Theratechnologies Faces Potential Supply Disruption For Its Top Selling Drug, Warns of Revenue Impact Due To Manufacturing Delays
Theratechnologies Faces Potential Supply Disruption For Its Top Selling Drug, Warns of Revenue Impact Due To Manufacturing Delays
The FDA review timeline could delay the resumption of product distribution, but the company is actively working with its manufacturer and the FDA to minimize patient impact.On Tuesday, Theratechnologies Inc. (NASDAQ:THTX) warned of a potential temporary supply disruption of Egrifta SV (tesamorelin for injection) in early 2025.
周二，Theratechnologies公司（纳斯达克股票代码：THTX）警告称，Egrifta SV（注射用特萨莫瑞林）可能在2025年初出现暂时的供应中断。
The FDA has approved Egrifta SV as the only treatment for HIV-related excess visceral abdominal fat.
FDA已批准Egrifta SV作为治疗艾滋病相关过多内脏腹部脂肪的唯一疗法。
The interruption is linked to an unexpected voluntary shutdown of the contract manufacturer's facility following an FDA inspection.
供应中断与合同制造商的设施由于FDA的检查而意外自愿停产有关。
The FDA review timeline could delay the resumption of product distribution, but the company is actively working with its manufacturer and the FDA to minimize patient impact.
FDA的审核时间表可能会延迟产品的再分发，但公司正在积极与其制造商和FDA合作，以最小化对患者的影响。
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Paul Lévesque, President and CEO of Theratechnologies, expressed confidence that patient needs in 2025 will be met despite this disruption.
Theratechnologies的总裁兼首席执行官Paul Lévesque表示，尽管出现这种中断，2025年患者的需求仍将得到满足，并对此表示信心。
To mitigate the risk of shortages, Theratechnologies plans to implement measures to manage Egrifta SV inventory levels through early January 2025.
为了减少短缺的风险，Theratechnologies计划通过2025年1月初采取措施来管理Egrifta SV的库存水平。
However, due to the supply challenges, the company anticipates a revenue shortfall of approximately $1.6 million for its fiscal year 2024.
然而，由于供应挑战，该公司预计其2024财年的营业收入将出现约160万美元的差额。
The contract manufacturer's facility underwent a voluntary three-month shutdown to address observations made by the FDA's Office of Compliance, which were unrelated to the Egrifta SV manufacturing process but concerned the facility's environment.
该代工厂自愿关闭了三个月，以解决FDA合规办公室提出的观察结果，与Egrifta SV制造过程无关，但与工厂环境有关。
The manufacturer aims to resume operations by mid-October, with the first batch of Egrifta SV slated for production on October 21.
该制造商计划在10月中旬恢复运营，首批Egrifta SV的生产预计于10月21日开始。
Theratechnologies must file a Prior Approval Supplement (PAS) with the FDA detailing changes made at the facility, which is expected around the manufacturing date. The FDA typically reviews PAS filings within four months.
Theratechnologies必须向FDA提交一份先前批准补充申请（PAS），详细说明工厂所做的更改，预计将在制造日期附近进行。FDA通常在四个月内审查PAS申请。
As the company's annual filing, it does not own or operate its manufacturing facilities and relies on third-party suppliers, such as Bachem, Jubilant, and Lyophilization Services of New England, to produce Egrifta SV.
作为公司的年度申报文件，其不拥有或经营制造设施，而是依赖第三方供应商（如Bachem、Jubilant和Lyophilization Services of New England）来生产Egrifta SV。
The company has not qualified alternative manufacturers, and the validation process for new suppliers could take up to three years, complicating any potential transition.
公司尚未对备选制造商进行评估，而向新供应商的验证过程可能需要长达三年的时间，从而使任何潜在的过渡变得复杂。
Price Action: THTX Stock is up 4.16% at $1.25 at the last check on Thursday.
价格走势：THTX股票上涨4.16%，报价为$1.25（最后一次查询为周四）。
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