, for the month of October 2020.

    "While we are beginning to see encouraging signs of recovery, the COVID-19 pandemic continues to hinder the number of procedures performed in the elective surgery market. Despite these headwinds, EXPAREL has enjoyed five consecutive months of year-over-year growth, demonstrating the market's overwhelming need for opioid-sparing postsurgical pain management. Importantly, EXPAREL growth rates are consistently and significantly exceeding those of the elective surgery market. We believe this is a particularly strong indicator of the expanding role EXPAREL is playing in shifting complex surgical procedures to the 23-hour stay environment, as well as broadening utilization in non-elective procedures, such as cesarean section, cardiothoracic and oncology surgeries. Given these trends, EXPAREL will be well positioned for more robust growth as the elective surgery market normalizes," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    The company's 2020 product sales have been negatively impacted by the COVID-19 pandemic, which mandated postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company's financial results for the fourth quarter or full year 2020.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com

    About EXPAREL®

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°®

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

     

    1 Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera° and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

    Investor Contact:
    Susan Mesco, (973) 451-4030
    susan.mesco@pacira.com 
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    aschneider@coynepr.com 

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  36. PARSIPPANY, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2020 Jefferies Virtual London Healthcare Conference at 2:05 PM GMT (9:05 AM ET) on Tuesday, November 17, 2020. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL®…

    PARSIPPANY, N.J., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2020 Jefferies Virtual London Healthcare Conference at 2:05 PM GMT (9:05 AM ET) on Tuesday, November 17, 2020. Live audio of the virtual event can be accessed by visiting the "Events" page of the company's website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

    About Pacira         

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, the company acquired the iovera⁰ system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    Company Contact:
    Pacira BioSciences, Inc.
    Christian Pedetti
    (973) 254-4387
    Christian.pedetti@pacira.com

    Primary Logo

    View Full Article Hide Full Article
  37. -- EXPAREL average daily sales at 110% of the prior year for the third quarter--

    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported financial results for the third quarter of 2020.

    "Throughout the third quarter, we continued to make meaningful progress in growing EXPAREL sales despite lingering challenges in the elective surgery market due to the COVID-19 pandemic. The ongoing transition from procedures in the inpatient setting to the 23-hour ambulatory surgical center setting has accelerated because of the pandemic and we expect this trend to continue. The recent…

    -- EXPAREL average daily sales at 110% of the prior year for the third quarter--

    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the leading provider of innovative non-opioid pain management options, today reported financial results for the third quarter of 2020.

    "Throughout the third quarter, we continued to make meaningful progress in growing EXPAREL sales despite lingering challenges in the elective surgery market due to the COVID-19 pandemic. The ongoing transition from procedures in the inpatient setting to the 23-hour ambulatory surgical center setting has accelerated because of the pandemic and we expect this trend to continue. The recent opening of our state-of-the art Pacira Innovation and Training Facility in Tampa is expected to further drive the adoption of EXPAREL and iovera° by providing digital and educational tools that meet the needs of our physician customers, as they seek to improve patient care in a variety of surgical settings. Looking ahead, Pacira remains well-positioned as the leading provider of innovative non-opioid pain management solutions," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

    Third Quarter 2020 Financial Results

    • Total revenues were $117.5 million in the third quarter of 2020, a 12% increase versus the $104.7 million reported for the third quarter of 2019.
    • EXPAREL net product sales were $113.7 million in the third quarter of 2020, a 12% increase versus the $101.5 million reported for the third quarter of 2019.
    • Third quarter 2020 iovera° net product sales were $2.7 million, a 3% increase versus the $2.6 million reported for the third quarter of 2019.
    • Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $0.4 million in the third quarter of 2020, compared to $0.3 million in the third quarter of 2019.
    • Third quarter 2020 royalty revenues were $0.6 million, compared to $0.3 million in the third quarter of 2019.
    • Total operating expenses were $99.9 million in the third quarter of 2020, compared to $102.3 million in the third quarter of 2019.
    • Research and development (R&D) expenses were $14.7 million in the third quarter of 2020, compared to $20.3 million in the third quarter of 2019. R&D expenses include $5.6 million and $7.8 million of product development and manufacturing capacity expansion costs in the third quarters of 2020 and 2019, respectively.
    • Selling, general and administrative (SG&A) expenses were $52.6 million in the third quarter of 2020, compared to $50.1 million in the third quarter of 2019.
    • GAAP net income was $130.1 million, or $3.03 per share (basic) and $2.94 (diluted), in the third quarter of 2020, compared to a GAAP net loss of $6.1 million, or $(0.15) per share (basic and diluted), in the third quarter of 2019. Included in GAAP net income in the third quarter of 2020 was a $124.6 million income tax benefit related to the release of a valuation allowance on deferred tax assets.
    • Non-GAAP net income was $29.9 million, or $0.70 per share (basic) and $0.68 (diluted), in the third quarter of 2020, compared to non-GAAP net income of $20.2 million, or $0.48 per share (basic and diluted), in the third quarter of 2019.
    • Adjusted EBITDA was $34.2 million in the third quarter of 2020, versus adjusted EBITDA of $24.8 million in the third quarter of 2019.
    • Pacira ended the third quarter of 2020 with cash, cash equivalents, short-term and long-term investments ("cash") of $576.2 million. Cash provided by operations was $39.8 million in the third quarter of 2020, compared to cash provided by operations of $18.4 million in the third quarter of 2019.
    • Pacira had 42.9 million basic weighted average shares of common stock outstanding in the third quarter of 2020.
    • Pacira had 44.3 million diluted weighted average shares of common stock outstanding in the third quarter of 2020.

    See "Non-GAAP Financial Information" below.

    Recent Highlights

    • Launch of state-of-the-art training center dedicated to advancing best practice regional approaches to manage acute pain.  In October 2020, Pacira announced the grand opening of the Pacira Innovation and Training Center of Tampa (the PITT). Designed to advance clinician understanding of the latest local, regional and field block approaches for managing pain, the PITT will provide an unparalleled training environment for healthcare providers working to reduce or eliminate patient exposure to opioids. The PITT is a fully adaptable environment constructed with guidance and input from leaders in the field of regional anesthesia, and is equipped with state-of-the-art technology and audio/visual capabilities to support a full range of educational events from didactic presentations to hands-on workshops.

       
    • Preliminary net product sales for September 2020.  In October 2020, Pacira reported preliminary unaudited net product sales of EXPAREL and iovera° of $39.5 million and $1.1 million, respectively, for the month of September 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19.

       
    • Positive CHMP opinion for EXPAREL for the treatment of postsurgical pain. In September 2020, Pacira announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for EXPAREL for postsurgical analgesia. The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The CHMP positive opinion was based on the results of four pivotal Phase 3 studies that demonstrated improvements in pain reduction and opioid use.

       
    • Collaboration with IPG to reduce postsurgical opioid prescribing and surgical procedure costs. In September 2020, IPG, the industry-leading provider of surgical cost management solutions, and Pacira announced a collaboration to reduce postsurgical opioid prescribing and surgical procedure costs across the IPG national health plan and provider network. Through this partnership, IPG will offer reimbursement for EXPAREL to its health plan provider clients across the country to further support its mission to bring high quality, cost-effective surgical solutions to the U.S. healthcare market. Pacira will work alongside IPG to provide education and training to ensure consistent, positive outcomes are achieved across procedures, clinicians, and provider facilities.

    Today's Conference Call and Webcast Reminder

    The Pacira management team will host a conference call to discuss the company's financial results and recent developments today, Thursday, October 29, 2020, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 5997369. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

    For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 5997369. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

    Non-GAAP Financial Information

    This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense and adjusted EBITDA, because such measures exclude acquisition-related charges (gains) and product discontinuation costs; stock-based compensation; amortization of debt discount; loss on early extinguishment of debt, amortization of acquired intangible assets, an income tax benefit, a step-up in basis of inventory in connection with the acquisition of MyoScience, Inc., (gain) loss on investment and the reversal of a deferred tax valuation allowance.

    These measures supplement the company's financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2020 and to help make managerial decisions. In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, including adjusted EBITDA.

    About Pacira BioSciences

    Pacira BioSciences, Inc. (NASDAQ:PCRX) is a leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company's long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera°® system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

    About EXPAREL

    EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

    Important Safety Information for Patients

    EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

    About iovera°

    The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system's "1×90" Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

    Important Safety Information

    The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud's disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

    Forward-Looking Statements

    Any statements in this press release about the company's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "believes," "anticipates," "plans," "estimates," "expects," "intends," "may," "will," "would," "could," "can" and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions on our business and results of operations; the cost and timing of an early termination payment to DePuy Synthes Sales, Inc.; the success of the company's sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company's ability to serve those markets; the company's plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company's existing business; the commercial success of iovera°; the rate and degree of market acceptance of iovera°; the size and growth of the potential markets for iovera° and our ability to serve those markets; our plans to expand the use of iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for iovera°; the recoverability of our deferred tax assets and other factors discussed in the "Risk Factors" of the company's most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company's views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company's views as of any date subsequent to the date of this press release.

     

    1Radnovich, R. et al. "Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial." Osteoarthritis and Cartilage (2017) p1-10.

    (Tables to Follow)



    Pacira BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     September 30,

    2020
     December 31,

    2019
    ASSETS   
    Current assets:   
         Cash and cash equivalents$125,244   $78,228  
         Short-term investments406,881   213,722  
         Accounts receivable, net46,143   47,530  
         Inventories, net68,542   58,296  
         Prepaid expenses and other current assets11,710   10,781  
              Total current assets658,520   408,557  
    Long-term investments44,062   64,798  
    Fixed assets, net125,527   104,681  
    Right-of-use assets, net76,047   38,124  
    Goodwill99,547   99,547  
    Intangible assets, net98,487   104,387  
    Deferred tax assets104,122   —  
    Equity investment and other assets13,957   10,971  
              Total assets$1,220,269   $831,065  
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
         Accounts payable$13,008   $12,799  
         Accrued expenses60,403   70,427  
         Lease liabilities7,455   4,935  
         Contingent consideration5,406   18,179  
         Income taxes payable—   1,333  
              Total current liabilities86,272   107,673  
    Convertible senior notes456,464   306,045  
    Lease liabilities72,448   40,938  
    Contingent consideration16,176   19,963  
    Other liabilities4,219   1,502  
    Total stockholders' equity584,690   354,944  
              Total liabilities and stockholders' equity$1,220,269   $831,065  
            

    Pacira BioSciences, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except per share amounts)

    (unaudited)

     Three Months Ended Nine Months Ended
     September 30, September 30,
     2020 2019 2020 2019
     Net product sales:       
          EXPAREL$113,714    $101,456    $288,029    $290,938   
          Bupivacaine liposome injectable suspension449    255    2,430    1,468   
          Total EXPAREL / bupivacaine liposome

          injectable suspension net product sales
    114,163    101,711    290,459    292,406   
          iovera°2,726    2,639    6,391    4,674   
     Total net product sales116,889    104,350    296,850    297,080   
     Royalty revenue595    335    1,823    1,522   
          Total revenues117,484    104,685    298,673    298,602   
            
    Operating expenses:       
         Cost of goods sold29,993    22,304    82,031    74,809   
         Research and development14,651    20,255    44,090    52,466   
         Selling, general and administrative52,561    50,128    140,683    146,559   
         Amortization of acquired intangible assets1,967    1,967    5,900    3,736   
         Acquisition-related charges (gains) and product discontinuation, net692    7,618    (1,599)  12,266   
              Total operating expenses99,864    102,272    271,105    289,836   
    Income from operations17,620    2,413    27,568    8,766   
            
    Other (expense) income:       
         Interest income1,025    1,736    3,936    5,709   
         Interest expense(7,132)  (5,940)  (18,609)  (17,631) 
         Loss on early extinguishment of debt(8,071)  —    (8,071)  —   
         Other, net2,708    (4,025)  2,571    (4,051) 
              Total other expense, net(11,470)  (8,229)  (20,173)  (15,973) 
    Income (loss) before income taxes6,150    (5,816)  7,395    (7,207) 
         Income tax benefit (expense)123,969    (271)  123,613    1,079   
    Net income (loss)$130,119    $(6,087)  $131,008    $(6,128) 
            
    Net income (loss) per share:       
         Basic net income (loss) per common share$3.03    $(0.15)  $3.09