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Pacira BioSciences Reports First Quarter 2021 Financial Results and Business Update

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

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

First Quarter 2021 Financial Highlights

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

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

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

First Quarter 2021 Financial Results

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

See “Non-GAAP Financial Information” below.

Recent Business Highlights

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

Financial Guidance

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

Today’s Conference Call and Webcast Reminder

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

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

Non-GAAP Financial Information

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

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

About Pacira BioSciences

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

About EXPAREL®

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

Important Safety Information for Patients

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

About iovera°

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

Important Safety Information

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

Forward-Looking Statements

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

 

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


Pacira BioSciences, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)

 March 31,
2021
 December 31,
2020
ASSETS   
Current assets:   
Cash and cash equivalents$66,699  $99,957 
Short-term investments523,364  421,705 
Accounts receivable, net52,583  53,046 
Inventories, net64,606  64,650 
Prepaid expenses and other current assets12,995  12,265 
Total current assets720,247  651,623 
Long-term investments34,971  95,459 
Fixed assets, net144,822  136,688 
Right-of-use assets, net72,888  74,492 
Goodwill99,547  99,547 
Intangible assets, net94,554  96,521 
Deferred tax assets104,467  106,164 
Equity investment and other assets16,053  14,019 
Total assets$1,287,549  $1,274,513 
    
LIABILITIES AND STOCKHOLDERS’ EQUITY   
Current liabilities:   
Accounts payable$9,110  $10,431 
Accrued expenses50,239  70,974 
Lease liabilities5,503  7,425 
Convertible senior notes (1)151,647  149,648 
Contingent consideration14,864  14,736 
Income taxes payable721  114 
Total current liabilities232,084  253,328 
Convertible senior notes (2)317,338  313,030 
Lease liabilities69,666  71,025 
Contingent consideration12,355  13,610 
Other liabilities5,288  3,832 
Total stockholders’ equity650,818  619,688 
Total liabilities and stockholders’ equity$1,287,549  $1,274,513 

(1) Relates to our 2.375% convertible senior notes due 2022. These notes are classified as current at March 31, 2021 and December 31, 2020 because the note holders can convert any time on or after October 1, 2021.
(2) Relates to our 0.750% convertible senior notes due 2025 that are not currently convertible.

Pacira BioSciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)

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

Pacira BioSciences, Inc.
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except per share amounts)
(unaudited)

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

Pacira BioSciences, Inc.
Reconciliation of GAAP Net Income to Adjusted EBITDA (Non-GAAP)
(in thousands)
(unaudited)

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

(1) Includes amortization of debt discount

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

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