House dust mites allergenics extract(ALK-Abello A/S)

The reputable scientific journal, The Lancet Regional Health – Europe, has published robust results from ALK’s house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet) phase 3 children trial, MT-12, evaluating the efficacy and safety in children (5-11 years) with house dust mite allergic rhinitis.1 With the acceptance for publication, ALK’s MT-12 phase 3 trial has been evaluated by the journal for its methodology, relevance, and clinical implications. This scrutiny helps ensure that only high-quality research is disseminated and underlines that ALK is among top researchers within its field. Henriette Mersebach, Executive Vice President of Research & Development at ALK says: “Having our successful MT-12 phase 3 trial published in this highly esteemed journal demonstrates that the research has undergone rigorous peer review and meets high scientific standards, and it is a significant mark of recognition within the scientific community.” This trial confirms earlier results reported in ALK’s adult house dust mite tablet trials and was conducted in accordance with ALK’s clinical development strategy to focus on children and to target allergies at an early stage in life. Important to expand evidence This pivotal phase 3 trial is an important advancement in expanding the evidence of allergy immunotherapy in children and represents the largest paediatric, randomised controlled trial conducted to date with house dust mite allergy immunotherapy. Henriette Mersebach says: “The global impact of respiratory allergies in the younger population underscores our responsibility to address and alleviate the burden of this disease. The MT-12 publication in The Lancet Regional Health – Europe highlights important new paediatric phase 3 data for the house dust mite SLIT-tablet and is essential for expanding the evidence of allergy immunotherapy to help more children live better lives by reducing the burden of allergy in the future.” Earlier this month, the results from another phase 3 children trial from ALK, the TT-06 tree SLIT-tablet clinical trial, was published in the scientific journal, Allergy, evaluating the efficacy and safety in children (5-17 years) with tree pollen induced allergic rhinoconjunctivitis2. This publication further adds to the credibility and validation of ALK’s successful trial results. With these two trials, ALK and Japanese partner, Torii have completed a total of 14 phase 3 children trials with the SLIT-tablets enrolling paediatric populations with respiratory allergy induced by grass, ragweed, tree and Japanese cedar pollen, and house dust mites. Advancements in allergy treatment in young children across key markets The house dust mite SLIT-tablet is marketed as ACARIZAX® in Europe and a number of international markets, as ODACTRA® in the USA, and as MITICURE™ in Japan. Japan is currently the only country where the house dust mite SLIT-tablet (MITICURE™) is approved for young children, while in other markets it is approved for the treatment of persistent moderate-to-severe house dust mite-induced allergic rhinitis for patients aged 12-65. In addition, in Europe, the tablet is also approved for house dust mite-induced allergic asthma in patients aged 18-65. The tree SLIT-tablet is marketed as ITULAZAX® in Europe and as ITULATEK® in Canada for patients aged 18 to 65 with moderate-to-severe allergic rhinitis and/or conjunctivitis induced by tree pollen3. The regulatory processes to secure approvals of the house dust mite and tree SLIT-tablets for children are ongoing, but subject to approval, the indications could become available in 2024/2025 in Europe and North America. For further information, please contact: Media: Maiken Riise Andersen, tel. +45 5054 1434Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. About the MT-12 and TT-06 trial designs MT-12 trial designThe randomised, double-blind, placebo-controlled trial took place between October 2019 and April 2023 and enrolled 1460 children (5-11 years) with moderate to severe house dust mite allergic rhinitis or rhinoconjunctivitis. Children were treated daily with either the house dust mite SLIT-tablet or placebo for one year. The trial was conducted at 95 sites in Europe and North America. The primary objective was to demonstrate efficacy of the house dust sublingual tablet compared toplacebo based on the total combined rhinitis symptom and medication use during the primary efficacy assessment period. The main secondary objectives were to demonstrate efficacy of the house dust mite sublingual tablet compared to placebo based on rhinitis symptoms, rhinitis medication use, combined rhinoconjunctivitis symptoms and medication use, quality of life, and to evaluate safety and tolerability. TT-06 trial designThe randomised, double-blind, placebo-controlled trial took place between April 2021 and July 2023 and enrolled 952 children (5-17 years) with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees in the birch homologous group. Children were treated daily with either the tree SLIT-tablet or placebo pre-seasonally and throughout one tree pollen season. The trial was conducted at 80 sites in Europe and Canada. The primary objective was to demonstrate efficacy of the tree sublingual tablet compared to placebo based on total combined rhinoconjunctivitis symptom and medication use during the birch pollen season. The main secondary objectives were to demonstrate efficacy of the tree sublingual tablet compared to placebo based on the combined rhinoconjunctivitis symptom and medication use during the tree pollen season, rhinoconjunctivits symptoms, medication use and quality of life during both the birch and tree pollen season, and to evaluate safety and tolerability. About the journal: The Lancet Regional Health – EuropeThe Lancet Regional Health – Europe is an open access journal, part of The Lancet's global initiative to advocate for health-care quality and access in all regions of the world. The journal fosters the advance of clinical practice and health policy in the European region, with the ultimate goal of improving health outcomes. It aspires to increase the quality of regional and national health research.The journal publishes high-quality original research that advocates change in, or illuminates, clinical practice and health policy in the European region. It also considers relevant reviews, commentaries, and opinion pieces. The journal invites submissions that are pertaining to regional health topics, including but not limited to prevention and management of infections and non-communicable diseases, improvement of healthy ageing, mental health, and the reduction of health inequalities. The journal can be found at www.thelancet.com/journals/lanepe/home About the journal: AllergyAllergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI), aims to advance, impact and communicate all aspects of the discipline of Allergy/Immunology, including educational, basic, translational and clinical research, and to maintain contact between basic and clinical Allergy/Immunology. Allergy is an international peer-reviewed journal with contributors and readers from all countries. The journal publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors and correspondences.The journal can be found at https://onlinelibrary-wiley-com.libproxy1.nus.edu.sg/journal/13989995 1 The results were published online on 26 November 2024: Schuster et al. The Lancet Regional Health – Europe 2025;48: 101136. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.lanepe.2024.1011362 The results were published in the scientific journal, Allergy, on November 4: Gappa M, et al. Allergy. 2024;00:1-12. doi: 10.1111/all.16363.3 Members of the birch homologous group Attachment Press release_phase 3 trial published in reputable journal_final

ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the Board of Directors has adopted a new corporate strategy (Allergy+) and 2028 financial ambitions. Allergy+ aims to further strengthen ALK’s leadership in allergy immunotherapy, establishing a leading position in food allergy and anaphylaxis, as well as pursuing new innovations to address adjacent allergic conditions with high unmet needs. The strategy targets average revenue growth of minimum 10% in local currencies (5-year CAGR) until 20281. The respiratory SLIT-tablet portfolio (‘tablets’) remains key to growth, as ALK broadens its patient reach and achieves full paediatric coverage. ALK continues to target an EBIT margin of ~25% in 2025 after which ALK will aim for annual profitability improvements in line with revenue growth implying a projected EBIT margin of around 25% until 2028.This will enable ALK to invest in strategic growth initiatives to bolster its long-term growth and profitability trajectory. ALK aspires to self-fund its development, implying that underlying margin improvements above ~25% will be reinvested in commercial activities, R&D, business development or infrastructure. This does not rule out that margins can be higher or lower in the strategy period subject to market conditions and the timing of strategic initiatives. ALK will maintain an efficient capital structure with a financial gearing of maximum 2 x NIBD/EBITDA. ALK will be disciplined about capital allocation to ensure flexibility to deliver on its growth ambitions while also generating attractive shareholder returns. ALK expects to generate increasing free cash flow, and cash will be allocated in the following order of priority: Investments in organic growth, including R&D (projected in the range of 10-15% of revenue p.a. in 2025-28); CAPEX (projected in the range of DKK 400-600 million p.a. in 2025-28 based on current plans); business development and licensing activities; and finally cash distribution to shareholders via dividends and/or share buyback programmes. CEO Peter Halling says: “We want to sustain ALK’s growth for many years to come and leverage our insights and business platforms to help more people with allergies to a better life.The new strategy prioritises high-potential growth levers – markets, projects and innovations - with the largest potential to generate strong returns and the greatest impact for patients and prescribers. We will allocate resources carefully, and we will simplify and reduce complexity across our business to effectively scale up ALK for future growth in revenue and earnings.” Allergy+ builds on ALK’s promise of providing life-changing solutions to the millions of people with allergy. The strategy is based on four pillars: Focus ALK will prioritise and focus the commercial activities as it works to strengthen its global position in respiratory allergy, primarily through extending the reach of its current tablet portfolio, which adresses 80% of the most important respiratory allergies worldwide. Key initiatives include targeted expansion to new patient groups, investments in high-impact markets, efforts to increase prescription depth and breadth among healthcare professionals and digital mobilisation of eligible patients and prescribers. A significant growth contribution is expected to come from completing ALK’s respiratory tablet portfolio and by leveraging the expected full paediatric coverage. Across markets, ALK will also explore collaborations with partners to speed up commercial adoption. Europe is expected to be ALK’s main growth driver towards 2028. To further leverage its strongholds and accelerate momentum, ALK will reallocate resources and increase investments in key European markets to support profitable growth while operations in certain other markets will be reduced until market conditions have improved. In North America, ALK remains focused on growing the prescription-based tablet business by building new sales channels and adding new products in the USA, especially among paediatricians. In China, ALK continues to work with the authorities on the regulatory review of the house dust mite tablet, ACARIZAX®. The commercial activities will be adapted to the launch timeline, currently planned for 2025. This launch timeline and additional commercial investments are pending feedback from the authorities on the ongoing review. Current business activities related to ALK’s SCIT products are expected to continue as is. In Japan, ALK will work closely with its partner, Torii to further broaden patient reach in light of the high prevalence rates of allergy. In Southeast Asia and India, ALK will continue to support current partners. Innovate To help more people with allergy, ALK will innovate and expand the R&D pipeline in a balanced way. ALK will maximise the value of its existing core products and diversify the portfolio into food allergy, anaphylaxis and other adjacent, allergic diseases with a potential to become new ‘growth levers’. ALK will also explore business development and licensing opportunities to advance these ambitions. Key initiatives include strengthening the evidence supporting ALK’s core products in new patient groups, such as children, and geographies, including the anticipated regulatory approvals of ACARIZAX® in China and India, and GRAZAX® in Japan as well as other life cycle management activities for core products. In food allergy, ALK’s objective is to build a portfolio of treatments that addresses the unmet medical need among the ~200 million people worldwide affected, particularly among children. This portfolio will be spearheaded by the peanut SLIT tablet, currently in clinical Phase I/II development for the treatment of peanut allergy. ALK intends to extend the portfolio to target other food allergies and include novel concepts and projects with new modes of actions. Treatment of acute life-threatening allergic reactions (anaphylaxis) remains a priority for ALK. The area is underserved - for instance, in the USA, where around 20 million people are at risk of suffering anaphylactic shocks, but only around 3 million carry an adrenaline autoinjector. ALK plans to develop a portfolio that consists of the already marketed autoinjector Jext®, a next-generation autoinjector (the Genesis project) as well as possible new innovations based on alternative administration forms, potentially in collaboration with partners. Subject to development timelines and regulatory approvals, launches are expected towards the end of the strategy period. Consequently, the collaboration with Windgap Medical will be terminated, which will have no financial impact on ALK. Building on its scientific leadership and core R&D capabilities within molecular and clinical allergology and immunology, ALK has also initiated innovation efforts targeting selected adjacent disease areas with strong scientific and commercial links to the existing product portfolio and channels. These efforts generally focus on allergic inflammatory conditions and mast cell driven pathologies and target diseases in the broader allergy space. Optimise To reduce complexity and maintain competitiveness, ALK will further optimise its operations and thereby create a robust foundation for future growth. Key initiatives include continous manufacturing and quality improvements, and expansion of production capacity for tablets to 800 million tablets annually by 2030 within ALK’s existing footprint. Furthermore, ALK will optimise the cost base, reduce structural complexities across the value chain, and invest in infrastructure such as digital solutions and AI. Longer-term, ALK will also explore options to optimise the global manufacturing footprint and further prune the product portfolio. As announced in the Q1 report (2 May 2024), ALK will implement optimisation and prioritisation initiatives to free up approximately DKK 250 million in 2025, of which roughly half will be reallocated to strategic investments and half will support ALK’s earnings ambitions. Cultivate The activities and targets in the new strategy are underpinned by ALK’s commitment to cultivate the capabilities of its people and organisation to foster a strong performance culture through high engagement, and conduct business sustainably by improving access to allergy care and reducing the environmental footprint. Key initiatives include investments in further developing and upskilling employees to ensure that the organisation retains the right capabilities and an agile culture of continuous learning and growth. ALK will conduct business ethically and responsibly while fostering a safe, diverse, and inclusive work environment. In support of sustainable development, ALK is committed to improving access to allergy care by expanding its reach among people with allergies through training of healthcare professionals and allergy awareness initiatives. ALK has also set science-based CO2 targets in line with the Paris Agreement and will reduce emissions (scope 1 and 2) by 42% in 2030 by transitioning towards renewable energy as the primary energy source and implementing general energy efficiency measures, with further reductions coming from ALK’s suppliers’ commitment to reducing their emissions. Unchanged outlook for 2024 The financial outlook for 2024 is unchanged compared to the annoucement on 2 May, 2024. ALK expects revenue to grow by 10-13% in local currencies. The EBIT margin is expected at 17-19%. Capital Markets Day ALK’s leadership team will further elaborate on the strategy at a Capital Markets Day on 4 June 2024 from 13:00 to 17:00 CEST at the company’s headquarters in Hørsholm, Denmark. The Capital Markets Day will be webcasted live on www.ir.alk.net/CMD where presentations and recordings will also be available. ALK-Abelló A/S For further information please contact:Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525Media: Maiken Riise Andersen, tel. +45 5054 1434 Forward-looking Statements This announcement contains forward-looking statements, including forecasts of future revenue, operating profit and cash flow as well as expected business-related events. Such statements are naturally subject to risks and uncertainties as various factors, some of which are beyond the control of ALK, may cause actual results and performance to differ materially from the forecasts made in this announcement. Such factors include but are not limited to general economic and business-related conditions, including legal issues, uncertainty relating to demand, pricing, reimbursement rules, regulatory approvals, partners' plans and forecasts, fluctuations in exchange rates, competitive factors and reliance on suppliers. Additional factors include the risks associated with the sourcing and manufacturing of ALK's products. ALK undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law. About ALKALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net. 1 Excluding sizeable effects from M&As or potential divestments. Attachment FM_12_UK_strategy_announcement_03062024 - final