ALK-Abelló (ALK) Investor Update summary

Strategic rationale and deal overview

• Secured the largest in-licensing deal in company history, acquiring exclusive rights to neffy®, the first approved adrenaline nasal spray for anaphylaxis, for an upfront payment of $145 million, with rights to future indications such as urticaria.

• The license covers all territories except the USA, Australia, New Zealand, Japan, and China, focusing on Europe and Canada for initial launches.

• neffy® aligns with the Allergy Plus strategy, expanding the portfolio in anaphylaxis, food allergy, and urticaria, and supports pediatric ambitions.

• The product is expected to transform emergency allergy care with needle-free, rapid, and reliable delivery, addressing significant unmet needs.

• neffy® received EU and US approvals in August 2024, with Canadian regulatory submission planned by year-end.

Market opportunity and product positioning

• Europe and Canada represent about one-third of the global adrenaline autoinjector market by volume, valued at DKK 1.6 billion, with significant untapped potential.

• Over 20 million people in Europe are at risk of anaphylaxis, but only about 2 million carry recommended rescue medication, indicating a large addressable market.

• neffy® offers advantages over autoinjectors: compact size, ease of use, longer shelf life, and superior temperature stability.

• Needle-free solutions are expected to drive market growth, appealing to patients with needle phobia, children, and non-compliant users.

• The company aims to become the market leader in anaphylaxis in Europe, with a portfolio including neffy®, Jext®, and the upcoming Genesis autoinjector.

Financial impact and guidance

• ARS Pharma receives an upfront payment of $145 million, milestone payments up to $320 million, and double-digit tiered royalties.

• The deal will be financed from available cash and credit, maintaining a net debt-to-EBITDA ratio below one.

• neffy® is expected to contribute to revenue from 2025, with initial impact below 1% of total revenue, and peak annual sales potential up to DKK 3 billion by the mid-2030s.

• Earnings accretion is expected within a few years, with EBIT margin from neffy® projected to exceed 25% after 2028.

• No change to long-term R&D ratio guidance; incremental investments will focus on commercialization and market expansion.