Heron Therapeutics (HRTX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #1 (Strong Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Since a c ...

文章核心观点 - 公司宣布FDA已受理ZYNRELEF®(bupivacaine和meloxicam)延迟释放溶液VAN的补充新药申请,并指定2024年9月23日为PDUFA目标日期 [1][2] - 如果获批,VAN将取代现有的通风瓶盖,简化无菌制备,大幅缩短ZYNRELEF的抽取时间 [2] - 公司与CrossLink的合作伙伴关系持续推进,预计到年底将增加约650名代表推广ZYNRELEF [3] - 公司对VAN获批及与CrossLink合作的前景表示乐观,认为将有助于更多医院采用ZYNRELEF作为手术后疼痛管理的必需品 [4] ZYNRELEF产品概况 - ZYNRELEF是首个也是唯一一个双重作用的局部麻醉药,结合局部麻醉剂布比卡因和非甾体抗炎药美洛昔康 [4] - ZYNRELEF是首个在III期临床试验中证明可显著减轻疼痛并显著增加术后72小时内无需使用阿片类药物患者比例的延迟释放局部麻醉药 [4] - ZYNRELEF最初于2021年5月获FDA批准用于成人软组织或关节周围注射,以产生术后72小时内的镇痛作用,后于2021年12月获批适应症扩大 [5] - 2024年1月23日,ZYNRELEF获批用于软组织和骨科手术,但不适用于高度血管化手术 [5] 安全性信息 - ZYNRELEF含有非甾体抗炎药,可增加心脏病发作和中风的风险,且风险随剂量和使用时间增加而升高 [6] - ZYNRELEF不能用于心脏旁路手术,可增加胃肠道出血、溃疡和撕裂的风险 [6] - ZYNRELEF禁用于对其成分过敏、有哮喘发作或其他类似药物过敏反应的患者,以及在分娩时作为阻滞剂使用 [7] - ZYNRELEF可能会影响神经系统和心血管系统,引起肝肾问题,降低某些降压药的疗效,并可能对胚胎有害 [9]

SAN DIEGO, May 29, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced the Prior Approval Supplement ("PAS") submission to the U.S. Food and Drug Administration ("FDA") for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN"). Heron expects to receive the assigned action date for completion of the FDA's review of this PAS within the next several weeks and anticipates an action ...

Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the 'long' context, investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Whil ...

Heron Therapeutics Q1 Earnings Call May 7, 2024 Forward-looking Statements and non-GAAP Disclosures This presentationcontains"forward-lookingstatements"asdefinedbythe PrivateSecurities LitigationReformActof1995.Wecaution investorsthatforward- 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, including, but not limited to, uncertainties related t ...

财务数据和关键指标变化 - 第一季度净收入为3460万美元,较2023年同期的2960万美元增长17% [10] - 第一季度毛利率为76%,较2023年同期的43%大幅提升 [10][26] - 第一季度净亏损为320万美元,较2023年同期的3270万美元大幅收窄 [28] - 公司预计2024年全年收入为1.38亿美元至1.58亿美元,毛利率为60%至70% [29] - 公司预计2024年全年营业费用(不含股份支付和折旧摊销)为1.08亿美元至1.6亿美元,EBITDA(不含股份支付)为亏损2200万美元至盈利300万美元 [29] 各条业务线数据和关键指标变化 - 肿瘤业务线CINVANTI和SUSTOL第一季度收入合计2920万美元,保持了良好的市场份额 [11] - 急性护理业务线第一季度收入为550万美元,较2023年同期增长45% [11] - ZYNRELEF第一季度收入为500万美元,连续两个季度保持在500万美元以上 [12] - APONVIE第一季度收入为50万美元,较去年同期持续增长 [12] 各个市场数据和关键指标变化 - 公司在北卡罗来纳州、南卡罗来纳州和佐治亚州的ZYNRELEF销量增长12倍,远高于其他地区 [17] - 公司在这三个州新增了20多名骨科医生使用ZYNRELEF,并在4月份新增了60个接触点和预计未来30天内新增40名用户 [17][18] 公司战略和发展方向及行业竞争 - 公司正在扩大CrossLink销售团队的覆盖范围,计划在2024年第四季度前培训并整合650名销售代表 [15][16] - CrossLink团队与骨科医生群体建立了深厚的关系,这将对ZYNRELEF的收入产生重大影响 [16][17] - 公司正在开发ZYNRELEF的新型给药装置,包括针头装置(VAN)和预充式注射器(PFS),以提高使用便利性 [21][22][23][24] 管理层对经营环境和未来前景的评论 - 公司对CINVANTI和SUSTOL的市场份额保持乐观,认为这些产品将在2024年保持一贯的稳定性 [11] - 公司对APONVIE的销售势头感到非常高兴,认为销售信息传达得更加有效,将带来持续的收入增长 [12][13][14] - 公司对CrossLink合作带来的影响感到非常乐观,认为这将对ZYNRELEF的收入产生重大影响 [16][17][18][19] - 公司预计2024年第四季度将实现盈利,并有信心不需要再融资 [29] 问答环节重要的提问和回答 问题1 **Serge Berlanger 提问** ZYNRELEF新适应症(脊柱、肩部和软组织手术)的使用情况如何? CINVANTI的强劲表现是否意味着这将成为新的基准水平? [33][34] **Craig Collard 和 Kevin Warner 回答** 公司已经看到一些脊柱和肩部手术医生开始使用ZYNRELEF,但使用过程中还需要一些适应时间。公司预计随着更多医院纳入ZYNRELEF,新适应症的使用将在第三、四季度体现出来。 CINVANTI的强劲表现反映了该产品在竞争环境中保持了良好的市场份额和价格水平,公司对此感到乐观。[36][37][38][41] 问题2 **Carl Byrnes 提问** 考虑到需求趋势改善、成本降低和毛利率提升,公司是否有可能提前于第四季度实现盈利? [45] **Ira Duarte 回答** 公司对业务发展感到非常满意,但仍保持谨慎态度,主要考虑到仍存在的一些诉讼问题。公司将努力控制费用,有望达到较低端的费用指引范围,这可能会提前实现盈利。但目前公司仍然坚持第四季度实现盈利的预期。[46][47][48][49] 问题3 **Tim Chiang 提问** 公司计划如何扩大CrossLink销售团队的覆盖范围,特别是在佛罗里达等大州? [53][54] **David Barozzino 回答** 公司正在每周进行2-3次的现场培训,计划在2024年底前实现在全50个州的覆盖。佛罗里达、纽约、德克萨斯和加利福尼亚等大州是重点关注区域,公司正在与当地经销商进行积极沟通。[57][58][59][60]

Heron Therapeutics (HRTX) reported $34.67 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 17.1%. EPS of -$0.02 for the same period compares to -$0.27 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $32.5 million, representing a surprise of +6.68%. The company delivered an EPS surprise of +75.00%, with the consensus EPS estimate being -$0.08.While investors closely watch year-over-year changes in headline numbers -- revenue and earnin ...

Heron Therapeutics (HRTX) came out with a quarterly loss of $0.02 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to loss of $0.27 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 75%. A quarter ago, it was expected that this pharmaceutical company would post a loss of $0.15 per share when it actually produced a loss of $0.07, delivering a surprise of 53.33%.Over the last four quarters, the compa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ Commission file number: 001-33221 HERON THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 94-2875566 (State or othe ...

318509926.1 Exhibit 99.1 Heron Therapeutics Announces First Quarter 2024 Financial Results and Highlights Recent Corporate Updates • Net Product Sales of $34.7 million, which increased from $29.6 million for the same period in 2023. Net Loss Per Share $(0.02), which decreased from $(0.27) for the same period in 2023. • Launched partnership with CrossLink Life Sciences, LLC to expand ZYNRELEF® promotional efforts in the first quarter of 2024. • Gross Margin improved to 76% for the quarter, up from 43% for th ...