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Exelixis, Inc. EXEL announced preliminary unaudited results for the fourth quarter and 2020 and provided the annual guidance for 2021. Concurrently, it provided an update on its business plans.
Net revenues for the fourth quarter were $270 million, while product revenues came in at $200 million. Research and development expenses were $155 million. Selling, general and administrative expenses were $83 million.
For 2020, revenues came in at $988 million, while product revenues were $741 million.
The guidance provided by the company for 2021 assumes a potential FDA approval and commercial launch of the combination of lead drug, Cabometyx (cabozantinib), with Bristol Myers’ BMY Opdivo (nivolumab) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), which has a Prescription Drug Use Fee Act (PDUFA) target action date of Feb 20, 2021. This market represents huge potential, as an estimated 15,000 patients with advanced RCC are eligible for first-line treatment every year in the United States, with immune checkpoint inhibitor (ICI) combination therapy consisting of approximately 80% of that market.
Revenues for 2021 are projected around $1.1-$1.2 billion.
We remind investors that the tablet formulation of cabozantinib is approved as Cabometyx in the United States for the treatment of patients with advanced RCC and those with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
Meanwhile, the company plans to evaluate Cabometyx further into additional indications. Revenues generated from approved indications of the drug are expected to support its pipeline progress.
In 2021, Exelixis expects to file a supplemental New Drug Application (sNDA) seeking approval of cabozantinib monotherapy in patients with radioactive iodine-refractory differentiated thyroid cancer (DTC) previously treated with a vascular endothelial growth factor receptor-targeted therapy.
The company intends to report top-line data from COSMIC-312, a global phase III study evaluating cabozantinib in combination with Roche’s RHHBY immunotherapy, Tecentriq (atezolizumab), versus Nexavar in previously untreated advanced HCC, for the co-primary endpoints of PFS and overall survival (OS) in the first half of 2021.
Assuming positive data, Exelixis anticipates filing an sNDA in 2021 seeking accelerated approval of cabozantinib in combination with Tecentriq, for the treatment of metastatic castration-resistant prostate cancer (CRPC).
Further, the company expanded the enrollment target to 840 patients to provide better evaluation for assessing the secondary endpoint of OS for COSMIC-313, the phase III study evaluating the triplet combination of cabozantinib, Opdivo and Yervoy versus the combination of Opdivo-Yervoy in patients with previously untreated advanced intermediate- or poor-risk RCC. It expects to complete the expanded enrollment in early 2021.
Exelixis is currently enrolling patients in the dose-escalation cohorts of the phase Ib clinical study of XL092 in combination with Tecentriq and expects to initiate enrollment in the clear cell and non-clear cell RCC, hormone-receptor-positive breast cancer and metastatic CRPC expansion cohorts shortly.
The company expects to initiate a phase I study of XL102 (formerly known as AUR102), alone or in combination therapy, for the treatment of inoperable, locally advanced or metastatic solid tumors, following the FDA’s acceptance of its IND. We note that Exelixis in-licensed XL102 from Aurigene Discovery Technologies Limited, a development-stage biotech company and a wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd. RDY.
Exelixis also plans to commence a phase I study of XB002 (formerly known as ICON-2), in patients with inoperable, locally advanced or metastatic solid tumors.
Shares of the company have increased 23.6% in the past year compared with the industry’s growth of 9.2%.
Cabometyx continues to hold up pretty well amid the pandemic and a potential label expansion of the drug will boost its growth prospects.
Exelixis currently carries a Zacks Rank #4 (Sell).
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