ALK-Abelló B

ALK announced that the National Institute for Health and Care Excellence (NICE) has recommended ACARIZAX® for treating persistent, moderate to severe house dust mite allergic rhinitis in adults and adolescents. This recommendation allows ACARIZAX® to be accessed through the National Health Service (NHS) in England, Wales, and Northern Ireland, making it eligible for reimbursement. ACARIZAX® is the first sublingual allergy immunotherapy product recommended by NICE, marking a significant step for ALK in the UK, where allergy tablets have been underutilized. Allergic rhinitis affects 26% of UK adults, with house dust mite being the most common airborne allergy. NICE's assessment of ACARIZAX®'s clinical benefits and cost-effectiveness is expected to lead to its implementation in NHS treatment practices by March. ALK also plans to seek NICE review for its sublingual tree tablet, ITULAZAX®, and extend approvals for both products to include children. ALK's UK business currently focuses on anaphylaxis treatments with products like the adrenaline pen Jext® and the upcoming nasal spray EURneffy®. While AIT tablet sales are modest, ALK anticipates long-term growth from its combined treatments. The NICE approval is not expected to impact ALK's revenue growth in 2025. ALK is a global pharmaceutical company specializing in allergy treatments, headquartered in Denmark and listed on Nasdaq Copenhagen.

The 2025 financial calendar for ALK (ALKB:DC / OMX: ALK B / AKBLF) will take place at ALK Bøge Allé 1, 2970 Hørsholm, Denmark. Written requests for specific business to be addressed at the Annual General Meeting (AGM) must be received by the company by January 29, 2025, and can be emailed to investor@alk.net. ALK-Abelló A/S is a global specialty pharmaceutical company based in Hørsholm, Denmark, focusing on allergy and allergic asthma treatments. The company employs approximately 2,900 people worldwide and is listed on Nasdaq Copenhagen. For more information, contact Investor Relations at +45 4574 7527 or Media at +45 5054 1434, or visit www.alk.net. An attachment titled "InvestorNews_20Dec24_FinancialCalendar.pdf" is mentioned.

ALK has announced positive interim results from its phase I/II clinical trial, named 'ALLIANCE,' for a sublingual immunotherapy (SLIT) tablet aimed at treating peanut allergies. The trial involved about 30 patients and focused on the safety and tolerability of various doses of the tablet. The results indicated that the tablet was safe and tolerable, with most side effects being mild to moderate and local. No serious adverse events were reported. Based on these findings, ALK has selected treatment doses for phase II, which will assess safety and efficacy against a placebo in about 125 patients in the USA and Canada, with completion expected in 2026. If successful, the trial could progress to phase III, aiming for regulatory approval in the late 2020s. Peanut allergies affect a significant number of children and adolescents in the USA and Europe, and this treatment could potentially improve their quality of life. The trial is part of ALK's broader efforts to develop food allergy treatments, utilizing similar technology as their SLIT tablets for respiratory allergies. ALK is a global pharmaceutical company headquartered in Denmark, specializing in allergy treatments.

ALK has announced that its European regulatory filing for ACARIZAX®, a sublingual allergy immunotherapy tablet for house dust mites, has been approved for use in children aged five to 11 in 21 EU countries. This approval follows a successful Phase 3 clinical trial involving 1,458 children, which demonstrated the treatment's efficacy and safety. The trial results were published in The Lancet Regional Health – Europe. Market introductions, including in Germany, are expected soon. ACARIZAX® is also marketed as ODACTRA® in the USA and MITICURE™ in Japan. The tablet is now approved in Europe for patients aged five to 65 with house dust mite allergic rhinitis and for allergic asthma in patients aged 18-65. A regulatory review is ongoing in the USA, and a separate review for ALK's tree tablet ITULAZAX® is underway in Europe and Canada, expected to conclude in 2025. ALK, a global pharmaceutical company specializing in allergy treatments, is based in Denmark and employs around 2,900 people worldwide.

The Lancet Regional Health – Europe has published the results of ALK's phase 3 trial, MT-12, which assessed the efficacy and safety of a house dust mite sublingual allergy immunotherapy tablet in children aged 5-11 with allergic rhinitis. The trial's publication signifies its high-quality research standards. Henriette Mersebach of ALK highlighted the significance of this recognition in expanding evidence for allergy immunotherapy in children. ALK's MT-12 trial, the largest pediatric trial of its kind, confirms previous adult trial results and aligns with their strategy to target early-stage allergies in children. Additionally, another ALK phase 3 trial, TT-06, evaluating a tree pollen SLIT-tablet, was published in the journal Allergy. ALK and Torii have completed 14 phase 3 trials involving children with various respiratory allergies. The house dust mite SLIT-tablet is marketed under different names globally, with Japan being the only country allowing its use in young children. Regulatory approvals for broader pediatric use in Europe and North America are anticipated by 2024/2025. ALK, a global pharmaceutical company based in Denmark, focuses on allergy and asthma treatments. The MT-12 trial involved 1,460 children, while the TT-06 trial involved 952 children, both conducted in multiple international sites.

ALK reported an 18% organic revenue growth and a 23% operating profit margin in the third quarter, driven by strong tablet sales and a rebound in Jext® sales, with significant contributions from Europe and international markets. The operating profit aligns with ALK's financial goals, and the full-year outlook remains unchanged. CEO Peter Halling highlighted the success in revenue and earnings improvement for the sixth consecutive year, noting strong tablet growth and progress in their Allergy+ strategy, including a new license agreement with ARS Pharma for the adrenaline nasal spray neffy®. A conference call for analysts and investors is scheduled for November 14, 2024, to discuss the financial results and outlook.

ALK has entered a strategic license agreement with ARS Pharmaceuticals, granting ALK exclusive global rights to the neffy® adrenaline nasal spray outside the USA, Australia, New Zealand, Japan, and China. This aligns with ALK's new strategy, Allergy+, and supports its long-term financial goals. Neffy® is the first approved needle-free emergency treatment for severe allergic reactions. It received market authorization in the EU and FDA approval in August 2024, with plans for Canadian regulatory submission by the end of 2024. ALK's CEO highlighted the agreement as a significant step in expanding into new disease areas. ALK will focus on European and Canadian markets, leveraging existing infrastructure, and sees potential in Asia and the Middle East. The agreement includes exclusive rights for new indications in licensed territories. ALK aims to diversify revenue growth, with neffy® expected to reach up to DKK 3 billion in annual peak sales. ARS Pharma will receive an upfront payment and potential milestone payments, with ALK financing these from its cash reserves. The agreement is projected to boost revenue growth from 2025, supporting ALK's unchanged financial ambitions.

ALK will release its financial results for the first nine months of 2024 on the morning of Thursday, November 14, 2024. The company will hold a presentation for investors and analysts at 1:30 p.m. CET on the same day, where management will discuss the results and future outlook. The presentation will feature ALK's President & CEO Peter Halling, CFO Claus Steensen Sølje, and VP, Head of IR Per Plotnikof. The event will be audio webcast live and available for replay on ALK's website. Those interested in joining via telephone must register in advance to receive the necessary dial-in details. Presentation slides will be accessible on ALK's website shortly before the meeting. ALK is a global pharmaceutical company specializing in allergy and allergic asthma treatments, headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. For more information, visit www.alk.net.

ALK-Abelló A/S has reported transactions by its managerial staff in compliance with article 19 of the EU Market Abuse Regulation. For more information, contact Investor Relations (Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525) or Media (Maiken Riise Andersen, tel. +45 5054 1434). An attached PDF document provides further details.

ALK (ALKB:DC / OMX: ALK B / AKBLF) has upgraded its full-year financial outlook due to strong sales of tablets and allergy immunotherapy products in Europe. The sales growth for 2024 is influenced by new patients, improved pricing, rebate adjustments, and competitive dynamics. The earnings upgrade is driven by higher sales, despite one-off costs of approximately DKK 60 million for optimization efforts. The Q2 report will be published on 22 August 2024, with a presentation for investors and analysts scheduled for 23 August 2024. ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma, headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. The announcement includes forward-looking statements subject to various risks and uncertainties.