We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Exelixis (EXEL) Q1 Earnings & Sales Top on Cabometyx Strength
Read MoreHide Full Article
Exelixis, Inc. (EXEL - Free Report) delivered a stellar first-quarter 2018, wherein both earnings and revenues beat estimates on strong performance of Cabometyx.
Following the announcement of the results, shares of Exelixis gained 5.97% in the after-market trading session. Exelixis’ shares have lost 6.5% over a year compared with the industry’s decline of 12.2%.
The company reported earnings of 37 cents, beating the Zacks Consensus Estimate of 16 cents, up from 5 cents earned in the year-ago quarter.
Net revenues came in at $212.3 million, up from $80.9 million in the year-ago quarter. The reported number surpassed the Zacks Consensus Estimate of $146.4 million and was up from $120.1 million reported in the previous quarter.
The FDA approved a tablet formulation of cabozantinib, (distinct from the capsule form) under the brand name Cabometyx in April 2016 for the treatment of advanced renal cell carcinoma (“RCC”) in patients who have received prior anti-angiogenic therapy.
Net product revenues came in at $134.3 million, up from $68.9 million in the year-ago quarter. The upside was driven by growth in the second and later-line advanced RCC business and the impact of additional sales following the FDA’s approval in December 2017 of the expanded indication for Cabometyx for the treatment of previously untreated advanced RCC.
Cabometyx generated $128.9 million net product revenues driven by growth in demand due to expanded indication. Demand was driven by increases in market share, refills for patient already on therapy and continued expansion of the prescriber base (20% sequential increase).
Cometriq (cabozantinib) capsules for the treatment of medullary thyroid cancer generated $5.3 million in net product revenues.
Total collaboration revenues were $78.1 million compared with $12 million earned in the year-ago quarter as the company recorded $45.8 million in revenues for a $50.0 million milestone payment due from Ipsen Pharma SAS (Ipsen) in the second quarter of 2018 for the potential approval of cabozantinib for the first-line treatment of advanced RCC by the European Commission.
In the reported quarter, research and development expenses increased 62.9% to $37.8 million stemming from higher personnel expenses, clinical trial costs and consulting and outside services. Selling, general and administrative expenses were $52.6 million, significantly up from $34.3 million driven by increases in corporate giving, personnel expenses and marketing activities resulting primarily from an increase in general and administrative headcount to support the company’s commercial and research and development organizations.
Pipeline Update
In March 2018, Exelixis submitted its sNDA to the FDA for Cabometyx as a treatment for patients with previously treated advanced hepatocellular carcinoma (“HCC”) based on positive results from the CELESTIAL trial. The FDA had previously granted orphan drug designation for the treatment of advanced HCC.
Exelixis’ European partner Ipsen received a positive opinion from the CHMP, the scientific committee of the EMA, for Cabometyx for the first-line treatment of adults with intermediate- or poor-risk advanced RCC. Ipsen also announced its application for variation to the Cabometyx marketing authorization had been validated by the EMA for the addition of a new indication for patients with previously treated advanced HCC. Exelixis is entitled to receive a $10.0 million milestone payment upon the acceptance of this filing payment as per the terms of the collaboration agreement with Ipsen.
Exelixis inked agreements with Bristol-Myers (BMY - Free Report) and Roche Holding (RHHBY - Free Report) to develop cabozantinib in combination with immunotherapy agents in 2017. In January 2018, Exelixis announced an amendment to the protocol for the phase Ib trial of cabozantinib in combination with Tecentriq in patients with locally advanced or metastatic solid tumors. The amendment added four new expansion cohorts to the trial, which now includes patients with non-small cell lung cancer and castration-resistant prostate cancer, in addition to previously included patients with RCC and urothelial carcinoma. The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.
Meanwhile, the IMspire150 (TRILOGY) trial, which evaluates the combination of Cotellic, Tecentriq, and Xelboraf in first-line BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma has completed enrolment while IMspire170, the trial evaluating the combination of Cotellic and Tecentriq versus Merck’s (MRK - Free Report) Keytruda in first-line BRAF wild-type metastatic or unresectable locally advanced melanoma, is currently enrolling.
2018 Guidance
Exelixis expects total costs and operating expenses for 2018 in the range of $430-$460 million.
Our Take
Exelixis’ first-quarter results were impressive wherein both earnings and sales beat estimates by a wide margin. Demand for Cabometyx grew by approximately 30% sequentially driven by increases in new patient starts and refills for patients already on therapy.
We expect sales to get a further boost in 2018 as the drug is now approved for first-line RCC which will increases the eligible patient population for Caobometyx in the United States by approximately 14,000 patients and grab market share from two key drugs — Sutent and Votrient in the first-line RCC market. However, competition has further stiffened up with the recent approval of Opdivo and Yervoy for the treatment of poor and intermediate risk first-line RCC.
We expect investors focus to remain on further label expansion of cabozantinib and Cotellic. A potential label expansion for advanced HCC will further boost the growth prospects of the company.
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Image: Bigstock
Exelixis (EXEL) Q1 Earnings & Sales Top on Cabometyx Strength
Exelixis, Inc. (EXEL - Free Report) delivered a stellar first-quarter 2018, wherein both earnings and revenues beat estimates on strong performance of Cabometyx.
Following the announcement of the results, shares of Exelixis gained 5.97% in the after-market trading session. Exelixis’ shares have lost 6.5% over a year compared with the industry’s decline of 12.2%.
The company reported earnings of 37 cents, beating the Zacks Consensus Estimate of 16 cents, up from 5 cents earned in the year-ago quarter.
Net revenues came in at $212.3 million, up from $80.9 million in the year-ago quarter. The reported number surpassed the Zacks Consensus Estimate of $146.4 million and was up from $120.1 million reported in the previous quarter.
Exelixis, Inc. Price and Consensus
Exelixis, Inc. Price and Consensus | Exelixis, Inc. Quote
Quarter in Detail
The FDA approved a tablet formulation of cabozantinib, (distinct from the capsule form) under the brand name Cabometyx in April 2016 for the treatment of advanced renal cell carcinoma (“RCC”) in patients who have received prior anti-angiogenic therapy.
Net product revenues came in at $134.3 million, up from $68.9 million in the year-ago quarter. The upside was driven by growth in the second and later-line advanced RCC business and the impact of additional sales following the FDA’s approval in December 2017 of the expanded indication for Cabometyx for the treatment of previously untreated advanced RCC.
Cabometyx generated $128.9 million net product revenues driven by growth in demand due to expanded indication. Demand was driven by increases in market share, refills for patient already on therapy and continued expansion of the prescriber base (20% sequential increase).
Cometriq (cabozantinib) capsules for the treatment of medullary thyroid cancer generated $5.3 million in net product revenues.
Total collaboration revenues were $78.1 million compared with $12 million earned in the year-ago quarter as the company recorded $45.8 million in revenues for a $50.0 million milestone payment due from Ipsen Pharma SAS (Ipsen) in the second quarter of 2018 for the potential approval of cabozantinib for the first-line treatment of advanced RCC by the European Commission.
In the reported quarter, research and development expenses increased 62.9% to $37.8 million stemming from higher personnel expenses, clinical trial costs and consulting and outside services. Selling, general and administrative expenses were $52.6 million, significantly up from $34.3 million driven by increases in corporate giving, personnel expenses and marketing activities resulting primarily from an increase in general and administrative headcount to support the company’s commercial and research and development organizations.
Pipeline Update
In March 2018, Exelixis submitted its sNDA to the FDA for Cabometyx as a treatment for patients with previously treated advanced hepatocellular carcinoma (“HCC”) based on positive results from the CELESTIAL trial. The FDA had previously granted orphan drug designation for the treatment of advanced HCC.
Exelixis’ European partner Ipsen received a positive opinion from the CHMP, the scientific committee of the EMA, for Cabometyx for the first-line treatment of adults with intermediate- or poor-risk advanced RCC. Ipsen also announced its application for variation to the Cabometyx marketing authorization had been validated by the EMA for the addition of a new indication for patients with previously treated advanced HCC. Exelixis is entitled to receive a $10.0 million milestone payment upon the acceptance of this filing payment as per the terms of the collaboration agreement with Ipsen.
Exelixis inked agreements with Bristol-Myers (BMY - Free Report) and Roche Holding (RHHBY - Free Report) to develop cabozantinib in combination with immunotherapy agents in 2017. In January 2018, Exelixis announced an amendment to the protocol for the phase Ib trial of cabozantinib in combination with Tecentriq in patients with locally advanced or metastatic solid tumors. The amendment added four new expansion cohorts to the trial, which now includes patients with non-small cell lung cancer and castration-resistant prostate cancer, in addition to previously included patients with RCC and urothelial carcinoma. The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.
Meanwhile, the IMspire150 (TRILOGY) trial, which evaluates the combination of Cotellic, Tecentriq, and Xelboraf in first-line BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma has completed enrolment while IMspire170, the trial evaluating the combination of Cotellic and Tecentriq versus Merck’s (MRK - Free Report) Keytruda in first-line BRAF wild-type metastatic or unresectable locally advanced melanoma, is currently enrolling.
2018 Guidance
Exelixis expects total costs and operating expenses for 2018 in the range of $430-$460 million.
Our Take
Exelixis’ first-quarter results were impressive wherein both earnings and sales beat estimates by a wide margin. Demand for Cabometyx grew by approximately 30% sequentially driven by increases in new patient starts and refills for patients already on therapy.
We expect sales to get a further boost in 2018 as the drug is now approved for first-line RCC which will increases the eligible patient population for Caobometyx in the United States by approximately 14,000 patients and grab market share from two key drugs — Sutent and Votrient in the first-line RCC market. However, competition has further stiffened up with the recent approval of Opdivo and Yervoy for the treatment of poor and intermediate risk first-line RCC.
We expect investors focus to remain on further label expansion of cabozantinib and Cotellic. A potential label expansion for advanced HCC will further boost the growth prospects of the company.
Zacks Rank
Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
5 Medical Stocks to Buy Now
Zacks names 5 companies poised to ride a medical breakthrough that is targeting cures for leukemia, AIDS, muscular dystrophy, hemophilia, and other conditions.
New products in this field are already generating substantial revenue and even more wondrous treatments are in the pipeline. Early investors could realize exceptional profits.
Click here to see the 5 stocks >>