Buy Or Sell Opportunity • 8h
Now 21% overvalued Over the last 90 days, the stock has fallen 14% to €29.80. The fair value is estimated to be €24.54, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has grown by 43%. For the next 3 years, revenue is forecast to grow by 12% per annum. Earnings are also forecast to grow by 14% per annum over the same time period. Announcement • Aug 15
ALK-Abelló A/S Tree Pollen And House Dust Mite Tablets Recommends By NICE For Paediatric Treatment In The UK Health System ALK-Abelló A/S announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended the company’s tree pollen tablet (ITULAZAX®) and house dust mite tablet (ACARIZAX®) for children with moderate to severe allergic rhinitis whose symptoms are not controlled by symptomatic treatment. ITULAZAX® is recommended for children aged 5 to 17 with birch pollen allergy and ACARIZAX® for children aged 5 to 11 with house dust mite allergy, making both tablets available to eligible children through the National Health Service (NHS). ITULAZAX® was already recommended by NICE for adults in August 2025 and ACARIZAX® for people aged 12 to 65 in March 2025. With these decisions, both of ALK-Abelló A/S’s sublingual immunotherapy tablets are now recommended for children as well as adults. The recommendations represent a significant shift in how severe hay fever and house dust mite allergy are managed in childhood, providing access to a treatment that targets the underlying cause of the allergy to deliver long-term symptom relief. The recommendations come against a backdrop of worsening allergy seasons with climate change reported to have prolonged the high-pollen season by one to two weeks compared with the 1990s. The decisions also follow the launch of the UK’s first National Allergy Strategy in April 2026. NICE conducts reviews to assess the clinical benefits and cost-effectiveness of healthcare interventions, treatments, and technologies. The institute published a Final Draft Guidance on August 14, 2026 appraising the clinical benefits and cost-effectiveness of the two sublingual immunotherapy tablets. NICE is expected to publish a Final Guidance in late August 2026, after which the NHS systems in England, Wales and Northern Ireland are required to implement ITULAZAX® and ACARIZAX® in the paediatric treatment practices. NICE’s recommendations follow the recent acceptance by the Scottish Medicines Consortium (SMC) of ACARIZAX® for patients with severe house dust mite allergic rhinitis, marking further progress towards improving access to allergen immunotherapy for eligible patients across Great Britain. The NICE recommendations do not affect ALK-Abelló A/S’s financial guidance for 2026. Announcement • Aug 06
Alk-Abelló's Subsidiary Alk-Abelló Pharmaceuticals Inc. Canada Announces Neffy Now Available Across Canada ALK-Abelló Pharmaceuticals Inc. Canada announced that neffy is now available across Canada, following its approval by Health Canada in April 2026. neffy is approved for use in adults and children with a body weight of 30 kg (66 pounds) or more for the emergency treatment of allergic reactions, including anaphylaxis to insect stings or bites, foods, medicines and other allergens, as well as anaphylaxis where the cause is not known or anaphylaxis caused by exercise. neffy 2 mg is a nasal spray designed to provide fast absorption of epinephrine. neffy delivers a full, single dose of epinephrine in a user-friendly format, without the need for priming. It has a 30-month shelf life and no special storage requirements, with the ability to withstand temperature excursions of up to 50°C. Freezing does not affect its shelf life, however if it is accidentally frozen the nasal spray should be allowed to thaw for at least one hour before use, because it will not activate if frozen. The most frequently occurring adverse reactions (very common events = 10%) observed in clinical studies of neffy were reported only after a second 2 mg dose (4 mg total) and include throat irritation (18.8%), headache (17.6%), nasal discomfort (12.9%) and feeling jittery (10.6%). Buy Or Sell Opportunity • Jul 06
Now 20% undervalued Over the last 90 days, the stock has risen 19% to €32.36. The fair value is estimated to be €40.68, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has grown by 43%. For the next 3 years, revenue is forecast to grow by 12% per annum. Earnings are also forecast to grow by 14% per annum over the same time period. Announcement • Jun 18
ALK Receives UK Approval For EURneffy 1 Mg As The First And Only Needle-Free Adrenaline Treatment For Young Children At Risk Of Anaphylaxis ALK announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for EURneffy 1 mg, the first and only needle-free adrenaline treatment for anaphylaxis for children aged 4 and older living with severe allergies in the UK – extending a class of treatment previously available only by injection. EURneffy 1 mg is now indicated in the UK for the emergency treatment of severe allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in children aged 4 years and over weighing 15 kg to less than 30 kg. This approval follows the existing UK marketing authorisation for EURneffy 2 mg, previously approved by the MHRA for the emergency treatment of anaphylaxis in adults and children weighing =30 kg. This approval means more people with severe allergies, including children aged 4 years and older who weigh 15 kg to less than 30 kg, will be eligible for treatment with EURneffy, the only needle-free adrenaline-based product currently approved in the UK. EURneffy provides rapid absorption of adrenaline within minutes of administration. EURneffy has an established safety profile, based on clinical data from the EURneffy development programme involving over 700 participants. The most common adverse reactions in subjects weighing 15 kg to less than 30 kg treated with EURneffy 1 mg included: nasal congestion (19.0%), upper respiratory tract congestion (14.3%), dry throat, nasal dryness, and paraesthesia (each 9.5%). There were no clinically relevant differences in the safety between the paediatric and adult populations treated with EURneffy. EURneffy 2 mg performed as well as traditional adrenaline auto-injectors or intramuscular adrenaline across a range of real-world scenarios examining the clinical pharmacological effect including single and repeat doses, self-administration, and situations with nasal congestion from allergies. EURneffy 1 mg dose demonstrated a comparable absorption and pharmacodynamic effect in children (15-30 kg) as the 2 mg dose in children and adults above 30 kg. EURneffy is the first and only needle-free adrenaline-based product approved for the emergency treatment of anaphylaxis in adults and children. EURneffy is well absorbed through the nose and distributed quickly into body tissues, offering a portable, pocket-sized alternative to injectable forms of adrenaline for treating severe allergic reactions. EURneffy has a total shelf life of 30 months (2 mg) and 24 months (1 mg), no special storage requirements and freezing does not affect its shelf life. Upon activation, EURneffy nasal spray delivers a full, single dose of adrenaline, without the need for priming. It is recommended that two EURneffy devices are carried to treat a potentially life-threatening emergency in case a second dose is required. In the UK and European Union, EURneffy 2 mg is approved for the emergency treatment of anaphylaxis in adults and children who weigh = 30kg, and EURneffy 1 mg is approved for the emergency treatment of anaphylaxis in children aged 4 and older who weigh from 15 kg to less than 30 kg. In the United States, Japan, China, Australia and Canada EURneffy 2 mg is approved under the brand name neffy 2 mg. In the US and Australia, neffy 1 mg has also been approved for children who weigh 15–30 kg (with an age restriction of 4 years and older in Australia) and in Japan, neffy 1 mg and 2 mg are approved for the emergency treatment of severe allergic reactions (anaphylaxis) in adults and children who weigh =15 kg. Announcement • May 06
Alk-Abelló A/S Upgrades Earnings Guidance for the Full-Year 2026 ALK-Abelló A/S upgraded earnings guidance for the full-year 2026. For the year, the company revenue is now expected to grow by 13-16% in local currencies (previously 11-15% growth) based on growth across all sales regions and product lines. The EBIT margin is now expected at around 26% (previously 25%). Reported Earnings • May 05
First quarter 2026 earnings released: EPS: kr.2.00 (vs kr.1.60 in 1Q 2025) First quarter 2026 results: EPS: kr.2.00 (up from kr.1.60 in 1Q 2025). Revenue: kr.1.77b (up 16% from 1Q 2025). Net income: kr.437.0m (up 23% from 1Q 2025). Profit margin: 25% (up from 23% in 1Q 2025). The increase in margin was driven by higher revenue. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 5.0% growth forecast for the Pharmaceuticals industry in Europe. Announcement • Apr 21
ALK Announces Successful Outcome of Phase 2 Trial with Its Tablet for Treatment of Peanut Allergy Demonstrating Early Onset of Efficacy ALK announced positive topline results from the phase 2 clinical trial (named ‘ALLIANCE’) with its once-daily investigational sublingual immunotherapy (‘SLIT’) tablet for the treatment of peanut allergy in patients aged 4-65 years. The trial included 150 patients and was a randomised, double-blinded placebo-controlled dose-finding phase 2 clinical trial evaluating safety and efficacy of two different doses of the peanut tablet compared to placebo. Patients were up-dosed followed by maintenance dosing for 24 weeks. After only 24 weeks of maintenance treatment, clear dose-dependent and statistically significant efficacy was demonstrated across multiple efficacy endpoints based either on the Tolerated Dose (TD) or Eliciting Dose (ED) as measured by a double-blind, placebo-controlled exit food challenge with peanut protein: TD300 efficacy endpoint: 49% of patients treated with the highest dose of the peanut tablet tolerated a dose of 300 mg peanut protein vs. 18% in placebo (p<0.001). TD600 efficacy endpoint:31% of patients treated with the highest dose of the peanut tablet tolerated a dose of 600 mg peanut protein vs. 8% of the placebo treated patients (p<0.01). TD1000 efficacy endpoint: 22% of patients treated with the highest dose of the peanut tablet tolerated a dose of 1.000 mg peanut protein vs. 2% in placebo (p<0.01). ED based efficacy endpointiii:65% of patients treated with the highest dose of the tablet responded to treatment when defining responders as patients with a baseline ED = 30 mg who achieved an ED = 300 mg or a patient with a baseline of ED = 100 mg who achieved an ED = 600 mg of peanut protein during the oral food challenge (24% in placebo, p<0.001). Efficacy was observed across all age groups. Treatment with the tablet was safe and well-tolerated across all treatment groups, and the level of treatment-related discontinuations was low. No treatment-related anaphylaxis or treatment-related serious adverse events were reported. The peanut tablet spearheads ALK’s future portfolio in food allergy, which also spans novel concepts in pre-clinical development targeting other pathways and indications. Announcement • Apr 17
ALK-Abelló A/S Receives Approval For Neffy 2 Mg As Needle-Free Anaphylaxis Treatment In Canada ALK announced that Health Canada has approved neffy 2 mg 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 exercise-induced anaphylaxis in adult and paediatric patients (=30 kg). The approval addresses a critical need for Canadians affected by severe allergies that put them at risk of anaphylaxis. neffy constitutes the first approved nasal adrenaline spray for timely emergency treatment. neffy is designed to fit into a pocket for portability. It also has a 30-month shelf life from time of manufacture and can withstand temperature excursions up to 50°C, key differentiators from adrenaline autoinjectors (AAIs). The regulatory approval was based on the review of data from the neffy development programme involving over 700 participants. No serious side effects were reported in clinical studies with neffy. Moreover, the clinical development programme has generated important clinical evidence across a range of real-world clinical scenarios. It is estimated that up to 2,500,000 people in Canada are affected by severe allergies. Canada will expectedly become ALK’s market outside of Europe. The market launch of neffy 2 mg in Canada is expected within the coming months. Submission for regulatory review in Canada of neffy 1 mg for children weighing 15-30 kg is expected later in 2026. neffy is developed by US-based ARS Pharmaceuticals Inc. In November 2024, ALK entered into a strategic license agreement with ARS Pharma granting ALK exclusive global rights to commercialise neffy with exception of the USA, Australia, New Zealand, Japan, and China. In May 2025, the partnership was extended to include a co-promotion agreement in the USA. The approval does not affect ALK’s financial guidance for 2026. Board Change • Apr 15
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 3 highly experienced directors. 5 independent directors (6 non-independent directors). Independent Director Jesper Hoeiland was the last independent director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Apr 01
Alk-Abelló A/S Announces EURneffy 1 Mg Approval Across the EU as the First and Only Needle-Free Adrenaline Treatment for Young Children ALK announced that children aged 4 and older living with severe allergies across the EU can now access the first and only needle-free adrenaline treatment for anaphylaxis, after the European Commission (EC) granted marketing authorisation for EURneffy 1 mg – extending a class of treatment previously available only by injection. EURneffy 1 mg is now indicated for the emergency treatment of anaphylaxis due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis in children aged 4 years and older with a bodyweight between 15 kg and 30 kg. This approval extends the existing marketing authorisation for EURneffy 2 mg, granted by the EC in August 2024 for the emergency treatment of anaphylaxis in adults and children weighing =30 kg. Anaphylaxis – the most severe, life-threatening form of allergic reaction requiring immediate intervention – affects an estimated 1 to 761 out of every 100,000 children in Europe each year, with food allergies responsible for more than two-thirds of cases. This approval means more people with severe allergies including children aged 4 years and older (=15 kg) will be eligible for treatment with EURneffy, the only needle-free adrenaline-based product currently approved across the EU. EURneffy provides rapid absorption of adrenaline within minutes of administration. EURneffy has an established safety profile, based on clinical data from the EURneffy development programme involving over 700 participants. The most common adverse reactions in subjects weighing 15 kg to less than 30 kg treated with EURneffy 1 mg included: nasal congestion (19.0%), upper respiratory tract congestion (14.3%), dry throat, nasal dryness, and paraesthesia (each 9.5%). There were no clinically relevant differences in the safety between the paediatric and adult populations treated with EURneffy. EURneffy 2 mg performed as well as traditional adrenaline auto-injectors or intramuscular adrenaline across a range of real-world scenarios examining the clinical pharmacological effect including single and repeat doses, self-administration, and situations with nasal congestion from allergies. EURneffy 1 mg dose demonstrated a comparable absorption and pharmacodynamic effect in children (15-30 kg) as the 2 mg dose in children and adults above 30 kg. This approval applies to all 27 European Union (EU) member states, Iceland, Norway and Liechtenstein. EURneffy is well absorbed through the nose and distributed quickly into body tissues, offering a portable, pocket-sized alternative to injectable forms of adrenaline for treating severe allergic reactions. EURneffy has a total shelf life of 30 months (2 mg) and 24 months (1 mg), no special storage requirements and freezing does not affect its shelf life. Upon activation, the EURneffy nasal spray delivers a full, single dose of adrenaline, without the need for priming. In the United States (US), Japan and China, EURneffy 2 mg is approved under the brand name neffy. In 2025 the US Food and Drug Administration (FDA) approved neffy 1 mg for the treatment of Type I Allergic Reactions, including anaphylaxis, in children who are aged 4 years and older and weigh 15–30 kg and Japan’s Pharmaceuticals and Medical Devices Agency (PDMA) approved neffy 1 mg and 2 mg doses for the emergency treatment of allergic reactions (anaphylaxis) in adults and children who weigh =15 kg. EURneffy /neffy 2 mg has also been approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and China’s National Medical Products Administration (NMPA).