SAN DIEGO, Jan. 12, 2015 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related conditions and central nervous system (CNS) disorders, announced today a business update including recent company highlights, the most recent Zohydro ER prescription trends and the Company's year-end 2014 cash position.
Acquired Brabant Pharma on October 24, 2014, obtaining global rights for an orphan drug in development for the treatment of Dravet syndrome, a rare and catastrophic form of epilepsy that begins in infancy.
Total prescriptions for Zohydro ER in the fourth quarter 2014 were approximately 19,000, a 26% increase compared to the third quarter 20141.
Secured a $20 million term loan and a $4 million revolving line of credit in December 2014.
Preliminary unaudited cash and cash equivalents as of December 31, 2014 were approximately $42.2 million. This includes $21.5 million in cash from the term loan and revolving line of credit secured in December 2014. An additional $8.5 million is being held in escrow from the proceeds of the sale of Sumavel DosePro to Endo Pharmaceuticals in May 2014.
Roger Hawley, chief executive officer of Zogenix, stated, "During the fourth quarter we continued to drive adoption of Zohydro ER, with positive feedback on product efficacy from physicians and patients. Entering 2015, we believe we are in a good position to further expand adoption of Zohydro ER with the potential U.S. Food and Drug Administration's approval and launch of a formulation with abuse deterrent properties and the potential addition of a co-promotion partner."
Mr. Hawley added, "We have several important clinical activities related to our new product pipeline planned for 2015. The multi-dose clinical trial for Relday will commence in January, with results expected to be available during the third quarter. In addition, we are preparing to begin enrollment in the Phase 3 clinical trial for ZX008 in the third quarter, a major milestone for our orphan drug product candidate for the treatment of Dravet syndrome that we acquired from Brabant Pharma in October 2014."
The preliminary unaudited cash position discussed above is subject to the completion of financial closing procedures and other developments that may arise between now and the time the financial results for the fourth quarter are finalized, as well as the completion of the audit of the 2014 financial statements. Therefore, actual results may differ materially from these estimates. In addition, the above estimates do not present all information necessary for an understanding of Zogenix's financial condition as of December 31, 2014. Zogenix expects to report full financial results for the fourth quarter and full year ended December 31, 2014 in early March 2015.
Zogenix, Inc. (Nasdaq:ZGNX) is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and CNS disorders who need innovative treatment alternatives to help them return to normal daily functioning.
Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "plans," "expects," "will," "potential" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding Zogenix's cash position as of December 31, 2014, the expected timing of the FDA approval and the commercial launch of a Zohydro ER formulation with abuse deterrent properties, continued adoption of Zohydro ER and the potential to add a co-promotion partner, and the timing of the commencement of clinical trials for Relday and ZX008. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: risks related to changes in estimated financial amounts based on the completion of financial closing procedures and the audit of the financial statements; Zogenix's dependence on the successful commercialization of Zohydro ER; Zogenix's ability to achieve broad market acceptance and generate revenues from sales of Zohydro ER; difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for an abuse deterrent formulation of Zohydro ER or any of Zogenix's other product candidates; Zogenix's dependence on third parties to develop an additional formulation of Zohydro ER, Relday and ZX008; public concern regarding the safety of drug products such as Zohydro ER and the impact of negative publicity and political influences relating to the regulation of the pain management market in general and opioids and Zohydro ER in particular; difficulties in identifying, negotiating and carrying out a co-promotions agreement for Zohydro ER; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Zohydro® ER is a registered trademark of Zogenix, Inc.
1 Symphony Health Solutions, Source® PHAST Prescription Weekly, February 2014 – December 2014
Zack Kubow, The Ruth Group