Abliva (ABLI) Q2 2024 earnings summary

Executive summary

• Positive interim analysis of the FALCON study with KL1333 confirmed strong safety and efficacy potential, increasing likelihood of successful study completion and regulatory approval.

• Both primary endpoints in the FALCON study passed futility, and the sample size was adjusted to 180 patients to enhance statistical power.

• Financing strengthened through a fully subscribed rights issue (SEK 46M) and convertible loan conversion (SEK 42M), extending cash runway.

• KL1333 and NV354 both hold Orphan Drug Designation in the US and EU; KL1333 also has Fast Track status in the US.

Financial highlights

• Net revenues were SEK 0 for both Q2 and H1 2024, unchanged from the prior year.

• Loss before tax for Q2 2024 was SEK 25.8M (Q2 2023: SEK 21.2M); H1 2024 loss before tax was SEK 43.9M (H1 2023: SEK 37.3M).

• Diluted loss per share was SEK 0.02 for Q2 and SEK 0.04 for H1, unchanged year-over-year.

• Cash and cash equivalents at June 30, 2024, were SEK 45.3M, down from SEK 63.8M a year earlier.

• Equity/assets ratio stood at 89% as of June 30, 2024 (June 30, 2023: 90%).

Outlook and guidance

• FALCON study interim analysis supports continued development; NDA submission targeted for end of 2027.

• Additional funding will be required to complete Wave 2 of the FALCON study; current liquidity supports operations for the next twelve months.

• Commercial opportunity for KL1333 estimated to exceed $1B in annual sales upon approval.