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Egetis Therapeutics (EGTX) investor relations material
Egetis Therapeutics Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary25 Nov, 2025
Executive summary
FDA granted Breakthrough Therapy Designation for Triac/Emcitate® for MCT8 deficiency, with a rolling NDA submission to begin December 2025 and anticipated completion in early 2026, supported by robust clinical data and positive pre-NDA meetings.
Positive results from the ReTRIEVE/ReTRIACt study support NDA submission and address regulatory feedback in France.
Triac/Emcitate® approved in the EU as the first and only treatment for MCT8 deficiency, with commercial launch in Germany and expansion through partnerships in Turkey and the Gulf region.
Exclusive distribution agreements signed for the Gulf Region and Türkiye, and an Expanded Access Program is active in the US.
Ongoing pricing and reimbursement processes in major EU markets, with alternative funding mechanisms in some countries.
Financial highlights
Q3 2025 revenue was SEK 17.4 million, up from SEK 9.4 million year-over-year; nine-month revenue reached SEK 44.6 million, up from SEK 35.3 million.
Gross profit margin was lower due to non-recurring milestone payments and SEK 23.6 million intangible R&D depreciation following EU approval.
Adjusted gross profit for nine months was SEK 35.3 million, showing improvement in margin versus prior year.
Net loss for nine months was SEK 222.8 million, improved from SEK 233.1 million; Q3 net loss was SEK 82.4 million, improved from SEK 86.2 million.
Cash at quarter-end was SEK 145.7 million, with an additional SEK 183 million raised post-period via an oversubscribed share issue.
Outlook and guidance
Rolling NDA submission for Triac/Emcitate® in the U.S. to begin December 2025, with full submission in early 2026 and expected FDA review completion in Q3 2026 if Priority Review is granted.
U.S. commercialization infrastructure being built, targeting around 25 FTEs at launch; increased commercial investment to be offset by reduced R&D costs.
Focus on optimizing pricing and reimbursement in Europe, with resubmission for reimbursement in France planned for early 2026 and a process expected to take one to two years.
How will ReTRIACt data impact French reimbursement?
Funding for US commercial infrastructure
Aladote development restart conditions
France reimbursement: How to address HAS objections?
U.S. launch investment: What is the net impact?
ReTRIACt P2 non-significance: Any FDA concern?
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Next Egetis Therapeutics earnings date
Q4 202526 Feb, 2026
Next Egetis Therapeutics earnings date
Q4 202526 Feb, 2026
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Frequently asked questions
Egetis Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of treatments for rare and severe diseases. Its portfolio includes late-stage product candidates targeting unmet medical needs. The company is headquartered in Stockholm, Sweden, and its shares are listed on the Nasdaq Stockholm.
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