Exelixis, Inc. ( EXEL Quick Quote EXEL - Free Report) delivered mixed results for fourth-quarter 2019, wherein earnings beat expectations, while revenues fell short of the same marginally.
Shares of Exelixis slid 3.7% in after-market trading. The company’s shares have lost 13.5% in the past year compared with the
industry’s decline of 5.8%.
Exelixis reported earnings of 22 cents, handily beating the Zacks Consensus Estimate of 15 cents. The bottom-line figure, however, declined from the year-ago quarter’s $1.15.
Net revenues came in at $240.3 million, increasing from the $228.6 million reported in the year-ago quarter. However, the revenue figure marginally missed the Zacks Consensus Estimate of $240.7 million.
Quarter in Detail
Net product revenues came in at $194.9 million, up 10.6% from the year-ago quarter, on continued growth of Cabometyx in the United States for the treatment of advanced renal cell carcinoma (RCC).
Cabometyx received another FDA approval for the treatment of patients with hepatocellular carcinoma, who have been previously treated with sorafenib, in January 2019. The label expansion of the drug for this indication in the United States also boosted sales.
Cabometyx generated $181.1 million of revenues. Patient demand grew 11% year over year and up 3% sequentially. Prescriber base grew 35% year over year and 6% sequentially.
Cometriq (cabozantinib capsules), for the treatment of medullary thyroid cancer, generated $13.8 million in net product revenues.
Exelixis also earned $17 million in royalty revenues based upon Ipsen’s cabozantinib-related revenues in the final quarter of 2019.
Total collaboration revenues were $45.4 million, down from the $52.4 million recorded in the year-ago quarter.
In the reported quarter, research and development expenses flared up significantly to $94.4 million from the $57.3 million due to rise in clinical trial costs, license and other collaboration costs, and personnel expenses. Selling, general and administrative (SG&A) expenses were $58 million, up 10.3% year over year, resulting from rise in personnel expenses and stock-based compensation.
In December 2019, Exelixis announced a collaboration agreement with Roche (
RHHBY Quick Quote RHHBY - Free Report) to evaluate cabozantinib in combination with Tecentriq, Roche’s PD-L1 immune checkpoint inhibitor, in patients with locally advanced or metastatic solid tumors. The clinical program, which will be co-funded by the companies, is expected to include three phase III pivotal trials in advanced non-small cell lung cancer, metastatic castration-resistant prostate cancer (mCRPC) and RCC.
Exelixis also announced positive results from IMspire150, the phase III study of Tecentriq, Cotellic and Zelboraf in patients with previously untreated BRAF V600 mutation-positive advanced melanoma. Genentech, a member of the Roche Group, Exelixis’ collaborator and the sponsor of the IMspire150 trial, informed Exelixis that the study met its primary endpoint of progression-free survival.
Based on continued encouraging efficacy and safety data, Exelixis plans to further expand the mCRPC cohort of COSMIC-021, the phase Ib trial of cabozantinib in combination with Tecentriq in patients with locally advanced or metastatic solid tumors. The cohort, which was previously expanded from 30 to 80 patients last July, will now include up to 130 patients.
Revenues for 2019 came in at $967.8 million, up from the prior year’s $853.8 million. Earnings per share came in at $1.16 compared with $1.55 per share reported in 2018.
Revenues are projected at $850-$900 million, while product revenues are estimated in the range of $725 million to $775 million. The Zacks Consensus Estimate of total revenues of $881.19 million lies within the projected range.
Exelixis’ earnings beat estimates in the fourth quarter, while sales fell short of the same by a whisker. Heightening competition from the recently-approved combination therapies impacted sales in the first-line RCC indication. Last year, the FDA approved Merck’s (
MRK Quick Quote MRK - Free Report) Keytruda in combination with Pfizer’s ( PFE Quick Quote PFE - Free Report) Inlyta for the first-line treatment of patients with advanced RCC. Competition has further intensified with the FDA approval of a combination regimen of Bavencio (avelumab) and Inlyta for the same. Given the increasing use of these therapies, we expect investors to focus on the label expansions of cabozantinib in the ongoing combination trials. Zacks Rank
Exelixis currently carries a Zacks Rank #3 (Hold). You can see
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