Biotech Values

[DewDiligence]

BFRM Reports FY4Q09 Results

[BFRM reestablished a modicum of respectability by reporting much better results in the fiscal fourth quarter ending Jun 30. Here’s why: quarterly revenue in the past seven quarters, in chronological order, was $18.6M (Dec07), $17.0M (Mar08), $16.7M (Jun08), $15.7M (Sep08), $16.7M (Dec08), $15.0M (Mar09), and $19.2M (Jun09). In other words, revenue in the latest quarter (81% in US) was the highest in the past 18 months and was a 15% increase year-over-year. (Quarter-over-quarter changes are less meaningful for BFRM because cosmetic procedures have a strong seasonal component with peaks in the late fall and late spring, which corresponds to BFRM’s fiscal second and fourth quarters.) FY4Q09 EPS was a loss of 0.04, down from a loss of 0.43 in FY4Q08. All told, BFRM has weathered the economic downturn in relatively good shape and held or even gained market share in the dermal-filler market.

That’s the good news. The bad news is that, despite aggressive cost-cutting, BFRM is still losing money and expects to continue losing money for at least another year. The company’s guidance for FY2010 (ending 6/30/10) is for revenue of $64-70M (vs $66.5M in FY2009 and $67.5M in FY2008), a GAAP loss of about $14M, and cash burn of about $10M.

To become profitable on a GAAP basis, BFRM would need to grow FY revenue to about $80M. Can they do it? I think they probably can in due course because Radiesse is a fine product. However, I do not see an urgency to buy now, especially after the big run-up the share price has had in 2009. Moreover, a new competitor, Sanofi-aventis, recently entered the cosmetic dermal-filler market with the FDA approval of Sculptra (#msg-40115547) and it’s unclear how well this product will fare.]
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http://finance.yahoo.com/news/BioForm-Medical-Reports-pz-3559500107.html?x=0&.v=1

›Wednesday August 19, 2009, 4:00 pm EDT

SAN MATEO, Calif., Aug. 19, 2009 (GLOBE NEWSWIRE) -- BioForm Medical, Inc. (Nasdaq: BFRM ) today announced its financial results for the fourth quarter and full fiscal year ended June 30, 2009. Net sales were $19.2 million for the quarter ended June 30, 2009 as compared to $16.7 million for the quarter ended June 30, 2008, an increase of $2.5 million or 15.0%. The net loss was $1.9 million for the quarter ended June 30, 2009 as compared to a net loss of $20.0 million for the quarter ended June 30, 2008, which included a one-time charge described below. Net sales were $66.5 million for fiscal year 2009 as compared to $67.5 million for fiscal year 2008, a decrease of $1.0 million or 1.5%. The net loss was $21.1 million for fiscal year 2009 as compared to $29.5 million for fiscal year 2008.

Operating Results:

Domestic sales were $15.5 million for the quarter ended June 30, 2009 as compared to $13.2 million for the quarter ended June 30, 2008, an increase of $2.3 million or 17.4%. International sales were $3.7 million for the quarter ended June 30, 2009 as compared to $3.5 million for the quarter ended June 30, 2008, an increase of $0.2 million or 5.7%.

Gross profit was $14.6 million for the quarter ended June 30, 2009 as compared to $14.4 million for the quarter ended June 30, 2008, an increase of $0.2 million or 1.4%. As a percentage of sales, gross profit for the quarter ended June 30, 2009 was 76.0% as compared to 86.3% for the quarter ended June 30, 2008. The decrease in gross profit margin for the quarter ended June 30, 2009 was primarily due to a one-time charge of $1.4 million associated with the write-down of certain inventory. Without this write-down of inventory, the gross profit margin for the quarter would have been in line with the Company's guidance of 80-83% of sales for fiscal 2009.

Operating expenses were $16.5 million for the quarter ended June 30, 2009 as compared to $34.7 million for the quarter ended June 30, 2008. The decrease of $18.2 million results primarily from two factors, a one-time charge of $11.2 million taken in the fourth quarter of fiscal 2008 for acquired in-process research and development associated with the Advanced Cosmetic Intervention asset purchase, and a reduction in quarterly operating expenses reflecting the cost savings actions taken during fiscal 2009.

Net loss per share applicable to common stockholders decreased to $0.04 for the quarter ended June 30, 2009 as compared to a net loss per share of $0.43 for the quarter ended June 30, 2008. This decrease in net loss per share reflects the higher revenues and lower operating expenses in the fourth quarter of fiscal 2009 as compared to the fourth quarter of fiscal 2008, which included a one-time charge of $11.2 million for in-process research and development.

As of June 30, 2009, BioForm Medical had $42.2 million in cash and cash equivalents, an increase of $0.8 million during the quarter versus $41.4 million for the quarter ended March 31, 2009. [I.e., BFRM was marginally cash-positive in the fourth quarter, but this good fortune is not expected to last.]

RADIESSE Dermal Filler Product Strategy:

* In March 2009, BioForm Medical launched, in the United States, a new 1.5cc RADIESSE Volume Advantage syringe intended to replace the core 1.3cc syringe form of RADIESSE dermal filler. The 1.5cc RADIESSE Volume Advantage remains priced at $295 per syringe and therefore provides physicians and patients with 15% more filler product at the same price per syringe, which may improve physician and patient satisfaction with RADIESSE dermal filler treatment.

* In April 2009, BioForm Medical launched, in the United States, a new 0.8cc RADIESSE Moderate Fill syringe at a list price of $199. [BFRM also offers a 1.5cc syringe with a list price of $299; the combination of the 0.8cc and 1.5cc offerings replaced the 1.3cc syringe, which had been the only formulation prior to April.] The 0.8cc RADIESSE Moderate Fill syringe is intended to enable the Company to capture additional U.S. dermal filler market share by providing a cost-effective way to use RADIESSE dermal filler to treat moderate nasolabial folds that have historically been treated with one of the 0.8cc or 1.0cc hyaluronic acid products.

* In July 2009, BioForm Medical announced FDA approval for a method of mixing RADIESSE dermal filler with lidocaine prior to injection. [This is not a major enhancement, IMO (#msg-39629935).] In clinical trials, this pre-mixing technique demonstrated an improvement in patient comfort and an increase in patient satisfaction with RADIESSE dermal filler procedures. In August 2009, the Company began shipping separate accessory kits, containing a luer-lock connector and an empty syringe, to facilitate physician adoption of this new mixing technique.

Polidocanol NDA Amendment Filed:

* In July 2009, BioForm Medical's partner, Chemische Fabrik KREUSSLER & Co. GmbH, filed with the FDA the additional manufacturing validation information requested by the FDA to complete the NDA submission for Polidocanol. BioForm Medical believes that this submission now permits the FDA to initiate its complete NDA review and the Company will be working with Kreussler throughout the review process.

Operating Expense Reduction Plan:

* In the second quarter of fiscal 2009, BioForm Medical implemented a plan to significantly reduce its operating expense run-rate by up to $20.0 million annually, or $5.0 million per quarter. During the third and fourth quarter of fiscal 2009, operating expenses of BioForm Medical have averaged $16.0 million per quarter as compared to an average of $21.2 million in the first and second quarter of fiscal 2009.

"We believe that the launch of our new syringe size strategy has accelerated market share gains for BioForm Medical in the most recent quarter," said Steve Basta, Chief Executive Officer of BioForm Medical. "Physicians have continued using our 1.5cc RADIESSE Volume Advantage syringe, and many physicians are finding that the 0.8cc RADIESSE Moderate Fill syringe provides an attractive alternative to hyaluronic acid product syringes for more moderate nasolabial fold treatments. We believe that this product bracketing strategy along with the recent approval of the lidocaine mixing procedure may enable us to increase our market share in future quarters. We remain cautious, however, about the impact of the current recession on the dermal filler market. Our guidance reflects caution about the economy balanced with enthusiasm for the responses we have received from physicians regarding our improved product offerings. We have also implemented our cost reduction measures effectively over the past two quarters and are now operating at the expense rate we have previously communicated as our operating expense guidance for fiscal 2010."

Fiscal Year 2010 Guidance:

BioForm Medical is providing the following financial guidance for the full fiscal year ended June 30, 2010:

* Revenues are expected to be approximately $64-70 million.

* Gross profit [i.e. gross margin] is expected to be approximately 80-83% of sales, with some possible fluctuation outside of this range on a quarterly basis.

* Operating expenses are expected to be approximately $64-68 million.

* Net loss is expected to be less than $14 million.

* Total cash used is expected to be less than $10 million.

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 provided in this press release. 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 877-591-4949 for callers in the U.S. and 719-325-4884 for international callers. Please notify the operator that you would like to join "BioForm Medical's Fourth Quarter & Fiscal 2009 Earnings Call" and provide the participant code "8574038", 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 Medical, please visit www.bioform.com.‹