Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, which are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chairman and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Based on their evaluation as of December 31, 2022, our Chief Executive Officer and Chairman and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2022.
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Management’s Report on Internal Control over Financial Reporting
Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP. Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chairman and Chief Financial Officer, management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2022, based on the criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based upon the results of the evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2022.
The effectiveness of our internal control over financial reporting as of December 31, 2022 was audited by KPMG LLP, our independent registered public accounting firm, which expressed an unqualified opinion on the effectiveness of our internal control over financial reporting as of December 31, 2022.
Changes in Internal Control over Financial Reporting
During the quarter ended December 31, 2022, our management integrated internal controls for the acquired Flexion business into our existing controls. Other than the controls enhanced or implemented to integrate the Flexion business, there have been no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
Information required by this item will be included in the proxy statement for our 2023 annual stockholders’ meeting and is incorporated by reference into this report.
Item 11. Executive Compensation
Information required by this item will be included in the proxy statement for our 2023 annual stockholders’ meeting and is incorporated by reference into this report.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters
Information required by this item will be included in the proxy statement for our 2023 annual stockholders’ meeting and is incorporated by reference into this report.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Information required by this item will be included in the proxy statement for our 2023 annual stockholders’ meeting and is incorporated by reference into this report.
Item 14. Principal Accountant Fees and Services
Information required by this item will be included in the proxy statement for our 2023 annual stockholders’ meeting and is incorporated by reference into this report.
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PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) Documents filed as part of this Annual Report on Form 10-K:
(1) Financial Statements
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Income
Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
The report of our independent registered accounting firm, KPMG LLP, with respect to the above-referenced financial statements and on internal control over financial reporting, is included in this Annual Report on Form 10-K. Their consent appears as Exhibit 23.1 of this Annual Report on Form 10-K.
Report of Independent Registered Public Accounting Firm
(2) Schedules
All financial statement schedules have been omitted because they are not required, are not applicable or the information is included in the consolidated financial statements or related notes thereto.
(3) Exhibits
The following exhibits are filed with, or incorporated by reference in this Annual Report on Form 10-K.
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EXHIBIT INDEX
Incorporation By Reference From
Exhibit
Number Description Form Exhibit Date
Filed
2.1
Agreement and Plan of Merger, dated March 4, 2019, by and among Pacira Pharmaceuticals, Inc., PS Merger, Inc., MyoScience, Inc., and Fortis Advisors LLC, as the securityholders’ representative. # † 8-K 2.1 3/5/2019
2.2
Agreement and Plan of Merger, dated as of October 11, 2021, by and among Flexion Therapeutics, Inc., Pacira BioSciences, Inc. and Oyster Acquisition Company Inc. 8-K 2.1 10/12/2021
3.1
Amended and Restated Certificate of Incorporation. 8-K 3.1 2/11/2011
3.2
Certificate of Amendment to the Amended and Restated Certificate of Incorporation, dated April 9, 2019. 8-K 3.1 4/9/2019
3.3
Second Amended and Restated Bylaws. 8-K 3.2 4/9/2019
4.1
Specimen Certificate Evidencing Shares of Common Stock. 10-Q 4.1 5/2/2019
4.2
Indenture (including form of 0.750% Convertible Senior Notes due 2025), dated July 10, 2020, between the Registrant and Computershare Corporate Trust, National Association, as trustee (formerly Wells Fargo Bank, National Association). 8-K 4.1 7/10/2020
4.3
Indenture (including form of 3.375% Convertible Senior Notes due 2024), dated as of May 2, 2017, by and between Flexion Therapeutics, Inc. and Computershare Corporate Trust, National Association, as trustee (formerly Wells Fargo Bank, National Association). 10-K 4.4 2/28/2022
4.4
First Supplemental Indenture, dated as of November 19, 2021, by and between Flexion Therapeutics, Inc. and Computershare Corporate Trust, National Association, as trustee (formerly Wells Fargo Bank, National Association).
10-K 4.5 2/28/2022
4.6
Description of Securities. 10-K 4.3 2/21/2020
10.1
Amended and Restated 2011 Stock Incentive Plan.*** 8-K 10.1 6/11/2021
10.2
Form of Nonstatutory Stock Option Agreement under the Amended and Restated 2011 Stock Incentive Plan for grants made prior to February 1, 2022.*** 8-K 10.3 6/4/2014
10.3
Form of Nonstatutory Stock Option Agreement (Employees) under the Amended and Restated 2011 Stock Incentive Plan for grants made on or after February 1, 2022.* *** 10-K 10.3 2/28/2022
10.4
Form of Nonstatutory Stock Option Agreement (Non-Employee Directors) under the Amended and Restated 2011 Stock Incentive Plan for grants made on or after February 1, 2022.* *** 10-K 10.4 2/28/2022
10.3
Form of Restricted Stock Unit Award Agreement (Employees) under the Amended and Restated 2011 Stock Incentive Plan.*** 10-Q 10.6 7/30/2015
10.4
Form of Restricted Stock Unit Award Agreement (Non-Employee Directors) under the Amended and Restated 2011 Stock Incentive Plan.*** 10-Q 10.7 7/30/2015
10.5
2014 Inducement Plan.*** 10-Q 10.1 5/1/2014
10.6
Amended and Restated 2014 Employee Stock Purchase Plan.*** 8-K 10.1 6/10/2022
10.7
Assignment Agreement, dated February 9, 1994, amended April 15, 2004, between the Registrant and Research Development Foundation. S-1/A 10.4 12/3/2010
10.8
Stock Purchase Agreement, dated January 8, 2007, between SkyePharma, Inc. and the Registrant. S-1/A 10.5 12/3/2010
10.9
Employment Agreement between the Registrant and David Stack.*** S-1/A 10.21 12/3/2010
10.10
Amendment No. 1 to Executive Employment Agreement, dated March 13, 2013, between the Registrant and David Stack.*** 8-K 99.3 3/18/2013
10.11
Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between the Registrant and David Stack.*** 10-Q 10.2 7/30/2015
10.12
Employment Agreement, dated November 29, 2012, between the Registrant and Kristen Williams.*** 10-Q 10.2 4/30/2015
10.13
Amendment No. 1 to Employment Agreement, dated March 13, 2013, between the Registrant and Kristen Williams.*** 10-Q 10.3 4/30/2015
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Incorporation By Reference From
Exhibit
Number Description Form Exhibit Date
Filed
10.14
Amendment No. 2 to Employment Agreement, dated June 30, 2015, between the Registrant and Kristen Williams.*** 10-Q 10.5 7/30/2015
10.15
Executive Employment Agreement, dated May 2, 2016, between the Registrant and Charles A. Reinhart, III.*** 10-Q 10.1 8/4/2016
10.16
Executive Employment Agreement, dated June 19, 2019, between the Registrant and Max Reinhardt.*** 10-Q 10.1 5/7/2020
10.17
Executive Employment Agreement, dated April 24, 2017, between the Registrant and Roy Winston.*** 10-Q 10.2 5/7/2020
10.18
Form of Indemnification Agreement between the Registrant and its directors and officers.*** S-1/A 10.32 1/13/2011
10.19
Commercial Outsourcing Services Agreement entered into as of August 25, 2011 by the Registrant and Integrated Commercialization Solutions, Inc.† 10-Q 10.1 8/25/2011
10.20
First Amendment to Commercial Outsourcing Services Agreement, dated August 1, 2013, between the Registrant and Integrated Commercialization Solutions, Inc.† 10-Q 10.1 10/31/2013
10.21
Second Amendment to Commercial Outsourcing Services Agreement, dated August 25, 2014, between the Registrant and Integrated Commercialization Solutions, Inc.† 10-Q 10.1 10/30/2014
10.22
Third Amendment to Commercial Outsourcing Services Agreement, dated April 29, 2015, between the Registrant and Integrated Commercialization Solutions, Inc.† 10-Q 10.1 7/30/2015
10.23
Fourth through Eleventh Amendments to Commercial Outsourcing Services Agreement, between the Registrant and Integrated Commercialization Solutions, Inc.†† 10-Q 10.3 5/7/2020
10.24
Pacira BioSciences, Inc. Deferred Compensation Plan.*** 8-K 10.1 6/11/2020
10.25
Amendment No. 1 to Pacira BioSciences, Inc. Deferred Compensation Plan.* ***
10.26
Pacira BioSciences, Inc. Long-Term Incentive Plan.*** 8-K 10.1 12/7/2020
10.27
Strategic Co-Production Agreement dated April 4, 2014, by and between the Registrant and Patheon UK Limited.† 10-Q 10.1 7/31/2014
10.28
Manufacturing and Supply Agreement dated April 4, 2014, by and between the Registrant and Patheon UK Limited.† 10-Q 10.2 7/31/2014
10.29
Technical Transfer and Service Agreement dated April 4, 2014, by and between the Registrant and Patheon UK Limited.† 10-Q 10.3 7/31/2014
10.30
Amended and Restated Consulting Agreement, dated April 3, 2012, between the Registrant and Gary Pace.*** 10-Q 10.1 5/9/2012
10.31
Second Amended and Restated Consulting Agreement, dated August 17, 2012, between the Registrant and Gary Pace.*** 10-Q 10.1 11/1/2012
10.32
Third Amendment to Consulting Agreement, dated September 11, 2013, between the Registrant and Gary Pace.*** 10-Q 10.3 10/31/2013
10.33
Fourth Amendment to Consulting Agreement, dated November 25, 2015, between the Registrant and Gary Pace.*** 10-K 10.57 2/25/2016
10.34
Executive Employment Agreement, dated May 29, 2017, between the Registrant and Dennis McLoughlin.*** 10-Q 10.1 5/2/2019
10.35
Contingent Value Right Agreement, dated as of November 19, 2021, by and between Pacira BioSciences, Inc. and American Stock Transfer & Trust Company, LLC. 8-K 10.1 11/19/2021
10.36
Credit Agreement, dated as of December 7, 2021, by and among Pacira BioSciences, Inc., the lenders from time to time party thereto and JPMorgan Chase Bank, N.A., as administrative agent.## 8-K 10.1 12/9/2021
10.37
Manufacturing and Supply Agreement dated July 31, 2015, between Flexion Therapeutics, Inc. and Patheon UK Limited, as amended to date.†† 10-K 10.36 2/28/22
10.38
Technical Transfer and Service Agreement dated July 31, 2015, between Flexion Therapeutics, Inc. and Patheon UK Limited, as amended to date.†† 10-K 10.37 2/28/22
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Incorporation By Reference From
Exhibit
Number Description Form Exhibit Date
Filed
10.39
Side Letter to the Manufacturing and Supply Agreement between Flexion Therapeutics, Inc. and Patheon UK Limited, dated as of April 8, 2020.†† 10-K 10.38 2/28/22
10.40
Executive Employment Agreement, dated May 4, 2020, between the Registrant and Jonathan Slonin.*** 10-Q 10.1 5/4/2022
21.1
Subsidiaries of the Registrant.*
23.1
Consent of KPMG LLP.*
31.1
Certification of Chief Executive Officer and Chairman pursuant to Exchange Act Rule 13a-14(a).*
31.2
Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a).*
32.1
Certification of Chief Executive Officer and Chairman and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.**
101.INS* Inline XBRL Instance Document.*
101.SCH* Inline XBRL Taxonomy Schema Document.*
101.CAL* Inline XBRL Taxonomy Calculation Linkbase Document.*
101.LAB* Inline XBRL Taxonomy Label Linkbase Document.*
101.PRE* Inline XBRL Taxonomy Presentation Linkbase Document.*
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document.*
104* Cover Page Interactive Data File (Formatted as Inline XBRL and contained in Exhibit 101).
* Filed herewith.
** Furnished herewith.
*** Denotes management contract or compensatory plan or arrangement.
† Confidential treatment has been requested or granted as to certain portions, which portions were omitted and filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Request.
†† Certain portions of the exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.
# Certain schedules have been omitted pursuant to Item 601(b)(2) of Regulation S-K under the Securities Exchange Act of 1934, as amended. The Company hereby undertakes to supplementally furnish copies of any omitted schedules to the Securities and Exchange Commission upon request.
## Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to supplementally furnish copies of any omitted schedules and exhibits to the Securities and Exchange Commission upon request.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
PACIRA BIOSCIENCES, INC.
/s/ DAVID STACK
Date: February 28, 2023 By: David Stack
Chief Executive Officer and Chairman
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ DAVID STACK Director, Chief Executive Officer and Chairman
(Principal Executive Officer) February 28, 2023
David Stack
/s/ CHARLES A. REINHART, III Chief Financial Officer
(Principal Financial Officer) February 28, 2023
Charles A. Reinhart, III
/s/ LAUREN RIKER Senior Vice President, Finance
(Principal Accounting Officer) February 28, 2023
Lauren Riker
/s/ LAURA BREGE Director February 28, 2023
Laura Brege
/s/ CHRISTOPHER J. CHRISTIE Director February 28, 2023
Christopher J. Christie
/s/ MARK FROIMSON Director February 28, 2023
Mark Froimson
/s/ YVONNE GREENSTREET Director February 28, 2023
Yvonne Greenstreet
/s/ MARK KRONENFELD Director February 28, 2023
Mark Kronenfeld
/s/ GARY PACE Director February 28, 2023
Gary Pace
/s/ ANDREAS WICKI Director February 28, 2023
Andreas Wicki
/s/ PAUL HASTINGS Lead Director February 28, 2023
Paul Hastings
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PACIRA BIOSCIENCES, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE YEAR ENDED DECEMBER 31, 2022
INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS
Page #
Report of Independent Registered Public Accounting Firm
F-2
Auditor Name: KPMG LLP
Auditor Location: Short Hills, NJ
Auditor Firm ID: 185
Consolidated Balance Sheets as of December 31, 2022 and 2021
F-4
Consolidated Statements of Operations for the years ended December 31, 2022, 2021 and 2020
F-5
Consolidated Statements of Comprehensive Income for the years ended December 31, 2022, 2021 and 2020
F-6
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2022, 2021 and 2020
F-7
Consolidated Statements of Cash Flows for the years ended December 31, 2022, 2021 and 2020
F-8
Notes to Consolidated Financial Statements
F-10
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors
Pacira BioSciences, Inc.:
Opinions on the Consolidated Financial Statements and Internal Control Over Financial Reporting
We have audited the accompanying consolidated balance sheets of Pacira BioSciences, Inc. and subsidiaries (the Company) as of December 31, 2022 and 2021, the related consolidated statements of operations, comprehensive income, stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 2022, and the related notes (collectively, the consolidated financial statements). We also have audited the Company’s internal control over financial reporting as of December 31, 2022, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the years in the three-year period ended December 31, 2022, in conformity with U.S. generally accepted accounting principles. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2022 based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission
Basis for Opinions
The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in the accompanying Management's Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s consolidated financial statements and an opinion on the Company’s internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
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Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Evaluation of the In-Process Research & Development Intangible Impairment Charge
As discussed in Notes 5 and 9 to the consolidated financial statements, the Company performs indefinite-lived intangible asset impairment testing on an annual basis and whenever events or changes in circumstances indicate the fair value of the indefinite-lived intangible asset has declined below its carrying amount. Fair value is estimated using a discounted cash flow model. The Company recorded an impairment charge of $26.1 million during 2022 related to in-process research & development (IPR&D) for ZILRETTA.
We identified the evaluation of the IPR&D intangible asset impairment charge as a critical audit matter. Evaluating the fair value measurement of this intangible asset was complex and required significant auditor judgment due to the high degree of subjectivity in evaluating certain assumptions used to estimate fair value. In particular, the fair value measurement was sensitive to management’s forecast of revenue and the discount rate assumptions. Changes in these assumptions could have a significant impact on the fair value of this intangible asset. In addition, the audit effort associated with the evaluation of the Company’s discount rate involved the use of valuation professionals with specialized skills and knowledge.
The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s process used to determine the fair value of its IPR&D intangible asset. This included controls related to the development of assumptions for forecasted revenues and discount rate. We evaluated the future revenue growth rates used by the Company to determine forecasted revenue, by comparing them to industry data that was assessed to be relevant and reliable. We involved valuation professionals with specialized skills and knowledge, who assisted in developing an independent estimate of the discount rate using inputs from publicly available market data and comparing the results to the Company's discount rate assumption.
Fair value measurement of the contingent consideration liability associated with the acquisition of Flexion
As discussed in Notes 5 and 12 to the consolidated financial statements, the Company recognized a contingent consideration liability at its estimated fair value on the acquisition date, in connection with the acquisition of Flexion Therapeutics, Inc. (Flexion). Subsequent changes to the fair value of the contingent consideration liability are recorded in the consolidated statement of operations in the period of change. The Company estimates the fair value using a probability-weighted discounted cash flow approach that is based on unobservable inputs and a Monte Carlo simulation. The fair value of the Flexion contingent consideration as of December 31, 2022 was $28.1 million.
We identified the evaluation of the fair value measurement of the contingent consideration liability related to achieving commercial and regulatory milestones associated with the acquisition of Flexion as a critical audit matter. Evaluating the fair value measurement of the contingent consideration liability required significant auditor judgment, due to the high degree of subjectivity inherent in certain assumptions with unobservable inputs that were used in the model. In particular, the fair value measurement was sensitive to management’s forecasts of revenues, estimated probabilities and timing related to the achievement of certain commercial and regulatory milestones, volatility, and discount rates. In addition, the audit effort associated with the evaluation of the Company’s volatility and discount rates involved the use of valuation professionals with specialized skills and knowledge.
The following are the primary procedures we performed to address this critical audit matter. We evaluated the design and tested the operating effectiveness of certain internal controls related to the Company’s fair value measurement process for the contingent consideration liability related to achieving commercial and regulatory milestones. This
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included controls related to the development of the assumptions for forecasted revenues, estimated probabilities and timing related to the achievement of certain milestones, volatility, and discount rates. We evaluated the forecasted revenues and certain commercial and regulatory milestone assumptions used in the Company’s models by comparing them to historical data, industry benchmarks and other third-party market data that were assessed to be relevant and reliable. We involved valuation professionals with specialized skills and knowledge, who assisted in developing an independent estimate of the discount rates and volatility assumptions using inputs from publicly available market data and comparing the results to the Company’s discount rates and volatility assumptions.
/s/ KPMG LLP
We have served as the Company’s auditor since 2015.
Short Hills, New Jersey
February 28, 2023
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PACIRA BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31,
2022 2021
ASSETS
Current assets:
Cash and cash equivalents $ 104,139 $ 585,578
Short-term available-for-sale investments 184,512 70,831
Accounts receivable, net 98,397 96,318
Inventories, net 96,063 98,550
Prepaid expenses and other current assets 15,223 14,771
Total current assets 498,334 866,048
Noncurrent available-for-sale investments 37,209 —
Fixed assets, net 183,512 188,401
Right-of-use assets, net 70,877 76,410
Goodwill 163,243 145,175
Intangible assets, net 540,546 623,968
Deferred tax assets 160,309 153,364
Investments and other assets 27,170 21,987
Total assets $ 1,681,200 $ 2,075,353
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 15,220 $ 10,543
Accrued expenses 89,785 127,555
Lease liabilities 9,121 7,891
Convertible senior notes, net — 350,466
Current portion of long-term debt, net 33,648 24,234
Income taxes payable — 429
Total current liabilities 147,774 521,118
Convertible senior notes, net 404,767 339,267
Long-term debt, net 251,056 335,263
Lease liabilities 64,802 71,727
Contingent consideration 28,122 57,598
Other liabilities 9,669 19,972
Total liabilities 906,190 1,344,945
Commitments and contingencies (Note 20)
Stockholders’ equity:
Preferred stock, par value $ 0.001 ; 5,000,000 shares authorized; none issued and outstanding at December 31, 2022 and 2021
— —
Common stock, par value $ 0.001 ; 250,000,000 shares authorized; 45,927,790 and 44,734,308 shares issued and outstanding at December 31, 2022 and 2021, respectively
46 45
Additional paid-in capital 924,095 942,091
Accumulated deficit ( 148,751 ) ( 211,895 )
Accumulated other comprehensive (loss) income ( 380 ) 167
Total stockholders’ equity 775,010 730,408
Total liabilities and stockholders’ equity $ 1,681,200 $ 2,075,353
See accompanying notes to consolidated financial statements.
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PACIRA BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
Year Ended December 31,
2022 2021 2020
Revenues:
Net product sales $ 664,150 $ 538,966 $ 426,614
Royalty revenue 2,673 2,442 3,033
Collaborative licensing and milestone revenue — 125 —
Total revenues 666,823 541,533 429,647
Operating expenses:
Cost of goods sold 199,295 140,255 117,328
Research and development 84,797 55,545 59,421
Selling, general and administrative 254,516 199,345 193,516
Amortization of acquired intangible assets 57,288 13,553 7,866
Acquisition-related charges (gains), impairment and other 10,903 42,911 5,166
Total operating expenses 606,799 451,609 383,297
Income from operations 60,024 89,924 46,350
Other (expense) income:
Interest income 4,542 896 4,629
Interest expense ( 39,976 ) ( 31,750 ) ( 25,671 )
Loss on early extinguishment of debt — — ( 8,071 )
Other, net ( 11,288 ) ( 2,666 ) 2,852
Total other expense, net ( 46,722 ) ( 33,520 ) ( 26,261 )
Income before income taxes 13,302 56,404 20,089
Income tax benefit (expense) 2,607 ( 14,424 ) 125,434
Net income $ 15,909 $ 41,980 $ 145,523
Net income per share:
Basic net income per common share $ 0.35 $ 0.95 $ 3.41
Diluted net income per common share $ 0.34 $ 0.92 $ 3.33
Weighted average common shares outstanding:
Basic 45,521 44,262 42,671
Diluted 46,538 45,630 43,682
See accompanying notes to consolidated financial statements.
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PACIRA BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In thousands)
Year Ended December 31,
2022 2021 2020
Net income $ 15,909 $ 41,980 $ 145,523
Other comprehensive (loss) income:
Net unrealized loss on investments, net of tax ( 662 ) ( 180 ) ( 3 )
Foreign currency translation adjustments 115 29 ( 1 )
Total other comprehensive loss ( 547 ) ( 151 ) ( 4 )
Comprehensive income $ 15,362 $ 41,829 $ 145,519
See accompanying notes to consolidated financial statements
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PACIRA BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2022, 2021 AND 2020
(In thousands)
Common Stock Additional
Paid-In
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income (Loss) Total
Shares Amount
Balance at December 31, 2019 41,908 $ 42 $ 753,978 $ ( 399,398 ) $ 322 $ 354,944
Exercise of stock options 1,428 2 45,227 — — 45,229
Vested restricted stock units 239 — — — — —
Common stock issued under employee stock purchase plan 62 — 2,546 — — 2,546
Stock-based compensation — — 39,920 — — 39,920
Retirement of equity component of 2022 convertible senior notes (Note 11) — — ( 33,089 ) — — ( 33,089 )
Equity component of 2025 convertible senior notes issued, net of deferred taxes of $ 20,450 (Note 11)
— — 64,619 — — 64,619
Other comprehensive loss (Note 13) — — — — ( 4 ) ( 4 )
Net income — — — 145,523 — 145,523
Balance at December 31, 2020 43,637 44 873,201 ( 253,875 ) 318 619,688
Exercise of stock options 732 1 23,833 — — 23,834
Vested restricted stock units 310 — — — — —
Common stock issued under employee stock purchase plan 55 — 2,811 — — 2,811
Stock-based compensation — — 42,246 — — 42,246
Other comprehensive loss (Note 13) — — — — ( 151 ) ( 151 )
Net income — — — 41,980 — 41,980
Balance at December 31, 2021 44,734 45 942,091 ( 211,895 ) 167 730,408
Reclassification of the equity component of convertible senior notes to liabilities upon adoption of Accounting Standards Update 2020-06 (Note 3) — — ( 96,468 ) 47,235 — ( 49,233 )
Exercise of stock options 690 1 24,386 — — 24,387
Vested restricted stock units 331 — — — — —
Common stock issued under employee stock purchase plan 71 — 2,954 — — 2,954
Stock-based compensation — — 48,092 — — 48,092
Issuance of common stock upon conversion of 2022 convertible senior notes (Note 11) 102 — 3,040 — — 3,040
Other comprehensive loss (Note 13) — — — — ( 547 ) ( 547 )
Net income — — — 15,909 — 15,909
Balance at December 31, 2022 45,928 $ 46 $ 924,095 $ ( 148,751 ) $ ( 380 ) $ 775,010
See accompanying notes to consolidated financial statements.
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PACIRA BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended December 31,
2022 2021 2020
Operating activities:
Net income $ 15,909 $ 41,980 $ 145,523
Adjustments to reconcile net income to net cash provided by operating activities:
Deferred taxes ( 7,945 ) 10,872 ( 126,613 )
Depreciation of fixed assets and amortization of intangible assets 91,501 28,548 19,908
Amortization of debt issuance costs 4,400 2,754 2,156
Amortization of debt discount 2,807 23,152 18,254
Loss (gain) on disposal of fixed assets 193 ( 10 ) 22
Loss on early extinguishment of debt — — 8,071
Stock-based compensation 48,092 42,246 39,920
Changes in contingent consideration ( 29,476 ) ( 989 ) 5,204
Impairment of indefinite-lived intangible asset 26,134 — —
Impairment of investment 10,000 — —
Loss (gain) on investment and other non-operating income, net 92 2,673 ( 1,618 )
Changes in operating assets and liabilities:
Accounts receivable, net ( 2,079 ) ( 10,434 ) ( 5,516 )
Inventories, net 2,486 ( 4,467 ) ( 6,353 )
Prepaid expenses and other assets ( 2,699 ) 1,142 ( 739 )
Accounts payable 6,272 ( 10,262 ) ( 3,312 )
Accrued expenses and income taxes payable ( 19,857 ) 5,451 ( 5,999 )
Other liabilities ( 556 ) ( 104 ) ( 2,467 )
Payment of contingent consideration — ( 6,835 ) ( 9,409 )
Net cash provided by operating activities 145,274 125,717 77,032
Investing activities:
Acquisition of Flexion Therapeutics, Inc. (net of cash acquired) — ( 420,042 ) —
Purchases of fixed assets ( 30,076 ) ( 45,866 ) ( 37,801 )
Purchases of available-for-sale investments ( 387,685 ) ( 611,488 ) ( 546,516 )
Sales of available-for-sale investments 237,576 1,068,736 307,870
Payment of contingent consideration ( 32,000 ) ( 4,000 ) —
Sale of equity investment — 9,057 —
Purchases of equity and debt investments ( 13,000 ) ( 17,187 ) ( 1,160 )
Net cash used in investing activities ( 225,185 ) ( 20,790 ) ( 277,607 )
Financing activities:
Proceeds from exercises of stock options 24,387 23,844 45,218
Proceeds from common stock issued under employee stock purchase plan 2,954 2,811 2,546
Proceeds from Term loan B facility maturing December 2026 — 363,750 —
Proceeds from debt component of the 2025 convertible senior notes — — 314,708
Proceeds from equity component of the 2025 convertible senior notes — — 87,792
Repayment of 2022 convertible senior notes ( 156,960 ) — ( 176,793 )
Retirement of equity component of the 2022 convertible senior notes — — ( 33,089 )
Repayment of 2024 convertible senior notes ( 192,609 ) — —
Repayment of Term loan B facility maturing December 2026 ( 78,125 ) — —
Payment of debt issuance and financing costs ( 1,175 ) ( 4,546 ) ( 12,487 )
Payment of contingent consideration — ( 5,165 ) ( 5,591 )
Net cash (used) provided by financing activities ( 401,528 ) 380,694 222,304
Net (decrease) increase in cash and cash equivalents ( 481,439 ) 485,621 21,729
Cash and cash equivalents, beginning of year 585,578 99,957 78,228
Cash and cash equivalents, end of year $ 104,139 $ 585,578 $ 99,957
See accompanying notes to consolidated financial statements.
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PACIRA BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (CONTINUED)
(In thousands)
Year Ended December 31,
2022 2021 2020
Supplemental cash flow information:
Cash paid for interest $ 33,295 $ 6,996 $ 7,205
Cash paid for income taxes, net of refunds $ 7,398 $ 3,221 $ 2,417
Non-cash investing and financing activities:
Issuance of common stock from conversion of 2022 convertible senior notes $ 3,040 $ — $ —
Fixed assets included in accounts payable and accrued liabilities $ 5,888 $ 6,828 $ 9,288
Net additions to contingent consideration liabilities $ — $ 45,241 $ —
See accompanying notes to consolidated financial statements.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1— DESCRIPTION OF BUSINESS
Pacira BioSciences, Inc. and its subsidiaries (collectively, the “Company” or “Pacira”) is the industry leader in its commitment to non-opioid pain management and providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only. The Company is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity. The Company’s long-acting, local analgesic, EXPAREL ® (bupivacaine liposome injectable suspension), was commercially launched in the United States, or U.S., in April 2012 and approved in select European countries and the United Kingdom, or U.K.,in November 2021. EXPAREL utilizes the Company’s proprietary multivesicular liposome, or pMVL, drug delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In November 2021, the Company acquired Flexion Therapeutics, Inc., or Flexion, and added ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension) to its product portfolio. ZILRETTA is the first and only extended-release, intra-articular (meaning in the joint) injection indicated for the management of osteoarthritis, or OA, knee pain. For more information, see Note 5, Flexion Acquisition . In April 2019, the Company added iovera° ® to its commercial offering with the acquisition of MyoScience, Inc., or MyoScience. The iovera° system is a handheld cryoanalgesia device used to deliver a precise, controlled application of cold temperature to targeted nerves.
Pacira is subject to risks common to companies in similar industries and stages, including, but not limited to, competition from larger companies, reliance on revenue from three products, reliance on a limited number of wholesalers, reliance on a limited number of manufacturing sites, new technological innovations, dependence on key personnel, reliance on third-party service providers and single source suppliers, protection of proprietary technology, compliance with government regulations and risks related to cybersecurity.
Coronavirus (COVID-19) Pandemic and Global Economic Conditions
Since early 2020, the Company’s revenues and supply chain have been impacted by COVID-19 pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and therapeutics, as well as the lessening of elective surgery restrictions, certain pandemic-related operational and staffing challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise. Direct and indirect effects of the pandemic and global economic conditions have and may continue to negatively impact the Company’s business, financial condition and results of operations. Such impacts may include the effect of prolonged periods of inflation and rising interest rates on the Company’s customers and suppliers and longer lead-times or the inability to secure a sufficient supply of materials. The situation remains dynamic and subject to rapid and possibly material changes. Additional negative impacts may also arise that the Company is unable to foresee. The nature and extent of such impacts will depend on future developments, which are highly uncertain and cannot be predicted.
NOTE 2— SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principles of Consolidation
These consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or GAAP, and in accordance with the rules and regulations of the United States Securities and Exchange Commission, or SEC. The accounts of the Company’s wholly owned subsidiaries are included in these consolidated financial statements. All intercompany balances and transactions have been eliminated in consolidation. Certain reclassifications from previously issued financial statements have been made to conform to the current presentation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and contingent liabilities, at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates are used for, among other things, revenue recognition, purchase price allocation, stock-based compensation, inventory costs, impairments of equity investments, long-lived assets, goodwill and other intangible assets, liabilities and accruals, including contingent consideration, and the valuation of deferred tax assets. The Company’s critical accounting estimates are those that are both most important to the Company’s consolidated financial condition and results of operations and require the most difficult, subjective or complex judgments on the part of management in their application, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
estimates or judgments used in the preparation of the consolidated financial statements, actual results could differ from these estimates.
Revenue From Contracts With Customers
The Company’s sources of revenue include (i) sales of EXPAREL in the U.S., European Union, or E.U. and U.K.; (ii) sales of ZILRETTA in the U.S.; (iii) sales of iovera° in the U.S., Canada and the E.U.; (iv) sales of, and royalties on, its bupivacaine liposome injectable suspension for veterinary use and (v) license fees and milestone payments. Royalty revenues are from the Company’s collaborative licensing agreements. See Note 4, Revenue , for further information on the Company’s accounting policies related to revenue from contracts with customers.
Collaborative Licensing and Milestone Revenue
The Company’s collaboration agreements generally involve a license to the Company’s products. In determining when to recognize the revenue under a collaboration agreement, the Company must assess whether the license is distinct, which depends upon whether the customer can benefit from the license and whether the license is separate from other performance obligations in the agreement. If the license is distinct, the Company must further assess whether the customer has a right to access or a right to use the license depending on whether the functionality of the license is expected to substantively change over time. If the license is not expected to substantively change, the revenue is recognized at the point in time when the license is provided. If the license is expected to substantively change, the revenue is recognized over the license period.
Revenue recognition from milestone payments is dependent upon the facts and circumstances surrounding the milestone payments. Milestone payments based on a non-sales metric such as a development-based milestone (e.g. obtaining regulatory approval) represent variable consideration and would be included in the transaction price subject to any constraints. If the milestone payments relate to future development, the timing of recognition depends upon historical experience and the significance a third-party has on the outcome. For milestone payments to be received upon the achievement of a sales threshold, the revenue from the milestone payments is recognized at the later of when the actual sales are incurred or the performance obligation to which the sales relate has been satisfied.
Royalty Revenue
Royalties are estimated and recognized as revenue when sales to the Company’s commercial partners occur, unless some constraint exists, as the royalties predominately relate to a supply agreement. Royalties are based on sales of the Company’s bupivacaine liposome injectable suspension product for veterinary use.
Concentration of Major Customers
The Company sells EXPAREL through a drop-ship program under which orders are processed through wholesalers (including AmerisourceBergen Health Corporation, Cardinal Health, Inc. and McKesson Drug Company), but shipments of the product are sent directly to individual accounts, such as hospitals, ambulatory surgery centers and individual physicians. The Company also sells EXPAREL directly to ambulatory surgery centers and physicians. The Company sells ZILRETTA primarily to specialty distributors and a specialty pharmacy, who then subsequently resell ZILRETTA to physicians, clinics and certain medical centers or hospitals. The Company also contracts directly with healthcare providers and intermediaries such as Group Purchasing Organizations, or GPOs. The Company sells its bupivacaine liposome injectable suspension for veterinary use to a third-party licensee in the U.S. and sells iovera° directly to end users.
The table below includes the percentage of revenues comprised by the Company’s three largest wholesalers in each period presented:
Year Ended December 31,
2022 2021 2020
Largest wholesaler 31 % 31 % 31 %
Second largest wholesaler 23 % 28 % 31 %
Third largest wholesaler 22 % 26 % 25 %
Total 76 % 85 % 87 %
The year ended December 31, 2022 included the first full-year of ZILRETTA net product sales. The Company began recognizing revenue from net product sales of ZILRETTA on November 19, 2021, the date of the Flexion Acquisition (as defined herein).
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Revenue from outside the U.S. accounted for less than 1 % of the Company’s total revenue for the years ended December 31, 2022 and 2021. The Company began selling EXPAREL in the E.U. and U.K. and iovera° in Canada in the fourth quarter of 2021. The Company had no revenue from outside the U.S. during the year ended December 31, 2020.
Research and Development Expenses
Research and development expenditures are expensed as incurred. These include both internal and external costs, of which a significant portion of development activities are outsourced to third parties, including contract research organizations. Clinical trial costs are accrued over the service periods specified in contracts and adjusted as necessary based on an ongoing review of the level of effort and actual costs incurred. Research and development costs are presented net of reimbursements from commercial partners.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to basis differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
The Company accrues interest and penalties, if any, on underpayment of income taxes, including those related to unrecognized tax benefits, as a component of income tax expense in its consolidated statements of operations.
Stock-Based Compensation
The Company’s stock-based compensation consists of grants of stock options and restricted stock units, or RSUs, to employees, consultants and non-employee directors, in addition to the opportunity for employees to participate in an employee stock purchase plan. The expense associated with these programs is recognized in the Company’s consolidated statements of operations based on their fair values as they are earned under the applicable vesting terms or the length of an offering period.
In calculating the estimated fair value of stock options and employee stock purchase plan share options granted, the Company uses the Black-Scholes option valuation model, or Black-Scholes model, which requires the consideration of the following variables for purposes of estimating fair value in addition to the closing price of the Company’s common stock on the date of grant:
• Expected term of the option
• Expected volatility
• Expected dividends
• Risk-free interest rate
The Company utilizes its historical volatility data to determine expected volatility over the expected option term. The Company uses an expected term based on its historical data from stock option activity. The risk-free interest rate is based on the implied yield on U.S. Department of the Treasury zero-coupon bonds for periods commensurate with the expected term of the options. The dividend yield on the Company’s common stock is estimated to be zero as the Company has not declared or paid any dividends since inception, nor does it have any intention to do so in the foreseeable future. Additionally, the Company’s ability to declare and pay a dividend in the future could be limited per the agreements governing its indebtedness. The Company records forfeitures of grants as they occur rather than estimating forfeitures during each reporting period.
Cash and Cash Equivalents
All highly liquid investments with maturities of 90 days or less when purchased are considered cash equivalents. Cash equivalents include corporate debt securities, asset-backed securities and money market funds. As of December 31, 2022, the carrying value of money market funds was $ 42.6 million. As of December 31, 2021, the carrying value of money market funds was $ 223.0 million, commercial paper was $ 19.0 million and asset-backed securities was $ 2.6 million. The carrying values approximate fair value as of December 31, 2022 and 2021.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Short-Term and Noncurrent Available-For-Sale Investments
Short-term available-for-sale investments consist of asset-backed securities collateralized by credit card receivables, investment grade commercial paper, corporate and government bonds, and other bonds issued in the U.S. (and denominated in the U.S. dollar) by foreign entities, all with maturities of greater than three months, but less than one year. Noncurrent available-for-sale investments consist of corporate and government agency bonds with maturities greater than one year. The Company evaluates the classification of its investments at the time of purchase and re-evaluates such determination at each balance sheet date, which includes an assessment of the intent to hold the available-for-sale securities. The Company’s investment policy sets minimum credit quality criteria and maximum maturity limits on its investments to provide for preservation of capital, liquidity and a reasonable rate of return. The Company classifies its investments as available-for-sale. Available-for-sale securities are recorded at fair value, based on current market valuations. Unrealized holding gains and losses on available-for-sale securities (except for credit losses) are excluded from net income (loss) and are reported as a separate component of accumulated other comprehensive (loss) income until realized. Realized gains and losses are included in interest income in the consolidated statements of operations and are derived using the specific identification method for determining the cost of the securities sold. The Company evaluates whether a credit loss exists, and in the event a credit loss does exist, the credit loss is recognized in the consolidated statements of operations based on the amount that the fair value is less than the amortized cost.
Inventories
Inventories consist of finished goods held for sale and distribution, raw materials and work in process. Inventories are stated at the lower of cost, which includes amounts related to material, labor and overhead, or net realizable value, and is determined using the first-in, first-out (“FIFO”) method. The Company periodically reviews its inventory to identify obsolete, slow-moving, or otherwise unsalable inventories, and establishes allowances for situations in which the cost of the inventory is not expected to be recovered.
Fixed Assets
Fixed assets are recorded at cost, net of accumulated depreciation and amortization. The Company reviews its property, plant and equipment assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Depreciation of fixed assets is provided over their estimated useful lives on a straight-line basis. The Company periodically reviews these useful lives relative to physical factors, economic factors and industry trends. If there are changes in the planned use of property or equipment, the useful lives assigned to these assets may need to be shortened, resulting in the recognition of accelerated depreciation expense in future periods. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or the related remaining lease terms. Useful lives by asset category are as follows:
Asset Category Useful Life
Computer equipment and software 1 to 3 years
Office furniture and equipment 5 years
Manufacturing and laboratory equipment 5 to 10 years
Asset Retirement Obligations
The Company has contractual obligations stemming from certain of its lease agreements to return leased space to its original condition upon termination of such lease agreements. The Company records its asset retirement obligations, or ARO, along with a corresponding capital asset in an amount equal to the estimated fair value of the ARO, based on the present value of expected future cash flows. In subsequent periods, the Company records expense to accrete the ARO to its full value. Each ARO capital asset is depreciated over the depreciable term of the associated fixed asset.
Leases
The Company recognizes right-of-use, or ROU, assets and lease liabilities at the commencement of its lease agreements. The leases are evaluated at commencement to determine whether they should be classified as operating or financing leases. Lease costs associated with operating leases are recognized on a straight-line basis, while lease costs for financing leases are recognized over the lease term using the effective interest method. The Company does not have any financing leases. The amount of ROU assets and lease liabilities to be recognized is impacted by the type of lease payments, the lease term and the
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
incremental borrowing rate. Variable lease payments are not included at commencement and are recognized in the period in which they are incurred.
The Company has elected to net the amortization of its ROU assets and the reduction of the lease liability principal in other liabilities in the consolidated statement of cash flows.
The lease term is based on the contractual term and is adjusted for any renewal options or termination rights that are reasonably certain to be exercised. The incremental borrowing rate is based on the rate the Company estimates it would pay on a collateralized basis over a similar term in a similar economic environment.
Acquisitions
In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values, with some exceptions. Assets acquired and liabilities assumed in a business combination that arise from contingencies are generally recognized at fair value. If fair value can be determined, the asset or liability is recognized; if fair value is not determinable, then no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an “exit price”) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Acquired in-process research and development, or IPR&D, is recognized at fair value and initially characterized as an indefinite-lived intangible asset, irrespective of whether the acquired IPR&D has an alternative future use. If the acquired net assets do not constitute a business under the acquisition method of accounting, the transaction is accounted for as an asset acquisition and no goodwill is recognized. In an asset acquisition, the amount allocated to acquired IPR&D with no alternative future use is recorded as an expense at the acquisition date.
Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired business are reflected in the Company’s consolidated financial statements after the closing date of the acquisition.
Contingent Consideration
Subsequent to an acquisition, the Company measures contingent consideration arrangements at fair value at each reporting period, with changes in fair value recognized in the consolidated statements of operations as acquisition-related charges (gains). Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales, costs of goods sold and regulatory approvals. In the absence of new information, changes in fair value reflect the passage of time towards achievement or expiration of the milestones, and are accreted to the period in which payments are expected to be made.
Goodwill
Goodwill represents the excess of the purchase price over the estimated fair value of the net assets acquired in a business combination and is not amortized, but is subject to impairment testing at least annually or when a triggering event occurs that could indicate a potential impairment exists.
Intangible Assets
Intangible assets with definite useful lives are amortized on a straight-line basis over their estimated useful lives and are recorded at cost, net of accumulated amortization. Indefinite-lived intangible assets are tested for impairment at least annually or when a triggering event occurs that could indicate a potential impairment exists. Impairment charges are recognized to the extent the carrying value exceeds its fair value.
Equity Investments
The Company holds investments in equity securities without a readily determinable fair value which are recognized at cost less any impairments, plus or minus any changes resulting from observable price changes in orderly transactions for a similar investment.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Impairments of Long-Lived Assets
Management reviews long-lived assets, including fixed assets and finite-lived intangible assets, for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets.
Per Share Data
Basic net income (loss) per common share is computed by dividing net income (loss) available (attributable) to common stockholders by the weighted average number of shares of common stock outstanding during the period.
Diluted net income (loss) per common share is calculated by dividing net income (loss) available (attributable) to common stockholders as adjusted for the effect of dilutive securities, if any, by the weighted average number of shares of common stock and dilutive common stock outstanding during the period. Potential common shares include the shares of common stock issuable upon the exercise of outstanding stock options, the RSUs expected to vest, and the shares of common stock expected to be purchased under the Company’s employee stock purchase plan (using the treasury stock method), and the potential common shares issuable upon conversion of the convertible senior notes using the if-converted method. Under the if-converted method, adjustments are made to the diluted net income (loss) per common share calculation as if the Company had converted the convertible senior notes on the first day of each period presented. Adjustments to the numerator are made to add back the interest expense associated with the convertible senior notes on a post-tax basis.
Foreign Currencies
The balance sheet accounts of the Company’s foreign subsidiaries with functional currencies other than the U.S. Dollar are translated using the exchange rate at each respective balance sheet date. Revenues and expenses are translated using the average exchange rates for each calendar month during the year. Translation adjustments are recorded as a component of accumulated other comprehensive (loss) income in the consolidated financial statements. Gains or losses from foreign currency exchanges are recorded in other, net in the consolidated statements of operations.
Segment Reporting
The Company is managed and operated as a single business focused on the development, manufacture, marketing, distribution and sale of non-opioid pain management and regenerative health solutions. The Company is managed by a single management team, and, consistent with its organizational structure, the Chief Executive Officer—who is the Company’s chief operating decision maker—manages and allocates resources at a consolidated level. Accordingly, the Company views its business as one reportable operating segment to evaluate its performance, allocate resources, set operational targets and forecast its future financial results.
NOTE 3— RECENT ACCOUNTING PRONOUNCEMENTS
Recently Adopted Accounting Pronouncements
In August 2020, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40), which limits the number of convertible debt instruments that require separate accounting to (i) those with embedded conversion features that are not clearly and closely related to the debt, that meet the definition of a derivative and that do not qualify for the scope exception from derivative accounting and (ii) convertible debt instruments issued with substantial premiums for which the premiums were recorded as paid-in capital. In addition, the new guidance requires diluted earnings per share calculations be prepared using the if-converted method instead of the treasury stock method. The Company elected to adopt the new guidance using a modified retrospective method of transition, which applied to transactions outstanding at January 1, 2022. As a result, effective January 1, 2022, the Company does not separately present in equity an embedded conversion feature for its convertible debt. Instead, the Company accounts for its convertible debt instruments wholly as debt. In addition, effective January 1, 2022, the Company does not record interest expense on the previously recorded discount on its convertible debt. The impact on the condensed consolidated balance sheet at January 1, 2022 increased net debt by approximately $ 64.9 million, reduced accumulated deficit by $ 47.2 million, reduced additional paid-in capital by $ 96.5 million and decreased deferred tax liabilities by $ 15.7 million.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 4— REVENUE
The Company’s sources of revenue are detailed in Note 2, Summary of Significant Accounting Policies . The Company does not consider revenue from sources other than sales of EXPAREL and ZILRETTA to be material sources of its consolidated revenue. As such, the following disclosure is limited to revenue associated with net product sales of EXPAREL and ZILRETTA.
Net Product Sales
The Company sells EXPAREL through a drop-ship program under which orders are processed through wholesalers based on orders of the product placed by end-users, namely hospitals, ambulatory surgery centers and healthcare provider offices. EXPAREL is delivered directly to the end-user without the wholesaler ever taking physical possession of the product. The Company primarily sells ZILRETTA to specialty distributors and a specialty pharmacy, who then subsequently resell ZILRETTA to physicians, clinics and certain medical centers or hospitals. The Company also contracts directly with healthcare providers and intermediaries such as GPOs. Product revenue is recognized when control of the promised goods are transferred to the customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for transferring those goods. EXPAREL and ZILRETTA revenue is recorded at the time the product is delivered to the customer.
Revenues from sales of products are recorded net of returns allowances, prompt payment discounts, service fees, government rebates, volume rebates and chargebacks. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. These amounts are treated as variable consideration, estimated and recognized as a reduction of the transaction price at the time of the sale, using the most likely amount method, except for returns, which is based on the expected value method. The Company includes these estimated amounts in the transaction price to the extent it is probable that a significant reversal of cumulative revenue recognized for such transaction will not occur, or when the uncertainty associated with the variable consideration is resolved.
Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified Department of Veteran Affairs hospitals and 340B entities at prices lower than the list prices charged to other customers. The 340B Drug Discount Program is a U.S. federal government program created in 1992 that requires participating drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at reduced prices. Customers charge the Company for the difference between the product payment and the statutory selling price to the qualified entity. Reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and trade receivables, net. Chargeback amounts are generally determined at the time of sale to the qualified government healthcare provider by customers, and the Company generally issues credits for such amounts within weeks of the customer’s notification to the Company of the sale. Reserves for chargebacks consist of credits that the Company expects to issue for units that the Company expects will be sold to qualified healthcare providers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit.
The calculation for some of these items requires management to make estimates based on sales data, historical return data, contracts, statutory requirements and other related information that may become known in the future. The adequacy of these provisions is reviewed on a quarterly basis.
The following table provides a summary of activity with respect to the Company’s sales related allowances and accruals related to EXPAREL for the years ended December 31, 2022, 2021 and 2020, as well as ZILRETTA for the years ended December 31, 2022 and 2021 (in thousands):
Pacira BioSciences, Inc. | 2022 Form 10-K | Page F-17
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Returns Allowances Prompt Payment Discounts Service
Fees Volume Rebates and Chargebacks Government Rebates Total
Balance at December 31, 2019 $ 540 $ 962 $ 1,486 $ 1,816 $ — $ 4,804
Provision 794 8,541 6,437 12,345 — 28,117
Payments/Adjustments ( 311 ) ( 8,496 ) ( 6,755 ) ( 12,561 ) — ( 28,123 )
Balance at December 31, 2020 1,023 1,007 1,168 1,600 — 4,798
Provision 3,095 10,388 10,112 17,101 1,139 41,835
Payments/Adjustments ( 757 ) ( 10,217 ) ( 7,644 ) ( 15,207 ) ( 378 ) ( 34,203 )
Balance at December 31, 2021 3,361 1,178 3,636 3,494 761 12,430
Provision 1,390 11,145 16,866 48,890 1,641 79,932
Payments/Adjustments ( 3,060 ) ( 11,136 ) ( 17,309 ) ( 46,932 ) ( 1,616 ) ( 80,053 )
Balance at December 31, 2022 $ 1,691 $ 1,187 $ 3,193 $ 5,452 $ 786 $ 12,309
Collaborative Licensing and Milestone Revenue
The Company’s collaborative licensing and milestone revenue recognition policy is discussed in Note 2, Summary of Significant Accounting Policies
Accounts Receivable
The majority of accounts receivable arise from product sales and represent amounts due from wholesalers, hospitals, ambulatory surgery centers, specialty distributors, a specialty pharmacy and individual physicians. Payment terms generally range from zero to 97 days from the date of the transaction, and accordingly, there is no significant financing component.
Performance Obligations
A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in Accounting Standards Codification, or ASC, 606. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied.
At contract inception, the Company assesses the goods promised in its contracts with customers and identifies a performance obligation for each promise to transfer to the customer a good that is distinct. When identifying individual performance obligations, the Company considers all goods promised in the contract regardless of whether explicitly stated in the customer contract or implied by customary business practices. The Company’s contracts with customers require it to transfer an individual distinct product, which represents a single performance obligation. The Company’s performance obligation with respect to its product sales is satisfied at a point in time, which transfers control upon delivery of EXPAREL and ZILRETTA to its customers. The Company considers control to have transferred upon delivery because the customer has legal title to the asset, physical possession of the asset has been transferred, the customer has significant risks and rewards of ownership of the asset and the Company has a present right to payment at that time.
Disaggregated Revenue
The following table represents disaggregated net product sales in the periods presented as follows (in thousands):
Year Ended December 31,
2022 2021 2020
Net product sales:
EXPAREL $ 536,899 $ 506,515 $ 413,338
ZILRETTA 105,517 12,683 —
iovera° 15,258 16,162 8,817
Bupivacaine liposome injectable suspension 6,476 3,606 4,459
Total net product sales $ 664,150 $ 538,966 $ 426,614
Pacira BioSciences, Inc. | 2022 Form 10-K | Page F-18
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The Company began recognizing revenue from net product sales of ZILRETTA on November 19, 2021, the date of the Flexion Acquisition (as defined herein).
NOTE 5— FLEXION ACQUISITION
Flexion Therapeutics, Inc.
On November 19, 2021, the Company acquired Flexion (the “Flexion Acquisition”), a biopharmaceutical company focused on the discovery, development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA, the most common form of arthritis, pursuant to an Agreement and Plan of Merger (the “Flexion Merger Agreement”), dated as of October 11, 2021, by and among the Company, Oyster Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of the Company (“Purchaser”), and Flexion. Following the completion of a successful tender offer for the shares of Flexion’s common stock, and pursuant to the terms of the Flexion Merger Agreement and in accordance with Section 251(h) of the General Corporation Law of the State of Delaware, Purchaser merged with and into Flexion with Flexion surviving as a wholly owned subsidiary of the Company. The Company changed the name of Flexion to Pacira Therapeutics, Inc. after completing the merger.
The total consideration for the Flexion Acquisition was approximately $ 578.8 million consisting of: (i) $ 448.5 million of cash paid to former Flexion stockholders and to settle restricted stock units and in-the-money stock options; (ii) an $ 85.1 million cash payment of Flexion debt not assumed by the Company and (iii) $ 45.2 million of estimated contingent consideration at the time of the acquisition related to contingent value rights, or CVRs, that were issued to Flexion shareholders and certain equity award holders in conjunction with the Flexion Acquisition. The consideration is subject to adjustments based on the achievement of certain potential milestone payments. At the time of the acquisition, the Company estimated that up to an additional $ 380.2 million in the aggregate may be payable to holders of the CVRs if each of the applicable milestones are achieved by December 31, 2030, as follows:
(i) $ 1.00 per CVR the first time that net sales of ZILRETTA in any calendar year equal or exceed $ 250.0 million;
(ii) $ 2.00 per CVR, the first time that net sales of ZILRETTA in any calendar year equal or exceed $ 375.0 million;
(iii) $ 3.00 per CVR, the first time that net sales of ZILRETTA in any calendar year equal or exceed $ 500.0 million;
(iv) $ 1.00 per CVR upon approval by the U.S. Food and Drug Administration, or FDA, of a Biologics License Application (BLA) for PCRX-201, a clinical stage gene therapy product candidate; and
(v) $ 1.00 per CVR upon approval by the FDA of a new drug application, or NDA, for PCRX-301, an investigational product candidate. In September 2022, based on the results of a completed phase 1 study, the Company decided to discontinue further development of PCRX-301.
The total consideration for the Flexion Acquisition was $ 578.8 million, which consisted of the following (in thousands, except per share amounts):
Fair Value of Purchase Price Consideration Amount
Fair value of purchase consideration paid at closing:
Cash consideration for all outstanding shares of Flexion’s common stock ( 50,392 shares of common stock acquired at $ 8.50 per share)
$ 428,333
Cash consideration paid to settle RSUs and in-the-money stock options 20,153
Cash paid to settle Flexion debt 85,118
533,604
Fair value of CVRs 45,241
Total purchase consideration $ 578,845
The Company accounted for the Flexion Acquisition using the acquisition method of accounting and, accordingly, has included the assets acquired, liabilities assumed and results of operations in its consolidated financial statements from the acquisition date of November 19, 2021.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The final allocation of the consideration transferred to the assets acquired and the liabilities assumed has been completed. The following tables set forth the allocation of the Flexion Acquisition purchase price to the estimated fair value of the net assets acquired at the acquisition date (in thousands):
Amounts Recognized at the Acquisition Date
(as previously
reported) (a)
Measurement Period Adjustments (b)
Amounts Recognized at the Acquisition Date
(as adjusted)
ASSETS ACQUIRED
Cash and cash equivalents $ 113,562 $ — $ 113,562
Short-term available-for-sale investments 11,153 — 11,153
Accounts receivable 32,838 — 32,838
Inventories 29,667 — 29,667
Prepaid expenses and other assets 4,852 — 4,852
Fixed assets 23,307 — 23,307
Deferred tax assets 58,015 ( 16,906 ) 41,109
Right-of-use assets 6,585 — 6,585
Identifiable intangible assets 480,000 — 480,000
IPR&D 61,000 — 61,000
Total assets $ 820,979 $ ( 16,906 ) $ 804,073
LIABILITIES ASSUMED
Accounts payable $ 9,794 $ — $ 9,794
Accrued expenses 22,746 1,162 23,908
Deferred revenue 10,000 — 10,000
Lease liabilities 6,585 — 6,585
Other liabilities 1,187 — 1,187
Long-term debt 201,450 — 201,450
Total liabilities 251,762 1,162 252,924
Total identifiable net assets acquired 569,217 ( 18,068 ) 551,149
Goodwill 9,628 18,068 27,696
Total consideration transferred $ 578,845 $ — $ 578,845
(a) As previously reported in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
(b) Represents the finalization of a tax study and pre-acquisition expenses that were paid by the Company in 2022, partially offset by the release of estimated reserves.
The acquired identifiable intangible assets and IPR&D assets were valued from a market participants’ perspective using a multi-period excess earnings methodology (income approach). The identifiable finite-lived intangible asset, ZILRETTA, is a developed technology for OA knee pain with a value of $ 480.0 million and a useful life of 9.7 years. A discount rate of 17.5 % was used in calculating the fair value of this technology. The IPR&D asset relates to the use of ZILRETTA for the treatment of OA pain of the shoulder and was valued at $ 60.0 million. The projected cash flows for this asset were adjusted for the probability of successful development and commercialization, and were discounted at 18.0 %.
The excess of the purchase price over the fair value of identifiable net assets acquired represents goodwill. This goodwill is primarily attributable to the value of combining ZILRETTA with iovera° and EXPAREL as a safe and effective non-opioid multimodal regimen for pain management, as well as the synergies of merging operations. The acquired goodwill and intangible assets are not deductible for tax purposes.
Refer to Note 9, Goodwill and Intangible Assets , and Note 18, Acquisition-related Charges (Gains), Impairment and Other, for further information related to the Flexion Acquisition.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Unaudited Pro Forma Summary of Operations
The following table shows the unaudited pro forma summary of operations for the years ended December 31, 2021 and 2020, as if the Flexion Acquisition had occurred on January 1, 2020. This pro forma information does not purport to represent what the Company’s actual results would have been if the acquisition had occurred as of January 1, 2020, and is not indicative of what such results would be expected for any future period (in thousands, except per share amounts):
Year Ended December 31,
2021 2020
Total revenues $ 630,942 $ 515,199
Net loss ( 67,264 ) ( 19,711 )
Pro forma basic and diluted net loss per share $ ( 1.52 ) $ ( 0.46 )
The unaudited pro forma financial information was prepared using the acquisition method of accounting and was based on the historical financial information of the Company and Flexion. The summary pro forma financial information primarily reflects the following pro forma adjustments:
• Removal of the acquisition-related transaction fees and costs, including certain stock-based compensation and other compensation expenses related to the acquisition, from the years ended December 31, 2021 and 2020;
• Recognition of the income tax benefit resulting from decreasing Flexion’s existing valuation allowance on deferred tax assets for the year ended December 31, 2021;
• Removal of Flexion’s interest expense and associated deferred financing cost amortization related to the $ 85.1 million of debt not assumed;
• Adjustments to the Company’s interest income for the cash used to acquire Flexion;
• Additional cost of goods sold related to a step-up value in inventory;
• Additional amortization expense from the acquired developed technology intangible assets;
• Additional depreciation of Flexion’s fixed assets; and
• Additional lease expense on Flexion’s ROU assets.
In addition, all of the above adjustments were adjusted for the applicable tax impact.
NOTE 6— INVENTORIES
The components of inventories, net are as follows (in thousands):
December 31,
2022 2021
Raw materials $ 39,810 $ 36,337
Work-in-process 28,853 35,182
Finished goods 27,400 27,031
Total $ 96,063 $ 98,550
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 7— FIXED ASSETS
Fixed assets, net, summarized by major category, consist of the following (in thousands):
December 31,
2022 2021
Machinery and equipment $ 118,684 $ 117,264
Leasehold improvements 61,302 59,740
Computer equipment and software 15,360 13,197
Office furniture and equipment 2,420 2,883
Construction in progress (1)
103,226 80,557
Total 300,992 273,641
Less: accumulated depreciation ( 117,480 ) ( 85,240 )
Fixed assets, net $ 183,512 $ 188,401
(1) The increase of $ 22.7 million in construction in progress is related to progress in the expansion of the Company’s manufacturing facilities, including an EXPAREL capacity expansion project at the Company’s Science Center Campus in San Diego, California and a ZILRETTA capital project at Thermo Fisher Scientific Pharma Services’s site in Swindon, England.
For information on useful lives by asset category, refer to Note 2, Summary of Significant Accounting Policies.
Depreciation expense for the years ended December 31, 2022, 2021 and 2020 was $ 34.2 million, $ 15.0 million and $ 12.0 million, respectively. During the years ended December 31, 2022, 2021 and 2020, the Company capitalized interest of $ 4.1 million, $ 3.9 million and $ 2.4 million, respectively. In 2022, the Company accelerated $ 10.5 million of depreciation expense for certain machinery and equipment for which no future economic benefit was identified.
As of December 31, 2022 and 2021, total fixed assets, net, includes leasehold improvements and manufacturing process equipment located outside of the U.S. in the amount of $ 44.7 million and $ 65.4 million, respectively.
As of December 31, 2022 and 2021, the Company had AROs of $ 3.3 million and $ 2.4 million, respectively, included in accrued expenses and other liabilities on its consolidated balance sheet, for costs associated with returning leased space to its original condition upon the termination of certain of its lease agreements.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 8— LEASES
The Company leases all of its facilities, including its EXPAREL and iovera° handpiece manufacturing facility at its Science Center Campus in San Diego, California. The Company also has an embedded lease with Thermo Fisher Scientific Pharma Services for the use of their manufacturing facility in Swindon, England. A portion of the associated monthly base fees has been allocated to the lease component based on a relative fair value basis.
The operating lease costs for the facilities include lease and non-lease components, such as common area maintenance and other common operating expenses, along with executory costs such as insurance and real estate taxes. Total operating lease costs are as follows (in thousands):
Year Ended December 31,
Operating Lease Costs 2022 2021 2020
Fixed lease costs $ 13,949 $ 11,976 $ 10,055
Variable lease costs 1,988 1,722 2,096
Sublease income ( 253 ) — —
Total $ 15,684 $ 13,698 $ 12,151
Supplemental cash flow information related to operating leases is as follows (in thousands):
Year Ended December 31,
2022 2021 2020
Cash paid for operating lease liabilities, net of lease incentives $ 14,357 $ 12,709 $ 14,347
Right-of-use assets recorded in exchange for lease obligations $ 3,324 $ 8,692 $ 42,191
The weighted average remaining lease terms and the weighted average discount rates are summarized as follows:
December 31,
2022 2021
Weighted average remaining lease term 6.83 years 7.77 years
Weighted average discount rate 7.05 % 6.96 %
As of December 31, 2022, maturities of the Company’s operating lease liabilities are as follows (in thousands):
Year Aggregate Minimum Payments Due
2023 $ 14,022
2024 13,928
2025 13,078
2026 12,814
2027 12,586
Thereafter 27,350
Total future lease payments 93,778
Less: imputed interest ( 19,855 )
Total operating lease liabilities $ 73,923
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 9— GOODWILL AND INTANGIBLE ASSETS
Goodwill
The Company’s goodwill results from the acquisition of Pacira Pharmaceuticals, Inc. from SkyePharma Holding, Inc. (now a subsidiary of Vectura Group plc), or Skyepharma, in 2007 (the “Skyepharma Acquisition”), the MyoScience Acquisition in 2019 and the Flexion Acquisition in 2021. The change in the carrying value of the Company’s goodwill is summarized as follows (in thousands):
Carrying Value
Balance at December 31, 2020 $ 99,547
Goodwill arising from milestones achieved under the Skyepharma Acquisition 36,000
Goodwill arising from the Flexion Acquisition 9,628
Balance at December 31, 2021 145,175
Goodwill arising from measurement period adjustments associated with the Flexion Acquisition (Note 5) 18,068
Balance at December 31, 2022 $ 163,243
The Skyepharma Acquisition was accounted for under Statement of Financial Accounting Standards 141, Accounting for Business Combinations , which was the effective GAAP standard at the date of acquisition. In connection with the Skyepharma Acquisition, the Company agreed to certain milestone payments for DepoBupivacaine products, including EXPAREL. In the fourth quarter of 2021, the Company met both of its two remaining milestones due to Skyepharma: $ 4.0 million upon the first commercial sale in the U.K., France, Germany, Italy or Spain, which was paid in the fourth quarter of 2021; and $ 32.0 million when annual net sales collected reached $ 500.0 million, which was paid in the first quarter of 2022. These milestone payments were treated as additions to the Skyepharma Acquisition and, therefore, recorded as goodwill.
Upon the Flexion Acquisition, the Company recorded goodwill totaling $ 9.6 million. Within one year from the Flexion Acquisition date, measurement period adjustments of $ 18.1 million were recorded to goodwill as the facts and circumstances existed prior to the acquisition date. The adjustments primarily represent the finalization of a tax study and pre-acquisition expenses. The acquired goodwill and intangible assets are not deductible for tax purposes.
Intangible Assets
Intangible assets, net, consists of the developed technology and IPR&D from the Flexion Acquisition and developed technology and customer relationships from the MyoScience Acquisition and are summarized as follows (dollar amounts in thousands):
December 31, 2022 Gross
Carrying Value Accumulated
Amortization Intangible
Assets, Net Weighted-Average
Useful Lives
Developed technologies $ 590,000 $ ( 84,376 ) $ 505,624 10 years, 5 months
Customer relationships 90 ( 34 ) 56 10 years
Total finite-lived intangible assets, net 590,090 ( 84,410 ) 505,680
Acquired IPR&D 34,866 — 34,866
Total intangible assets, net $ 624,956 $ ( 84,410 ) $ 540,546
December 31, 2021 Gross
Carrying Value Accumulated
Amortization Intangible
Assets, Net Weighted-Average
Useful Lives
Developed technology $ 590,000 $ ( 27,097 ) $ 562,903 10 years, 5 months
Customer relationships 90 ( 25 ) 65 10 years
Total finite-lived intangible assets, net 590,090 ( 27,122 ) 562,968
Acquired IPR&D 61,000 — 61,000
Total intangible assets, net $ 651,090 $ ( 27,122 ) $ 623,968
Amortization expense on intangible assets for the years ended December 31, 2022 and 2021 was $ 57.3 million and $ 13.6 million, respectively. The increase in expense in 2022 is the result of a full year of amortization associated with ZILRETTA for OA knee pain acquired as part of the Flexion Acquisition in November 2021.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Assuming no changes in the gross carrying amount of these intangible assets, the future estimated amortization expense on the finite-lived intangible assets will be $ 57.3 million from 2023 to 2030, $ 37.4 million in 2031, $ 7.9 million in 2032 and $ 2.2 million in 2033.
The Company reviews its indefinite-lived intangible assets for impairment annually and whenever an event or change in circumstances arises that indicates the carrying amount of an indefinite-lived intangible asset is at risk of not being recoverable. During the year ended December 31, 2022, the annual impairment assessment for ZILRETTA acquired IPR&D for the treatment of OA pain of the shoulder was conducted through a recoverability test at December 31, 2022 by comparing the $ 60.0 million carrying value of the asset against the fair value through a discounted cash flow model of $ 33.9 million based on new facts and circumstances. The change in fair value was primarily driven by later timelines for the completion of clinical trials impacting revenue forecasts, among other factors. An impairment of $ 26.1 million was recognized within acquisition-related charges (gains), impairment and other in the consolidated statements of operations for the year ended December 31, 2022 based on the amount its previous carrying value exceeded its updated fair value.
NOTE 10— ACCRUED EXPENSES
Accrued expenses consist of the following (in thousands):
December 31,
2022 2021
Accrued selling, general and administrative expenses $ 11,927 $ 12,063
Accrued research and development expenses 4,065 5,480
Other accrued operating expenses 14,959 14,912
Compensation and benefits (1)
26,198 45,491
Termination fee (2)
13,000 —
Accrued royalties (3)
3,400 35,298
Accrued interest 8,941 5,358
Product returns and wholesaler service fees 7,295 8,953
Total $ 89,785 $ 127,555
(1) At December 31, 2021, compensation and benefits included $ 18.4 million of accrued severance associated with the Flexion Acquisition.
(2) See Note 20, Commitments and Contingencies , for more information.
(3) At December 31, 2021, accrued royalties included a $ 32.0 million milestone payment to Skyepharma that was met in the fourth quarter of 2021 for achieving annual net sales collected of $ 500.0 million on the Company’s DepoBupivacaine products, including EXPAREL. This milestone was paid in the first quarter of 2022. See Note 9, Goodwill and Intangible Assets , for more information .
NOTE 11— DEBT
The carrying value of the Company’s outstanding debt is summarized as follows (amounts in thousands):
December 31,
2022 2021
Term loan B facility maturing December 2026 $ 284,704 $ 359,497
0.750 % Convertible senior notes due August 2025
396,126 330,627
3.375 % Convertible senior notes due May 2024
8,641 201,249
2.375 % Convertible senior notes due April 2022 (1)
— 157,857
Total $ 689,471 $ 1,049,230
(1) The 2022 Notes (as defined below) matured on April 1, 2022.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Term Loan B Facility
In December 2021, the Company entered into a term loan credit agreement (the “Credit Agreement”) with JP Morgan Chase Bank, N.A., as administrative agent and the initial lender. The term loan issued under the Credit Agreement (the “Term Loan”) was issued at a 3 % discount and allows for a single-advance term loan B facility in the principal amount of $ 375.0 million and is secured by substantially all of the Company’s and each subsidiary guarantor’s assets. Subject to certain conditions, the Company may, at any time, on one or more occasion, add one or more new classes of term facilities and/or increase the principal amount of the loans of any existing class by requesting one or more incremental term facilities. The net proceeds of the Term Loan were approximately $ 363.8 million after deducting an original issue discount of $ 11.2 million.
The total debt composition of the Term Loan is as follows (in thousands):
December 31,
2022 2021
Term Loan maturing December 2026 $ 296,875 $ 375,000
Deferred financing costs ( 3,919 ) ( 4,443 )
Discount on debt ( 8,252 ) ( 11,060 )
Total debt, net of debt discount and deferred financing costs $ 284,704 $ 359,497
The Term Loan matures on December 7, 2026 and requires quarterly repayments of principal in the amount of $ 9.4 million commencing June 30, 2022, and increasing to $ 14.1 million commencing December 31, 2025, with a remaining balloon payment of approximately $ 137.5 million due at maturity. The Company is required to make mandatory prepayments of principal from (i) the Company’s excess cash flow (as defined in the Credit Agreement) existing in any fiscal year and if the Senior Secured Leverage Ratio (as defined in the Credit Agreement) for such fiscal year exceeds certain predetermined limits (ii) net proceeds (as defined in the Credit Agreement) of non-ordinary course assets sales and casualty events and (iii) debt issuance proceeds (other than permitted debt under the Credit Agreement). Prepayment penalties for the Term Loan were 2 % in the first loan year plus an interest make-whole payment, 2 % in the second loan year, 1 % in the third loan year and nothing thereafter. Prepayment penalties generally do not apply to mandatory prepayment obligations under the Credit Agreement, such as prepayments due in connection with excess cash flow. During the year ended December 31, 2022, the Company made scheduled principal payments of $ 28.1 million in the aggregate. In addition, during the year ended December 31, 2022, the Company made an additional prepayment of $ 51.0 million, which included a $ 50.0 million reduction in principal and a $ 1.0 million prepayment penalty recorded as part of its deferred financing costs to be included in interest expense prospectively.
The Term Loan requires the Company to, among other things, maintain (i) a first lien net leverage ratio, determined as of the last day of any fiscal quarter, of no greater than 1.75 to 1.00 and (ii) liquidity, at any time, of at least $ 150.0 million. The Term Loan also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions. As of December 31, 2022, the Company was in compliance with all financial covenants under the Credit Agreement.
The Company may elect to borrow either term benchmark borrowings or alternate base rate borrowings. Term benchmark borrowings bear interest at a variable rate per annum equal to the Adjusted Term SOFR Rate (as defined in the Credit Agreement) (subject to a 75 basis points floor) plus an applicable margin of 700 basis points. Alternate base rate borrowings bear interest at a variable rate per annum determined using a base rate (subject to a 175 basis points floor) equal to the greatest of (i) the Prime Rate (as defined in the Credit Agreement) in effect on such day, (ii) the NYFRB Rate (as defined in the Credit Agreement) plus 50 basis points or (iii) the Adjusted Term SOFR Rate (as defined in the Credit Agreement) plus 100 basis points, subject to certain exceptions, plus an applicable margin of 600 basis points. As of December 31, 2022, borrowings under the Term Loan consisted entirely of term benchmark borrowings at a rate of 10.78 %.
Convertible Senior Notes Due 2025
In July 2020, the Company completed a private placement of $ 402.5 million in aggregate principal amount of its 0.750 % convertible senior notes due 2025, or 2025 Notes, and entered into an indenture with Computershare Corporate Trust, N.A. (formerly Wells Fargo Bank, N.A.), or 2025 Indenture, with respect to the 2025 Notes. The 2025 Notes accrue interest at a fixed rate of 0.750 % per year, payable semiannually in arrears on February 1 st and August 1 st of each year, beginning on February 1, 2021. The 2025 Notes mature on August 1, 2025.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The total debt composition of the 2025 Notes is as follows (in thousands):
December 31,
2022 2021
0.750 % convertible senior notes due August 2025
$ 402,500 $ 402,500
Deferred financing costs ( 6,374 ) ( 7,155 )
Discount on debt — ( 64,718 )
Total debt, net of debt discount and deferred financing costs $ 396,126 $ 330,627
The net proceeds from the issuance of the 2025 Notes were approximately $ 390.0 million, after deducting commissions and the offering expenses paid by the Company. A portion of the net proceeds from the 2025 Notes was used by the Company to repurchase $ 185.0 million in aggregate principal amount of its then-outstanding 2.375 % convertible senior notes due 2022 in privately-negotiated transactions for a total of $ 211.1 million of cash (including accrued interest). The Company’s transaction costs of approximately $ 12.5 million related to the issuance of the 2025 Notes are amortized to interest expense over the five-year term of the 2025 Notes.
Holders may convert the 2025 Notes at any time prior to the close of business on the business day immediately preceding February 3, 2025, only under the following circumstances: (i) during any calendar quarter (and only during such calendar quarter), if the last reported sale price of the Company’s common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130 % of the conversion price on each applicable trading day; (ii) during the five -business day period immediately after any five consecutive trading day period (the “measurement period”) in which the trading price (as defined in the 2025 Indenture) per $1,000 principal amount of notes for each trading day of the measurement period was less than 98 % of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (iii) upon the occurrence of specified corporate events, including a merger or a sale of all or substantially all of the Company’s assets; or (iv) if the Company calls the 2025 Notes for redemption, until the close of business on the business day immediately preceding the redemption date. The conditions for conversion were not met during the calendar quarter ended December 31, 2022.
On or after February 3, 2025, until the close of business on the second scheduled trading day immediately preceding August 1, 2025, holders may convert their 2025 Notes at any time.
Upon conversion, holders will receive the principal amount of their 2025 Notes and any excess conversion value, calculated based on the per share volume-weighted average price for each of the 40 consecutive trading days during the observation period (as more fully described in the 2025 Indenture). For both the principal and excess conversion value, holders may receive cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s option. The initial conversion rate for the 2025 Notes is 13.9324 shares of common stock per $1,000 principal amount, which is equivalent to an initial conversion price of $ 71.78 per share of the Company’s common stock. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. The initial conversion price of the 2025 Notes represents a premium of approximately 32.5 % to the closing sale price of $ 54.17 per share of the Company’s common stock on the Nasdaq Global Select Market on July 7, 2020, the date that the Company priced the private offering of the 2025 Notes.
As of December 31, 2022, the 2025 Notes had a market price of $908 per $1,000 principal amount. In the event of conversion, holders would forgo all future interest payments, any unpaid accrued interest and the possibility of further stock price appreciation. Upon the receipt of conversion requests, the settlement of the 2025 Notes will be paid pursuant to the terms of the 2025 Indenture. In the event that all of the 2025 Notes are converted, the Company would be required to repay the $ 402.5 million in principal value and any conversion premium in any combination of cash and shares of its common stock (at the Company’s option).
Prior to August 1, 2023, the Company may not redeem the 2025 Notes. On or after August 1, 2023 (but, in the case of a redemption of less than all of the outstanding 2025 Notes, no later than the 40 th scheduled trading day immediately before the maturity date), the Company may redeem for cash all or part of the 2025 Notes if the last reported sale price (as defined in the 2025 Indenture) of the Company’s common stock has been at least 130 % of the conversion price then in effect for (i) each of at least 20 trading days (whether or not consecutive) during any 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related notice of redemption and (ii) the trading day immediately before the date the Company sends such notice. The redemption price will equal the sum of (i) 100 % of the principal amount of the 2025 Notes being redeemed, plus (ii) accrued and unpaid interest, including additional interest, if any, to, but excluding, the
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
redemption date. In addition, calling the 2025 Notes for redemption will constitute a “make-whole fundamental change” (as defined in the 2025 Indenture) and will, in certain circumstances, increase the conversion rate applicable to the conversion of such notes if it is converted in connection with the redemption. No sinking fund is provided for the 2025 Notes.
If the Company undergoes a fundamental change, as defined in the 2025 Indenture, subject to certain conditions, holders of the 2025 Notes may require the Company to repurchase for cash all or part of their 2025 Notes at a repurchase price equal to 100 % of the principal amount of the 2025 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, if a make-whole fundamental change occurs prior to August 1, 2025, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with the make-whole fundamental change.
The 2025 Notes are the Company’s general unsecured obligations that rank senior in right of payment to all of its indebtedness that is expressly subordinated in right of payment to the 2025 Notes, and equal in right of payment to the Company’s unsecured indebtedness. The 2025 Notes are also effectively junior in right of payment to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness, and are structurally subordinated to any debt or other liabilities (including trade payables) of the Company’s subsidiaries.
While the 2025 Notes are currently classified on the Company’s consolidated balance sheet at December 31, 2022 as long-term debt, the future convertibility and resulting balance sheet classification of this liability is monitored at each quarterly reporting date and is analyzed dependent upon market prices of the Company’s common stock during the prescribed measurement periods. In the event that the holders of the 2025 Notes have the election to convert the 2025 Notes at any time during the prescribed measurement period, the 2025 Notes would then be considered a current obligation and classified as such.
Prior to January 1, 2022, under the previous ASC 470-20, Debt with Conversion and Other Options , an entity used to separately account for the liability and equity components of convertible debt instruments that may be settled entirely or partially in cash upon conversion in a manner that reflects the issuer’s economic interest cost. The liability component of the instrument used to be valued in a manner that reflected the market interest rate for a similar nonconvertible instrument at the date of issuance. The initial carrying value of the liability component of $ 314.7 million was calculated using a 5.78 % assumed borrowing rate. The equity component of $ 87.8 million, which represented the conversion option, was determined by deducting the fair value of the liability component from the par value of the 2025 Notes and was recorded in additional paid-in capital on the consolidated balance sheet at the issuance date. The equity component used to be treated as a discount on the liability component of the 2025 Notes, which was amortized over the five-year term of the 2025 Notes using the effective interest rate method.
Resulting from ASU 2020-06, ASC 470-20 was revised effective January 1, 2022 which eliminated the requirement to separately account for the embedded conversion features that are not clearly and closely related to the debt, that meet the definition of a derivative and that do not qualify for the scope exception from derivative accounting and convertible debt instruments issued with substantial premiums for which the premiums were recorded as paid in capital. Effective January 1, 2022, the 2025 Notes debt discount carrying value of $ 64.7 million was eliminated and there was a $ 1.7 million increase in deferred financing costs offset by additional paid-in capital, accumulated deficit and deferred tax assets. For additional information regarding the adoption of ASU 2020-06, see Note 3 , Summary of Significant Accounting Policies .
The 2025 Notes do not contain any financial or operating covenants or any restrictions on the payment of dividends, the issuance of other indebtedness or the issuance or repurchase of securities by the Company. The 2025 Indenture contains customary events of default with respect to the 2025 Notes, including that upon certain events of default, 100% of the principal and accrued and unpaid interest on the 2025 Notes will automatically become due and payable.
Convertible Senior Notes Due 2024 Assumed from the Flexion Acquisition
Prior to the Flexion Acquisition, in May 2017, Flexion issued an aggregate of $ 201.3 million principal amount of 3.375 % convertible senior notes due 2024 (the “Flexion 2024 Notes”), pursuant to the indenture, dated as of May 2, 2017 (the “Original Flexion Indenture”), between Flexion and Computershare Corporate Trust, N.A. (formerly Wells Fargo Bank, N.A.), as trustee (the “Flexion Trustee”), as supplemented by the First Supplemental Indenture, dated as of November 19, 2021, between Flexion and the Flexion Trustee (the “First Supplemental Flexion Indenture” and, together with the Original Flexion Indenture, the “Flexion Indenture”). The Flexion 2024 Notes have a maturity date of May 1, 2024, are unsecured, and accrue interest at a rate of 3.375 % per annum, payable semi-annually on May 1 and November 1 of each year. Upon the Flexion Acquisition, the principal was assumed and recorded at fair value by the Company.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Upon conversion of the Flexion 2024 Notes, at the election of each holder thereof, each Flexion 2024 Note was convertible into cash, shares of Flexion’s common stock, or a combination thereof, at Flexion’s election, at a conversion rate of approximately 37.3413 shares of Flexion common stock per $1,000 principal amount of the Flexion 2024 Notes, which corresponded to an initial conversion price of approximately $ 26.78 per share of Flexion’s common stock. As a result of the Flexion Acquisition, and in connection with the Notice (as defined below), holders of the Flexion 2024 Notes became entitled to certain Flexion Acquisition-related conversion and repurchase rights, as discussed below. In addition, as a result of the Flexion Acquisition and as discussed in more detail below, any future conversion rights are subject to the occurrence of any future events giving rise to such conversion rights under the Flexion Indenture.
On December 6, 2021, as a result of the Flexion Acquisition and in accordance with the Flexion Indenture, Flexion provided a Fundamental Change Company Notice and Offer to Purchase (the “Notice”) to the holders of the Flexion 2024 Notes and offered to repurchase for cash all of the outstanding Flexion 2024 Notes, at a repurchase price in cash equal to 100 % of the principal amount of the Flexion 2024 Notes being repurchased, plus accrued and unpaid interest thereon to, but excluding, January 7, 2022, subject to the terms and conditions set forth therein. The offer to purchase expired at 5:00 p.m., New York City time, on January 6, 2022, as scheduled.
Any holder that did not exercise its repurchase right in accordance with the terms of the Notice retained the conversion rights associated with such holder’s Flexion 2024 Notes under the Flexion Indenture. For conversion of Flexion 2024 Notes in connection with the Fundamental Change and the Make-Whole Fundamental Change (each as defined in the Flexion Indenture) resulting from the Flexion Acquisition, each $1,000 principal amount of the Flexion 2024 Notes was convertible into (i) $ 317.40 in cash and (ii) 37.3413 CVRs, based on the conversion rate of 37.3413, prior to 5:00 p.m., New York City time, on January 7, 2022. Alternatively, holders could retain their Flexion 2024 Notes and such Flexion 2024 Notes would remain outstanding subject to their existing terms, including with respect to a holder’s right to receive interest payments on the Flexion 2024 Notes and exercise any future conversion rights that may arise under the Flexion Indenture.
On January 7, 2022, following the expiration of the offer to purchase, the Company accepted the $ 192.6 million aggregate principal amount of Flexion 2024 Notes that were validly tendered (and not validly withdrawn). No Flexion 2024 Notes were converted in connection with the Notice. At December 31, 2022, the remaining principal outstanding was $ 8.6 million.
Convertible Senior Notes Due 2022
In March 2017, the Company completed a private placement of $ 345.0 million in aggregate principal amount of 2.375 % convertible senior notes due 2022, or 2022 Notes, and entered into an indenture with respect to the 2022 Notes. The 2022 Notes accrued interest at a fixed rate of 2.375 % per year, payable semiannually in arrears on April 1 st and October 1 st of each year. In July 2020, the Company used part of the net proceeds from the issuance of the 2025 Notes to repurchase $ 185.0 million aggregate principal amount of the 2022 Notes in privately negotiated transactions for an aggregate of $ 211.1 million in cash (including accrued interest). The partial repurchase of the 2022 Notes resulted in an $ 8.1 million loss on early extinguishment of debt during the year ended December 31, 2020.
The total debt composition of the 2022 Notes is as follows (in thousands):
December 31,
2022 2021
2.375 % convertible senior notes due April 2022
$ — $ 160,000
Deferred financing costs — ( 223 )
Discount on debt — ( 1,920 )
Total debt, net of debt discount and deferred financing costs $ — $ 157,857
On April 1, 2022, the 2022 Notes matured and the Company settled the remaining outstanding principal balance of $ 160.0 million and a conversion premium of $ 4.8 million through a cash payment of $ 156.9 million and the issuance of 101,521 shares of the Company’s common stock, which increased additional paid-in capital by $ 3.0 million.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Interest Expense
The following table sets forth the total interest expense recognized in the periods presented (dollar amounts in thousands):
Year Ended December 31,
2022 2021 2020
Contractual and other interest expense $ 36,880 $ 9,759 $ 7,650
Amortization of debt issuance costs 4,400 2,754 2,156
Amortization of debt discount 2,807 23,152 18,254
Capitalized interest and other (Note 7)
( 4,111 ) ( 3,915 ) ( 2,389 )
Total $ 39,976 $ 31,750 $ 25,671
Effective interest rate on total debt 5.47 % 6.66 % 7.15 %
Upon the adoption of ASU 2020-06 effective January 1, 2022, the Company eliminated the convertible debt discounts associated with the 2022 Notes and the 2025 Notes that were originally recorded as offsets to the embedded conversion features recognized in equity. Effective January 1, 2022, the Company does not record interest expense on previously recorded discounts on convertible debt attributable to the convertible feature. The deferred financing costs previously allocated to the conversion features have been re-allocated to the outstanding debt. For additional information regarding the adoption of ASU 2020-06, see Note 3 , Summary of Significant Accounting Policies .
NOTE 12— FINANCIAL INSTRUMENTS
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or be paid to transfer a liability in the principal or most advantageous market in an orderly transaction. To increase consistency and comparability in fair value measurements, the FASB established a three-level hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The three levels of fair value measurements are:
• Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
• Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
• Level 3: Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
The carrying value of financial instruments including cash and cash equivalents, accounts receivable and accounts payable approximate their respective fair values due to the short-term nature of these items. The fair value of the Company’s convertible senior notes are calculated utilizing market quotations from an over-the-counter trading market for these notes (Level 2). The fair value of the Company’s acquisition-related contingent consideration is reported at fair value on a recurring basis (Level 3). The carrying amounts of convertible notes receivable without readily determinable fair values have not been adjusted for either an impairment or upward or downward adjustments based on observable transactions, whereas an equity investment was fully impaired during the year ended December 31, 2022.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
At December 31, 2022, the carrying values and fair values of the Company’s financial assets and liabilities were as follows (in thousands):
Carrying
Value Fair Value Measurements Using
Level 1 Level 2 Level 3
Financial Assets and Financial Liabilities Measured at Fair Value on a Recurring Basis:
Financial Asset:
Equity investments $ 15,877 $ — $ — $ 15,877
Convertible notes receivable $ 5,315 $ — $ — $ 5,315
Financial Liabilities:
Acquisition-related contingent consideration $ 28,122 $ — $ — $ 28,122
Financial Liabilities Measured at Amortized Cost:
Term loan B facility due December 2026 $ 284,704 $ — $ 292,422 $ —
0.750 % convertible senior notes due 2025 (1)
$ 396,126 $ — $ 365,269 $ —
3.375 % convertible senior notes due 2024 (2)
$ 8,641 $ — $ 8,641 $ —
(1) The closing price of the Company’s common stock as reported on the Nasdaq Global Select Market was $ 38.61 per share at December 31, 2022 compared to a conversion price of $ 71.78 per share. At December 31, 2022, as the conversion price was above the stock price, the requirements for conversion have not been met. The maximum conversion premium that could have been due on the 2025 Notes at December 31, 2022 is approximately 5.6 million shares of the Company’s common stock, which assumes no increase in the conversion rate for certain events.
(2) Relates to the Flexion 2024 Notes. For more information, See Note 11, Debt .
Certain assets and liabilities are measured at fair value on a non-recurring basis, including assets and liabilities acquired in a business combination and long-lived assets, which would be recognized at fair value if deemed impaired or if reclassified as assets held for sale. The fair value in these instances would be determined using Level 3 inputs.
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
Equity and Convertible Note Investments
The Company holds strategic investments in clinical and preclinical stage privately-held biotechnology companies in the form of equity and convertible note investments. The following investments have no readily determinable fair value and are recorded at cost minus impairment, if any, plus or minus observable price changes of identical or similar investments (in thousands):
Equity Investments Convertible Notes Receivable Total
Balance at December 31, 2020
$ 12,802 $ — $ 12,802
Purchases 12,967 4,220 17,187
Divestiture of investment ( 11,642 ) — ( 11,642 )
Foreign currency adjustments — ( 88 ) ( 88 )
Balance at December 31, 2021
14,127 4,132 18,259
Purchases 11,750 1,250 13,000
Impairment ( 10,000 ) — ( 10,000 )
Foreign currency adjustments — ( 67 ) ( 67 )
Balance at December 31, 2022
$ 15,877 $ 5,315 $ 21,192
During the year ended December 31, 2022, an impairment of an equity investment of $ 10.0 million was recorded in other, net in the consolidated statements of operations.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
During the year ended December 31, 2021, the Company sold an equity investment for net cash proceeds of $ 9.1 million and recognized a realized loss of $ 2.6 million, which was recorded in other, net in the consolidated statements of operations. The fair value of the divested equity investment was based on a Level 1 input.
In February 2023, the Company invested $ 4.0 million in a convertible note receivable.
Acquisition-Related Contingent Consideration
The Company has recognized contingent consideration related to the Flexion Acquisition and the MyoScience Acquisition in the amount of $ 28.1 million and $ 57.6 million as of December 31, 2022 and 2021, respectively. Refer to Note 5, Flexion Acquisition and Note 18, Acquisition-related Charges (Gains), Impairment and Other, for more information.
The Company’s contingent consideration obligations are recorded at their estimated fair values and are revalued each reporting period if and until the related contingencies are resolved. The Company has measured the fair value of its contingent consideration using a probability-weighted discounted cash flow approach that is based on unobservable inputs and a Monte Carlo simulation. These inputs include, as applicable, estimated probabilities and the timing of achieving specified commercial and regulatory milestones, estimated forecasts of revenue and costs and the discount rates used to calculate the present value of estimated future payments. Significant changes may increase or decrease the probabilities of achieving the related commercial and regulatory events, shorten or lengthen the time required to achieve such events, or increase or decrease estimated forecasts.
In November 2021, the Company completed the Flexion Acquisition, which provided for contingent consideration related to CVRs that were issued to Flexion shareholders and certain equity award holders which could aggregate up to a total of $ 372.3 million if certain regulatory and commercial milestones are met. The aggregate amount was previously $ 425.5 million prior to the Company’s September 2022 decision to formally discontinue further development of PCRX-301. The Company’s obligation to make milestone payments is limited to those milestones achieved through December 31, 2030, and are to be paid within 60 days of the end of the fiscal quarter of achievement. As part of the purchase price consideration related to the Flexion Acquisition, the Company recorded contingent consideration of $ 45.2 million, which represented the Company’s potential achievement of meeting the regulatory and commercial milestones. From the date of the Flexion Acquisition through December 31, 2021, the Company recorded an additional $ 1.2 million liability. For the year ended December 31, 2022 , the Company recorded a gain of $ 18.3 million primarily due to adjustments to near-term forecasts for the earnout period of the Flexion contingent consideration, which were recorded as acquisition-related gains in the consolidated statements of operations. At December 31, 2022, the weighted average discount rate was 15.0 %. The probability of payment for the achievement of the remaining regulatory milestone by the expiration date was reduced to 12.5 % at December 31, 2022 from 15 % at December 31, 2021. The reduction in the probability of payment is due to the likelihood of achievement prior to the expiration date being reduced to 50 % from 100 % due to revised timing in conducting clinical trial studies, whereas the probability of success in regulatory approval has improved to 25 % from 15 %. As of December 31, 2022 and 2021, the contingent consideration liability related to the Flexion Acquisition was recognized in the amount of $ 28.1 million and $ 46.4 million, respectively.
In April 2019, the Company completed the MyoScience Acquisition pursuant to the terms of an Agreement and Plan of Merger, which provided for contingent milestone payments of up to an aggregate of $ 100.0 million upon the achievement of certain regulatory and commercial milestones. The Company’s obligation to make milestone payments is limited to those milestones achieved through December 31, 2023, and are to be paid within 60 days of the end of the fiscal quarter of achievement. As of December 31, 2022, the maximum potential remaining milestone payments to be paid are $ 43.0 million. For the year ended December 31, 2022, the Company recognized a contingent consideration gain of $ 11.2 million due to the reduced probability of meeting the MyoScience contingent consideration milestones by December 31, 2023, the expiration date for achieving the remaining milestones.
For the years ended December 31, 2021 and 2020, the Company recognized an acquisition-related gain of $ 2.2 million and an acquisition-related charge of $ 5.2 million, respectively, as a result of revisions to the probabilities of regulatory milestones being met and future projections, which have been included in acquisition-related charges (gains) in the consolidated statements of operations. At December 31, 2022, the probability of success for the regulatory milestone that has not yet been met was reduced to zero . As of December 31, 2022 and 2021, the fair value associated with the contingent consideration liability related to the MyoScience Acquisition has been assessed as zero and $ 11.2 million, respectively.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The following table includes the key assumptions used in the valuation of the Company’s contingent consideration:
Assumption Flexion Ranges Utilized as of
December 31, 2022
Discount rates 14.9 % to 15.1 %
Probability of payment for achievement of regulatory milestones 0 % to 12.5 %
Projected year of achieving or expiration of regulatory milestones 2030
The change in the Company’s contingent consideration recorded at fair value using Level 3 measurements is as follows (in thousands):
Contingent
Consideration
Fair Value
Balance at December 31, 2020 $ 28,346
Contingent consideration related to the Flexion Acquisition 45,241
Fair value adjustments and accretion ( 989 )
Payments made or offset against amounts due ( 15,000 )
Balance at December 31, 2021 57,598
Fair value adjustments and accretion ( 29,476 )
Balance at December 31, 2022 $ 28,122
Available-for-Sale Investments
Short-term investments consist of asset-backed securities collateralized by credit card receivables, investment grade commercial paper and corporate, federal agency and government bonds with maturities greater than three months, but less than one year. Noncurrent investments consist of federal agency bonds with maturities greater than one year but less than three years. Net unrealized gains and losses (excluding credit losses, if any) from the Company’s short-term and noncurrent investments are reported in other comprehensive (loss) income. At December 31, 2022, all of the Company’s short-term and noncurrent investments are classified as available-for-sale investments and are determined to be Level 2 instruments, which are measured at fair value using standard industry models with observable inputs. The fair value of the commercial paper is measured based on a standard industry model that uses the three-month U.S. Treasury bill rate as an observable input. The fair value of the asset-backed securities and corporate bonds is principally measured or corroborated by trade data for identical issues in which related trading activity is not sufficiently frequent to be considered a Level 1 input or that of comparable securities. At the time of purchase, all short-term and noncurrent investments had an “A” or better rating by Standard & Poor’s.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The following summarizes the Company’s investments at December 31, 2022 and 2021 (in thousands):
December 31, 2022 Investments:
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
(Level 2)
Current:
Asset-backed securities $ 6,836 $ — $ ( 3 ) $ 6,833
Commercial paper 134,423 23 ( 386 ) 134,060
U.S. federal agency bonds 41,971 — ( 337 ) 41,634
U.S. government bonds 2,003 — ( 18 ) 1,985
Subtotal 185,233 23 ( 744 ) 184,512
Noncurrent:
U.S. federal agency bonds 22,783 2 ( 66 ) 22,719
U.S. government bonds 14,499 — ( 9 ) 14,490
Subtotal 37,282 2 ( 75 ) 37,209
Total $ 222,515 $ 25 $ ( 819 ) $ 221,721
December 31, 2021 Investments:
Cost Gross
Unrealized
Gains Gross
Unrealized
Losses Fair Value
(Level 2)
Current:
Asset-backed securities $ 3,182 $ — $ — $ 3,182
Commercial paper 57,533 80 ( 2 ) 57,611
Corporate bonds 9,936 102 — 10,038
Total $ 70,651 $ 182 $ ( 2 ) $ 70,831
At December 31, 2022, there were no investments available for sale that were materially less than their amortized cost.
The Company elects to recognize its interest receivable separate from its available-for-sale investments. At December 31, 2022 and 2021, the interest receivable recognized in prepaid expenses and other current assets was $ 0.8 million and $ 0.1 million, respectively.
Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, short-term and noncurrent available-for-sale investments and accounts receivable. The Company maintains its cash and cash equivalents with high-credit quality financial institutions. Such amounts may exceed federally-insured limits.
As of December 31, 2022, three wholesalers each accounted for over 10% of the Company’s accounts receivable at 34 %, 19 % and 18 %. As of December 31, 2021, four wholesalers each accounted for over 10% of the Company’s accounts receivable at 30 %, 20 %, 17 % and 11 %. For additional information regarding the Company’s wholesalers, see Note 2 , Summary of Significant Accounting Policies . EXPAREL and ZILRETTA revenues are primarily derived from major wholesalers and specialty distributors that generally have significant cash resources. The Company performs ongoing credit evaluations of its customers as warranted and generally does not require collateral. Allowances for credit losses on the Company’s accounts receivable are maintained based on historical payment patterns, current and estimated future economic conditions, aging of accounts receivable and its write-off history. As of December 31, 2022 and 2021, the Company did not deem any allowances for credit losses on its accounts receivable necessary.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 13— STOCKHOLDERS’ EQUITY
Common Stock
The Company is authorized to issue up to 250,000,000 shares of common stock, of which 45,927,790 and 44,734,308 were issued and outstanding at December 31, 2022 and 2021, respectively.
Preferred Stock
The Company is authorized to issue up to 5,000,000 shares of preferred stock. No preferred stock was issued or outstanding at either December 31, 2022 or 2021.
Accumulated Other Comprehensive (Loss) Income
The following table illustrates the changes in the balances of the Company’s accumulated other comprehensive (loss) income for the periods presented (in thousands):
Net Unrealized Gains
(Losses) From Available-For-Sale Investments Unrealized Foreign Currency Translation Accumulated Other Comprehensive (Loss) Income
Balance at December 31, 2019 $ 322 $ — $ 322
Net unrealized loss on investments ( 3 ) — ( 3 )
Foreign currency translation adjustments — ( 1 ) ( 1 )
Balance at December 31, 2020 319 ( 1 ) 318
Net unrealized loss on investments, net of tax (1)
( 180 ) — ( 180 )
Foreign currency translation adjustments — 29 29
Balance at December 31, 2021 139 28 167
Net unrealized loss on investments, net of tax (1)
( 662 ) — ( 662 )
Foreign currency translation adjustments — 115 115
Balance at December 31, 2022 $ ( 523 ) $ 143 $ ( 380 )
(1) Net of a $ 0.2 million and $ 0.1 million tax benefit for the years ended December 31, 2022 and 2021, respectively.
NOTE 14— STOCK PLANS
Stock Incentive Plans
The Company’s amended and restated 2011 stock incentive plan, or 2011 Plan, was originally adopted by its board of directors and approved by its stockholders in June 2011 and was amended in June 2014, June 2016, June 2019 and June 2021. The June 2021 amendment and approval by the Company’s stockholders increased the number of shares of common stock authorized for issuance as equity awards under the plan by 1,500,000 shares.
The 2011 Plan allows the granting of incentive stock options, non-statutory stock options, restricted stock awards and other stock-based awards. In April 2014, the Company’s board of directors also adopted the 2014 Inducement Plan.
The Company’s stock option grants have an exercise price equal to the closing price of the Company’s common stock on the date of grant, generally have a 10-year contractual term and vest in increments (typically over four years from the date of grant, although the Company may occasionally grant options with different vesting terms, including grants made to its non-employee directors). The Company also grants RSUs to employees and non-employee directors generally vesting in increments over four years from the date of grant, except for such grants made to non-employee directors. The Company uses authorized but unissued shares of its common stock to satisfy its obligations under these plans.
Employee Stock Purchase Plan
The Company’s Amended and Restated Employee Stock Purchase Plan, or ESPP, was originally adopted by its board of directors in April 2014, approved by the Company’s stockholders in June 2014 and amended and restated in June 2022. The June 2022 amendment and restatement increased the number of shares of common stock that may be sold under the plan by an additional 500,000 shares from the originally provided 500,000 shares. The purpose of the ESPP is to provide a vehicle for
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
eligible employees to purchase shares of the Company’s common stock at a discounted price and to help retain and motivate current employees as well as attract new talent. Under the ESPP, up to 1,000,000 shares of common stock may be sold. The ESPP expires in June 2032. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code, or IRC. The maximum fair market value of stock which can be purchased by a participant in a calendar year is $ 25,000 . Six -month offering periods begin on January 1 and July 1 of each year. During an offering period, eligible employees have the opportunity to elect to purchase shares of the Company’s common stock on the purchase dates of June 30 and December 31 (or the last trading day of an offering period). The per share purchase price is equal to 85 % of the fair market value of the Company’s common stock on either the offering date or the purchase date, whichever is lesser. During the year ended December 31, 2022, 71,301 shares were purchased and issued through the ESPP.
The following tables contain information about the Company’s stock incentive plans at December 31, 2022:
Stock Incentive Plan Awards Reserved For Issuance Awards
Issued Awards Available For Grant
2011 Plan 14,431,701 13,858,585 573,116
2014 Inducement Plan 175,000 36,076 138,924
Total 14,606,701 13,894,661 712,040
Employee Stock Purchase Plan Shares Reserved
For Purchase Shares
Purchased Shares Available
For Purchase
ESPP 1,000,000 480,350 519,650
Stock-Based Compensation
Compensation expense for stock options and RSUs is based on the estimated grant date fair value of an award recognized over the requisite service period on a straight-line expense attribution method. Compensation expense for ESPP share options is based on the estimated grant date fair value of the ESPP shares and the grant date number of shares that can be purchased, which is recognized as expense on a straight-line expense attribution method over the length of an offering period.
The Company recognized stock-based compensation expense in its consolidated statements of operations for the years ended December 31, 2022, 2021 and 2020 as follows (in thousands):
Year Ended December 31,
2022 2021 2020
Cost of goods sold $ 5,967 $ 5,891 $ 5,589
Research and development 6,594 5,465 5,211
Selling, general and administrative 35,531 30,890 29,120
Total $ 48,092 $ 42,246 $ 39,920
Stock-based compensation from:
Stock options $ 26,800 $ 25,980 $ 26,749
RSUs 20,310 15,335 12,266
ESPP 982 931 905
Total $ 48,092 $ 42,246 $ 39,920
Related income tax benefit $ 10,219 $ 8,989 $ 8,578
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The following table summarizes the Company’s stock option activity and related information for the period from December 31, 2019 to December 31, 2022:
Number of
Stock Options Weighted
Average
Exercise Price (Per Share) Weighted Average
Remaining
Contractual
Term (Years) Aggregate
Intrinsic Value
(in Thousands)
Outstanding at December 31, 2019 6,706,378 $ 42.80 7.05 $ 50,652
Granted 1,502,803 47.50
Exercised ( 1,428,111 ) 31.67 $ 34,227
Forfeited ( 426,925 ) 42.08
Expired ( 119,027 ) 71.71
Outstanding at December 31, 2020 6,235,118 45.98 6.97 $ 102,955
Granted 890,277 60.27
Exercised ( 732,117 ) 32.56 $ 23,967
Forfeited ( 278,233 ) 46.46
Expired ( 64,505 ) 80.31
Outstanding at December 31, 2021 6,050,540 49.32 6.59 $ 81,407
Granted 1,061,630 59.99
Exercised ( 689,464 ) 35.37 $ 23,983
Forfeited ( 113,506 ) 54.97
Expired ( 36,206 ) 79.90
Outstanding at December 31, 2022 6,272,994 $ 52.38 6.28 $ 2,011
Exercisable at December 31, 2022 4,224,921 $ 50.51 5.17 $ 1,997
Vested and expected to vest as of December 31, 2022 6,272,994 $ 52.38 6.28 $ 2,011
As of December 31, 2022, $ 45.4 million of total unrecognized compensation cost related to unvested stock options is expected to be recognized over a weighted average period of 2.6 years. The Company’s stock options have a maximum expiration date of ten years from the date of grant.
The weighted average fair value of stock options granted for the years ended December 31, 2022, 2021 and 2020 was $ 25.60 , $ 26.74 and $ 22.40 per share, respectively. The fair values of stock options granted were estimated using the Black-Scholes model with the following weighted average assumptions:
Year Ended December 31,
Black-Scholes Weighted Average Assumption 2022 2021 2020
Expected dividend yield None None None
Risk-free interest rate 1.37 % - 4.17 %
0.43 % - 1.21 %
0.22 % - 1.60 %
Expected volatility 45.1 % 49.1 % 53.5 %
Expected term of options 4.92 years 5.36 years 5.36 years
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The following table summarizes the Company’s RSU activity and related information for the period from December 31, 2019 to December 31, 2022:
Number of
Restricted Stock Units Weighted
Average Grant
Date Fair Value (Per Share) Aggregate
Intrinsic Value
(in Thousands)
Unvested at December 31, 2019 631,141 $ 41.87 $ 28,591
Granted 665,476 48.70
Vested ( 239,085 ) 41.91
Forfeited ( 100,079 ) 44.43
Unvested at December 31, 2020 957,453 46.34 $ 57,294
Granted 446,450 60.81
Vested ( 309,779 ) 45.16
Forfeited ( 138,847 ) 50.67
Unvested at December 31, 2021 955,277 52.85 $ 57,479
Granted 621,149 60.11
Vested ( 331,196 ) 50.25
Forfeited ( 95,768 ) 56.00
Unvested and expected to vest as of December 31, 2022 1,149,462 $ 57.26 $ 44,381
As of December 31, 2022, $ 52.7 million of total unrecognized compensation cost related to unvested RSUs is expected to be recognized over a weighted average period of 2.9 years. The Company’s RSUs have a maximum vest date of four years from the date of grant. The fair values of RSUs awarded are equal to the closing price of the Company’s common stock on the date of grant.
The fair values of the ESPP share options granted were estimated using the Black-Scholes model with the following weighted average assumptions:
Year Ended December 31,
Black-Scholes Weighted Average Assumption 2022 2021 2020
ESPP share option fair value $ 15.26 - $ 15.86
$ 15.16 - $ 15.23
$ 11.02 - $ 17.54
Expected dividend yield None None None
Risk-free interest rate 0.22 % - 2.52 %
0.50 % - 0.90 %
0.14 % - 1.57 %
Expected volatility 39.5 % 37.0 % 44.9 %
Expected term of ESPP share options 6 months 6 months 6 months
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 15— NET INCOME PER SHARE
Potential common shares are excluded from the diluted net income per share computation to the extent that they would be antidilutive. If the Company reported a net loss for the year, no potentially dilutive securities would be included in the computation of diluted net loss per share. As discussed in Note 11, Debt , the Company has the option to pay cash for the aggregate principal amount due upon the conversion of its 2025 Notes, and intends to do so.
ASU 2020-06 was adopted on January 1, 2022 and requires the Company to use the if-converted method to calculate the number of potentially dilutive shares for convertible debt. Under the if-converted method, adjustments are made to the diluted net income per common share calculation as if the Company had converted the convertible debt on the first day of each period presented. Adjustments to the numerator are made to add back the interest expense associated with the convertible debt on a post-tax basis. Adjustments to the denominator reflect the number of shares assumed to be convertible at the beginning of the period. For additional information regarding the adoption of ASU 2020-06, see Note 3, Recent Accounting Pronouncements . For the years ended December 31, 2021 and 2020, the Company used the treasury stock method to calculate dilutive shares on its convertible debt.
The following table sets forth the computation of basic and diluted net income per common share for the years ended December 31, 2022, 2021 and 2020 (in thousands, except per share amounts):
Year Ended December 31,
2022 2021 2020
Numerator:
Net income—basic $ 15,909 $ 41,980 $ 145,523
Denominator:
Weighted average common shares outstanding—basic 45,521 44,262 42,671
Computation of diluted securities:
Dilutive effect of stock options 787 1,030 783
Dilutive effect of RSUs 226 298 227
Dilutive effect of conversion premium on the 2022 Notes — 38 —
Dilutive effect of ESPP purchase options 4 2 1
Weighted average common shares outstanding—diluted 46,538 45,630 43,682
Net income per share:
Basic net income per common share $ 0.35 $ 0.95 $ 3.41
Diluted net income per common share $ 0.34 $ 0.92 $ 3.33
The following table summarizes the outstanding stock options, RSUs, ESPP purchase options and convertible senior notes that were excluded from the diluted net income per common share calculation because the effects of including these potential shares were antidilutive in the periods presented (in thousands):
Year Ended December 31,
2022 2021 2020
Weighted average number of stock options 2,821 2,141 4,237
Convertible senior notes (1)
6,206 — —
Weighted average number of RSUs 417 116 99
Weighted average ESPP purchase options 7 13 16
Total 9,451 2,270 4,352
(1) The convertible senior notes were antidilutive for the year ended December 31, 2022, in conjunction with a $ 5.1 million if-converted method adjustment to the numerator that adds back the interest expense associated with the convertible debt on a post-tax basis under ASU 2020-06.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
NOTE 16— INCOME TAXES
Income (loss) before income taxes and the related tax (benefit) expense is as follows (in thousands):
Year Ended December 31,
2022 2021 2020
Income (loss) before income taxes:
Domestic $ 21,068 $ 64,751 $ 17,000
Foreign ( 7,766 ) ( 8,347 ) 3,089
Total income before income taxes $ 13,302 $ 56,404 $ 20,089
Current taxes:
Federal $ — $ — $ ( 6 )
State 5,309 3,533 1,185
Foreign 29 19 —
Total current taxes $ 5,338 $ 3,552 $ 1,179
Deferred taxes:
Federal $ ( 2,781 ) $ 12,554 $ ( 99,164 )
State ( 5,164 ) ( 1,682 ) ( 27,449 )
Total deferred taxes $ ( 7,945 ) $ 10,872 $ ( 126,613 )
Total income tax (benefit) expense $ ( 2,607 ) $ 14,424 $ ( 125,434 )
A reconciliation of income tax (benefit) expense at the U.S. federal statutory rate to the provision for income taxes is as follows (dollars in thousands):
Year Ended December 31,
2022 2021 2020
Amount Tax Rate Amount Tax Rate Amount Tax Rate
U.S. statutory rate applied to income before taxes $ 2,793 21.00 % $ 11,845 21.00 % $ 4,219 21.00 %
State taxes ( 448 ) ( 3.37 ) % 2,154 3.82 % 632 3.15 %
Foreign taxes 248 1.86 % ( 651 ) ( 1.15 ) % 639 3.18 %
Executive compensation 1,267 9.53 % 719 1.27 % 765 3.81 %
Change in valuation allowance 2,871 21.58 % 3,695 6.55 % ( 130,150 ) ( 647.87 ) %
Stock-based compensation ( 1,795 ) ( 13.49 ) % ( 2,144 ) ( 3.80 ) % ( 216 ) ( 1.08 ) %
Tax credits ( 2,542 ) ( 19.11 ) % ( 1,690 ) ( 3.00 ) % ( 1,591 ) ( 7.92 ) %
Interest expense ( 3,477 ) ( 26.14 ) % — — % — — %
Contingent consideration ( 3,841 ) ( 28.88 ) % 247 0.44 % — — %
Nondeductible expenses 1,164 8.75 % 1,929 3.42 % 149 0.74 %
Reserves 984 7.40 % ( 738 ) ( 1.31 ) % 1,539 7.66 %
Convertible debt — — % — — % ( 1,048 ) ( 5.22 ) %
Other 169 1.27 % ( 942 ) ( 1.67 ) % ( 372 ) ( 1.84 ) %
Income tax (benefit) expense and effective tax rate $ ( 2,607 ) ( 19.60 ) % $ 14,424 25.57 % $ ( 125,434 ) ( 624.39 ) %
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Deferred taxes reflect the tax effects of the differences between the amounts recorded as assets and liabilities for financial reporting purposes and the comparable amounts recorded for income tax purposes. At each reporting date, the Company considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. During the year ended December 31, 2020, the Company determined there was sufficient positive evidence to conclude that it was more-likely-than-not the domestic deferred taxes of $ 126.6 million were realizable and, therefore, the domestic valuation allowance was released. The Company maintains a full valuation allowance on its foreign net deferred tax balances as it is more-likely-than-not the tax benefits are not realizable.
Significant components of the Company’s deferred tax assets and liabilities at December 31, 2022 and 2021 are as follows (in thousands):
December 31,
2022 2021
Deferred tax assets:
Net operating loss carryforwards $ 151,495 $ 174,203
Federal and state credits 23,098 35,414
Accruals and reserves 19,979 29,691
Stock based compensation 27,473 24,545
Deferred revenue — 2,430
Inventory reserves 4,889 572
Other 11,036 2,441
Total deferred tax assets 237,970 269,296
Deferred tax liabilities:
Depreciation and amortization ( 54,743 ) ( 81,418 )
Discount on convertible senior notes 13 ( 15,521 )
Total deferred tax liabilities ( 54,730 ) ( 96,939 )
Deferred tax assets, net of deferred tax liabilities 183,240 172,357
Less: valuation allowance ( 22,931 ) ( 18,993 )
Net deferred tax assets $ 160,309 $ 153,364
As of December 31, 2022, the Company’s federal net operating losses, or NOLs, and federal tax credit carryforwards totaled $ 571.8 million and $ 16.6 million, respectively. The Company also had state NOLs and state tax credit carryforwards of $ 518.0 million and $ 6.5 million, respectively, which are subject to change on an annual basis due to variations in the Company’s annual state apportionment factors. The federal and state NOLs will begin to expire in 2032 and 2028, respectively. The Company had non-U.S. tax NOLs of $ 6.5 million at December 31, 2022. The non-U.S. NOLs do not expire.
Since the Company had cumulative changes in ownership of more than 50 % within a three-year period, under IRC sections 382 and 383, the Company’s ability to use certain NOLs, tax attributes and credit carryforwards to offset taxable income or tax will be limited. Such ownership changes were triggered by the initial acquisition of the Company’s stock in 2007 as well as cumulative ownership changes arising as a result of the completion of the Company’s initial public offering, other financing transactions and the Flexion Acquisition in 2021. As a result of these ownership changes, the Company estimates $ 516.2 million of federal NOLs are subject to annual limitations and are estimated to be available as follows: $ 32.6 million will come available in 2023, $ 32.5 million in 2024, $ 32.4 million in 2025, $ 28.3 million in 2026, and $ 6.9 million in 2027 and thereafter.
In accordance with ASC Topic 740, the Company establishes a valuation allowance for deferred tax assets that, in its judgment, are not more-likely-than-not realizable. These judgments are based on projections of future income—including tax-planning strategies—by individual tax jurisdictions. In each reporting period, the Company assesses the likelihood that its deferred tax assets will be realized and determines if adjustments to its valuation allowance are appropriate. The Company had a net increase in its valuation allowance of $ 3.9 million and $ 16.5 million for the years ended December 31, 2022 and 2021, respectively. The current year net increase in The Company’s valuation allowance includes $ 2.5 million against U.S. capital loss carryforwards, $ 0.9 million against Flexion Acquisition state attributes and $ 0.5 million against foreign net deferred tax assets. The Company continues to maintain a full valuation allowance against foreign net deferred tax assets since it is more-likely-than-not the tax benefit related to the foreign losses are not realizable.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
In 2022 , the Company recorded a $ 2.7 million net reduction to unrecognized tax benefits, or UTBs of which $ 3.7 million is a full reduction in Flexion acquired tax credits, offset by a $ 0.2 million increase related to prior year tax credit and $ 0.8 million related to tax credit positions taken during the year. The Company’s UTB liability at December 31, 2022 was $ 6.3 million. The change in the Company’s UTBs for the year ended December 31, 2022 is summarized as follows (in thousands):
Unrecognized
Tax Benefit
Balance as December 31, 2020 $ 6,076
Reduction for prior year positions ( 1,355 )
Additions for current year positions 4,300
Balance at December 31, 2021 9,021
Reduction for prior year positions ( 3,526 )
Additions for current year positions 827
Balance at December 31, 2022 $ 6,322
The UTBs as of December 31, 2022, 2021 and 2020 would, if subsequently recognized, favorably impact the effective income tax rate.
The Company regularly assesses the likelihood of additional tax assessments by jurisdiction and, if necessary, adjusts its reserve for UTBs based on new information or developments. Due to the Company’s tax credit carryforwards, the reserve was recorded as a reduction of the Company’s deferred tax assets, and any potential deficiency would not result in a tax liability. Therefore, no interest or penalties were recognized in income tax expense for the years ended December 31, 2022, 2021 and 2020.
The Company is currently subject to audit by the U.S. Internal Revenue Service, or IRS, for the years 2019 through 2022, and state tax jurisdictions for the years 2018 through 2022. However, the IRS or states may still examine and adjust an NOL arising from a closed year to the extent it is utilized in a year that remains subject to audit. The Company’s previously filed income tax returns are not presently under audit by the IRS or state tax authorities.
NOTE 17— EMPLOYEE BENEFIT PLANS
401(k) Plan
The Company’s 401(k) plan is a deferred salary arrangement under section 401(k) of the IRC. Under the 401(k) plan, participating U.S. employees may defer a portion of their pre-tax earnings which are eligible for a discretionary percentage match as defined in the 401(k) plan and determined by the Company’s board of directors (up to the maximum amount permitted by the IRC). The Company recognized $ 3.4 million, $ 2.8 million and $ 2.9 million of related compensation expense for its 401(k) discretionary match for the years ended December 31, 2022, 2021 and 2020, respectively.
Deferred Compensation Plan
In June 2020, the Company’s board of directors adopted the Company’s Deferred Compensation Plan, or DCP. The Company intends that the DCP constitute, and be construed and administered as, an unfunded plan of deferred compensation within the meaning of the Employee Retirement Income Security Act of 1974, as amended, and the IRC of 1986, as amended, under which eligible participants may elect to defer the receipt of current compensation. Eligible participants include select management and highly compensated employees of the Company, including the Company’s named executive officers. Pursuant to the DCP, subject to any minimum and maximum deferral requirements that the administrator of the DCP may establish, participants may elect to defer their base salary and annual incentive awards. In addition to elective deferrals, the DCP permits the Company to make matching and certain other discretionary contributions to the participants. The company contributes assets to a rabbi trust to accumulate funds to pay benefits under the DCP. Funds held in the rabbi trust must be used to pay benefits to DCP participants, except in the case of the Company’s bankruptcy or insolvency, in which case, they become subject to claims by the Company’s creditors. The Company recognized $ 0.3 million of related compensation expense for its DCP discretionary match for the year ended December 31, 2022 and $ 0.2 million for each of the years ended December 31, 2021 and 2020. The carrying value of assets held in the rabbi trust substantially equaled the DCP liability as of both December 31, 2022 and 2021, with balances of $ 4.3 million and $ 2.6 million, respectively. The rabbi trust asset is classified within other assets and the DCP liability is classified within other liabilities in the consolidated balance sheets.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Cash Long-Term Incentive Plan
In December 2020, the Company’s board of directors adopted a cash long-term incentive plan, or LTIP, commencing in 2021, focused on pre-determined, objective performance goals. The LTIP provides cash awards to participants based on the achievement of certain performance goals during each applicable performance period from January 1 through December 31 of each calendar year. Award amounts ranging from 0 % to 225 % of the target cash award can be earned based on achievement of two equally weighted financial metrics: net revenue and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA), with a relative total shareholder return modifier based on the Company’s stock price performance relative to the companies comprising the S&P Pharmaceuticals Select Industry Index. The performance period for these metrics is one year , with an additional three years of time-vesting following the performance period. For the years ended December 31, 2022 and 2021, the Company recognized $ 1.0 million and $ 1.2 million of related compensation expense under the LTIP, respectively, all of which related to the 2021 performance period. Amounts earned for the 2021 performance year are payable to participants in January 2025 after the three-year vesting period concludes. No amounts were earned for the 2022 performance period. As of December 31, 2022 and 2021, there was $ 2.2 million and $ 1.2 million included in other liabilities in the consolidated balance sheets, respectively.
NOTE 18— ACQUISITION-RELATED CHARGES (GAINS), IMPAIRMENT AND OTHER
Acquisition-related charges (gains), impairment and other for the years ended December 31, 2022, 2021 and 2020 are summarized below (in thousands):
Year Ended December 31,
2022 2021 2020
Severance-related expenses $ 4,494 $ 26,371 $ —
Acquisition-related fees 1,032 10,963 —
Other acquisition expenses 5,719 3,566 150
Total acquisition-related charges 11,245 40,900 150
Flexion contingent consideration ( 18,292 ) 1,174 —
MyoScience contingent consideration ( 11,184 ) ( 2,163 ) 5,204
Impairment of acquired IPR&D 26,134 — —
Termination of license agreement 3,000 — —
Nuance Biotech Co. Ltd. agreement dissolution costs — 3,000 —
Discontinuation of DepoCyt(e) — — ( 188 )
Total acquisition-related charges (gains), impairment and other $ 10,903 $ 42,911 $ 5,166
Flexion Acquisition
The Company recognized acquisition-related and other costs of $ 11.2 million and $ 40.2 million during the years ended December 31, 2022 and 2021, respectively, primarily for severance, legal fees, third-party services and other one-time charges related to the Flexion Acquisition. See Note 5, Flexion Acquisition , for more information.
On November 19, 2021, as part of the purchase price consideration related to the Flexion Acquisition, the Company recorded a contingent consideration of $ 45.2 million, which represents the Company’s potential achievement of meeting regulatory and sales-based milestones. For the year ended December 31, 2022, the Company recognized a contingent consideration gain of $ 18.3 million due to a decrease to the fair value of its contingent consideration. From the date of the acquisition through December 31, 2021, the Company recorded a contingent consideration charge of $ 1.2 million. See Note 12, Financial Instruments , for information regarding the method and key assumptions used in the fair value measurements of the Company’s contingent consideration.
MyoScience Acquisition
The Company recognized contingent consideration gains of $ 11.2 million and $ 2.2 million for the years ended December 31, 2022 and 2021, respectively, and a contingent consideration charge of $ 5.2 million for the year ended December 31, 2020. See Note 12, Financial Instruments , for information regarding the method, key assumptions used in the fair value measurements of contingent consideration and more information regarding the changes in fair value.
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PACIRA BIOSCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
The Company recognized acquisition-related and other charges of $ 0.7 million and $ 0.2 million during the years ended December 31, 2021 and 2020, respectively, related to one-time termination benefits and fees associated with the MyoScience Acquisition.
Impairment of Acquired IPR&D
For the year ended December 31, 2022, an impairment of $ 26.1 million for an acquired IPR&D intangible asset related to ZILRETTA for the treatment of OA pain of the shoulder was recognized based on the amount its previous carrying value of $ 60.0 million exceeded its fair value of $ 33.9 million. See Note 9, Goodwill and Intangible Assets , for more information.
Termination of License Agreement
The Company recognized expense of $ 3.0 million in the year ended December 31, 2022 related to the termination of a license agreement. See Note 20, Commitments and Contingencies , for more information.
Nuance Biotech Co. Ltd.
In June 2018, the Company entered an agreement with Nuance Biotech Co. Ltd., or Nuance, a China-based specialty pharmaceutical company, to advance the development and commercialization of EXPAREL in China. Under the terms of the agreement, the Company had granted Nuance the exclusive rights to develop and commercialize EXPAREL. In April 2021, the Company and Nuance agreed to a mutual termination of the agreement due to the lack of a viable regulatory pathway that adequately safeguards the Company’s intellectual property against the risk of a generic product, which included dissolution costs of $ 3.0 million during the year ended December 31, 2021.
DepoCyt(e) Discontinuation
In April 2018, the Company received formal notice of the termination of a Supply Agreement and a Distribution Agreement (and all related agreements as subsequently amended) from Mundipharma International Corporation Limited and Mundipharma Medical Company, respectively (collectively, “Mundipharma”). In November 2019, the Company reached a settlement with Mundipharma and made a $ 5.3 million payment related to the DepoCyt(e) discontinuation which had previously been accrued.
The Company recorded a gain of $ 0.2 million during the year ended December 31, 2020 related to the discontinuation of its DepoCyt(e) manufacturing activities in June 2017. The foregoing references to DepoCyt(e) mean DepoCyt ® when discussed in the context of the U.S. and Canada and DepoCyte ® when discussed in the context of the E.U.
NOTE 19— COMMERCIAL PARTNERS AND OTHER AGREEMENTS
Thermo Fisher Scientific Pharma Services
In April 2014, the Company and Thermo Fisher entered into a Strategic Co-Production Agreement, a Technical Transfer and Service Agreement (the “EXPAREL Technical Transfer and Service Agreement”) and a Manufacturing and Supply Agreement to collaborate in the manufacture of EXPAREL. Under the terms of the EXPAREL Technical Transfer and Service Agreement, Thermo Fisher agreed to undertake certain technical transfer activities and construction services needed to prepare its Swindon, England facility for the manufacture of EXPAREL in two dedicated suites. The Company contracted to purchase EXPAREL from Thermo Fisher, beginning with FDA approval of the first suite, which occurred in May 2018. Commercial production began in February 2019. The Company is now utilizing a second, larger-scale dedicated manufacturing suite. Under these agreements, the Company makes monthly base fee payments to Thermo Fisher. Unless earlier terminated by giving notice of up to two years (other than termination by the Company in the event of a material breach by Thermo Fisher), this agreement will expire in May 2028.
Prior to the Flexion Acquisition, in July 2015, Flexion and Thermo Fisher entered into a Manufacturing and Supply Agreement and a Technical Transfer and Service Agreement related to the manufacture of ZILRETTA at the same Thermo Fisher site in Swindon, England where the Company’s EXPAREL suites are located. Thermo Fisher agreed to undertake certain transfer activities and construction services needed to prepare its facility for the commercial manufacture of ZILRETTA in dedicated manufacturing suites. Flexion provided Thermo Fisher with certain equipment and materials necessary to manufacture ZILRETTA. The Company pays a monthly base fee to Thermo Fisher for the operation of the manufacturing suites and a per product fee for each vial of ZILRETTA based upon a forecast of commercial demand. The Company also reimburses Thermo Fisher for purchases of materials and equipment made on its behalf, certain nominal expenses and additional services. Unless earlier terminated (other than termination by the Company in the event that Thermo Fisher does not
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
meet specified milestones or for a breach by Thermo Fisher), the Company will be obligated to pay for the costs incurred by Thermo Fisher associated with the removal of its manufacturing equipment and for Thermo Fisher’s termination costs up to a specified capped amount.
Eurofarma Laboratories S.A.
In June 2021, the Company entered into a distribution agreement with Eurofarma Laboratories S.A., or 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 in Latin America, including Argentina, Brazil, Colombia and Mexico. In addition, Eurofarma is responsible for regulatory filings for EXPAREL in these countries. The Company received a $ 0.3 million upfront payment that is partially refundable upon certain circumstances and will receive royalties based on Eurofarma’s future commercialization of the product and is also eligible to receive milestone payments that are triggered by the achievement of certain regulatory and commercial events. The Company recognized $ 0.1 million of collaborative licensing and milestone revenue in its consolidated statements of operations during the year ended December 31, 2021.
Verve Medical Products, Inc.
In July 2021, the Company entered into a licensing agreement with Verve Medical Products, Inc. for the distribution of iovera° in Canada. The Company began selling iovera° in Canada in the fourth quarter of 2021.
DePuy Synthes Sales, Inc.
In January 2017, the Company announced a Co-Promotion Agreement with DePuy Synthes Sales, Inc., or DePuy Synthes, part of the Johnson & Johnson family of companies, to market and promote the use of EXPAREL for orthopedic procedures in the U.S. DePuy Synthes field representatives, specializing in joint reconstruction, spine, sports medicine, trauma and cranio-maxillofacial (CMF) procedures, collaborated with and supplemented the Company’s field teams by expanding the reach and frequency of EXPAREL education in the hospital surgical suite and ambulatory surgery center settings.
In July 2020, the Company notified DePuy Synthes that the Co-Promotion Agreement would terminate on January 2, 2021. The Company recorded termination-related costs of $ 8.8 million which were recorded in selling, general and administrative expense during the year ended December 31, 2020.
Aratana Therapeutics, Inc.
In December 2012, the Company entered into a worldwide license, development and commercialization agreement with Aratana Therapeutics, Inc., a wholly owned subsidiary of Elanco Animal Health, Inc., or Aratana. Under the agreement, the Company granted Aratana an exclusive royalty-bearing license, including the limited right to grant sublicenses, for the development and commercialization of the Company’s bupivacaine liposome injectable suspension product for veterinary use. Under the agreement, Aratana developed and obtained FDA approval for the use of the product in veterinary surgery to manage postsurgical pain. The Company is eligible to receive from Aratana up to an aggregate of $ 40.0 million upon the achievement of commercial milestones. Aratana is required to pay the Company a tiered double-digit royalty on certain net sales made in the U.S. If the product is approved by foreign regulatory agencies for sale outside of the U.S., Aratana will be required to pay the Company a tiered double-digit royalty on such net sales. Royalty rates will be reduced by a certain percentage upon the entry of a generic competitor for animal health indications into certain jurisdictions or if Aratana must pay royalties to third parties under certain circumstances. Unless terminated earlier pursuant to its terms, the license agreement is effective until July 2033, after which Aratana has the option to extend the agreement for an additional five-year term, subject to certain requirements.
Aratana began purchasing bupivacaine liposome injectable suspension product in 2016, which they market under the trade name NOCITA ® (a registered trademark of Aratana) for veterinary use.
NOTE 20— COMMITMENTS AND CONTINGENCIES
Legal Proceedings
From time to time, the Company has been and may again become involved in legal proceedings arising in the ordinary course of its business, including those related to patents, product liability and government investigations. Except as described below, the Company is not presently a party to any legal proceedings that it believes to be material, and is not aware of any pending or threatened litigation against the Company which it believes could have a material adverse effect on its business, operating results, financial condition or cash flows.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
MyoScience Milestone Litigation
In August 2020, the Company and its subsidiary, Pacira CryoTech, Inc. (“Pacira CryoTech”), filed a lawsuit in the Court of Chancery of the State of Delaware against Fortis Advisors LLC (“Fortis”), solely in its capacity as representative for the former securityholders of MyoScience, and certain other defendants, seeking declaratory judgment with respect to certain terms of the merger agreement for the MyoScience Acquisition (the “MyoScience Merger Agreement”), specifically related to the achievement of certain milestone payments under the MyoScience Merger Agreement. In addition, the Company and Pacira CryoTech sought general, special and compensatory damages against the other defendants related to breach of fiduciary duties in connection with the purported achievement of milestone payments under the MyoScience Merger Agreement, and breach of the MyoScience Merger Agreement and certain other agreements with the defendants. In October 2020, Fortis filed an answer and counterclaim against the Company and Pacira CryoTech seeking to recover certain milestone payments under the MyoScience Merger Agreement. The total remaining value of these milestones is $ 30.0 million, plus attorneys’ fees. The Company believes that the counterclaim from Fortis is without merit and intends to vigorously defend against all claims. The Company is unable to predict the outcome of this action at this time.
eVenus Pharmaceutical Laboratories Litigations
In October 2021, the Company received a Notice Letter advising that eVenus Pharmaceutical Laboratories, Inc., or eVenus, of Princeton, New Jersey, submitted to the FDA an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification seeking authorization for the manufacturing and marketing of a generic version of EXPAREL (266 mg/20 mL) in the U.S. prior to the expiration of U.S. Patent No. 11,033,495 (the ’495 patent).
In November 2021, the Company filed a patent infringement suit against eVenus and its parent company in the U.S. District Court for the District of New Jersey (21-cv-19829) asserting infringement of the ’495 patent. This triggered an automatic 30-month stay of final approval of the eVenus ANDA. On January 6, 2022, eVenus filed an Answer with counterclaims to the Complaint, alleging the ’495 patent is invalid and/or not infringed through the manufacture, sale, or offer for sale of the product described in product described in eVenus’s ANDA submission.
In December 2021, the Company received a second Notice Letter advising that eVenus submitted to the FDA an amendment to its ANDA with a Paragraph IV Certification seeking authorization for the manufacturing and marketing of a generic version of EXPAREL (133 mg/10 mL) in the U.S. prior to the expiration of the ’495 patent. In the Notice Letter, eVenus also advised that it submitted a Paragraph IV Certification to the FDA seeking authorization for the manufacturing and marketing of a generic version of EXPAREL (266 mg/20 mL and 133 mg/10 mL) in the U.S. prior to the expiration of U.S. Patent No. 11,179,336 (the ’336 patent). eVenus further alleges in the Notice Letter that both the ’495 patent and the ’336 patent are invalid and/or not infringed.
In February 2022, the Company filed a second patent infringement suit against eVenus and its parent company in the U.S. District Court for the District of New Jersey (22-cv-00718) asserting that the 133 mg/10 mL ANDA product will infringe the ’495 and ’336 patents and that the 266 mg/20 mL ANDA product will infringe the ’336 patent. This filing triggered a second automatic 30-month stay of final approval for the 133 mg/10 mL ANDA product.
These litigations are in their early stages, and the Company is unable to predict their outcome at this time.
Research Development Foundation
Pursuant to an agreement with the Research Development Foundation, or RDF, the Company was required to pay RDF a low single-digit royalty on the collection of revenues from certain products, for as long as certain patents assigned to the Company under the agreement remain valid. RDF has the right to terminate the agreement for an uncured material breach by the Company, in connection with its bankruptcy or insolvency or if it directly or indirectly opposes or disputes the validity of the assigned patent rights. The Company’s ’495 patent issued on June 15, 2021. Thereafter, RDF asserted that the issuance of that patent extends the Company’s royalty obligations under the agreement until 2041. The Company believes that the royalty period under the agreement ended on December 24, 2021 with the expiration of its U.S. Patent No. 9,585,838. Because of the disagreement over the interpretation of the agreement, in December 2021, the Company filed a declaratory judgment lawsuit in the U.S. District Court for the District of Nevada (21-cv-02241). The lawsuit seeks a declaration from the court that the Company owes no royalties to RDF with respect to its EXPAREL product after December 24, 2021. During the pendency of the lawsuit, the Company will continue to pay royalties to RDF under protest, however, the Company is unable to predict the outcome of this action at this time.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
Purchase Obligations
The Company has approximately $ 73.3 million of minimum, non-cancelable contractual commitments for contract manufacturing services and $ 5.2 million of minimum, non-cancelable contractual commitments for the purchase of certain raw materials as of December 31, 2022. Subsequent to December 31, 2022, the Company entered into an additional $ 2.8 million of minimum, non-cancelable contractual commitments for marketing sponsorships.
Other Commitments and Contingencies
Termination of License Agreement
Prior to the Flexion Acquisition, in March 2020, Flexion entered into an exclusive license agreement with Hong Kong Tainuo Pharma Ltd., or HK Tainuo, and Jiangsu Tainuo Pharmaceutical Co. Ltd., a subsidiary of China Shijiazhuang Pharmaceutical Co, Ltd., for the development and commercialization of ZILRETTA in Greater China (consisting of mainland China, Hong Kong, Macau and Taiwan). Under the terms of the agreement, HK Tainuo paid Flexion an upfront payment of $ 10.0 million during the year ended December 31, 2020 which was recorded as deferred revenue as of December 31, 2021. The Company was also eligible to receive up to $ 32.5 million in aggregate development, regulatory and commercial sales milestone payments under the exclusive license agreement. HK Tainuo was responsible for the clinical development, product registration and commercialization of ZILRETTA in Greater China. The Company was solely responsible for the manufacture and supply of ZILRETTA to HK Tainuo for all clinical and commercial activities. The terms related to product manufacturing and supply, including pricing and minimum purchase requirements agreed to in the license agreement, were to be covered by a separate supply agreement which was never finalized.
In July 2022, the Company submitted notice to HK Tainuo of its intent to pursue termination of the license agreement. As of December 31, 2022, $ 13.0 million was recorded within accrued expenses in the consolidated balance sheet. The $ 13.0 million related to the termination of the license agreement was subsequently paid in January 2023.
Pediatric Trial Commitments
The FDA, as a condition of EXPAREL approval, has required the Company to study EXPAREL in pediatric patients, as well as the administration of EXPAREL as a nerve block in the pediatric setting. The Company was granted a deferral for the required pediatric trials until after the indications were approved in adults. Similarly, in Europe, the Company agreed with the European Medicines Agency, or EMA, on a Pediatric Investigation Plan as a prerequisite for submitting a Marketing Authorization Application (MAA) in the E.U. Despite the U.K.’s withdrawal from the E.U., the agreed pediatric plan is applicable in the U.K.
In December 2019, the Company announced positive results for its extended pharmacokinetic and safety study (“PLAY”) for local analgesia in children aged six to 17 undergoing cardiovascular or spine surgeries. Those positive results were the basis for the submission of a supplemental New Drug Application, or sNDA, in the U.S. and Type II variations in the E.U. and U.K. to expand the EXPAREL label to include use in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia. In March 2021, the Company announced that the FDA approved the submission of the sNDA in the U.S. The EMA and the Medicines and Healthcare Products Regulatory Agency, or MHRA, are still reviewing the Type II variations. The Company is working with the FDA, MAA and MHRA to finalize the regulatory pathway for its remaining pediatric commitments.
Contingent Milestone Payments
Refer to Note 5, Flexion Acquisition and Note 12 , Financial Instruments , for information on potential contingent milestone payments related to the Flexion Acquisition and MyoScience Acquisition.
PCRX-201
PCRX-201 was added to the Company’s portfolio as part of the Flexion Acquisition as discussed in Note 5, Flexion Acquisition . Prior to the Flexion Acquisition, in February 2017, Flexion entered into an agreement with GQ Bio Therapeutics GmbH (formerly named GeneQuine Biotherapeutics GmbH) to acquire the global rights to PCRX-201, a gene therapy product candidate. As part of the agreement, up to an aggregate of $ 56.0 million of payments could become due upon the achievement of certain development and regulatory milestones, including up to $ 4.5 million through initiation of a Phase 2 proof of concept clinical trial and, following successful proof of concept, up to an additional $ 51.5 million in development and global regulatory approval milestone payments.
Pacira BioSciences, Inc. | 2022 Form 10-K | Page F-47
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.