Bupivacaine liposome

恒瑞医药投资价值深度分析：创新驱动，全球起航 一、核心结论速览 - 恒瑞医药已完成从仿制药龙头到创新药驱动的战略转型，创新药收入占比超60%，进入收获期 - 财务极其稳健：资产负债率12.14%，流动比率>8，经营现金流强劲，研发投入占比29.4%（2024年） - 管线全球领先：147款在研药物，94%为独立原创，未来3年预计获批40余项创新成果 - 国际化加速：12项创新药海外授权，ADC与GLP-1平台价值凸显，海外收入与里程碑收入进入兑现期 - 估值处于合理区间：当前PE约56倍，低于历史均值，机构目标价51-100元，平均80.14元 - 风险可控：集采影响减弱，创新药放量对冲，国际化与技术平台构筑新护城河 二、公司概况：中国创新药标杆 恒瑞医药（600276.SH，01276.HK）创立于1970年，是中国领先的创新型国际化制药企业，专注于抗肿瘤、手术麻醉、代谢疾病等领域 。公司已从连云港的地方药企成长为全球研发管线排名第8（中国第1）的医药巨头，累计研发投入超500亿元，全球研发团队超5000人，在中国、美国、日本等设立14个研发中心 。 三、财务分析：稳健增长，质量优异 - 业绩表现：2025年前三季度营收231.88亿元（+14.85%），归母净利润57.51亿元（+24.50%），扣非净利润55.9亿元（+21.1%），净利润增速显著高于营收增速，盈利能力提升 。2024年营收279.85亿元（+22.63%），净利润63.37亿元（+47.28%），创历史新高。 - 收入结构质变：创新药收入占比从2021年的25%提升至2025年上半年的60.66%，成为绝对核心引擎 。2025年Q3创新药收入占比进一步提升至55%以上，彻底摆脱对仿制药依赖。 - 财务健康度：资产负债率12.14%（2025Q3），流动比率>8，速动比率>6，短期偿债能力极强。经营活动现金流净额91.1亿元（2025Q3，+98.68%），回款能力强劲，为研发与国际化提供充足资金。 - 研发投入强度：2024年研发投入82.28亿元，占营收比重29.40%，连续多年保持20%以上，位居全国医药行业前列。 四、核心竞争力：创新+全产业链+国际化 1. 研发管线护城河 - 规模领先：147款在研药物，全球排名第8，其中94%为独立原创，覆盖肿瘤、代谢、自免等10余个治疗领域 。 - 技术平台前沿：构建ADC（HRMAP平台）、PROTAC、双抗、GLP-1/GIP双靶点等先进技术平台，多项产品处于全球第一梯队 。 - 临床进展顺利：400余项临床试验在国内外开展，100多个自主创新产品在临床开发，7项国际多中心Ⅲ期项目推进中 。 - 未来三年爆发：预计获批40余项创新成果，2025年重点产品包括HER2 ADC瑞康曲妥珠单抗、GLP-1双靶点药物HRS9531等11项。 2. 产品矩阵优势 产品类别 核心产品 市场地位 增长潜力 肿瘤免疫 卡瑞利珠单抗 PD-1单抗市场占比>20%适应症持续拓展，海外授权推进 ADC 瑞康曲妥珠单抗、SHR-A1904 HER2、Claudin18.2领域国内领先 2025年预计贡献15亿元收入 代谢疾病 HRS9531（GLP-1/GIP）、HRS-7535（口服GLP-1） 双靶点+口服剂型差异化竞争 潜在市场规模超百亿元 双抗 瑞拉芙普α（PD-L1/TGF-β） 全球首个获批同类产品 胃癌适应症专利护城河 3. 国际化加速变现 - 海外授权创纪录：已完成12项创新药海外授权，包括卡瑞利珠单抗美国授权、SHR-4849（DLL3 ADC）全球授权等，潜在里程碑收入超10亿美元。 - 海外上市突破：多款仿制药（如布比卡因脂质体）获美国FDA批准，创新药氟唑帕利、海曲泊帕等海外临床推进中 。 - 全球研发布局：14个研发中心，覆盖中美日澳瑞，全球研发团队超5000人，提升全球临床效率与创新能力 。 4. 全产业链优势 - 生产质控领先：通过欧美日等规范市场认证，注射剂出口欧美日20余个注册批件，产品进入40余个国家 。 - 销售网络强大：覆盖全国各级医院，肿瘤药领域市占率约12%，医生与患者粘性高，转换成本高。 - 专利护城河：大中华区授权专利1084件，欧美日专利7513件，为创新药提供长期保护。 五、行业前景与政策环境 1. 行业增长确定性高 - 中国创新药市场规模预计2025年达1.5万亿元，年复合增长率15-20%。 - 肿瘤、代谢疾病等领域未满足医疗需求巨大，创新药渗透率持续提升。 - 全球创新药市场扩容，中国创新药“出海”迎来黄金期。 2. 政策环境优化 - 医保谈判常态化，创新药快速纳入医保，加速放量（13款自研创新药已纳入医保）。 - 集采影响减弱，仿制药业务占比下降，创新药成为增长核心，抗风险能力增强。 - 国家鼓励创新药研发，优先审评审批政策加速创新成果转化。 六、风险挑战分析 1. 研发风险：创新药研发周期长、投入大、失败率高，部分管线可能面临临床失败风险。 2. 竞争加剧：国内外药企在ADC、GLP-1等热门领域竞争激烈，可能导致产品定价压力与市场份额争夺。 3. 政策风险：医保谈判降价幅度较大，可能影响创新药盈利能力；集采政策可能进一步扩大范围。 4. 国际化风险：海外临床推进不及预期，FDA审批标准严格，可能导致上市延迟；文化差异与合规风险增加运营成本。 七、估值分析与投资建议 1. 估值水平 - 当前股价对应2025年PE约56倍，低于历史均值（近10年约65倍），处于合理区间。 - 与国际创新药巨头（如罗氏、默克）PE30-40倍相比，考虑成长性溢价，估值具备吸引力。 - 机构目标价区间51-100元，平均80.14元，较当前股价（约60元）有30%以上上涨空间。 2. 盈利预测 - 2025-2027年归母净利润预计为86.66/100.73/121.31亿元，同比增长37%/16%/20%，EPS分别为1.31/1.52/1.83元。 - 创新药收入年复合增长25%（公司目标），海外授权里程碑收入与产品销售将持续增厚业绩。 3. 投资建议 - 投资评级：买入 - 目标价：75-80元（对应2026年PE约50倍） - 投资逻辑：创新药转型成功，管线进入收获期，国际化加速变现，财务稳健，估值合理，长期成长空间广阔。 - 风险提示：研发失败、竞争加剧、医保谈判降价超预期、海外拓展不及预期。 八、总结 恒瑞医药正处于从“中国创新药龙头”向“全球医药科技巨头”跨越的关键时期，创新+国际化双轮驱动将开启新一轮增长周期。公司凭借全球领先的研发管线、全产业链优势与稳健的财务状况，有望在未来3-5年实现业绩翻倍，成为全球制药行业的重要力量。投资者可逢低布局，分享中国创新药崛起的红利。

-- Record-high EXPAREL sales driven by volume growth of 7 percent, marking strongest fourth quarter performance in three years-- BRISBANE, Calif., Jan. 08, 2026 (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 reported preliminary, unaudited total revenue of $726.4 million for the year ended December 31, 2025, compared with $701.0 million for the year ended December 31, 2024. The company also repurchased 2.0 million shares of its common stock during the fourth quarter. “We closed 2025 having achieved another year of solid execution and meaningful progress advancing our 5x30 strategic priorities, leaving us well-positioned for sustainable, long-term success,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Strong EXPAREL volume growth in the second half of the year underscores the value of our commercial investments and positions us for significant and sustainable revenues moving forward. We enter 2026 with momentum that provides us with a strong foundation and clear line of sight to further operational progress and an exciting chapter of growth ahead.” Preliminary Unaudited Fourth Quarter Revenue Highlights Fourth quarter EXPAREL net product sales of $155.8 million in 2025, compared with $147.7 million in 2024. Fourth quarter volume growth of 7 percent was partially offset by a shift in vial mix and discounting associated with the launch of a new group purchasing organization (GPO) partnership. Fourth quarter ZILRETTA net product sales of $33.0 million in 2025, compared with $33.1 million in 2024. Fourth quarter iovera° net product sales of $7.0 million in 2025, compared with $6.5 million in 2024. Other revenue, comprised of sales of bupivacaine liposome injectable suspension, was $1.1 million in the fourth quarter of 2025, compared with zero in the fourth quarter of 2024. Preliminary Unaudited Full-Year Revenue Highlights Full-year EXPAREL net product sales of $575.1 million in 2025, compared with $549.0 million in 2024. Full-year volume growth of 6 percent was partially offset by a shift in vial mix and discounting associated with the company’s new GPO partnerships. Full-year ZILRETTA net product sales of $116.6 million in 2025, compared with $118.1 million in 2024. Full-year iovera° net product sales of $24.2 million in 2025, compared with $22.8 million in 2024. Other revenue, comprised of sales of bupivacaine liposome injectable suspension and royalties, was $10.5 million in 2025, compared with $11.1 million in 2024. 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 2025. Pacira expects to report its complete financial results for the fourth quarter and full-year 2025, along with the company’s financial guidance, later in the first quarter of 2026. Share Repurchase Program During the fourth quarter of 2025, the company repurchased 2.0 million shares of its common stock through open market transactions for $50.0 million (exclusive of broker fees and excise tax incurred). At December 31, 2025, the company had 41.1 million shares of common stock outstanding and $150.0 million remaining on its current share repurchase authorization, which expires December 31, 2026. Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Pacira today announced the granting of inducement awards on January 5, 2026 to ten new employees under Pacira’s Amended and Restated 2014 Inducement Plan (the “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 People & Compensation Committee of the Board of Directors (the “Committee”) without stockholder approval. Six employees received stock options to purchase an aggregate of 14,000 shares of Pacira common stock and ten employees received restricted stock units for an aggregate of 22,300 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 $25.10 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 January 2, 2027. 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 iovera ® º, 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 a pipeline of clinical-stage assets for musculoskeletal pain and adjacencies, its most advanced product candidate, PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy, is in Phase 2 clinical development for osteoarthritis of the knee. To learn more about Pacira, visit 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 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 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 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°. About PCRX-201 (enekinragene inzadenovec) PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today. In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee—a testament to its promise and potential. Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of knee osteoarthritis. To learn more about PCRX-201 and the company’s clinical development program, please visit the investor events section of the company’s investor website. About the High-capacity Adenovirus Vector Platform In February 2025, in support of the company’s ‘5x30’ growth strategy, Pacira acquired GQ Bio Therapeutics GmbH (GQ Bio) and its novel high-capacity adenovirus (HCAd) vector gene therapy vector platform. This platform solves many of the challenges in the field of gene therapy that have prevented its utilization in treating common diseases, such as osteoarthritis. Key features include: The HCAd vector is much more efficient at delivering genes into cells compared to many other gene therapies that rely on adenovirus associated virus, or AAV, vectors. As a result, the desired effect can be achieved with much smaller doses. The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors. Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at therapeutically appropriate intervals. Lower dose levels and efficient delivery of genes into cells means that thousands of doses can be produced in a single batch. As a result, therapies built on the HCAd platform are expected to have a commercially attractive and viable cost of goods profile. Beyond PCRX-201 and other product candidates in preclinical development, the company has identified numerous well-validated cytokines that could also be the basis for locally administered genetic therapies using the HCAd platform. 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: '5x30', our growth and business strategy, our future outlook, the strength and efficacy of our intellectual property protection and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, 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, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States 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 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 and 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. 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. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC. CONTACT: Investor Contact: Susan Mesco, (973) 451-4030 susan.mesco@pacira.com Media Contact: Sara Marino, (973) 370-5430 sara.marino@pacira.com