3 unchanged sentences
(In thousands, except share and per share amounts)
−Removed: September 30,
2024 December 31,
20 unchanged sentences
Current portion of convertible senior notes, net 8,641 8,641
−Removed: Current portion of long-term debt, net — 33,648
Total current liabilities 93,444 97,383
9 unchanged sentences
5,000,000 shares authorized;
−Removed: none issued and outstanding at September 30, 2023 and December 31, 2022
+Added: none issued and outstanding at March 31, 2024 and December 31, 2023
Common stock, par value $ 0.001 ;
250,000,000 shares authorized;
−Removed: 46,426,836 and 45,927,790 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively
+Added: 46,517,410 and 46,481,174 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively
Additional paid-in capital 989,780 976,633
Accumulated deficit ( 97,817 ) ( 106,796 )
−Removed: Accumulated other comprehensive loss ( 10 ) ( 380 )
+Added: Accumulated other comprehensive income 152 247
Total stockholders’ equity 892,162 870,130
7 unchanged sentences
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Net product sales $ 165,824 $ 159,431
6 unchanged sentences
Amortization of acquired intangible assets 14,322 14,322
−Removed: Contingent consideration charges (gains), restructuring charges and other 3,356 489 ( 1,150 ) ( 13,232 )
+Added: Contingent consideration (gains) charges, restructuring charges and other 1,903 12,107
Total operating expenses 153,905 163,432
−Removed: Income from operations 17,721 21,289 54,507 69,917
−Removed: Other (expense) income:
+Added: Income (loss) from operations 13,212 ( 3,091 )
+Added: Other income (expense):
Interest income 3,903 3,142
2 unchanged sentences
Other, net ( 159 ) ( 10 )
−Removed: Total other expense, net ( 1,120 ) ( 19,220 ) ( 26,526 ) ( 38,547 )
−Removed: Income before income taxes 16,601 2,069 27,981 31,370
−Removed: Income tax expense ( 5,743 ) ( 2,762 ) ( 10,896 ) ( 5,359 )
+Added: Total other income (expense), net 428 ( 23,383 )
+Added: Income (loss) before income taxes 13,640 ( 26,474 )
+Added: Income tax (expense) benefit ( 4,661 ) 6,938
Net income (loss) $ 8,979 $ ( 19,536 )
Net income (loss) per share:
−Removed: Basic net income (loss) per common share $ 0.23 $ ( 0.02 ) $ 0.37 $ 0.57
−Removed: Diluted net income (loss) per common share $ 0.23 $ ( 0.02 ) $ 0.37 $ 0.56
+Added: Basic and diluted net income (loss) per common share $ 0.19 $ ( 0.43 )
Weighted average common shares outstanding:
8 unchanged sentences
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Net income (loss) $ 8,979 $ ( 19,536 )
Other comprehensive income (loss):
−Removed: Net unrealized gain (loss) on investments, net of tax 146 ( 163 ) 362 ( 1,056 )
+Added: Net unrealized (loss) gain on investments, net of tax ( 108 ) 251
Foreign currency translation adjustments 13 ( 8 )
−Removed: Total other comprehensive income (loss) 163 ( 65 ) 370 ( 837 )
+Added: Total other comprehensive (loss) income ( 95 ) 243
Comprehensive income (loss) $ 8,884 $ ( 19,293 )
4 unchanged sentences
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
−Removed: FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022
−Removed: (In thousands)
−Removed: Common Stock Additional
−Removed: Capital Accumulated
−Removed: Deficit Accumulated Other Comprehensive Loss
−Removed: Shares Amount Total
−Removed: Balance at June 30, 2023 46,409 $ 46 $ 950,626 $ ( 142,524 ) $ ( 173 ) $ 807,975
−Removed: Exercise of stock options 1 — 25 — — 25
−Removed: Vested restricted stock units 17 — — — — —
−Removed: Stock-based compensation — — 12,530 — — 12,530
−Removed: Other comprehensive income (Note 10) — — — — 163 163
−Removed: Net income — — — 10,858 — 10,858
−Removed: Balance at September 30, 2023 46,427 $ 46 $ 963,181 $ ( 131,666 ) $ ( 10 ) $ 831,551
−Removed: Common Stock Additional
−Removed: Capital Accumulated
−Removed: Deficit Accumulated Other Comprehensive Loss
−Removed: Shares Amount Total
−Removed: Balance at June 30, 2022 45,802 $ 46 $ 895,151 $ ( 137,956 ) $ ( 605 ) $ 756,636
−Removed: Exercise of stock options 37 — 1,563 — — 1,563
−Removed: Vested restricted stock units 25 — — — — —
−Removed: Stock-based compensation — — 12,682 — — 12,682
−Removed: Other comprehensive loss (Note 10) — — — — ( 65 ) ( 65 )
−Removed: Net loss — — — ( 693 ) — ( 693 )
−Removed: Balance at September 30, 2022 45,864 $ 46 $ 909,396 $ ( 138,649 ) $ ( 670 ) $ 770,123
−Removed: See accompanying notes to condensed consolidated financial statements.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 7
−Removed: PACIRA BIOSCIENCES, INC.
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
−Removed: FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022
+Added: FOR THE THREE MONTHS ENDED MARCH 31, 2024 AND 2023
(In thousands)
1 unchanged sentence
Capital Accumulated
−Removed: Deficit Accumulated Other Comprehensive Loss
+Added: Deficit Accumulated
+Added: Comprehensive
Shares Amount Total
Balance at December 31, 2023 46,481 $ 46 $ 976,633 $ ( 106,796 ) $ 247 $ 870,130
−Removed: Exercise of stock options 63 — 1,939 — — 1,939
Vested restricted stock units 36 1 — — — 1
−Removed: Common stock issued under employee stock
−Removed: purchase plan 50 — 1,672 — — 1,672
+Added: Common stock withheld for employee withholding tax liabilities on vested restricted stock units — — ( 4 ) — — ( 4 )
Stock-based compensation — — 13,151 — — 13,151
−Removed: Other comprehensive income (Note 10) — — — — 370 370
+Added: Other comprehensive loss (Note 10) — — — — ( 95 ) ( 95 )
Net income — — — 8,979 — 8,979
−Removed: Balance at September 30, 2023 46,427 $ 46 $ 963,181 $ ( 131,666 ) $ ( 10 ) $ 831,551
+Added: Balance at March 31, 2024 46,517 $ 47 $ 989,780 $ ( 97,817 ) $ 152 $ 892,162
Common Stock Additional
Capital Accumulated
−Removed: Deficit Accumulated Other Comprehensive (Loss) Income
+Added: Deficit Accumulated
+Added: Comprehensive
Shares Amount Total
Balance at December 31, 2022 45,928 $ 46 $ 924,095 $ ( 148,751 ) $ ( 380 ) $ 775,010
−Removed: Reclassification of the equity component of convertible senior notes to liabilities upon adoption of Accounting Standards Update 2020-06 (1)
−Removed: — — ( 96,468 ) 47,235 — ( 49,233 )
Exercise of stock options 12 — 334 — — 334
Vested restricted stock units 30 — — — — —
−Removed: Common stock issued under employee stock
−Removed: purchase plan 37 — 1,821 — — 1,821
Stock-based compensation — — 11,990 — — 11,990
−Removed: Issuance of common stock upon conversion of 2022 convertible senior notes 102 — 3,040 — — 3,040
−Removed: Other comprehensive loss (Note 10) — — — — ( 837 ) ( 837 )
−Removed: Net income — — — 26,011 — 26,011
−Removed: Balance at September 30, 2022 45,864 $ 46 $ 909,396 $ ( 138,649 ) $ ( 670 ) $ 770,123
−Removed: (1) Effective January 1, 2022, the Company adopted Accounting Standards Update 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) on a modified retrospective method of transition.
−Removed: As a result, the Company no longer separately presents in equity an embedded conversion feature for its convertible debt.
+Added: Other comprehensive income (Note 10) — — — — 243 243
+Added: Net loss — — — ( 19,536 ) — ( 19,536 )
+Added: Balance at March 31, 2023 45,970 $ 46 $ 936,419 $ ( 168,287 ) $ ( 137 ) $ 768,041
See accompanying notes to condensed consolidated financial statements.
4 unchanged sentences
(In thousands)
−Removed: Nine Months Ended
−Removed: September 30,
+Added: Three Months Ended
Operating activities:
−Removed: Net income $ 17,085 $ 26,011
−Removed: Adjustments to reconcile net income to net cash provided by operating activities:
+Added: Net income (loss) $ 8,979 $ ( 19,536 )
+Added: Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Deferred taxes 3,463 ( 7,342 )
5 unchanged sentences
Changes in contingent consideration ( 3,806 ) 11,618
−Removed: Impairment of investment — 10,000
−Removed: Other losses 2,415 377
+Added: Other net losses (gains) 73 ( 23 )
Changes in operating assets and liabilities:
10 unchanged sentences
Sales of available-for-sale investments 43,361 126,245
−Removed: Payment of contingent consideration — ( 32,000 )
−Removed: Purchases of equity and debt investments ( 6,758 ) ( 13,000 )
−Removed: Net cash provided by (used in) investing activities 69,167 ( 236,374 )
+Added: Purchases of debt investments — ( 4,000 )
+Added: Net cash (used in) provided by investing activities ( 15,530 ) 66,183
Financing activities:
Proceeds from exercises of stock options — 333
−Removed: Proceeds from shares issued under employee stock purchase plan 1,672 1,820
+Added: Payment of employee withholding taxes on restricted stock unit vests ( 4 ) —
Proceeds from Term loan A facility — 149,550
−Removed: Repayment of 2022 convertible senior notes — ( 156,960 )
−Removed: Repayment of 2024 convertible senior notes — ( 192,609 )
Repayment of Term loan B facility — ( 296,875 )
3 unchanged sentences
Net cash used in financing activities ( 2,817 ) ( 153,905 )
−Removed: Net decrease in cash and cash equivalents ( 5,020 ) ( 476,154 )
+Added: Net increase (decrease) in cash and cash equivalents 30,754 ( 68,594 )
Cash and cash equivalents, beginning of period 153,298 104,139
2 unchanged sentences
Cash paid for interest $ 3,969 $ 17,634
−Removed: Cash paid for income taxes, net of refunds $ 2,072 $ 4,216
+Added: Net cash (received) paid for income taxes $ ( 245 ) $ 201
Non-cash investing and financing activities:
−Removed: Issuance of common stock from conversion of 2022 convertible senior notes $ — $ 3,040
Fixed assets included in accounts payable and accrued liabilities $ 607 $ 2,252
5 unchanged sentences
NOTE 1— DESCRIPTION OF BUSINESS
+Added: Business Overview
Pacira BioSciences, Inc.
−Removed: and its subsidiaries (collectively, the “Company” or “Pacira”) is the industry leader in its commitment to non-opioid pain management and providing non-opioid pain management options to as many patients as possible to redefine the role of opioids as rescue therapy only.
−Removed: 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.
+Added: and its subsidiaries (collectively, the “Company” or “Pacira”) is the therapeutic area leader in non-opioid pain management with a stated corporate mission of providing non-opioid pain management options to as many patients as possible and redefining the role of opioids for rescue therapy only.
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.
−Removed: EXPAREL utilizes the Company’s proprietary multivesicular liposome (pMVL) drug delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time.
+Added: 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 (the “Flexion Acquisition”), and added ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension) to its product portfolio.
5 unchanged sentences
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.
−Removed: 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.
+Added: Effective January 2, 2024, the Company appointed a new Chief Executive Officer.
+Added: Consistent with the Company’s predecessor chief operating decision maker, 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 2— SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 unchanged sentences
Therefore, these interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”).
−Removed: The condensed consolidated financial statements at September 30, 2023, and for the three and nine-month periods ended September 30, 2023 and 2022, are unaudited, but include all adjustments (consisting of only normal recurring adjustments) which, in the opinion of management, are necessary to present fairly the financial information set forth herein in accordance with GAAP.
+Added: The condensed consolidated financial statements at March 31, 2024, and for the three-month periods ended March 31, 2024 and 2023, are unaudited, but include all adjustments (consisting of only normal recurring adjustments) which, in the opinion of management, are necessary to present fairly the financial information set forth herein in accordance with GAAP.
The condensed consolidated balance sheet at December 31, 2023 is derived from the audited consolidated financial statements included in the Company’s 2023 Annual Report.
7 unchanged sentences
The Company sells EXPAREL through a drop-ship program under which orders are processed through wholesalers (including AmerisourceBergen Health Corporation, Cardinal Health, Inc.
−Removed: and McKesson Drug Company), but shipments of the product are sent directly to individual accounts, such as hospitals, ambulatory surgery centers and individual doctors.
−Removed: The Company also sells EXPAREL directly to ambulatory surgery centers and physicians.
−Removed: The Company sells ZILRETTA primarily to specialty distributors and specialty pharmacies, who then subsequently resell ZILRETTA to physicians, clinics and certain medical centers or hospitals.
−Removed: The Company also contracts directly with healthcare providers and intermediaries such as Group Purchasing Organizations, or GPOs.
−Removed: The Company sells its bupivacaine liposome injectable suspension for veterinary use to a third-party licensee in the U.S.
−Removed: and sells iovera° directly to end users.
+Added: 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 table below includes the percentage of revenues comprised by the Company’s three largest wholesalers in each period presented:
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Largest wholesaler 36 % 32 %
2 unchanged sentences
Total 79 % 79 %
+Added: Recent Accounting Pronouncements Not Adopted as of March 31, 2024
+Added: In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures.
+Added: The ASU amendment improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on an interim and annual basis.
+Added: The new segment disclosure requirements apply for entities with a single reportable segment.
+Added: The ASU’s amendments are effective for fiscal years beginning after December 15, 2023 and interim periods thereafter, with early adoption permitted.
+Added: The ASU amendment will require adoption on a retrospective basis.
+Added: The Company is currently evaluating the impact of adopting ASU 2023-07 on its consolidated financial statements.
+Added: In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures .
+Added: The ASU amendment addresses investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information.
+Added: The ASU’s amendments are effective for fiscal years beginning after December 15, 2024 and may be adopted on a prospective or retrospective basis.
+Added: The Company is currently evaluating the impact of adopting ASU 2023-09 on its consolidated financial statements.
NOTE 3— REVENUE
2 unchanged sentences
(ii) ZILRETTA in the U.S.;
−Removed: (iii) iovera° in the U.S., Canada and the E.U.
−Removed: and (iv) sales of its bupivacaine liposome injectable suspension for veterinary use.
+Added: (iii) iovera° in the U.S., Canada and Europe and (iv) sales of its bupivacaine liposome injectable suspension for veterinary use.
Royalty revenues are related to a collaborative licensing agreement from the sale of its bupivacaine liposome injectable suspension for veterinary use.
5 unchanged sentences
The Company primarily sells ZILRETTA to specialty distributors and specialty pharmacies, who then subsequently resell ZILRETTA to physicians, clinics and certain medical centers or hospitals.
−Removed: The Company also contracts directly with healthcare providers and intermediaries such as GPOs.
−Removed: 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.
−Removed: EXPAREL and ZILRETTA revenues are recorded at the time the products are transferred to the customer.
+Added: The Company also contracts directly with healthcare providers and intermediaries such as group purchasing organizations, or GPOs.
+Added: Product revenue is recognized when control of the promised goods are transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for transferring those goods.
+Added: EXPAREL and ZILRETTA revenue is recorded at the time the products are transferred 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.
−Removed: 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.
+Added: 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
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 10
+Added: 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.
−Removed: 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.
+Added: 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, participating GPO members and 340B entities at prices lower than the list prices charged to other customers.
The 340B Drug Discount Program is a U.S.
2 unchanged sentences
Reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and trade receivables, net.
−Removed: 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
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 11
−Removed: amounts within weeks of the customer’s notification to the Company of the sale.
+Added: 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.
15 unchanged sentences
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Net product sales:
4 unchanged sentences
Total net product sales $ 165,824 $ 159,431
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 11
NOTE 4— INVENTORIES
The components of inventories, net are as follows (in thousands):
−Removed: September 30, December 31,
+Added: March 31, December 31,
Raw materials $ 51,608 $ 54,099
2 unchanged sentences
Total $ 96,782 $ 104,353
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 12
NOTE 5— FIXED ASSETS
Fixed assets, net, summarized by major category, consist of the following (in thousands):
−Removed: September 30, December 31,
+Added: March 31, December 31,
Machinery and equipment (1)
+Added: $ 106,670 $ 121,773
Leasehold improvements 58,835 61,826
4 unchanged sentences
accumulated depreciation (1)
+Added: ( 120,454 ) ( 135,306 )
Fixed assets, net $ 171,804 $ 173,927
−Removed: For the three months ended September 30, 2023 and 2022, depreciation expense was $ 4.1 million and $ 5.8 million, respectively.
−Removed: For the three months ended September 30, 2023 and 2022, there was $ 0.7 million and $ 1.1 million of capitalized interest on the construction of manufacturing sites, respectively.
−Removed: For the nine months ended September 30, 2023 and 2022, depreciation expense was $ 14.1 million and $ 18.0 million, respectively.
−Removed: For the nine months ended September 30, 2023 and 2022, there was $ 2.8 million and $ 2.9 million of capitalized interest on the construction of manufacturing sites, respectively.
−Removed: At September 30, 2023 and December 31, 2022, total fixed assets, net includes manufacturing process equipment and leasehold improvements located in Europe in the amount of $ 38.3 million and $ 44.7 million, respectively.
−Removed: As of September 30, 2023 and December 31, 2022, the Company had asset retirement obligations of $ 4.0 million and $ 3.3 million, respectively, included in accrued expenses and other liabilities on its condensed consolidated balance sheets, for costs associated with returning leased spaces to their original condition upon the termination of certain of its lease agreements.
+Added: (1) During the three months ended March 31, 2024, the Company disposed of $ 19.0 million of fully depreciated machinery and equipment associated with its 45-liter EXPAREL manufacturing process at the Thermo Fisher Scientific Pharma Services facility located in Swindon, England.
+Added: The Company continues to operate its 200-liter EXPAREL manufacturing process at the same facility.
+Added: For the three months ended March 31, 2024 and 2023, depreciation expense was $ 4.1 million and $ 5.3 million, respectively.
+Added: For the three months ended March 31, 2024 and 2023, there was $ 0.7 million and $ 1.4 million of capitalized interest on the construction of manufacturing sites, respectively.
+Added: At March 31, 2024 and December 31, 2023, total fixed assets, net, includes manufacturing process equipment and leasehold improvements located in Europe in the amount of $ 34.3 million and $ 36.8 million, respectively.
+Added: As of March 31, 2024 and December 31, 2023, the Company had asset retirement obligations of $ 3.9 million and $ 4.3 million, respectively, included in accrued expenses and other liabilities on its condensed consolidated balance sheets, for costs associated with returning leased spaces to their original condition upon the termination of certain of its lease agreements.
NOTE 6— LEASES
3 unchanged sentences
Since July 2022 and February 2023, the Company has been recognizing sublease income for laboratory space leased in Woburn, Massachusetts and a portion of office space leased in Burlington, Massachusetts, respectively, from leases that were assumed as part of the Flexion Acquisition.
−Removed: During the third quarter of 2023, the Company partially exited its Burlington, Massachusetts office space lease that had been assumed as part of the Flexion Acquisition through a one-time termination fee of $ 0.8 million, which released its obligation of $ 1.6 million in future cash payments for the respective proportion of square footage exited.
−Removed: The partial lease termination resulted in a nominal gain which was recorded within contingent consideration charges (gains), restructuring charges and other in the condensed consolidated statements of operations.
+Added: In February 2024, the lease and sublease term concluded for the laboratory space in Woburn, Massachusetts.
Pacira BioSciences, Inc.
2 unchanged sentences
Total operating lease expense, net is as follows (in thousands):
−Removed: Three Months Ended Nine Months Ended
−Removed: September 30, September 30,
−Removed: 2023 2022 2023 2022
+Added: Three Months Ended
Fixed lease costs $ 3,497 $ 3,628
3 unchanged sentences
Supplemental cash flow information related to operating leases is as follows (in thousands):
−Removed: Nine Months Ended
−Removed: September 30,
+Added: Three Months Ended
Cash paid for operating lease liabilities, net of lease incentives $ 3,219 $ 3,763
2 unchanged sentences
The weighted average remaining lease terms and the weighted average discount rates are summarized as follows:
−Removed: September 30,
Weighted average remaining lease term 5.81 years 6.61 years
2 unchanged sentences
Year Aggregate Minimum
−Removed: 2023 (remaining three months) $ 3,249
+Added: 2024 (remaining nine months) $ 9,777
Thereafter 16,426
2 unchanged sentences
Total operating lease liabilities $ 61,449
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 14
NOTE 7— GOODWILL AND INTANGIBLE ASSETS
The Company’s goodwill results from the acquisition of Pacira Pharmaceuticals, Inc.
−Removed: (the Company’s California operating subsidiary) from SkyePharma Holding, Inc., or Skyepharma, (now a subsidiary of Vectura Group plc) in 2007 (the “Skyepharma Acquisition”), the MyoScience Acquisition in 2019 and the Flexion Acquisition in 2021.
−Removed: The balance at each of September 30, 2023 and December 31, 2022 was $ 163.2 million.
−Removed: The Skyepharma Acquisition occurred in March 2007, prior to the requirements to record contingent consideration at fair value under ASC 805-30.
−Removed: In connection with the Skyepharma Acquisition, the Company agreed to certain milestone payments for DepoBupivacaine products, including EXPAREL.
−Removed: The final Skyepharma milestone payment of $ 32.0 million when annual net sales collected reached $ 500.0 million was achieved in the fourth quarter of 2021 and paid during the first quarter of 2022.
+Added: (the Company’s California operating subsidiary) from SkyePharma Holding, Inc.
+Added: (now Vectura Group Limited, a subsidiary of Philip Morris International, Inc.) in 2007, the MyoScience Acquisition in 2019 and the Flexion Acquisition in 2021.
+Added: The goodwill balance at each of March 31, 2024 and December 31, 2023 was $ 163.2 million.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 13
Intangible Assets
Intangible assets, net, consists of the in-process research and development, or IPR&D, and developed technology from the Flexion Acquisition and developed technology and customer relationships from the MyoScience Acquisition and are summarized as follows (dollar amounts in thousands):
−Removed: September 30, 2023 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Weighted-Average Useful Lives
+Added: March 31, 2024 Gross Carrying Value Accumulated Amortization Intangible Assets, Net Weighted-Average Useful Lives
Developed technologies $ 590,000 $ ( 155,975 ) $ 434,025 10 years, 5 months
9 unchanged sentences
Total intangible assets, net $ 624,956 $ ( 141,698 ) $ 483,258
−Removed: Amortization expense on intangible assets was $ 14.3 million for both the three months ended September 30, 2023 and 2022 and $ 43.0 million for both the nine months ended September 30, 2023 and 2022.
−Removed: 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 $ 14.3 million for the remaining three months of 2023, $ 57.3 million each year from 2024 to 2030, $ 37.4 million in 2031, $ 7.9 million in 2032 and $ 2.2 million in 2033.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 15
+Added: Amortization expense on intangible assets was $ 14.3 million for both the three months ended March 31, 2024 and 2023.
+Added: 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 $ 43.0 million for the remaining nine months of 2024, $ 57.3 million each year from 2025 to 2030, $ 37.4 million in 2031, $ 7.9 million in 2032 and $ 2.2 million in 2033.
The carrying value of the Company’s outstanding debt is summarized as follows (in thousands):
−Removed: September 30, December 31,
+Added: March 31, December 31,
Term loan A facility maturing March 2028 $ 112,477 $ 115,202
−Removed: Term loan B facility maturing December 2026 (1)
0.750 % Convertible senior notes due August 2025
2 unchanged sentences
Total $ 520,328 $ 522,437
−Removed: (1) The TLB Term Loan (as defined below) was refinanced on March 31, 2023 as discussed below.
+Added: (1) The 3.375 % convertible senior notes due May 2024 matured and were repaid on May 1, 2024.
2028 Term Loan A Facility
−Removed: On March 31, 2023, the Company entered into a credit agreement (the “TLA Credit Agreement”) with JPMorgan Chase Bank, N.A., as administrative agent, and certain lenders, to refinance the indebtedness outstanding under the Company’s TLB Credit Agreement (as defined and discussed below).
+Added: On March 31, 2023, the Company entered into a credit agreement (the “TLA Credit Agreement”) with JPMorgan Chase Bank, N.A., as administrative agent, and certain lenders, to refinance the indebtedness outstanding under the Company’s then-existing TLB Credit Agreement (as defined and discussed below).
The term loan issued under the TLA Credit Agreement (the “TLA Term Loan”) was issued at a 0.30 % discount and provides for a single-advance term loan A facility in the principal amount of $ 150.0 million, which is secured by substantially all of the Company’s and any subsidiary guarantor’s assets.
1 unchanged sentence
The net proceeds of the TLA Term Loan were approximately $ 149.6 million after deducting an original issue discount of $ 0.4 million.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 14
The total debt composition of the TLA Term Loan is as follows (in thousands):
−Removed: September 30,
+Added: March 31, December 31,
Term loan A facility maturing March 2028 $ 113,750 $ 116,563
3 unchanged sentences
The TLA Term Loan matures on March 31, 2028 and the TLA Credit Agreement requires quarterly repayments of principal in the amount of $ 2.8 million which commenced on June 30, 2023, increasing to $ 3.8 million commencing March 31, 2025, with a remaining balloon payment of approximately $ 85.3 million due at maturity.
−Removed: Due to voluntary principal prepayments of $ 27.8 million made during the three months ended September 30, 2023, the Company is not required to make further principal payments for the remainder of 2023 and 2024.
+Added: Due to voluntary principal prepayments made, the Company is not required to make further principal payments until March 2026, although the Company retains the option to do so.
The TLA Credit Agreement requires the Company to, among other things, maintain (i) a Senior Secured Net Leverage Ratio (as defined in the TLA Credit Agreement), determined as of the last day of each fiscal quarter, of no greater than 3.00 to 1.00 and (ii) a Fixed Charge Coverage Ratio (as defined in the Credit Agreement), determined as of the last day of each fiscal quarter, of no less than 1.50 to 1.00.
+Added: The TLA Credit Agreement requires the Company to maintain an unrestricted cash and cash equivalents balance of at least $ 500.0 million less any prepayments of the 2025 Notes (as defined below) at any time from 91 days prior to the maturity date through the earlier of (i) the latest maturity date of the 2025 Notes and (ii) the date on which there is no outstanding principal amount of the 2025 Notes.
The TLA Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions.
−Removed: As of September 30, 2023, the Company was in compliance with all financial covenants under the TLA Credit Agreement.
+Added: As of March 31, 2024, the Company was in compliance with all financial covenants under the TLA Credit Agreement.
The Company may elect to borrow either (i) alternate base rate borrowings or (ii) term benchmark borrowings or daily simple SOFR (as defined in the TLA Credit Agreement) borrowings.
1 unchanged sentence
Each term loan borrowing that is a term benchmark borrowing or daily simple SOFR borrowing bears interest at a rate per annum equal to (i) the Adjusted Term SOFR Rate or Adjusted Daily Simple SOFR (as each is defined in the Credit Agreement), plus (ii) a spread based on the Company’s Senior Secured Net Leverage Ratio ranging from 3.00 % to 3.75 %.
−Removed: During the nine months ended September 30, 2023, the Company made a scheduled principal payment of $ 2.8 million as well as $ 27.8 million of voluntary principal prepayments.
−Removed: As of September 30, 2023, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 8.47 %.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 16
+Added: During the three months ended March 31, 2024, the Company made a $ 2.8 million voluntary principal prepayment.
+Added: During the year ended December 31, 2023, the Company made a scheduled principal payment of $ 2.8 million as well as $ 30.6 million of voluntary principal prepayments.
+Added: As of March 31, 2024, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 8.41 %.
2026 Term Loan B Facility
In December 2021, the Company entered into a term loan credit agreement (the “TLB Credit Agreement”) with JPMorgan Chase Bank, N.A., as administrative agent and the initial lender.
−Removed: The term loan issued under the Credit Agreement (the “TLB Term Loan”) was issued at a 3.00 % discount and allowed for a single-advance term loan B facility in the principal amount of $ 375.0 million, which was secured by substantially all of the Company’s and each subsidiary guarantor’s assets.
+Added: The term loan issued under the TLB Credit Agreement (the “TLB Term Loan”) was issued at a 3.00 % discount and allowed for a single-advance term loan B facility in the principal amount of $ 375.0 million, which was secured by substantially all of the Company’s and each subsidiary guarantor’s assets.
The net proceeds of the TLB Term Loan were approximately $ 363.8 million after deducting an original issue discount of $ 11.2 million.
+Added: During the three months ended March 31, 2023, the Company repaid the outstanding $ 296.9 million principal on the TLB Term Loan, which resulted in a $ 16.9 million loss on early extinguishment of debt.
On March 31, 2023, the Company used the $ 149.6 million of net borrowings under the TLA Credit Agreement and cash on hand to repay the indebtedness outstanding under the TLB Credit Agreement and concurrently terminated the TLB Credit Agreement.
The Company incurred a prepayment fee of 2.00 % of the outstanding principal balance of the TLB Term Loan in connection with the termination.
−Removed: The total debt composition of the TLB Term Loan was as follows (in thousands):
−Removed: September 30, December 31,
−Removed: Term loan B facility maturing December 2026 $ — $ 296,875
−Removed: Deferred financing costs — ( 3,919 )
−Removed: Discount on debt — ( 8,252 )
−Removed: Total debt, net of debt discount and deferred financing costs $ — $ 284,704
−Removed: During the nine months ended September 30, 2023, the Company made a scheduled principal payment of $ 9.4 million and repaid the outstanding $ 287.5 million principal on the TLB Term Loan, which resulted in a $ 16.9 million loss on early extinguishment of debt.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 15
Convertible Senior Notes Due 2025
4 unchanged sentences
The total debt composition of the 2025 Notes is as follows (in thousands):
−Removed: September 30, December 31,
+Added: March 31, December 31,
0.750 % convertible senior notes due August 2025
1 unchanged sentence
Deferred financing costs ( 3,290 ) ( 3,906 )
−Removed: Total debt, net of debt discount and deferred financing costs $ 397,976 $ 396,126
−Removed: 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.
−Removed: 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).
+Added: Total debt, net of deferred financing costs $ 399,210 $ 398,594
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 if certain circumstances are met, including if during the previous calendar quarter, the last reported sales price of the Company’s common stock was greater than 130 % of the conversion price then applicable for at least 20 out of the last 30 consecutive trading days of the quarter.
−Removed: During the quarter ended September 30, 2023, the conditions for conversion were not met.
+Added: During the quarter ended March 31, 2024, the conditions for conversion were not met.
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.
1 unchanged sentence
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.
−Removed: The initial conversion rate for the 2025 Notes is 13.9324 shares of common stock per $1,000
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 17
−Removed: principal amount, which is equivalent to an initial conversion price of $ 71.78 per share of the Company’s common stock.
+Added: 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.
−Removed: As of September 30, 2023, the 2025 Notes had a market price o f $909 pe r $1,000 principal amount.
+Added: As of March 31, 2024, the 2025 Notes had a market price o f $953 pe r $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.
1 unchanged sentence
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).
−Removed: Beginning on 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.
+Added: Since 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 redemption date.
1 unchanged sentence
No sinking fund is provided for the 2025 Notes.
−Removed: While the 2025 Notes are currently classified on the Company’s condensed consolidated balance sheet at September 30, 2023 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.
+Added: While the 2025 Notes are currently classified on the Company’s condensed consolidated balance sheet at March 31, 2024 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.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 16
Convertible Senior Notes Due 2024 Assumed from the Flexion Acquisition
−Removed: Prior to the Flexion Acquisition, on May 2, 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.
+Added: 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”).
−Removed: The Flexion 2024 Notes mature on May 1, 2024, are unsecured and accrue interest at a rate of 3.375 % per annum, payable semi-annually on May 1 st and November 1 st of each year.
+Added: The Flexion 2024 Notes had a maturity date of May 1, 2024, were unsecured, and accrued interest at a rate of 3.375 % per annum, payable semi-annually on May 1 st and November 1 st of each year.
Upon the Flexion Acquisition, the principal was assumed and recorded at fair value by the Company.
4 unchanged sentences
No Flexion 2024 Notes were converted in connection with the Notice.
−Removed: At September 30, 2023, the remaining principal outstanding is $ 8.6 million.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 18
−Removed: Convertible Senior Notes Due 2022
−Removed: 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.
−Removed: 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.
+Added: At March 31, 2024, the remaining principal outstanding was $ 8.6 million, which was repaid upon its maturity on May 1, 2024.
Interest Expense
1 unchanged sentence
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Contractual interest expense $ 3,311 $ 9,350
1 unchanged sentence
Amortization of debt discount 24 675
−Removed: Capitalized interest and other (Note 5)
+Added: Capitalized interest (Note 5)
( 700 ) ( 1,373 )
4 unchanged sentences
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.
−Removed: To increase consistency and comparability in fair value measurements, the Financial Accounting Standards Board (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.
+Added: 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:
5 unchanged sentences
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.
−Removed: 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).
−Removed: The fair value of the Company’s acquisition-related contingent consideration is reported at fair value on a recurring basis (Level 3).
−Removed: The carrying amounts of equity investments and 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.
+Added: The fair value of the Company’s convertible
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 17
−Removed: At September 30, 2023, the carrying values and fair values of the following financial assets and liabilities were as follows (in thousands):
+Added: senior notes and its TLA Term Loan are calculated utilizing market quotations from an over-the-counter trading market for these notes (Level 2).
+Added: The fair value of the Company’s acquisition-related contingent consideration is reported at fair value on a recurring basis (Level 3).
+Added: The carrying amounts of equity investments and 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.
+Added: At March 31, 2024, the carrying values and fair values of the following financial assets and liabilities were as follows (in thousands):
Carrying Value Fair Value Measurements Using
12 unchanged sentences
$ 8,641 $ — $ 8,641 $ —
−Removed: (1) The closing price of the Company’s common stock as reported on the Nasdaq Global Select Market was $ 30.68 per share at September 30, 2023 compared to a conversion price of $ 71.78 per share.
−Removed: At September 30, 2023, as the conversion price was above the stock price, the requirements for conversion have not been met.
+Added: (1) The closing price of the Company’s common stock as reported on the Nasdaq Global Select Market was $ 29.22 per share at March 31, 2024 compared to a conversion price of $ 71.78 per share.
+Added: At March 31, 2024, 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 is 5.6 million shares of the Company’s common stock, which assumes no increase in the conversion rate for certain corporate events.
+Added: (2) The 3.375 % convertible senior notes due May 2024 matured and were repaid on May 1, 2024.
Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
6 unchanged sentences
Purchases — 6,758 6,758
−Removed: Impairment ( 10,000 ) — ( 10,000 )
Foreign currency adjustments — 61 61
1 unchanged sentence
15,877 12,134 28,011
−Removed: Purchases — 6,758 6,758
Foreign currency adjustments — ( 104 ) ( 104 )
−Removed: Balance at September 30, 2023
+Added: Balance at March 31, 2024
$ 15,877 $ 12,030 $ 27,907
Acquisition-Related Contingent Consideration
−Removed: The Company has recognized contingent consideration related to the Flexion Acquisition and the MyoScience Acquisition in the amount of $ 24.3 million and $ 28.1 million as of September 30, 2023 and December 31, 2022, respectively.
−Removed: For more information, see Note 14, Contingent Consideration Charges (Gains), Restructuring Charges and Other .
+Added: The Company has recognized contingent consideration related to the Flexion Acquisition in the amount of $ 20.9 million and $ 24.7 million as of March 31, 2024 and December 31, 2023, respectively.
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.
1 unchanged sentence
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.
−Removed: 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.
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 18
+Added: 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 contingent value rights 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.
1 unchanged sentence
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.
−Removed: During the three months ended September 30, 2023, the Company recorded charges of $ 2.8 million primarily due to market volatility which affects the liability’s present value.
−Removed: During the nine months ended September 30, 2023, the Company recorded gains of $ 3.8 million due to adjustments to long-term forecasts which reduced the probability of meeting the sales-based contingent consideration milestones by December 31, 2030, the expiration date for achieving the milestones.
−Removed: The gains recognized during the nine months ended September 30, 2023 were partially offset by a decrease in the assumed discount rate that is utilized in calculating the liability’s present value, based on a significant improvement in the Company’s incremental borrowing rate resulting from the TLA Credit Agreement entered into in March 2023.
−Removed: During the three and nine months ended September 30, 2022, the Company recorded gains of $ 0.5 million and $ 13.8 million, respectively, primarily due to adjustments to near-term forecasts for the earnout period of the contingent consideration.
−Removed: These adjustments were recorded as contingent consideration charges (gains), restructuring charges and other in the condensed consolidated statements of operations.
−Removed: At September 30, 2023, the weighted average discount rate was 10.6 % and the probability of payment for the achievement of the remaining regulatory milestone by the expiration date was 12.5 %.
−Removed: As of September 30, 2023 and December 31, 2022, a contingent consideration liability related to the Flexion Acquisition was recognized in the amount of $ 24.3 million and $ 28.1 million, respectively.
−Removed: 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.
−Removed: 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.
−Removed: As of September 30, 2023, the maximum potential remaining milestone payments to be paid are $ 43.0 million.
−Removed: At September 30, 2023, the probability of success for the regulatory milestone that has not yet been met was assessed as zero .
−Removed: As of September 30, 2023 and December 31, 2022, a contingent consideration liability related to the MyoScience Acquisition has been assessed as zero .
−Removed: During the three and nine months ended September 30, 2022 , the Company recognized contingent consideration gains of $ 0.5 million and $ 9.6 million, respectively, due to the reduced probability of meeting the contingent consideration milestones by December 31, 2023, the expiration date for achieving the milestones.
+Added: During the three months ended March 31, 2024, the Company recorded a gain of $ 3.8 million primarily due to an adjustment reflecting the probability of achieving the remaining regulatory milestone by December 31, 2030, the expiration date.
+Added: During the three months ended March 31, 2023, the Company recorded a charge of $ 11.6 million, which was due to a decrease to the assumed discount rate based on a significant improvement in the Company’s incremental borrowing rate resulting from the TLA Credit Agreement entered into in March 2023.
+Added: These adjustments were recorded within contingent consideration (gains) charges, restructuring charges and other in the condensed consolidated statements of operations.
+Added: At March 31, 2024, the weighted average discount rate was 8.6 %.
The following table includes the key assumptions used in the valuation of the Company’s contingent consideration:
−Removed: Assumption Flexion Ranges
+Added: Assumption Ranges
Utilized as of
−Removed: September 30, 2023
+Added: March 31, 2024
Discount rates 8.0 % to 9.3 %
−Removed: Probabilities of payment for regulatory milestones 0 % to 12.5 %
−Removed: Projected year of payment for regulatory and commercial milestones 2030
+Added: Probability of payment for remaining regulatory milestone 0 %
The change in the Company’s contingent consideration recorded at fair value using Level 3 measurements is as follows (in thousands):
4 unchanged sentences
Fair value adjustments and accretion ( 3,806 )
−Removed: Balance at September 30, 2023
+Added: Balance at March 31, 2024
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.
−Removed: Noncurrent investments consist of federal agency bonds and government bonds with maturities greater than one year but less than three years.
+Added: Noncurrent investments consist of asset-backed securities collateralized by credit card receivables and contain 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 investments are reported in other comprehensive income (loss).
−Removed: At September 30, 2023 and December 31, 2022, all of the
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 21
−Removed: 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.
+Added: At March 31, 2024 and December 31, 2023, 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, with the exception of U.S.
+Added: government bonds, 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.
1 unchanged sentence
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.
+Added: The fair value of U.S.
+Added: government bonds is based on level 1 trading activity.
At the time of purchase, all available-for-sale investments had an “A” or better rating by Standard & Poor’s.
−Removed: The following summarizes the Company’s short-term and noncurrent available-for-sale investments at September 30, 2023 and December 31, 2022 (in thousands):
−Removed: September 30, 2023 Investments
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 19
+Added: The following summarizes the Company’s short-term and noncurrent available-for-sale investments at March 31, 2024 and December 31, 2023 (in thousands):
+Added: March 31, 2024 Investments
Losses Fair Value
+Added: (Level 1) Fair Value
Asset-backed securities $ 25,345 $ — $ ( 38 ) $ — $ 25,307
Commercial paper 94,138 28 ( 51 ) — 94,115
+Added: Corporate bonds 7,984 — ( 6 ) — 7,978
federal agency bonds 9,479 — ( 10 ) — 9,469
3 unchanged sentences
Losses Fair Value
+Added: (Level 1) Fair Value
Asset-backed securities $ 9,539 $ 1 $ — $ — $ 9,540
3 unchanged sentences
Subtotal 125,228 104 ( 49 ) 14,879 110,404
−Removed: federal agency bonds 22,783 2 ( 66 ) 22,719
−Removed: government bonds 14,499 — ( 9 ) 14,490
+Added: Asset-backed securities 2,403 7 — — 2,410
Subtotal 2,403 7 — — 2,410
Total $ 127,631 $ 111 $ ( 49 ) $ 14,879 $ 112,814
−Removed: At September 30, 2023, there were no investments available for sale that were materially less than their amortized cost.
+Added: At March 31, 2024, 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.
−Removed: At September 30, 2023 and December 31, 2022, the interest receivable from its available-for-sale investments recognized in prepaid expenses and other current assets was $ 0.4 million and $ 0.8 million, respectively.
+Added: At March 31, 2024 and December 31, 2023, the interest receivable from its available-for-sale investments recognized in prepaid expenses and other current assets was $ 0.1 million and $ 0.4 million, respectively.
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents, short-term and long-term available-for-sale investments and accounts receivable.
1 unchanged sentence
Such amounts may exceed federally-insured limits.
−Removed: As of September 30, 2023, three wholesalers each accounted for over 10% of the Company’s accounts receivable, at 37 %, 18 % and 15 %.
+Added: As of March 31, 2024, three wholesalers each accounted for over 10% of the Company’s accounts receivable, at 39 %, 19 % and 16 %.
At December 31, 2023, three wholesalers each accounted for over 10% of the Company’s accounts receivable, at 37 %, 19 % and 16 %.
3 unchanged sentences
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.
−Removed: As of September 30, 2023 and December 31, 2022, the Company did no t deem any allowances for credit losses on its accounts receivable necessary.
+Added: As of March 31, 2024, there were $ 0.1 million of allowances for credit losses on its accounts receivable associated with iovera°.
+Added: As of December 31, 2023, the Company did no t deem any allowances for credit losses on its accounts receivable necessary.
Pacira BioSciences, Inc.
1 unchanged sentence
NOTE 10— STOCKHOLDERS’ EQUITY
−Removed: Accumulated Other Comprehensive Loss
−Removed: The following tables illustrate the changes in the balances of the Company’s accumulated other comprehensive loss for the periods presented (in thousands):
−Removed: Net Unrealized Gain (Loss) From Available-For-Sale Investments Unrealized Foreign Currency Translation Accumulated Other Comprehensive Loss
+Added: Accumulated Other Comprehensive Income (Loss)
+Added: The following tables illustrate the changes in the balances of the Company’s accumulated other comprehensive income (loss) for the periods presented (in thousands):
+Added: Net Unrealized Gain (Loss) From Available-For-Sale Investments Unrealized Foreign Currency Translation Accumulated Other Comprehensive Income
Balance at December 31, 2023
$ 124 $ 123 $ 247
−Removed: Net unrealized gain on investments, net of tax (1)
+Added: Net unrealized loss on investments, net of tax (1)
+Added: ( 108 ) — ( 108 )
Foreign currency translation adjustments — 13 13
−Removed: Balance at September 30, 2023
+Added: Balance at March 31, 2024
$ 16 $ 136 $ 152
−Removed: Net Unrealized (Loss) Gain From Available-For-Sale Investments Unrealized Foreign Currency Translation Accumulated Other Comprehensive (Loss) Income
+Added: Net Unrealized Gain (Loss) From Available-For-Sale Investments Unrealized Foreign Currency Translation Accumulated Other Comprehensive Loss
Balance at December 31, 2022
$ ( 523 ) $ 143 $ ( 380 )
−Removed: Net unrealized loss on investments, net of tax (1)
−Removed: ( 1,056 ) — ( 1,056 )
+Added: Net unrealized gain on investments, net of tax (1)
Foreign currency translation adjustments — ( 8 ) ( 8 )
−Removed: Balance at September 30, 2022
+Added: Balance at March 31, 2023
$ ( 272 ) $ 135 $ ( 137 )
−Removed: (1) Net of a $ 0.2 million tax expense and $ 0.3 million tax benefit for the nine months ended September 30, 2023 and 2022, respectively.
+Added: (1) Net of a nominal tax benefit and $ 0.2 million tax expense for the three months ended March 31, 2024 and 2023, respectively.
+Added: Share Repurchase Program
+Added: On May 7, 2024, the Company announced that its Board of Directors has approved a new share repurchase program, effective immediately, which authorizes the Company to purchase up to an aggregate of $ 150.0 million of the Company’s outstanding common stock.
+Added: Repurchases under this program may be made at management’s discretion on the open market or through privately negotiated transactions.
+Added: The share repurchase program may be suspended or discontinued at any time by the Company and has an expiration date of December 31, 2026.
NOTE 11— STOCK PLANS
−Removed: Stock Incentive Plans
−Removed: 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 and restated in June 2014, June 2016, June 2019, June 2021 and June 2023.
−Removed: In June 2023, the Company’s stockholders approved the amendment and restatement which increased the number of shares of common stock authorized for issuance as equity awards under the 2011 Plan by 3,300,000 shares.
−Removed: The 2011 Plan allows the granting of incentive stock options, non-statutory stock options, restricted stock units and other stock-based awards.
Stock-Based Compensation
1 unchanged sentence
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Cost of goods sold $ 1,128 $ 1,724
1 unchanged sentence
Selling, general and administrative 7,985 8,391
+Added: Contingent consideration (gains) charges, restructuring charges and other 2,235 —
Total $ 13,151 $ 11,990
7 unchanged sentences
Equity Awards
−Removed: The following tables contain information about the Company’s stock option and restricted stock unit, or RSU, activity for the nine months ended September 30, 2023:
+Added: The following tables contain information about the Company’s stock option and restricted stock unit, or RSU, activity for the three months ended March 31, 2024:
Stock Options Number of
3 unchanged sentences
Granted 900,995 31.95
−Removed: Exercised ( 62,680 ) 30.93
Forfeited ( 155,397 ) 46.84
Expired ( 245,082 ) 50.23
−Removed: Outstanding at September 30, 2023
+Added: Outstanding at March 31, 2024
7,580,264 47.35
6 unchanged sentences
Forfeited ( 102,206 ) 47.71
−Removed: Unvested at September 30, 2023
+Added: Unvested at March 31, 2024
1,422,991 45.26
−Removed: The weighted average fair value of stock options granted during the nine months ended September 30, 2023 wa s $ 16.21 per share.
+Added: The weighted average fair value of stock options granted during the three months ended March 31, 2024 was $ 13.65 per share.
The fair values of stock options granted were estimated using the Black-Scholes option valuation model with the following weighted average assumptions:
−Removed: Black-Scholes Weighted Average Assumption Nine Months Ended September 30, 2023
+Added: Black-Scholes Weighted Average Assumption Three Months Ended March 31, 2024
Expected dividend yield None
5 unchanged sentences
Under the ESPP, employees may elect to contribute after-tax earnings to purchase shares at 85 % of the closing fair market value of the Company’s common stock on either the offering date or the purchase date, whichever is lesser.
−Removed: During the nine months ended September 30, 2023, 50,634 shares were purchased and issued through the ESPP.
+Added: During the three months ended March 31, 2024, no shares were purchased and issued through the ESPP.
Pacira BioSciences, Inc.
1 unchanged sentence
NOTE 12— NET INCOME (LOSS) PER SHARE
−Removed: Basic net income (loss) per common share is calculated by dividing the net income (loss) attributable to common shares by the weighted average number of common shares outstanding during the period.
+Added: Basic and diluted net income (loss) per common share is calculated by dividing the net income (loss) attributable to common shares by the weighted average number of common shares outstanding during the period.
Diluted net income (loss) per common share is calculated by dividing the net income (loss) attributable to common shares by the weighted average number of common shares outstanding plus dilutive potential common shares outstanding during the period.
4 unchanged sentences
Potential common shares are excluded from the diluted net income (loss) per common share computation to the extent they would be antidilutive.
−Removed: The following table sets forth the computation of basic and diluted net income (loss) per common share for the three and nine mon ths ended September 30, 2023 and 2022 (in thousands, except per share amounts):
+Added: The following table sets forth the computation of basic and diluted net income (loss) per common share for the three mon ths ended March 31, 2024 and 2023 (in thousands, except per share amounts):
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Net income (loss)—basic $ 8,979 $ ( 19,536 )
6 unchanged sentences
Dilutive effect of RSUs 85 —
−Removed: Dilutive effect of ESPP purchase options — — 2 3
Weighted average common shares outstanding—diluted 52,193 45,949
−Removed: Net income per share:
−Removed: Basic net income (loss) per common share $ 0.23 $ ( 0.02 ) $ 0.37 $ 0.57
−Removed: Diluted net income (loss) per common share $ 0.23 $ ( 0.02 ) $ 0.37 $ 0.56
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 25
+Added: Net income (loss) per share:
+Added: Basic and diluted net income (loss) per common share $ 0.19 $ ( 0.43 )
The following table summarizes the outstanding stock options, RSUs, ESPP purchase options and convertible senior notes that were excluded from the diluted net income (loss) per common share calculation because the effects of including these potential shares were antidilutive in the periods presented (in thousands):
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Weighted average number of stock options 7,662 6,362
3 unchanged sentences
Total 8,944 13,162
−Removed: For the three months ended September 30, 2022 and nine months ended September 30, 2023, the antidilutive impact associated with the Company’s convertible senior notes would have included an interest expense add-back to net income of $ 1.0 million and $ 3.1 million, respectively.
+Added: (1) The convertible senior notes were antidilutive for the three months ended March 31, 2023, in conjunction with a $ 1.0 million if-converted method adjustment to the numerator that adds back the interest expense associated with the convertible senior notes on a post-tax basis.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 23
NOTE 13— INCOME TAXES
−Removed: Income before income taxes and income tax expense are as follows (dollar amounts in thousands):
+Added: Income (loss) before income taxes and income tax expense (benefit) are as follows (dollar amounts in thousands):
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
Income (loss) before income taxes:
1 unchanged sentence
Foreign ( 17 ) 1,299
−Removed: Total income before income taxes $ 16,601 $ 2,069 $ 27,981 $ 31,370
−Removed: Income tax expense $ 5,743 $ 2,762 $ 10,896 $ 5,359
+Added: Total income (loss) before income taxes $ 13,640 $ ( 26,474 )
+Added: Income tax expense (benefit) $ 4,661 $ ( 6,938 )
Effective tax rate 34 % 26 %
−Removed: The Company’s income tax expense represents the estimated annual effective tax rate applied to the year-to-date domestic operating re sults adjusted for certain discrete tax items.
−Removed: The Company’s effective tax rates for the three and nine months ended September 30, 2023 include costs related to non-deductible stock-based compensation and non-deductible executive compensation, partially offset by credits and a fair value adjustment for Flexion contingent consideration.
−Removed: The Company’s effective tax rates for the three and nine months ended September 30, 2022 include costs related to non-deductible executive compensation, valuation allowances recorded against non-U.S.
−Removed: operating results and U.S.
−Removed: capital losses, partially offset by benefits for a first quarter Skyepharma milestone payment, a fair value adjustment for Flexion contingent consideration and the impact of stock-based compensation adjustments.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 26
−Removed: NOTE 14— CONTINGENT CONSIDERATION CHARGES (GAINS), RESTRUCTURING CHARGES AND OTHER
−Removed: Contingent consideration charges (gains), restructuring charges and other for the three and nine months ended September 30, 2023 and 2022 summarized below (in thousands):
+Added: The Company’s income tax expense (benefit) represents the estimated annual effective tax rate applied to the year-to-date domestic operating re sults adjusted for certain discrete tax items.
+Added: The Company’s effective tax rate for the three months ended March 31, 2024 include costs related to non-deductible stock-based compensation and non-deductible executive compensation, partially offset by tax credits and a fair value adjustment for Flexion contingent consideration.
+Added: The Company’s effective tax rate for the three months ended March 31, 2023 includes costs for a fair value adjustment to Flexion contingent consideration and a valuation allowance recorded against non-U.S.
+Added: results, partially offset by tax credits and stock-based compensation benefits.
+Added: As of March 31, 2024 and December 31, 2023, the Company has an income tax payable balance of $ 1.0 million that is included in other liabilities within the condensed consolidated balance sheets.
+Added: NOTE 14— CONTINGENT CONSIDERATION (GAINS) CHARGES, RESTRUCTURING CHARGES AND OTHER
+Added: Contingent consideration (gains) charges, restructuring charges and other for the three months ended March 31, 2024 and 2023 summarized below (in thousands):
Three Months Ended
−Removed: September 30, Nine Months Ended
−Removed: September 30,
−Removed: 2023 2022 2023 2022
−Removed: Severance-related expenses $ — $ 194 $ — $ 4,259
−Removed: Acquisition-related fees 390 905 1,588 4,918
−Removed: Other acquisition expenses — 433 — 985
−Removed: Total acquisition-related charges 390 1,532 1,588 10,162
Flexion contingent consideration $ ( 3,806 ) $ 11,618
−Removed: MyoScience contingent consideration — ( 523 ) — ( 9,557 )
Restructuring charges 5,535 —
−Removed: Total contingent consideration charges (gains), restructuring charges and other $ 3,356 $ 489 $ ( 1,150 ) $ ( 13,232 )
−Removed: Flexion Acquisition and Contingent Consideration
−Removed: The Company recognized acquisition-related costs of $ 0.4 million and $ 1.6 million during the three and nine months ended September 30, 2023 , respectively, primarily related to vacant and underutilized Flexion leases.
−Removed: The Company recognized acquisition-related costs of $ 1.5 million and $ 10.2 million during the three and nine months ended September 30, 2022, respectively, primarily related to severance, legal fees, third-party services and other one-time charges.
−Removed: The Company recognized $ 2.8 million of contingent consideration charges and $ 3.8 million of contin gent consideration gains during the three and nine months ended September 30, 2023, respectively.
−Removed: The Company recognized $ 0.5 million and $ 13.8 million of contingent consideration gains during the three and nine months ended September 30, 2022, respectively .
−Removed: See Note 9 , 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.
−Removed: MyoScience Contingent Consideration
−Removed: The Company recognized $ 0.5 million and $ 9.6 million of contingent consideration gains during the three and nine months ended September 30, 2022, respectively.
−Removed: See Note 9 , 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.
+Added: Acquisition-related fees 174 489
+Added: Total contingent consideration (gains) charges, restructuring charges and other $ 1,903 $ 12,107
+Added: Flexion Acquisition Contingent Consideration
+Added: During the three months ended March 31, 2024, t he Company recognized a $ 3.8 million contingent consideration gain.
+Added: During the three months ended March 31, 2023, the Company recorded a $ 11.6 million contingent consideration charge.
+Added: See Note 9 , Financial Instruments , for information regarding the method and key assumptions used in the fair value measurements of contingent consideration and more information regarding the changes in fair value.
Restructuring Charges
−Removed: In J une 2023, t he Company implemented a restructuring plan in an effort to improve its operational efficiencies.
−Removed: The restructuring charges are predominantly related to one-time employee termination benefits through a reduction of headcount, such as severance and related costs.
−Removed: During the three and nine months ended September 30, 2023, t he Company recognized $ 0.2 million and $ 1.1 million, respectively, of restructuring charges, of which substantially all has been paid.
+Added: In February 2024, the Company initiated a restructuring plan to ensure it is well positioned for long-term growth.
+Added: The restructuring plan includes:
+Added: (i) reshaping the Company’s executive team, (ii) reallocating efforts and resources from the Company’s ex-U.S.
+Added: and certain early-stage development programs to its commercial portfolio in the U.S.
+Added: market and (iii) reprioritizing investments to focus on commercial readiness for the implementation of separate Medicare reimbursement for EXPAREL at average sales price plus 6 percent in outpatient settings beginning in January 2025 and broader commercial initiatives in key areas, such as strategic national accounts, marketing and market access and reimbursement.
+Added: The Company recognized $ 5.5 million of restructuring charges for the three months ended March 31, 2024 related to employee termination benefits, such as the acceleration of share-based compensation, severance, and, to a lesser extent, other employment-related
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 24
+Added: termination costs, as well as contract termination costs.
+Added: The Company’s restructuring charges as of March 31, 2024, including the beginning and ending liability balances, are summarized below (in thousands):
+Added: Employee Termination Benefits (1)
+Added: Contract Termination Costs Total
+Added: Balance at December 31, 2023 $ — $ — $ —
+Added: Charges incurred 2,567 733 3,300
+Added: Cash payments made / settled ( 386 ) — ( 386 )
+Added: Balance at March 31, 2024 $ 2,181 $ 733 $ 2,914
+Added: (1) During the three months ended March 31, 2024, there was $ 2.2 million of employee termination benefits related to share-based compensation excluded from the table above as they are non-cash and recorded against additional paid-in capital.
+Added: Acquisition-Related Fees
+Added: The Company recognized acquisition-related costs of $ 0.2 million and $ 0.5 million during the three months ended March 31, 2024 and 2023 , respectively, primarily related to vacant and underutilized Flexion leases that were assumed from the Flexion Acquisition.
NOTE 15— COMMITMENTS AND CONTINGENCIES
−Removed: 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.
+Added: 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 its patents and intellectual property, 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.
2 unchanged sentences
(“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.
−Removed: In addition, the Company and Pacira
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 27
−Removed: 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.
+Added: 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.
−Removed: A trial was conducted in September 2023, and a decision is expected in the second half of 2024.
+Added: A trial was conducted in September 2023, and a decision is expected in the coming months.
The Company is unable to predict the outcome of this action at this time.
5 unchanged sentences
District Court for the District of New Jersey (21-cv-19829) asserting infringement of the ‘495 patent.
−Removed: This triggered an automatic 30-month stay of final approval of the eVenus ANDA.
−Removed: 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.
+Added: This triggered an automatic 30-month stay of final approval of the eVenus ANDA which expires on July 1, 2024.
+Added: 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 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.
−Removed: 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.
+Added: In the second 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.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 25
11,179,336 (the ‘336 patent).
2 unchanged sentences
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.
−Removed: This filing triggered a second automatic 30-month stay of final approval for the 133 mg/10 mL ANDA product.
+Added: This filing triggered a second automatic 30-month stay of final approval for the 133 mg/10 mL ANDA product which expires on July 1, 2024.
The first and second patent infringement suits were consolidated.
2 unchanged sentences
The Company has subsequently voluntarily dismissed its claims with respect to the ‘336 Patent.
−Removed: A trial on the remaining claims is currently scheduled for February 2024.
+Added: The trial on the remaining claim was conducted in February 2024 with a decision expected in the coming months.
In April 2023, the Company filed a third patent infringement suit against eVenus, its parent company, and Fresenius Kabi USA, LLC, in the U.S.
2 unchanged sentences
In July 2023, eVenus filed its answer with claims for declaratory judgment, alleging patent invalidity, non-infringement and inequitable conduct with respect to the ‘348 patent as well as the Company’s other patents, U.S.
−Removed: 11,357,727 and 11,452,691.The parties have subsequently dismissed all patents other than the ’348 patent from this litigation.
−Removed: The Company is unable to predict the outcome of this litigation at this time.
+Added: 11,357,727 and 11,452,691.
+Added: The parties have subsequently dismissed all patents other than the ‘348 patent from this litigation.
+Added: The Company is unable to predict the outcome of these litigations at this time.
Research Development Foundation
4 unchanged sentences
The Company believes that the royalty period under the agreement ended on December 24, 2021 with the expiration of its U.S.
−Removed: Because of the disagreement over the interpretation of the agreement, in December 2021, the Company filed a declaratory judgment
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 28
−Removed: lawsuit in the U.S.
+Added: 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.
−Removed: On August 8, 2023, the United States District Court, District of Nevada, granted the Company’s motion for partial summary judgment in respect to the Company’s claim for a declaration that it no longer owes royalties for EXPAREL made under the 45-liter manufacturing process as of December 24, 2021.
+Added: On August 8, 2023, the U.S.
+Added: District Court, District of Nevada, granted the Company’s motion for partial summary judgment in respect to the Company’s claim for a declaration that it no longer owes royalties for EXPAREL made under the 45-liter manufacturing process as of December 24, 2021.
As a result, the Company expects to receive $ 14.5 million from RDF, representing the royalties that the Company paid to RDF under protest after December 24, 2021 for EXPAREL made from the 45-liter manufacturing process.
−Removed: Once it becomes probable that the settlement amount will be received, the Company will record a settlement gain within other operating expenses in the condensed consolidated statement of operations.
−Removed: During the pendency of the remaining lawsuit, the Company will continue to pay royalties associated with the 200-liter manufacturing process to RDF under protest.
+Added: Once it becomes probable that the settlement amount will be received, the Company will record a settlement gain within other operating income (expense), net in the condensed consolidated statement of operations.
+Added: In November 2023, the U.S.
+Added: District Court, District of Nevada conducted a mediation that did not result in a settlement.
+Added: During the pendency of the remaining lawsuit, the Company will continue to pay royalties associated with the 200-liter EXPAREL manufacturing process to RDF under protest.
+Added: A trial is currently scheduled for September 2024.
The Company is unable to predict the outcome of this action at this time.
1 unchanged sentence
Pediatric Trial Commitments
−Removed: The FDA, as a condition of EXPAREL approval, has required the Company to study EXPAREL for infiltration and as a brachial plexus block in the pediatric setting.
+Added: The FDA, as a condition of EXPAREL approval, has required the Company to study EXPAREL for infiltration and as a brachial plexus block in pediatric patients.
The Company was granted deferrals for the required pediatric trials until after the indications were approved in adults.
1 unchanged sentence
Despite the U.K.’s withdrawal from the E.U., the agreed pediatric plan is applicable in the U.K.
−Removed: 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.
−Removed: Those positive results were the basis for the submission of a supplemental New Drug Application, or sNDA, in the U.S.
−Removed: to include use in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia.
−Removed: In March 2021, the Company announced that the FDA approved the sNDA in the U.S.
−Removed: and U.K., the Company also submitted the results of the PLAY study as Type II variations in the E.U.
−Removed: to include the use of EXPAREL in children aged six years or older as a field block for treatment of somatic post-operative pain for small- to medium-sized wounds.
−Removed: The EMA and the Medicines and Healthcare Products Regulatory Agency, or MHRA, in the U.K.
−Removed: both approved the variations in their respective regions in November 2022.
The Company received notification from the FDA in October 2023 that its pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients.
−Removed: The Company is still working with the FDA, EMA and MHRA to finalize the regulatory pathways for its remaining pediatric commitments.
+Added: The Company is still working with the FDA, EMA and Medicines and Healthcare Regulatory Agency (MHRA) to finalize the regulatory pathways for its remaining pediatric commitments.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 26
Contingent Milestone Payments
−Removed: Refer to Note 9, Financial Instruments , for information on potential contingent milestone payments related to the Flexion Acquisition and MyoScience Acquisition.
+Added: Refer to Note 9, Financial Instruments , for information on potential contingent milestone payments related to the Flexion Acquisition.
PCRX-201, a novel, intra-articular gene therapy product candidate that produces the anti-inflammatory protein interleukin-1 receptor antagonist (IL-1Ra) treating OA pain in the knee, was added to the Company’s portfolio as part of the Flexion Acquisition in November 2021.
−Removed: 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.
+Added: Prior to the Flexion Acquisition, in February 2017, Flexion entered into an agreement with GQ Bio Therapeutics 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.
+Added: In February 2024, the FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201 for the treatment of OA pain of the knee.
Pacira BioSciences, Inc.
3 unchanged sentences
This Quarterly Report on Form 10-Q and certain other communications made by us contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to:
−Removed: the Flexion Acquisition (as defined below) and the costs and benefits thereof, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, patent terms, development of products, strategic alliances and intellectual property.
+Added: our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, patent terms, development of products, strategic alliances and intellectual property and any other statements that are not historical facts.
For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement.
−Removed: We often use the words “believe,” “anticipate,” “plan,” “estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,” “can” and similar expressions to help identify forward-looking statements.
+Added: We often use the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would” and similar expressions to help identify forward-looking statements.
We cannot assure you that our estimates, assumptions and expectations will prove to have been correct.
Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others:
−Removed: the successful transition of our chief executive officer and chairman;
−Removed: risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur;
−Removed: the lingering impact of the COVID-19 pandemic on elective surgeries, our manufacturing and supply chain, global and United States, or U.S., economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations;
+Added: the integration of our new chief executive officer;
+Added: risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur;
+Added: our manufacturing and supply chain, global and United States, or U.S., economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations;
the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL ® (bupivacaine liposome injectable suspension), ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension) and iovera° ® ;
9 unchanged sentences
our commercialization and marketing capabilities;
−Removed: our ability to successfully complete an EXPAREL capacity expansion project in San Diego, California;
−Removed: our ability to successfully complete a ZILRETTA capital project in Swindon, England;
+Added: our ability to successfully complete capital projects;
the outcome of any litigation;
1 unchanged sentence
the recoverability of our deferred tax assets;
−Removed: and assumptions associated with contingent consideration payments.
+Added: assumptions associated with contingent consideration payments;
+Added: and the anticipated funding or benefits of our share repurchase program.
Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change.
3 unchanged sentences
“Risk Factors” included in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”) and in other reports as filed with the SEC.
−Removed: Unless the context requires otherwise, references to “Pacira,” “we,” the “Company,” “us” and “our” in this Quarterly Report on Form 10-Q refer to Pacira BioSciences, Inc.
+Added: Unless the context requires otherwise, references to “Pacira,” the “Company,” “our,” “us” and “we” in this Quarterly Report on Form 10-Q refer to Pacira BioSciences, Inc.
and its subsidiaries.
1 unchanged sentence
| Q1 2024 Form 10-Q | Page 28
−Removed: Pacira is the industry leader in our commitment to non-opioid pain management and providing non-opioid pain management options to as many patients as possible to redefine the role of opioids as rescue therapy only.
−Removed: We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.
+Added: Pacira is the therapeutic area leader in non-opioid pain management with a stated corporate mission of providing non-opioid pain management options to as many patients as possible and redefining the role of opioids for rescue therapy only.
Our long-acting, local analgesic EXPAREL ® (bupivacaine liposome injectable suspension) utilizes our unique pMVL drug delivery technology that encapsulates drugs without altering their molecular structure and releases them over a desired period of time.
−Removed: In the U.S., EXPAREL is the only opioid-free, long-acting local and regional analgesic approved for infiltration, field blocks and interscalene brachial plexus nerve block to produce local or regional postsurgical analgesia.
−Removed: EXPAREL is also approved for infiltration in pediatric patients aged six years and older in the U.S.
+Added: In the U.S., EXPAREL is a long-acting, non-opioid option proven to manage postsurgical pain.
+Added: EXPAREL is the only product indicated for local analgesia via infiltration in patients aged six years and older and regional analgesia via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and adductor canal block in adults.
In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults and children aged six years and older.
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We drop-ship EXPAREL directly to end-users based on orders placed to wholesalers or directly to us, and there is no product held by wholesalers.
−Removed: With the acquisition of Flexion Therapeutics, Inc., or Flexion, in November 2021 (the “Flexion Acquisition”), we acquired ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular therapy that can provide major relief for osteoarthritis, or OA, knee pain for three months and has the potential to become an alternative to hyaluronic acid, platelet rich plasma injections or other early intervention treatments.
+Added: With the acquisition of Flexion Therapeutics, Inc., or Flexion, in November 2021 (the “Flexion Acquisition”), we acquired ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular, or IA, therapy that can provide major relief for osteoarthritis, or OA, knee pain for three months and has the potential to become an alternative to hyaluronic acid, platelet rich plasma injections or other early intervention treatments.
With the acquisition of MyoScience, Inc., or MyoScience, in April 2019 (the “MyoScience Acquisition” ) , we acquired iovera° ® , a handheld cryoanalgesia device used to deliver a precise, controlled application of cold temperature to targeted nerves, which we sell directly to end users.
−Removed: EXPAREL, ZILRETTA and the iovera° system are highly complementary products as long-acting, non-opioid therapies that alleviate pain.
+Added: EXPAREL, ZILRETTA and iovera° are highly complementary products as long-acting, non-opioid therapies that alleviate pain.
We expect to continue to pursue the expanded use of EXPAREL, ZILRETTA and iovera° in additional procedures;
progress our earlier-stage product candidate pipeline;
−Removed: advance regulatory activities for EXPAREL, ZILRETTA, iovera° and our other product candidates;
+Added: advance regulatory activities for EXPAREL, ZILRETTA, iovera°, PCRX-201 and our other product candidates;
invest in sales and marketing resources for EXPAREL, ZILRETTA and iovera°;
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Global Economic Conditions
−Removed: Direct and indirect effects of global economic conditions may negatively impact our business, financial condition and results of operations.
−Removed: Such impacts may include, but are not limited to, the effect of prolonged periods of inflation on our customers and suppliers and longer lead-times or the inability to secure a sufficient supply of materials.
+Added: Direct and indirect effects of global economic conditions have in the past, and may continue to, negatively impact our business, financial condition and results of operations.
+Added: Such impacts may include the effect of prolonged periods of inflation which could, among other things, result in higher costs for labor, raw materials and services;
+Added: cause patients to defer or cancel medical procedures, thereby adversely impacting our revenues;
+Added: and negatively impact our suppliers which could result in longer lead-times or the inability to secure a sufficient supply of materials.
+Added: The current macroeconomic environment remains dynamic and subject to rapid and possibly material changes.
Additional negative impacts may also arise that we are unable to foresee.
−Removed: The nature and extent of such impacts are subject to material change, and will depend on future developments which are dynamic, highly uncertain and cannot be predicted.
+Added: The nature and extent of such impacts will depend on future developments, which are highly uncertain and cannot be predicted.
Recent Highlights
−Removed: • In October 2023, we announced the appointments of Marcelo Bigal, MD, PhD, Abraham Ceesay, Michael Yang and Alethia Young to our Board of Directors.
−Removed: Each of the new directors adds diversity of experience and background to the Pacira board of directors, while also enhancing racial and gender diversity.
−Removed: Following these director appointments, Pacira now has 12 experienced directors, all with relevant industry experience.
−Removed: • In October 2023, we announced a grant of $2.5 million to the American Society of Anesthesiologists, or ASA, Charitable Foundation, to advance the medical specialty of anesthesiology and pain medicine;
−Removed: facilitate best-in-class clinician education and improve patient care.
−Removed: We also joined ASA’s Industry Supporter Program to support the Society’s more than 56,000 physician anesthesiologist members to improve patient care and reduce reliance on opioids for the treatment of postsurgical or chronic pain.
−Removed: As an Industry Supporter, Pacira is helping to establish a strong, mutually beneficial relationship with the anesthesiology community, strengthen collaboration between physician anesthesiologists and industry, and add to the value the Society provides to patients and the public, while providing invaluable year-round support of ASA programs and priorities related to non-opioid alternatives and postsurgical care.
+Added: • In February 2024, the FDA approved our sNDA for a 200-liter EXPAREL manufacturing suite at our Science Center Campus in San Diego, California.
+Added: We expect to start selling commercial product manufactured in this 200-liter suite later this year, which could help drive a more favorable cost of commercial product sold and benefit EXPAREL gross margins over time.
+Added: • In February 2024, the FDA granted a Regenerative Medicine Advanced Therapy, or RMAT, designation to PCRX-201 (enekinragene inzadenovec), our novel IA helper-dependent adenovirus (HDAd) gene therapy product candidate that codes for interleukin-1 receptor antagonist (IL-1Ra) for the treatment of OA pain of the knee.
+Added: The RMAT application was supported by the preliminary safety and efficacy findings from a Phase 1 open-label, proof-of-concept, single ascending dose trial that enrolled 72 patients in two three-dose cohorts:
+Added: a co-administered IA steroid cohort and a cohort that did not receive a steroid.
+Added: PCRX-201 was well tolerated, with efficacy observed through at least 52 weeks at all doses and cohorts.
+Added: Established under the 21 st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising therapies—including genetic therapies—that are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and for which preliminary clinical evidence indicates that the drug or therapy has the potential to address an unmet medical need.
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 29
−Removed: In the U.S., EXPAREL is currently indicated for single-dose infiltration in patients six years of age and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.
+Added: • In March 2024, the United States Patent and Trademark Office issued Patent No.
+Added: 11,925,706 (the ‘706 patent) claiming composition of matter, Patent No.
+Added: 11,918,565 (the ‘565 patent) claiming method of use as a sciatic nerve block in the popliteal fossa and Patent No.
+Added: 11,931,459 (the ‘459 patent) claiming method of use in pediatric patients.
+Added: Each of these EXPAREL patents are listed in the FDA’s “ Approved Drug Products with Therapeutic Equivalence Evaluations ” (the “Orange Book”).
+Added: The ‘706 patent has an expiration date of January 22, 2041 and the ‘459 and ‘565 patents have expiration dates of March 17, 2042 and February 2, 2043, respectively.
+Added: • In April 2024, investigators presented encouraging preliminary results from a 72-patient study of PCRX-201 data at the Osteoarthritis Research Society International, or OARSI, 2024 World Congress in Vienna, Austria.
+Added: The data showed that a single IA injection of PCRX-201 demonstrated sustained clinical effect as assessed by patient-reported outcomes at all dose levels for at least one-year post-injection.
+Added: Importantly, PCRX-201 was shown to be well-tolerated with a favorable safety profile.
+Added: We expect to submit updated data demonstrating PCRX-201’s effectiveness through two years for presentation at a medical meeting in the second half of 2024.
+Added: • On May 7, 2024, we announced that the Board of Directors has approved a new share repurchase program—effective immediately—which authorizes us to purchase up to an aggregate of $150.0 million of our outstanding common stock.
+Added: Repurchases under this program may be made at management’s discretion on the open market or through privately negotiated transactions.
+Added: The share repurchase program may be suspended or discontinued at any time by the Company and has an expiration date of December 31, 2026.
+Added: We expect to fund the share repurchase program using a combination of existing cash reserves and future cash flows.
+Added: In the U.S., EXPAREL is currently indicated for local analgesia via infiltration in patients aged six years and older and regional analgesia via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block in adults.
Safety and efficacy have not been established in other nerve blocks.
−Removed: In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults, and in children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.
−Removed: EXPAREL Label and Global Expansion
−Removed: • Lower extremity nerve block.
−Removed: The FDA is currently reviewing our sNDA seeking expansion of the EXPAREL label to include lower extremity nerve block procedures with a Prescription Drug User Fee Act, or PDUFA, action date of November 13, 2023.
−Removed: Our application is based on positive results from two Phase 3 registration studies.
−Removed: The first study, which evaluated EXPAREL admixed with bupivacaine HCl as a femoral nerve block in the adductor canal in patients undergoing total knee arthroplasty, or TKA, achieved the primary endpoint, demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.01).
−Removed: EXPAREL admixed with bupivacaine HCl also achieved a statistically significant reduction in postsurgical opioid consumption through 96 hours (p<0.01) compared with bupivacaine HCl, a key secondary endpoint.
−Removed: The second study, which evaluated EXPAREL as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, achieved the primary endpoint by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.00001).
−Removed: EXPAREL achieved a statistically significant reduction in postsurgical opioid consumption (p<0.00001) and a statistically significant percentage of opioid-free subjects (p<0.001) through 96 hours compared with bupivacaine HCl, which were key secondary endpoints.
−Removed: EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.
+Added: In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults and children aged six years and older.
+Added: EXPAREL Label Activities
+Added: • Launching EXPAREL in two new lower extremity nerve block indications.
+Added: In February 2024, we launched EXPAREL in two key lower extremity nerve blocks—namely an adductor canal block and a sciatic nerve block in the popliteal fossa.
+Added: We believe these two key nerve blocks provide the opportunity to significantly expand EXPAREL utilization within surgeries of the knee, lower leg, and foot and ankle procedures.
+Added: The launch is supported by two successful head-to-head Phase 3 studies in which EXPAREL demonstrated four days of superiority to bupivacaine.
• Pediatrics.
−Removed: We expect to initiate a Phase 1 pharmacokinetic study after which we would initiate a registration study to support expansion of the EXPAREL single-dose infiltration label to include patients under six years of age.
−Removed: If successful, we expect this study, followed by a larger Phase 3 study, will support expansion of the EXPAREL labels in the U.S.
+Added: We are launching a Phase 1 pharmacokinetic study of EXPAREL as a single-dose post-surgical infiltration administration in patients under six years of age.
+Added: If successful, we expect this study, followed by a Phase 3 registration study, will support expansion of the EXPAREL labels in the U.S.
We are also discussing with the FDA, EMA and Medicines and Healthcare Products Regulatory Agency (MHRA) our regulatory strategy for EXPAREL administered as a nerve block in the pediatric setting.
−Removed: The Company received notification from the FDA in October 2023 that its pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients.
+Added: We received notification from the FDA in October 2023 that our pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients.
• Stellate ganglion block.
−Removed: Planning is underway for a multicenter Phase 3 registration study of EXPAREL as a stellate ganglion block for preventing postoperative atrial fibrillation after cardiothoracic surgery.
−Removed: We are working with a steering committee of Key Opinion Leaders in regional anesthesia and stellate ganglion blocks to help finalize study design.
−Removed: We are also working to align with the FDA on our plan to expand the EXPAREL label to include stellate ganglion block in the event that the results of the Phase 3 study are sufficiently positive.
−Removed: We believe a stellate ganglion block utilizing EXPAREL will be critical in an unmet need with post-operative ventricular and atrial dysrhythmias.
−Removed: • Global expansion.
−Removed: In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in children aged six years or older.
−Removed: We launched EXPAREL in the U.K.
−Removed: and targeted E.U.
−Removed: countries in 2021.
−Removed: In Latin America, we have a distribution agreement with Eurofarma Laboratories S.A., or Eurofarma, for the development and commercialization of EXPAREL.
−Removed: Eurofarma has the exclusive right to market and distribute EXPAREL in 19 countries in Latin America, including Argentina, Brazil, Colombia and Mexico.
−Removed: In addition, Eurofarma will be responsible for regulatory filings for EXPAREL in these countries.
−Removed: We will receive royalties and are also eligible to receive regulatory- and commercial-based milestone payments that are triggered by the achievement of certain events.
−Removed: ZILRETTA is the first and only extended-release, intra-articular therapy for OA knee pain.
−Removed: ZILRETTA employs a proprietary microsphere technology combining triamcinolone acetonide, or TA, a commonly administered, immediate-release corticosteroid, with a poly lactic-co-glycolic acid, or PLGA, matrix to provide extended pain relief.
−Removed: PLGA is a proven extended-release delivery vehicle that is metabolized to carbon dioxide and water as it releases drug in the intra-articular space
+Added: Planning is underway for a multicenter EXPAREL Phase 3 registration program as a stellate ganglion block for preventing postoperative atrial fibrillation after cardiothoracic surgery.
+Added: We worked with a steering committee of Key Opinion Leaders, or KOLs, in regional anesthesia and stellate ganglion blocks to design our program and we are awaiting FDA feedback on study design.
+Added: We believe a stellate ganglion block utilizing EXPAREL will be critical in an unmet need with post-operative atrial fibrillation, or POAF.
+Added: POAF is a common and costly complication after cardiothoracic surgery, occurring after up to 40% of cardiac procedures and 20% of thoracic procedures, and often results in an extended intensive care unit and/or hospital stay, as well as higher long-term risk.
+Added: A stellate ganglion block is a sympathetic nerve block which can stabilize the heart.
+Added: Since POAF typically occurs around the third day after surgery, a long-acting block with EXPAREL provided at the time of surgery may enhance current prophylactic measures.
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 30
−Removed: and is used in other approved drug products and surgical devices.
+Added: EXPAREL Clinical Benefits
+Added: We believe EXPAREL can replace the use of bupivacaine delivered via elastomeric pumps as the foundation of a multimodal regimen for long-acting postsurgical pain management.
+Added: Based on our clinical data, EXPAREL:
+Added: • provides long-lasting local or regional analgesia;
+Added: • is a ready-to-use formulation;
+Added: • expands easily with saline or lactated Ringer’s solution to reach a desired volume;
+Added: • can be administered for local analgesia via infiltration and for regional analgesia via field block, as well as brachial plexus nerve block, sciatic nerve block in the popliteal fossa and adductor canal block;
+Added: • facilitates treatment of a variety of surgical sites.
+Added: We believe EXPAREL is a key component of long-acting postsurgical pain management regimens that reduce the need for opioids.
+Added: Based on the clinical data from our Phase 3 and Phase 4 clinical studies as well as data from retrospective health outcomes studies, EXPAREL significantly reduces opioid usage while improving postsurgical pain management.
+Added: ZILRETTA is the first and only extended-release, intra-articular therapy for OA knee pain.
+Added: ZILRETTA employs a proprietary microsphere technology combining triamcinolone acetonide, or TA, a commonly administered, immediate-release corticosteroid, with a poly lactic-co-glycolic acid, or PLGA, matrix to provide extended pain relief.
+Added: PLGA is a proven extended-release delivery vehicle that is metabolized to carbon dioxide and water as it releases drug in the intra-articular space and is used in other approved drug products and surgical devices.
The ZILRETTA microspheres slowly and continuously release triamcinolone acetonide into the knee to provide significant pain relief for 12 weeks, with some people experiencing pain relief through 16 weeks.
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shortly thereafter.
−Removed: We believe ZILRETTA’s extended-release profile may also provide effective treatment for OA pain of the shoulder, and we intend to initiate a Phase 3 trial investigating ZILRETTA in shoulder OA in the first half of 2024.
−Removed: In addition, we are evaluating a study in knee OA patients comparing ZILRETTA to immediate release TA in patients with Type 2 diabetes.
+Added: We believe ZILRETTA’s extended-release profile may also provide effective treatment for OA pain of the shoulder.
ZILRETTA Clinical Benefits
−Removed: ZILRETTA combines a commonly administered steroid, TA, with PLGA, delivering a 32 mg dose of TA to provide extended therapeutic concentrations in the joint and persistent analgesic effect.
+Added: ZILRETTA combines TA, a commonly administered steroid, with a proprietary, extended-release microsphere technology to administer extended therapeutic concentrations in the joint and persistent analgesic effect.
Based on the strength of its pivotal and other clinical trials, we believe that ZILRETTA represents an important treatment option for the millions of patients in the U.S.
1 unchanged sentence
The pivotal Phase 3 trial showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through 16 weeks.
−Removed: Both the magnitude and duration of pain relief provided by ZILRETTA in clinical trials were clinically meaningful with the magnitude of pain relief among the largest seen to date in OA clinical trials.
−Removed: The overall frequency of treatment-related adverse events in these trials was similar to those observed with placebo, and no drug-related serious adverse events were reported.
We believe that ZILRETTA holds the potential to become the corticosteroid of choice given its safety and efficacy profile, and the fact that it is the first and only extended-release corticosteroid on the market.
In September 2021, the American Association of Orthopaedic Surgeons, or AAOS, updated its evidence-based clinical practice guidelines, finding ZILRETTA can improve patient outcomes over traditional immediate-release corticosteroids.
−Removed: Planning is underway for a multicenter Phase 3 registration study of ZILRETTA for the treatment of glenohumeral OA.
−Removed: We received agreement from the FDA to move forward with that study, and we plan to expand the ZILRETTA label to include OA of the shoulder in the event that the results of the Phase 3 study are sufficiently positive.
+Added: In 2024, we launched a Phase 3 registration study to evaluate the safety and efficacy of ZILRETTA for the management of OA pain of the shoulder.
+Added: If the study is successful, we plan to seek approval to expand the ZILRETTA label to include OA pain of the shoulder.
The iovera° system is a non-opioid handheld cryoanalgesia device used to produce precise, controlled doses of cold temperature to targeted nerves.
3 unchanged sentences
It is also indicated for the relief of pain and symptoms associated with arthritis of the knee for up to 90 days.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 31
iovera° Clinical Benefits
−Removed: There is a growing body of clinical data demonstrating success with iovera° treatment for OA of the knee.
−Removed: Surgical intervention is typically a last resort for patients suffering from OA of the knee.
−Removed: In one study, the majority of the patients suffering from OA of the knee experienced pain relief up to 150 days after being treated with iovera°.
+Added: There is a growing body of clinical data demonstrating success with iovera° treatment for a wide range of chronic pain conditions.
+Added: Some of our strongest data relates directly to the improvement of OA pain of the knee.
+Added: Surgical intervention is typically a last resort for patients suffering from OA pain of the knee.
+Added: In one study, the majority of the patients suffering from OA pain of the knee experienced pain relief up to 150 days after being treated with iovera°.
Preliminary findings demonstrated reductions in opioids, including:
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• Patients who were administered iovera° were far less likely to take opioids six weeks after surgery.
−Removed: The number of patients taking opioids six weeks after TKA in the control group was three times the number of patients taking opioids in the cryoanalgesia group (14% vs.
−Removed: 44%, p<0.01).
+Added: The number of patients taking opioids six weeks after total knee arthroplasty, or TKA, in the control group was three times the number of patients taking opioids in the cryoanalgesia group (14 percent vs.
+Added: 44 percent, p<0.01).
• Patients in the iovera° group demonstrated a statistically significant reduction in pain scores from their baseline pain scores at 72 hours (p<0.05) and at 12 weeks (p<0.05).
1 unchanged sentence
• iovera° is safe and effective with immediate pain relief that can last for months as the nerve regenerates over time;
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 33
−Removed: • iovera° is repeatable;
+Added: • iovera° is repeatable, with no diminishing effectiveness over time and repeat use;
• The iovera° technology does not risk damage to the surrounding tissue;
1 unchanged sentence
• iovera° can be delivered precisely using ultrasound guidance or an anatomical landmark.
+Added: A study published in 2021 that included 267 patients (169 who underwent cryoneurolysis with iovera° compared to 98 patients who did not receive iovera° treatment) showed that patients who were treated with iovera° had 51% lower daily morphine milligram equivalents during their hospital stay and a 22% lower mean pain score versus those who were not.
+Added: In addition, the iovera° group had greater function at discharge, a shorter length of hospital stay and received significantly fewer opioids, including discharge prescriptions at week 2 and week 6 after surgery.
In September 2021, the AAOS updated its evidence-based clinical practice guidelines, reporting that denervation therapy—including cryoneurolysis—may reduce knee pain and improve function in patients with symptomatic OA of the knee.
−Removed: We are also encouraged by usage of iovera° in other areas.
−Removed: Key Opinion Leaders in orthopedics, spine and anesthesia are interested in replacing heat-based radiofrequency ablation with iovera° cold therapy.
−Removed: There is interest across a wide range of treatment opportunities such as low back pain, spine, spasticity and rib fracture.
−Removed: We intend to use investigator-initiated studies and grants to develop data across these areas.
−Removed: iovera° Global Expansion
−Removed: In July 2021, we entered into a licensing agreement with Verve Medical Products, Inc.
−Removed: for the distribution of iovera° in Canada.
−Removed: We began selling iovera° in Canada in the fourth quarter of 2021.
−Removed: Additionally, we began selling iovera° in the E.U.
−Removed: through a contracted sales force in the first quarter of 2022.
The Osteoarthritis Market
5 unchanged sentences
In some cases, it also causes reduced function and disability—some people are no longer able to do daily tasks or work.
−Removed: According to the Centers for Disease Control and Prevention, OA affects over 32.5 million adults in the U.S.
+Added: According to the Centers for Disease Control and Prevention (CDC), OA affects over 32.5 million adults in the U.S.
The lifetime risk of developing symptomatic knee OA is 45 percent according to the Arthritis Foundation.
3 unchanged sentences
Surgical intervention is typically a last resort for patients suffering from OA of the knee.
−Removed: With the addition of ZILRETTA to our product offering, we can now offer clinicians the flexibility to individualize OA knee pain treatment with either ZILRETTA or a drug-free nerve block with iovera° based on patient factors and preference, physician training, site of care and reimbursement considerations.
−Removed: Clinical Development Programs
−Removed: PCRX-201 is a novel, IA gene therapy product candidate that produces the anti-inflammatory protein, IL-1Ra, for treating OA pain in the knee.
−Removed: Based upon compelling initial Phase 1 efficacy and safety data for PCRX-201, we are preparing to initiate a second Phase 1 study in OA of the knee and intend to request a Regenerative Medicine Advanced Therapy, or RMAT, designation.
−Removed: PCRX-201 was added to our portfolio as part of the Flexion Acquisition.
−Removed: pMVL-Based Clinical Programs
−Removed: Given the proven safety, flexibility and customizability of our pMVL drug delivery technology platform for acute, sub-acute and chronic pain applications, we have several pMVL-based products in clinical development.
−Removed: Following data readouts from preclinical and feasibility studies for these candidates, we have prioritized three programs for clinical development:
−Removed: (i) PCRX-401, a dexamethasone-pMVL for low back pain;
−Removed: (ii) PCRX-501, a high potency bupivacaine-pMVL for longer-lasting pain relief (20.0 mg/mL) and (iii) EXPAREL for intrathecal analgesia (13.3 mg/mL).
−Removed: We initiated a second Phase 1 study of EXPAREL for intrathecal analgesia in June 2023.
+Added: With ZILRETTA, we now offer clinicians the flexibility to individualize OA knee pain treatment with either ZILRETTA or a drug-free nerve block with iovera° based on patient factors and preference, physician training, site of care and reimbursement considerations.
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 32
+Added: Clinical Development Programs
+Added: PCRX-201 was added to our product development portfolio as part of the Flexion Acquisition.
+Added: PCRX-201 is a novel, helper-dependent adenoviral vector expressing interleukin-1 receptor antagonist (IL-1Ra).
+Added: After injection, the vector enters joint cells and turns them into factories to produce sustained therapeutic levels of IL-1Ra and inhibit the IL-1 pathway to manage pain and mitigate OA-related joint damage while remaining localized to the joint space.
+Added: In a Phase 1 proof-of-concept study of patients with moderate to severe OA of the knee, PCRX-201 was well tolerated with improvements in knee pain observed across all doses.
+Added: In February 2024, the FDA granted PCRX-201 an RMAT designation.
+Added: Our RMAT application was supported by the preliminary safety and efficacy findings from a Phase 1 open-label, proof-of-concept, single ascending dose trial that enrolled 72 patients in two three-dose cohorts:
+Added: a co-administered IA steroid cohort and a cohort that did not receive a steroid.
+Added: PCRX-201 was well tolerated, with efficacy observed through at least 52 weeks at all doses and cohorts.
+Added: The highest level of efficacy was achieved in the co-administered steroid group, which showed a greater percentage of patients with at least a 50% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores, as well as a meaningful improvement in (Knee Injury and Osteoarthritis Outcomes Score) KOOS functional assessment.
+Added: The 52-week data were presented at the Osteoarthritis Research Society International (OARSI) 2024 World Congress in April 2024 and we expect to submit the 104-week efficacy and safety data for presentation at a medical meeting later this year.
+Added: pMVL-Based Clinical Program
+Added: Given the proven safety, flexibility and customizability of our pMVL drug delivery technology platform for acute, sub-acute and chronic pain applications, we have another pMVL-based product in clinical development.
+Added: Following data readouts from preclinical and feasibility studies, we initiated a second Phase 1 study of EXPAREL for intrathecal analgesia in June 2023.
External Innovation
−Removed: In parallel to our internal clinical programs, our business development team is pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today.
+Added: In parallel to our internal clinical programs, we are pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today.
We are using a combination of strategic investments, in-licensing and acquisition transactions to buildout a pipeline of innovation to improve patients’ journeys along the neural pain pathway.
2 unchanged sentences
CarthroniX, Inc.
−Removed: Phase 1-Ready CX-011, a small molecule modulator of gp130 formulated as an intra-articular injection designed to slow joint degeneration by mediating IL-6 cytokines Knee OA
+Added: Phase 1-Ready CX-011, a small molecule modulator of gp130 formulated as an IA injection designed to slow joint degeneration by mediating IL-6 cytokines Knee OA
Genascence Corporation Phase 1b Adeno-associated virus (AAV) based gene therapy engineered to deliver Interleukin-1 Receptor Antagonist (IL-1Ra) to target cells in joint(s)
7 unchanged sentences
Our current product portfolio and internal product candidate pipeline, along with anticipated milestones over the next 12 to 18 months, are summarized in the table below:
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 36
Pacira Training Facilities
−Removed: We maintain and operate two training facilities—one in Tampa, Florida and one in Houston, Texas.
+Added: We maintain and operate two Pacira Innovation and Training, or PIT, facilities—one in Tampa, Florida and one in Houston, Texas.
These sites were constructed with a singular goal in mind:
1 unchanged sentence
These facilities provide clinicians with flexible, state-of-the-art environments for interactive, hands-on instruction on the latest and most innovative local, regional and field block approaches for managing pain, improving patient care and enabling patient migration to the 23-hour stay environment.
−Removed: Tampa, Florida
−Removed: In October 2020, we opened the Pacira Innovation and Training, or PIT, Center of Tampa.
−Removed: We designed this facility to help advance clinician understanding of the latest local, regional and field block approaches for managing pain.
−Removed: The PIT of Tampa provides an unparalleled training environment for healthcare providers working to reduce or eliminate patient exposure to opioids.
−Removed: The PIT of Tampa supports a full range of educational events to advance clinician understanding of the latest local, regional, and field block approaches for managing pain and reducing or eliminating exposure to opioids.
−Removed: Our principal executive offices and corporate headquarters are also located at the PIT of Tampa.
−Removed: The PIT of Tampa consists of approximately 13,000 square-feet of fully adaptable space and is equipped with state-of-the-art technology and audio/visual capabilities and features several distinct training spaces including a simulation lab equipped with seven ultrasound scanning stations;
−Removed: a lecture hall featuring a 4½-foot tall by 24-foot wide liquid crystal display video wall to support live, virtual and even global presentations;
−Removed: and a green-screen broadcast studio designed to livestream content with single or multiple hosts.
−Removed: In addition to our EXPAREL programs, we are hosting ongoing workshops to train new users on best practice techniques for iovera° administration at the PIT of Tampa.
−Removed: Led by healthcare professionals, these labs include didactic lectures and hands-on trainings including live model nerve scanning and identification using ultrasound and peripheral nerve stimulation.
−Removed: At no fee to the organization, the PIT of Tampa also serves as a venue for national anesthesia provider organizations to host their own workshops and training sessions to educate healthcare providers.
−Removed: Houston, Texas
−Removed: In January 2023, we opened our second training facility, the Houston Pacira Innovation and Training Center, in Houston, Texas.
−Removed: This 19,000 square-foot state-of-the-art facility features a 125-seat adaptive lecture hall featuring the same liquid crystal display video wall that the PIT of Tampa has, a broadcast studio and both wet and dry lab space for cadaver and other interactive workshops.
−Removed: A simulation lab is equipped with eight advanced ultrasound machines equipped with artificial intelligence and 3-D training software in addition to professional medical lighting and in-ceiling cameras.
−Removed: The PIT of Houston is core to developing both our physician champions and community-based clinicians who want to stay on the forefront of opioid-sparing pain management.
−Removed: With this new training facility, we have doubled our capacity and ability to host programs for EXPAREL, ZILRETTA and iovera°.
+Added: Each of our PIT facilities feature distinct training spaces, including simulation labs equipped with ultrasound scanning stations;
+Added: lecture halls that feature liquid crystal display video walls to support live, virtual and global presentations;
+Added: and green-screen broadcast studios to livestream content with single or multiple hosts.
+Added: The PIT of Houston has both wet and dry lab space for cadaver and other interactive workshops.
+Added: The PIT of Tampa also houses our principal executive offices and corporate headquarters.
Pacira BioSciences, Inc.
1 unchanged sentence
Results of Operations
−Removed: Comparison of the Three and Nine Months Ended September 30, 2023 and 2022
−Removed: Total revenues consist of sales of (i) EXPAREL in the U.S., E.U., and U.K.;
+Added: Comparison of the Three Months Ended March 31, 2024 and 2023
+Added: Net product sales consist of sales of (i) EXPAREL in the U.S., E.U., and U.K.;
(ii) ZILRETTA in the U.S.;
−Removed: (iii) iovera° in the U.S., Canada and the E.U.
−Removed: and (iv) sales of, and royalties on, our bupivacaine liposome injectable suspension for veterinary use.
+Added: (iii) iovera° in the U.S., Canada and Europe and (iv) sales of our bupivacaine liposome injectable suspension for veterinary use.
+Added: Royalty revenues are related to a collaborative licensing agreement from the sale of our bupivacaine liposome injectable suspension for veterinary use.
The following table provides information regarding our revenues during the periods indicated, including percent changes (dollar amounts in thousands):
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
+Added: March 31, % Increase / (Decrease)
Net product sales:
6 unchanged sentences
Total revenues $ 167,117 $ 160,341 4%
−Removed: EXPAREL revenue decreased 3% and 1% in the three and nine months ended September 30, 2023 versus 2022, respectively, primarily due to decreases of 4% in net selling price per unit in each period related to enrolling EXPAREL in the 340B drug pricing program and expanding other contracting activities, partially offset by a January 2023 price increase.
−Removed: EXPAREL revenue was also impacted by increases in gross vial volumes of 2% and 4% in the three and nine months ended September 30, 2023 versus 2022, respectively, and reduced by 1% due to a shift in sales mix in both periods.
−Removed: ZILRETTA revenue increased 9% and 6% in the three and nine months ended September 30, 2023 versus 2022, respectively, primarily due to increases of 6% in gross kit volume in both periods and increases of 2% and 1% in net selling price per unit during the applicable periods.
−Removed: Net product sales of iovera° increased 18% and 28% in the three and nine months ended September 30, 2023 versus 2022, respectively, due to increases of 22% and 31% in Smart Tip volume and increases of 2% and 3% in selling price per Smart Tip, respectively, partially offset by a higher returns allowance.
−Removed: Bupivacaine liposome injectable suspension net product sales decreased 71% and 59% in the three and nine months ended September 30, 2023 versus 2022, respectively.
−Removed: Its related royalties decreased 62% and 46% in the three and nine months ended September 30, 2023 versus 2022, respectively, primarily due to the timing and product mix of orders and related sales made by Aratana Therapeutics, Inc.
−Removed: for veterinary use.
−Removed: The following tables provide a summary of activity with respect to our sales related allowances and accruals related to EXPAREL and ZILRETTA for the nine months ended September 30, 2023 and 2022 (in thousands):
−Removed: September 30, 2023 Returns
+Added: EXPAREL revenue increased 2% in the three months ended March 31, 2024 versus 2023.
+Added: Components of the increase included a 3% increase in gross vial volume, which was offset by a shift in product mix.
+Added: EXPAREL revenue was also impacted by a 2% increase in selling price per unit related to a January 2024 price increase, which was partially offset by sales related allowances as a result of group purchasing organization contracting.
+Added: ZILRETTA revenue increased 6% in the three months ended March 31, 2024 versus 2023 primarily due to a 7% increase in net selling price per unit related to increases of gross selling price per unit and favorable sales related allowances, partially offset by a 1% decrease in kit volume.
+Added: Net product sales of iovera° increased 26% in the three months ended March 31, 2024 versus 2023 primarily due to an increase of 34% in Smart Tip volume, partially offset by a 2% decrease in selling price per Smart Tip due to increased sales to clinics.
+Added: Bupivacaine liposome injectable suspension revenue increased more than 100% in the three months ended March 31, 2024 versus 2023 and its related royalties increased 42% primarily due to the sales mix of vial sizes and the timing of orders placed for veterinary use.
+Added: The following tables provide a summary of activity with respect to our sales related allowances and accruals related to EXPAREL and ZILRETTA for the three months ended March 31, 2024 and 2023 (in thousands):
+Added: March 31, 2024 Returns
Allowances Prompt
5 unchanged sentences
Payments / Adjustments (175) (3,087) (5,064) (26,320) (333) (34,979)
−Removed: Balance at September 30, 2023 $ 2,114 $ 1,148 $ 3,389 $ 6,758 $ 914 $ 14,323
+Added: Balance at March 31, 2024 $ 1,769 $ 1,278 $ 3,404 $ 5,350 $ 1,478 $ 13,279
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 35
−Removed: September 30, 2022 Returns
+Added: March 31, 2023 Returns
Allowances Prompt
5 unchanged sentences
Payments / Adjustments (328) (2,921) (4,162) (22,689) (396) (30,496)
−Removed: Balance at September 30, 2022 $ 1,512 $ 1,105 $ 2,925 $ 4,524 $ 742 $ 10,808
−Removed: Total reductions of gross product sales from sales-related allowances and accruals were $95.5 million and $52.8 million, or 16.3% and 9.7% of gross product sales, for the nine months ended September 30, 2023 and 2022, respectively.
−Removed: The overall 6.6% increase in sales-related allowances and accruals as a percentage of gross product sales was primarily related to accruals as a result of enrolling EXPAREL in the 340B drug pricing program and chargeback-related allowances.
+Added: Balance at March 31, 2023 $ 1,828 $ 1,204 $ 3,308 $ 5,312 $ 802 $ 12,454
+Added: Total reductions of gross product sales from sales-related allowances and accruals were $34.3 million and $30.6 million, or 17.1% and 16.2% of gross product sales, for the three months ended March 31, 2024 and 2023, respectively.
+Added: The overall 0.9% increase in sales-related allowances and accruals as a percentage of gross product sales was primarily related to accruals as a result of higher chargeback-related allowances from expanded contracting efforts.
Cost of Goods Sold
3 unchanged sentences
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
+Added: March 31, % Increase / (Decrease)
Cost of goods sold $ 47,416 $ 49,020 (3)%
Gross margin 72 % 69 %
−Removed: Gross margin increased six percentage-points in the three months ended September 30, 2023 versus 2022, mainly due to lower royalty expense due to no longer owing royalties for EXPAREL made under the 45-liter manufacturing process (as further discussed below) and lower inventory reserves.
−Removed: These increases were partially offset by an increase in sales-related allowances and accruals as a result of enrolling EXPAREL in the 340B drug pricing program which resulted in a lower net selling price in the period.
−Removed: Also offsetting were higher ZILRETTA product cost sold in the period.
−Removed: Gross margin remained flat in the nine months ended September 30, 2023 versus 2022, mainly due to higher EXPAREL product cost and sales-related allowances and accruals as a result of enrolling EXPAREL in the 340B drug pricing program, which resulted in a lower net selling price in the period.
−Removed: This was offset by higher costs in 2022 for the transition of iovera° manufacturing sites and next-generation handheld devices.
−Removed: On August 8, 2023, the United States District Court, District of Nevada, concluded we are no longer obligated to pay royalties to the Research and Development Foundation for EXPAREL made under the 45-liter manufacturing process.
+Added: Gross margin increased three percentage-points in the three months ended March 31, 2024 versus 2023 primarily due to lower EXPAREL product cost and lower royalty expense as discussed below, partially offset by higher inventory reserves.
+Added: On August 8, 2023, the U.S.
+Added: District Court, District of Nevada, concluded we were no longer obligated to pay royalties to the Research and Development Foundation for EXPAREL made under the 45-liter manufacturing process.
For more information, see Note 15, Commitments and Contingencies , to our condensed consolidated financial statements included herein.
2 unchanged sentences
Clinical and preclinical development expenses include costs for clinical personnel, clinical trials performed by third-parties, toxicology studies, materials and supplies, database management and other third-party fees.
−Removed: Product development and manufacturing capacity expansion expenses include development costs for our products, which include personnel, equipment, materials and contractor costs for process development and product candidates, development costs related to significant scale-ups of our manufacturing capacity and facility costs for our research space.
+Added: Product development and manufacturing capacity expansion expenses include development costs for our products, which include personnel, research equipment, materials and contractor costs for process development and product candidates, development costs related to significant scale-ups of our manufacturing capacity and facility costs for our research space.
Regulatory and other expenses include regulatory activities related to unapproved products and indications, medical information expenses, registry expenses and related personnel.
Stock-based compensation expense relates to the costs of stock option grants, awards of restricted stock units, or RSUs, and our employee stock purchase plan, or ESPP.
−Removed: The following table provides a breakout of our research and development expenses during the periods indicated, including percent changes (dollar amounts in thousands):
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 36
+Added: The following table provides a breakout of our research and development expenses during the periods indicated, including percent changes (dollar amounts in thousands):
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
+Added: March 31, % Increase / (Decrease)
Clinical and preclinical development $ 6,346 $ 5,261 21%
4 unchanged sentences
% of total revenues 11 % 11 %
−Removed: Total research and development expense increased 7% and decreased 16% in the three and nine months ended September 30, 2023 versus 2022, respectively.
−Removed: Clinical and preclinical development expense decreased 19% and 56% in the three and nine months ended September 30, 2023 versus 2022, respectively, due to the completion of two EXPAREL lower extremity nerve block trials in bunionectomy and TKA in the third quarter of 2022, toxicology studies that are near completion for product candidates, partially offset by start-up costs for both ZILRETTA shoulder and iovera° spasticity trials.
−Removed: Product development and manufacturing capacity expansion expense increased 30% and 52% in the three and nine months ended September 30, 2023 versus 2022, respectively, mainly attributable to the continued scale-up activities of our EXPAREL manufacturing capacity at our Science Center Campus in San Diego, California (for which a prior approval supplement was submitted to the FDA in October 2023 with an anticipated PDUFA action date in February 2024), as well as new product development costs related to gene therapy.
−Removed: Regulatory and other expense increased 20% and 29% in the three and nine months ended September 30, 2023 versus 2022, respectively, due to increased enrollment and additional sites related to an observational iovera° registry study which tracks patients’ symptoms and experience with pain management related to OA of the knee, and increased medical information publications.
−Removed: Stock-based compensation increased 25% and 22% in the three and nine months ended September 30, 2023 versus 2022, respectively, primarily due to greater equity awards outstanding for research and development personnel, partially offset by a lower fair value of newer equity awards granted.
+Added: Total research and development expense increased 6% in the three months ended March 31, 2024 versus 2023.
+Added: Clinical and preclinical development expense increased 21% in the three months ended March 31, 2024 versus 2023 due to the start-up and enrollment in a ZILRETTA shoulder trial and an EXPAREL pediatric trial, and start-up activities in an iovera° spasticity trial.
+Added: These increases were partially offset by the winding down of a PCRX-201 Phase 1 study for knee OA as follow-up visits of subjects were completed in November 2023, and the completion of toxicology studies for product candidates.
+Added: Product development and manufacturing capacity expansion expense decreased 4% in the three months ended March 31, 2024 versus 2023, primarily attributable to the near-completion of pre-commercial scale-up activities of our EXPAREL manufacturing capacity at our Science Center Campus in San Diego, California.
+Added: The FDA approved an sNDA for our 200-liter EXPAREL manufacturing suite in February 2024.
+Added: This decrease is partially offset by ongoing product development costs related to PCRX-201 and an iovera° medial branch Smart Tip.
+Added: Regulatory and other expense increased 16% in the three months ended March 31, 2024 versus 2023 due to increased enrollment and additional sites related to an observational registry study which tracks patients’ symptoms and experience with pain management related to OA of the knee.
+Added: Stock-based compensation decreased 4% in the three months ended March 31, 2024 versus 2023 primarily due to the impact of a February 2024 restructuring program which resulted in accelerated stock-based compensation for those impacted being recorded in contingent consideration (gains) charges, restructuring charges and other.
Selling, General and Administrative Expenses
7 unchanged sentences
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
+Added: March 31, % Increase / (Decrease)
Sales and marketing $ 39,435 $ 41,579 (5)%
3 unchanged sentences
% of total revenues 43 % 44 %
−Removed: Total selling, general and administrative expense increased 11% and 7% in the three and nine months ended September 30, 2023 versus 2022, respectively.
−Removed: Sales and marketing expense increased 14% and 8% in the three and nine months ended September 30, 2023 versus 2022, respectively, driven by an increase in marketing investments in our products, including educational initiatives and programs related to the impact of opioids and postsurgical pain management and our national advocacy campaign designed to educate patients about non-opioid treatment options.
−Removed: In 2023, we also invested in strategic partnerships with sports organizations, such as the Ladies Professional Golf Association (LPGA) and National Football League Alumni Association (NFLA), to increase awareness of the availability and benefits of non-opioid options to manage acute and chronic pain for athletes, including postsurgical pain and knee OA.
−Removed: We also expanded our investment in clinician training in the use of EXPAREL and iovera° at our training facility in Tampa, as well as the opening of a second training facility in Houston, Texas in January 2023.
−Removed: We also announced a new grant to the ASA’s Charitable Foundation to advance the medical specialty of anesthesiology and pain medicine, facilitate best in-class clinician education and improve patient care.
−Removed: General and administrative expense increased 13% and 10% in the three and nine months ended September 30, 2023 versus 2022, respectively, primarily driven by legal fees attributable to ongoing litigation.
−Removed: For more information, see Note 15, Commitments and Contingencies, to our condensed consolidated financial statements included herein.
−Removed: Stock-based compensation decreased 3% and 4% for the three and nine months ended September 30, 2023 versus 2022, respectively, primarily due to a decrease in the number of equity awards outstanding for selling, general and administrative personnel.
+Added: Total selling, general and administrative expense increased 2% in the three months ended March 31, 2024 versus 2023.
+Added: Sales and marketing expense decreased 5% in the three months ended March 31, 2024 versus 2023, which is attributable to the impact of a February 2024 restructuring program.
+Added: These measures involved reallocating resources and prioritizing investing in programs to drive awareness and education for our customers and enhance our marketing, market access and reimbursement teams and value creation for the implementation of separate Medicare reimbursement for EXPAREL at average sales price plus 6 percent in outpatient settings beginning in January 2025.
+Added: We expect investments in these programs to increase in the remaining nine months of 2024.
+Added: General and administrative expense increased 18% in the three months ended March 31, 2024 versus 2023 primarily driven by legal fees primarily attributable to ongoing litigation.
+Added: We also incurred compensatory costs associated with the transition to our new Chief Executive Officer effective January 2, 2024, which include compensation related to the current Chief Executive Officer and to the former Chief Executive Officer who remains employed by the Company in an advisory role, and, to a lesser extent, third-party consulting.
+Added: For more information on our ongoing litigation, see Note 15, Commitments and Contingencies, to our condensed consolidated financial statements included herein.
+Added: Stock-based compensation decreased 5% for the three months ended March 31, 2024 versus 2023 primarily due to the impact from the February 2024 restructuring program which resulted in accelerated stock-based compensation for those impacted being recorded in contingent consideration (gains) charges, restructuring charges and other.
Amortization of Acquired Intangible Assets
1 unchanged sentence
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
+Added: March 31, % Increase / (Decrease)
Amortization of acquired intangible assets $ 14,322 $ 14,322 —%
6 unchanged sentences
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
−Removed: Contingent consideration 2,793 (1,043) N/A (3,847) (23,394) (84)%
−Removed: Acquisition-related charges $ 390 $ 1,532 (75)% $ 1,588 $ 10,162 (84)%
−Removed: Restructuring charges 173 — N/A 1,109 — N/A
−Removed: Total contingent consideration charges (gains), restructuring charges and other $ 3,356 $ 489 100% + $ (1,150) $ (13,232) (91)%
−Removed: Total contingent consideration charges (gains), restructuring charges and other increased by more than 100% in the three months ended September 30, 2023 versus 2022 and decreased 91% in the nine months ended September 30, 2023 versus 2022.
−Removed: During the three months ended September 30, 2023, we recognized contingent consideration charges (gains), restructuring charges and other of $3.4 million in charges, which were primarily driven by an increase in the contingent consideration milestones for the Flexion Acquisition due to market volatility which affects the liability’s present value.
−Removed: During the nine months ended September 30, 2023, we recognized contingent consideration charges (gains), restructuring charges and other of $1.2 million in gains.
−Removed: These gains were primarily due to adjustments to long-term forecasts which reduced the probability of meeting the sales-based contingent consideration milestones for the Flexion Acquisition by December 31, 2030, the expiration date for achieving the milestones.
−Removed: The contingent consideration gain was partially offset by a decrease in the assumed discount rate that is utilized in calculating the liability’s present value, based on a significant improvement in our incremental borrowing rate.
−Removed: Partially offsetting these gains were acquisition-related charges primarily related to vacant and underutilized Flexion leases.
−Removed: In addition, in June 2023, we implemented a restructuring plan in an effort to improve our operational efficiencies and recognized one-time employee termination benefits through a reduction of headcount.
−Removed: During the three months ended September 30, 2022, we recognized contingent consideration charges (gains), restructuring charges and other of $0.5 million in charges.
−Removed: These charges are primarily related to severance and other employee related costs, legal and other professional fees, third-party services and other one-time charges associated with the Flexion Acquisition, which were partially offset by gains from changes in the fair value of contingent consideration related to the Flexion Acquisition and MyoScience Acquisition.
−Removed: During the nine months ended September 30, 2022, we recognized contingent consideration charges (gains), restructuring charges and other of $13.2 million in gains.
−Removed: These gains were primarily driven by reductions in acquisition contingent consideration liabilities due to adjustments to near-term forecasts for the applicable period during which the Flexion contingent consideration may be achieved under the Flexion merger agreement and due to the reduced probability of meeting the MyoScience contingent consideration milestones by December 31, 2023, the expiration date for achieving those milestones .
−Removed: These gains were partially offset by severance and other employee related costs, legal and other professional fees, third-party services and other one-time charges associated with the Flexion Acquisition.
+Added: March 31, % Increase / (Decrease)
+Added: Flexion contingent consideration $ (3,806) $ 11,618 N/A
+Added: Restructuring charges 5,535 — N/A
+Added: Acquisition-related fees 174 489 (64)%
+Added: Total contingent consideration (gains) charges, restructuring charges and other $ 1,903 $ 12,107 (84)%
+Added: Total contingent consideration (gains) charges, restructuring charges and other decreased 84% in the three months ended March 31, 2024 versus 2023.
+Added: During the three months ended March 31, 2024, we recognized a contingent consideration gain of $3.8 million primarily due to an adjustment reflecting the probability of achieving the remaining Flexion regulatory milestone by December 31, 2030, the expiration date.
+Added: During the three months ended March 31, 2023, we recognized a contingent consideration charge of $11.6 million, which was due to a decrease to the assumed discount rate based on a significant improvement in our incremental borrowing rate resulting from the TLA Credit Agreement (as defined below) entered into in March 2023.
+Added: During the three months ended March 31, 2024, we recognized restructuring charges of $5.5 million related to employee termination benefits, such as the acceleration of share-based compensation, severance, and, to a lesser extent, other employment-related termination costs, as well as contract termination costs.
For more information, see Note 9, Financial Instruments and Note 14, Contingent Consideration Charges (Gains), Restructuring Charges and Other , to our condensed consolidated financial statements included herein.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 42
−Removed: Other Expense, Net
−Removed: The following table provides information regarding other expense, net during the periods indicated, including percent changes (dollar amounts in thousands):
+Added: Other Income (Expense), Net
+Added: The following table provides information regarding other income (expense), net during the periods indicated, including percent changes (dollar amounts in thousands):
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
−Removed: Interest expense $ (3,464) $ (9,856) (65)% $ (16,918) $ (28,935) (42)%
+Added: March 31, % Increase / (Decrease)
Interest income $ 3,903 $ 3,142 24%
−Removed: Loss on early extinguishment of debt — — N/A (16,926) — N/A
+Added: Interest expense (3,316) (9,589) (65)%
+Added: Loss on early extinguishment of debt — (16,926) (100)%
Other, net (159) (10) 100% +
−Removed: Total other expense, net $ (1,120) (19,220) (94)% $ (26,526) $ (38,547) (31)%
−Removed: Total other expense, net decreased 94% and 31% in the three and nine months ended September 30, 2023 versus 2022, respectively.
−Removed: The 65% and 42% decrease in interest expense during the three and nine months ended September 30, 2023, respectively, was primarily driven by entering into the TLA Term Loan (as defined below) in March 2023 in order to retire our term loan B and related credit agreement (the “TLB Term Loan”), and, to a lesser extent, the absence of our 2.375% convertible senior notes that matured in April 2022.
−Removed: Retiring our TLB Term Loan is expected to significantly further reduce our 2023 full-year interest expense as our new TLA Term Loan carries approximately $140.0 million less principal and an interest rate that is 400 basis points lower than the interest rate applicable under the retired TLB Term Loan.
−Removed: The increases in interest income in the three and nine months ended September 30, 2023 versus the comparable periods in 2022 were due to higher interest rates and overall investment balances.
−Removed: In conjunction with the entry into the TLA Credit Agreement (as defined below), we incurred a $16.9 million loss on early extinguishment of debt recognized as a result of the retirement of $287.5 million aggregate principal of our TLB Term Loan in the nine months ended September 30, 2023.
+Added: Total other income (expense), net $ 428 $ (23,383) N/A
+Added: Total other income, net was $0.4 million in the three months ended March 31, 2024.
+Added: Total other expense, net was $23.4 million in the three months ended March 31, 2023.
+Added: The 24% increase in interest income in the three months ended March 31, 2024 versus 2023 was due to higher interest rates and overall investment balances.
+Added: The 65% decrease in interest expense during the three months ended March 31, 2024 versus 2023 was primarily driven by lower principal outstanding associated with the TLA Term Loan (as defined below) that was entered into on March 31, 2023 which replaced our then-outstanding TLB Term Loan (as defined below) that had a higher principal balance and interest rates.
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 39
+Added: In conjunction with the entry into the TLA Credit Agreement, we incurred a $16.9 million loss on early extinguishment of debt recognized as a result of the retirement of $287.5 million aggregate principal of our TLB Term Loan (as defined below) in the three months ended March 31, 2023.
For more information, see Note 8, Debt , to our condensed consolidated financial statements included herein.
−Removed: Other, net expense during the three and nine months ended September 30, 2022 included a $10.0 million impairment related to an equity investment.
−Removed: Income Tax Expense
−Removed: The following table provides information regarding our income tax expense during the periods indicated, including percent changes (dollar amounts in thousands):
+Added: Income Tax Expense (Benefit)
+Added: The following table provides information regarding our income tax expense (benefit) during the periods indicated, including percent changes (dollar amounts in thousands):
Three Months Ended
−Removed: September 30, % Increase / (Decrease) Nine Months Ended
−Removed: September 30, % Increase / (Decrease)
−Removed: 2023 2022 2023 2022
−Removed: Income tax expense $ 5,743 $ 2,762 100% + $ 10,896 $ 5,359 100% +
+Added: March 31, % Increase / (Decrease)
+Added: Income tax expense (benefit) $ 4,661 $ (6,938) N/A
Effective tax rate 34 % 26 %
−Removed: The effective tax rates were 35% and 39% for the three and nine months ended September 30, 2023, respectively.
−Removed: The effective tax rates were 133% and 17% for the three and nine months ended September 30, 2022, respectively.
+Added: The effective tax rates were 34% and 26% for the three months ended March 31, 2024 and 2023, respectively.
Income tax expense represents the estimated annual effective tax rate applied to the year-to-date domestic operating results adjusted for certain discrete tax items.
−Removed: The effective tax rate for the three and nine months ended September 30, 2023 include costs related to non-deductible stock-based compensation and non-deductible executive compensation, partially offset by credits and a fair value adjustment for the Flexion contingent consideration.
−Removed: The effective tax rates for the three and nine months ended September 30, 2022 include costs related to non-deductible executive compensation, valuation allowances recorded against non-U.S.
−Removed: operating results and U.S.
−Removed: capital losses, partially offset by benefits for a first quarter milestone payment to SkyePharma Holding, Inc.
−Removed: (now a subsidiary of Vectura Group plc),
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 43
−Removed: or Skyepharma, a fair value adjustment for Flexion contingent consideration and the impact of stock-based compensation adjustments.
+Added: The effective tax rate for the three months ended March 31, 2024 include costs related to non-deductible stock-based compensation and non-deductible executive compensation, partially offset by tax credits and a fair value adjustment for the Flexion contingent consideration.
+Added: The effective tax rate for the three months ended March 31, 2023 includes costs for a fair value adjustment to Flexion contingent consideration, and a valuation allowance recorded against non-U.S.
+Added: results, offset by tax credits and stock-based compensation benefits.
Liquidity and Capital Resources
3 unchanged sentences
We have financed our operations primarily with the proceeds from the sale of convertible senior notes and other debt, common stock, product sales and collaborative licensing and milestone revenue.
−Removed: As of September 30, 2023, we had an accumulated deficit of $131.7 million, cash and cash equivalents and available-for-sale investments of $235.2 million and working capital of $353.6 million.
−Removed: We expect that our cash and available-for-sale investments on hand will be adequate to cover our short-term liquidity needs, and that we would be able to access other sources of financing should the need arise.
+Added: As of March 31, 2024, we had an accumulated deficit of $97.8 million, cash and cash equivalents and available-for-sale investments of $325.9 million and working capital of $449.7 million.
+Added: We expect that our cash and cash equivalents and available-for-sale investments on hand will be adequate to cover our short-term liquidity needs, and that we would be able to access other sources of financing should the need arise.
Summary of Cash Flows
The following table summarizes our cash flows from operating, investing and financing activities for the periods indicated (in thousands):
−Removed: Nine Months Ended
−Removed: September 30,
+Added: Three Months Ended
Condensed Consolidated Statements of Cash Flows Data:
3 unchanged sentences
Financing activities (2,817) (153,905)
−Removed: Net decrease in cash and cash equivalents $ (5,020) $ (476,154)
+Added: Net increase (decrease) in cash and cash equivalents $ 30,754 $ (68,594)
Operating Activities
−Removed: During the nine months ended September 30, 2023, net cash provided by operating activities was $107.1 million, compared to $103.2 million during the nine months ended September 30, 2022.
−Removed: The increase of $3.8 million was attributable to increased interest income and lower interest expense, partially offset by the payment of a $13.0 million termination fee relating to a licensing agreement.
−Removed: Investing Activities
−Removed: During the nine months ended September 30, 2023, net cash provided by investing activities was $69.2 million, which reflected proceeds from $89.3 million of available-for-sale investment sales (net of purchases), partially offset by purchases of fixed assets of $13.4 million for fill lines for our products and equipment for an EXPAREL capacity expansion project at our Science Center Campus in San Diego, California and purchases of equity and debt investments of $6.8 million.
−Removed: During the nine months ended September 30, 2022, net cash used in investing activities was $236.4 million, which reflected $166.8 million of available-for-sale investment purchases (net of maturities), a $32.0 million contingent consideration milestone payment that had been achieved in the fourth quarter of 2021 associated with our 2007 acquisition of Pacira Pharmaceuticals, Inc.
−Removed: from Skyepharma, purchases of fixed assets of $24.6 million for fill lines for our products and equipment for an EXPAREL capacity expansion project at our Science Center Campus in San Diego, California and purchases of equity and debt investments of $13.0 million.
−Removed: Financing Activities
−Removed: During the nine months ended September 30, 2023, net cash used in financing activities was $181.3 million, which consisted of a $296.9 million repayment of TLB Term Loan principal as well as a $5.8 million prepayment penalty in connection with the retirement of the TLB Term Loan facility and $30.6 million repayments of TLA Term Loan principal, partially offset by the net proceeds from the TLA Term Loan of $149.6 million, proceeds from the exercise of stock options of $1.9 million and $1.7 million from the issuance of common stock through our ESPP.
−Removed: See Note 8, Debt , to our condensed consolidated financial statements included herein for further discussion on the TLA Term Loan and TLB Term Loan.
+Added: During the three months ended March 31, 2024, net cash provided by operating activities was $49.1 million, compared to $19.1 million during the three months ended March 31, 2023.
+Added: The increase of $30.0 million was attributable to increased revenue, lower interest paid and a $13.0 million payment made in the prior year for a termination fee relating to a licensing agreement.
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 40
−Removed: During the nine months ended September 30, 2022, net cash used in financing activities was $343.0 million, which primarily consisted of a $192.6 million principal repayment of the 3.375% convertible senior notes due 2024 (the “Flexion 2024 Notes”) as part of a repurchase offer to the holders of the Flexion 2024 Notes that was triggered by the Flexion Acquisition, $157.0 million to settle the 2022 Notes that matured on April 1, 2022 and $18.8 million of scheduled repayments of Term Loan principal, partially offset by $23.5 million of proceeds from the exercise of stock options and $1.8 million from the issuance of common stock through our ESPP.
+Added: Investing Activities
+Added: During the three months ended March 31, 2024, net cash used in investing activities was $15.5 million, which reflected $12.7 million of outflows from available-for-sale investment purchases (net of sales), as well as $2.8 million of capital expenditures for manufacturing product fill lines and for an EXPAREL capacity expansion project at our Science Center Campus in San Diego, California.
+Added: During the three months ended March 31, 2023, net cash provided by investing activities was $66.2 million, which reflected proceeds from $76.7 million of available-for-sale investment sales (net of purchases), partially offset by purchases of fixed assets of $6.6 million for fill lines for our products and equipment for an EXPAREL capacity expansion project at our Science Center Campus in San Diego, California and purchases of equity and debt investments of $4.0 million.
+Added: Financing Activities
+Added: During the three months ended March 31, 2024, net cash used in financing activities was $2.8 million for a voluntary prepayment of TLA Term Loan principal.
+Added: See Note 8, Debt , to our condensed consolidated financial statements included herein for further discussion on the TLA Term Loan.
+Added: During the three months ended March 31, 2023, net cash used in financing activities was $153.9 million, which primarily consisted of a $296.9 million repayment of TLB Term Loan principal as well as a $5.8 million prepayment penalty, partially offset by the net proceeds from the TLA Term Loan of $149.6 million.
2028 Term Loan A Facility
4 unchanged sentences
Each term loan borrowing which is a term benchmark borrowing or daily simple SOFR borrowing bears interest at a rate per annum equal to (i) the Adjusted Term SOFR Rate or Adjusted Daily Simple SOFR (as each is defined in the TLA Credit Agreement), plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 3.00% to 3.75%.
−Removed: During the nine months ended September 30, 2023, we made a scheduled principal payment of $2.8 million as well as $27.8 million of voluntary principal prepayments.
−Removed: Due to voluntary principal prepayments of $27.8 million made during the three months ended September 30, 2023, we are not required to make further principal payments for the remainder of 2023 and 2024.
−Removed: As of September 30, 2023, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 8.47%.
+Added: During the three months ended March 31, 2024, we made a voluntary principal prepayment of $2.8 million.
+Added: Due to voluntary principal prepayments made, we are not required to make further principal payments for the year ended December 31, 2024, although we retain the option to do so.
+Added: As of March 31, 2024, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 8.41%.
The TLA Credit Agreement requires us to, among other things, maintain (i) a Senior Secured Net Leverage Ratio (as defined in the Credit Agreement), determined as of the last day of each fiscal quarter, of no greater than 3.00 to 1.00 and (ii) a Fixed Charge Coverage Ratio (as defined in the TLA Credit Agreement), determined as of the last day of each fiscal quarter, of no less than 1.50 to 1.00.
+Added: The TLA Credit Agreement requires us to maintain an unrestricted cash and cash equivalents balance of at least $500.0 million less any prepayments of the 2025 Notes (as defined below) at any time from 91 days prior to the maturity date through the earlier of (i) the latest maturity date of the 2025 Notes and (ii) the date on which there is no outstanding principal amount of the 2025 Notes, which we expect to accomplish.
The TLA Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions.
−Removed: As of September 30, 2023, we were in compliance with all financial covenants under the TLA Credit Agreement.
−Removed: See Note 8, Debt , to our condensed consolidated financial statements included herein for further discussion.
−Removed: 2026 Term Loan B Facility
−Removed: In December 2021, we entered into the $375.0 million TLB Term Loan which was secured by substantially all of our and any subsidiary guarantor’s assets and was scheduled to mature on December 7, 2026, subject to certain exceptions set forth in the TLB Credit Agreement.
−Removed: On March 31, 2023, we used the $149.6 million of net borrowings under the TLA Credit Agreement and cash on hand to repay the indebtedness outstanding under the TLB Credit Agreement and concurrently terminated the TLB Credit Agreement.
−Removed: We incurred a prepayment fee of 2.00% of the outstanding principal balance of the TLB Term Loan in connection with the termination.
−Removed: During the nine months ended September 30, 2023, we made a scheduled principal payment of $9.4 million and repaid the outstanding $287.5 million principal on the TLB Term Loan, which resulted in a $16.9 million loss on early extinguishment of debt.
+Added: As of March 31, 2024, we were in compliance with all financial covenants under the TLA Credit Agreement.
See Note 8, Debt , to our condensed consolidated financial statements included herein for further discussion.
3 unchanged sentences
The 2025 Notes mature on August 1, 2025.
−Removed: At September 30, 2023, the outstanding principal on the 2025 Notes was $402.5 million.
+Added: At March 31, 2024, the outstanding principal on the 2025 Notes was $402.5 million.
See Note 8, Debt , to our condensed consolidated financial statements included herein for further discussion.
−Removed: 2024 Convertible Senior Notes
−Removed: In November 2021, as part of the Flexion Acquisition, we assumed $201.3 million in aggregate principal amount of the Flexion 2024 Notes.
−Removed: The Flexion 2024 Notes have a maturity date of May 1, 2024, are unsecured, and accrue interest at a rate
Pacira BioSciences, Inc.
| Q1 2024 Form 10-Q | Page 41
−Removed: of 3.375% per annum, payable semi-annually on May 1 st and November 1 st of each year.
−Removed: In January 2022, we repurchased $192.6 million aggregate principal amount of the Flexion 2024 Notes.
−Removed: At September 30, 2023, the outstanding principal on the Flexion 2024 Notes was $8.6 million.
−Removed: See Note 8, Debt , to our condensed consolidated financial statements included herein for further discussion.
Future Capital Requirements
−Removed: We believe that our existing cash and cash equivalents, available-for-sale investments and cash received from product sales will be sufficient to enable us to fund our operating expenses, capital expenditure requirements and payment of the interest and principal on our TLA Term Loan, Flexion 2024 Notes and 2025 Notes (collectively, the “Notes”) through the next 12 months.
+Added: We believe that our existing cash and cash equivalents, available-for-sale investments and cash received from product sales will be sufficient to enable us to fund our operating expenses, capital expenditure requirements and payment of the interest and principal on our TLA Term Loan and 2025 Notes through the next 12 months.
Our future use of operating cash and capital requirements will depend on many forward-looking factors, including, but not limited to:
1 unchanged sentence
See Note 9, Financial Instruments , to our condensed consolidated financial statements included herein for more information;
−Removed: • the cost and timing of potential remaining milestone payments to former MyoScience security holders, which could be up to an aggregate of $43.0 million if certain regulatory and commercial milestones are met.
−Removed: See Note 9, Financial Instruments , to our condensed consolidated financial statements included herein for more information;
−Removed: • the impact of global economic conditions—including the impact of inflation—on our product and material costs, supply chain, longer lead-times, an inability to secure a sufficient supply of materials, our operating expenses and our business strategy;
+Added: • the impact of global economic conditions—including the impact of inflation—on our product, material and labor costs, supply chain, longer lead-times, an inability to secure a sufficient supply of materials, our operating expenses and our business strategy;
• the timing of and extent to which the holders of our 2025 Notes elect to convert their 2025 Notes, the timing of principal and interest payments on our TLA Term Loan and the timing and impact of increases to the variable interest rate on our TLA Term Loan borrowings in accordance with the terms of the TLA Credit Agreement;
−Removed: • the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°, including markets outside of the U.S.;
−Removed: • the cost and timing of expanding and maintaining our manufacturing facilities, including the current EXPAREL capacity expansion project at our Science Center Campus in San Diego, California (for which a prior approval supplement was submitted to the FDA in October 2023 with an anticipated PDUFA action date in February 2024) and capital projects at the Thermo Fisher site in Swindon, England;
+Added: • the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°;
+Added: • the cost and timing of expanding and maintaining our manufacturing facilities;
• the cost and timing of additional strategic investments, including additional investments under existing agreements;
10 unchanged sentences
There have been no significant changes to our critical accounting policies nor any recently issued accounting pronouncements that are expected to have a material impact on our financial results since December 31, 2023.
−Removed: Pacira BioSciences, Inc.
−Removed: | Q3 2023 Form 10-Q | Page 46
Contractual Obligations
−Removed: Except for entry into the new TLA Credit Agreement and termination of the TLB Credit Agreement as described in Note 8, Debt , to our condensed consolidated financial statements included herein, there have been no material changes in our contractual obligations relating to our indebtedness, lease obligations and purchase obligations from those reported in our 2022 Annual Report.
+Added: There have been no material changes in our contractual obligations relating to our indebtedness, lease obligations and purchase obligations from those reported in our 2023 Annual Report.
For more information on our contractual obligations and commercial commitments, see Part II, Item 7 in our 2023 Annual Report .
+Added: Pacira BioSciences, Inc.
+Added: | Q1 2024 Form 10-Q | Page 42
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.