Richard Davies wrote: The UK has a good crop of technology pioneers in cloud computing - for example ElasticHosts, FlexiScale, Flexiant, OnApp - and also some strong government initiatives such as G-Cloud.
We will have to see whether this kind of technical leadership converts into swift mass-market adoption or not.
PRINCETON, NJ -- (MARKET WIRE) -- 11/01/05 -- Barrier Therapeutics, Inc. (NASDAQ: BTRX), a
pharmaceutical company developing and commercializing products in the field
of dermatology, today announced its financial results for the third quarter
ended September 30, 2005. Net loss for the quarter was $12.1 million,
which represents a loss of $ .50 per share.
"We have seen several positive developments in the third quarter, following
a challenging second quarter," commented Geert Cauwenbergh, Ph.D., Chairman
and Chief Executive Officer. "On the commercial side, we are starting to
see encouraging prescription numbers for Solagé®, suggesting that the
efforts of our small sales force are starting to bear fruit. We've also
had progress on the development side with both Vusion, formerly known as
Zimycan, and Sebazole. In addition, the positive results achieved with
oral Rambazole in a Phase 2a study in moderate to severe inflammatory
acne, and the encouraging biological data seen with topical Rambazole in
volunteers, continue to build on our hopes for this potentially valuable
asset in our pipeline."
Third Quarter Financial Results
Total revenue for the quarter was $626,000 as compared to $223,000 for the
same period in 2004. Included in this total is $155,000 of net product
revenue from the U.S. and Canadian sales of Solagé®, which was acquired in
February 2005. Product revenues for the quarter include the first
shipments of Barrier labeled product in both territories. Additional
revenue represents income from a research grant from the Belgian government
and revenue related to contract payments. Revenue in the third quarter of
last year consisted only of revenue from the Company's research grant and
revenue related to contract payments.
Total cost of product revenues (exclusive of amortization of product
rights) which includes cost of finished goods and distribution expenses was
$75,000 for the quarter. We did not report cost of product revenues during
2004 as we did not have product sales. Amortization expense related to the
product rights for Solagé® was $88,000 for the quarter.
Research and development expenses for the three months ended September 30,
2005 totaled $7.6 million, as compared to $8.0 million for the same period
in 2004. Aggregate spending related to the Company's four late stage
product candidates, Vusion, Sebazole, Hyphanox and Liarozole, totaled
$2.9 million this quarter, as compared to approximately $4.6 million for
the same period in 2004. The decline in costs was primarily related to
reduced clinical activity for Sebazole and Hyphanox. During the quarter,
development expenses of $2.0 million were incurred for our earlier stage
clinical product candidates as compared to $843,000 in the same period of
2004. During the quarter we incurred significant manufacturing development
expenses related to clinical trial materials for Azoline. Internal
research and development expenses, primarily personnel and related costs,
were $2.4 million during the quarter, as compared to $2.1 million in the
corresponding period in 2004.
Sales and marketing expenses for the quarter were $3.9 million, consisting
primarily of personnel costs, and the costs related to our contract sales
organization, as well as marketing and market research expenses related to
Solagé® and VANIQA®. Total sales and marketing expenses of $1.1 million
were incurred during the third quarter of 2004.
General and administrative expenses were $1.7 million for the quarter ended
September 30, 2005 compared to $1.8 million in the third quarter of 2004.
This change is a result of increases in professional fees and other public
company related expenses that was more than offset by a reduction in stock
compensation expense.
As a result of higher interest rates, net interest income for the third
quarter of 2005 increased to $761,000 from $433,000 in the third quarter of
2004.
Net loss for the third quarter of 2005 was $12.1 million, which represents
a loss of $.50 per share, as compared to a net loss of $10.2 million for
the third quarter of 2004, which represented a loss per share of $.47.
At September 30, 2005, the Company had $88.9 million in cash, cash
equivalents and marketable securities, as compared to $89.1 million as of
December 31, 2004.
Third Quarter 2005 and Recent Operational Highlights:
-- Receipt of notification from the U.S. Food & Drug Administration (FDA)
that the Company's submission to address the May 2005 not approvable letter
for Vusion, formerly known as Zimycan, has been considered a complete
response by the FDA. This designation by the FDA indicates that the
appropriate information has been provided for their review. The Company
believes that this response provides the FDA with the information necessary
to complete its review of the New Drug Application (NDA) within
approximately six months from the date of the submission of the response,
which occurred in August 2005.
-- Announcement that Barrier will retain worldwide rights for all
licensed indications to its oral antifungal product candidate, Hyphanox.
Janssen Pharmaceutica Products, L.P. held an option for the rights to
Hyphanox, which had been negotiated as part of Barrier's initial license to
the product rights. Barrier triggered the option based on the results of
its Phase 3 non-inferiority clinical trial in vaginal candidiasis, in which
Hyphanox demonstrated clinical efficacy that was not inferior to
fluconazole, but did not reach the primary regulatory endpoint of non-
inferiority to fluconazole for therapeutic cure.
-- Receipt of positive data from a Phase 2a proof of concept study with
an oral formulation of Rambazole in the treatment of moderate to severe
inflammatory acne in which 16 of 17 subjects (94%) experienced a reduction
in total acne lesion count of more than 50% and 6 of 17 subjects (35%) were
considered "cleared or almost cleared" after 12 weeks of treatment with
1mg/day.
-- Receipt of encouraging biomarker data from a double-blind, vehicle
controlled clinical pharmacology study with the topical formulation of
Rambazole, in which each of 15 healthy volunteers were treated for 9 days
with both the drug at a 0.07% or a 0.35% concentration and its vehicle.
The levels of biomarkers obtained with the higher concentration of the
topical Rambazole were similar to those reported in the literature for
currently marketed concentrations of topical retinoic acid and none of the
volunteers had signs of irritation.
-- Submission of an NDA for Sebazole at the end of September. The FDA is
now reviewing the submission to determine if it is acceptable for filing.
Conference Call & Webcast Information
Barrier's senior management will host a conference call today, Tuesday,
November 1, 2005 at 4:30 p.m. New York time, to review 2005 third quarter
financial results and provide a Company update. Live audio of the
conference call will be available to investors, members of the news media
and the general public by dialing 1-888-889-2497 (in the United States) or
1-973-582-2710 (internationally). A playback of the call will be available
by dialing 1-877-519-4471 (in the United States), or 1-973-341-3080
(internationally) and entering passcode 6574112. To access the call by
live webcast, please visit the Investor Relations section of our website at
http://www.barriertherapeutics.com. An archived version of the webcast
will also be available at the same location.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the
discovery, development and commercialization of pharmaceutical products in
the field of dermatology. The Company currently markets Solagé® (mequinol
2%, tretinoin 0.01%) Topical Solution in the U.S. and Canada for the
treatment of solar lentigines, a common condition also known as "age
spots," and recently obtained the Canadian distribution rights for VANIQA®
(eflornithine hydrochloride) Cream 13.9% for slowing the growth of unwanted
facial hair in women. Barrier has eight product candidates in various
stages of clinical development. The four most advanced product candidates
include Vusion (formerly known as Zimycan) for the treatment of diaper
dermatitis complicated by candidiasis, which is under FDA review, and three
products, which are in or entering Phase 3 clinical trials for the
treatment of seborrheic dermatitis, onychomycosis, and congenital
ichthyosis. Barrier has product candidates in earlier stages of clinical
development for the treatment of acne, psoriasis and fungal infections.
The Company is headquartered in Princeton, New Jersey and has wholly owned
subsidiaries in Geel, Belgium and Ontario, Canada. Web site:
http://www.barriertherapeutics.com.
Safe Harbor Statement
In addition to historical facts or statements of current condition, this
press release contains forward-looking statements within the meaning of the
"Safe Harbor" provisions of The Private Securities Litigation Reform Act of
1995, including statements regarding the ability of Barrier's sales force
to be effective, the prospects and timing of regulatory action for Vusion
and Sebazole, and the future potential for our product candidates,
including Rambazole. Forward-looking statements provide Barrier's current
expectations or forecasts of future events. Barrier's performance and
financial results could differ materially from those reflected in these
forward-looking statements due to Barrier's ability to execute its
commercial and clinical strategy, the decisions of regulatory authorities,
the results of our clinical trials and strategic decisions regarding its
pipeline, general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries generally. For a
discussion of these and other risks and uncertainties that may effect the
forward-looking statements please see the risk factors in our Quarterly
Report on Form 10Q, which is on file with the Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Barrier undertakes
no obligation to update publicly any forward-looking statement.
Barrier Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(All amounts in thousands, except share and per share amounts)
(unaudited)
Three months ended Nine months ended
September 30, September 30,
2005 2004 2005 2004
Revenues:
Net product revenue $ 155 $ - $ 460 $ -
Contract revenue 150 25 521 25
Grant revenue 321 198 770 557
---------- ---------- ---------- ----------
Total Revenues 626 223 1,751 582
Costs and expenses:
Cost of goods sold 75 116
Amortization of
Product Rights 88 232
Research and
development 7,626 7,961 24,417 20,056
Sales and marketing 3,918 1,078 7,959 2,719
General and
administrative 1,730 1,767 6,141 5,148
---------- ---------- ---------- ----------
Total costs and
expenses 13,437 10,806 38,865 27,923
---------- ---------- ---------- ----------
Loss from operations (12,811) (10,583) (37,114) (27,341)
Interest income, net 761 433 2,098 911
---------- ---------- ---------- ----------
Net loss (12,050) (10,150) (35,016) (26,430)
Preferred stock
accretion - - (4,592)
---------- ---------- ---------- ----------
Net loss attributable
to common stockholders $ (12,050) $ (10,150) $ (35,016) $ (31,022)
========== ========== ========== ==========
Basic and diluted net
loss attributable to
common stockholders
per share
$ (0.50) $ (0.47) $ (1.49) $ (2.51)
Weighted average
shares outstanding -
basic and diluted
23,962,649 21,549,794 23,536,482 12,357,817
Pro forma basic and
diluted net loss
attributable to common
stockholders per share
$ (1.49) $ (1.61)
Pro forma weighted
average shares
outstanding - basic
and diluted 23,536,482 19,315,131
Certain amounts have been reclassified to conform to the current period
presentation.
The pro forma net loss per share attributable to common stockholders gives
effect to the conversion of Barrier's outstanding shares of redeemable
convertible preferred stock into common stock as if each occurred when the
preferred stock was issued.
Barrier Therapeutics, Inc.
Balance Sheet Data
(in thousands)
September 30, December 31,
2005 2004
(unaudited)
Cash and cash equivalents $ 33,827 $ 11,908
Marketable securities 55,107 77,173
Total assets 95,211 92,784
Current liabilities 8,693 8,771
Total liabilities and
stockholders equity 95,211 92,784
Contact:
Barrier Therapeutics, Inc.
Anne M. VanLent
609-945-1202