Group 1 - ALK will publish its annual report for 2025 on February 20, 2026, and will host a presentation for investors and analysts later that day at 1:30 p.m. CET [1] - The presentation will be led by ALK's management team, including Peter Halling (President & CEO), Claus Steensen Sølje (CFO), and Per Plotnikof (VP, Head of IR) [1] - The meeting will be available as a live audio webcast and can be replayed on ALK's website [2] Group 2 - Participants can join the conference call by registering through a provided link, and they will receive dial-in details via email [3] - The presentation materials will be accessible on ALK's website shortly before the meeting begins [4] Group 3 - ALK is a global specialty pharmaceutical company focused on allergy, involved in the entire value chain from development to marketing of products for respiratory allergies and anaphylaxis [6] - The company is headquartered in Denmark, employs around 2,700 people, and is listed on Nasdaq Copenhagen [6]

Core Insights - Regeneron Pharmaceuticals is set to present 36 abstracts at the 2026 AAAAI Annual Meeting, highlighting new Phase 3 data for investigational allergen-blocking antibodies targeting cat and birch allergies, as well as new insights on Dupixent's efficacy across various diseases [1][2] Regeneron's Pipeline and Research - The company is pioneering first-in-class treatments for cat and birch allergies, with Phase 3 data demonstrating the potential to alleviate ocular symptoms in adults [2][3] - Additional registration-enabling trials for these allergy treatments are planned for this year, aiming to evaluate similar endpoints over longer follow-up periods [3] - Regeneron's broader allergy pipeline includes innovative strategies aimed at eliminating all IgE-mediated allergies [3] Dupixent Insights - New analyses on Dupixent will be presented, focusing on its impact on allergy sensitization in children with atopic dermatitis, measuring IgE levels for various allergens over a treatment period of up to 1.5 years [4] - Real-world analyses will assess the potential benefits of initiating Dupixent earlier in asthma treatment, comparing its effects on exacerbation rates and corticosteroid use against other treatment options [5] - Late-breaking data from the Phase 3 AIMS trial for allergic fungal rhinosinusitis (AFRS) will also be shared, which supports a supplemental Biologics License Application currently under Priority Review [6] Presentation Details - The full list of Regeneron's presentations at the AAAAI includes various studies on allergic inflammation, immunological evaluations, and the efficacy of antibody cocktails in treating allergic conditions [7][8]

Inside Information ALK (ALKB:DC / OMX: ALK B) today announced that the Committee for Medicinal Products for Human Use (‘CHMP’) of the European Medicines Agency has adopted a positive opinion recommending the granting of the marketing authorisation for EURneffy® (the trade name for neffy® in the EU) to include a 1 mg nasal adrenaline spray for the emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exer ...

Group 1 - ALK will publish its results for the first nine months (Q3) of 2025 on 13 November 2025 [1] - An investor and analyst presentation will be held on the same day at 1:30 p.m. CET, featuring comments on the results and future outlook [1] - Key representatives from ALK during the presentation will include Peter Halling (President & CEO), Claus Steensen Sølje (CFO), and Per Plotnikof (VP, Head of IR) [1] Group 2 - The meeting will be available as a live audio webcast and can be replayed on ALK's website [2] - Participants can join the conference call by registering through a provided link, receiving dial-in details via email [3] - The presentation materials will be accessible on ALK's website shortly before the meeting begins [4] Group 3 - ALK-Abelló A/S is a global specialty pharmaceutical company focused on allergy and allergic asthma treatments [6] - The company markets allergy immunotherapy treatments and other related products and services [6] - ALK is headquartered in Hørsholm, Denmark, employs around 2,800 people globally, and is listed on Nasdaq Copenhagen [6]

Neffy Approval and Indication - Neffy (epinephrine nasal spray) has been approved for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children weighing ≥30kg[4, 65] - The available dose strength is a 2 mg nasal spray device[8] - A supplemental regulatory application (sNDA) for a 1 mg dose for children 15 kg to <30 kg is expected to be filed with the FDA in Q3 2024[2, 22] Addressing Unmet Needs and Market Opportunity - Only 10%-20% of patients with active prescriptions use them as indicated, highlighting significant limitations with current treatment options[5] - Approximately 40 million patients have type 1 allergic reactions, with ~20 million diagnosed and under physician care[25] - The US severe allergic reaction market has shown consistent growth, with a +6.5% Compound Annual Growth Rate (CAGR) since 2010 and +12.7% Year-over-Year (YoY) growth in 2023[25] - Market research indicates a 45% reduction in time to use with neffy compared to current devices, suggesting faster administration[30] Clinical Trial Data and Safety - Registrational studies demonstrate comparable pharmacodynamic (PD) surrogates for efficacy and pharmacokinetic (PK) with approved products[19] - In clinical trials, 100% of patients responded to a single dose of neffy within the first 15 minutes, and did not require a second dose of epinephrine per treatment guidelines in an oral food challenge induced anaphylaxis study[41] - The most common adverse events (>2%) with a single dose of neffy were mild nasal discomfort (9.7%) and mild headache (6%)[12, 19] Commercialization and Market Access - A commercial force of 110 sales representatives and area sales managers will target 12,500 allergy specialists and high decile prescribers[38] - The company anticipates at least 80% unrestricted access in the US by mid-2025[62] - A co-pay buy-down program will reduce the patient co-pay to $25 for commercially insured patients[48, 49] Global Expansion and Future Development - Filings by partners in Australia, China, and Japan are expected in 2024, with filings planned in Canada and other regions[22, 62] - Phase 2b trial results for treating acute urticaria exacerbations in CSU patients on antihistamine therapy are expected in 2025[23, 62] - The company has a strong balance sheet of $218.7 million and an expected operating runway of at least 3 years to support US commercialization[62]

Core Viewpoint - ARS Pharmaceuticals has entered into a co-promotion agreement with ALK-Abelló A/S to promote neffy, an epinephrine nasal spray, targeting pediatricians and enhancing access to this needle-free treatment for severe allergic reactions, particularly ahead of the back-to-school season [1][2][3] Company Overview - ARS Pharmaceuticals is focused on empowering at-risk patients and caregivers to protect against severe allergic reactions that could lead to anaphylaxis [1][17] - The company is commercializing neffy, the only approved needle-free treatment for Type I allergic reactions, including anaphylaxis, for patients aged 4 years and older who weigh at least 33 pounds [4][6][17] Partnership Details - The agreement allows ARS Pharma to recognize all U.S. revenue and maintain sole responsibility for U.S. commercialization activities, including marketing and distribution [2][5] - ALK will promote neffy to approximately 9,000 pediatricians, representing about 55% of all community-use epinephrine prescriptions in the U.S. [2][5] - The partnership includes performance-based payments for ALK based on exceeding specific market share thresholds, starting at 30% of net revenue above an initial threshold in the second year [5] Market Strategy - ARS Pharma plans to launch a direct-to-consumer campaign in May 2025, coinciding with the availability of a 1 mg dose for children over four years old [3] - The company anticipates broadening unrestricted commercial access for neffy over the summer, ensuring a smooth prescribing experience for patients and physicians [3] Financial Outlook - ARS Pharma expects its operating expenses to increase by approximately $3 million per quarter starting in Q3 2025, but this will not impact its cash flow for 2025 [3]