Hansa Biopharma (HNSA) Q3 2024 earnings summary

Executive summary

• Achieved record Idefirix/IDEFIRIX sales in Q3 2024, reaching SEK 69.5 million (MSEK), up 321% year-over-year, with four consecutive quarters of strong growth and expanded adoption in EU transplant clinics.

• Year-to-date Idefirix sales totaled SEK 164.2 million, driven by increased clinical utilization and repeat use in key EU markets.

• Significant progress in clinical pipeline, including full randomization in the U.S. CONFIDES phase III kidney transplant trial, high enrollment in PAES and GOOD-IDES-02 phase III trials, and positive results for HNSA-5487 supporting development in neuro autoimmune diseases.

• Expanded reimbursement to 15 European markets, covering 75% of the EU transplant market, with 113 clinics ready and 32 centers with clinical experience.

• Ongoing investments in R&D and commercialization support a broad pipeline in autoimmune, gene therapy, and transplantation.

Financial highlights

• Q3 2024 revenue totaled SEK 78.4 million, with SEK 69.5 million from Idefirix sales and SEK 8.9 million from contract revenue, offset by a SEK 29.7 million provision for retroactive rebates.

• Year-to-date Idefirix revenue was SEK 164.1 million; trailing 12-month product sales reached SEK 207.3 million.

• Q3 product sales increased 321% year-over-year; year-to-date Idefirix revenue up 171% over prior year.

• Q3 2024 operating loss was SEK 116.9 million, improved from SEK 202.2 million in Q3 2023; cash and cash equivalents at September 30, 2024, were SEK 553.5 million.

• Share issue in Q2 2024 increased cash balances by SEK 354.3 million net, securing a cash runway into 2026.

Outlook and guidance

• Multiple Phase 3 data readouts expected in H2 2025, including CONFIDES (kidney transplant) and GOOD-IDES-02 (anti-GBM), with potential BLA submissions to follow.

• Spain and Italy expected to contribute materially to sales in 2025 as reimbursement and hospital budget integration progress.

• Additional gene therapy and preclinical studies to commence in late 2024 and 2025; R&D expenses may rise with new HNSA-5487 trials.

• U.S. commercialization build-up planned ahead of expected launch, with SG&A ramp-up likely around mid-2025.

• Continued expansion anticipated in Europe, Australia, and other global markets.