Zogenix, Inc. Presents at 2014 Morgan Stanley Global Healthcare Conference, Sep-10-2014 10:20 AM
Sep 2 14
Zogenix, Inc. Presents at 2014 Morgan Stanley Global Healthcare Conference, Sep-10-2014 10:20 AM. Venue: The Grand Hyatt Hotel, New York, New York, United States. Speakers: Roger L. Hawley, Chief Executive Officer, Interim Chief Commercial Officer and Director.
Zogenix, Inc. Announces New Post-Hoc Analysis Data Showing the Indicated 12-Hour Dose of Zohydro ER
Sep 2 14
Zogenix, Inc. announced new post-hoc analysis data showing that the indicated 12-hour dose of Zohydro(R) ER, (hydrocodone bitartrate) Extended-Release Capsules, CII, provided durable pain relief over the entire dosing interval. This finding is important because a major concern for all extended-release pain medications is the potential for lack of consistent pain relief throughout the entire day, especially at the end of the dosing. The goal of extended-release opioids is to provide sustained delivery of medication and continuous pain relief over the entire dosing interval, reducing or eliminating the need to take rescue pain medication. Chronic pain patients experiencing interruptions in sleep frequently have higher degrees of pain and reduced functioning the following day. These data will be presented at PAINWeek, the national conference on pain for clinicians specializing in pain management taking place this week in Las Vegas. The multi-center, enriched enrollment, randomized withdrawal study evaluated the efficacy and safety of Zohydro ER in opioid-experienced subjects with moderate-to-severe chronic low back pain. This new analysis examined the durability of pain relief throughout the 12-hour dosing interval by examining patterns of rescue medication utilization in patients with chronic low back pain. The study began with an open-label, conversion/titration phase (<=6 weeks) in which 150 subjects with moderate-to-severe chronic low back pain were converted from their current opioid to Zohydro ER dosed every 12 hours. After the conversion/titration phase, subjects were randomized in a double-blind fashion to Zohydro ER or placebo for the 12-week treatment phase. Rescue medication was permitted up to twice daily. Key findings include: During more than 75% of dosing days, rescue medication was not needed after the evening dose of Zohydro ER suggesting that patient sleep was not interrupted due to the need to take rescue pain medicine, less than 10% of rescue doses were taken during the last 4 hours of nighttime dosing and less than 20% of rescue doses were taken during the last 4 hours of daytime dosing showing no pattern of end of dose interval failure, Zohydro ER provides an effective option for patients using immediate-release opioid medication chronically who are at risk for acetaminophen-induced liver injury.
Zogenix, Inc. Announces Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2014; Provides Earnings Guidance for the Year 2014; Announces Impairment of Long-Lived Assets for the Second Quarter Ended June 30, 2014
Aug 5 14
Zogenix, Inc. announced unaudited consolidated earnings results for the second quarter and six months ended June 30, 2014. For the quarter, the company reported total revenue of $9,161,000 against $8,942,000 a year ago. Income from operations was $54,948,000 against loss from operations of $12,479,000 a year ago. Net income before income taxes was $62,865,000 against net loss before income taxes of $13,332,000 a year ago. Net income was $62,865,000 or $0.45 basic and diluted per share against net loss of $13,332,000 or $0.13 basic and diluted per share a year ago. Net loss adjusted for certain non-cash or non-recurring items was $26,478,000 or $0.19 diluted per share against $13,240,000 or $0.13 diluted per share a year ago.
For the six months, the company reported total revenue of $16,836,000 against $15,924,000 a year ago. Income from operations was $27,689,000 against loss from operations of $27,657,000 a year ago. Net income before income taxes was $41,933,000 against net loss before income taxes of $34,389,000 a year ago. Net income was $41,933,000 or $0.16 diluted per share against net loss of $34,389,000 or $0.34 basic and diluted per share a year ago. Net loss adjusted for certain non-cash or non-recurring items was $55,665,000 or $0.39 diluted per share against $29,956,000 or $0.30 diluted per share a year ago.
The company provided earnings guidance for the year 2014. For the year, the company expects to continue on sell-through revenue recognition methodology for Zohydro ER at least through the remainder of 2014. Expecting and $240 average net selling price per prescription for Zohydro ER for the remainder of 2014. Expecting high single-digit effective markup rate over manufacturing cost, reflecting recognition of revenue deferred at closing of the Endo transaction Expecting product gross margin of approximately 80% for Zohydro ER, reflecting a manufacturing fee of 15% on Zohydro ER net product revenue, plus internal manufacturing overhead and other costs. The company expects to report no interest expense for the HealthCare Royalty Partners debt, which has been repaid.
For the second quarter, the company reported impairment of long-lived assets of $838,000.