PCRX Pacira BioSciences Inc.

60.12
+0.73  (+1%)
Previous Close 59.39
Open 59.99
52 Week Low 27.46
52 Week High 64.44
Market Cap $2,569,659,621
Shares 42,742,176
Float 30,220,698
Enterprise Value $2,598,239,989
Volume 461,525
Av. Daily Volume 562,000
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Upcoming Catalysts

Drug Stage Catalyst Date
EXPAREL - pediatric patients
Postoperative Pain Management
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
EXPAREL
Post surgical pain
Approved
Approved
Approval announced April 6, 2018.
EXPAREL
Postsurgical pain
Approved
Approved
Approved October 31, 2011.

Latest News

  1. -- CHMP opinion supported by four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery --

    -- European Commission decision on the Marketing Authorization Application (MAA) expected in November 2020 --

    PARSIPPANY, N.J., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), a leading provider of innovative non-opioid pain management options, today 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.

    "This positive CHMP opinion brings Pacira one step closer to realizing our vision of establishing Pacira as the global leader in innovative…

    -- CHMP opinion supported by four pivotal studies showing EXPAREL reduced pain scores and opioid use following surgery --

    -- European Commission decision on the Marketing Authorization Application (MAA) expected in November 2020 --

    PARSIPPANY, N.J., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), a leading provider of innovative non-opioid pain management options, today 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.

    "This positive CHMP opinion brings Pacira one step closer to realizing our vision of establishing Pacira as the global leader in innovative non-opioid pain management," said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences. "We are particularly pleased with the CHMP's broad recommendation for EXPAREL across a variety of surgical settings and administration techniques. We look forward to the EMA's final decision and the opportunity to bring a safe and effective opioid alternative to surgical patients across Europe."

    The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The CHMP recommended granting EXPAREL marketing authorization with the following indication: EXPAREL is indicated 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. EXPAREL should be administered in a setting where trained personnel and appropriate equipment are available. The European Commission will review the CHMP opinion and is expected to adopt a final decision in November 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein.

    The CHMP positive opinion 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.
    • 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.

    EXPAREL is indicated 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 million patients.

    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.

    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
    
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    

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  2. ALPHARETTA, Ga. and PARSIPPANY, N.J., Sept. 15, 2020 (GLOBE NEWSWIRE) -- IPG, the industry-leading provider of surgical cost management solutions, and Pacira BioSciences, Inc. (NADSAQ: PCRX), a leading provider of non-opioid pain management options, today 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® (bupivacaine liposome injectable suspension) 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…

    ALPHARETTA, Ga. and PARSIPPANY, N.J., Sept. 15, 2020 (GLOBE NEWSWIRE) -- IPG, the industry-leading provider of surgical cost management solutions, and Pacira BioSciences, Inc. (NADSAQ: PCRX), a leading provider of non-opioid pain management options, today 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® (bupivacaine liposome injectable suspension) 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.

    "We look forward to working with Pacira on this joint commitment to decrease surgical costs, reliance on opioids, and opioid-related adverse events through the reimbursement and expanded utilization of EXPAREL," said Brian Holt, Chief Innovation Officer of IPG. "By increasing access to non-opioid options, our health plan partners can reduce the need for postsurgical opioids with no impact on the quality of care provided, all while helping to lower the total cost of the surgery and out-of-pocket costs for patients."

    Under the terms of the partnership, the organizations will co-develop clinician-facing educational materials and EXPAREL resources that will support best practice pain management for surgical patients.

    "The use of non-opioid postsurgical pain management plays an integral role in improved clinical and economic outcomes, as well as increased patient satisfaction," said Dave Stack, Chief Executive Officer and Chairman of Pacira BioSciences, Inc. "We are excited to partner with IPG on this initiative and commend their leadership in reducing opioids to offer patients the highest quality postsurgical recovery experience."

    "This collaboration furthers our commitment to quality and affordability of surgical care." said Vince Coppola, President and Chief Executive Officer of IPG.

    IPG works with the leading national and regional health plans across the country and their partnering providers, including large chains and independent ambulatory surgery centers.

    About IPG

    IPG is the leading provider of Device Benefit Management solutions, working with health plans, providers, surgical facilities and patients across the country to improve quality and reduce costs for surgical procedures through optimization of the most effective site of care and device selection, resulting in more affordable high-quality care to consumers. For more information about IPG, call us at 866.753.0046, or visit us on the web at www.ipg.com.

    About Pacira BioSciences

    Pacira BioSciences, Inc. 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.

    Company Contacts:

    Pacira BioSciences, Inc.

    Susan Mesco, (973) 451-4030

    IPG

    Kerry Lee Perry, (404) 849-1380

    Media Contact:

    Coyne Public Relations

    Alyssa Schneider, (973) 588-2270

     

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  3. PARSIPPANY, N.J., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX) today announced that it will present at the 2020 H.C. Wainwright 22nd Annual Global Investment Conference at 3:30 PM ET on Monday, September 14, 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 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, 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

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  4. -- EXPAREL average daily sales at 111% of the prior year for the month of August 2020 --

    PARSIPPANY, N.J., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), a 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 $36.1 million and $0.8 million, respectively, for the month of August 2020.

    "We continue to broaden the use of EXPAREL with our surgery center and anesthesia partners as regional approaches are enabling the ongoing shift of inpatient procedures to the 23-hour stay environment.  This demand is driving a steady increase in EXPAREL sales with average daily sales in August…

    -- EXPAREL average daily sales at 111% of the prior year for the month of August 2020 --

    PARSIPPANY, N.J., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), a 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 $36.1 million and $0.8 million, respectively, for the month of August 2020.

    "We continue to broaden the use of EXPAREL with our surgery center and anesthesia partners as regional approaches are enabling the ongoing shift of inpatient procedures to the 23-hour stay environment.  This demand is driving a steady increase in EXPAREL sales with average daily sales in August at 111 percent of 2019 levels," said Dave Stack, chairman and chief executive officer of Pacira BioSciences.  "The COVID-19 pandemic has created a critical need for expedited recovery, making EXPAREL-based enhanced recovery protocols more relevant than ever for patients, healthcare providers and payers across all sites of care. We expect these trends to continue as key states ease pandemic restrictions on elective procedures and as physicians and patients opt for shorter hospital stays for these and certain emergent procedures, such as Cesarean sections."

    During the second quarter of 2020, the company's 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 financial results for the third quarter or full year 2020. 

    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, 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.

    ________________________________

    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.

    Investor Contact:

    Susan Mesco, (973) 451-4030



               

    Media Contact:

    Coyne Public Relations

    Alyssa Schneider, (973) 588-2270

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  5. -- EXPAREL average daily sales return to year-over-year growth in month of June 2020 --
    -- Conference call today at 8:30 a.m. ET --

    PARSIPPANY, N.J., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), a leading provider of innovative non-opioid pain management options, today reported financial results for the second quarter of 2020.

    "We are very pleased to report that since the peak of the impact from COVID-19 in April, we've seen a steady and continued increase in EXPAREL sales. This is a testimony to the resolve of our physician partners who are dedicated to ensuring that patients receive their much-needed surgeries, particularly in the ambulatory setting," said Dave Stack, chairman and chief executive officer…

    -- EXPAREL average daily sales return to year-over-year growth in month of June 2020 --

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

    PARSIPPANY, N.J., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), a leading provider of innovative non-opioid pain management options, today reported financial results for the second quarter of 2020.

    "We are very pleased to report that since the peak of the impact from COVID-19 in April, we've seen a steady and continued increase in EXPAREL sales. This is a testimony to the resolve of our physician partners who are dedicated to ensuring that patients receive their much-needed surgeries, particularly in the ambulatory setting," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "This pandemic has accelerated the shift of inpatient procedures to the 23-hour stay environment and we are well positioned to lead the way with our innovative opioid alternatives."

    "Today, we are in a stronger position than ever as we wind down our partnership with DePuy Synthes and take full ownership of the EXPAREL franchise. Our recent financing strengthens our financial foundation and supports our strategy to expand our footprint in non-opioid pain management and regenerative health solutions while simultaneously ramping the top and bottom lines," continued Mr. Stack.

    Second Quarter 2020 Financial Results

    • Total revenues were $75.5 million in the second quarter of 2020, a 26% decrease versus the $102.6 million reported for the second quarter of 2019.
    • EXPAREL net product sales were $73.0 million in the second quarter of 2020, a 26% decrease versus the $98.9 million reported for the second quarter of 2019.
    • Second quarter 2020 iovera° net product sales were $1.4 million, a 31% decrease versus the $2.0 million reported for the second quarter of 2019.
    • Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $0.8 million in the second quarter of 2020, compared to $0.9 million in the second quarter of 2019.
    • Second quarter 2020 royalty revenues were $0.3 million, compared to $0.8 million in the second quarter of 2019.
    • Total operating expenses were $82.7 million in the second quarter of 2020, compared to $97.3 million in the second quarter of 2019.
    • Research and development (R&D) expenses were $13.6 million in the second quarter of 2020, compared to $17.8 million in the second quarter of 2019. R&D expenses include $6.1 million and $6.8 million of product development and manufacturing capacity expansion costs in the second quarters of 2020 and 2019, respectively.
    • Selling, general and administrative (SG&A) expenses were $43.3 million in the second quarter of 2020, compared to $49.1 million in the second quarter of 2019.
    • GAAP net loss was $7.3 million, or $0.17 per share (basic and diluted), in the second quarter of 2020, compared to GAAP net income of $2.7 million, or $0.07 per share (basic) and $0.06 per share (diluted), in the second quarter of 2019.
    • Non-GAAP net income was $5.0 million, or $0.12 per share (basic and diluted), in the second quarter of 2020, compared to non-GAAP net income of $17.5 million, or $0.42 per share (basic) and $0.41 per share (diluted), in the second quarter of 2019.
    • Adjusted EBITDA was $8.5 million in the second quarter of 2020, versus adjusted EBITDA of $21.9 million in the second quarter of 2019.
    • Pacira ended the second quarter of 2020 with cash, cash equivalents, short-term and long-term investments ("cash") of $335.1 million. Cash used in operations was $15.6 million in the second quarter of 2020, compared to cash provided by operations of $22.8 million in the second quarter of 2019.
    • Pacira had 42.2 million basic weighted average shares of common stock outstanding in the second quarter of 2020.
    • For non-GAAP measures, Pacira had 42.9 million diluted weighted average shares of common stock outstanding in the second quarter of 2020.

    See "Non-GAAP Financial Information" below.

    Recent Highlights

    • Preliminary net product sales for July 2020.  Today the company also reported preliminary unaudited net product sales of EXPAREL and iovera° of $38.1 million and $0.8 million, respectively, for the month of July 2020. Given the rapidly changing variables related to the COVID-19 pandemic, the company does not have sufficient visibility to accurately forecast the impact of the pandemic and is currently not providing full-year 2020 financial guidance. In order to provide greater transparency, the company plans to report monthly intra-quarter unaudited net product sales until it has gained sufficient visibility around the impacts of COVID-19.

       
    • FDA acceptance of sNDA for EXPAREL use in pediatric patients. In August 2020, Pacira announced the U.S. Food and Drug Administration (FDA) has accepted the submission of its supplemental new drug application (sNDA) seeking expansion of the EXPAREL label to include single-dose infiltration to provide postsurgical analgesia in children aged six and over. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is March 22, 2021.

       
    • Issuance of $402.5 million aggregate principal amount of 0.750% convertible senior notes due 2025. In July 2020, Pacira issued $402.5 million in aggregate principal amount of convertible senior notes due 2025 in a private placement. Pacira used approximately $211.1 million of the net proceeds to repurchase $185.0 million aggregate principal amount of its outstanding 2.375% Convertible Senior Notes due 2022. Pacira intends to use the remainder of the net proceeds from the offering for general corporate purposes, including working capital, research and development expenditures and the license or acquisition of complementary products and/or technologies.

       
    • Conclusion of EXPAREL agreement with DePuy Synthes. In July 2020, Pacira announced the conclusion of its agreement with DePuy Synthes Sales Inc. to jointly market and promote the use of EXPAREL for orthopedic procedures in the United States. Under this collaboration, which began in January 2017, DePuy Synthes field representatives, specializing in joint reconstruction, spine, sports medicine, trauma and cranio-maxillofacial procedures, collaborate with the Pacira field teams to support EXPAREL use and education in orthopedic surgical settings. In addition to partnering with DePuy Synthes in support of orthopedic surgical procedures, Pacira field representatives have remained the overall EXPAREL account managers and commercial leads for soft tissue surgeons, anesthesiologists, and ambulatory surgery centers.

    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, August 6, 2020, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 3276818. 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 3276818. 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; amortization of acquired intangible assets, an income tax benefit and step-up in basis of inventory in connection with the acquisition of MyoScience, Inc. and gain on investment.

    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, 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

     

    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.

    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°; 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.

    (Tables to Follow)



    Pacira BioSciences, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

        
     June 30,

    2020
     December 31,

    2019
    ASSETS   
    Current assets:   
      Cash, cash equivalents and short-term investments$335,053   $291,950  
      Accounts receivable, net44,013   47,530  
      Inventories, net66,690   58,296  
      Prepaid expenses and other current assets18,328   10,781  
      Total current assets455,823   408,557  
    Long-term investments8,261   64,798  
    Fixed assets, net113,297   104,681  
    Right-of-use assets, net77,799   38,124  
    Goodwill99,547   99,547  
    Intangible assets, net100,454   104,387  
    Equity investment and other assets10,930   10,971  
      Total assets$866,111   $831,065  
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Current liabilities:   
      Accounts payable$9,160   $12,799  
      Accrued expenses47,684   70,427  
      Lease liabilities7,620   4,935  
      Contingent consideration4,504   18,179  
      Income taxes payable1,615   1,333  
      Total current liabilities70,583   107,673  
    Convertible senior notes314,182   306,045  
    Lease liabilities73,888   40,938  
    Contingent consideration16,326   19,963  
    Other liabilities2,984   1,502  
    Total stockholders' equity388,148   354,944  
      Total liabilities and stockholders' equity$866,111   $831,065  
     
     

    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,
     2020 2019 2020 2019
     Net product sales:       
      EXPAREL$73,046    $98,868    $174,315    $189,482   
      Bupivacaine liposome injectable suspension775    921    1,981    1,213   
      Total EXPAREL / bupivacaine liposome

      injectable suspension net product sales
    73,821    99,789    176,296    190,695   
      iovera°1,395    2,035    3,665    2,035   
     Total net product sales75,216    101,824    179,961    192,730   
     Royalty revenue289    780    1,228    1,187   
      Total revenues75,505    102,604    181,189    193,917   
            
    Operating expenses:       
      Cost of goods sold22,305    25,201    52,037    52,505   
      Research and development13,620    17,827    29,440    32,210   
      Selling, general and administrative43,342    49,126    88,122    96,431   
      Amortization of acquired intangible assets1,967    1,770    3,933    1,770   
      Acquisition-related charges (gains)

      and product discontinuation, net
    1,418    3,405    (2,290)  4,647   
      Total operating expenses82,652    97,329    171,242    187,563   
    Income (loss) from operations(7,147)  5,275    9,947    6,354   
            
    Other (expense) income:       
      Interest income1,323    1,817    2,911    3,973   
      Interest expense(5,456)  (5,878)  (11,477)  (11,691) 
      Other, net3,969    (87)  (136)  (26) 
      Total other expense, net(164)  (4,148)  (8,702)  (7,744) 
    Income (loss) before income taxes(7,311)  1,127    1,245    (1,390) 
      Income tax benefit (expense)42    1,603    (356)  1,349   
    Net income (loss)$(7,269)  $2,730    $889    $(41) 
            
    Net income (loss) per share:       
      Basic net income (loss) per common share$(0.17)  $0.07    $0.02    $(0.00) 
      Diluted net income (loss) per common share$(0.17)  $0.06    $0.02    $(0.00) 
    Weighted average common shares outstanding:       
      Basic42,221    41,384    42,126    41,312   
      Diluted42,221    42,345    42,861    41,312   
                    
                    

    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,
     2020 2019 2020 2019
    GAAP net income (loss)$(7,269)  $2,730    $889    $(41) 
            
    Non-GAAP adjustments:       
      Acquisition-related charges (gains)

      and product discontinuation, net
    1,418    3,405    (2,290)  4,647   
      Stock-based compensation9,222    7,783    18,070    15,217   
      Amortization of debt discount3,660    3,405    7,254    6,749   
      Amortization of acquired intangible assets1,967    1,770    3,933    1,770   
      Recognition of step-up basis in inventory from acquisition—    220    —    220   
      Income tax benefit in connection with acquisition—    (1,828)  —    (1,828) 
      Gain on investment(3,979)  —    (8)  —   
      Total Non-GAAP adjustments12,288    14,755    26,959    26,775   
            
    Non-GAAP net income$5,019    $17,485    $27,848    $26,734   
            
    GAAP basic net income (loss) per common share$(0.17)  $0.07    $0.02    $(0.00) 
    GAAP diluted net income (loss) per common share$(0.17)  $0.06    $0.02    $(0.00) 
            
    Non-GAAP basic net income per common share$0.12    $0.42    $0.66    $0.65   
    Non-GAAP diluted net income per common share$0.12    $0.41    $0.65    $0.63   
            
    Weighted average common shares outstanding - basic42,221    41,384    42,126    41,312   
    Weighted average common shares outstanding - diluted42,937    42,345    42,861    42,231   
            
    Cost of goods sold reconciliation:       
    GAAP cost of goods sold$22,305    $25,201    $52,037    $52,505   
      Recognition of step-up basis in inventory from acquisition—    (220)  —    (220) 
      Stock-based compensation(1,284)  (1,156)  (2,503)  (2,247) 
    Non-GAAP cost of goods sold$21,021    $23,825    $49,534    $50,038   
            
    Research and development reconciliation:       
    GAAP research and development$13,620    $17,827    $29,440    $32,210   
      Stock-based compensation(1,357)  (1,257)  (2,544)  (2,475) 
    Non-GAAP research and development$12,263    $16,570    $26,896    $29,735   
            
    Selling, general and administrative reconciliation:       
    GAAP selling, general and administrative$43,342    $49,126    $88,122    $96,431   
      Stock-based compensation(6,581)  (5,370)  (13,023)  (10,495) 
    Non-GAAP selling, general and administrative$36,761    $43,756    $75,099    $85,936   
     
     

    Pacira BioSciences, Inc.

    Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA

    (in thousands)

    (unaudited)

     Three Months Ended Six Months Ended
     June 30, June 30,
     2020 2019 2020 2019
    GAAP net income (loss)$(7,269)  $2,730    $889    $(41) 
            
      Interest income(1,323)  (1,817)  (2,911)  (3,973) 
      Interest expense (1)5,456    5,878    11,477    11,691   
      Income tax (benefit) expense (2)(42)  (1,603)  356    (1,349) 
      Depreciation expense3,023    3,512    5,877    7,111   
      Amortization of acquired intangible assets1,967    1,770    3,933    1,770   
    EBITDA1,812    10,470    19,621    15,209   
            
    Other adjustments:       
      Acquisition-related charges (gains) and product

      discontinuation, net
    1,418    3,405    (2,290)  4,647   
      Stock-based compensation9,222    7,783    18,070    15,217   
      Recognition of step-up basis in

      inventory from acquisition
    —    220    —    220   
      Gain on investment(3,979)  —    (8)  —   
    Adjusted EBITDA (non-GAAP)$8,473    $21,878    $35,393    $35,293   

    (1) Includes amortization of debt discount

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

    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
    
    
    Media Contact:
    Coyne Public Relations
    Alyssa Schneider, (973) 588-2270
    

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