益普生Ipsen（IPN）2019年年度報告「巴黎泛歐證券交易所」.pdf

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1、NadineLiving with fibrodysplasia ossificans progressivaBerlin,Germany2019 Annual ReportTABLE OF CONTENTS04 Bold and bigger steps for patients06 2019 Highlights08 We listen to and learn from patients10 For Nadine12 For Josep14 For Diana16 An authentic dialogue with our stakeholders18 Creating long-te

2、rm value for all stakeholders20 Our materiality matrix assessment22 Living our commitment to CSR 24 Our people are the key to Ipsens success25 Bringing Science to People 26 The Board of Directors27 The Executive Leadership Team28 We innovate for patients30 Attracting the most promising external inno

3、vation 32 Our key indicators36 Our R&D pipeline is richer than ever38 Focus on our assets in oncology40 Focus on our assets in neuroscience42 Focus on our assets in rare diseases44 Focus on our assets in consumer healthcare46 Our global presence48 Our manufacturing and R&D siteswe are confident that

4、 palovarotene can play a critical role in the treatment of fibrodysplasia ossificans progressiva,and we are working to bring this potential treatment to patients around the world as soon as possible.We continue to go from strength to strength as a company and have adapted extremely well to change,pa

5、rticularly with the departure of our former Chief Executive Officer,David Meek,who helped transform Ipsen into one of the fastest-growing companies in our industry.Our growth strategy remains unchanged,and we will continue to build on a strong Executive Leadership Team and our rich global talent poo

6、l.How important is it for you as a company to put your patients first?AC:We are committed to a future where patients have access to life-changing treatments for hard-to-treat cancers,complex rare diseases and severe neurological conditions a future in which we make no compromises and no patient is l

7、eft behind.Our key areas of focus Oncology,Neuroscience and Rare Diseases include extremely devastating diseases with limited options.We often say at Ipsen that“patients cannot wait”,and because of that we constantly seek innovative ways to improve the design and accelerate the execution of our deve

8、lopment strategies to serve those patients better.Patients needs are a reminder to all of us at Ipsen as to why we get up each morning and come to work.We know they cannot wait for us.Bold and bigger steps for patientsan interview with Aymeric Le Chatelier Chief Executive Officer and Chief Financial

9、 Officer“Patients needs are a reminder to all of us at Ipsen as to why we get up each morning and come to work.”2019 was an important year for Ipsen.What were some of the highlights?Aymeric Le Chatelier:2019 was a pivotal year for Ipsen as a leading global biopharmaceutical company focused on innova

10、tion and Specialty Care.Our focus on developing new solutions for targeted debilitating diseases continues to benefit patients and improve their lives through innovative medicines in Oncology,Neuroscience,Rare Diseases and Consumer HealthCare.That focus has also resulted in significant financial rew

11、ards.I am very pleased that in 2019,Ipsen surpassed the 2.5 billion euros mark in terms of sales for the first time,with operating profitability also hitting historical highs of 30%of net sales.We made bold and bigger steps into new areas,completing the acquisition of Clementia Pharmaceuticals and g

12、aining a first-in-class asset,palovarotene,as well as the in-licensing agreement with Blueprint Medicines.This greatly enhanced our Rare Diseases portfolio,providing us with a major springboard area in which we intend to grow significantly over the next decade.Our Oncology franchise continued to dem

13、onstrate healthy double-digit growth across all major geographies,with our Somatuline business increasing its global footprint,thanks to its superior clinical profile and new differentiated delivery system.It was also a stellar year for Cabometyx with approvals secured in the treatment of kidney and

14、 liver cancer in several new markets,including Hong Kong,Canada,South Korea and the Middle East.It delivered a very strong operating performance,driven by increased market-share gains in all our territories.Our Neuroscience franchise also performed well with Dysport which enjoyed another year of dou

15、ble-digit growth.And our Consumer Healthcare business made significant progress in becoming more sustainable and autonomous,despite a challenging competitive environment in China.We also advanced our R&D pipeline,which has never been as rich as it is today,with five Phase III or registration trials

16、scheduled for 2020.These include two new Phase III trials for Onivyde based on highly promising data released in 2019 for second-line small cell lung cancer and first-line metastatic pancreatic cancer.What were some of the years particular challenges?AC:The strategic acquisition of Clementia was a k

17、ey milestone for Ipsen,paving the way for new and exciting opportunities in the area of Rare Diseases.However,the setback in the palovarotene program with the partial clinical hold for patients under 14 years old was disappointing for us and even more so for patients and their families.However,What

18、are your ambitions for 2020 and beyond?AC:Following another excellent year of operating performance in 2019,we want to see that continue in 2020.Our ambition is to increase the value of our internal pipeline by transforming our R&D organization and prioritizing key internal programs in our strategic

19、 therapeutic areas.We will continue to execute on disciplined business development and our external innovation strategy to bring in new assets and build an innovative and sustainable pipeline of products and solutions for patients.We will also further grow and maximize our best-in-class Specialty Ca

20、re products in Oncology,Neuroscience and Rare Diseases and continue the transformation of our Consumer HealthCare business.Finally,our future success centers on embracing patients at every level of the company,and we will continue our cultural and organizational transformation to make patients our p

21、artners.For us to succeed,they must be at the heart of everything we do.As we are completing this interview,COVID-19 is sweeping across the world.What are your priorities in these unprecedented times and how are you supporting COVID-19 relief efforts?AC:Right from the very beginning,we established a

22、 cross-functional global crisis management team at Ipsen to continually assess the evolution of the pandemic and take the appropriate actions.Our priorities are clear:ensure the health and safety of our colleagues around the world while focusing on business continuity so that patients can access the

23、 medicines they need.On behalf of my colleagues,I am very proud to be part of an industry that is part of the solution.At Ipsen,we are doing everything we can to support ongoing COVID-19 relief efforts.For example,on April 1,2020,we announced a 2 million euros donation to the Institut Pasteur to sup

24、port the 21 research projects currently ongoing to combat COVID-19.We are also proudly supporting a number of initiatives launched by public authorities and trade associations such as the International Federation of Pharmaceutical Manufacturers&Associations and the European Federation of Pharmaceuti

25、cal Industries&Associations.While we are proud to do our part at the global level,I am also delighted to see our local teams come together during these exceptional times supporting COVID-19 relief efforts through donations of medical equipment,providing much needed food to food banks and acts of sol

26、idarity.04 05IPSEN ANNUAL REPORT2019 2019 Highlights2019 was a pivotal year for Ipsen.Our focus on developing new solutions for targeted debilitating diseases continues to benefit patients and improve their lives through innovative medicines in Oncology,Neuroscience,Rare Diseases and Consumer Health

27、Care.January 11,2019Ipsen demonstrated a leadership position in neurotoxin research with 50+posters presented at the 2019 TOXINS International ConferenceApril 18,2019Ipsen completed the acquisition of Clementia Pharmaceuticals,significantly enhancing its Rare Diseases portfolio with a late-stage dru

28、g candidate,palovarotene,for the treatment of rare bone disordersMay 14,2019We hosted an Investor Day to highlight our innovative R&D pipeline and provide our financial outlook for 2022May 24,2019New data from clinical studies on investigational uses of cancer medicines Cabometyx,Onivyde,and Somatul

29、ine were presented at the 2019 ASCO Annual MeetingJune 12,2019Together with Debiopharm,we extended and strengthened the strategic partnership through 2034,to ensure patient access to Decapeptyl for the treatment of certain urological,gynecological and pediatric conditionsJuly 5,2019Together with Ser

30、vier,we announced initial Phase 1/2 clinical data evaluating Onivyde as an investigational first-line treatment for metastatic pancreatic cancer at the ESMO 21st World Congress September 8,2019Together with Servier,we announced initial Phase II/III clinical data evaluating investigational Onivyde as

31、 a second-line treatment for small cell lung cancer(SCLC)at the IASLC 2019 World Conference September 23,2019We announced positive results from Phase IIIb/IV ENGAGE study of the combination of Dysport with Guided Self-rehabilitation Contracts in adult patients with upper and lower limb spastic hemip

32、aresisSeptember 27,2019We showcased the results of clinical trials with Cabometyx in a variety of difficult-to-treat conditions at the 2019 ESMO Congress November 5,2019We appointed Howard Mayer,M.D.,as Executive Vice President and Head of Research and DevelopmentOctober 16,2019Together with Bluepri

33、nt Medicines,we announced an exclusive global license agreement to develop and commercialize BLU-782,a highly selective investigational ALK2 inhibitor for the treatment of fibrodysplasia ossificans progressiva(FOP)December 6,2019We initiated a partial clinical hold on palovarotene IND120181 and IND1

34、35403 studiesDecember 18,2019We announced the departure of David Meek as Chief Executive Officer and the appointment of Aymeric Le Chatelier,currently Chief Financial Officer,as Interim CEOJanuary 14,2020We appointed Steven Hildemann,M.D.,Ph.D.,as Executive Vice President,Chief Medical Officer,Head

35、of Global Medical Affairs and Pharmacovigilance effective March 1,2020January 24,2020Our palovarotene clinical program in FOP reached prespecified interim analysis futility criteria.However,based on encouraging therapeutic activity signals observed in post-hoc analyses and recommendations from the I

36、ndependent Data Monitoring Committee,Ipsen opted not to discontinue the trial but temporarily pause dosing 06 07IPSEN ANNUAL REPORT2019 We listen to and learn from patientsIts all about working with patients,for patients to improve their everyday lives.By listening to patients from the start to unde

37、rstand what is most important to them,we can co-create solutions together.DianaLiving with poststrokespasticitySintra,Portugal08 09Nadine is 28 years old.When she was 13,she was diagnosed with fibrodysplasia ossificans progressiva(FOP),an ultra-rare disease that turns muscle into bone.It was her mom

38、 who first noticed that something was wrong with Nadine and that her condition had started to take hold.“Id started to limp but I hadnt noticed as I had no pain,”she says.Then,at the age of 22,the disease spread to Nadines shoulder and then to her jaw,which affected her enormously.“That left me real

39、ly handicapped because food has been my life since I was little.My first words were to do with food.Thats why it was so tough for me,”she says.“Preparing food took ages and I had to chop things very small and overcook them.I really went into my shell when my jaw became paralyzed.”From that point on,

40、Nadine became reluctant to leave the house,and whenever she did,she said she would never eat for fear of what people might think.But her friends and family helped her overcome her fears.“They encouraged me to get out of the house and do things,to keep all of my hobbies so that I didnt totally cut my

41、self off from society.That was really good for me,”Nadine says.In particular,she turned to singing,which has helped her greatly.“When I sing,I forget everything around me,”she says.“I get a real buzz out of singing with other people,being together,seeing other people and getting to know them.Thats a

42、 real pleasure for me.My favorite song right now is called Teardrops.The tune sounds a little sad,but the message is beautiful.It says that one person is always there for another.Its a song about friendship and never being alone.”Through her work in a laboratory,Nadine has recently been able to star

43、t researching her illness and says she feels very lucky to be able to do so.“Its extraordinary.For me,its a real privilege to be mobile enough to do this.When Im in the lab,I manage to forget about FOP.Im just focused on my research project and not on my individual case.”She calls working on her own

44、 illness a“double motivation”.She says:“You know there are other patients out there and that the results we produce could be something others will benefit from,not just me.This helps me in difficult moments to find motivation.”“When Im in the lab,I manage to forget about FOP.Im just focused on my re

45、search project and not on my individual case.”For NadineNadineLiving with fibrodysplasia ossificans progressivaBerlin,Germany10 11IPSEN ANNUAL REPORT2019JosepLiving with liver cancerBarcelona,Spain“I have to be here,by my familys side.I cant abandon them.I have to live a long time.”For JosepJose Mar

46、ia is 84.It has been two years since his liver cancer was discovered.“When I get up in the morning,I open the window in my room,and I say:Thank you life.Thank you very much”.Jose Maria still works.He is an upholsterer,something he calls an art form and something he says allows him to forget about hi

47、s cancer.“I still use the same tools as when I was an apprentice:my hammer,my scissors,my needles and my nails.It frees me from bad thoughts,from my illness.I dont want to give it up,”he says.Jose Maria has been married to his wife for 56 years and she has been at the forefront of his fight against

48、his illness.“She always gives me encouragement,”he says.“Come on,lets go dancing.Lets walk,she says and I follow her.I follow her advice and thats how Ive always lived.All my life.”He has two daughters and three grandchildren and says he is happiest when they are all together.“I love them,”he says.“

49、I have to be here,by my familys side.I cant abandon them.I have to live a long time.”Despite having liver cancer,Jose Maria says his life has not changed.“I follow my habits:my dancing,my excursions,my trips.I even think I can do what I couldnt do before with more vigor.I feel much better.I even loo

50、k more handsome.”Dancing has given him a new lease of life and unlocked a new energy inside him.“I dance almost every day.Every day,dancing,dancing.I feel alive when I dance.Tap dancing is my life now.Its the dance I like the most.And I want to continue until I dance like Fred Astaire.”12 13IPSEN AN

51、NUAL REPORT2019“I managed to find the strength to fight the stroke and become who I am again.I discovered I could be strong and overcome difficulties.”For DianaDiana had a stroke eight years ago.She was at home celebrating her wedding anniversary with her husband when suddenly her life changed.“My h

52、usband called 911,but they didnt immediately think I was having a stroke.They thought I was too young.At the time I was 34,and they didnt believe it could be a stroke,”she says.Diana was rushed to hospital and remembers waking up with a severe headache.She couldnt move her body but recalls feeling v

53、ery happy to be alive.“I thought to myself.Have I survived to be like this,in a hospital bed unable to move?Without being able to live my life.Without being able to do anything.”she says.“I didnt know if I would ever walk again.I didnt know if I could feed myself,if I was going to have to wear diape

54、rs for the rest of my life.I just knew I had my husband by my side and that was very important to me.”Diana says the love she has for her children and her husband got her through that dark time and enabled her to recover.“I managed to find the strength to fight the stroke and become who I am again,”

55、she says.“I discovered I could be strong and overcome difficulties and,even more,give strength to other people going through what I have.”Diana suffers from spasticity,a condition in which certain muscles are continuously contracted.She cant even make small movements with her left hand,but because o

56、f the treatment Diana is receiving she says she has been able to get her life back.“Now I have less pain because of my treatment.Eight years after the stroke,I almost have a normal life,”she says.“Today,I am so grateful to be here,to have seen my son begin university and my youngest daughter start h

57、igh school,to be present on a daily basis.”Diana says she is very thankful for her treatment and the difference it has made.“To be able to walk again,without a wheelchair,walking hand in hand with my husband makes me very proud.”DianaLiving with poststrokespasticitySintra,Portugal14 15IPSEN ANNUAL R

58、EPORT2019 An authentic dialogue with our stakeholders To be a trusted and credible organization,we must conduct our business with unwavering honesty,fairness,integrity and accountability.Continuous dialogue with stakeholders,such as patients,healthcare professionals,policy makers and many others,hel

59、ps us to better understand their concerns and expectations.It allows us to direct our actions towards creating long-term value for all.JanaineMarketing,Specialty CareSo Paulo,Brazil16 1791%Fighting against corruption:91%of Ipsen employees completed the Anticorruption training in 2019.The Wrexham ind

60、ustrial site has incorporated energy efficiency into its new building,including solar panels to self-generate the buildings energy requirement.0.88%The medicalized accident frequency rate was reduced to 0.88%in 2019(compared with 1.45%in 2018).Ipsen puts patients first and acts to provide concrete r

61、esponses to the needs and expectations of a wide variety of stakeholders,particularly those in healthcare.We maintain transparent and regular dialogue with our main stakeholders(employees,healthcare professionals and patients,investors and the financial community,suppliers and partners,regulatory au

62、thorities and agencies,local communities and the media)to provide reliable and factual information,develop partnerships,and support patients associations,with the ultimate goal of providing differentiated and innovative solutions for patients.It is by paying close attention to those stakeholders tha

63、t we can create long-term value for all the parties involved in our business success.To create that value,however,it is crucial for us to be a trusted and credible organization that conducts its business with unwavering honesty,fairness and integrity.We are all responsible and accountable for comply

64、ing with the rules in the many countries in which we operate.And we do not,and will not,tolerate any failure in the fields of conflicts of interest,corruption and unfair competition.Our bold and entrepreneurial spirit combined with the highest ethical standards constitutes the heart of our organizat

65、ion.We know our reputation is in our own hands and our code of conduct is crucial in guiding every decision we make.We encourage all our stakeholders to always speak up and raise any questions that might arise,and we pledge to always treat any issue that is raised with the highest levels of professi

66、onalism and confidentiality.To be trusted,we know that we also have to be transparent,and we disclose and share information with all our stakeholders,whether through our Universal Registration Document,our Investor Days,the disclosure of our scientific publications to the general public,or through o

67、ur continuous dialogue with patient advocacy groups,regulatory authorities and R&D partners.Ipsen is also firmly committed to protecting the environment and supporting civil society and the communities in which the company operates through dedicated actions.To that end,Ipsen has been part of the Uni

68、ted Nations Global Compact since 2012 and has continuously contributed to the achievement of the UN Sustainable Development Goals.Our Environment,Health and Safety record is also vitally important.We take our duties in this area very seriously and focus on policies that allow us to:design products t

69、hat are safe and sustainable;prevent pollution and conserve natural resources;provide a safe,injury-free workplace;easily communicate our plans,goals and results;and continuously improve our systems and approaches.In the end,patient centricity means collaborating across the entire company,from R&D t

70、o post-marketing,in order to identify unmet medical needs and deliver outcomes that genuinely improve the lives of patients.Creating long-term value for all stakeholdersPATIENT ADVOCACY GROUPSCOMMERCIAL PARTNERSCIVIL SOCIETYREGULATORY AUTHORITIESPOLICY MAKERSCOMMUNITIESSUPPLIERSHCPs/HCOsR&D PARTNERS

71、P A T I E N T SIPSEN ANNUAL REPORT18 192019 Our materiality matrix assessmentCATEGORYCONTRIBUTION TO THE SDGsISSUEDESCRIPTION AND LINKS TO IPSENS ACTIVITIESImproving peoples lives by offering innovative and safe medicinesProduct quality Protecting patients against the risks inherent to the biologica

72、l action of medicinal products and ensuring that the benefit/risk for all products is positive.Product safetyNon-compliance with security requirements that could jeopardize patients health.Counterfeit productsCounterfeit products of low quality and not complying with Ipsens health standards,which ma

73、y endanger patients health and generate a loss in sales revenues.Responsible product promotionImproper marketing claims resulting in legal proceedings and mistrust of patients and Healthcare professionals,which could damage Ipsen.Access to medicineThe implementation of initiatives and actions to imp

74、rove healthcare in countries where access to medicines is difficult and diseases are difficult to treat.Enhancing integrity to maintain a trusted relationship with our stakeholdersData privacyInability to ensure the integrity and confidentiality of data,resulting in the disclosure or theft of patien

75、ts 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 rightsRespect of human rights in Ipsens operations and supply chain.Driving our employees excellence and engagemen

76、tHealth 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 health.Talent attractionLoss and/or lack of key skills leading to delays in key programs and the launch of resear

77、ch 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 jeopardize the achievement of some objectives and lead to a corresponding impact on the Groups results or financial

78、position.Minimizing ourenvironmental impactClimate and energyDecrease in energy consumption in order to improve the efficiencyof Ipsens operations and reduce greenhouse gas emissions;adaptation to climate change.Management ofwater,waste and air emissionsWater,waste and air pollution due to Ipsens ac

79、tivity,which could causesignificant damage to sensitive areas or ecosystems and to health.The following SDGs have been selected for progressIMPROVING PATIENTS LIVES BY OFFERING INNOVATIVE AND SAFE MEDICINESDRIVING OUR EMPLOYEES EXCELLENCE AND ENGAGEMENTMINIMIZING OUR ENVIRONMENTAL IMPACTBringing hig

80、h-quality product to patientsIpsen provides the highest standards in terms of safety and quality for all its productsBatch Acceptance level:99.5%(2019).Responsible promotion with the Code of Conduct Ipsen through its Code of Conduct commits to promote its products,prescription-only,over-the-counter,

81、medical devices or food supplements in accordance with the applicable laws,regulations and industry codes.Completion rate of training on the Code of Conduct:90%(2019).Encourage employees to participate in the Ipsen Community DayIpsen is committed to encouraging and supporting the involvement of its

82、employees in healthcare,patient and caregiver charities.In 2019,more than 1,300 employees,representing more than 22%of our colleagues,spent up to one day of their working time with healthcare communities.Great Place to Work/Well-being Ipsen encourages its affiliates to seek external recognition awar

83、ds such as“Great/Best Place to Work”to encourage their efforts to improve well-being at work.Numerous sites have obtained“Great/Best Place to Work”certification,seven in 2019 and two in 2018.The Dreux site Absolute carbon emissions were decreased by nearly 6%between 2018 and 2019 by reducing energy

84、consumption at R&D and manufacturing sites.Signature of the French Business Climate PledgeFor the first time in 2019,Ipsen is part of the Climate Pledge made by 99 companies alongside the largest employer federation in France(MEDEF)to drastically reduce greenhouse gas emissions through investments i

85、n innovation and R&D.In 2019,for the first time,we decided to perform a materiality analysis assessing the expectations of our main stakeholders in terms of Company Social Responsibility.The analysis led to the identification of the following critical business,social and environmental matters.To ref

86、lect our specific contribution to the 2030 United Nations Agenda for Sustainable Development,we have aligned our CSR expectations with the United Nations Sustainable Development Goals.IPSEN ANNUAL REPORT20 212019In addition to our commitment to improving patients lives around the world,Ipsen is also

87、 firmly dedicated to protecting the environment and supporting society and the communities in which we operate.Aymeric Le Chatelier,our Chief Executive Officer,puts it simply:“Our vision is to harness the power of our people to have a responsible and sustainable impact on patients,society and the en

88、vironment.”As a company,we strive to empower our employees to make decisions with these values in mind.Le Chatelier goes further and says:“Promoting the needs and rights of employees,patients and society,as well as the environment at large,is crucial,and it is the objective and essence of our CSR si

89、gnature:a human journey of shared commitments.”Our CSR strategy In 2019,we clarified our commitments to each pillar that of employees,patients,society and the environment and set up measures to assess our progress in these areas over time.And for the first time last year,we introduced three CSR crit

90、eria into our external financing facility,highlighting the importance Ipsen places on sustainability.These indicators include increasing the number of women in senior leadership roles,reducing our greenhouse gas emissions and encouraging our employees to volunteer at and support healthcare associati

91、ons.We have decided to be bold and donate the benefit of any sustainability discount or premium Living our commitment to CSR In terms of CSR,we are proud to have had a number of great successes in 2019,and here are just a few:Ipsen joined the Access Accelerated program,a global partnership of more t

92、han 25 biopharma ceutical companies set up to address the growing challenge of non-communicable diseases.The program develops,measures,and replicates sustainable programs in low-and middle-income countries to advance access to NCD prevention and care.The Dreux site conducted a major energy assessmen

93、t and identified that it could reduce its energy consumption and the corresponding scope 1 and 2 carbon equivalent emissions.In 2019,the site implemented several of these projects and achieved a 10%energy reduction.In 2020,another significant energy reduction is planned.At our site in Signes,we have

94、 greatly improved the energy efficiency of our production of Somatuline,one of our flagship products,and significantly increased our output of the drug at the site while lowering the energy requirement needed to do so.We are also working on installing solar panels at Signes to make the building more

95、 sustainable.LIsle-sur-la-Sorgue conducted a biodiversity assessment and implemented habitat improvement recommendations.This improved the habitat for bird species.Our Environment,Health and Safety team launched a 10-year plan to further enhance our EHS policies.As such,the management team at our si

96、te in LIsle-sur-la-Sorgue completed a preliminary design for a reverse osmosis system,which allows at least 50%of the water used at the site to be reused.The project will be operational at the beginning of 2023.Lastly,the Ipsen Green Chemistry team has reduced the amount of solvents needed to manufa

97、cture new peptide products by more than 50%.to non-profit organizations that provide access to healthcare services for the most vulnerable.As such,International Health Partners,one of the largest non-profit organizations in delivering medicines to low and middleincome countries,has been selected as

98、a key beneficiary of these payments.We have also renewed our annual commitment to the Sustainable Development Goals of the United Nations Global Compact,which we initiated in 2012.We have also for the first time become one of 99 companies to sign up to the French Business Climate Pledge,a concerted

99、attempt to drastically reduce global greenhouse gas emissions.Our commitmentWe remain dedicated to promoting ethical,responsible and transparent professional practices.Feryal Ghouadni,VP Company Social Responsibility,says:“Today,its not enough for companies to simply turn a profit.We now have a resp

100、onsibility to give back to society,and we must make a commitment to fulfil this expectation.As a leading global biopharmaceutical company,we also have to be a leader when it comes to social responsibility and show all our stakeholders that we are bold and serious about it.”H I G H L I G H T SIPSEN A

101、NNUAL REPORT22 232019What sets us apart is our patient-and people-centric approach.At Ipsen,we always strive to put patients first,but we cant do that without our people.Around the world we have almost 6,000 colleagues and we care about the growth and development of each and every one of them.In 201

102、8,we finalized and launched our One Ipsen Way of Being five guiding principles that drive our decision-making on a daily basis.The aim of those five principles to trust each other,to share and learn every day,to own our outcomes,honour our word,and to strive to win together-is to foster an environme

103、nt that encourages colleagues to innovate and improve the lives of our patients around the world.In 2019,Ipsen was recognized as a Great or Best Place to Work in Our people are the key to Ipsens success2020 FOCUSTalent development is our focus for 2020.Without our people,we cannot deliver on our str

104、ategy that of putting patients at the heart of everything we do.To make that happen we must attract and retain top talent globally and take the time to mentor and invest in our people so that they can unlock their full potential.Russia,Algeria,Greece,the Netherlands,Brazil,Mexico,Italy and Ireland,a

105、nd this is something were really proud of.We encourage our colleagues to respect each other as well as our stakeholders,to be entrepreneurial,to ensure that they and we as a company make ethical decisions,and that we are all accountable and responsible.When it comes to our people,we have a strong fo

106、cus on three key areas:their capabilities,contribution and commitment.That focus begins by attracting and retaining top talent globally,by sharing our financial success with our employees,and by encouraging an inclusive and collaborative workplace.By doing all of this,we can fully engage our people

107、and harness the power of our colleagues and ensure that Ipsen has a responsible and sustainable impact on patients,society and the environment.And our 2019 Engagement Survey,which almost 90%of our colleagues participated in,shows the great strides we are making in terms of our people.The survey show

108、ed that the overwhelming majority of our people are optimistic about the future of the company and that they greatly appreciate their work environment and the way they are treated by their managers.Crucially,for our patients our people said their work makes them want to give their best every day.“I

109、am very proud of the commitment of Ipsens colleagues during the COVID-19 outbreak to deliver patients,while supporting the society and communities in which we operate.”Rgis Mulot,Executive Vice-President,Chief Human Resources Officer Bringing Science to PeopleThe mission of Fondation Ipsen is Scienc

110、e for People.Fondation Ipsen works in partnership with leading international organizations such as the journal Science,UNESCO,OECD,the National Press Foundation,Institut Pasteur,Institut Curie,Mayo Clinic and the Olympic Committee.Its goal is to disseminate scientific knowledge to people.The Fondati

111、on operates under the aegis of Fondation de France.In 2019,Fondation Ipsen reached 4.5 million people.How?We collaborated on:12 international live webinars with the journal Science A diploma in Public Health with Institut Pasteur to help 8,000 learners around the world The World Science Report with

112、UNESCO to guide science policy in 143 countries We invited 24 of the worlds leading science journalists to Paris to write about science 24 plays for the public 25 science podcasts for familiesBookLab,our publishing house delivered:9,000 scientific manga books 2 books for the public in collaboration

113、with the National Institutes of Health 18,000 scientific stories for children,in partnership with Institut Curie We asked Professor James A.Levine,M.D.,Ph.D.,President of Fondation Ipsen since November 2017,about what we can expect for 2020.2020 saw a new collaboration with the Olympic Committee to

114、publish books about Paralympians as inspirational figures for children.We began work with OECD,to use artificial intelligence to drive international scientific economic development.Our world report with UNESCO on global science policy will be released for free worldwide.Scientific books for children

115、 in collaboration with Institut Curie will be completed.Our podcast series about science in France has grown in popularity beyond all our expectations and we will support three podcast channels.We have committed with the journal Science to a 3-year program to explain science to people by bringing th

116、e worlds leading scientists into the public arena.Our collaboration with the National Press Foundation will advance.We plan to work with the worlds leading scientific journalists to discuss successful approaches to environmental reform.We are working on a new program with Mayo Clinic to co-develop c

117、hildrens health books with children and their doctors.How has the Fondation responded to the COVID-19 pandemic?The COVID-19 pandemic brought the skill set and capacity of Fondation Ipsen into focus.We urgently convened an international webinar on the science of coronavirus with the journal Science,i

118、n which over 350,000 people took part;we developed a book for children about coronavirus with Institut Curie;Institut Pasteur launched a learning platform about emerging viruses;we worked with OECD and UNESCO to expand the international reach of scientific collaboration in the post-COVID era;we have

119、 developed an international scientific magazine for children living in poverty explaining coronavirus to them in multiple languages.We also initiated a program for people living in confinement in France to share their experiences.IPSEN ANNUAL REPORT24 252019(1)See Chapter 5 of the 2019 Universal Reg

120、istration Document for further information.(2)Independent Director.(3)Director of non-French nationality,including binational.(4)Represented by Anne Beaufour.(5)Represented by Philippe Bonhomme.(6)Director representing the employees.The Board of DirectorsThe Board of Directors(1)determines Ipsens bu

121、siness strategy and oversees its implementation.It has established six permanent specialized committees to assist in fulfilling its oversight and monitoring responsibilities.The current composition and role of the Board of Directors and its Committees as of March 31,2020 are described below.NOMINATI

122、ONS COMMITTEEChairperson:Carol Xueref(3)Members:Beech Tree S.A.(5)and Paul Sekhri(2,3)T H E B OA R D O F D I R E C T O R SChairman:Marc de Garidel-Vice-Chairman:Antoine FlochelMembers:Highrock S.r.l(represented by Anne Beaufour)-Henri Beaufour-Beech Tree S.A.(represented by Philippe Bonhomme)-Margar

123、et Liu(2,3)-Michle Ollier(3)-Jean-Marc Parant(6)-Paul Sekhri(2,3)-Carol Stuckley(2,3)-Piet Wigerinck(2,3)-Carol Xueref(3)ETHICS AND GOVERNANCE COMMITTEEChairperson:Margaret Liu(2,3)Members:Carol Xueref(3)Beech Tree S.A.(5)and Jean-Marc Parant(6)AUDIT COMMITTEEChairperson:Carol Stuckley(2,3)Members:P

124、aul Sekhri(2,3)and Beech Tree S.A.(5)INNOVATION AND DEVELOPMENT COMMITTEE-CONSUMER HEALTHCAREChairman:Marc de Garidel Members:Beech Tree S.A.(3,5)and Carol Xueref(3)Permanent guests:Highrock S.r.l(4)and Henri BeaufourCOMPENSATION COMMITTEEChairman:Antoine Flochel Members:Carol Stuckley(2,3)Piet Wige

125、rinck(2,3)and Carol Xueref(3)INNOVATION AND DEVELOPMENT COMMITTEE-SPECIALTY CAREChairman:Marc de Garidel Members:Antoine Flochel,Margaret Liu(2,3),Michle Ollier(3),Paul Sekhri(2,3)and Piet Wigerinck(2,3)Permanent guests:Highrock S.r.l(4)and Henri Beaufour50%Non-French Directors including binational4

126、5%Gender balance within the Board of DirectorsT H E 6 S P E C I A L I Z E D C O M M I T T E E SAymeric Le Chatelier Interim Chief Executive Officer*,Executive Vice-President,Chief Financial OfficerDominique Laymand Executive Vice-President,Ethics&Social Responsibility Chief Officer Dominique Bery Ex

127、ecutive Vice-President,Strategy&TransformationHoward Mayer,M.D.Executive Vice-President,Head of Research and Development Franois Garnier Executive Vice-President,General Counsel Rgis Mulot Executive Vice-President,Chief Human Resources OfficerBenoit Hennion Executive Vice-President and President,Con

128、sumer HealthCareAidan Murphy Executive Vice-President,Technical Operations Steven Hildemann,M.D.,Ph.D.Executive Vice-President,Chief Medical Officer Richard Paulson Executive Vice-President and Chief Executive Officer of Ipsen North America 5nationalities20%Gender balance The Executive Leadership Te

129、am14 Board and 33 Committee meetings in 2019 with an attendance rate of 93%The Executive Leadership Team(“ELT”)is responsible for establishing consistent management policies and managing the Companys day-to-day operations throughout the Group.The ELT is also tasked with assisting the Chairman of the

130、 Board of Directors in implementing the Boards decisions.The ELT is composed of the Chief Executive Officer and nine Executive members.The current composition of the ELT as of March 31,2020 is as follows:EXTENDED MANAGEMENT TEAM Christian Marcoux,Senior Vice-President,Global CommunicationsHlne Ranno

131、u,Vice-President,Global Internal AuditJames Levine,M.D.,Ph.D.President,Fondation Ipsen*Following the departure of David Meek in December 2019,Aymeric Le Chatelier,Chief Financial Officer,was appointed as interim Chief Executive Officer.IPSEN ANNUAL REPORT26 272019 We innovate for patientsOur goal is

132、 to leave no patient behind and our mission is to prolong and improve patients lives by launching at least one new molecular entity or meaningful indication each year.We also aim to build new strategic relationships with partners who share our passion and commitment to delivering innovation to patie

133、nts around the world.R&D teamMilton Park,UK28 29 Attracting the most promising external innovation CSR strategy-3 pillarsActivity&Strategic Focus AreasResultsResources2019 was a pivotal year for Ipsen.Our sales surpassed the EUR 2.5 billion mark for the first time,with operating profitability also h

134、itting a historical high of 30%of net sales.We also made bold and groundbreaking steps into the area of rare diseases with the completion of our landmark acquisition of Clementia Pharmaceuticals.Our mission is to improve patients lives by delivering on our growth strategy.Core to the strategy is att

135、racting the most promising external innovation so that we can develop and deliver impactful new therapies for more patients around the world affected by cancer,neurological and rare diseases.Our R&D pipeline is the most robust it has been in Ipsens 90-year history.Never has it been as rich as it is

136、today,with multiple Phase III or registration trials scheduled for 2020 our most ever.And by the end of 2020,our firepower for business development will return to EUR 1 billion.Our vitally important Oncology franchise also continued to demonstrate strong double-digit growth across all our major geog

137、raphies,with our blockbuster Somatuline product surpassing the great success of previous years.We committed to becoming a leading oncology company globally,and today,we are proud to say we are one of the worlds top-15 oncology players.But we will not stop there,our intention being to double our grow

138、th in this area by 2023.We will continue to be a key player in oncology,but our goal is to deliver a company in which no single business area represents more than 25%of our revenues,and that means further increasing and delivering excellence across our Neuroscience,Rare Diseases and Consumer HealthC

139、are franchises to deliver global sales of EUR 2.8 billion by 2022.And we have 5,800 committed and loyal colleagues working across the globe to make that happen,with the aim of reinforcing and extending that geographical footprint by expanding our presence in key growth markets such as Japan.At Ipsen

140、,patients are at the heart of everything we do,but we also listen to our stakeholders to ensure our business remains future-proofed in this fast-changing but exciting industry.2.8bnTarget for global sales by 202230%Ipsens profitability hit a historical high of 30%in 20191bnThe amount available for b

141、usiness development opportunities by the end of 2020“Our vision of being a leading global biopharmaceutical company that improves the lives of patients through innovative new medicines remains as strong as ever.”R&DSALES&MARKETINGMANUFACTURINGNEUROSCIENCECONSUMER HEALTHCARERARE DISEASESONCOLOGYP A T

142、 I E N T SNEW PRODUCTS FOR PATIENTSENHANCING INTEGRITY TO MAINTAIN A TRUSTED RELATIONSHIP WITH OUR PARTNERS DRIVING OUR EMPLOYEES EXCELLENCE AND ENGAGEMENTINVESTMENTS IN BUSINESS DEVELOPMENT AND R&DMINIMIZING OUR ENVIRONMENTAL IMPACTOUR GROWTH AND STRONG FINANCIAL PERFORMANCEOUR PORTFOLIO AND PIPELI

143、NEOUR PARTNERSHIPOUR PEOPLEOUR MANUFACTURINGOUR ENVIRONMENTAL CAPITALOUR FINANCIAL ASSETIPSEN ANNUAL REPORT201930 31Our key indicators20192,576+14.8%*2019782.6 30.4%core operating margin20182,225+20.1%*2018659.9 29.7%core operating margin20171,909+21.1%*2017503.626.4%core operating marginSales and o

144、perating income growthIPSEN SALES(in millions)OPERATING INCOME(in millions)*Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.Sales growth adjusted for consolidation scope.*Find out more in th

145、e 2019 Universal Registration Document,section 5-Corporate governance and legal information.2.8bn COMPANY SALES28%CORE OPERATING MARGINOwnership of Ipsens share capital as of March 31,2020*41.3%FREE FLOAT2.3%OTHER SHAREHOLDERS26.03%HIGHROCK26.03%BEECH TREE4.34%SCHWABE 2022 financial outlookUpdated o

146、n May 202032 33IPSEN ANNUAL REPORT2019*Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.Sales growth adjusted for consolidation scope.*France,Germany,Italy,United Kingdom and Spain.33%Major W

147、estern European Countries*+13.3%*Sales growth30%North America+19.5%*Sales growth19%Other European Countries+12.9%*Sales growth18%Rest of the world+12.8%*Sales growthSales by geographic areaSales by therapeutic areaA strong commitment to R&D620+EMPLOYEES WORKING IN R&D3 MAJOR R&D CENTERS6 CLINICAL ST

148、UDIES IN PHASE III*Year-on-year growth excluding foreign exchange impact established by recalculating net sales for the relevant period at the rate used for the previous period.Sales growth adjusted for consolidation scope.89%Specialty Care+17.2%*Sales growth72%Oncology15%Neuroscience3%Rare Diseases

149、11%Consumer HealthCare-1.2%*Sales growth 201938915.1%of 2019 sales2018302 13.6%of 2018 sales 201726613.9%of 2017 sales R&D investments(in millions)34 35IPSEN ANNUAL REPORT2019 Our R&D pipeline is richer than ever389MThe amount invested in R&D in 20193Global R&D hubs in Oxford,UK;Paris-Saclay,France;

150、Cambridge,U.S.620+More than 620 staff dedicated to R&DIPSEN INNOVATION CENTER|BIOLABSIn April 2019,we were extremely proud to open our Biolabs facility in Kendall Square,Cambridge,the global heart of biotech innovation.The Innovation Center is a collaborative space for early-stage life sciences comp

151、anies,entrepreneurs,researchers and investors to bring new therapies for patients with cancer,rare diseases and neurological disorders.There are 15-20 emerging biotech companies that have the ability to access our expertise.This in turn allows Ipsen to be connected to the Cambridge biotech ecosystem

152、 that fosters innovative science and technology.OUR PIPELINEWe are growing our pipeline with new drugs and new indications in Oncology,Neuroscience and Rare Diseases to serve patients worldwide.2019 was another excellent year of operating performance at Ipsen with continued double-digit top-line gro

153、wth.Our aim is to see that continuing in 2020 and the development of our R&D business will be crucial to making that happen.Our late-stage R&D pipeline is the most robust in Ipsens history and we intend to further advance our pipeline programs in 2020 in order to deliver strong,sustainable growth fo

154、r many years to come.We appointed Dr.Howard Mayer in December to lead this vital organization and he was given a clear mandate to grow our R&D portfolio,execute on clinical programs,attract world-class talent and position the organization for many future successes.That is already happening.Our futur

155、e business prospects are extremely healthy and our R&D pipeline demonstrates that.Never has it been as rich as it is today,with our most ever Phase III or registration trials scheduled for 2020.In addition,we have nine significant regulatory submissions planned from 2019 to 2022.We continue to inves

156、t in external innovation in three key therapeutic areas Oncology,Neuroscience and Rare Diseases and are evaluating assets in these areas in all phases of clinical development.By the end of 2020 our firepower for development will return to a mighty EUR1billion.We tackle some of the most difficult-to-

157、treat cancers and continually bring new patient treatment options,including two new Phase III trials for Onivyde based on highly promising data released in 2019 for second-line small cell lung cancer and first-line metastatic pancreatic cancer.Additionally,in April 2020,we announced positive top-lin

158、e results from our pivotal Phase lll CheckMate-9ER trial evaluating Cabometyx in combination with Opdivo(nivolumab)in previously untreated advanced or metastatic renal cell carcinoma.This trial met its primary endpoint of progression-free survival at final analysis,as well as the secondary endpoints

159、 of overall survival(OS)at a pre-specified interim analysis,and objective response rate.This holds great promise for us,allowing us to further “Our late-stage pipeline is the most robust in Ipsens history.We are actively growing our oncology,rare diseases and neuroscience pipelines as we continue to

160、 deliver meaningful treatments to patients around the world.”expand the drug and make it the tyrosine kinase inhibitor of choice.We want to fulfill our promise to bring at least one new asset or major indication to the market each year and our teams are working tirelessly to do just that.But it is p

161、atients who ultimately inspire us to make that happen.Their insights and experience are at the forefront when we design our clinical trials.We listen to them in order to properly understand what matters most.And thats because patients cant wait.Our products have the potential to provide meaningful c

162、linical benefits and weve made a commitment to innovate for improved outcomes,including extending lives,function and quality of life.This is what drives us.Howard Mayer,M.D.Executive Vice-President and Head of Research&Development36 37As of February 13,2020 Oncology Rare Diseases Neuroscience New ch

163、emical entity*Trial paused following prespecified interim futility analysis;pending further assessment*Partial clinical hold for all patients 14 years of age as of December 6,2019,GEP-NET:gastroenteropancreatic neuroendocrine tumors,HCC:hepatocellular carcinoma,PDAC:pancreatic ductal adenocarcinoma,

164、PUL:pediatric upper limb,mrBoNT/A:recombinant Botulinum Toxin Type A,rBoNT/E:recombinant Botulinum Toxin Type E,RCC:renal cell carcinoma,SCLC:small cell lung cancer,1L:First line,2L:Second line,3M:3-monthPHASE IIIREGISTRATIONDYSPORT Glabellar lines(China)DYSPORT Glabellar linesPRECLINICALPHASE IPHAS

165、E IILONGER-ACTING TOXIN mrBoNT/ALONGER-ACTING TOXIN mrBoNT/A IPN10360(rBoNT/E)Glabellar linesCABOMETYX Solid tumors combination with atezolizumab177Lu-IPN-01072(Satoreotide tetraxe-tan)GEP-NET and non-NETIPN60090(MD Anderson)177Lu-IPN-01087 NTSR1 Solid tumors68Ga-IPN-01070(Satoreotide trizoxetan)GEP

166、-NET and breast cancer imagingDYSPORT Hallux ValgusDYSPORTVulvodyniaDECAPEPTYL 3M Endometriosis(China)CABOMETYXHCC 1L combination with atezolizumabCABOMETYXRCC 1L combination with nivolumabIPN60120 (Palovarotene)FOPBLU-782(ALK2 inhibitor)FOPIPN60120 (Palovarotene)FOP Chronic*,*IPN60120 (Palovarotene

167、)MOONIVYDESCLC 2LONIVYDEPDAC 1LFocus onOur assets in oncology 14Ipsen is among the worlds top 14 pharmaceutical companies specializing in oncology72%of Ipsens sales come from the Oncology unit30Ipsen has a rich 30-year history in oncology2019 was another remarkable year for Ipsen in Oncology,with co

168、ntinued strong double-digit growth across all our major geographies.Our blockbuster Somatuline(lanreotide)notched up solid double-digit growth in 2019,fuelled by the implementation of a new delivery system,which allowed us to consolidate our position as a top oncology company.Ipsen has built its str

169、ength in oncology through solid long-term partnerships which are fast-tracking new approaches to target hard-to-treat cancers that are often overlooked as research targets.A great example of our partnerships is our collaboration with Exelixis,with Cabometyx(cabozantinib)securing vital approvals in 2

170、019 for the treatment of kidney and liver cancer in many markets,including Hong Kong,Canada,South Korea and the Middle East.Putting patients firstWe tackle some of the most difficult-to-treat cancers and continually bring new treatment options to patients.As such,we are delighted to be able to relea

171、se extremely promising data from the Phase III trial for our drug Onivyde pegylated liposomal(irinotecan)in the battle against second-line small cell lung cancer and first-line metastatic pancreatic cancer.Our goal is to make Onivyde the standard of care in rare cancers.We have also underlined our c

172、ommitment to patients living with neuroendocrine tumors and have ten company-sponsored studies currently in progress to examine various aspects of the disease,while supporting a further seven investigator-initiated pieces of work.Achieving better cancer outcomes calls for different thinking and a fe

173、arless approach to research.Our commitment and bold approach to research has been,and continues to be,key to delivering results for patients in most need.The future is brightOncology is vital to Ipsen and is at the core of everything we do.The franchise accounts for more than two-thirds of the compa

174、nys entire sales,ranking Ipsen among the worlds top 14 pharmaceutical companies specializing in oncology.But we think we can do even better,and by putting patients first we have no doubt we can grow this vitally important franchise further.Our future success centers on embracing patients at every le

175、vel of the company and for Oncology that is no different.For us to succeed,patients must be at the heart of everything we do.BOOSTING OUR PORTFOLIO IN ONCOLOGYIpsen offers a broad range of high-quality,innovative treatments to help improve the lives of patients with cancer.BLADDER CANCER2nd most fre

176、quent urological cancer,after prostate cancerHEXVIXImproved treatment and improved detection and resection of non-invasive bladder cancer(5).MEDULLARY THYROID CANCER5%of thyroid cancersCOMETRIQSignificant difference in the duration of progression-free survival with cabozantinib(11.2 months)versus pl

177、acebo(4 months)(1).RENAL CELL CARCINOMAMore than 250,000 new cases per year worldwideCABOMETYX1st and only multi-targeted therapy to prolong survival,slow disease progression,and shrink tumors in 1L and 2L RCC(4).BREAST CANCER20%of invasive breast cancer in premenopausal patientsDECAPEPTYL86.6%disea

178、se-free survival at five years when added to tamoxifen,22%risk reduction in distant recurrence when added to exemestane(2).HEPATOCELLULAR CARCINOMA On the global scale,primary liver cancer is a major contributor to both cancer incidence and mortality.It is the sixth most commonly occurring cancer in

179、 the world and the second largest cause of cancer mortalityCABOMETYXSignificant overall survival benefit in patients with previously treated advanced hepatocellular carcinoma(HCC)(3).PROSTATE CANCER2nd most common type of cancer in menDECAPEPTYLOver 90%of patients achieve and maintain medical castra

180、tion below the most stringent threshold levels(20 ng/dl)(9).NEUROENDOCRINE TUMORS171,000 people living with NETs in the United States.Incidence rate of approximately 6.98 cases per 100,000 people(6a)SOMATULINEA 53%relative risk reduction of disease progression or death(6b).PANCREATIC CANCER3rd leadi

181、ng cause of cancer-related death in the United StatesONIVYDESignificant improvement of overall survival in adult patients with metastatic adenocarcinoma of the pancreas(8).CARCINOID SYNDROMEOccurs in about 20%of all neuroendocrine tumors(7a)XERMELOReduction in bowel movements in heavily pretreated p

182、atients;30%improvement for more than 50%of the study period in durable responders(7b).38 39Our Neuroscience franchise continues to perform very well.Today,it represents 18%of our Specialty Care business,with almost 1,000 employees working within Neuroscience.The business unit is integral to the comp

183、anys overall strategy and long-term growth,notching up sales of almost 400 million in 2019.Key to that success is Dysport(abobotulinumtoxinA),our flagship spasticity and cervical dystonia therapy,which enjoyed double-digit growth year on year and has proven to be vitally important to patients.Dyspor

184、t has been revolutionary,and we have secured approvals around the world for the drugs use in the treatment of spasticity in adults suffering from traumatic brain injury and multiple sclerosis and those who have had a stroke.It has also been integral in the treatment of upper limb spasticity in child

185、ren with cerebral palsy.And Dysports impact continues to increase.At the end of 2019,and early this year,it was granted approval in the U.S.and several European countries,including the U.K.and France,for the treatment of upper limb focal spasticity in pediatric patients.We are extremely proud of the

186、se important advances for children living with spasticity,who can now benefit from long-lasting symptom relief.The next 10 yearsOver the next decade,our Precision TSI technology will be front and center of an unrivalled research program that is driving a new generation of recombinant neurotoxins.Dev

187、eloped at our R&D center in Oxford,this proprietary cutting-edge technology enables us to not only manufacture botulinum neurotoxins identical to those found in nature,but to make specific changes,modifying aspects of their function to enhance their potential therapeutic applications.Utilizing this

188、powerful Precision TSI technology platform,we have the potential to design a new generation of neurotoxins that can bring new clinical benefits to patients and open horizons that extend beyond neuroscience and into areas such as oncology,endocrinology,pain management,regenerative medicine and rare d

189、iseases.For over 30 years,Ipsen has been a leader in neuroscience,seeking to understand patients needs and developing solutions to meet them.We are rightly proud of what we have achieved and very much look forward to the next 30 years.Focus onOur assets in neuroscience BOOSTING OUR THERAPEUTIC PORTF

190、OLIO IN NEUROSCIENCEWith botulinum toxin type A Dysport,Ipsen is able to offer a single product(0)to treata range of therapeutic indications.BLEPHAROSPASMBlepharospasm is an abnormal contraction of the eyelid that can be chronic and persistentPrevalence from 16 to 133 cases per million(4a)(4b).Signi

191、ficant reduction of the frequency and intensity of facial spasms as well as sustained improvement in the reduction of functional disability up to 16 weeks(5).HEMIFACIAL SPASMHemifacial spasm is a neuromuscular disease characterized by irregular,involuntary muscle contractions on one side of the face

192、Estimated prevalence of 14.5/100,000 in women and 7.4/100,000 in men(6).Significant reduction in functional disability and improvement of quality of life(7).PEDIATRIC LOWER LIMB SPASTICITYCerebral palsy is the most common cause of spasticity and physical disability in childrenPrevalence of 1.5 to 3

193、cases per 1,000 live births(9)(10).90 percent of patients with CP will present spastic hypertonia(11).Sustained clinical improvements in muscle tone,spasticity,overall clinical benefit and goal attainment across treatment cycles,for children aged 2 and above.ADULT SPASTICITYSpasticity is one of the

194、most common and disabling conditions associated with many neurological diseases in adults(stroke,traumatic brain injury,etc.).It is characterized by velocity-dependent muscle hyperactivityIncidence of post-stroke spasticity between 17%and 42,6%(8).Significant and sustained improvement of muscle tone

195、 and passive function after repeated injections in adult upper limb spasticity,as well as significant and sustained reduction of tone associated with improvement of walking in adult lower limb spasticity.CERVICAL DYSTONIACervical dystonia is a rare neurological disorder characterized by involuntary

196、muscle contractions in the neck that cause abnormal movements and posture of the neck and headPrevalence estimated at 57 cases per million in the EU(1)and at 89 cases per million in the USA(2).Sustained symptom control and a significant reduction of disease associated pain with reduction of symptoms

197、 for up to 15-17 weeks(3).AXILLARY HYPERHIDROSISAxillary hyperhidrosis(HH)is excessive sweating due to overactivity of the sweat glands.It affects about 1%-3%of the population(12)The median duration of efficacy ranges from 5 to 9 months(13).30Ipsen has been a leader in neuroscience for more than 30

198、years40 4118%Our Neuroscience franchise represents 18%of our Specialty Care businessRare diseases have been a key focus for Ipsen for many years,with the goals of bringing scientific advancements to patients,investing significantly in R&D and leveraging global expertise across our local presence.We

199、have established rare disease assets,which include approved treatments for two rare growth disorders:severe primary IGF-1 deficiency and acromegaly.In 2019,Ipsen made the strategic decision to expand its presence in rare diseases with the acquisition of Clementia and its lead investigational agent p

200、alovarotene,and the signature of an exclusive license agreement with Blueprint Medicines for the development and commercialization of IPN 60130(BLU-782).Our goal is to be able to offer the broadest possible suite of treatment options for people living with fibrodysplasia ossificans progressiva(FOP)a

201、n ultra-rare disease in which muscle tissue and connective tissue,such as tendons and ligaments,are gradually replaced by bone.We have encountered a few hurdles,including the delay in the palovarotene clinical trial program,but we remain absolutely committed to bringing palovarotene to people living

202、 with FOP as fast as possible.Our ultimate goal is to leave no patient behind.With a long history and expertise in specialized medicines,we remain focused on building a leading franchise in Rare Diseases.A cornerstone of the companyOur team are committed to making innovative new treatments available

203、 as quickly as possible to people with rare diseases,so-called because they affect a very small proportion of the patient population,ranging from several hundreds to many thousands of people worldwide.Further developing our presence in rare diseases constitutes a natural path forward for us.We will

204、continue to expand in this area of high unmet medical needs,leveraging expertise from development to commercialization to establish leadership positions and provide innovative treatments.Patients and their families best understand the complexity and challenges of living with a rare disease.This is w

205、hy we are committed to collaborating with rare disease patients and integrating their insights into our efforts from the early stages of R&D.Focus onOur assets in rare diseases “With a long history and expertise in specialized medicines and an innovative late-stage product pipeline,we are deeply com

206、mitted to delivering life-changing treatments to rare disease patients around the world.”A STRONG PORTFOLIO IN RARE DISEASESWe are deeply committed to drug development in the area of rare and ultra-rare diseases where there are multiple high unmet medical needs and often a limited understanding of t

207、he disease itself.Today,Ipsen offers a broad range of high-quality,innovative treatments to help improve the lives of patients with rare diseases.Our ultimate goal is to leave no patient behind.INCRELEXis a recombinant insulin-like growth factor(IGF-1)that treats Severe Primary IGF1 Deficiency(SPIGF

208、D),an extremely rare growth disorder.It has obtained orphan drug status based on the low incidence of the disease,which affects fewer than two people per 10,000(1).In 2017,a new European Ipsen manufacturing site was approved by both the European Medicines Agency and the Food and Drug Administration

209、to produce Increlex.It is the only drug available in Europe and U.S.for children living with severe primary insulin-like growth factor deficiency(2).DECAPEPTYLis approved for the treatment of central precocious puberty(CPP)(1).There is potential opportunity for greater use of this treatment in the E

210、uropean Union,China and Russia.NUTROPINAQis a liquid formulation of recombinant human growth hormone administered with the NutropinAq Pen(1).Available in more than 20 countries,notably in Europe and Australia,it is indicated in children and adults for the treatment of growth failure stemming from va

211、rious origins.SOMATULINEis used for the long-term treatment of acromegaly in patients who cannot be treated with surgery or radiation.Acromegaly is a rare disease caused by excessive growth hormone production resulting from a tumor in the pituitary gland.Between 2.8 to 13.7 people in 100,000 are aff

212、ected by this disease(1)(2).Building a leading Rare Diseases franchiseWith a long history and expertise in specialized medicines,we remain focused on building a leading Rare Disease franchise.In April 2019,we made great strides in doing so by establishing a leadership position in fibrodysplasia ossi

213、ficans progressiva(FOP)with the acquisition of Clementia Pharmaceuticals and its anchor asset,palovarotene.We further strengthened that position in October 2019 by entering into an exclusive,global license agreement with Blueprint Medicines for the development and commercialization of IPN 60130(form

214、erly BLU-782),an oral,highly selective investigational ALK2 inhibitor being developed for the treatment of FOP.PALOVAROTENE:WE REMAIN ABSOLUTELY COMMITTED TO BRINGING PALOVAROTENE TO PEOPLE LIVING WITH FOP AS FAST AS POSSIBLEPalovarotene is a RAR agonist being developed as a potential treatment for

215、patients with ultra-rare and debilitating bone diseases including fibrodysplasia ossificans progressiva(FOP)and multiple osteochondromas(MO)as well as other conditions including dry eye disease.Palovarotene has rare pediatric disease and breakthrough therapy designations for the treatment of an ultr

216、a-rare bone disorder.Despite some clinical challenges in the past year,we are delighted to have a positive path forward for palovarotene,the most advanced clinical program for the treatment of FOP,and will continue our conversations with the health authorities to determine the most appropriate regul

217、atory path forward.We are committed to making innovative therapeutic treatments available to people with rare diseases and supporting them and their families.KEY MILESTONESApril 18,2019-Ipsen completed the acquisition of Clementia Pharmaceuticals,significantly enhancing its Rare Diseases portfolio w

218、ith a late-stage drug candidate,palovarotene,for the treatment of rare bone disorders.December 6,2019-We initiated partial clinical hold for palovarotene IND120181 and IND135403 studies.January 24,2020-Our palovarotene clinical program in FOP reached pre-specified interim analysis futility criteria.

219、However,based on encouraging therapeutic activity signals observed in post-hoc analyses and recommendations from the Independent Data Monitoring Committee,Ipsen opted not to discontinue the trial but to temporarily pause dosing.March 26,2020-Ipsen is to reinitiate palovarotene dosing in patients 14

220、years of age and older with fibrodysplasia ossificans progressiva.It is also set to terminate MO-Ped trial(PVO-2A-201)in patients with multiple osteochondromas to analyze accumulated data and assess the future of palovarotene in this indication.42 43Focus on Our assets in consumer healthcare 80Our p

221、roducts are available in 80 countries,with China,France and Russia as our top three marketsIn parallel to Ipsens mission,we are fully committed to making our Consumer Healthcare business autonomous and sustainable through our core ambition:bring care and comfort to the daily lives of people around t

222、he world with healthcare solutions they can trust.Despite a challenging environment in our top two markets,China and France,we made significant progress in 2019 in achieving our ambition.We developed and delivered a portfolio of strong and purposeful products for pa-tients and consumers.A few years

223、ago,we reinvigorated our portfolio with Smecta,our number-one brand in the Gastro Intestinal category.We have since pursued cognitive disorders,pain,as well as cough and cold brands.And in 2019,we rolled out a number of meaningful line extensions,including probiotics and medical devices across most

224、of our major geographies.From a geographic standpoint,we walked the talk in 2019 in terms of our strategy.We reinforced our footprint in Europe and established our presence in Italy and Central and Eastern Europe.Russia another one of our top markets also delive-red remarkable growth.Lastly,we made

225、great strides in growing our autonomy last year.Since April 2019,most of the assets and teams have been integrated in a dedicated legal structure.This strategic move aims to maximize our chances of winning in the Consumer Healthcare arena.It creates the conditions for operating this business with cu

226、sto-mized operational processes fully adapted to the competitive consumer healthcare environment.It also creates the optimal conditions to deliver on our next strategic objective for this activity:reach critical mass and sustainability through business development.BOOSTING OUR PORTFOLIO IN CONSUMER

227、HEALTHCAREThe Ipsen Consumer HealthCare product portfolio continues to grow,improving existing treatments and providing new solutions for patients and consumers.Gastrointestinal conditionsADENURIC(1)First major treatment of gout for more than 40 years and best in class for the treatment of symptomat

228、ic gout.TANAKAN(1)Standardized,patented ginkgo biloba extract(EGb 761)for the symptomatic treatment of such cognitive disorders as memory deficit and concentration disturbances in the elderly,and for vertigo and tinnitus.Other conditionsFORLAX Reactivates the bowels natural efficacy and restores the

229、 regular frequency of stools within 24 to 48 hours to respect the natural rhythm.It operates by reeducating the bowel without irritating the bowel or making it dependent.SMECTAGO(2)This ready-to-use liquid stick is used in the short-term treatment of acute diarrhea,in addition to use for dietary mea

230、sures.PAXELADINE(1)Used for irritative cough,allergic cough,cough in patients with heart disease,tracheitis,bronchitis and other conditions.PRONTALGINE(1)An analgesic for the treatment of moderate to severe pain,combining paracetamol,caffeine and codeine.BUSCOPAN(1)An antispasmodic used to relieve s

231、mooth muscle spasms(cramps)in the stomach and intestines and in the bladder and urethra.FORTRANS(1)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 weigh

232、t with added electrolytes.ETIASA(1)Treats Inflammatory Bowel Diseases(ulcerative colitis and Crohns disease)during acute phase and to maintain remission.SMECTA(1)Stops and treats diarrhea,removes the toxins and germs at the heart of the problem,helps to repair intestinal damage with its natural coat

233、ing properties and relieves abdominal pain.SMEBIOCTA COMFORTA scientifically selected microbiotic strain that interacts with the microbiota to help the management of intestinal discomfort.SMEBIOCTA PROTECTAn exclusive high dose combination of a yeast and a microbiotic strain that helps to protect th

234、e intestinal microbiota and restore its balance.Can be taken during antibiotherapy.EZICLEN/IZINOVA(1)New generation of bowel cleansing preparation.Reduces considerably the quantity of liquid to be ingested by the patient,improves the cleansing quality,and increases the efficacy of colonoscopies.SMEC

235、TAGAS(2)An exclusive dual action against gas and bloating that favors fast gas elimination and restores a healthy gut microbiota.FORLAXGO(2)Ready-to-use liquid stick,Forlaxgo is a laxative treatment of occasional constipation in adults and children from 8 years old.A ROBUST,90-YEAR HISTORYIpsens his

236、tory shows how entrepreneurship,ambition and tenacity have transformed the small-town French pharmacy created in 1929 into a global leader in Specialty Care.With this same mindset,we are transforming our heritage in primary care into a successful Consumer HealthCare business that is both sustainable

237、 and autonomous.44 45United StatesBrazilAustraliaSingaporeVietnamTaiwanChinaSwedenFinlandLithuaniaLatviaCanadaMexicoFinlandUnited StatesBrazilAustraliaSingaporeVietnamTaiwanChinaSwedenFinlandLithuaniaLatviaPortugalFranceItalyHungaryGermanyBelgiumSpainAlgeriaTunisiaUkraineRomaniaCzech RepublicPolandN

238、etherlandsUnitedKingdomIrelandDenmarkGreeceCanadaMexicoRussiaKazakhstanLebanonSouth KoreaDubaiSwitzerlandSlovakiaOur global presenceIpsen operates in 115 countries.Our most important sites in R&D and manufacturing are located in China,France,Ireland,the United Kingdom and the United States.Over 115c

239、ountries whereIpsen products are registered4pharmaceutical development centers37countries where Ipsen has a direct presence3R&D hubsFinlandUnited StatesBrazilAustraliaSingaporeVietnamTaiwanChinaSwedenFinlandLithuaniaLatviaPortugalFranceItalyHungaryGermanyBelgiumSpainAlgeriaTunisiaUkraineRomaniaCzech

240、 RepublicPolandNetherlandsUnitedKingdomIrelandDenmarkGreeceCanadaMexicoRussiaKazakhstanLebanonSouth KoreaDubaiSwitzerlandSlovakia46 47IPSEN ANNUAL REPORT2019Our manufacturingand R&D sitesAt Ipsen,we draw on our manufacturing and R&D expertise to propose life-changing molecules across the globe.R&D O

241、xfordDesigned to foster innovation and collaboration in Neuroscience,this pioneering R&D center hosts Ipsens technological platform for botulinum toxins and has unique experience in recombinant botulinum toxins technology.The site also hosts other R&D activities such as regulatory affairs,pharmacovi

242、gilance,publications,and clinical development.R&D BerlinThe Berlin site specializes in the radiopharmaceutical development of peptides and small molecules.These activities focus on radiolabeling process development and validation.GERMANYMANUFACTURING AND R&D DublinAs Ipsens center for the production

243、 and development of peptide active pharmaceutical ingredients(APIs),the site produces the APIs for both Somatuline and Decapeptyl.It also handles chemical process and analytical method activities for peptide and small molecule APIs.MANUFACTURING CorkThis site joined Ipsen as a result of a joint vent

244、ure with Schwabe.The extract of ginkgo biloba-EGb 761-is produced there and used for Tanakan and Ginkor.IRELANDMANUFACTURING AND R&DCambridgeThe R&D site is dedicated to enhancing the pipeline with clinical assets,with a focus on Oncology and Rare Diseases.It also hosts teams dedicated to coordinati

245、ng and conducting worldwide clinical research and North America regulatory activities.The manufacturing site produces the bulk drug product for Onivyde patients worldwide.UNITED STATESMANUFACTURING AND R&DWrexhamThe site is the companys sole biological R&D and fully integrated manufacturing facility

246、.This center of expertise is specialized in active ingredients,clinical drug and commercial manufacturing and distribution.Some teams focus on the development of novel products in Neuroscience supported by bioprocess,formulation and analytical functions,while others work in lifecycle management and

247、new recombinant toxin manufacturing projects.UNITED KINGDOMFRANCEMANUFACTURING AND R&DDreuxThe manufacturing site,specialized in the production of oral formulations,also handles the global distribution of products.R&D activities focus on the pharmaceutical development of new products for Specialty C

248、are(Oncology and Rare Diseases)and Consumer HealthCare.The site also hosts the clinical supply chain activities for clinical studies.MANUFACTURINGLIsle-sur-la-SorgueLIsle-sur-la-Sorgue is Ipsens only site for processing clays,notably used in Smecta,Bedelix,Actapulgite and Gelox.Approximately two-thi

249、rds of the production is for Europe and China.R&D Paris-SaclayThe sites core mission is to accelerate clinical development,translational and fundamental research to deepen the understanding of the molecular,pharmacologic,pharmacodynamic and pharmacokinetic properties of new molecules in Oncology,Neu

250、roscience and Rare Diseases.MANUFACTURINGSignesThis facility specializes in the manufacturing and packaging of injectable formulations,particularly sustained release formulations of peptides(Decapeptyl/Pamorelin,Somatuline and NutropinAq).The site exports to over 70 countries worldwide.MANUFACTURING

251、 TianjinPresent in Tianjin since 1992,Ipsen created a local production facility for Smecta in 2000.The site packages this product for the Chinese market and is also the distribution platform for Ipsens portfolio and other medical products in China.CHINAR&D BeijingCreated in Beijing in 2012,the Asia

252、Group Drug Development team is the platform in charge of clinical trial coordination in Asia.48 49IPSEN ANNUAL REPORT2019Thank 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 Ipse

253、n or its partners in more than one country.Produced by Ipsen,Global Communications.Designed,edited and printed by:Photo credits:CAPA Pictures:Frank Rogozienski-Adam Wiseman-Pierre-Olivier-Patrick Wack-Toni Ricart-Pedro GuimaresDisclaimerThe Ipsen Annual Report is a non-promotional document intended

254、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 strictly prohibited.ReferencesPages 38-39 MEDULLARY THYROID CANCER(

255、1)Cometriq SmPC:https:/www.ema.europa.eu/en/documents/product-information/cometriq-epar-product-information_en.pdf BREAST CANCER(2)Decapeptyl Public assessement report:http:/www.mhra.gov.uk/home/groups/par/documents/websiteresources/con811924.pdf HEPATOCELLULAR CARCINOMA(3)Cabometyx SmPC:https:/www.

256、ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf RENAL CELL CARCINOMA(4)SmPC Cabometyx:https:/www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf BLADDER CANCER(5)Hexvix information:https:/ NEUROENDOCRINE TUMORS(6a)Dasa

257、ri,JAMA Oncology 2017.0589(6b)Caplin,N Engl J Med 2014;371:224-33 CARCINOID SYNDROME(7a)Cella-Clinical Therapeutics/Volume 40,Number 12,2018(7b)Xermelo SmPC:https:/www.ema.europa.eu/en/documents/product-information/xermelo-epar-product-information_en.pdf PANCREATIC CANCER(8)Onivyde SmPC:https:/www.a

258、ccessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf PROSTATE CANCER(9)SmPC Decapeptyl is available on InternetPages 40-41(0)https:/www.medicines.org.uk/emc/product/7261/smpc(1)Epidemiological Study of Dystonia in Europe(ESDE)Collaborative Group.A prevalence study of primary dystonia in eight

259、European countries.J Neurol 2000;247(10):787-92(2)Nutt JG,Muenter MD,Aronson A et al.Epidemiology of focal and generalized dystonia in Rochester,Minnesota.Mov Dis 1988;3(3):188-94(3)Truong D,Brodsky M,Lew M,et al.Long-term efficacy and safety of botulinum toxin type A(Dysport)in cervical dystonia.Pa

260、rkinsonism Relat Disord 2010;16(5):316-23(4a)Defazio G,Hallett M,Jinnah HA et al.Blepharospasm 40 years later.Mov Disord 2017;32(4):498-509(4b)Steeves TD,Day L,Dykeman J et al.The prevalence of primary dystonia:a systematic review and meta-analysis.Mov Disord 2012;27(14):1789-96(5)Truong D,Comella C

261、,Fernandez HH,et al.Efficacy and safety of purified botulinum toxin type A(Dysport)for the treatment of benign essential blepharospasm:a randomized,placebo-controlled,phase II trial.Parkinsonism Relat Disord 2008;14:407-14.(6)Tan NC,Chan LL,Tan EK.Hemifacial spasm and involuntary facial movements.QJ

262、M 2002;95(8):493-500(7)Tsai CP,Chiu MC,Yen DJ,et al.Quantitative assessment of efficacy of Dysport(botulinum toxin type A)in the treatment of idiopathic blepharospasm and hemifacial spasm.Acta Neurol Taiwan 2005;14:61-8(8)Milinis K et al.Disability and Rehabilitation,2015;29:1-11(9)Himmelmann K,Hagb

263、erg 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(10)Cans C.Surveillance of cerebral palsy in Europe:a collaboration(11)Lance JW.Symposium synopsis.In:Feldman RG,Young RR,Koeller C.Spast

264、icity:disordered motor control.Chicago:Year Book Medical,1980;485-494(12)J.Hornberger et al,Journal of Am Acad Dermatol;August 2004(13)M.Lecouflet,MD et al,J Am Acad Dermatol 2013;69:960-64,M.Heckmann et al,N Engl J Med 2001;344:488-493Pages 42-43 SOMATULINE ACROMEGALY(1)Lavrentaki et al.Pituitary 2

265、017(to reference the epi part)(2)Somatuline SmPC(available on Internet)INCRELEX(1)https:/www.ema.europa.eu/en/documents/orphan-designation/eu/3/06/373-public-summary-positive-opinion-orphan-designationmecasermin-treatment-primary-insulin-growth_en.pdf(2)Increlex SmPC:https:/www.ema.europa.eu/en/docu

266、ments/product-information/increlex-epar-product-information_en.pdf NUTROPINAQ(1)NutropinAq SmPC https:/www.ema.europa.eu/en/documents/product-information/nutropinaq-epar-product-information_en.pdf DECAPEPTYL(1)Decapeptyl SmPC(available on internet)P44-45:(1)Product CCDS(Company Core Data Sheet)(2)Product Intended Use Document(3)Scientific BrochureDISCLAIMER AND REFERENCES65,quai Georges-Gorse92100 Boulogne-BillancourtFFOLLOW USOn Twitterhttps:/ Facebookhttps:/ LinkedInhttps:/ YouTubehttps:/