• Pacira BioSciences Reports Record Revenue of $135.6 Million for the Second Quarter of 2021

    المصدر: Nasdaq GlobeNewswire / 03 أغسطس 2021 08:00:03   America/New_York

    -- 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

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