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1、PAT IENT SFORT OGE THERF OCU SINTE GRATE D A N N U A L R EP ORT 2 0 2 0S OC IETYA N D2 I 3INTEGRATED ANNUAL REPORT 2020IntroductionOur Strategy04 Focus.Together.For patients and society.06 Q&A with CEO David Loew10 A new strategy for a new era of Ipsen12 For patients and society13 Creating value for
2、 patients17 Creating value for society22 Creating value for patients,society and all stakeholders24 Partnering with stakeholders to create long-term value26 Taking responsibility for the future28 Rare But Not Alone30 Employees:embodying our company values 32 The Board of Directors33 The Executive Le
3、adership Team34 Identifying and mitigating risk across the board36 2020 highlightsOur ActivitiesIpsen Around the World38 Building a sustainable R&D pipeline40 Creating value in oncology42 Creating value in rare disease44 Creating value in neuroscience46 Creating value in Consumer HealthCare48 Our gl
4、obal presence50 Our production and R&D sites52 Our key financial indicators56 Beyond numbers58 DisclaimerTABLE OF CONTENTS2 0 2 0 W A S A Y E A R O F C H A N G E See pp.4-5 for our new strategy See pp.6-9 for an interview with our new CEO I N C L U D I N G T H E I N T R O D U C T I O N O F I P S E N
5、 S N E W G R O U P S T R A T E G Y See pp.10-11 for more information about our four new strategic priorities See pp.12-25 for the value they enable us to create for patients and society W H I C H G U I D E S O U R P A S S I O N A T E E M P L O Y E E S A T E V E R Y L E V E L See pp.26-29 for the iss
6、ues Ipsen is taking on See pp.30-31 for more about our commitment to our employees See pp.32-33 for more about our leadership E N A B L I N G U S T O M I T I G A T E R I S K,A C H I E V E S U C C E S S See pp.34-35 for our risk management See pp.36-37 for our 2020 highlights A N D C R E A T E M O R
7、E V A L U E A L L O V E R T H E W O R L D See pp.38-47 for details on how we plan to build on our success in the future See pp.48-51 for details of our R&D and manufacturing presence worldwide M E A S U R E D B Y S T R O N G K P I s.See pp.52-55 for our key financial indicators See pp.56-57 for our
8、key non-financial indicators4 I 5INTEGRATED ANNUAL REPORT 2020INTEGRATED ANNUAL REPORT 2020F O C U S.T O G E T H E R.F O R P A T I E N T S A N D S O C I E T Y.While facing the challenges presented by COVID-19,Ipsen made great strides in 2020 and announced a new Group strategy under the overarching t
9、heme of Focus.Together.For patients&society.This strategy is strongly informed by our commitment to innovate for patient care.This is Ipsens inaugural Integrated Annual Report.Through it,we aim to show how we use our resourceshuman,intellectual,financial,manufacturing and socialto bring value to all
10、 stakeholders:healthcare systems,patients,employees,communities and,moreover,shareholders.Bringing in new leadershipIn July 2020,Ipsen welcomed its new CEO,David Loew.He initiated a strategic review which is laid out in this report.To support him in this endeavor,he was accompanied by the Executive
11、Leadership Team(ELT)which welcomed new members in 2020:Bartek Bednarz was promoted to EVP,Global Product and Portfolio Strategy and Patrice Zagame took on the role of EVP,Specialty Care International.Joining us from the industry,Steven Hildemann came on board in January as Ipsens EVP,Chief Medical O
12、fficer,Head of Global Medical Affairs,Patient Safety and Patient Affairs.Philippe Lopes-Fernandes followed in October,taking up the position of EVP,Chief Business Officer.In early 2021,Gwenan White was brought on as our EVP,Communications and Public Affairs.The ELT and all of Ipsens employees are ra
13、llied around our mission:to prolong and improve patients lives and health outcomes.Ipsens new strategy:Focus.Together.For patients&society.With a focus on transformative medicines in three key therapeutic areas with unmet needsoncology,rare disease and neurosciencethe strategic review identified whe
14、re to make significant changes.The new strategy has four main pillars:Bring the full potential of our innovative medicines to patients Build a high-value sustainable pipeline Deliver efficiencies to enable targeted investments and support our growth Boost a culture of collaboration and excellenceWit
15、h our distinctive positioning and portfolio of transformative medicines,Ipsen will continue growing,even with potential changes in the competitive environment.This commitment to growth stands for the short-,medium-and long-term.Ipsen has a robust late-stage pipeline today and will build a stronger,m
16、ore sustainable pipeline for the long term.There is a high ambition for external innovation and very clear priorities.Ipsen will build a distinctive organization and culture,with a strong focus on what truly makes a difference for patients.Our highly committed teams will write the next chapter of Ip
17、sens growth story with best-in-class execution to deliver on the promise to Focus.Together.For patients&society.This new strategy will enable Ipsen to generate value for shareholders.In 2020,we delivered good results with Group sales growth above 2%,despite the impact of the COVID-1 9 pandemic.Looki
18、ng towards 2024,Ipsen is aiming for a Compound Average Growth Rate between 2%and 5%and expects to generate a cumulative 3 billion for pipeline expansion.FOCUS means carefully choosing our actions;channeling our efforts where they will make the most positive impact.We must listen more intently toPATI
19、ENTS to gain further understanding of their journey and determine where they need more supportparticularly in terms of access to medicine and its delivery.Ipsen strives to benefitSOCIETY by serving communities and protecting the environment.KEEPING FOCUSED THROUGH THE PANDEMICThroughout the COVID-19
20、 pandemic,we had two guiding principles:secure employees safety and ensure patients had access to medicines.In 2020,Ipsen:Created new programs to ensure patients safety and continued access to treatments Kept manufacturing sites running safely and efficiently,maintaining consistent supply for patien
21、ts Moved work to digital platforms,ensuring employees safetyWe must workTOGETHER with all actors in the healthcare sector to address patients challenges.Ipsens vision is to be a leading global mid-size biopharmaceutical company,with a focus on transformative medicines in three key therapeutic areas:
22、oncology,rare disease and neuroscience.6 I 7INTEGRATED ANNUAL REPORT 2020David Loew became Ipsens Chief Executive Officer in July 2020,bringing with him nearly 30 years of leadership and experience across a range of therapeutic areas.Here,he reflects on the unprecedented events of the past year and
23、what lies ahead for Ipsen.What is it about Ipsen that made you want to join?I felt great enthusiasm for Ipsens position and potential.Despite the challenges we will face in the near future with generics competition against Somatuline(lanreotide),I see growth potential that we can unlock within our p
24、ipeline and on other brands,as well as additional external opportunities we can tap into with our existing firepower.Ipsen is well positioned to amplify its positive impact for all involved:patients,employees,society and shareholders.There is also a palpable sense of purpose among Ipsen employees.Th
25、ey want to make a difference for patients.These positive impressions were confirmed during my Listening Tour over my first 120 days here.Looking back at Ipsens 2020,what would you want most to highlight?I applaud everyone at Ipsen who kept us moving forward.Our manufacturing and production sites con
26、tinued operating throughout the year.We had no stockouts at any sitea major achievement.Our employees around the world went above and beyond and adapted to every change the pandemic brought.In 2020,we continued to build on our strength in oncology.We presented very promising results from the CheckMa
27、te-9ER clinical trial for Cabometyx(cabozantinib)in renal cell cancer(RCC),as well as 17 abstracts at the European Society for Medical Oncology(ESMO)Virtual Congress,a new record for Ipsen.Furthermore,Onivyde(irinotecan liposome injection)achieved Fast Track designation from the US Food&Drug Adminis
28、tration(FDA)for investigation in patients with small cell lung cancer(SCLC)as well as in first-line combination treatment for pancreatic ductal adenocarcinoma(PDAC).Across our other therapeutic areas,we presented seven abstracts at the American Society for Bone and Mineral Research(ASBMR)and 12 abst
29、racts at the World Congress for Neurorehabilitation(WCNR).We also announced promising results from our Phase III trial for our investigational treatment palovarotene in an ultra-rare orphan disease,fibrodysplasia ossificans progressiva(FOP),at the ASBMR Annual Meeting.As a new CEO,you conducted a st
30、rategic reviewwhat were your key learnings?We have identified solid foundations we can build on:we have a robust specialty care portfolio with leading market shares.Somatuline “Thanks to both external and internal innovation,we can expect to see advances in our treatments.We plan to grow 2-5%as a co
31、mpany in the next five years.”“I see growth potential that we can unlock within our pipeline and on other brands,as well as additional external opportunities we can tap into with our existing firepower.”Q&A WITH DAVID LOEW,CHIEF EXECUTIVE OFFICER8 I 9INTEGRATED ANNUAL REPORT 20203.Deliver efficienci
32、es to enable targeted investment and growth by implementing smart spending initiatives and manufacturing efficiencies so we can be even more impactful in developing transformative treatments for patients;4.Boost a culture of collaboration and excellence.What is your vision for Ipsen?Where would you
33、like to take the company?Our vision is to be a leading global mid-size biopharmaceutical company with a focus on transformative medicines in oncology,rare disease and neuroscience,especially in areas of high unmet medical need.More specifically,I see us as being able to grow in many ways,including i
34、n efficiency.Thanks to both external and internal innovation,we can expect to see advances in our treatments.We plan to grow 2-5%as a company in the next five years.We have exciting plans for double-digit growth with Cabometyx,Onivyde,Dysport,Decapeptyl and,upon approval,the launch of palovarotene.T
35、hese plans translate to Ipsen launching a new treatment or indication at a significant pace of one to two launches per year.We will also accelerate our internal pipeline,which currently includes six Phase III programs in the making.Externally,we want to license several compounds annually.Your overar
36、ching theme includes For patients&society.What societal responsibility does Ipsen bear as an organization?I am passionate about corporate sustainability and,within Ipsen,we have clear goals and KPIs to which our 5,700 employees are committed.Uniquely,we have included corporate social responsibility(
37、CSR)metrics in the compensation of our management and in our credit facility.Our concern for society means Based on these key learnings,you unveiled a new Group strategy.Could you talk about that?We will focus on three therapeutic areasoncology,rare disease and neuroscience.In oncology,we have a str
38、ong position and want to go further.The market continues to grow;it is characterized by strong scientific progress and there are many segments with high unmet medical needs to be addressed.We will maintain a focus on solid tumors while also expanding for the first time to hematological tumors given
39、the clear synergies.In rare disease,we already have a platform with a presence in acromegaly and we plan to expand our capabilities with the potential launch of palovarotene in FOP.We are planning on expanding our field beyond endocrinology and bone disease.In neuroscience,we have a leadership posit
40、ion with Dysport(abobotulinumtoxinA).However,we can further excel and accelerate,for example for the treatment of patients living with spasticity.Consumer HealthCare is considered as non-core and we are advancing in the strategic review of this business.Were calling this new strategy Focus.Together.
41、For patients&society.Were directing the full strength of our resources toward well-defined priorities for the next four years:1.Bring the full potential of our innovative medicines to patients by maximizing the value of our core products and capturing the full potential of our portfolio;2.Build a hi
42、gh-value sustainable pipeline by accelerating our external innovation strategy and strengthening our pipeline,supported by 3 billion in cumulative firepower by 2024;is a treatment of choice in neuroendocrine tumors(NETs)in almost all markets.The same applies for Decapeptyl(triptorelin embonate),wher
43、e for prostate cancer we have the number one position in many markets.We are seeing a growing contribution of our newer medicines,where we have achieved tyrosine kinase inhibitor(TKI)market leadership with Cabometyx in RCC in most European countries.With Onivyde,we have established a strong position
44、 in second-line PDAC,leveraging our oncology presence in the US.Another big strength is that we now have a truly global presence,with the US representing one third of sales,the five largest European countries representing another third and the remaining third coming from the rest of the world.This m
45、akes Ipsen an attractive partner for licensing compounds.Across the globe,we have highly engaged employees,who are passionate about what they do and who have stood up to the challenges of the COVID-19 pandemic.Lastly,we have strong in-house development capabilities that enable us to leverage new ass
46、ets and maximize our important life cycle management activities.However,we also have to acknowledge that there are areas where we need to make further progress and where we are facing some challenges.We are now facing competition in some key markets from direct generics for our key medicine,Somatuli
47、ne.We also need to optimize our cost structure by spending smarter,namely by focusing our resources on the highest-impact activities and by generating manufacturing efficiencies.We have a solid late-stage pipeline,but we have more work to do on external innovation to strengthen it across all stages
48、of development.In order to achieve that,we will have to improve both the quality and the quantity of our external innovation execution.“As a company,we achieved incredible successes in 2020.This was all while managing COVID-19,likely the most globally disruptive event of our lifetime.”not only worki
49、ng for the health of patients,but also for the well-being of our employees,communities and planet.Our CSR approach is based on three pillars employees,communities and the environment and is fully embedded in this strategy,contributing to the sustainability of our business model,which is built on a s
50、trong ethical culture.Our first area of focus is our employees.We want to be recognized as an employer of choice and to attract and retain great talents.We have given ourselves the very tangible objective of being recognized as an awarded employer in most of our locations.On top of this,we profoundl
51、y believe in the value of diversity as well as inclusion and want to foster the professional development of our employees.With regards to communities,we encourage all our employees to support healthcare and environmental organizations as part of their professional engagement.And,as a company,we are
52、committed to advancing access to treatments and care.Last but not least:the environment.We want to significantly reduce our environmental footprint across all our sites and activities.I am convinced that companies must shift their approach and make strong commitments to protecting the environment.AN
53、 INTERVIEW WITH DAVID LOEW,CHIEF EXECUTIVE OFFICERINTEGRATED ANNUAL REPORT 202010 I 11Ipsen will maximize the value of our core products,building on strong market positions for Somatuline,Decapeptyl and Dysport,while aiming to achieve double-digit growth for Cabometyx and Onivyde by launching new in
54、dications.The Group is looking forward to filing for marketing authorization approval for palovarotene,which will offer the first potential treatment for the prevention of new bone formation(heterotopic ossification)for fibrodysplasia ossificans progressiva(FOP),and is readying the organization for
55、a potential launch.Our objective is to take patient-centricity to the next level by truly impacting medical care and patient outcomes in our therapeutic areas,notably by building a deep understanding of the patient journey.Patient insights are essential to challenge the status quo,while collaboratio
56、n with healthcare systems can bring about advancements for patients around the world.We will expand our geographic presence and establish ourself in attractive markets,including Japan.Ipsen is also building on lessons from the COVID-19 pandemic by connecting to doctors virtually,offering tailored ho
57、mecare and delivering medicines directly to patients.This will further strengthen the companys position as a partner of choice.1 Bring the full potential of our innovative medicines to patients2 Build a high-value sustainable pipeline3 Deliver efficiencies to enable targeted investment and growth4 B
58、oost a culture of collaboration and excellenceA NEW STRATEGY FOR A NEW ERA OF IPSENThe most promising assets in our pipeline will be accelerated and prioritized:Cabometyx,Onivyde,palovarotene,IPN60130 and recombinant long-acting neurotoxins.Ipsen will execute an ambitious and focused external innova
59、tion and business development plan to add important new assets to our existing portfolio,with a cumulative firepower of 3 billion over the next four years.The scope of external innovation efforts will be expanded across all stages of development,including late and early stage deals.Priorities have b
60、een clearly defined for each therapeutic area:Oncology We will maintain a focus on solid tumors and will also expand to hematological tumors given the clear synergies.We will be targeting niche tumor types or biomarker segments of broader tumor types.In other words,we will typically be looking for b
61、iomarkers with no greater than 5%positivity,as these are indications that are of less focus for large multinationals.We will also favor medicines with life cycle management potential.Rare Disease We will expand focus in this therapeutic area,going beyond endocrinology and bone diseases.In terms of t
62、echnologies,our approach will evaluate both established and innovative technologies,including some gene-based modalities.Neuroscience We will focus on accelerating our in-house recombinant long-acting toxins,based on their potentially differentiated profiles and the significant growth we expect in t
63、he market.We will also focus on moving our preclinical targeted secretion inhibitor programs forward,while in terms of external innovation,we will target rare neurological disorders.Efficiencies are a key part of the Groups financial outlook for 2024 and will support growth with three objectives:inv
64、est in the growth of established products;support the launch of new medicines or new indications;and fuel external innovation.In order to achieve this,specific initiatives will be launched under the umbrella Efficiency for Growth,aimed at aligning with mid-sized Specialty Care peers and at decreasin
65、g our operating expenses.Efficiencies will be captured in multiple areas:Smart spending Simpler operations Manufacturing efficiencies Digital transformationAttracting,developing and retaining highly engaged talent is essential,by building on Ipsen employees strong engagement and supporting their pro
66、fessional development.Ipsen will nurture a culture of focus and high performance by increasing accountability for faster and better decision-making.In addition,we want to broaden and deepen our expertise as well as fully leverage the collective intelligence of the company.The Group will accelerate o
67、ur efforts to truly embrace diversity in all our facets and make Ipsen a more inclusive organization.Ipsens commitment extends to the well-being of all employees,patients,healthcare systems and communities.Under the overarching theme of Focus.Together.For patients&society,Ipsen will be focusing on f
68、our strategic priorities to accelerate our innovation and drive positive impact for patients,employees,shareholders and society a strategy for the short and long term.12 I 13INTEGRATED ANNUAL REPORT 202012 I 13 AND SOCIETYFOR PATIENTSIpsens priority is to improve the lives of patients,their caregive
69、rs,their communities and,ultimately,society.We leverage our existing assets and seek opportunities to go further and reach more patients,advocacy groups and healthcare providers.We consider the entire experience of illness and treatment,in order to pinpoint areas of unmet need.We know every patient
70、is unique and requires their own support system.We are honored to be a part of the journey for patients and caregivers.PATIENTSF O RPatients are the heart of everything we do.Our focus on the fields of oncology,rare disease and neuroscience enables us to develop an ever-greater understanding of pati
71、ents needs and experiences.In 2020,despite difficulties due to COVID-19-induced lockdowns,Ipsen increased efforts to support and maintain an open dialogue with patient organizations.L I V E R CA N CE R AWA R E N E S S M O N T H In October 2020,Ipsen,in collaboration with the European Liver Patients
72、Association(ELPA),launched an awareness campaign across our social media.The initiative drew attention to the importance of the liver and treatments for liver cancer.The campaigns central question was:“Is your liver working too hard?”We created animated representations of different organs in the bod
73、y,such as our main character,Liv the Liver.Over four episodes released each week in October,we emphasized the risk factors for liver cancer.We plan to build on this success in 2021 and continue drawing attention to liver health worldwide.Campaign highlights:26 social media posts across Facebook,Inst
74、agram,LinkedIn and Twitter 470,000 video views across social media channels Over 1.5 million social media impressions,more than any large-scale disease awareness campaign in Ipsens history14 I 15INTEGRATED ANNUAL REPORT 2020O N C O L O G YWE ARE BUILDING ON OUR POSITION in solid tumors to become eve
75、n stronger in our support for these patients.We will work to better treat niche tumors or biomarker segments of broader tumor types.ARTIFICIAL INTELLIGENCE PLAYS a part in our innovative research.In the US for example,we are applying machine learning to our NET clinical trial data,with which we can
76、build better predictive models and deliver better patient outcomes.OUR TEAM OF GLOBAL EXPERTS and researchers develop life-changing treatments for people living with rare disease.We have made great strides in the treatment of rare disease in endocrinology and ultra-rare bone disease.Now,we are looki
77、ng to address other rare diseases with high unmet needs.THE FONDATION IPSEN IS SHIFTING its primary focus towards rare disease detection.The Fondation,whose motto is“Rare But Not Alone,”raises awareness of rare disease among children and parents.In 2020,the Fondation reached 10.4 million people worl
78、dwide through publications,webinars and podcasts.WE WORK WITH PATIENTS to meet their treatment needs,alongside healthcare professionals and caregivers.Through our patient-centric approach,we identify and address high unmet medical needs.Our portfolio includes treatments for neuroendocrine tumors(NET
79、s)and cancers of the kidney,prostate,pancreas,liver and breast.YEARS OF ONCOLOGY RESEARCH,FOCUSING ON CANCERS WITH HIGH UNMET MEDICAL NEEDS 35BETWEENOF PATIENTS WITH A RARE DISEASE ARE CHILDRENRARE DISEASES AFFECT AN ESTIMATED 400 MILLION PEOPLE WORLDWIDE(1)75%5,000AND 8,000“I got out for walks and
80、bicycle rides and went on holidays with my wife to places I never thought Id be able to see.”R ON N Y living with a NET“Its extraordinary for a patient like me to be able to research their own illness.For me,its a real privilege to be mobile enough to do this.When Im in the lab,I manage to forget ab
81、out FOP.Im just focused on my research project and not on my individual case.”NADI NE living with fibrodysplasia ossificans progressiva(FOP)R A R E D I S E A S E16 I 17INTEGRATED ANNUAL REPORT 2020N E U R O S C I E N C ENEUROSCIENCE IS ADVANCING at an unprecedented rate and we at Ipsen are proud to
82、be at the forefront of this transformation.Our focus is on enabling children and adults suffering from debilitating and degenerative neurological disorders to take back control of their lives.NEUROSCIENCE IS CENTRAL to Ipsens internal innovation and external partnering,integral to the companys overa
83、ll strategy and a key driver of long-term value and growth.“Our family is special because we are able to adapt for Misha.We live differently,but its Misha who has given us the opportunity to live a happy life and the chance to understand what value we can have in life.”AN N Amother of Misha,living w
84、ith pediatric spasticitySOCIETYF O RIpsen has a responsibility to society and this was never more evident than in 2020.We responded to an unprecedented year by redoubling our efforts to support patients,communities and the planet.YEARS OF NEUROSCIENCE EXPERTISE AND INSIGHTS25WITH DYSPORT(ABOBOTULINU
85、MTOXINA),WE TREAT A WIDE RANGE OF THERAPEUTIC INDICATIONS INCLUDING SPASTICITY,CERVICAL DYSTONIA AND CEREBRAL PALSY18 I 19INTEGRATED ANNUAL REPORT 2020F O R E M P L O Y E E S“Achieving the position of an employer of choice is tough and maintaining it is equally hard work.But at Ipsen,we recognize th
86、at our employees are the cornerstone of our success.Only together can we achieve our ambition to improve patients health outcomes.”AT IPSEN,WE DO EVERYTHING in our power to ensure the health,safety and engagement of Ipsen employees.We:Encourage internal promotion and enable everyone at Ipsen to deve
87、lop their leadership skills through our Ipsen Leadership Pathway Promote diversity and inclusion through large-scale initiatives and workplace discussions,such as our World Caf online forum Support employees throughout the COVID-19 pandemic,nurturing their mental and physical well-being as they adap
88、t to new ways of workingR G I S MU LOT Executive Vice President&Chief HR Officer“We aim to be active members of our local communities,support the environment and help those in need.And given the challenging context of COVID-19,there is greater need than ever.”DAVI D LOE W CEO COUNTRIES WORLDWIDE WHE
89、RE IPSEN IS RECOGNIZED AS AN AWARDED EMPLOYEROF EMPLOYEES FORMALIZED A DEVELOPMENT PLAN WITH THEIR MANAGER IN 2020 1397%RAISED BY EMPLOYEES PARTICIPATING IN IPSEN IN MOTION PATIENT ADVOCACY GROUPS COLLABORATED WITH IPSEN IN 202050,000210F O R C O M M U N I T I E SWE CONSTANTLY SEEK NEW optimal ways
90、to help patients,their caregivers and healthcare providers.For the benefit of all,we strive to build a healthier world.Through a combination of Ipsen Community Day efforts and well-being programs like Ipsen in Motion,we encourage all employees to give back to the communities in which we live and wor
91、k.We empower all Ipsen employees to spend half a day volunteering as part of our Community Day initiative.In 2020,our Ipsen in Motion initiative raised 50,000 toward medical research and we intend to go even further in 2021.Because we outperformed our Environmental,Social and Governance(ESG)criteria
92、,Ipsen was also able to donate 70,000 to International Health Partners,bringing medicines and health supplies to some of the worlds most underserved communities.INTEGRATED ANNUAL REPORT 202020 I 21STRATEGYStrong companies are guided by clear strategies.Considering the needs of all of our stakeholder
93、s,and under the guidance of our Executive Leadership Team(ELT)and Board of Directors,we have solidified our purpose and strategic direction.With four strategic pillars guiding our actions,our employees and stakeholders benefit from our keen understanding of how we can leverage our assets and the val
94、ue we can create.F O R T H E E N V I R O N M E N TCLIMATE CHANGE IS THE CHALLENGE of our generation.Ipsen is committed to playing our part in creating a more sustainable future.Our environmental program will reduce our environmental footprint and help preserve our natural world.At the Dreux site,emp
95、loyees have identified and actively monitor populations of endangered fish species native to the area.The teams efforts ensure their safe navigation of the stream that passes through the site.We have far exceeded our targets for carbon emissions reductions and are in a strong position to meet our go
96、als.REDUCTION OF GREENHOUSE GAS EMISSIONS COMPARED TO 2019*DECREASE IN ENERGY USE SINCE 2016REDUCTION IN CARBON EMISSIONS IN 2020 ALONE,FAR SURPASSING OUR 3%TARGET*12%16%8%“For me,living in a healthy environment means living in a safe environment,in an environment where you can breathe and you can b
97、e treated with quality medicines that are delivered with care.”D O MIN IQ U E L AY M A N D Executive Vice President,Chief Ethics and Social Responsibility Officer*intensity achievements(tons of CO2 per square meter)w22 I 23Our assets and resources contribute to the sustainability of our business mod
98、el,which is based on a strong ethical culture.Our value-creation model demonstrates the positive outcomes of our vital work for patients,employees and society.Our mission:prolonging and improving patients lives and health outcomes.Our vision:to be a leading global mid-size biopharmaceutical company
99、with a focus on transformative medicines in oncology,rare disease and neuroscience.CREATING VALUE FOR PATIENTS,SOCIETY AND ALL STAKEHOLDERSOUR CAPITALSOUR CONTRIBUTIONSOUR VALUE CREATION FINANCIAL 2.6 billion net sales Net debt 0.6x EBITDA A publicly traded business under family control HUMAN 5,700
100、employees in more than 30 countries 13 countries where Ipsen is recognized as an Awarded Employer Medicalized accident frequency rate of 0.31 in 2020,down from 1.45 in 2018 RESEARCH&DEVELOPMENTIpsen develops innovative medicines to address high unmet medical needs and deliver outcomes that improve p
101、atients lives.We continuously invest both in our internal R&D platforms,as well as in external innovation to build a sustainable pipeline across all stages of development.DEMONSTRATING A STRONG FINANCIAL PERFORMANCECore operating margin of 32%of our net sales INVESTING IN BUILDING A SUSTAINABLE PIPE
102、LINE3 billion cumulative firepower for pipeline expansion by 2024 CARING FOR AND DEVELOPING EMPLOYEES42%gender balance in the Global Leadership Team PROVIDING INNOVATIVE SOLUTIONS TO PATIENTS16 R&D programs BRINGING SCIENCE TO PEOPLE100%of our scientific publications are made publicly available for
103、free PROTECTING THE ENVIRONMENT12%reduction of our greenhouse gas emissions compared to 2019(scope 1&2 without car fleet emissions)PRODUCTIONWe leverage our high-quality manufacturing network and end-to-end supply chain to deliver our medicines to patients in a safe and reliable manner.We aim to ens
104、ure product quality excellence,as well as compliance with regulatory and legal requirements and good manufacturing practices.COMMERCIALIZATIONWe own global commercial capabilities and work with healthcare providers to successfully bring our medicines to the right patients.We work with regulators and
105、 payers to secure broad access to our medicines across the world.MANUFACTURING Eight internal manufacturing sites 85 million units produced 67 million manufacturing investment External CMO partners NATURAL*2%reduction in energy consumption 34%reduction in water consumption 11%reduction in waste*comp
106、ared to 2019 SOCIAL AND RELATIONSHIP Collaborations with healthcare professionals and patient associations to improve impact for patients Partnerships with external organizations to accelerate innovation and expand access to medicines INTELLECTUAL 550+employees in R&D Four global R&D hubs in Cambrid
107、ge(US),Oxford(UK),Paris(France)&Shanghai(China)15%of sales invested in R&D24 I 25INTEGRATED ANNUAL REPORT 2020P A R T N E R I N G W I T H S TA K E H O L D E R S T O C R E AT E L O N G-T E R M V A L U ETo ensure the best possible patient outcomes,we work with all stakeholders to develop strategies,ma
108、ke decisions and achieve our ambitions.Ipsen operates in a rapidly evolving and challenging environment.We collaborate with all stakeholders across the value chain to look for long-term solutions,in order to keep on developing and delivering the innovation and treatments that patients and society ex
109、pect from us.Upholding a tradition of transparencyIn every stakeholder interaction,Ipsen complies with the highest ethics and compliance standards.On top of our own Ipsen Code of Conduct,we also follow the Codes of the International Federation of Pharmaceutical Manufacturers&Associations(IFPMA)and E
110、uropean Federation of Pharmaceutical Industries and Associations(EFPIA),as well as local Codes such as that of the UK Association of the British Pharmaceutical Industry(ABPI),a reference in the field.At Ipsen,we are convinced that all interactions must be transparent and conducted in a trustworthy m
111、anner with business integrity.We disclose information related to transfers of value to healthcare professionals and healthcare organizations,as well as information on clinical trials,scientific publications and interest representation activities.Putting our heads togetherIpsen has a long tradition o
112、f working with all stakeholders in the healthcare ecosystem,always for the benefit of patients.We maintain a constant and open dialogue with relevant stakeholders,such as academic institutions,patient advocacy groups,medical societies,health authorities,payers and regulators.In 2020,despite difficul
113、ties due to COVID-19-induced lockdowns,Ipsen increased efforts to support and maintain an open dialogue with the 210 patient organizations with which we worked.We are also committed to working with industry organizations.Ipsen is a Board member of IFPMA,EFPIA,G5 Sant,Pharmaceutical Research and Manu
114、facturers of America and the Biological Innovation Organization.We are actively involved in global,regional,national and local trade associations to co-create better patient access and more efficient healthcare systems.With regulators and payers,we work to secure broad availability of our medicines
115、across the world.We carefully follow and monitor local regulations regarding the promotion,packaging and sales of products to maintain access for all patients.By working more closely with regulatory authorities,we were able to increase the number of file submissions in 2020 to bring more innovations
116、 to patients.We are also doing our part to make the world a more just and equitable place.Ipsen partners with Access Accelerated,a not-for-profit that works in communities that lack sufficient access to healthcare to address non-communicable diseases.94%COMPLETION RATE OF EMPLOYEE TRAINING ON THE CO
117、DE OF CONDUCT(1)37MATTERS REPORTED TO BUSINESS ETHICS IN 2020,DEMONSTRATING A SPEAK UP CULTUREINSTITUTIONAL STAKEHOLDERSPARTNER STAKEHOLDERSPUBLIC STAKEHOLDERSR&D partnersCommercial partnersEmployeesSuppliersRegulatory authoritiesPolicy makersHealthcare professionals Healthcare organizationsCivil so
118、cietyCommunitiesPatient advocacy groupsInvestors and analystsMediaPATIENTSPATIENT-CENTRICITY:THE KEY TO CREATING VALUE(1)Our Code of conduct is available for download on our website26 I 27INTEGRATED ANNUAL REPORT 2020C S R A T T H E H E A R T O F O U R S T R A T E G Y“Our Company Social Responsibili
119、ty approachbased on the three pillars,employees,communities and the environmentis fully embedded in our strategy,contributing to the sustainability of our business model and based on a strong ethical culture.By working with all stakeholders I am convinced we can move mountains to have a positive imp
120、act for patients and society.At Ipsen,we are all inspired to achieve this together.”David Loew,CEO of Ipsen2M DONATION TO INSTITUT PASTEUR TO FUND VITAL COVID-19 RESEARCH 1 IN 4EMPLOYEESTOOK PART IN IPSEN COMMUNITY DAY 20208%REDUCTIONIN CARBON EMISSIONS IN 2020 ALONE,FAR EXCEEDING OUR 3%REDUCTION TA
121、RGET Pillar 1:Employees The health and safety of our employees is of the utmost importance.Thanks to continuous efforts,our medicalized accident rate decreased to 0.31 in 2020,down from 1.45 in 2018.Despite the challenges posed by the potential spread of COVID-19 in the workplace,employees adapted q
122、uickly and efficiently to new ways of working in factories,offices and the field.Thanks to our manufacturing teams tireless efforts,we had no stockouts last year.Ipsen was able to mitigate the impacts of the pandemic and to maintain all wages without the need for government support.Pillar 2:Communit
123、iesWe empower our workforce to give back to society through initiatives like Ipsen Community Day.The 2020 Community Day initiative encouraged Ipsen employees to spend half a day volunteering for a worthy cause.One in four employees took part.Thanks to their efforts,we gave back to medical charities,
124、the environment and our local communities.In 2020,Ipsen renewed its commitment to introduce Environmental,Social and Governance(ESG)criteria into the conditions of our external financing facility.A donation of 70,000 was made to International Health Partners,chosen for its outstanding work bringing
125、medicines and health supplies to some of the worlds poorest and most underserved places.Pillar 3:The environmentAt Ipsen,we are conscious that focusing on people and communities also means taking care of the planet.For example,we have embedded caring for the environment in our Ipsen Code of Conduct:
126、“Protect the environment throughout the entire product life cycle.”We are also part of the French Business Climate Pledge along with 99 other major companies.We upheld this agreement in 2020 by reducing our impact on the environment.Between 2016 and 2020,our greenhouse gas emissions fell by 32%,whil
127、e our energy use decreased by 16%.Our water consumption also dropped by 38%.We plan a further 40%reduction on our 2019 carbon emissions by 2025.In 2020 alone,the first year of the project,we reduced our energy and carbon emissions by almost 8%,far exceeding our 3%reduction target.In 2020,a Global Bi
128、odiversity Policy was created for the sustainable management of Ipsen sites.Many sites have proactively begun local initiatives such as habitat creation/enhancement,bird feeding stations,tree planting and the installation of beehives.Our requirement to protect the environment throughout the entire p
129、roduct life cycle also drives us to ensure our raw materials are responsibly sourced.Our Procurement team has partnered with EcoVadis to evaluate the sustainability of our most critical suppliers.CATEGORYCONTRIBUTION TO THE SDGSISSUE DESCRIPTION AND LINKS TO IPSENS ACTIVITIESImproving peoples lives
130、by offering innovative and safe medicines Product qualityProtecting patients against the risks inherent to the biological action of medicines and ensuring that the benefit/risk for all products is positive.Product safetyNon-compliance with security requirements that could jeopardize patients health.
131、Counterfeit productsCounterfeit products of low quality and not complying with Ipsens health standards,which may endanger patients health and generate a loss in sales revenues.Responsible product promotionImproper marketing claims resulting in legal proceedings and mistrust of patients and healthcar
132、e professionals,which could damage Ipsen.Access to medicineThe implementation of initiatives and actions to improve healthcare in countries where access to medicines is difficult and diseases are difficult to treat.Enhancing integrity to maintain a trusted relationship with our stakeholders Data pri
133、vacyInability to ensure the integrity and confidentiality of data,resulting in the disclosure or theft of patients information and the breach of data privacy.AnticorruptionCorruption and conflict-of-interest situations,which could lead to major fines and penalties and damage to Ipsens image.Human ri
134、ghtsRespect of human rights in Ipsens operations and supply chain.Driving our employees excellence and engagement Health and safetyWeak health-and-safety policies,failure to respect health-and-safety policies in the operations and the supply chain,which could result in incidents impacting employees
135、health.Talent attractionLoss and/or lack of key skills leading to delays in key programs and the launch of research projects,which could jeopardize Ipsens ability to improve patients health.Employee engagementNegative impacts on employee motivation or on the quality of labor relations that could jeo
136、pardize the achievement of some objectives and lead to a corresponding impact on the Groups results or financial position.Minimizing ourenvironmental impact Climate and energyDecrease in energy consumption in order to improve the efficiencyof Ipsens operations and reduce greenhouse gas emissions;ada
137、ptation to climate change.Management of water,waste and air emissionsWater,waste and air pollution due to Ipsens activity,which could causesignificant damage to sensitive areas or ecosystems and to health.The following SDGs have been selected for improvement:O U R M A T E R I A L I T Y M A T R I X A
138、 S S E S S M E N TIntegrating UN Sustainable Development Goals,our materiality analysis identifies 13 main CSR risks,classified into four categories.Source:Association LIRE,TogoSource:Association LIRE,TogoINTEGRATED ANNUAL REPORT 202028 I 29R A R E B U T N O T A L O N EWith its new strategic focus,F
139、ondation Ipsen aims to shed light on living with a rare disease.For decades,Fondation Ipsen has worked to improve lives by providing scientific information to the public and connecting the scientific community.It was established in 1983,under the aegis of the Fondation de France.Since then,it has co
140、ntributed to major advances in biological and medical research by organizing numerous scientific conferences.The Fondation also encouraged creativity in the scientific community by awarding prizes to innovative researchers,with a particular focus on neuroscience,endocrinology,longevity and oncology.
141、An epicenter of science communicationThe Fondation has always strived to serve the general public,rallied around the guiding principle“Science for All.”In 2020,the Fondation reached 10.4 million people worldwide,using traditional and modern channels to inform the public.Publications:the Fondations B
142、ookLab circulated 150,000 books and magazines in 50 countries and in four languages,including the Little Issue,a scientific magazine for children in underserved communities.Podcasts:in 2020,Fondation Ipsens podcast channels attracted over 36,500 listeners from around the world.Webinars:the Fondation
143、 organized three webinars on COVID-19 in partnership with Science,the worlds largest scientific journal,each attended by 40-60,000 people.Trainings:More than 44,700 learners (students and healthcare professionals)in over 100 countries received Institut Pasteur/Fondation Ipsen training in internation
144、al public health,notably including training in reemerging viruses.Joining forces for the most underserved patientsBuilding on its legacy of engaging the public and the scientific community,Fondation Ipsens new“Rare But Not Alone”strategic focus is a reorientation of its efforts toward rare disease a
145、wareness and early detection.All people with rare disease deserve respect,dignity and an accurate and timely diagnosis.Fondation Ipsen is rolling up its sleeves to help make this a reality.There is much work to be done:between 5,000 and 8,000 rare diseases affect an estimated 400 million people worl
146、dwide,and 75%of patients with a rare disease are children.Fondation Ipsen is uniquely equipped to raise awareness and address these problems.To advance“Rare But Not Alone,”Fondation Ipsen plans to:1.Amplify the voices of patients with rare diseases and those of their caregivers2.Develop new rare dis
147、ease communication strategies for children3.Engage leading science journals and journalists to report on rare disease detection4.Reach underserved communities to promote awareness of rare diseases5.Develop international open-access communications and training in rare disease detection6.Fight discrim
148、ination and stigma faced by patients living with rare disease and handicapsThis new focus is ambitious,but it must be realized in order to end the unnecessary suffering caused by delayed detection and diagnosis for patients around the world.75%OF PATIENTS WITH A RARE DISEASE ARE CHILDREN 1 IN 4 PATI
149、ENTS WAIT FOUR YEARS FOR AN ACCURATE DIAGNOSIS OF A RARE DISEASE50%OF PATIENTS DO NOT HAVE AN ACCURATE DIAGNOSISIMP LE ME NTING CH A NGEBeginning in 2021,Fondation Ipsen will implement many new programs that facilitate its new direction in rare disease detection in underrepresented communities.These
150、 include:International webinars with Science magazineFor the first time in its history,Science will feature a nine-part documentary series on the detection of rare disease.Broadcast worldwide,these nine international webinars will reach the global scientific community.Engaging journalists in rare di
151、sease reporting Fondation Ipsen will leverage its longtime engagement with the media to further the cause of early detection.It will connect leading science journalists to patients,caregivers and advocacy groups to help build awareness around rare disease and delayed diagnosis.Educating healthcare p
152、rofessionalsAdvancing work already begun in this area,Fondation Ipsen will partner with leading universities to help educate thousands of healthcare professionals worldwide about rare disease detection.Rare disease advocacyThe Fondation will leverage its world-renowned publishing house to highlight
153、the plight of patients with rare disease,especially children.Working with organizations such as the Mayo Clinic,the National Institute for Health and the International Paralympic Committee,Fondation Ipsen will distribute books for children and adults internationally.Advocacy for patients will be adv
154、anced through targeted events such as the Paralympic Games in Tokyo and Paris.30 I 31INTEGRATED ANNUAL REPORT 2020E M P L O Y E E S:E M B O D Y I N G O U R C O M P A N Y V A L U E SOur employees are fundamental to the value we provide for patients,society and the environment.Throughout a particularl
155、y challenging 2020,we continued to focus on the primary goals of keeping our people safe,enabling them to grow and improving the employee experience.2020 required changes in every aspect of our operations.At the outbreak of the pandemic,a crisis team was rapidly set up to ensure communication with a
156、ll Ipsen sites,and a series of safety measures were implemented:regular health checks at our factories and remote working for our corporate teams,as well as virtual summits and conferences.Through all of the turbulent ups and downs,our committed,passionate employees adapted to new ways of working wh
157、ile continuing to put patients first.Providing a positive environment Striving to be known as a workplace of choice,our sites achieved various certifications in 2020:Currently certified as Best Places to Work in Algeria and Tunisia Top Employer Certification in Russia Great Place to Work certificati
158、ons in Australia,China,Greece,Italy,Mexico,Sweden and the UK These are in addition to employer awards that Ipsen previously received in France(Shingo Prize),the Netherlands(Great Place to Work)and Brazil(Great Place to Work).Building on all our ongoing efforts,we believe we can obtain employer-of-ch
159、oice certifications by 2024 in over 75%of the countries in which we do business.One way we aim to make this a reality is by encouraging a Speak Up culture.Any suspected violation of Ipsens Code of Conduct(1)can be reported via a safe,confidential forum within which employees can raise any concerns.W
160、e care for our employees as much as we care for patients,and we believe employees should be treated fairly,wherever they are located.Thats why we have been implementing a global benefits standard applicable in every country where we have employees.This includes access to health insurance,maternity a
161、nd paternity leave,life insurance and retirement.Our greatest assetDespite 75%of our employees working from home in 2020,we continued to foster collaboration through virtual events.We believe in continuous learning and development,so we actively advise,coach and empower our employees to develop them
162、selves by making every day a learning experience.Our goal is to ensure that 100%of Ipsen employees have a personalized development plan.Our focus now is on building a resilient hybrid work model.By listening to our employees and working with them,we will continue to evolve our offices and factories,
163、prioritizing health and safety.We can use this past years experience to build the best possible workplace for our employees.It is now clearer than ever before that the well-being of patients depends on the well-being of our employees.The evolved Ipsen Way of BeingTo help us implement our new Group s
164、trategy,adapt to our employees needs and build on our past success,the updated Ipsen Way of Being is organized into five pillars.Each one is crucial to cultivating a culture of collaboration and excellence among our teams.These interconnected values and behaviors reinforce one another,while also adv
165、ancing the new Ipsen strategy.We lead with purposeOur inclusive and diverse teams openly engage with our communities.Our decisions are ethical and our actions compliant.We are dedicated to caring for Ipsen employees and the environment.We learn and share every dayDriven by data,science and deep insi
166、ghts into the healthcare system,we leverage our collective intelligence to test,experiment and pilot initiatives.We are externally-focused so we can fully understand and interact with each stakeholder in the healthcare ecosystem.We drive for successDetermined to be the partner of choice for all of o
167、ur stakeholders,we are agile,decisive and committed to proactive collaboration.We innovate to address patients most difficult challenges and channel our optimism into an entrepreneurial spirit.We trust each otherTogether we build trust through respect,listening,an openness to feedback and taking res
168、ponsibility for our words and actions.As active communicators,we are ready to speak up to advance progress.We own the outcomeWe consistently promote single-point accountability.We understand the importance of celebrating success and are committed to unleashing our full potential and excellence in ex
169、ecution.5,700EMPLOYEESIN OVER 30 COUNTRIES 13COUNTRIESWHERE IPSEN IS RECOGNIZED AS AN AWARDED EMPLOYERFOCUS.TOGETHER.FOR PATIENTS&SOCIETY.each otherWe Trustthe outcomeWe Own with purposeWe Lead&Shareevery dayWe Learnfor successWe DriveIpsenWay of Being(1)Our Code of conduct is available for download
170、 on our website(1)For more information on the independent activities of each committee,see:https:/ member.(3)Company governed by Luxembourg law,represented by Philippe Bonhomme.(4)Director representing the employees.(5)Company governed by Luxembourg law,represented by Anne Beaufour.(6)Director coopt
171、ed on May 28,2020.SIX SPECIALIZED COMMITTEESNOMINATIONS COMMITTEE(1)Chairperson:Carol Xueref Members:Paul Sekhri(2)Beech Tree SA(3)ETHICS AND GOVERNANCE COMMITTEEChairperson:Margaret Liu(2)Members:Carol Xueref Jean-Marc Parant(4)Beech Tree SA(3)COMPENSATION COMMITTEEChairman:Antoine FlochelMembers:C
172、arol Stuckley(2)Piet Wigerinck(2)Carol XuerefAUDIT COMMITTEEChairperson:Carol Stuckley(2)Members:Beech Tree SA(3)Paul Sekhri(2)THE BOARD OF DIRECTORSCHAIRMAN:Marc de Garidel VICE-CHAIRMAN:Antoine FlochelMEMBERS:Highrock SARL (represented by Anne Beaufour)Henri Beaufour Beech Tree SA (represented by
173、Philippe Bonhomme)Laetitia Ducroquet Margaret Liu David Loew Michle Ollier Jean-Marc Parant Paul Sekhri Carol Stuckley Piet Wigerinck Carol XuerefGENERAL SECRETARY:Olivier JochemINNOVATION AND DEVELOPMENT COMMITTEE-SPECIALTY CAREChairman:Marc de GaridelMembers:Antoine Flochel Margaret Liu(2,)Michle
174、Ollier Paul Sekhri(2)Piet Wigerinck(2)Permanent guests:Highrock SARL(5)Henri BeaufourDavid Loew(6)INNOVATION AND DEVELOPMENT COMMITTEE-CONSUMER HEALTHCAREChairman:Marc de GaridelMembers:Beech Tree S.A.(3)Carol Xueref Permanent guests:Highrock SARL(5)Henri BeaufourDavid Loew(6)David Loew Chief Execut
175、ive OfficerBartosz(Bartek)Bednarz Executive Vice President,Head of Global Product&Portfolio Strategy Dominique Bery Executive Vice President,Strategy&TransformationHoward Mayer,M.D.Executive Vice President,Head of R&D Franois Garnier Executive Vice President,General Counsel Rgis Mulot Executive Vice
176、 President,Chief HR OfficerPatrice Zagame Executive Vice President,Specialty Care InternationalTo be appointed Chief Executive Officer,Ipsen North AmericaBenoit Hennion Executive Vice President,CHCAidan Murphy Executive Vice President,Technical Operations Steven Hildemann,M.D.,Ph.D.Executive Vice Pr
177、esident,Chief Medical Officer Gwenan White Executive Vice President,Communications and Public AffairsDominique Laymand Executive Vice President,Ethics&Social Responsibility Officer Aymeric Le Chatelier Executive Vice President,Chief Financial OfficerPhilippe Lopes-Fernandes Executive Vice President,
178、Chief Business Officer 15+EXECUTIVE LEADERSHIP TEAM MEETINGS IN 2020 10+BOARD MEETINGS IN 2020 RESPONSIBILITY STARTS AT THE TOPThe ELT is wholly committed to supporting and strengthening CSR initiatives company-wide and considers itself in the service of all stakeholdersincluding employees,sharehold
179、ers and wider society.For these reasons,the ELT monitors Ipsens Long-Term Incentive(LTI)Plan.In incorporating CSR initiatives into the ELTs LTIs,we have three main goals.First,we seek to bring gender balance to the Global Leadership Team(GLT).In 2020,we surpassed our target and reached 42%of women w
180、ithin the GLT.Next,we aim to increase the number of employees participating in Ipsen Community Day.We reached this goal in 2020,with 26%participation.Finally,we made good progress in decreasing our greenhouse gas emissions,from 0.127 to 0.112 tCO2e/m2,exceeding our expectations.32 I 33INTEGRATED ANN
181、UAL REPORT 2020T H E B O A R D O F D I R E C T O R ST H E E X E C U T I V E L E A D E R S H I P T E A MThe Board of Directors determines Ipsens business strategy and oversees its implementation.The Board provides accurate information about Ipsens operations to company shareholders and the general pu
182、blic.It ensures the company has reliable procedures for identifying,measuring and monitoring its commitments and risks,as well as adequate financial and operational internal controls.The Executive Leadership Team(ELT)establishes consistent management policies and manages the companys day-to-day oper
183、ations.The ELT also assists the Chairman of the Board of Directors in implementing the Boards decisions.The ELT is composed of the Chief Executive Officer and 13 Executive members.The current composition of the ELT as of 27 May 2021 is as follows:I D E N T I F Y I N G A N D M I T I G A T I N G R I S
184、 K A C R O S S T H E B O A R DEvery year,Ipsens Risk Management team undertakes a global risk assessment pilot to identify potential major risks and to ensure that appropriate mitigation is implemented,in line with Ipsens risk appetite.The Risk Committee meets at least once a quarter to facilitate t
185、he implementation of our risk management strategy.The following are some of the primary risks of which Ipsen is aware and which we consider material,and how we are turning them into opportunities.Business risksThe business risks facing Ipsen range from cyberattacks and third-party failures to proble
186、ms with acquisition and integration activities.Market competition and dependence on products is one of our principal risks.We operate in rapidly evolving and highly competitive markets,and our main threats are major international pharmaceutical groups with greater experience and capital resources.We
187、 are also facing competition from generic drugs.Our Somatuline Autogel(lanreotide)formulation patent in the United States is no longer protected,and Somatuline will only be protected for the neuroendocrine tumor(NET)indication based on orphan drug status until December 2021.To counteract this,we are
188、 seeking new growth markets,as well as external innovation partnerships.Failure in research and development is another risk that we are working hard to minimize.In 2020,Ipsen spent 405.6 million on R&D,but we could be unable to recover these investments if clinical trials are not as successful as an
189、ticipated or medicines do not receive regulatory approval.We are looking to license several new compounds every year,which will help us create a sustainable future.Industrial and environmental risksIndustrial risks are those related to the supply chain,including potential shortages and disruptions,w
190、hile environmental risks generally fall under the umbrella of company social responsibility.Environmental and safety risks could be exacerbated if environment,health and safety laws are further reinforced.This could create significant liabilities and costs for Ipsen and make our handling,production,
191、use,reuse,or processing of substances or pollutants subject to more stringent inspections.To limit this risk,we are developing new sustainability measures.We also maintain insurance coverage relative to our activities,including industrial and R&D site insurance,disruption cover and environmental lia
192、bility insurance.Our LIsle-sur-la-Sorgue site is designing a reverse osmosis system that aims to decrease water usage by at least 50%when it goes online in 2025.Financial risksFinancial risks include those related to interest and exchange rates,share price fluctuation and liquidity and counter parti
193、es.Exchange rate risks are a particular issue due to our international presence and could impact results.To mitigate the effect of currency rate changes,we hedge the budgeted amount of foreign currency cash flow through currency derivatives.Our Market Committee meets regularly to review and approve
194、forex policy,provide guidelines and validate the hedging strategy.Regulatory and legal risksRegulatory and legal risks encompass,among others,the risk of counterfeiting,product liability and legal and administrative proceedings.Risks related to intellectual property can arise when the expiration of
195、a patent leads to the emergence of a generic drug and substantial competition.In such a case,Ipsen cannot be certain that we will be able to develop other patentable inventions or that patents for which we have applied will be granted.The undesired disclosure of critical information,like private dat
196、a or strategic information,is of special concern in our digital age.Strict procedures are in place to mitigate that risk.We are working hard to raise awareness among all employees of the importance of data protection in every situation thanks to tailored and regularly updated trainings.FOR A COMPLET
197、E LIST OF IDENTIFIED RISKS,PLEASE SEE CHAPTER 2 OF OUR 2020 UNIVERSAL REGISTRATION DOCUMENT.INTEGRATED ANNUAL REPORT 202034 I 352 JULY 2020Ipsen joins a clinical collaboration with Exelixis and Roche to fund the recently initiated CONTACT-01 and CONTACT-02 global Phase III pivotal trials to evaluate
198、 Cabometyx(cabozantinib)in combination with atezolizumab in metastatic non-small cell lung cancer and metastatic castration-resistant prostate cancer.14 JANUARY 2020Ipsen appoints Steven Hildemann,MD,PhD as Executive Vice President,Chief Medical Officer and Head of Global Medical Affairs and Pharmac
199、ovigilance,effective 1 March 2020.11 MARCH 2020 Ipsen presents data at the ENETS Annual Conference 2020 which highlights new insights into the treatment of neuroendocrine tumors(NETs)and acromegaly.The presentation includes quantitative findings from patients and healthcare professionals.4 MAY 2020I
200、psen enters an option agreement with Canadian research commercialization center IRICoR and the Universit de Montral for the worldwide rights to a high-value oncology program.8 JUNE 2020We publish eight abstracts in the Journal of the Endocrine Society,including data from a first-of-its-kind study in
201、to the one-year natural progression of fibrodysplasia ossificansprogressiva(FOP)and the impact of heterotopic ossification(HO)on patients physical mobility over time.17 JUNE 2020 Ipsen receives FDA Fast Track designation for Onivyde(liposomal irinotecan)as a first-line combination treatment for meta
202、static pancreatic cancer.Fast Track facilitates medicine development and gets these life-saving drugs to patients faster.25 AUGUST 2020Ipsens research scientists present the first-ever Phase III trial results for an investigational medicine for the prevention of HO for FOP at the American Society fo
203、r Bone and Mineral Research(ASBMR)Annual Meeting.28 MAY 2020Ipsen appoints David Loew as Chief Executive Officer,effective 1 July 2020.22 OCTOBER 2020 Ipsen delivers sales growth in the first nine months of 2020 despite the impact of COVID-19.2 SEPTEMBER 2020Ipsen appoints Bartek Bednarz,Executive V
204、ice President,Global Product&Portfolio Strategy,and Patrice Zagame,Executive Vice President,Specialty Care International,to the Executive Leadership Team.25 SEPTEMBER 2020Ipsen appoints Philippe Lopes-Fernandes as Executive Vice President,Chief Business Officer,effective 1 October 2020.14 SEPTEMBER
205、2020Ipsen showcases our commitment to patient-centric advances in oncology with a company-record 17 abstracts presented at the European Society for Medical Oncology(ESMO)2020 Virtual Congress,covering a wide-range of cancer types and therapies.7-11 OCTOBER,2020 Ipsens research scientists present 12
206、abstracts at the 11th World Congress for NeuroRehabilitation(WCNR),taking place jointly with the 25th Congress of the French Society of Physical and Rehabilitation Medicine(SOFMER).30 NOVEMBER 2020Ipsen receives FDA Fast Track designation for Onivyde as a second-line monotherapy treatment for small
207、cell lung cancer(SCLC),allowing us to address another unmet medical need.1 DECEMBER 2020Ipsen unveils its new Group strategy:Focus.Together.For patients&society,with a focus on oncology,rare disease and neuroscience.We also reaffirm our commitment to R&D and our sustainable pipeline.1 APRIL 2020 Ips
208、en donates 2 million to the Institut Pasteur to support their COVID-19 research efforts.MARCH 2020 The Shingo Institute awards a gold medal prize for manufacturing excellence to Ipsens manufacturing site in Signes.INTEGRATED ANNUAL REPORT 202036 I 372 0 2 0 H I G H L I G H T S Thanks to the tireless
209、 efforts of our workforce,we have made great strides in oncology,rare disease and neuroscience research,all while joining the global fight against the COVID-19 pandemic.19 SEPTEMBER 2020At the ESMO Virtual Congress,Ipsen announces the first presentation of results from the pivotal Phase III CheckMat
210、e-9ER clinical trial,in which Cabometyx(cabozantinib)in combination with nivolumab demonstrated significant improvements across all efficacy endpoints,including overall survival,in previously untreated advanced renal cell carcinoma(RCC).1(1)Phase II ready;(2)Submission expected in 2021.Ax:Aesthetics
211、,Tx:Therapeutics,FOP:Fibrodysplasia ossificans progressiva,HCC:Hepatocellular carcinoma,NSCLC:Non-small cell lung cancer,mCRPC:Metastatic castrate-resistant prostate cancer,SCLC:Small cell lung cancer,PDAC:Pancreatic ductal adenocarcinoma,NDO:Neurogenic detrusor overactivity,1L:First line,2L:Second
212、line.Oncology Rare Disease NeuroscienceCabometyx+atezolizumab 1L HCCCabometyx+atezolizumab 2L NSCLCOnivyde 2L SCLCCabometyx+atezolizumab 2L mCRPCOnivyde 1L PDACIPN60120(Palovarotene)FOP38 I 39INTEGRATED ANNUAL REPORT 2020B U I L D I N G A S U S T A I N A B L E R&D P I P E L I N E Throughout 2020,Ips
213、en continued to develop new treatments and technologies.Ipsen is determined to support patients and healthcare communities,now and in the future,and we are building a stronger,future-proof R&D pipeline.Our research decisions are always guided by patient outcomes.Neuroscience:thinking aheadIpsen is t
214、he worlds only company to have recombinant neurotoxins in development and our world-class R&D centers are pushing technological boundaries to develop the next generation of recombinant toxins.These include long-acting neurotoxins IPN10200 and IPN59011,expected to address a broad range of conditions.
215、Investing in the pipelineWith over 3 billion to add new assets to build this future-proof pipeline,we aim to develop a diversified portfolio and find other reliable and sustainable partners.We will continue to develop innovative treatments for unmet medical needs,while working with governments and o
216、rganizations around the world to gain wide availability for our products.PHASE ICabometyx+atezolizumab solid tumorsIPN59011Longer-acting neurotoxinAxIPN10200Longer-acting neurotoxinAxPIPELINE AS OF 22 APRIL 2021PHASE II2IPN60130(BLU-782)FOP(1)PHASE III3REGISTRATION4Dysport solutionGlabellar linesDys
217、portNDO(2)At Ipsen,our research decisions are always guided by patient outcomes.Emphasizing a culture of open innovation,we focus our R&D efforts on accelerating prioritized internal projects while actively sourcing external assets.Our new strategy reinforces our focus on R&D in our three main areas
218、:oncology,rare disease and neuroscience.As we target differentiated medicines in these core areas,we will add ground-breaking new treatments to our portfolio.We will also maximize the value of our current pipeline assets.30 years at the cutting edge of oncologyCabometyx(cabozantinib)is the first and
219、 only multi-targeted tyrosine kinase inhibitor(TKI)therapy to prolong survival,slow disease progression and shrink tumors in first-line and second-line renal cell carcinoma(RCC)in monotherapy and in first-line RCC in association with nivolumab.The European Medicines Agency(EMA)recently approved the
220、combination of Cabometyx and nivolumab for the first-line treatment of patients living with advanced RCC,a decision which recognizes the significance of the CheckMate-9ER clinical trial data and the value this combination can bring to patients.Onivyde(irinotecan liposome injection)received Fast Trac
221、k designation from the US Food and Drug Administration(FDA)as a second-line monotherapy treatment for small cell lung cancer(SCLC).In 2020,Onivyde also received Fast Track designation in combination with 5-fluorouracil/leucovorin(5-FU/LV)and oxaliplatin(OX)for patients with previously untreated,unre
222、sectable,locally advanced and metastatic pancreatic ductal adenocarcinoma(PDAC).Tackling rare diseaseDiscussions with regulators,including the FDA and the EMA,are ongoing and our teams are progressing with our filing submissions of palovarotene for the prevention of new bone formation(heterotopic os
223、sification)in fibrodysplasia ossificans progressiva(FOP).4GLOBAL R&D HUBS IN PARIS-SACLAY,FRANCE;OXFORD,UK;CAMBRIDGE,US;AND SHANGHAI,CHINA405.6MINVESTED IN R&D IN 2020550EMPLOYEES DEDICATED TO R&DOUR R&D POWER BASESOur main R&D centers are located in world-class scientific hubs(Paris-Saclay,France;O
224、xford,UK;Cambridge,US;Shanghai,China)to facilitate external innovation in line with our new strategy.These sites form an“innovation grid,”sharing knowledge and ideas in real-time and leveraging the collective intelligence of the entire healthcare ecosystem.INTEGRATED ANNUAL REPORT 202040 I 41Our dec
225、ades of work in oncology have generated differentiated treatments in indications with high unmet medical needs,such as neuroendocrine tumors,renal cell carcinoma,pancreatic cancer,prostate cancer,hepatocellular carcinoma and breast cancer.Blazing new trailsWe strive to develop treatments that bring
226、value to patients,helping improve and extend their lives.We plan to enter areas in which we can compete effectively by targeting niche tumor types or biomarker segments of broader tumor types.Our goal is to access the most promising external innovation to fuel our R&D pipeline.Better together:partne
227、ring for external innovationIpsen develops successful partnerships with public institutions as well as pharmaceutical and biotechnology companies.Here are some examples of our current partners in oncology:Debiopharm(Lausanne,Switzerland)Licensing agreement to manufacture and market Decapeptyl(tripto
228、relin)globally(not including the US,Japan,and certain Latin American and Asian countries)for locally advanced or metastatic prostate cancer and endocrine-responsive early-stage breast cancer.Exelixis(San Francisco,California,US)Exclusive licensing agreement to commercialize and develop cabozantinib,
229、Exelixis lead oncology drug,in regions outside the US and Japan.Servier(Suresnes,France)Exclusive licensing agreement for the commercialization by Servier of Onivyde outside of the US and Taiwan.PharmaEngine(Taipei,Taiwan).Commercial rights to Onivyde in Taiwan.Among the top pharmaceutical companies
230、 in the world specializing in oncology,we address challenges posed by the most difficult-to-treat cancers.THE IPSEN ONCOLOGY PORTFOLIO:TACKLING SOME OF THE MOST DIFFICULT-TO-TREAT CANCERS 4 BREAST CANCER The second most common cancer in the world and the most frequent in women.65%to 75%of all breast
231、 cancers are hormone receptor positive.(4a)DECAPEPTYL(triptorelin pamoate)86.6%disease-free survival at 5 years when added to adjuvant tamoxifen.(4b)22%risk reduction in distant recurrence when added to adjuvant exemestane.(4c)1 MEDULLARY THYROID CANCER 5%of thyroid cancers.(1a)COMETRIQ(cabozantinib
232、)Significant and clinically meaningful difference in progression-free survival with cabozantinib(11.2 months)versus placebo(4 months).(1b)3 CARCINOID SYNDROME Occurs in about 20%of all patients living with NETs.(3a)XERMELO(telotristat ethyl)Reduction in bowel movements in heavily pre-treated patient
233、s.30%improvement for more than 50%of the study period in durable responders.(3b)5 RENAL CELL CARCINOMA(RCC)More than 250,000 new cases per year worldwide.(5a)CABOMETYX(cabozantinib)First and only multi-targeted tyrosine kinase inhibitor therapy to prolong survival,slow disease progression and shrink
234、 tumors in first-line and second-line RCC in monotherapy and in first-line combination with nivolumab;Ipsen is funding several trials to explore the combination of cabozantinib with other agents in solid tumors.(5b)2 NEUROENDOCRINE TUMORS(NETS)171,000 people live with NETs in the United States,with
235、an incidence rate of approximately 6.98 cases per 100,000 people.(2a)NETs are now the fastest growing class of cancers worldwide,accounting for around 2%of all cancers at any time.(2b)SOMATULINE(lanreotide)53%relative risk reduction of disease progression or death.(2c)New delivery system with an imp
236、roved design was approved in 2019 in Europe and the US,and will be approved in more countries in 2021.7 PANCREATIC CANCERThe third leading cause of cancer-related death in the United States.(7a)ONIVYDE(irinotecan liposome injection)Significant improvement of overall survival in adult patients with m
237、etastatic adenocarcinoma of the pancreas.Numerous investigator-sponsored studies are ongoing to explore Onivyde in monotherapy and in combination with other treatments for different types of cancer.(7b)8 PROSTATE CANCERThe second most common type of cancer in men.(8a)DECAPEPTYLOver 90%of patients ac
238、hieve and maintain medical castration below the most stringent threshold levels(20 ng/dl).(8b)6 HEPATOCELLULAR CARCINOMA(HCC)On a global scale,primary liver cancer is a major contributor to both cancer incidence and mortality.It is the sixth most commonly occurring cancer in the world and the second
239、 largest cause of mortality.HCC is the most common type of primary liver cancer.(6a)CABOMETYXSignificant overall survival benefit in patients living with previously treated advanced hepatocellular carcinoma.(6b)4 1 2 3 56 7 8C R E A T I N G V A L U E I N O N C O L O G YREDUCING NEED FOR DOCTORS VISI
240、TS DURING COVID-19Those living with cancer seek every opportunity to limit their COVID-19 risk,including decreasing the number of in-person appointments.Somatuline independent injection enabled more patients to administer injections at home,reducing the number of hospital appointments.Decapeptyl has
241、 a twice-yearly dosing frequency indication for prostate cancer,an appealing,valuable treatment option.68%of patients have been found to prefer fewer injections and a simplified treatment pathway,which decreases stress and enables people to focus on healing.76%OF COMPANY SALES ARE FROM IPSENS ONCOLO
242、GY TREATMENTS1,145MIN SALES OF SOMATULINE AUTOGEL/DEPOT IN 2020 4 ACROMEGALY SOMATULINE(lanreotide)(3a)is used in the long-term treatment of acromegaly when the circulating levels of growth hormone(GH)and/or insulin like growth factor(IGF-1)remain abnormal after surgery and/or radiotherapy or for wh
243、om surgery and/or radiotherapy is not an option.It is also used to relieve the symptoms associated with acromegaly.Also offered in the Somatuline Autogel self-administering syringe.(3b)5 NEUROENDOCRINE TUMORS(NETS)SOMATULINE is used for the treatment of adults with neuroendocrine tumors.1 GROWTH FAI
244、LURE IN CHILDREN NUTROPINAQ(somatropin)(1)treats girls of two years and older with Turner syndrome,and prepubertal children with growth failure associated with chronic renal insufficiency.3 GROWTH FAILURE IN CHILDREN AND ADOLESCENTS WITH CONFIRMED SEVERE PRIMARY INSULIN-LIKE GROWTH FACTOR-1 DEFICIEN
245、CY(IGFD)INCRELEX (mecasermin)(2)is used for patients living with primary IGFD,an ultra-rare disease affecting normal bone and tissue growth and development,which can result in growth failure.2 GROWTH HORMONE DEFICIENCY IN ADULTS NUTROPINAQ serves adults living with growth hormone deficiency,acting a
246、s a replacement of endogenous growth hormone.7 CENTRAL PRECOCIOUS PUBERTY(CPP)DECAPEPTYL (triptorelin pamoate)(4)is an agonist analog of the natural gonadotropin-releasing hormone(GnRH)currently available in three sustained-released formulations (1,3 and 6 months).It is approved to treat central pre
247、cocious puberty(CPP).6 CARCINOID SYNDROME SOMATULINEserves for the treatment of carcinoid syndrome.4 1 2 3 7 56We offer a range of innovative treatments to help those with high unmet medical need.Here is a look at these therapies:INTEGRATED ANNUAL REPORT 202042 I 43In 2020,we continued our commitmen
248、t to treating the rarest diseases,targeting those in bone disease,endocrinology and other areas with high unmet medical needs.We are motivated to alleviate patients symptoms and improve their quality of life as much as possible.We support medicine candidates across all stages of development,relying
249、on both established and innovative technologies to develop new potential treatments.Bringing science to the peopleIn 2020,we built on our acquisition of Clementia Pharmaceuticals and our partnership with Blueprint Medicines to present some groundbreaking findings.At the American Society for Bone and
250、 Mineral Research(ASBMR)annual meeting,we shared seven abstracts and presentations including the first-ever global,multi-center,Phase III trial results for the prevention of new bone formation(heterotopic ossification)in fibrodysplasia ossificans progressiva(FOP).We are also setting ambitious target
251、s to bring more medicines to people who need them.We currently have two rare disease assets in development and will continue to seek out and pioneer in new therapeutic areas.By conducting world-first clinical trials,we help continue the search for life-altering medicines.Working together,our resilie
252、nt teams are overcoming clinical development challenges to progress in our ground-breaking work and enter into dialogue with regulators,in the hopes of eventually filing our treatments globally.We will continue to leverage our expertise from the R&D stage through commercialization to establish our l
253、eadership and provide innovative rare disease treatments.An emphasis on patient advocacyWe collaborate with clinical,family and advocacy partners in rare disease.Together,we innovate to find new solutions and address unmet medical needs.In 2020,Ipsen again supported the Virtual FOP Family Gathering
254、organized by the International Fibrodysplasia Ossificans Progressiva Association(IFOPA).We need to provide caregivers and physicians with treatment options to help people living with rare diseases.Both internal and external innovation are essential to this goal.Working together with the rare disease
255、 community,we strive to better understand the challenges faced by patients and their families,and then build on our expertise to address them.C R E A T I N G V A L U E I N R A R E D I S E A S E95%OF RARE DISEASES HAVE NO AVAILABLE TREATMENT OPTIONS YETWHAT LIFE-CHANGING LOOKS LIKELEADING THE WAY IN
256、FOP TREATMENTAt the ASBMR meeting in September,our 12-month data included a first-of-its-kind study entitled,“A Natural History Study of Fibrodysplasia Ossificans Progressiva(FOP).Our scientists followed patients over the course of 36 months and documented the impact of heterotopic ossification(HO)o
257、n patients physical functioning.This formed the comparator arm for the ongoing MOVE trial,the first and only multi-center Phase III study of FOP.We contrasted the outcomes of those who had been treated and those who had not,providing insights that will benefit all researchers working to treat this r
258、are disease.The FDA recently acknowledged this type of trial design as critical to advancing research in ultra-rare diseases.ONE PRODUCT,MULTIPLE INDICATIONS3522114 3 CERVICAL DYSTONIA Cervical dystonia is a rare neurological disorder characterized by involuntary muscle contractions in the neck that
259、 cause abnormal movements and posture of the neck and head.Prevalence is estimated at 57 cases per million in the EU(4a)and at 89 cases per million in the US.(4b)5 HEMIFACIAL SPASM Hemifacial spasm is a neuromuscular disease characterized by irregular,involuntary muscle contractions on one side of t
260、he face.Estimated prevalence of 14.5/100,000 in women and 7.4/100,000 in men.(6)4 BLEPHAROSPASMBlepharospasm is an abnormal contraction of the eyelid that can be chronic and persistent.Prevalence is from 16 to 133 cases per million.(5a)(5b)2 PEDIATRIC SPASTICITY Cerebral palsy(CP)is the most common
261、cause of spasticity and physical disability,with a prevalence of 1.5 to 3 cases per 1,000 live births.(3a)(3b)90%of patients with CP will present spastic hypertonia.(3c)1 ADULT SPASTICITYSpasticity is one of the most common and disabling conditions associated with many neurological diseases in adult
262、s(stroke,traumatic brain injury,etc.).It is characterized by velocity-dependent muscle hyperactivity.Incidence of post-stroke spasticity ranges between 17%and 42.6%.(2)Botulinum toxin type A Dysport(1)has been a game changer for patients living with debilitating neurological conditions.Worldwide,it
263、has helped relieve pain,restore motor function and make peoples lives easier.INTEGRATED ANNUAL REPORT 202044 I 45With over 25 years of research,development and commercial experience in neuroscience,Ipsen is fully committed to improving health outcomes for patients suffering from debilitating neurolo
264、gical disorders.C R E A T I N G V A L U E I N N E U R O S C I E N C E Progressing for patients during the pandemicIn 2020 Ipsen saw the expansion of approvals for Dysport(abobotulinumtoxinA)in several countries.For example,its US label was expanded to treat both upper and lower limb spasticity in pe
265、diatric patients,regardless of the etiology.This indication expansion adds to the list of numerous countries where Dysport is now approved for Pediatric Upper-Limb Spasticity,making Dysport the first and only toxin to be approved in pediatric upper and lower limbs in most of our geographies.Ipsen al
266、so championed the use of real-world evidence in the assessment of neurotoxins effectiveness in upper and lower limb spasticity.Our Global Manufacturing and Supply chain overcame all the challenges posed by the pandemic and kept delivering for patients across the world,Leading the digital transformat
267、ion in neurosciencePatients with neurological disorders were severely impacted by the closure of clinics around the world due to the pandemic.As a result,they could no longer receive treatment and care for severe,debilitating neurological conditions.Ipsen developed virtual tools and resources to hel
268、p healthcare professionals support their patients remotely and prepare their clinics to accelerate their reopening.Even when access to healthcare professionals was limited by the local situation,we continued to inform the scientific community on new data by taking part in virtual international congr
269、esses,with over 120 presentations and 32 manuscripts,leading to over 80 citations throughout the healthcare ecosystem.In many countries,Ipsen hosted critical online training and engagement sessions,reaching thousands of healthcare professionals.Countries intensified their collaborations;for example
270、Ipsens teams in Italy and the UK provided a joint platform for healthcare professionals to exchange best practices in patient management under lockdown scenarios.Strength in partnershipIn 2020,Ipsen and Galdermas collaboration was critical in ensuring the continuity of operations.Ipsen received appr
271、oval for Dysport in China for aesthetic indications,a critically important launch for our partnership.THE ONE AND ONLYIpsen is the only company to have recombinant neurotoxins in development,building on our strong heritage.IPN59011 and IPN10200,our candidate long-acting neurotoxins,are being develop
272、ed in aesthetic and therapeutic indications.1STCOMPANY TO HAVE RECOMBINANT NEUROTOXINS IN DEVELOPMENT350M IN SALES OF DYSPORT BUSCOPAN(1)(hyoscine butylbromide)An antispasmodic used to relieve smooth muscle spasms(cramps)in the stomach and intestines,as well as the bladder and urethra.EZICLEN/IZINOV
273、A(1)(BLI-800)A new generation of sulfate-based bowel cleansing preparation.Reduces the quantity of liquid to be ingested by the patient,improves the cleansing quality,and increases colonoscopy efficacy.ETIASA(1)(mesalazine)Treats inflammatory bowel diseases(ulcerative colitis and Crohns disease)duri
274、ng acute phase to maintain remission.FORTRANS(1)(macrogol 4000 and salts combinations)A colon-cleansing solution to use before an endoscopy procedure(colonoscopy),surgery,or radiology.The active substance is Macrogol 4000,a linear polymer of polyethylene glycol(PEG)of high molecular weight with adde
275、d electrolytes.FORLAXGO(2)This ready-to-use liquid stick is a laxative treatment for occasional constipation in adults and children 8 years or older.GASTROINTESTINAL CONDITIONS TANAKAN(1)(EGb761)Standardized,patented ginkgo biloba extract for the symptomatic treatment of cognitive disorders such as
276、memory and attention disturbances in adults.In some countries,it is also being researched as an adjunctive treatment for vertigo of vestibular origin,in addition to vestibular rehabilitation and the symptomatic treatment of tinnitus.OTHER CONDITIONS FORLAX(Macrogol 4000)An osmotic laxative that reac
277、tivates the bowels natural efficacy and restores the regular frequency of stools within 24 to 48 hours without irritation or dependence.SMECTAGO(2)This ready-to-use liquid stick is used for the short-term treatment of acute diarrhea,in addition to dietary measures.PAXELADINE(1)(oxeladin hydrogen cit
278、rate)For the symptomatic treatment of non-productive cough.Used for irritative cough,allergic cough,cough in patients with heart disease,tracheitis,bronchitis and other conditions.PRONTALGINE(1)(Codeine,caffeine,paracetamol)An analgesic for the treatment of moderate to severe pain,combining paraceta
279、mol,caffeine and codeine.SUPPOSITORIA GLYCERINI(glycerol)Local action laxative;licensed in the Czech Republic.PRONTADOL(Paracetamol and 50 mg of caffeine)For the symptomatic treatment of mild to moderate pain and/or febrile conditions.SMECTA(1)(diosmectite)Stops and treats diarrhea,removes the toxin
280、s and germs at the heart of the problem,helps repair intestinal damage with its natural coating properties and relieves abdominal pain.SMEBIOCTA COMFORT(Lactobacillus plantarum 299v)A scientifically-selected microbiotic strain that interacts with microbiota to help manage intestinal discomfort.SMEBI
281、OCTA PROTECT(Saccharomyces boulardii,Lactobacillus rhamnosus GG and vitamin C)An exclusive high-dose combination of a yeast and a microbiotic strain that helps to protect the intestinal microbiota and restore its balance.Can be taken during antibiotherapy.SMECTAGAS(2)Exclusive dual action against ga
282、s and bloating that favors fast gas elimination and contributes to restoring a healthy gut microbiota.INTEGRATED ANNUAL REPORT 202046 I 47Ipsens Consumer HealthCare division has transformed from a prescription-based model to a combination of prescription and over-the-counter(OTx)treatments.The team
283、has made great strides,building a range of effective medications and solutions,while also working tirelessly to improve usability for our customers.This enables us to regularly offer new combinations and formulations for the benefit of patients and consumers.Adapting to new environmentsConsumer Heal
284、thCare faced considerable challenges this year,with enhanced expansion of generics in China and France,as well as COVID-19s impact on sales.Social distancing had a negative impact on the diarrhea market and impacted sales of Smecta(diosmectite),while the burden on hospitals decreased demand for bowe
285、l cleansers,also impacting sales.In spite of these difficulties,our committed team persisted and created conditions for a sustainable future for our business.Employees continued to bring care and comfort to patients around the world,with new launches such as Prontadol(paracetamol and 50 mg of caffei
286、ne)in France and new partnerships,such as the K-Max distribution agreement in China.Already,we have seen the first encouraging signs of market recovery in China in Q4 of 2020,for both diarrhea medications and bowel cleansers.Our three main manufacturing sitesin Dreux and LIsle-sur-la-Sorgue,France a
287、nd Tianjin,Chinaare certified to ISO 14001(environment)and OHSAS 18001(health and safety).The Dreux site also achieved ISO 50001(energy savings)certification at the end of 2020,in recognition of the long-haul efforts of the team in this direction.With over 90 years of pharmaceutical expertise and a
288、diversified portfolio,Ipsens Consumer HealthCare business provides care and comfort in the daily lives of millions of customers every year.C R E A T I N G V A L U E I N C O N S U M E R H E A L T H C A R EA NEW PARTNERSHIP IN CHINAIn 2020,Ipsen entered into a strategic partnership with McKin in China
289、 for the distribution of K-Max,an American range of all-natural-ingredient nutrition products verified by the Chinese“Blue Hat”quality label.This deal opens a new avenue for Ipsens retail business in China,with the expansion of our promotion and distribution know-how to food supplements.45YEARS OF E
290、XPERTISE IN FUNCTIONAL GASTROINTESTINAL DISORDERS3AWARDS FOR BEST PLACE TO WORK IN CHINA,RUSSIA AND ALGERIAPROFILES OF KEY CONSUMER HEALTHCARE PRODUCTSUnited StatesBrazilAustraliaSingaporeVietnamTaiwanChinaSwedenFinlandLithuaniaLatviaCanadaMexicoFinlandUnited StatesBrazilAustraliaSingaporeVietnamTai
291、wanChinaSwedenFinlandLithuaniaLatviaPortugalFranceItalyHungaryGermanyBelgiumSpainAlgeriaTunisiaUkraineRomaniaCzech RepublicPolandNetherlandsUnitedKingdomIrelandDenmarkGreeceCanadaMexicoRussiaKazakhstanLebanonSouth KoreaUAESwitzerlandSlovakiaFinlandUnited StatesBrazilAustraliaSingaporeVietnamTaiwanCh
292、inaSwedenFinlandLithuaniaLatviaPortugalFranceItalyHungaryGermanyBelgiumSpainAlgeriaTunisiaUkraineRomaniaCzech RepublicPolandNetherlandsUnitedKingdomIrelandDenmarkGreeceCanadaMexicoRussiaKazakhstanLebanonSouth KoreaUAESwitzerlandSlovakia48 I 49INTEGRATED ANNUAL REPORT 2020O U R G L O B A L P R E S E
293、N C E30COUNTRIES WHERE IPSEN HAS A DIRECT PRESENCE 115COUNTRIES WHERE IPSEN MEDICINES ARE REGISTERED4GLOBAL R&D HUBS5,700EMPLOYEESAROUND THE WORLD 4PHARMACEUTICALDEVELOPMENT CENTERS Ipsen is a global company,with operations in over 115 countries.Our largest sites in R&D and manufacturing are located
294、 in France,Ireland,the United Kingdom,the United States and China.This year,we have seen the power of a collective global effort and its potential to revolutionize medicine.Going forward,we will strengthen our existing links while creating new connections.We have plans to establish operations in Jap
295、an and expand our presence in the Middle East and Latin America.Countries where Ipsen operatesPharmaceutical development centersR&D hubsFRANCE PARIS-SACLAY R&D Power Base The sites core mission is to accelerate clinical development and deepen our understanding of new molecules in oncology,rare disea
296、se and neuroscience.DREUX Manufacturing and R&DDreux manufactures medicines for the CHC business,notably Smecta,Bedelix,Forlax,Fortrans,Tanakan and Eziclen.Dreux also supports the global distribution of products and hosts clinical supply chain activities for our clinical programs.In addition,Dreux d
297、evelops the groundbreaking Novel Formulation Technologies drug delivery system.SIGNES ManufacturingThis site specializes in the aseptic manufacturing of sustained release injectable products.Signes also performs testing,packaging and distribution of Ipsen specialty products,notably Somatuline and De
298、capeptyl,which are distributed globally to over 70 countries.UNITED KINGDOM OXFORD R&D Power BaseWelcoming around 100 employees including neuroscience researchersour Milton Park site was designed to encourage innovation and collaboration.It also hosts our technological platform for botulinum toxins.
299、WREXHAM Manufacturing and R&DThis world-class biological campus is specialized in the manufacturing of biological neurotoxins.The site has full end-to-end capabilities,from development,active ingredient and aseptic manufacturing,to testing,packaging and distribution.The site is also a strategic R&D
300、center for the development of recombinant neurotoxins.Wrexham produces and distributes Dysport worldwide to more than 85 countries.IRELAND CORK ManufacturingThis site produces extract of ginkgo biloba EGb 761,which is used in the production of Tanakan and Ginkor.DUBLIN Manufacturing and R&DThis site
301、 manufactures bulk peptide active pharmaceutical ingredients(APIs)for Somatuline and Decapeptyl.Dublin is also a center for R&D product development for peptides and small molecules.CHINA TIANJIN ManufacturingThe local production facility for Smecta,Tianjin also packages and distributes the rest of I
302、psens portfolio and other medical products in China.BEIJING R&DEstablished in 2012,the Asia Group Drug Development team oversees clinical trial coordination in Asia.SHANGHAI R&D Power BaseThe Ipsen Innovation Hub opened in 2019 develops strategies to register new indications and compounds in China.I
303、t also works with Global External Innovation and Partnering to pursue more in-country development opportunities.NORTH AMERICA CAMBRIDGE,US Manufacturing and R&D Power BaseThe site specializes in the manufacture of Onivyde,a liposomal formulation.Onivyde is manufactured under aseptic conditions,teste
304、d and distributed worldwide for commercial and clinical use.The site also hosts clinical and regulatory teams working to facilitate the approval of products by global health authorities,including the FDA and Health Canada.Placing Ipsen at the center of the biotech revolution in Cambridge,our Bioscie
305、nce R&D center primarily focuses on oncology and rare disease.MONTREAL,CANADA AND NEWTON,US R&D CentersThese R&D centers focus on developing palovarotene as a potential treatment to prevent new bone formation(heterotopic ossification)for fibrodysplasia ossificans progressiva(FOP)and other diseases.L
306、ISLE-SUR-LA-SORGUE ManufacturingThis is Ipsens only site for processing clays,used in Smecta,Bedelix,Actapulgite and Gelox.Signes wins the Shingo PrizeThe Shingo Institute,part of the Jon M.Huntsman School of Business at Utah State University,has awarded the Shingo Gold Prize to Ipsen Pharma Biotech
307、 in Signes,France.The Shingo Prize is an internationally recognized award for operational excellence.At the core of Shingo is the respect for individual employees and a focus on value creation for the customer.Sandrine Garcia,head of the Signes site,said,“This award is the result of the dedication a
308、nd hard work of all our employees in ensuring that the medicines we manufacture make a remarkable impact on the lives of patients around the world.”Technical Operations works tirelessly through the pandemicPeople around the world depend on Ipsen and our medicines.Even with the world in full lockdown
309、,our Technical Operations team pioneered new ways of working,coordinating shipments around border closures,flight cancellations and fluctuations in demand.The manufacturing,supply and support teams ensured there were no stockouts,so patients would never miss a dose.Aidan Murphy,EVP,Technical Operati
310、ons,reflected on his teams success,stating,“We passionately believe that people make the difference.Our teams have continuously demonstrated this with commitment,resilience and courage,ensuring our life changing products get to our patients.”50 I 51INTEGRATED ANNUAL REPORT 2020O U R P R O D U C T I
311、O N A N D R&D S I T E S Ipsen scientists and innovators around the world are working to develop life-changing treatments.Through our vast global network and collective expertise,we are changing patients lives for the better.Our collective expertise relies on several production and R&D sites across E
312、urope,North America and China.20202,592M2020829.3M 32%of sales 20192,576M2019782.6M 20182,225M2018659.9M Sales and operating income growthIPSEN SALESCORE OPERATING INCOMEGROUP NET SALES CAGR 2020-24 BETWEEN +2%&+5%LOWER SG&A AS A%OF NET SALES BY 20243BN CUMULATIVE FIREPOWER FOR PIPELINE EXPANSION BY
313、 2024 BASED ON NET DEBT BELOW 2.0X EBITDA Ownership of Ipsens share capital As of 31 December 202040.86%PUBLIC26.03%HIGHROCK26.03%BEECH TREE4.34%MR SCHWABE 2024 financial outlookO U R K E Y F I N A N C I A L I N D I C A T O R S0.79%OTHER SHAREHOLDERS0.25%EMPLOYEE FCPE 0.22%FINVESTAN 0.17%ADMINISTRAT
314、ORS 1.3%TREASURE SHARES OTHER52 I 53INTEGRATED ANNUAL REPORT 2020Despite the challenges of 2020,Ipsen came out stronger and more committed than ever to improving patients lives.31.8%MAJOR WESTERN EUROPEAN COUNTRIES33.1%NORTH AMERICA19.3%OTHER EUROPEAN COUNTRIES15.8%REST OF THE WORLDOur medicines are
315、 registered in more than 115 countries Sales by geographic area Sales by therapeutic area A strong commitment to R&D550 EMPLOYEES WORKING IN R&D4 GLOBAL R&D HUBS IN CAMBRIDGE(US),OXFORD(UK),PARIS(FRANCE)&SHANGHAI(CHINA)20MEDICINES IN OUR PORTFOLIO2020405.6M15.6%of sales2019389M 2018302M R&D investme
316、ntsONCOLOGY1,969.8M 76%of salesRARE DISEASE55.2M 2.1%of salesNEUROSCIENCE356.1M 13.7%of salesCONSUMER HEALTHCARE210.6M 8.1%of sales54 I 55INTEGRATED ANNUAL REPORT 2020 Employees Communities The environmentB E Y O N D N U M B E R SThe value we create is not just measured through our financial figures
317、.Fully dedicated to CSR,we are as proud of our non-financial indicators as we are of our financial results.56 I 57INTEGRATED ANNUAL REPORT 202013COUNTRIES WHERE IPSEN IS RECOGNIZED AS AN AWARDED EMPLOYER,UP FROM SEVEN IN 2019210PATIENT ADVOCACY GROUPS COLLABORATED WITH IPSEN GLOBALLY IN 20201,300EMP
318、LOYEES44,700 STUDENTS AND HEALTHCARE PROFESSIONALS IN 100+COUNTRIES RECEIVED INSTITUT PASTEUR/FONDATION IPSEN TRAINING 30COUNTRIES VOLUNTEERED FOR OUR 2020 COMMUNITY DAYNEARLY 1,000EMPLOYEES PARTICIPATED IN IPSEN IN MOTION140EMPLOYEES CONTRIBUTED INSIGHTS,WHICH LED TO THE DEVELOPMENT OF THE NEW IPSE
319、N WAY OF BEING 90%42%OF WOMEN APPOINTED TO THE GLOBAL LEADERSHIP TEAM(GLT)WERE PROMOTED INTERNALLYGENDER BALANCE ON THE GLTREDUCTION IN ENERGY CONSUMPTION COMPARED TO 201616%REDUCTION OF PROCESS WASTE45%REDUCTION IN WATER CONSUMPTION30%REDUCTION OF GREENHOUSE GAS EMISSIONS FROM 2016 TO 202032%36,500
320、 LISTENERS TO FONDATION IPSENS PODCASTSCredits:Thank you to all the Ipsen staff members who appear in this publication.All product names listed in this document are either licensed to Ipsen or are registered trademarks of Ipsen or its partners in more than one country.Produced by Ipsen,Global Commun
321、ications:Gwenan White,Fanny Allaire,Hlose Levallois,Mary-Elizabeth Hackett,Jaya Marcellin.Designed by:Edited by:Photo credits:CAPA Pictures:Pguimaraes-Pierre-Olivier-Adam Wiseman-Matthew Bender-Patrick Wack-S Alexandrov-Julien Lutt,Getty Images/Marko Geber,iS Images/zhangshuang,iS Images/Andrew Merr
322、y,Getty Images/Johner Images,Getty Images/Hudzilla,Getty Images/The Good Brigade,Getty Images/AerialPerspective Images,Getty Images/Kirill Rudenko,Getty Images/Xuanyu Han,iS Productions,Option K/Hamid FADAVI,Philippe Castao,Association Togo Ipsen 2021/Angie/Hollis&Bean58 I 59DisclaimerThe Ipsen Inte
323、grated Annual Report is a non-promotional document intended to provide corporate-related information to shareholders or other stakeholders requiring this information.This document is not intended for the promotion of Ipsens products.The use of this document beyond the above stated purpose is strictl
324、y prohibited.ReferencesPage 15:Rare Disease(1)https:/www.who.int/medicines/areas/priority_medicines/Ch6_19Rare.pdf?ua=1 pp.40-41:Creating value in oncology MEDULLARY THYROID CANCER(1a)https:/www.macmillan.org.uk/cancer-information-and-support/thyroid-cancer/medullary(1b)Cometriq SmPC:https:/www.ema.
325、europa.eu/en/documents/product-information/cometriq-epar-product-information_en.pdf NEUROENDOCRINE TUMORS(NETS)(2a)Dasari,Arvind,et al.,2017.https:/ E.,et al.,2014.https:/www.nejm.org/doi/full/10.1056/nejmoa1316158.2014.CARCINOID SYNDROME(3a)Cella,David,et al.https:/ SmPC:https:/www.ema.europa.eu/en
326、/documents/product-information/xermelo-epar-product-information_en.pdf BREAST CANCER(4a)Decapeptyl SmPC:https:/www.medicines.org.uk/emc/product/963/smpc(4b)Globocan.iarc Last access July 2020.Siegel RL et al.CA Cancer J Clin;69:734;2019(4c)Allison KH et al.ASCO/CAP Guideline.J Clin Oncol 38:1346-136
327、6;2020 RENAL CELL CARCINOMA(5a)https:/pubmed.ncbi.nlm.nih.gov/22750267/(5b)Cabometyx SmPC:https:/www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf HEPATOCELLULAR CARCINOMA(6a)https:/www.cancerresearchuk.org/about-cancer/liver-cancer/types(6b)Cabometyx SmPC:
328、https:/www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf PANCREATIC CANCER(7a)https:/pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/#:text=Pancreatic%20cancer%20has%20the%20highest,States%20after%20lung%20and%20colon.(7b)Onivyde SmPC:https:/www.me
329、dicines.org.uk/emc/product/9200/smpc#gref PROSTATE CANCER(8a)https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC6497009/#:text=Prostate%20cancer%20is%20the%20second%20most%20frequent%20malignancy%20(after%20lung,2018%20%5B1%2C%202%5D.(8b)Decapeptyl SmPC:https:/www.medicines.org.uk/emc/product/780/smpc#gref
330、DISCL AIMER AND REFERENCESpp.42-43:Creating value in rare disease NUTROPINAQ(1)NutropinAq SmPC:https:/www.ema.europa.eu/en/documents/product-information/nutropinaq-epar-product-information_en.pdf INCRELEX(2)Increlex SmPC:https:/www.ema.europa.eu/en/documents/product-information/increlex-epar-product
331、-information_en.pdf SOMATULINE(3a)Somatuline SmPC:https:/www.medicines.org.uk/emc/product/965/smpc(3b)Somatuline Autogel SmPC:https:/www.medicines.org.uk/emc/medicine/25104#gref DECAPEPTYL(4)Decapeptyl SmPC:https:/www.medicines.org.uk/emc/product/780/smpc#grefpp.44-45:Creating value in neuroscience
332、DYSPORT(1)Dysport SmPC:https:/www.medicines.org.uk/emc/product/7261/smpc ADULT SPASTICITY(2)K.Milinis,C.A.Young&on behalf of the Trajectories of Outcome in Neurological Conditions(TONiC)study(2016)Systematic review of the influence of spasticity on quality of life in adults with chronic neurological
333、 conditions,Disability and Rehabilitation,38:15,1431-1441,DOI:10.3109/09638288.2015.1106592 PEDIATRIC SPASTICITY(3a)Himmelmann K,Hagberg G,Beckung E,et al.The changing panorama of cerebral palsy in Sweden.IX.Prevalence and origin in the birth-year period 1995-1998.ActaPaediatr 2005;94(3):287-294(3b)Surveillance of Cerebral Palsy in Europe.Surveillance of cerebral palsy in Europe:a collaboration of