Q3 2024 Egetis Therapeutics AB (publ) Earnings Call Transcript
Key Points
- Egetis Therapeutics AB (STU:P0F) remains on track with its marketing authorization application for MCT8 with the EMA, having responded to the 180-day questions as per the stipulated timelines.
- The European Thyroid Association issued guidelines recommending the use of theatrical or MCT8 as a long-term therapy for MCT8 deficiency, which supports future commercialization efforts.
- New data from a retrospective study showed that theatrical treatment significantly reduces the risk of all-cause mortality in patients with MCT8 deficiency, enhancing the drug's value proposition.
- The ReTRIACt study has shown improved recruitment progress, with additional clinical sites opened in the US, increasing the total number of patients included to 17.
- Egetis Therapeutics AB successfully executed a $30 million directed share issue, which was oversubscribed, indicating strong investor confidence despite challenging market conditions.
- Revenues for the third quarter were lower compared to the same period last year, attributed to lump order patterns from countries where the drug can be reimbursed at the preapproval stage.
- The recruitment for the ReTRIACt study has not met expectations in previous quarters, and there is a recognition of potential dropouts in the study.
- The company faces challenges in the European market with a lengthy reimbursement process expected to take 1 to 2 years post-approval.
- The patent application for theatrical is not as strong as a composition of matter patent, which may affect exclusivity and protection against generic competition.
- There is uncertainty regarding the timing of the CHMP opinion from the EMA, which could impact the European approval timeline.
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Thank you operator, good morning and a warm welcome to GT Therapeutics Webcast for the quarter three reports and results.
For those I haven't had the privilege to meet before. My name is Nicklas Westerholm and I am the CEO of the company with me today. I also have our CFO Yilmaz Mahshid, Karl HÃ¥rd, our head of investor relations and business development and Henrik Krook, our head of commercial operations globally.
What we are planning to cover today are updates on several important milestones delivered during the quarter.
We will touch upon the progress for our marketing authorization application for MCT8 with the EMA.
The guidelines for diagnosis and management of MCT8 deficiency issued in July by the European Thyroid Association.
The new data published through an abstract concerning survival. The data was presented at the 46th annual meeting of the European Thyroid Association in September.
The retrack status, obviously important
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