Theratechnologies Announces a Risk of a Temporary Supply Disruption for EGRIFTA SV® in Early 2025
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) announced a potential temporary supply disruption for EGRIFTA SV® in early 2025 due to its contract manufacturer's voluntary shutdown following an FDA inspection. The company is implementing measures to manage inventory levels until early January 2025, estimating a US$1.6 million shortfall in EGRIFTA SV® revenue for fiscal year 2024. Despite this, Theratechnologies remains confident in avoiding patient impact and delivering strong Adjusted EBITDA for the current fiscal year.
The manufacturer plans to resume activities by mid-October, with EGRIFTA SV® production scheduled for October 21, 2024. Theratechnologies must file a Prior Approval Supplement (PAS) with the FDA to resume distribution, which typically takes four months for review. The company will provide further updates on material developments.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) ha annunciato una potenziale interruzione temporanea della fornitura di EGRIFTA SV® all'inizio del 2025 a causa della chiusura volontaria del suo produttore contrattuale dopo un'ispezione della FDA. L'azienda sta attuando misure per gestire i livelli di inventario fino all'inizio di gennaio 2025, stimando un carenza di US$1,6 milioni nei ricavi di EGRIFTA SV® per l'anno fiscale 2024. Nonostante ciò, Theratechnologies rimane fiduciosa di evitare impatti sui pazienti e di raggiungere un forte EBITDA rettificato per l'anno fiscale attuale.
Il produttore prevede di riprendere le attività entro metà ottobre, con la produzione di EGRIFTA SV® programmata per il 21 ottobre 2024. Theratechnologies deve presentare un Supplemento per Approvazione Precedente (PAS) alla FDA per riprendere la distribuzione, che di solito richiede quattro mesi per la revisione. L'azienda fornirà ulteriori aggiornamenti su sviluppi significativi.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) anunció una posible interrupción temporal en el suministro de EGRIFTA SV® a principios de 2025 debido al cierre voluntario de su fabricante contratado tras una inspección de la FDA. La empresa está implementando medidas para gestionar los niveles de inventario hasta principios de enero de 2025, estimando un déficit de US$1.6 millones en los ingresos de EGRIFTA SV® para el año fiscal 2024. A pesar de esto, Theratechnologies sigue confiando en evitar impactos en los pacientes y en lograr un fuerte EBITDA ajustado para el año fiscal actual.
El fabricante planea reanudar actividades para mediados de octubre, con la producción de EGRIFTA SV® programada para el 21 de octubre de 2024. Theratechnologies deberá presentar un Suplemento de Aprobación Previa (PAS) a la FDA para reanudar la distribución, lo cual normalmente toma cuatro meses para la revisión. La empresa proporcionará más actualizaciones sobre desarrollos importantes.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX)는 FDA 검토 후 계약 제조업체의 자발적 폐쇄로 인해 2025년 초 EGRIFTA SV®의 잠재적인 일시적 공급 중단을 발표했습니다. 이 회사는 2025년 1월 초까지 재고 수준을 관리하기 위한 조치를 시행하고 있으며, 2024 회계 연도에 대한 160만 달러의 수익 부족을 예상하고 있습니다. 그럼에도 불구하고 Theratechnologies는 환자에게 영향을 미치지 않고 현재 회계 연도에 강력한 조정 EBITDA를 제공할 수 있다는 자신감을 가지고 있습니다.
제조업체는 10월 중순에 활동을 재개할 계획이며, EGRIFTA SV® 생산은 2024년 10월 21일로 예정되어 있습니다. Theratechnologies는 배급 재개를 위해 FDA에 사전 승인 보충서(PAS)를 제출해야 하며, 통상적으로 검토에는 4개월이 소요됩니다. 이 회사는 중요한 개발 사항에 대한 추가 업데이트를 제공할 것입니다.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) a annoncé une potentielle interruption temporaire de l'approvisionnement de EGRIFTA SV® début 2025 en raison de la fermeture volontaire de son fabricant sous contrat suite à une inspection de la FDA. L'entreprise met en œuvre des mesures pour gérer les niveaux d'inventaire jusqu'au début de janvier 2025, estimant un manque à gagner de 1,6 million de dollars US sur les revenus d'EGRIFTA SV® pour l'exercice fiscal 2024. Malgré cela, Theratechnologies reste confiante quant à l'absence d'impact sur les patients et à la réalisation d'un solide EBITDA ajusté pour l'exercice fiscal en cours.
Le fabricant prévoit de reprendre ses activités d'ici la mi-octobre, avec une production d'EGRIFTA SV® prévue pour le 21 octobre 2024. Theratechnologies doit déposer un Supplément de Demande d'Approbation Préalable (PAS) auprès de la FDA pour reprendre la distribution, ce qui prend généralement quatre mois pour être examiné. L'entreprise fournira des mises à jour supplémentaires sur les développements importants.
Theratechnologies Inc. (TSX: TH) (NASDAQ: THTX) kündigte eine mögliche vorübergehende Unterbrechung der Versorgung mit EGRIFTA SV® Anfang 2025 aufgrund der freiwilligen Schließung seines Vertragsherstellers nach einer FDA-Inspektion an. Das Unternehmen setzt Maßnahmen um, um die Bestände bis Anfang Januar 2025 zu verwalten, und schätzt ein Fehlbetrag von 1,6 Millionen US-Dollar bei den EGRIFTA SV®-Einnahmen für das Geschäftsjahr 2024. Trotz dieser Umstände ist Theratechnologies zuversichtlich, negative Auswirkungen auf Patienten zu vermeiden und ein starkes bereinigtes EBITDA für das laufende Geschäftsjahr zu erzielen.
Der Hersteller plant, seine Aktivitäten bis Mitte Oktober wieder aufzunehmen, wobei die Produktion von EGRIFTA SV® für den 21. Oktober 2024 vorgesehen ist. Theratechnologies muss einen Antrag auf vorherige Genehmigung (PAS) bei der FDA einreichen, um die Verteilung wieder aufzunehmen, was normalerweise vier Monate für die Prüfung in Anspruch nimmt. Das Unternehmen wird weitere Informationen zu wichtigen Entwicklungen bereitstellen.
- Theratechnologies remains confident in avoiding patient impact in 2025
- The company expects to deliver strong Adjusted EBITDA in the current fiscal year
- Manufacturer plans to resume activities by mid-October 2024
- EGRIFTA SV® production is scheduled for October 21, 2024
- Risk of temporary supply disruption for EGRIFTA SV® in early 2025
- Estimated US$1.6 million shortfall in EGRIFTA SV® revenue for fiscal year 2024
- FDA review of Prior Approval Supplement (PAS) may take up to four months
- Potential impact on Q4 2024 revenues due to inventory management measures
Insights
The unexpected shutdown of Theratechnologies' contract manufacturer's facility poses significant challenges for the company's EGRIFTA SV® supply chain. This disruption could lead to a
The FDA's observations, while not directly related to EGRIFTA SV®'s manufacturing process, highlight regulatory compliance issues that could have broader implications for the contract manufacturer's operations. The required Prior Approval Supplement (PAS) adds a layer of uncertainty, with a four-month FDA review timeline potentially extending the supply disruption.
Despite these challenges, management's confidence in avoiding patient impact and maintaining strong Adjusted EBITDA suggests underlying operational resilience. Investors should closely monitor the PAS approval process and any updates on remediation efforts, as these will be critical for normalizing supply and revenue streams.
Theratechnologies' supply chain vulnerability is evident in this situation. Relying on a single contract manufacturer for a key product like EGRIFTA SV® exposes the company to significant risks. The three-month voluntary shutdown and subsequent FDA review process create a precarious timeline, potentially leading to supply shortages in early 2025.
The company's ability to manage inventory levels until January 2025 is commendable, but it's a short-term solution. Long-term strategies should focus on diversifying manufacturing sources or bringing production in-house to mitigate future risks. The
Investors should consider how Theratechnologies plans to strengthen its supply chain resilience and whether this incident will prompt a reevaluation of its manufacturing partnerships and risk management strategies.
The FDA's observations at the contract manufacturer's facility, while not directly related to EGRIFTA SV®, raise concerns about the overall quality control and compliance standards. The requirement for a Prior Approval Supplement (PAS) indicates that the changes made are significant enough to warrant thorough FDA review.
The four-month review timeline for the PAS is standard, but it introduces a critical bottleneck in resuming normal operations. Theratechnologies' ability to swiftly prepare and submit a comprehensive PAS will be crucial. The company's proactive approach in working closely with the FDA is positive, but the outcome remains uncertain.
This situation highlights the importance of maintaining robust quality systems across the entire supply chain. Investors should assess Theratechnologies' oversight of its contract manufacturers and its ability to ensure compliance with evolving regulatory standards to prevent future disruptions.
MONTREAL, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced a risk of a temporary supply disruption for EGRIFTA SV® (tesamorelin for injection) in early 2025 caused by an unexpected voluntary shutdown of the Company’s contract manufacturer’s facility following an inspection by the US Food and Drug Administration (FDA), as well as the FDA review timeline to resume distribution of the product.
“We are collaborating closely with our manufacturer and other stakeholders and will continue to work with the FDA to resume production of EGRIFTA SV®,” said Paul Lévesque President and CEO at Theratechnologies. “We remain confident that we will avoid any impact on patients in 2025.”
The Company will implement measures to carefully manage the inventory levels of EGRIFTA SV® to meet patient demand until early January 2025, and estimates that these measures will result in a shortfall of approximately US
“Although this situation will affect revenues in the fourth quarter of 2024, we remain on track to deliver a strong Adjusted EBITDA in the current fiscal year and will be providing more details as part of the release of our third quarter results in October,” concluded Lévesque.
Background:
Theratechnologies’ manufacturer of EGRIFTA SV® recently implemented a three-month voluntary shutdown of its facility to address observations by the FDA Office of Compliance, following a plant inspection. The observations issued by the FDA are not related to the manufacturing process of EGRIFTA SV®, but rather related to the manufacturing environment of the facility. The manufacturer is finalizing its remediation measures and has confirmed to the Company that it plans to resume activities by mid-October. Based on these timelines, a batch of EGRIFTA SV® is currently scheduled to be manufactured on October 21, 2024.
In order to resume distribution of EGRIFTA SV®, Theratechnologies was requested by the FDA to file a Prior Approval Supplement (PAS) describing the changes made by its manufacturer. The Company expects to file the PAS on or around the manufacturing date. A PAS is reviewed by the FDA within four months of receipt.
The Company will update the market on any further material developments.
EGRIFTA SV® is distributed in the United States only.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”) within the meaning of applicable securities laws, that are based on management’s beliefs and assumptions and on information currently available to it. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them.
The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding: (i) the time period related to the availability of EGRIFTA SV® to patients; (ii) the effectiveness of the measures to be implemented by the Company to manage the inventory level of EGRIFTA SV®; (iii) the dates on which the Company’s manufacturer will resume its manufacturing activities and the manufacture of a new batch of EGRIFTA SV®; and (iv) the monetary impact on the Company’s revenue for the fiscal year 2024.
Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on these statements since actual results may vary from the Forward-Looking Statements contained in this press release. Certain assumptions made in preparing the Forward-Looking Statements include that: (i) the FDA will be satisfied with the remediation measures implemented by the manufacturer in response to the observations issued by the FDA and the manufacturer will resume its activities by mid-October and will manufacture a new batch of EGRIFTA SV® on October 21, 2024; (ii) no delay in the implementation of the remaining remediation measures at the manufacturer’s site will occur; (iii) the information allowing the Company to file a PAS will be available to the Company prior to October 21, 2024; (iv) the new batch of EGRIFTA SV® to be manufactured will meet the specifications for market release; (v) the FDA will approve the PAS as filed by the Company; (vi) current market demand for EGRIFTA SV® will remain unaffected; and (vii) the financial impact assessment made by the Company about the potential revenue shortfall from EGRIFTA SV® is accurate.
Forward-Looking Statements assumptions are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those that are disclosed in or implied by such Forward-Looking Statements. These risks and uncertainties include, but are not limited to: (i) the issuance of additional observations by the FDA to the manufacturer following the finalization of their review of the remediation measures implemented at the manufacturer’s site; (ii) a delay by the manufacturer in implementing the final remediation measures at the manufacturer’s site; (iii) the receipt of negative results from the implemented remediation measures; (iv) a delay in providing the information from the remediation measures to the Company; (v) a delay by the Company in filing the PAS; (vi) a decrease in demand for EGRIFTA SV® due to the risk of shortage; (vii) the failure of the new batch of EGRIFTA SV® to meet the specifications allowing its release to the market; and (viii) the FDA non-approval of the PAS to be filed by the Company.
The Company refers current and potential investors to the “Risk Factors” section of the Company’s Form 20-F dated February 21, 2024 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date.
The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
Contacts:
Investor inquiries:
Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com
438-315-6608
Media inquiries:
Julie Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
FAQ
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