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-- Conference call today at 4:30 p.m. ET -- TAMPA, Fla., July 30, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported financial results for the second quarter of 2024. Second Quarter 2024 Financial Highlights Total revenues of $178.0 millionNet product sales of $136.9 million for EXPAREL, $30.7 million for ZILRETTA, and $5.7 million for iovera°Net income of $18.9 million, or $0.41 per share (basic) and $0.39 per share (diluted)Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of $62.1 million See “Non-GAAP Financial Information” below. “The first half of the year was marked by meaningful progress towards our commercial, clinical, and business objectives. With a focus on strong execution, we maintained solid sales across all three of our opioid-sparing products, strengthened our balance sheet, and realigned our leadership team to better position us for long-term success,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Looking ahead to the back half of the year, we remain sharply focused on preparations to maximize the benefit of separate EXPAREL reimbursement for outpatient procedures with the implementation of NOPAIN in January 2025.” “We have multiple initiatives underway to drive awareness around the opioid-sparing benefits of EXPAREL ahead of NOPAIN. Recent progress includes the publication of three robust real-world studies that demonstrate the opioid-sparing and economic benefits of EXPAREL and the launch of a national awareness and educational campaign. We remain confident this important reimbursement milestone will drive expanded EXPAREL utilization in outpatient settings and drive accelerated topline growth in 2025 and beyond,” continued Mr. Lee. Recent Business Highlights Centers for Medicare and Medicaid Services (CMS) propose new reimbursement for EXPAREL in all outpatient surgical environments beginning January 1, 2025. In July 2024, CMS issued its proposed Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule for 2025. In the proposed rule, EXPAREL® (bupivacaine liposome injectable suspension) is one of six covered non-opioids—two of which are specific to ophthalmology— qualifying for separate Medicare reimbursement in both the ambulatory surgical center (ASC) and hospital outpatient (HOPD) settings. Pending finalization, this policy would go into effect beginning January 1, 2025. The proposed rule reflects impending implementation of the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which mandates separate CMS payment for qualifying non-opioid drugs and devices across the HOPD and ASC settings. The law was passed as part of the Consolidated Appropriations Act of 2023. $150 Million Share Repurchase Program. In May 2024, the company announced a new share repurchase program which authorizes the company to repurchase up to an aggregate of $150 million of its outstanding common stock. Repurchases under the program may be made at management’s discretion on the open market or through privately negotiated transactions. The share repurchase program may be suspended or discontinued at any time by the company and has an expiration date of December 31, 2026. Concurrently with the pricing of the offering of the 2029 Notes discussed below, the company entered into separate privately negotiated agreements with certain of the initial purchasers of the 2029 Notes or their respective affiliates and/or certain other financial institutions to repurchase 837,240 shares of its common stock for $25.0 million. Issuance of $287.5 million aggregate principal amount of 2.125% convertible senior notes due 2029. In May 2024, Pacira issued $287.5 million in aggregate principal amount of 2.125% convertible senior notes due 2029 (the 2029 Notes) in a private placement. Pacira used approximately $191.0 million of the net proceeds to repurchase $200.0 million aggregate principal amount of its outstanding 0.750% convertible senior notes due 2025, approximately $26.7 million of the net proceeds to fund the cost of entering into capped call transactions associated with the issuance, and approximately $25.0 million of the net proceeds for the share repurchase referenced above. Pacira intends to use the remainder of the net proceeds from the offering for general corporate purposes, including working capital and research and development expenditures. Second Quarter 2024 Financial Results Total revenues were $178.0 million in the second quarter of 2024, versus $169.5 million reported for the second quarter of 2023.EXPAREL net product sales were $136.9 million in the second quarter of 2024, versus $135.1 million reported for the second quarter of 2023. Second quarter volume growth of 3 percent was offset by contracted discounts and vial mix. There were 63 selling days in the second quarter of 2024 and 64 selling days in the second quarter of 2023.ZILRETTA net product sales were $30.7 million in the second quarter of 2024, versus $29.3 million reported for the second quarter of 2023.Second quarter 2024 iovera° net product sales were $5.7 million, versus $4.4 million reported for the second quarter of 2023.Sales of bupivacaine liposome injectable suspension to third-party licensees were $3.2 million in the second quarter of 2024, versus $0.7 million reported for the second quarter of 2023.Total operating expenses were $149.8 million in the second quarter of 2024, compared to $129.6 million in the second quarter of 2023.Research and development (R&D) expenses were $20.3 million in the second quarter of 2024, compared to $18.8 million in the second quarter of 2023. R&D expenses included $7.3 million and $9.3 million of product development and manufacturing capacity expansion costs in the second quarters of 2024 and 2023, respectively.Selling, general and administrative (SG&A) expenses were $68.1 million in the second quarter of 2024, compared to $64.9 million in the second quarter of 2023.GAAP net income was $18.9 million, or $0.41 per share (basic) and $0.39 (diluted) in the second quarter of 2024, compared to $25.8 million, or $0.56 per share (basic) and $0.51 (diluted) in the second quarter of 2023.Non-GAAP net income was $44.2 million, or $0.96 per share (basic) and $0.89 per share (diluted) in the second quarter of 2024, compared to $36.0 million, or $0.78 per share (basic) and $0.71 per share (diluted), in the second quarter of 2023.Adjusted EBITDA was $62.1 million in the second quarter of 2024, compared to $54.3 million in the second quarter of 2023.Pacira ended the second quarter of 2024 with cash, cash equivalents and available-for-sale investments (“cash”) of $404.2 million. Cash provided by operations was $53.2 million in the second quarter of 2024, compared to $43.5 million in the second quarter of 2023.Pacira had 46.2 million basic and 50.5 million diluted weighted average shares of common stock outstanding in the second quarter of 2024. See “Non-GAAP Financial Information” below. 2024 Financial Guidance Today the company is reiterating its full-year 2024 financial guidance as follows: Total revenue of $680 million to $705 million;Non-GAAP gross margin of 74% to 76%;Non-GAAP R&D expense of $70 million to $80 million;Non-GAAP SG&A expense of $245 million to $265 million; andStock-based compensation of $50 million to $55 million. See “Non-GAAP Financial Information” below. Today’s Conference Call and Webcast Reminder The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Tuesday, July 30, 2024, at 4:30 p.m. ET. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register at investor.pacira.com/upcoming-events. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the “Events” page on the Pacira website at investor.pacira.com. Non-GAAP Financial Information This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP gross margin, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, non-GAAP net income, non-GAAP net income per common share, non-GAAP weighted average diluted common shares outstanding, EBITDA (earnings before interest, taxes, depreciation and amortization) and adjusted EBITDA, because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends. These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2024 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of the company’s financial statements by providing greater transparency into the ongoing operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. The non-GAAP measures presented here are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures. About Pacira Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to providing non-opioid pain management options to as many patients as possible to redefine the role of opioids as rescue therapy only. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and ioveraº®, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com. About EXPAREL® (bupivacaine liposome injectable suspension) EXPAREL is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults. The safety and effectiveness of EXPAREL have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa, or an adductor canal block. The product combines bupivacaine with multivesicular liposomes, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the multivesicular liposome platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com. Important Safety Information about EXPAREL for Patients EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old, for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder. About ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) On October 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis (OA)- related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com. Indication and Select Important Safety Information for ZILRETTA Indication: ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee. Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated. Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product. Warnings and Precautions: Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment. Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions. Please see ZILRETTALabel.com for full Prescribing Information. About iovera°® The iovera° system uses the body’s natural response to cold to treat peripheral nerves and immediately reduce pain without the use of drugs. Treated nerves are temporarily stopped from sending pain signals for a period of time, followed by a restoration of function. Treatment with iovera° works by applying targeted cold to a peripheral nerve. A precise cold zone is formed under the skin that is cold enough to immediately prevent the nerve from sending pain signals without causing damage to surrounding structures. The effect on the nerve is temporary, providing pain relief until the nerve regenerates and function is restored. Treatment with iovera° does not include injection of any substance, opioid, or any other drug. The effect is immediate and can last up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. Additional information is available at www.iovera.com. Indication and Select Important Safety Information for iovera°® Indication: iovera° applies freezing cold to peripheral nerve tissue to block and/or relieve pain for up to 90 days. It should not be used to treat central nervous system tissue. Important Safety Information Do not receive treatment with iovera° if you experience hypersensitivity to cold or have open and/or infected wounds near the treatment site.You may experience bruising, swelling, inflammation and/or redness, local pain and/or tenderness, and altered feeling at the site of application.In treatment area(s), you may experience damage to the skin, skin darkening or lightening, and dimples in the skin.You may experience a temporary loss of your ability to use your muscles normally outside of the treatment area.Talk to your doctor before receiving treatment with iovera°. Forward-Looking Statements Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute 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 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, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act and 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. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the integration of our new chief executive officer; 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; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the ability to successfully integrate any future acquisitions into our existing business; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. (Tables to Follow) Pacira BioSciences, Inc.Condensed Consolidated Balance Sheets(in thousands)(unaudited) June 30,2024 December 31,2023ASSETS Current assets: Cash and cash equivalents$247,053 $153,298Short-term available-for-sale investments 157,173 125,283Accounts receivable, net 104,779 105,556Inventories, net 103,438 104,353Prepaid expenses and other current assets 19,771 21,504Total current assets 632,214 509,994Noncurrent available-for-sale investments — 2,410Fixed assets, net 168,850 173,927Right-of-use assets, net 56,264 61,020Goodwill 163,243 163,243Intangible assets, net 454,614 483,258Deferred tax assets 135,136 144,485Investments and other assets 36,499 36,049Total assets$1,646,820 $1,574,386 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$18,730 $15,698Accrued expenses 64,811 64,243Lease liabilities 9,149 8,801Current portion of convertible senior notes, net — 8,641Total current liabilities 92,690 97,383Convertible senior notes, net 479,549 398,594Long-term debt, net 109,751 115,202Lease liabilities 50,146 54,806Contingent consideration 22,401 24,698Other liabilities 13,005 13,573Total stockholders’ equity 879,278 870,130Total liabilities and stockholders’ equity$1,646,820 $1,574,386 Pacira BioSciences, Inc.Condensed Consolidated Statements of Operations(in thousands, except per share amounts)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Net product sales: EXPAREL$136,852 $135,127 $269,282 $265,535 ZILRETTA 30,707 29,261 56,546 53,595 iovera° 5,674 4,384 10,704 8,385 Bupivacaine liposome injectable suspension 3,154 695 5,679 1,383 Total net product sales 176,387 169,467 342,211 328,898 Royalty revenue 1,636 — 2,929 910 Total revenues 178,023 169,467 345,140 329,808 Operating expenses: Cost of goods sold 44,262 48,207 91,678 97,227 Research and development 20,338 18,824 38,576 35,964 Selling, general and administrative 68,126 64,850 140,152 135,693 Amortization of acquired intangible assets 14,322 14,322 28,644 28,644 Contingent consideration charges (gains), restructuring charges and other 2,735 (16,613) 4,638 (4,506)Total operating expenses 149,783 129,590 303,688 293,022 Income from operations 28,240 39,877 41,452 36,786 Other income (expense): Interest income 4,749 2,111 8,652 5,253 Interest expense (3,884) (3,865) (7,200) (13,454)Gain (loss) on early extinguishment of debt 7,518 — 7,518 (16,926)Other, net (39) (269) (198) (279)Total other income (expense), net 8,344 (2,023) 8,772 (25,406)Income before income taxes 36,584 37,854 50,224 11,380 Income tax expense (17,698) (12,091) (22,359) (5,153)Net income$18,886 $25,763 $27,865 $6,227 Net income per share: Basic net income per common share$0.41 $0.56 $0.60 $0.14 Diluted net income per common share(1)$0.39 $0.51 $0.58 $0.13 Weighted average common shares outstanding: Basic 46,174 46,088 46,337 46,019 Diluted(1) 50,539 52,054 51,366 46,285 (1) Diluted net income per common share was calculated in consideration of the “if-converted” method associated with the Company’s convertible senior notes. Refer to the Reconciliation of GAAP to Non-GAAP Financial Information included herein for the inputs used in the computation. Pacira BioSciences, Inc.Reconciliation of GAAP to Non-GAAP Financial Information(in thousands, except per share amounts)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 GAAP net income$18,886 $25,763 $27,865 $6,227 Non-GAAP adjustments: Contingent consideration charges (gains), restructuring charges and other: Changes in the fair value of contingent consideration 1,509 (18,258) (2,297) (6,640)Restructuring charges(1) (2) 504 936 3,804 936 Acquisition-related expenses(3) 230 709 404 1,198 Step-up of acquired Flexion Therapeutics, Inc. fixed assets and inventory to fair value and other — 1,727 — 3,834 Stock-based compensation 12,524 10,955 25,675 22,945 Chief Executive Officer transition costs(4) 294 — 571 — (Gain) loss on early extinguishment of debt (7,518) — (7,518) 16,926 Amortization of debt discount 23 28 47 703 Amortization of acquired intangible assets 14,322 14,322 28,644 28,644 Tax impact of non-GAAP adjustments(5) 3,456 (182) (1,890) (14,471)Total non-GAAP adjustments 25,344 10,237 47,440 54,075 Non-GAAP net income$44,230 $36,000 $75,305 $60,302 GAAP basic net income per common share$0.41 $0.56 $0.60 $0.14 GAAP diluted net income per common share$0.39 $0.51 $0.58 $0.13 GAAP net income used for basic earnings per share$18,886 $25,763 $27,865 $6,227 Interest expense on convertible senior notes, net of tax 762 1,029 1,790 — GAAP net income used for diluted earnings per share$19,648 $26,792 $29,655 $6,227 Non-GAAP basic net income per common share$0.96 $0.78 $1.63 $1.31 Non-GAAP diluted net income per common share$0.89 $0.71 $1.50 $1.20 Non-GAAP net income$44,230 $36,000 $75,305 $60,302 Interest expense on convertible senior notes, net of tax(6) 762 1,029 1,790 2,057 Non-GAAP net income used for diluted earnings per share(6)$44,992 $37,029 $77,095 $62,359 Weighted average common shares outstanding - basic 46,174 46,088 46,337 46,019 Weighted average common shares outstanding - diluted 50,539 52,054 51,366 46,285 Non-GAAP weighted average common shares outstanding - basic 46,174 46,088 46,337 46,019 Non-GAAP weighted average common shares outstanding - diluted(6) 50,539 52,054 51,366 51,892 Pacira BioSciences, Inc.Reconciliation of GAAP to Non-GAAP Financial Information (continued)(in thousands)(unaudited)(1) In February 2024, the Company initiated a restructuring plan to ensure it is well positioned for long-term growth. The restructuring plan includes: (i) reshaping the Company’s executive team; (ii) reallocating efforts and resources from the Company’s ex-U.S. and certain early-stage development programs to its commercial portfolio in the U.S. 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. The charges related to employee termination benefits, severance, and, to a lesser extent, other employment-related termination costs. (2) Approximately $0.5 million and $2.7 million of restructuring charges were excluded from this line item as they are included in the stock-based compensation line item for the three and six months ended June 30, 2024, respectively. (3) Acquisition-related expenses related to vacant and underutilized leases assumed from the acquisition of Flexion Therapeutics, Inc. (“Flexion”). (4) The Company appointed a new chief executive officer (“CEO”) effective January 2, 2024. CEO transition costs include compensation costs related to the transition of the former CEO who remains employed by the Company in an advisory role. (5) The tax impact of non-GAAP adjustments is computed by: (i) applying the statutory tax rate to the income or expense adjusted items; (ii) applying a zero-tax rate to adjusted items where a valuation allowance exists; and (iii) excluding discrete tax benefits and expenses primarily associated with tax deductible and non-deductible stock-based compensation.For the three and six months ended June 30, 2024, the GAAP effective income tax rates were approximately 48% and 45%, respectively, and the non-GAAP effective income tax rate for both the three and six months ended June 30, 2024 was approximately 24% with the difference from GAAP primarily relating to the impact of excluding both discrete tax expenses associated with non-deductible stock-based compensation, primarily related to expired stock options, and non-deductible tax expenses related to executive compensation.For the three and six months ended June 30, 2023, the GAAP effective income tax rates were approximately 32% and 45%, respectively, and the non-GAAP effective income tax rate for both the three and six months ended June 30, 2023 was approximately 25% with the difference from GAAP primarily relating to the impact of excluding discrete tax expenses associated with non-deductible stock-based compensation and tax expenses related to executive compensation. (6) For the three months ended June 30, 2023 and the three and six months ended June 30, 2024, there were no non-GAAP adjustments when calculating the diluted weighted average common shares outstanding or the interest expense add back under the “if-converted” method.For the six months ended June 30, 2023, the then-outstanding $402.5 million aggregate principal 0.75% convertible senior notes due 2025, or 2025 Notes, were excluded from diluted net income per common share on a GAAP basis as the impact would have been antidilutive. These potential securities resulted in a dilutive impact on diluted net income per common share reported on a non-GAAP basis.For the six months ended June 30, 2023, non-GAAP adjustments to diluted weighted average shares outstanding included the impact of the 2025 Notes as if they converted on the first day of the period presented, which resulted in an additional 5.6 million common shares upon an assumed conversion and added back $2.1 million of interest expense, net of tax, to non-GAAP net income. The Company has the option to settle its 2025 Notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock.Prior year amounts were reclassified to conform to the current year presentation.Pacira BioSciences, Inc.Reconciliation of GAAP to Non-GAAP Financial Information (continued)(in thousands)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold$44,262 $48,207 $91,678 $97,227 Step-up of acquired Flexion fixed assets and inventory to fair value and other — (1,727) — (3,834)Stock-based compensation (1,259) (1,436) (2,387) (3,160)Non-GAAP cost of goods sold$43,003 $45,044 $89,291 $90,233 Research and development reconciliation: GAAP research and development$20,338 $18,824 $38,576 $35,964 Stock-based compensation (1,925) (1,722) (3,728) (3,597)Non-GAAP research and development$18,413 $17,102 $34,848 $32,367 Selling, general and administrative reconciliation: GAAP selling, general and administrative$68,126 $64,850 $140,152 $135,693 CEO transition costs (294) — (571) — Stock-based compensation (8,848) (7,797) (16,833) (16,188)Non-GAAP selling, general and administrative$58,984 $57,053 $122,748 $119,505 Weighted average shares outstanding - diluted reconciliation: GAAP weighted average common shares outstanding - diluted 50,539 52,054 51,366 46,285 Dilutive common shares associated with the 2025 Notes(1) — — — 5,607 Non-GAAP weighted average common shares outstanding - diluted 50,539 52,054 51,366 51,892 (1) For the six months ended June 30, 2023, potential common shares of the 2025 Notes were excluded from diluted net income per common share on a GAAP basis because they would have been antidilutive. These potential securities resulted in a dilutive impact on diluted net income per common share reported on a non-GAAP basis. Pacira BioSciences, Inc. Reconciliation of GAAP Net Income to Adjusted EBITDA (Non-GAAP)(in thousands)(unaudited) Three Months Ended Six Months Ended June 30, June 30, 2024 2023 2024 2023 GAAP net income$18,886 $25,763 $27,865 $6,227 Interest income (4,749) (2,111) (8,652) (5,253)Interest expense (1) 3,884 3,865 7,200 13,454 Income tax expense 17,698 12,091 22,359 5,153 Depreciation expense 4,541 4,732 8,645 10,012 Amortization of acquired intangible assets 14,322 14,322 28,644 28,644 EBITDA 54,582 58,662 86,061 58,237 Other adjustments: Contingent consideration charges (gains), restructuring charges and other: Changes in the fair value of contingent consideration 1,509 (18,258) (2,297) (6,640)Restructuring charges (2) 504 936 3,804 936 Acquisition-related expenses 230 709 404 1,198 Step-up of acquired Flexion inventory to fair value and other — 1,261 — 2,566 Stock-based compensation 12,524 10,955 25,675 22,945 CEO transition costs 294 — 571 — (Gain) loss on early extinguishment of debt (7,518) — (7,518) 16,926 Adjusted EBITDA$62,125 $54,265 $106,700 $96,168 (1) Includes amortization of debt discount and debt issuance costs.(2) Approximately $0.5 million and $2.7 million of restructuring charges were excluded from this line item as they are included in the stock-based compensation line item for the three and six months ended June 30, 2024, respectively. Pacira BioSciences, Inc.Reconciliation of GAAP to Non-GAAP 2024 Financial Guidance(dollars in millions) GAAP to Non-GAAP Guidance GAAP Impact of GAAP to Non-GAAP Adjustments (1) Non-GAAPTotal revenues $680 to $705 — $680 to $705Gross margin 73% to 75% Approximately 1% 74% to 76%Research and development expense $78 to $90 $8 to $10 $70 to $80Selling, general and administrative expense $280 to $310 $35 to $45 $245 to $265Stock-based compensation $50 to $55 — —(1) The full-year impact of GAAP to Non-GAAP adjustments primarily relates to stock-based compensation.

-- Proposed Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment System Rule extends separate payment from ambulatory surgical centers to include the hospital outpatient environment – -- Rule implements the NOPAIN Act, signed into law as part of the Consolidated Appropriations Act of 2023 -- TAMPA, Fla., July 10, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NSDQ: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the Centers for Medicare and Medicaid Services (CMS) has issued its proposed Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule for 2025. In the proposed rule, EXPAREL® (bupivacaine liposome injectable suspension) is one of six covered non-opioids—two of which are specific to ophthalmology— qualifying for separate Medicare reimbursement in both the ambulatory surgical center (ASC) and hospital outpatient (HOPD) settings. Pending finalization, this policy would go into effect beginning January 1, 2025. The proposed rule reflects impending implementation of the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which mandates separate CMS payment for qualifying non-opioid drugs and devices across HOPD and ASC settings. The law was passed as part of the Consolidated Appropriations Act of 2023. “Following several years of advocacy for reimbursement policy reform to allow increased patient and provider access to non-opioids, we are pleased to see EXPAREL included as one of only six qualifying non-opioid drugs to treat postsurgical pain in the proposed rule,” said Frank D. Lee, Chief Executive Officer of Pacira. “As the only covered single-dose product approved for both local and regional analgesia across surgical procedures, we believe this new reimbursement—pending finalization—will offer clinicians increased ability to utilize a best-in-class option for achieving long-lasting non-opioid pain control with an increased ability to transition to the outpatient environment.” Proposed Medicare payment rates for covered non-opioid drug products—as outlined in the proposed rule—equate to average sales price (ASP) + 6% in the HOPD and ASC environments. The six products and associated reimbursement rates included in the rule are as follows: Non-Opioid DrugProposed Separate CMS Payment Rate (Per Billing Unit)*EXPAREL$1.41Zynrelef$0.73Xaracoll$0.85Ketorolac tromethamine injection$0.702Dextenza$117.01Omidria$97.12 *Payment rates given in the proposed rule are subject to change and may not be the same payment rate listed in the final rule later this year. EXPAREL is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks. It has been used in over 14 million patients across the United States to date. To view the preliminary rule in its entirety, visit the Federal Register. About Pacira BioSciences Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only. The company is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain, and spasticity. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting, local analgesia currently approved for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular, injection indicated for the management of osteoarthritis knee pain; and ioveraº®, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com. About EXPAREL® EXPAREL (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older, and postsurgical regional analgesia via an interscalene brachial plexus block in adults, a sciatic nerve block in the popliteal fossa in adults, and an adductor canal block in adults. The safety and effectiveness of EXPAREL have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa, or an adductor canal block. The product combines bupivacaine with multivesicular liposomes, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the multivesicular liposome platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com. Important Safety Information about EXPAREL for PatientsEXPAREL should not be used in obstetrical paracervical block anesthesia. In studies in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder. Forward-Looking StatementsAny statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute 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 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 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. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the integration of our new chief executive officer; 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; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the ability to successfully integrate any future acquisitions into our existing business; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

AdisInsight是Springer旗下面向药物研发、疾病治疗和决策的数据库。 近年来，随着渐冻症在社会上的认知度不断提高，越来越多的人开始“看见”并逐渐了解这个罕见病。但遗憾的是，现有的疗法仍无法治愈渐冻症，只能做到减缓症状的恶化和预防并发症，尽可能提高患者的生活质量和独立生活的能力。 我们基于AdisInsight数据库推出了一份专题报告《深入洞察：渐冻症药物格局分析》，通过分析渐冻症药物的开发现状、未来发展趋势、全球市场竞争格局等，致力于帮助专业人士和制药企业全面了解当前的研发趋势和行业趋势，充分撬动渐冻症药物的市场潜力，进而惠及更多患者，“解冻”他们的治愈之路，延长他们的生命。 渐冻症，全称为肌萎缩侧索硬化（Amyotrophic Lateral Sclerosis，ALS），又名鲁·盖瑞氏症，是一种罕见的神经系统疾病，会影响运动神经元——这些位于脑和脊髓中的神经细胞控制着随意肌运动。随着运动神经元退化、死亡，它们不再向肌肉传递信息，这会导致肌肉衰弱，开始抽搐（肌束颤动），并日渐消瘦（萎缩）。最终，脑部丧失了发起并控制自主运动的能力。随着时间的推移，患者还可能出现语言或决策困难，并伴有痴呆。 在这份报告中，我们提取了目前AdisInsight数据库里所有的渐冻症药物，包括已上市的药物、获得监管机构批准的药物、正在接受审评的药物，以及处于不同临床开发阶段的药物。此外，我们还分析了渐冻症药物开发领域中的关键药企，以及研究重点——尤其是作用机制和药物性质的发展趋势。最后，我们分析了渐冻症药物开发中达成的协议与合作，以揭示渐冻症制药巨头合作战略中的关键行业趋势。 欢迎扫码获取报告全文，全面了解渐冻症药物的开发现状、未来发展趋势等。 不同阶段药物状态的分布分析（2009-2023年） 随着渐冻症患病率的上升，2009-2023年间渐冻症药物档案数量逐渐增加。2023年是渐冻症药物开发项目数量最多的一年，这一年渐冻症药物数量大幅上升，共有147款药物处于临床开发阶段，7款专门用于治疗渐冻症的药物上市。在已上市的渐冻症药物中，由美国企业研发的数量最多，其次是加拿大、日本和韩国。 处于不同研发阶段的渐冻症药物的年度趋势 获批药物 以下药物在世界范围内获得批准用于治疗渐冻症，如Edaravone（依达拉奉），该药于2019年在中国获批。 已获批准的渐冻症药物 处于后期临床开发阶段的药物 在处于后期临床开发阶段的13款药物中，有6款药物正在开展III期临床试验，其他7款药物正在开展II/III期临床试验。 部分处于后期临床开发阶段的药物，欢迎获取报告阅读完整版表格并了解其全球分布情况 处于临床开发阶段的主要参与者 在渐冻症药物临床开发阶段，罗氏（Roche）拥有四种药物居于领先地位，其次是渤健（Biogen）、Ionis Pharmaceuticals、Isis Pharmaceuticals 和诺华（Novartis），这表明该领域的研发实力雄厚，但竞争也同样激烈。 处于渐冻症药物临床开发阶段的主要参与者 渐冻症药物开发格局 报告总结了处于各个开发阶段的渐冻症药物，包括全球各地已上市的药物、处于不同临床开发阶段的药物、渐冻症靶点趋势分析、以及即将问世的渐冻症疗法等。 欢迎扫码获取完整版报告，全面把握渐冻症药物的研发趋势和行业趋势。 渐冻症药物类别 根据AdisInsight数据库中的药物档案数据，我们总结了药物数量排名前15位的渐冻症药物类别。其中小分子药物数量最多（183），其次是基因疗法（62）和生物蛋白（61）。对处于后期临床开发阶段药物的分析表明小分子药物是渐冻症药物开发中比较成熟的类别，大多数渐冻症上市药物均属于此类，包括Exservan、Radicut、Teglutik、Rilutek等，这表示多功能、潜在更易获取的疗法已成为研发战略重点。 整体渐冻症药物市场中的主要参与者 全球范围内，有多家企业致力于渐冻症药物的研发，既有老牌制药巨头，也包括生物科技新星。参与渐冻症药物开发的企业众多、投资规模庞大，展现了该行业正在共同努力，致力于解决亟需满足的渐冻症医疗需求。 投身渐冻症药物开发的主要制药公司 渐冻症药物协议 渐冻症是一种存在巨大医疗需求且亟需满足的罕见病，需要大量的前期投资并开展合作，才能完成整个药物开发周期。因此，多方合作至关重要。根据AdisInsight数据库，超过40%的协议为合作研发协议，这表明在对抗这种退行性罕见疾病中合作的重要性。另一种主要的协议为授权协议（34%），其他则包括总协议、开发和营销协议，以及购买协议。 欢迎扫码获取报告，了解哪些制药企业达成了何种渐冻症药物协议及进展如何。 总体而言，渐冻症药物开发已逐步取得了重大进步，前景广阔。正在开发中的渐冻症药物数量逐渐上升，表明人们正加大投入，以寻找更加有效的渐冻症药物或疗法。制药巨头的积极参与、靶向特定蛋白的研发策略，以及对小分子药物的青睐有望带来更有效的创新疗法。当前的渐冻症药物研发以协作为基础，明确聚焦于有效靶点，代表了一种专门用于攻克渐冻症的综合方法。随着科学界不断阐明渐冻症的复杂性、开发更有针对性的疗法，我们期待渐冻症患者的治愈之路将逐渐“解冻”。 AdisInsight数据库试用申请 AdisInsight是以科学数据为依据，面向药物研发、疾病治疗和决策的数据库。其所含信息包括药物的疗效、安全性、研发者、交易和专利，以及药物上市成功率预测等，为您提供全球药物治疗有力的最新证据，帮助用户始终处于研究领域的前沿。如您对AdisInsight数据库感兴趣，欢迎推荐您所在机构申请试用。 扫码申请试用AdisInsight 获取生物制药领域专题报告、浏览每月重大事件回顾资讯、了解相关数据库解决方案等，欢迎扫码进入生物制药资源中心！ 相关阅读： 面向药物研发、疾病治疗和决策的数据库 | AdisInsight 生物类似药的下一波浪潮 | 全球市场格局与未来趋势分析报告 《新兴靶点：癌症治疗》报告 | 癌症治疗靶点选择趋势 想要在制药和生物技术领域投资少踩坑？您需要一个GPS 免费视频教程 | AdisInsight数据库8个使用指南，一次全送上！ 全球药物研发情况和趋势回顾 | AdisInsight 2022年度报告 版权声明： 本文由施普林格∙自然上海办公室负责编译。中文内容仅供参考，一切内容以报告原文为准。欢迎转发分享本文，如需转载，请联系 China@nature.com。 © 2024 Springer Nature Limited. All Rights Reserved 欢迎点击“阅读原文”免费获取《深入洞察：渐冻症药物格局分析》报告全文