Short answer
Exelixis Inc (EXEL) filed its Q2 2018 10-Q quarterly report on Aug 1, 2018 for the quarter ended Jun 29, 2018.
Exelixis Inc Q2 2018 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Q2 revenue $186.1M vs $99.0M YoY, up $87.1M
- Net income $87.5M vs $17.7M YoY, with no operating margin figures disclosed
- Best product CABOMETYX revenue $141.1M vs $80.9M; worst COMETRIQ $4.7M vs $7.1M
- Cash and investments $595.9M at June 30 vs $457.2M at December 31; six-month operating cash flow $146.6M vs $74.4M
- Outlook: higher 2018 R&D expenses, competition and reimbursement pressure, FDA HCC decision date January 14, 2019
Risk Factors
- New compliance risk: GDPR replaced the EU Data Privacy Directive on May 25, 2018, increasing privacy-sanctions and cross-border data-transfer exposure
- Generic competition risk: FDA’s February 2018 cabozantinib bioequivalence guidance may signal an ANDA investigation threatening CABOMETYX and COMETRIQ pricing
- Regulatory pricing risk: Medicare Part D manufacturer discount increased from 50% to 70% effective January 1, 2019
- Operational risk: Headquarters relocation from South San Francisco to Alameda in the second quarter of 2018 may disrupt operations and increase employee turnover
- Financial risk: $595.9 million cash and investments at June 30, 2018, including $594.3 million available for operations, remains dependent on CABOMETYX and COMETRIQ revenues
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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