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.
RADIESSE(r) 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. 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. 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 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(r) 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.
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 nature and timing of FDA review of the Polidocanol NDA, the Company's ability to gain market share as a result of its product offerings and strategy, the Company's ability to achieve and sustain operating expense reductions, and, the Company's financial guidance for fiscal year 2010, are all forward looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties, which may cause BioForm Medical's actual results to differ materially from the statements contained herein. BioForm Medical's financial results for the quarter ended June 30, 2009, as discussed in this release, are preliminary and subject to adjustment. Further information on potential risk factors that could affect BioForm Medical's business and its financial results are detailed in its latest Form 10-Q as filed with the Securities and Exchange Commission on May 13, 2009. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. BioForm Medical undertakes no obligation to update publicly any forward looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
BIOFORM MEDICAL, INC.
SUMMARY OF OPERATIONS (unaudited)
(in thousands, except per share data)
Three months ended Twelve months ended
June 30, June 30,
---------------------- ----------------------
2009 2008 2009 2008
--------- --------- --------- ---------
Net U.S. sales $ 15,465 $ 13,220 $ 53,651 $ 54,393
Net International
sales 3,705 3,492 12,867 13,090
--------- --------- --------- ---------
Net sales 19,170 16,712 66,518 67,483
Cost of sales 4,565 2,289 13,020 11,393
--------- --------- --------- ---------
Gross profit 14,605 14,423 53,498 56,090
--------- --------- --------- ---------
Operating expenses:
Sales and
marketing 12,160 17,702 54,583 56,912
Research and
development 2,149 2,690 9,551 9,313
Acquired
in-process
research and
development -- 11,230 -- 11,230
General and
administrative 2,175 3,090 10,233 9,882
--------- --------- --------- ---------
Total operating
expenses 16,484 34,712 74,367 87,337
--------- --------- --------- ---------
Other income
(expense), net
Interest income,
net 49 412 660 1,902
Other income
(expense), net (12) (51) (713) 110
--------- --------- --------- ---------
Loss before income
taxes (1,842) (19,928) (20,922) (29,235)
Provision for
income taxes 35 80 197 290
--------- --------- --------- ---------
Net loss $ (1,877) $(20,008) $(21,119) $(29,525)
========= ========= ========= =========
Net loss per common
share, basic and
diluted $ (0.04) $ (0.43) $ (0.46) $ (0.94)
Weighted-average
number of common
shares used in per
share calculation,
basic and diluted 46,350 46,257 46,334 31,276
BIOFORM MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited)
(in thousands)
Years Ended June 30,
------------------------
2009 2008
--------- ---------
Assets
Current assets:
Cash and cash equivalents $ 42,162 $ 59,204
Accounts receivable, net of allowance
for doubtful accounts of $1,343 at
June 30, 2009 and $836 at June 30,
2008 12,034 10,989
Inventories 4,894 8,167
Prepaid royalties 1,259 929
Prepaid other 1,249 1,603
Other current assets 357 805
--------- ---------
Total current assets 61,955 81,697
Property and equipment, net 7,599 9,037
Prepaid royalties 1,869 3,288
Other assets 244 548
--------- ---------
Total assets $ 71,667 $ 94,570
========= =========
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 1,297 $ 3,533
Deferred revenues 515 454
Accrued royalty expenses 299 280
Accrued liabilities 5,866 8,066
Capital lease obligations, current
portion 41 34
--------- ---------
Total current liabilities 8,018 12,367
Capital lease obligations, long-term
portion 28 60
--------- ---------
Total liabilities 8,046 12,427
Total stockholders' equity 63,621 82,143
--------- ---------
Total liabilities and stockholders'
equity $ 71,667 $ 94,570
========= =========