Zogenix Announces Preliminary Fourth Quarter 2012 Gross Product Sales
SAN DIEGO, Jan. 7, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a
pharmaceutical company commercializing and developing products for the
treatment of central nervous system disorders and pain, announced today
preliminary unaudited gross product sales for the quarter ended December 31,
2012. Zogenix expects to report fourth quarter 2012 gross product sales of
approximately $13.5 million on 145,200 units shipped, with unit volume up
approximately 9% sequentially from third quarter 2012 and 26% from fourth
For the full year 2012, Zogenix announced preliminary unaudited net product
revenue of approximately $36 million, up approximately 18% over 2011 and
slightly below previously issued guidance of $37 million for 2012.
Preliminary unaudited cash and cash equivalents as of December 31, 2012 were
approximately $41.2 million.
Roger Hawley, chief executive officer of Zogenix, stated, "In 2012 we
continued to drive SUMAVEL DosePro prescription growth and added a new
co-promotion partner that provides incremental growth potential in 2013 and
beyond. We expect our net product revenue for the year to be slightly below
our guidance primarily due to the impact from Hurricane Sandy in the Northeast
region. However, we did achieve 9% unit volume growth in the fourth quarter
and believe we are well positioned to continue expanding utilization of
SUMAVEL DosePro as an important attack specific treatment choice for migraine
Mr. Hawley added, "During the year we also made good progress with our new
product initiatives. The December 7^th FDA Advisory Committee meeting resulted
in a negative vote for Zohydro ER, but we remain engaged with the FDA in our
ongoing efforts to gain approval. We remain confident in the benefit/risk
balance of Zohydro ER as a new treatment option that addresses unmet medical
needs for patients suffering with chronic pain. Separately, we recently
announced positive single-dose pharmacokinetic (PK) results from our Phase 1
clinical trial for Relday and the extension of the study to include a 100 mg
dose arm, which results we believe will accelerate the development timeline
and partnering activities for this new potential treatment option for the
long-acting antipsychotic market."
The preliminary estimates discussed above are subject to the completion of
financial closing procedures, including final adjustment of allowances for
sales returns and discounts, 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 2012 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,
2012.Zogenix expects to report full financial results for the fourth quarter
and full year ended December 31, 2012 in early March 2013.
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville,
California, is a pharmaceutical company commercializing and developing
products for the treatment of central nervous system disorders and pain.
Zogenix's first commercial product, SUMAVEL^® DosePro^® (sumatriptan
injection) Needle-free Delivery System, was launched in January 2010 for the
acute treatment of migraine and cluster headache. Zogenix's lead
investigational product candidate, Zohydro™ ER (hydrocodone bitartrate), is an
oral, extended-release formulation of various strengths of hydrocodone,
without acetaminophen, intended for administration every 12 hoursfor around
the clock management of moderate to severe chronic pain. In May 2012, Zogenix
submitted to the FDA a New Drug Application for Zohydro ER and was assigned a
PDUFA target action date of March 1, 2013 by the FDA. Zogenix's second
investigational product candidate, Relday™, is a proprietary, long-acting
injectable formulation of risperidone for the treatment of schizophrenia; an
investigational new drug application was submitted to the FDA in May 2012.
For additional information, please visit www.zogenix.com.
SUMAVEL ®, DosePro ®, Relday™ and Zohydro™ ER are trademarks of Zogenix, Inc.
Forward Looking Statements
Zogenix cautions you that statements included in this press release are not a
description of historical facts are forward-looking statements. Words such as
"believes," "anticipates," "plans," "expects," "indicates," "will," "intends,"
"potential," "suggests," "assuming," "designed" 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: preliminary financial estimates for
the fourth quarter 2012 and full year 2012, as well as Zogenix's cash position
as of December 31, 2012; continued expansion of the utilization of SUMAVEL
DosePro; acceleration of the development timeline and partnering activities
for Relday; and the timing of reporting of full financial results for 2012.
The inclusion of forward-looking statements should not be regarded as a
representation by Zogenix that any of its plans will be achieved. Actual
results may differ from those set forth in this press 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; the market potential for migraine treatments, and Zogenix's
ability to compete within that market; Zogenix's ability to successfully
execute its sales and marketing strategy for the commercialization of SUMAVEL
DosePro;Zogenix's reliance on Mallinckrodt to co-promote SUMAVEL
DosePro;inadequate therapeutic efficacy or unexpected adverse side effects
relating to SUMAVEL DosePro that could prevent its ongoing commercialization,
or that could result in recalls or product liability claims; the potential for
Zohydro ER to receive regulatory approval on a timely basis or at all; the
potential for adverse safety findings relating to Zohydro ER or negative
publicity concerning opioids in general to delay or prevent regulatory
approval or commercialization; the potential for delays associated with any
additional data required by the FDA to be submitted by Zogenix in support of
the NDA; the ability of Zogenix and its licensors to obtain, maintain and
successfully enforce adequate patent and other intellectual property
protection of its products and product candidates and the ability to operate
its business without infringing the intellectual property rights of others;
difficulties in identifying, negotiating and carrying out strategic
transactions relating to Zohydro ERand Relday; the inherent risks of clinical
development of Relday and Zogenix's dependence on its collaboration with
DURECT Corporation to develop Relday; and other risks described in Zogenix's
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 press 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.
Zack Kubow | The Ruth Group
646.536.7020 | email@example.com
Caitlin Cox | The Ruth Group
646.536.7033 | firstname.lastname@example.org
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