Urinary Incontinence, Stress

近日，“东北药茅”长春高新发布的2023年年报中披露了大额分红计划，计划每10股派发现金红利45元。在生长激素纳入部分地区集采的不利局面之下，长春高新依然能够高调地响应号召大额分红，格局实在让人敬佩。或许是子公司百克生物带状疱疹疫苗营收的爆发给了长春高新这样撒钱的底气。然而，细究之下，长春高新并未如市场流言描述的那样不堪，支柱仍旧坚挺，“爆品”正在来袭。支柱屹立不倒根据最新年报，2023年，长春高新总营收制药板块总营收136.13亿元，同比增长13.93%；净利润45.32亿元，增长9.47%；归母扣非净利润45.16亿元，增长9.63%。其中，基因工程/生物类药品营收129.11亿元，增长14.35%；中成药营收7.03亿元，增长6.72%。以子公司为单位看，2023年，金赛药业实现收入110.84亿元，同比增长8.48%；百克生物实现收入18.25亿元，增长70.30%；华康药业实现收入7.03亿元，增长6.73%。长春高新2023年主要营收数据来源：招股书从利润的贡献程度看，金赛药业实现归母净利润45.14亿元，同比增长7.04%，贡献了超99%的净利。这一靓丽的数据一举击破了市场对长春高新不利的传言，极大地安抚了投资者的恐慌情绪。不过在过去的两年中，长春高新的挑战确实是巨大的。2022年3月，广东联盟双氯芬酸等药品集中带量采购中，金赛药业的生长激素粉针产品中选，相对最高有效申报价的降幅达52.46%；2022年11月，粉针中标福建省带量集采；2022年11月，粉针中标河北省集采。此外，在2023年11月浙江省第四批集采结果公告中，金赛药业、安科生物的短效水针、短效粉针以及未名海济、联合赛尔的短效粉针中标。尽管长春高新在2023年半年报中就曾表示过集采相关产品收入增幅高于公司整体生产激素产品的收入增幅，基本实现了以价换量的目标，但依旧无法遏制住市场流言。加上此前的集采开始执行，集采利刃的重挫不说伤筋动骨，至少在市值上已经很受伤，连续两年多的跌势十分难看。难道生长激素的前景真的已经蒙尘？基因重组人生长激素（rhGH）已经成为现代生物技术生产的重要产品之一，目前国内市场在售的生长激素类型有三种，分别为短效生长激素（粉针剂）、短效生长激素（水针剂）、以及长效生长激素（水针剂）。短效生长激素需要每日注射给药，而长效生长激素每周仅需注射一次，能减少因注射相关的不适，是解决儿童用药依从性差的重要手段之一。在国内，这三款产品的竞争格局呈金字塔型。1998年，金赛药业在国内上市了第一款重组人生长激素粉针剂，也是目前竞争厂家最多的一款产品，共有7家企业的粉针获得中国上市许可，其中5家中国企业、2家外企；2005年，金赛药业获批上市国内第一款短效水针剂，目前仅有金赛药业、安科生物和诺和诺德3家企业获批生产；2014年，金赛药业的聚乙二醇化重组人生长激素水针剂（金赛增）获批上市，是我国首个、且目前唯一市场在售的长效人生长激素。国内已上市的生长激素产品来源：民生证券从历年金赛药业各剂型生长激素收入占比看，粉针剂型占其营收比重较低，短效水针营收占比最多，而长效水针目前处于放量增长阶段。根据药渡数据，集采前后，长春高新生长激素整体院内市场的市占率未发生明显变化，2020-2023年前三季度，市占率分别为77.26%、75.86%、76.77%和77.55%，独霸市场。国内2023年前三季度生长激素院内市场格局来源：药渡数据随着人们生活水平的提高，对生长激素认识的不断加深，未来生长激素的市场规模还将继续扩大。生长激素临床应用主要为治疗矮小症，目前我国接受正规治疗比例较低。根据第七次人口普查数据，按我国需要治疗的4-15岁人群基数及约3%的患病率计算，现存矮小症发病人数约640万。目前病理性矮小症通常可通过皮下注射补充生长激素以进行治疗，这一治疗方法逐渐得到广泛认可和应用。但据中华医学会数据显示，矮小症主要人群得到规范化治疗的比例低于5%。另一方面，我国重组人生长激素在成人市场运用较为匮乏。在美国大约有75%的生长激素使用者年龄超过20岁，而他们用生长激素的主要目的在于抗衰老和增肌，类比下来，发展国内重组人生长激素成人市场也具备可行性。因此在需求端，生长激素这个产品本身依然有着巨大的有效需求未被满足，整个生长激素的价值创造远远没有到头。当然，“单品独大”的局面是危险的，长春高新也非常清楚，如何摆脱生长激素依赖症，是其今后发展的重点。在研发管线中，有多个可能的“爆品”正在呼之欲出，不仅如此，其另一增长的长矛百克生物也已破土，一切都在向好的方向发展。重磅登场撑未来百克生物在2023年收获了一款重磅疫苗----带状疱疹疫苗（商品名：感维）。带状疱疹疫苗在国内的关注度不亚于HPV疫苗，甚至在市场规模上可能更大，主要是因为中国的带状疱疹疫苗接种率太低了，50岁以上人群的接种率仅0.31%。在百克生物的带状疱疹减毒活疫苗获批上市之前，在中国只有一款葛兰素史克（GSK）的基因重组亚单位疫苗Shingrix（欣安立适）上市销售。欣安立适于2020年在中国获批，但由于定价的问题，该款疫苗在中国的销售业绩并不理想。此前，根据上海疾控中心公布的价格，欣安立适的价格为1603.5元/剂，全接种价格为3207元（两剂），在一些私立医疗机构接种的价格普遍在3600元-4500元。该疫苗为自费项目，这样的价格对大多数老人来说，比较难以接受。百克生物的感维虽然是减毒活疫苗，保护率不远及重组蛋白疫苗欣安立适。但感维也有自己的优势，首先是适用人群更广，其接种年龄下限为40岁，比欣安立适多10年；其次是感维仅需接种一针，每针售价1369元。相较于欣安立适需接种两针，每针售价1598元，感维具有一定的价格优势。因此我们看到，2023年百克生物实现了业绩大爆发，全年总营收18.25亿元，大增70.3%。其中，带状疱疹疫苗收入8.83亿元，仅用不到一年就赶超百克生物此前的支柱产品水痘疫苗。百克生物2023年营收组成来源：年报百克生物已长出獠牙，长春高新的焦虑就会消减不少。但长春高新似乎还不满足，在过去的2023年里，研发费用大增26.85%，达到17.23亿元，正在从硬件到软件全方面提升竞争力。在硬件建设上，子公司金赛药业全球科创总部及研发中心在上海张江国际医学园区开工建设；金赛药业创新软件医疗器械全国总部及产业集群落户重庆科学城，一期生产线正式投入生产；金赛药业数字化产业链贯通工程建设项目成功申请国家级重点项目，将通过数字化转型推动产业链贯通。在人才的投入上，长春高新也在不遗余力，截至2023年底，其相关研发人员已达有1329人，增长15.97%。重点在研方面，聚乙二醇重组人生长激素注射液特发性身材矮小（ISS）、先天性卵巢发育不全综合征（Turner综合征）所致儿童的生长障碍等适应症已进入上市评审阶段；增加小于胎龄儿（SGA）适应症已完成II期临床；成人生长激素缺乏适应症已开始III期临床，正在进行患者入组；已向美国FDA提交IND申请。注射用金纳单抗新增获批开展用于结缔组织病相关的间质性肺病（CTD-ILD）的临床试验。亮丙瑞林注射乳剂新增获批开展儿童中枢性性早熟、绝经前乳腺癌的临床试验，在晚期前列腺癌方面，已经完成III期临床；在儿童中枢性性早熟方面，该产品是目前国内首个获批开展临床研究的治疗儿童中枢性性早熟的6个月长效原位凝胶制剂，III期临床研究已完成首例患者入组工作。金妥昔单抗注射液在持续推进用于晚期胃或胃食管结合部腺癌适应症相关III期临床。EG017片（选择性雄激素受体调节剂）用于压力性尿失禁（SUI）、EG017软膏用于干眼症等适应症II期临床相关患者持续入组中。此外，NK3R小分子拮抗剂GS1-144、重组人促卵泡激素-CTP融合蛋白注射液、长效黄体酮周制剂GenSci125等临床试验都在有序推进中。长春高新2023年研发人员变动情况来源：年报百克生物虽然没有抓住新冠疫情的红利，但在后续产品的布局上，纵观国内同行，可与之匹敌的可不多见。目前形成了多层次的研发管线和丰富的项目储备，在研产品包括13种疫苗和3种传染病预防相关的单抗。其中，液体鼻喷流感疫苗即将申请上市许可，项目进展基本与预期一致；百白破疫苗（三组分）已完成I期临床试验，正在进行III期临床试验的准备工作；狂犬单抗正在进行I期临床研究；冻干狂犬疫苗（人二倍体细胞）以及破伤风单抗的临床试验申请已获得批准，即将开展I期临床研究。此外，百克生物的在研产品还包括RSV疫苗及抗体、阿尔茨海默病治疗性疫苗等，形成了阶梯化的产品管线，为未来产品的市场开拓打下良好基础。结语当然，如果非要追究长春高新的隐忧也不是没有，生育率降低算是一个。但同时，老龄化加重也带来了带状疱疹疫苗的增量。此消彼长之间，很难估算是否对长春高新存在不利。不过从长春高新发展战略中，我们也看到了它的努力，努力摆脱对生长激素的依赖，努力扩展其他产品的收入，努力丰富研发管线。在吃尽生长激素红利之后，长春高新的这些努力将撑起这家“东北药茅”的未来。后续发展如何，药渡还将持续关注。参考资料长春高新、百克生物年报、官网、公告等信达证券研报《长春高新，延续“好生意”模式》，经理人杂志，2024-02-18《7连板！快解套了》，芝士起源2024-03-20

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX) announced that its stockholders have voted today to adopt Axonics’ merger agreement with Boston Scientific Corporation (NYSE: BSX). According to preliminary voting results from the special meeting of stockholders held earlier today, a majority of the shares of Axonics’ common stock outstanding and entitled to vote at the special meeting voted in favor of adopting the merger agreement. Final voting results, as tabulated by an independent inspector of election, will be reported on a Form 8-K to be filed with the U.S. Securities and Exchange Commission. “We want to thank Axonics’ stockholders for their strong support of our transaction with Boston Scientific,” said Raymond W. Cohen, chief executive officer of Axonics. “Our team is looking forward to the global impact we can make as part of Boston Scientific as we endeavor to bring our life-changing therapies to more patients than ever before.” The closing of the transaction is expected to occur in the first half of 2024 and remains subject to certain conditions, including receipt of approvals or clearances, or the expiration, termination or waiver of applicable waiting periods under U.S. and foreign antitrust laws. About Axonics Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022. Axonics® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid®, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. For more information, visit . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like “may,” “will,” “likely,” “should,” “expect,” “anticipate,” “future,” “plan,” “believe,” “intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,” “continue,” and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics’ ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by and among Axonics, Boston Scientific Corporation (“Boston Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific (“Merger Sub”), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the “Merger”), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics’ ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics’ current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics’ business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics’ industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics’ competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics’ markets, and risks related to other factors described under “Risk Factors” in other reports and statements filed with the U.S. Securities and Exchange Commission (“SEC”), including Axonics’ most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics’ website at and on the SEC’s website at . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. View source version on businesswire.com: Contacts Axonics contact: Neil Bhalodkar IR@axonics.com Source: Axonics, Inc. View this news release online at:

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the Axonics R20™ rechargeable sacral neuromodulation (SNM) system has received CE Mark approval. The R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to once every 6 to 10 months for only one hour. The implant utilizes the same small 5cc form factor as the previous generation (Axonics R15™) and is paired with the same tined lead and intuitive, easy to use patient remote control. The R20 also provides physicians and their patients with enhanced programming capabilities and expanded MRI labeling. “Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said Raymond W. Cohen, chief executive officer. “Patients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The R20 represents another significant breakthrough for rechargeable neuromodulation devices and underscores Axonics’ commitment to continuous innovation. We are confident that our keen focus on the incontinence patient population has the potential to drive significant market expansion in both the U.S. and international markets in the years ahead.” Axonics expects to commence sales of the R20 to European customers in mid-April. The R20 received approval from the U.S. FDA in January 2023 and from Health Canada in December 2022. About Axonics Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022. Axonics® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid®, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. For more information, visit . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like “may,” “will,” “likely,” “should,” “expect,” “anticipate,” “future,” “plan,” “believe,” “intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,” “continue,” and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics’ ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by and among Axonics, Boston Scientific Corporation (“Boston Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific (“Merger Sub”), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the “Merger”), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics’ ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics’ current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics’ business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics’ industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics’ competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics’ markets, and risks related to other factors described under “Risk Factors” in other reports and statements filed with the U.S. Securities and Exchange Commission (“SEC”), including Axonics’ most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics’ website at and on the SEC’s website at . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. Additional Information and Where to Find It In connection with the contemplated Merger, Axonics filed on February 22, 2024 with the SEC a definitive proxy statement relating to a special meeting of Axonics’ stockholders to be held for the purpose of obtaining stockholder approval of the Merger Agreement and other related matters (the “Proxy Statement”). The Proxy Statement was mailed to Axonics’ stockholders on or about February 22, 2024. Axonics may also documents with the SEC regarding the contemplated Merger. This document is not a substitute for the Proxy Statement or any other document that Axonics has filed or may the SEC in connection with the contemplated Merger. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF AXONICS ARE URGED TO READ THE PROXY STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER SOLICITING MATERIALS AND ANY OTHER DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC IN CONNECTION WITH THE CONTEMPLATED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY CONTAIN OR WILL CONTAIN, AS APPLICABLE, IMPORTANT INFORMATION ABOUT AXONICS, BOSTON SCIENTIFIC AND THE CONTEMPLATED MERGER. Investors and security holders may obtain free copies of the Proxy Statement and other filings containing important information about Axonics on the SEC’s website at , on Axonics’ website at or by contacting Axonics’ Investor Relations department via email at IR@axonics.com. Participants in the Solicitation Axonics and its directors and executive officers may, under SEC rules, be deemed participants in the solicitation of proxies from the stockholders of Axonics in connection with the contemplated Merger. Information regarding the identity of potential participants in the solicitation of proxies in connection with the proposed Merger, and their direct or indirect interests, by security holdings or otherwise, is included in the Proxy Statement. Additional information regarding Axonics’ directors and executive officers is contained in the Proxy Statement, Axonics’ Definitive Proxy Statement on Schedule 14A for Axonics’ 2023 Annual Meeting of Stockholders, which was filed with the SEC on May 1, 2023 (and specifically, the following sections: “Security Ownership of Certain Beneficial Owners, Executive Officers and Directors”, “Certain Relationships and Related-Party Transactions”, “Executive Officers”, “Proposal 1–Election of Directors”, “Director Compensation”, and “Executive Compensation”) and in Axonics’ Current Report on Form 8-K, which was filed with the SEC on October 4, 2023. To the extent holdings of the Company’s securities by the directors or executive officers have changed since the amounts set forth in the Proxy Statement, such changes have been or will be reflected on Initial Statement of Beneficial Ownership of Securities on Form 3, Statement of Changes in Beneficial Ownership on Form 4, or Annual Statement of Changes in Beneficial Ownership on Form 5 filed with the SEC, which are available at EDGAR Search Results (sec.gov). These documents (when available) are available free of charge as described in the preceding section. View source version on businesswire.com: Contacts Neil Bhalodkar IR@axonics.com Source: Axonics, Inc. View this news release online at: