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1、2023 INTEGRATED ANNUAL REPORTINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS2The people behind Ipsens purpose and passion“I am inspired every day by the dedication of the people here at Ipsen and the amazing opportunity we have to really make a difference for patien
2、ts and their families.”Eight-year-old Savannah lives with fibrodysplasia ossificans progressiva(FOP).“If someones sad about FOP,then I would say,Its okay,because FOP is rare,and that means youre special.”Daniel is Senior Director,Neuroscience Marketing,North America.Behind the disease statistics and
3、 the performance indicators are people.Some are living with high unmet medical needs.Some are not.But they all share a common trait:they want to have a positive impact.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS3Contents The people behind Ipsens purpose and pass
4、ion:meet Daniel and Savannah 22023 highlights and key results 4Bringing Ipsen into the next phase of growth:David Loew,Chief Executive Officer 52023:successfully implementing our strategy 7 Dynamic growth built on solid foundations 8Striving for balance across our business 9Ipsens growth strategy:ac
5、celerating innovation 10Generation Ipsen 11 Purpose,passion,precision 12 The people behind Ipsens purpose and passion:meet Hub and Stphane 14Oncology 15 Rare Disease 17 Neuroscience 19 Prioritizing communication with patient organizations 21 R&D and innovation:a closer look 23 Expanding our high-val
6、ue,sustainable pipeline 24Digital transformation to boost performance 25 Our global presence 26Our production sites 27 The people behind Ipsens purpose and passion:meet Gill and Jay 28 Generation Ipsen:our four pillars 30Accelerating value addressing risk 31Environment:caring for the planet 32Patien
7、ts:driving everything we do 33People:making a real impact,every day 34People:caring for our communities 35Governance:acting with integrity and responsibility 36Fondation Ipsen 37The people behind Ipsens purpose and passion:meet Jude and Marie 38 Board of Directors 40 Executive Leadership Team 41Crea
8、ting value for patients and society 42Assessing and defending against risks 4320222023 financial KPIs 442023 total sales 45The people behind Ipsens purpose and passion:meet Stephen and Justine 46References and credits 48Forward-looking statements 49INTRODUCTIONTHERAPY AREAS2023 BUSINESS REVIEWGENERA
9、TION IPSENCORPORATE GOVERNANCEINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS42023 highlights and key resultsEntering the next phase of growthFour new medicines or indications for near-term launchOnivyde elafibranorBylvay Sohonos In March 2023,Ipsen acquired Albireo
10、 Pharma,a leading innovator in the treatment of rare liver conditions.Albireos novel bile-acid modulators,such as Bylvay(odevixibat),offer promising results for rare pediatric and adult cholestatic liver diseases.Bylvay was approved in its second indication in June 2023 by the U.S.Food and Drug Admi
11、nistration(FDA)for patients living with cholestatic pruritus due to Alagille syndrome.The acquisition of Albireo demonstrates Ipsens continued strengthening of its rare disease expertise and focus.Albireo acquisition enriches Rare Disease portfolio*At constant exchange rates.Of total sales.Based on
12、net debt at 2.0 x EBITDA.in the Global Leadership Teamadded since 2020recognize Ipsen as an employer of choicein absolute facility and fleet(Scopes 1&2)carbon emissions vs 2019 base year53%252536%WOMENNEW ASSETSCOUNTRIESREDUCTIONtotal salescore operating margininvestment in R&D (20%of total sales)in
13、 available firepower (end 2023)growth platform salessales of new medicines3.128bn32%619m1.9bn+13%*119mINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS5Bringing Ipsen into the next phase of growthDavid Loew,Chief Executive Officer 2023 marked the beginning of a new ph
14、ase for Ipsen,one that we began preparing when we launched our strategy at the end of 2020.Over the past three years,we have shifted from reliance on the blockbuster Somatuline(lanreotide)to four growth platforms:Onivyde(irinotecan liposome injection),Cabometyx(cabozantinib),Dysport(abobotulinumtoxi
15、nA)and Decapeptyl(triptorelin).Weve enriched our portfolio,acquiring Epizyme(oncology)in 2022,and Albireo(rare liver disease)in early 2023.Our pipeline has also expanded,adding more than 25 new assets since 2020.This growth has been possible thanks to the efficiencies we have generated,which we have
16、 used to reinvest in expanding our pipeline and launching new medicines.Were developing our expertise and presence in rare liver diseases,with both Bylvay and the investigational medicine elafibranor,for which we expect regulatory decisions in the coming months in the U.S.and Europe.This progress de
17、monstrates that our strategy is delivering,leading to a stronger,more resilient Ipsen.A robust strategy Three years ago,Ipsen was facing headwinds:our blockbuster medicine had lost exclusivity and generic competitors were beginning to appear.Our pipeline was also low on promising assets.To continue
18、to flourish and ensure we could bring crucial innovation to patients,we needed to diversify our portfolio and expand our pipeline.Our mission,“Focus.Together.For patients and society,”gave us a clear direction,while the four pillars of strategy laid out our next steps.Our ambition:to be a leading gl
19、obal mid-size biopharmaceutical company in our three therapy areas of Oncology,Rare Disease and Neuroscience.Its exciting to see how far we have already come,and to look ahead to our big plans for 2024 and beyond to continue on our growth trajectory.“Over the past three years,we have shifted from re
20、liance on the blockbuster Somatuline to four growth platforms.Our strategy is delivering,leading to a stronger,more resilient Ipsen.”Ipsens strategy Bring the full potential of our innovative medicines to patients Build a high-value,sustainable pipeline Deliver efficiencies to enable investments and
21、 support growth Boost a culture of collaboration,excellence and impact on society“My goal is to ensure that Ipsen is sustainable across the board:environmentally,but also in terms of the health and longevity of the business,of our culture,and of society as a whole.”INTRODUCTIONCORPORATE GOVERNANCEGE
22、NERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS6Sustainability:a core value at Ipsen Sustainability has always been important at Ipsen,with its 95-year history and its commitment to improving peoples health.But sustainability is more than just a question of carbon footprint.Since joining the company
23、 in 2020,my goal has been to ensure that Ipsen is sustainable across the board:environmentally,of course,but also in terms of the health and longevity of the business,of our culture,and of society as a whole.Generation Ipsen:Environment,Patients,People,Governance Everyone at Ipsen is deeply proud of
24、 the contributions we make to improving the lives of people living with high unmet medical needs.And everyone at Ipsen strives continually to do more:were proud of our culture of impact.Thats one of the reasons we created Generation Ipsen,our sustainability framework.Were ambitious,not only in terms
25、 of what we do,but also how we do it.We want to have a positive impact across the board.That means taking tangible steps to preserve the environment for future generations.It means building a culture where talent is nurtured and developed in a diverse,equitable and inclusive environment.It means ens
26、uring we bring transformative medicines to patients,and in doing so,listening to them every step of the way.And it means upholding the highest ethical standards at every step,ensuring robust governance across the organization.Youll find a lot more information in the coming pages about how we are bui
27、lding robust actions across all four pillars of Generation Ipsen.Im very proud of the progress weve made in each of these four pillars.A bright future ahead 2023 saw a tremendous amount of progress,teeing us up for another strong year in 2024.With four potential launches this year,were focused on ex
28、cellence,execution and rapidity.We continue to set bold goals and ensure we have the resources to achieve them.We have a bright future ahead,guided by our deep-rooted belief that taking a sustainable approach will ensure we make a positive impact and deliver outstanding results for people around the
29、 world living with high unmet medical needs.David Loew,Ipsen CEOINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS72023:successfully implementing our strategyOur ambition is to be a leading,global mid-size biopharmaceutical company with a focus on transformative medici
30、nes in Oncology,Rare Disease and Neuroscience.Focus.Together.For patients and society.In 2020,we rolled out our strategy,designed to boost and focus our collective strengths to create a real impact for people living with high unmet medical needs worldwide.Over the past three years,our strategy has d
31、elivered sustainable growth,ensuring a strong foundation for the future.Achieving our goals Since 2020,our strategy has delivered tangible results.Our growth platforms have seen a double-digit increase in sales,while our enhanced commercial and medical capabilities helped us manage the decline of So
32、matuline following the arrival of competitors in various markets.Our focus on external innovation has enabled us to diversify our pipeline and portfolio.Since 2020,we have added more than 25 new programs to our pipeline through partnerships,licensing and acquisitions.This includes Bylvay,through our
33、 acquisition of Albireo in early 2023.We have further expanded manufacturing capacities and rolled out efficiency initiatives,all while embracing a simplification mindset and digital tools.We continue to foster a culture of inclusion and excellence.In 2023,for the first time,women made up over half
34、of our Global Leadership Team.And in the same year,25 Ipsen sites received external certifications for our culture.Last but certainly not least,we continue to reduce our carbon(CO2)footprint,having switched to 95%green electricity use in 2023.Four pillars for sustainable growthBring the full potenti
35、al of our innovative medicines to patientsBuild a high-value,sustainable pipelineDeliver efficiencies to enable investments&support growthBoost a culture of collaboration,excellence&impact on societyNEW PROGRAMS added to Ipsens portfolio through partnership,licensing and acquisitions since 2020of el
36、ectricity used in Ipsen facilities is renewable2595%INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS8Dynamic growth built on solid foundationsOur strategy is serving as a springboard into the next phase of Ipsens transformation:growth and expansionFour promising laun
37、ch opportunities are driving growth across our business.In February 2024,Onivyde was approved by the FDA for use in first-line pancreatic ductal adenocarcinoma(PDAC).Our two rare liver disease assets,Bylvay and elafibranor,have the potential to deliver benefits to patients.We are already rolling out
38、 Bylvay for Alagille syndrome in the U.S.,and we anticipate a regulatory decision for elafibranor for primary biliary cholangitis under a brand name in 2024.Sohonos saw U.S.FDA approval in August 2023.Sohonos is the first-ever treatment for the ultra-rare bone disorder fibrodysplasia ossificans prog
39、ressiva(FOP).Looking aheadOur mid-term priorities are clear.We have several more launch opportunities that we expect to drive attractive growth,and we aim to complement these with further expansion of our pipeline.Over the longer term,Ipsen will build on this momentum to deliver a more balanced and
40、diversified portfolio of medicines across our three therapy areas.Our ambition is to achieve sustained growth through the end of the decade and beyond,supported both by our internal pipeline and by further acquisitions and in-licensing opportunities.4that reached at least 500 million each in sales i
41、n 2023MEDICINESINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS9Striving for balance across our businessAchieving balancebetween therapeutic areas as well as across geographies is a key long-term goal of our dynamic growth phaseToday,our Oncology business accounts fo
42、r 75%of total annual sales.Over the next three years,we aim to diversify our pipeline by investing in promising treatments in all three of our therapy areas:Oncology,Rare Disease and Neuroscience.Pursuing growth opportunities in all regionsBalance is our ambition:not only across our therapy areas,bu
43、t also across geographies.We aim to achieve a balance between European,American and Rest of World markets.In North America,we see strong growth potential and aim to leverage our growth through multiple potential launches.Meanwhile,we see ample opportunities in the Asia-Pacific and Latin America mark
44、ets to increase our presence and the availability of our treatments.North Americaof total sales1of total sales1of total sales1Europe2Rest of World33%40%27%Total sales per region1.Based on September year-to-date 2023 total sales.2.Europe is defined here as the E.U.,the U.K.,Iceland,Liechtenstein,Norw
45、ay and Switzerland.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS10Spotlight on our late-stage programsBylvay(Phase III)is in late-stage development to treat biliary atresia,a rare pediatric liver disease.Already available for other indications in the U.S.and Europ
46、e,Bylvay has the potential to improve patient well-being even further.Dysport is in two Phase III clinical studies:for managing chronic migraine,and for managing episodic migraine.Elafibranor(Phase II)is an investigative second-line treatment for primary sclerosing cholangitis(PSC).Additionally,it i
47、s in registration phase and under U.S.FDA priority review for primary biliary cholangitis(PBC),a rare liver disease.IPN10200(Phase II),a long-acting neurotoxin,is under evaluation to treat glabellar lines and adult upper limb spasticity,and its potential will also be evaluated for other indications.
48、It has the potential to deliver better outcomes for patients with an increased duration of action leading to a potential reduction in injection frequency and enhanced tolerability.Tazverik(Phases II and III)is a first-in-class chemotherapy-free EZH2 inhibitor indicated for patients with relapsed or
49、refractory follicular lymphoma(FL).For the past three years,we have strengthened our clinical development expertise across our three therapeutic areas.Our well-established expertise in small molecule and complex biologic development,our clinical know-how and our strong partnerships give us the rapid
50、 scale-up model we need to execute with precision and focus.We continue to accelerate innovation through partnership by design to bring first-or best-in-class treatments to patients around the world.We are strengthening and expanding our pipeline at every stage of development to drive sustainable gr
51、owth.We recognize that the best innovation takes place in academia and biotechs.For this reason,we source our pipeline through external innovation.We choose partners who share our vision,culture and focus going above and beyond to create a relationship that delivers shared success.Our pipeline is co
52、nstantly evolving and advancing.Bringing high-stakes innovation to patients is never simple,but we remain unfazed by challenges.With the experience,expertise and capability to deliver continued R&D excellence,our 700 R&D employees and our external partners are progressing our pipeline of innovations
53、 to bring new treatments to patients.Ipsens growth strategy:accelerating innovation NEW PROGRAMSEARLY DEVELOPMENTadded to Ipsens portfolio through partnerships,licensing and acquisitions since 2020programs added since 20202515INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAP
54、Y AREAS11Generation Ipsen is a transformative sustainability strategy,signaling Ipsens commitment to positive change.Anchored by four pillars Environment,Patients,People and Governanceit reflects our dedication to shaping a better,healthier world.The strategy sets Ipsen on a course to lead in sustai
55、nability,patient-centric innovation,employee well-being and ethical governance,contributing to a better,healthier world for future generations.See pages 32-36 to learn more about each of our pillars and how they support the mission of Generation Ipsen.Generation Ipsen Our framework for positive chan
56、geGovernanceActing with integrityand responsibilityPeoplePassionate people makinga real impact,every dayPatientsPatients drive everything we doEnvironmentCaring for the planetTHE CORE PILLARS OFGENERATION IPSENINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS12In 2023
57、,in line with our Generation Ipsen commitment to positive change,we announced our support for five outstanding athletes training for the 2024 Paralympic Games in Paris.These athletes,featured throughout this report,represent some of the core qualities that Ipsen prizes in its own workforce.Facing un
58、ique barriers,each of them has taken mindful risks throughout their careers,working together with teammates to go faster,higher,stronger.In 2024,Ipsen is embracing the Olympic and Paralympic Games in several other ways:Through the Ipsen in Motion 2024 challenge,employees around the world are engagin
59、g in wellness activities while supporting various inclusion-oriented NGOs and associations.Ipsen is offering Paris-area employees 10 days paid leave if chosen as official volunteers for the Olympic and Paralympic Games.Building on its 2020 Paralympic Games involvement,Fondation Ipsen promotes parasp
60、orts to raise awareness of diversity and inclusion of people with disabilities.Purpose,passion,precision Ipsen supports athletes for the Paris 2024 Paralympic Games“Believe in yourself and believe in your dreams.Hard work pays off.”Margot Boulet,Rowing A parachute accident left Margot with an ankle
61、prosthesis and lumbar arthrodesis.She became a champion rower anyway,earning a bronze medal with her team at the 2020 Paralympic Games in Tokyo in 2021.And she has qualified for the 2024 Paralympic Games in Paris.Watch this video to learn more about Ipsens support of para athletes“Help your teammate
62、s.Learn something every day.Smile.Enjoy the little things.If you focus on these four things,everything will be okay.”Valentin Bertrand,Long jumpLiving with hemiplegia and Crohns disease,Valentin earned a bronze medal at the Para World Championships in Paris in 2023.He has now set his sights on anoth
63、er medal in Paris at the 2024 Paralympic Games.13INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 14The people behind Ipsens purpose and passion“Sometimes,just having somebody to talk to can help a lot.There are people out there who would love to talk to you if youre
64、 going through this.”“As a Global Environmental Sustainability Director,I see myself as a bridge.I bridge the gap between environmental responsibility and the core mission of our company.Ultimately,my work is about ensuring that while we develop life-changing medicines today,we also safeguard our pl
65、anet for a healthier tomorrow.”Hub has been living with post-stroke spasticity since 2021.Stphane is Global Environmental Sustainability Director,France.Behind the disease statistics and the performance indicators are people.Some are living with high unmet medical needs.Some are not.But they all sha
66、re a common trait:they want to have a positive impact.14INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 15Onivyde receives 2nd FDA approval for pancreatic cancerIn February 2024,Onivyde(irinotecan liposome injection)secured U.S.FDA approval together with oxaliplatin
67、,fluorouracil and leucovorin(NALIRIFOX)as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma(mPDAC).1 Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC.For more than 35 years,Oncology has
68、 been the foundation of our business and it remains at the core of our strategy.The largest of our therapy areas,it accounted for three quarters of Ipsens total sales in 2023.The strength of our Oncology portfolio,spanning solid tumors and hematological cancer(blood cancer),stems from our ability to
69、 focus our efforts where we can have the most impact for patients.Our impactful treatments are now available to patients across nine different forms of cancer in multiple indications.Diagnosing a better futureThe cancer treatment landscape is evolving rapidly,but many patient populations still face
70、significant unmet needs.That is why we continue to develop new therapies that address the needs of those diagnosed with the most difficult-to-treat cancers,providing the greatest potential to change lives.We believe that best-in-class oncology therapies can help people live longer and better with ca
71、ncer.Cabometyx(cabozantinib)as monotherapy and in combination has an established efficacy and safety profile across multiple advanced tumor types,including kidney,liver and thyroid cancer.First launched in 2016,it is now available in over 60 countries,with potential for future new indications.Decape
72、ptyl(triptorelin)continues to have a positive impact for people living with prostate or breast cancer across the world.On behalf of all who may benefit from Decapeptyl,we advocate for access across indications.Tazverik(tazemetostat),a first-in-class EZH2-inhibitor,has accelerated approval from the U
73、.S.FDA for the treatment of both relapsed or refractory follicular lymphoma and metastatic or locally advanced epithelioid sarcoma.In addition to our medicines,we develop patient support programs and home care programs.For example,in some countries,we provide both an injection service and an injecti
74、on teaching service.In this way,people living with neuroendocrine tumors can have the opportunity to autonomously administer their Somatuline Autogel/Somatuline Depot(lanreotide)injections.ASSETS we aim to add across our therapy areas by 202520OF IPSENS NET SALES in 2023 were from our Oncology portf
75、olio75%Full label details can be found here:Cabometyx E.U.SmPC https:/www.ema.europa.eu/en/medicines/human/EPAR/cabometyxDecapeptyl E.U.SmPC https:/www.medicines.org.uk/emc/product/963/smpc#grefOnivyde U.S.PI https:/ U.S.PI https:/www.accessdata.fda.gov/drugsatfda_docs/label/2020/213400s000lbl.pdfSo
76、matuline E.U.SmPC https:/www.medicines.org.uk/emc/product/4808/smpc U.S.PI https:/www.accessdata.fda.gov/drugsatfda_docs/label/2014/022074s011lbl.pdfOncologyHelping patients live longer and better with cancerINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 16Over hal
77、f of people living with kidney cancer say that they are not as involved as they want to be in decisions about their care.1 At Ipsen,we intend to drive awareness of the benefits of shared decision-making(SDM).SDM involves healthcare professionals,often across a multidisciplinary team,actively discuss
78、ing care decisions together with patients.They jointly consider clinical evidence,as well as patient values and preferences,when selecting the best treatment for them.Including patients and their loved ones fully in the decision-making process acknowledges patients as experts regarding their own bod
79、ies and their particular experiences with the disease.Multiple studies have shown that patient engagement and the adoption of an SDM approach can have a positive impact on well-recognized treatment outcomes,including overall survival2,quality of life and treatment adherence.3Together for Kidney Canc
80、erLaunched in 2021,Together for Kidney Cancer is a global disease-awareness initiative created by Ipsen,in partnership with the International Kidney Cancer Coalition,for healthcare professionals and people living with kidney cancer.It aims to raise awareness of the importance of empowering and equip
81、ping the kidney cancer community to participate in SDM.More than wordsThe Together for Kidney Cancer campaign was built around a series of one-to-one conversations with people living with kidney cancer and caregivers.From those discussions,Ipsen launched a series of bespoke illustrations that visual
82、ly reflect peoples feelings,experiences and perspectives.Illustrations from this campaign are shown on this page.Encouraging actionIn 2023,Ipsen convened a roundtable meeting where 11 kidney cancer patient awareness groups,along with patients and healthcare professionals(HCPs)across seven countries,
83、identified SDM barriers and drivers.Ipsen also commissioned a survey of 95 oncologists and nurses in nine countries to uncover their attitudes and approaches to SDM in kidney cancer.This has informed an action plan to support wider uptake of SDM in kidney cancer care.OF PATIENTS would like to be mor
84、e involved in decisions about their care,a figure unchanged in six years50%OncologyDriving shared decision-making in kidney cancer careINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 17Embracing the challenges inherent to rare disease research and development,we are
85、 dedicated to providing a better future for those patients who too often get left behind.For three decades,Ipsen has fostered a patient-first,science-led,data-driven growth mindset in working to continuously improve the health and prolong the lives of people living with rare diseases.We drive change
86、 by embracing innovation and seeking unique solutions to unique problems.Our priority is advancing treatments for and knowledge of rare bone,liver and endocrine diseases.Our company-wide expertise in rare cancers and neurological conditions informs our work in rare disease,where incremental benefits
87、 can be life-changing.Unlocking potential every day In 2021 we entered the rare liver space following our strategic partnership with GENFIT;in 2023,we developed our capabilities further with the acquisition of Albireo Pharma,Inc.We have now built a strong pipeline for the treatment of rare cholestat
88、ic liver disease,with three assets across five indications.Rare DiseaseOrdinary people with extraordinary ambitionsYEARS average time for a rare disease diagnosis in the U.S.2YEARS average development time for a new rare disease medicine3817Forging our own path in FOP treatment In August 2023,the U.
89、S.Food and Drug Administration(FDA)approved Sohonos(palovarotene)as the first treatment for FOP.4 We are committed to continuing to deliver innovation to people living with this devastating condition through our pivotal Phase II clinical trial to assess the effectiveness and safety of two dosage reg
90、imens of oral fidrisertib(IPN60130)for fibrodysplasia ossificans progressiva(FOP).5New era of PBC managementOur pivotal Phase III ELATIVE trial evaluated the efficacy and safety of investigational elafibranor in the treatment of those living with primary biliary cholangitis(PBC),a rare liver disease
91、.Clinical trial results demonstrated significant improvements versus placebo in biomarkers predictive of disease progression for patients on elafibranor.6 By June 2024,Ipsen hopes to see the first regulatory decisions for this investigational medicine that could offer a step-change in the management
92、 of PBC.OF RARE DISEASES currently have no effective treatment195%Full label details can be found here:Sohonos U.S.PI https:/ E.U.PI https:/www.ema.europa.eu/en/documents/product-information/bylvay-epar-product-information_en.pdf U.S.PI https:/ U.S.PI https:/ GOVERNANCEGENERATION IPSEN2023 BUSINESS
93、REVIEWTHERAPY AREAS 18We are learningWe host advisory boards with patients and healthcare professionals to understand what they expect from treatment,what wider support they need,and what will help raise awareness of rare liver diseases more widely.The problem is complexThere are many unique challen
94、ges to bringing forward medical innovations for rare diseases.For example,there is often no precedent,and only very limited existing data,when initiating clinical development programs.Moreover,it can be hard to enroll an adequate number of patients in clinical studies,and regulatory and access proce
95、sses are typically not adjusted to the requirements of rare diseases.Limited or no knowledge Many healthcare professionals may not have a good understanding of these liver conditions due to their rarity,meaning more common conditions are often suspected first.This can lead to delayed diagnosis,with
96、patients undergoing burdensome and unnecessary tests and appointments,as well as referrals to inappropriate specialists in an effort to treat symptoms.1Feeling unheardIt can be difficult to describe just how severe the symptoms of these diseases can be,especially for caregivers advocating on behalf
97、of babies and children.This leaves many feeling silenced and unheard.Rare DiseaseUnderstanding how to best support people living with a rare liver diseaseNavigating rare liver diseasesMeeting the challenges of innovationWe are listeningWe annually survey approximately 250 patient organizations we wo
98、rk with,including those supporting rare liver diseases,to understand how well we are meeting the needs of these patient communities and what we can do to improve our support and the way we work.It is our ambition to not only improve the health and prolong the lives of people living with rare liver d
99、isease,but to support them every step along their care pathway.1.American Liver Foundation Rare Liver Diseases.Available here:https:/liverfoundation.org/about-your-liver/facts-about-liver-disease/rare-liver-diseases/.Last accessed:janvier 2024.2.Pericleous M,et al.(2022)Defining and characterising a
100、 toolkit for the development of a successful European registry for rare liver diseases:a model for building a rare disease registry.Clinical Medicine(London)22(4):340-347.Available here:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC9345223/.Last accessed:January 2024INTRODUCTIONCORPORATE GOVERNANCEGEN
101、ERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 19Harnessing the power of toxin biologyDysport(abobotulinumtoxinA)is a botulinum neurotoxin(BoNT)that improves symptoms and quality of life for patients living with neurological and movement disorders including spasticity,cervical dystonia and cerebral
102、palsy.We are also conducting a Phase III study to evaluate the efficacy and safety of Dysport for the treatment of chronic and episodic migraine in adults.Our work in neurotoxins also extends to aesthetic use.Distributed in partnership with Galderma,Dysport is licensed for aesthetic applications in
103、85 markets worldwide.We develop and manufacture Dysport at our world-class campus in Wrexham,U.K.In 2023,we underlined our focus on neurotoxins with a 75 million investment in the site to enable us to meet growing demand and facilitate the future manufacture of long-acting neurotoxins.The Wrexham si
104、te uses 100%renewable energy across its production and research units.In early 2023,the site was awarded a grant by the U.K.government in recognition of its outstanding contributions to the life sciences ecosystem.Pioneering innovation in toxin therapyOur long-acting neurotoxin(LANT)is a type of BoN
105、T discovered through Ipsens proprietary technology and research expertise.It was developed to address the unmet patient need for longer-acting treatments for neurological symptoms including muscle stiffness,spasms and pain.In preclinical models,LANT have shown a longer duration of action.They could
106、improve patients quality of life by relieving symptoms between treatments,reducing the frequency of injections.Our LANT went into clinical development in 2021.In 2023,programs investigating aesthetic and therapeutic applications entered Phase II.Leveraging world-class manufacturing facilities and 30
107、 years of clinical experience,Ipsen continues to advance neurotoxin innovation for therapeutic and aesthetic indications.Today,all areas of neuroscience are transforming rapidly,and Ipsen is at the forefront of this innovation with continued investment in research.Our core focus is supporting childr
108、en and adults with debilitating and degenerative neurological and movement disorders.Cervical dystonia:driving improvements in the patient journey Our deep understanding of conditions such as cervical dystonia highlights touchpoints on the patient journey that require overhaul and improvement.In an
109、international survey of over 1,000 cervical dystonia patients,over half were diagnosed more than one year after the onset of symptoms and two thirds were misdiagnosed at least once.Insights such as these guide our clinical development and the support we give to patients and healthcare professionals.
110、MARKETS WORLDWIDE where Dysport is available for aesthetic indications85YEARS clinical experience in neuroscience30NeuroscienceAt the forefront of neurotoxin innovationFull label details can be found here:Dysport EMC https:/www.medicines.org.uk/emc/search?q=Dysport U.S.https:/www.accessdata.fda.gov/
111、drugsatfda_docs/label/2023/125274s125lbl.pdfINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 20Stroke is among the leading causes of death and disability worldwide,with one in four people over the age of 25 experiencing a stroke during their lifetime.Today,nearly 60%
112、1 of people who suffer a stroke will survive,but the impacts on patients and their carers can be life-changing.2 One of the main consequences of stroke is post-stroke spasticity,which affects more than a quarter of survivors and can develop up to a year after stroke.Ensuring that patients are inform
113、ed and educated on what symptoms to look out for is key.This is a major challenge,as in many countries there are no established care pathways for stroke survivors after they are discharged from specialist services.Deepening understanding of post-stroke careAt Ipsen,we are working to address the issu
114、e and support patients and their loved ones on the long road to recovery.Our EPITOME study seeks to identify potential improvements in treatment and care.Our protocol for this study was co-developed with patients.In addition to our clinical studies,we are working in partnership with bodies such as t
115、he World Stroke Organization and the Stroke Alliance for Europe(SAFE)to better understand why patients today are not getting the treatment they deserve.We also commissioned a CensusWide survey to understand patients experience.This highlighted that at least one in three stroke survivors were not inf
116、ormed by their neurologist about potential post-stroke complications.Proudly improving standards of care through HCP networking&training Ipsen created the Ixcellence Network for physical medicine and rehabilitation specialists,neurologists and other clinicians working in the area of spasticity and m
117、ovement disorders.Driven by a global steering committee of experts,the initiative empowers HCPs to share their experience and expertise in treating these complex conditions,with the aim to improve standards of care across the world.Ipsens Ixcellence training program helps experienced physicians impr
118、ove their management of patients with cervical dystonia or focal spasticity.Watch our documentary,Rising to the Challenge,Life After Stroke,which premiered on World Stroke DayPEOPLE OVER THE AGE OF 25 are expected to experience a stroke in their livesSTROKE SURVIVORS of a total 13.7 million who expe
119、rience their first strokeSTROKE SURVIVORS are forced to leave their jobs due to the impact of their stroke1 in 48.2m1 in 4NeuroscienceImproving care for stroke survivorsINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS 21Prioritizing communication with patient organiz
120、ationsAt the heart of everything we do are people living with cancer,rare disease or neurological conditions.As we work to develop treatments that improve outcomes,we want to ensure that the insights,perspectives and experiences of people impacted by these conditions are informing our work.Pillars o
121、f collaboration shape the way we communicate with patient organizationsDialogueFrom the very start,we open a two-way dialogue with patient organizations so we can better understand community needs and how challenges can be addressedCollaborationEffective relationships require that patient organizati
122、ons be respected for their perspectivesTransformationWe are always adapting Ipsens approach to make a meaningful difference for the communities we serve250116 6869PATIENT ORGANIZATIONS collaborated with Ipsen in 2023OncologyRare DiseaseNeuroscience64,000 PEOPLE diagnosed with pancreatic cancer annua
123、lly in the U.S.640,000 PEOPLE in the U.S.have post-stroke spasticity.20 DIFFERENT TYPES of rare liver disease have already been identifed.Committed to the pancreatic cancer communityIn the United States,pancreatic cancer is one of the most difficult cancer types to detect and treat.For metastatic ca
124、ncer,its most advanced form,only 13%of people survive for five years.Three U.S.patient advocacy organizations are dedicated to the 64,000 people diagnosed each year:Lets Win!Pancreatic Cancer,the Lustgarten Foundation,and Pancreatic Cancer Action Network(PanCAN).Together,they offer a blend of resour
125、ces,education and research to support the pancreatic cancer community.Ipsen provides grants and sponsorships to these organizations.Lets Win breaks down barriers between patients,doctors and researchers to improve access to research information and treatment options.Lustgarten is the largest private
126、 funder of pancreatic cancer research,with a collaborative,science-focused research strategy.With its robust patient services program and its advocacy for policy change,PanCAN focuses on community building,knowledge sharing and scientific research.These organizations efforts help patients and their
127、loved ones,benefit the broader healthcare ecosystem and keep pancreatic cancer top of mind for all stakeholders,including policymakers.“I focus on the smaller,everyday objectives to achieve my big goals.Its important to do things step-by-step,so youre not overwhelmed by the big picture.”Anglina live
128、s with muscle paralysis brought on by polio.A bronze medalist at the 2017 World Para Athletics Championships in London,she represented France at the 2020 Paralympic Games in Tokyo in 2021 and aims to do so again in Paris in 2024.Anglina Lanza,Long jump,200m22INTRODUCTIONCORPORATE GOVERNANCEGENERATIO
129、N IPSEN2023 BUSINESS REVIEWTHERAPY AREAS23MarketedClinicalPreclinicalOur pipeline growth is fueled by external innovation and underpinned by our research capabilities and clinical development expertise.We have acquired,partnered and in-licensed along the development continuum and across Oncology,Rar
130、e Disease and Neuroscience.By creating and nurturing partnerships with some of the best innovators in life sciences,we are playing to both our strengths and those of our partners.Our partners bring early discovery,strong target biology and optimization of a clinical candidate.In turn,we bring solid
131、evaluation,clearly defined potential for differentiation,and clinical positioning.Our clinical know-how enables us to deliver rigorous clinical and regulatory execution essential to transforming a molecule into a medicine.And Ipsen puts its money where its mouth is.In 2023,we invested 619 million in
132、 R&D to help shape the future of how we support people living with disease.R&D and innovation:a closer lookSupporting the foundations of healthcare Throughout the healthcare ecosystem in which we live and work,Ipsen plays an integral role.We are once again hosting our Golden Ticket competition,in pa
133、rtnership with BioLabs-Htel Dieu.Additionally,we aim to impact sustainability efforts while embedding sustainability into partnership strategies.In early 2024,we participated in a panel discussion at BioEurope Spring,entitled“Towards a Greener Globe:Biopharmas Path to Sustainable Futures.”619m700INV
134、ESTMENT IN R&D representing 20%of total 2023 salesEMPLOYEES dedicated to R&DFinding the right fit with partnerships and programs Science comes first when Ipsen selects new partners at every stage.We focus on high-value programs that deliver better outcomes for patients.Since 2020,Ipsen has added mor
135、e than 25 new programs to the pipeline.And we continue to make progress in gaining approvals.In the U.S.,we are already rolling out Bylvay for Alagille syndrome,and Sohonos has also been introduced now in the U.S.,Canada and elsewhere.And we are not slowing down.Over the next three years,our active
136、portfolio will deliver major milestones for patients:we aim to obtain three regulatory decisions and five pivotal trial readouts across Oncology,Rare Disease and Neuroscience.Active partnerships added since 2021INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS24Expand
137、ing our high-value,sustainable pipelineOur pipeline is more sustainable than ever thanks to Ipsens internal and external growth strategies.Our in-house end-to-end pharmaceutical development and manufacturing capabilities make us the ideal partner for pioneers in academia and biotech.We leverage our
138、excellence in global clinical and regulatory execution as we bring more vital treatments to patients.1234PHASE IPHASE IIPHASE IIIREGISTRATIONFIDRISERTIB FOPCABOMETYX+ATEZOLIZUMAB 2L mCRPCODEVIXIBAT1 Alagille syndromeIPN60210 R/R multiple myeloma and R/R DLBCLELAFIBRANOR PSCTAZVERIK+R2 2L FLELAFIBRAN
139、OR 2L PBCRITIVIXIBAT(IPN60250)PSCIPN10200 Longer-acting neurotoxin AxBYLVAY Biliary atresiaIPN10200 Longer-acting neurotoxin TxDYSPORT Chronic&episodic migraineR/R:relapsed/refractory;DLBCL:diffuse large B-cell lymphoma;FOP:fibrodysplasia ossificans progressiva;PSC:primary sclerosing cholangitis;Ax:
140、aesthetics;Tx:therapeutics;2L:second line;mCRPC:metastatic castration-resistant prostate cancer;R2:lenalidomide+rituximab;FL:follicular lymphoma;PBC:primary biliary cholangitis.1.E.U.OncologyRare DiseaseNeurosciencePipeline as of end March 20245PIVOTAL DATA READOUTS Ipsen plans to complete by 2026IP
141、N00194 Solid tumorsINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS25Digital transformation to boost performanceAt Ipsen,we see digital transformation as a key enabler of the companys vision.We aim to leverage effective data and analytics,and proven digital solutions
142、,to propel the sourcing,development and delivery of Ipsens transformative medicines.While we continue to plan further initiatives that will benefit Ipsen and its external stakeholders,here are some of the projects where we delivered transformative impact in 2023:SCORE is a clinical study oversight s
143、olution launched in January 2023.It improves the collection efficiency,accuracy and quality of clinical study data.Bringing together over 60 studies,SCORE improves monitoring and decision-making processes,and helps anticipate execution deviations.Over 130 colleagues across R&D and Medical Affairs no
144、w use SCORE.Ipsens China Prostate Cancer Patient Support Program is a two-way digital health platform.It enables communication between people with prostate cancer and healthcare professionals(HCPs)between injections and/or visits,to help track disease progression,monitor patients,share educational c
145、ontent and provide appointment reminders.As of April 2024,341 HCPs and 1,190 patients have enrolled.The Digital Content Factory is a platform and service that enables global and local teams to develop content at scale and provide differentiated customer service.Contentsuch as emails,websites and lea
146、fletscan be customized faster and re-used across countries and communication channels.In addition to these projects,we also took major steps toward integrating artificial intelligence(AI)into Ipsen methodologies and workstreams,developing AI awareness campaigns,guidance and projects.Dysport Dosing G
147、uide supports HCPs The Dysport Dosing Guide is a progressive web app designed to improve the experience of Dysport injectors by making toxin dosing easier.Since its launch in Mexico in May 2023,this guide has been adopted by 170 HCPs.It was launched in Canada in March 2024,and is now in use by over
148、80 HCPs there.100+250+USERS trained on Digital Content Factory across 13 countriesusing Dysport Dosing Guide across Mexico and CanadaHCPsINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS26 Luxembourg Canada United States Russian Federation Portugal France Ireland Gree
149、ce Sweden China Singapore Vietnam Taiwan Hong Kong S.A.R China KSA(Kingdom of Saudi Arabia)Japan South Korea Australia Kazakhstan U.A.E.Latvia Lithuania Tunisia Algeria Spain Italy Hungary Romania Slovakia Czech Rep.Poland Netherlands Switzerland Belgium Austria Germany Ukraine Mexico Brazil Colombi
150、a United Kingdom COUNTRIES where Ipsen products are marketedEMPLOYEES around the worldCOUNTRIES where Ipsen has a direct presenceSITEShousing Global R&D colleagues worldwideCountries whereIpsen has a direct presencePharmaceutical developmentcenters80+5,00035+4Our global presenceIpsen is an internati
151、onal company,with products marketed in more than 80 countries.With more than 5,000 employees working to create value for patients and society around the world,we have a global reach while still being an agile,mid-sized organization.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEW
152、THERAPY AREAS27Our production sitesOur team at Signes specializes in the aseptic manufacturing of sustained release injectable products.Signes also performs testing,packaging and distribution of Ipsen specialty products,notably Somatuline,Decapeptyl and Onivyde.Following significant investment to me
153、et market growth and demand,our world-class biologic campus in Wrexham increased production capacity for its flexible drug product facility(FDPF).Also a strategic R&D center for the development of recombinant neurotoxins,Wrexham produces and distributes Dysport,Azzalure and Alluzience worldwide.Our
154、Cambridge,Massachusetts,site specializes in the manufacture of Onivyde bulk for the U.S.market.The site manufactures bulk peptide active pharmaceutical ingredients(APIs)for Somatuline and Decapeptyl.Dublin is also a center of peptide and small-molecule product development,and release testing for Dys
155、port for the E.U.market.Signes,FranceWrexham,U.K.Cambridge,U.S.Dublin,IrelandPACKS produced in 202314.5mINVESTEDincluding 111m in technical operations130mThrough our global network and collective expertise,we are changing patients lives for the better.Since 2020,we have expanded our manufacturing ca
156、pacity in line with the third pillar of our strategy.Today,all of our production sites are powered by 100%renewable energy.Excellence in action The U.K.government awarded the Wrexham site a grant in early 2023 in recognition of its outstanding contributions to the life sciences ecosystem.Since 2021,
157、the Signes site has had a Gold Shingo award for operational excellence.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS28The people behind Ipsens purpose and passion“Im inspired by the positive change I see through advancement in medicines.My personal inspiration is
158、my mother;she passed away from cancer during my teenage years.Working within oncology gives me a very clear purpose I want to make sure access to innovative medicines is available to everyone.”Gill has been living with primary biliary cholangitis(PBC)for two decades.Jay is Oncology Sales Lead,U.K.Be
159、hind the disease statistics and the performance indicators are people.Some are living with high unmet medical needs.Some are not.But they all share a common trait:they want to have a positive impact.“My hope for the future is that people with PBC can get diagnosed more easily.I want people to unders
160、tand it more and of course,that there will also be a cure for PBC.”28“Find the solution to move forward.Thats the key over the long term.Keep moving.”Mathieu is a five-time French champion in para-badminton and was a bronze medalist at the 2022 World Championships.He has lived with right-thigh paral
161、ysis since being diagnosed with cancer at 17.Mathieu Thomas,Badminton 29INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS30Generation Ipsen:our four pillarsGeneration Ipsen is both the bedrock and the conduit for our sustainability efforts.Through our Generation Ipsen
162、 strategy,we set ambitious goals across four pillars,aiming to drive positive action and leave a lasting impact for a better and healthier world.Patients drive everything we do Delivering a truly patient-focused experience Enabling access to good health Driving innovation Passionate people making a
163、real impact,every day Caring for our teams and our communities Nurturing and rewarding talent Embracing diversity,equity and inclusion Acting with integrity and transparency Doing what is right,not what is easy Being guided by our strategy:Focus.Together.For patients and society.Delivering success t
164、hrough responsible management Caring for the planet Leading on climate Preserving natural resources and ecosystems Enhancing product sustainabilityEnvironmentKey TargetsKey TargetsKey TargetsKey TargetsPatientsPeopleGovernance50%reduction in absolute Scope 1&2 emissions,along with Scope 3 reduction
165、by 2030Net zero by 2045Reducing time by 25%between U.S.Food and Drug Administration(FDA)/European Medicines Agency(EMA)approvals and other regulatory submissions Tiered pricing framework for launchesGlobal Leadership Team gender target exceeded 53%women in 2023 Gender pay equality across all markets
166、 by 2026 Senior-leadership compensation linked to achievement of bolder ESG targets ISO 37001 certification for anti-corruption management systems*These chapter references refer to our Universal Registration Document,downloadable from our website hereINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2
167、023 BUSINESS REVIEWTHERAPY AREAS31Accelerating value addressing risk Integrating the United Nations(UN)Sustainable Development Goals(SDGs),our materiality analysis identifies 13 main sustainability risks,selected and classified into four categories.CATEGORYSDGCONTRIBUTIONNAME OF THE RISK/OPPORTUNITY
168、DESCRIPTION OF RISK AND LINKS TO IPSENS ACTIVITIESCHAPTERREFERENCES*Improving peoples lives by offering innovative and safe medicinesProduct qualityProtecting patients against the risks inherent to the biologic action of medicinal products and ensuring that benefit/risk for all products is positive.
169、2.2.2 and 4.2.1Product and patient safetyNon-compliance with security requirements that could jeopardize patients health.2.2.2 and 4.2.2Commitment to ensure supply continuity Risk of a shortage in the supply of Ipsens medicines.2.2.2 and 4.2.3Counterfeit products Counterfeit products of low quality
170、and not complying with Ipsens quality standards may endanger patients health and generate a loss in sales revenues.2.2.2 and 4.2.4Responsible product promotion Counterfeit products of low quality and not complying with Ipsens health standards may endanger patients health and generate a loss in sales
171、 revenues.2.2.2 and 4.2.5Access to health The implementation of initiatives and actions to improve healthcare in countries where access to medicines is difficult and diseases are difficult to treat.4.2.6Enhancing integrity to maintain a trusted relationship with our stakeholders Data privacyInabilit
172、y to ensure integrity and confidentiality of data,resulting in disclosure or theft of patients information and breach of data privacy.2.2.2 and 4.3.1Anti-corruption Conflict of interest Corruption and conflicts of interest could lead to major fines and penalties and damage to Ipsens image.2.2.2,4.3.
173、2 and 4.3.3Human rightsRespect of human rights in Ipsens operations and in its supply chain.4.3.4Driving our employees excellence and engagementTalent attraction,retention and engagement Risk of loss and/or lack of key capabilities leading to delay or failure of key programs,research&commercializati
174、on projects,which would jeopardize Ipsens ability to improve patients health.Lack of reduced engagement and/or lack of respect for Ipsens values/Way of Being would lead to reduced productivity,absenteeism,and turnover impacting Ipsens ability to improve patients health.4.4.1 and 4.4.2Health and safe
175、tyCompliance or risk control failure could result in incidents causing injury or impacting employees health.2.2.2 and 4.4.4 Minimizing our environmental impactClimate and energyThe climate risk related to business and supply chain disruption.Failure to take action on climate change could have an imp
176、act on investor confidence and talent retention.2.2.2 and 4.5.1Management of water,waste and air emissionsFailure of compliance or risk control could result in water,waste and/or air pollution harming the environment and/or human health.2.2.2 and 4.5.33GOOD HEALTHAND WELL-BEING17PARTNERSHIPSFOR THE
177、GOALS5GENDEREQUALITY8DECENT WORK AND ECONOMIC GROWTH3GOOD HEALTHAND WELL-BEING4QUALITYEDUCATION8DECENT WORK AND ECONOMIC GROWTH16PEACE,JUSTICE AND STRONG INSTITUTIONS16PEACE,JUSTICE AND STRONG INSTITUTIONS8DECENT WORK AND ECONOMIC GROWTH9INDUSTRY,INNOVATION AND INFRASTRUCTURE12RESPONSIBLECONSUMPTION
178、 AND PRODUCTION13CLIMATEACTION15LIFEON LAND6CLEAN WATER AND SANITATION1.Vs.baseline year,2019.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS32Environment:caring for the planet Our three Environment focus areas:Leading on climate Our goal is simple:to lead on climat
179、e action with science-based targets.In this vein,we are committed to achieving net-zero emissions by 2045.Our Fleet for Future project will transform the vehicles we use,worldwide.Ipsen plans to transition at least 30%of our fleet to battery electric vehicles(BEV)by 2025 to reduce Scopes 1 and 2 car
180、bon emissions.Were also investing in high-efficiency equipment and solutions across our sites.Preserving natural resources and ecosystems Through the Ipsen Natural Resource Preservation Program,we are decreasing waste and encouraging recycling.More than half (51%)of waste from Ipsen facilities is no
181、w sent for either recycling or recovery treatment,up from 22%in 2019.Enhancing product sustainability Were committed to increasing circularity,designing products with a focus on recyclability,implementing sustainable value chain opportunities and actively reducing waste.95%of Ipsens global energy co
182、nsumption comes from green electricitySince 2012,Ipsen has been a member of the UN Global Compact.These six UN SDGs help guide our environmental efforts:8DECENT WORK AND ECONOMIC GROWTH13CLIMATEACTION9INDUSTRY,INNOVATION AND INFRASTRUCTURE15LIFEON LAND12RESPONSIBLECONSUMPTION AND PRODUCTION6CLEAN WA
183、TER AND SANITATION36%REDUCTION IN 2023 compared to 2019 in absolute Scope 1 and 2 emissions vs.a target of 50%by 20301INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS33Patients:driving everything we do25%percentage by which we will reduce time between receiving FDA/E
184、MA approvals and filing for registration in other marketsOur Patients pillar aims to drive innovation and increase access,affordability and quality and improve patient experience.This ties in with these UN SDGs:17PARTNERSHIPSFOR THE GOALSOur three Patient focus areas:Delivering a truly patient-focus
185、ed experience To learn from patients firsthand and address their unique needs,we have many initiatives that connect Ipsen directly to the patient community.We work with 260 patient organizations(POs)worldwide and are piloting patient experience mapping with POs in nine indications.And 100%of Ipsen-l
186、ed clinical studies include patient input.Ipsens 2023 Global Patient Organization engagement survey,featuring the perspectives of 85 POs,revealed an overall satisfaction score of 8.7/10,an increase since 2022.Findings are used annually to help Ipsen deliver on what matters most to patients and careg
187、ivers.Enabling access to good healthTo improve patient access to life-altering treatments,we aim to reduce the time between receiving approvals from the U.S.FDA or the EMA and filing for other regulatory submissions.Given the range of healthcare systems worldwide,we also take different approaches to
188、 enable access to our medicines,including:Tiered pricing approaches,based on gross national income levels Innovative value strategies,such as outcome-based/responder-based contracting,which links the value of our medicines to outcomes and real-world benefits Patient assistance programs,helping patie
189、nts bridge the gap pending reimbursement and/or afford their medications in pay-out-of-pocket health care systems Driving innovationOur research&development is led by what matters most to patients.We have invested continuously in our R&D pipeline,allocating billions of euros to partnerships and coll
190、aborations.GOOD HEALTHAND WELL-BEING3for launches TIERED PRICING FRAMEWORK INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS34Embracing diversity,equity and inclusion(DE&I)We value each persons uniqueness within a diverse workforce:53%of our Global Leadership Team and
191、 38.5%of our Executive Leadership Team are women.We drive fairness through equitable people processes,for example through our Gender Pay Program where we have set a 2026 target date for gender pay equality across all markets.We promote an inclusive culture through quarterly events and the establishm
192、ent of employee resource groups.Progress is measured by an annual DE&I survey.People:making a real impact,every dayTaking into account our employees alongside broader society and communities,our People pillar is influenced by three UN SDGs:5GENDEREQUALITY8DECENT WORK AND ECONOMIC GROWTH16PEACE,JUSTI
193、CE AND STRONG INSTITUTIONSOur three People focus areas:Caring for our teams and our communitiesWe create a meaningful work environment and care for every single employee.Recognized as a Great Place to Work in 25 countries,our goal is to be an employer of choice for more than 80%of our employees by e
194、nd-2024.Our Ipsen in Motion global sports challenge to promote employee health and well-being raised money for organizations including Stroke Association UK and the Jane Goodall Institute Canada.We also engage with communities,with 43%of team members taking part in Community Day in 2023.Nurturing an
195、d rewarding all talentWe focus on continuous skills and career development to ensure future-readiness.In 2023,96.5%of all employees updated their development plan and 90%of employees defined a career interest.Ipsen Career Month was back with the motto“I own my growth.”We foster positive engagement a
196、nd support rapid transformation via our Culture Manifesto.Progress is assessed annually via our People Experience Survey.Our Bravo!internal reward program recognizes employees.Rewarding our top talentOur Ipsen Total Rewards Framework is guided by three principles:We reward what matters We share our
197、success We care about our people as much as our people care about patientsBy rewarding those who go above and beyond,we encourage everyone to be the best they can be.in our Global Leadership Team53%WOMENfor gender pay equality across all markets2026TARGET DATEINTRODUCTIONCORPORATE GOVERNANCEGENERATI
198、ON IPSEN2023 BUSINESS REVIEWTHERAPY AREAS35People:caring for our communitiesOur dedication to a healthy,happy workforce leads directly to high employee engagement in programs like Ipsen Community Day.Ipsen in Motion,our global sports challenge that promotes the health and well-being of our employees
199、,took place again in 2023.Whether for a month or the whole year,participants tracked their physical activity and raised money for the charity of their choice.Last year,Ipsen in Motion supported organizations including Stroke Association UK and the Jane Goodall Institute Canada,among others.Following
200、 a successful Ipsen Career Month in 2022,we organized a 2023 edition in May.The motto of this years event was“I own my growth.”Speakers shared their career stories and key lessons learned over the years.Around 550 people attended this online event live from all over the world,and countless more have
201、 been able to watch the recording through our MyIpsen intranet.Personalizing development plansIpsen has now rolled out Individual Development Planning throughout the company.This program encourages employees to set goals for their current job and define a target position they would like to attain.In
202、 2023,90%of employees defined a career interest,and 96%of employees updated their development plan.43%40,000of employees took part in Community Dayraised through Ipsen in Motion to support local patient organizations550participants in Ipsen Career Month in May 202396%of employees updated their Indiv
203、idual Development Plan in 2023INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS36Ipsen is committed to fighting corruption and has a zero-tolerance policy towards it.Our Anti-Corruption position paper outlines our efforts to prevent corruption and to act professionall
204、y,fairly,and with integrity in all business dealings and relationships.Guided by our strategy:Focus.Together.For Patients and society.Ipsen monitors CSR KPIs and reports these figures to a dedicated Ethics,Governance&CSR Committee of the Board of Directors.Creating an ethical culture requires everyo
205、nes contributions,and our leaders have a particularly important role to play in setting a strong example.Therefore,we incentivize our companys executives to prioritize ethical concerns and anti-corruption messaging.Success delivered through responsible managementWe measure our ethical culture with e
206、mployee surveys,and continuously adapt based on this feedback.We are always enhancing initiatives like Ipsens Business Ethics program by adding new training materials,policies and procedures as needed.Governance:acting with integrity and responsibilityProtecting against data leaksIn a world where da
207、ta is everything,leaks pose an ever-bigger threat.This is why Ipsen has enhanced our mandatory annual training modules for employees,who play a key part in the data protection compliance pathway.By raising awareness and understanding,we have reduced data breaches to only one in 2023.Our three Govern
208、ance focus areas:Doing what is right,not what is easySince 2019 we have maintained and updated a Code of Conduct.We annually renew our commitment to the Code to ensure we act with fairness,integrity,and accountability,and demonstrate our unwavering respect for patients,employees,and stakeholders.Emp
209、loyees are required to receive training on the Code of Conduct(available in 15 languages)when they first join Ipsen and receive additional training annually.CERTIFICATION for anti-corruption management systemsISO 37001 Our Governance pillar is about ethical and responsible business practices,transpa
210、rency,and ensuring we stay true to our vision.It is aligned with these four UN SDGs:4QUALITYEDUCATION8DECENT WORK AND ECONOMIC GROWTH16PEACE,JUSTICE AND STRONG INSTITUTIONSGOOD HEALTHAND WELL-BEING3INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS37Fondation IpsenA ke
211、y 2023 objective was to accelerate scientific research.Fondation Ipsen is the nucleus for the rare disease network at Fondation de France and in the European Union.Working with the Fondation Maladies Rares,Fondation Ipsen developed a Massive Open Online Course to advocate for accelerated diagnosis o
212、f rare diseases.Additionally,Fondation Ipsen immersed itself in the rare disease entrepreneurship ecosystem by organizing meetings in Silicon Valley that connected funders to start-up biotechnology companies.The foundation developed an economic toolkit to improve success in the biotechnology sectorn
213、ow published in a major scientific journaland a global artificial intelligence initiative published with the Organisation for Economic Co-operation and Development(OECD).In 2023,Fondation Ipsens publishing division,BookLab,published 27 new educational books focused on rare diseases and disability.Fo
214、ndation Ipsen also distributed 42,000 copies of its quarterly childrens science magazine,Little Issue,to 750 libraries,as well as in underserved populations.Acting to accelerate rare disease diagnosis Supporting and promoting parasportsFondation Ipsen sponsored the wheelchair rugby Womens Cup and ho
215、sted a parasports education week in Magny-les-Hameaux,France.The events,attended by thousands of children,promoted awareness of and participation in parasports.Publishing“Science Unlocked”for the public and professionals In 2023,Fondation Ipsen launched a new book concept,Science Unlocked.These book
216、s talk about complex scientific subjects in a clear and precise format.Furthermore,December 2023 saw the launch of the first issue of a national magazine,Soln,to promote inclusion and a fairer society.Lastly,23 Fondation Ipsen/National Press Foundation journalists advocated for rare disease awarenes
217、s worldwide.Want to learn more about rare diseases and Fondation Ipsen?Visit our dedicated digital platform to find webinars,podcasts,stories and more.of people with a rare disease do not receive an accurate diagnosis at first,with an average delay of 1.5 years50%Created in 1983 under the aegis of F
218、ondation de France,Fondation Ipsen improves the lives of people living with rare diseases by contributing to advances in scientific research and policy.Additionally,it organizes conferences and publishes books and online content for professionals,families and children seeking to understand rare cond
219、itions.Artificial Intelligence in Science,publication in collaboration with OECDWomens CupCindy and Enzo,the heroes of Fondation Ipsens manga on rare diseaseINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS38The people behind Ipsens purpose and passion“My main source
220、of inspiration is Ipsens mission to serve patients and society.The talents I recruit contribute to drug development,clinical research and other key areas.They bring new ideas and skills to the company,and their contribution stimulates innovation and long-term growth.”Jude was five months old when he
221、 was diagnosed with Progressive Familial Intrahepatic Cholestasis(PFIC).Marie,Talent Acquisition Manager,France.Behind the disease statistics and the performance indicators are people.Some are living with high unmet medical needs.Some are not.But they all share a common trait:they want to have a pos
222、itive impact.“We noticed bruises on his back,and his skin was jaundiced but for the most part,he was a happy boy.That all changed after bloodwork showed abnormalities in his liver levels.”“Be patient,it takes time.You cant become a champion in one day.Train.”Galle,living with hemiplegia due to an ac
223、cident,won silver in the 10m air pistol event at the 2023 sport shooting Para World Championships in Peru.With a gold medal at the French championships in early 2024,she is now hoping to qualify for Paris 2024.Galle Edon,Sport shooting39INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS R
224、EVIEWTHERAPY AREAS40Board of DirectorsThe 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 public.It ensures the company has reliable procedures for identifyi
225、ng,measuring and monitoring its commitments and risks,as well as adequate financial and operational internal controls.The Board appoints five permanent committees to assist in its oversight and monitoring responsibilities.Chairperson1:Marc de Garidel2Vice-Chairperson1:Antoine FlochelMembers1:Highroc
226、k S.r.l.7 represented by Anne BeaufourHenri Beaufour2 Beech Tree S.A.7 represented by Philippe BonhommeNaomi Binoche8Laetitia Ducroquet8Margaret Liu3David Loew4Michle Ollier2Pascal Touchon3,5Piet Wigerinck3Karen Witts3Carol XuerefEthics,Governance and Corporate Social Responsibility(CSR)CommitteeCha
227、irperson:Margaret Liu3 Members:Beech Tree S.A.7 represented by Philippe BonhommeNaomi Binoche8Carol XuerefNomination CommitteeChairperson:Carol Xueref Members:Beech Tree S.A.7 represented by Philippe BonhommePascal Touchon3Compensation CommitteeChairperson:Antoine Flochel Members:Laetitia Ducroquet8
228、Piet Wigerinck3Karen Witts3Carol Xueref11 Executive Leadership Team(ELT)meetings25 Committee meetings12 Board meetingsAudit CommitteeChairperson:Karen Witts3 Members:Beech Tree S.A.7 represented by Philippe BonhommePascal Touchon3Innovation and Development CommitteeChairperson:Marc de Garidel Member
229、s:Antoine Flochel Margaret Liu3 Michle Ollier Pascal Touchon3 Piet Wigerinck3The Board of DirectorsFive Board Committees1,6Permanent guests:Highrock S.r.l.7 represented by Anne BeaufourHenri Beaufour David Loew4members of the Board of Directors7 women 7 men1.As of 13 May 2024.2.Term of office renewe
230、d during 2023 AGM.3.Independent Director.4.CEO as of 1 July 2020.5.Cooptation by the Board of Directors effective 4 October 2023;this decision will be the object of a request for ratification at the next AGM.6.For more information on the activities of each committee,visit https:/ governed by Luxembo
231、urg law.8.Director representing the employees.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS41Executive Leadership Team The ELT is composed of the Chief Executive Officer and 12 other executive members,as of 13 May 2024David Loew Chief Executive OfficerCatherine Ab
232、i-Habib Executive Vice President,Head of StrategyRgis Mulot Executive Vice President,Chief Human Resources OfficerFranois Garnier Executive Vice President,General CounselSandra Silvestri,M.D.,Ph.D.Executive Vice President,Chief Medical Officer Bartek Bednarz Executive Vice President,Head of Global P
233、roduct and Portfolio StrategyAidan Murphy,Ph.D.Executive Vice President,Head of Technical OperationsChristelle Huguet Executive Vice President,Head of R&D Aymeric Le Chatelier Executive Vice President,Chief Financial OfficerGwenan White Executive Vice President,Head of CommunicationsKeira Driansky E
234、xecutive Vice President,President,North America Mari Scheiffele Executive Vice President,President,InternationalPhilippe Lopes-Fernandes Executive Vice President,Chief Business Officer1.Ipsen Total Energy Consumption Normalized to Revenue(MWh/millions in).2.Ipsen Total Water Consumption Normalized t
235、o Revenue(m3/millions in).3.Scopes 1+2 market-based reduction.4.Plus 8 in early development.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS42Creating value for patients and societyAt Ipsen,we maximize our resources and assets to deliver real impact for people living
236、 with high unmet medical needs.Production qualitya high-quality manufacturing network and end-to-end supply chain for safe,reliable medicinesGlobal commercializationto bring medicines to patients worldwideOur financial resources 3.1bn total sales Net cash 64mOur assets and resources contribute to th
237、e sustainability of our Business Model based on a strong ethical culturefor patients,employees and society while protecting the environment.Our teams Over 5,000 employees in 42 countries 25 countries with HR certifications 20%1 reduction in energy consumption 11%2 reduction in water consumptionOur e
238、nvironmental commitmentsOur science 19.8%of sales invested in R&D 4 global R&D hubs 900 employees in R&DOur manufacturing networkProduct portfolio 32 medicines in our portfolio 112 countries where our medicines are registered 77.3m manufacturing investment 4 internal manufacturing sites External CMO
239、 partnersfirepower for pipeline extensiongreenhouse gas emissions reduction3share of women on the Global Leadership Teamshare of scientific publications made public for freecore operating margin of net salesR&D programs41.9bn36%53.2%100%1532%Investing in building a sustainable pipelineDemonstrating
240、strong financial performanceProtecting the environmentCaring for and developing employeesBringing science to peopleProviding innovative solutions to patientsR&D investmentfor a sustainable pipeline across all stages of developmentOur relationships Collaboration with healthcare professionals and pati
241、ent organizations Partnerships with external organizations to accelerate innovationINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS43Assessing and defending against risksBusiness risk:research&development We continue to build a sustainable pipeline of innovative asse
242、ts and have transformed our R&D model.Part of this strategy involves acquisitions,which could fail or underperform.Our External Innovation&Business Development organization works tirelessly to assess opportunities and conduct quick and effective due diligence.Financial risk:share price fluctuation T
243、he share price could see fluctuation due to changes in Ipsens or its competitors performance.R&D successes or failures,whether our own or our partners,could also cause a change in share price.By delivering a more diversified and balanced portfolio,we can mitigate potential damage.Industrial and envi
244、ronmental risks:supply shortagesDespite a strong end-to-end supply chain organization,the marketing of certain products by Ipsen could be affected by supply shortages and other disruptions,due notably to systemic,regulatory or technical issues.These risks are regularly assessed and managed through r
245、obust and continuous improvement of manufacturing processes,critical suppliers risk management,insurance prevention actions,capital investments,security stocks and business continuity plans.Regulatory and legal risks:intellectual property(IP)The expiration of a patent may result in substantial compe
246、tition due to the emergence of a generic drug.Other IP-related risks include patents that may be ruled invalid or unenforceable,or competitors who may infringe upon or circumvent existing patents.Ipsens IP strategy is defined and implemented to fight against these risks.Ipsen continuously improves i
247、ts risk management and internal control to be compliant with French authority frameworks and standards.Each year,we identify our greatest risks and utilize three lines of defense to mitigate them.Four risk factors:Our risks fall into four broad categories.Below,we spotlight one risk from each.For mo
248、re information on our risk factors,please see chapter 2 of our 2023 Universal Registration Document,available on .INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS4420222023 financial KPIsTotal salesCore operating marginR&D investment202220222023202320233.128bn20223.0
249、25bn619m1.001bn445m1.115bn15%of total sales37%of total sales20%of total sales32%of total sales+13%sales of growth platformsDysport+15%Onivyde+6%Cabometyx+23%Decapeptyl+17%North America only;excludes sales to ex-U.S.partner.INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY A
250、REAS452023 total salesSales by therapy areaNeuroscienceRare DiseaseOncology21%4%75%1.Europe is defined here as the E.U.,the U.K.,Iceland Liechtenstein,Norway and Switzerland.Sales by geographic areaEurope1North AmericaRest of World40%33%27%Sales by medicineDysportSomatulineDecapeptylCabometyxOnivyde
251、Growth platforms:1.893bnNew medicines649m1.066bn546m535m164m119mOther51mINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS46The people behind Ipsens purpose and passion“The need to adapt to the ever-changing landscape of healthcare keeps me motivated and excited to com
252、e to work each day.Our efforts can make a real difference in peoples lives this drives me to seek innovative solutions.”Stephen was diagnosed with a neuroendocrine tumor (NET)four years ago.Justine is Associate Director,Business Integrated Insights,North America.Behind the disease statistics and the
253、 performance indicators are people.Some are living with high unmet medical needs.Some are not.But they all share a common trait:they want to have a positive impact.“I had never heard of this cancer,its extremely rare.I was terrified.I was lucky to find some groups to chat with.Its the most important
254、 thing Ive found since being diagnosed.A friend of mine said,Were not dying of cancer,were living with cancer.”46INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS47“The successful execution of our strategy,Focus.Together.For patients and society,has enabled us to reac
255、h more people living with high unmet medical needs than ever before,while delivering strong financial performance and putting in place the building blocks for future sustainable success.”INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS48References and creditsp.15:Onc
256、ology:helping patients live longer and better with cancer1.Ipsens Onivyde regimen,a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma,approved by FDA.Available at:https:/ shared decision making in kidney cancer care1 International Kidney Cancer Coalition(IKCC)
257、,2023-International Kidney Cancer Coalition Global Survey 2022.Accessed:October 2023.Available at:https:/ikcc.org/wp-content/uploads/2023/10/P101739-IKCC-Global-Survey-2022-Global-Report-FINAL-2.pdf 2 European Cancer Organisation,2023-Shared-Decision Making.Accessed:October 2023.Available at:https:/
258、www.europeancancer.org/2-standard/85-eccp-shared-decision-making 3 Fiorillo,A.et al.The role of shared decision-making in improving adherence to pharmacological treatments in patients with schizophrenia:a clinical review.Annals of General Psychiatry,(19)43.2020.doi:10.1186/s12991-020-00293-4.p.17:Ra
259、re Disease:ordinary people with extraordinary ambitions1 National Library of Medicine-A comprehensive study of the rare diseases and conditions targeted by orphan drug designations and approvals over the forty years of the Orphan Drug Act.Available at:https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC1029
260、0406/#:text=Based%20on%20our%20study%2C%20we,their%20t reatment%2C%20diagnosis%20or%20prevention.2 Nastler-Parr et al.Value in Health.2018.21:493-500 3 Tufts CSSD Impact Report.May/June 2018;20(3)4 Ipsen-US FDA approves Ipsens Sohonos(palovarotene)capsules,the first and only treatment for people wit
261、h fibrodysplasia ossificans progressive.Available at:https:/ ClinicalTrials.gov-A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib(IPN60130)for the Treatment of Fibrodysplasia Ossificans Progressiva(FOP).Available at:https:/classic.clinicaltrials.gov/ct2/show/NCT
262、05039515.6 Genfit-Ipsen and GENFIT Announce Positive Results from Phase III ELATIVE trial of elafibranor in patients with primary biliary cholangitis,a rare cholestatic liver disease.Available at:https:/ how to best support people with rare liver disease1 Benito-Lozano J,Arias-Merino G,Gmez-Martnez
263、M,et al.(2022)Diagnostic Process in Rare Diseases:Determinants Associated with Diagnostic Delay.International Journal of Environmental Research and Public Health 19(11):6456.Available at:https:/pubmed.ncbi.nlm.nih.gov/35682039/.p.20:Improving care for stroke survivors1 Kuriakose D,Xiao Z.Pathophysio
264、logy and Treatment of Stroke:Present Status and Future Perspectives.Int J Mol Sci.2020;21(20):7609.Published 2020 Oct 15.doi:10.3390/ijms21207609 2 Krishnan S,Pappadis MR,Weller SC,et al.Needs of Stroke Survivors as Perceived by Their Caregivers:A Scoping Review.Am J Phys Med Rehabil.2017;96(7):487-
265、505.doi:10.1097/PHM.0000000000000717DisclaimerThe Ipsen Integrated 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
266、 of this docment beyond the above-stated purpose is strictly prohibited.CreditsThank 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
267、.Produced by Ipsen,Global Communications:Gwenan White,Amy Wolf,Mary-Elizabeth Hackett,Konstantinos Kampanos,Hlose De Touchet and Jaya Marcellin.Designed by Edited by French translation by Photo creditsThe images used in the creation of this integrated annual report belong to Ipsen;they may not be co
268、pied in whole or in part without authorization.PhotographersMatt Branscombe/BSC Photo Studio(pp.2,14);Pierre-Olivier/CAPA Pictures(pp.5,7-9,41,47);Picture Impact Production(pp.6,10,43);Porter Gifford/CAPA Pictures(pp.7,11,30,34,43);Richard Knew/Knew Productions(p.7);Ioan Sad/CAPA Pictures(pp.11,28,3
269、0,33);Julien Lutt/CAPA Pictures(pp.11,30,36);H&B(pp.12-13,22,29,39);Pguimaraes/CAPA Pictures(p.20);La Fondation Ipsen(p.37);Raven,Judes mom(p.38);Liz Linder Photography(p.41);Sarah Palmer/CAPA Pictures(p.46);(pp.2,11,14,28,30,32,35,38,41,46)/Ipsen/All Rights Reserved Stock imagesShutterstock(Front c
270、over,p.25);AdobeStock(p.18)Other illustrationsThe Noun Project.(icons);Oncology Franchise communication(p.16);The United Nations(pp.31-34,36)Ipsen 2024/bcw/Hollis&Bean/Mai Tran&CoINTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS49Forward-looking statementsThe forward-
271、looking statements,objectives and targets contained herein are based on Ipsens management strategy,current views and assumptions.Such statements involve known and unknown risks and uncertainties that may cause actual results,performance or events to differ materially from those anticipated herein.Al
272、l of the above risks could affect Ipsens future ability to achieve its financial targets,which were set assuming reasonable macroeconomic conditions based on the information available today.Use of the words believes,anticipates and expects and similar expressions are intended to identify forward-loo
273、king statements,including Ipsens expectations regarding future events,including regulatory filings and determinations.Moreover,the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions,which may alter these paramete
274、rs.These objectives are based on data and assumptions regarded as reasonable by Ipsen.These targets depend on conditions or facts likely to happen in the future,and not exclusively on historical data.Actual results may depart significantly from these targets given the occurrence of certain risks and
275、 uncertainties,notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets,notably for regulatory or competition reasons.Ipsen must face or might face competition from generic medicine that m
276、ight translate into a loss of market share.Furthermore,the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested signi
277、ficant sums.Therefore,Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials,or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned.There can be
278、no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful.If underlying assumptions prove inaccurate or risks or uncertainties materialize,actual results may differ materially from those set forth in the forward-looking sta
279、tements.Other risks and uncertainties include but are not limited to,general industry conditions and competition;general economic factors,including interest rate and currency exchange rate fluctuations;the impact of pharmaceutical industry regulation and healthcare legislation;global trends toward h
280、ealthcare cost containment;technological advances,new medicine and patents attained by competitors;challenges inherent in new-medicine development,including obtaining regulatory approval;Ipsens ability to accurately predict future market conditions;manufacturing difficulties or delays;financial inst
281、ability of international economies and sovereign risk;dependence on the effectiveness of Ipsens patents and other protections for innovative medicines;and the exposure to litigation,including patent litigation,and/or regulatory actions.Ipsen also depends on third parties to develop and market some o
282、f its medicines which could potentially generate substantial royalties;these partners could behave in such ways which could cause damage to Ipsens activities and financial results.Ipsen cannot be certain that its partners will fulfil their obligations.It might be unable to obtain any benefit from th
283、ose agreements.A default by any of Ipsens partners could generate lower revenues than expected.Such situations could have a negative impact on Ipsens business,financial position or performance.Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements,
284、targets or estimates contained in this press release to reflect any change in events,conditions,assumptions or circumstances on which any such statements are based,unless so required by applicable law.Ipsens business is subject to the risk factors outlined in its registration documents filed with th
285、e French Autorit des Marchs Financiers.The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsens latest Universal Registration Document,available on .INTRODUCTIONCORPORATE GOVERNANCEGENERATION IPSEN2023 BUSINESS REVIEWTHERAPY AREAS5065,quai Georges Gorse92100 Boulogne-BillancourtFranceStay connected with Ipsen.Scan our QR code to easily find all Ipsens website and social media links in one place.