Exelixis (EXEL), Bristol-Myers (BMY) : upbeat trial results of a Kidney cancer treatment

the companies said a phase 3 study of a treatment for kidney cancer met its primary and secondary endpoints. "The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients," said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute.

Bristol-Myers announces announced that CheckMate -743, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) in combination with Yervoy in previously untreated malignant pleural mesothelioma met its primary endpoint of overall survival

Opdivo plus Yervoy prolonged survival compared to chemotherapy at interim analysis in CheckMate -743.
Malignant pleural mesothelioma is a rare and aggressive cancer with limited treatment options.
Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in OS compared to chemotherapy (pemetrexed and cisplatin or carboplatin).

=Exelixis (EXEL) reported earnings on Thur 1 Nov 2018 (a/h)

• Nov. 1: #1; vol. 5M

ALAMEDA, Calif. (AP) _ Exelixis Inc. (EXEL) on Thursday reported third-quarter earnings of $126.6 million.

On a per-share basis, the Alameda, California-based company said it had profit of 41 cents.

The results exceeded Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for earnings of 19 cents per share.

The drug developer posted revenue of $225.4 million in the period, also exceeding Street forecasts. Five analysts surveyed by Zacks expected $166.4 million.

Exelixis shares have fallen 51 percent since the beginning of the year. In the final minutes of trading on Thursday, shares hit $14.95, a decline of 38 percent in the last 12 months.

=Exelixis (EXEL) reported earnings on Wed 2 May 2018 (a/h)

Exelixis beats by $0.21, beats on revs; co also announces collaboration with Invenra 

• Reports Q1 (Mar) earnings of $0.37 per share, $0.21 better than the Capital IQ Consensus of $0.16; revenues rose 162.5% year/year to $212.35 mln vs the $142.75 mln Capital IQ Consensus.
  • Total revenues also include collaboration revenues of $78.1 million for the quarter ended March 31, 2018 compared to $12.0 million for the comparable period in 2017.
  • The company is maintaining its guidance that total costs and operating expenses for the full year will be between $430 million and $460 million. This guidance includes approximately $50 million of non-cash costs and expenses related primarily to stock-based compensation expense.
• Exelixis will receive an exclusive, worldwide license to one preclinical asset, and Exelixis and Invenra intend to pursue up to six additional discovery projects during the term of the collaboration, which in total are directed to three discovery programs. In consideration for the exclusive worldwide license and other rights contained in the collaboration agreement, Exelixis will pay Invenra an upfront payment of $2.0 million plus $2.0 million at initiation of each discovery project. Invenra is eligible to receive payments of up to $131.5 million based on the achievement of specific pre-clinical, clinical development and regulatory milestones for any product containing a lead preclinical asset in the first indication. Upon successful commercialization of a product, Invenra is eligible to receive global milestone payments up to $325 million, if certain sales thresholds are achieved as well as single digit tiered royalties on net sales of the approved product.

=Exelixis (EXEL) reported earnings on Wed 1 Nov 2017 (a/h)

Exelixis beats by $0.18, beats on revs 

• Reports Q3 (Sep) earnings of $0.26 per share, $0.18 better than the Capital IQ Consensus of $0.08; revenues rose 145.2% year/year to $152.5 mln vs the $104.91 mln Capital IQ Consensus.
• 2017 Guidance
  • The company is updating its guidance that total costs and operating expenses for the full year will be between $285 million and $295 million. This guidance includes approximately $25 million of non-cash costs and expenses related primarily to stock-based compensation expense.
• "In addition to strong financial performance, the third quarter of 2017 was marked by significant clinical and regulatory milestones that continue to drive us forward in our mission to help cancer patients recover stronger and live longer," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "In August, we completed the filing for CABOMETYX in previously untreated advanced RCC, which has been accepted by the FDA and granted Priority Review. With an upcoming FDA action date of February 15, 2018, our commercial team is fully prepared for a potential launch of CABOMETYX in this expanded indication to bring this much needed option to even more patients with advanced RCC as quickly as possible. In addition, based on the positive results from the CELESTIAL pivotal trial, demonstrating that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival for patients with advanced hepatocellular carcinoma, we are moving rapidly to complete our U.S. regulatory filing in the first quarter of next year." 

=Exelixis (EXEL) reported earnings Wed 3 Aug 2016 (a/h)

The genomics-based drug discovery company posted a loss of $0.16 per share, above the forecasts of a $0.27 per share loss, while revenue of $36.3 million more than doubled the consensus estimate of $17.96 million. Exelixis expects operating expenses in the range of $250 million-to-$270 million for the full year.

Exelixis CEO Michael M. Morrissey said in a statement that his team worked “tirelessly” to bring forward its kidney cancer treatment Cabometyx, and that the company is encouraged by the initial response and developments. A Phase II trial of the drug recently achieved its primary endpoint, as significant improvement was seen in progression-free survival rates in patients with previously untreated advanced renal cell carcinoma.
Kenneth Tropin’s Graham Capital Management owns approximately 13.21 million shares of Exelixis as of the end of the first quarter.