Artes Medical, Inc. (Nasdaq:ARTE), a medical aesthetics company,
today reported recent company highlights and financial results for
the three months ended September 30, 2008. Financial Results The
Company reported product sales of $2.3 million for the quarter
ended September 30, 2008, an increase of $1.1 million, or 85%, over
product sales of $1.2 million for the quarter ended September 30,
2007. In addition, during the third quarter, the Company shipped
over $500,000 of ArteFill to physicians to support the on-going
long-term safety study, completing initial enrollment during
October. This quarterly increase in sales resulted from the
expansion of the Company�s field sales force, increased consumer
marketing, continued increase in the number of ArteFill-trained
physicians, and the launch of ElevessTM, a new FDA-approved
temporary dermal filler. Revenues for the quarter ended September
30, 2007 also included license fee revenue of $5.5 million
representing an accelerated royalty payment from a third party. The
Company reported improved gross profit resulting from increased
product sales and allocation of manufacturing overhead. In this
regard, the Company reported a negative gross profit on product
sales for the quarter ended September 30, 2008 of $82 thousand
compared with a negative gross profit for the quarter ended
September 30, 2007 of $1.8 million. Total operating expenses for
the quarter ended September 30, 2008 were $10.4 million, an
increase of $3.0 million, over the quarter ended September 30, 2007
operating expenses of $7.4 million. This increase in operating
expenses is primarily due to the Company�s expanded sales force,
increased consumer marketing initiatives for ArteFill, costs to
launch Elevess and costs associated with the Company�s five-year
post-marketing safety and skin test removal studies. This resulted
in a net loss of $11.2 million for the quarter ended September 30,
2008, compared to $3.7 million for the quarter ended September 30,
2007, which was reduced by the one-time receipt of the $5.5 million
accelerated royalty payment. The Company also reported cash and
cash equivalents of $5.9 million as of September 30, 2008. "The
top-line growth in product sales reflects the progress we have made
over the past year," said Christopher J. Reinhard, Executive
Chairman, Artes Medical, Inc. �While the challenging economic times
have adversely impacted the aesthetics sector, we have advanced
product revenues over the prior year period while launching a new
product, Elevess. The summer is often considered a slow quarter for
sales in our industry. However, we and all of our competitors have
experienced the negative effects of the current recession and
credit crisis and the weather conditions in the Gulf Coast region,
especially during the month of September. As a result, based on the
deteriorating economic outlook, unfavorable market and poor
financial metrics of the medical aesthetics industry, the Company
is not in a position at this time to estimate projected revenues
for the fourth quarter of the year. We are therefore suspending our
guidance for the remainder of the 2008 calendar year.� Recent
Company Highlights In August, the Company announced its commercial
launch of Elevess, an FDA-approved hyaluronic acid-based dermal
filler with lidocaine for patient comfort. The Company previously
announced that it had broadened its product portfolio through an
agreement with Anika Therapeutics to sell Elevess exclusively in
the U.S. Elevess and ArteFill allow the Company to offer both
short-term and long-lasting solutions to wrinkle correction. The
Company announced completion of enrollment in its 1,000-patient,
5-year post-marketing ArteFill study required by the FDA, and
completion of enrollment and treatment in its ArteFill skin test
removal study in October. In connection with the post-marketing
study, the Company shipped ArteFill valued at approximately $1.8
million during the year, including over $500,000 during the third
quarter. In September, the Company announced it had completed a
financing with accredited investors raising approximately $2.4
million from a private placement of its common stock and related
warrants. This financing represents an important first step in
raising additional equity capital. The Company announced the
promotion of Michael K. Green to Chief Operating Officer in
September. In addition to his continued responsibilities as Chief
Financial Officer, Mr. Green assumed oversight responsibility for
departments including marketing, sales, manufacturing, clinical and
regulatory, corporate facilities, information technology and human
resources. The Company announced in October the winner of the
�ArteFill Face Forward Makeover Contest� -- celebrating women's
changing lives. The grand prize winner received a complimentary
treatment with ArteFill and a $10,000 makeover. About Artes
Medical, Inc. Artes Medical is a medical aesthetics company focused
on developing, manufacturing and commercializing new and innovative
medical aesthetic products including injectable products for the
dermatology and plastic surgery markets. The Company�s initial
product, ArteFill, is being marketed to men and women as a
treatment option for the correction of nasolabial folds. Additional
information about Artes Medical and ArteFill is available at
www.artesmedical.com and www.artefill.com. Forward-Looking
Statements This news release contains forward-looking statements
that are based on the Company�s current beliefs and assumptions and
on information currently available to its management.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause the Company�s actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements.�As a result of these
risks, uncertainties and other factors, which include the Company�s
history of net losses, its ability to timely raise additional funds
to support its operations, its ability to manage its operating
expenses, its limited experience in commercializing ArteFill and
Elevess, its future receipt of FDA approval to extend the efficacy
period of ArteFill beyond six months and eliminate the skin test
requirement, and the risk that the Company�s revenue projections
may prove incorrect because of unexpected difficulty in generating
sales and market acceptance of ArteFill or Elevess, readers are
cautioned not to place undue reliance on any forward-looking
statements included in this press release. A more extensive set of
risks and uncertainties is set forth in the Company�s SEC filings
available at www.sec.gov. These forward-looking statements
represent beliefs and assumptions only as of the date of this news
release, and the Company assumes no obligation to update these
forward-looking statements publicly, even if new information
becomes available in the future. Artes Medical� and ArteFill� are
registered trademarks of Artes Medical, Inc.�All other trademarks
referred to in this press release are the property of their
respective owners. Artes Medical, Inc. Condensed Consolidated
Statements of Operations (in thousands, except per share data)
(Unaudited) � � Three Months Ended September 30, Nine Months
EndedSeptember 30, � 2008 � � � 2007 � � 2008 � � � 2007 � �
Revenues: Product sales $ 2,261 $ 1,220 $ 7,095 $ 4,716 License
fees � - � � 5,500 � � - � � 6,232 � � 2,261 6,720 7,095 10,948 �
Cost of product sales � 2,343 � � 3,002 � � 7,404 � � 6,880 � �
Gross profit (loss) � (82 ) � 3,718 � � (309 ) � 4,068 � �
Operating expenses: Selling and marketing 4,347 2,846 14,673 8,252
General and administrative 2,943 3,022 10,530 9,513 Research and
development � 3,088 � � 1,541 � � 7,865 � � 3,709 � � � 10,378 � �
7,409 � � 33,068 � � 21,474 � � Loss from operations (10,460 )
(3,691 ) (33,377 ) (17,406 ) � Other income (expense): Interest
expense (1,063 ) (342 ) (2,755 ) (873 ) Interest income 20 310 219
1,181 Other income (expense), net � 227 � � (10 ) � 235 � � - � �
Loss before benefit from income taxes (11,276 ) (3,733 ) (35,678 )
(17,098 ) � Benefit from income taxes � 70 � � 51 � � 217 � � 151 �
� Net loss $ (11,206 ) $ (3,682 ) $ (35,461 ) $ (16,947 ) � � Basic
and diluted net loss per share $ (0.67 ) $ (0.22 ) $ (2.14 ) $
(1.03 ) � Basic and diluted weighted average shares � 16,654,516 �
� 16,493,767 � � 16,561,289 � � 16,444,915 � Artes Medical, Inc.
Condensed Consolidated Balance Sheets (in thousands, except per
share data) (Unaudited) � September 30, December 31, 2008 2007
Assets Current Assets: Cash and cash equivalents $ 5,858 $ 20,293
Accounts receivable, net 1,470 792 Inventories, net 6,075 5,528
Other current assets � 790 � � 1,044 � � Total Current Assets
14,193 27,657 � Property and equipment, net 5,798 5,034
Intangibles, net 1,255 2,385 Other assets � 604 � � 645 � � Total
Assets $ 21,850 � $ 35,721 � � Liabilities and Stockholders� Equity
(Deficit) Current Liabilities: Accounts payable and accrued
expenses $ 6,132 $ 3,074 Accrued compensation and benefits 1,571
1,802 Revenue interest financing, current portion 1,775 - Term note
payable, current portion - 1,250 Revolving credit line - 5,000
Other current liabilities � 120 � � 42 � � Total Current
Liabilities 9,598 11,168 � Revenue interest financing, less current
portion (net of discount of $1,016) 13,391 - Note payable (net of
discount of $779) 5,721 - Term note payable (net of discount of
$165) - 2,231 Deferred tax liability 316 915 Other liabilities
2,051 783 Commitments and Contingencies Stockholders� Equity
(Deficit): Series A Participating Preferred Stock, $0.001 par
value, 200,000 shares authorized; 0 shares issued and outstanding -
- Common stock, $0.001 par value, 200,000,000 shares authorized;
19,742,285 and 16,514,163 shares issued and outstanding at
September 30, 2008 and December 31, 2007, respectively 20 17
Additional paid-in capital 132,501 126,894 Accumulated deficit �
(141,748 ) � (106,287 ) � Total Stockholders' Equity (Deficit) �
(9,227 ) � 20,624 � � Total Liabilities and Stockholders� Equity
(Deficit) $ 21,850 � $ 35,721 �
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