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Investor Relations14 Oct 2025
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Egetis Therapeutics (EGTX) investor relations material
Egetis Therapeutics Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary21 Aug, 2025
Executive summary
FDA granted Breakthrough Therapy Designation for tiratricol in July 2025, expediting US regulatory review for MCT8 deficiency based on robust survival data from an international cohort study.
Commercial launch of tiratricol (Emcitate®) in Germany began in May 2025, marking a transition to commercial-stage operations and successful conversion of managed access patients to commercial packs.
Expanded commercialization strategy includes direct sales in Europe and the US, exclusive partnerships for Japan and Turkey, and ongoing discussions for MENA region distribution.
Expanded Access Program for tiratricol is active in the US, with 14 hospitals participating and over 100 patients identified.
Ongoing preparations for US launch include a pre-NDA meeting request to the FDA, NDA submission planned for 2025, and expanded access programs.
Financial highlights
H1 2025 revenues reached SEK 27.1 million, up from SEK 25.9 million year-over-year; Q2 revenues were SEK 14.5 million, up from SEK 13.9 million.
Gross profit margin declined due to nonrecurring milestone payments and intangible R&D depreciation following European approval; adjusted gross profit for H1 was SEK 21.7 million, showing improvement in both nominal and margin terms.
Operating loss for H1 was SEK -143.1 million, nearly flat year-over-year; after-tax loss improved to SEK -140.5 million from SEK -146.9 million.
Cash position at June 2025 was SEK 202.6 million, with H1 cash flow at SEK -143.4 million.
Equity ratio at 54% (down from 62%); earnings per share for H1 2025 was SEK -0.4 (vs. -0.5); average number of employees increased to 39.
Outlook and guidance
Key 2025 priorities include optimizing EU pricing and reimbursement, completing the ReTRIACt study, initiating US NDA submission, and preparing for US launch.
No revenue guidance provided for 2025 due to ongoing pricing and reimbursement processes in key EU markets.
Ongoing discussions with BlackRock regarding extension of EUR 15 million loan facility (Tranche B).
ReTRIACt study's role in US NDA submission?
German launch: patient conversion & new starts?
Gross profit margin trend post non-recurring costs?
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Next Egetis Therapeutics earnings date
Q3 20257 Nov, 2025
Next Egetis Therapeutics earnings date
Q3 20257 Nov, 2025
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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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