Exelixis, Inc. (EXEL) 2024年CSR報告「NASDAQ」.pdf

1、2024 Corporate Values&Sustainability ReportOCTOBER 202422024 Exelixis CV&SReportAbout This ReportLetter From Our CEOAbout UsOur Approach to ESGAccess to Innovative and Safe Cancer MedicinesOur PipelineInvestment into R&DSafe and Ethical Clinical TrialsSupporting PatientsProduct Quality and Patient S

2、afetyCommunity Engagement and AdvocacyEmployee Giving and Volunteer Programs(EGVP)Select EGVP SpotlightsPatient AdvocacyPatient Education and Advocacy Partnerships Government Affairs and Public PolicyStakeholder EngagementOur People and CultureOur WorkforceTalent and Leadership DevelopmentEmployee E

3、ngagementSpotlight on a Diverse and Inclusive WorkforceDiversity Metrics and Anti-Discrimination PolicyEmployee Health and SafetyEnvironmental ManagementEnergy and TransportationWaste ManagementGovernance and Responsible Business PracticesCorporate Governance and Oversight of ESG InitiativesBoard Co

4、mpositionBusiness EthicsEthics CommitteeA Focus on ComplianceEthical Marketing of Pharmaceutical ProductsData Security and PrivacyRisk Management and Business ContinuityVendor Management and Supply Chain ResilienceVendor Selection and MonitoringBusiness Continuity in Our Value ChainFrameworks and St

5、andardsSustainability Accounting Standards Board(SASB)StandardsDisclosure Statement34568223144516670Table Contentsof32024 Exelixis CV&SReportAbout This ReportThis report outlines our progress related to the companys environmental,social and governance(ESG)initiatives and strategy and reflects our cu

6、rrent state as of June 30,2024,unless specified otherwise.Throughout the report,we also guide readers to additional sources of information located on our corporate website.To ensure a focus on the ESG topics most relevant to our business and key stakeholders,we leveraged leading ESG frameworks and s

7、tandards,notably the United Nations Sustainable Development Goals(UN SDGs)and the Sustainability Accounting Standards Board(SASB),now part of the International Financial Reporting Standards(IFRS)Foundation.More information about our alignment to these frameworks can be found in the“Frameworks and St

8、andards”section at the back of this report.We have also indicated alignment to specific SDGs that offer the greatest opportunity for impact given the relevance to our business activities throughout the report.The Exelixis team is united in our mission to help cancer patients recover stronger and liv

9、e longer.As we work to build on the contribution that CABOMETYX(cabozantinib)has made to cancer treatment by advancing our pipeline of investigational medicines,were committed to making a positive impact in our communities and the world at large.Once again,Im pleased to share Exelixis latest Corpora

10、te Values&Sustainability(CV&S)Report,which tracks the companys progress against our four core environmental,social and governance(ESG)themes first introduced in 2022:Access to Innovative and Safe Cancer Access to Innovative and Safe Cancer Medicines;Community Engagement and Advocacy;Our People and M

11、edicines;Community Engagement and Advocacy;Our People and Culture;and Environmental Management.Culture;and Environmental Management.Highlights from our reporting year include:Amplifying corporate initiatives that are focused on improving the lives Amplifying corporate initiatives that are focused on

12、 improving the lives of patients impacted by cancer.of patients impacted by cancer.Our“Clinical Trial Inclusiveness Initiative”enhanced the accessibility and diversity of our clinical trials to ensure prospective patients from underrepresented populations have the information they need to understand

13、 and enroll in our clinical studies.We are resolute in our commitment to provide support programs so that no patient prescribed an Exelixis medication will go without it due to lack of insurance or inability to pay.Giving back to thousands of nonprofit organizations through our Giving back to thousa

14、nds of nonprofit organizations through our Employee Giving and Volunteer programs.Employee Giving and Volunteer programs.Exelixis employees have supported more than 1,700 nonprofits at the local,regional and national levels,including through our donation matching program and volunteering more than 5

15、,600 hours since 2022.Our teams have furthered important causes including STEM education,homebuilding and animal welfare,in addition to our long-standing commitment to patient education,support and advocacy.Letter From Our CEOEnhancing our talent management programs with new educational Enhancing ou

16、r talent management programs with new educational offerings and growing our inclusive culture.offerings and growing our inclusive culture.We want every employee to feel a sense of belonging to the Exelixis team and its mission.Our newly launched two-year program,Exelixis Leadership Foundations,helps

17、 managers engage and lead their teams to achieve effective outcomes together.Three new Employee and Business Resource Groups nurture an environment where employees can bond over shared experiences,encourage each other and uniquely contribute to company culture.Improving our understanding of electric

18、ity and natural gas usage and Improving our understanding of electricity and natural gas usage and enhancing sustainability practices at our Alameda headquarters.enhancing sustainability practices at our Alameda headquarters.We are committed to conducting business in a way that respects the environm

19、ent and Earths changing climate.Our energy dashboard,along with our new data-driven HVAC monitoring system,providesperformance insights and opportunities that allow us to continue to optimize our use of important resources.Further,our green transportation and responsible waste management programs he

20、lp us lessen our environmental impact.These are but a few of the highlights;for more detail,I encourage you to review the report in full.As always,thank you for your interest in these important initiatives,which are a critical component of Exelixis overall strategy to create sustained value for all

21、of the companys stakeholders.Sincerely,Michael M.Morrissey,Ph.D.President and Chief Executive Officer,Exelixis52024 Exelixis CV&SReportThe Exelixis CredoExelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care.Powered by drug

22、 discovery and development excellence,we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules,antibody-drug conjugates(ADC)and other biotherapeutics.This comprehensive approach harnesses

23、decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product,CABOMETYX(cabozantinib).Our discovery efforts have also resulted in three other commercially available products,COMETRIQ(cabozantinib),COTELLI

24、C(cobimetinib)and MINNEBRO(esaxerenone),and we have entered partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide.Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more cancer patients hope for the fu

25、ture.About UsWe drive for results,so patientscan survive and thrive.We are resilient in theface of adversity,and tirelessin advancing our science.We celebrate our long history ofprolific drug discovery andrigorous drug development.We unite to launch innovative medicines for difficult-to-treat cancer

26、s.We exist to give people hope one drug,one patient at a time.We are Exelixis62024 Exelixis CV&SReportOur Approach to ESGExelixis mission is to help cancer patients recover stronger and livelonger.As we strive to extend and improve cancer patients lives,we also recognize the need to contribute posit

27、ively to the world in which we operate and the communities where we live and work.To that end,we expect every Exelixis employee to commit to the highest standards of ethical behavior and demonstrate values and principles that reflect both global awareness and sustainability.This means integrating en

28、vironmental,social and ethical governance considerations directly into our research and development(R&D)projects and business operations as we strive to create sustained value for all our stakeholders.Our ESG programs align with this socially oriented mission,and the four core ESG themes around whic

29、h our report is centered capture our perspective of viewing everything we do through the lens of delivering for our patients:Underlying these core ESG themes are responsible business practices and a focus on sound and ethical corporate governance,rooted in the corporate values reflected in our Corpo

30、rate Code of Conduct available here.Access to Innovative and Safe Cancer Medicines 12Community Engagement and Advocacy3Our People and Culture 4Environmental ManagementExceed TogetherApply rigor,resourcefulness and respect to maximize opportunities and deliver impactful results.Excel for PatientsInno

31、vate to design solutions and remove barriers to show how much we care.Be ExceptionalTake the right action and lead others todo the right thing at the right time in the right way.Exelixis Corporate Values72024 Exelixis CV&SReportMade significant progress in improving accessibility and diversity in ou

32、rclinical trialsEnhanced our talent management programs,with new offerings such as the Exelixis Leadership Foundations program,and continued to build on our culture of belonging with the addition of our eighth Employee Resource Group,VERGE Developed and implemented an energy dashboard to help us tra

33、ck electricity and natural gas usage across the building footprint of our Alameda campus 13472024 Exelixis CV&SReport2024 Exelixis HighlightsGave back to more than 1,700 nonprofit organizations in our community through our Employee Giving and Volunteer Programs282024 Exelixis CV&SReportAccess to Inn

34、ovative and Safe Cancer MedicinesWe can only accomplish our mission to help cancer patients if the medicines we discover and develop are innovative and fulfill unmet medical needs.These medicines must be of the highest quality,have an acceptable safety profile,be available expeditiously when prescri

35、bed by healthcare professionals(HCPs)and be accessible to cancer patients despite lack of insurance or inability to pay.Good Health&Well-BeingIndustry,Innovation&Infrastructure92024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Our PipelinePowered by our expertise and investments

36、 in drug discovery and development,we are working to evolve our product portfolio rapidly to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules,antibody-drug conjugates and other biotherapeutics.This comprehensive approach harnesse

37、s 30 years of investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship molecule,cabozantinib,and our commercial products,CABOMETYX and COMETRIQ.Increasing the number of novel and differentiated antiIncreasing the number of novel and dif

38、ferentiated anti-cancer cancer agents in our pipeline is agents in our pipeline is essential to our overall strategy and business goals.We will continue working to expand our oncology product pipeline with new programs exploring multiple modalities and mechanisms of action,which we hope will provide

39、 potential pathways for us to improve outcomes for a larger number of patients with cancer.U.S.regulatory submissions for new indications for cabozantinib anticipated in 20242differentiated clinical programs in our pipeline across our small molecule and biotherapeutics portfolios 4development candid

40、ate(DC)programs that are or may be the subjects of Investigational New Drug(IND)filings in 20242newDC programs to be designated in 2024,at least2DC programs that may be the subjectsof IND filings in 2025,at least2102024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Continued Exec

41、ution Across All Exelixis Pipeline ProgramsPre-INDPhase 1Phase 1b/2PivotalXB628:PD-L1+NKG2AXL309:USP1Zanzalintinib:MET/VEGFR/AXLMultiple solid tumorsCabozantinib:NETXB371:TF-TOPOiXB010:5T4-MMAECabozantinib:mCRPCXB064:ILT2XL495:PKMYT1Zanzalintinib:CRCXB033:IL13R2-TOPOiADU-1805:SIRP*Zanzalintinib:nccR

42、CCZanzalintinib:SCCHNZanzalintinib:NET*Small MoleculeMonoclonal AntibodyAntibody-Drug ConjugateBispecific AntibodyDrug ModalityDrug ModalityCombination PartnerCombination PartnerPD-(L)1Novel ICI(e.g.,LAG-3)Other(e.g.,VEGF)MMAE=monomethyl auristatin ETF=tissue factorCRC=colorectal carcinomaILT2=Ig-li

43、ke transcript 2PD-(L)1=programmed death ligand 1 or programmed cell death protein 1NKG2A=natural killer cell receptor group 2AnccRCC=non-clear cell renal cell carcinomaIL13R2=interleukin 13 receptor alpha 2SCCHN=squamous cell carcinoma of head and neckmCRPC=metastatic castration-resistant prostate c

44、ancerPKMYT1=protein kinase membrane associated tyrosine/threonine 1SIRP=signal-regulatory protein alphaTOPOi=topoisomerase inhibitorUSP1=ubiquitin specific peptidase 1NET=neuroendocrine tumorsLAG-3=lymphocyte-activation gene 3ICI=immune checkpoint inhibitor*Sairopa B.V.(Sairopa)and Exelixis have an

45、exclusive clinical development and option agreement providing Exelixis the right to acquire ADU-1805*New trial to be initiated in the first half of 2025112024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Investment into R&DBiopharmaceutical R&D requires extensive investment beca

46、use the process of discovering,refining and testing compounds for safety and efficacy is long and labor-intensive.Across the industry,companies test thousands of compounds in the laboratory,but only a handful of those compounds are advanced into clinical trials in cancer patients.Hundreds of patient

47、s are typically enrolled in clinical trials to assess a drug candidates safety and efficacy,and the data from these trials are reviewed by independent regulatory agencies,such as the U.S.Food and Drug Administration(FDA)and the European Medicines Agency,in an iterative process.Approximately 12%of th

48、e investigational medicines that make it into phase 1 clinical trials ultimately receive regulatory approval.1On average,it takes 10-15 years to develop a single new medicine.2At Exelixis,we have a disciplined and focused approach to R&D and critically evaluate assets through all stages of developme

49、nt,advancing only those programs that meet our rigorous standards.To advance our development efforts in an efficient and cost-effective manner,we leverage a diverse set of external collaborators and partners.Four products discovered by Exelixis have gone through this rigorous process and been approv

50、ed for sale:CABOMETYX,COMETRIQ,COTELLIC and MINNEBRO.The revenue generated from the sale of these commercialized products by us and by our international collaboration partners helps to fuel the discovery and development of the next generation of drug candidates for cancer patients.In fiscal year 202

51、3,57%of our total revenues were reinvested in R&D.We will continue to invest in R&D to improve the standard of care for cancer patients,exploring innovative treatments and therapies to enhance patient outcomes.122024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Safe and Ethical

52、Clinical TrialsExelixis conducts its sponsored clinical trials with the highest ethical standards.We are committed to full compliance with international guidelines such as the International Conference for Harmonisation(ICH)and Good Clinical Practice(GCP),as well as local health authority requirement

53、s.Clinical Site Assessment and ComplianceSite selection procedures and routine monitoring are critical to the safety and reliability of our clinical operations.Prior to initiating operations at any clinical site,we assess its resources and clinical trial experience to determine the suitability of fa

54、cilities,staff and equipment.Every site and clinical trial undergo a vigorous vetting process to ensure scientific quality and regulatory compliance.Once a trial begins,we conduct routine monitoring at each study site to ensure protocol and GCP adherence,site quality and patient safety and rights.In

55、 particular,our Quality Assurance team conducts risk-based,independent site audits for each study.The clinical audit program assesses all sites for baseline risk,and the frequency of site audits is then determined according to relevant risk factors.We actively monitor for breaches of GCP standards,m

56、isconduct or violations of patient rights or safety.Should any such breach,misconduct,or violation occur,we assess the facts and circumstances and,if warranted,report to the FDA and comparable authorities in other countries.132024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Tra

57、nsparency and Informed ConsentIt is essential that patients have a complete understanding of the potential risks and potential benefits of participating in a clinical trial.In keeping with the best practices of clinical study,we provide patients with all the information they require to make an infor

58、med decision regarding whether to participate or continue participation in an Exelixis clinical trial.In particular:Patients must provide informed consent via signature before they can be enrolled in a clinical study.The information provided to patients in this process must be reviewed and approved

59、by the local or central Institutional Review Board,local health authorities and by independent ethics committees monitoring the trial.Informed consents are updated as new information becomes known during an active trial.We also review the informed consent form templates for each clinical-stage compo

60、und at least once per year(or more frequently if needed based on the availability of new information relating to a particular clinical development program)to determine whether any updates are needed.We believe this system of keeping patients informed on an ongoing basis is critical for patient safet

61、y as we continue to develop innovative treatments for various types of cancers.Publication of Clinical Trial ResultsWe comply with regulatory requirements in the publication of clinical trial results throughthe U.S.National Library of Medicine.Please visit https:/clinicaltrials.gov/for furtherinform

62、ation on our published clinical activities.Safe and Ethical Clinical Trials142024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Safe and Ethical Clinical TrialsDiversity in Clinical TrialsAt Exelixis,we understand our role and responsibility in designing clinical trials that addr

63、ess important medical needs and are accessible to patients around the world across all racial and ethnic communities and economic backgrounds,including those who have been historically underrepresented inclinical trials.We are proud of the actions we have taken to help make our clinical trials avail

64、able to a diverse patient population,including:Clinical Trial Design and PlanningContinuing our Clinical Trial Inclusiveness Initiative,a cross-functional collaboration within our Clinical Operations/Clinical Development,Medical Affairs,Regulatory Affairs and Public Affairs teams aimed at ensuring d

65、iversity is considered,implemented and tracked within our clinical trial programs from the planning stage through study readout,and beyondInstituting diversity action plans for each of our phase 3 studies,while also being proactive in incorporating diversity into our earlier phase studies Establishi

66、ng the Consent Innovation Lab,a cross-functional team to ensure prospective patients can easily understand our clinical trials,and continuing to evolve our informed consent form templates based on lessons learned in the field Broadening our definition of diversity to include variable education level

67、s,different disabilities and socioeconomic factors as examples to inform the accessibility of our trialsImplementing a data-informed assessment of trial protocols to understand any differences and potential impacts based on race,ethnicity and other factorsCommunity Outreach and Patient ResourcesWork

68、ing with our investigators to continue expanding our community outreach and educational efforts within and around our clinical trial sitesUtilizing data-driven geo-mapping methods during the site selection phase to maximize accessibility to various communitiesInforming patients about our travel reim

69、bursement process to support increased participationEngaging patients as subject matter experts to provide feedback on study concepts and materialsPreparing multilingual materials to educate patients across diverse communities about each clinical trialUtilizing social media and digital marketing cha

70、nnelsto further reach prospective patients from historically underrepresented communities152024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1During the study development phase for STELLAR-303,we leveraged epidemiology data to understand the prevalence of certain tumor-specific m

71、utations across different racial and ethnic groups.Enrollment plans were therefore adjusted to reflect these epidemiological facts rather than merely the rate of CRC in the U.S.population.The diversity plan for STELLAR-303 helped fulfill the recruitment goals of our Clinical Trial Inclusiveness Init

72、iative by translating patient-friendly educational materials into different languages and engaging local communities to provide trial education for racial and ethnic minority populations near trial sites.We also selected sites in the U.S.in areas with high minority populations for recruitment via ge

73、o-mapping and feasibility questionnaires that included questions specific to diversity,and worked with social media influencers within Black or African American communities for select sites in the U.S.to educate potential patients about the trial.As noted above,these recruitment strategies have help

74、ed increase patient enrollment in STELLAR-303 from underrepresented communities,in particular from Black or African American,Hispanic or Latino and Asian populations,which in turn improves our understanding of the potential effectiveness of our therapies across these patient populations.Safe and Eth

75、ical Clinical Trials162024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines13.2%4.8%1.6%8.6%7.5%OtherNot ReportedAmerican Indian/Alaska NativeAsianAfrican AmericanWhiteSafe and Ethical Clinical TrialsWhile we have seen considerable progress in recruiting and retaining a diverse pati

76、ent population for our clinical trials over the past several years,we know there is always more work to be done to improve access to clinical trial opportunities.We will continue to stay diligent and informed as new guidance from health authorities and other stakeholders in the industry becomes avai

77、lable.Our Clinical Trial Inclusiveness Initiative will also remain in place to ensure our internal team members are aware of existing barriers and integrate diversity throughout each stage of clinical trial development.This will help us continue to increase the enrollment of patients from underrepre

78、sented communities in studies across all phases of our clinical research.Diversity Efforts in Our Ongoing Phase 3 Study STELLAR-303For STELLAR-303,our phase 3 study evaluating zanzalintinib in previously treated patients with colorectal cancer(CRC),we established a diversity action plan and made sig

79、nificant progress in recruiting a more diverse patient population versus our historical clinical trials and oncology trials generally.Upon completion of enrollment during the third quarter of 2024,the racial composition of U.S.participants in STELLAR-303 was 74.2%White,8.6%Asian,7.5%Black or African

80、 American and 1.6%American Indian or Alaska Native,with 3.2%identifying with other racial groups and 4.8%not reporting their race.Regarding ethnicity,12.4%of STELLAR-303 patients in the U.S.identified as being of Hispanic or Latino background.74.2%12.4%83.8%3.8%Hispanic/LatinoNot Hispanic/LatinoNot

81、ReportedSpotlight:Racial CompositionEthnicity172024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1For the pricing of our products,we consider several factors:How to expand appropriate patient access to Exelixis products,while balancing substantial investments necessary to maximiz

82、e our chance of discovering,developing and commercializing the next generation of innovative therapiesThe value proposition offered by each of our products,including relevant healthcare economic information connected with product use and the strength of the products clinical data relative to other a

83、pproved and late-stage investigational products in the same therapeutic categoryThe prices and formulary positioning of competing cancer therapiesManufacturing costs that enable us to produce medicines of the highest quality for our patients,while supporting a robust global supply chain and ongoing

84、continued enhancement of our manufacturing operationsSupporting PatientsCancer accounts for almost 10 million deaths annually.3On top of the hardships of illness and recovery,patients with cancer frequently contend with financial obstacles to accessing the best care available to treat their illness.

85、Every cancer patient deserves the opportunity to obtain care optimized for them,and we believe biopharmaceutical companies should strive to make therapies widely accessible upon prescription by an HCP.Access and AffordabilityAt Exelixis,our core corporate values call upon us to Be Exceptional in wha

86、t we do and how we lead,Excel for Patientsby going the extra mile to work on their behalf and Exceed Together both as a business and contributor to the scientific community.We work tirelessly and dedicate substantial financial resources in our mission to offer patients high-quality and effective can

87、cer treatments with acceptable safety profiles.Once our products are commercially available,we aim to maximize patient access by providing discounts and rebates to public and private insurers and safety net providers with the expectation that intermediaries in the pharmaceutical supply system,such a

88、s pharmacy benefit managers,will pass those discounts and rebates through to patients.We are resolute in our commitment that no patient prescribed an Exelixis medicine will go without it due to lack of insurance or inability to pay.For such patients,we provide financial assistance,if permitted,or ou

89、r product at no cost,if they meet all specific program eligibility criteria.182024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Supporting PatientsPatient AssistanceWe provide our approved medicines at no cost to uninsured and underinsured patients who meet financial qualificati

90、ons and also provide copayment and coinsurance assistance to eligible commercially insured patients.Exelixis Access Services(EASE)is the umbrella of programs under which we provide a variety of support to help patients commence therapy with an Exelixis product as soon as possible following prescript

91、ion by an HCP.EASE Case Managers serve as a single point of contact for HCPs and their patients,providing the information necessary to navigate access to these services and programs.Patients benefit from a variety of services,including:The Free Trial Program that provides eligible patients with quic

92、k access to CABOMETYX for 30 days at no cost after a prescribing decision has been made and while their payer coverage is being investigated.Patients can receive product as soon as the next day.The EASE Co-Pay Program that assists commercially insured patients with out-of-pocket medication costs.Eli

93、gible patients may pay as little as$0 per month.The EASE Patient Assistance Program(PAP)that enables eligible uninsured and underinsured patients to receive their medication free of charge.Clinical outreach and support services that connect oncology nurses or other HCPs with patients enrolled in PAP

94、 to help them understand how to take their medicine and mitigate side effects.We are proud of our EASE programs and believe that by providing these services,we make it easier for patients to continue to take their Exelixis medications as their prescribing HCPs have determined to maximize their poten

95、tial medical benefits.Since the initiation of EASE in 2016,the EASE PAP and the EASE Co-Pay Program have enrolled nearly 13,000 patients combined.For more information,please visit our Patient Access website at https:/www.ease.us.Determine eligibility for financial assistance offeringsCo-Pay ProgramP

96、atient Assistance Program(PAP)Facilitate access to treatment30-day free trial programDose exchange program Confirmation of coverage and out-of-pocket responsibilityBenefits investigationsPrior authorization assistanceAppeals support and follow-up192024 Exelixis CV&SReportAccess to Innovative and Saf

97、e Cancer Medicines1Product Quality and Patient SafetyAt Exelixis,concern for patients is central At Exelixis,concern for patients is central and the quality and integrity of our and the quality and integrity of our products is paramount.Our Quality Policy products is paramount.Our Quality Policy and

98、 Quality Manual are designed to and Quality Manual are designed to ensure our products are developed in ensure our products are developed in compliance with regulated Good Practice compliance with regulated Good Practice(GxPGxP)guidelines.)guidelines.All new hires receive training on the Quality Pol

99、icy so that every Exelixis employee,regardless of job function,understands the role they play in protecting patient wellness.The Quality Manual describes the principles and framework of our Quality Management System(QMS),which supports the development,clinical evaluation,pharmacovigilance,clinical a

100、nd commercial manufacturing and post-marketing surveillance of pharmaceutical products throughout the product lifecycle.All employees,temporary staff and contractors working within the QMS or otherwise operating GxP functions are required to review and adhere to the standards set forth in the Qualit

101、y Manual.Product QualityWe audit our enterprise-wide internal processes and systems with qualified independent Quality Assurance auditors to critically assess our capabilities and evaluate our adherence to required policies,processes and procedures.The QMS aligns with the ICH guidelines as well as a

102、pplicable global health authority regulations.The performance of our QMS,as defined in the Quality Manual,is assessed by senior quality professionals at quarterly Quality Council meetings.Audit metrics are presented at these meetings to review trends,potential actions and continuous improvement acti

103、vities.As described in more detail below,the Quality Council reports to the Exelixis Ethics Committee,a governance feedback mechanism that helps us follow through on the integrity and ethical expectations set by our Board of Directors and senior management.We focus on product quality and oversee our

104、 3rd-party manufacturers to ensure our products are always safe and efficacious,which includes comprehensive review and monitoring of our manufacturing batch data and performing stability trending analysis.We perform ongoing,routine signal detection for all marketed and development products.We also

105、conduct annual product quality audits that drive corrective action or feedback to contract manufacturing organizations(CMOs)and identify any emerging issues.202024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Patient SafetyWe proactively monitor the safety profile of our product

106、s through their lifecycle,from preclinical and clinical development through the post-market experience and develop risk management and communication strategies designed to ensure the safety of the patients treated with them.The Exelixis Benefit-Risk Executive Committee is responsible for reviewing p

107、roduct benefit-risk assessments.Membership in this committee includes the Chief Medical Officer,Senior Vice President of Global Patient Safety and heads of various teams within the broader Clinical Development organization,as well as other employees on an ad-hoc basis.We have set up the necessary sa

108、fety data collection and exchange from global partners through our Global Safety Database(GSDB).The GSDB compiles,integrates and produces reports of adverse event data from all sources(e.g.,clinical trials,post-marketing reports made through our channels and otherwise,literature sources and regulato

109、ry authorities).It is used to collect,monitor,store,assess,analyze and report clinical trial serious adverse events and post-marketing adverse events.All employees are trained annually on how and when to report adverse events.Our objective is for every Exelixis employee to understand the minimum req

110、uirements for adverse event reporting,regardless of job function.Product Quality and Patient SafetyWe collect various types of safety data relating to adverse events and special situations pertaining to our products in order to:Maintaincomprehensive safety profiles on our medicinal productsHelp keep

111、 patients safe and HCPs informedAnalyze aggregate data for potential safety signalsMeet our regulatory reporting obligationsMaintainour integrity212024 Exelixis CV&SReportAccess to Innovative and Safe Cancer Medicines1Product Integrity and TrackingOur patients expect us to be stewards of their healt

112、h and well-being,and to act immediately and comprehensively to protect them should the need arise.We strive to fulfill this expectation and help keep patients safe and HCPs informed,while continuously meeting our global regulatory reporting obligations and maintaining our corporate integrity.Our ant

113、i-counterfeiting and serialization practices are designed to safeguard the integrity of our products.In accordance with the Drug Supply Chain Security Act(DSCSA),every unit of a finished Exelixis product is given a unique serialized number,creating a data chain that allows us to track that unit acro

114、ss our supply chain.We regularly review and revise our procedures to ensure compliance with the DSCSA.Our Quality Assurance organization,in partnership with Global Patient Safety and other teams,assures that incoming product complaints related to safety are resolved in a timely manner.In the event t

115、hat a product recall is necessary,we are ready to execute on robust internal procedures,terms and requirements with our suppliers,and communication to the proper authorities.We have not yet needed to recall a product;however,we conduct mock recalls(either ourselves or with our partners)to confirm pe

116、rtinent processes remain ready.Product Quality and Patient Safety222024 Exelixis CV&SReportCommunity Engagement and AdvocacyBeyond serving patients by developing innovative medicines,at Exelixis we recognize the importance of connecting with other stakeholder groups.These include communities in whic

117、h our employees live and work,and like-minded organizations that are dedicated to improving cancer care,education,outreach and advocacy.Through our comprehensive Charitable Contribution Program,we broaden our impact and create partnerships to benefit organizations that are dedicated to the causes we

118、 care about.We also offer employees the opportunity to engage with their community through the Exelixis Employee Giving and Volunteer Programs,knowing that together as a team we can always do more.Industry,Innovation&Infrastructure232024 Exelixis CV&SReportCommunity Engagement and Advocacy 2Employee

119、 Giving and Volunteer Programs(EGVP)To build on our long-standing value of giving back to our local communities,we offer two meaningful programs to our employees the Exelixis Employee Giving and Volunteer Programs that provide opportunities for our team to make a purposeful impact in communities whe

120、re they live and work.Both programs are open to all regular,full-time and part-time employees,and eligibility to participate starts on day one of employment.nonprofit organizations at the local,regional and nonprofit organizations at the local,regional and national levels national levels our employe

121、es have supported since the inception of these programs 1,700 company donation matches company donation matches up to$1,000 for eligible charities per year1:1hours of paid time off per year hours of paid time off per year to support volunteer work in the local community and rewards earned for every

122、hour volunteered25hours volunteered hours volunteered since 20225,600Employee Giving ProgramThe Employee Giving Program doubles the impact of employee donations to philanthropic and community organizations that are important to them.Our employees support hundreds of different organizations each year

123、 with focus areas ranging across a broad spectrum of causes.Employee Volunteer ProgramIn 2022,we launched the Exelixis Employee Volunteer Program to complement our Employee Giving Program,with a focus on giving back to the communities where we live and work in a meaningful way.242024 Exelixis CV&SRe

124、portCommunity Engagement and Advocacy 2Select EGVP SpotlightsCASE STUDY:Habitat for Humanity(HFH)East Bay/Silicon Valley Exelixis employees have provided support to HFH through our EGVP by participating in team volunteer events at the organization and by providing charitable donations to support the

125、 organizations mission.Employees have utilized their volunteer time off at HFH on several occasions to build playhouses,which are donated to families and local community charities,and for home builds,where employees use their time to construct and repair homes in the East Bay.252024 Exelixis CV&SRep

126、ortCommunity Engagement and Advocacy 2CASE STUDY:CASE STUDY:Helping Shelter Animals Get Adopted in the Bay AreaAs we develop therapies to help cancer patients recover stronger and live longer,we apply the same results-driven mindset to enhance the communities where we live and work.In 2023,in collab

127、oration with the Exelixis EGVP and the Exelixis Charitable Contribution Program,we launched a partnership with Friends of the Alameda Animal Shelter(FAAS).Dozens of our employees have since volunteered at FAAS,walking dogs and interacting with cats to give them exercise and a break from their kennel

128、s,or completing office tasks and cleanup projects at the facility.These small efforts go a long way to assist the FAAS staff and help the animals become more adoptable,which will free up space in the shelter for the arrival of new animals.We also invited FAAS leadership to speak to our employees abo

129、ut the animal shelters various programs during a speaker series presentation.Community Engagement and Advocacy 2262024 Exelixis CV&SReportCommunity Engagement and Advocacy 2EGVP HighlightsIn the second half of 2023 and first half of 2024,our employees gathered on campus for several volunteer events

130、for local nonprofit organizations Together,they:Assembled more than 2,000 STEM(science,technology,engineering and mathematics)kits,in partnership with Life Science Cares Bay Area,benefiting Scientific Adventures for Girls and Pacific Islanders Encouraging Fun,Engineering,Science&Technology in the Sa

131、n Francisco Bay Area,and ACHIEVEability in PhiladelphiaAssembled more than 350 back-to-school teacher desk kits for teachers of Alameda,CA,Oakland,CA,and Norristown,PA,school districtsHosted two blood drives with the Stanford Blood Center and American Red Cross,collecting more than 70 units of blood

132、Built 500 nature kits in recognition of Earth Day with Life Science Cares Bay Area,which were then delivered to the San Mateo Parks Foundation for local students to use during their nature adventure programs272024 Exelixis CV&SReportCommunity Engagement and Advocacy 2Patient AdvocacyExelixis is comm

133、itted to raising awareness of health-related cancer issues and providing the public with accurate and appropriate information,assistance and/or education on the prevention,diagnosis and treatment of disease.Guided by our Policy on Interactions with Patients and Patient Advocacy Groups,our Advocacy R

134、elations team interacts with patients,caregivers and patient advocacy groups to advance initiatives that foster a healthcare environment in which all individuals and families impacted by cancer have the education,resources and psychosocial support necessary to feel empowered in their cancer journey.

135、This includes,but is not limited to,programs that address disparities in cancer care,peer-to-peer support,non-medical financial aid,resource navigation and treatment education.The following are examples of nonprofit patient advocacy organizations that Exelixis supports through its Charitable Contrib

136、ution Program:Academy of Oncology Nurse&Patient Navigators American Association for Cancer ResearchAmerican Cancer Society Cancer Action NetworkBlue Faery:The Adrienne Wilson Liver Cancer AssociationCancer Support Community San Francisco Bay AreaCancerCareConquer Cancer,the ASCO FoundationFamily Rea

137、chFriends of Cancer ResearchInternational Kidney Cancer CoalitionKidney Cancer AssociationKidney Cancer Coalition Learn Advocate Connect Neuroendocrine Tumor SocietyNational Alliance for CaregivingNational Health CouncilNational Kidney FoundationNeuroendocrine Cancer Awareness NetworkNational Compre

138、hensive Cancer Network FoundationProstate Conditions Education CouncilThyCa:Thyroid Cancer Survivors AssociationWomens Cancer Resource CenterZERO Prostate Cancer282024 Exelixis CV&SReportCommunity Engagement and Advocacy 2Patient Education and Advocacy Partnerships National Comprehensive Cancer Netw

139、ork(NCCN)Alliance for Cancer Care Equity2024 marked the third year that we have supported NCCNs Alliance for Cancer Care Equity program.The Alliance,which NCCN launched in partnership with the American Cancer Society Cancer Action Network and the National Minority Quality Forum,is made up of a broad

140、 and diverse group of stakeholders seeking to advance cancer care systems transformation at the federal level.The Alliance is focused on three high-impact areas to address cancer disparities:diversity in clinical trials;screening and early detection;and patient navigation.Activities for the third ye

141、ar of this effort include hosting a briefing for policymakers,launching an informational web platform and hosting quarterly meetings with government representatives to identify collaboration opportunities.ZERO Prostate Cancer ZERO360 HelplineExelixis is a proud supporter of ZERO360,ZERO Prostate Can

142、cers free,comprehensive support service for individuals and families impacted by prostate cancer.Through ZERO360,experienced case managers help patients with prostate cancer with a variety of issues,including insurance navigation,financial aid resources,navigating employer benefits,psychosocial supp

143、ort and more.Since its inception,ZERO360 has served over 5,000 patients,and demand for the program is continuing to grow.National Alliance for Caregiving(NAC)Cancer Caregiving CollaborativeIn 2023,the NAC launched a novel program to link stakeholders across the cancer and caregiving continuum in eff

144、orts to address the unmet needs of cancer caregivers,called the Cancer Caregiving Collaborative.Exelixis is a seed investor of this important initiative and participated in a design workshop with 40+key opinion leaders to help the Collaborative identify core priorities and set the agenda of issues t

145、o address within research,policy and health systems.Thus far,the Collaborative has already championed a Medicare rule change so that HCPs are reimbursed for training family caregivers,elevated the voices of cancer caregivers through national stories and launched new resources to help other cancer ad

146、vocacy organizations better support family caregivers.Womens Cancer Resource Center(WCRC)Community OutreachSince 1986,WCRC has improved the quality of life for women with cancer in the Bay Area and advanced equity in cancer care,especially for low-income people,people of color and queer/trans people

147、.Exelixis provides annual support for WCRCs free services including psychotherapy,support groups,a health and wellness program,community-based cancer navigation and information,and referral to community resources.These services seek to increase adherence to cancer treatment,advance self-empowerment

148、and ultimately improve health.292024 Exelixis CV&SReportCommunity Engagement and Advocacy 2Government Affairs and Public PolicyThe voices of small and mid-sized innovative biopharmaceutical companies like Exelixis are rarely heard in national debates over prescription drug pricing and regulatory pol

149、icy.While the role that these companies play in public health is underappreciated,it is outsized.These biotech companies are engines of discovery that drive critical advances in the fight against many diseases,including cancer.Emerging biopharma companies were responsible for the development of 61%o

150、f new oncology drugs in 2023 and often spend many years,and billions of dollars,attempting to develop a single prescription medicine,all at the risk of the company and its shareholders.4We engage with key federal and state policymakers,patient advocacy groups and other We engage with key federal and

151、 state policymakers,patient advocacy groups and other industry stakeholders who share our interest in the promotion of a productive and healthy industry stakeholders who share our interest in the promotion of a productive and healthy public health ecosystempublic health ecosystem.Since the passage o

152、f the Inflation Reduction Act in 2022,we continue to engage both Congress and federal health agencies on the implementation of the law and its potential impacts on us,which includes providing comment letters on proposed rulemaking related to the new Medicare Drug Price Negotiation Program.We are als

153、o highly engaged in the debate over reforms and improvements to the 340B Drug Pricing Program,designed to provide vulnerable patients access to affordable medications.We are working with policymakers to ensure the 340B Drug Pricing Programs original intent to assist patients is maintained without im

154、peding the development of life-saving new medicines.Today,Exelixis represents a clear voice in the debate over these important public policies,and our Government Affairs team located in Washington,D.C.,has helped to drive greater awareness and acknowledgment from legislators and policymakers of the

155、important role played by emerging biotech companies in our nations medical innovation ecosystem.Exelixis participates as a corporate member in biotechnology advocacy organizations as part of its advocacy and public policy initiatives with federal,state and local policymakers.Examples of these organi

156、zations include:American Association for Cancer Research American Cancer Society Cancer Action Network American Society of Clinical Oncology Bay Area Council Biocom California Biotechnology Innovation Organization Life Sciences PA302024 Exelixis CV&SReportCommunity Engagement and Advocacy 2Stakehold

157、er EngagementIn order to achieve our goal of delivering results and new medicines to improve outcomes for cancer patients,we rely on the partnership,support and commitment of several key stakeholder groups.Outreach is not limited to our Investor Relations&Public Affairs team;employees from our Marke

158、ting,Sales and HR teams,along with members of senior management,also engage in stakeholder outreach.More information on how we engage with our stakeholders is included in the following table.StakeholderKey methods of engagementOutcomesHCPsForums and advisory groupsIndustry conferencesMeetingsNewslet

159、tersPress releases and corporate updatesWebsite and online channelsCommunity inclusionEducationGoal achievementInnovation and collaborationTransparencyPatient advocacyAdvocacy conferencesCharitable contributions,sponsorships and medical education grantsForums and advisory groupsMeetingsWebsite and o

160、nline channelsCommunity inclusionEducationInnovation and collaborationTransparencyInvestment communityAnnual(10-K)and quarterly(10-Q)reports and proxy statementEarnings calls/webcastsInvestor conferencesIndustry conferencesMeetings Non-deal roadshowsOther SEC filingsPress releases and corporate upda

161、tesWebsite and online channelsAccess to managementEducationGoal of achieving appropriate valuationTransparencyEmployeesAnnual and midyear performance assessmentsCompany town halls and eventsExelixis ethics helplineEmployee resource and business groups SurveysWebsite and company intranetWorkshops and

162、 professional development coursesEmployee retention,development and engagementEmployee educationRecruitment of diverse and high-quality candidatesLocal communitiesCommunity support donations and sponsorshipsEmployee Giving and Volunteer ProgramsCommunity supportEmployee engagementFederal and state l

163、egislators,policymakers,regulatorsCongressional briefingsDirect lobbyingEngagement with industry trade associations and coalitionsFormal regulatory commentsEducate policymakers and legislatorsPromote manufacturer transparencyImprove public policiesExternal partners/vendorsAuditing,monitoring,review

164、meetingsGoal achievementInnovation and collaborationTransparency312024 Exelixis CV&SReportOur Peopleand CultureAt Exelixis,we nurture a culture of belonging where all employees feel empowered.We respect and appreciate each employees unique perspective and experiences and believe that celebrating,enc

165、ouraging and supporting both our employees similarities and differences contributes to our company mission.Our employees needs are paramount in our planning of benefits programs and our broader efforts to cultivate and maintain a welcoming and inclusive professional environment.We include feedback f

166、rom our employees when advancing our initiatives around creating an inclusive and collaborative workforce,as we take pride in our core corporate values to Be Exceptional,Excel for Be Exceptional,Excel for PatientsPatients and Exceed TogetherExceed Together,and remain committed to fostering a culture

167、 where each and every employee feels a sense of belonging to the Exelixis team and our mission.Industry,Innovation&InfrastructureDecent Work&Economic GrowthGender Equality322024 Exelixis CV&SReportOur People and Culture3Our WorkforceIn January 2024,we announced that our Board of Directors had author

168、ized a corporate restructuring plan to reduce our workforce and rebalance our cost structure in alignment with our strategic priorities,including reducing real estate commitments and expenses,and terminating certain licensing partnerships.As of June 30,2024,we had 1,121 full-time equivalent employee

169、s,representing a 14%decrease in our employee workforce in the first six months of 2024 and an 8%decrease from the beginning of 2023.A majority of employees are located at our principal offices in Alameda,with others working from our King of Prussia offices,field-based roles or remotely.Employee Comp

170、ositionEnd of FY 2022End of FY 2023As of June 30,2024Total headcount(#fullTotal headcount(#full-time employees)time employees)1,2231,3101,121Change in employee workforce as compared to end of previous year(%)Change in employee workforce as compared to end of previous year(%)287(14)Employees on R&D t

171、eams(#fullEmployees on R&D teams(#full-time employees)time employees)600672550Employees on commercial,general and administrative teams Employees on commercial,general and administrative teams(#full(#full-time employees)time employees)623638571Employee DegreesEmployees with Ph.D.,M.D.,PharmD degrees(

172、#fullEmployees with Ph.D.,M.D.,PharmD degrees(#full-time employees)time employees)270314255Employees with other professional degrees(#fullEmployees with other professional degrees(#full-time employees)time employees)111119112We continually assess employee turnover,recruitment initiatives,compensatio

173、n and benefits programs,safety in performing critical laboratory work,diversity and other matters relevant to human capital management.We review results of these assessments on a periodic basis with the Compensation Committee of our Board of Directors,which is charged with oversight of the developme

174、nt,implementation and effectiveness of our policies and strategies relating to human capital management.332024 Exelixis CV&SReportOur People and Culture3Our WorkforceTalent Management,Compensation and BenefitsAt Exelixis,we invest in our individual employees equitably to build our collective strengt

175、h as a team.We understand the importance of attracting and retaining the right talent to help us achieve our mission.We provide competitive compensation packages,and all our employees are eligible for cash bonuses and grants of long-term incentive awards.We regularly evaluate our compensation progra

176、ms with an independent compensation consultant and utilize industry benchmarking to ensure we are competitive with the biotechnology and biopharmaceutical companies against which we compete for talent.Pay EquityWe utilize a third-party firm to conduct an annual pay equity analysis as part of our com

177、mitment to fair compensation for all employees.Our most recent analysis demonstrated no gender or ethnicity-based disparities.gender pay ratio parityFactors such as job grade,education,title,tenure and managerial status were the primary variables impacting pay.1:1342024 Exelixis CV&SReportOur People

178、 and Culture3Our WorkforceBenefitsWe continue to expand and improve our benefit offerings toensure that they are diverse,equitable and inclusive.As a cornerstone of the Exelixis employee experience,we offer a wide selection of programs and services to support our employees in meeting and balancing t

179、heir needs at work,at home and in life,including an attractive mix of healthcare,insurance and other benefit plans.Our inclusive benefits are also designed to support family life with options such as generous parental leave policies,grandparent leave,adoption,surrogacy and fertility programs,new par

180、ent and nursing mother support programs,mental health services,childcare tuition subsidy and tutoring services,dependent care for children and adults,family care coordination and pet insurance.More information on our benefits programs is available here.-Mental health coverage-Subsidized commuter ben

181、efits-Other wellness benefitsThis includes:-Medical,dental and vision benefits-Wellness subsidy program-Virtual and on-site fitness classes-Adoption assistance352024 Exelixis CV&SReportOur People and Culture3Talent and Leadership DevelopmentSpearheaded by our Learning and Development team,we offer a

182、 comprehensive range of learning experiences tailored for both people leaders and individual contributors.Our philosophy emphasizes practical application following workshop delivery.To achieve this,we organize content into a structured learning series or practicum.The sequence for each practicum typ

183、ically includes an initial workshop followed by two practice labs.Whether delivered in-person or virtually,our content ensures accessibility regardless of geographical constraints.Highlights from our learning programs include:Development courses ranging from technical training to competency-based wo

184、rkshops Leadership development programs facilitated by external partners who are experts in their respective fields Specific onboarding programs and support for new leaders to accelerate their successful acclimation Certification programs and other professional development opportunities on an as-nee

185、ded basisTopics for workshops include:Accountability without Control Active Listening Art of Disagreeing Gracefully Be a Culture Catalyst Building Team Engagement Getting Things Done!Giving Feedback Influencing without Authority Intro to Lean Six Sigma Manager as a Coach Navigating Tricky Performanc

186、e Conversations Own It!Your Destiny,Your Career Project Management for Non-Project Managers Successfully Lead ChangeManagers also take an active role in identifying individualized development plans to assist their employees in realizing their full potential and creating opportunities for promotions

187、and added responsibilities that enhance the engagement and retention of our workforce.In 2024,we established the Exelixis Leadership Foundations,a comprehensive two-year leadership program designed exclusively to assist managers in achieving outcomes effectively.The program includes eight mandatory

188、practicums,each held quarterly,with content structured around the same competencies that make up our annual employee performance evaluations.In addition,we offer a tuition reimbursement program for all full-time and part-time employees of up to$5,250 per calendar year to support employees in champio

189、ning their own learning.362024 Exelixis CV&SReportOur People and Culture3Employee EngagementWe host quarterly all-employee meetings to provide updates about the company.Following these meetings,employees receive a survey to provide feedback and ask any questions of the senior management team.During

190、the past five completed fiscal years,our employee turnover has remained consistently below average for the U.S.life sciences industry.of our employees have been with us for more than five years,and many of our current employees have returned to Exelixis after working elsewhere.Our longest tenured em

191、ployees have been with Exelixis for 26 years.26%372024 Exelixis CV&SReportOur People and Culture3Spotlight on a Diverseand Inclusive WorkforceWorkforce diversity,in all its forms,is essential to help us continue to evolve as a collaborative,inclusive organization that celebrates our similarities and

192、 differences.We are early in our journey,but we are fully committed to the ongoing process.Workforce Diversity Advisory Committee:A group of widely diverse employee representatives dedicated to elevating our efforts to create and promote an inclusive culture at Exelixis to help us deliver on our mis

193、sion of helping cancer patients recover stronger and live longer.As an interface between all employees and our senior management team,the committee focuses on the development of the annual goals focused on a diverse and inclusive workforce,as well as improving workplace climate to enable all employe

194、es to feel valued,seen and respected.The committees members represent multiple ethnic backgrounds,gender identities,departments,divisions,job levels and locations.Employee Resource Groups(ERGs)and Business Resource Groups(BRGs):Our ERGs and BRGs exist to empower employees with a common identity to m

195、eet and support one another,fostering a strong sense of community and belonging.These groups,which are voluntary and employee-led,provide a platform for networking,career development and personal growth,putting control of these aspects in the hands of employees themselves.382024 Exelixis CV&SReportO

196、ur People and Culture3Spotlight on a Diverse and Inclusive WorkforceERGs,typically formed around shared characteristics such as gender,race,ethnicity,sexual orientation or other backgrounds tied to personal identity,are a testament to our commitment to inclusivity.They provide a space where employee

197、s can feel valued and respected for their uniqueness.BE(BlackEXELence)exists to develop and drive the advancement of Exelixis employees of African descent by fostering an environment that supports diversity,inclusiveness and equity.In honor of Minority Health Month,BE and EXELJuntos hosted the WCRC

198、to speak on a panel with employees to discuss ways to bridge care gaps for underserved communities.EXELability empowers and celebrates those with disabilities in an inclusive,supportive environment that focuses on their capabilities and strengths.For Mental Health Awareness Month,they partnered with

199、 local non-profits that provide services for those with apparent and non-apparent challenges for an on-site resource fair.EXELJuntos celebrates the multifaceted Latino community at Exelixis while creating a supportive environment that fosters the professional development of its members.They honored

200、the legacy of Cesar Chavez and the United Farm Workers(UFM)movement by organizing a volunteer opportunity at a local food bank.They also worked collaboratively with BE and OPEN(Out and Proud Exelixis Network)this year with volunteer activities in the local community.OPEN(Out and Proud Exelixis Netwo

201、rk)increases the visibility of the LGBTQ+community at Exelixis while fostering a culture of allyship through volunteer,networking and personal/professional development opportunities.For Pride Month,they organized the Progress Pride flag raising at both sites,arranged a company-wide event on both cam

202、puses,volunteered with EXELJuntos at a community-based organization that serves LGBTQIA+seniors in Alameda County and participated in various Bay Area Pride celebrations.PACE(Pan Asian Community at Exelixis)celebrates the Asian American and Pacific Islander(AAPI)cultural diversity and history by pro

203、moting a supportive network of understanding with the larger Exelixis community.This year,they hosted lunch gatherings to celebrate Lunar New Year and Eid al-Fitr,hosted an internal spotlight employee speaker series and were significant supporters of the non-profit organization Pacific Islanders Enc

204、ouraging Fun,Engineering,Science and Technology,hosting volunteer events both on-site and in the community.Parents EXEL promotes an inclusive work-life environment by strengthening efforts to ensure that contributions to work are balanced with an employees personal needs and family responsibilities.

205、Parents EXEL hosted a book drive for National Reading Month to benefit reading-centered organizations active in Alameda and King of Prussia.They were able to donate more than 750 books to support the awareness month.WE(Women of Exelixis)is a community that champions diverse women leaders at Exelixis

206、 through mentoring,empowering and supporting each others growth and achievements.For International Womens Day,they hosted a panel that discussed inclusion through allyship.VERGE(Veterans Employee Resource Group of Exelixis)works to be a strategic partner within Exelixis to embrace and grow a proud c

207、ommunity of employee veterans who support and encourage each other through shared experiences,veteran recruitment,professional career development and employee retention.VERGE is our newest ERG,and we are excited about its future impact on our corporate culture.392024 Exelixis CV&SReportOur People an

208、d Culture3ACE(Administrative Community of Exelixis)provides a forum for administrative leaders to exchange knowledge and best practices as well as find support and camaraderie.Spotlight on a Diverse and Inclusive WorkforceBRGs are a vital part of our company,serving as a bridge between isolated job

209、roles.Doing so fosters a sense of connection and community,making employees in these roles feel less isolated and more part of a larger team,thereby enhancing their sense of belonging.Our BRGsheld multiple networking events and professional development opportunities for their members and the Exelixi

210、s community.PMC(Project Management Community)provides a space for colleagues to make connections,find support and share common practices on project Outreach to the Next GenerationIn partnership with our ERG and BRG leaders,we host on-site career days for high school students from communities surroun

211、ding our corporate headquarters.This year,we hosted over 150 students from Alameda and Oakland Unified School Districts.We also partnered with Alameda High School students and participated in the Island Hack-a-thon,a STEM event for over 100 middle and high school students in Alameda.392024 Exelixis

212、CV&S Report402024 Exelixis CV&SReportOur People and Culture3Diversity MetricsTotal Employee:High-Level Diversity(%)End of FY 2022End of FY 2023As of June 30,2024Women52%51%51%Racial/ethnic minorities59%59%58%VeteransLess than 1%Less than 1%Less than 1%Total Employee:Racial/Ethnic Diversity(%)White41

213、%41%42%Asian43%43%43%Black or African American5%5%6%Multiracial4%4%4%Hispanic or Latino6%5%5%Native Hawaiian or Pacific Islander1%1%1%Native American or Alaska NativeLess than 1%Less than 1%Less than 1%Employee Resource Groups(ERGs)&Business Resource Groups(BRGs)End of FY 2022End of FY 2023As of Jun

214、e 30,2024#of ERGs778#of BRGs112As of June 30,2024ExecutivesManagers38%45%55%ProfessionalStaff40Gender Diversity by Employment Hierarchy(Women,%of Total)412024 Exelixis CV&SReportOur People and Culture3Anti-DiscriminationPolicy41Exelixis is an equal opportunity employer and maintains policies that pr

215、ohibit unlawful discrimination based onrace,color,religion,gender,sexual orientation,gender identity/expression,national origin/ancestry,age,disability,marital status and veteran status.Our anti-discrimination policy and complaint procedures are included in our employee handbook and reiterated in pe

216、riodic trainings given to all employees and managers.422024 Exelixis CV&SReportOur People and Culture3We promote and foster a safe environment and strive to provide employees with the tools and environment they need in order to perform their work safely.Our Lab Safety Committee is composed of leader

217、ship from our Discovery,Pharmaceutical Operations and Supply Chain and Facilities teams and oversees the working conditions in our laboratory and office environments.The Lab Safety Committee,in collaboration with our Employee Health and Safety team,also conducts laboratory safety inspections monthly

218、.Our Operations team conducts sitewide safety inspections twice a year to ensure site safety.Full safety reports are presented to the Exelixis Ethics Committee during quarterly meetings.We adhere to the standards set by the Environmental Protection Agency,the Occupational Safety and Health Administr

219、ation(OSHA),Cal-OSHA and Bay Area Air Quality Management District,among other governing bodies,to ensure compliance with laws and regulations to maintain a safe working environment.Employee Health and Safety432024 Exelixis CV&SReportOur People and Culture3Employee Health and SafetyEmergency Prepared

220、ness and Safety TrainingOur emergency preparedness program includes annual emergency evacuation drills for all on-site employees.External defibrillators are present in all of our buildings,and we include first aid responders as part of the Exelixis Security team.All new laboratory staff are trained

221、on chemical hygiene,the use of personal protective equipment and other relevant laboratory safety topics,including working with blood-borne pathogens.Staff are retrained annually through our learning management system.We also extend these trainings to Facilities staff and others who support our work

222、 in the labs.To maintain a safe environment for all staff,we regularly perform thorough safety inspections of our laboratories and continuously update our procedures based on the observations made during these inspections.Additionally,we conduct periodic industrial hygiene monitoring to ensure lab s

223、taff working with certain known hazardous chemicals do not exceed regulated exposure limits,and we regularly test and certify fume hoods,biosafety cabinets and other individual pieces of equipment on which employees rely to maintain a safe work environment.Our Accident and Incident Investigation Pro

224、gram governs our response to workplace injury or chemical exposure.We have an excellent safety record.From January 2024 through June 2024,we recorded three minor work-related injuries,resulting in zero days of missed work,during which time our total recordable incident rate(TRIR)was 0.799.Our TRIR f

225、or 2023 was 0.4,and our TRIR for 2022 was 1.14.Our TRIR in 2022 was higher than later years due to COVID isolation rules at the time.When isolation rules changed in 2023,we recorded fewer lost worktime cases from occupational exposures.After reviewing each incident,we found that none resulted from i

226、nsufficient safety procedures,and we provided retraining to employees as necessary.442024 Exelixis CV&SReportEnvironmental ManagementAt Exelixis,we are committed to conducting business in a way that respects our environment and the Earths changing climate.As part of this commitment,we recognize that

227、 climate change threatens human safety and well-being on a dramatic scale.We feel all businesses especially those like ours that are dedicated to human health have a duty to minimize their impact on climate change and promote a long and prosperous future for all of Earths inhabitants.In 2023 and thr

228、oughout 2024,we have enhanced our environmentally sustainable practices across our facilities and operations.For example,we have significantly improved our understanding of our energy and environmental footprint through our tracking system for electricity and natural gas usage.Additionally,we have r

229、ecently implemented an advanced HVAC monitoring system,which analyzes all our HVAC trend data and employs over 180 data-driven rules to identify and pinpoint opportunities for improving the efficiency of our HVAC systems,resulting in further energy savings.We plan to incorporate more of these practi

230、ces as we continue pursuing our mission to help cancer patients recover stronger and live longer.Responsible Consumption&Production452024 Exelixis CV&SReportEnvironmental Management4Energy and TransportationAs a growing healthcare company engaging in energy-intensive R&D operations,we prioritize red

231、ucing our energy use where possible and shifting our energy consumption to renewable sources.Sustainable FacilitiesA key facet of our environmental strategy is to invest in energy-and water-efficient equipment,technology and other building features as we continue to grow our physical footprint.Our f

232、acilities meet,and in many cases exceed,building code standards for energy efficiency and environmental impact.Our Alameda campus is the hub for most of our business activities,with six facilities that together serve as the home office for more than 60%of our employees.Our largest building at our Al

233、ameda campus(1951 Harbor Bay Parkway)received a LEED BD+C Gold Certification through the U.S.Green Building Council in November 2022.LEED-certified buildings improve efficiency,lower carbon emissions,save money and are a vital part of mitigating the effects of climate change.As part of the certifica

234、tion process,the 1951 Harbor Bay Parkway building was assessed on how well it addresses carbon,energy,water,waste,transportation,materials,health and indoor environmental quality.*AMPs power mix comes from clean energy sources,including“eligible renewable”sources and large hydroelectric sources.Abou

235、t 80%of AMPs power mix came from eligible renewable resources,including:(i)geothermal from the geysers in Lake and Sonoma Counties;(ii)biomass(landfill gas)from Pittsburg,Butte,Santa Cruz,Richmond and Half Moon Bay;(iii)small hydroelectric from Graeagle and Tuolumne County;and(iv)winds from the High

236、 Winds Project in Sonoma County.An additional 20%of AMPs power mix comes from large hydroelectric projects in California.Large hydroelectric sources produce clean energy.Since the State of California does not count power from large hydroelectric dams as“eligible renewable,”AMP describes its energy m

237、ix as“clean”instead of“renewable.”Important sustainability-oriented featuresacross the broader Alameda campus include:LED light sources,occupancy sensors and daylight LED light sources,occupancy sensors and daylight sensors installedsensors installedto minimize our energy usage for lighting in all o

238、f our recently constructed offices and labs70 electric vehicle(EV)charging stations campuselectric vehicle(EV)charging stations campus-wide wide to support the growing number of our employees who commute via EV Rooftop and carport solar panels Rooftop and carport solar panels to support the campuss

239、power needs 100%clean electricity clean electricity from Alameda Municipal Power(AMP)*in addition to power generated from our on-site solar panelsHVAC efficiency HVAC efficiency through monitoring system that identifies opportunities for energy savings and system preservation Water conservation prog

240、ram Water conservation program that includes indoor water-use reduction measures,as well as drought-tolerant landscaping and a water-smart irrigation system that monitors weather conditions and soil moisture levels70EV STATIONSCLEANENERGYWATEREFFICIENCYSOLARENERGYLIGHTEFFICIENCYHEATEFFICIENCY462024

241、Exelixis CV&SReportEnvironmental Management4Alameda Campus Energy UseOur Information Technology(IT)and Facilities teams have developed and implemented our“Energy Dashboard”software system to help us track energy and natural gas usage across the building footprint of our Alameda campus.This tool not

242、only synthesizes and organizes data to give us insights on our performance but also provides opportunities to optimize our use of these resources.We aim to better understand our baseline environmental footprint in order to set reduction and efficiency goals in the years to come.Alameda campus energy

243、 usageTwelve months ended June 30,2023 Twelve months ended June 30,2024Total net electricity usage*(kWh)5,318,2205,794,740Total gross electricity usage*(kWh)5,952,4206,380,940Total solar electricity generation*(kWh)634,200586,200Total gross natural gas usage*(therms)168,429148,806*Includes total ele

244、ctricity usage across all buildings at Alameda campus,less total solar electricity generated for the 1951 Harbor Bay Parkway building(and 1951 Harbor Bay Parkway is the only building at the Alameda campus that generates solar electricity)*Includes total electricity usage across all buildings at Alam

245、eda campus*Includes total solar electricity generated for the 1951 Harbor Bay Parkway building*Includes total natural gas usage across all buildings at Alameda campus,except for the 1951 Harbor Bay Parkway building,which does not use any natural gas472024 Exelixis CV&SReportEnvironmental Management4

246、0750,0001,500,0002,250,0003,000,0001601170117511801185119510750,0001,500,0002,250,0003,000,000160117011751180118511951Electricity(kWh)Gross UsageJuly 22-June 23 vs July 23-June 24Electricity(kWh)Net UsageJuly 22-June 23 vs July 23-June 24Gas(Therms)Gross UsageJuly 22-June 23 vs July 23-June 24Alamed

247、a Campus Energy UseThe graphs below provide a more detailed breakdown of our electricity and natural gas usage from each of the buildings at our Alameda campus:July 22 June 23July 23 June 24July 22 June 23July 23 June 24July 22 June 23July 23 June 24022,50045,00067,50090,000112,500160117011751180118

248、51Alameda Campus AddressAlameda Campus AddressAlameda Campus Address482024 Exelixis CV&SReportEnvironmental Management41951 Harbor Bay Parkway(Alameda,CA,Campus)CASE STUDY:220KsquarefeetOur LEED Gold-certified building at 1951 Harbor Bay Parkway was designed with efficient glazing and shading,and th

249、is all-electric building mitigates greenhouse gas(GHG)emissions with the purchase of renewable energy to supplement the energy generated by the solar panel system.The building was situated to take advantage of natural light while reducing heat gain,and the architect worked closely with the contracto

250、r,consultants and vendors to design an energy-efficient glass fiber reinforced concrete panel and energy-efficient glass/dual-pane window system.The following graph provides a month-by-month analysis of total electricity usage,on-site solar generation and net electricity usage for the 1951 Harbor Ba

251、y Parkway building during the period from July 2023 through June 2024:-60000-40000-20000020000400006000080000100000120000140000020,00040,00060,00080,000100,000120,000140,000160,000UsageSolar GeneratedNet UsageTotal Electricity Consumption and Solar Generation for 1951(kWh)100%electric powered,includ

252、ing for heat and hot water,eliminating the need for on-site natural gas Energy-efficient features in building design,including rooftop solar panels,a Variable Refrigerant Flow HVAC system that optimizes heating and cooling efficiency,and fan coil units that provide precise temperature control and im

253、proved air qualityUsage and GeneratedAxis Title492024 Exelixis CV&SReportEnvironmental Management4Green TransportationReducing GHG emissions is an important factor in combating climate change and protecting our planet.To help reduce the GHG footprint of our commuting workforce,we have maintained an

254、extensive commuter support program since 2019 to replace single-occupancy vehicle trips with shared transport.Transportation options include shuttles and vanpools with subsidies for employees using mass transit or rideshare programs.We have continued to improve our vanpool and other commuter program

255、s serving our employees who work at the Alameda campus,providing them alternatives to single-occupancy vehicles for their commute to work.Participation in these programs remained relatively stable from July 2023 through June 2024,after having more than doubled during the preceding 12-month period.Fu

256、rthermore,we are increasing our support for employees who commute to our Alameda campus using EVs,including the installation of 20 additional charging ports in April 2024,as the level of participation has continued to increase.As of June 30,2024,over 25%of employees who work on-site in Alameda utili

257、ze our EV charging stations.We subsidize the usage rates for these charging stations so that our employees pay less than market price to charge their EVs.502024 Exelixis CV&SReportEnvironmental Management4Waste ManagementChemical waste and potentially harmful materials are necessary consequences of

258、the drug discovery process.As an organization,we aim for strict adherence to applicable laws and regulations regarding the handling of hazardous materials and wastes that are used or generated in the course of business.On a yearly basis,we review our hazardous waste streams and collaborate with vend

259、ors specialized in hazardous waste disposal to identify additional opportunities for the reduction,consolidation or upcycling of overall waste.As an example,we have upcycled certain waste streams to use in fuels blending for energy generation that would otherwise have been incinerated.We have also i

260、nstituted measures to minimize the amount of office waste that we produce,such as removing waste bins at individual workstations and instead instituting fewer communal waste stations,and we have implemented biofuels recycling for cooking oils used in our cafeteria,as well as strategic composting dis

261、posal for organic matter.Wherever possible,we take steps to decrease the environmental impact of our laboratory activities,such as supercritical fluid chromatography,which utilizes an environmentally friendly approach to purifying small molecules and reduced our use of flammable and reduced our use

262、of flammable and hazardous solvents by approximately 19,340 liters from July 2023 through June 2024.hazardous solvents by approximately 19,340 liters from July 2023 through June 2024.Hazardousand Medical WasteTwelve months ended June 30,2023 Twelve monthsended June 30,2024*Hazardous Waste Generated(

263、lbs)33,682 52,995Medical Waste Generated(lbs)39,340 44,488*While the amount of hazardous and medical waste increased somewhat from July 2023 through June 2024 compared to the prior 12 months,much of this increase is attributable to our disposal of laboratory equipment following the discontinuation o

264、f certain scientific programs in connection with the corporate restructuring implemented in early 2024.To mitigate the large amounts of laboratory waste generated as a byproduct of our R&D activities,in 2021 we implemented a solvent dispensing system that eliminates the typical packaging for commonl

265、y used chemicals.From July 2023 through June 2024,roughly 4,080 pounds of glassware,cardboard and foam were diverted by use From July 2023 through June 2024,roughly 4,080 pounds of glassware,cardboard and foam were diverted by use of 204 kegs instead of glass bottle cases.of 204 kegs instead of glas

266、s bottle cases.We continue to investigate innovative ways to reduce our environmental impact,including our“take back”programs in the U.S.,which allow for easy disposal of unused products.We make sure products that are no longer needed by the patient can be disposed of properly.Any expired products a

267、re destroyed,and there is a certificate of destruction for the product.512024 Exelixis CV&SReportGovernance&Responsible Business PracticesAt Exelixis,we recognize that a solid foundation of good governance,corporate responsibility and accountability is essential for our company to be successful in i

268、ts mission to improve outcomes for cancer patients.We embed strong legal and regulatory compliance practices and oversight into our scientific and business activities so that these are conducted in a legal and ethical manner,and in the best interests of all Exelixis stakeholders.We have created and

269、work to uphold a rigorous culture of compliance at every level of our organization so that we can safely and effectively deliver on our corporate mission.522024 Exelixis CV&SReportGovernance and Responsible Business Practices5Corporate Governance and Oversight of ESG InitiativesOur Board of Director

270、s represents our stockholders and remains committed to responsible stewardship of our business,including directing that it be conducted in a manner whereby the Exelixis team can do its best work and further the companys mission to help cancer patients recover stronger and live longer.In carrying out

271、 its duties,our Board adheres to its established Corporate Governance Guidelines,which cover,among other things,director independence,board composition,structure and functioning,director selection criteria,diversity,annual evaluations,overboardingguidelines and our majority voting policy.The Board h

272、as also established five standing committees to assist with its oversight responsibilities.Audit Committee Oversees our financial reporting process and ensures the integrity of our financial statementsCompensation Committee Oversees our compensation policies,plans and programsNominating and Corporat

273、e Governance Committee(NCGC)Oversees all aspects of our corporate governance functions Committees of the Board of DirectorsResearch&Development Committee Responsible for oversight of various scientific matters related to our drug discovery and preclinical and clinical development programRisk Committ

274、ee Reviews managements responsibility to assess,manage and mitigate risks associated with our business and operational activities532024 Exelixis CV&SReportGovernance and Responsible Business Practices5Corporate Governance and Oversight of ESG InitiativesEach committee of the Board operates pursuant

275、to a written charter that is reviewed annually,as well as within the governing parameters set forth in our Corporate Governance Guidelines,Certificate of Incorporation and Bylaws.In particular,the NCGC is responsible for reviewing and assessing the companys sustainability strategy and policies,inclu

276、ding with respect to ESG matters,and for overseeing management in its implementation of ESGprograms and sustainability efforts.The Compensation Committee of the Board of Directors has oversight of our policies and strategies relating to human capital management including,but not limited to,recruitin

277、g,retention,career development and progression,management succession planning(other than CEO succession),diversity and employment practices.The execution of our ESG programs involves the collaboration of representatives across various business teams,including Legal Affairs&Compliance,Quality Assuran

278、ce,Public Affairs&Investor Relations,Human Resources,Facilities and others.All members of Exelixis senior management team play an active role in shaping our ESG strategy and participate in its development.Furthermore,management periodically provides updates on our ESG programs to the NCGC and full B

279、oard of Directors as necessary.542024 Exelixis CV&SReportGovernance and Responsible Business Practices5Board CompositionIn considering candidates for directorship,the Exelixis Board of Directors emphasizes a diversity of viewpoints,background,experience and other characteristics such as,but not limi

280、ted to,gender,race and ethnicity.Accordingly,when evaluating prospective Board candidates,the NCGCconsiders candidates who would contribute to diversity,including both women and individuals from underrepresented communities who meet the relevant business and search criteria.In the director candidate

281、 review process,the NCGC evaluates prospective candidates in the context of the existing membership of the Board(including the qualities and skills of the existing directors),our operating requirements and the long-term interests of our stockholders.Moreover,the Board of Directors recognizes the val

282、ue of refreshment,and five new independent directors have joined our Board since May 2023.The refreshment of our Board during recent years underscores our commitment to upholding best-in-class corporate governance to ensure the right balance of skills and expertise to guide our continual evolution a

283、nd long-term strategic plan.Part I:Gender IdentityFemaleMaleDirectors47Part II:Demographic BackgroundFemaleMaleBlack or African American01White36Hispanic or Latina10BOARD INDEPENDENCE91%BOARD DIVERSITY36%Gender45%Ethnicity or National Origin10 out of 11 members of the Board are independent under the

284、 SEC rules and regulations and the Nasdaq listing standards4 out of 11 members of the Board are women5 out of 11 members of the Board identify as non-White or were born outside of the U.S.552024 Exelixis CV&SReportGovernance and Responsible Business Practices5Business EthicsCommitment to High Standa

285、rds and EthicsOur Code of Conduct reflects the values that drive the performance of our business operations and describes how our officers,directors,employees and contractors are expected to conduct themselves when representing Exelixis.The Code of Conduct also underscores our commitment to comply w

286、ith laws that regulate our business activities as a biotechnology company.We expect all our employees to understand and abide by our Code of Conduct and other relevant policies that are essential to their daily duties and our business.Each employee is trained on,and reviews and acknowledges,these po

287、licies in their initial onboarding;they then undergo refresher training on an annual basis or when there is a change in law that warrants training.We believe in continuous improvement and will periodically engage third parties to evaluate our compliance procedures.Management and the NCGC review the

288、Code of Conduct each year and approve updates as appropriate.Select Policies Critical to our BusinessRecognizing and Reporting Safety Data (e.g.,adverse events)Respect for Privacy and Protection of Personal Information PolicyInsider Trading PolicyCybersecurity PoliciesSocial Media and CorporateCommu

289、nications PolicyRecords and InformationManagement PolicyGlobal Trade Compliance PolicyCorporate Travel and Expense Policy562024 Exelixis CV&SReportGovernance and Responsible Business Practices5Exelixis has established an internal governance structure that is designed to assist senior management with

290、 risk management,the ethical leadership of the company and maintenance of its culture of compliance.The management-level Ethics Committee provides regular reports on how the company is fulfilling the commitments stated in our Code of Conduct,including compliance with applicable international,federal

291、 and state laws,regulations and guidelines.It also provides a reliable mechanism for the escalation of challenges and issues of concern as they arise within the matrix of the companys complex business operations.The Ethics Committee sits at the top of our internal risk and ethics management structur

292、e.Led by Exelixis President and Chief Executive Officer,the Ethics Committee is responsible for oversight of our business ethics,fulfillment of legal and regulatory requirements and maintenance of the safety and quality of our products.Six subcommittees,each with deep expertise in the relevant areas

293、 of Exelixis operations,operate under the Ethics Committees guidance to identify,respond to,and escalate key issues or concerns,as needed.The Ethics Committee also helps functional team leaders to identify and evaluate business risks,enabling the mitigation of those risks more effectively.Ethics Com

294、mittee reports are shared with members of the Risk Committee of our Board of Directors(with certain topic areas referred to the other committees of the Board of Directors in accordance with such committees charters),providing a regular and reliable flow of information so our directors may fulfill th

295、eir own duties.Business EthicsEthics Committee572024 Exelixis CV&SReportGovernance and Responsible Business Practices5Board of Directors(Board Risk and Audit Committees)Ethics Committee(Executive Management)Securities Compliance CommitteeOversees SEC regulatory compliance and maintains Insider Tradi

296、ng rules and programQuality ControlOversees GxPcompliance and maintains R&D/Manufacturing Quality Management SystemsBenefit-Risk Executive CommitteeMaintains core data&communications with respect to all patient safety aspects of Exelixis productsHealthcare Compliance CommitteeOversees integrity of t

297、he companys financial interactions with healthcare providersInformation Governance CouncilOversees data managements,data integrity/loss prevention,privacy and other information governance mattersInformation Security Governance CommitteeOversees cybersecurity and information security initiatives and

298、incidentsBusiness EthicsEthics Committee582024 Exelixis CV&SReportGovernance and Responsible Business Practices5A Focus on ComplianceOur commitment to ethics and compliance is reflected in our products,business activities and culture.It influences not only what our employees do but also how they do

299、it.Our dedication to compliance is demonstrated through:Efforts and activities to promote clear and understandable policies,procedures and tools assisting complianceExtensive training programs and testing to evaluate understandingMonitoring and auditing systems to ensure employees and vendors are co

300、mplying with requirementsAs part of our compliance training program,which aligns to our Business Conduct Manual,we track training completion for Exelixis personnel.Certain trainings are company-wide,such as those concerning our Code of Conduct,cybersecurity efforts and drug safety reporting,while ot

301、hers are role-based and tailored toward specific employee teams,such as our Commercial,Medical Affairs and Clinical Development teams.These specific teams receive more detailed training regarding compliant interactions with members of the healthcare community.In addition to role-specific trainings,a

302、ll employees receive between four and six hours of required healthcare compliance and other training annually.Trainings are made up of interactive,online and live modalities as appropriate to balance flexibility and access with strong engagement and retention.Knowledge checks allow us to assess empl

303、oyee proficiency and comprehension,and surveys and focus groups are periodically used to obtain feedback and measure training effectiveness.A robust reminder and escalation process ensures training completion,and in 2023,over 99%of our employees completed all their required trainings.Ethics Helpline

304、 and Whistleblower SupportEmployees and other stakeholders are encouraged to report any potential concerns under confidence to Legal Affairs&Compliance,Human Resources,any member of Exelixis senior management or the Ethics Committee.As part of this program,employees may also provide information to m

305、embers of the Ethics Committee directly,on either an anonymous or self-identified basis,via the Exelixis Ethics Helpline,at www.ExelEthicsH.We have no tolerance for retaliation or discrimination against employees who raise good faith questions or concerns.Any act or threat of retaliation by other Ex

306、elixis personnel will be considered a serious violation of our Code of Conduct.The Board of Directors,through the Audit Committee,receives quarterly reports of disclosures made through the Ethics Helpline,as well as any concerns raised to the Ethics Committee or otherwise submitted through our inter

307、nal compliance reporting system.592024 Exelixis CV&SReportGovernance and Responsible Business Practices5Ethical Marketing of Pharmaceutical ProductsWe are committed to the ethical marketing of our products.Advertising and promotional activities,including product-specific and disease state awareness

308、efforts,serve the broader healthcare community by sharing important medical and programmatic information that help inform patients,HCPs and related stakeholders in a manner that can ultimately lead to improved patient access and care.Our Sales and Marketing teams serve a critical role educating abou

309、t our products and the data in our FDA-approved product labels.Consistent with our legal and ethical obligations,we prohibit the promotion of our products for off-label use,and only in appropriate forums for scientific exchange or in response to specific requests do we supply HCPs with medical infor

310、mation that is beyond the scope of our product labeling.Promotional Policy and ProcessWe maintain a review and approval process for all promotional material.Exelixis Review of Advertising,Marketing and Promotion Committee includes representatives from Regulatory Affairs,Legal Affairs&Compliance,and

311、Medical Affairs and is responsible for reviewing and approving all Exelixis promotional and disease state materials used by Exelixis Field Commercial Personnel.Promotional information regarding Exelixis products is complete,not misleading and consistent with FDA labeling.It describes safety informat

312、ion fully and accurately and is approved by the appropriate Exelixis review committee prior to use.Training and ComplianceMembers of our Sales and Marketing teams,including new hires,receive training on ethical drug commercialization,so they are equipped with an appropriate understanding of our inte

313、rnal policies,as well as applicable laws and regulations,prior to engaging in product promotion.Our field-based employees receive extensive,detailed training,both virtually and in-person,covering the best compliant practices for interacting directly with HCPs.Then,we have an extensive sales-focused

314、monitoring program in place to evaluate their ongoing compliance with expectations.Our teams are encouraged to work collaboratively with the Legal Affairs&Compliance department to take a proactive approach in identifying,reporting and addressing any areas of potential violation or concern.Any issues

315、 identified are tracked in a compliance log and metrics are reported quarterly to the Healthcare Compliance Committee and Ethics Committee.602024 Exelixis CV&SReportGovernance and Responsible Business Practices5Data Security and PrivacyWe understand the importance of keeping patient,employee and com

316、pany data secure.Our established programs,policies and procedures are designed towards maintaining security,preventing data breaches and guiding our responses to any cyber-attacks or other incidents.CybersecurityExelixis maintains a cybersecurity and information security program,which leverages best

317、 practices and standards.Given the gravity of these risks,such as those arising from phishing campaigns and ransomware,cybersecurity risks are given very high priority.They are regularly evaluated as part of our broader risk management activities and as a fundamental component of our internal contro

318、l system.The scope of our evaluation encompasses our internally managed IT systems and key business functions and sensitive data operated or managed by third-party service providers.All employees receive cybersecurity training upon hire with annual or more frequent training thereafter with job-speci

319、fic topic considerations.As of June 30,2024,virtually all employees have completed their required annual cybersecurity training or are undergoing their initial trainings as new hires.In addition,our IT team conducts ongoing phishing tests and follows up directly with employees who require additional

320、 training.Our Information Security Incident Response Plan(the Response Plan)sets forth our response protocol for cybersecurity threats and cybersecurity incidents(such as a data security breach)and is maintained by the Information Security Governance Committee,which reviews the Response Plan on an a

321、nnual basis.The Response Plan is designed to provide a framework for how we identify,escalate and respond in the event of a data security breach and designates personnel who are responsible for these functions.Cybersecurity threats,including as a result of any previous cybersecurity incidents,have n

322、ot materially affected us,including our business strategy,results of operations or financial condition.612024 Exelixis CV&SReportGovernance and Responsible Business Practices5Data Security and PrivacyPersonal Data PrivacyExelixis respects patient privacy and avoids exposures to protected health info

323、rmation,except where clearly necessary for operations.We require that any patient data we do receive be securely maintained.For instance,it is de-coupled from identifying information,which still allows our teams to monitor patient treatment responsibly.Data from third-party contract research organiz

324、ations are stored in vendor systems that are validated for GCP requirements and include the auditing of controls and access.Our Respect for Privacy and Protection of Personal Information Policy is the guiding document for privacy,which includes provisions and guidance relating to the handling and ma

325、nagement of patient,employee and other personal information to maintain compliance with applicable laws and regulations,such as the Health Insurance Portability and Accountability Act(HIPAA),General Data Protection Regulation(GDPR)and California Consumer Privacy Act(CCPA,as subsequently amended by t

326、he California Privacy Rights Act),among others.All employees receive training on this policy,and certain teams receive more specific privacy training as may be appropriate for their job function.622024 Exelixis CV&SReportGovernance and Responsible Business Practices5Risk Management and Business Cont

327、inuity Risk ManagementThe Ethics Committee and its reporting subcommittees facilitate dynamic risk management throughout the company by maintaining close supervision of each element of our business and driving insights through regular risk-based reporting.We supplement that reporting with periodic“d

328、eep-dive”assessments in areas of business operations identified as higher risk.To complete these assessments,we retain the services of outside experts or counsel,ensuring both appropriate expertise and sufficient objectivity are brought to the task of evaluating the effectiveness of the relevant ope

329、rational activity and its level of legal and regulatory compliance.In addition to these ongoing risk assessment activities,each year,our Healthcare Compliance and Quality Assurance teams conduct their own annual risk assessments,taking a close look at business activities that combine significant ope

330、rational complexity with high inherent legal and regulatory risk,such as financial interactions with HCPs and product manufacturing operations,and execute their annual audit and monitoring plans.These annual risk assessments inform decision-making concerning where the company should focus particular

331、 attention through deep-dive assessments,as well as audit and monitoring activities.Business ContinuityThe Business Continuity Management Program incorporates elements of incident management,emergency response,disaster recovery and crisis communications across the company into a cohesive effort focu

332、sed on the timely restoration of business operations following a major disaster or other emergency.The program aligns with the best practices established by the Disaster Recovery Institute International(DRII)and the International Organization for Standardization(ISO).Business continuity is part of t

333、he larger emergency preparedness strategy,which improves resiliency to disasters by unifying mitigation,prevention,protection,response and recovery efforts across the company.As such,Exelixis is prepared to rapidly identify,respond to and recover from a wide range of hazards,including building hazards,earthquakes,pandemics,cybersecurity incidents,workplace violence(or acts of civil disturbance or