| Three Months Ended December 31, 2024 (2023) | Twelve Months Ended December 31, 2024 (2023) |
| Revenue was SEK 313.4 M (5.4 M) | Revenue was SEK 334.7 M (16.8 M) |
| Operating profit/loss was SEK 290.4 M (-19.8 M) | Operating profit/loss was SEK 241.9 M (-81.1 M) |
| Net profit/loss was SEK 247.1 M (-28.7 M) | Net profit/loss was SEK 188.7 M (-95.8 M) |
| Cash and cash equivalent SEK 303.3 M (31.0) | Cash and cash equivalent SEK 303.3 M (31.0) |
| Basic earnings/loss per share was SEK 2.21 (-0.45) | Basic earnings/loss per share was SEK 1.77 (-1.52) |
| Diluted earnings/loss per share were SEK 2.17 (-0.45) | Diluted earnings/loss per share were SEK 1.76 (-1.52) |
Business highlights in Q4 2024
- October 1, Saniona provides update on major progress for SAN2355. The company has identified a stable solid form of the substance and completed the synthesis optimization.
- October 7, Saniona initiates SAN711 Biomarker study.
- October 14, Saniona Ion Channel Research Collaborations with Boehringer Ingelheim Reaches Milestone, resulting in a research milestone payment of EUR 500,000 (approximately SEK 5.7 million).
- October 23, Fenja Capital II A/S (previously Formue Nord Fokus A/S) requested conversion of outstanding convertibles for a total nominal amount of SEK 2 million.
- November 6, Saniona's partner, Productus Medix, did not receive approval from Mexican regulatory agency (COFEPRIS) for tesofensine for obesity. Medix has entered a dialogue with the agency regarding the path forward as it appears that the decision by COFEPRIS has not been based on the full data package submitted by Medix. In February 2025, Medix revised its application based on COFEPRIS's feedback. Medix now sees a clear path to regulatory approval.
- November 12, Saniona comments on Medix's recent regulatory submission for tesofensine in obesity.
- November 26, Saniona Announces Licensing Agreement with Acadia Pharmaceuticals for SAN711 in Neurological Diseases.
- December 16, Saniona repays remaining debt and Fenja Capital II A/S coverts convertibles for SEK 2 million.
Significant events after the reporting period
- January 10, Saniona's Nomination Committee proposes John Haurum as New Chairman of the Board of Directors.
- January 15, Saniona's joint venture, Cephagenix, secures seed funding from AdBio Partners and AbbVie ventures, with up to EUR 9 million.
- February 10, Medix is revising its application based on COFEPRIS's feedback. Medix now sees a clear path to regulatory approval and expects to resubmit the dossier shortly.
- February 20, Medix resubmits tesofensine application to COFEPRIS.
Comments from the CEO
"2024 was a defining year for Saniona, crowned by a strategic partnership that significantly strengthened our financial position. This enables us to advance three internal programs toward Phase 2 development while maintaining flexibility to maximize their value. With a clear path forward, we are positioned to build on our momentum, explore new strategic opportunities, and continue delivering on our mission to bring innovative treatments to patients in need".
For more information, please contact
Thomas Feldthus, CEO, +45 22109957; thomas.feldthus@saniona.com
About Saniona
Saniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of neurological disorders. Saniona's internal pipeline includes SAN2219, targeting acute repetitive seizures; SAN2355, addressing refractory focal onset seizures; and SAN2465, positioned for major depressive disorders. Saniona has two strategic development collaborations. SAN711 is being prepared for Phase 2 for essential tremor in collaboration with Acadia Pharmaceuticals and tesofensine is out licensed for obesity to Medix, which has submitted a market authorization application (MAA) in Mexico. In addition, Saniona oversees two clinical programs poised for collaboration. Tesomet is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease. Saniona partners include Acadia Pharmaceuticals, Boehringer Ingelheim GmbH, Productos Medix S.A de S.V, AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market.
For more information, visit www.saniona.com.
This information is information that Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-02-27 08:00 CET.
