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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.
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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).

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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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