Health News
BIOFORM REPORTS FINANCIAL RESULTS FOR THE FOURTH QUARTER AND FULL FISCAL YEAR ENDED JUNE 30, 2008
Operating Results:
Domestic sales were
Operating expenses were
Net loss per share applicable to common stockholders decreased to
Fiscal Year 2009 Guidance:
BioForm Medical is providing the following financial guidance for the full
fiscal year ended
-- Revenues are expected to be approximately $74 to $78 million.
-- Gross profit is expected to average approximately 81% to 83% as a
percentage of sales on an annual basis, with some possible fluctuation
outside of this range on a quarterly basis.
-- Operating expenses are expected to be approximately $84 to $86 million.
-- Net loss is expected to be approximately $20 to $23 million.
Product Pipeline Update:
BioForm Medical is providing the following update on its product pipeline:
-- RADIESSE(R) Dermal Filler Next-Generation Products: The Company has a
number of ongoing programs evaluating new forms, applications and
indications of its patent protected RADIESSE dermal filler technology.
The first new commercial product derived from these efforts is expected
to be a form of RADIESSE dermal filler with Lidocaine which may improve
comfort for patients and flow characteristics for physicians, and is
expected to be launched in the United States and Europe in calendar
year 2009.
-- RADIESSE(R) Dermal Filler Post-Market Studies: The Company has
completed and submitted to FDA the results of two post-approval studies
for RADIESSE filler -- a three-year post-approval open-label follow-up
to the pivotal nasolabial fold study to evaluate the long-term safety
and duration of effect with RADIESSE filler, and a study to assess the
safety of RADIESSE dermal filler in nasolabial folds in persons of
color. In the three-year study in nasolabial folds, more than 30% of
treated nasolabial folds were rated by the treating investigator as
improved in patients who were two to three years from their last
injection. No long-term product related adverse events or
delayed-onset adverse events were reported in the study. In the
persons of color study, observed adverse events were typical of dermal
fillers such as redness, swelling, and bruising, and the study found
that RADIESSE dermal filler is safe for use in persons of color. These
studies were conducted pursuant to the requirements of the FDA
associated with the approval for RADIESSE dermal filler for facial
folds and wrinkles.
-- POLIDOCANOL: As announced in a separate press release today, positive
results from the Phase III clinical trial of Polidocanol (European
trade name Aethoxysklerol(R)), a sclerotherapy product for the
treatment of spider and reticular veins, have been submitted to FDA as
part of the New Drug Application (NDA) process. In addition to this
clinical report, BioForm Medical's partner, Kreussler, is completing
manufacturing documentation for a newly expanded manufacturing
facility. The final manufacturing documentation is expected to be
completed and submitted to FDA before the end of calendar year 2008,
consistent with BioForm Medical's previously reported expected timeline
for completion of the NDA submission.
-- RELAXED EXPRESSIONS(TM): As previously announced on April 30, 2008,
BioForm Medical acquired from ACI a minimally invasive bi-polar
radiofrequency 510(k) medical device (renamed "Relaxed
Expressions(TM)") cleared to selectively reduce nerve function. The
Company has recently received an additional 510(k) clearance for a new
treatment profile software upgrade designed to improve outcomes of
procedures with the device. The Company has filed an Investigational
Device Exemption (IDE) with the FDA to conduct clinical studies
specifically intended to support an FDA application seeking clearance
to market this product for the treatment of frown lines. The Company
expects to also seek a CE Mark and certain other international
registrations of the Relaxed Expressions device for aesthetics
indications.
-- BIOGLUE Aesthetic(TM) Medical Adhesive: The Company and its partner,
CryoLife, Inc. announced in June 2008 the receipt of a CE Mark for
BioGlue Aesthetic(TM) Medical Adhesive for browplasties in Europe.
Pre-launch activities continue on a limited basis with early users, to
help the Company in its evaluation and development program to identify
and optimize uses of BioGlue Aesthetic adhesive. In the United States,
BioForm has completed a 30-patient feasibility study for the use of
BioGlue Aesthetic adhesive conducted under a U.S. IDE which
demonstrated raised brow position in 89% of patients at 6 months.
BioForm is working with its clinical advisors and FDA to determine the
best design for a pivotal study of BioGlue Aesthetic adhesive to
support U.S. approval.
"We are pleased to report sales performance for the quarter and fiscal
year ended
Conference Call:
BioForm Medical will hold a conference call today at
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in
Forward-Looking Statements: This press release contains forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995. Specifically, statements concerning the introduction of new
RADIESSE products or the timing thereof, the timing of completing a
Polidocanol NDA submission to FDA, the timing of an FDA application or receipt
of FDA clearance, or international regulatory clearances, to market Relaxed
Expressions for the treatment of frown lines or other aesthetic indications,
the ability of the Company to optimize uses of BioGlue Aesthetic adhesive in
Contact:
Adam Gridley
650.286.4025
Vice President, Corporate Development
BioForm Medical, Inc.
BIOFORM MEDICAL, INC.
SUMMARY OF OPERATIONS (unaudited)
(in thousands, except per share data)
Three months ended Twelve months ended
June 30, June 30,
2008 2007 2008 2007
Net U.S. sales $13,220 $12,726 $54,393 $39,215
Net International sales 3,492 2,624 13,090 8,199
Net sales 16,712 15,350 67,483 47,414
Cost of sales 2,289 2,901 11,393 8,769
Gross profit 14,423 12,449 56,090 38,645
Operating expenses:
Sales and marketing 17,702 11,783 56,912 38,186
Research and development 2,690 3,763 9,313 7,756
Acquired in-process research
and development 11,230 - 11,230 -
General and administrative 3,090 1,957 9,882 6,990
Total operating expenses 34,712 17,503 87,337 52,932
Other income (expense), net
Interest income, net 412 199 1,902 842
Other income (expense), net (51) 6 110 68
Loss before income taxes (19,928) (4,849) (29,235) (13,377)
Provision for income taxes 80 72 290 195
Net loss $(20,008) $(4,921) $(29,525) $(13,572)
Net loss per common share, basic
and diluted $(0.43) $(1.20) $(0.94) $(3.54)
Weighted-average number of
common shares used in per
share calculation, basic
and diluted 46,257 4,104 31,276 3,839
BIOFORM MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands)
Years Ended June 30,
2008 2007
Assets
Current assets:
Cash and cash equivalents $59,204 $17,610
Accounts receivable, net of allowance for
doubtful accounts of $836 at June 30, 2008
and $428 at June 30, 2007, 10,989 7,725
Inventories 8,167 4,864
Prepaid royalties 929 -
Prepaid other 1,603 1,194
Other current assets 805 262
Total current assets 81,697 31,655
Property and equipment, net 9,037 5,741
Prepaid royalties 3,288 -
Other assets 548 103
Total assets $94,570 $37,499
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $3,533 $3,754
Deferred revenues 454 446
Accrued royalty expenses 280 869
Accrued liabilities 8,066 6,686
Capital lease obligations, current portion 34 20
Total current liabilities 12,367 11,775
Capital lease obligations, long-term portion 60 36
Total liabilities 12,427 11,811
Total stockholders' equity 82,143 25,688
Total liabilities and stockholders' equity $94,570 $37,499
SOURCE BioForm Medical, Inc.
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