Exelixis, Inc
.
EXEL
reported earnings of 29 cents in the fourth quarter, which comfortably beat the Zacks Consensus Estimate of 7 cents. In the year-ago quarter, the company had reported earnings of 9 cents per share.
Excluding stock-based compensation expense, earning per share came in at 35 cents, up from 14 cents in the year-ago quarter.
Net revenues came in at $451.1 million, which increased from $270 million reported in the year-ago quarter and surpassed the Zacks Consensus Estimate of $358 million.
Exelixis’ shares have lost 17.4% in the past year compared with the
industry
’s decline of 38.8%.
Image Source: Zacks Investment Research
Quarter in Detail
Net product revenues came in at $302.7 million, up from $200.3 million reported in the year-ago quarter. The upside was primarily led by an increase in sales volume that was primarily driven by the strong uptake for the combination therapy of Cabometyx (cabozantinib tablets) and
Bristol-Myers’
BMY
Opdivo (nivolumab) following FDA approval in January.
Bristol-Myers’ Opdivo is one of the leading revenue generators of the company and is approved for various oncology indications.
Cabometyx generated revenues of $295.1 million. Cabometyx is approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma (HCC). Cometriq (cabozantinib capsules) for the treatment of medullary thyroid cancer generated $7.6 million in net product revenues.
Exelixis earned $29.3 million in royalty revenues.
Collaboration revenues, comprising license revenues and collaboration services revenues, were $148.5 million in the quarter.
In the fourth quarter, Exelixis recorded in license revenues a $100.0 million milestone from Ipsen in connection with the achievement of $400.0 million in net sales in its related license territory over four consecutive quarters. Exelixis expects to receive this payment in the first quarter of 2022.
In the reported quarter, research and development expenses were $222.3 million compared with $154.3 million in the year-ago quarter. Selling, general and administrative expenses were $99.3 million, up from $82.4 million in the year-ago quarter.
2021 Results
Revenues in 2021 were $1,435.0 million compared with $987.5 million in 2020. Earnings per share came in at 72 cents, up from 35 cents in 2020.
Pipeline Update
Enrollment was completed for CONTACT-01, the phase III study evaluating cabozantinib in combination with Tecentriq versus docetaxel in patients with metastatic non-small cell lung cancer (NSCLC). Interim data from the study are anticipated in the second half of 2022.
In December 2021, Exelixis announced the initiation of the dose-escalation stage of STELLAR-002, a phase Ib study evaluating XL092 in combination with immuno-Oncology (IO) therapies in advanced solid tumors.
2022 Guidance
Revenues are projected within $1.525-$1.625 billion, while product revenues are estimated in the range of $1.325 billion to $1.425 billion.
Our Take
Exelixis’ fourth-quarter results were encouraging, with a beat on both counts. The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC has boosted sales. However, competition is stiff in this space and capturing additional market share might become tough.
Merck
’s
MRK
Keytruda in combination with
Pfizer
’s
PFE
Inlyta is also indicated for the first-line treatment of patients with advanced RCC.
Merck’s Keytruda, an anti-PD-1 therapy, is approved for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence, following nephrectomy or nephrectomy and resection of metastatic lesions.
Pfizer’s Inlyta has shown strong performance, driven by continued adoption in the United States and Europe. Pfizer’s older drug Sutent is also approved for advanced RCC.
Exelixis currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
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