11 unchanged sentences
The foregoing reference to our corporate website is not intended to, nor shall it be deemed to, incorporate information on our corporate website into this Annual Report by reference, and the inclusion of our website address in this Annual Report is an inactive textual reference only and is not intended to be an active link to our corporate website.
−Removed: Pacira is the industry leader in our commitment to non-opioid pain management and providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only.
+Added: As the therapeutic area leader in non-opioid pain management, our stated corporate mission is providing non-opioid pain management options to as many patients as possible and redefining the role of opioids for rescue therapy only.
We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.
−Removed: Our long-acting, local analgesic EXPAREL ® (bupivacaine liposome injectable suspension) was commercially launched in April 2012.
−Removed: EXPAREL 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: 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.
+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.
2 unchanged sentences
With the acquisition of Flexion Therapeutics, Inc.
−Removed: (the “Flexion Acquisition”) in November 2021, we acquired ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular therapy that can provide major relief for OA knee pain for three months and has the potential to become an alternative to hyaluronic acid, or HA, and platelet rich plasma, or PRP, injections or other early intervention treatments.
+Added: 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 OA knee pain for three months and has the potential to become an alternative to hyaluronic acid, or HA, and platelet rich plasma, or PRP, injections or other early intervention treatments.
With the acquisition of MyoScience, Inc.
−Removed: (the “MyoScience Acquisition” ) in April 2019, 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.
+Added: 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.
EXPAREL, ZILRETTA and the iovera° system are highly complementary products as long-acting, non-opioid therapies that alleviate pain.
8 unchanged sentences
| 2023 Form 10-K | Page 73
−Removed: Tab le of Contents
−Removed: Flexion Acquisition
−Removed: In November 2021, we completed the Flexion Acquisition pursuant to the Flexion Merger Agreement, under which Flexion became our wholly owned subsidiary and added ZILRETTA, a non-opioid corticosteroid that employs a proprietary microsphere technology to provide extended pain relief, to our commercial offering.
−Removed: The addition of ZILRETTA to our innovative non-opioid product portfolio directly aligns with our mission to provide an opioid alternative to as many patients as possible and address medical needs along the neural pain pathway.
−Removed: The total consideration of $578.8 million included an initial payment of $428.3 million which represented $8.50 in cash per share of Flexion common stock, $20.2 million paid to settle restricted stock units and in-the-money stock options, an $85.1 million cash payment of Flexion debt not assumed by us and $45.2 million in contingent consideration representing the fair value of contingent value rights, or CVRs, that were issued in conjunction with the Flexion Acquisition.
−Removed: The Flexion Merger Agreement provided for one non-tradeable CVR per share of Flexion common stock as well as one CVR per share for certain Flexion equity awards.
−Removed: Each CVR entitles Flexion shareholders to contingent milestone payments of up to an aggregate of $8.00 in cash per share of Flexion common stock if certain milestones are met on or prior to December 31, 2030.
−Removed: At the date of the Flexion Acquisition, we estimated that up to an additional $380.2 million in the aggregate may be payable to holders of the CVRs if each of the applicable milestones are achieved.
−Removed: The fair value of the contingent consideration related to the Flexion Acquisition is revalued each reporting period if and until the related contingencies are resolved.
−Removed: For more information, see Note 5, Flexion Acquisition , to our consolidated financial statements included herein.
+Added: Table of Content s
Recent Highlights
−Removed: • In January 2023, we submitted our sNDA to the FDA seeking expansion of the EXPAREL label to include sciatic nerve blocks in the popliteal fossa and femoral nerve blocks in the adductor canal, with an anticipated FDA action date under the Prescription Drug User Fee Act in the second half of 2023.
−Removed: The sNDA is supported by two successful Phase 3 studies in which EXPAREL achieved statistically significant reductions in postsurgical pain control and opioid consumption through 96 hours compared with bupivacaine HCl.
−Removed: • In January 2023, we opened our second Innovation and Training Center in Houston.
−Removed: This state-of-the-art facility features a 125-seat adaptive lecture hall, broadcast studio and both wet and dry lab space for cadaver and other interactive workshops, as well as advanced ultrasound machines equipped with artificial intelligence training software.
−Removed: This training center is core to developing physician thought leaders and community-based clinicians wanting to stay at the forefront of opioid-sparing pain management.
−Removed: • In November 2022, both the EMA’s CHMP and the MHRA approved marketing authorization for an expanded indication of EXPAREL to include use in children aged 6 years and older as a field block for the treatment of somatic post-operative pain from small- to medium-sized surgical wounds.
−Removed: The approval was based on the results of our Phase 3 PLAY study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries.
−Removed: Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg.
−Removed: The EMA’s approval is applicable to all 27 E.U.
−Removed: member states plus Iceland, Norway and Liechtenstein, and the MHRA’s approval is applicable in the U.K.
−Removed: EXPAREL was initially approved by the EC and in the U.K.
−Removed: in November 2020 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.
−Removed: • In October 2022, the USPTO issued patent number 11,452,691.
−Removed: This patent is a chemical composition patent, with an expiration date of January 22, 2041.
−Removed: This patent is now listed in the FDA’s Orange Book and is the eighth listed patent.
−Removed: The company also received a Notice of Allowance from the USPTO for a U.S.
−Removed: Patent Application that is a product by process patent for EXPAREL.
−Removed: After issuance, Pacira will submit this patent for listing in the Orange Book.
−Removed: Coronavirus (COVID-19) Pandemic and Global Economic Conditions
−Removed: Since early 2020, our revenues and supply chain have been impacted by COVID-19 pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives.
−Removed: While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and therapeutics, as well as the lessening of elective surgery restrictions, certain pandemic-related operational and staffing challenges persist.
−Removed: It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.
−Removed: Direct and indirect effects of the pandemic and global economic conditions have and may continue to negatively impact our business, financial condition and results of operations.
−Removed: Such impacts may include the effect of prolonged periods of inflation and rising interest rates on our
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 71
−Removed: Tab le of Contents
−Removed: customers and suppliers and longer lead-times or the inability to secure a sufficient supply of materials.
−Removed: The situation remains dynamic and subject to rapid and possibly material changes.
+Added: • In December 2023, our Board of Directors appointed Frank D.
+Added: Lee as Chief Executive Officer and a member of the Board.
+Added: Lee brings more than three decades of global experience and a strong track record of product development and commercial leadership success across a wide range of therapeutic areas within the biotech and pharmaceutical industry.
+Added: Most recently he served as Chief Executive Officer and member of the board of directors of Forma Therapeutics, Inc., or Forma, from March 2019 through its acquisition by Novo Nordisk A/S in October 2022.
+Added: During his tenure at Forma, Mr.
+Added: Lee transformed the company from an early-stage drug discovery company into one focused on the clinical development of lead assets in rare hematologic disorders and cancer.
+Added: Prior to Forma, Mr.
+Added: Lee spent 13 years at Genentech, Inc.—a member of the F.
+Added: Hoffmann-La Roche AG—in a series of leadership positions of increasing scope and responsibility for delivering transformative medicines to patients.
+Added: • In November 2023, the FDA approved our sNDA to expand the EXPAREL label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
+Added: The approval is supported by two successful randomized, double-blind, active-controlled, multicenter Phase 3 studies designed to evaluate the efficacy, safety, and pharmacokinetics of EXPAREL versus bupivacaine HCl.
+Added: One study evaluated EXPAREL as a single-dose adductor canal block and the second study evaluated EXPAREL as a single-dose sciatic nerve block in the popliteal fossa.
+Added: Both studies met their primary endpoints by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.01).
+Added: Additionally, EXPAREL achieved statistical significance for the studies’ secondary endpoint of reduced postsurgical opioid consumption (p<0.01).
+Added: EXPAREL as a sciatic nerve block in the popliteal fossa also achieved statistical significance for the percentage of opioid-free subjects (p<0.01).
+Added: In both studies, EXPAREL maintained a safety profile consistent with bupivacaine HCl.
+Added: The data from the Phase 3 study supporting the indication for a single-dose sciatic nerve block in the popliteal fossa was published in the Journal of Clinical Anesthesia in February 2024.
+Added: • In November 2023, the USPTO issued Patent Nos.
+Added: 11,819,574 and 11,819,575, claiming composition of EXPAREL prepared by an enhanced manufacturing process and composition of matter for EXPAREL, respectively.
+Added: Each of these EXPAREL patents are listed in the FDA’s “ Approved Drug Products with Therapeutic Equivalence Evaluations ” (the “Orange Book”).
+Added: These two patents are among the ten Orange Book listed patents that are now listed for EXPAREL, all with an expiration date of January 22, 2041.
+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 will help drive a more favorable mix of commercial product sold and benefit EXPAREL gross margins over time.
+Added: • In February 2024, we announced that we were awarded a national group purchasing agreement for Brand Pharmaceuticals with Premier.
+Added: Effective January 1, 2024, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for EXPAREL.
+Added: This collaboration is aimed at improving patient care and optimizing cost savings to healthcare organizations and will allow Premier members to access EXPAREL.
+Added: Global Economic Conditions and Inflation
+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 our patients to defer or cancel medical procedures, thereby adversely impacting our revenues;
+Added: and negatively impact our suppliers which could cause 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.
The nature and extent of such impacts will depend on future developments, which are highly uncertain and cannot be predicted.
−Removed: We continue to actively monitor the situation and will implement measures recommended by federal, state or local authorities, or that we determine are in the best interests of our patients, employees, partners, suppliers, shareholders and stakeholders.
−Removed: For a description of risks facing the Company that relate to the COVID-19 pandemic or any other future pandemic, epidemic or outbreak of contagious disease, see Item 1A .
−Removed: “ Risk Factors ” in this Annual Report.
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 74
Results of Operations
2 unchanged sentences
(ii) ZILRETTA in the U.S.;
−Removed: (iii) iovera° in the U.S., Canada and the E.U.;
−Removed: (iv) sales of, and royalties on, our bupivacaine liposome injectable suspension primarily for veterinary use and (v) license fees and milestone payments.
+Added: (iii) iovera° in the U.S., Canada and Europe and (iv) sales of, and royalties on, our bupivacaine liposome injectable suspension for veterinary use.
The following table provides information regarding our revenues during the years indicated, including percent changes (dollar amounts in thousands):
2 unchanged sentences
EXPAREL $ 538,120 $ 536,899 0%
−Removed: 105,517 12,683 100% +
+Added: ZILRETTA 111,098 105,517 5%
iovera° 19,685 15,258 29%
2 unchanged sentences
Royalty revenue 2,733 2,673 2%
−Removed: Collaborative licensing and milestone revenue — 125 (100)%
Total revenues $ 674,978 $ 666,823 1%
−Removed: (1) ZILRETTA net product sales for the year ended December 31, 2021 were attributable to the period beginning November 19, 2021, the date of the Flexion Acquisition.
−Removed: EXPAREL net product sales increased 6% in 2022 compared to 2021, primarily due to increases of 5.5% in gross vial volume and increases of 3.6% in gross selling price per unit, partially offset by the sales mix of EXPAREL vial sizes and higher gross to net adjustments primarily due to our participation in 340B drug pricing and other strategic partnerships.
−Removed: Although the demand for EXPAREL has continued to increase primarily as a result of ASCs and anesthesiologists broadening the use of long-acting EXPAREL regional approaches as a foundation of multimodal opioid-minimization strategies that enable shifting inpatient procedures to 23-hour sites of care, the elective surgery market has faced post-pandemic-related challenges due to regional surges in COVID-19 variant cases, staffing shortages and fatigue from care teams and economic and inflationary pressures on consumer confidence.
−Removed: EXPAREL utilization remains above the overall sharp decline in elective surgical procedures relative to pre-pandemic baseline levels due to increased utilization in outpatient settings and emergent procedures.
−Removed: As a result of the Flexion Acquisition in November 2021, we acquired ZILRETTA.
−Removed: We recognized net product sales of $105.5 million and $12.7 million for the years ended December 31, 2022 and 2021, respectively.
−Removed: Net product sales during the year ended December 31, 2021 were attributable to the period beginning on November 19, 2021, the closing date of the Flexion Acquisition.
−Removed: Net product sales of iovera° decreased 6% in 2022 versus 2021 primarily due to a delay in the transition from generation 1 to generation 2 iovera° products and short-term variations in reimbursement policies in certain territories.
−Removed: We have seen the greatest iovera° demand as a pain relief for patients in advance of TKA procedures and in chronic pain management, particularly for people with mild to severe OA of the knee.
−Removed: Bupivacaine liposome injectable suspension revenue increased 80% in 2022 versus 2021, and its related royalties increased 9%, primarily due to the sales mix of vial sizes of orders placed for veterinary use.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 72
−Removed: Tab le of Contents
−Removed: Any renewed government suspension of or reluctance of patients to have elective procedures would impact our future sales of EXPAREL, ZILRETTA and iovera° during the lingering effects and uncertainty surrounding the ongoing COVID-19 pandemic and the impact of economic conditions including inflation on consumers' healthcare choices.
+Added: EXPAREL revenue remained flat in 2023 compared to 2022, primarily due to an increase in gross vial volume of 4% versus 2022 and reduced by 1% due to a shift in sales mix.
+Added: EXPAREL revenue was also impacted by a decrease of 3% in net selling price per unit related to enrolling EXPAREL in the 340B drug pricing program and expanding other contracting activities, partially offset by a January 2023 price increase.
+Added: ZILRETTA revenue increased 5% in 2023 compared to 2022, primarily due to an increase of 3% in kit volume and 2% in selling price per unit, net of customer discounting due to expanded contracting efforts.
+Added: Net product sales of iovera° increased 29% in 2023 versus 2022 primarily due to a 33% increase in Smart Tip volume and a 1% increase in selling price per Smart Tip.
+Added: Bupivacaine liposome injectable suspension revenue decreased 48% in 2023 versus 2022, and its related royalties increased 2%, primarily due to the sales mix of vial sizes and the timing of orders placed for veterinary use.
Cost of Goods Sold
5 unchanged sentences
Gross margin 73% 70%
−Removed: Gross margin decreased four percentage points in 2022 as compared to 2021 due to higher inventory reserves, accelerated depreciation for certain machinery and equipment for which no future economic benefit was identified and the ZILRETTA step-up of fixed assets and inventory to fair value in accordance with purchase accounting, partially offset by unplanned downtime in the prior period.
+Added: Gross margin increased three percentage points in 2023 as compared to 2022 mainly due to lower inventory reserves, accelerated depreciation recorded in 2022 for certain machinery and equipment and lower royalty expense as discussed below, partially offset by a lower net selling price for EXPAREL largely as a result of enrolling in the 340B drug pricing program.
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 75
+Added: Table of Content s
+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.
+Added: For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
Research and Development Expenses
1 unchanged sentence
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.
−Removed: Regulatory and other expenses include regulatory activities related to unapproved products and indications, medical information expenses and related personnel.
+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.
+Added: 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.
7 unchanged sentences
% of total revenue 11% 13%
−Removed: Total research and development expense increased 53% in 2022 as compared to 2021.
−Removed: Clinical and preclinical development expense increased 89% in 2022 versus 2021 due to ongoing expenses and completion of two EXPAREL lower extremity nerve block trials in bunionectomy and TKA, ongoing trials for the product candidates acquired as part of the Flexion Acquisition and toxicology studies for product development candidates.
−Removed: The prior year was affected by clinical trial delays related to the COVID-19 pandemic, whereas the current year included an expanded product candidate pipeline internally and as a result of the Flexion Acquisition, including ongoing expenses for PCRX-201, an IA gene therapy candidate for OA.
−Removed: Product development and manufacturing capacity expansion expense increased 27% in 2022 versus 2021 mainly attributable to the significant scale-up of our EXPAREL manufacturing capacity at our Science Center Campus in San Diego, California.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 73
−Removed: Tab le of Contents
−Removed: Regulatory and other expenses increased 21% in 2022 versus 2021 in support of the E.U.
−Removed: EXPAREL pediatric submission and in the U.S., the sNDA for lower extremity nerve block, which we submitted to the FDA in January 2023 seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal and sciatic nerve block in the popliteal fossa.
−Removed: Stock-based compensation increased 21% in 2022 versus 2021 primarily due to an increase in the amount of equity awards outstanding for research and development personnel.
−Removed: We expect that research and development costs for 2023 will be modestly lower than 2022, with a focus on ZILRETTA, iovera°, PCRX-201 and PCRX-401.
−Removed: We believe ZILRETTA’s extended-release profile may provide effective treatment for OA pain of the shoulder and intend to initiate a Phase 3 trial investigating ZILRETTA in shoulder OA.
−Removed: We also intend to initiate an OA Knee safety study of ZILRETTA in patients with Type 2 diabetes and a Phase 3 trial investigating iovera° in patients with spasticity, as well as plan to submit an IND application for PCRX-401 to initiate a Phase 1 trial for low back pain.
+Added: Total research and development expense decreased 10% in 2023 as compared to 2022.
+Added: Clinical and preclinical development expense decreased 46% in 2023 versus 2022 due to the completion of two EXPAREL lower extremity nerve block trials in bunionectomy and TKA in the third quarter of 2022 and toxicology studies that are near completion for product candidates, partially offset by start-up costs for the EXPAREL intrathecal, ZILRETTA shoulder and iovera° spasticity trials.
+Added: Product development and manufacturing capacity expansion expense increased 35% in 2023 versus 2022, primarily attributable to new product development costs related to PCRX-201 and the continued significant scale-up activities of our EXPAREL manufacturing capacity at our Science Center Campus in San Diego, California, for which an sNDA for a 200-liter EXPAREL manufacturing suite was approved by the FDA in February 2024.
+Added: Regulatory and other research and development expenses increased 22% in 2023 versus 2022 due to increased enrollment and additional sites related to an observational registry study designed to assess clinical and patient reported outcomes in patients with pain associated with OA and TKA and increased medical information publications.
+Added: Stock-based compensation increased 32% in 2023 versus 2022 primarily due to the acceleration of stock compensation awards related to a terminated executive in 2023.
Selling, General and Administrative Expenses
1 unchanged sentence
General and administrative expenses consist of compensation and benefits for legal, finance, regulatory activities related to approved products and indications, compliance, information technology, human resources, business development, executive management and other supporting personnel.
−Removed: It also includes professional fees for legal, audit, tax and consulting services.
+Added: It also includes professional fees for legal, audit,
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 76
+Added: Table of Content s
+Added: tax and consulting services.
Stock-based compensation expense relates to the costs of stock option grants, RSU awards and our ESPP.
6 unchanged sentences
% of total revenue 40% 38%
−Removed: Total selling, general and administrative expenses increased 28% in 2022 as compared 2021.
−Removed: Sales and marketing expense increased 31% in 2022 versus 2021, driven by a sales force expansion supporting both ZILRETTA and iovera° following the completion of the Flexion Acquisition in November 2021 and fully staffing a contracted sales force in Europe for EXPAREL.
−Removed: Increases also included expenses for patient reimbursement support for ZILRETTA.
−Removed: We are continuing our marketing investment in our products, which includes 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: Additionally, we continued our investment in clinician training in the use of EXPAREL and iovera° at our PIT of Tampa.
−Removed: The addition of ZILRETTA to our commercial portfolio provides clinicians with two unique OA treatment options to individualize patient care.
−Removed: General and administrative expense increased 29% in 2022 versus 2021, driven by administrative support costs as a result of the Flexion Acquisition in November 2021, including transition expenses during integration, legal costs including intellectual property protection and additional support for our expansion into European markets.
−Removed: Stock-based compensation increased 15% in 2022 versus 2021, primarily due to the number of equity awards outstanding for selling, general and administrative personnel and accelerated stock-based compensation expense.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 74
−Removed: Tab le of Contents
+Added: Total selling, general and administrative expenses increased 6% in 2023 as compared to 2022.
+Added: Sales and marketing expense increased 6% in 2023 compared to 2022, driven by an increase in marketing investments in our products, including marketing EXPAREL’s newly approved indication for use as a lower extremity nerve block, 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.
+Added: In 2023, we 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.
+Added: We 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 our second training facility in Houston, Texas in January 2023.
+Added: We also committed to a grant to the American Society of Anesthesiologists’ Charitable Foundation to advance the medical specialty of anesthesiology and pain medicine, facilitate best in-class clinician education and improve patient care.
+Added: In 2024, we expect to make further investments in our marketing strategy, particularly in preparation for the commencement of the NOPAIN Act, which will take effect beginning on January 1, 2025.
+Added: These investments include programs to drive awareness and education for our customers and enhance our marketing, market access and reimbursement teams.
+Added: General and administrative expense increased 12% in 2023 versus 2022 primarily driven by legal fees attributable to ongoing litigation—for more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
+Added: Stock-based compensation decreased 5% in 2023 versus 2022 primarily due to the acceleration of stock compensation awards related to terminated executives in the prior year.
Amortization of Acquired Intangible Assets
2 unchanged sentences
Amortization of acquired intangible assets $ 57,288 $ 57,288 —%
−Removed: Amortization of acquired intangible assets increased substantially in 2022 versus 2021 due to 2022 being the first full year after the completion of the Flexion Acquisition.
−Removed: We acquired a developed technology intangible asset for ZILRETTA for OA knee pain, which is being amortized over a useful life of approximately ten years.
−Removed: For more information, see Note 5, Flexion Acquisition, to our consolidated financial statements included herein.
−Removed: Acquisition-Related Charges (Gains), Impairment and Other
−Removed: The following table provides a summary of the costs related to the Flexion Acquisition, MyoScience Acquisition, commercial agreements, termination costs and other activities during the years indicated, including percent changes (dollar amounts in thousands):
+Added: As part of the Flexion Acquisition and the MyoScience Acquisition, we acquired intangible assets consisting of developed technology intangible assets and customer relationships, with estimated useful lives between 9 and 14 years.
+Added: For more information, see Note 5, Flexion Acquisition, and Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 77
+Added: Table of Content s
+Added: Contingent Consideration (Gains) Charges, Acquisition-related Charges and Other
+Added: The following table provides a summary of the costs related to contingent consideration, restructuring charges, acquisition-related charges and other activities during the years indicated, including percent changes (dollar amounts in thousands):
Year Ended December 31, % Increase / (Decrease)
−Removed: Acquisition-related (gains) charges $ (18,231) $ 39,911 N/A
−Removed: Impairment of acquired in-process research & development 26,134 — N/A
+Added: Contingent consideration gains $ (3,424) $ (29,476) (88)%
+Added: Acquisition-related charges 1,963 11,245 (83)%
+Added: Impairment of acquired in-process research & development — 26,134 (100)%
Other 1,109 3,000 (63)%
−Removed: Total acquisition-related charges (gains), impairment and other $ 10,903 $ 42,911 (75)%
−Removed: In 2022, we recognized acquisition-related gains of $18.2 million.
−Removed: These gains were primarily driven by reductions in acquisition contingent consideration liabilities due to adjustments to 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.
−Removed: For more information, see Note 12, Financial Instruments and Note 18, Acquisition-related Charges (Gains), Impairment and Other , to our consolidated financial statements included herein.
−Removed: In 2021, we recognized acquisition-related charges of $39.9 million.
−Removed: These charges were primarily driven by severance and other employee related costs, investment banking, legal and other professional fees, third-party services and other one-time charges associated with the Flexion Acquisition.
−Removed: These charges were partially offset by a gain from changes in fair value associated with the contingent consideration related to the MyoScience Acquisition.
−Removed: In 2022, we recognized an impairment of $26.1 million for an acquired in-process research and development intangible asset related to ZILRETTA for the treatment of an OA pain of the shoulder based on the amount its previous carrying value exceeded its fair value.
+Added: Total contingent consideration (gains) charges, acquisition-related charges and other $ (352) $ 10,903 N/A
+Added: In 2023, we recognized contingent consideration gains of $3.4 million due to a decrease in the fair value of the Flexion contingent consideration.
+Added: The decrease was primarily due to adjustments in the assumption for the 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.
+Added: The impact of this assumption on the fair value was partially offset by a decrease to the assumed discount rate based on a significant improvement in our incremental borrowing rate resulting from the TLA Credit Agreement entered into in March 2023.
+Added: In 2022, we recognized contingent consideration gains of $29.5 million primarily due to adjustments to near-term forecasts for the earnout period of the Flexion contingent consideration and a gain due to the reduced probability of meeting the MyoScience contingent consideration milestones by December 31, 2023—the expiration date for achieving those milestones .
+Added: For more information, see Note 12, Financial Instruments and Note 18, Contingent Consideration (Gains) Charges, Acquisition-related Charges and Other , to our consolidated financial statements included herein.
+Added: In 2023, we recognized acquisition-related charges of $2.0 million related to vacant and underutilized leases assumed as part of the Flexion Acquisition.
+Added: In 2022, we recognized acquisition-related charges of $11.2 million 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.
+Added: In 2022, we recognized an impairment of $26.1 million for an acquired in-process research and development intangible asset related to ZILRETTA for the treatment of OA pain of the shoulder based on the amount its previous carrying value exceeded its fair value.
See Note 9, Goodwill and Intangible Assets , for more information.
−Removed: In 2022, we recognized expense of $3.0 million related to the termination of a license agreement.
+Added: In 2023, we recognized other operating expenses of $1.1 million that included a restructuring plan in an effort to improve our operational efficiencies and recognized one-time employee termination benefits through a reduction of headcount.
+Added: In 2022, we recognized other operating expense of $3.0 million related to the termination of a license agreement.
See Note 20, Commitments and Contingencies , to our consolidated financial statements included herein for more information.
−Removed: In 2021, we agreed to a mutual termination of our development and commercialization agreement with Nuance Biotech Co.
−Removed: to advance the development and commercialization of EXPAREL in China due to the lack of a viable regulatory pathway that adequately safeguards our intellectual property against the risk of a generic product, that led to dissolution costs of $3.0 million.
+Added: For more information, see Note 18, Contingent Consideration (Gains) Charges, Acquisition-related Charges and Other , to our consolidated financial statements included herein.
Pacira BioSciences, Inc.
| 2023 Form 10-K | Page 78
−Removed: Tab le of Contents
+Added: Table of Content s
Other Expense, Net
3 unchanged sentences
Interest income 11,444 4,542 100% +
+Added: Loss on early extinguishment of debt (16,926) — N/A
Other, net (186) (11,288) (98)%
Total other expense, net $ (25,974) $ (46,722) (44)%
−Removed: Total other expense, net increased 39% in 2022 versus 2021.
−Removed: The 26% increase in interest expense was due to the $375.0 million Term Loan entered into in December 2021.
−Removed: This increase was partially offset by the absence of debt discount amortization associated with our convertible notes in 2022 due to adopting Accounting Standards Update, or ASU, 2020-06 in 2022, and the maturation of our 2.375% convertible senior notes due 2022, or 2022 Notes, on April 1, 2022.
−Removed: For additional information regarding the adoption of ASU 2020-06, see Note 2 , Summary of Significant Accounting Policies, to our consolidated financial statements herein.
−Removed: We made a $50.0 million principal prepayment on our Term Loan in December 2022 in addition to the quarterly required principal payments of $9.4 million and plan to make an additional prepayment in 2023.
+Added: Total other expense, net decreased 44% in 2023 versus 2022.
+Added: The 49% decrease in interest expense was primarily driven by entering into the TLA Term Loan (as defined below) in March 2023 in order to retire our term loan B facility 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.
For more information, See Note 11, Debt, to our consolidated financial statements herein.
−Removed: Interest income significantly increased in 2022 versus 2021 due to overall investment balances and higher interest rates.
+Added: Interest income significantly increased in 2023 versus 2022 due to higher interest rates and overall investment balances.
+Added: 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 2023.
+Added: For more information, See Note 11, Debt, to our consolidated financial statements herein.
Other, net expense for 2022 included a $10.0 million impairment of an equity investment.
−Removed: Other, net expense for 2021 included a realized loss on the sale of an equity investment in the amount of $2.6 million.
−Removed: Income Tax (Benefit) Expense
−Removed: The following table provides information regarding our income tax (benefit) expense during the years 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 years indicated, including percent changes (dollar amounts in thousands):
Year Ended December 31, % Increase / (Decrease)
−Removed: Income tax (benefit) expense $ (2,607) $ 14,424 N/A
+Added: Income tax expense (benefit) $ 19,746 $ (2,607) N/A
Effective tax rate 32% (20)%
−Removed: We recorded an income tax benefit of $2.6 million for the year ended December 31, 2022 and income tax expense of $14.4 million for the year ended December 31, 2021.
+Added: We recorded income tax expense of $19.7 million for the year ended December 31, 2023 and an income tax benefit of $2.6 million for the year ended December 31, 2022.
The effective tax rate of 32% for the year ended December 31, 2023 differed from the U.S.
−Removed: statutory tax rate of 21% due to non-taxable contingent consideration fair value gains, tax deductible interest for a Skyepharma milestone payment and tax credits, partially offset by valuation allowances recorded against capital loss carryforwards and non-deductible executive compensation.
+Added: statutory tax rate of 21% primarily due to non-deductible stock-based and executive compensation and non-U.S.
+Added: valuation allowances, partially offset by tax credits.
The effective tax rate of (20)% for the year ended December 31, 2022 differed from the U.S.
−Removed: statutory tax rate of 21% due to non-deductible expenses and valuation allowances recorded against capital loss carryforwards, partially offset by stock-based compensation deductions and tax credits.
+Added: statutory tax rate of 21% due to non-taxable contingent consideration fair value gains, tax deductible interest for a Skyepharma milestone payment and tax credits, partially offset by valuation allowances recorded against capital loss carryforwards and non-deductible executive compensation.
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 79
+Added: Table of Content s
Liquidity and Capital Resources
2 unchanged sentences
We are primarily dependent on the commercial success of EXPAREL and ZILRETTA.
−Removed: 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.
+Added: 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 revenue.
As of December 31, 2023, we had an accumulated deficit of $106.8 million, cash and cash equivalents and available-for-sale investments of $281.0 million and working capital of $412.6 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.
−Removed: In March 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act was signed into law in response to the COVID-19 pandemic.
−Removed: The CARES Act, among other things, allowed for certain measures to increase liquidity for businesses
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 76
−Removed: Tab le of Contents
−Removed: such as the deferral of employer payroll taxes, a tax credit for retaining employees and other provisions.
−Removed: We benefited from the provision to defer the payment of certain employer payroll taxes in the amount of $2.8 million for the year ended December 31, 2020 and remitted $1.4 million in each of December 2021 and 2022.
−Removed: We remitted an additional $0.6 million in December 2022 on behalf of the benefit Flexion received prior to our completion of the Flexion Acquisition.
+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
6 unchanged sentences
Financing activities (183,031) (401,528)
−Removed: Net (decrease) increase in cash and cash equivalents $ (481,439) $ 485,621
+Added: Net increase (decrease) in cash and cash equivalents $ 49,159 $ (481,439)
Operating Activities
In 2023, net cash provided by operating activities was $154.6 million compared to $145.3 million in 2022.
−Removed: The increase of $19.6 million was attributable to increased net product sales from both ZILRETTA—acquired as part of the Flexion Acquisition in November 2021—and EXPAREL, offset by increases in all operating expense lines to support the existing and newly acquired products and product candidates, a slightly lower gross margin and increased interest payments.
+Added: The increase of $9.4 million was attributable to an improved gross margin, increased interest income and reduced interest expense, partially offset by a $13.0 million termination fee relating to a licensing agreement and a negative impact on the changes in working capital.
Investing Activities
+Added: In 2023, net cash provided by investing activities was $77.5 million, which reflected $99.5 million of available-for-sale investment maturities (net of purchases), purchases of fixed assets of $15.2 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 debt investments of $6.8 million in external complementary development stage product candidates.
In 2022, net cash used in investing activities was $225.2 million, which reflected $150.1 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 $30.1 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 of investments in external complementary development stage product candidates.
−Removed: In 2021, net cash used in investing activities was $20.8 million, which was primarily driven by the $420.0 million cash portion of the purchase price consideration, net of cash received, associated with the Flexion Acquisition and $45.9 million of capital expenditures, largely for equipment for our new 200-liter EXPAREL capacity expansion project at our Science Center Campus in San Diego, California.
−Removed: These uses of cash were partially offset by the net sale of available-for-sale investments of $457.2 million to fund the cash portion of the purchase price consideration associated with the Flexion Acquisition.
+Added: from Skyepharma, purchases of fixed assets of $30.1 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 in external complementary development stage product candidates.
Financing Activities
−Removed: In 2022, net cash used by financing activities was $401.5 million, which consisted of a $192.6 million principal repayment of 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 $78.1 million of payments of Term Loan principal that included a principal prepayment of $50.0 million, partially offset by $24.4 million of proceeds from the exercise of stock options and $3.0 million from the issuance of common stock through our ESPP.
−Removed: In 2021, net cash provided by financing activities was $380.7 million, which consisted of net proceeds from the Term Loan of $359.2 million, the exercise of stock options of $23.8 million and $2.8 million from the issuance of shares through our ESPP.
−Removed: We also made contingent consideration payments to MyoScience securityholders, of which $5.2 million was classified as a financing activity based on the recognition at the time of the MyoScience Acquisition.
−Removed: Equity Financings
−Removed: From our inception in December 2006 through December 31, 2022, we have raised $344.5 million of net proceeds from the sale of common stock and other equity securities via public offerings.
+Added: In 2023, net cash used in financing activities was $183.0 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 $33.4 million repayments of TLA Term Loan principal, partially offset by the net proceeds from the TLA Term Loan of $149.6 million, $2.8 million from the issuance of common stock through our ESPP and proceeds from the exercise of stock options of $1.9 million.
+Added: In 2022, net cash used in financing activities was $401.5 million, which consisted of a $192.6 million principal repayment of 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 our 2.375% convertible senior notes that matured on April 1, 2022 and $78.1 million of payments of TLB Term Loan principal that included a principal prepayment of $50.0 million, partially offset by $24.4 million of proceeds from the exercise of stock options and $3.0 million from the issuance of common stock through our ESPP.
Pacira BioSciences, Inc.
| 2023 Form 10-K | Page 80
−Removed: Tab le of Contents
+Added: Table of Content s
+Added: Equity Financings
+Added: From our inception in December 2006 through December 31, 2023, we have raised $344.5 million of net proceeds from the sale of common stock and other equity securities via public offerings.
+Added: 2028 Term Loan A Facility
+Added: On March 31, 2023, we entered into a credit agreement (the “TLA Credit Agreement”) to refinance the indebtedness outstanding under our TLB Credit Agreement (as defined and discussed below).
+Added: 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 our and any subsidiary guarantor’s assets and matures on March 31, 2028.
+Added: We 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.
+Added: Each term loan borrowing which is an alternate base rate borrowing bears interest at a rate per annum equal to (i) the Alternate Base Rate (as defined in the TLA Credit Agreement), plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 2.00% to 2.75%.
+Added: 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%.
+Added: During the year ended December 31, 2023, we made a scheduled principal payment of $2.8 million as well as $30.6 million of voluntary principal prepayments.
+Added: Due to the voluntary principal prepayments made during the year ended December 31, 2023, 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 December 31, 2023, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 8.46%.
+Added: At December 31, 2023, the outstanding principal on the TLA Term Loan was $116.6 million.
+Added: The TLA Credit Agreement requires us 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 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 the Company to maintain an unrestricted cash and cash equivalents balance of at least $500.0 million less any prepayments of the 2025 Notes 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.
+Added: The TLA Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions.
+Added: As of December 31, 2023, we were in compliance with all financial covenants under the TLA Credit Agreement.
+Added: See Note 11, Debt, to our consolidated financial statements included herein for further discussion.
2026 Term Loan B Facility
−Removed: In December 2021, we entered into the $375.0 million Term Loan which is secured by substantially all of the Company’s and any subsidiary guarantor’s assets and is scheduled to mature on December 7, 2026, subject to certain exceptions set forth in the Credit Agreement.
−Removed: The Company may elect to borrow either alternate base rate borrowings or term benchmark borrowings.
−Removed: Each term loan borrowing which is an alternate base rate borrowing bears interest at a variable rate per annum equal to the Alternate Base Rate (as defined in the Credit Agreement) subject to a 1.75% floor, plus 6.00%.
−Removed: Each term loan borrowing which is a term benchmark borrowing bears interest at a variable rate per annum equal to (i) the Adjusted Term SOFR Rate (as defined in the Credit Agreement) subject to a 0.75% floor plus (ii) 7.00%.
−Removed: The Credit Agreement requires us to, among other things, maintain (i) a first lien net leverage ratio, determined as of the last day of any fiscal quarter, of no greater than 1.75 to 1.00 and (ii) liquidity, at any time, of at least $150.0 million.
−Removed: The Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions.
−Removed: As of December 31, 2022, the Company was in compliance with all financial covenants under the Credit Agreement.
−Removed: At December 31, 2022, we had $296.9 million in outstanding borrowings under the Term Loan.
−Removed: We made a $50.0 million principal prepayment on our Term Loan in December 2022 in addition to the quarterly required principal payments of $9.4 million and plan to make an additional prepayment in 2023.
−Removed: See Note 11, Debt , to our consolidated financial statements included herein for further discussion of the Term Loan.
+Added: In December 2021, we entered into the $375.0 million TLB Term Loan which was secured by substantially all of the Company’s 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.
+Added: 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.
+Added: We incurred a prepayment fee of 2.00% of the outstanding principal balance of the TLB Term Loan in connection with the termination.
+Added: During the year ended December 31, 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: See Note 11, Debt , to our consolidated financial statements included herein for further discussion of the TLB Term Loan.
2025 Convertible Senior Notes
6 unchanged sentences
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 of 3.375% per annum, payable semi-annually on May 1 and November 1 of each year.
+Added: The Flexion 2024 Notes have a maturity date of May 1, 2024, are unsecured, and accrue interest at a rate
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 81
+Added: Table of Content s
+Added: of 3.375% per annum, payable semi-annually on May 1 and November 1 of each year.
In January 2022, we repurchased $192.6 million aggregate principal amount of the Flexion 2024 Notes.
2 unchanged sentences
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 Term Loan and our Notes, and any conversions of our Notes through the next 12 months.
−Removed: Our future use of operating cash and capital requirements will depend on many forward-looking factors, including, but not limited to, the following:
−Removed: • the cost and timing of the potential Flexion milestone payments in connection with the Flexion Acquisition, which could be up to an aggregate of $372.3 million if certain regulatory and commercial milestones are met.
−Removed: The aggregate amount was previously $425.5 million prior to our September 2022 decision to formally discontinue further development of PCRX-301.
+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, Flexion 2024 Notes and 2025 Notes (collectively, the “Notes”) through the next 12 months.
+Added: Our future use of operating cash and capital requirements will depend on many forward-looking factors, including, but not limited to:
+Added: • the cost and timing of the potential milestone payments to former Flexion stockholders, which could be up to an aggregate of $372.3 million if certain regulatory and commercial milestones are met.
See Note 5, Flexion Acquisition , and Note 12, Financial Instruments , to our consolidated financial statements included herein for more information;
−Removed: • the cost and timing of potential remaining milestone payments to 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 12, Financial Instruments , to our consolidated financial statements included herein for more information;
−Removed: • the impact of the COVID-19 pandemic and global economic conditions, including the volume and delays of suspended elective surgical procedures, clinical trials, longer lead-times, an inability to secure a sufficient supply of materials and the inflationary impact on the cost of materials;
−Removed: • the timing of and extent to which the holders of our Notes elect to convert their Notes and the timing of principal and interest payments on our Term Loan;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 78
−Removed: Tab le of Contents
−Removed: • the timing and impact of increases to the variable interest rate on our Term Loan borrowings in accordance with the terms of the Credit Agreement;
−Removed: • the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°, including 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 and a ZILRETTA capital project at the Thermo Fisher site in Swindon, England;
+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;
+Added: • the timing of and extent to which the holders of our Notes elect to convert their 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;
+Added: • the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°, including markets outside of the U.S.;
+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;
−Removed: • the costs related to legal and regulatory issues;
−Removed: • the impact of inflation on our product costs, supply chain, operating expenses and business strategy;
−Removed: • the costs of performing additional clinical trials for our products, including the additional pediatric trials required by the FDA and EMA as a condition of approval of EXPAREL;
+Added: • the costs related to legal and regulatory matters;
+Added: • the costs of performing additional clinical trials for our products, including the additional pediatric trials required by the FDA and EMA as a condition of the approval of EXPAREL;
• the costs for the development and commercialization of other product candidates;
3 unchanged sentences
We have no committed external sources of funds, and additional equity or debt financing may not be available on acceptable terms, if at all.
−Removed: In particular, capital market disruptions or negative economic conditions, especially in light of the COVID-19 pandemic, may hinder our access to capital.
+Added: In particular, capital market disruptions or negative economic conditions may hinder our access to capital.
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 82
+Added: Table of Content s
Contractual Obligations
−Removed: We had two convertible senior notes outstanding as of December 31, 2022, for which $8.6 million in aggregate principal amount is due on the 2024 Notes in May 2024 and $402.5 million in aggregate principal amount is due on our 2025 Notes in August 2025.
+Added: We had two convertible senior notes outstanding as of December 31, 2023, for which $8.6 million in aggregate principal amount is due on the Flexion 2024 Notes in May 2024 and $402.5 million in aggregate principal amount is due on our 2025 Notes in August 2025.
The remaining interest payments on our Notes is $6.1 million, of which an estimated $3.1 million is due in 2024.
−Removed: We also have a Term Loan with $296.9 million in outstanding principal with contractually obligated principal payments of $37.5 million in each of 2023 and 2024, $42.2 million in 2025 and $179.7 million in 2026.
−Removed: The remaining interest payments on the Term Loan are approximately $115.4 million based on the current interest rate.
+Added: We also have the TLA Term Loan with $116.6 million in outstanding principal.
+Added: Due to voluntary principal prepayments of $30.6 million made during the year ended December 31, 2023, we are not contractually obligated to make principal payments in 2024.
+Added: As of December 31, 2023, there are contractually obligated principal payments of $1.3 million in 2025, $15.0 million in both 2026 and 2027 and $85.3 million in 2028.
+Added: The remaining interest payments of the TLA Term Loan are approximately $39.6 million based on the current interest rate.
In the normal course of business, we enter into various lease agreements for manufacturing, research and development and corporate activities, which are typically classified as operating leases under the provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 842, Leases .
1 unchanged sentence
For more information, refer to Note 8, Leases , to our consolidated financial statements included herein.
−Removed: In addition, we have approximately $73.3 million of minimum, non-cancelable contractual commitments for contract manufacturing services as of December 31, 2022, of which $18.3 million is due within one year, and the remaining $55.0 million is due in one to three years.
+Added: In addition, we have approximately $71.4 million of minimum, non-cancelable contractual commitments for contract manufacturing services as of December 31, 2023, of which $21.1 million is due within one year, and the remaining $50.3 million is due in one to five years.
We have approximately $14.2 million of minimum, non-cancelable contractual commitments for the purchase of certain raw materials as of December 31, 2023, of which $7.7 million is due within one year, and the remaining $6.5 million is due in one to two years.
−Removed: Subsequent to December 31, 2022, we entered into an additional $2.8 million of minimum, non-cancelable contractual commitments for marketing sponsorships, of which $0.9 million is due within one year, and the remaining $1.9 million is due in one to two years.
+Added: As of December 31, 2023, we had $4.9 million of other minimum, non-cancelable contractual commitments.
As part of the Flexion Acquisition, there are up to $372.3 million in potential payments if all regulatory and commercial milestones are met.
−Removed: The aggregate amount was previously $425.5 million prior to our September 2022 decision to formally discontinue further development of PCRX-301.
+Added: The aggregate amount was previously $425.5 million prior to our September 2022 decision to formally discontinue further development of PCRX-301, an investigational product candidate.
For more information, see Note 5, Flexion Acquisition , to our consolidated financial statements included herein.
−Removed: As part of the MyoScience Acquisition, upon the achievement of certain regulatory and commercial milestones, there are up to $43.0 million in potential milestone payments available as of December 31, 2022.
−Removed: The MyoScience milestone achievement period ends on December 31, 2023.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 79
−Removed: Tab le of Contents
Critical Accounting Estimates
10 unchanged sentences
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.
−Removed: 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.
+Added: We include 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.
The calculation of some of these items requires management to make estimates based on sales data, historical return data, contracts, statutory requirements and other related information that may become known in the future.
4 unchanged sentences
Historically, adjustments to these estimates to reflect actual results or updated expectations have not been material.
+Added: Pacira BioSciences, Inc.
+Added: | 2023 Form 10-K | Page 83
+Added: Table of Content s
The summary of activity with respect to our sales related allowances and accruals for the years ended December 31, 2023, 2022 and 2021 appears in Note 4, Revenue , to our consolidated financial statements included herein.
Contingent Consideration
−Removed: Subsequent to an acquisition, we measure contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as acquisition-related charges (gains), impairment and other.
−Removed: Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales, costs of goods sold and regulatory approvals.
+Added: Subsequent to an acquisition, we measure contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as contingent consideration (gains) charges, acquisition-related charges and other.
+Added: Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales and regulatory approvals.
In the absence of new information, changes in fair value reflect the impact of the passage of time towards the potential achievement of the milestones.
The following table includes the key assumptions used in the valuation of our contingent consideration milestones:
−Removed: Assumption Flexion Ranges Utilized as of
+Added: Assumption Flexion Ranges
+Added: Utilized as of
December 31, 2023
7 unchanged sentences
The impact of a hypothetical 100 basis point increase in the discount rate would have reduced the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2023 by $1.2 million.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2022 Form 10-K | Page 80
−Removed: Tab le of Contents
Recent Accounting Pronouncements
1 unchanged sentence
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.