ITEM 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On June 20, 2008, the employment of Jeff Wells, Senior Vice President, Product Development of BioForm Medical, Inc. since June 2007, and a named executive officer of BioForm Medical, ended. BioForm Medical's existing Vice President, Regulatory Affairs & Quality Assurance, Vice President, Clinical Affairs, and Vice President, R&D, who reported to Mr. Wells, will report to Steven Basta, CEO of BioForm Medical, to whom they reported prior to the commencement of Mr. Wells' employment.‹
[BFRM has not been growing very fast for a supposed growth company. In fact, revenue has been declining for the past half year: it was $18.6M in FY2Q08, $17.0M in FY3Q08, and $16.7M in FY4Q08. Moreover, the guidance in this PR for FY09 (ending 6/30/09) revenue is $74-78M; the midpoint of this range represents a growth rate only 13%, which is hardly impressive for the aesthetic-medicine business. BFRM points to weak US consumer confidence as an excuse for the unimpressive numbers, but does this ring true? I’m not sure.
I do think BFRM’s main product, Radiesse, is an excellent dermal filler, probably the best one on the market. However, I’d like to see at least one quarter of decent revenue growth before making a commitment to this stock.]
SAN MATEO, Calif., Sept. 4 /PRNewswire-FirstCall/ -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2008. Net sales were $16.7 million for the quarter ended June 30, 2008 as compared to $15.4 million for the quarter ended June 30, 2007, an increase of $1.3 million or 8.4%. The net loss was $20.0 million for the quarter ended June 30, 2008 as compared to a net loss of $4.9 million for the quarter ended June 30, 2007. Net sales were $67.5 million for fiscal year 2008 as compared to $47.4 million for fiscal year 2007, an increase of $20.1 million or 42.4%. The net loss was $29.5 million for the fiscal year 2008 as compared to $13.6 million for fiscal year 2007. The $20.0 million net loss in the fourth quarter and the $29.5 million net loss for fiscal year 2008 each included an $11.2 million charge for acquired in-process research and development arising from the purchase of substantially all assets of Advanced Cosmetic Intervention, Inc. (ACI) in April 2008.
Operating Results:
Domestic sales were $13.2 million for the quarter ended June 30, 2008 as compared to $12.7 million for the quarter ended June 30, 2007, an increase of $0.5 million or 3.9%. International sales were $3.5 million for the quarter ended June 30, 2008, as compared to $2.6 million for the quarter ended June 30, 2007, an increase of $0.9 million or 34.6%. Gross profit was $14.4 million for the quarter ended June 30, 2008 as compared to $12.4 million for the quarter ended June 30, 2007, an increase of $2.0 million, or 16.1%. As a percentage of sales, gross profit for the quarter ended June 30, 2008 was 86.3% as compared to 81.1% for the quarter ended June 30, 2007. The increase in gross profit margin for the quarter ended June 30, 2008 was primarily due to a variation of production volume and overhead expense incurred, and lower royalty license expense.
Operating expenses were $34.7 million in the quarter ended June 30, 2008 as compared to $17.5 million in the quarter ended June 30, 2007. The increase in operating expenses was primarily attributable to the expensing of in-process research and development arising from the acquisition of assets from ACI, an increase in sales and marketing costs as a result of the expansion of the Company's sales forces in the United States and Europe in early fiscal 2008, expansion of the Company's clinical education programs, and additional higher employee-related expenses.
Net loss per share applicable to common stockholders decreased to $0.43 for the quarter ended June 30, 2008 as compared to $1.20 for the quarter ended June 30, 2007, due primarily to the increase in the shares outstanding as a result of the sale of 11.5 million shares of common stock in the Company's November 2007 initial public offering and the conversion of 30.4 million shares of preferred stock into common stock concurrent with this public offering.
Fiscal Year 2009 Guidance:
BioForm Medical is providing the following financial guidance for the full fiscal year ended June 30, 2009:
• 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® 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® 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®), 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 June 30, 2008 in line with the guidance we provided in our third quarter fiscal 2008 conference call and earnings release. Our guidance for fiscal year 2009 reflects an expectation that the current dermal filler market softness will persist for two more quarters, with only modest recovery starting thereafter," commented Steve Basta, Chief Executive Officer of BioForm Medical, Inc. "In fiscal 2009, we are focused on training and education to drive clinical confidence among RADIESSE dermal filler users, expanding the RADIESSE filler user base through new account conversions, and developing our future products, which we believe will contribute to accelerating revenue growth in fiscal 2010 and beyond."
Conference Call:
BioForm Medical will hold a conference call today at 2:00 pm Pacific Time (5:00 p.m. Eastern Time) to discuss the financial results and guidance. The conference call will be webcast live on the Investor Relations section of BioForm Medical's website at http://www.bioform.com. The conference call may be accessed by dialing 888-287-5530 for callers in the U.S. and 719-785-1786 for international callers. Please notify the operator that you would like to join "BioForm Medical's Fourth Quarter & Fiscal 2008 Earnings Call" and provide the participant code "2257477", if prompted.
About BioForm Medical, Inc.:
BioForm Medical, Inc. is a medical aesthetics company headquartered in San Mateo, California, developing products that enhance aesthetic procedures performed in dermatology and plastic surgery practices. BioForm Medical's lead product is Radiesse® dermal filler, a long-lasting filler for use in facial aesthetics. BioForm Medical is developing several future aesthetics products, including a radiofrequency treatment to reduce nerve function in the forehead, a sclerotherapy treatment for spider veins, and a surgical adhesive for brow lifts. For more information about BioForm, please visit http://www.bioform.com.‹
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