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Pacira Reports Record Fourth Quarter and Full-Year Revenues

February 20, 2020 8:01 AM

— Full-year 2019 revenue increases 25 percent to $421 million versus 2018 —
— Total 2020 revenue guidance of between $485 million and $500 million —
— Anesthesia-driven regional approaches are expanding and driving strong EXPAREL growth —
— Conference call today at 8:30 a.m. ET —

PARSIPPANY, N.J., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX) today reported financial results for the fourth quarter and full-year of 2019 and provided 2020 financial guidance.

“By every measure, 2019 was an outstanding year for Pacira. We are delighted to report record revenues for EXPAREL® with our sixth consecutive quarter of more than 20 percent growth,” said Dave Stack, chairman and chief executive officer of Pacira BioSciences. “Demand has continued to mount within the anesthesia community as EXPAREL-based nerve and field blocks take hold as institutional protocol. Additionally, we enhanced our non-opioid pain management product portfolio with the addition of iovera°® and we are seeing great interest from the marketplace around this innovative system.”

“Looking forward, we intend to capitalize on this momentum with robust topline growth that will drive substantial operating leverage and cash flow, providing significant financial flexibility to invest in future growth opportunities. Our mission for 2020 remains steadfast as we continue to propel our global leadership in non-opioid pain management and deliver multiple milestones, including the publication of new data in C-section, label-expansion initiatives for pediatrics and lower extremity nerve block, and the advancement of regulatory activities in Europe, Canada, and China,” added Mr. Stack.

2019 Full-Year and Fourth Quarter Financial Highlights

Recent Highlights

Fourth Quarter 2019 Financial Results

Full-Year 2019 Financial Results

2020 Outlook

Pacira announces its full-year 2020 financial guidance as follows. Pacira expects:

See “Non-GAAP Financial Information” and “Reconciliations of GAAP to Non-GAAP 2020 Financial Guidance” below.

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 20, 2020, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8765839. 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 8765839. 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, because such measures exclude milestone revenue; acquisition-related charges, product discontinuation costs and other expense; 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 loss on investment and other non-operating income.

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 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, and a reconciliation of our GAAP to non-GAAP 2020 financial guidance for gross margins, R&D expense and SG&A expense.

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.

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.

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 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,
2019
December 31,
2018
ASSETS
Current assets:
Cash, cash equivalents and short-term investments$291,950 $383,454
Accounts receivable, net47,530 38,000
Inventories, net58,296 48,569
Prepaid expenses and other current assets10,781 7,946
Total current assets408,557 477,969
Long-term investments64,798 25,871
Fixed assets, net104,681 108,670
Right-of-use assets, net38,124
Goodwill99,547 62,040
Intangible assets, net104,387
Equity investment and other assets10,971 14,803
Total assets$831,065 $689,353
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$12,799 $14,368
Accrued expenses70,427 45,865
Lease liabilities4,935
Convertible senior notes (1) 338
Contingent consideration18,179
Income taxes payable1,333 90
Total current liabilities107,673 60,661
Convertible senior notes (2)306,045 290,592
Lease liabilities40,938
Contingent consideration19,963
Other liabilities1,502 16,874
Total stockholders’ equity354,944 321,226
Total liabilities and stockholders’ equity$831,065 $689,353

(1) Relates to our 3.25% convertible senior notes due 2019 that matured on February 1, 2019.
(2) Relates to our 2.375% convertible senior notes due 2022 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,
2019 2018 2019 2018
Net product sales: 2019 2018
EXPAREL$116,939 $94,422 $407,877 $331,112
Bupivacaine liposome injectable suspension1,685 293 3,153 1,315
Total EXPAREL / bupivacaine liposome injectable suspension net product sales118,624 94,715 411,030 332,427
iovera°3,221 7,896
Total net product sales121,845 94,715 418,926 332,427
Collaborative licensing and milestone revenue 3,000
Royalty revenue579 400 2,100 1,850
Total revenues122,424 95,115 421,026 337,277
Operating expenses:
Cost of goods sold31,904 23,979 106,712 86,845
Research and development19,653 14,174 72,119 55,688
Selling, general and administrative54,223 44,647 200,782 177,265
Amortization of acquired intangible assets1,967 5,703
Acquisition-related charges, product discontinuation and other12,965 53 25,230 1,564
Total operating expenses120,712 82,853 410,546 321,362
Income from operations1,712 12,262 10,480 15,915
Other income (expense):
Interest income1,667 2,004 7,376 6,497
Interest expense(5,997) (5,753) (23,628) (21,949)
Other, net(923) (191) (4,976) (888)
Total other expense, net(5,253) (3,940) (21,228) (16,340)
Income (loss) before income taxes(3,541) 8,322 (10,748) (425)
Income tax expense(1,347) (37) (268) (46)
Net income (loss)$(4,888) $8,285 $(11,016) $(471)
Net income (loss) per share:
Basic and diluted net income (loss) per common share$(0.12) $0.20 $(0.27) $(0.01)
Weighted average common shares outstanding:
Basic41,784 41,148 41,513 40,911
Diluted41,784 42,219 41,513 40,911

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,
2019 2018 2019 2018
GAAP net income (loss) $(4,888) $8,285 $ (11,016) $(471)
Non-GAAP adjustments:
Milestone revenue (1) (3,000)
Acquisition-related charges, product discontinuation and other12,965 53 25,230 1,564
Stock-based compensation9,189 8,186 33,650 31,725
Amortization of debt discount3,530 3,286 13,746 12,799
Amortization of acquired intangible assets1,967 5,703
Income tax benefit in connection with acquisition (1,828)
Recognition of step-up basis in inventory from acquisition 220
Loss on investment and other non-operating income, net1,023 4,981 854
Total Non-GAAP adjustments28,674 11,525 81,702 43,942
Non-GAAP net income$23,786 $19,810 $70,686 $43,471
GAAP basic and diluted net income (loss) per common share$(0.12) $0.20 $(0.27) $(0.01)
Non-GAAP basic net income per common share$0.57 $0.48 $1.70 $1.06
Non-GAAP diluted net income per common share$0.56 $0.47 $1.67 $1.04
Weighted average common shares outstanding - basic41,784 41,148 41,513 40,911
Weighted average common shares outstanding - diluted42,612 42,219 42,370 41,869
Cost of goods sold reconciliation:
GAAP cost of goods sold$31,904 $23,979 $106,712 $86,845
Stock-based compensation(1,174) (1,047) (4,665) (4,478)
Recognition of step-up basis in inventory from acquisition (220)
Non-GAAP cost of goods sold$30,730 $22,932 $101,827 $82,367
Research and development reconciliation:
GAAP research and development$19,653 $14,174 $72,119 $55,688
Stock-based compensation(1,342) (1,164) (5,114) (3,934)
Non-GAAP research and development$18,311 $13,010 $67,005 $51,754
Selling, general and administrative reconciliation:
GAAP selling, general and administrative$54,223 $44,647 $200,782 $177,265
Stock-based compensation(6,672) (5,975) (23,871) (23,313)
Non-GAAP selling, general and administrative$47,551 $38,672 $176,911 $153,952

(1) Represents a $3.0 million upfront payment earned under our agreement with Nuance Biotech Co. Ltd. for the development and commercialization of EXPAREL in China.

Pacira BioSciences, Inc.
Reconciliation of GAAP to Non-GAAP 2020 Financial Guidance
(dollars in millions)

GAAP to Non-GAAP Guidance GAAP Stock-Based Compensation Non-GAAP
Total revenues $485 to $500
EXPAREL net product sales $465 to $475
iovera° net product sales $15 to $20
Gross margin 75% to 77% Approx. 1% 76% to 78%
Research and development expense $64 to $76 $4 to $6 $60 to $70
Selling, general and administrative expense $207 to $219 $27 to $29 $180 to $190
Stock-based compensation $35 to $40


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