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Exelixis, Inc. (EXEL - Free Report) reported earnings of 30 cents in the second quarter, which easily beat the Zacks Consensus Estimate of 5 cents. The bottom line also increased from the year-ago quarter’s earnings of 21 cents per share.
Net revenues came in at $385.2 million, which increased from $259.5 million reported in the year-ago quarter and comfortably surpassed the Zacks Consensus Estimate of $296 million.
Net product revenues came in at $284.2 million, up from $178.7 million reported in the year-ago quarter. The upside was primarily driven by an increase in sales volume that was primarily driven by the strong uptake for the combination therapy of Cabometyx (cabozantinib) and Bristol-Myers’ (BMY - Free Report) Opdivo (nivolumab) following FDA approval in January.
Cabometyx generated $275.6 million of revenues. Cabometyx (cabozantinib tablets) 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 $8.6 million in net product revenues. Exelixis earned $24.9 million in royalty revenues.
Collaboration revenues, comprising license revenues and collaboration services revenues, were $61.3 million in the quarter compared with $21.5 million in the year-ago quarter.
In the reported quarter, research and development expenses increased to $148.8 million from the year-ago quarter’s $114.9 million due to a rise in clinical trial costs. Selling, general and administrative (SG&A) expenses were $98.5 million, up from $59.8 million.
Pipeline Update
In January 2021, Exelixis obtained the FDA’s approval for its supplemental new drug application (sNDA) for Cabometyx in combination with Opdivo as a first-line treatment of patients with advanced RCC. Subsequently, in March 2021, Exelixis’ partner Ipsen received approval from the European Commission for this combination as a first-line treatment for advanced RCC.
In June, Exelixis and Ipsen announced detailed results from the phase III COSMIC-311 study of cabozantinib in patients with previously treated RAI-refractory differentiated thyroid cancer (DTC). Results from the study met the primary endpoint of demonstrating significant improvement in progression-free survival (PFS) and served as the basis for the sNDA submitted to the FDA in June.
In August, Exelixis announced that the FDA accepted the company’s sNDA for Cabometyx as a treatment for patients 12 years and older with DTC who have progressed following prior therapy and are RAI-refractory (if RAI is appropriate). The FDA granted Priority Review designation and assigned a target action date of Dec 4, 2021.
In April, Exelixis announced that the FDA accepted its IND to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors, and in June, a phase I trial was initiated.
In June, Exelixis and Ipsen announced that COSMIC-312, the ongoing phase III study evaluating cabozantinib in combination with Roche’s (RHHBY - Free Report) Tecentriq versus sorafenib in patients with previously untreated advanced HCC, met one of the primary endpoints, demonstrating significant improvement in PFS at the planned primary analysis.
2021 Guidance Updated
Revenues are now projected at $1,300-$1,400 million (previous projection: $1,150-$1,250 million) while product revenues are estimated in the range of $1,050-$1,150 million (previous projection: $950-$1,050 million).
Our Take
Exelixis’ second-quarter results were encouraging with beat on both counts. The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC has boosted sales.
Exelixis’ shares have gained 20.6% in the past year compared with the industry’s growth of 14.2%.
Image: Bigstock
Exelixis (EXEL) Beats on Q2 Earnings & Revenues, Ups Sales View
Exelixis, Inc. (EXEL - Free Report) reported earnings of 30 cents in the second quarter, which easily beat the Zacks Consensus Estimate of 5 cents. The bottom line also increased from the year-ago quarter’s earnings of 21 cents per share.
Net revenues came in at $385.2 million, which increased from $259.5 million reported in the year-ago quarter and comfortably surpassed the Zacks Consensus Estimate of $296 million.
Exelixis, Inc. Price, Consensus and EPS Surprise
Exelixis, Inc. price-consensus-eps-surprise-chart | Exelixis, Inc. Quote
Quarter in Detail
Net product revenues came in at $284.2 million, up from $178.7 million reported in the year-ago quarter. The upside was primarily driven by an increase in sales volume that was primarily driven by the strong uptake for the combination therapy of Cabometyx (cabozantinib) and Bristol-Myers’ (BMY - Free Report) Opdivo (nivolumab) following FDA approval in January.
Cabometyx generated $275.6 million of revenues. Cabometyx (cabozantinib tablets) 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 $8.6 million in net product revenues. Exelixis earned $24.9 million in royalty revenues.
Collaboration revenues, comprising license revenues and collaboration services revenues, were $61.3 million in the quarter compared with $21.5 million in the year-ago quarter.
In the reported quarter, research and development expenses increased to $148.8 million from the year-ago quarter’s $114.9 million due to a rise in clinical trial costs. Selling, general and administrative (SG&A) expenses were $98.5 million, up from $59.8 million.
Pipeline Update
In January 2021, Exelixis obtained the FDA’s approval for its supplemental new drug application (sNDA) for Cabometyx in combination with Opdivo as a first-line treatment of patients with advanced RCC. Subsequently, in March 2021, Exelixis’ partner Ipsen received approval from the European Commission for this combination as a first-line treatment for advanced RCC.
In June, Exelixis and Ipsen announced detailed results from the phase III COSMIC-311 study of cabozantinib in patients with previously treated RAI-refractory differentiated thyroid cancer (DTC). Results from the study met the primary endpoint of demonstrating significant improvement in progression-free survival (PFS) and served as the basis for the sNDA submitted to the FDA in June.
In August, Exelixis announced that the FDA accepted the company’s sNDA for Cabometyx as a treatment for patients 12 years and older with DTC who have progressed following prior therapy and are RAI-refractory (if RAI is appropriate). The FDA granted Priority Review designation and assigned a target action date of Dec 4, 2021.
In April, Exelixis announced that the FDA accepted its IND to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors, and in June, a phase I trial was initiated.
In June, Exelixis and Ipsen announced that COSMIC-312, the ongoing phase III study evaluating cabozantinib in combination with Roche’s (RHHBY - Free Report) Tecentriq versus sorafenib in patients with previously untreated advanced HCC, met one of the primary endpoints, demonstrating significant improvement in PFS at the planned primary analysis.
2021 Guidance Updated
Revenues are now projected at $1,300-$1,400 million (previous projection: $1,150-$1,250 million) while product revenues are estimated in the range of $1,050-$1,150 million (previous projection: $950-$1,050 million).
Our Take
Exelixis’ second-quarter results were encouraging with beat on both counts. The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC has boosted sales.
Exelixis’ shares have gained 20.6% in the past year compared with the industry’s growth of 14.2%.
Image Source: Zacks Investment Research
The pipeline progress has been impressive too.
Exelixis currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Repligen Corporation (RGEN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings estimates for Repligen have moved up 43 cents for 2021 in the past 60 days. The stock is up 32.9% year to date.