Allergy Therapeutics PLC (AGY) 2024年年度報告「LSE」.pdf

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1、Transforming livesAnnual Report and Accounts 2024ContentsStrategic report01 About us02 At a glance03 How it works05 Chairman and Chief Executive Officers review07 Market need09 Business model10 Purpose and cultural values11 Environment,social and governance 23 Strategic framework24 Key performance i

2、ndicators(“KPIs”)26 Our products27 R&D report29 Effective risk management30 Principal risks and uncertainties34 Financial reviewGovernance36 Board of Directors38 Corporate governance report44 Nomination Committee report45 Audit and Risk Committee report48 Directors remuneration report56 Directors re

3、port58 Statement of Directors responsibilitiesFinancial statements59 Independent auditors report 67 Consolidated income statement68 Consolidated statement of comprehensive income69 Consolidated statement of financial position70 Consolidated statement of changes in equity71 Consolidated cash flow sta

4、tement72 Notes to the consolidated financial statements109 Company balance sheet110 Company statement of changes in equity 111 Notes to the Company financial statements115 Glossary116 Shareholder informationAbout usOur purpose is to transform patients lives and the lives of people around themthrough

5、 our vision of breaking new ground in immunology treatment through specialist expertise.Delivered through our strategyExpanding in EuropeStrong pipelineUS entrySee more on page 23Underpinned by our culturePatient FirstVisionaryMenschlichkeitCommitmentSee more on page 10Strategic report01Allergy Ther

6、apeutics plc Annual Report and Accounts 2024Strategic reportAt a glanceAllergen immunotherapy addresses the cause of allergy,not just the symptoms.LocationsSalesDirect presenceDistributor Future marketsSales by country%Sales by product%Pollinex Quattro|40%Pollinex|30%Other|10%Acarovac|6%Oralvac|6%Ty

7、rosine S/TU|5%Venomil|3%Germany|49%Spain|16%Austria|9%Netherlands|7%Italy|6%Switzerland|5%UK|3%Czech&Slovak|3%Other|2%Strategic report02Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportHow it worksHow does immunotherapy transform lives?Allergies are the immune systems response

8、 to substances it thinks are a threat but which are usually harmless,such as pollen,house dust mites or animal fur.Allergies can vary greatly in severity.At best they are annoying,at worst they can be life-threatening.Commonly used medicines such as antihistamines and steroid-based medicines,are oft

9、en used to address the symptoms of allergies,however the symptoms can return once you stop taking the medicine because they only suppress symptoms.Immunotherapy is the only treatment which affects the underlying cause of an allergy.Immunotherapy involves administering gradually increasing doses of a

10、n allergen extract(e.g.grass or tree pollen)in order to reduce the symptoms of allergy,such as sneezing,an itchy or runny nose,a blocked nose or itchy,watery eyes.It was first carried out over 100 years ago and is now in widespread use around the world.It is sometimes referred to as desensitisation

11、therapy.Subcutaneous immunotherapy is the most common form of specific immunotherapy and involves a course of injections that build up tolerance to particular allergens through small,controlled doses.Over time,this desensitises the inappropriate immune response so the body doesnt overreact and creat

12、e the histamine release that causes allergy symptoms.Sublingual immunotherapy is an alternative to injected immunotherapy.For this form of treatment,daily drops or tablets containing the specific allergen are placed under the tongue.The first dose of the sublingual immunotherapy is usually administe

13、red in a clinic under observation,then the patient will be required to self-administer the treatment every day at home.Strategic report03Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportHow it works continuedAllergen immunotherapy addresses the cause of allergy,not just the sy

14、mptoms.No treatmentHistamine leads to classic symptoms of allergy4Patient comes into contact with an allergenTreatmentTreated with allergenspecific immunotherapy3IgE binds to immune cells causing histamine release upon exposure to allergenMast cellIgE21Th2 cell stimulates B cells to produce IgE inte

15、rleukin-13interleukin-4Activated B cellT cellB cellIgEIgE2Th1 cell stimulates B cells to produce IgG Activated B cellinterferon-gammaT cellB cellIgEIgGIgGIncreased IgG production inhibits the production of IgEHistamineMast cellIgEIgGLower levels of IgE prevent excess release of histamine and reduce

16、symptoms of allergy43Strategic report04Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportIntroductionThis past year has been one of continued resilience,progress and commitment.Through our highly focused approach to the Groups business priorities and a steadfast commitment to o

17、ur Grass and Peanut allergy R&D programmes,we have continued our financial recovery and achieved notable clinical progress.Both showcase our determination in the face of adversity and demonstrate how we live our values every day.We have committed to enhance the Groups manufacturing capabilities and

18、reduce operating costs in all areas,pre-R&D and exceptionals,to ensure Allergy Therapeutics is on a strong footing for the future.Alongside these commitments and considering our challenges,our commercial business in Europe has performed well in its fundamentals.The second half of the year brought th

19、e first period of half year revenue growth seen since 2021,which the Board believe signals the return to sustainable growth.Board composition Throughout the year,there were changes in our Board composition.We were pleased to appoint Dr.Shaun Furlong as an Executive Director.Shaun has proven himself

20、to be an invaluable asset to us since his appointment as Group Financial Controller in April 2022 and more recently as Chief Financial Officer in August 2023.We also welcomed David Ball as an independent Non-Executive Director and Chair of the Boards Audit and Risk Committee,bringing over 25 years o

21、f financial markets expertise to our team.Additionally,we bid farewell to Mary Tavener,who resigned from her position as a Non-Executive Director after five years of dedicated service,and we thank her for her contributions.As a result of these changes,we reviewed the membership of our Committees,fur

22、ther details of the changes of membership are set out in each Committee report,see pages 44 to 49 for more information.Financial performance and clinical development Two halvesTwo halves financial performance This year was a year of two halves.On one side,financially the Company continued to face ch

23、allenges.Nonetheless,it continued to extend its cash runway with cost-saving initiatives and by securing investment.On the other side,we have celebrated success in the clinical development of our products.Following the satisfaction of FDI clearance conditions,the open offer and subscription was laun

24、ched.This led to the mandatory cash offer by SkyGem.These events saw a dramatic change to our shareholder base,approximately 93%of which now sits with SkyGem and Southern Fox.The loan facility provided by SkyGem and Southern Fox was amended twice in the period.In December 2023 we announced a 40m loa

25、n facility with SkyGem and Southern Fox,of which 7.5m was initially committed.Through successful discussions with our major shareholders,we have secured a further 15m drawdown from our existing facility.This additional funding extended our cash runway into Q1 2025,providing us with the financial fle

26、xibility to advance our innovative R&D pipeline.We would like to express our gratitude to our shareholders for their continued support and trust in Allergy Therapeutics,which has been instrumental in our ability to pursue our growth objectives.We have experienced two years of extraordinary events an

27、d acknowledge the effect this has had,particularly on minority shareholders,our employees who have navigated the financial constraints together with the Company every day and our communities who we have had to support in a different way based on our cash runway.For further information about our fina

28、ncial performance please see page 34.Two halves clinical development Successes in our clinical development initiatives provide further drive to continue the pursuit of our goals.Grass MATA MPL a new approach to managing allergic rhinoconjunctivitis due to grass pollenThe successful completion of the

29、 pivotal Phase III G306 trial for Grass MATA MPL in November 2023 provided further evidence demonstrating the beneficial treatment effect of our grass pollen allergy immunotherapy candidate,supporting our strategy to register the product with the Paul Ehrlich Institute(PEI)under the TAV programme in

30、 Germany.The primary endpoint of G306 demonstrated a statistically significant improvement of 20.3%(p=0.00024)for Grass MATA MPL compared to placebo,providing evidence of a substantial reduction in daily symptoms and use of relief medication among participants receiving the immunotherapy candidate.C

31、hairman and Chief Executive Officers reviewPeter Jensen OBEChairman 5 November 2024Manuel LlobetChief Executive Officer 5 November 2024Strategic report05Allergy Therapeutics plc Annual Report and Accounts 2024Chairman and Chief Executive Officers review continuedPerformance and development continued

32、Grass MATA MPL a new approach to managing allergic rhinoconjunctivitis due to grass pollen continuedA highly statistically significant improvement in the Rhinoconjunctivitis Quality of Life Questionnaire(p=0.0003)was also observed during the peak season and the protective biomarker immunoglobulin(Ig

33、G4),measured during the grass pollen season,showed an approximately five-fold increase after treatment with Grass MATA MPL compared to placebo(p0.0001),consistent with data from the earlier G309 exploratory field trial.These robust results support our plans for regulatory submission,with discussions

34、 progressing well with the PEI on the clinical data package and also in chemistry,manufacturing and controls.We are on track for submission in Germany in calendar Q4 2024,positioning Grass MATA MPL as the first subcutaneous grass allergy immunotherapy registered via the TAV programme.Concurrently,we

35、 are exploring US registration opportunities,with plans to engage with the FDA regarding the clinical programme to meet US requirements.Our long term paediatric trial,G308,has commenced,marking another milestone toward regulatory approval.We are excited to bring this innovative therapy to market,add

36、ressing a critical need for new treatments for grass pollen allergies,which significantly impact the quality of life for many individuals.Bringing Grass MATA MPL to this point in its development has been a huge undertaking for the Group,with significant investment.We are extremely encouraged by the

37、possibility of bringing this state-of-the-art immunotherapy to the market.Grass pollen,a common cause of seasonal allergy,significantly impacts the lives of many people,and new treatment options are desperately needed.The continued investment,particularly over the last two years,has,of course,been c

38、hallenging and we would like to especially thank the major shareholders SkyGem and Southern Fox for their support.For further information on Grass MATA MPL please see the R&D report on page 27.VLP Peanut delivering a paradigm shift in the treatment of peanut allergyThe clinical development of the Gr

39、oups innovative,short-course peanut allergy vaccine candidate,VLP Peanut,via subcutaneous injection,is progressing well.We believe this product has the potential to be a ground-breaking,disease-modifying immunotherapy that could bring a significant positive impact to the lives of patients,families a

40、nd health systems affected by peanut allergy.As one of the most common food allergies,peanut allergies affect approximately 1-2%of the US population.The Phase I/IIa PROTECT trial,our first-in-human study evaluating the safety and tolerability of VLP Peanut in healthy and peanut allergic adult subjec

41、ts,has progressed over the past 12 months.Our promising safety and tolerability data have provided a solid basis for the design of our upcoming Phase IIb study.Ahead of that,the PROTECT trial will generate the first biomarker-led efficacy data,among higher-dose peanut allergic patients.This data is

42、expected to be available in Q4 2024.Updates from the trial and plans for further progression to Phase II can be found in the R&D report on page 27.Post Period Funding Post period,on 15 October 2024,the Group entered into a 40m secured senior loan facility(the“Hayfin Facility”)with Hayfin Healthcare

43、Opportunities LuxCo S.a.r.l.,a fund advised by Hayfin Capital Management LLP(“Hayfin”).Also on 15 October 2024,following discussions with major shareholders,SkyGem Acquisition Limited(an affiliate of ZQ Capital Management Limited)and Southern Fox Investments Limited(together the“Shareholder Lenders”

44、),the existing loan facility of 40m,details of which were announced on 27 December 2023,has been increased to 50m and its term extended to October 2030.For further information please see Note 34.Outlook Looking ahead,we remain focused on advancing our pipeline of innovative allergy vaccines,expandin

45、g our market presence and delivering value to patients and shareholders alike.As we navigate the path forward,we remain committed to our mission of transforming the lives of people affected by allergies through our immunotherapy treatments.Peter Jensen OBE Manuel Llobet Chairman Chief Executive Offi

46、cer5 November 2024 5 November 2024Strategic report06Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportMarket needMarket needAllergy Therapeutics is well placed to respond to the trends driving demand for immunotherapies.Market need The market is made up of two parts:those with

47、mild to moderate symptoms who can be treated with over-the-counter products and those who suffer from more severe symptoms for whom immunotherapy treatment may be required.The percentage of allergy sufferers in the population is increasing.The reason is not completely clear,although it has been sugg

48、ested this is due to increased urbanisation and better hygiene.As with most medicines,patients do not always adhere to dosing requirements when the symptoms are gone,potentially reducing the effectiveness of treatment.Market characteristics Over-the-counter products are available at pharmacists whil

49、e immunotherapy products are provided via doctors who specialise in allergies.Most markets for immunology are either mostly subcutaneous(e.g.Germany or the US)or sublingual(e.g.France or Italy).The European market is mature and grows slowly due to varying levels of reimbursement or access to immunot

50、herapy treatment.Our response and innovation Allergy Therapeutics unique selling point is ultra-short and short-course treatments to aid higher patient adherence to treatment.The Group is spending significant amounts on research and development on a range of products.Real-world evidence(“RWE”)has ma

51、de significant advancements recently in the pharmaceutical industry.Typically,RWE was mainly used for analysing electronic health records and data from wearable devices;however,today this has proven to become one of the major tools for vaccine development and testing.Allergy Therapeutics incorporate

52、s eDiaries into its clinical trials.This provides for greater interaction with the subject via mobile device for daily observations and improving data collection response through reminders and alerts.Pollen allergiesMarket need Digitalisation is more about solving problems through tracking real-life

53、 data,ensuring patient adherence,artificial intelligence(“AI”)driven selection of candidates,analytics and documentation of all areas of clinical trials,manufacturing and regulatory filings.Given the growth in the analysis of human diseases and the number of pharmaceutical products being used to tre

54、at them,digitalisation is becoming a necessity rather than a nice-to-have.Machine learning algorithms combined with data analytics can boost predictive medicine and make it possible to track the effects of different therapies on groups of patients over time.Market characteristics This is a new and f

55、ast-expanding market.Some parts of it are simply necessities for such processes as filing for approval,recording of patients during trials or scanning large databases.There is a growing market of digitalisation which could be considered as types of medical devices that are reimbursable by certain he

56、alth authorities and can bring direct benefits to patients.This market is driven by technology gains in the broader IT area,big data,as well as by pharmaceutical requirements.AI is becoming pivotal in healthcare as the global AI healthcare market size is expected to reach$148.4bn by 2029.Our respons

57、e and innovation Use of digital solutions to record the data from patients enrolled in clinical trials enables more accurate data gathering.Reminders that pop up on mobile devices ensure patients are reminded to record their symptoms in real time rather than waiting until they remember,at which poin

58、t they may not recall facts as well.Use of apps to collate and share data on local pollen counts,location of nearest allergy clinics and reminders to take medication all assist in the maintenance of dosing for patients to enable them to better control their condition.DigitalisationStrategic report07

59、Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportMarket need continuedMarket need continuedRegulatory environmentMarket need Given the potential effects of a product that has not been properly manufactured,tested or studied in a real-life environment,regulation is critical.Reg

60、ulation also creates a level playing field where it is clear to all developers and manufacturers what is required.Market characteristics The regulatory environment for the pharmaceutical market is quite mature but there are some pockets where historical arrangements continue.In Europe,the pollen all

61、ergy market is moving to a position where all major allergy treatments need to have marketing authorisation.In the US,the pollen allergy market for severe allergies is still mostly treated by individual allergists diluting concentrates and administering them to patients.There is pressure to move tow

62、ards GMP manufactured products.Our response and innovation Allergy Therapeutics already has two platforms that are approved and is working towards marketing authorisation for the MATA MPL platform.The Group is in regular contact with regulators to collaborate on best practice and develop meaningful

63、processes.The Group aims to bring the MATA MPL platform,once approved,to the US market as the first subcutaneous approved product on the market.Food allergiesMarket need There is significant need for products in this sector as the current treatment is mostly achieved through avoidance,with only one

64、product approved and available.As with pollen allergies,the percentage of the population with food allergies has increased significantly over the last decade.Approximately 2.5%of the general population in a country is affected by a food allergy.There is additionally more awareness about the issue am

65、ongst the general population.The target for severe allergies in this area is a product that has the potential to substantially reduce the risk of adverse outcomes upon allergen exposure.Market characteristics This is a new market with only one product approved for peanut allergy.This product is a fi

66、rst-generation product that builds up tolerance to peanuts through daily treatment over an extended period.It is likely that treatments for food allergies will be administered by allergists,similar to pollen,due to their knowledge of treatment and the similarities of the two markets.Peanut allergy i

67、s expected to be the most valuable segment within the food allergy market by 2030.The key severe food allergy markets are peanut and other types of nuts,shellfish and dairy.Our response and innovation The Group has licensed VLP Peanut and developed a product that has the potential to become a next-g

68、eneration product with the aim of significantly reducing or eliminating allergic reactions to peanuts through a small number of injections.The ongoing Phase I/IIa VLP Peanut PROTECT trial began in March 2023 and is evaluating the maximum safe and tolerated dose and includes assessment of biomarker e

69、fficacy in peanut allergic patients.Healthy subjects in the PROTECT trial have now received a 400-fold dose increase of VLP Peanut,providing strong confidence that the VLP technology is safe and well tolerated.Patients allergic to peanuts have received subcutaneous dosing of the vaccine with no safe

70、ty signals observed.If this product proves to be successful,the same platform could also be used to develop treatments for other food allergies.Strategic report08Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportBusiness modelOur purpose is to transform patients lives and the l

71、ives of people around them.Our resourcesWhat we doValue creationSpecialist expertiseThe specialist expertise of our employees drives and inspires us to transform lives.Innovation As a global pioneering team we innovate to advance treatments in immunotherapy.Income generated from operations or fundin

72、g Income generated is re-invested back into our business to drive growth.Research and developmentWe have a strong pipeline of new products at various stages of development and continue to enhance our existing product range.ManufacturingWe maintain our own and contracted accredited facilities in the

73、UK and Spain which produce our medicines for clinical trials and sale.SalesCurrently we sell in 14 markets and we plan to develop these further and expand into new markets.We utilise our resources to create value for all our stakeholders which include patients,employees,healthcare professionals and

74、investors.Our approach to value creation is underpinned by our cultural values:Patient First,Visionary,Menschlichkeit(Humanity),Commitment.Strategic report09Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportPurpose and cultural valuesOur purpose is to transform patients lives a

75、nd the lives of people around them.Our cultural valuesOur core beliefs and principles help guide everyone at Allergy Therapeutics to work towards the same goals;these values shape our vision and support our culture.We seek to truly understand how patient lives are affected by allergies.We make decis

76、ions,supported by data,on what adds value for our patients.We never compromise on quality and safety for our patients.We will always strive for the highest quality standards for our patients.We show courage by being innovative and always look for better ways to do things.We are not afraid to try new

77、 things and learn from our experiences.We are pioneering,we are future-focused and work with drive and passion.We deliver robust plans by looking ahead to anticipate future changes,challenges and opportunities.Showing humanity and treating each other with honesty and respect.We treat each other the

78、way we would want to be treated.We foster an inclusive culture by valuing and encouraging different perspectives,experiences and views.We work ethically and share information and ideas in an open way to help others succeed.We do what is right,even when it is sometimes difficult,and support each othe

79、r to be themselves.We approach everything with integrity,we are fully committed and engaged in what we do and we never give up.We walk the talk and do what we say we are going to do.We work together as one team and actively collaborate across team/department/market boundaries.We take accountability

80、for our performance and personal development.Patient FirstPutting patients at the centre of everything we doVisionaryLeading the way with innovation,courage and passionMenschlichkeit(Humanity)Leading the way with innovation,courage and passionCommitmentWorking together as one team with integrity See

81、 more on pages 13 and 19 See more on pages 7,8 and 27 to 28 See more on pages 12 to 14 See more on pages 12 to 14 and 23Strategic report10Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportOperating responsiblyEnvironment,social and governanceOur planet See more on page 15Our pe

82、ople See more on page 20Our patients See more on page 19Our responsible governance See more on page 22Our purpose is to transform the lives of our patients and the people around them.We are committed to doing this whilst behaving in a socially responsible manner.Our ESG strategy focuses on four pill

83、ars:our patients;our people;our planet;and our responsible governance.Our activities during the year have delivered progress against all four pillars.Allergy Therapeutics transforms the lives of our patients while delivering sustainable value to all our stakeholders.We understand the value of aligni

84、ng our purpose to our strategic decision-making,which is supported by a culture of ethics,quality and patient safety.The business operates to high standards of governance and compliance.There is an increasing expectation from stakeholders for us to measure and communicate the effectiveness of our ES

85、G strategy as well as to ensure that our business model,objectives and future goals are aligned to our sustainability roadmap.This year weve focused on extending our cash runway and funding,resulting,understandably,in there being less progress on reducing our impact on the environment.We believe our

86、 stakeholders would however expect this focus on extending our cash runway and funding to take priority.Strategic report11Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportEngagement with stakeholdersEngaging with our stakeholders is an integral part of how we operate as a busi

87、ness.We actively seek to understand what really matters to them and ensure that we take this into account in our decision-making,both at a strategic and an operational level.Positive relationships with our stakeholders,who have an interest in our business and may be impacted by the decisions we make

88、,are key to our long-term success.Stakeholder engagement enables us to continue to make and deliver our products to patients around the world and maintain a motivated workforce and dependable supply chains.It encourages customer confidence in our products and helps us maintain close relationships wi

89、th healthcare professionals.This should be read in conjunction with the comments from the Chairman and CEO on page 5 around key issues during the year impacting stakeholders.In the table below,and on the following pages,we set out our key stakeholder groups,their material issues and how we engage wi

90、th them.Environment,social and governance continuedInvestorsWe engage with our investors,shareholders,analysts and banks to ensure they have a good understanding of our business,progress against our strategic priorities and to address any concerns.Key issues for them Sustainable business performance

91、 and growth Return on investment Clinical performance Financial performanceEngagement through the yearOrdinarily the Chairman,CEO and CFO attend meetings with investors to discuss strategic progress,financial and operational performance,and other matters relevant to shareholders.Following a similar

92、pattern to the prior year,the Group has predominantly engaged with investors by way of RNS announcements or during General Meetings.Two of our major shareholders,SkyGem Acquisitions and Southern Fox,also have representatives on our Board.The AGM is an opportunity for shareholders,including non-insti

93、tutional ones,to hear directly from the Board on the Groups performance and strategic direction and to ask questions.LinksGovernance:see pages 38 to 43Outcomes Clarity on strategy and approach Understanding progress against these goalsOur peopleOur people are essential to the success and growth of o

94、ur organisation.Our team of talented,experienced and diverse individuals help us to lead the way in allergy immunotherapy.We have an honest and open relationship with our workforce,encouraging them to have their say,whilst ensuring they remain supported.We engage with each other respectfully and hel

95、p make Allergy Therapeutics a fair and inclusive place to work.Key issues for them Communication more clear and consistent communication during this critical time Wellbeing having greater awareness of wellbeing support available Workload to be manageable and not a cause of stress Recognition receivi

96、ng sufficient performance feedback Goal setting knowing what is expected Strategy being inspired by our mission and purpose Reward having a fair reward process Growth opportunities to progress career and learn Job security the assurance of continuing employment regardless of any external forces that

97、 might impact the businessEngagement through the yearThe Company heavily invested in training through the year in line with its value of commitment to take accountability for our performance and personal development.In Spain,the Company continued to support staff who were undertaking English languag

98、e courses.In Germany,a mentoring programme,a Junior Development programme and Culture Cafe was launched.In the UK,team leaders and managers attended a five-part You Make The Difference training programme focused on continuous improvement as managers.This is in addition to the Companys standard annua

99、l training programme covering behaviour,compliance,quality,pharmacovigilance and IT security.Employee engagement has not been without difficulty during the year as the business focused on cost reduction to extend its cash runway.It was imperative to the Company to keep investing in its employees not

100、 only by way of training,but also by making a Company-wide pay increase.LinksOperating responsibly our people:see pages 20 and 21OutcomesContinuous training of employees who drive the future of the business.Strategic report12Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportEnv

101、ironment,social and governance continuedOur patients Our patients rely on us to produce products that can help to transform their quality of life.Every day we make a difference to the lives of patients through the provision of high-quality products with good safety and efficacy profiles.Key issues f

102、or them Improving quality of life Efficacy Product safety ConvenienceEngagement through the yearFor our consumer healthcare products,we engage with patients via digital channels(websites,social media),advertising(across multiple media,including TV,print media and in-store promotions in pharmacies an

103、d retail stores),in addition to providing basic product information as part of our Medical Information function.For prescription-only medicines,our direct engagement with patients is much more limited,due to regulatory constraints governing promotional activities.LinksBusiness model:see page 9Outcom

104、es Better understanding of our products and their safety profile Better outcomes from treatmentHealthcare professionals(“HCPs”)We care about the needs of our HCPs.We focus on delivering quality products efficiently.Key issues for them Product safety Cost Efficacy Availability Training in the adminis

105、tration of productsEngagement through the yearOur sales force engage with prescribers of our products through regular meetings,either face-to-face or virtual.We provide training and information on use of our products via our medical team.We have organised symposiums focusing on our pipeline products

106、 and met with HCPs at conferences where they are able to obtain information from us.LinksOperating responsibly:see pages 11 to 15OutcomesWe are perceived to be a trusted and reliable partner with a focus on science and developing new technologies.Communities We look to minimise any negative impacts

107、from our operations and to support sustainable socio-economic development and growth in our local communities.We recognise that through proactive,strategic stakeholder and community engagement we can increase the profile of the business.Key issues for them Local employment opportunities Environmenta

108、l management Operational impactsEngagement through the yearWe actively recruit from the local communities.LinksOperating responsibly our people:see pages 20 to 21OutcomesContinued its support for activities in STEM subjects in Europe,organising work experience activities and placements for students

109、in Spain and the UK.Engagement with stakeholders continuedStrategic report13Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportEnvironment,social and governance continuedGovernments and regulators As a manufacturer and distributor of medicinal product we must comply with GMP and

110、 GDP.We are regulated by various authorities in the territories in which we operate including the MHRA in the UK.We look to develop and maintain constructive relationships with regulators and the national and local governments of the countries in which we operate.Key issues for them Compliance with

111、regulatory,legal and taxation requirements TransparencyEngagement through the yearOur Executive Team,regulatory teams and operational management engage with governments and regulators in the countries in which we operate.We ensure a collaborative approach in areas such as product characterisation an

112、d clinical study design.Ensuring we meet our regulators expectations to maintain continued compliance with regulatory legislation is enabled through proactive and collaborative engagement in direct discussion or other forums such as contributions in agency-sponsored research.LinksR&D report:see page

113、s 27 to 28Outcomes Open and constructive relationship with regulatorsSuppliers Our suppliers play a key role in helping the business deliver its purpose to transform the lives of our patients.We form strong,sustainable and trusted partnerships and look to secure excellent value for money,whilst mini

114、mising risk in our supply chain.Key issues for them Transparency in the supply chain Responsible sourcing and human rights Compliance with laws Competitive pricing Equitable terms Payment termsEngagement through the year Our approach to quality throughout the supply chain helps us to ensure the prod

115、ucts we supply to customers are of the right quality and safety standards for our patients and the environment.The supply chain is generally managed by our procurement team.This year the procurement team have focused on supplier engagement.In the year,we were able to mitigate any supply chain risks

116、by pre-ordering key manufacturing supplies and ensuring we had numerous suppliers for key materials.LinksGovernance:see pages 38 to 43Outcomes Able to stock many key supplies for continued vaccine manufacture,despite shortage of vaccine components in the marketEngagement with stakeholders continuedS

117、trategic report14Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportEnvironment,social and governance continuedNonFinancial and Sustainability Information StatementFor financial years beginning on or after April 2022,Companies Act legislation in relation to climate-related finan

118、cial disclosures(“CRFD”)has been in force and applicable to Allergy Therapeutics.These requirements are based on the recommendations of the Task Force on Climate-Related Financial Disclosures(“TCFD”)and are organised under the same subject areas:Governance and Risk Management,Strategy and Metrics an

119、d Targets.Given this close alignment,we worked towards the TCFD recommendations in our first year of reporting,but have subsequently concluded that our disclosures should specifically refer to the eight items required by CRFD.(a)Description of the governance arrangements in relation to assessing and

120、 managing climate-related risks and opportunities;(b)how they are identified,assessed and managed;and(c)how these processes are integrated into the Companys overall risk-management process.Considering climate-related risks and opportunities formed part of the governance structure referred to on page

121、 39 and was the remit of the ESG Committee during the year.Part of the role of that committee was to report such risks and opportunities where considered appropriate to the Executive Team for further assessment before their potential inclusion in discussions with the Audit and Risk Committee and,ult

122、imately,the Board.Since the year end,we have decided to streamline these arrangements by disbanding the ESG Committee as well as the Climate Risk Team and making climate-related risks and opportunities(and ESG risks and opportunities more widely)part of a standing risk and opportunities item for con

123、sideration by the Executive Team at its monthly meetings.This brings discussion of these matters into the mainstream of operational governance of the Group and ensures that they are on the agenda of the Groups Executive Team.A further governance change has been to move responsibility for the Groups

124、approach to ESG to the Company Secretary.Her Group-wide role gives visibility to all parts of its operations and her involvement in setting agendas for the meetings of the Board,its Committees and the Executive Team,making up the Groups governance structure,will ensure the relevant risks and opportu

125、nities are considered in a consistent and timely manner.In 2022,with the assistance of external consultants,the Group identified and assessed climate-related risks and opportunities in the following categories:Physical risks,in the form of acute and chronic impacts such as the increased severity of

126、extreme weather events(including flooding,heatwaves,wildfires and hurricanes)and chronic alterations(including the rise in mean temperatures and extreme variability in weather patterns).Transition risks,which relate to the transition to a low-carbon economy and could include policy and legal changes

127、,changing consumer behaviour and reputational risks.Climate opportunities,such as improved energy efficiency,new products and services and new markets.Our planet15Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportEnvironment,social and governance continuedNonFin

128、ancial and Sustainability Information Statement continuedWe did not see significant changes in our business model or strategy or the external conditions during 2023 and consequently did not re-perform this process during 2023.The risks and opportunities that are included in our risk-management proce

129、ss therefore remain unchanged and are outlined below.We will refresh our assessment of the key risks and opportunities during the second half of 2024.A Group risk register is maintained and emerging risks or changes to risk profiles are reported and discussed at Executive Team meetings.The Executive

130、 Team reports on principal risks to the Audit and Risk Committee on a quarterly basis for consideration as part of its responsibilities delegated by the Board(see page 45).While climate and ESG-related risks may not meet the Groups criteria for principal risks(and therefore not be included in the de

131、liberations of the Audit and Risk Committee and brought to the attention of the Board),they will be discussed by the Executive Team.The Audit and Risk Committee and the Board reviews and approves the ESG section of the Annual Report and Accounts.When evaluating potential risks and opportunities,we c

132、onsider their magnitude and likelihood.Impact and likelihood are both scored out of 5 and multiplied to give a combined score out of 25.While there is no specific cut-off for principal risks,anything above 15 is considered“very high”.(d)Description of the principal climate-related risks and opportun

133、ities arising in connection with the Companys operations and the time periods by which reference to which those risks and opportunities are assessed;and(e)Description of the actual and potential impacts of the climate-related risks and opportunities on the Companys business model and strategy.These

134、risks and opportunities have been assessed over the following time periods:Short termMedium termLong term2024-20302030-20402040-2050Physical risk:Change in weather patternsThe increased frequency and severity of extreme weather events in the different climate scenarios referred to later in this repo

135、rt could threaten the safety of our primary physical assets,located in Spain and the UK.In the short term,extreme heat waves,particularly in Spain,are adversely affecting the productivity and health of our employees.In addition,longer term rises in temperatures and increased flooding(either from rai

136、nfall or rising sea levels)could disrupt our access to essential raw materials.In the medium and long term,climate-related disasters will become more frequent and chronic changes in weather patterns would impact our sites.Transitional risks:Low carbon technology transitionDisruptive climate policies

137、 or legal changes could disturb our supply chain,or our manufacturing processes if we and our supply chain are not able to respond to them effectively.One impact could be an increase in costs throughout our supply chain and the need to address these through internal efficiencies or potential price r

138、ises for our products.We anticipate changes such as these to occur in the medium to long term.Increased raw material costsCritical minerals and other materials essential for clean energy production and storage are expected to increase in price in the short and medium term due to scarcity and rising

139、demand.These increased costs are likely to affect the entire supply chain,placing pressure on all businesses to apply stringent cost control in other areas and to review selling prices.Carbon pricing and regulationsThe potential imposition of carbon taxes on businesses in the short,medium or long te

140、rm,or the application of price adjustment mechanisms(for example,the EU Carbon Border Adjustment Mechanism)could increase both our direct and indirect costs,with the same potential outcomes as for increased raw material costs.Increasing regulation in areas such as recycled or recyclable packaging ma

141、y require changes to our sourcing of packaging and its cost,and the processes employed to package our products.Climaterelated opportunityPublic sector incentives The European Union has introduced public incentives to facilitate the deployment of clean technologies.We will monitor the possibility of

142、utilising these initiatives to assist in our carbon-reduction measures.(f)Analysis of the resilience of the Companys business model and strategy,taking into consideration different climate-related scenarios.The climate-related risks and opportunities described above have been analysed under three po

143、tential climate-related scenarios:The Net Zero by 2050 scenario described by the International Energy Agency envisions a substantial deployment of clean energy technologies and the rapid adoption of renewable energy sources.It incentivises governments,investors and the private sector to implement gl

144、obal climate commitments,with the aim of limiting the rise in global temperatures to 1.5C by 2050.Developing economies stand to benefit from this energy transition,as funding and capacity-building opportunities become available for accelerating global energy deployment.Our planet continued16Allergy

145、Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportEnvironment,social and governance continuedNonFinancial and Sustainability Information Statement continuedClimaterelated opportunity continuedPublic sector incentives continued The Delayed Transition,as defined by the Ne

146、twork for Greening the Financial System(“NGFS”),portrays a world marked by global climate inaction until 2030.Consequently,stringent new policies will be implemented to halve greenhouse gas(“GHG”)emissions by 2040.These urgent measures will become necessary as nations grapple with significant social

147、 and economic shocks resulting from a decade of inaction.This scenario aims to cap global warming at 1.8C by 2050,reducing it to 1.5C by 2100.The Current Policies scenario by the NGFS,depicts a lack of ambition from both the governments and the private sector.Consequently,current global commitments(

148、e.g.the Paris Agreement)lose momentum,and there is neither a shared interest nor a collective effort to achieve Net Zero by mid-century.Furthermore,climate inaction will result in global warming reaching 2C by 2050 and potentially increasing to at least 3C by the end of the century.Therefore,governm

149、ents will need to confront the adverse consequences of social inequality,climate-induced migration and the need for robust adaptation plans.Physical risk:Change in weather patternsGiven the requirement to transport most of our products via controlled-temperature freighters,we must ensure that these

150、carriers can adhere to the GDP(Good Distribution Practices)rules,maintaining and controlling cold conditions while transporting goods over long distances,especially during heat waves.We need to consider any flooding risk,for which we will develop a resilience plan for our site in Worthing.These risk

151、s are more likely to materialise and sooner in the Delayed Transition and Current Policies scenarios and they would therefore require detailed resilience plans to be developed in the short term.Transitional risks:Low carbon technology transitionWe are developing the Energy Centre in Worthing to stre

152、ngthen our business security,become independent from GSK and tackle any technology risk.The transition to low-carbon technology will take place over a longer time period in the Delayed Transition and Current Policies scenarios.In the event that governments in our operating territories implement ince

153、ntives to encourage businesses to transition under the Net Zero by 2050 scenario and/or introduce penalties for continued use of fossil fuels,we will investigate the measures available to react to these.Increased raw material cost,production costs due to changing input pricesWe will commit to use lo

154、w carbon materials to provide our products with more efficient packaging materials.For our products in Spain we have prepared the SIGRE Annual Packaging Declaration for the 2022-2023 financial year,providing detailed information on the quantity and type of packaging placed on the market.Additionally

155、,we will maintain our commitment to ensure adequate environmental management of medicines and packaging to align with our customers changing behaviour to address climate change.Carbon pricing and regulationsBy 2050,we are committed to reducing 95%of our total carbon emissions so any carbon price or

156、additional costs of future regulations would have a minor impact on our financial planning.Additionally,we are creating alliances with our packaging suppliers to aim for the use of certified recyclable materials in our final products.(g)Description of the targets used by the Company to manage climat

157、e-related risks and realise climate-related opportunities and of performance against those targets;and(h)Description of the key performance indicators used to assess progress against targets used to manage climate-related risks and realise climate-related opportunities and of the calculations on whi

158、ch those key performance indicators are based.We do not currently have any targets in place to manage the climate-related risks and realise the climate-related opportunities referred to in this report and therefore do not have any key performance indicators.We will reconsider our climate-related ris

159、ks and opportunities during the year and set targets and KPIs as part of this process.Our planet continued17Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportEnvironment,social and governance continuedStreamlined Energy and Carbon Reporting(“SECR”)During the yea

160、r,Allergy Therapeutics has continued to capture emissions data as required by SECR regulations Group-wide.The collection and creation of the SECR report was facilitated externally by a third party,who have been engaged to provide independent verification of the calculation of our SECR data,in accord

161、ance with the relevant regulations.Under the SECR requirements,this report covers Scope 1 direct emissions,which includes natural gas,district heating,wood heating,diesel oil,refrigerant gas and Company-owned vehicles,Scope 2 indirect emissions which incorporates electricity and purchased steam,and

162、the only Scope 3 emissions required to disclose,which are associated with business travel in employees private vehicles.The results are shown in the table below.There has been a total of 2,687 tonnes of CO2e emitted during FY24,which compares to 3,006 tonnes for the prior financial year.Reporting pe

163、riodJuly 2023 June 2024Reporting periodRevised1 July 2022 June 2023Originally reported in periodJuly 2022 June 2023PercentagechangeTotal energy use covering purchased electricity(kWh)4,271,1454,188,7584,188,7582%Total energy use covering combustion of gas(kWh)314,253284,946284,94610%Total energy use

164、 covering business travel Company and grey fleet(kWh)1,830,9012,033,8501,294,090-10%Total energy use covering diesel oil(kWh)439,39271,20971,209517%Total energy use covering steam district heating(kWh)20,30051,00051,000-60%Total energy use covering purchased steam(kWh)3,256,0524,892,6744,892,674-33%

165、Total energy use covering wood heating(kWh)41,55641,55641,5560%Total energy use(kWh)10,173,59911,563,99310,824,231-12%Total emissions generated through use of purchased electricity(tCO2e)1,1741,1511,151.22%Total emissions generated through combustion of gas(tCO2e)676160.810%Total energy use covering

166、 diesel oil(tCO2e)1042120.8395%Total emissions generated through business travel Company and grey fleet(tCO2e)632679436.8-7%Total emissions generated through use of refrigerant gas(tCO2e)174948.9-66%Total emissions generated through steam district heating(tCO2e)41111.4-61%Total emissions generated t

167、hrough purchased steam(tCO2e)6891,0341,033.6-33%Total emissions generated through use of wood heating(tCO2e)110.60%Total gross emissions(tCO2e)2,6873,0062,764-11%Total mileage1,992,6822,139,7301,432,096-7%Total estate size(sq ft)221,993221,993221,9930%Intensity ratio total gross emissions(kgCO2 per

168、sq ft)12.1013.5412.45-11%Intensity ratio transport emissions(kgCO2 per mile)0.320.320.310%1.Information revised following provision of further data post year end.Our planet continued18Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportEnvironment,social and gover

169、nance continuedWe strive to deliver the best immunology treatments for patients.Our products and their associated adjuvant technologies address the causes of patient symptoms rather than masking them.We believe the best products for a thriving business are also the best products for patients.Therefo

170、re,our product pipeline reflects this,with programmes investigating allergens of serious concern such as peanut allergy.Allergies reduce quality of life by preventing individuals and their loved ones from enjoying the everyday activities that most take for granted.At their most severe,allergies can

171、be fatal.Whatever the severity of an allergy,the wider implications are negative.Many patients and their families live in fear and can feel isolated or excluded.We believe our work in allergy treatment is transforming lives and the lives of the people around them.For more information on how we engag

172、e with our patients,please see page 13.Our shorter-course treatments take four to six injections,over the course of 4 to 13 weeks.Alternative therapies in the US can take 50-100 injections and up to 15 across Europe.Our approach increases efficiency for healthcare professionals and frees up time for

173、 our patients.Biodegradable adjuvantsAdjuvants are added to vaccines to enhance and modify immune responses and can increase efficacy and reduce the number of injections required for a treatment.A number of vaccines use aluminium salts as an adjuvant;however,in the 1970s we began developing natural

174、biodegradable alternatives and,today,all our vaccines are aluminium free and feature natural adjuvants only.Our quality cultureHealthcare professionals rely on our quality products,our knowledge and our trusted partnership to deliver the best care for their patients.The purpose of the Allergy Therap

175、eutics is to transform the lives of our patients and those around them.To achieve this,quality and the provision of quality products becomes integral to all aspects of our business.The supply of our products is becoming ever more complex and,with the significant regulatory changes taking place acros

176、s the sector,the expectations of us are increasingly demanding.We use our Quality Management System(“QMS”)to meet the requirements of our customers and patients in conformance with current legal and regulatory requirements.Our manufacturing and distributor licences underpin our QMS.All of our sites

177、are audited regularly,by a combination of internal audit,regulatory inspection and by our pharmaceutical business partners we see this as a core part of doing business.Quality is part of everything we do,this is set out in our Code.We work with a quality mindset,always putting patient safety first.A

178、 quality product is what our patients have the right to expect.Our employees are trained to have the ability to understand the importance of quality and to consider quality in everything they do.Our supply chain is assessed to ensure the standards we,and our patients,expect are met and maintained.Ou

179、r patients19Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportEnvironment,social and governance continuedOur people are the key to our success and we are proud of the pioneering and groundbreaking work they carry out that can transform a patients life.For us to

180、succeed we need to foster an environment where our people can flourish.We support our employees to make a difference to the business through a structured performance management process and feedback.In October 2023,taking inflation into consideration,the Group applied a global pay rise to all employe

181、es.Furthermore,we provide a competitive compensation and benefits package.We recognise our employees commitment to the Group and ensure we celebrate milestone work anniversaries for all employees by offering additional annual leave days.Furthermore,100 employees were awarded via our rewards and reco

182、gnition programme this year.Wellbeing and lifestyleThe wellbeing of our people continues to be of the utmost importance to the Group.During the year,we enhanced our lifestyle programme,Be Well,with a focus on practical support:for example,on-site bike maintenance for our UK employees,and access to b

183、ikes for our German team.We have continued to ensure our employee support offer is strong,with Employee Assistance programmes launched in many of our countries.Through our providers we are able to offer products such as private healthcare,access to remote medical and physio advice,mental health supp

184、ort and a variety of wellness content that we share with our people.In the last year,the Employee Assistance programmes have expanded their service offerings in the majority of our countries.Furthermore,we have installed free feminine vending units for all staff at our Worthing site in the UK.Where

185、some roles can be carried out remotely and others must be on site or in the office,the business has introduced a set of hybrid working principles throughout the Group that recognise the benefits to the business,the environment and individuals of working flexibly,but also the importance of face-to-fa

186、ce contact and meeting the needs of our stakeholders.EngagementWe continue to deliver our quarterly internal newsletters and our All Hands calls which is delivered live with recorded versions typically made available for anyone not able to attend.Both these avenues prove to be important communicatio

187、n pillars in order to provide operational and strategic business updates as well as a chance for employees to ask questions.TalentOur aim is to manage talent effectively and ensure that we have sufficient capability to realise our strategy.Our people 20Allergy Therapeutics plc Annual Report and Acco

188、unts 2024Strategic reportStrategic reportEnvironment,social and governance continuedTraining and developmentWe have continued to use the DiscoverLearn system to assign mandatory training courses on compliance and information security topics across the Group.As well as the repeat courses from the pre

189、vious year,we introduced global mandatory training on intellectual property and sustainability,targeted information security training for high-risk employee groups(e.g.Executives,HR and Finance)and internally created laboratory skills video training for employees in Method Development and QC.The ave

190、rage global completion percentage for all mandatory training courses assigned via DiscoverLearn was 96%.DiscoverLearn additionally provides employees with access to learning resources and opportunities for personal and professional development.From April 2024,a select list of optional learning was m

191、ade available to employees in our DACH countries who had previously only been able to use DiscoverLearn for mandatory training.122 optional learning courses have been used by employees across the Group,with the most popular training including delegation,mindfulness,time management,Microsoft Excel an

192、d our Allergy Therapeutics products.Live learning workshops on key business topics have also been delivered by internal and external trainers,with a total number of 168 attendees taking part in 24 workshops during this time.To help build the capabilities and confidence of UK team leaders and manager

193、s working in Supply Operations,Quality and R&D,a new multi-session in-person training programme was designed and delivered by the OD team,with support from UK HR.21 delegates across two cohort groups took part in the programme,with parts 1-5 running between January and July 2024.Feedback from the de

194、legates showed that 82%of survey respondents said the programme helped them to improve in their role and 91%said they would recommend the training to other team leaders and managers.Performance managementAllergy Therapeutics has a culture of encouraging continuous performance and development in orde

195、r to increase productivity and performance.Annual performance objectives for each employee are agreed at performance meetings,with check-in meetings held regularly throughout the year.Performance is measured against objectives set for the previous year and individual performance ratings underpin dis

196、cretionary annual bonus awards.Culture and valuesWe have four values which comprise of Patients First,Visionary,Menschlichkeit and Commitment.Our values go straight to the heart of everything we do,driving our culture.Our values directly connect our people and their work at Allergy Therapeutics to o

197、ur purpose.We have robust policies,including our Code which is an extension of our core values.It is a set of principles and expectations that guide the behaviours of everyone working for and on behalf of Allergy Therapeutics.For more information on how we are evolving culture within the business,pl

198、ease see page 10.Diversity and inclusionWe believe that every person in the Group has a part to play in creating value.We understand the benefits of a diverse and inclusive workforce.All aspects of diversity,including physical and other disabilities,are considered when making appointments at all lev

199、els.We are keen to develop diverse talent across the business and to ensure that opportunities for training,development and promotion are made equally available to all.As part of our Diversity,Equity and Inclusion strategy we have been providing ways to raise awareness,educate our employees and crea

200、te conversations.As an equal opportunities employer we welcome applications from anyone with the skills,experience and commitment to succeed.Our Code sets our expectations to treat everyone equally and with respect acknowledging that for us to succeed we need to foster an environment where we can fl

201、ourish.For applicants,as well as employees,with disabilities,this includes considering any reasonable workplace adjustments that might support them in fulfilling roles.Our gender pay gap reflects the fact that we have a smaller proportion of women than men occupying senior leadership roles.During th

202、e year we have engaged a range of contractors who coincidentally are male which has made a difference to our figures this year,with contracting salaries typically being higher.More information can be found in our gender pay gap report on our website .Responsible employerAllergy Therapeutics is an ac

203、credited Living Wage Employer for its UK operations.The real Living Wage is higher than the governments minimum,or National Living Wage,and is an independently calculated hourly rate of pay that is based on the actual cost of living.It is calculated each year and is announced by the Living Wage Foun

204、dation as part of Living Wage Week.We are now one of nearly 13,000 employers in the UK who voluntarily choose to pay the real Living Wage because we believe that a hard days work deserves a fair days pay.This commitment applies to not only directly employed staff,but also to our third-party contract

205、ed staff,such as our cleaning and maintenance staff.During the year,the Company implemented redundancies,ensuring that these decisions were made in a manner consistent with its core values.The process was carried out with a focus on fairness,transparency,and responsibility,aiming to minimise disrupt

206、ion while supporting those affected.These actions reflected the Companys commitment to maintaining integrity and respect throughout difficult circumstances.Our people continued21Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportEnvironment,social and governance

207、continuedAt Allergy Therapeutics,our four core values of Patient First,Visionary,Menschlichkeit and Commitment shape how we work and are at the heart of any decision we make.We value our reputation.We want to be a trusted business partner to all our stakeholders:our patients,employees,investors,supp

208、liers and also the communities in which we operate.Creating,building and maintaining trust requires a strong and longterm commitment towards high standards of ethics throughout the entire business.Ethics and complianceIn previous years,we implemented an improved Ethics and Compliance framework which

209、 provided all Group employees with clear expectations of standards of behaviour and ensured a consistent culture of integrity.The framework is subject to ongoing development and periodic review.During the year further updates were made expanding on topics such as fraud and intellectual property.Heal

210、th and safetyKeeping our people safe and well is our absolute priority at Allergy Therapeutics.This extends to the safety of any contractors,our patients and our local communities.The Board of Directors has overall responsibility for health and safety and this includes approving the health and safet

211、y strategy and reviewing performance at each Board meeting.During the year,we continued to embed best practice health and safety standards within the business across all our sites;all employees and contractors receive training in health and safety and during the year we recorded one lost time injury

212、(2023:zero).We are taking steps to strengthen our safety culture and have established a Health&Safety Council,which meets regularly.Our Safety Champions meet regularly,forming the Safety Committee and also the Safety Council which is comprised of management.Safety-based objectives are being incorpor

213、ated into the operations and quality teams performance agreements to help drive improvements in our safety culture and safety performance.Our focus on health goes beyond physical health.We provide employees with a dedicated website that offers advice and guidance on how to improve wellbeing.During t

214、he year,the business remained focused on raising awareness for those suffering from mental health and we have trained Mental Health First Aiders on our main sites.The wellbeing programme delivers regular campaigns and training.Modern slaveryIn accordance with the Modern Slavery Act 2015,the Board ha

215、s approved a Modern Slavery and Human Trafficking Statement,which has been published on our website.The statement details the steps we take to avoid slavery and human trafficking in our own operations and in our supply chain.We believe that our own operations present minimal risk,but recognise that

216、a higher level of risk is posed by the suppliers we engage with to provide goods and services.Science,Technology,Engineering and Mathematics(“STEM”)As a healthcare group with a focus on improving allergy treatments through advanced technology,we want to encourage and support the next generation of s

217、cientists and healthcare professionals.During the year,the Group continued its support for activities in STEM subjects in Europe,organising work experience activities and placements for students in Spain and the UK.Allergyrelated initiativesIn the year the Group attended the European Academy of Alle

218、rgy and Clinical Immunology(“EAACI”)exhibiting a corporate booth,scientific symposium and poster presentations.EAACI helps drive awareness of the existence of allergy treatments,supports the training of a new generation of allergists and supports initiatives into food allergy and awareness.We were a

219、warded the Outstanding Poster Presentation Award for our poster presentation Meta-analysis of primary endpoint of PQ Grass field studies and optimised dose and treatment regimen of PQ Grass.Other community projectsDuring the year,the Company donated needles and syringes to InterCare,a charity that f

220、ocuses on medical aid for Africa.Our responsible governance22Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportExpanding in EuropeStrong pipelineUS entryStrategic priorities Strongly performing profitable business Growing existing market share,additional product

221、 registrations and entering new markets Drive market position by world-class supply chain and increased patient adherenceStrategic priorities New technologies underpin pipeline depth in convenient products Investment strategy supported by improving EBITDA pre-R&DStrategic priorities Significant oppo

222、rtunity in largest allergy market Develop market access approach and relationships Secure funding for successful clinical development plans to deliver market access strategyProgress in 2023/2455.2mProgress in 2023/247 products in pipelineProgress in 2023/24Net sales of 55.2m(2023:59.6m)representing

223、a 7%reduction as a consequence of manufacturing capacity allocated to investigational medicinal product batches for use in clinical trials,and the ongoing programme of continuous improvement across the supply chain and quality systems paving the way for increased capacity.EBITDA pre-R&D and exceptio

224、nal costs was a loss of 6.8m(2023:loss of 10.6m).Effective cost controls implemented during the year have significantly reduced the operating cost base of the Group(pre-R&D and exceptional costs).Revenue for H2 has increased by 2%to 21.6m(H2 2023:21.2m),representing the first period of half-year gro

225、wth seen since 2021.Progress towards the registration of approved products.Collaborative meetings held with the Paul-Ehrlich-Institut(“PEI”)to discuss proposed Chemistry,Manufacture and Controls(“CMC”)and clinical packages in support of upcoming Grass MATA MPL Marketing Authorisation Application(“MA

226、A”),on track for submission in Q4 2024.G306 pivotal Phase III trial to evaluate efficacy and safety of Grass MATA MPL met primary endpoint.The primary endpoint of the trial,“Combined Symptom&Medication Score(“CSMS”)averaged over the peak pollen season”,demonstrated a statistically significant improv

227、ement of 20.3%(p=0.00024)for Grass MATA MPL compared to placebo,providing evidence of a substantial reduction in daily symptoms and use of relief medication among participants receiving Grass MATA MPL.First-in-human Phase I PROTECT trial began dosing trial participants in March 2023.Dosing of health

228、y volunteers in the first two cohorts completed.Patients who are allergic to peanuts had previously completed skin-prick testing in the PROTECT trial and have now also received subcutaneous dosing of the candidate vaccine.The peanut allergic patient cohort has now completed three incremental dose le

229、vels over two months with no safety signals observed.G306 pivotal Phase III trial completed to support registration in the US.US key opinion leaders involved in P101 VLP Peanut(PROTECT)trial.Plans underway for discussions with the US FDA on progression of clinical programme including the study G307

230、to meet the required total number of US subjects treated using the product intended for registration.Objectives for 2024/25Objectives for 2024/25Objectives for 2024/25Sales recoveryInitiate the recruitment of subjects for the long-term paediatric trial for Grass MATA MPLProgression of the VLP Peanut

231、 clinical programme towards Phase IIImprovement in gross marginProceed with submission for the registration of Grass MATA MPL in EUImprovement in EBITDA pre-R&D and exceptionalsComplete the VLP Peanut PROTECT studyStrategic framework23Allergy Therapeutics plc Annual Report and Accounts 2024Strategic

232、 reportStrategic reportWe measure performance against key performance indicators which are selected to reflect Group strategy.Key performance indicators(“KPIs”)Financial measuresNet revenue1EBITDA preR&D and exceptionals2R&D expenditureCash and available facilities355.2m(6.8)m22.9m12.9m202184.3m2022

233、72.8m202359.6m202455.2m202121.0m20227.6m2023(10.6)m2024(6.8)m202112.9m202215.7m202320.1m202422.9m202140.3m7.0m202220.5m10.0m202314.8m 14.75m202412.9m 0mAvailable committed facilityCashWhy is it a KPI?Net revenue tracks the Groups ability to generate and fulfil demand for its products.“Net revenue”is

234、 as defined in IFRS 15.Why is it a KPI?EBITDA pre-R&D and exceptionals is a measure of the Groups ability to generate cash for reinvestment in product development.This is an alternative performance measure,see Note 4 for a reconciliation to the equivalent IFRS measurement.Why is it a KPI?R&D expendi

235、ture tracks the Groups ability and commitment to develop existing and new products.Why is it a KPI?Cash and available facilities measures the resource that we have to fund trading and research and development activity until products can be sold.PerformanceRecent years have seen a decline in net reve

236、nue due to supply constraints from the manufacturing pause in 2022 and capacity allocated to investigational medicinal product batches for use in clinical trials.PerformanceRecent years have seen a decline,reflecting the decrease in revenue;however it has improved in 2024 as a consequence of the cos

237、t-saving initiatives undertaken to significantly reduce the cost base of the Group(pre-R&D and exceptionals).PerformanceYear-on-year the Group has invested more in R&D as it progresses its products through the clinical trial processes.PerformanceSufficient cash and available facilities have been mai

238、ntained throughout the period4.As at June 24 the Group had 17.5m of the uncommitted shareholder loan facility available.Link to strategyNet revenue is linked to our first strategic pillar,Expanding in Europe,see page 23.Link to strategyEBITDA pre-R&D and exceptionals is linked to our first strategic

239、 pillar,Expanding in Europe,see page 23.Link to strategyR&D expenditure is linked to all of our strategic pillars,see page 23.Link to strategyAvailable funding is linked to all of our strategic pillars,see page 23.1.Net revenue is gross revenue once cash discounts and statutory rebates have been ded

240、ucted.2.EBITDA pre-R&D and exceptional items is operating profit/(loss)before interest and tax with depreciation,amortisation,R&D expenditure and exceptional items included in operating profit/(loss)before interest and tax added back.3.Cash and available facilities is cash at bank and in hand plus a

241、ny committed but undrawn loan facilities available.Uncommitted facilities available in FY23 and FY24 are disclosed separately.4.Post period,further funding was secured,for further information please refer to Note 34 for details of events after the balance sheet date.24Allergy Therapeutics plc Annual

242、 Report and Accounts 2024Strategic reportStrategic reportNonfinancial measuresNumber of products in pipelineGross emissions(tCO2e)172,687 tCO2e 202110202210202392024720212022202320242,687 tCO2e3,006 tCO2e22,712 tCO2e3,017 tCO2eTotalWhy is it a KPI?The success of the Group is dependent on having a po

243、rtfolio of existing and new products at various stages of development.Why is it a KPI?We are committed to reducing the impact of the Group on the environment and track this using this standard objective measure.PerformanceGrass MATA MPL continues its development with successful read outs in key pivo

244、tal trials and plans are progressing to first register the product with the PEI under the TAV programme in Germany.The PROTECT trial(VLP Peanut)continues to run as planned and data observed thus far supports the hypo-allergic safety profile of VLP Peanut.Efficacy suggestive biomarker analysis is exp

245、ected to be available in Q4 2024.PerformanceOur emissions have increased over the last couple of years as more employees have returned to the workplace.This increase has been driven by an increase in purchased steam in the UK.For future years,we aim to strengthen our business security with our own E

246、nergy Centre in Worthing.Link to strategyThe number of products in pipeline is linked to all of our strategic pillars,see page 23.Link to strategyManaging the Groups gross emissions is a core element of our cultural value,Our planet,see pages 15 to 18.Key performance indicators(“KPIs”)continued1.Thi

247、s is based on SECR data.2.Amount restated from prior year due to estimated data being replaced with actual data.25Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportSince specific immunotherapy was first carried out successfully in the early 20th Century,it has b

248、ecome established as the only therapy that addresses the cause of serious allergic reactions.Our productsThe Group sells both injectable and sublingual(oral)allergen-specific immunotherapies.The most commonly prescribed are those for the treatment of pollen-related allergies,particularly for allergi

249、es to grasses,weeds and trees.The therapies trade under various brand names depending on the market,e.g.Pollinex Quattro,Polligoid and TA Grser Top.Pollinex QuattroPollinex Quattro,launched in 1999,heralded a transformation in immunotherapy by introducing allergy vaccination with only four injection

250、s per course.The short-course regime can be achieved due to the use of MicroCrystalline Tyrosine(“MCT”)adsorbed allergoids,an improved extract allergen that has been modified in order to lower allergenicity while maintaining most of the immunogenicity,and the innovative adjuvant monophosphoryl-lipid

251、 A(“MPL”).An adjuvant is a substance which improves the immune response to an antigen or allergen.Oralvac Our sublingual product is Oralvac Compact,with a dosing schedule which allows for a more rapid and simple escalation of dosage,making treatment more convenient for patients and doctors.The cours

252、e can be taken by the patient in their own home and is raspberry flavoured for improved patient compliance.VenomilWasp and bee treatment is provided by our freeze-dried Venomil product,which can be used via a rush dosing regimen.Venom ATL Polistes DominulaVenom ATL Polistes Dominula is available as

253、a treatment option in Spain.This is a vaccine and diagnostic product which can be ordered by community pharmacies or hospitals.SynbioticsSynbiotics are special formulations of prebiotics and probiotics.Synbiotics act as bio-immunomodulators of the immunologic response.The Group supplies three synbio

254、tic products(Kallergen-Th,ATI-Prob and Pollagen)across Spain,Austria,Germany and Italy.The Group additionally supplies a synbiotic product,Syngut,specifically designed for food and lactose intolerance.The products contain specific combinations of Lactobacilli and Bifidobacteria.Between 2015 and 2016

255、,two further products were launched in line with the WAO guidelines for atopic dermatitis prevention:our first synbiotic in drops,Kallergen Baby,for the prevention of atopic dermatitis in children from birth to three years old;and Kallergen Mamy,for pregnant women with high risk of atopic disease.Ac

256、arovac PlusAcarovac Plus is a novel MCT-adsorbed,modified-allergen product developed to address the cause of perennial mite allergy.The product has been standardised to meet a dose regime consistent with one vial convenience.Clinical evaluation has been completed,demonstrating excellent patient tole

257、rability and serological analyses consistent with a favourable shift in Th1/Th2 balance compared with an unmodified version of the product(one-year follow-up study with Dr Albert Roger,Director of the Allergy Unit at Hospital Universitari Germans Trias i Pujol,Barcelona,Spain).Our productsThe Group

258、sells a wide range of aluminium-free allergy therapies and diagnostics.The majority of revenue arises from sales of allergy therapies.26Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportWe think beyond symptom management and aim to treat the causes.Together were

259、 changing the way people think about allergies.Clinical progression of the MATA MPL platform Grass MATA MPL,the Groups short-course subcutaneous allergen-specific immunotherapy(“SCIT”)candidate that aims to address the cause of symptoms of allergic rhinoconjunctivitis due to grass pollen,has made hu

260、ge strides this year with the successful completion of the pivotal Phase III G306 trial which supports our strategy to register the product with the Paul-Ehrlich-Institut(“PEI”)under the TAV programme in Germany.The pivotal Phase III G306 trial completed in Q4 2023 and met the primary endpoint where

261、 the active treatment group demonstrated a highly statistically significant reduction in Combined Symptom&Medication Score(“CSMS”)of-20.3%(p0.00024)compared to placebo over the peak pollen season.In addition,a strong,statistically significant induction of the protective biomarker IgG4 was seen durin

262、g the grass pollen season between active and placebo(p0.0001)and there was a statistically significant overall improvement in the quality-of-life score,according to the Rhinoconjunctivitis Quality of Life Questionnaire(“RQLQ”)(p0.0003).No unexpected safety events were observed with Grass MATA MPL 27

263、,600 SU.Positive regulatory discussions were held with the PEI early in 2024 regarding the results of the pivotal Phase III G306 trial,as well as the data in support of CMC requirements and the subsequent regulatory pathway to national registration.During these meetings,key trial data from the pivot

264、al Phase III G306 trial were shared,alongside supporting CMC data that the Group plans to use as the basis for the proposed marketing authorisation application(“MAA”).Feedback was constructive and the PEI confirmed that,subject to the usual regulatory approval procedures and detailed data analysis,t

265、he Group may proceed with a MAA.As previously announced,the Group intends to submit a MAA to PEI in Q4 2024 and this remains on track.The completion of the G309 and G306 field studies represents a significant milestone in plans for registration in the US.Following an earlier successful end of Phase

266、II meeting with the FDA,the subsequent studies were designed to support a pathway forward to BLA in the US with both G309 and G306 studies including US subjects and it is also planned to include US subjects in the upcoming five-year long paediatric study(G308),which is expected to begin later in 202

267、4.A specific requirement for the FDA will involve a further study,known as G307,to meet the required total number of US subjects treated using the product intended for registration and the Group is planning for meetings with the FDA to agree a route forward.The total US allergy immunotherapy market

268、is estimated to be worth$2.4bn with around 25%of the patients suffering from grass allergy.This offers the potential for peak sales for Grass MATA MPL of about$300m to$400m per annum.VLP PeanutThe clinical development for the Groups innovative,short-course peanut allergy vaccine candidate,VLP Peanut

269、,via subcutaneous injection is progressing as planned.The ongoing Phase I/IIa VLP Peanut PROTECT trial is evaluating the maximum safe and tolerated dose of the Groups peanut allergy vaccine candidate and includes assessment of biomarker efficacy in peanut allergic patients.The trial,which is being r

270、un in centres in the US,is being conducted in two parts:Part A:Open-label study of healthy subjects(Group A1)who are undergoing subcutaneous dosing with ascending concentrations of VLP Peanut.Peanut allergic subjects(Group A2)underwent skin prick tests performed with ascending concentrations of the

271、vaccine candidate.Part B:Following satisfactory safety results from Part A,the study has proceeded to a double-blind,placebo-controlled Part B enrolling peanut allergic patients who are receiving subcutaneous injections of the vaccine candidate.Patients who are allergic to peanuts had previously com

272、pleted skin-prick testing in the PROTECT trial and to date they have now completed three incremental subcutaneous dose levels over two months with no safety signals observed.Healthy subjects in the PROTECT trial have received a 400-fold dose increase of VLP Peanut,providing strong confidence that th

273、e VLP technology within the vaccine candidate is safe and well tolerated at high cumulative doses.This is essential for further clinical development of VLP Peanut as the trials external safety review committee agreed that the doses administered so far have been safe and well tolerated and dose incre

274、ments in next cohorts can proceed as planned to similarly high doses in peanut allergic patients,to establish the dose range to be considered for the upcoming Phase IIb study.The PROTECT trial continues to run as planned and data observed thus far supports the hypo-allergic safety profile of VLP Pea

275、nut which is a key step in realising its potential as a transformative option for peanut allergy sufferers.Efficacy suggestive biomarker analysis is expected to be available in Q4 2024.No safety signal has been observed to date.We are hugely encouraged by the progress of the PROTECT trial and believ

276、e that the data provides assurance of the hypo-allergic safety profile of VLP Peanut,a key step in realising the potential of this transformative option for peanut allergy sufferers.The likely posology of VLP Peanut is just three injections,followed by a further boost after a number of years,represe

277、nting a significantly lower burden of dosing for patients compared with currently available oral treatments.These only increase tolerability to the peanut allergen and require daily dosing over many months or years,which can limit adherence.While transient monoclonal antibody treatments have shown p

278、otential in the field of peanut allergy therapeutics,they remain expensive,require regular treatment and are not disease modifying.R&D reportSuccessful outcome of Phase III clinical trial and progression of Phase I/IIa peanut27Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportS

279、trategic reportR&D report continuedVLP Peanut continuedThe availability of a safe and effective short-course vaccine that provides long-term protection and induces a long-lasting protective immune response would present a paradigm shift in how peanut allergy can be managed and has the potential to b

280、e a significant product in the worldwide food allergy market.VLP Peanut reflects the Groups commitment to the development of transformative treatment options,with the ultimate goal of improving the patient experience and delivering better patient outcomes.Use of the VLP platform in areas outside of

281、allergy The Group continue to evaluate new vaccine candidates via initial pre-clinical assessment in disease areas outside of allergy such as cancer and eosinophilic asthma.These vaccine candidates are based upon the same VLP technology the Group is utilising in the VLP Peanut programme and offer th

282、e potential to be disruptive in these disease areas.Scientific conferencesDuring the 2024 European Academy of Allergy and Clinical Immunology(“EAACI”)meeting in Valencia,Spain,the Group presented 13 poster sessions and held a symposium announcing the results and potential of the Grass subcutaneous c

283、linical programme.Vaccination against peanut allergy via viruslike particles 5+APCIFN-CD4+T helper cellPeanut VLP vaccineActivated B cellMemory B cellsPlasma cellsAllergen-specific IgG antibodiesAra h 2Ara h 1Fc RIFcyRIIbSTOPAra h 3Ara h 6Ara h 4IgGIgE1Peanut antigens displayed on the surface of VLP

284、s do not illicit an allergic reaction because they only activate a limited number of neighbouring mast cells.2Instead,the design of the vaccine candidate allows efficient trafficking of VLPs to antigen-presenting cells(“APCs”)and B cells.3There is therefore direct uptake of VLPs via APCs where they

285、interact with CD4+T helper cells,releasing interferon-gamma(IFN-).4The interaction between activated B cells(subsequent to antigen uptake)and Th1 cells is essential for long-lived IgG response and memory B cell response.In the presence of high levels of IgG antibodies specific for a single allergen,

286、IgG-immune complexes are formed and inhibit IgE-medicated signals,including those from IgE molecules cross-linked by other peanut allergens preventing anaphylaxis upon accidental exposure.Th1 cellIntellectual property patentsThe Groups patent portfolio contains both granted patents and pending paten

287、t applications,covering both marketed and pipeline products.This year the Group continued to file patent applications to protect competitive position,especially focusing on expanding protection of VLPs.Our diverse portfolio provides protection for products,platform technologies and methods of manufa

288、cture.The portfolio continues to be maintained in over 30 jurisdictions,including both the United States and Europe.PipelineFor further information about our R&D pipeline please visit our website at https:/ Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportOur risk mana

289、gement framework and internal control systems enable the Group to identify,assess and prioritise risks within the business and seek to minimise,control and monitor their impact.This helps us to meet our strategic objectives and deliver the long-term growth and viability of our business.The Board has

290、 overall responsibility for Group risk management and it is firmly embedded within our everyday business activities and our culture.Risk is a standing agenda item at Board meetings,where principal and emerging risks are reported,together with the actions taken to mitigate them.The Board has delegate

291、d responsibility for the review of the adequacy and effectiveness of the Groups internal control framework to the Audit and Risk Committee.The Executive Team are responsible for the day-to-day operational and commercial activity across the Group and are therefore responsible for the management of ri

292、sks in their own business functions.Senior leaders across the business identify and manage the risks for their division or function and a risk register is maintained which contains all current and emerging risks.The severity of each risk is assessed through a combination of each risks likelihood and

293、 impact.In assessing impact,consideration is given to financial,reputational and regulatory factors,and risk mitigation plans are established.Any emerging risks or changes to risk profiles are reported and discussed at Executive Team meetings.This gives rise to a more risk-aware culture and consiste

294、ncy in decision-making across the organisation in line with the corporate strategy.All corporate decision-making takes risk into account,in a measured way,while continuing to drive business growth.The risk framework manages rather than eliminates risk and has helped us to develop a more risk-aware c

295、ulture.Effective risk managementWe recognise that our purpose and mission can only be realised through effective risk management.Risk management structureAudit and Risk CommitteeMonitors the internal control framework.Reviews and discusses risks,controls and mitigation measures.The Executive TeamIde

296、ntifies and manages risk on a day-to-day basis.Maintains a risk register where the likelihood and impact of risks are assessed,risk responses are formulated,action plans to mitigate risks are developed and progress is tracked.BoardOverall responsibility for risk management framework and internal con

297、trols across the Group.Reports to the Board on its work and conclusionsReports on risk to the Audit and Risk Committee29Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportRiskDescription of risk and impactMitigationDevelopments in 2024Clinical,legal and regulator

298、y The Group operates in several highly regulated environments for the testing,manufacture and supply of its products.Compliance with clinical and regulatory requirements affects not only the cost of product development and resource use,but also the time required to comply.Increased regulation may re

299、quire products to be amended to comply with regulations and/or products have to be withdrawn,reducing revenues and/or increasing costs(such as the TAV process or Coordination Group for Mutual Recognition and Decentralisation Procedures Human(“CMDh”).Regulatory authorities are increasingly focused on

300、 the benefit/risk of pharmaceutical products and safety data,making it more onerous to obtain regulatory approval.Failure of a critical trial could lead to the requirement to withdraw a product from the market,a delay in development of a new product and loss of investor confidence in the Groups abil

301、ity to carry out successful clinical trials.The Group must remain compliant with all relevant laws and regulations and this can be a fast-changing landscape.Intellectual property may be challenged at any time and any unsuccessful defence may cause the Group to lose protection for its products and su

302、bsequently affect further development and sales.The Group is reliant on some intellectual property owned by external stakeholders that,if lost,could hinder the commercialisation of some of its products.Working with reputable third parties.Learnings from previous trials.Compliance systems are in plac

303、e to ensure all clinical,manufacturing and marketing activities comply with regulations in the EU and other territories.Standard operating procedures are maintained to ensure compliance with good manufacturing practice.Strict monitoring of new industry regulations and engagement with key regulatory

304、authorities to inform the Groups strategic direction and identify factors likely to affect the future development,performance and position of the Groups business.The Group has a regulatory team that tracks changes in the regulations.The Group continues to work to ensure its products remains complian

305、t with ongoing regulatory requirements in order for such products to remain on the market.The Group works to minimise the risk of clinical failures by reviewing all factors in a trial,such as diaries,posology or patient training.Policies and procedures are in place in order to comply with legislatio

306、n and the Group considers that its standards are in line with those of quoted businesses of a similar size,but these may not be enough to avoid breaches.Know-how protected by non-disclosure agreements.The use of internal and external patent experts.Arrangements in place to notify the Group of any in

307、fringements of our intellectual property,which it would defend robustly.The Group has continued to invest in additional compliance resource,quality management systems training and guidance.Collaborative meetings held with the Paul-Ehrlich-Institut(“PEI”)to discuss proposed Chemistry,Manufacture and

308、Controls(“CMC”)and clinical packages in support of upcoming Grass MATA MPL Marketing Authorisation Application(“MAA”),on track for submission in Q4 2024.Principal risks and uncertaintiesThe Board has overall responsibility for the Groups system of risk management.In common with many pharmaceutical c

309、ompanies,the Group faces a number of risks and uncertainties.Internal controls are in place to help identify,assess,manage and mitigate these risks.30Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportPrincipal risks and uncertainties continuedRiskDescription of

310、risk and impactMitigationDevelopments in 2024IT software and systems The business is heavily dependent on IT systems to operate.Any failure of the hardware or software could significantly impact the business Cybercrime continues to pose a threat with the risk of data theft,fraud or data ransom.Inves

311、tment has been made in renewing the servers and supporting software to make the infrastructure more robust.Regular reviews of vulnerabilities to cyber attack are carried out by experienced external parties.Investment in software to protect the business and access to systems.Review of IT structure an

312、d support.Regular cyber security training of staff.Continued to implement recommendations from prior independent third-party review of cyber security.Production and product liability A significant majority of the Groups products are manufactured on the Worthing site,which is shared with GSK.Any disr

313、uption to production caused by internal or external factors could materially affect the business.Production is reliant on raw materials,some of which are from single sources.Any disruption to supply could have a significant effect on production.The Worthing site is leased from GSK and there is a ris

314、k that the lease is terminated or not renewed.A production failure,variation in batch leading to out-of-specification,loss production time,storage or distribution of products outside of permitted temperature controls,or insufficient product stock could result in wide ranging financial impact.Despite

315、 extensive product testing prior to market launch,products may produce unanticipated adverse side effects that may hinder their marketability.The Group may be insufficiently covered for any potential litigation,which in some cases can potentially be open-ended.The Groups manufacturing facilities and

316、 those of some of its suppliers are subject to regulatory requirements and there is a risk that such facilities may not comply with such requirements leading to special measures or closure.Regular maintenance and upgrade of the facility and equipment undertaken.In respect of the lease,the Group has

317、negotiated a long termination notice period.In respect to steam and utilities to the Worthing site,a plan has been formulated and is being executed for the Group to become independent of GSK.Work continues on reducing variability and the methods for testing content.Maintenance of product liability i

318、nsurance and ensuring systems and processes relating to the manufacture,storage and distribution of its products are compliant and regularly reviewed.The pharmacovigilance team receives and processes reports of adverse reactions,medication errors,off-label use and other special situations.It monitor

319、s and analyses safety data trends and addresses any arising safety issues.Quality assurance procedures are in place with regular checks and reviews to ensure standards are maintained.Safety stocks maintained to protect against vaccine shortages or dual sourcing where possible.Category management pro

320、cess implemented to ensure ongoing development of long-term strategic relationships with key supply partners.Multi-year supply agreements established and renewed for critical materials ensuring continuity of supply.Improved risk management processes in place with appropriate mitigation strategies in

321、 place.Collaborating with supply partners to promote sustainable supply initiatives,particularly with natural raw materials subject to climate risk.Dual sourcing initiatives developed for critical materials.New Energy Centre is being commissioned which will make the Group independent in terms of ene

322、rgy supply from GSK.The business continues to invest in further upgrades to ensure that the highest standards are maintained at its manufacturing facilities.Kicked off strategic reviews looking at ways of further expanding our production capacity.Aligning production to ensure stock levels meet antic

323、ipated sales forecasts.31Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportPrincipal risks and uncertainties continuedRiskDescription of risk and impactMitigationDevelopments in 2024Commercially viable production pipeline Continued development of viable new prod

324、ucts and their successful registration and marketing,while costly and lengthy,is key to the success of the Group.Significant investment is no guarantee that a product will receive regulatory approval and/or will be commercially successful.Significant number of new products in the pipeline.The Group

325、works with key opinion leaders to raise awareness of products,new products and their benefits to patients.Market research for new products.Ongoing work on new registrations for approved products in other markets.Collaborative meetings held with the Paul-Ehrlich-Institut(“PEI”)to discuss proposed Che

326、mistry,Manufacture and Controls(“CMC”)and clinical packages in support of upcoming Grass MATA MPL Marketing Authorisation Application(“MAA”),on track for submission in Q4 2024.Financial Adequate funding may not be available to the Group,either through reserves or external partners,for day-to-day wor

327、king capital and/or the advancement of clinical trials.Failure to obtain further funding may cast doubt on the Groups ability to continue as a going concern and/or lead to postponement or cancellation of clinical trials.The majority of the Groups sales are denominated in Euros whilst the manufacturi

328、ng and most corporate administration costs are in the UK and denominated in Sterling,therefore the Group is exposed to exchange rate fluctuations.Robust measures are in place for the Board to understand,review and approve the funding requirements of the Group on a regular basis.The major shareholder

329、s are aware of the Group funding needs over the next 12 months and remain supportive of the business.Note 27 in the notes to the consolidated financial statements gives details of the Groups objectives and policies for risk management of financial instruments.The major shareholders have provided sus

330、tained funding to the Group over the last 18 months,most recently via the participation in the uncommitted 40m loan facility.Continued work to maximise cash position in the business.Reduction of overheads through ongoing effective cost control.Post period,further funding was secured,for further info

331、rmation please refer to Note 34 for details of events after the balance sheet date.32Allergy Therapeutics plc Annual Report and Accounts 2024Strategic reportStrategic reportPrincipal risks and uncertainties continuedRiskDescription of risk and impactMitigationDevelopments in 2024Key personnel The Gr

332、oup is reliant on a number of key qualified scientific,technical and management personnel.Competition for such personnel is intense and there can be no assurance that the Group will be able to continue to attract and retain such personnel.Loss of these key personnel could adversely impact the effect

333、iveness of the Groups operations.Externally benchmarking remuneration and developing succession planning.The Group has created a process to identify and develop talent in the organisation.The Group has approved a new LTIP plan for key personnel,for further information please see page 48.The Remuneration Committee has put in place appropriate measures to retain key personnel.Economic Competitors ma