• Pacira BioSciences Reports Full-Year and Fourth Quarter 2020 Financial Results

    ソース: Nasdaq GlobeNewswire / 25 2 2021 07:00:03   America/Chicago

    — 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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