Release Date: November 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Egetis Therapeutics AB (STU:P0F, Financial) 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.
Negative Points
- 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.
Q & A Highlights
Q: Regarding the US trial, you have included 17 patients and eight have completed and four are in the running phase. Does it mean that the five patients have dropped out, or are they still subject to screening? And for the ones who dropped out, is there any reason you can share?
A: Nicklas Westerholm, CEO: We have made good progress in recruitment. There are dropouts, which are common in studies, with a dropout rate around 20%. The dropouts are not related to the study drug but could be due to personal reasons like family illness. We continue to focus on recruitment.
Q: Regarding the European process, are there any unexpected issues with the 180-day list of questions from the EMA? And what is the go-to-market strategy in Europe once approved?
A: Nicklas Westerholm, CEO: The 180-day questions are manageable, and we plan to respond by November 12. We are on track for CHMP opinion without surprises. Our go-to-market strategy will initially focus on Germany, France, Italy, and Spain, with reimbursement dialogues in parallel.
Q: Could the survival data you published impact pricing negotiations with authorities in Europe and the US?
A: Nicklas Westerholm, CEO: The survival data is important for pricing and reimbursement discussions in Europe and the US. It will be part of our dialogues with authorities and is crucial for our interactions with the FDA for the new drug application.
Q: What is driving the recent increase in the value of priority review vouchers from $100 million to $150 million?
A: Nicklas Westerholm, CEO: The increase in PRV value is driven by demand and supply dynamics. This is favorable for us as we plan for potential divestment of a voucher in the US.
Q: Can you provide context on the patent application for processes of preparation and its strength compared to orphan drug designation?
A: Nicklas Westerholm, CEO: The patent is related to CMC and manufacturing improvements. It is not as strong as a composition of matter patent but will help with exclusivity and protection against generic penetration if approved.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
