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Exelixis (EXEL) Q3 Earnings & Sales Top, Cabometyx Aids Growth
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Exelixis, Inc. (EXEL - Free Report) reported earnings of 31 cents per share for the third quarter of 2022, up from 20 cents per share in the year-ago quarter, and beat the Zacks Consensus Estimate of 25 cents.
Including stock-based compensation expense, earnings per share came in at 23 cents, up from 12 cents in the year-ago quarter. The year-over-year increase in earnings was mainly due to higher revenues.
Net revenues came in at $411.7 million, which surpassed the Zacks Consensus Estimate of $404 million and increased from $328 million reported in the year-ago quarter.
Exelixis’ shares have lost 8% in the year so far compared with the industry’s decline of 21.2%.
Image Source: Zacks Investment Research
Quarter in Detail
Net product revenues came in at $366.5 million, up from $263.1 million in the year-ago quarter. The upside was primarily led by higher sales volume.
Cabometyx (cabozantinib) generated revenues of $361.4 million. It 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 $5.1 million in net product revenues.
EXEL earned $30.3 million in royalty revenues.
Collaboration revenues, comprising license revenues and collaboration services revenues, were $45.3 million in the quarter compared with $65.3 million in the year-ago quarter. The decrease in collaboration revenues was primarily related to decreases in recognition of milestone-related revenues and reimbursement of development costs.
In the reported quarter, research and development expenses were $198.8 million, up from $163.4 million in the year-ago quarter. The increases in research and development expenses were primarily related to the rise in clinical trial costs, personnel expenses, consulting and outside services expenses and stock-based compensation expenses. Selling, general and administrative expenses were $115 million, up from $101.6 million in the year-ago quarter.
Pipeline Update
In September, Exelixis presented results from the dose-escalation stage of STELLAR-001, an ongoing phase Ib study evaluating XL092 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. Data showed that XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels with a manageable safety profile.
Last month, Exelixis expanded its 2021 Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb (BMY - Free Report) to include the use of the fixed-dose combination of Opdivo and relatlimab in the ongoing phase Ib STELLAR-002 study, which is evaluating XL092 in combination with multiple immune checkpoint inhibitors in advanced solid tumors.
Exelixis entered into an exclusive clinical development and option agreement with Sairopa B.V. for ADU-1805. Per the terms, Exelixis will make an upfront payment of $40 million to Sairopa and an additional $70 million in near-term milestone payments for an option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies, and for certain expenses to be incurred by Sairopa in conducting prespecified phase I studies of ADU-1805 during the option period.
Exelixis also entered into an exclusive collaboration agreement with Cybrexa Therapeutics, which gave it the right to acquire CBX-12 (alphalex exatecan), a clinical-stage, first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance the delivery of exatecan to tumor cells.
Revenues are projected between $1.575 billion and $1.600 billion (previous guidance: $1.525-$1.625 billion), while product revenues are estimated in the range of $1.375 billion-1.400 billion (previous range: $1.325-$1.425 billion).
Our Take
Exelixis’ third-quarter results were strong, with a beat on both counts. Demand growth is being driven primarily by the longer duration of therapy for patients on Cabometyx in combination with Opdivo in first-line RCC. However, competition is stiff in this space and capturing additional market share might become tough.
Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.
Merck’s (MRK - Free Report) Keytruda, in combination with Pfizer’s (PFE - Free Report) Inlyta, is also indicated for the first-line treatment of patients with advanced RCC.
MRK’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.
PFE’s Inlyta is also approved for the treatment of advanced RCC after failure of one prior systemic therapy as a single agent. Pfizer’s older drug, Sutent, is also approved for advanced RCC.
Image: Bigstock
Exelixis (EXEL) Q3 Earnings & Sales Top, Cabometyx Aids Growth
Exelixis, Inc. (EXEL - Free Report) reported earnings of 31 cents per share for the third quarter of 2022, up from 20 cents per share in the year-ago quarter, and beat the Zacks Consensus Estimate of 25 cents.
Including stock-based compensation expense, earnings per share came in at 23 cents, up from 12 cents in the year-ago quarter. The year-over-year increase in earnings was mainly due to higher revenues.
Net revenues came in at $411.7 million, which surpassed the Zacks Consensus Estimate of $404 million and increased from $328 million reported in the year-ago quarter.
Exelixis’ shares have lost 8% in the year so far compared with the industry’s decline of 21.2%.
Image Source: Zacks Investment Research
Quarter in Detail
Net product revenues came in at $366.5 million, up from $263.1 million in the year-ago quarter. The upside was primarily led by higher sales volume.
Cabometyx (cabozantinib) generated revenues of $361.4 million. It 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 $5.1 million in net product revenues.
EXEL earned $30.3 million in royalty revenues.
Collaboration revenues, comprising license revenues and collaboration services revenues, were $45.3 million in the quarter compared with $65.3 million in the year-ago quarter. The decrease in collaboration revenues was primarily related to decreases in recognition of milestone-related revenues and reimbursement of development costs.
In the reported quarter, research and development expenses were $198.8 million, up from $163.4 million in the year-ago quarter. The increases in research and development expenses were primarily related to the rise in clinical trial costs, personnel expenses, consulting and outside services expenses and stock-based compensation expenses. Selling, general and administrative expenses were $115 million, up from $101.6 million in the year-ago quarter.
Pipeline Update
In September, Exelixis presented results from the dose-escalation stage of STELLAR-001, an ongoing phase Ib study evaluating XL092 as a single agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. Data showed that XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels with a manageable safety profile.
Last month, Exelixis expanded its 2021 Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb (BMY - Free Report) to include the use of the fixed-dose combination of Opdivo and relatlimab in the ongoing phase Ib STELLAR-002 study, which is evaluating XL092 in combination with multiple immune checkpoint inhibitors in advanced solid tumors.
Exelixis entered into an exclusive clinical development and option agreement with Sairopa B.V. for ADU-1805. Per the terms, Exelixis will make an upfront payment of $40 million to Sairopa and an additional $70 million in near-term milestone payments for an option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies, and for certain expenses to be incurred by Sairopa in conducting prespecified phase I studies of ADU-1805 during the option period.
Exelixis also entered into an exclusive collaboration agreement with Cybrexa Therapeutics, which gave it the right to acquire CBX-12 (alphalex exatecan), a clinical-stage, first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance the delivery of exatecan to tumor cells.
Exelixis, Inc. Price, Consensus and EPS Surprise
Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote
2022 Guidance Updated
Revenues are projected between $1.575 billion and $1.600 billion (previous guidance: $1.525-$1.625 billion), while product revenues are estimated in the range of $1.375 billion-1.400 billion (previous range: $1.325-$1.425 billion).
Our Take
Exelixis’ third-quarter results were strong, with a beat on both counts. Demand growth is being driven primarily by the longer duration of therapy for patients on Cabometyx in combination with Opdivo in first-line RCC. However, competition is stiff in this space and capturing additional market share might become tough.
Bristol-Myers’ Opdivo, one of its leading revenue generators, is approved for various oncology indications.
Merck’s (MRK - Free Report) Keytruda, in combination with Pfizer’s (PFE - Free Report) Inlyta, is also indicated for the first-line treatment of patients with advanced RCC.
MRK’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.
PFE’s Inlyta is also approved for the treatment of advanced RCC after failure of one prior systemic therapy as a single agent. 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.