APL-2006

关注并星标CPHI制药在线   今年下半年以来，据不完全统计，美国已经有53家生物医药企业宣布裁员，当然Biotech是里面的裁员绝对主力，裁员潮有一举超越上半年的趋势。根据Fierce网站统计数据，今年上半年累计有83家生物医药企业裁员，相比2022年上半年的60家增加了40%。       止不住的裁员潮也直接反映了目前行业的颓势，但令人遗憾的是，目前行业颓势仍旧没有上扬趋势，反而在8月以来，随着几家明星Biotech企业的裁员，让行情仿佛又来到了新一轮谷底。       连续三家明星Biotech裁员       8月29日，作为补体药物开发领先者之一的Apellis Pharmaceuticals宣布将对公司组织进行调整，计划裁减225名员工，即当前员工人数的25%，力求到2024年节省3亿美元总成本，同时宣布放弃两项临床前项目（ APL-1030 以及 APL-2006），Apellis Pharmaceuticals同样也手握一款商业化产品，即用于治疗地图样萎缩（GA）的C3抑制剂Pegcetacopla（Syfovre）。       紧接着8月31日， Sage Therapeutics 宣布计划重组公司的业务运营和管线开发等事项，以支持长期业务增长目标，包括 2026 年底在市场上推出针对女性产后抑郁症（PDD）的 ZURZUVAE，大手一挥宣布裁员40%，大约将辞退270名员工。       9月12日，开发出首款获批的CAR-T疗法Abecma的2seventy bio（Bluebird分拆）也宣布了裁员计划，其宣布启动一项全面的战略重组计划，旨在简化其业务运营和研发模式，包括推进更少的研发管线，以节省大量资金，并使公司走上长期增长的道路。作为重组的一部分，2seventy准备裁撤176个职位，即约40%的员工。       当然上述三家公司只是目前Biotech乃至生物医药裁员潮的缩影，已经有商业化产品的公司尚且如此，占绝大多数仍然在临床甚至临床前阶段探索的Biotech的行情如何也是不言而喻，如何跑过行业谷底寒冬生存下来，是每一个行业从业者在近两年必须要面对的问题。       全球裁员潮愈演愈烈       上文已经提及，今年下半年以来，据不完全统计，美国已经有超过50家生物医药企业宣布裁员，现将宣布裁员的公司进行简单情况梳理，如下表所示：       寒冬之下，Biotech公司的融资难度在不断上升，裁员其实主要也分为以下几点原因：首先大部分是遭遇临床挫折的公司或者没有关键进展的公司，因为无法继续融资被动裁员；另一方面也有许多Biotech为保证现金流安全选择主动裁员，通过削减成本保证安全进展到关键节点以进行下一轮融资；此外手握上市品种的公司因为商业化不及预期也只能选择精简团队，其实也都是无奈之举。       尽管整个医药行业的裁员潮愈演愈烈，但却出现了一个令人费解的现象，目前在美国市场上的职位空缺却并没有减少趋势，反而从今年三月份以来，美国市场对生命科学人才的需求量在与日俱增。根据咨询公司JLL的数据显示，今年6月的职位空缺为有记录以来的第六高，和2022年的峰值持平，同比增长高达11%。此外也有数据显示，目前企业端对AI制药领域的人才需求量正在暴增。       图1：美国生物医药行业职位空缺分析（来源：JLL）       与此同时，资金链短缺、缺少现金流来源的Biotech给了众多MNC机会，以相对较低的对价进行收并购，于是并购数量在近两年也有较大数量的增长。今年3月，辉瑞宣布斥资约430亿美元收购ADC龙头Seagen公司，以扩展其肿瘤学管线。赛诺菲宣布斥资近29亿美元收购了Provention Bio，囊获了Provention的核心产品-抗CD3的单克隆抗体teplizumab（TZIELD），其是去年11月获FDA批准的首 款能延缓1型糖尿病发作的药物。今年4月，默沙东宣布斥资约108亿美元收购Prometheus Biosciences，将获得Prometheus研发管线中抗TL1A单克隆抗体PRA023，并扩大其在免疫学领域的影响力，今年6月，诺华与Chinook Therapeutics达成了一项约35亿美元的协议和合并计划，扩充肾脏产品管线。       国内企业难以独善其身       尽管目前公开途径披露信息较少，但从其他途径也不难得知，从今年开始，国内医药企业裁员现象也是愈演愈烈，根据医药经济报信息，连日来从各家CXO企业陆续发布的2023年中报信息可以看到，与2022年年报的在职人员情况作对比，头部企业裁员压力山大，药明康德员工人数甚至骤降三千。       图2：CXO企业在职人数变化（来源：医药经济报）       CXO企业的人数减少直接反映出上游订单量减少，尽管还没有大量曝光，但目前已经有零零散散的消息显示国内的Biotech也在纷纷裁员，在全球行业不景气的情况下，国内当然也难以独善其身。       裁员潮乃至行业寒冬到底什么时候能回暖，你我也都在等待。       参考资料：       1. Biopharma Layoff Tracker 2023: 2seventy bio, Enlivex, CSL Vifor and More Cut Staff，Biospace；       2. 药明康德、凯莱英、昭衍新药等大裁员，最高超3000人！营收利润"双降"，CXO的增长逻辑还在吗？医药经济报；       3. https://www.drugdiscoverytrends.com/biotech-layoffs-job-openings-2023/；   智药研习社近期课程报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

Apellis Pharmaceuticals is laying off about 25% of its staff to find up to $300 million in savings, making it the latest biotech company that is shrinking now to find a way to grow in the future. The corporate shakeup will turn the company’s focus to selling an eye disease drug whose launch earlier this year has been clouded by post-marketing reports of a rare complication. The restructuring announced Tuesday will cut about 225 full time employees. As of the end of 2022, Waltham, Massachusetts-based Apellis reported its headcount was 767. The company said its field-based commercial and medical employees will be minimally affected by the cuts. Those workers will be tasked with the ramping up the commercialization of Syfovre, a drug approved in February for treating the vision-loss disorder geographic atrophy. Syfovre is a peptide drug designed to block C3, a protein of the complement system that’s associated with the excessive immune response contributing to geographic atrophy. In July, reports of a type of eye inflammation called occlusive retinal vasculitis surfaced in a small number of patients who received Syfovre. Apellis later confirmed the adverse effect in seven patients who received the drug, which is administered as an injection into the eye. No such complications were reported in clinical testing of Syfovre, and the company said there were no indications that the manufacturing process contributed to these adverse effects. In an update of its review of the eye complications, Apellis said last week that it identified variations in the 19-gauge filter needle included in certain injection kits. While Apellis said it has not found a causal relationship between this needle and the reported adverse effects, the company is recommending clinicians use kits with the 18-gauge filter needle. In the first half of this year, Apellis reported $85.7 million in Syfovre sales. The company said workers remaining following the restructuring will focus on supporting the U.S. commercial launch of the drug as well as potential launches in other markets. A European Medicines Agency decision is expected early next year. The company has prioritized an initial launch in Germany. The drug is still under review in Canada, Australia, the United Kingdom, and Switzerland. The commercialization push comes as Syfovre faces new competition from Izervay, an Astellas Pharma geographic atrophy drug that won its FDA approval in early August. As Apellis focuses its efforts on marketing Syfovre, it will scale back efforts on its first FDA-approved product, Empaveli. That drug, which contains pegcetacoplan, the same main component of Syfovre, is a treatment for the rare blood disorder paroxysmal nocturnal hemoglobinuria. But Empaveli has not become a big revenue generator for the company. In the first half of 2023, Apellis reported $42.7 million in revenue for that product. The restructuring will reduce the company’s expenses for that drug. Apellis will also shelve two preclinical programs: APL-030 for neurological disorders and APL-2006, a potential treatment for both geographic atrophy and the wet form of age-related macular degeneration. Apellis will continue developing a systemic version of pegcetacoplan for treating immune complex membranoproliferative glomerulonephritis and C3 glomerulopathy, two rare kidney diseases with no approved treatments. A Phase 3 study is underway testing the drug in both diseases. Preliminary data are expected in 2024. But Apellis will not start any new programs with systemic pegcetacoplan. The restructuring is expected to lead to up to $300 million in savings through 2024. In addition to $70 million in savings related to the layoffs, up to $230 million is related to eliminating planned external expenses. The layoffs will lead to a one-time charge of between $9 million and $11 million, which will be incurred mainly in the second half of this year. “These were difficult, but necessary, decisions,” Apellis CEO Cedric Francois said in a prepared statement. “We are thankful for the commitment and contributions of our colleagues who have worked relentlessly to advance life-changing medicines for some of the most challenging diseases patients face.”