10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(Mark One)

þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended March 31, 2009

OR

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Transition Period from                      to                     

Commission File Number 001-33791

BIOFORM MEDICAL, INC.

(Exact name of the Registrant as specified in its charter)

Delaware	39-1979642
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

1875 South Grant Street, Suite 200

San Mateo, California 94402

(Address of principal executive office and zip code)

(650) 286-4000

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  þ    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ¨    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer  ¨	Accelerated filer  ¨	Non-accelerated filer  þ	Smaller reporting company  ¨
		(do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  þ

As of April 30, 2009, there were 46,350,702 shares ($0.01 par value per share) of registrant’s common stock outstanding.

BIOFORM MEDICAL, INC.

FORM 10 - Q

Quarterly Period Ended March 31, 2009

TABLE OF CONTENTS

		Page
PART I. FINANCIAL INFORMATION
ITEM 1.	FINANCIAL STATEMENTS
	Condensed Consolidated Balance Sheets as of March 31, 2009 (unaudited) and June 30, 2008	3
	Unaudited Condensed Consolidated Statements of Operations for the Three and Nine Months Ended March  31, 2009 and 2008	4
	Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended March 31, 2009 and 2008	5
	Notes to Unaudited Condensed Consolidated Financial Statements	6
ITEM 2.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	15
ITEM 3.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	22
ITEM 4T.	CONTROLS AND PROCEDURES	23
PART II. OTHER INFORMATION
ITEM 1.	LEGAL PROCEEDINGS	24
ITEM 1A.	RISK FACTORS	24
ITEM 2.	UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS	36
ITEM 3.	DEFAULTS UPON SENIOR SECURITIES	36
ITEM 4.	OTHER INFORMATION	37
ITEM 5.	EXHIBITS	38
SIGNATURES		39

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PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

BIOFORM MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

	March 31, 2009			June 30, 2008
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	41,417		$	59,204
Accounts receivable, net of allowance for doubtful accounts of $1,278 at March 31, 2009 and $836 at June 30, 2008		10,594			10,989
Inventories		7,159			8,167
Prepaid royalties		1,176			929
Prepaid other		1,422			1,603
Other current assets		469			805
Total current assets		62,237			81,697
Property and equipment, net		8,242			9,037
Long-term prepaid royalties		2,315			3,288
Intangible assets, net		126			369
Other assets		256			179
Total assets	$	73,176		$	94,570
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	1,625		$	3,533
Deferred revenue		921			454
Accrued royalty expense		249			280
Accrued liabilities		5,640			8,066
Capital lease obligations, current portion		34			34
Total current liabilities		8,469			12,367
Capital lease obligations, long-term portion		35			60
Total liabilities		8,504			12,427
Commitment and contingencies (Note 4)
Stockholders’ equity:
Preferred stock, 10,000 shares authorized, $0.01 par value, zero outstanding		—			—
Common stock, 100,000 shares authorized, $0.01 par value, 46,342 shares issued and outstanding at March 31, 2009, 46,300 shares issued and outstanding at June 30, 2008		463			463
Additional paid-in capital		160,561			158,480
Accumulated other comprehensive income (loss)		(97	)		212
Accumulated deficit		(96,255	)		(77,012	)
Total stockholders’ equity		64,672			82,143
Total liabilities and stockholders’ equity	$	73,176		$	94,570

The accompanying notes are an integral part of these condensed consolidated financial statements.

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BIOFORM MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share information)

(unaudited)

	Three months ended March 31,						Nine months ended March 31,
	2009			2008			2009			2008
Net sales	$	14,991		$	16,954		$	47,348		$	50,771
Cost of sales		2,918			3,232			8,455			9,104
Gross profit		12,073			13,722			38,893			41,667
Operating expenses:
Sales and marketing		11,508			14,347			42,423			39,210
Research and development		2,168			2,259			7,401			6,623
General and administrative		1,844			2,548			8,058			6,792
Total operating expenses		15,520			19,154			57,882			52,625
Other income (expenses), net
Interest income, net		71			742			609			1,490
Other income (expenses), net		(128	)		262			(700	)		161
Loss before income taxes		(3,504	)		(4,428	)		(19,080	)		(9,307	)
Provision for income taxes		61			69			162			210
Net loss	$	(3,565	)	$	(4,497	)	$	(19,242	)	$	(9,517	)
Net loss per share, basic and diluted	$	(0.08	)	$	(0.10	)	$	(0.42	)	$	(0.36	)
Weighted-average number of shares used in computing loss per share calculation, basic and diluted		46,336			46,229			46,328			26,319

The accompanying notes are an integral part of these condensed consolidated financial statements.

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BIOFORM MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

	Nine months ended March 31,
	2009			2008
Cash flows from operating activities
Net loss	$	(19,242	)	$	(9,517	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		1,518			995
Impairment of long-lived assets		208			—
Loss on disposal of fixed assets		53			8
Provision for doubtful accounts		949			518
Provision for inventory obsolescence		72			159
Stock-based compensation expense for employees		1,965			1,648
Stock-based compensation expense for non-employees		50			125
Changes in operating assets and liabilities:
Accounts receivable		(1,026	)		(3,420	)
Inventories		387			(1,508	)
Prepaid royalties		726			(4,236	)
Prepaid expenses and other assets		272			(3,032	)
Accounts payable		(1,858	)		(1,627	)
Deferred revenue		471			28
Accrued liabilities		(2,424	)		(461	)
Net cash used in operating activities		(17,879	)		(20,320	)
Cash flows from investing activities
Purchase of property and equipment		(835	)		(3,806	)
Net cash used in investing activities		(835	)		(3,806	)
Cash flows from financing activities
Net proceeds from the issuance of common stock in initial public offering		—			83,095
Payments on capital leases		(26	)		(26	)
Proceeds from the issuance of common stock under stock option plans		66			253
Net cash provided by financing activities		40			83,322
Effect of exchange rate changes on cash		887			16
Net increase (decrease) in cash and cash equivalents for the period		(17,787	)		59,212
Cash and cash equivalents at beginning of period		59,204			17,610
Cash and cash equivalents at end of period	$	41,417		$	76,822
Supplemental disclosures of non-cash investing and financing activities
Conversion of convertible preferred stock	$	—		$	(303	)
Purchase of property and equipment under capital leases	$	—		$	(84	)
Disposal of property and equipment through capital lease terminations	$	—		$	11

The accompanying notes are an integral part of these condensed consolidated financial statements.

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BIOFORM MEDICAL, INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(in thousands, except per share data)

Note 1 – The Company and Description of Business, Initial Public Offering and Capitalization of Preferred Stock

The Company and Description of Business

BioForm Medical, Inc. (“we,” “our”, “us”) is a medical aesthetics company incorporated in Delaware on July 12, 1999. Our corporate headquarters are located in San Mateo, California, with manufacturing and research and development sites in Franksville, Wisconsin, and European subsidiaries in the Netherlands and the United Kingdom. We are focused on developing and commercializing products that are used by physicians to enhance their patients’ appearance and are dedicated to bringing doctors and their patients’ safe and effective products for use in dermatology, plastic surgery and facial plastic surgery.

We currently have two main products, RADIESSE^® and COAPTITE^®. RADIESSE^® is an FDA-approved dermal filler that is marketed for a number of applications including the correction of moderate to severe folds and wrinkles, including nasolabial folds; for the restoration or correction of the signs of facial fat loss or lipoatrophy in patients with human immunodeficiency virus; and for vocal fold augmentation (“VFA”). COAPTITE^® is an FDA-approved tissue-bulking agent used to treat female stress urinary incontinence (“SUI”).

Initial Public Offering and Conversion of Preferred Stock

In November 2007, we completed our initial public offering of common stock (“IPO”) and we sold and issued 11,500 shares of common stock at an issuance price of $8 per share. We raised a total of $92,000 in gross proceeds from the IPO, or $83,095 in net proceeds after deducting underwriting discounts and other associated costs. Upon the closing of the IPO, all shares of convertible preferred stock then outstanding were automatically converted into 30,367 shares of common stock.

Capitalization summary upon closing of initial public offering:

Common stock issued and outstanding as of September 30, 2007	4,222
Shares of common stock issued upon stock option exercises before IPO	67
Net exercise of outstanding warrant prior to IPO	44
Sale of common stock through IPO	11,500
Conversion of preferred stock into common stock upon the closing of the IPO	30,367
Common stock issued and outstanding after IPO	46,200

Note 2 – Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles (“GAAP”) for complete financial statements. These statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the fiscal year ended June 30, 2008 included in our Annual Report on Form 10-K filed with the SEC on September 26, 2008.

In our opinion, the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary, which are normal and recurring in nature, for a fair presentation of our financial position and of our results of operations for the periods presented. These condensed consolidated financial statements are not necessarily indicative of the results to be expected for the entire year. We derived the condensed consolidated balance sheet as of June 30, 2008 from the audited consolidated financial statements at that date.

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Comprehensive Income (Loss)

Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss). Our comprehensive loss consists of net losses and unrealized gains on foreign exchange translations. The following table lists the components of comprehensive loss as of the end of the periods indicated.

	Three months ended March 31,						Nine months ended March 31,
	2009			2008			2009			2008
Net loss	$	(3,565	)	$	(4,497	)	$	(19,242	)	$	(9,517	)
Unrealized foreign currency translation gain		97			66			309			210
Comprehensive loss	$	(3,468	)	$	(4,431	)	$	(18,933	)	$	(9,307	)

Net Loss per Common Share

We compute basic and diluted net loss per share by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Options to purchase common stock are not included in this calculation because their inclusion would be anti-dilutive. All outstanding warrants and convertible preferred stock have been exercised and converted into common stock as of December 31, 2007. There were no warrants or convertible preferred stock issued or outstanding as of March 31, 2009 and 2008.

A reconciliation of the numerator and denominator used in the calculation of basic and diluted net loss per common share is as follows:

	Three months ended March 31,						Nine months ended March 31,
	2009			2008			2009			2008
Numerator:
Net loss	$	(3,565	)	$	(4,497	)	$	(19,242	)	$	(9,517	)
Denominator:
Weighted-average common shares outstanding		46,336			46,229			46,328			26,319
Loss per share
Basic and diluted	$	(0.08	)	$	(0.10	)	$	(0.42	)	$	(0.36	)

The following outstanding options were excluded from the computation of diluted loss per common share for the periods presented because including them would have had an anti-dilutive effect:

	March 31,
	2009	2008
Options to purchase common stock	4,232	5,526

Fair Value Measurements

As of July 1, 2008, we adopted the Financial Accounting Standards Board (“FASB”) Statement of Financial Accounting Standards No. 157, Fair Value Measurements (“SFAS 157”). SFAS 157 established a framework for measuring fair value and clarified the definition of fair value within that framework. SFAS 157 does not require any new fair value measurements. SFAS 157 introduced, or reiterated, a number of key concepts which form the foundation of the fair value measurement approach to be utilized for financial reporting purposes. The fair value of our financial instruments reflect the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). SFAS 157 also established a fair value hierarchy that prioritizes the use of inputs used in valuation techniques into the following three levels:

Level 1—Quoted prices in active markets for identical assets and liabilities.

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Level 2—Inputs, other than quoted prices in active markets that are observable either directly or indirectly.

Level 3—Unobservable inputs, in which there is little or no market data, which require the reporting entity to develop its own assumption.

The adoption of SFAS 157 did not have a material effect on our financial condition and results of operations, as we do not have any financial instruments that are required to be measured at fair value under the framework of SFAS 157.

In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The Fair Value Option for Financial Assets and Financial Liabilities—Including an amendment of FASB Statement of Financial Accounting Standards No. 115 (“SFAS 159”). SFAS 159 provides companies with an option to report selected financial assets and liabilities at fair value. The objective of SFAS 159 is to reduce both complexity in accounting for financial instruments and the volatility in earnings caused by measuring related assets and liabilities differently. Most of the provisions in SFAS 159 are elective; however, the amendment to FASB Statement of Financial Accounting Standards No. 115, Accounting for Certain Investments in Debt and Equity Securities (“SFAS 115”), applies to all entities with available-for-sale and trading securities. SFAS 159 is effective as of the beginning of an entity’s first fiscal year beginning after November 15, 2007. Though SFAS 159 is effective for fiscal 2009 beginning as of July 1, 2008, we do not have any eligible financial assets or financial liabilities that are eligible for the fair value option under SFAS 159 as of March 31, 2009. As such SFAS 159 does not have any impact on our results of operations and financial position.

Recent Accounting Pronouncements

In December 2007, the FASB issued Statement of Financial Accounting Standards No. 141 (revised 2007), Business Combinations (“SFAS 141(R)”). SFAS 141(R) requires entities that acquire control of another business or businesses to measure and recognize any obligations to make payments conditioned on the outcome of future events (contingent consideration) at the fair value of the contingent consideration at the acquisition date. SFAS 141(R) includes in the definition of contingent consideration any right held by the acquirer to the return of previously transferred consideration if specific conditions are met. SFAS 141(R) also defines a bargain purchase and requires the acquirer to recognize the excess fair value involved in such a purchase in earnings as a gain attributable to the acquirer. SFAS 141(R) is effective for acquisitions occurring on or after the beginning of the first annual reporting period beginning on or after December 15, 2008. The FASB has prohibited earlier adoption of SFAS 141(R). We will adopt SFAS 141(R) in fiscal 2010 and are currently evaluating the effect that the adoption of SFAS 141(R) will have on our results of operations and financial position.

In December 2007, the FASB issued Statement of Financial Accounting Standards No. 160, Noncontrolling Interests in Consolidated Financial Statements (“SFAS 160”). SFAS No. 160 is an amendment of Accounting Research Bulletin No. 51 and applies to all entities that have an outstanding noncontrolling interest in one or more subsidiaries or that deconsolidate a subsidiary. The statement clarifies the definition of a noncontrolling interest, proscribe how transactions involving a noncontrolling interest are to be recorded and revises disclosure in the consolidated financial statement. This statement is effective for fiscal years beginning on or after December 15, 2008 and shall be applied prospectively when initially applied, except for the presentation and disclosure requirements which shall be applied retrospectively for all period presented. We will adopt SFAS 160 in fiscal 2010 and do not believe it will have a significant impact on our results of operations or financial position.

In March 2008, the FASB issued Statement of Financial Accounting Standards No. 161, Disclosures about Derivative Instruments and Hedging Activities (“SFAS 161”). SFAS No. 161 requires enhanced disclosures about an entity’s derivative and hedging activities. This statement is effective for financial statements issued for fiscal years beginning after November 15, 2008. The Company does not currently use derivative instruments or engage in hedging activities and, therefore, this statement is not applicable to the Company.

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Note 3 – Certain Balance Sheet Components

	March 31, 2009			June 30, 2008
Inventories
Raw materials	$	3,368		$	3,232
Work-in-process		2,896			3,728
Finished goods		1,191			1,566
Reserves for excess and obsolete inventory		(296	)		(359	)
	$	7,159		$	8,167
Property and Equipment
Land	$	327		$	327
Building and leasehold improvements		3,347			3,331
Machinery and equipment		5,864			5,275
Furniture, fixtures, and office equipment		4,426			4,380
Construction-in-progress		86			188
		14,050			13,501
Less: accumulated depreciation		(5,808	)		(4,464	)
	$	8,242		$	9,037
Other Accrued Liabilities
Accrued compensation	$	2,836		$	4,293
Accrued legal and patent expenses		163			116
Accrued marketing programs		13			101
Accrued taxes, permits, licenses		173			1,523
Other accrued liabilities		2,455			2,033
	$	5,640		$	8,066

Note 4 – Commitments and Contingencies

Lease Commitments

We have entered into several capital leases for office equipment. We had $128 in assets under capital lease obligations at March 31, 2009 and June 30, 2008. Accumulated depreciation associated with these capital leases was $44 and $27 at March 31, 2009 and June 30, 2008, respectively.

The following schedule summarizes the future minimum lease payments for all capital and operating leases as of March 31, 2009:

Years ending June 30,	Capital Lease			Operating Lease
2009 (remaining 3 months)	$	10		$	186
2010		40			676
2011		17			554
2012		7			544
2013		1			79
Total minimum lease payments		75		$	2,039
Less amounts representing interest		(6	)
Present value of minimum lease payments		69
Less current portion		(34	)
Long term portion of capital lease obligations	$	35

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License Agreements

In fiscal 2007, we entered into agreements with Chemische Fabrik KREUSSLER & Co. GmbH (“Kreussler”) that provided us exclusive U.S. distribution rights for Polidocanol, and with CryoLife, Inc. (“CryoLife”) for exclusive U.S., Canadian and European distribution rights for aesthetics applications for BIOGLUE^®. We charged $2,200 to research and development expense in fiscal 2007 for non-cancelable payments required under these two agreements. Of this amount, we paid $500 in fiscal 2007 and paid the remaining $1,700 in fiscal 2008. Contingent payments totaling $3,200 under the agreement with Kreussler and $500 under the agreement with CryoLife will become due upon success in reaching specified clinical and regulatory milestones. Due to the uncertainties inherent in medical clinical trials and regulatory review by the FDA, we are unable to predict if or when the contingent payments under these two agreements will become payable, except for a $700 license payment to Kreussler that we believe may become payable during the fourth quarter of fiscal 2009.

Under a license from Artes Medical related to patents held by them that apply to implantable products containing microsphere particles, we were obligated to pay royalties based on sales of our products. On September 21, 2007, we executed an agreement with Artes Medical to pre-pay all royalty obligations payable to Artes Medical in the future by making two payments totaling $5,500 which were made in the second quarter of fiscal 2008. These payments replaced any royalty that we would have been obligated to pay to Artes Medical in the future under the terms of the license. These payments were recorded as prepaid royalty and are expensed as a percentage of sales based on estimated future sales over the life of the related patents.

Cost Reduction Plan

As part of our cost reduction plan implemented in November 2008, we reduced our workforce by 36 employees, and reduced operating expenses through the suspension and deferral of various programs throughout virtually all functions of the organization. We incurred approximately $784 of expense for severance, medical coverage, and outplacement services for severed employees, which are principally classified in General and Administrative expenses in the Condensed Consolidated Statement of Operations for the nine months ended March 31, 2009. In addition, for the second quarter ended December 31, 2008 we recognized $208 of impairment charge related to the write-off of the assembled workforce intangible, related to our acquisition of ACI. This impairment charge is classified in Research and Development expenses in the Condensed Consolidated Statement of Operations for the nine months ended March 31, 2009. There were no expenses remaining to be incurred related to the cost reduction plan for the quarter ended March 31, 2009.

Legal Contingencies

From time to time, we may become a party to litigation and subject to product liability claims in the ordinary course of the business. Although the results of litigation and claims cannot be predicted with certainty, we believe that the final outcome of such matters will not have any material adverse effect on our business, results of operations or financial condition as of March 31, 2009.

Note 5 – Stockholders’ Equity

On November 9, 2007, we filed our amended and restated certificate of incorporation, pursuant to which all preferred stock was converted to common stock and we increased the number of shares authorized to 100,000 shares of common stock and 10,000 shares of undesignated preferred stock.

Each share of common stock has the right to one vote. The holders of common stock are entitled to dividends when funds are legally available and when declared by the Board of Directors.

Note 6 – Stock Based Compensation

Stock Option Plans

We have one active stock option plan, the 2007 Equity Incentive Plan (the “2007 Plan”), which became effective as of our IPO in November 2007. Previously we granted stock options under three other plans: the 2003 (Active) Stock Plan, the 2003 (Terminated) Stock Plan, and the 2000 Plan. All three of these earlier plans have been terminated and we can no longer grant stock options under them. Of these earlier plans, the only plan with options previously granted that are still outstanding is the 2003 (Active) Stock Plan. The outstanding options from the 2003 (Active) Stock Plan remain in effect.

As of the effectiveness of our IPO we became authorized to issue stock options, stock appreciation rights, restricted stock and restricted stock units or performance shares and units for 4,000 common shares under the 2007 Plan. The pool of shares available for use in the 2007 Plan increases on the first day of each fiscal year beginning with the 2008 fiscal year, in an amount equal to the lesser of (i) 4,000 shares, (ii) 4% of the outstanding shares on the last day of the immediately preceding fiscal year or (iii) such number of shares determined by the Board of Directors. On July 1, 2008, the shares

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authorized for issuance under the 2007 Plan automatically increased by 1,852 shares. The 2007 Plan states that the exercise price of options and stock appreciation rights will not be less than 100% of the fair market value of the underlying common stock on the date of the grant. The Board of Directors, or its designate, will determine the exercise price for restricted stock or restricted stock units and performance shares or units. The Board of Directors, or its designee, has the authority to set vesting periods, conditions, performance goals and incentives for all awards. Options granted under the 2007 Plan generally have a four year vesting term, have an exercise price equal to the fair market value on the date of grant, and have a ten year life from the date of grant. Options under the three earlier plans were generally granted on the same terms. As of March 31, 2009 and 2008, there were 4,070 and 5,410 shares, respectively, available for grant under the 2007 Plan.

Stock Option Repricing

On December 19, 2008, we filed a Tender Offer Statement on Schedule TO with the SEC, which allowed officers and employees of BioForm Medical, Inc. and its subsidiaries the opportunity to exchange outstanding options to purchase shares of our common stock with a per share exercise price equal to or greater than $3.70, which we referred to as “Eligible Options,” for new options to purchase the same number of shares of our common stock, which we referred to as “Replacement Options,” under the terms and under the conditions set forth in the Tender Offer. This Offer commenced on December 22, 2008 and expired on January 22, 2009.

We have priced and granted the Replacement Options at a per share exercise price of $1.12 on January 22, 2009, which was the closing price on the expiration date of the Tender Offer. We cancelled and subsequently exchanged a total of 3,688 eligible options for replacement options during the offering period, 1,812 shares of which were tendered from our 2003 (Active) Stock Plan and 1,876 shares of which were tendered from our 2007 Equity Incentive Plan. The total amount of additional incremental stock-based compensation cost resulting from the tender offer (or exchange) was approximately $1,258, which will be added to the unamortized stock compensation not yet expensed of $5,783 for the cancelled options and recognized ratably over the new four year vesting period which commenced on the grant date (January 22, 2009). Each Replacement Option has been issued subject to the terms and conditions of the 2007 Equity Incentive Plan, and all eligible options received in the exchange both from the 2003 (Active) Stock Plan and from the 2007 Equity Incentive Plan, have been cancelled as of January 22, 2009 and returned to the 2007 Equity Incentive Plan.

Of the $627 of stock-based compensation recognized this quarter, approximately $302 related to the stock-based compensation costs associated with the Replacement Options for the quarter ended March 31, 2009.

Stock-Based Compensation Expense

Effective July 1, 2006, we adopted the provisions of Statement of Financial Accounting Standards No. 123R, Share-Based Payment (“SFAS 123R”) using the prospective method. SFAS 123R establishes accounting for stock-based awards made to employees and directors. Accordingly, stock-based compensation expense is measured at grant date, based on the fair value of the award, and is recognized as expense over the remaining requisite service period.

Under SFAS 123R, stock-based awards, including stock options, are recorded at fair value as of the grant date and recognized on a straight-line basis, as expense over the employee’s requisite service period (generally the vesting period). Because our non-cash stock compensation expense is based on awards ultimately expected to vest, it has been reduced by an estimate for future forfeitures. SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

The weighted-average grant date fair value per share of employee stock options granted for the nine month period ended March 31, 2009 and 2008 was $0.79 and $3.18, respectively, calculated using the Black-Scholes option pricing model with the following weighted average assumptions:

	Nine months ended March 31,
	2009		2008
Weighted-average expected volatility	55	%	45	%
Weighted-average expected term (years)	4.92		4.59
Weighted-average risk-free interest rate	2.10	%	4.62	%
Dividend yield	0.00	%	0.00	%

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The assumptions were developed as follows:

Expected Volatility—As we have minimal trading history for our common stock, the expected stock price volatility for our common stock was estimated by taking the median historic stock price volatility for industry peers based on daily price observations over a period equivalent to the expected term of the stock option grants. Industry peers consist of several public companies in the biotech medical device industry similar in size, stage of life cycle and financial leverage.

Expected Term —The expected term were developed by analyzing BioForm Medical’s historical option exercise patterns.

Risk-Free Rate —The risk-free interest rate assumption was based on zero coupon U.S. Treasury instruments whose term was consistent with the expected term of our stock option grants.

Expected Dividend Yield —We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we used an expected dividend yield of zero.

Common Stock Fair Value — The fair value of our common stock is equal to the price at which our stock trades in the open stock market. Prior to our public offering in November 2007 the fair value of our common stock was determined by independent contemporaneous valuations prepared by an independent third party valuation firm. In conducting these valuations, we used a two-step methodology that first estimated our fair value as a whole, and then allocated a portion of the enterprise value to our common stock. This approach is consistent with the methods outlined in the American Institute of Certified Public Accountants (“AICPA”) Practice Aid Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The valuation methodology utilized the “income approach” to estimate enterprise value. This enterprise value was then tested for reasonableness utilizing the “market approach.” The income approach involved projecting future cash flows, discounting them to present value using discount rates ranging from 24% to 30% based upon a risk adjusted weighted average cost of capital of comparable companies, and applying probabilities for success of our product candidates to the resulting discounted cash flows. The projection of future cash flows, the determination of an appropriate discount rate and the estimates of probability for success of our product candidates each involved a significant degree of judgment.

Forfeitures —SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeiture rates refer to the likelihood that unvested options will be cancelled or forfeited due to termination of employment. In developing the expected future forfeiture rates, we analyzed unvested cancellations experience since September 2000.

Stock Options Granted to Employees

We recognized $627 of employee stock-based compensation expense during the three months ended March 31, 2009, and charged $43, $214, $98 and $272 to cost of sales, sales and marketing, research and development, and general and administrative expense, respectively. We recognized $1,965 of employee stock-based compensation expense during the nine months ended March 31, 2009, and charged $134, $640, $310 and $881 to cost of sales, sales and marketing, research and development, and general and administrative expense, respectively. We recognized $540 of employee stock-based compensation expense during the three months ended March 31, 2008, and charged $31, $185, $76 and $248 to cost of sales, sales and marketing, research and development, and general and administrative expense, respectively. We recognized $1,648 of employee stock-based compensation expense during the nine months ended March 31, 2008, and charged $101, $526, $248 and $773 to cost of sales, sales and marketing, research and development, and general and administrative expense, respectively. We did not recognize any income tax benefit related to stock-based compensation expense in the condensed consolidated statement of operations for the three and nine month periods ended March 31, 2009 or 2008.

The total compensation cost related to unvested stock option grants not yet recognized as of March 31, 2009 was $11,957 and the weighted-average period over which these grants are expected to vest is 3.4 years.

The following table summarizes activity under our stock option plans from January 1, 2009 through March 31, 2009:

Options	Shares Subject to Outstanding Options		Weighted Average Exercise Price		Weighted- average Remaining Contractual Term (Years)	Aggregate Intrinsic Value
Options outstanding at December 31, 2008	6,910		$	3.77
Granted	3,823		$	1.12
Exercised	(24	)	$	1.09
Forfeited or expired	(4,122	)	$	4.97
Options outstanding at March 31, 2009	6,587		$	1.49	8.61	$	810
Vested and expected to vest	5,852		$	1.51	8.47	$	743
Exercisable at March 31, 2009	1,822		$	1.72	6.42	$	389

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Aggregate intrinsic value for stock options represents the difference between the closing price per share of our common stock on the last trading day of the fiscal period and the option exercise price, multiplied by the number of in-the-money stock options outstanding, vested and expected to vest, and exercisable at March 31, 2009.

Stock Options Granted to Non-Employees

We recognized $50 of expense related to stock options granted to non-employees for the three and nine month periods ended March 31, 2009. Stock based compensation due to stock options granted to non-employees in the three month period ended March 31, 2008 was $(1), all of which was charged to sales and marketing expense. Stock based compensation due to stock options granted to non-employees in the nine month period ended March 31, 2008 was $125, of which $15 and $110 were charged to sales and marketing expense and general and administrative expense, respectively.

Stock options granted to non-employees were valued using the Black-Scholes option pricing model with the following assumptions:

	Nine months ended March 31,
	2009		2008
Weighted-average expected volatility	55	%	45	%
Weighted-average expected term (years)	4.92		10
Weighted-average risk-free interest rate	2.10	%	4.24	%
Dividend yield	0.00	%	0.00	%

We estimated the expected stock price volatility for our common stock by taking the median historic stock price volatility for industry peers based on daily price observation over a period equivalent to the expected term of the non-employee stock option grants. Industry peers consist of several public companies in the life science industry similar in size, stage of life cycle and financial leverage.

Note 7 – Income Taxes

Our provision for income taxes was $61 and $69 for the three month periods ended March 31, 2009 and March 31, 2008, respectively. Our provision for income taxes was $162 and $210 for the nine month periods ended March 31, 2009 and March 31, 2008, respectively. Our provision for income taxes relates to income taxes in our foreign subsidiaries.

Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. Accordingly, our net deferred tax assets at March 31, 2009 and June 30, 2008 have been fully offset by a valuation allowance.

The total amount of our unrecognized tax benefits was $177 as of March 31, 2009 and $169 as of June 30, 2008. None of our unrecognized tax benefits, if recognized, would affect our effective tax rate at present because they would only result in an adjustment of our valuation allowance.

We have no accrued interest or penalties related to tax contingencies. Any tax-related interest and penalties would be included in income tax expense in the consolidated statements of operations.

Our federal net operating loss carry forwards expire between 2014 and 2029 if not utilized. Our federal and state research and development tax credit carry forwards expire between 2019 and 2029 if not utilized. Due to our cumulative net operating loss position, all U.S. federal and state income tax returns since inception in 1999 are subject to tax authority examination.

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Note 8 – Segment Reporting

We operate in one business segment, which encompasses the developing, manufacturing and marketing of medical aesthetic products. We use one measurement of profitability and do not segregate our business for internal reporting.

The following is a summary of net sales by geographic area (based on location of customer):

	Three months ended March 31,				Nine months ended March 31,
	2009		2008		2009		2008
Domestic	$	12,178	$	14,025	$	38,186	$	41,173
International		2,813		2,929		9,162		9,598
Total	$	14,991	$	16,954	$	47,348	$	50,771

We operate from facilities in the United States and the Netherlands. Net long-lived assets were as follows:

	March 31, 2009		June 30, 2008
Domestic	$	7,838	$	8,447
International		404		590
Total	$	8,242	$	9,037

No customer accounted for 10% or more of net sales in the three or nine months ended March 31, 2009 or 2008. No one customer’s receivable balance is greater than 10% of the total account receivable balance at March 31, 2009 or June 30, 2008.

Note 9 – Subsequent Event

On April 24, 2009, we filed a written certification to the escrow agent associated with the Asset Purchase Agreement between BioForm and Advanced Cosmetic Intervention, Inc. (“ACI”) asserting that we are entitled to receive the entire $2,000 balance of the escrow amount being held by the escrow agent as a result of material misrepresentations made by ACI to us at the time of purchase. We are unable to estimate at this time the amount, if any, of the recovery from escrow and, accordingly, have not recorded a receivable for this matter.

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see the “Risk Factors” section in Item 1A of Part II of this Form 10-Q. We caution the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Form 10-Q. We undertake no obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this Form 10-Q.

Overview

We are a medical aesthetics company focused on developing and marketing products that are used by physicians to enhance the appearance of their patients. We were incorporated in Delaware in 1999 and commenced operations in 2000. From 2001 to 2003 we received certain U.S. and international regulatory clearances and approvals for, and engaged in commercial sales of, RADIESSE^® and COAPTITE^®. We obtained FDA pre-market approval, or PMA, for our key commercial application of RADIESSE^® in December 2006. Our core product is RADIESSE^® injectable dermal filler which is designed to provide long-lasting, cost-effective and safe aesthetic benefits for patients. As of December 2008, we have shipped more than 1,000,000 syringes of RADIESSE^® worldwide since 2002. We have also developed and commercialized COAPTITE^® tissue-bulking agent which is FDA approved and marketed through our distribution agreement with Boston Scientific for use in the treatment of stress urinary incontinence in adult females. We manufacture RADIESSE^® and COAPTITE^® at our facilities in Wisconsin, though we depend upon suppliers to manufacture components used in our products.

We currently market our products through over 100 direct sales and clinical training representatives in the United States and Europe and a complementary network of third party distributors in more than 30 countries. Our primary customers are dermatologists, plastic surgeons and facial plastic surgeons. RADIESSE^® is generally used for the treatment of facial wrinkles and folds. Medical aesthetics procedures such as these are generally not covered by health insurance; instead, consumers pay for these treatments with personal funds. COAPTITE^® is used to treat stress urinary incontinence in adult females, which is generally covered by health plans in the United States. Reimbursement coverage of COAPTITE^® procedures is generally not provided internationally, which we believe has been primarily responsible for limiting sales of COAPTITE^® outside the United States.

In addition to our existing RADIESSE^® and COAPTITE^® products on the market, we have development programs and distribution rights to additional products and their applications that are in various stages of development.

• RADIESSE^®— We have recently launched two new syringe formats of RADIESSE^® - the 1.5cc RADIESSE^® Volume Advantage syringe and the 0.8cc RADIESSE^® Moderate Fill syringe. In addition, we have a number of ongoing programs evaluating new forms, applications and indications of our patent protected RADIESSE^® technology. The first new commercial product derived from these efforts is expected to be a combination of RADIESSE^® and Lidocaine, which is designed to improve comfort for patients and flow characteristics for physicians. In March 2009, we announced the results of a clinical trial evaluating the combination of Lidocaine and RADIESSE^®, which demonstrated an approximately 60% reduction of pain, and comparable safety and effectiveness of mixed and non-mixed RADIESSE^®. Further, 96% of patients indicated that the difference in pain would affect their choice of treatment. These results were recently submitted to the FDA under a PMA supplement, and, assuming FDA approval within the anticipated time frame, is expected to be approved in calendar year 2009.

• Polidocanol—In May 2007, we entered into an exclusive licensing and distribution agreement in the United States for Polidocanol, a leading sclerotherapy treatment in Europe for varicose veins (sold outside of the United States under the trade name Aethoxysklerol^®). According to the terms of this agreement, the manufacturer of Polidocanol, Chemische Fabrik KREUSSLER & Co. GmbH (“Kreussler”), is responsible for conducting the clinical trial and submitting regulatory filings for approval of Polidocanol to the FDA, and, assuming approval is received, will exclusively manufacture the product for us. We will be the exclusive distributor of the product in the United States and be responsible for all sales, marketing, and clinical training activities. In July 2008, Kreussler submitted data to the FDA demonstrating that Polidocanol met the primary endpoint of its Phase III clinical trial. Kreussler plans to submit the manufacturing documentation related to the New Drug Application (“NDA”) for Polidocanol in the fourth quarter of our fiscal 2009.

• RELAXED EXPRESSIONS™—In April 2008, we acquired substantially all of the assets of Advanced Cosmetic Intervention (“ACI”), and its licensor, related to a device that is currently cleared via a 510(k) by the FDA to create radiofrequency (“RF”) heat lesions in nerve tissue. As part of our cost reduction measures, we have deferred our clinical development specifically intended to support an FDA application and other foreign applications seeking clearance to market this product (tradename RELAXED EXPRESSIONS™) for a specific indication directed to the treatment of frown lines.

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• BIOGLUE AESTHETIC™—In October 2006, we licensed the exclusive United States, Canadian and European distribution rights for medical aesthetic applications of BIOGLUE^®, a Class III medical device manufactured by CryoLife. Under the terms of our development, distribution and supply agreement, we are responsible for all clinical trials and regulatory filings for cosmetic and plastic surgery applications and will be responsible for sales and marketing of BIOGLUE AESTHETIC™ in these applications. We have completed an early feasibility stage clinical trial with BIOGLUE AESTHETIC™ for use as a less invasive alternative for tissue fixation in browplasty, or forehead lift procedures. We have received a CE Mark for BIOGLUE AESTHETIC™ for browplasty procedures in Europe. CryoLife will remain the exclusive manufacturer of BIOGLUE AESTHETIC™. As part of our cost reduction measures, we have deferred clinical development of BIOGLUE AESTHETIC™.

Contingent payments totaling $3.2 million under the agreement with Kreussler and $0.5 million under the agreement with CryoLife will become due upon success in reaching specified clinical and regulatory milestones. Under the agreement with ACI for the purchase of the RELAXED EXPRESSIONS™ product and technology, we are required to pay contingent consideration based on a percentage of future sales plus a one-time payment of $7.5 million in the event sales exceed $60 million in any calendar year from 2011 to 2014. Due to the uncertainties inherent in medical clinical trials and regulatory review by the FDA, as well as future sales, we are unable to predict if or when the contingent payments under these agreements will become payable except for a $0.7 million payment to Kreussler that we believe will likely become payable during the fourth quarter of fiscal 2009. We expect that our future revenue may grow materially as a result of these product candidates and any other future products or indications, if and when we introduce them.

As is common with many companies in the aesthetics sector, we experience the effects of seasonality on our revenues. The first quarter of our fiscal year, which runs from July through September, is typically the slowest quarter of the year, and we also generally observe a modest slowness in our third quarter, which runs from January through March. Our second and fourth quarters, which run from October to December and April to June, respectively, are typically the stronger quarters of our fiscal year. The effects of this seasonal pattern may be affected or masked by significant impacts from macroeconomic factors.

Sales of RADIESSE^® generated more than 90% of our revenue in the third quarter and the first nine months of both fiscal 2009 and fiscal 2008. Other revenue consists primarily of the sale of COAPTITE^®.

We expect that the key factors influencing our revenue in the future will include:

• physician and patient satisfaction with our product offerings, particularly our various RADIESSE^® offerings;

• the strength of our direct sales and clinical training teams in the United States and Europe and our international distribution arrangements;

• timing and scope of regulatory approvals that we have and may receive in the future;

• the strength or weakness of consumers’ confidence and economic activity in the countries in which we sell our products;

• competitive dynamics in the marketplace; and

• attractiveness of our sales and marketing promotional programs versus our competitors.

We believe that tight credit markets, weak economies, and low consumer confidence in the United States and our major international markets are adversely impacting spending on certain cosmetic procedures, including treatment with RADIESSE^®. We anticipate that adverse macroeconomic conditions will continue to adversely affect the dermal filler market through at least the end of calendar 2009, and likely beyond calendar 2009. Our expectations regarding the nature or timing of any macroeconomic recovery, as well as any recovery in the dermal filler market, are highly uncertain and extended macroeconomic weakness and low consumer discretionary spending may impact our future sales and alter seasonal patterns in our revenue.

To reach our goal of sustained profitability we will need to increase revenues while carefully managing our operating expenses. In November 2008, we implemented steps to reduce our annual rate of operating expenses through savings in program activities and personnel reductions in most functions other than our field sales personnel. To increase revenues, we will depend on growth in sales of RADIESSE^® in the United States and international markets, as well as success in gaining approval from the FDA and regulatory agencies in other countries to market the other products that we have in various stages of development and clinical trials. Competition in the markets for aesthetic medical products is very active. Many dermal filler products are already approved and sold throughout the world and we anticipate that other new fillers will be brought to market in future years. Some competing products are marketed by companies that are considerably larger and have greater

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resources than we do. Our industry is also characterized by pricing pressure in the form of volume discounting and, in some cases, price reductions and bundling discounts. We offer customers the opportunity to purchase product at lower unit prices if they purchase more units of RADIESSE^®. These factors have contributed to a decline in the average selling price for RADIESSE^® and may continue to do so in the future.

Results of Operations

Comparison of the three and nine months ended March 31, 2009 and 2008

The following table sets forth certain data as a percentage of net sales for the periods indicated. Dollars are in thousands.

	Three months ended March 31,
	2009					2008				% Change
	Amount			% (a)		Amount			% (a)
Net sales	$	14,991		100.0		$	16,954		100.0	(11.6	)
Cost of sales		2,918		19.5			3,232		19.1	(9.7	)
Gross profit		12,073		80.5			13,722		80.9	(12.0	)
Operating expenses
Sales and marketing expenses		11,508		76.8			14,347		84.6	(19.8	)
Research and development expenses		2,168		14.5			2,259		13.3	(4.0	)
General and administrative expenses		1,844		12.3			2,548		15.0	(27.6	)
Other income (expense), net		(57	)	(0.4	)		1,004		5.9	(105.7	)
Provision for income taxes		61		0.4			69		0.4	(11.6	)
Net loss	$	(3,565	)			$	(4,497	)
	Nine months ended March 31,
	2009					2008				% Change
	Amount			% (a)		Amount			% (a)
Net sales	$	47,348		100.0		$	50,771		100.0	(6.7	)
Cost of sales		8,455		17.9			9,104		17.9	(7.1	)
Gross profit		38,893		82.1			41,667		82.1	(6.7	)
Operating expenses
Sales and marketing expenses		42,423		89.6			39,210		77.2	8.2
Research and development expenses		7,401		15.6			6,623		13.0	11.7
General and administrative expenses		8,058		17.0			6,792		13.4	18.6
Other income (expense), net		(91	)	(0.2	)		1,651		3.3	(105.5	)
Provision for income taxes		162		0.3			210		0.4	(22.9	)
Net loss	$	(19,242	)			$	(9,517	)

(a) Expressed as a percentage of net sales

Comparison of the three months ended March 31, 2009 and 2008

Net Sales

Net sales were $15.0 million for the third quarter of fiscal 2009 as compared to $17.0 million for the third quarter of fiscal 2008, a decrease of $2.0 million or 11.8%. Domestic sales were $12.2 million for the third quarter of fiscal 2009 as compared to $14.0 million for the third quarter of fiscal 2008, a decrease of $1.8 million or 12.9%. International sales were $2.8 million for the third quarter of fiscal 2009 as compared to $2.9 million for the third quarter of fiscal 2008, a decrease of $0.1 million or 3.4%. The decrease in net sales resulted from significant weakness in consumer confidence and the economy during the third quarter of fiscal 2009 compared to the same period in fiscal 2008.

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Cost of Sales

Cost of sales was $2.9 million for the third quarter of fiscal 2009 as compared to $3.2 million for the third quarter of fiscal 2008, a decrease of $0.3 million or 9.4%. The decrease was primarily due to a decrease in the volume of units sold.

Gross Profit

Gross profit was $12.1 million for the third quarter of fiscal 2009 as compared to $13.7 million for the third quarter of fiscal 2008, a decrease of $1.6 million, or 11.7%. The gross profit, as a percentage of net sales, for the third quarter of fiscal 2009 was 80.5% as compared to 80.9% for the third quarter of fiscal 2008. We anticipate that our gross margin will remain in a range of 80% to 83% for the remainder of fiscal 2009.

Sales and Marketing Expenses

Our sales and marketing expenses were $11.5 million for the third quarter of fiscal 2009 as compared to $14.3 million for the third quarter of fiscal 2008, a decrease of $2.8 million or 19.6%. As a percentage of net sales, sales and marketing expenses were 76.8% of net sales for the third quarter of fiscal 2009 as compared to 84.6% for the same period in fiscal 2008. The dollar decrease was primarily due to decreased marketing and promotional activities, as well as lower costs resulting from a reduction of our workforce under the cost reduction plan implemented in November 2008.

Research and Development Expenses

Our research and development expenses were $2.2 million for the third quarter of fiscal 2009 as compared to $2.3 million for the third quarter of fiscal 2008, a decrease of $0.1 million or 4.3%. As a percentage of net sales, research and development expenses were 14.5% for the third quarter of fiscal 2009 as compared to 13.3% for the third quarter of fiscal 2008. The dollar decrease in research and development was primarily due to a $0.3 million decrease in development expenses as a result of the cost reduction plan. These decreases were partially offset by a $0.2 million increase in regulatory and clinical activities.

General and Administrative Expenses

Our general and administrative expenses were $1.8 million for the third quarter of fiscal 2009 as compared to $2.5 million for the third quarter of fiscal 2008, a decrease of $0.7 million, or 28.0%. As a percentage of net sales, general and administrative expenses were 12.3% in the third quarter of fiscal 2009 as compared to 15.0% in the third quarter of fiscal 2008. The dollar decrease was primarily due to lower general and administrative expenses as a result of the cost reduction plan.

Other Income (Expense), Net

Other income (expense), net for the third quarter of fiscal 2009 decreased $1.1 million when compared to the third quarter of fiscal 2008. The decline in other income was primarily due to a decrease in interest income of $0.7 million due to lower interest rates and a lower balance in our interest bearing money market fund.

Provision for Income Taxes

Our provision for income taxes for the third quarter of fiscal 2009 decreased slightly when compared to the third quarter of fiscal 2008 due to a reduction in income tax expense in a foreign subsidiary.

Net Loss

Our net loss decreased during the third quarter of fiscal 2009 when compared to the third quarter of fiscal 2008 due to the factors discussed above.

Comparison of the nine months ended March 31, 2009 and 2008

Net Sales

Net sales were $47.3 million for the first nine months of fiscal 2009 as compared to $50.8 million for the same period in fiscal 2008, a decrease of $3.5 million or 6.9%. Domestic sales were $38.2 million for the first nine months of fiscal 2009 as compared to $41.2 million for the same period in fiscal 2008, a decrease of $3.0 million or 7.3%. International sales were $9.2 million for the first nine months of fiscal 2009 as compared to $9.6 million for the same period in fiscal 2008, a decrease of $0.4 million or 4.2%. The decrease in net sales resulted from significant weakness in consumer confidence and the economy during the first nine months of fiscal 2009 compared to the same period in fiscal 2008.

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Cost of Sales

Cost of sales was $8.5 million for the first nine months of fiscal 2009 as compared to $9.1 million for the same period in fiscal 2008, a decrease of $0.6 million, or 6.6%. The decrease was primarily due to a decrease in the volume of units sold.

Gross Profit

Gross profit was $38.9 million for the first nine months of fiscal 2009 as compared to $41.7 million for the same period in fiscal 2008, a decrease of $2.8 million, or 6.7%. The gross profit as a percentage of sales was 82.2% for the first nine months of fiscal 2008 and fiscal 2009.

Sales and Marketing Expenses

Our sales and marketing expenses were $42.4 million for the first nine months of fiscal 2009 as compared to $39.2 million for the same period in fiscal 2008, an increase of $3.2 million or 8.2%. As a percentage of net sales, sales and marketing expenses were 89.6% of net sales for the first nine months of fiscal 2009 as compared to 77.2% for the same period in fiscal 2008. The dollar increase was primarily due to increases in employee related expenses of $4.0 million offset by a decrease in marketing and promotional activities under the cost reduction plan of $0.8 million.

Research and Development Expenses

Our research and development expenses were $7.4 million for the first nine months of fiscal 2009 as compared to $6.6 million for the same period in fiscal 2008, an increase of $0.8 million or 12.1%. As a percentage of net sales, research and development expenses were 15.6% for the first nine months of fiscal 2009 as compared to 13.0% for the same period of fiscal 2008. The dollar increase in research and development was due to higher regulatory expenses of $0.6 million and development expenses of $1.1 million. These increases were partially offset by savings realized as a result of the reduction of our workforce under the cost reduction plan of $0.9 million.

General and Administrative Expenses

Our general and administrative expenses were $8.1 million for the first nine months of fiscal 2009 as compared to $6.8 million for the same period in fiscal 2008, an increase of $1.3 million, or 19.1%. As a percentage of net sales, general and administrative expenses were 17.0% in the first nine months of fiscal 2009 as compared to 13.4% in the same period of fiscal 2008. The dollar increase was primarily due to higher employee expenses of $0.3 million, higher outside services of $0.6 million and higher bad debt expense of $0.5 million. These increases were partially offset by savings from our cost reduction plan.

Other Income (Expense), Net

Other income (expense), net for the first nine months of fiscal 2009 decreased $1.7 million when compared to the same period in fiscal 2008. Interest income decreased $0.9 million due to a lower balance in our interest bearing money market fund and decrease in interest rates. Foreign exchange loss increased $0.8 million due to the strengthening of the U.S. Dollar during fiscal 2009.

Provision for Income Taxes

Our provision for income taxes for the first nine months of fiscal 2009 decreased slightly when compared to the same period of fiscal 2008. The decrease was primarily due to lower income tax expense in a foreign subsidiary.

Net Loss

Our net loss increased during the first nine months of fiscal 2009 when compared to the same period in fiscal 2008 due to the factors discussed above.

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Liquidity and Capital Resources

The following table highlights selected cash flow components for the first nine months of fiscal 2009 and 2008 (dollars in thousands).

	Nine months ended March 31,
Cash provided by (used in):	2009			2008
Operating activities	$	(17,879	)	$	(20,320	)
Investing activities		(835	)		(3,806	)
Financing activities		40			83,322

We have incurred losses and generated negative annual cash flows from operating activities in all but one year since inception and had an accumulated deficit of approximately $96.3 million as of March 31, 2009. Our primary source of liquidity has been through private placements of shares of our preferred stock and the sale of common stock in association with our initial public offering in November 2007. Cumulative net proceeds from the issuance of preferred and common stock totaled approximately $160.6 million. We anticipate that our primary source of liquidity through approximately the end of fiscal 2010 will be our cash and cash equivalents and thereafter, it will be cash provided by operations assuming we reach our goal of sustained profitable operations.

Operating Activities

In the first nine months of fiscal 2009, net cash used in operating activities was $17.9 million as compared to $20.3 million in the comparable period of fiscal 2008. In fiscal 2009, losses from operations, and a reduction of accrued liabilities were primarily responsible for the cash used in operating activities. In fiscal 2008, losses from operations and increases in operating assets were primarily responsible for the cash used in operating activities.

Investing Activities

Net cash used in investing activities was $0.8 million in the first nine months of fiscal 2009 as compared to $3.8 million in the comparable period of fiscal 2008. During the first nine months of fiscal 2009, our purchases of capital assets such as equipment, computers, furniture and leasehold improvements for use in production, research, selling and general and administrative activities have been scaled down significantly compared to the first nine months of fiscal 2008.

Financing Activities

In the first nine months of fiscal 2009, net cash provided from financing activities was less than $0.1 as compared to net cash provided from financing activities of approximately $83.3 million during the first nine months of fiscal 2008. Our primary financing activity in the first nine months of fiscal 2009 was related to cash received from exercises of stock options offset by principal payments on capital leases. Our primary financing activity in the first nine months of fiscal 2008 related to cash received from our IPO in November 2007.

Sufficiency of Current Cash and Cash Equivalents

Our cash and cash equivalents (“cash”) were $41.4 million as of March 31, 2009. We believe that our current cash balance will be sufficient to meet our anticipated cash needs, including for working capital purposes, capital expenditures, and contractual obligations for at least the next 12 months. We may require additional cash resources due to changes in business conditions or other future developments, including any investments or acquisitions we may decide to pursue. In any of these cases, we may seek to sell equity or debt securities or to obtain a credit facility. It is uncertain whether equity or debt financing may be available to us when needed on terms that are acceptable to us or at all. The sale of convertible debt securities or additional equity securities could result in additional dilution to our stockholders. The incurrence of indebtedness would result in debt service obligations and could result in operating and financial covenants that would restrict our operations. In addition, there can be no assurance that any additional financing will be available on acceptable terms, if at all. We anticipate that, from time to time, we may evaluate acquisitions of complementary businesses, technologies or assets. However, there are no current understandings, commitments or agreements with respect to any acquisitions.

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Contractual Obligations

The following table summarizes our significant contractual obligations as of March 31, 2009 (dollars in thousands):

	Payments Due By Periods
	Total		Less Than 1 Year		1-3 Years		3-5 Years		More Than 5 Years
Capital lease obligations	$	75	$	41	$	32	$	2	$	—
Operating lease obligations		2,039		723		1,120		197		—
Purchase obligations		1,323		1,323		—		—		—
Royalty obligations		249		249		—		—		—
Total	$	3,686	$	2,336	$	1,153	$	199	$	—

Off-Balance Sheet Arrangements

We do not have any relationships with unconsolidated entities or financial partners, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not have any undisclosed borrowings or debt, and we have not entered into any synthetic leases. We are, therefore, not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships.

Recent Accounting Pronouncements

Information with respect to recent accounting pronouncements may be found in Note 1 of Notes to Unaudited Condensed Consolidated Financial Statements in this quarterly report, which information is incorporated herein by reference.

Critical Accounting Policies

We have made no material changes to the disclosures regarding critical accounting policies made in our Annual Report on Form 10-K for the year ended June 30, 2008, which was filed with the SEC on September 26, 2008.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

Interest Rate and Credit Risk

We have exposure to interest rate risk that relates primarily to our investment portfolio. All of our current investments are classified as cash or cash equivalents and carried at cost, which approximates market value. Our cash equivalents consist of a money market fund account which holds securities with maturities of less than 90 days. We do not currently use or plan to use derivative financial instruments in our investment portfolio. The risk associated with fluctuating interest rates is limited to our cash equivalents, and we do not believe that a 10% change in interest rates would have a significant impact on our interest income, operating results or liquidity.

As of March 31, 2009, our cash and cash equivalents were maintained by financial institutions in the United States, the United Kingdom and the Netherlands, and our current deposits are in excess of insured limits. We believe that the financial institutions that hold our investments are financially sound and, accordingly, that minimal credit risk exists with respect to these investments. At this point in time, our liquidity has not been materially impacted by the current credit environment and we do not expect that it will be materially impacted in the near future.

Our accounts receivable primarily relate to revenues from the sale of RADIESSE^® directly to individual physicians, hospitals, and medical clinics in the United States and select countries in Europe. Outside the United States and select countries in international markets we sell RADIESSE^® to distributors. We sell COAPTITE^® only through distributors, and most sales are in the United States. No single customer represented more than 10% of our receivables as of March 31, 2009.

Foreign Currency Risk

The functional currencies of our operations in the United States, the Netherlands, and the United Kingdom are the U.S. Dollar, or USD, the Euro, and the Pound Sterling, respectively. Revenue is normally generated in an operating unit’s functional currency. Operating expenses are usually in the local currency of the operating unit, which mitigates a portion of the exposure related to currency fluctuations. Intercompany transactions between our domestic and foreign operations are generally denominated in USD. At month-end, foreign currency-denominated accounts receivable and intercompany balances are marked to market and unrealized gains and losses are included in other income (expense), net.

Our foreign currency exchange gains and losses have been generated primarily from fluctuations in the Euro versus the USD and in the Euro versus the Pound Sterling. It is uncertain whether these currency trends will continue. In the future, we may experience foreign currency exchange losses on our accounts receivable and intercompany receivables and payables. Foreign currency exchange losses could have a material adverse effect on our business, operating results and financial condition.

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ITEM 4T.  CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management evaluated, with the participation of our Chief Executive Officer and our Principal Financial Officer, the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our Chief Executive Officer and our Principal Financial Officer have concluded that our disclosure controls and procedures are effective to ensure that information we are required to disclose in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to management as appropriate to allow for timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS

We are not a party to any material pending or threatened litigation.

ITEM 1A.  RISK FACTORS

Risks Related to Our Business

We have a history of net losses, and we may not be able to achieve profitability even if we are able to generate significant revenues and significantly reduce operating expenses.

We have incurred net losses of $29.5 million, $13.6 million and $11.4 million for the fiscal years ended June 30, 2008, 2007 and 2006, respectively, and, as of March 31, 2009, we had an accumulated deficit of approximately $96.3 million. We have financed our operations primarily through private placements of equity securities and our IPO in November 2007. We have devoted substantially all of our resources to research and development of our products and the commercialization of RADIESSE^® and our other products. We expect to continue operating at a net loss at least during fiscal 2009 and may continue do so in the future.

On November 6, 2008, in response to general economic conditions and the impact on our business, we announced a cost reduction plan designed to reduce annual operating expenses by up to $20.0 million per year, through, at least, fiscal 2010. As part of this plan, we reduced our workforce by 36 employees, and reduced operating expenses through the suspension and deferral of various programs throughout virtually all functions of the organization. These reductions could have a material and adverse impact on our future operating performance. If we are unable to maintain or grow revenue from existing products and launch new products while incurring operating expenses at our current and planned lower levels, the timing of, or our ability to achieve, profitability would be adversely affected. We cannot assure you that we will be able to achieve or sustain profitability even if we are able to generate significant revenues. Our failure to maintain or grow revenue or to achieve and sustain profitability would negatively impact the market price of our common stock and require us to seek additional funding, if such funding is then available to us on terms acceptable to us or at all, and the potential difficulty in raising additional funding has increased due to recent adverse conditions in the equity and credit markets.

We have a limited operating history, and we expect our financial condition and operating results to fluctuate on a quarterly and annual basis in potentially unpredictable ways.

We were incorporated in 1999 and commenced operations in 2000. From 2001 to 2003, we received certain U.S. and international regulatory approvals for, and engaged in commercial sales of, RADIESSE^® and COAPTITE^®. We obtained FDA pre-market approval, or PMA, for our key commercial application of RADIESSE^®, the correction of moderate to severe facial wrinkles and folds, in December 2006. Accordingly, we have a limited history of operations upon which to evaluate our business. Our operating results may fluctuate significantly in the future as a result of a variety of factors, many of which are outside of our control. Factors relating to our business that may contribute to quarterly and annual fluctuations include the following factors:

• the rate of market adoption of RADIESSE^® and other future products that we may offer;

• the success of products competitive with RADIESSE^® that are now available or that may become commercially available in the future;

• the timing of regulatory clearances or approvals and success of the introduction of new products;

• the effectiveness of promotional and marketing campaigns by us or our competitors;

• seasonal variations in demand;

• the overall strength of the minimally-invasive aesthetics market, generally, and the strength of the dermal filler market, specifically;

• changes in general economic conditions and the related impact on discretionary spending on elective procedures; and

• the performance of our independent distributors, partners and suppliers.

The current economic slowdown in the United States and our major international markets has led to lower consumer spending that has been responsible for a decline in demand for certain cosmetic procedures and, consequently, the decline in some aesthetic product makers’ results of operations, including our own. A significant shortfall in demand for our products could have an immediate and material adverse effect on our business, results of operations and financial condition. We have implemented plans to reduce our operating expenses significantly, but we may not be successful in reducing operating expenses in the time frame, or to the extent, anticipated. We may not be able to compensate adequately for any unexpected

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shortfall in revenue, or to maintain and grow revenues while fully implementing our cost saving measures. Accordingly, a significant shortfall in demand for our products, as well as the implementation of operating expense reductions, could have an immediate and material adverse effect on our business, results of operations and financial condition. Due to the various factors mentioned above, and others, the results of any prior quarterly or annual periods, or guidance regarding expectations of future results, should not be relied upon as an indication of our future operating performance.

If the current slowdown in demand for medical aesthetic procedures in general, or RADIESSE^® procedures in particular, lasts longer than anticipated, our future operating performance will be adversely impacted.

The success of our business depends on consumer demand for medical aesthetic procedures, which is highly sensitive to macroeconomic conditions. The current worldwide economic slowdown has led to lower consumer discretionary spending and a decline in dermal filler procedures in recent quarters. While we believe that there is pent-up demand and the beginnings of a recovery in the aesthetics market, the demand for dermal filler procedures may not return to historic levels of growth, even if there is an economic recovery. Turmoil in financial markets, declining consumer confidence, negative wealth effects of declines in housing values and the stock market, and other factors could further weaken medical aesthetics procedure demand, on both a short and long term basis. The macroeconomic weakness in the world economy and current worldwide financial market uncertainty may last longer than we anticipate, or have a greater adverse effect on our revenues and operating results than we anticipate.

While we believe that we may be winning market share from our competitors, and that the recent slowdown in demand for RADIESSE^® is the result of lower consumer demand for cosmetic procedures generally, the decline could also reflect a weakening of our competitive position or physician or patient preference for other products. If the declining revenue is due to competitive factors rather than overall demand for cosmetic procedures, then we may not see the increase in revenue that we would otherwise expect with a recovery in the U.S. and international economies and consumer demand for aesthetic procedures.

If RADIESSE^® and our other products fail to compete effectively and gain greater market adoption, our business will suffer.

RADIESSE^® currently is our primary product, and we expect it to remain so for the next several years. RADIESSE^® competes against products that are more established and accepted within our target markets.

Our largest direct competitors in the key U.S. market include Allergan, Medicis, and Johnson & Johnson, and there are many other companies that compete directly or indirectly with us or that are likely to compete with us in the near future, both in the United States and internationally. Many of our current and future competitors have significantly greater financial resources, reputation and experience in the aesthetics market than we do, as well as broader aesthetic product offerings. Competing effectively will require us to distinguish our company and RADIESSE^® from our competitors and their products, which will be dependent on factors such as:

• the safety, effectiveness and ease of use of RADIESSE^® and duration of cosmetic benefit;

• patient and physician satisfaction with RADIESSE^® compared to other injectable aesthetic products and alternative treatments;

• the cost of RADIESSE^® to our physician customers relative to alternative products and the price that those physicians, in turn, charge for the corresponding procedure;

• the effectiveness of our sales and marketing efforts;

• our ability to obtain additional regulatory approvals and promote RADIESSE^®;

• our ability to co-promote our filler along with complementary products that we may seek to introduce;

• our ability to establish a strong and widely-recognized reputation for RADIESSE^® and our company as a whole;

• our ability to offer a broader portfolio of aesthetic products;

• the results and publication in prominent journals of clinical studies that may be conducted by us or our competitors comparing RADIESSE^® with competing products;

• intellectual property protection; and

• the overall size and rate of growth of the dermal filler market.

Our other current products are, and contemplated future products, including a combination of RADIESSE^® and Lidocaine, Polidocanol, RELAXED EXPRESSIONS^TM and BIOGLUE AESTHETIC^TM, will be, subject to similar competitive risks as RADIESSE^®. If we are unable to effectively distinguish RADIESSE^®, or any of our other current or future products, from those of our competitors, we are unlikely to gain significant market share and our prospects for growth would be harmed. Moreover, if we are unable to offer a broader set of aesthetic products, we will likely be unable to gain significant additional share of the aesthetics market.

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Our largest competitors enjoy sales and marketing advantages that could make it difficult for us to compete effectively and which could result in our future performance not meeting our expectations.

Even if we are able to demonstrate to a potential user that our product is superior to alternatives offered by competitors, we may not be able to convert the potential user to our product. Our largest competitors enjoy sales and marketing advantages that could influence patients and physicians to choose their products over ours, regardless of relative safety and effectiveness of the products. For example, our largest competitors have implemented expensive national direct-to-consumer marketing campaigns to promote their dermal filler products. These campaigns may lead consumers to develop a strong brand preference for an alternate product even before their initial visit with a physician.

Competitors have also influenced physician practice through aggressive promotional campaigns that offer significant discounts to physicians who choose their products over competing products. Some competitors also have the ability to influence a physician’s practice by co-promoting, or bundling, the sale of two different but related products, such as a dermal filler and a botulinum toxin. Bundling of complementary products may permit these companies to enjoy efficiencies with respect to their sales and marketing efforts, may permit unique discounting and cross-selling opportunities, and reinforce company and brand loyalty. We believe that the products we have under development, including Polidocanol, RELAXED EXPRESSIONS™ and BIOGLUE AESTHETIC™ will significantly enhance our competitive position. However, even if we are able to commercialize and co-promote new products, we may be unable to generate expected sales and our financial performance may suffer due to various other competitive factors, including pricing, patient satisfaction and customer loyalty to the products of our competitors. List price reductions, volume discounting and bundling discounts, along with our own volume discount promotions, have in the past contributed to, and may in the future contribute to, a decline in RADIESSE^® selling prices.

Competition in the aesthetics market is characterized by frequent product introductions, and products not yet available could result in significant additional competition.

Our current and future competitors will introduce new products or new formulations of existing products that will result in near-term and long-term increased competition. While there are a number of competing dermal fillers in the United States, there are many others available internationally. Some of the dermal fillers available domestically and internationally claim to have benefits that may be perceived as equivalent to or better than other leading dermal fillers, including RADIESSE^®, based upon such factors as durability, cost, comfort, scope of approved marketing claims or ease of treatment. If dermal fillers are perceived to offer benefits that are equivalent to or better than RADIESSE^®, demand for, and revenue derived from, RADIESSE^® could be harmed. The frequent introduction of dermal fillers may create market confusion that may make it more difficult to differentiate the benefits of RADIESSE^® over competing products. In addition, the entry of multiple products and new competitors may lead some of our competitors to adopt pricing strategies that could adversely impact pricing in the filler marketplace generally.

The failure of RADIESSE^® to meet physicians’ or patients’ expectations, or to provide a compelling alternative to competitors’ products, could inhibit demand for RADIESSE^® and negatively impact our financial performance.

Most procedures performed using RADIESSE^® are elective procedures, the cost of which must be borne by the patient and are not reimbursable through government or private health insurance. The decision to undergo a RADIESSE^® procedure is thus driven by patient demand for an aesthetics procedure, and patients often play a central role in the selection of the dermal filler to be used.

Our future success depends upon patients having a positive experience with RADIESSE^®. We believe that patients who have a positive experience with RADIESSE^® may be more likely to return for additional treatments and refer new patients, which we believe would increase physician demand for RADIESSE^®. However, results obtained from a RADIESSE^® procedure will vary depending on the experience and technique of the treating physician, the volume of dermal filler injected, the patient’s expectations of the results that will be achieved, and the duration of the results. Patients may be dissatisfied with their RADIESSE^® treatment experience if immediate or long-term results do not match their expectations, if they find the procedure too painful, or if they find that the temporary side-effects of treatment such as swelling and bruising outweigh the benefit received. Additionally, we believe that patient demand for RADIESSE^® is, in many cases, influenced by price. Treatment with a single syringe of RADIESSE^® may cost a patient more than treatment with a single syringe of many other dermal fillers. If a RADIESSE^® treatment produces results that do not meet physicians’ and patients’ expectations, or if physicians and patients generally believe it is too expensive for the results obtained, our reputation, repeat sales, word of mouth referral opportunities and future sales could suffer.

While initial response to our two new product offerings, 1.5cc RADIESSE^® Volume Advantage and 0.8cc RADIESSE^® Moderate Fill, has been generally positive, and we believe that they will enhance our competitive position, we cannot predict whether this implementation of our competitive strategy will be perceived by physicians and patients as a sufficiently compelling value proposition to significantly alter their purchasing behavior, or to result in a meaningful advantage over our competition, increased market share, or enhanced operating performance.

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Negative perception regarding RADIESSE^®, even if unfounded, may inhibit adoption.

Gaining physician confidence and converting new accounts is important to our ability to significantly enhance our competitive position and our opportunity for significant growth in our business. There are many dermal filler products and alternate treatments from which to choose for facial aesthetic applications. Practitioners must believe that RADIESSE^® presents an attractive alternative before they will recommend it to their patients. The rate of physician adoption of RADIESSE^® may be adversely affected by negative perception of the product, even if such perception is unfounded. Practitioners may be influenced by the negative comments of another practitioner, which may lead them to not adopt the product.

Moreover, because we cannot control how practitioners use RADIESSE^®, there is a risk that practitioners or patients could develop negative perceptions regarding RADIESSE^® on the basis of treatments for which RADIESSE^® is not suitable and has not received regulatory approval. For instance, there have been published reports of lumpiness associated with the use of RADIESSE^® injected into the lips, a type of treatment for which RADIESSE^® has not been approved. Competitors have in the past promoted their dermal filler products by criticizing RADIESSE^®, and we expect that means of competition to continue into the future. If practitioners believe that RADIESSE^® is unsafe, ineffective, unsatisfactory, too expensive, difficult to use or inappropriate for certain applications, they may not adopt it, which could result in our future sales not meeting our expectations.

Dermal filler injections generally may be painful to the patient and many practitioners consider adoption of pain reduction practices to be important. Several companies have developed fillers that incorporate Lidocaine in some fashion to reduce pain upon injection. If a physician or other practitioner perceives Radiesse^® injection to be more painful than injection of alternative fillers, or if we are delayed in obtaining approval to market our Radiesse^® product mixed with Lidocaine, we may be at a competitive disadvantage. We recently presented the results of a clinical trial evaluating the safety and effectiveness of mixing Lidocaine with RADIESSE^® dermal filler. This 50-patient split-face trial at two clinical sites demonstrated that RADIESSE^® dermal filler mixed with Lidocaine was found to be less painful than RADIESSE^® dermal filler not mixed with Lidocaine, while having comparable aesthetic correction. The results were recently submitted to the FDA as a PMA supplement. We cannot predict the likelihood or timing of FDA approval of this supplement. If we do not obtain FDA approval to market this product, or, if approved, if this treatment is not commercially successful, we may not be successful at competing with other dermal fillers that may have integral Lidocaine which could have a material adverse impact on our future operating results.

Study results finding RADIESSE^® preferable to competing products may not lead to an increase in market share.

While we have recently conducted and published clinical studies that we believe demonstrate the advantages of RADIESSE^® over other leading dermal fillers, the publication and promotion of these study results may not lead to increased market share. Physicians and patients may not be persuaded by our clinical study data to demand RADIESSE^® over our competitors’ products. A number of factors, including price, marketing practices and name recognition, past experience, perception and other factors may lead potential customers to choose our competitors’ products, instead. Additionally, a competitor may perform its own study that contradicts the results of our previously published studies.

A substantial part of our operating expenses are related to sales, marketing and clinical education. If we are not as successful or effective as our competitors in these activities, our revenue may be lower than expected.

Our ability to achieve significant growth in revenues depends, in large part, on our success in recruiting, training and retaining experienced and productive direct sales personnel. Our marketing organizations in the United States and Europe compete with much larger, more established and better funded marketing activities by larger competitors. If our sales representatives take longer than expected to reach anticipated productivity, if they fail to compete effectively for the time and attention of physicians and office representatives, or if they fail to meet expectations, we may not achieve our revenue goals.

We believe that clinical confidence in the use of RADIESSE^® is important in physician adoption of RADIESSE^®, and we invest substantial resources in clinical education activities. Our efforts to train physicians may not be adequate or successful in increasing physician confidence and comfort in using RADIESSE^® frequently in their practice. Even if physician confidence in RADIESSE^® increases, that may not result in more orders since the decision to choose a product is dependent upon many factors beyond just clinical comfort and confidence.

Our failure to retain or effectively utilize our sales representatives, marketing and clinical education personnel, or our failure to compete effectively in physician, patient and office staff awareness of RADIESSE^® could have a material adverse effect on our sales and results of operations.

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We may incur significant additional sales and marketing expenses if and when we launch new products.

We believe that our ability to increase revenue on current products and successfully launch new products without incurring significant additional sales and marketing expenses is a key to our transition to profitability. While we believe that our existing sales and marketing infrastructure will allow us to increase revenue on current products and successfully launch new products, we may need to incur significant additional costs for sales and marketing to accomplish these goals. We base our belief regarding the adequacy of our existing sales and marketing organization on a number of assumptions, which may or may not prove to be correct. For example, we believe that, if and when approved by the FDA, our Polidocanol product will be widely adopted without significant marketing expense because awareness of Polidocanol is already high in vein centers and dermatologists are performing a significant number of sclerotherapy procedures. We also believe that our sales organization will be able to commercialize the product, despite our limited commercial experience in selling pharmaceuticals and complying with pharmaceutical specific compliance regulations. Additionally, we believe that our existing sales and marketing organization, which is accustomed to selling relatively inexpensive disposable products like RADIESSE^®, will be able to effectively market and sell RELAXED EXPRESSIONS™, a more expensive capital equipment product, if and when it is approved. However, we may be incorrect about these and other assumptions we have made about the market for our new product candidates. If our assumptions are incorrect, then we may decide that our existing sales and marketing infrastructure is inadequate and incur significant additional sales and marketing expenses that would adversely affect our results of operations, and the timing of, or our ability to achieve, profitability.

To successfully market and sell RADIESSE^® internationally, we must address additional risks associated with operations in foreign countries.

International sales accounted for 17%, 19%, and 19% of our total revenue for fiscal 2007, fiscal 2008 and the first nine months of fiscal 2009, respectively. We believe that a significant portion of our business will continue to come from international sales through increased penetration in countries where we currently sell RADIESSE^®, combined with expansion into new international markets. In several countries in Europe, we have a direct sales organization. We principally rely on third party distributors to sell our products outside of Europe. Our success internationally is subject to a number of risks, including:

• difficulties in penetrating markets in which our competitors’ products are more established;

• intense competition, including with products that are not available in the United States that may claim to offer benefits similar to or better than RADIESSE^®, and with products that may be sold at substantially lower prices than RADIESSE^®;

• maintaining existing and obtaining new foreign certification and regulatory clearances and approvals;

• difficulties in managing international operations;

• difficulties identifying effective distributors and managing distributor relationships;

• export restrictions, trade regulations and foreign tax laws;

• reduced or no protection for intellectual property rights in some countries;

• fluctuating foreign currency exchange rates; and

• political and economic instability.

Our other current products are, and contemplated future products will be, subject to similar international risks as RADIESSE^®. If we are unable to effectively manage the risks associated with international operations, we may be unable to effectively sell RADIESSE^® outside of the United States, causing our revenue to be lower than expected and harming our results of operations.

We depend on single manufacturer relationships for supply of our CaHA particles. Any disruption of these relationships could affect our ability to supply product and could harm our business.

We currently depend on a single contract manufacturer, Tulsa Dental Specialties, for the small CaHA particles used in RADIESSE^® and a single contract manufacturer, CAM Implants, for the larger CaHA particles used in COAPTITE^®, our CaHA bulking agent for the treatment of female stress urinary incontinence. Our agreement with Tulsa Dental Specialties runs through May 2010 and then renews for an additional two-year term, unless terminated pursuant to its terms. Our agreement with CAM Implants runs through November 2009 and renews each year for a further year unless terminated pursuant to its terms. Neither agreement is terminable at will by either party. Our reliance on these manufacturers subjects us to several unpredictable risks, the occurrence of any of which could lead to a disruption of our operations, including:

• delays in production of CaHA particles that meet our specifications or failure to meet rigorous regulatory requirements;

• fluctuation in production quantity or quality due to changes in demand from us or their other customers;

• the inability to meet our production needs, if demand for RADIESSE^® or COAPTITE^® increases significantly;

• our CaHA manufacturers’ failure to comply with the terms of the contracts, or the termination thereof pursuant to the terms of the contracts;

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• damage to, or other interruption of, operations at a particular facility; and

• increases to the price that we pay for the production of CaHA.

Efforts that we may undertake to negotiate terms of supply in the future or to reduce our reliance on these manufacturers could harm our relationships with them. Obtaining alternate manufacturers would be an expensive and lengthy process and would require additional regulatory approvals, which may not be obtained. We could experience production delays related to the evaluation and testing of CaHA particles from alternate manufacturers and obtaining corresponding regulatory qualifications. Any interruption in the supply of CaHA or our inability to obtain CaHA from alternate sources at acceptable prices, in a timely manner, could impair our ability to meet the demand of our customers, which would have an adverse effect on our business.

We depend on Boston Scientific to market and sell COAPTITE^®, and if Boston Scientific is not successful or reduces its efforts to sell COAPTITE^®, our revenues will be harmed.

We currently depend on Boston Scientific to sell COAPTITE^®, the sales of which constituted less than 10% of our revenues for fiscal 2007, fiscal 2008, and the first nine months of fiscal 2009. Boston Scientific is a very large corporation. While we believe our relationship with Boston Scientific is in good standing, COAPTITE^® represents an immaterial amount of Boston Scientific’s overall revenue and Boston Scientific may in the future determine that resources currently directed to selling COAPTITE^® should be redirected to higher priority projects or they may lack motivation to grow or maintain sales of COAPTITE^®. If this were to occur, our expectations of future COAPTITE^® revenues would be harmed.

We do not expect our acquisition of an RF-nerve lesion product to result in significant revenue unless we obtain an additional FDA clearance and are able to demonstrate to physicians and patients that the product is an attractive alternative to existing treatments.

In April 2008, we acquired substantially all of the assets of Advanced Cosmetic Intervention, or ACI and its licensor JNJ Technologies. The RELAXED EXPRESSIONS™ device is currently cleared via a 510(k) by FDA to create RF heat lesions in nerve tissue. While we believe this technology will ultimately offer patients an attractive alternative therapy to Botox for the treatment of frown lines, the product cannot be marketed for uses beyond its current 510(k) indication without specific additional 510(k) clearance. We expect to conduct clinical studies to support a FDA application and other foreign applications for clearance to begin marketing this product for the treatment of frown lines in 2010. However, these clinical studies will be expensive and time consuming and may not yield results that would lead the FDA to approve a 510(k) application for the treatment of frown lines. We also expect to engage in clinical evaluation of the device to ensure that it has consistent, predictable and compelling treatment outcomes prior to full commercial launch. If we do not receive this additional FDA clearance, or if the clearance is delayed or limited in scope, or our clinical evaluation is not favorable, our marketing efforts will be significantly limited, and expectation of future revenue from this product will be harmed.

Additionally, while we believe that there are compelling synergies between this product and RADIESSE^®, we cannot predict how successful we will be in marketing this new product to our target customer base. Historically, we have sold RADIESSE^®, a relatively inexpensive disposable device, and therefore cannot judge how successful we will be in selling the RELAXED EXPRESSIONS™ device, a relatively expensive capital equipment product. Factors such as price of the product and of the treatment, clinical trial results and journal publications, regulatory clearances, early adopter experience, the effectiveness of our sales force and our marketing efforts, physician and patient loyalty to alternative products, and competitive response will all impact our ability to successfully commercialize this product. While we anticipate that this product could have a significant revenue impact on our business once an FDA clearance for the treatment of frown lines is obtained, we may never achieve a significant positive revenue impact from this product.

If we are unable to commercialize Polidocanol, an investigational sclerotherapy drug that has recently completed its Phase III clinical trial, our expectation of future revenue growth would be harmed.

An important part of our strategy includes the successful introduction to the U.S. market of Polidocanol, an injectable sclerosing drug for the treatment of varicose veins. We have acquired the exclusive U.S. distribution rights to Polidocanol from its German manufacturer, Kreussler. Although Polidocanol has been used internationally for decades, it is not currently approved for sale in the United States. We cannot sell Polidocanol in the United States before a new drug application, or NDA, is approved by the FDA. The development and regulatory approval of a new drug is subject to a number of risks and is never certain.

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In order to support the NDA submission, the manufacturer of Polidocanol conducted a Phase III clinical trial for the use of Polidocanol in treating spider and reticular veins. The trial was conducted based on a design resulting from Kreussler’s communication with the FDA regarding a special protocol assessment, or SPA. Several risks still remain regarding FDA’s review of the clinical study including:

• Kreussler has limited experience conducting clinical trials pursuant to FDA requirements and obtaining FDA approvals;

• Kreussler, or the contract clinical research organization managing the study, may have failed to follow proper protocols or may have failed to fully and properly execute the clinical study;

• the FDA may determine in its clinical trial inspections that the trial was not adequately performed or may raise other questions from its clinical review of the trial data; and

• the FDA may find that the clinical data does not demonstrate to its satisfaction the safety and efficacy of the product.

If the FDA requires further clinical trials prior to approval, we may be subject to a number of risks, including:

• any future trial would be designed and conducted by Kreussler, so decisions that could affect the success of the trial would be outside of our control;

• any future trial may fail to meet its primary or secondary endpoints for effectiveness or may otherwise not meet the rigorous statistical criteria established with the FDA; or

• undesirable side effects or safety issues might arise that might delay or adversely effect future approval.

In addition to the clinical data review, Kruessler must submit the required manufacturing documentation to complete the NDA filing. While we expect Kruessler’s manufacturing documentation submission to be completed in the fourth quarter of fiscal 2009 and we anticipate FDA approval during calendar 2010, the timing and success of these prerequisites to commercialization are subject to uncertainties that are outside of our control including:

• delays may occur in completing validations and submitting manufacturing documentation;

• the FDA may require further tests or validation of the manufacturing facilities or processes; or

• the manufacturing equipment, facilities or processes may need to be modified or revalidated and documentation resubmitted to gain approval by the FDA.

We have experienced delays in the past due to manufacturing validations and documentations associated primarily with activities at a contract manufacturer working with Kreussler. The anticipated NDA filing in the fourth quarter of Fiscal 2009 is subject to the outcome of certain manufacturing process validations, and any further required process validation work or additional documentation could further delay the NDA submission. A delay in NDA submission or of FDA approval would delay the U.S. introduction of the product and could harm our expected future operations.

Sales of Polidocanol, if approved by FDA, may be adversely impacted by multiple competitive products including pharmacy compounded materials available at low cost to physicians.

Even if Polidocanol receives FDA approval, our success in marketing and selling the product will be subject to a number of further risks. Despite the success of Polidocanol internationally, and its safety and efficacy profile, physicians in the United States may not choose Polidocanol over other sclerotherapy products currently available in the United States, or over the use of generic pharmacy compounded Polidocanol, for a number of reasons, including price sensitivity or satisfaction with the existing products. If we are not able to achieve significant sales of Polidocanol, our expected future operating performance would be adversely affected.

We are developing BIOGLUE AESTHETIC™ for aesthetics applications, and we cannot provide assurance that we will be successful in our goal of commercializing the product candidate.

We have acquired exclusive U.S., Canadian and European distribution rights for aesthetics applications of BIOGLUE AESTHETIC™, a Class III medical device, from CryoLife. Although the FDA cleared BIOGLUE^® in 2001 as an adjunct to sutures and staples for use in open surgical repair of large vessels, these clearances may not be used to promote aesthetic applications. We intend to seek FDA clearance for the use of BIOGLUE AESTHETIC™ for aesthetic applications, and hope to obtain such clearance by approximately 2012 or 2013, but we are at an early stage in our development efforts. Our timing for clearance has been delayed from an anticipated 2011 date by our implementation of cost-saving measures. We have completed a 30-patient feasibility study to evaluate the safety and effectiveness of BIOGLUE AESTHETIC™ as a method for tissue fixation in patients undergoing browplasty. We are in the process of designing a pivotal clinical study to support FDA approval. Even though we believe the results of our feasibility study generated encouraging data, a positive pivotal study may not produce safety or effectiveness data that would be adequate to support FDA approval.

Even if we are able to obtain FDA clearance for tissue fixation in browplasty or any other application for which we might seek approval, the commercialization effort may be difficult. The use of a surgical adhesive in aesthetics applications will be novel, and would require physicians to migrate from existing and well-accepted surgical methods. If we are not successful at any stage of our efforts, clinical, regulatory or commercial, BIOGLUE AESTHETIC™ will not develop into a meaningful component of our business.

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We are developing a combination of RADIESSE^® and Lidocaine and other future forms of RADIESSE^® products, and we cannot provide assurance that we will be successful in our goal of commercializing the product candidate or candidates.

We have conducted a clinical trial to support FDA approval for a combination of RADIESSE^® and Lidocaine, the results from which have been submitted to the FDA under a PMA supplement. We believe we may be able to begin selling this product in the second half of calendar year 2009, but the timing and receipt of FDA approval for such a combination product is subject to risks associated with any medical device new product development initiative. Uncertainties in product development may include manufacturing, regulatory, or clinical trial risks, including the potential for adverse safety events or negative or ambiguous results. Furthermore, even if we receive FDA approval for a combination of RADIESSE^® and Lidocaine, there is no assurance that this product will prove commercially successful. Our other future forms of RADIESSE^® or derivative products also involve significant product development risks and uncertainties and may not be successfully developed or commercially successful.

If we are unable to hire and retain key employees, our ability to manage and expand our business will be harmed.

Our success largely depends on the skills, experience and efforts of our officers and other key employees, including Steve Basta, our Chief Executive Officer, Dennis Condon, our President and Chief Business Officer, and Adam Gridley, Senior Vice President, Corporate Development, along with our ability to retain these employees and to hire new employees to fill significant needs as we grow our business. We may not be able to attract or retain qualified management, sales, finance and technology personnel in the future due to intense competition for hiring experienced personnel. Additionally, any of our officers and other employees may terminate their employment at any time. The loss of any of our senior management team members could weaken our management expertise and harm our business.

We may acquire additional products or product candidates in the future, and any costs associated with the acquisition or any difficulty integrating operations could reduce our revenues, increase our costs and harm our operating results.

We have acquired or in-licensed several of our current products and product candidates. In order to grow our business, we intend to acquire or in-license additional products and product candidates that we believe have significant commercial potential and that complement our existing products and products under development. Any growth through acquisitions or in-licensing will be dependent upon the continued availability of suitable acquisition or in-license product candidates at favorable prices and upon advantageous terms and conditions. Integrating any newly-acquired product or product candidate could be expensive and time-consuming. Other companies, many of which may have substantially greater resources and reputation, compete with us for the right to acquire and in-license products or product candidates. Any cash acquisition we pursue would diminish the resources available to us for other uses, and any stock acquisition would dilute our stockholders’ ownership. Our future product development efforts also could result in large and immediate write-offs, incurrence of debt and contingent liabilities or amortization of expenses related to intangible assets, any of which could increase our expenses and adversely affect our results of operations and financial condition.

We could become involved in product liability suits, which could result in expensive and time consuming litigation, payment of substantial damages and an increase in our insurance rates.

Product liability litigation in the medical device industry is common, and from time to time, we may receive complaints or be named in lawsuits claiming that our products failed to provide the desired outcome or were in some manner associated with an adverse outcome for the patient. These claims could divert management’s attention from our core business, be expensive to defend and result in sizable damage awards against us. We maintain product liability insurance with liability coverage limits that we believe are adequate and customary for the nature of our business, and we submit these claims to our insurance carrier. However, we may not have sufficient insurance coverage for all future claims, and we may not be able to obtain additional or expanded insurance in amounts or scope sufficient to provide us with adequate coverage against all potential liabilities. Any product liability claims brought against us, with or without merit, could increase our product liability insurance rates or prevent us from securing continuing coverage, could harm our reputation in the industry and reduce product sales. Product liability claims in excess of our insurance coverage would be paid out of cash reserves, harming our financial condition and reducing our operating results.

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Risks Related to Regulatory Matters

If we fail to maintain necessary FDA approvals or if we fail to comply with applicable federal and state regulations, we could be subject to enforcement action and our commercial operations would be harmed.

We have obtained FDA pre-market approvals and 510(k) clearances for our products for several indications. However, our approvals and clearances could be revoked if safety concerns arise. The FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by the FDA or state agencies, which may include any of the following actions:

• warning letters, adverse publicity, fines, injunctions, consent decrees and civil penalties;

• repair, replacement, refunds, recall or seizure of our product;

• operating restrictions or partial suspension or total shutdown of production;

• refusing our requests for 510(k) clearance or pre-market approval of new products, new intended uses or modifications to our existing product;

• withdrawing 510(k) clearance or pre-market approvals that have already been granted; and

• criminal prosecution.

Our FDA approvals for RADIESSE^® and COAPTITE^® contain certain requirements for post-approval studies of the long-term safety and/or efficacy of those products. Clinical studies conducted after approval are subject to the same risks as clinical studies conducted prior to approval; for example, such studies may be delayed or halted if the product is shown not to be effective, if patients experience unacceptable side affects or if patients do not enroll in the studies at the rate we expect. In addition, the FDA may alter the parameters of the post-approval studies, including by requiring different endpoints, inclusion criteria, or study sizes, all of which may affect the cost of conducting such trials. These post-approval studies thus have the potential to reduce our revenues, increase our expenses, and render our approved products not commercially viable.

Additionally, administration of our products by healthcare professionals is subject to regulations that vary by state. For example, federal regulations allow our products to be sold to, or on the order of, “licensed practitioners,” as determined on a state-by-state basis. As a result, in some states, non-physicians may legally administer RADIESSE^®. However, a state could change its regulations at any time, disallowing sales to particular types of healthcare professionals. If we sell our products to practitioners who are not permitted by state regulation to perform the treatment, we could be subject to enforcement action.

Polidocanol, a part of our product pipeline, will be regulated as a pharmaceutical by the FDA, when and if approved in the United States.

Pharmaceutical companies are subject to significant regulation by a number of national, state and local governments and agencies. The FDA administers requirements covering testing, manufacturing, safety, effectiveness, labeling, storage, record keeping, approval, sampling, advertising and promotion of products. Several states have also instituted laws and regulations covering some of these same areas. Failure to comply with applicable regulatory requirements could, among other things, result in:

• fines;

• changes to advertising;

• suspensions of regulatory approvals of products;

• product withdrawals and recalls;

• delays in product distribution, marketing and sale and

• civil or criminal sanctions.

If we want to expand our marketing claims, we will need to obtain additional FDA clearances or approvals, which may not be granted.

We are developing additional formulations of our CaHA technology. Before a new use of or claim for a product can be marketed in the United States, it must first receive FDA approval. The marketing of a product for an indication or application that has not received approval will be viewed as “off-label promotion” and could subject us to an FDA enforcement action, including the issuance of a warning letter and adverse publicity. In addition, any modifications that we may make to the

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formulation of RADIESSE^® or its manufacturing that would significantly affect its safety or effectiveness or that would constitute a major change in its intended use will require a new FDA approval. The FDA may require us to conduct clinical trials to support new indications or formulations, such trials may be time-consuming and expensive, and may produce results that do not result in approval of our FDA application. Delays in obtaining future approvals would adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn would harm our revenue and potential future profitability. In the event that we do not obtain additional FDA approvals for future indications or uses, our ability to promote our products in the United States and to grow our revenue could be limited.

If we or our third-party manufacturers fail to comply with the FDA’s Quality System Regulation, our business would suffer.

We and our third-party manufacturers are required to demonstrate and maintain compliance with the FDA’s Quality System Regulation, or QSR. The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and shipping of our product. The FDA enforces the QSR through periodic unannounced inspections. We and our third-party manufacturers have been, and in the future will be, subject to such inspections. Our failure, or the failure of our third-party manufacturers, to take prompt and satisfactory corrective action in response to an adverse QSR inspection could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our product, civil or criminal penalties or other sanctions, which would cause our sales and business to suffer.

We may not be able to obtain or maintain international regulatory qualifications or approvals for our products, which could harm our business.

Sales of our products outside the United States are subject to foreign regulatory requirements that vary widely from country to country. The foreign regulatory approval process may include all of the risks associated with obtaining FDA clearance or approval, in addition to other risks. Complying with international regulatory requirements can be an expensive and time consuming process, and approval is not certain. The time required to obtain foreign clearances or approvals may exceed the time required for FDA clearance or approval, and requirements for such clearances or approvals may differ significantly from FDA requirements. Foreign regulatory authorities may not clear or approve our product for the same uses cleared or approved by the FDA. Although we have obtained approval to affix the CE Mark to RADIESSE^® for use in the European Union, we may not be able to maintain such approval.

We may not be able to obtain permission to affix the CE Mark to new products or to modifications of RADIESSE^®. In addition, we may fail to obtain any additional regulatory qualifications, clearances or approvals or to comply with additional legal obligations required by the individual member countries of the European Union or other countries in which we seek to market our products. The FDA also regulates the import and export of drugs and medical devices from the United States. If we are not successful in obtaining and maintaining foreign regulatory approvals or complying with United States import and export regulations, our business will be harmed.

Foreign regulatory agencies periodically inspect manufacturing facilities both in the United States and abroad. We may fail to pass inspections of our facilities by applicable regulatory authorities or entities both in the United States and in other countries. Delays in receiving necessary qualifications, clearances or approvals to market our products outside the United States, or the failure to receive those qualifications, approvals, or to comply with other foreign regulatory requirements, could limit or prevent us from marketing our products or enhancements in international markets. Additionally, the imposition of new requirements could significantly affect our business and our product, and we might not be able to adjust to such new requirements. If we fail to comply with applicable foreign regulations, we could face substantial penalties, and our business, operations and financial condition could be adversely affected.

Risks Related to Our Intellectual Property

Intellectual property rights provide us with only limited protection against competition.

While we attempt to protect our products through patents and other intellectual property rights, there are few barriers to entry that would prevent new entrants or existing competitors from developing products that compete directly with ours. For example, while we believe our CaHA-based dermal filler technology maintains a strong intellectual property position, there are companies employing competing technologies that claim to have a similar clinical effect to ours which are not CaHA-based. There are also competitive products incorporating calcium based materials such as CaHA in formulations that may be designed to circumvent our patents. In addition, our patents covering the core technologies used in RADIESSE^® and COAPTITE^® expire in the United States beginning in 2012, and internationally beginning in 2013, with the last-to-expire U.S. patent expiring in 2020. Expired patents will not prevent competitors from legally introducing products based on this technology. As a result, we believe that we will have to continually innovate and improve our products and technologies and file new patent applications and obtain new patents relating to such innovations and technologies to maintain intellectual property protection and to compete successfully.

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Patent applications may not issue as patents or, if issued, may not issue in a form that will be advantageous to us. Any patents we obtain may be challenged, invalidated or legally circumvented by third parties. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by consultants, vendors, former employees or current employees, despite the existence generally of confidentiality agreements, security measures and other contractual restrictions, and any litigation that we initiate to protect our intellectual property may be costly, time consuming for management and may not be successful.

Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, third parties may independently develop similar technologies. Moreover, we do not have patent rights in all foreign countries in which a market may exist, and where we have applied for foreign patent rights, the laws of many foreign countries will not protect our intellectual property rights to the same extent as the laws of the United States.

We may be involved in future costly intellectual property litigation, which could impact our future business and financial performance.

Our industry has been characterized by frequent intellectual property litigation. For example, we were involved in litigation with one of our competitors, Artes Medical, over rights to intellectual property underlying both of our companies’ lead products, which resulted in the execution of a settlement and license agreement with Artes Medical in 2005. Our competitors or other patent holders may in the future assert that RADIESSE^® and the methods we employ are covered by their patents. If our products are found to infringe, we could be prevented from marketing them or have to pay substantial license fees or royalties to a third party. We may also initiate litigation against third parties to protect our own intellectual property. Companies may market products for competing purposes in a direct challenge to our intellectual property position, and we may be required to initiate litigation in order to stop them. The unauthorized use of our intellectual property could reduce or eliminate any competitive advantage we have, cause us to lose sales, or otherwise harm our business. Our intellectual property has not been fully tested in court. If we initiate litigation to protect our rights, we run the risk of having our patents invalidated, which would undermine our competitive position.

Litigation related to infringement and other intellectual property claims, with or without merit, is unpredictable, can be expensive and time-consuming and could divert management’s attention from our core business. If we lose this kind of litigation, a court could require us to pay substantial damages and prohibit us from using technologies essential to RADIESSE^®, any of which would have a material adverse effect on our business, results of operations and financial condition. We do not know whether necessary licenses would be available to us at all or on satisfactory terms, or whether we could redesign RADIESSE^® or processes to avoid infringement.

Risks Related to Our Common Stock and Being a Public Company

We expect that the price of our common stock will fluctuate substantially.

The market price of our common stock is likely to be highly volatile and may fluctuate substantially due to many factors, including:

• volume and timing of RADIESSE^® sales;

• the introduction of new products or product enhancements by us or our competitors;

• disputes or other developments with respect to our intellectual property rights or the intellectual property rights of others;

• product liability claims or other litigation;

• quarterly variations in our or our competitors’ results of operations;

• sales of large blocks of our common stock, including sales by our executive officers and directors;

• developments in our industry;

• changes in governmental regulations or in the status of our regulatory approvals or applications;

• changes in earnings estimates or recommendations by securities analysts; and

• changes in the economy, credit availability, and consumer sentiment and purchasing patterns; and

• significant fluctuations in the overall stock markets that may lead investors to buy or sell our stock even in the absence of any changes in our results or outlook; and

• general market conditions and other factors, including factors unrelated to our operating performance or the operating performance of our competitors.

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These and other factors may make the price of our stock volatile and subject to unexpected fluctuation.

If our public guidance or our future operating performance does not meet investor expectations, our stock price could decline.

If our actual results do not meet our public guidance, or our guidance or actual results do not meet the expectations of third-party financial analysts, our stock price could decline significantly. Our business typically has a short sales cycle, so that we do not have significant backlog of orders at the start of a quarter, and our ability to sell RADIESSE^® successfully is subject to many uncertainties, as discussed in these risk factors. Additionally, our public guidance is based, in part, on assumptions regarding matters outside our control, like macroeconomic conditions. If our assumptions are incorrect (as, for example, would be the case if the current economic slowdown persists longer than we anticipate), our guidance could be significantly and adversely affected. In light of these factors, it is difficult for us to estimate with accuracy our future results. Our expectations regarding these results will be subject to numerous risks and uncertainties that could make actual results differ materially from those anticipated.

Our financial and disclosure controls and procedures are expensive to implement and may not be sufficient to ensure timely and reliable reporting of financial information, which could materially harm our stock price and NASDAQ listing.

We are required to comply with the Sarbanes-Oxley Act of 2002, or Sarbanes-Oxley Act, and the related rules and regulations of the SEC, including the requirements that we maintain disclosure controls and procedures and adequate internal control over financial reporting. We are also required to comply with marketplace rules and corporate governance standards of NASDAQ. Compliance with the Sarbanes-Oxley Act and other SEC and NASDAQ requirements is expensive and requires significant management resources. The effectiveness of our controls and procedures implemented to comply with these requirements may in the future be limited by a variety of factors, including:

• faulty human judgment and simple errors, omissions or mistakes;

• fraudulent action of an individual or collusion of two or more people;

• inappropriate management override of procedures; and

• the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial information.

If we are unable to complete the required assessment as to the adequacy of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act, or if we fail to maintain internal control over financial reporting, our ability to produce timely, accurate and reliable periodic financial statements could be impaired, and we could be subject to NASDAQ delisting, SEC investigation and civil or criminal sanctions. Additionally, our ability to obtain additional financing could be impaired. A lack of investor confidence in the reliability and accuracy of our public reporting could cause our stock price to decline.

Our directors, officers and principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders.

Our officers, directors and principal stockholders each holding more than 5% of our common stock collectively control more than a majority of our outstanding common stock. As a result, these stockholders, if they act together, will be able to control the management and affairs of our company and most matters requiring stockholder approval, including the election of directors and approval of significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change in control and might adversely affect the market price of our common stock. This concentration of ownership may not be in the best interests of our other stockholders.

Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and Bylaws, and Delaware law, contain provisions that could discourage a takeover or frustrate any attempt by stockholders to change the directors or management of our company.

Our amended and restated certificate of incorporation and bylaws, and Delaware law, contain provisions that might enable our management to resist a takeover and might make it more difficult for an investor to acquire a substantial block of our common stock to cause changes in our management team or corporate strategy. These provisions include:

• a classified board of directors;

• advance notice requirements to stockholders for matters to be brought at stockholder meetings;

• a supermajority stockholder vote requirement for amending certain provisions of our amended and restated certificate of incorporation and bylaws;

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• limitations on stockholder actions by written consent;

• provisions permitting the issuance of blank check preferred shares without stockholder consent; and;

• the right to issue preferred stock without stockholder approval, which could be used to dilute the stock ownership of a potential hostile acquirer.

We are also subject to the provisions of Section 203 of the Delaware General Corporation Law that, in general, prohibit any business combination or merger with a beneficial owner of 15% or more of our common stock unless the holder’s acquisition of our stock was approved in advance by our board of directors. These provisions might discourage, delay or prevent a change in control of our company or a change in our management. The applicability of these provisions could adversely affect the voting power of holders of common stock and limit the price that investors might be willing to pay in the future for shares of our common stock.

We have a large number of authorized but unissued shares of stock.

Our certificate of incorporation provides for 100,000,000 shares of authorized common stock. The issuance of additional shares of common stock may have a dilutive effect on earnings per share and relative voting power. There are no current plans to issue any additional shares of common stock, other than increases from time to time in the number of shares that are reserved for issuance under our equity incentive plans. However, we could use the shares of common stock that are available for future issuance in dilutive equity financing transactions, or to oppose a hostile takeover attempt or delay or prevent changes in control or changes in or removal of management, including transactions that are favored by a majority of the stockholders or in which the stockholders might otherwise receive a premium for their shares over then-current market prices or benefit in some other manner.

In addition, our certificate of incorporation provides for 10,000,000 shares of preferred stock, all of which are available for future issuance. Although there are currently no plans to do so, our board of directors may, without further stockholder approval, issue up to 10,000,000 shares of preferred stock with such rights, preferences and privileges as our board may determine. These rights, preferences and privileges may include dividend rights, conversion rights, voting rights and liquidation rights that may be greater than the rights of our common stock. As a result, the rights of holders of our common stock are subject to, and could be adversely affected by, the rights of holders of any preferred stock that may be issued in the future.

We have not paid dividends in the past and do not expect to pay dividends in the future, and any return on investment may be limited to the value of our stock.

We have never paid cash dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future. The payment of dividends on our common stock will depend on our earnings, financial condition and other business and economic factors affecting us at such time as our board of directors may consider relevant. If we do not pay dividends, our stock may be less valuable because a return on your investment will only occur if our stock price appreciates.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None applicable.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None applicable.

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ITEM 4. OTHER INFORMATION

None applicable.

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BIOFORM MEDICAL, INC.

ITEM 5. EXHIBITS

Exhibit No.	Description
31.01	Certification of Chief Executive Officer under Securities Exchange Act Rule 13a-14(a).
31.02	Certification of Principal Financial and Accounting Officer under Securities Exchange Act Rule 13a-14(a).
32.01	Certification of Chief Executive Officer pursuant to 18 U.S. C. 1350 and Securities Exchange Act Rule 13a-14(b).
32.02	Certification of Principal Financial and Accounting Officer pursuant to 18 U.S. C. 1350 and Securities Exchange Act Rule 13a-14(b).

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

BioForm Medical, Inc.

Date: MAY 13, 2009	By:	/s/ STEVEN L. BASTA
		STEVEN L. BASTA
		CHIEF EXECUTIVE OFFICER
		(PRINCIPAL EXECUTIVE OFFICER)
Date: MAY 13, 2009	By:	/s/ FREDERICK LWEE
		FREDERICK LWEE
		PRINCIPAL FINANCIAL OFFICER
		(PRINCIPAL FINANCIAL AND ACCOUNTING OFFICER)

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EX-31.01

Exhibit 31.01

CERTIFICATION OF EXECUTIVE OFFICER PURSUANT TO RULE 13A-14(A) OF THE

SECURITIES EXCHANGE ACT AND SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Steven L. Basta, Chief Executive Officer of registrant, certify that:

1. I have reviewed this quarterly report on Form 10-Q of BioForm Medical, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including any consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: MAY 13, 2009	By:	/s/ STEVEN L. BASTA
		STEVEN L. BASTA
		Chief Executive Officer

EX-31.02

Exhibit 31.02

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO RULE 13A-14(A) OF THE

SECURITIES EXCHANGE ACT AND SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Frederick Lwee, Principal Financial Officer of registrant, certify that:

1. I have reviewed this quarterly report on Form 10-Q of BioForm Medical, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including any consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting;

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: MAY 13, 2009	By:	/S/ FREDERICK LWEE
		FREDERICK LWEE
		Principal Financial Officer

EX-32.01

Exhibit 32.01

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350

The undersigned, Steven L. Basta, Chief Executive Officer of BioForm Medical, Inc. (the “Company”), pursuant to 18 U.S.C. §1350, hereby certifies that:

(i) the Quarterly Report on Form 10-Q for the period ended March 31, 2009 of the Company (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934.

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: MAY 13, 2009	By:	/s/ STEVEN L. BASTA
		STEVEN L. BASTA
		Chief Executive Officer

EX-32.02

Exhibit 32.02

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO

18 U.S.C. SECTION 1350

The undersigned, Frederick Lwee, Principal Financial Officer of BioForm Medical, Inc. (the “Company”), pursuant to 18 U.S.C. §1350, hereby certifies that:

(i) the Quarterly Report on Form 10-Q for the period ended March 31, 2009 of the Company (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934.

(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: MAY 13, 2009	By:	/s/ FREDERICK LWEE
		FREDERICK LWEE
		Principal Financial Officer