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.

ALK (ALKB:DC / OMX: ALK B / AKBLF) will hold a Capital Markets Day on June 4 from 13.00 to 17.00. Investors, analysts, and other stakeholders are invited to listen in as ALK’s Leadership team discusses their strategy, key priorities, and value drivers. Topics will include global leadership in respiratory allergy, key markets, growth drivers, R&D, and manufacturing processes. The event will feature presentations from ALK’s CEO, EVP Commercial Operations, SVP Global Marketing, EVP R&D, EVP Product Supply, and CFO. The event will be webcast live and available for replay on ALK’s website. Institutional investors can also attend in person. For more information, contact Investor Relations at ALK-Abelló A/S. ALK is a global pharmaceutical company specializing in allergy treatments, headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. More details can be found at www.alk.net.

ALK has reported a 10% organic revenue growth and a 41% increase in operating profit in Q1 2024, primarily driven by European tablet sales. Sales outside Europe had a slow start due to temporary sales fluctuations and product shipment phasing. The company has upgraded its full-year revenue growth forecast to 10-13% from the previous 9-12%. CEO Peter Halling attributed the strong Q1 performance to operational leverage and cost management, adding that they are implementing optimisation measures to reinvest in growth initiatives without compromising profitability. ALK will host a conference call to review financial results and outlook on 3 May 2024.

ALK has updated its full-year financial outlook for 2024. Revenue is now projected to grow by 10-13% in local currencies, up from the previous estimate of 9-12%. This adjustment is primarily due to recent growth in European tablet sales. The EBIT margin is still expected to be 17-19%, but the earnings outlook now includes one-off costs of around DKK 60 million related to optimization initiatives. These costs were not included in the original outlook from February 8, 2024. ALK has also moved forward the release of its Q1 results from May 3, 2024, to May 2, 2024. The company specializes in allergy and allergic asthma treatments, employs about 2,900 people globally, and is listed on Nasdaq Copenhagen.

ALK, a global specialty pharmaceutical company, will release its Q1 2024 financial results on 3 May 2024. The company will also host a presentation at 12:30 CET on the same day, where ALK's management will discuss the results and future outlook. The meeting will be webcasted live and a replay will be available on ALK's website. Those interested in participating via telephone can register through a provided link. The presentation slides will be uploaded to ALK's website shortly before the meeting commences. For more information, contact details for Investor Relations and Media are provided.

ALK has approved the granting of up to 250,000 share-based instruments as part of its long-term incentive plan (LTIP) for 2024, in line with the remuneration policy adopted at the Annual General Meeting in March 2023. The LTIP, which includes share options and performance shares, aims to incentivise long-term value creation and align the interests of the Board of Management and key employees with shareholders. The share options can be exercised over a four-year period after vesting, with an exercise price set at DKK 126 each. The performance shares will be transferred three years after the grant, subject to certain conditions. The total market value of the LTIP for 2024 is approximately DKK 24 million. No share-based instruments have been granted to members of the Board of Directors.