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CELEBRATING 25 YEARS of PROGRESS for PATIENTS for PROGRESS of YEARS 25 CELEBRATING Annual Report 2019 Report Annual

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CELEBRATING 25 YEARS of PROGRESS for PATIENTS for PROGRESS of YEARS 25 CELEBRATING Annual Report 2019 Report Annual CELEBRATING 25 YEARS OF PROGRESS FOR PATIENTS FOR PROGRESS YEARS OF 25 CELEBRATING Annual Report 2019 Annual Report Exelixis, Inc. Annual Report 2019 2019 HIGHLIGHTS In 2019, Exelixis marked its 25th anniversary. Our progress during the year highlights how far we’ve come since our early days. More than that, though, it underscores our commitment to pushing scientific and technological boundaries to advance our mission to help cancer patients recover stronger and live longer. As we move through 2020, our team has the same drive and passion for the work as we did when we first opened our doors back in 1994. 610+ employees committed to our mission at year-end 2019, an increase of 27% year over year 12 ongoing or planned trials with label-enabling potential, including four announced in 2019 $1 billion in annual global net revenues for the cabozantinib franchise1 20 ongoingon preclinical programs across ExelixisExxelixis internal disdiscovery and our partners, includingincludi three that ccocouldould reach the clinic this year 4 Commerciallyommerciallymmerciallymerciallyerciallyrciallyciallyiallyallyllyy availablavailablea pprproproduprodproductproducts benefittingttingtingingngg patientsatientstientsientsentsntstlblbi ono a ggloglobal basis 1 Including revenues generated by Ipsen Pharma SAS, our partner in cabozantinib’s global development and commercialization outside of the United States and Japan TO OUR STOCKHOLDERS Before I reflect on our progress in 2019, I want to take a moment to acknowledge the obvious: the coronavirus pandemic is making 2020 a markedly different year for the world, our industry, and for Exelixis. Despite this, I’m confident in our ability to navigate these difficult times and the significant challenges posed by COVID-19. For patients with cancer, continuity of treatment is paramount. Even though the U.S. medical system is under pressure right now, we are encouraged by the dedication of clinical teams across the country to ensure cancer patients receive the care they need. At Exelixis, we are working proactively with our clinical trial sites around the world to ensure their access to the best care available and study-related drugs. Moreover, our fundamental business remains strong: we finished 2019 with roughly $1.4 billion in cash and investments, and no debt, fueled largely by strong sales for the cabozantinib franchise during the year. As we move forward, I’m grateful to the healthcare professionals on the front lines of the pandemic, to our biopharma industry colleagues working tirelessly to develop COVID-19 vaccines and therapies, and to the Exelixis team for remaining fully engaged and united in our own mission on behalf of patients with cancer. 201920 9 wasw as a milestonem ileestoo e yeary eaar for Exelixis. Exelixis It wasw thet company’s 25th anniversary, soso wewe hadhad ampleammple opportunityopppo to reflect on the events and shared experiences thattht ata hhaveave mamadeade EExelixisx what it is today. But since nostalgia isn’t an outsized elementelememennt ofo ooururu corporate culture, we alsoo did a lot of looking forward, laying thetthhe groundworkgrouundd for the company we wannt Exelixis to be in the next 25 years anda d beyondbey — a science-driven, collaboraative organization with a laser focus onn deliveringd wave after wave of innovativve medicines for patients with cancer. ThanksT to the team’s hard work, we madee good progress toward becoming that company in 2019 and are poised to continue that progress in 2020. Maximizing Cabozantinib In 2020 and beyond, we are focused on Since its first regulatory approval in 2012, our dramatically expanding the number of patients who can benefit from cabozantinib. lead medicine, cabozantinib, has expanded beyond its initial orphan drug indication to We’re running a broad set of trials designed 1500 $1,388.6 to fully evaluate cabozantinib’s potential in increasingly larger clinical opportunities. In 1200 2019, it remained the number one prescribed diverse forms of cancer, including multiple $851.6 single-agent tyrosine kinase inhibitor for studies with Ipsen and Takeda, our partners 900 in cabozantinib’s global clinical development renal cell carcinoma (RCC) and previously 600 treated hepatocellular carcinoma (HCC), and commercialization. The work includes $457.2 nine ongoing, potentially label-enabling and the only single-agent therapy shown 300 to extend life in those indications. These studies that, if successful, could yield as many as four new or expanded indications – 0 distinctions have helped propel cabozantinib 2017 2018 2019 to become a global oncology franchise, with in forms of kidney, prostate, thyroid, and liver approvals in 52 countries and global annual cancer – for cabozantinib. Three additional Year-End Cash phase 3 pivotal studies are planned to start and Investments net revenues that exceeded $1 billion for the (in millions) first time in 2019.1 later this year as part of our clinical trial collaboration exploring the potential of cabozantinib (CABOMETYX®) in combination 1 Including revenues generated by Ipsen Pharma SAS, our partner in cabozantinib’s global development and commercialization outside of the United States and Japan 1 A Dynamic, Growing Pipeline Cabozantinib has long been a foundational element of our business, but it’s far from our only growth driver. Having established our lead product as a global oncology franchise, we’re now intensely focused on building out our pipeline with a new generation of Exelixis medicines. The strategy is two-pronged: we’re conducting internal drug discovery activities at Exelixis while also pursuing with atezolizumab (TECENTRIQ®), Roche’s targeted business development opportunities anti-PD-L1 antibody. Our slate of ongoing to bring additional innovative, high-quality studies includes CheckMate 9ER, the assets into our development organization. Bristol-Myers Squibb-sponsored phase 3 In total, there are now approximately 20 pivotal trial that evaluates cabozantinib plus ongoing discovery programs spread across nivolumab (Opdivo®) versus sunitinib in our internal research activities and work previously untreated RCC, positive results resulting from the collaboration, option, from which would create space for this and/or license agreements signed with combination in an increasingly competitive StemSynergy, Invenra, Iconic Therapeutics treatment landscape. It also includes and Aurigene over the past two years. COSMIC-312, our phase 3 pivotal study of Pending continued positive data, we cabozantinib plus atezolizumab versus anticipate submitting investigational new sorafenib in previously untreated advanced drug (IND) filings for up to three compounds HCC, an important component of our work – two small molecules and a next-generation to expand this market. antibody-drug conjugate targeting Tissue We’re also excited about the progress of Factor – by the end of this year. In addition, COSMIC-021, our ongoing phase 1b trial of multiple development candidates are cabozantinib plus atezolizumab in locally moving through preclinical development, advanced or metastatic solid tumors. When and some of these could advance into fully enrolled, this large study will include up clinical development next year. to 1,700 patients across 24 cohorts. After Alongside our business development efforts, expanding the trial’s primary metastatic it’s been particularly exciting to see the castration-resistant prostate cancer (mCRPC) Exelixis drug discovery team ramp up its cohort twice, we presented encouraging work and contribute to our portfolio. In early data at this year’s ASCO Genitourinary 2019, we were gratified to see XL092, the Cancers Symposium in February; we’ve first internally discovered Exelixis compound guided that, based on regulatory feedback to reach the clinic since 2009, begin the from the U.S. Food and Drug Administration dose-finding portion of its phase 1 clinical and if supported by further data from the testing. Our next steps for XL092 will be to trial, we intend to pursue accelerated enroll several expansion cohorts, as well as approval in an mCRPC indication. We also additional cohorts evaluating XL092 in expect to present data from the non-small combination with immune checkpoint cell lung cancer (NSCLC) cohort of COSMIC-021 inhibitors. and potentially other cohorts from this trial when the data is sufficiently mature. If our efforts to expand cabozantinib’s reach are successful, we could quadruple the number of patients in the United States who may benefit from this important therapy to approximately 181,000 – a major achievement in our mission. For more information on the cabozantinib clinical development program, see page eight of this Annual Report. Exelixis Compound Library, Alameda, CA 2 “Cabozantinib has long been a foundational element of our business, but it’s far from our only growth driver.” Exelixis Discovery Laboratories, Alameda, CA Reframing the Opportunity that can take our business, and the field As we build our pipeline, we’re also expanding of cancer research, even further. With an our physical presence by adding office and emphasis on resilience, execution, and lab space at our Alameda headquarters. collaboration, we are working hard to write When completed, we expect to have more a new chapter for Exelixis and advance on than tripled the size of our present campus our mission to help cancer patients recover to a total of approximately 440,000 square stronger and live longer. Thanks for your feet, providing us with the necessary continued interest and support of Exelixis footprint
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