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Bluebird Bio, a company that steered three gene therapies to FDA approval but struggled to commercialize them, has found the cash it needs to put those therapies on stronger financial footing by
Bluebird Bio是一家成功将三种基因疗法推向FDA批准但难以将其商业化的公司,现已找到资金,以将其疗法置于更坚实的财务基础上。
reaching a deal
达成协议
to sell itself to two private equity firms for about $29 million.
以大约2900万美元的价格将自己出售给两家私募股权公司。
Carlyle and SK Capital Partners have agreed to pay $3 in cash for each share of Bluebird, the biotech announced Friday. That price is a 57% discount to the company’s closing stock price Thursday. The deal is heavily backloaded. Bluebird shareholders could receive $66.8 million more, but only if the company’s gene therapies achieve a specified sales goal..
凯雷集团和SK资本合伙人公司已同意为蓝鸟生物的每股股票支付3美元现金,这家生物技术公司周五宣布。这一价格较该公司周四的收盘价折让57%。该交易严重偏向后期回报。蓝鸟生物的股东可能还会额外获得6680万美元,但前提是该公司的基因疗法达到特定的销售目标。
When the deal closes, Bluebird will be led by new CEO David Meek, whose industry experience includes the chief executive roles at Mirati Therapeutics and Ipsen. Bluebird said Carlyle and SK Capital will provide the biotech with the primary capital to scale the commercial delivery of its gene therapies, pricey one-time treatments that offer patients a potential cure..
当交易完成时,Bluebird 将由新任首席执行官 David Meek 领导,他的行业经验包括在 Mirati Therapeutics 和 Ipsen 担任首席执行官。Bluebird 表示,凯雷集团和 SK Capital 将为这家生物技术公司提供主要资本,以扩大其基因疗法的商业化推广,这些昂贵的一次性治疗为患者提供了潜在的治愈可能。
Exclusive
独家的
Improving the Healthcare Financial Experience to Help Care Flow
改善医疗金融体验,助力医疗流程顺畅
Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all.
Zelis 首席执行官阿曼达·艾塞尔分享了她对公司如何解决碎片化健康金融系统问题以造福所有人的看法。
By Stephanie Baum
作者:斯蒂芬妮·鲍姆
While Bluebird has been generating revenue from its FDA-approved gene therapies, it has also relied heavily on a particular financial vehicle to cover expenses, such as the manufacturing of these complex therapies. The 2022 FDA approvals of
虽然蓝鸟公司已经通过其获得FDA批准的基因疗法产生了收入,但它也严重依赖一种特定的金融工具来支付诸如这些复杂疗法的制造等费用。2022年FDA批准了
Zynteglo, for the rare blood disorder beta thalassemia
Zynteglo,用于治疗罕见的血液疾病β-地中海贫血
, and
,以及
Skysona, for the ultra-rare neurological disease cerebral adrenoleukodystrophy
Skysona,用于治疗超罕见的神经系统疾病肾上腺脑白质营养不良
, each came with a priority review voucher. These vouchers are typically awarded to a new therapy that is first to treat a rare disease. The voucher program was intended to encourage more rare disease drug R&D, and companies awarded PRVs may apply them toward speedier FDA review of a future rare disease therapy.
,每个都附带一个优先审查券。这些券通常授予首个治疗罕见病的新疗法。该券计划旨在鼓励更多罕见病药物的研发,获得优先审查券的公司可将其用于未来罕见病疗法的更快FDA审查。
However, biotechs typically view these vouchers as non-dilutive financing that’s monetized by selling them to big pharma companies at prices topping $100 million..
然而,生物技术公司通常将这些券视为非稀释性融资,通过以超过1亿美元的价格出售给大型制药公司来实现货币化。
Bluebird found buyers for the PRVs awarded for the Zynteglo and Skysona approvals. But the 2023 FDA approval of Lyfgenia in sickle cell disease did not come with a voucher. That approval was announced concurrent with the
Bluebird 为 Zynteglo 和 Skysona 的获批所奖励的 PRVs 找到了买家。但 2023 年 FDA 对镰状细胞病药物 Lyfgenia 的批准并未附带券。该批准与
regulatory nod for Casgevy, a Vertex Pharmaceuticals gene therapy
监管机构对Casgevy点头,这是一种Vertex Pharmaceuticals的基因疗法
for the same indication. Casgevy’s approval did come with a PRV. Financial analysts who follow Bluebird noted that lacking a voucher to monetize would make commercialization of Lyfgenia challenging.
用于相同的适应症。Casgevy的批准确实附带了一张优先审评券(PRV)。关注Bluebird的金融分析师指出,缺乏可变现的券将使Lyfgenia的商业化具有挑战性。
In 2024, Bluebird entered a series of debt agreements to support its operations. The company also appealed the FDA denial of a PRV for Lyfgenia. The agency denied the biotech’s appeals three times. Last September, Bluebird implemented a restructuring that cut 94 employees, representing about 25% of its workforce.
2024年,蓝鸟公司签订了一系列债务协议以支持其运营。该公司还对FDA拒绝为Lyfgenia颁发优先审评券(PRV)提出了上诉。该机构三次拒绝了这家生物技术公司的上诉。去年九月,蓝鸟公司实施了一项重组计划,裁减了94名员工,约占其员工总数的25%。
As of the end of the third quarter of 2024, Bluebird .
截至2024年第三季度末,蓝鸟公司 。
reported
已报告
its cash position was $70.7 million. The company projected it would have enough money to last into the first quarter of 2025. The dwindling cash put the company at risk of defaulting on its loans.
其现金头寸为7070万美元。该公司预计其资金将足够支撑到2025年第一季度。不断减少的现金使公司面临贷款违约的风险。
Bluebird said Friday that the sale agreement follows a comprehensive review that included meeting with more than 70 potential investors and partners over the course of five months. The board of directors determined that without a significant infusion of capital, Bluebird was at risk of loan default, leaving acquisition by Carlyle and SK Capital as “the only viable solution to generate value for stockholders.”.
蓝鸟公司在周五表示,这项出售协议是在进行了全面审查之后达成的,审查过程包括在五个月内与70多位潜在投资者和合作伙伴会面。董事会认为,如果不进行大规模的资本注入,蓝鸟公司面临贷款违约的风险,因此被凯雷集团和SK资本收购是“为股东创造价值的唯一可行方案”。
presented by
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What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations
什么让医疗行业的首席信息官夜不能寐:在技术投资与消费者期望之间取得平衡
When it comes to managing inbound phone calls, underperformance has devastating cost implications.
当谈到管理来电时,表现不佳会带来毁灭性的成本影响。
By Stephanie Baum
作者:斯蒂芬妮·鲍姆
“After an extensive review process, this acquisition represents the best path forward — maximizing value for stockholders and bringing significant capital, commercial expertise, and a commitment to provide more patients the opportunity to benefit from potentially transformative gene therapies,” current Bluebird CEO Andrew Obenshain said in a prepared statement..
“经过广泛的审查过程,此次收购代表了前进的最佳路径——最大化股东价值,并带来大量的资本、商业专业知识,以及致力于为更多患者提供机会受益于潜在的变革性基因疗法,”现任蓝鸟生物首席执行官安德鲁·奥本沙因在一份准备好的声明中表示。
Beyond the upfront payment, Bluebird shareholders could receive $6.84 more per share under a contingent value right (CVR) included in the agreement. Shareholders will get that cash if the company’s gene therapies achieve $600 million in net sales in any 12 consecutive month period up to the end of 2027..
根据协议中包含的或有价值权(CVR),除了预付款外,蓝鸟生物的股东每股可能再获得6.84美元。如果该公司在2027年底前的任何连续12个月内,其基因疗法实现6亿美元的净销售额,股东将获得这笔现金。
To William Blair analyst Sami Corwin, the probability of Bluebird achieving the CVR revenue goal is low. In a note sent to investors, Corwin said her firm models Bluebird net sales of $282.9 million for this year, $409.4 million for 2026, and $546.4 million for 2027. She said Bluebird’s dwindling cash and distance from profitability made a transition away from the public markets likely inevitable.
威廉·布莱尔分析师萨米·科温认为,蓝鸟实现CVR收入目标的可能性很低。科温在发送给投资者的报告中表示,她所在的公司预计蓝鸟今年的净销售额为2.829亿美元,2026年为4.094亿美元,2027年为5.464亿美元。她指出,蓝鸟不断减少的现金以及距离盈利的遥远,使得其退出公开市场几乎成为不可避免的趋势。
But she also noted the hefty discount of the acquisition price, which led to the stock trading down about 40% following the announcement of the deal..
但她也指出了收购价格的高额折扣,这导致该交易宣布后股价下跌了约40%。
The Bluebird acquisition, which still needs the customary approvals, is expected to close in the first half of this year. When the transaction is complete, Bluebird shares will no longer be publicly traded.
蓝鸟收购案还需要完成惯例的审批程序,预计在今年上半年完成。交易完成后,蓝鸟公司的股票将不再公开交易。
Pfizer’s Gene Therapy Pullback Continues With Termination of Beqvez
辉瑞继续缩减基因治疗领域,终止了Beqvez项目。
Bluebird Bio isn’t the only company with gene therapy commercialization challenges. Pfizer is discontinuing development and commercialization of hemophilia B gene therapy Beqvez less than a year after it
Bluebird Bio 并不是唯一一家面临基因治疗商业化挑战的公司。辉瑞在推出 B 型血友病基因疗法 Beqvez 不到一年后,便停止了其开发和商业化工作。
landed FDA approval
获得了FDA的批准
.
。
In a statement to Nikkei Asia, which was
在一份提供给《日经亚洲》的声明中,
first to report
第一个报告
the development Thursday, Pfizer cited limited interest from patients and physicians. That tracks with the experiences of
周四,辉瑞公司提到了患者和医生兴趣有限。这与经历相符。
CSL Behring, which markets the hemophilia B gene therapy Hemgenix
营销血友病B基因疗法Hemgenix的CSL Behring公司
, and BioMarin Pharmaceutical, maker of the
,以及生产该药物的BioMarin制药公司,
hemophilia A gene therapy Roctavian
血友病A基因疗法Roctavian
. Pfizer’s discontinuation of Beqvez comes two months after the pharma giant
辉瑞停止Beqvez的供应是在这家制药巨头两个月前
gave Sangamo Therapeutics a termination notice for the partnership on a hemophilia A gene therapy
给了Sangamo Therapeutics一份关于血友病A基因治疗合作的终止通知
that was being prepared for an FDA submission.
那正被准备用于FDA的提交。
Pfizer has been culling gene therapy from its portfolio and pipeline. In 2023, the pharma giant
辉瑞公司一直在从其产品组合和研发管线中削减基因疗法。2023年,这家制药巨头
sold its preclinical gene therapies
出售了其临床前基因疗法
to Alexion, the rare disease subsidiary of AstraZeneca. Last summer, Pfizer announced the
给阿斯利康的罕见病子公司Alexion。去年夏天,辉瑞宣布了
discontinuation
停止,终止
of its gene therapy for Duchenne muscular dystrophy, a move followed a
其基因疗法用于治疗杜氏肌营养不良症,此举随后被跟随。
Phase 3 failure
第三阶段失败
.
。
Hemophilia patients still have treatment options. Infusions of clotting proteins and regular dosing of certain drugs may be chronic therapies, but patients are familiar with them and apparently, comfortable continuing with them rather than opting for the expensive but one-time treatment from gene therapy.
血友病患者仍有治疗选择。输注凝血蛋白和定期服用某些药物可能是长期疗法,但患者已经熟悉这些方法,并且显然愿意继续使用它们,而不是选择昂贵但一次性的基因治疗。
Despite Pfizer’s pullback from gene therapies for hemophilias, the company still has a presence in these blood disorders. Last October, the .
尽管辉瑞公司已经退出了血友病的基因疗法,但该公司在这些血液疾病领域仍然占有一席之地。去年十月,。
FDA approved Hympavzi
FDA批准了Hympavzi
, a once-weekly injectable antibody drug that Pfizer developed as a treatment for both hemophilia A and B.
,一种每周注射一次的抗体药物,辉瑞公司将其开发为治疗甲型和乙型血友病的药物。
Photo: crazydiva, Getty Images
照片来源:crazydiva,Getty Images
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