Bupivacaine

-- Conference call today at 4:30 p.m. ET -- TAMPA, Fla., May 07, 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 first quarter of 2024. First Quarter 2024 Financial Highlights Total revenues of $167.1 millionNet product sales of $132.4 million for EXPAREL, $25.8 million for ZILRETTA, and $5.0 million for iovera°Net income of $9.0 million, or $0.19 per share (basic and diluted)Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of $44.6 million See “Non-GAAP Financial Information” below. “Sales are off to a solid start for all three of our trusted, opioid-sparing products and we remain sharply focused on driving accelerated growth in 2025 and beyond,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “We are pleased with the progress we are making advancing the launch of EXPAREL in two new lower extremity nerve block indications, and we are receiving positive market receptivity across all sites of care. We are also preparing for a significant growth catalyst ahead with the implementation of separate Medicare reimbursement for EXPAREL at average sales price plus 6 percent in outpatient settings beginning in January 2025. We believe this important reimbursement milestone will expand patient access to EXPAREL and drive greater utilization in outpatient procedures.” “Our confidence in Pacira’s future remains steadfast and the $150 million stock buyback announced today underscores our belief in our team, products, and growth outlook,” added Mr. Lee. Recent Business Highlights New $150 Million Share Repurchase Program. Today the company announced its Board of Directors has approved a new share repurchase program effective immediately, which authorizes the company to purchase up to an aggregate of $150 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. The company expects to fund the share repurchase program using a combination of existing cash reserves and future cash flows.Positive Efficacy and Safety Data of PCRX-201 (enekinragene inzadenovec) Presented at OARSI 2024 World Congress. In April 2024, investigators presented encouraging preliminary results from a 72-patient study of PCRX-201 data at the Osteoarthritis Research Society International, or OARSI, 2024 World Congress in Vienna, Austria. PCRX-201 is the company’s novel, intra-articular helper-dependent adenovirus gene therapy product candidate that codes for interleukin-1 receptor antagonist (IL-1Ra), for the treatment of osteoarthritis of the knee. The data showed that a single intra-articular injection of PCRX-201 demonstrated sustained clinical effect as assessed by patient-reported outcomes at all dose levels for at least one-year post-injection. Importantly, PCRX-201 was shown to be well-tolerated with a favorable safety profile. The company expects to submit updated data demonstrating PCRX-201’s effectiveness through two years for presentation at a medical meeting in the Fall.PCRX-201 Granted Regenerative Medicine Advance Therapy (RMAT) Designation. In March 2024, the company announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201. The company’s RMAT application was supported by the preliminary safety and efficacy findings from the company’s Phase 1 study.Three New EXPAREL Patents. In March 2024, the United States Patent and Trademark Office issued Patent No. 11,925,706 claiming composition of matter, Patent No. 11,918,565 claiming method of use as a sciatic nerve block in the popliteal fossa, and Patent No. 11,931,459 claiming method of use in pediatric patients. Each of these EXPAREL patents are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”). The ‘706 patent has an expiration date of January 22, 2041 and the ‘459 and ‘565 patents have expiration dates of March 17, 2042 and February 2, 2043, respectively. First Quarter 2024 Financial Results Total revenues were $167.1 million in the first quarter of 2024, versus $160.3 million reported for the first quarter of 2023.EXPAREL net product sales were $132.4 million in the first quarter of 2024, versus $130.4 million reported for the first quarter of 2023. First quarter volume growth of 3 percent was offset by contracted discounts and vial mix. There were 62 selling days in the first quarter of 2024 and 63 selling days in the first quarter of 2023.ZILRETTA net product sales were $25.8 million in the first quarter of 2024, versus $24.3 million reported for the first quarter of 2023.First quarter 2024 iovera° net product sales were $5.0 million, versus $4.0 million reported for the first quarter of 2023.Sales of bupivacaine liposome injectable suspension to third-party licensees were $2.5 million in the first quarter of 2024, versus $0.7 million reported for the first quarter of 2023.Total operating expenses were $153.9 million in the first quarter of 2024, compared to $163.4 million in the first quarter of 2023.Research and development (R&D) expenses were $18.2 million in the first quarter of 2024, compared to $17.1 million in the first quarter of 2023. R&D expenses included $7.4 million and $7.7 million of product development and manufacturing capacity expansion costs in the first quarters of 2024 and 2023, respectively.Selling, general and administrative (SG&A) expenses were $72.0 million in the first quarter of 2024, compared to $70.8 million in the first quarter of 2023.GAAP net income was $9.0 million, or $0.19 per share (basic and diluted) in the first quarter of 2024, compared to a GAAP net loss of $19.5 million, or $(0.43) per share (basic and diluted) in the first quarter of 2023.Non-GAAP net income was $31.1 million, or $0.67 per share (basic) and $0.62 per share (diluted) in the first quarter of 2024, compared to $24.3 million, or $0.53 per share (basic) and $0.49 per share (diluted), in the first quarter of 2023.Adjusted EBITDA was $44.6 million in the first quarter of 2024, compared to $41.9 million in the first quarter of 2023.Pacira ended the first quarter of 2024 with cash, cash equivalents and available-for-sale investments (“cash”) of $325.9 million. Cash provided by operations was $49.1 million in the first quarter of 2024, compared to $19.1 million in the first quarter of 2023.Pacira had 46.5 million basic and 52.2 million diluted weighted average shares of common stock outstanding in the first quarter of 2024.For non-GAAP measures, Pacira had 52.2 million diluted weighted average shares of common stock outstanding in the first 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, May 7, 2024, at 4:30 p.m. ET. To participate in the conference call, dial 1-800-715-9871 and provide the passcode 6363041. International callers may dial 1-646-307-1963 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the “Events” page on the Pacira website at investor.pacira.com. 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 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) March 31,2024 December 31,2023ASSETS Current assets: Cash and cash equivalents$184,052 $153,298Short-term available-for-sale investments 141,838 125,283Accounts receivable, net 101,639 105,556Inventories, net 96,782 104,353Prepaid expenses and other current assets 18,802 21,504Total current assets 543,113 509,994Noncurrent available-for-sale investments — 2,410Fixed assets, net 171,804 173,927Right-of-use assets, net 58,626 61,020Goodwill 163,243 163,243Intangible assets, net 468,936 483,258Deferred tax assets 141,057 144,485Investments and other assets 36,542 36,049Total assets$1,583,321 $1,574,386 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$8,982 $15,698Accrued expenses 66,818 64,243Lease liabilities 9,003 8,801Current portion of convertible senior notes, net 8,641 8,641Total current liabilities 93,444 97,383Convertible senior notes, net 399,210 398,594Long-term debt, net 112,477 115,202Lease liabilities 52,446 54,806Contingent consideration 20,892 24,698Other liabilities 12,690 13,573Total stockholders’ equity 892,162 870,130Total liabilities and stockholders’ equity$1,583,321 $1,574,386 Pacira BioSciences, Inc.Condensed Consolidated Statements of Operations(in thousands, except per share amounts)(unaudited) Three Months Ended March 31, 2024 2023 Net product sales: EXPAREL$132,430 $130,408 ZILRETTA 25,839 24,334 iovera° 5,030 4,001 Bupivacaine liposome injectable suspension 2,525 688 Total net product sales 165,824 159,431 Royalty revenue 1,293 910 Total revenues 167,117 160,341 Operating expenses: Cost of goods sold 47,416 49,020 Research and development 18,238 17,140 Selling, general and administrative 72,026 70,843 Amortization of acquired intangible assets 14,322 14,322 Contingent consideration (gains) charges, restructuring charges and other 1,903 12,107 Total operating expenses 153,905 163,432 Income (loss) from operations 13,212 (3,091)Other income (expense): Interest income 3,903 3,142 Interest expense (3,316) (9,589)Loss on early extinguishment of debt — (16,926)Other, net (159) (10)Total other income (expense), net 428 (23,383)Income (loss) before income taxes 13,640 (26,474)Income tax (expense) benefit (4,661) 6,938 Net income (loss)$8,979 $(19,536) Net income (loss) per share: Basic and diluted net income (loss) per common share$0.19 $(0.43)Weighted average common shares outstanding: Basic 46,499 45,949 Diluted 52,193 45,949 Pacira BioSciences, Inc.Reconciliation of GAAP to Non-GAAP Financial Information(in thousands, except per share amounts)(unaudited) Three Months Ended March 31, 2024 2023 GAAP net income (loss)$8,979 $(19,536) Non-GAAP adjustments: Contingent consideration (gains) charges, restructuring charges and other: Changes in the fair value of contingent consideration (3,806) 11,618 Restructuring charges (1) (2) 3,300 — Acquisition-related fees (3) 174 489 Step-up of acquired Flexion fixed assets and inventory to fair value and other — 2,107 Stock-based compensation 13,151 11,990 CEO transition costs (4) 277 — Loss on early extinguishment of debt — 16,926 Amortization of debt discount 24 675 Amortization of acquired intangible assets 14,322 14,322 Tax impact of non-GAAP adjustments (5) (5,346) (14,289)Total non-GAAP adjustments 22,096 43,838 Non-GAAP net income$31,075 $24,302 GAAP basic and diluted net income (loss) per common share$0.19 $(0.43) GAAP net income (loss) used for basic earnings per share$8,979 $(19,536)Interest expense on convertible senior notes, net of tax 1,029 — GAAP net income (loss) used for diluted earnings per share$10,008 $(19,536) Non-GAAP basic net income per common share$0.67 $0.53 Non-GAAP diluted net income per common share$0.62 $0.49 Non-GAAP net income$31,075 $24,302 Interest expense on convertible senior notes, net of tax (6) 1,029 1,029 Non-GAAP net income used for diluted earnings per share (6)$32,104 $25,331 Weighted average common shares outstanding - basic 46,499 45,949 Weighted average common shares outstanding - diluted 52,193 45,949 Non-GAAP Weighted average common shares outstanding - basic 46,499 45,949 Non-GAAP Weighted average common shares outstanding - diluted (6) 52,193 51,730 (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 $2.2 million of restructuring charges were excluded from this line item as they are included in the stock-based compensation line item.(3) For the three months ended March 31, 2024 and 2023, acquisition-related fees 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 months ended March 31, 2024, the GAAP effective income tax rate was approximately 34% and the non-GAAP effective income tax rate was approximately 24%, with the difference from GAAP primarily due to the impact of excluding both discrete tax expenses associated with non-deductible stock-based compensation and tax expenses related to executive compensation. For the three months ended March 31, 2023, the GAAP effective income tax rate was approximately 26% and the non-GAAP effective income tax rate was approximately 23%, with the difference from GAAP primarily due to the impact of excluding tax expenses related to non-U.S. valuation allowances and non-deductible executive compensation.(6) For the three months ended March 31, 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 three months ended March 31, 2023, the $402.5 million aggregate principal 0.75% convertible senior notes due 2025, or 2025 Notes, were excluded on a GAAP basis as the impact to diluted net loss per common share 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 three months ended March 31, 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 $1.0 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 March 31, 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold$47,416 $49,020 Step-up of acquired Flexion fixed assets and inventory to fair value and other — (2,107)Stock-based compensation (1,128) (1,724)Non-GAAP cost of goods sold$46,288 $45,189 Research and development reconciliation: GAAP research and development$18,238 $17,140 Stock-based compensation (1,803) (1,875)Non-GAAP research and development$16,435 $15,265 Selling, general and administrative reconciliation: GAAP selling, general and administrative$72,026 $70,843 CEO transition costs (277) — Stock-based compensation (7,985) (8,391)Non-GAAP selling, general and administrative$63,764 $62,452 Weighted average shares outstanding - diluted reconciliation: GAAP weighted average common shares outstanding - diluted 52,193 45,949 Dilutive common shares associated with the 2025 Notes (1) — 5,608 Dilutive common shares associated with stock options and restricted stock units — 173 Non-GAAP weighted average common shares outstanding - diluted 52,193 51,730 (1) For the three months ended March 31, 2023, potential common shares of the 2025 Notes were excluded from diluted net loss 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 (Loss) to Adjusted EBITDA (Non-GAAP)(in thousands)(unaudited) Three Months Ended March 31, 2024 2023 GAAP net income (loss)$8,979 $(19,536) Interest income (3,903) (3,142) Interest expense (1) 3,316 9,589 Income tax expense (benefit) 4,661 (6,938) Depreciation expense 4,104 5,280 Amortization of acquired intangible assets 14,322 14,322 EBITDA 31,479 (425) Other adjustments: Contingent consideration (gains) charges, restructuring charges and other: Changes in the fair value of contingent consideration (3,806) 11,618 Restructuring charges (2) 3,300 — Acquisition-related fees 174 489 Step-up of acquired Flexion inventory to fair value and other — 1,305 Stock-based compensation 13,151 11,990 CEO transition costs 277 — Loss on early extinguishment of debt — 16,926 Adjusted EBITDA$44,575 $41,903 (1) Includes amortization of debt discount and debt issuance costs.(2) Approximately $2.2 million of restructuring charges were excluded from this line item as they are included in the stock-based compensation line item. 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.

Net Product Sales of $34.7 million, which increased from $29.6 million for the same period in 2023. Net Loss Per Share $(0.02), which decreased from $(0.27) for the same period in 2023. Launched partnership with CrossLink Life Sciences, LLC to expand ZYNRELEF® promotional efforts in the first quarter of 2024. Gross Margin improved to 76% for the quarter, up from 43% for the same period last year. FDA approval of expanded indication for ZYNRELEF received on January 23, 2024. Heron to host its first ever Investor Day event on Wednesday, May 15, 2024 in New York, New York. SAN DIEGO, May 7, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three months ended March 31, 2024 and highlighted recent corporate updates. "We are extremely pleased with our ability to improve the financial efficiency of the business by growing revenues, improving margins, and reducing expenses. We made tremendous progress this quarter by promptly training CrossLink sales representatives and integrating them into our commercial execution, while also training our own commercial team on the newly expanded label for ZYNRELEF," said Craig Collard, Chief Executive Officer of Heron. Business Highlights The ZYNRELEF Vial Access Needle ("VAN") program, to allow for the rapid preparation and administration of ZYNRELEF in the operating room, remains on track for a Prior Approval Supplement ("PAS") submission in Q2 2024 and an anticipated launch in late 2024. The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate use of ZYNRELEF, continues to progress with an expected submission for approval in 2026. The training and integration of CrossLink Life Sciences, LLC ("CrossLink") sales representatives to promote ZYNRELEF to orthopedic surgeons has progressed quickly, with a total of 191 CrossLink sales representatives, to date, having completed training and actively engaging with their respective physicians. As we continue to expand our reach across the nation, we anticipate an additional fifty CrossLink sales representatives will complete training and be ready to engage with their respective physicians on ZYNRELEF within the next thirty days. Following the FDA's approval for the expanded indication of ZYNRELEF on January 23, 2024, ZYNRELEF is now approved for postsurgical analgesia for up to 72 hours after soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. Heron will host its Investor Day event on Wednesday, May 15, 2024, from 9:30 a.m. – 12:30 p.m. ET in New York, New York. Members of Heron's leadership team will give presentations during the event highlighting Heron's recent organizational transformation and the commercial opportunity across the acute care and oncology franchises. To register for the event to attend in-person or virtually, please click here. Financial Guidance for 2024 The Company reaffirms its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA: Acute Care Franchise Acute Care Franchise Net Product Sales: For the three months ended March 31, 2024, acute care franchise Net Product Sales were $5.5 million, which increased from $3.8 million for the same period in 2023. ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three months ended March 31, 2024 was $5.0 million, which increased from $3.5 million for the same period in 2023. APONVIE® Net Product Sales: Net Product Sales of APONVIE for the three months ended March 31, 2024 was $0.5 million, which increased from $0.3M, for the same period in 2023. Oncology Care Franchise Oncology Care Franchise Net Product Sales: For the three months ended March 31, 2024, oncology care franchise Net Product Sales was $29.2 million, which increased from $25.8 million for the same period in 2023. CINVANTI® Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three months ended March 31, 2024 was $25.6 million, which increased from $22.8 million for the same period in 2023. SUSTOL® Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three months ended March 31, 2024 was $3.6 million, which increased from $3.0 million, for the same period in 2023. Conference Call and Webcast Heron will host a conference call and webcast on May 7, 2024 at 8:30 a.m. ET. The conference call can be accessed by dialing (646) 307-1963 for domestic callers and (800) 715-9871 for international callers. Please provide the operator with the passcode 1497932 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron's website at . An archive of the teleconference and webcast will also be made available on Heron's website for sixty days following the call. About ZYNRELEF for Postoperative Pain ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. Please see full prescribing information, including Boxed Warning, at . About APONVIE for Postoperative Nausea and Vomiting (PONV) APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023. Please see full prescribing information at . About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at . About SUSTOL for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at . About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit . Non-GAAP Financial Measures To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting. In our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; we exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business; Adjusted Operating Expenses Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, depreciation and amortization, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. The Company has not provided a reconciliation of its full-year 2024 guidance for adjusted EBITDA or adjusted operating expenses to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition related expense and litigation settlements. These items are uncertain and depend on various factors that are outside of the Company's control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period. Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; revenue, adjusted EBITDA and other financial guidance provided by the Company; the results of the commercial launch of APONVIE; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF; the timing of the Company's development of the VAN program and receipt of required regulatory approvals; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement CrossLink Life Sciences; the outcome of the Company's pending ANDA litigation; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; any inability or delay in achieving profitability. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. [email protected] 858-251-4400 SOURCE Heron Therapeutics, Inc.