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Exelixis (EXEL) Announces Preliminary Q4 and 2022 Results
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Exelixis (EXEL - Free Report) announced preliminary financial results for the fourth quarter and full year 2022 and provided financial guidance for 2023.
Total revenues for the fourth quarter were roughly $415 million and around $1.6 billion for 2022. The cost of goods sold was roughly 4.1%. Research and development expenses for the fourth quarter of 2022 were around $340 million and $895 million for 2022. Selling, general and administrative expenses were roughly $120 million for the fourth quarter and $460 million for 2022.
Revenues for 2023 are projected around $1.77 billion - $1.87 billion. Net product revenues are estimated around $1.57 billion - $1.675 billion. Research and development expenses are estimated around $1 billion - $1.05 billion. Selling, general and administrative expenses are projected around $475 million - $525 million. Effective tax rate is estimated around 20% -22%.
Exelixis is advancing more than 10 discovery programs through internal and collaborative efforts and expects to progress up to five new development candidates into preclinical development in 2023.
Exelixis plans to expand the phase III development program for zanzalintinib (XL092) with multiple new phase III trial initiations of zanzalintinib in combination with several immuno-oncology (IO) therapies in 2023. In 2022, Exelixis initiated STELLAR-303, which evaluates zanzalintinib in combination with Tecentriq versus Stivarga in patients with colorectal cancer (CRC) that is not microsatellite instability-high or mismatch repair-deficient, who have progressed after or are intolerant to the current standard of care, as well as STELLAR-304, which evaluates zanzalintinib in combination with Opdivo versus sunitinib in patients with advanced non-clear cell renal cell carcinoma.
The company also plans to accelerate the development of XB002, its next-generation tissue factor-targeting ADC, both as a monotherapy and in combination with immuno-oncology (IO) and other targeted therapies, across a wide range of tumor types. The dose-escalation stage of JEWEL-101, the first-in-human phase I study evaluating XB002 as a single agent and in combination with Opdivo, is ongoing.
Exelixis expects to initiate the cohort expansion stage of the study after the recommended dose and/or the maximum-tolerated dose for XB002 have been determined, as well as advance additional combination cohorts in the study to identify sensitive tumor types.
The first-in-human QUARTZ-101 phase I study evaluating XL102, its potent, selective, irreversible and orally bioavailable small molecule CDK7 inhibitor, into the cohort expansion and potential combination cohorts is also expected to be advanced in 2023. The phase 1 QUARTZ-101 study is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity and effect on biomarkers of XL102 administered alone and in multiple combination regimens in patients with advanced solid tumors.
Exelixis expects to evaluate the anti-tumor activity and efficacy of XL102 in additional patients in the single-agent dose-escalation cohorts, in the tumor-specific cohort expansion stage and in planned combination cohorts. XL102 will be evaluated in patients with certain types of ovarian, breast and prostate cancers in the cohort expansion stage of QUARTZ-101.
Exelixis has also forged strategic collaborations to advance its pipeline. Exelixis expects its partner Cybrexa to continue to advance its phase study program for CBX-12 throughout 2023, including dose-expansion cohorts. Under the terms of the agreement announced in November 2022, Exelixis has the option to acquire CBX-12 upon evaluation of a pre-specified clinical data package that includes certain phase I results.
In the first quarter of 2023, Exelixis expects its partner Sairopa to file an investigational new drug (IND) filing for ADU-1805, a potential best-in-class monoclonal antibody targeting SIRPα to block the SIRPα–CD47 checkpoint. Per the terms, Exelixis has the option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies upon review of data from prespecified phase 1 clinical studies of ADU-1805 to be completed by Sairopa during the option period.
Exelixis plans to advance XB010, the first custom ADC generated through the company’s biotherapeutics network of collaborations, in 2023.
Exelixis’ shares have lost 7% in the year so far compared with the industry’s decline of 16.3%.
Image Source: Zacks Investment Research
Lead drug Cabometyx is a tablet formulation of cabozantinib approved for treating patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
The approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo has fueled sales of the drug.
Bristol-Myers’ Opdivo is one of the leading revenue generators for the company and is approved for various oncology indications.
The pipeline progress has been encouraging and the company’s efforts to expand its portfolio will reduce dependence on its lead drug.
Zacks Rank and Stocks to Consider
Exelixis currently carries a Zacks Rank #5 (Strong Sell).
Loss per share estimates for Syndax Pharmaceuticals for 2022 and 2023 have narrowed by 11 cents and 20 cents, respectively, over the past 60 days. Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Immunocore have narrowed by 77 cents and 92 cents, respectively, in the past 60 days. Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
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Exelixis (EXEL) Announces Preliminary Q4 and 2022 Results
Exelixis (EXEL - Free Report) announced preliminary financial results for the fourth quarter and full year 2022 and provided financial guidance for 2023.
Total revenues for the fourth quarter were roughly $415 million and around $1.6 billion for 2022. The cost of goods sold was roughly 4.1%. Research and development expenses for the fourth quarter of 2022 were around $340 million and $895 million for 2022. Selling, general and administrative expenses were roughly $120 million for the fourth quarter and $460 million for 2022.
Revenues for 2023 are projected around $1.77 billion - $1.87 billion. Net product revenues are estimated around $1.57 billion - $1.675 billion. Research and development expenses are estimated around $1 billion - $1.05 billion. Selling, general and administrative expenses are projected around $475 million - $525 million. Effective tax rate is estimated around 20% -22%.
Exelixis, Inc. Price and Consensus
Exelixis, Inc. price-consensus-chart | Exelixis, Inc. Quote
Exelixis is advancing more than 10 discovery programs through internal and collaborative efforts and expects to progress up to five new development candidates into preclinical development in 2023.
Exelixis plans to expand the phase III development program for zanzalintinib (XL092) with multiple new phase III trial initiations of zanzalintinib in combination with several immuno-oncology (IO) therapies in 2023. In 2022, Exelixis initiated STELLAR-303, which evaluates zanzalintinib in combination with Tecentriq versus Stivarga in patients with colorectal cancer (CRC) that is not microsatellite instability-high or mismatch repair-deficient, who have progressed after or are intolerant to the current standard of care, as well as STELLAR-304, which evaluates zanzalintinib in combination with Opdivo versus sunitinib in patients with advanced non-clear cell renal cell carcinoma.
The company also plans to accelerate the development of XB002, its next-generation tissue factor-targeting ADC, both as a monotherapy and in combination with immuno-oncology (IO) and other targeted therapies, across a wide range of tumor types. The dose-escalation stage of JEWEL-101, the first-in-human phase I study evaluating XB002 as a single agent and in combination with Opdivo, is ongoing.
Exelixis expects to initiate the cohort expansion stage of the study after the recommended dose and/or the maximum-tolerated dose for XB002 have been determined, as well as advance additional combination cohorts in the study to identify sensitive tumor types.
The first-in-human QUARTZ-101 phase I study evaluating XL102, its potent, selective, irreversible and orally bioavailable small molecule CDK7 inhibitor, into the cohort expansion and potential combination cohorts is also expected to be advanced in 2023. The phase 1 QUARTZ-101 study is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity and effect on biomarkers of XL102 administered alone and in multiple combination regimens in patients with advanced solid tumors.
Exelixis expects to evaluate the anti-tumor activity and efficacy of XL102 in additional patients in the single-agent dose-escalation cohorts, in the tumor-specific cohort expansion stage and in planned combination cohorts. XL102 will be evaluated in patients with certain types of ovarian, breast and prostate cancers in the cohort expansion stage of QUARTZ-101.
Exelixis has also forged strategic collaborations to advance its pipeline. Exelixis expects its partner Cybrexa to continue to advance its phase study program for CBX-12 throughout 2023, including dose-expansion cohorts. Under the terms of the agreement announced in November 2022, Exelixis has the option to acquire CBX-12 upon evaluation of a pre-specified clinical data package that includes certain phase I results.
In the first quarter of 2023, Exelixis expects its partner Sairopa to file an investigational new drug (IND) filing for ADU-1805, a potential best-in-class monoclonal antibody targeting SIRPα to block the SIRPα–CD47 checkpoint. Per the terms, Exelixis has the option to obtain an exclusive, worldwide license to develop and commercialize ADU-1805 and other anti-SIRPα antibodies upon review of data from prespecified phase 1 clinical studies of ADU-1805 to be completed by Sairopa during the option period.
Exelixis plans to advance XB010, the first custom ADC generated through the company’s biotherapeutics network of collaborations, in 2023.
Exelixis’ shares have lost 7% in the year so far compared with the industry’s decline of 16.3%.
Image Source: Zacks Investment Research
Lead drug Cabometyx is a tablet formulation of cabozantinib approved for treating patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
The approval of Cabometyx for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ (BMY - Free Report) Opdivo has fueled sales of the drug.
Bristol-Myers’ Opdivo is one of the leading revenue generators for the company and is approved for various oncology indications.
The pipeline progress has been encouraging and the company’s efforts to expand its portfolio will reduce dependence on its lead drug.
Zacks Rank and Stocks to Consider
Exelixis currently carries a Zacks Rank #5 (Strong Sell).
A couple of top-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) and Immunocore Holdings plc (IMCR - Free Report) . Both carry a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Syndax Pharmaceuticals for 2022 and 2023 have narrowed by 11 cents and 20 cents, respectively, over the past 60 days. Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
Loss per share estimates for Immunocore have narrowed by 77 cents and 92 cents, respectively, in the past 60 days. Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.