ALK-Abelló B

Ticker/ISIN
ALK B
DK0061802139
Marknad/Land
Main Market, Copenhagen
Sweden

Senaste sammanfattade pressmeddelande från 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.

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Nyheter för investerare: Invitation to the presentation of ALK's results for the first six months (Q2) 2024 on Friday 23 August 2024

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.

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Insiderinformation: ALK upgrades its full-year revenue and earnings outlook

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.

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Insiderinformation: ALK provides update on regulatory process for the house dust mite allergy tablet in China

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.

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Insiderinformation: ALK launches new growth strategy and 2028 financial ambitions

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Nyheter för investerare: ALK's European registration application for ITULAZAX® for paediatric indication accepted for review

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.

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Nyheter för investerare: Listen in on ALK's Capital Markets Day on 4 June 2024

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.

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Interimsrapport: Three-month interim report (Q1) 2024 (unaudited) 

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.

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Insiderinformation: ALK upgrades its full-year revenue outlook

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.

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Nyheter för investerare: Invitation to the presentation of ALK's first quarter results on Friday 3 May 2024

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.

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Övrig information som ska lämnas enligt börsens regler: Grant of share-based long-term incentive instruments to members of the Board of Management and key employees

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.

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