ALK-Abelló B

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.

ALK (ALKB:DC / OMX: ALK B / AKBLF) will release its results for the first six months of 2024 on the morning of 23 August 2024. A presentation for investors and analysts will be held at 1:30 p.m. CEST on the same day, featuring comments from ALK’s management and a Q&A session. The presentation will include Peter Halling (President & CEO), Claus Steensen Sølje (CFO), and Per Plotnikof (VP, Head of IR). The event will be audio webcast live and available for replay on ALK’s website. Participants can also join via telephone by registering through a provided link. Presentation slides will be accessible on ALK’s website shortly before the meeting. For further information, contact Per Plotnikof for investor relations or Maiken Riise Andersen for media inquiries. ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma, headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen.

ALK has upgraded its full-year financial outlook due to better-than-expected sales in Q2 and an improved forecast for the rest of the year. This upgrade is attributed to strong tablet sales, better performance of injection- and drop-based allergy immunotherapy products, and improved pricing in parts of Europe. The earnings outlook also benefits from higher sales growth and operational leverage, despite one-off costs of approximately DKK 60 million for optimization efforts. Recent news from China does not affect this updated outlook. CEO Peter Halling highlighted strong momentum in the core business and growing demand for allergy immunotherapy medicines. ALK will release its Q2 report on August 23, 2024. ALK is a global pharmaceutical company specializing in allergy treatments, headquartered in Denmark and listed on Nasdaq Copenhagen. The announcement includes forward-looking statements subject to various risks and uncertainties.

ALK has decided to withdraw its Biologic License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy tablet in China. Despite this, ALK will continue to seek regulatory approval for the HDM tablet in China, potentially requiring additional clinical data from Chinese patients. This delay does not affect ALK's financial guidance for 2024 or its goal of achieving a 25% EBIT margin by 2025, nor does it impact its long-term financial growth ambitions. The BLA was accepted for review in February 2023, following a clinical trial waiver in March 2022 that allowed ALK to file based on data from non-Chinese patients. ALK plans to resubmit an updated application and will continue the roll-out of the tablet in certain parts of China’s Medical Pilot Zones. ALK's commercial activities in China will be adjusted to a new launch timeline, which will be determined after further discussions with the authorities. Currently, ALK's business in China focuses on the injectable SCIT product ALUTARD SQ®, which has seen significant sales growth. The HDM tablet is approved in 43 countries for treating HDM-induced allergic rhinitis and, in some cases, allergic asthma. ALK is a global specialty pharmaceutical company headquartered in Denmark, employing around 2,900 people worldwide.

ALK (ALKB:DC / OMX: ALK B / AKBLF) announced that the European regulatory filing for its ITULAZAX® (tree sublingual allergy immunotherapy tablet) for young children has been accepted for review. The review process is expected to take up to nine months, with potential market introductions in Europe from the first half of 2025. The filing includes data from a Phase 3 clinical trial involving 952 children, which showed a 22% improvement in symptoms compared to placebo. ALK's Executive Vice President of Research and Development, Henriette Mersebach, emphasized the significance of this step for treating children's tree pollen allergies and for ALK's growth. ITULAZAX® is currently approved in Europe for patients aged 18-65. ALK-Abelló A/S is a global pharmaceutical company specializing in allergy treatments, headquartered in Hørsholm, Denmark.