Corporate Update
- Initiated the first Phase 3 clinical trial of ZX008 in North America for the treatment of seizures in Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy.
- Received Fast Track designation from the FDA for ZX008 in Dravet syndrome.
- Presented updated data from the ongoing open-label clinical trial in Belgium demonstrating sustained effectiveness and cardiovascular-related safety, as well as high levels of sleep quality and quality of life, in the cohort of Dravet syndrome patients who began add-on treatment with ZX008 as early as 2010.
- Completed the three months ended March 31, 2016, with $132.2 million in cash and cash equivalents. Zogenix’s expected cash runway extends through 2017.
“Zogenix remains focused on advancing our ZX008 Phase 3 program for Dravet syndrome, with the North American clinical trial having recently been initiated and our multi-national study expected to begin very shortly,” said Stephen J. Farr, Ph.D., President and CEO. “The most recent sustained efficacy and safety data generated from the open-label Belgian study continued to support our confidence in the potential of this new treatment. In addition, we believe the relatively high levels of sleep quality and quality of life reported in the most recent updated results reflect the seizure control in these patients.”
First Quarter 2016 Financial Results Compared to First Quarter 2015 Financial Results
As a result of the sale of the Zohydro ER business, all Zohydro ER revenue and expenses have been excluded from continuing operations for all periods herein and reported as discontinued operations. All prior period information has been recast to conform to this presentation.
- Total revenue for the first quarter of 2016 was $9.2 million, consisting entirely of contract manufacturing revenue. This compared with total revenue of $4.6 million in the same quarter last year, which included$4.2 million of contract manufacturing revenue and $0.4 million of service and other product revenue. The increase in contract manufacturing revenue in the first quarter of 2016 was due primarily to an increase in expenses billed to Endo International Plc under the supply agreement between the two companies.
- First quarter 2016 research and development expenses totaled $8.0 million, up from $5.2 million in the first quarter a year ago, as the Company continued preparations for its two Phase 3 studies for ZX008 and initiated the North American study.
- First quarter 2016 selling, general and administrative expenses totaled $6.1 million, compared with $6.3 million in the first quarter a year ago.
- Net loss from continuing operations for the first quarter of 2016 was $10.2 million, essentially unchanged from the same quarter a year ago.
- Net loss from discontinued operations was $0.2 million for the first quarter of 2016, compared with a net loss of $12.7 million in the first quarter a year ago.
- Total net loss for the first quarter of 2016 was $10.4 million, or $0.42 per share, compared with a net loss of $22.9 million, or $1.19 per share, for the first quarter a year ago.
- Cash and cash equivalents at March 31, 2016 totaled $132.2 million, as compared to $155.3 million atDecember 31, 2015.
2016 Financial Guidance
Zogenix is reiterating its previously provided financial guidance for the full year 2016.
- Research and development expenses are expected to be $54-59 million, reflecting initiation and ramp-up of ZX008 clinical studies;
- Selling, general and administrative expenses are expected to be $25-27 million; and
- Contract manufacturing revenue from the supply of Sumavel DosePro to Endo is expected at a low single-digit markup over cost of contract manufacturing. (Original Source)
Shares of Zogenix closed today at $9.85, down $0.02 or -0.20%. ZGNX has a 1-year high of $21.65 and a 1-year low of $7.90. The stock’s 50-day moving average is $10.19 and its 200-day moving average is $11.39.
On the ratings front, Zogenix has been the subject of a number of recent research reports. In a report issued on May 5, Leerink Swann analyst Paul Matteis maintained a Buy rating on ZGNX. Separately, on April 21, Brean Murray Carret’s Difei Yang maintained a Buy rating on the stock and has a price target of $28.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Paul Matteis and Difei Yang have a total average return of -21.3% and -18.0% respectively. Matteis has a success rate of 19.5% and is ranked #3753 out of 3828 analysts, while Yang has a success rate of 22.5% and is ranked #3811.
Zogenix, Inc. is a pharmaceutical company, which is engaged in commercializing and developing products for the treatment of central nervous system disorders and pain with novel drug delivery platforms. The company’s product portfolio includes: Sumavel DosePro, Zohydro and Relday. Zogenix was founded by Stephen J. Farr, Cam L. Garner, Roger L. Hawley, Bret E. Megargel, Jonathan M. Rigby and John J. Turanin on May 11, 2006 and is headquartered in San Diego, CA.