Environmental, Social & Governance
A commitment to our environment, society and governance
Disclosure Statement: This publication provides information regarding Exelixis’ goals, efforts and objectives and otherwise includes forward-looking statements. Some material is referenced to other company documents, and links are provided to those documents where appropriate. Exelixis’ goals, efforts and objectives are aspirational and are not guarantees or promises that such goals, efforts and objectives will be met. Exelixis’ actual results and the timing of events could differ materially from those anticipated in such aspirational and other forward-looking statements. See “Forward-looking statements” for additional important information about these aspirational and other forward-looking statements.
Exelixis’ mission is to help cancer patients recover stronger and live longer. As we strive to extend and improve cancer patients’ lives, we recognize the need also to contribute positively to society as a whole. To that end, Exelixis expects that its employees will commit to the highest standards of ethical behavior and maintain values and principles that reflect both global awareness and sustainability. This means integrating environmental, social and governance (ESG) considerations directly into our research and development (R&D) projects, business operations and investment processes as we strive to create sustained value for all our stakeholders.
Read about Exelixis’ commitment to ESG from our President and Chief Executive Officer, Michael M. Morrissey, Ph.D.
Our governance and compliance
At Exelixis, we recognize that good governance, corporate responsibility and accountability are critical to our quest to treat and defeat cancer. We embed strong compliance practices and oversight into our scientific and business activities with the goal that these activities be conducted in a legal and ethical manner and in the best interests of all Exelixis’ stakeholders, in particular, the patients we serve. We have created and work to uphold a rigorous culture of compliance at every level of our organization so that we can safely and effectively deliver on our ongoing mission.
Our internal governance structure
In order to assist our Company’s leaders in their efforts to reinforce and enhance a culture of compliance throughout the organization and foster ethical decision making, Exelixis has established a governance structure that is designed to provide senior management with regular and systematic reports on matters relating to the commitments stated in the Company’s Corporate Code of Conduct, along with its compliance with applicable international, federal and state laws, regulations and guidelines.
At the top of Exelixis’ structure sits the Ethics Committee. Led by Exelixis’ President and Chief Executive Officer, the Ethics Committee is responsible for oversight of the Company’s business ethics, quality and compliance. Each of the Ethics Committee’s subcommittees includes deep expertise in the relevant areas of Exelixis’ operations, enabling us to identify, respond to and escalate key issues or concerns, as needed. The Ethics Committee also oversees and manages significant risks to our Company and works toward effectively ascertaining, addressing and mitigating those risks. Ethics Committee reports are shared with the Risk Committee of our Board of Directors, providing a regular and reliable flow of information so Board Members may fulfill their own duties.
There are five subcommittees that work together under the Ethics Committee’s guidance, while each maintains a designated area of focus. The five subcommittees under the Ethics Committee are:
- Quality Council: Governs the quality management system, which is designed to ensure that our preclinical, clinical and manufacturing operations meet Good Practice (GxP) quality guidelines and regulator expectations throughout the lifecycle of our products. The Quality Council oversees the implementation and performance of Exelixis’ quality management system elements (including documentation, training and auditing) relating to the development and manufacture of Exelixis’ products. The Quality Council is also charged with the responsibility for oversight of the continuous improvement program designed to address areas of concern, assist with necessary remediation and ensure that the capabilities of the quality management system are not reduced or interrupted.
- Executive Safety Committee: Manages the evolving safety profile of Exelixis’ investigational and marketed products as part of the Company’s Good Pharmacovigilance Practices. The Executive Safety Committee works to ensure that product risks are properly communicated to protect patient safety and public health through product labels and Investigator’s Brochures.
- Healthcare Compliance Committee: Assesses risks and conducts other activities to evaluate the effectiveness of Exelixis’ healthcare compliance program, particularly with respect to our interactions with healthcare professionals. The Healthcare Compliance Committee focuses especially on achieving excellence in policy development, training, auditing and monitoring practices. In addition, the Healthcare Compliance Committee receives information about current and emerging risks and regulatory enforcement trends in healthcare-related areas that may affect the Company’s business, and also evaluates the internal mechanisms for reporting, investigating and correcting any violations of the Corporate Code of Conduct or other applicable policies.
- Privacy Review Team: Evaluates potential data privacy risks and the security of patients’ protected health information. The Privacy Review Team receives information about current and emerging risks and regulatory enforcement trends concerning data privacy relevant to the Company’s operations, and also implements the policies, procedures and training programs designed to maintain Exelixis’ compliance with applicable data protection laws and regulations.
- Securities Compliance Committee: Manages the activity of persons and entities associated with Exelixis related to the Company’s stock in light of U.S. Securities and Exchange Commission regulations. The Securities Compliance Committee administers the Company’s Insider Trading Policy and determines appropriate trading practices for the Company, including the establishment of trading windows and blackout periods for executive management and certain other employees.
Commitment to high standards and ethics
We are proud of our comprehensive compliance program, which reflects commitments to high standards of corporate conduct and integrity, as outlined in Exelixis’ Corporate Code of Conduct and reflected by our internal policies (including our Policy for Recoupment of Variable Compensation, or Clawback Policy). We are dedicated to maintaining a culture that encourages responsible corporate action at every level in our organization. To accomplish this goal, we require that all of our employees are trained on, and we expect them to understand and abide by, our Corporate Code of Conduct and the additional policies and practices that are essential to their daily work activities and our business. All new and current employees are required to review and acknowledge these policies as part of their initial orientation to the Company, and then review and acknowledge them again on a routine basis.
In addition to acknowledging and agreeing to our key policies, our employees are also required to participate in training programs covering the details of those policies and how to best comply with their terms. These training programs consist of both live (in-person or virtual) classroom sessions and interactive online modules. Some are assigned to the entire Company, such as trainings concerning our Corporate Code of Conduct, cybersecurity efforts and drug safety reporting, while others are directed toward specific employee teams, such as our Commercial, Medical Affairs and Clinical Development teams who, as an example, receive more detailed training concerning compliant interactions with members of the healthcare community. As part of our onboarding process, all new employees are assigned to Exelixis’ general introductory training program, plus additional role-based trainings as needed, and thereafter our employees continue to participate in both refresher and new training programs throughout their employment at Exelixis.
Our commitments to ethics and compliance are embodied in our products, business activities and culture, as well as reflected in our sustainability efforts; they influence not only what our employees do, but also how they do it.
Access to health
At Exelixis, we value being exceptional in what we do and how we lead, excelling for patients by going the extra mile and exceeding together as a business and contributor to the scientific community. By the time the data package for an Exelixis medicine is submitted for approval with the U.S. Food and Drug Administration (FDA) and other regulatory agencies, it reflects research and development efforts undertaken by hundreds of people, over many years, investing hundreds of millions of dollars. We dedicate substantial financial resources and work tirelessly in our efforts to offer patients high-quality, safe and effective cancer treatments. Moreover, once our products are available, we have a firm, voluntary commitment that no patient prescribed an Exelixis medicine will go without it due to lack of insurance or inability to pay.
Dedicated R&D efforts
Exelixis is on a mission to help cancer patients recover stronger and live longer. A critical part of that mission is discovering and developing new cancer-fighting medicines — all of which are created through years of extensive R&D.
R&D has traditionally been the largest line item in Exelixis’ budget, comprising over 50% of our operating expenses in fiscal year 2020, and we maintain a high ratio of R&D investment to net revenue received relative to our industry. The revenue we generate from our commercialized products helps fuel the discovery and development of the next generation of drug candidates. Based on our calculations, we have spent more than $3.8 billion on R&D from the inception of our business through the end of 2020.
Biopharmaceutical R&D is so expensive because the process of discovering, refining and testing compounds for safety and effectiveness is long and labor intensive — as it should be. On average, it can take 10 to 15 years to develop a single new medicine, making it a risky and iterative discovery and development process. Thousands of compounds are tested in the lab in order to select the best candidates for clinical trials in cancer patients, and fewer than 12% of the investigational medicines that make it into phase 1 clinical trials are ultimately approved by the FDA.i Hundreds of patients are typically enrolled in clinical trials to assess the safety and efficacy of each potential medicine, and the data from these trials are reviewed by independent regulatory agencies, such as the FDA and the European Medicines Agency. Only after these agencies find that the drug has an appropriate safety and efficacy profile and ultimately issue a formal regulatory approval can the drug be marketed. To date, four products discovered by Exelixis have gone through this rigorous process and received regulatory approval: CABOMETYX® (cabozantinib) tablets, COMETRIQ® (cabozantinib) capsules, COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone). These commercially available products are now available to patients in many territories across the globe.
We are continuing to evaluate our flagship molecule, cabozantinib, both as a single agent and in combination with other therapies, in a broad development program comprising over 100 ongoing or planned clinical trials across multiple indications. Having shown anti-tumor activity with objective responses in over 20 forms of solid tumors as of the end of 2020, cabozantinib is the subject of multiple phase 3 pivotal studies, including COSMIC-311, COSMIC-312, COSMIC-313, CONTACT-01, CONTACT-02 and CONTACT-03, and a large multi-cohort phase 1b study, COSMIC-021.
We are also reinvesting in drug discovery and clinical development efforts to build a robust pipeline beyond cabozantinib, and we have made significant advancements in identifying next-generation small-molecule therapies and biologics, including in-licensed compounds, that we believe have the potential to provide therapeutic benefit for patients. Notable compounds in preclinical or early-stage clinical development as of the end of 2020 include XL092, XL102 and XB002.
The R&D process in general includes extensive trial and error, with the number of failures far exceeding the number of breakthroughs. Nevertheless, we believe these setbacks encountered by our industry help to inform and guide us toward eventually creating better treatments for patients.
Pricing and programs
Cancer is a leading cause of death worldwide,ii with more than 19 million new diagnoses each year.iii On top of the hardships of illness and recovery, patients with cancer commonly contend with financial and other challenges in their lives. We know oncology therapies are indispensable for the patients who are battling cancer and believe biopharmaceutical companies should strive to make these therapies accessible to those who need them.
We consider several factors in our pricing decisions:
- How to maximize appropriate patient access to Exelixis products and the Company’s quest to discover, develop and commercialize innovative therapies that improve the treatment of cancer.
- The value proposition for each of our products (including the strength of clinical data supporting use of the product relative to approved and late-stage investigational products in the same therapeutic category), healthcare economic information, and the product’s overall risk/benefit profile.
- The R&D costs associated with both the individual product under consideration and the Company’s aggregate R&D expenditures, as well as impact to patient access to the Company’s treatment for medically appropriate uses, and competitor prices and formulary positioning.
- The investments we have made in R&D and the need to reinvest in research to improve the drug, identify new clinical indications and discover new compounds.
- The manufacturing costs that we continue to incur to support a robust global supply chain and ongoing continued enhancement of our manufacturing operations, enabling us to continue to produce medicines of the highest quality standards for our patients.
Exelixis has a firm, voluntary commitment that no patient prescribed an Exelixis medicine will go without it due to lack of insurance coverage or inability to pay. This commitment includes providing mandatory and voluntary discounts and rebates to public and private insurers and safety net providers. If a patient with a prescription does not have insurance or cannot afford our product, we will provide financial assistance, if permitted, or will provide the patient with the drug at no cost.
Through our patient assistance programs, we provide medicine to uninsured and underinsured patients with qualifying financial need at no cost, and also provide copayment and coinsurance assistance to eligible commercially insured patients. Specifically, our Exelixis Access Services (EASE) program serves as a resource for questions and needs related to insurance coverage, financial assistance and treatment support for U.S. patients who are prescribed CABOMETYX or COMETRIQ. The program connects healthcare providers and their patients with an EASE Case Manager who can assist with the access journey. EASE Case Managers serve as a single point of contact for both patients and healthcare providers, offering prompt support with payer coverage, financial assistance and treatment coordination. Eligible patients benefit from a variety of services, including:
- Free Trial and Quick Start programs that provide cancer patients with quick access to CABOMETYX at no cost after a prescribing decision has been made and while their payer coverage is being investigated.
- EASE Co-Pay Program that assists commercially insured patients with out-of-pocket medication costs.
- EASE Patient Assistance Program (PAP) that allows uninsured and underinsured patients who meet the program’s eligibility criteria to receive their medication free of charge.
- Clinical outreach and support program that connects oncology nurses or other healthcare providers with patients enrolled in PAP to help them understand how to take their medicine and mitigate side effects.
Our analysis of patients enrolled in the EASE PAP demonstrated that lower-income cancer patients who were prescribed CABOMETYX and participated in a proactive patient support and financial assistance program were more likely to adhere to their physician’s treatment plan and stayed on therapy longer than patients who did not receive proactive patient support.
At Exelixis, we take pride in providing cancer patients with access to our medicines and in developing programs to support them along their journey.
Clinical Trial Diversity
At Exelixis, we recognize that many racial and ethnic communities are underrepresented in clinical research. Inclusive clinical trial design improves the quality and equity of treatments for key affected populations. For this reason, to improve representation of diverse communities in Exelixis-sponsored clinical trials, our Clinical Development and Medical Affairs teams have launched an Inclusiveness Initiative.
According to the American Society for Clinical Oncology, African American/Black and Hispanic or Latino individuals collectively make up just 8.6% of cancer clinical trial participants overall yet comprise roughly 31% of the U.S. population.iv The objectives of the Inclusiveness Initiative are to identify, discuss and implement solutions that will increase the number of patients from these and other underrepresented populations in all phases of Exelixis clinical trials. We are piloting the program in prostate cancer because it disproportionately impacts the Black community. Black men are 1.7 times more likely to be diagnosed with prostate cancer than white men, and 2.2 times more likely to die from the disease.v
In CONTACT-02, our ongoing phase 3 study of cabozantinib in combination with atezolizumab in metastatic castration-resistant prostate cancer, our clinical operations team is reviewing our “Potential Areas of Scientific Interest” criteria and giving special consideration to external investigators who submit proposals with specific relevance to Black patient populations. Also, in keeping with the goals of our Inclusiveness Initiative, we are collecting input from key opinion leaders on prostate cancer clinical trial representation, including two experts with deep expertise in outreach and recruitment within Black communities. We intend to make follow-up visits to CONTACT-02 sites several months after site initiation to assess and further support the sites’ inclusive recruitment efforts.
This pilot program in prostate cancer is just the beginning. We believe it will inform clinical programs in other therapeutic areas and sub-populations, and we look forward to sharing those findings as they emerge.
Taking responsibility for our products
The well-being of patients is a top priority for us. Our Corporate Code of Conduct holds every Exelixis employee accountable to safe and ethical standards of work and behavior, and is designed to ensure our products are developed in compliance with GxPs.
As a core reflection of Exelixis values, product responsibility is monitored by teams with a direct chain of reporting to our Ethics Committee and overseen by our Board of Directors. This process is designed to allow us to escalate and address issues quickly and holistically.
Exelixis strives to assure quality by independently guiding and assessing adherence to procedures and compliance with regulatory standards and expectations. We work cross-functionally to design and maintain quality processes that support compliance with our internal procedures as well as with regulatory expectations and standards, including those of national health authorities and those that are synchronized through cooperative agreements, such as the International Conference on Harmonization.
Ensuring Quality Assurance Internally
We audit our internal processes across departments and disciplines with qualified independent Quality Assurance auditors, who are knowledgeable of current compliance expectations and industry practice, in order to critically assess the capability of and adherence to our processes. The performance of the internal quality management system is assessed at the Quality Council and includes reviews of audit outcomes so that opportunities for continuous improvement can be identified and implemented. This feedback mechanism helps us to follow through on the integrity and ethical standards set by our Ethics Committee.
Ensuring Quality Assurance Externally
Externally, we audit our third-party materials and service suppliers rigorously, both before and after entering into a contract, and we regularly evaluate whether our level of oversight for each vendor is appropriate based on the criticality of the service or materials provided and the past performance of the vendor.
As Exelixis utilizes third-party contract manufacturing organizations (CMOs) to manufacture our commercial and investigational products, we continually evaluate their ability to meet the appropriate quality standards and their compliance with applicable Good Manufacturing Practices. When selecting potential CMOs, we evaluate their technical expertise, regulatory track-record and other aspects such as those with respect to environmental, health and safety matters, as well as their overall business reputation, and Exelixis will not utilize CMOs that do not meet our strict selection criteria. Our selection criteria also include assessing whether candidates have had any product recalls, use of insufficiently trained workforce, child labor or other human rights abuses, regulatory violations, or embargoes or sanctions. In addition, given the increase in commercial and clinical demand for our products, we assess each potential CMO’s financial stability and business continuity management plan. After contracting with a CMO, we continue to conduct audits and periodic reviews designed to ensure the consistent supply of safe and efficacious products for our patients. During the COVID-19 pandemic, we have maintained our strong auditing standards through the development of a fully remote audit program to facilitate the continuation of our quality assurance process. When it is safe to do so, we plan to reassess our standard audit procedures and determine the extent to which we should resume conducting certain audits in person.
As part of our efforts to ensure a robust global supply chain, we have established a strong network of highly competent and reputable manufacturers and suppliers who manufacture our products to meet our inventory targets, and we continue to enhance our supply chain by incrementally adding additional suppliers where needed. During the COVID-19 pandemic, we have conducted more frequent check-ins with our vendors to ensure the consistency and effectiveness of our supply chain partners, and as of the date of our Annual Report on Form 10-K for the 2020 fiscal year, we had not experienced production delays or seen significant impairment to our supply chain.
In addition, as part of our governance structure with our manufacturers and suppliers, we have established an ongoing cross-functional and team-based communication plan with appropriate management and executive oversight between Exelixis and these third parties. The communication plan is designed to ensure that: (a) our CMOs continue to meet our on-time product delivery needs; (b) we continue to monitor and address any issues that arise during the manufacturing process; and (c) we continue to enhance our manufacturing processes appropriately. The cross-functional teams consist of both Quality Assurance and technical experts.
Exelixis is responsible for proactively monitoring the safety profile of our products through their entire product lifecycle (from preclinical and clinical development through the post-market experience), and developing risk management and communication strategies designed to ensure the safety of the patients treated with our products.
During clinical development, Exelixis monitors and evaluates reports of adverse drug effects experienced by clinical trial participants. Our goal is to minimize risks to patients and to proactively address and manage the product, as we develop well-characterized benefit-risk profiles based on available safety and efficacy information.
Even following regulatory approval, Exelixis continues to collect safety data relating to adverse events on an ongoing basis in order to maintain comprehensive safety profiles for our products. Aggregate reviews of safety data allow Exelixis to perform signal management (detection, evaluation and assessment), which involves analyzing the adverse reaction data to see if there are new risks associated with a product or whether current risks have changed, and implementing additional risk management measures, if necessary.
Above all, we strive to help keep patients safe and healthcare providers informed, while continuously looking to meet our global regulatory reporting obligations and maintaining Exelixis’ corporate integrity.
Exelixis requires that patient data are secure during and after a clinical trial. All of our computerized systems used in relation to clinical trials are assessed to maximize cybersecurity and the protection of data integrity, and we require that all clinical trial patient data be pseudonymized before they get to Exelixis. Each patient is assigned a unique identification number, and we work only with relevant descriptive information about the patient, such as age, sex and health condition as it pertains to the trial. It is our policy not to process patient-identifying information, and we do not have access to any clinical records that might identify specific patients.
We are also diligent in providing patients with an informed consent document that contains the information they need throughout their participation in a study:
- Patients provide informed consent via signature before they can enroll in the study.
- The informed consent document is updated as new information becomes known, for example, resulting from internal surveillance processes or upon receipt of new guidance from a partner whose product we are using in a given study.
- Exelixis reviews the informed consent document at least once per year to determine whether changes need to be made and consent needs to be renewed.
We believe this system of keeping patients informed on an ongoing basis is critical for protecting them as we work together to unlock treatments for various types of cancers.
Product integrity and tracking
Exelixis strives to safeguard the integrity of the Company’s products with careful anticounterfeiting and serialization practices. We review our procedures relating to counterfeit prevention and response on an annual basis and revise them as needed. As part of the requirements of the Drug Supply Chain Security Act, every unit of a finished Exelixis product is now given a unique serial number, creating a data chain that allows us to track that unit in our supply chain.
We also have a system in place to manage product recalls, which entails internal procedures, terms and requirements with our suppliers, and communication to the proper authorities in the event it should be necessary. Although we have never conducted a product recall, our procedures do require biennial mock recalls to confirm that our systems stay robust and appropriate based on our distribution channels globally. Our patients put their health and trust in our hands, and we are ready to act immediately and comprehensively should the need arise.
Exelixis is committed to conducting business in a way that respects our environment and the Earth’s changing climate, and that is also consistent with serving the well-being of our patients, employees and all our stakeholders. We have already incorporated many environmentally sustainable practices into our facilities and operations, and we plan to incorporate more of these practices as we continue to grow. Our Business Operations team has the important responsibility of overseeing our environmental sustainability commitments and our environmental, health and safety programs.
As part of our commitment, we recognize that 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 Earth’s inhabitants.
As a growing healthcare company (with 773 employees at the end of 2020 and continuing to increase in 2021) engaging in energy-intensive R&D operations, we prioritize reducing our energy use where possible and reallocating our energy use to renewable sources.
In 2018, we moved our headquarters to a state-of-the-art facility in Alameda, CA, which meets and, in many cases, exceeds building code standards for energy efficiency and environmental impact, and is designed to help maximize collaboration among employees and enable novel drug discovery. For example, we installed all new LED light sources, occupancy sensors and daylight sensors to minimize our energy usage for lighting in all of our newly constructed offices and labs. In 2019, we installed four new electric vehicle (EV) charging stations to supplement the eight stations already existing in our business park in order to support our staff members who commute via EV. While the EV charging stations were not regularly utilized in 2020 as a result of most employees working remotely during the COVID-19 pandemic, we expect these EV charging stations will continue to help reduce our carbon footprint when more of our employees return to working on-site. In addition, our electricity in Alameda comes from Alameda Municipal Power, which delivers 100% clean energy. Finally, in October 2019, we signed a build-to-suit lease for a new ~220,000 square foot building adjacent to our current campus in Alameda. We have committed to a 100% carbon-neutral energy footprint for the operation of that building, which we anticipate occupying in 2022. This new building is being constructed with carbon-offsetting concrete, will use 100% electric power, and will generate approximately 50% of its total power needs from rooftop- and carport-mounted solar panels. We have made these and considerable additional investments toward constructing the building in a way that supports the wellness of our employees, our fellow citizens, and our environment, and are pursuing a LEED BD+C Gold Certification through the US Green Building Council.
Greenhouse gas emissions from employee commuting
Reducing the emission of greenhouse gases is an important factor in combating climate change and protecting our planet. To help reduce the carbon footprint of our commuting workforce, we put into place an extensive commuter support program to replace single-occupancy vehicle trips with shared transport. Transportation options include:
- Private shuttle fleet
- Vanpool fleet
- Carpool program
- Subsidies for employees using mass transit or carpooling
- Emergency ride home program
From March 2019 through February 2020 (the twelve-month period preceding the COVID-19 pandemic), our commuter support programs resulted in approximately 24% of our workforce based in the Alameda campus utilizing means other than single-occupant vehicles for their commute to work, reducing CO2 emissions by over 840 U.S. tons — equivalent to taking more than 164 cars off the road for a year. *
*Per EPA estimate of 5.1 U.S. tons of CO2 emitted by the average passenger vehicle in one year.
**Beginning in March 2019, we also utilized a private ferry service connecting Oyster Point in South San Francisco to Harbor Bay in Alameda as part of our commuter support program. The information presented in this chart includes the impact on emissions from employee use of the ferry service through December 2019. The ferry service was subsequently discontinued in February 2020.
We paused our commuter support programs in March 2020 due to the onset of the COVID-19 pandemic and the transition of the majority of our employees to working from home. This shift to remote working also had a significant impact on our carbon emissions from employee commuting, reducing CO2 emissions by over 624 U.S. tons through end of 2020 — equivalent to taking more than 122 cars off the road for a year.
Chemical waste and potentially harmful materials are necessary consequences of the drug discovery process. As an organization, we aim for strict adherence to applicable laws and regulations with regard to our handling of hazardous materials and wastes that are used or generated in the course of our business. In addition, we have instituted measures to minimize the amount of office waste that we produce, with a strong focus on reducing, reusing and recycling.
- We have eliminated our use of radioactive isotopes through safer alternatives.
- We do not provide waste bins in individual workspaces and instead provide waste sorting stations throughout our buildings in order to facilitate proper sorting of compostable and recyclable waste. This approach has the added benefit of dramatically reducing our consumption of plastic can liners, which themselves lead to unnecessary waste and environmental contamination. We encourage our employees to appropriately sort their waste in order to reduce the impact our growing workforce has on the environment.
- We generally provide reusable, stainless steel utensils instead of disposable utensils for our employees to use during meal times.
- We provide eco-friendly, BPI-certified compostable paper plates, cups and napkins for our employees to use during meal times.
Human capital management and workforce diversity
Our mission to help cancer patients recover stronger and live longer depends on the talent and dedication of our employees. We therefore invest in building their collective strength as a team by hiring the best qualified candidates available and fostering growth opportunities for individuals.
At Exelixis, we value being exceptional in what we do and how we lead, excelling for patients by going the extra mile to care for them and exceeding together as a business and contributor to the scientific community. We strive to live these values every day across the Company, integrating them into everything from our interview, hiring and onboarding processes to our performance evaluation, rewards and promotion programs. The power of our values shines through in the high quality of our workforce and their achievements.
At the end of 2020, we had 773 full-time equivalent employees, representing a 25% increase in our employee workforce as compared to the end of 2019. Of these employees, 409 are members of our various research and development teams and 364 are members of our various commercial and general and administrative teams. Of these employees, 126 hold Ph.D. degrees, 12 hold M.D. (or foreign equivalent) degrees, 20 hold PharmD degrees and 65 hold other professional degrees such as a J.D. or M.B.A. Exelixis is an equal opportunity employer and maintains policies that prohibit unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Our anti-discrimination policy and complaint procedures are included in our employee handbook and reiterated in periodic trainings given to all employees and managers.
We are proud to employ a diverse workforce that, as of the end of 2020, was 52% non-white and 53% women. In addition, 48% of our positions that manage other employees directly were held by non-whites and 46% were held by women, and women made up 33% of our senior leadership team.
During the past five years, our employee turnover has remained consistently below average for the U.S. life sciences industry generally, as well as for life sciences companies located in northern California (even after our 2018 move from South San Francisco to our new headquarters in Alameda, which is located on the East side of the San Francisco Bay). More than 10% 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 employee has been with Exelixis for 22 years. As part of our investment in our human capital resources, we continually assess employee turnover, recruitment initiatives, compensation 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 development, implementation and effectiveness of our policies and strategies relating to human capital management.
The health and safety of our staff members has remained a top priority during the COVID-19 pandemic. In March 2020, ahead of the shelter in place orders issued by the State of California and Alameda County, we implemented a work-from-home policy for all of our employees other than minimal on-site staffing to maintain critical infrastructure operations. During the months that followed, we implemented numerous additional precautions and enhanced safety and social distancing protocols to help diminish the risk of transmission of the virus as certain employees began to return to working at our Alameda headquarters in June 2020. In particular, we reduced the number of employees working on-site to primarily those laboratory and site operations personnel required to continue our important drug discovery work, provided such employees were comfortable working on-site. These staff members – already familiar with personal protective equipment (PPE) and enhanced safety measures – have undergone additional detailed training on our COVID-19 safety and social distancing protocols that are necessary to safely perform their job duties in our on-site facilities.
We also implemented on-site, rapid PCR COVID-19 testing, and utilize a mobile device app and web interface for our team members who regularly work at our headquarters, which enables registered users to schedule their on-site tests at Exelixis and provides them with daily symptom tracking, as well as contact tracing and educational resources for any team member who may have tested positive.
We will continue to monitor the latest guidance issued by health authorities and have instituted several policies and procedures to protect against the spread of COVID-19 among our workforce. As of the end of 2020, these policies and procedures included frequent disinfection of common areas by our operations staff and investments in re-engineering workspace safety, such as installing plexiglass partitions, providing ample supplies of hand sanitizer, sanitizing wipes and facemasks for use by our staff, and adjusting our ventilation systems in an effort to minimize risks of airborne transmission.
Although most of our employees worked remotely in 2020, which required us to devise new ways of working and collaborating, as of the date of our Annual Report on Form 10-K for the 2020 fiscal year, the COVID-19 pandemic has only had a modest impact on our productivity and has not caused significant interruptions in our general business operations. We maintained efficiencies in our workstreams and organizational cohesion by expanding the use of technology systems, increasing the frequency and clarity of communications from executive management, and finding ways to improve coordination across business units. Despite the challenges introduced by the COVID-19 pandemic, during the 2020 fiscal year, our team’s collective resilience, focus and commitment helped us to continue to execute across our key business priorities and achieve important milestones, including:
- Announcing and presenting multiple positive clinical trial results, including data from two pivotal phase 3 studies
- Initiating three global pivotal phase 3 clinical studies
- Submitting a supplemental New Drug Application for the combination of CABOMETYX and nivolumab as a first-line treatment in advanced renal cell carcinoma, presenting key data at the European Society for Medical Oncology Virtual Congress 2020, and subsequently executing the commercial launch after receiving FDA approval in January 2021
- Advancing our early-stage pipeline, including expanding phase 1 clinical trial enrollment for XL092, and progressing two discovery programs, XL102 and XB002, into early-stage clinical development
- Increasing our employee headcount by more than 25% over the course of 2020
Ongoing commitment to safety
We insist on providing employees with the tools and environment they need to perform their work safely. We strive to adhere to the standards set by the Occupational Safety and Health Administration (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. All new laboratory staff are trained on chemical hygiene, the use of PPE, and other relevant laboratory safety topics, including working with blood-borne pathogens, and current staff are retrained regularly. We also extend these trainings to facilities staff and others who support our work 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 staff 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.
Because of our training and inspection practices, we have an excellent safety record:
- From 2016-2020, we recorded only fifteen minor work-related injuries, resulting in only twenty-four days of missed work, across a workforce ranging from 100 to more than 700 employees during that time period. After reviewing each incident, we found that none resulted from insufficient safety procedures, and we provided retraining to employees as necessary.
In addition, we make ergonomic workspace evaluations a priority for all new hires and existing employees who request them to ensure they inhabit a comfortable work environment.
Employee benefits and culture
Exelixis strives to build and nurture a culture where all employees feel empowered to be their authentic selves. We respect and appreciate each employee’s unique perspective and experiences, and value their contribution to our mission. It is important that we celebrate, encourage and support similarities and differences to drive innovation for the benefit of our employees, patients and community. The strength of our business culture served us well in addressing the unique challenges that emerged in 2020, and our leadership team engaged regularly with the entire organization to listen and respond to areas of concern, both within our Company and with respect to critical national issues relating to the COVID-19 pandemic and social justice.
We provide generous compensation packages designed to attract and retain high-quality employees, and all of our employees are eligible for cash bonuses and grants of equity awards. We regularly evaluate our compensation programs with an independent compensation consultant and utilize industry benchmarking in an effort to ensure they are competitive compared to similar biotechnology and biopharmaceutical companies with which we compete for talent, as well as fair and equitable across our workforce with respect to gender, race and certain other personal characteristics. In addition, we are proud to provide a variety of programs and services to help employees meet and balance their needs at work, at home and in life, including an attractive mix of healthcare, insurance and other benefit plans. We deliver a benefits program that is designed to keep our employees and their families healthy, which includes not only medical, dental and vision benefits, but also dependent care, mental health and other wellness benefits. A list of our benefits programs is available online at our Careers page.
In line with our core values of being exceptional, excelling for our patients and exceeding together, we are committed to taking the right action and leading others to do the right thing at the right time in the right way. We pay particular attention to the career development of our most valued asset: our employees. We offer a tuition reimbursement program, as well as professional development courses ranging from technical training, competency-based workshops and leadership development programs facilitated by external partners who are experts in their respective fields. Direct managers also take an active role in identifying individualized development plans to assist their employees in realizing their full potential and creating opportunities for promotions and added responsibilities that enhance the engagement and retention of our workforce.
We strive to be a workplace where everyone can be their authentic selves and feel safe and encouraged to exceed together. That’s how we bring value to the individual Exelixis employee — and how our employees bring value to all those we serve.
This publication contains forward-looking statements, including, without limitation, statements related to: Exelixis’ expectation that its employees will commit to the highest standards of ethical behavior and maintain values and principles that reflect both global awareness and sustainability; Exelixis’ commitment that no patient prescribed an Exelixis medicine will go without it due to lack of insurance or inability to pay; the potential for Exelixis’ pipeline to provide therapeutic benefit for patients; Exelixis’ plans to increase inclusivity in its clinical trials; Exelixis’ plans to reassess its standard audit procedures, including a potential return to conducting certain audits in-person when it is safe to do so following the COVID-19 pandemic; Exelixis’ plans to incorporate more environmentally sustainable practice into its facilities as it continues to grow; Exelixis’ expectation that continued use of EV charging stations, operations in a new building in 2022 and other measures will help reduce Exelixis’ environmental footprint; and other statements relating to Exelixis’ goals, efforts and objectives. Any statements that refer to expectations, projections or other characterizations of future events or circumstance are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the continuing COVID-19 global pandemic and its impact on Exelixis’ clinical trial, drug discovery and commercial activities; the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis and its partners’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis’ ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the US and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib and other Exelixis products; Exelixis’ dependence on third party vendors for the development, manufacture and supply of its products and product candidates; Exelixis’ ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis’ marketed products; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2021, and in Exelixis’ future filings with the SEC. All forward-looking statements in this publication are based on information available to Exelixis as of October 5, 2021, the date of this publication, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.
- PhRMA Chart Pack: Biopharmaceuticals in Perspective, Fall 2020. Available at https://www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/A-C/ChartPack_Biopharmaceuticals_in_Perspective_Fall2020.pdf. Accessed April 2021.
- World Health Organization. Cancer Key Facts. Available at https://www.who.int/news-room/fact-sheets/detail/cancer. Accessed April 2021.
- World Health Organization’s International Agency for Research on Cancer. All Cancers Fact Sheet. Globocan 2020. Available at https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf. Accessed April 2021.
- ASCO Clinical Treatment Act: Medicaid Enrollees Need Clinical Trial Access. Available at: https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2020-clinical-treatment-act-infographic-dec-update.pdf. Accessed September 2021.
- ACS Cancer Facts and Figures for African Americans 2019-2021. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2019-2021.pdf. Accessed September 2021.