Granisetron

精彩内容近日，中药OTC龙头太极集团公布2023年业绩报告，实现营收156.23亿元（+10.58%），归母净利润8.22亿元（+131.99%）。核心品种放量明显，藿香正气口服液收入22.71亿元（+45%），急支糖浆（独家品种）收入8.81亿元（+67%）等。太极集团坚持创新驱动，研发投入大增81%，2款中药1类新药冲刺上市。净利润大涨132%！中药大单品业绩亮眼3月29日，太极集团公布2023年业绩报告，报告期内公司实现营收156.23亿元，同比增长10.58%；归母净利润8.22亿元，同比增长131.99%；扣非归母净利润7.74亿元，同比增长111.35%。从分行业看，医药工业销售收入103.88亿元，同比增长19.4%。其中，现代中药销售收入66.04亿元（+31.64%），化药销售收入37.84亿元（+2.72%）；医药商业销售收入77.26亿元，同比降低3.31%；中药材资源板块销售收入10.17亿元，同比增长118.71%。医药工业已然成为太极集团业绩增长引擎，近年来随着主品品牌力持续释放、渠道整合力持续加强等，该板块收入持续增长。从分领域收入看，消化及代谢用药为第一大品类，2023年收入28.81亿元（+36.99%）；此外，呼吸系统用药、抗感染药物、神经系统用药、大健康产品、心脑血管用药、抗肿瘤及免疫调节药分别录得收入26.42亿元（+42.21%）、18.69亿元（-0.21%）、8.98亿元（-2.36%）、8.5亿元（22.67%）、7.66亿元（10.94%）、2.46亿元（-27.26%）。2023年太极集团分领域收入情况（单位：亿元）来源：公司公告，米内网整理从细分产品收入看，核心中药产品放量明显，其中藿香正气口服液（医保甲类、OTC甲类）销售收入22.71亿元，同比增长45%；急支糖浆（独家品种，医保乙类、OTC甲类双跨）销售收入8.81亿元，同比增长67%；通天口服液（独家品种，医保乙类、OTC甲类）销售收入3.16亿元，同比增长10%；鼻窦炎口服液（独家品种，医保乙类、OTC甲类双跨）销售收入2.61亿元，同比增长22%。藿香正气口服液为太极集团OTC第一大单品，具有解表祛暑、化湿和中的功效，适用于外感风寒、内伤湿滞或夏伤暑湿所致的感冒。米内网数据显示，无论是院内市场（中国公立医疗机构终端），还是零售市场（城市实体药店+网上药店），在祛暑剂品牌排名中，太极集团的藿香正气口服液均连续多年稳居首位。太极集团另一款OTC独家大单品——急支糖浆为全国医保乙类、OTC甲类（双跨）品种，是市场上较为畅销的止咳平喘中成药。近年来在中国城市实体药店终端止咳平喘中成药产品排名中，急支糖浆均稳居第二。现代中药是太极集团战略规划重要组成部分，其目标是以现代中药智造为主，通过内生发展加外延扩张，力争“十四五”末即2025年营业收入达到500亿元，净利润率不低于医药行业平均水平，并努力成为世界一流的中药企业。为实现上述愿景，太极集团多管齐下加码中药板块：2024年3月，涪陵区与太极集团举行签约仪式，计划打造300亿级产能智造中心，即全球最大的中药提取与口服制剂智造中心、创新中药及生物医药智造中心。2023年12月，太极集团接连公布5个投资项目，包括拟对旗下中药材公司和中药饮片厂各增资4800万元；投资23亿元投建2个产能中心，分别为国药太极西南医药产业基地项目一期工程、涪陵制药厂太极医药城二期建设项目；拟以150万元在澳门投资设立全资子公司......2款中药1类新药冲刺，重磅注射剂备战第十批集采在太极集团“十四五”战略规划中，科技创新被列为发展战略之首，明确了要加快新药研发和大品种二次开发。近年来，公司不断加大研发力度，2023年研发投入2.91亿元，同比增长约81%，全年开展重点研发项目31项，其中中药16项，化药14项，生物药1项。近年来太极集团研发投入情况（单位：亿元）来源：公司公告，米内网整理截至报告期末，太极集团拥有研发人员943人，占公司总人数比例约为7.5%。在中药新药研发方面，1.1类新药芪灯明目胶囊治疗糖尿病黄斑水肿“附条件批准上市”临床试验已完成部分病例入组；治疗慢性稳定性心绞痛（血瘀证）的1.1类创新中药——丹七通脉片完成IIb期研究总结报告及专家咨询论证；改良型新药双苓止泻颗粒的研究正在开展中；华盖散颗粒、金水六君煎等3.1类古代经典名方中药复方制剂的生产注册研究正在进行中。在化药方面，目前太极集团已有15个仿制药通过或视同通过一致性评价，涵盖全身用抗感染药物、神经系统药物、呼吸系统用药、全身用激素类制剂(不含性激素和胰岛素)、消化系统及代谢药5个治疗大类。太极集团过评情况注：带*为国采中选来源：米内网一致性评价进度数据库太极集团的左氧氟沙星氯化钠注射液、氢溴酸西酞普兰片、枸橼酸咖啡因注射液、异烟肼片、地塞米松磷酸钠注射液已在国采中顺利中标。余下的过评品种中，有2个暂未纳入国采，其中盐酸格拉司琼注射液已满足5家及以上的充分竞争条件，目前有齐鲁制药、成都倍特药业、福安药业、成都普什制药、太极集团5家企业过评。格拉司琼注射剂是一种强效、高选择性的5-羟色胺受体拮抗剂，主要用于放疗、细胞毒类药物化疗等引起的恶心和呕吐，该产品2022年在中国公立医疗机构终端的销售额超过3亿元，其中福安药业主导市场，近年来占比均超过70%。此外，太极集团还有13个品种提交一致性评价补充申请在审，其中盐酸吗啡缓释片、葡萄糖酸钙片、复方甘草片等品种暂无企业过评；2个新分类报产品种在审（不含联合申报），其中盐酸羟考酮缓释片目前仅2个国产企业拥有生产批文。太极集团新分类报产且在审的品种来源：米内网中国申报进度（MED）数据库中医药利好政策不断，超7成中药企业业绩喜人在过去的2023年，中医药行业陆续迎来了多项重磅政策：国家药监局发布《中药注册管理专门规定》，进一步加强中药新药研制与注册管理；国务院办公厅印发《中医药振兴发展重大工程实施方案》，推进中医药振兴发展；八部委联合印发《“十四五”中医药文化弘扬工程实施方案》，提出12项重要任务，明确大力弘扬中医药文化；CDE发布《中药新药临床试验用药品的制备研究技术指导原则（试行）》，为中药新药临床试验用药品的制备、质量控制等研究提供技术指导......在系列利好政策催化下，2023年中药企业业绩普遍向好。截至3月30日，A股中药板块有46家上市企业披露了2023年业绩数据（含年报、业绩快报及业绩预告），其中有30余家归母净利润呈正增长，占已披露业绩数据的公司比重超过7成。白云山、云南白药、华润三九、同仁堂、太极集团、片仔癀等企业营业收入超100亿元，依次为755.15亿元、391.1亿元、247.39亿元、178.6亿元、156.2亿元、100.35亿元。白云山、华润三九、东阿阿胶、片仔癀、同仁堂、天士力、云南白药等企业净利润超10亿元，其中云南白药达40.94亿元，为目前已披露业绩的中药上市企业中，净利润最高的企业。步长制药、珍宝岛、广誉远、益佰制药、太极集团、ST康美、天士力、太龙药业等企业归母净利润同比增长超过100%。其中天士力净利润预计11.27亿～13.17亿元，同比增长521.59%～592.65%，为目前已披露业绩的中药上市企业中，净利润增速最高的企业。部分中药企业2023年业绩情况来源：东方财富网，米内网整理2024年以来，中医药行业也是政策不断：2月5日，国家药监局综合司公开征求《中药标准管理专门规定（征求意见稿）》意见，旨在进一步加强中药标准管理，建立符合中医药特点的中药标准体系，促进中医药传承创新发展；2月26日，国家卫健委等三部门联合印发《关于进一步加强新时代卫生健康文化建设的意见》。其中提到，要挖掘传承中医药文化精髓，要推动中医药文化融入生产生活；3月5日，十四届全国人大二次会议在北京开幕，政府工作报告再次提及中医药，强调要促进中医药传承创新，加强中医优势专科建设......中医药是国家顶层政策支持的板块，一方面随着审评审批制度改革等顶层设计，利好中药创新药发展，为行业提供增量；另一方面大多数中成药均聚焦OTC渠道，受集采、医保控费等影响较小，在老龄化、大众自我诊疗意识增长的社会背景下，具备长期成长空间。在系列利好政策推动下，中医药行业正在迈向高质量发展阶段，市场空间也将逐步打开。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至3月30日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

2023 oncology care franchise revenue was $107.9 million, exceeding full-year 2023 guidance ZYNRELEF® achieved quarterly record of $5.6 million in Q4 Net Product Sales Ended 2023 with cash and cash equivalents of $80.4 million Announced partnership with CrossLink Life Sciences, LLC to expand ZYNRELEF promotional efforts on January 7, 2024 Received FDA approval for expanded indication of ZYNRELEF on January 23, 2024 SAN DIEGO, March 12, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three and twelve months ended December 31, 2023 and highlighted recent corporate updates. "In the fourth quarter of 2023, Heron saw continued positive momentum and an increased sales trajectory in both our acute care and oncology care franchises, illustrating how the strategic decisions made over the past year have positioned the Company for long-term success and profitability," said Craig Collard, Chief Executive Officer of Heron. "I am pleased to share this quarterly update and look forward to building upon what we achieved in the fourth quarter of 2023, providing substantial value and meaningful solutions in the acute care and oncology care settings." 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 the second half of 2024. The ZYNRELEF Prefilled Syringe ("PFS"), to allow for immediate use of ZYNRELEF, continues to progress with an expected submission for approval in 2026. Gross Margin improved to 71% for the quarter, up from 58% in the same period last year. ZYNRELEF generated record quarterly revenues of approximately $5.6 million. The CrossLink Life Sciences, LLC partnership finalized on January 7, 2024, will ultimately provide up to 650 additional sales representatives promoting ZYNRELEF to orthopedic surgeons. Received FDA approval of our supplemental New Drug Application ("sNDA") for ZYNRELEF which expands the ZYNRELEF label to approximately 13 million procedures annually. 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 and twelve months ended December 31, 2023, acute care franchise Net Product Sales were $6.1 million and $19.1 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022. ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF (bupivacaine and meloxicam) extended-release solution for the three and twelve months ended December 31, 2023 were $5.6 million and $17.7 million, respectively, which increased from $3.9 million and $10.2 million, respectively, for the same periods in 2022. APONVIE® Net Product Sales: Net Product Sales of APONVIE for the three and twelve months ended December 31, 2023 were $0.5 million and $1.4 million, respectively, with no sales in the comparable prior year periods. APONVIE became commercially available in the U.S. on March 6, 2023. Oncology Care Franchise Oncology Care Franchise Net Product Sales: For the three and twelve months ended December 31, 2023, oncology care franchise Net Product Sales were $28.1 million and $107.9 million, respectively, which increased from $26.1 million and $97.5 million, respectively, for the same periods in 2022. CINVANTI® Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and twelve months ended December 31, 2023 were $24.3 million and $94.9 million, respectively, which increased from $23.1 million and $87.3 million, respectively, for the same periods in 2022. SUSTOL® Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and twelve months ended December 31, 2023 were $3.8 million and $13.0 million, respectively, which increased from $3.0 million and $10.2 million, respectively, for the same periods in 2022. Conference Call and Webcast Heron will host a conference call and webcast on March 12th, 2024 at 4:30 pm 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 6135354 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 60 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. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU. 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 the only 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 and the accompanying reconciliations, 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. Reconciliations of adjusted EBITDA and adjusted operating expenses to the most directly comparable GAAP financial measures are included in this press release. 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.