Exelixis, Inc. (NASDAQ:EXEL) is an oncology company at the forefront of cancer care, innovating next-generation medicines and combination regimens. Through its commitment to drug discovery, development, and commercialization, Exelixis has produced four marketed pharmaceutical products, two of which are formulations of its flagship molecule, cabozantinib. The company continues to evolve its product portfolio, leveraging its investments, expertise, and strategic partnerships to target an expanding range of tumor types and indications with its clinically differentiated pipeline of small molecules and biotherapeutics, including antibody-drug conjugates (ADCs).

Financials

In the fiscal year 2023, Exelixis reported annual revenues of $1,830,208,000 and net income of $207,765,000. The company's annual operating cash flow was $333,324,000, and its annual free cash flow was $170,355,000. These strong financial results demonstrate Exelixis' ability to generate substantial cash flow to fund its ongoing operations and pipeline development.

For the first quarter of 2024, Exelixis reported total revenues of $425,226,000, including net product revenues of $378,523,000 from its cabozantinib franchise. This represents a 4% increase in net product revenues compared to the first quarter of 2023. The company's collaboration revenues, which include license revenues and collaboration services revenues, were $46,703,000 for the first quarter of 2024.

Business Overview

Exelixis' flagship product, CABOMETYX® (cabozantinib), is an inhibitor of multiple tyrosine kinases, including MET, AXL, VEGF receptors, and RET. CABOMETYX has been approved by the U.S. Food and Drug Administration (FDA) and in 68 other countries for the treatment of advanced renal cell carcinoma (RCC), previously treated hepatocellular carcinoma (HCC), and previously treated, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC).

The company's other marketed products are COTELLIC® (cobimetinib), an inhibitor of MEK approved as part of multiple combination regimens to treat specific forms of advanced melanoma and marketed under a collaboration with Genentech, Inc., and MINNEBRO® (esaxerenone), an oral, non-steroidal, selective blocker of the mineralocorticoid receptor, approved for the treatment of hypertension in Japan and licensed to Daiichi Sankyo Company, Limited.

Exelixis continues to leverage its operating cash flows to advance a broad array of diverse biotherapeutics and small molecule programs for the treatment of cancer, as well as to support ongoing company-sponsored and externally sponsored trials evaluating cabozantinib. The product candidates furthest along in the company's pipeline are zanzalintinib, a novel, potent, third-generation oral tyrosine kinase inhibitor (TKI) that targets VEGF receptors, MET, and the TAM kinases, and XB002, a next-generation tissue factor (TF)-targeting ADC.

Exelixis' research collaborations and in-licensing arrangements are intended to enhance its early-stage pipeline and expand its ability to discover, develop, and commercialize novel therapies with the goal of providing new treatment options for cancer patients and their physicians. The company's drug discovery efforts are supplemented through in-licensing investigational oncology assets or obtaining options to acquire other investigational oncology assets from third parties if they demonstrate evidence of clinical success.

Recent Developments

The company's cabozantinib franchise continues to be a key driver of its success. In the first quarter of 2024, CABOMETYX net product revenues grew 4% year-over-year, highlighting its role as a leading TKI globally. Exelixis and its partners, Ipsen and Takeda, are working to expand the cabozantinib franchise into additional indications, including neuroendocrine tumors (NET) and metastatic castration-resistant prostate cancer (mCRPC).

The CABINET phase 3 pivotal study, conducted under Exelixis' Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's Cancer Therapy Evaluation Program (NCI-CTEP), evaluated cabozantinib versus placebo in patients with previously treated advanced or metastatic pancreatic or extra-pancreatic NET. The study demonstrated a substantial prolongation of the time to disease progression or death in both the pancreatic NET and extra-pancreatic NET cohorts, with a safety profile consistent with cabozantinib's known profile.

Additionally, the CONTACT-02 phase 3 pivotal trial, which evaluated the combination of cabozantinib and atezolizumab versus a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and soft-tissue disease who have progressed after treatment with one prior NHT, met one of its two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS). The company is discussing a potential regulatory submission with the FDA based on these results.

Exelixis' pipeline activities are not limited to the cabozantinib franchise. The company is also advancing its novel TKI, zanzalintinib, in a growing development program that targets indications with high unmet need. Zanzalintinib is being evaluated in multiple phase 1b/2 and phase 3 clinical trials, both as a monotherapy and in combination with immune checkpoint inhibitors (ICIs).

The company's biotherapeutics programs, led by its lead ADC candidate, XB002, are also progressing. XB002 is a next-generation TF-targeting ADC that is being evaluated in the JEWEL-101 phase 1 study, both as a single agent and in combination with nivolumab, in patients with advanced solid tumors.

Liquidity

Exelixis' financial position remains strong, with $1.6 billion in cash, cash equivalents, and investments as of March 31, 2024. The company's robust operating cash flow and free cash flow generation provide the flexibility to invest in internal R&D activities, pursue external business development opportunities to expand its pipeline, and return capital to shareholders through its $450 million share repurchase program.

Outlook

The company's outlook remains positive, as it continues to execute on its strategic priorities. Exelixis is well-positioned to drive further growth and value creation for its shareholders through the continued advancement of its cabozantinib franchise, the development of its promising pipeline assets, and its disciplined approach to capital allocation.