SOUTH SAN FRANCISCO, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Anesiva,
Inc. (Nasdaq: ANSV) today reported financial results and accomplishments for
the second quarter and six months ended June 30, 2008.
"The 2008 second quarter marked a significant advance for Anesiva as we
introduced Zingo(TM) in the U.S. pediatric hospital market," said Michael L.
Kranda, president and chief executive officer. "In addition, I'm pleased to
report that our Phase 3 trials of Adlea(TM) for the management of acute pain
following total knee replacement surgeries and bunionectomy surgeries are
nearing full patient enrollment. As a result, we anticipate releasing top-line
data from both trials in the fourth quarter of this year."
"While we continue to make progress in our current commercial and clinical
initiatives, I am conducting a full strategic review of the company's
programs, timelines and resource allocations," Mr. Kranda said. "Based on the
results of this evaluation, in early September I intend to present a
comprehensive forward-looking plan for Anesiva's growth as a company focused
on the late-stage development and commercialization of novel products that
address unmet needs in the treatment of pain." Mr. Kranda was appointed
Anesiva's president, chief executive officer and member of the board of
directors in June 2008.
Second Quarter 2008 Financial Results
Total operating expenses in the second quarter of 2008 were $22.1 million,
including $1.6 million in non-cash stock-based compensation, compared to total
operating expenses of $14.7 million, including $2.4 million in non-cash stock-
based compensation, in the second quarter of 2007. For the six months ended
June 30, 2008, total operating expenses were $43.9 million compared to
$27.4 million for the six months ended June 30, 2007, and include $3.2 million
and $4.5 million in non-cash stock-based compensation in the 2008 and 2007
periods, respectively.
Operating expenses during the quarter primarily related to the continued
development and commercial preparations to launch, Zingo, a fast-acting,
needle-free, local anesthetic, for the pediatric indication. Additional
operating expenses related to the ongoing development of Adlea, which is being
evaluated in Phase 3 trials for the treatment of acute pain following total
knee replacement surgeries and bunionectomy surgeries.
For the second quarter of 2008, the net loss was $21.9 million, or $0.54
per share. In the second quarter of 2007, the net loss was $13.8 million, or
$0.51 per share. The net loss for the six months ended June 30, 2008 was $43.4
million, or $1.08 per share, and for the six months ended June 30, 2007, the
net loss was $25.5 million or $0.93 per share.
As of June 30, 2008, cash, cash equivalents and investments were
$48.7 million compared to $90.8 million at December 31, 2007. The company
believes it has sufficient resources to fund anticipated expenses for the
remainder of 2008 and into 2009.
Commercial and Product Development Updates:
Zingo
-- Following the Zingo U.S. commercial launch in late June, Anesiva began
supplying hospitals in its target pediatric market. The early phase of
the Zingo launch is focused on supporting initial product experiences
and formulary review and acceptance processes in these institutions.
Commenting on the initial Zingo launch, Nancy E. Donahue, senior vice
president, sales and marketing, said, "While it is too early to provide
meaningful sales metrics as we are just six weeks into the launch, initial
qualitative feedback from healthcare providers who have used Zingo suggests
that they are very pleased with its performance and ease of use. We continue
to conduct training sessions for selected healthcare providers to advocate for
better venous access pain management for their pediatric patients, to grow
membership in RNVoice, and to experience increased visits to
http://www.manageivpain.com."
-- The FDA accepted Anesiva's electronic sNDA filing to expand the Zingo
label indication to include adults. Under the Prescription Drug User
Fee Act (PDUFA), the agency is expected to make a decision regarding
approval by January 2009.
-- The journal Pediatrics published full results of one of the two pivotal
Phase 3 pediatric trials of Zingo.
-- Anesiva signed an exclusive Zingo licensing and distribution agreement
with Green Vision Company for territories in the Middle East, and
expanded the territories covered under the license and distribution
agreement with Sigma Tau SpA to include most of Europe.
Adlea
-- During the second quarter, Phase 3 enrollment began in a trial of Adlea
for the management of acute pain following total knee replacement
surgery. This multicenter, double-blind, placebo-controlled study will
evaluate the efficacy and safety of a single dose of Adlea or placebo
administered prior to closure of the surgical wound. Total planned
enrollment is 214 patients. Enrollment continued in a 300 patient Phase
3 trial of Adlea in patients undergoing bunionectomy surgery.
-- Anesiva initiated a Phase 2 trial with Adlea for the management of
acute pain following arthroscopic shoulder surgery. Total planned
enrollment in this multicenter, double-blind, dose-escalation, placebo-
controlled trial is 74 patients.
-- Several Adlea posters will be presented at the upcoming World Congress
on Pain, a major international meeting to be held August 17-22, 2008.
Studies to be presented will include:
* A Phase 2, 185-patient randomized, placebo-controlled, dose-
escalation study in bunionectomy surgeries, which demonstrated
statistically significant reductions in average and worst pain scores
in the 1 mg Adlea dose group compared to placebo. In addition,
patients in the 1 mg Adlea group had a statistically significantly
longer median time to first use of an opioid or another acute pain
treatment compared to placebo. This Phase 2 trial is the basis for
the ongoing Phase 3 Adlea trial in bunionectomy surgeries, which
compares the same 1 mg Adlea dose to placebo control; the primary
endpoint in both trials is reduction in pain up to 32 hours post-
surgery for Adlea versus placebo.
* An exploratory clinical study in painful osteoarthritis of the knee
in which Adlea was generally well-tolerated, particularly when
stepwise dosing was used to reduce pain on injection in this non-
surgical setting. The study also generated longer-term data
suggesting reduced pain scores compared to baseline for up to the
eight week study endpoint.
* An independent presentation on long-term follow up from a study in
herniotomy surgeries which showed that, two years post-surgery, Adlea
treatment did not differ from placebo with regard to long-term
effects on sensory function in the surgical area.
* Preclinical studies suggesting that a single, clinically relevant
dose of Adlea does not have observable adverse effects on wound and
bone healing. A separate preclinical study demonstrated that a single
dose of Adlea caused a prolonged decrease in specific neuronal
markers and the TRPV1 receptor, suggestive of desensitization of the
nerve fibers, which gradually reversed several weeks following
treatment.
Additional Development
-- Anesiva out-licensed worldwide rights to its NF-kappa B Decoy program
to Transcription Factor Therapeutics, Inc. Anesiva will receive an
upfront licensing fee, and will be entitled to receive milestone
payments totaling up to $114 million if two products are
commercialized. NF-kappa B is a protein implicated in autoimmune and
inflammatory disease processes, therapeutic areas outside Anesiva's
current focus on pain management.
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be
the leader in the development and commercialization of novel pharmaceutical
products for pain management. The company's first commercial product,
Zingo(TM), is available in the U.S. for the reduction of pain associated with
peripheral venous access procedures in children ages three to 18. For full
Zingo prescribing information and other information, visit
http://www.zingo.com. An sNDA is under review at FDA to expand the Zingo label
indication to include adults.
The next product in Anesiva's pipeline, Adlea(TM), is currently being
evaluated in Phase 3 clinical trials for the management of acute pain
following orthopedic surgeries. Adlea has been shown to reduce pain after only
a single administration for up to weeks to months in multiple settings based
on the results of several mid-stage clinical trials for site-specific, acute
and chronic, moderate-to-severe pain.
Anesiva is based in South San Francisco, CA. For more information about
Anesiva's leadership in the development of products for pain management, and
an overview of the clinical challenges being addressed by its product
candidates, go to http://www.anesiva.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within the
meaning of the safe harbor provisions of the United States Private Securities
Litigation Reform Act of 1995. Words such as "expect," "estimate," "project,"
"budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could,"
"should," "believes," "predicts," "potential," "continue," and similar
expressions are intended to identify such forward-looking statements. Forward-
looking statements in this press release include matters that involve known
and unknown risks, uncertainties and other factors that may cause actual
results, levels of activity, performance or achievements to differ materially
from results expressed or implied by this press release. Such risk factors
include, among others: whether Zingo gains FDA approval in the adult
indication, the degree to which Zingo gains market acceptance, and whether the
Adlea clinical trials will be successful. Actual results may differ materially
from those contained in the forward-looking statements in this press release.
Additional information concerning these and other risk factors is contained in
Anesiva's annual report on Form 10-K for the year ended December 31, 2007, and
its most recent filing on Form 10-Q.
Anesiva, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
For the three months For the six months
ended June 30, ended June 30,
2008 2007 2008 2007
Contract revenues $302 $- $303 $-
Operating expenses:
Manufacturing start-up costs 1,125 - 1,125 -
Research and development 13,063 8,412 26,447 15,374
Sales, general and
administrative 7,914 6,246 16,371 12,000
Total operating expenses 22,102 14,658 43,943 27,374
Loss from operations (21,800) (14,658) (43,640) (27,374)
Interest expense and other income (111) 820 137 1,858
Loss before minority interest (21,911) (13,838) (43,503) (25,516)
Minority interest in loss of
variable interest entity 52 - 61 -
Net loss $(21,859) $(13,838) $(43,442) $(25,516)
Basic and diluted net loss per
common share $(0.54) $(0.51) $(1.08) $(0.93)
Weighted average shares used to
compute basic and diluted net
loss per common share 40,328 27,376 40,299 27,353
Anesiva, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
June 30, December 31,
2008 2007
(Unaudited) (Note)
Assets
Cash and cash equivalents $48,667 $90,840
Other current assets 4,082 2,225
Total current assets 52,749 93,065
Property and equipment, net 17,733 15,276
Other assets, non-current 1,466 1,395
Total assets $71,948 $109,736
Liabilities and stockholders' equity
Current liabilities $15,117 $12,175
Long term obligations 7,882 9,047
Minority interest 485 -
Total stockholders' equity 48,464 88,514
Total liabilities and stockholders' equity $71,948 $109,736
(Note): Derived from audited financial statements at that date.
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