Shares of Exelixis, Inc. (NASDAQ:EXEL) ended Wednesday session in green amid volatile trading. The shares closed up +0.70 points or 5.69% at $13.01 with 7.46 million shares getting traded. Post opening the session at $12.63, the shares hit an intraday low of $12.62 and an intraday high of $13.19 and the price vacillated in this range throughout the day. The company has a market cap of $2.97 billion and the numbers of outstanding shares have been calculated to be 230.33 million shares.
Exelixis, Inc. (EXEL) on September 14, 2016 announced that the European Commission (EC) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. CABOMETYX was granted accelerated assessment by the European Medicines Agency, and is the first therapy to demonstrate in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival (OS), progression-free survival (PFS) and objective response rate (ORR). This approval allows for the marketing of CABOMETYX in all 28 member states of the European Union, Norway and Iceland.
EC approval of CABOMETYX triggers a $60 million milestone payment to Exelixis under the licensing agreement with Ipsen for the commercialization and further development of CABOMETYX indications outside of the United States, Canada and Japan. The approval is based on the results of the large, randomized phase 3 METEOR trial.
“The marketing authorization of CABOMETYX by the European Commission to treat patients with advanced renal cell carcinoma reflects the strong efficacy results observed with cabozantinib in the phase 3 METEOR trial, and is an important milestone in our collaboration with Ipsen,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “This marketing authorization helps address an unmet medical need in Europe by providing patients with a new therapy that slows disease progression and prolongs overall survival. We look forward to further examining the use of CABOMETYX in earlier lines of therapy and in other difficult-to-treat cancers.”
Shares of Amedica Corporation (NASDAQ:AMDA) ended Wednesday session in red amid volatile trading. The shares closed down -0.01 points or -0.97% at $1.02 with 7.35 million shares getting traded. Post opening the session at $1.05, the shares hit an intraday low of $0.99 and an intraday high of $1.13 and the price vacillated in this range throughout the day. The company has a market cap of $26.64 million and the numbers of outstanding shares have been calculated to be 23.58 million shares.
Amedica Corporation (AMDA) on Aug 11, 2016 announced financial results for the second quarter ended June 30, 2016.
Second Quarter 2016 Financial Results
Total product revenue was $4.0 million in the second quarter of 2016 as compared to $4.8 million in the same period of 2015, a decrease of $0.8 million, or 16%. This decrease was due to lower private label sales during the quarter and weaker than expected commercial sales in a key geographic region during the implementation of the Company’s commercial sales expansion strategy. We expect that our commercial sales expansion strategy will be substantially completed during the third quarter with benefits expected to be realized during the fourth quarter of 2016 and into 2017. The decrease in revenue for the second quarter 2016 was also attributable, in part, to continued market pricing pressure and hospital vendor consolidation.
Cost of revenue decreased $0.3 million, or 25%, as compared to the same period in 2015. The decrease in cost of revenue was primarily due to the decline in product sales. Excluding the impact of excess or obsolete inventory for both periods, second quarter 2016 gross margins ended at 83% of total sales, as compared to 78% during the prior year period. The increase in gross margins as a percentage of sales is primarily attributable to lower private label sales, which have lower gross margins, and to a lesser extent, the impact of the medical device excise tax moratorium.
Operating expenses decreased $0.5 million, or 8%, as compared to the same period in 2015. This decline in operating expenses is primarily due to a decrease of $0.3 million in commissions as a result of decreased sales and a $0.2 million decrease in personnel related expenses.