Amphastar Pharmaceuticals (AMPH) 2025 Conference June 05, 2025 02:00 PM ET Speaker0 Good afternoon and welcome to day two of the Jefferies Global Healthcare Conference. My name is Dennis Ding, biotech analyst here. I have the great pleasure of having Amphastar Pharmaceuticals here up with me for fireside chat. We have CFO Bill Peters as well as the EVP of Corporate Administration Jacob Liawatadui, here with us. Welcome. Speaker1 Thank you. Thank you. Speaker0 So maybe to kick things off, like, don't you giv ...

All statements in this presentation and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other ...

纪要涉及的公司 Amphastar Pharmaceuticals (AMPH) 核心观点和论据 1. **2025年为转型年，销售先降后平**：2025年公司部分产品销售下滑，肾上腺素小瓶、胰高血糖素、Fotonodion等产品面临竞争，且FDA审批速度放缓；但公司有4个产品有望在今年实现2 - 3个产品的推出，预计年底销售增长，全年销售相对持平[1][2][3]。 2. **FDA效率有所提升**：尽管FDA有裁员情况，但公司实际经历显示其在某些方面效率更高，如进行了为期5天的检查，两个行动日期均达成，其中一个还提前一周[5][6]。 3. **政府调查带来机遇与挑战**：政府的232调查主要针对口服固体制剂、抗感染药等依赖中国的关键药物，公司在美国制造成品有机会，但依赖部分美国境外的组件和原料药，若对组件和原料药征税公司会处于劣势，若对成品征税则有利，目前不确定性大，公司参与相关讨论并密切关注[7][8][9]。 4. **AMP2产品获批信心提升**：FDA曾错过AMP2的行动日期，公司长期沟通未得到明确答复，近期因获得FDA药物短缺奖，公司高层与CEDAR主任交流后两周收到信息请求（IR），公司一天内响应，对该产品获批信心提高；该产品IQVIA销售额超5亿美元，市场无仿制药，有CGT指定，但获批情况不确定，且公司该产品制造能力有限，即使独家仿制药市场份额可能低于25%[12][13][23][34][38]。 5. **AMP7产品有望获批**：今年初收到轻微的完整回复函（CRL），预计在未来几周回复，第三季度有行动日期，获批后有180天排他期可能，若问题轻微监管审查时间可能为90天，有望成为2025年的业绩贡献者[40][41][42]。 6. **Primatene和Baqsimi业务竞争壁垒高**：Primatene Mist是OTC产品，市场规模1亿美元，因专利保护到明年且开发仿制药成本高、收益低，不太可能有竞争对手；Baqsimi有配方专利、设备专利及组合专利，有效期超10年，公司是唯一可将胰高血糖素放入特定设备的公司，产品难以被仿制，生命周期长[48][54][55]。 7. **MannKind合作效果初显**：公司与MannKind达成共同推广协议，支付其推广Baqsimi，双方实现共赢，公司扩大销售队伍且成本经济，已在脚本数据和医生推广方面看到效果，覆盖了公司未涉及的地区和医生[58][59][61]。 8. **产品销售峰值时间**：公司产品销售峰值将在向Lilly支付款项的五年期之后，但未明确具体时间[65][67][68]。 9. **利润率难以回到去年水平**：去年因与Lilly交易有一次性事件，今年虽预计接下来四个产品推出后利润率高于一季度，但无法回到去年水平[69][70]。 10. **部分产品面临竞争压力**：胰高血糖素试剂盒一季度有新竞争对手Beatrice进入，二季度影响将更明显；肾上腺素多剂量小瓶业务去年有新竞争对手，销量、利润率和价格下降，目前预填充注射器业务规模超过多剂量小瓶[71][72]。 11. **资本分配优先考虑内分泌和专利产品**：公司倾向于在内分泌领域扩张，同时关注专利产品领域，寻找合适的内分泌产品或利用自身制造专长开发其他领域产品[76][77]。 12. **胰岛素业务有优势**：公司胰岛素走可互换途径，患者转换关键；已在胰岛素生产上进行大量投资，包括在法国购买API设施、在中国建设API制造和在美国建设高速成品生产线，目前产能未充分利用，后续无需大量资本支出，相信能以高于当前50%的利润率销售胰岛素[79][80][82]。 其他重要但可能被忽略的内容 - 公司曾对AMP2与FDA有16次互动，但此前未得到有效反馈，此次收到IR后认为取得进展[18]。 - 公司预计今年实现销售持平需两个产品贡献业绩，对各产品推出概率进行加权计算[44][46]。 - 公司因在肾上腺素预填充注射器短缺时供应100%市场获得FDA短缺奖，且有能力供应所有短缺产品，但市场多为双来源供应[73][74]。

生物科技论坛动态 - 近期论坛讨论集中在covered call策略机会上 投资者可注册两周免费试用实时获取交易观点 [1] - The Biotech Forum提供包含12-20只高潜力生物科技股的模拟组合 以及实时交易讨论和周度研究报告 [1] - 论坛每周更新市场评论和投资组合情况 [1] Amphastar制药公司分析 - 该公司(纳斯达克:AMPH)作为小型制药商重新受到关注 2025年初被指出股价处于低位 [1] - 分析师披露持有AMPH的多头头寸 包括股票、期权或其他衍生品 [2] 注：文档3为合规披露内容，按任务要求不予提取。所有数据引用均保留原文数值单位，未涉及风险提示等非核心信息。

Table of Contents 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 transition period from to Commission file number 001-36509 AMPHASTAR PHARMACEUTICALS, INC. (Exact name of Registrant as specified in its charter) Delaware 33-0702205 (State or other jurisdiction of incorporation or organization) 11570 6 th Street Rancho Cucamonga, CA 91730 (Address of principal executive offices) ...

Amphastar Pharmaceuticals (AMPH) reported $170.53 million in revenue for the quarter ended March 2025, representing a year-over-year decline of 0.8%. EPS of $0.74 for the same period compares to $1.04 a year ago.The reported revenue represents a surprise of -0.69% over the Zacks Consensus Estimate of $171.71 million. With the consensus EPS estimate being $0.66, the EPS surprise was +12.12%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compar ...

Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.74 per share, beating the Zacks Consensus Estimate of $0.66 per share. This compares to earnings of $1.04 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 12.12%. A quarter ago, it was expected that this specialty pharmaceutical company would post earnings of $0.96 per share when it actually produced earnings of $0.92, delivering a surprise of -4.17%.Over t ...

Amphastar Pharmaceuticals (AMPH) Q1 2025 Earnings Call May 07, 2025 05:00 PM ET Company Participants Dan Dischner - Senior Vice President of Human Resources & Corporate CommunicationBill Peters - EVP, CFO & DirectorTony Marrs - Executive VP of Regulatory Affairs & Clinical OperationsCerena Chen - VP - Biotech and Pharma Equity Research Conference Call Participants David Amsellem - Sr. Research AnalystJason Gerberry - MD & Equity Research Analyst - Biotech & PharmaEkaterina Knyazkova - AnalystNone - Analyst ...

Amphastar Pharmaceuticals (AMPH) Q1 2025 Earnings Call May 07, 2025 05:00 PM ET Company Participants Dan Dischner - Senior Vice President of Human Resources & Corporate CommunicationBill Peters - EVP, CFO & DirectorTony Marrs - Executive VP of Regulatory Affairs & Clinical OperationsCerena Chen - VP - Biotech and Pharma Equity Research Conference Call Participants David Amsellem - Sr. Research AnalystJason Gerberry - MD & Equity Research Analyst - Biotech & PharmaEkaterina Knyazkova - AnalystNone - Analyst ...

Corporate Presentation May 2025 Highly Purified Peptide/Protein Proprietary Injectables Inhalation Intranasal Biosimilar Interchangeable Complex Generic Combination Products Forward Looking Statements This presentation and the accompanying oral presentation contain forward-looking statements, of Amphastar Pharmaceuticals, Inc. ("Amphastar", "we". "our" and that are based on our management's current expectations and assumptions and on information currently available to management. Forward-looking statements ...