Allergy Therapeutics PLC (AGY) 2019年年度報告「LSE」.pdf

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1、Annual report and accounts 2019Transforming livesAllergy Therapeutics plcAnnual report and accounts 2019What we doWere committed to transforming lives by breaking new ground in immunology treatment through specialist expertiseContentsStrategic report1 Highlights2 At a Glance 4 How immunotherapy is t

2、ransforming lives6 Transforming lives of our patients8 Chairmans Statement10 Chief Executive Officers Review14 Macro and Micro Trends16 Market Overview18 Business Model20 Strategic Framework22 Our Products26 Research&Development Report 201930 Operating Responsibly34 Key Performance Indicators35 Risk

3、 Management36 Principal Risks and Uncertainties41 Financial ReviewGovernance44 Board of Directors46 Corporate Governance Report51 Communications with Stakeholders52 Nomination Committee Report54 Audit Committee Report56 Directors Remuneration Report64 Directors Report66 Statement of Directors Respon

4、sibilitiesFinancial statements67 Independent Auditors Report to the Members of Allergy Therapeutics plc72 Consolidated Income Statement73 Consolidated Statement of Comprehensive Income74 Consolidated Balance Sheet75 Consolidated Statement of Changes in Equity76 Consolidated Cash Flow Statement77 Not

5、es to the Financial Statements113 Company Balance Sheet114 Statement of Changes in Equity(Company)115 Notes to Company Balance Sheet119 Definition of Non-GAAP Measures 120 Shareholder InformationAllergy Therapeutics plcAnnual report and accounts 2019How we do itWeve a history of innovation,combined

6、with a pioneering spirit1998Allergy Therapeutics was formed following a successful management buy-out from SmithKline Beecham and remains headquartered in Worthing,UK.1999Allergy Therapeutics created Pollinex Quattro;utilising a novel adjuvant system,an entire years treatment could be completed in j

7、ust four injections.2004Allergy Therapeutics became a publicly listed company on the London Stock Exchanges AIM.2008The G301 Phase III clinical study conducted in Europe and the USA demonstrated that Pollinex Quattro has statistically significant clinical benefits over placebo.2013Acarovac Plus was

8、launched.This modified allergen house dust mite subcutaneous immunotherapy is dosed from a single vial for added patient convenience.See more on page|232018The Group publishes positive pre-clinical results in the development of a vaccine targeted against peanut allergy using Virus-Like Particles(VLP

9、)combined with peanut allergens.See more on page|282019The Paul Ehrlich Institute and the FDA agreed to allow Allergy Therapeutics to commence Phase III studies for PQ Grass to be conducted simultaneously in the US and Europe.See more on page|26Allergy Therapeutics plcAnnual report and accounts 2019

10、Financial statementsGovernanceStrategic report 01Financial Highlights Good growth across key countries and products with 0.5 point increase in market share2 in European business to 14.1%(2018:13.6%)Scale up of VLP-based(virus like particle)peanut product going well following encouraging initial disc

11、ussions with regulatory authorities;Phase I trial due to commence next year Successful modified House Dust Mite Phase I safety trial Primary endpoint of Birch MATA MPL Phase III trial not met but learnings being applied to clinical,field-trial planning Successful completion of legal action resulting

12、 in 6m settlement with costs recovered in 2020Operating HighlightsHighlights8%Revenue growth(both reported and constant currency rate)122%Increase in pre-R&D operating profit to 11.3m(2018:9.3m)as a result of sales growth and lower overhead cost growth(2018:9.3m)27.4mStrong cash balance at 30 June 2

13、019(2018:15.5m)3.5mNet profit for the year including Inflamax settlement of 6m(2018:Net loss of 7.5m)See more on page|101 Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year on year comparison excluding the e

14、ffects of foreign exchange movements.2 Market data and internal estimates for 12 months to 30 June 2019 for Allergy Therapeutics direct sales competitive markets excluding UK and Switzerland due to lack of competitor information.Allergy Therapeutics plcAnnual report and accounts 201902At a GlanceWe

15、are visionary73.7mRevenue 2019(2018:68.3m)61%Revenue generated from Germany(2018:61%)See more on page|17Our reachWe have a well-established commercial presence in Europe and are focused on the US market and other new opportunities.We are a visionary immunology business with specialist experience in

16、the research and development of allergy treatments.Our values have created a culture based around Vision,Commitment and Menschlichkeit(humanity).We take extraordinary ideas and bring them to market enhancing treatments and transforming peoples lives.Direct presence Distributor marketPre-clinicalPhas

17、e lPhase llPhase lllPollinex Quattro GrassPollinex Quattro BirchPollinex Quattro RagweedPollinex Quattro TreesOralvac Grass,Trees and House Dust MiteAcarovac platformPolyvac PeanutSales by country%Germany|61%Spain|10%Austria|7%Italy|7%Netherlands|4%Switzerland|3%UK|3%Czech Republic|1%Slovakia|1%Othe

18、r|3%Sales by product%Pollinex|19%Venomil|5%Pollinex Quattro|42%Oralvac|13%Tyrosine S/TU|5%Tyromilbe|6%Acarovac Plus|3%Third party products|6%Diagnostics|1%Also available as Named Patient ProductAllergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernance 03Strategic reportSa

19、lesOur pipeline includes allergy vaccines for grass,tree and house dust mite,as well as peanut.Our ultra-short course treatments offers the simplicity of four injections,increased tolerability and demonstrated efficacy.Our adjuvant technologies improve therapies by allowing them to increase efficacy

20、.Adjuvant systems to boost performance of vaccines outside allergy are also under evaluation.Our pipeline See more on page|17Allergy Therapeutics plcAnnual report and accounts 201904How it worksHow immunotherapy is transforming livesImmunotherapy is the practice of administering gradually increasing

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

22、esensitisation.Allergies are the immune systems response to substances it thinks are a threat but which are usually harmless,such as pollen,house dust mites or cat fur.1234IgEHistamineMast cellMast cellIgGActivatedB cell interleukin-4interleukin-13IgEIgGT cellB cellinterleukin-4interleukin-13T cellB

23、 cellIgEActivatedB cell IgEPatient comes intocontact with an allergen Th2 cell stimulates B cells to produce IgE IgE binds to immune cellscausing histamine releaseupon exposure to allergenHistamine leads to classic symptoms of allergy Th1 Cell stimulates B cells to produce IgG Increased IgG producti

24、on inhibits the production of IgE Lower levels of IgE prevent excess release of histamine and reduce symptoms of allergy Treated with allergen specific immunotherapy A patient who is sufering from an allergy:A patient who is treated with allergen immunotherapy:1234IgGHistamineIgEMast cellIgGActivate

25、dB cell interleukin-4interleukin-13IgEIgGT cellB cellinterleukin-4interleukin-13T cellB cellIgETh1 Cell stimulates B cells to produce IgG Increased IgG production inhibits the production of IgE Lower levels of IgE prevent excess release of histamine and reduce symptoms of allergy Treated with allerg

26、en specific immunotherapy Patient comes into contact with an allergen A patient who is treated with allergen immunotherapy:Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernance 05Strategic reportImmunotherapy is the only treatment which affects the underlying cause of

27、 an allergy.The alternative is to continue with medicines which suppress the symptoms of hay fever,such as anti-histamines and steroid-based medicines.Subcutaneous immunotherapy is the most common form of specific immunotherapy and involves a course of injections that build up tolerance to particula

28、r allergens through small,controlled doses.Over time this desensitises the inappropriate immune response so the body doesnt overreact and create the histamine release that causes allergy symptoms.Sublingual immunotherapy is an alternative to injection immunotherapy.For this form of treatment,daily d

29、rops or tablets containing the specific allergen are placed under the tongue.The first dose of the sublingual immunotherapy is usually administered in a clinic under observation,then the patient will be required to self-administer the treatment every day at home.Allergy Therapeutics plcAnnual report

30、 and accounts 201906How its working for patientsPaediatrician Dr Reinhard Erdl is a pioneer in the treatment of allergic diseases.During his time working in hospitals,he has treated allergies in children and adolescents.Dr Erdl has been afflicted by pollen allergies himself since he was young and in

31、 1999,he decided to try out a new treatment on himself.In that first year of treatment,he felt much better.After the third year of treatment,he was symptom-free and has remained so until today.He has since used this treatment very successfully in his practice and now treats the parents as well as th

32、e children,saying“They come and say to me,My child is so much better after treatment,I want to have it for myself.”Transforming lives of our patientsAllergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernance 07Strategic reportWe have a high success rate in the treatment of

33、 allergies.I think that the formula for success is the combination of effective ingredients and our extensive care and diagnosis of patients throughout the entire period of treatment.Dr Reinhard Erdl Paediatrician,MunichAllergy Therapeutics plcAnnual report and accounts 201908Chairmans StatementChai

34、rmans Statement Peter JensenChairmanAllergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 09Commercial performance this year has been strong with growth in sales and further gains in market share in an increasingly tough regulatory environment.It is en

35、couraging to see growth across many areas of the business,including a significant increase in pre-R&D operating profit as well as a net profit for the year.Clinical performanceThis years clinical performance was affected by the results of the pivotal Phase III Birch trial.Whilst missing the primary

36、end-point was unexpected,we have learned valuable lessons from the trial that will be applied in the next clinical field trial.Notably,however,we had a successful outcome of our modified House Dust Mite MATA Phase I trial and the commercial scale up of the Virus Like Particle(VLP)based Peanut produc

37、t is progressing well.In the next 12 months,we expect to begin the first inhuman trial of the peanut product.VLP is an exciting technology platform that offers great potential in many other allergy areas and we look forward to its clinical development.In June 2019,litigation concluded in our favour

38、against a Clinical Research Organisation(CRO)(Inflamax)relating to the poorly-run Phase II Grass MATA MPL trial that took place in the US in 2015-16.Compensation of 6m has been agreed and,although no agreement in respect of legal costs was reached at the balance sheet date,a cost reimbursement of 3.

39、2m has been received and will be recognised in 2020.This was an important result for the Group.We have always had full confidence in the Grass MATA MPL product and it is good to have this matter resolved.BoardThe Board is committed to maintaining and developing effective corporate governance process

40、es.Following a review of the Board succession plans,we strengthened the Board with the appointment of Mary Tavener as a Non-Executive Director.It is intended that Mary will succeed Stephen Smith as Chairman of the Audit Committee,following the release of this years Annual Results.Mary brings with he

41、r an impressive breadth of executive experience at AIM listed businesses and her perspective will be invaluable.Looking aheadThe Board and management continue to focus on growing our current business through the delivery of patient-focused,short-course injectable treatments while developing a pipeli

42、ne of next-generation allergy immunology products.Initial sales for the year look strong and we have much to look forward to in the mid-term with opportunities for the Grass MATA MPL product in the US and the development of the VLP platform.The Group recognises that there will be increasing regulato

43、ry requirements in the allergy sector presenting both challenges and opportunities in the short and mid-term.On behalf of the Board,I would like to thank all the employees of Allergy Therapeutics for their commitment,creativity and teamwork.Peter JensenChairman24 September 201922%Increase in pre-R&D

44、 operating profit to 11.3m(2018:9.3m)2019 was a year of strong commercial performance.Allergy Therapeutics plcAnnual report and accounts 201910Chief ExecutiveOfficers ReviewCEOs ReviewManuel LlobetChief Executive OfficerNet sales by region DACH|56.0mSouthern Europe|13.0mROW(inc.UK)|4.7m Allergy Ther

45、apeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 11This years performance has shown yet again that Allergy Therapeutics focus on scientifically advanced products that are convenient for patients is the right approach for our business.Net sales grew by 8%to 73

46、.7m(2018:68.3m)in constant and actual terms,in a market where grass pollen incidence dipped due to the very high temperatures at the end of last summer.The Group continued to gain market share within its core markets in Europe and data for the key markets,in which we operate,for the 12 months to Jun

47、e 2019 showed a market share increase of 0.5 points to 14.1%from 13.6%.Our operating profit before R&D grew 22%,as a result of leveraging our sales growth which is a measure used by management to assess the trading performance.The strong operating performance and the settlement of the legal case wit

48、h Inflamax led to a net profit of 3.5m.We ended the year with a strong cash balance of 27.4m.European businessThe European business has continued to expand with particularly strong growth in Austria,The Netherlands and Spain.In terms of products,Venomil,Acarovac Plus,Pollinex and Pollinex Quattro we

49、re the top performers.Higher sales of Venomil,used for bee and wasp allergies,have been driven by a number of allergists using the product for the first time.The increase of Pollinex and Pollinex Quattro has been driven by increased penetration of the markets due to the quality of the products and t

50、he expertise of our sales and marketing team.We continue to look for new markets and we are exploring potential partnership options for the Chinese market.Clinical trialsThis year was affected by the results of the Birch MATA MPL Phase III trial.The results were unexpected given the two successful P

51、hase II Birch trials and success of this product on a named-patient basis.Extensive work has been undertaken to understand the reasons for the results,including engaging with external experts and our analysis is still underway.We will ensure that the learnings are applied to the fully funded Grass M

52、ATA MPL Phase III trial due to start,subject to final design,in autumn 2020.If this clinical trial is successful,the only further trial that will be required before submission of the Biological Licence Application(BLA)is the completion of the safety database,opening up a potential US market of appro

53、ximately$2bn.The Group is in dialogue with the German regulatory authorities about the results of the Birch MATA MPL Phase III trial.The team will focus first on applying the lessons to the Grass MATA MPL trial before returning to any further clinical trial in relation to Birch.Allergy Therapeutics

54、plcAnnual report and accounts 201912LitigationAs reported in June 2019,the Group has accepted a financial settlement of$7.6m(6.0m)plus costs from Inflamax following successful litigation in relation to the Grass Phase II trial undertaken in the US in 2015 and 2016.This credit is disclosed in the R&D

55、 expenses.The Group had commenced proceedings in the English High Court for breach of contract and misrepresentation.In July 2019,the Group received a further$4.1m of legal cost reimbursement that will be recognised in the 2020 financial year as no agreement in respect of legal costs was reached at

56、the balance sheet date.The result has drawn a line under the trial and achieved compensation for the costs incurred.Pipeline progressIn May 2019,we announced the successful completion of the House Dust Mite Phase I trial to evaluate safety and tolerability of our investigational house dust mite alle

57、rgy vaccine.The Phase II dosing trial is currently planned to start in 2020.The product,which is the only short-course treatment for perennial house dust mite,is state of the art and has great potential with patients across Europe,the USA and China.The estimated global market is$3-4bn.The VLP-based

58、Peanut product continues to progress well at this early stage.We had successful meetings with Paul Ehrlich Institute(PEI)and Swissmedic,the Swiss regulatory authority,to discuss an outline protocol for the first in-human trial that is due to take place in the summer of next year.The project has been

59、 fully endorsed by both regulatory authorities.The industrial scaleup of the product is progressing well with completion of manufacture of the Investigational Medicinal Product(IMP)batches and stability testing about to begin.There is a potential global market of$8bn for a product treating this curr

60、ent unmet need.The German TAV process continues with the Oralvac Mite Phase II trial due to start within the 2020 financial year.Additionally,discussions are underway within the European Member states to harmonise marketing authorisations for all allergen medicinal products.Consultation is at an ear

61、ly stage but the indication is that regulatory requirements for all allergen products will be increasing but that approval of a product in one European country will provide access to all of the European member states.All our products that began the TAV process remain in it with further work expected

62、 on the remaining products.OutlookManagement expects that the next financial year will show further growth in sales.Gross margin percentage is likely to be similar to the 2019 financial year.Other operating costs are likely to rise reflecting additional cost in technical support in preparation for B

63、rexit of approximately 1.5m.Research and development costs are likely to be slightly higher than in 2019 as we prepare for the Grass Phase III trial,due to begin in autumn 2020 subject to final design,as well as the Oralvac Mite Phase II trial.The Group has made preparations,where possible,relating

64、to Brexit contingency planning including capital investments of 1.3million on cold storage facilities and a quality control laboratory in Spain and moving stock of approved products to the Spanish facility in advance of the deadline.The Group continues to monitor all developments closely.We remain p

65、ositive about the future of Allergy Therapeutics and are excited for the year ahead.Manuel LlobetChief Executive Officer24 September 2019Chief ExecutiveOfficers Review continued3.5mNet profit for the year(including the Inflamax settlement)(2018:loss of 7.5m)See more on page|41Allergy Therapeutics pl

66、cAnnual report and accounts 2019Financial statementsGovernanceStrategic report 13Evolving our cultureInspired by our purpose to transform lives,we have defined the culture we want in our business,which will enable the business to realise our ambitious strategy and strengthen our competitive advantag

67、e.We have engaged with our employees,leaders and other stakeholders to collectively create a vision for our future culture and organisation,which builds on our current strengths.Our values,Vision,Commitment and Menschlichkeit(Humanity),are at the core of our culture.To evolve our culture further,thi

68、s year we have taken a number of deliberate steps:Defined our employer brand,aligned with our refreshed corporate brand Created a global community of senior leaders and culture champions,who are supported through an ongoing learning and development programme Invested in development of our most senio

69、r leaders to enable them to grow,not only as individual leaders,but also as a team of role-models for the whole organisation Designed a global performance management approach to facilitate high performance,accountability,dialogue and growth Introduced a global digital platform to underpin all our pe

70、ople management practices and facilitate global communication and connectivity Implemented a global capability development programme for our people managers to create a consistent employment experience for all our employeesGoing forward we will focus on developing globally consistent and cutting edg

71、e approaches to talent management,succession planning,reward and leadership development.Our evolving culture was evident in recent actions and business achievements,from successfully collaborating across teams to prepare for Brexit to learning from our Birch 301 Phase III study outcomes.Our employee

72、s have also worked together with a single global mindset when responding to market opportunities in order to secure further growth for the business.Our cultureOne Team&Anticipation Accountability&Growth Transparent Relationships Our differentiating culture behavioursOur valuesVisionCommitment Mensch

73、lichkeit(Humanity)Allergy Therapeutics plcAnnual report and accounts 201914Macro and Micro TrendsMacro and Micro TrendsWe continue to review macro and micro trends in both allergy and the allergy immunology market,so that any opportunities for the business can be identified.Macro trendsMicro trendsA

74、llergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 15Increase in pollen allergy potential due to:Increase in personal hygiene and spread of the Western lifestyle Urbanisation and changes in social mobility Climate change&associated changes to allerge

75、nic componentsRapid increase in food allergies due to:Changes in diet associated with the Western lifestyle such as low fibre and high sugar Lack of exposure to certain foods(e.g.peanut)at an early enough age Reduction in exposure to sunlight and subsequent decrease in vitamin D Digitalisation and A

76、I in medicine Thanks to improved technology platforms,greater analysis of clinical and patient data will be possible allowing refined treatments based on real clinical experience from other patients Digitalisation of medical records could allow better analysis of allergy changes in the population an

77、d treatment optimisationUse of probiotics to address respiratory and food allergies The microbiome is recognised as being important to well-being and changes in gut health have been associated with allergy Research into the microbiome and the relationship between preventing or curing allergic diseas

78、es is ongoing State of the art biotechnology developments such as VLP could permit precise and targeted removal of allergy The VLP platform aims to induce protective immunity,enabling shorter therapy duration and an enhanced tolerability profile in disease areas such as peanut allergyRegulatory land

79、scape Regulators in Europe are increasing their focus on ensuring medicines are registered and fit for purpose The Groups experience within the German TAV process and the plans to register the named-patient product portfolio leave us well-placed to meet these guideline changesAdherence and convenien

80、ce Adherence is an issue for all medicines Medications should be easy to adhere to and should be convenient to use Tablet-based therapies are convenient,but compliance can be an issue Injections given in a physicians office ensure compliance,and a short-course treatment regimen aids convenienceAller

81、gy Therapeutics plcAnnual report and accounts 201916Market OverviewOur marketsAllergy Therapeutics continues to maintain a strong presence in Europe with established operations in 19 markets,either directly or via partnerships.Germany remains the Groups main market,generating approximately 61%of the

82、 Groups revenue in the 12 months ending 30 June 2019.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernance 17Strategic reportCentral Europe(DACH Region)Germany Germany is the largest allergy immunotherapy market in Europe and our German subsidiary,Bencard Allergie Gmb

83、H,is the largest subsidiary of Allergy Therapeutics.It has been one of the fastest growing companies in the allergy sector in Germany over the past two decades.Bencard Allergie is situated in Munich and currently employs approximately 140 staff members,including our corporate medical team,pharmacovi

84、gilance team and are involved in coordination of clinical trial studies.The broad product portfolio comprises allergen-specific immunotherapies for numerous allergies,including pollen,house dust mite and mould allergies,as well as pet and insect allergies.The range also includes probiotics available

85、 over the counter from pharmacies as supportive medication to help with the allergy symptoms.Germany remains a key focus for the Group with continued strengthening of sales and marketing,which has been instrumental to an increase in market share.AustriaThe Austrian market for allergen immunotherapy

86、has grown by 7%in the last fiscal year,boosted by the sublingual tablet market(+10%)and the subcutaneous allergoid market(+13%).Two new competitors have announced that they will be entering the Austrian market in the next fiscal year,proving that this small market is one of the most dynamic in Europ

87、e.SwitzerlandThis year,our Swiss subsidiary was able to capitalise on opportunities in the Swiss market when competition had a significantly reduced portfolio(including ash tree pollen products).This has allowed for significant growth and has enabled the Swiss subsidiary to bridge the gap until new

88、products can be licensed.Southern EuropeSpainThe whole market in Spain grew 8%over the last year,however the allergoid immunotherapy segment has grown 10%.The advanced allergoid products at Allergy Therapeutics allow the Group to be in a strong position to achieve further growth in the coming years.

89、Spain continues to be a valuable market,with approximately 300,000 immunotherapy patients a year.Of the injectable immunotherapy products,modified allergens remain the treatment of choice for Spanish physicians with Acarovac Plus now the best-selling Group product in the Spanish market.ItalyThe tota

90、l Italian allergy immunotherapy market,after years of continuous decrease,has shown a recovery in the last 16 months(+4%in value)despite the impact of adverse economic conditions in the country.The Italian immunotherapy market is dominated by sublingual products.The main risk to the business remains

91、 the reducing of prices in public hospital tenders in some regions,although this could be partially managed through direct sales to those same hospitals.We are also adding a SCIT mite product to our portfolio in Italy this year which would be an opportunity to grow sales.Despite the challenges menti

92、oned above,we believe there remains a significant opportunity to continue growing our market share(currently 16%)in this important market which is the fourth largest in Europe.Outside immunotherapy,the Italian Synbiotic market remains one of the largest in Europe.Our approach is to focus in the alle

93、rgy related segment of the synbiotic market.Rest of WorldNetherlandsThe market in the Netherlands started to grow sharply this year(+21%IMS MAT June 2019/16.5M)helped by the continued leading growth of Allergy Therapeutics(+23.5%)and the launch of a mite tablet product by a competitor two years ago.

94、The market is dominated by Allergy Therapeutics and ALK.Two years ago,Allergy Therapeutics entered into an exclusive licensing agreement in the Netherlands to promote the grass tablet product Oralair(+10%growth)which now competes with ALKs Grazax.Looking forward,we expect to continue leading the gro

95、wth in the Dutch market with our own SCIT Pollen product Pollinex(23%market share/MAT June 2019)and speeding up the growth of Oralair.UK The UK is an important market due to its potential for future growth for the Group.Whilst currently,there is limited use of allergy vaccines in the UK,there is pot

96、ential for this to change and the Group has focused on marketing to the medical community to promote greater awareness of more suitable treatment options.Pollinex is the only pollen SCIT product currently registered in the UK.Emerging marketsThe Company is continuing the development of new markets i

97、n Europe with newly registered products and planning ahead for the registration and launch of new products in other areas of the world during the next fiscal year.Allergy Therapeutics plcAnnual report and accounts 201918Business ModelHow we create valueOur business model enables us to achieve our pu

98、rpose of transforming lives.Our resources01Income generated from operations:The income we generate is invested to grow our business.02Specialist expertise:The specialist expertise of our employees drives and inspires us to transform lives.03Innovation:We are a global pioneering team,innovating to ad

99、vance treatments in allergy immunotherapy.See more on page|13Underpinned by our culture and valuesAllergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 19What we doHow we create value for stakeholdersResearch&Development(key to future growth)Focused on

100、:new pipeline products such as VLP Peanut marketed products for serious reactions to allergens such as house dust mite,venom and pollensManufacturing We maintain quality grade A manufacturing facilities in the UK and Spain which produce our medicines for sale and any clinical trial batches.Investmen

101、t was made into our Spanish facilities during 2019 to mitigate any potential adverse impact of Brexit.Sales As a result of our growth strategy,we sell our products in 19 markets and plan to expand into the US and other new markets,transforming the lives of more patients worldwide.See Our Strategy on

102、 page|20 for more detail on our growth plansFor investors:We create value through strong growth in our markets and our pipeline developments.For patients:We strive to deliver the best immunology treatments for patients.We transform lives for the better.For our employees:We offer our employees the op

103、portunity to grow careers and make a real difference to the business.For healthcare professionals:Healthcare professionals rely on our quality products,our knowledge and our trusted partnerships to deliver the best care for their patients.See more on pages|17 and 24 See more on page|24We are ambitio

104、us people who transform lives through the ideas we develop and bring to market.Our values shape how we work every day,enabling us to maintain a high-achieving culture with a single global mind-set.Allergy Therapeutics plcAnnual report and accounts 201920Strategic FrameworkThree pillars of business01

105、0203EuropeanPipelineUS MarketOur strategic pillarsOur strategy is based on three pillars of the business.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 21Strategic prioritiesProgress in 2018-19Objectives for 2019-20 Continued growth of business

106、Leverage pre-R&D profitability Focused investment Implement synbiotics strategy Successful completion of TAV process for all commercial products Completion of clinical trials on House Dust Mite MATA product and global marketing approval Successful design and undertaking of clinical trials of Polyvac

107、 Peanut leading to market approval Develop Bencard Adjuvant Systems and enter strategic partnership Complete trials of Grass MATA MPL and marketing approval Decide route to market either via distributor or own sales force in US Release clinical hold on Ragweed and PQ Trees and complete trials Bring

108、further products in the pipeline through clinical trials(House Dust Mite MATA and Polyvac Peanut)73.7m Net sales of 73.7m (2018:68.3m)8%Growth in sales96%Delivery on time and in full by supply chain of vaccines22%Continued strong growth in pre-R&D operating profitContinued strong growth of sales and

109、 market sharePreparation for Grass MATA MPL Phase III trial to start in autumn 2020Apply for clinical hold on Trees and Ragweed to be liftedImprove pre-R&D profitability furtherPrimary end point of Birch MATA MPL Phase III not reachedSuccessful Phase I clinical safety study for House Dust Mite MATA

110、MPL completedScale-up of Polyvac Peanut progressing wellStart of Grass MATA MPL Phase III trial delayed to collect learnings from Birch trialDevelopment of Key Opinion Leaders in the USStart of Oralvac Phase II dosing trialCompletion of scale-up and start of first in-human peanut studyAllergy Therap

111、eutics plcAnnual report and accounts 201922Our ProductsOur ProductsThe Group sells a wide range of aluminium-free allergy therapies and diagnostics.The majority of revenue arises from sales of allergy therapies.Our productsSince specific immunotherapy was first carried out successfully in the early

112、20th Century,it has become established as the only therapy that addresses the cause of serious allergic reactions.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 23Our products The Group sells both injectable and sublingual(oral)allergen-specific

113、 immunotherapies.The most commonly prescribed are those for the treatment of pollen-related allergies,particularly for allergies 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.Our extensive range of wel

114、l-characterised diagnostics includes in excess of 80 diagnostics in Germany with marketing authorisations and specialised allergens for other markets.According to the current opinion of expert immunologists,immunoglobulin E(IgE)mediated allergies(type I allergies)are due to deregulation of the T hel

115、per lymphocyte(Th)cells.Whereas healthy people develop tolerance to allergens,allergy sufferers have a Th2-dominated immune response with increased IgE and corresponding clinical symptoms.This deregulation of the immune system can be counteracted efficiently using specific immunotherapy(SIT).By admi

116、nistering high doses of allergen in a controlled fashion,the balance between Th1 and Th2 response to the allergen can be restored.Since SIT was first carried out successfully by Leonard Noon in 1911,it has become established as the only therapy addressing the cause of type I allergies.Pollinex Quatt

117、ro,launched in 1999,heralded a transformation in immunotherapy by introducing allergy vaccination with only four injections 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 or

118、der to lower allergenicity while maintaining most of the immunogenicity,and the innovative adjuvant monophosphoryl-lipid A(MPL).An adjuvant is a substance which improves the immune response to an antigen or allergen.MPL is derived from a lipopolysaccharide(LPS)which is obtained from the cell wall of

119、 Salmonella Minnesota R595 using a process of extraction,purification and detoxification.As a vaccine adjuvant,MPL has been used for many years.Vaccines containing MPL have been evaluated in various indications such as cervical cancer and malaria at GlaxoSmithKline(GSK).Two vaccines with an adjuvant

120、 system containing MPL Fendrix,a hepatitis B vaccine and Cervarix,a HPV vaccine to protect against cervical cancer have received broad approval in Europe,the US,Japan and Canada.The adjuvant effect of MPL in SIT has been documented in numerous studies and is seen in its essential role of promoting t

121、he switch from a Th2-directed immune response(with IgE induction)to a Th1-directed immune response.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 course can b

122、e taken by the patient in their own homes and is raspberry flavoured for improved patient compliance.Wasp and bee treatment is provided by our freeze dried Venomil product,which can be used via a rush dosing regimen.SynbioticsSynbiotics are special formulations of prebiotics and probiotics.Synbiotic

123、s act as bio-immunomodulators of the immunologic response.In June 2012,the Group launched three new synbiotic products(Kallergen-Th,ATI-Prob and Pollagen)across Spain and Italy.Since then,Austria and Germany have also been added.In 2013,the Group launched a further new synbiotic product,Syngut,speci

124、fically designed for food and lactose intolerance.The products contain specific combinations of Lactobacilli and Bifidobacteria.Between 2015 and 2016,two further products were launched in line with the WAO guidelines for atopic dermatitis prevention:our first synbiotic in drops,Kallergen Baby for th

125、e prevention of atopic dermatitis in children from birth to three years old;and Kallergen Mamy for pregnant women with high risk of atopic disease.Acarovac PlusAcarovac Plus was launched in Spain in March 2013 and is a novel MCT-adsorbed,modified-allergen product developed to address the cause of pe

126、rennial 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 tolerability and serological analyses consistent with a favourable shift in Th1/Th2 balance compared with an unmodi

127、fied 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,Spain1).Penicillin diagnosticsDAP is a product for exclusive use in the diagnosis of type I,or immediate hypersensitivity to benzyl penicill

128、in and related antibiotics(beta lactams)by means of cutaneous tests(prick and intradermal).Allergic reactions to beta lactams are the most common cause of severe adverse drug reactions and there is an increasing prevalence in the population.DAP is supplied to Italy,the UK and the Netherlands.1 Roger

129、,et al.,Immunotherapy 2016,8(10),1169-1174.Allergy Therapeutics plcAnnual report and accounts 201924Acarovac Plus is a novel MCT-adsorbed,modified-allergen product developed to address the cause of perennial mite allergy.Our Products continuedOur productsModified Allergen(Allergoid)Native AllergenRe

130、combinant AllergenMicrocrystalline Tyrosine(MCT)Monophosphoryl Lipid A(MPL)Virus-Like Particles(VLP)PollinexPollinex QuattroOralvacAcarovac PlusAcarovac MPL1VenomilPeanut21 Product has completed phase l clinical study.2 Product under pre-clinical investigation,full product profile yet to be determin

131、ed.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 25Strategy in action Growth in European MarketsSince the foundation of the Spanish affiliate 20 years ago,it has not only achieved excellent results,but what makes us feel most proud is that we h

132、ave been able to do so whilst embedding and living our core values.Our actions and behaviours are always established around whats most important for our employees,patients and doctors.Beginning with the recruitment of our employees,we encourage our teams to work as One Team,to contribute their ideas

133、,to recognise their achievements and to support their professional development.We believe that living the values of the Company,by taking ownership and being role models,is the best way to achieve our objectives.The Spanish office began as a small team in Barcelona that promoted and distributed name

134、d-patient product(NPPs)vaccines.In 2015 we expanded with the acquisition of the manufacturing site in Alcal de Henares,Madrid.This doubled the number of staff and we developed high performance departments in Spain such as Quality Assurance,Quality Control and Microbiology Centres for the development

135、 and manufacture of NPPs.The merger of the two companies involved a great effort of coordination and communication that continues today with the integration of the quality systems with our UK head office.Due to the excellent performance of the teams and our forward thinking strategy,we are now able

136、to tackle upcoming challenging projects like becoming the EU QP release site for all vaccines delivered in the EU once the UK implements Brexit.Today in Spain,we employ 86 people who are always seeking excellence in their work and we are proud to say that all these achievements have led us in 2019 t

137、o open new offices in Barcelona that will enable us to continue to support the global team.Glria Garcia Directora General Allergy Therapeutics IbericaAllergy Therapeutics plcAnnual report and accounts 201926Research&Development Report 2019Based on these encouraging results and class-leading research

138、,the Group is evaluating all technical and clinical development options to optimise the candidate product to match the defined Target Product Profile.The Group is aiming to deliver a best-in-class product for the Global Market including China and US.In collaboration with the Helmholtz Centre,Munich

139、the Group established a mouse model of HDM allergy to assess the benefit of adjuvants.The mouse model was developed to more closely resemble symptoms of allergic asthma in humans.Sensitised mice were immunized with native and modified extracts with and without adjuvant candidates.The results of the

140、HDM-specific immunotherapy model indicated adjuvant benefits in 8 independent biomarker assays.Analysis of VLP platform in cancer immunotherapy The Group recently completed a detailed study investigating the use of VLP technology in cancer immunotherapy.The research,Vaccination with nanoparticles co

141、mbined with micro-adjuvants protects against cancer(Mohsen M et al.),undertaken by the Groups adjuvant research division,Bencard Adjuvant Systems and published in the Journal for Immunotherapy of Cancer,investigated the protective efficacy of the Groups adjuvant system against cancer and showed that

142、 the combination of MCT and VLPs caused tumour regression in an aggressive melanoma mouse model and initiated a highly protective CD8 T-cell immune response.European and US clinical development of Subcutaneous Immunotherapies(SCIT)As part of the German TAV(Therapie allergene Verordnung)regulatory or

143、dinance framework,clinical evaluation of the Pollinex Quattro(PQ)products is being undertaken to enable market authorisation.Two successful dose selection studies have been performed PQ Birch 203 and PQ Birch 204 completed in April 2016,and the Group progressed with a Phase III field study PQ Birch

144、301.The Birch MATA MPL 301 study design was a multi-centre,double-blind,placebo-controlled study to test the efficacy of cumulative doses of PQ Birch for birch-pollen induced seasonal allergic rhinitis.The European study took place in Germany,Poland,Austria and Sweden with 582 patients over 59 centr

145、es being randomised into active and placebo arms,evaluating the safety and efficacy in allergic symptoms as determined by the combined symptom medication score(CSMS).The Birch MATA MPL Phase III trial did not meet the primary endpoint.The results were unexpected given the previous two successful Pha

146、se II trials and the success of this product on a named-patient basis.Extensive work has been undertaken to understand the reasons for the results,including engaging with external experts and ensuring learnings are applied to subsequent clinical trial designs planned by the Group.The team are focuss

147、ing on applying the lessons to the Grass MATA MPL trial before returning to further clinical trials evaluating PQ Birch.Following the successful G205 dose selection study,a Phase II study designed to explore the safety and response of different cumulative doses of PQ Grass for grass pollen induced s

148、easonal allergic rhinitis in 2018,the Group are progressing with the design and planning of the G306 phase III study.The Group presented the positive results from the Phase II PQ Grass trial to the PEI and FDA and agreement was reached on the appropriate dose to progress into Phase III,as well as ot

149、her essential features of the trial design.Accordingly,in order to finalise the design of the trial and incorporate the latest clinical evidence,the trial is expected to commence in H2 2020,to be aligned with the 2020/2021 allergy season.The Groups goal remains to be the first allergy immunotherapy

150、company to launch a short course,subcutaneous and aluminium free Grass allergy therapy in the US.Acarovac next generation products for dust mite immunotherapy In May 2019,the Group presented positive Phase I safety and tolerability data for Mite subcutaneous allergoid preparations including MCT and

151、MPL adjuvants(Monophosphoryl Lipid A)in patients with house dust mite(HDM)-induced allergic rhinoconjunctivitis.The AM101 trial was an open-label study to assess the safety and tolerability in adult patients with house dust mite-mediated allergic rhinoconjunctivitis.The primary endpoint was the safe

152、ty and tolerability of seven injections of Acarovac MPL administered over 6-12 weeks each 1-2 weeks apart.The formulation was well-tolerated.The safety profile was satisfactory and the reported adverse events were consistent with what have been observed with similar formulations of allergy vaccines.

153、Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 27Extensive scientific contributions to the 2019 EAACI congress This year at the 38th Annual Congress of the European Academy of Allergy and Clinical Immunology(EAACI)in Lisbon,Portugal,Allergy Ther

154、apeutics presented a series of 17 poster presentations over three days.Other events held by the Group at EAACI included a company-sponsored symposium entitled:“Transforming Allergy Treatment”,providing a summary of the Groups world-leading innovation in the field of allergy immunotherapies.The sympo

155、sium included an overview of the Groups registered venom immunotherapy and the clinical importance of the presence of the major allergen Api m 10.OralvacThe German TAV process is progressing well,with the Oralvac Mite Phase II trial planned first.This multi-centre,combined dose-tolerability and dose

156、-ranging study is designed to determine the optimal safe and effective dose of OV Mites in subjects with allergic rhinitis and/or rhinoconjunctivitis due to house dust mite.All products that began the TAV process remain within it with further work expected on the remaining products.Real-world eviden

157、ce Real-world evidence is increasingly considered an important source of data by organisations such as the NICE or the FDA.A huge amount of valuable medical information is recorded by physicians in Electronic Clinical Records.This data is considered to replicate conditions in real life.In Spain,the

158、Group is undertaking a retrospective non-interventional study(real-world evidence based on big data analysis)in patients allergic to olive pollen who have been treated with an ultra-short-course olive allergy vaccine containing MPL in the last five years.Innovative,broad pipeline and marketed produc

159、tsPre-clinicalPhase lPhase llPhase lllMarket/RegisteredGrass MATA Short course SCIT Tree MATA Short course SCIT Ragweed MATA Short course SCIT Bee Venom SCIT Short course SCIT Wasp Venom SCIT Short course SCIT Grass MATA MPL Short course Grass SCIT with MPLBirch MATA MPL Short course Birch SCIT with

160、 MPL Ragweed MATA MPL Short course Ragweed SCIT with MPL Trees MATA MPL Short course Tree SCIT with MPLOral Grass,Trees and House Dust Mite Sublingual immunotherapy with flexible-dosingModified Mite Platform Short course modified HDM SCIT+MPLPeanut SCIT Short course Peanut SCITSCIT:Subcutaneous Immu

161、notherapyMATA:Modified Allergen Tyrosine AdsorbedAlso available as a Named Patient productAllergy Therapeutics plcAnnual report and accounts 201928Research&Development Report 2019 continuedVLP Peanut timelineVLP PeanutThe Groups innovative peanut vaccine focused on a subcutaneous application of reco

162、mbinant peanut allergen coupled with its state-of-the-art VLP(Virus-like Particle)platform with the aim of inducing protective immunity is progressing well.The Group had positive meetings with regulatory authorities to discuss the potential protocol for the first in human trial of the VLP-based Pean

163、ut product,due to start in H2 2020.Commercial scale-up continues to make good progress with the manufacture of IMP(investigational medicinal product)and stability on schedule.The Group is also looking to expand the VLP technology into other allergy areas.Test in vitro to determine product profilePro

164、of of concept testing in animal models to demonstrate potential efficacy and safetyDesign manufacturing systems to ensure production of material to GMP requirements and commercial viabilityTesting to ensure GMP material meets initial specifications and maintains stability over 12 monthsManufacture o

165、f stability and toxicology materials according to scale-up parametersTesting to ensure IMP material doesnt cause toxicity(including reproductive and juvenile toxicology evaluation)First in human(skin prick test)study initiatedStageDurationProof-of-concept1-2 yearsPre-clinical2 yearsScale-up1 yearIMP

166、 manufacture4 monthsStability testing12 monthsToxicology4 monthsPhase I(a)6 monthsAllergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 29Strategy in action Progress in the USInvestor interactionDuring the year there has been increased activity in our

167、engagement with potential US investors.The reason for this is multifaceted.Management wishes to diversify the shareholder base and increase the potential sources of funding for the pipeline and the US Strategy.The team has been on several non-deal roadshows and attended the 2019 JP Morgan Conference

168、 week.Initial feedback from potential investors has been positive with interest shown in the VLP peanut product,largely due to the visibility of the two companies already listed in the US with first generation peanut products(DBV,Aimmune),as well as the potential for a MATA MPL product in the US mar

169、ket.Several of the investors had first or second hand knowledge of the current treatments available in the US and immediately saw the benefit of our clinically proven ultra-short course product.Further,the successful trading model applied in Europe gives confidence in the ability of the business to

170、move products to market.KOL interactionThe science team has also been busy with allergy conferences and visits to individual KOLs to build up a network for the Grass MATA MPL Phase III trial starting in autumn 2020.As well as this,the advice of KOLs has been sought in relation to the development pla

171、ns for the VLP peanut product,due to start first in human trials in the middle of next year.The US is considered a key market for this product with an estimated 4.7m people allergic to peanut by 2025(Delveinsight 2017).This interaction is important to understand the potential market,to assess the be

172、st approach in respect of clinical development and to raise the profile of our products and potential products among the medical community.Allergy Therapeutics plcAnnual report and accounts 201930Operating ResponsiblyOperating ResponsiblyOur commitment to operate responsibly focuses on four core are

173、as:our people,our patients,our communities and our planet.This is underpinned by a commitment to high standards of business practices.Our people are at the heart of our business and we provide a range of support and training opportunities that enable us to develop the right talent to implement our s

174、trategy and help individuals to maximise their potential.We support initiatives that help increase young peoples interests and aspirations in careers in science,technology,engineering and mathematics(“STEM”)and act as an Enterprise Adviser for Davison School for Girls near our UK headquarters specif

175、ically providing girls with a better understanding of the wide range of opportunities in a STEM related career.We are committed to minimising the impact of our operations on the environment and are conscious of the principles of conservation:reduce,reuse and recycle.We demand the highest standards o

176、f health and safety,and ethical practices in areas such as modern slavery,tax evasion,bribery and corruption,and undertake regular audits of suppliers to ensure that they are working to the same standards.Community and environmental initiatives across the business are managed by each office.This rep

177、ort explains more about our activities in each of our areas of focus.In line with our commitment to transform lives,we are committed to conducting our business in a responsible way.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 31PeopleOur peopl

178、e are the key to our success and we are proud of the pioneering and ground-breaking work they carry out that can transform a patients life.We aim to develop careers by identifying and supporting talented individuals to ensure that we have a workforce capable of realising our ambitious strategy.We re

179、view succession planning of our Senior Executives at Nomination Committee meetings to ensure that the business has procedures in place to safeguard continuity of leadership.In addition,we are developing a globally consistent talent management and succession planning approach which we plan to impleme

180、nt over the next year.We support our employees to make a difference to the business through a structured performance management process.Achievement of an individuals objectives is rewarded through a discretionary bonus.We provide a competitive compensation and benefits package which includes discret

181、ionary share awards for eligible employees.We are committed to growth and investing in technology,both to advance our product portfolio and to allow us to operate globally.We now have established a good practice of working globally and virtually by utilising technology.We have also invested in a glo

182、bal finance system to increase the efficiency of Group reporting.In addition,we have launched our global people system that supports the growing business and provides global consistency in our approach to people.Culture and valuesOur three core values:Vision,Commitment and Menschlichkeit(Humanity)sh

183、ape how we work and are at the heart of every decision the business makes.For more information on how we are evolving culture within the business,please see page 13.Case studyOver the Wall campI was buzzing after camp,a truly life-affirming experience!I hope that in some small way I was able to cont

184、ribute.I have gained so much more from the camp than I ever imagined.Before the campers arrived,every person on site received allergy and anaphylaxis training,including use of adrenaline auto-injectors.The site was made free of all airborne allergens and rooms and surfaces were deep cleaned.Meals ha

185、d been meticulously planned so that each child could eat every single item on the menu.This led to mealtimes being relaxed and fun not something the campers experienced in everyday life.The campers were supported by experienced and dedicated volunteers,as well as a team of doctors and nurses who wor

186、ked around the clock keeping the children safe.The children could be themselves rather than being held back by fear and limitations.Mike supported a team of campers,encouraging them to complete activities such as the climbing wall and inspiring them to try new foods.Children with severe allergies ar

187、e often excluded from school trips and other residential camps due to the inability for the setting to cater for their allergies.Over the Wall provides safe,therapeutic recreation camps which help to develop the confidence,self-esteem and coping strategies of the campers.Allergy Therapeutics sponsor

188、ed the Over the Wall allergy camp held in October 2018 and Mike Shaw,an employee of Allergy Therapeutics,volunteered as a camp recorder.Many of the children who attended this camp had never been away from home before.Some had never eaten a meal that wasnt prepared at home by their parents.Allergy Th

189、erapeutics plcAnnual report and accounts 201932Operating Responsibly continuedOur communitiesDuring the year,the Group worked to benefit the communities in which we operate and to support various allergy related initiatives.Science,Technology,Engineering and Mathematics(“STEM”)During the year,the Co

190、mpany continued its support to activities in STEM subjects in the local Sussex community.As a healthcare company with a focus on improving allergy treatments through advanced technology,we want to encourage and support the next generation of scientists and healthcare professionals.STEM activities du

191、ring the year included our participation in the Sussex STEM careers fair day,an exciting and interactive day attended by students and the community.Bev Lees,the Group Operations Director,continued work as Enterprise Adviser for Davison School for Girls.In addition,Bev also became a member of the Exe

192、cutive Management Group“Full STEaM Ahead”for Coastal West Sussex.The Company sent its apprentices to Davison school for a day to support the apprenticeship programme and Bev Lees gave a talk on opportunities in the Company.Five-Year 10 students and four A-level students were provided with work exper

193、ience places involving engineering,manufacturing and laboratories.It also provided the opportunity for an A Level student to work on a four-week science project through the Nuffield Research placement scheme.Other initiatives around the group were the continued support for the Aluminium for Bread ch

194、arity in Germany where our employees collect aluminium and other metals to support a childrens charity in Bolivia,support to the Special Olympics in Switzerland among others.Allergy related initiativesThe Group are platinum sponsors of the European Academy of Allergy and Clinical Immunology“EAACI”.E

195、AACI help drive awareness of the existence of allergy treatments,support the training of a new generation of allergists and supports initiatives into food allergy and awareness.DiversityWe believe that every person in the Group has a part to play in creating value and we understand the benefits of a

196、 diverse workforce.There is strong female representation across the business and we are keen to develop female talent.In recognition of the benefits of diversity at all levels in the business,the Company announced in 2018 that it aims to have 30%female representation on the Board by 2025 so that our

197、 Board composition will better reflect the gender diversity within the Group.This year,Mary Tavener was appointed as our first female member of the Board.In addition,with our digital people system platform,we will be increasingly monitoring and taking proactive action to improve diversity across the

198、 organisation,beyond gender.Modern slaveryIn accordance with the Modern Slavery Act 2015,the Board has 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 operation

199、s and in our supply chain.We believe that our own operations present minimal risk,but recognise that a higher level of risk is posed by the suppliers we engage with to provide goods and services.In the year ahead,we plan to provide further guidance to our employees and continue our ongoing engagemen

200、t and audit of our suppliers.Our patientsAllergies 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 be fatal.Whatever the severity of an allergy,the wider implications are negativ

201、e.Many patients and their families live in fear and can feel isolated or excluded.There is no doubt that our work in allergy treatment is transforming lives.For more information on how we consider our patients well-being and safety throughout the product life cycle,please see page 33.We strive to de

202、liver 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.Therefore our product pipeline reflec

203、ts this with programmes investigating allergens of serious concern such as peanut allergy.Our shorter course treatments take 4 6 injections,over the course of 3 to 5 weeks.Alternative therapies in the USA can take 50100 injections and up to 15 across Europe.Our approach increases efficiency for heal

204、thcare professionals and frees up time for our patients.Healthcare professionals rely on our quality products,our knowledge and our trusted partnership to deliver the best care for their patients.96%of our products were delivered on time during the year.Biodegradable adjuvantsAdjuvants are added to

205、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 biodegradable alternatives and today,all our vaccines are al

206、uminium free and feature natural adjuvants only.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 33Additionally,the Group supports a number of allergy related initiatives such as the German Association for Allergology and Clinical Immunology“DGAKI

207、”and the German Foundation for Prevention of Allergies and Respiratory Diseases,the Italian Association of Allergists and Immunologists,and the Austrian Society of the Paediatricians allergy education programme.Our planetWe are committed to responsibly managing the environmental impact of our operat

208、ions and the products that we sell.We also recognise that using resources efficiently and reducing our carbon footprint can help to reduce costs.The energy used to power and heat our offices,distribution centres and manufacturing facilities is the greatest contributor to our carbon footprint and als

209、o represents a significant cost to the business.Throughout the year we have monitored our energy usage to identify energy saving opportunities in compliance with the Energy Saving Opportunity Scheme Regulations“ESOS”.Actions taken to reduce our energy use in Worthing have included the upgrade to mor

210、e efficient air handling unit motors in our manufacturing facility,the new units use approximately 40%less energy than the previous units.The Group uses a video conferencing communication system,allowing us to operate globally while reducing the number of flights that we take,therefore reducing our

211、overall carbon footprint.Our staff are encouraged,where possible,to take trains rather than fly when travelling between offices or when on business.We continue to work hard to reduce waste within the business.Waste created by inefficient use of resources can be costly to the business.In response,we

212、operate recycling and waste reduction initiatives in all of our offices.We apply the Waste Hierarchy principles when segregating our waste.We have made efforts during the year to reduce single use plastic waste in all our offices and in our manufacturing processes.As a business we want to have a pos

213、itive impact on the planet and during the next financial year we will continue to focus on reducing our energy consumption and waste and will be aligning our efforts and commitments across the Group.Case studyPutting patient safety firstTraining and educationThe Medical Team provides training to Hea

214、lth Care Professionals(HCPs)in the correct administration of our products and also trains them in the management of any complicated reactions.Such training can save lives.Our Medical Team consists of experienced medical doctors who understand the different needs of patients and are able to provide t

215、hem with accessible and comprehensive information.They can be contacted to provide information to both HCPs and patients for any drug-related enquiry.The team receives direct feedback from these enquiries that allows them to constantly improve the handling and safety of our products.Pharmacovigilanc

216、eA globally acting Pharmacovigilance team constantly monitors the drug safety of all our products on the market.There are a number of controls in place to detect and address safety concerns early,such as the monitoring and timely collection of relevant information,risk assessments and safety update

217、reports.Our Local Safety Officers,in each country where our products are marketed,provide training to our employees or the employees of the distributor to make them aware of safety information or product risks.The well-being and safety of our patients is at the heart of everything that we do.Through

218、out the life cycle of our products,we work to ensure that the safety and benefits to our patients are maximised by having systems and processes in place for continuous review of all the products in our portfolio,including marketed products and those in development.Clinical researchAll our clinical s

219、tudies are performed according to current Good Clinical Practice guidelines using suitably trained personnel.Before a trial starts,an independent ethics committee reviews the protocols.All risks associated with the trials are tracked to ensure that quality and safety standards are maintained through

220、out.Ensuring quality in manufacturing and supplyWe have extensive quality control and quality assurance processes in place.Our products are manufactured in accordance with both Good Manufacturing Practice regulations and our internal quality management system.Our suppliers are also expected to ensur

221、e consistent high quality and safety in the production of our raw materials.This approach safeguards patient safety and helps us to deliver quality products.Revenue constant exchange rate1 m58.562.869.3201720182019EBITDA excluding R&D m9.311.313.4201720182019Operational marketsPercentage market shar

222、ein the markets in whichwe operate13.0%13.6%14.1%201720182019Allergy Therapeutics plcAnnual report and accounts 201934Key Performance Indicators(“KPIs”)Strategic objectiveKPIAnalysisGraphMaximise revenueMaximise funds available from operational activities for investment in other R&D and other value

223、adding projectsMaximise market share in the countries into which we sell our productsRevenue at constant exchange rate(GBP:EUR exchange rate 1.21)Total revenue measured at a constant budgeted foreign exchange rateEBITDA excluding R&DProfit before interest,tax,depreciation,amortisation and research a

224、nd development expenditureCombination of IMS Health data and information collected by independent third partiesCountries in which we have a distributor,agent or direct sales forceRevenue at constant exchange rate has grown satisfactorily compared to the two prior yearsEBITDA excluding R&D has increa

225、sed year on year due to sales growth and good cost controlThe Group continues to make market share gains based on best in class technology,excellent supply chain and a strong sales and marketing team1 GBP:EUR exchange rate 1.21.Constant currency uses prior year weighted average exchange rates to tra

226、nslate current year foreign currency denominated revenue to give a year-on-year comparison excluding the effects of foreign exchange movements.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 35Risk Management We recognise that our purpose and mis

227、sion can only be realised through effectiverisk management.Our Risk Management Framework is designed to enable us to assess and determine what our key risks are and how to manage them appropriately.That then enables us to meet our strategic objectives and deliver the long-term growth and viability o

228、f our business.The Board has overall responsibility for the Groups risk management.It reviews principal risks and uncertainties and mitigation strategies and considers how those risks may affect the achievement of business objectives.The Board has delegated responsibility for the review of the adequ

229、acy and effectiveness of the internal control framework to the Audit 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 risk.To ensure that there is a more integrated and deeper focu

230、s on applying and evolving risk management,principal and emerging risks are reported and discussed at each monthly Executive Team meeting.The Audit Committee reviews the key risks on an annual basis and any emerging risks can be identified and reported to the Board.The risk framework manages rather

231、than eliminates risk and has helped us to develop a more risk-aware culture.Risk Management Structure BoardOverall responsibility for risk framework and internal controlsAudit CommitteeMonitors internal control frameworkReviews and discusses risks,controls and mitigation measuresThe Executive TeamId

232、entifies and manages riskCompiles Risk Register which is reviewed on a bi-annual basisImplements mitigation measuresReports to the Board on its work and conclusionsReports to the Audit CommitteeAllergy Therapeutics plcAnnual report and accounts 201936Principal Risks and UncertaintiesThe Board has ov

233、erall responsibility for the Groups system of risk management.In common with many pharmaceutical companies,the Group faces a number of risks and uncertainties.Internal controls are in place to help identify,manage and mitigate these risks.The main risks have been identified as follows:RiskDescriptio

234、n of risk and impactMitigationDevelopments in 2019Commercially Successful Products Continued development of viable new products and their successful registration and marketing is key to the success of the Group and is a costly and lengthy process.Rationale for new product development may indicate po

235、tential;however,following significant investment there is no guarantee that a product will be commercially successful.Developing and commercialising Pollinex Quattro products in the US,seeking PEI market authorisation for Pollinex Quattro products in Germany.Continuing to increase market share acros

236、s Europe as well as developing new markets to spread risk.Successful Phase II Grass Trial opening possibility of a final Phase III trial to get a product into the US market.Continued growth in sales in the year.Production A significant majority of the Groups products are manufactured on the Worthing

237、 site which is shared with GSK.Any disruption to production caused by internal or external factors could materially affect the business.The site is also leased from GSK and therefore there is a mid-term risk that the lease is terminated.Any failure in production could lead to a product recall.Regula

238、r maintenance and upgrade of the facility is undertaken.Recovery plan in place.In respect of the lease,the Group has negotiated a longer termination notice period and has a contingency plan in place.IT disaster recovery plan.Work is underway on cyber training and review of procedures.Good communicat

239、ion with GSK over the period.Assessment of cyber vulnerability with action plan for changes.Product Liability Despite 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 f

240、or any potential litigation which in some cases can potentially be open-ended.Groups manufacturing facilities and 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.Maintenance of product liability insu

241、rance and ensuring systems and processes relating to the manufacture of its products are compliant and regularly reviewed.Pharmacovigilance team in place to monitor and address any safety issues arising including non-compliance in the treatment of patients.The Group has had audits by regulators in t

242、he UK,Spain and Switzerland which have not identified any critical issues.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 37RiskDescription of risk and impactMitigationDevelopments in 2019Intellectual Property Patents may be challenged at any tim

243、e and any unsuccessful defence may cause the Group to lose protection for its products and subsequently 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 it products.Intern

244、al and external patent experts.Internal controls are in place to avoid disclosure of patentable material and to protect existing patents.Arrangements are in place to notify the Group of any infringements of our intellectual property which it would defend robustly.In several areas,the Group has stren

245、gthened its control through new patents and new,complex processing methods.Economic A high level of risk is attached to the research,development and commercialisation of innovative drugs.The Group ensures that business cases are scrutinised before Board approval and that any increases in costs are j

246、ustified.Competitors may reduce prices or increase sales investment making maintaining market share less profitable.Key suppliers may be unable to execute contractual requirements that hamper product development,the route to markets or current sales,but the Group maintains appropriate measures to pr

247、otect its supply chains where possible.The Group may be unable to attract partners or licensees on favourable terms or recruit the right staff to help develop and market its products.Approximately 61%(2018:61%)of Group sales are made in Germany and therefore Group results are particularly sensitive

248、to German legislation and government policies and performance of the German market.Pharmaceutical products are subject to far greater controls on price in certain markets than other products in the marketplace.Some governments intervene directly in setting price levels and rebates paid into public h

249、ealth funds,especially with an increasing aged population in developed countries.The Group cannot accurately predict when,where and how such controls and restrictions may be altered,either to its benefit or detriment.Continuous effort to expand its revenue outside Germany.Development of new products

250、 and increase clinical data to protect market position.Regular reviews are conducted of pricing and reimbursement levels and assessments of healthcare reforms on pricing.Reimbursement levels have remained stable over the year and in certain cases,price rises have been allowed.Allergy Therapeutics pl

251、cAnnual report and accounts 201938Principal Risks and Uncertainties continuedRiskDescription of risk and impactMitigationDevelopments in 2019EU Referendum The referendum in the UK to leave the EU could pose a significant risk for the Group.Short-term risk;the referendum outcome has and may continue

252、to impact exchange rates and investor confidence.Medium term risk impact is not clear given the uncertain nature of the future arrangements between the UK and the rest of the EU.Significant potential areas of risk are regulatory,fiscal and financial.Mitigation in relation to currencies is noted unde

253、r Financial Risks.In relation to other aspects of this risk,the Group has considered at a detailed level the potential effects.Contingency plans have been implemented with some parts completed to limit damage as far as possible in the event of a hard Brexit and the UK moving to third country status.

254、Active liaison with regulatory authorities in order to minimise disruption.Investment in cold storage facilities in Alcal,Spain.Creation of a parallel testing team and equipment in Alcal.Increased production to cover the full years demand for approved products for Continental Europe which was then s

255、hipped to Alcal,Spain.Financial Adequate funding may not be available to the Group,either through reserves or external partners for the advancement of clinical trials,manufacturing and marketing.Failure to obtain further funding may lead to postponement or cancellation of programmes.A majority of th

256、e Groups sales are denominated in euros whilst the manufacturing and most corporate administration costs are in the UK and therefore the Group is exposed to volatility in exchange rate fluctuations.The Board actively reviews the financial requirements of the Group on a regular basis in order to ensu

257、re that adequate funding is available.Monitoring exchange rates regularly with implementation of hedges to mitigate such risks.Note 24 in the Notes to the Financial Statements gives details of the Groups objectives and policies for risk management of financial instruments.Equity raise in July 2018.S

258、ettlement of litigation has reduced risk and increased funds available.Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 39RiskDescription of risk and impactMitigationDevelopments in 2019Clinical and Regulatory The Group operates in a highly regula

259、ted environment for the testing,manufacture and supply of its products.Compliance with clinical and regulatory requirements within the EU affects not only the cost of product development and resource use,but also the time required to comply.Increased regulation may require products to be amended to

260、comply with regulations and/or products have to be withdrawn,reducing revenues and/or increasing costs.Regulatory authorities such as the FDA are increasingly focused on the benefit/risk of pharmaceutical products and safety data making it more onerous to obtain regulatory approval.Compliance system

261、s are in place 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 ke

262、y regulatory 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 maintains good relations with the small number of specialised suppliers for its raw materials for its products.The

263、unsuccessful Phase III Birch trial has led to an in depth investigation to identify causes and take action where necessary.There is ongoing dialogue with the PEI,the MHRA and the FDA in respect of trials and development.Internal Controls The internal control system is designed to manage rather than

264、eliminate risk,but it can only provide reasonable and not absolute assurance against material misstatement or loss.Internal controls are designed for the safeguarding of assets,the maintenance of proper accounting records,the reliability of financial information,compliance with appropriate legislati

265、on,regulation and best practice and the identification and management of business risk.An internal audit function is in place,reporting directly to the Audit Committee,which carries out periodic reviews of the Groups subsidiaries.Budgeting and reporting systems are in place,with results compared to

266、annual budgets and half-yearly forecasts using variance analysis.Internal audits continue to be carried out on a rotational basis.Allergy Therapeutics plcAnnual report and accounts 201940Principal Risks and Uncertainties continuedRiskDescription of risk and impactMitigationDevelopments in 2019Key Pe

267、rsonnel The Group 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 imp

268、act the effectiveness of the Groups operations.Continued investment in training and development as well as externally benchmarking remuneration and developing succession planning.The Group has created an organisational development function and invested in HR systems to track and develop talent.Compl

269、iance The Group aims to remain compliant with all relevant laws and regulations.The recent significant increase in such regulations around data protection,taxation and many other areas has increased the risk of a breach of regulations that could lead to a substantial fine.Policies and procedures in

270、place in order to comply with legislation and considers that its standards are above those of quoted businesses of a similar size but these may not be enough to avoid breaches.The Group has continued to invest in additional compliance resource.Allergy Therapeutics plcAnnual report and accounts 2019F

271、inancial statementsGovernanceStrategic report 41Financial ReviewOverviewThe core business has continued to grow profitably with results for the 12 months to 30 June 2019 achieving an operating profit excluding R&D2 of 11.3m(2018:9.3m).Including R&D expense of 7.0m(2018:16.0m),the Group reported an o

272、perating profit of 4.4m(2018:loss 6.7m).The operating profit includes a one-off settlement of$7.6m(6.0m)relating to the Inflamax litigation.The net profit after tax for the period was 3.5m(2018:loss of 7.5m).2019 Germany m2019 Other m2019 Total m2018 Germany m2018 Other m2018 Total mRevenue45.028.77

273、3.742.026.368.3Add rebates 3.83.84.24.2Gross revenue48.828.777.546.226.372.5Adjustment to retranslate at prior year foreign exchange rate0.20.10.3Gross revenue at constant currency149.028.877.846.226.372.52019 Germany m2019 Other m2019 Total m2018 Germany m2018 Other m2018 Total mRevenue45.028.773.7

274、42.026.368.3Adjustment to retranslate at prior year foreign exchange rate0.20.10.3Revenue at constant currency145.228.874.042.026.368.31 Constant currency uses prior year weighted average exchange rates to translate current year foreign currency denominated revenue to give a year-on-year comparison

275、excluding the effects of foreign exchange movements.2 Operating profit(pre-R&D)is calculated by adding back R&D expenditure for the year to the operating profit of the year to arrive at an operating profit(pre-R&D)of 11.3m(2018:9.3m).Revenue from Germany was 61%(2018:61%)of total reported revenue.Re

276、bates were lower this year due to changes in product composition that may not continue in 2020.Sales of Venomil and Acarovac Plus continued to grow very strongly while Pollinex and Pollinex Quattro achieved reasonable growth.Total sales from other products contributed 3.8m for the year ended 30 June

277、 2019(2018:4.1m).Revenue in Germany grew well in the year with revenue at constant currency1 increasing to 45.2m(2018:42.0m),an increase of 8%.All the main European markets(except for Italy)exhibited good sales growth at constant currency1 with Spain showing 12%;the Netherlands 16%;Austria 13%and Ge

278、rmany 8%.The Group continues to develop new and existing markets to reduce reliance on the German market.Gross profitCost of sales increased to 18.4m(2018:17.0m).The gross margin was 75%(2018:75%),leading to a gross profit of 55.3m(2018:51.3m).Operating expensesTotal overheads were 1.1m lower than p

279、rior year at 57.6m(2018:58.7m),excluding the credit in relation to the Inflamax legal settlement.This was due to a 3m reduction in R&D expenses in the year due to lower clinical activity partially offset by increased administration expenses.Sales,marketing and distribution costs which were mainly in

280、 continental Europe,remained flat at 27.0m(2018:27.1m)other administration expenses increased by 2.1m to 17.6m(2018:15.5m)which included 0.6m of Brexit-related costs.The rest of the increase was driven by additional investment in compliance and support functions.Other income in the year of 0.6m(2018

281、:0.6m)was all due to R&D tax credits in the UK.TaxThe current and prior year tax charges are predominately made up of provisions for tax in the Italian and German subsidiaries.RevenueRevenue increased by 8%to 73.7m(2018:68.3m).The impact of currency has been negligible in comparison to the prior yea

282、r with the weighted average Euro exchange rate in the year was 1.12 to 1 compared to 1.13 in 2018.Revenue at constant currency1 was 8%higher at 74.0m(2018:68.3m)as shown in the table below:Allergy Therapeutics plcAnnual report and accounts 201942Balance sheetProperty,plant and equipment increased by

283、 1.4m to 11.5m(2018:10.1m)with investment in new manufacturing plant to replace older equipment and increase automation.Goodwill was similar to last year at 3.4m(2018:3.4m),whilst other intangible assets were reduced slightly due to 1.4m(2018:1.5m).Total current assets,excluding cash,increased to 19

284、.2m(2018:15.3m).Inventory increased further by 0.6m due to early production of commercial stock as part of Brexit preparations(cover for approved products for the 2020 financial year).Trade and other receivables have increased due to a receivable related to the legal settlement(3.2m)as well as timin

285、g.Cash and cash at hand increased to 27.4m from 15.5m in 2018.The fair value of derivative financial instruments was a liability of 0.4m in 2019(2018:0.1m).Retirement benefit obligations,which relate solely to the German pension scheme,increased to 11.7m(2018:10.3m).The increase in the liability was

286、 mainly driven by the reduction in the discount rate from 1.85%to 1.45%.The Group had a net cash inflow of 11.8m in the year(2018:6.6m cash outflow)primarily due to an equity raise,good trading and settlement of the Inflamax legal case.CurrencyThe Group uses forward exchange contracts to mitigate ex

287、posure to the effects of exchange rates.The current policy of the Group is to cover,on average,about 70%of the net Euro exposure for a year on a declining basis.Financing The Groups debt on its balance sheet relates to activities in Spain and consists of the loans acquired as a result of the Alerpha

288、rma acquisition(0.9m)and further loans(1.5m)arranged to fund development of products in the Spanish market.The overdraft facility was unused at 30 June 2019 but has since been renewed for a further 12 months to cover seasonal funding requirements.In July 2018,the Group completed a successful placing

289、 and subscription of 40m shares,raising 10.6m gross(10.2m net of expenses)The Directors believe that the Group will have adequate facilities for the foreseeable future and accordingly they continue to adopt the going concern basis in preparing the full year results.For further details,see Note 1,Goi

290、ng Concern.LegalOn 23 February 2015,the Company received notification that the Federal Office for Economics and Export(BAFA)had made a decision to reverse their preliminary exemption to the increased manufacturers rebate in Germany for the period July to December 2012.The Company was granted a preli

291、minary exemption to the increased rebate for this period by BAFA in 2013.The Company recognised revenue of 1.4m(1.1m at that time,1.2m now)against this exemption in the year ended 30 June 2013.All other preliminary exemptions(granted for periods up to 30 June 2012)have previously been ratified as fi

292、nal by BAFA.After taking legal advice,the Company has lodged an appeal against this decision and is confident that the exemption will be reinstated.Therefore,as at 30 June 2019,no provision has been recognised for the repayment of the rebate refund of 1.4m(1.2m).This position will be kept under revi

293、ew.Nicolas WykemanChief Financial OfficerThe Strategic Report,as set out on pages 1 to 42,has been approved by the BoardOn behalf of the BoardNicolas WykemanDirector24 September 2019Financial Review continuedAllergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrateg

294、ic report 43ContentsGovernance44 Board of Directors46 Corporate Governance Report51 Communications with Stakeholders52 Nomination Committee Report54 Audit Committee Report56 Directors Remuneration Report64 Directors Report66 Statement of Directors ResponsibilitiesGovernanceAllergy Therapeutics plcAn

295、nual report and accounts 201944Board of DirectorsPeter JensenChairman Manuel LlobetChief Executive Officer Nick WykemanChief Financial Officer Peter is responsible for the leadership of the Board,ensuring its effectiveness and setting its agenda.Peter held a number of senior positions in his 21 year

296、s with SmithKline-Beecham,including Chairman of Consumer Healthcare Europe and President of Worldwide Supply Operations.He has previously held Non-Executive or Chairman roles at a number of public and private companies including Domino Printing Sciences plc,Glenmorangie plc and Genetix Group plc.Man

297、uel has been CEO of Allergy Therapeutics plc since 2009,shaping strategy and driving growth.Prior to this,Manuel was the Principal Consultant for Biohealth LLC and CEO of International Operations of the Weinstein familys group of companies.Nick joined Allergy Therapeutics plc in 2016 as Finance Dire

298、ctor.He leads the finance function developing and implementing financial strategy.Nick is a Chartered Accountant and previously held positions at Skyepharma PLC(now part of Vectura Group plc)and Quest International(a division of ICI PLC).External appointments Chairman Sandown Park Racecourse Screend

299、ragon(Software)Limited Home of Horseracing Trust Limited British Sporting Art TrustTrustee of National Horseracing Museum External appointments NoneExternal appointments None A N*Key to CommitteesA Audit CommitteeN Nomination CommitteeR Remuneration Committee*Denotes Chairman of a CommitteeAllergy T

300、herapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 45Stephen Smith Non-Executive Director and Senior Independent Director Tunde OtulanaNon-Executive DirectorMary TavenerNon-Executive Director Scott LeinenweberNon-Executive Director Stephen is a Chartered Man

301、agement Accountant,Fellow of the Association of Corporate Treasurers and member of the Institute for Turnaround.During his career he held a number of financial roles in UK listed companies.Since 1995 he has operated as an independent executive and has since taken on a number of board,advisory or exe

302、cutive roles.Tunde is Senior Vice President and Chief Medical Officer at Mallinckrodt Pharmaceuticals where he has responsibility for all global medical functions.His career includes leadership roles at Boehringer Ingelheim Pharmaceutical Inc.and the US Food and Drug Administration(FDA).Mary has ext

303、ensive experience in the healthcare sector,having spent more than 19 years as Chief Financial Officer and Board member of AIM listed Advanced Medical Solutions(“AMS”).At AMS,Mary was responsible for strategy and risk management,finance,operations,regulatory and legal.Mary is a Fellow of the Chartere

304、d Institute of Management Accountants(FCMA)and a Fellow of the Association of Corporate Treasurers(FCT).Prior to joining AMS,Mary was the Group Financial Controller of BTP plc.Scott Leinenweber is Vice President of Investor Relations and Licensing&Acquisitions at Abbott Laboratories and is their nom

305、inated Director on the Board.Scott started his career at Abbott in 1997 as a financial analyst,before moving into product management,sales and marketing roles across Abbotts businesses.External appointments Roles include Chairman of Tensator Holdings Limited,Rio Laranja Holdings Limited,Icknield Lim

306、ited and Non-Executive Director of EAT Limited(until 2 July 2019).External appointments NoneExternal appointments Cuddington&Sandiway Parish Playing Fields Association Limited.External appointments Abbott Healthcare Private Limited(an Indian subsidiary of Abbott Laboratories).A*N R*N RAAllergy Thera

307、peutics plcAnnual report and accounts 201946Corporate Governance ReportDear Shareholder,I am pleased to introduce the Companys 2019 Corporate Governance Report.The Board recognises that good corporate governance is essential to building a successful business that is sustainable for the long term.I a

308、m very pleased to say that we are again able to report full compliance with each of the 10 principles of the Quoted Companies Alliance Corporate Governance Code“QCA Code”and that our governance framework continues to ensure that the Group operates effectively and with integrity.As well as ensuring c

309、ompliance with the QCA Code,we also continue to monitor any developments in the UK Corporate Governance Code to keep abreast of matters which we feel should also be considered for an AIM company like ourselves,and this year,we have considered the Companys purpose,ensuring that it is aligned to our v

310、alues,strategy and culture.The Corporate Governance Statement,together with the Committee Reports that follow,explain how our governance framework works and how the Group has applied the 10 principles of the QCA Code this year.Our governance framework promotes a culture of accountability and respons

311、ibility which is supported by our values and behaviours.During the year,the Board has promoted open and transparent discussion,and has provided constructive challenge and support to the business.Ensuring that we have succession plans in place for all our Board members plays a vital part in making su

312、re that the Board remains effective in supporting the Companys growth strategy.Over the year,the Nomination Committee undertook a review of the composition and membership of the Board and its Committees.Following this review,a careful search and recruitment process was carried out and we were deligh

313、ted to announce on 19 June 2019 the Non-Executive appointment of Mary Tavener,for which biographical details can be found on page 45.Like many business in the UK,we have been navigating the varied political uncertainties of Brexit throughout the year and have continued to focus on our systems of ris

314、k management and internal controls.Details of our principal risks and uncertainties can be found on pages 36 to 40.Thank you for your continued support and the Board looks forward to meeting any shareholder who can join us at our Annual General Meeting on 25 November 2019.Peter JensenChairman 24 Sep

315、tember 2019Allergy Therapeutics plcAnnual report and accounts 2019Financial statementsGovernanceStrategic report 47Corporate Governance StatementThe Board has adopted the Quoted Companies Alliance Corporate Governance Code(QCA Code).The Board believes that this Code provides an appropriate and suita

316、ble governance framework for a group of our size and complexity.This Corporate Governance Statement addresses how the Group complies with each of the 10 principles of the QCA Code;however further disclosure relating to each principle can be found in other sections of the 2019 Annual Report and Accou

317、nts(the“2019 Report”)as indicated below:NumberPrinciple:Disclosure in the 2019 Report:1.Establish a strategy and business model which promote long-term value for shareholders Pages 18 212.Seek to understand and meet shareholder needs and expectations See page 513.Take into account wider stakeholder

318、and social responsibilities and their implications for long-term success Pages 30 334.Embed effective Risk management,considering both opportunities and threats,throughout the organisation Pages 35 405.Maintain the Board as a well-functioning,balanced team led by the Chairman Page 47 50 6.Ensure tha

319、t between them the Directors have the necessary up-to-date experience,skills and capabilities Page 44,45&537.Evaluate Board performance based on clear and relevant objectives,seeking continuous improvement Page 50 8.Promote a corporate culture that is based on ethical values and behaviours Page 139.

320、Maintain governance structures and processes that are fit for purpose and support good decision making by the BoardPages 48 6310.Communicate how the Company is governed and is performing by maintaining a dialogue with shareholders and other relevant stakeholdersPages 46 51The BoardThe Board is colle

321、ctively responsible for the long-term success of the Company and for its leadership,strategy,values,standards,control and management.Day-to-day management of the Group is delegated to the Executive Team,subject to formal delegated authority limits;however,certain matters are reserved for whole Board

322、 approval.These matters are reviewed periodically and include Board and Committee composition,strategy,funding decisions and corporate transactions among others.Directors are required to commit sufficient time to their role to appropriately discharge their duties.All Directors are offered regular tr

323、aining to develop their knowledge and ensure they stay up-to-date on matters for which they have responsibility as a Board member.Allergy Therapeutics plcAnnual report and accounts 201948Corporate Governance Report continuedBoard and Committee balance and compositionAs at 30 June 2019,the Board comp

324、rised the Chairman,two Executive Directors and four Non-Executive Directors.The table below summarises the membership of the Board and Committees.The Board keeps under review its current composition,which provides a sufficiently wide range of skills experience to enable it to pursue its strategic go

325、als and to address anticipated issues in the foreseeable future.Biographies of each Director can be found on pages 44 and 45 of the 2019 Report.Board independenceThe Board has considered the independence of the Non-Executive Directors,and the table on the next page sets out those considered to be in

326、dependent in character and judgement.Stephen(Steve)Smith has served on the Board for more than 10 years and will be offering himself up for re-election at this years Annual General Meeting(“AGM”).The Nomination Committee gave particular consideration to recommending that Steve Smith be reappointed c

327、oncluding that Steve continues to make a valuable contribution to the work of the Board and its Committees.Despite the length of his service on the Board,the Nomination Committee concluded that Steve retains his independent status as he continues to challenge the Executive Directors and makes indepe

328、ndent decisions.The Board will continue,with the support of the Nomination Committee,to consider any appropriate additions to the Board to further broaden the experience and effectiveness of the Board as the Group continues to grow.Roles and responsibilities Role Name Responsibility ChairmanPeter Je

329、nsenThe Chairmans primary role is to lead the Board and ensure that it operates effectively.In particular,the Chairman sets the Boards agenda and ensures that adequate time is available for discussion of all agenda items.Additionally,the Chairman promotes a culture of openness and debate with effect

330、ive contributions from Non-Executive Directors and ensuring constructive relations between themselves and the Executive Directors.CEOManuel Llobet The CEOs role is the day-to-day running of the Group and includes the development and implementation of strategy,decisions made by the Board and operatio

331、nal management of the Group,supported by the Executive Team.CFONick Wykeman The CFOs role is the day to day management of the Groups finances including the development and implementation of financial strategy.Senior Independent Director Steve Smith The Senior Independent Director(SID)provides advice

332、 and additional support and experience to the Chairman and can perform an intermediary role to other Directors,if necessary.Non-Executive Directors Tunde Otulana;Mary Tavener;Scott LeinenweberNon-executive Directors are responsible for bringing an external perspective,sound judgement and objectivity

333、 to the Boards deliberations and decision making,and to support and constructively challenge the Executive Directors using their broad range of experience and expertise.Company Secretary Sara Goldsbrough The Company Secretary attends all Board and Committee meetings and is responsible for advising the Chairman and Board on all corporate governance matters and ensuring good information flows betwee