Fasciculation

-- Brendan Teehan named Chief Commercial Officer and Krys Corbett named Chief Business Officer -- -- Key additions expected to support company’s 5x30 path to becoming an innovative biopharmaceutical organization -- PARSIPPANY, N.J., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced two key appointments to its executive leadership team. Brendan Teehan has been named Chief Commercial Officer and Krys Corbett, Esq. has been named Chief Business Officer. “We are pleased to welcome Brendan and Krys, and their accomplished track records to Pacira,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Their extensive experience will further strengthen our executive team at an important stage in our business progression as we transition into an innovative biopharmaceutical organization. Brendan’s experience maximizing pharmaceutical brands, coupled with Krys’ portfolio management and deep partnering expertise, will enhance our ability to seamlessly execute our 5x30 strategy to grow our strong commercial base business and advance a robust pipeline to enhance growth and value creation.” Mr. Teehan is an accomplished biopharmaceutical executive with a 30-year track record of successfully building and leading commercial teams. He brings extensive expertise in both privately and publicly held companies across multiple large and rare disease therapeutic categories and development stages. Prior to joining Pacira, Mr. Teehan held various commercial leadership positions at Acadia Pharmaceuticals, Inc., most recently as Chief Operating Officer and Head of Commercial where he was responsible for all commercial functions. Prior to Acadia, he served in a variety of commercial leadership roles at Tesaro, Inc., Raintree Oncology Services, Amgen, Inc., and Johnson & Johnson. Mr. Teehan holds a B.A. in Government and Political Science from the University of Notre Dame and an M.B.A. from Carnegie Mellon University. Ms. Corbett brings more than 25 years of industry experience across business development, strategic transactions, alliance management, and product portfolio management to Pacira. Prior to joining Pacira, she led portfolio and product strategy for clinical and preclinical-stage programs at Lyell Immunopharma. Before that, Ms. Corbett was Head of Business Development, General Counsel, and Corporate Secretary for Oric Pharmaceuticals. Earlier in her career, she served in alliance and asset management leadership roles at Roche and Genentech. Ms. Corbett began her career at the law firm Wilson Sonsini Goodrich and Rosati. She holds a B.A. in Political Science from Brigham Young University and a J.D. from Duke University. About Pacira Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. 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, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa 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. The company is also advancing the development of PCRX-201, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, 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 is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days. When stimulation compatible components are used, the iovera° system can also facilitate targeting nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue. 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 “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” 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 ‘5x30’, our growth and business strategy, our future outlook, contributions of new executives, our intellectual property and patent terms, our 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, development of products, strategic alliances, 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: 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; assumptions used for estimated future cash flows associated with determining the fair value of the Company; 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. These forward-looking statements involve known and unknown risks, uncertainties and other important factors that 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.

BAAR, Switzerland--( BUSINESS WIRE )--Novocure (NASDAQ: NVCR) today reported preliminary unaudited financial and operational results for the quarter and full year ended December 31, 2024. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields). “Novocure is at an exciting inflection point as we continue to expand our multi-indication TTFields treatment platform. In 2024, we brought Optune Gio ® to more than 4,000 glioblastoma patients across the globe, earned FDA approval and launched Optune Lua ® in non-small cell lung cancer in the U.S., announced two additional successful Phase 3 trial readouts and released our next generation arrays,” said Ashley Cordova, Chief Executive Officer. “With two additional indication launches on the horizon, we are well positioned for 2025 and beyond. This progress demonstrates our steadfast commitment to our patient-forward mission: together with our patients, we strive to extend survival in some of the most aggressive forms of cancer.” Financial updates for the year and fourth quarter ended December 31, 2024*: Total preliminary net revenues for the year were $605.2 million, an increase of 19% compared to the prior year. 2024 growth was primarily driven by our successful launch in France and significantly improved approval rates in the U.S., which are now reflected in our revenue baseline. 2025 net revenue growth is expected to closely reflect growth in Optune Gio active patients. Total preliminary net revenues for the fourth quarter were $161.3 million, an increase of 21% compared to the same period in 2023. The U.S., Germany, France and Japan contributed $107.2 million, $17.7 million, $16.0 million and $8.5 million, respectively, with other active markets contributing $9.9 million. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $2.0 million. Improved approval rates in the U.S. resulted in $8.3 million of increased net revenue from prior period claims during the quarter, which we believe should not be considered in our 2025 baseline. This is in addition to the $14.0 million of increased revenue from prior period claims disclosed through the third quarter. Cash, cash equivalents and short-term investments were $959.9 million as of December 31, 2024. Operational updates for the fourth quarter ended December 31, 2024: As of December 31, 2024, there were 4,126 total active patients on TTFields therapy globally. 1,520 Optune Gio prescriptions were received in the quarter, consistent with the same period in 2023. Optune Gio prescriptions from the U.S., Germany, France and Japan contributed 897; 190; 194 and 109 prescriptions, respectively, with the remaining 130 prescriptions received from other active markets. As of December 31, 2024, there were 4,077 active Optune Gio patients on therapy. Active Optune Gio patients from the U.S., Germany, France and Japan contributed 2,161; 564; 426 and 420 active patients, respectively, with the remaining 506 active patients contributed by other active markets. On October 15, 2024, Optune Lua was approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic non-small cell lung cancer (NSCLC) concurrently with PD-1/PD-L1 inhibitors or docetaxel, in adults who have progressed on or after a platinum-based regimen. As of December 31, 2024, 52 Optune Lua prescriptions were received for NSCLC. As of December 31, 2024, there were 20 active NSCLC patients on Optune Lua. Additionally, there were 29 active mesothelioma patients on Optune Lua around the globe. In Q1 2026, Novocure intends to stop reporting new prescriptions and focus on active patients by indication and material market as the key operating statistic. Fourth quarter and recent updates and achievements: In October, the FDA granted Breakthrough Device designation for the use of TTFields therapy for brain metastases from non-small cell lung cancer. Breakthrough Device designation provides more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of marketing applications upon filing, and expedited review of pre-Premarket Approval Application (PMA) manufacturing and quality systems compliance inspections. In October, the FDA approved Novocure’s new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio for the treatment of adult patients with glioblastoma (GBM). In December, the company announced the Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer. Novocure plans to submit the full data for presentation at an upcoming medical congress. In December, the FDA granted Breakthrough Device designation for the use of TTFields therapy for the treatment of unresectable, locally advanced pancreatic cancer. In January 2025, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved Novocure’s new HFE transducer arrays for use with Optune Gio for the treatment of adult patients with GBM. Anticipated clinical milestones: Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026) Data from Phase 3 TRIDENT clinical trial in newly diagnosed GBM (2026) Fourth quarter and full year 2024 financial results conference call: Novocure will host a conference call and webcast to discuss full year and fourth quarter 2024 financial results at 8:00 a.m. EST on Thursday, February 27, 2025. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link. The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations , and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. *The unaudited results in this press release are preliminary and subject to the completion of the Company’s annual independent audit and, therefore, are subject to adjustment. About Novocure Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer. Novocure’s global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter. Forward-Looking Statements In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion. Important Safety Information What is Optune Gio ® approved to treat? Optune Gio is a wearable, portable, FDA-approved device indicated to treat a type of brain cancer called glioblastoma multiforme (GBM) in adult patients 22 years of age or older. Newly diagnosed GBM If you have newly diagnosed GBM, Optune Gio is used together with a chemotherapy called temozolomide (TMZ) if: Your cancer is confirmed by your healthcare professional AND You have had surgery to remove as much of the tumor as possible Recurrent GBM If your tumor has come back, Optune Gio can be used alone as an alternative to standard medical therapy if: You have tried surgery and radiation and they did not work or are no longer working AND You have tried chemotherapy and your GBM has been confirmed by your healthcare professional Who should not use Optune Gio? Optune Gio is not for everyone. Talk to your doctor if you have: An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment . Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction Do not use Optune Gio if you are pregnant or are planning to become pregnant . It is not known if Optune Gio is safe or effective during pregnancy. What should I know before using Optune Gio? Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure ® , the maker of Optune Gio. Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment What are the possible side effects of Optune Gio? Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions. Please visit OptuneGio.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions. Important Safety Information What is Optune Lua ® approved to treat? Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on or after a platinum-based regimen. Who should not use Optune Lua? Optune Lua for mNSCLC is not for everyone. Talk to your doctor if you have: An electrical implant. Use of Optune Lua together with electrical implants has not been tested and may cause the implanted device not to work properly A known sensitivity to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with Optune Lua may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and difficulty breathing Do not use Optune Lua if you are pregnant or are planning to become pregnant. It is not known if Optune Lua is safe or effective during pregnancy. What should I know before using Optune Lua? Optune Lua should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure ® , the maker of Optune Lua. Do not use any parts that did not come with Optune Lua Treatment Kit sent to you by Novocure or given to you by your doctor Do not get the device or transducer arrays wet Please be aware that Optune Lua has a cord that plugs into an electrical socket. Be careful of tripping when it’s connected If you have an underlying serious skin condition where the transducer arrays are placed, discuss with your doctor whether this may prevent or temporarily interfere with Optune Lua treatment. What are the possible side effects of Optune Lua? The most common side effects of Optune Lua when used together with certain immunotherapy and chemotherapy drugs were dermatitis, pain in the muscles, bones, or joints, fatigue, anemia, alopecia (hair loss), dyspnea, nausea, cough, diarrhea, anorexia, pruritus (itching), leukopenia, pneumonia, respiratory tract infection, localized edema (swelling), rash, pain, constipation, skin ulcers, hypokalemia (low potassium levels), hypoalbuminemia (low albumin levels), hyponatremia (low sodium levels), and dysphagia (difficulty swallowing). Other potential adverse effects associated with the use of Optune Lua include treatment related skin irritation, allergic reaction to the adhesive or to the gel, overheating of the array leading to pain and/or local skin burns, infections at site where the arrays make contact with the skin, local warmth and tingling sensation beneath the arrays, medical device site reaction, muscle twitching, and skin breakdown/skin ulcer. Talk to your doctor if you have any of these side effects or questions. Please visit OptuneLua.com for Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Company also reports preliminary unaudited 2024 revenue of $701.0 millionPARSIPPANY, N.J., Jan. 10, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced its five-year growth-oriented plan to accelerate its ongoing transition into an innovative biopharmaceutical organization and become a therapeutic area leader in musculoskeletal pain and adjacencies. In addition, the company reported preliminary unaudited total revenue of $701.0 million for the year ended December 31, 2024, compared with $675.0 million for the year ended December 31, 2023. 5x30 Path to growth and value creation The company intends to achieve the following five objectives by 2030 (“5x30”): Patients: More than three million patients treated per yearProduct revenue: Double-digit compounded annual growth rateProfitability: Five percentage point gross margin improvement over 2024Pipeline: Clinical pipeline expansion with five novel programs in developmentPartnerships: Establishing five partnerships including pipeline and commercial agreements “We enter 2025 with a sharp focus on growth, operational excellence and a clear mission to deliver innovative, non-opioid pain therapies to transform the lives of patients,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Looking ahead, I am energized to lead Pacira during this exciting new chapter as we advance our 5x30 plan to address unmet patient needs in musculoskeletal pain and adjacencies. With a best-in-class commercial portfolio that is producing significant cash flow, we believe we are well equipped to extend our leadership in non-opioid pain management and transform Pacira into an innovative biopharmaceutical organization with a robust pipeline to support sustainable growth and enhanced value creation.” Preliminary Unaudited Fourth Quarter Revenue Highlights Fourth quarter EXPAREL net product sales of $147.7 million in 2024, compared with $143.9 million in 2023. Volume growth and a price increase in 2024 were partially offset by a shift in vial mix and discounting associated with the company’s new group purchasing organization, or GPO, partnerships.Fourth quarter ZILRETTA net product sales of $33.1 million in 2024, compared with $28.7 million in 2023.Fourth quarter iovera° net product sales of $6.5 million in 2024, compared with $6.0 million in 2023.Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was zero in the fourth quarter of 2024, compared with $2.6 million in the fourth quarter of 2023. Preliminary Unaudited Full-year Revenue Highlights Full-year EXPAREL net product sales of $549.0 million in 2024, compared with $538.1 million in 2023. Full-year net product sales were comprised of average daily volume growth of 4 percent. There were 249 selling days in 2024 and 250 selling days in 2023.Full-year ZILRETTA net product sales of $118.1 million in 2024, compared with $111.1 million in 2023.Full-year iovera° net product sales of $22.8 million in 2024, compared with $19.7 million in 2023.Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was $11.1 million in 2024, compared with $6.1 million in 2023. The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2024. Pacira expects to report its complete financial results for the fourth quarter and full-year 2024, along with the company’s financial guidance, later in the first quarter of 2025. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Pacira today announced the granting of inducement awards on January 3, 2025 to eight new employees under Pacira’s Amended and Restated 2014 Inducement Plan as a material inducement to each employee's entry into employment with the company. In accordance with Nasdaq Listing Rule 5635(c)(4), the awards were approved by the Compensation Committee of the Board of Directors. Four employees received stock options to purchase an aggregate of 20,300 shares of Pacira common stock and eight employees received restricted stock units for an aggregate of 30,400 shares of Pacira common stock. The stock options have a 10-year term and a four-year vesting schedule with 25 percent of the underlying shares vesting on the first anniversary of the recipient’s first day of employment and in successive equal quarterly installments over the 36 months thereafter. The stock options have an exercise price of $18.40 per share, the closing trading price of Pacira common stock on the Nasdaq Global Select Market on the date of grant. Each restricted stock unit represents the contingent right to receive one share of Pacira common stock and the restricted stock unit awards vest annually in four equal installments beginning on the first anniversary of January 2, 2025. Vesting of the equity awards is subject to the employee’s continued employment with Pacira. Each equity award is also subject to the terms and conditions of an award agreement. About Pacira Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. 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, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa 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. The company is also advancing the development of PCRX-201, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, 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 is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days. When stimulation compatible components are used, the iovera° system can also facilitate targeting nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue. 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 “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” 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 ‘5x30’, our growth and business strategy, our future outlook, contributions of new executives, our intellectual property and patent terms, our 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, development of products, strategic alliances, 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: 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; assumptions used for estimated future cash flows associated with determining the fair value of the Company; 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. These forward-looking statements involve known and unknown risks, uncertainties and other important factors that 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. Investor Contact:Susan Mesco, (973) 451-4030susan.mesco@pacira.com Media Contact:Sara Marino, (973) 370-5430sara.marino@pacira.com