Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2014 |
Summary of Significant Accounting Policies | |
Basis of Presentation and Use of Estimates | |
(a) Basis of Presentation and Use of Estimates |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Assets and liabilities which are subject to significant judgment and use of estimates include the allowance for doubtful accounts, sales return reserves, provision for warranties, valuation of inventories, recoverability of long-lived assets, valuation allowances with respect to deferred tax assets, useful lives associated with property and equipment and finite lived intangible assets, and the valuation and assumptions underlying stock-based compensation and other equity instruments. On an ongoing basis, the Company evaluates its estimates compared to historical experience and trends, which form the basis for making judgments about the carrying value of assets and liabilities. In addition, the Company engages the assistance of valuation specialists in concluding on fair value measurements in connection with stock-based compensation and other equity instruments. |
|
Liquidity | |
(b) Liquidity |
Since inception, the Company has incurred net losses. During the years ended December 31, 2014, 2013, and 2012 the Company incurred net losses of $5,811, $19,125, and $23,433, respectively. The Company provided $450 of cash in operations for the year ended December 31, 2014 and used $25,877 and $29,846 of cash in operations during the years ended December 31, 2013 and 2012, respectively. At December 31, 2014 and 2013 the Company had an accumulated deficit of $134,046 and $128,235, respectively. At December 31, 2014, the Company had cash and cash equivalents of $96,729. The Company's ability to continue to meet its obligations and to achieve its business objectives is dependent upon, amongst other things, generating sufficient revenues. The Company believes that it has the ability to continue as a going concern through at least December 31, 2015. |
|
Cash and Cash Equivalents | |
(c) Cash and Cash Equivalents |
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents consist primarily of checking accounts. |
|
Concentration of Credit and Supplier Risks | |
(d) Concentration of Credit and Supplier Risks |
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company's cash and cash equivalents are deposited in demand accounts at a financial institution that management believes is creditworthy. The Company is exposed to credit risk in the event of default by this financial institution for cash and cash equivalents in excess of amounts insured by the Federal Deposit Insurance Corporation (FDIC). Management believes that the Company's investments in cash and cash equivalents are financially sound and have minimal credit risk and the Company has not experienced any losses on its deposits of cash and cash equivalents. |
The Company currently purchases all of its Breast Products from one supplier under an exclusivity contract. The supplier and its production facility are located in Brazil. The Company is exposed to risks of foreign regulations in Brazil that could hinder the Company's ability to import goods, as well as halts or limitations in productions due to events outside of the Company's control occurring at the production facility. This could result in the Company not being able to acquire the inventory needed to meet customer demand, which would result in possible loss of sales and affect operating results adversely. Management believes that there is minimal risk of such events occurring. |
|
Fair Value of Financial Instruments | |
(e) Fair Value of Financial Instruments |
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and customer deposits are reasonable estimates of their fair value because of the short maturity of these items. The fair value of the common stock warrant liability is discussed in Note 2(f). The fair value of our long-term debt is based on the amount of future cash flows associated with the instrument discounted using our current market rate. At December 31, 2014, the carrying value of the long-term debt was not materially different from the fair value. |
|
Fair Value Measurements | |
(f) Fair Value Measurements |
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: |
• | Level 1—Quoted prices in active markets for identical assets or liabilities. | | | | | | | | | | | | |
• | Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. | | | | | | | | | | | | |
• | Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. | | | | | | | | | | | | |
The Company's common stock warrant liabilities are carried at fair value determined according to the fair value hierarchy described above. The Company has utilized an option pricing valuation model to determine the fair value of its outstanding common stock warrant liabilities. The inputs to the model include fair value of the common stock related to the warrant, exercise price of the warrant, expected term, expected volatility, risk-free interest rate and dividend yield. Prior to the IPO, the Company determined the fair value per share of the underlying common stock by taking into consideration its most recent sale of its convertible preferred stock as well as additional factors that the Company deems relevant. Subsequent to the IPO, the warrants are valued using the fair value of common stock as of the measurement date. The Company historically has been a private company and lacks company-specific historical and implied volatility information of its stock. Therefore, it estimates its expected stock volatility based on the historical volatility of publicly traded peer companies for a term equal to the remaining contractual term of the warrants. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve for time periods approximately equal to the remaining contractual term of the warrants. The Company has estimated a 0% dividend yield based on the expected dividend yield and the fact that the Company has never paid or declared dividends. As several significant inputs are not observable, the overall fair value measurement of the warrants is classified as Level 3. |
The following tables present information about the Company's liabilities that are measured at fair value on a recurring basis as of December 31, 2014 and 2013 and indicate the level of the fair value hierarchy utilized to determine such fair value: |
|
| | Fair Value Measurements as of | |
December 31, 2014 Using: |
| | Level 1 | | Level 2 | | Level 3 | | Total | |
Liabilities: | | | | | | | | | | | | | |
Liability for common stock warrants | | $ | — | | | — | | | 420 | | | 420 | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
|
|
| | Fair Value Measurements as of | |
December 31, 2013 Using: |
| | Level 1 | | Level 2 | | Level 3 | | Total | |
Liabilities: | | | | | | | | | | | | | |
Liability for common stock warrants | | $ | — | | | — | | | 90 | | | 90 | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
The following table provides a rollforward of the aggregate fair values of the Company's common stock warrants for which fair value is determined by Level 3 inputs: |
|
Fair value upon issuance during 2013 | | $ | 44 | | | | | | | | | | |
Increase in fair value through December 31, 2013 | | | 46 | | | | | | | | | | |
| | | | | | | | | | | | | |
Balance, January 1, 2014 | | | 90 | | | | | | | | | | |
Fair value of warrants upon issuance during 2014 | | | 110 | | | | | | | | | | |
Increase in fair value through December 31, 2014 | | | 220 | | | | | | | | | | |
| | | | | | | | | | | | | |
Balance, December 31, 2014 | | $ | 420 | | | | | | | | | | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
The company recognized changes in the fair value of these warrants in other (expense) income, net in the statement of operations. |
|
Property and Equipment | |
(g) Property and Equipment |
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life of the asset; generally three years. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful life of the related asset. Upon retirement or sale of an asset, the cost and related accumulated depreciation or amortization are removed from the balance sheet and any resulting gain or loss is reflected in operations in the period realized. Maintenance and repairs are charged to operations as incurred. |
|
Goodwill and Other Intangible Assets | |
(h) Goodwill and Other Intangible Assets |
Goodwill represents the excess of the purchase price over the fair value of net assets of purchased businesses. Goodwill is not amortized, but instead subject to impairment tests on at least an annual basis and whenever circumstances suggest that goodwill may be impaired. The Company's annual test for impairment is performed as of October 1 of each fiscal year. The Company makes a qualitative assessment of whether it is more likely than not that a reporting unit's fair value is less than its carrying amount before applying the two-step goodwill impairment test. If the Company concludes that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, it is not required to perform the two-step impairment test for that reporting unit. |
Under the first step of the test, the Company is required to compare the fair value of a reporting unit with its carrying amount, including goodwill. If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is not considered impaired and the second step of the test is not performed. If the results of the first step of the impairment test indicate that the fair value of a reporting unit does not exceed its carrying amount, then the second step of the test is required. The second step of the test compares the implied fair value of the reporting unit goodwill with the carrying amount of that goodwill. The impairment loss is measured by the excess of the carrying amount of the reporting unit goodwill over the implied fair value of that goodwill. |
Management evaluates the Company as a single reporting unit for business and operating purposes as all of the Company's revenue streams are generated by the same underlying products via sales in the United States of America. In addition, the majority of the Company's costs are, by their nature, shared costs that are not specifically identifiable to a geography or product line, but relate to all products. As a result, there is a high degree of interdependency among the Company's net sales and cash flows for the entity and identifiable cash flows for a reporting unit separate from the entity are not meaningful. |
Judgments about the recoverability of purchased finite-lived intangible assets are made whenever events or changes in circumstance indicate that impairment may exist. Each fiscal year the Company evaluates the estimated remaining useful lives of purchased intangible assets and whether events or changes in circumstance warrant a revision to the remaining periods of amortization. Recoverability of finite-lived intangible assets is measured by comparison of the carrying amount of the asset to the future undiscounted cash flows the asset is expected to generate. The intangible asset is amortized to the statement of operations based on estimated cash flows generated from the intangible over its estimated life. |
|
Impairment of Long-Lived Assets | |
(i) Impairment of Long-Lived Assets |
The Company's management routinely considers whether indicators of impairment of long-lived assets are present. If such indicators are present, management determines whether the sum of the estimated undiscounted cash flows attributable to the assets in question is less than their carrying value. If less, the Company will recognize an impairment loss based on the excess of the carrying amount of the assets over their respective fair values. Fair value is determined by discounted future cash flows, appraisals or other methods. If the assets determined to be impaired are to be held and used, the Company will recognize an impairment charge to the extent the present value of anticipated net cash flows attributable to the asset are less than the asset's carrying value. The fair value of the asset will then become the asset's new carrying value. There have been no impairments of long-lived assets recorded during the years ended December 31, 2014, 2013 and 2012. The Company may record impairment losses in future periods if factors influencing its estimates change. |
|
Revenue Recognition | |
(j) Revenue Recognition |
The Company sells its product directly to customers in markets where it has regulatory approval. The Company offers a six-month return policy and recognizes revenue net of sales discounts and returns in accordance with the Financial Accounting Standards Board, or FASB, Accounting Standards Codification 605, Revenue Recognition (ASC 605). ASC 605 requires that six basic criteria must be met before revenue can be recognized when a right of return exists: |
• | the seller's price to the buyer is substantially fixed or determinable at the date of sale; | | | | | | | | | | | | |
• | the buyer has paid the seller, or the buyer is obligated to pay the seller and the obligation is not contingent on resale of the product; | | | | | | | | | | | | |
• | the buyer's obligation to the seller would not be changed in the event of theft or physical destruction or damage of the product; | | | | | | | | | | | | |
• | the buyer acquiring the product for resale has economic substance apart from that provided by the seller; | | | | | | | | | | | | |
• | the seller does not have significant obligations for future performance to directly bring about resale of the product by the buyer; and | | | | | | | | | | | | |
• | the amount of future returns can be reasonably estimated. | | | | | | | | | | | | |
Appropriate reserves are established for anticipated sales returns based on historical experience, recent gross sales and any notification of pending returns. The Company recognizes revenue when title to the product and risk of loss transfer to customers, provided there are no remaining performance obligations required of the Company or any written matters requiring customer acceptance. The Company allows for the return of product from customers within six months after the original sale and records estimated sales returns as a reduction of sales in the same period revenue is recognized. Sales return provisions are calculated based upon historical experience with actual returns. Actual sales returns in any future period are inherently uncertain and thus may differ from the estimates. If actual sales returns differ significantly from the estimates, an adjustment to revenue in the current or subsequent period would be recorded. The Company has established an allowance for sales returns of $10,018 and $8,270 as of December 31, 2014 and 2013, respectively, recorded net against accounts receivable in the balance sheet. |
A portion of the Company's revenue is generated from consigned inventory of breast implants maintained at doctor, hospital, and clinic locations. The customer is contractually obligated to maintain a specific level of inventory and to notify the Company upon use. For these products, revenue is recognized at the time the Company is notified by the customer that the product has been implanted. Notification is usually through the replenishing of the inventory and the Company periodically reviews consignment inventories to confirm accuracy of customer reporting. FDA regulations require tracking the sales of all implanted products. |
Shipping and handling charges are largely provided to customers free of charge. The associated costs are viewed as part of the Company's marketing programs and are recorded as a component of sales and marketing expense in the statement of operations. For the years ended December 31, 2014, 2013 and 2012 these costs amounted to $1,305, $1,021 and $354, respectively. |
In other cases, shipping and handling charges may be invoiced to customers based on the amount of products sold. In such cases, shipping and handling fees collected are recorded as revenue and the related expense as a component of cost of goods sold. |
|
Accounts Receivable and Allowance for Doubtful Accounts | |
(k) Accounts Receivable and Allowance for Doubtful Accounts |
Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability to collect from some of its customers. The allowances for doubtful accounts are based on the analysis of historical bad debts, customer credit-worthiness, past transaction history with the customer, and current economic trends. If the financial condition of the Company's customers were to deteriorate, adversely affecting their ability to make payments, additional allowances may be required. The Company has established an allowance for doubtful accounts of $312 and $273 as of December 31, 2014 and 2013, respectively. |
|
Inventories and Cost of Goods Sold | |
(l) Inventories and Cost of Goods Sold |
Inventories represent finished goods that are recorded at the lower of cost or market on a first-in, first-out basis (FIFO). The Company periodically assesses the recoverability of all inventories to determine whether adjustments for impairment or obsolescence are required. The Company evaluates the remaining shelf life and other general obsolescence and impairment criteria in assessing the recoverability of the Company's inventory. |
The Company recognizes the cost of inventory transferred to the customer in cost of goods sold when revenue is recognized. |
At December 31, 2014 and 2013, approximately $1,989 and $528, respectively, of the Company's inventory was held on consignment at doctors' offices, clinics, and hospitals. The value and quantity at any one location is not significant. |
|
Income Taxes | |
(m) Income Taxes |
The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. |
The Company accounts for uncertain tax position in accordance with ASC 740-10, Accounting for Uncertainty in Income Taxes. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination of the position's sustainability and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of tax benefit might change as new information becomes available. |
|
Research and Development Expenditures | |
(n) Research and Development Expenditures |
Research and development costs are charged to operating expenses as incurred. Research and development, or R&D, primarily consist of clinical expenses, regulatory expenses, product development, consulting services, outside research activities, quality control, and other costs associated with the development of the Company's products and compliance with Good Clinical Practices, or GCP, requirements. R&D expenses also include related personnel and consultant compensation and stock-based compensation expense. |
|
Advertising | |
(o) Advertising |
Expenses related to advertising are charged to sales and marketing expense as incurred. Advertising costs were $1,548, $801 and $510 for fiscal years 2014, 2013 and 2012, respectively. |
|
Stock-Based Compensation | |
(p) Stock-Based Compensation |
The Company applies the fair value provisions of ASC 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all employee share-based payments, including stock options and the employee stock purchase plan. ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. All option grants valued are being expensed on a straight-line basis over their vesting period. |
|
Product Warranties | |
(q) Product Warranties |
The Company offers a limited warranty and a lifetime product replacement program for the Company's silicone gel breast implants. Under the limited warranty program, the Company will reimburse patients for certain out-of-pocket costs related to revision surgeries performed within ten years from the date of implantation in a covered event. Under the lifetime product replacement program, the Company provides no-charge replacement breast implants under a covered event. The programs are available to all patients implanted with the Company's silicone breast implants after April 1, 2012 and are subject to the terms, conditions, claim procedures, limitations and exclusions. Timely completion of a device tracking and warranty enrollment form by the patient's Plastic Surgeon is required to activate the programs and for the patient to be able to receive benefits under either program. |
The following table provides a rollforward of the accrued warranties: |
|
| | December 31, | | | | | | | |
| | 2014 | | 2013 | | | | | | | |
Beginning balance | | $ | 515 | | $ | 123 | | | | | | | |
Payment made during the period | | | (1 | ) | | — | | | | | | | |
Changes in accrual related to warranties issued during the period | | | 509 | | | 392 | | | | | | | |
Changes in accrual related to pre-existing warranties | | | (62 | ) | | — | | | | | | | |
| | | | | | | | | | | | | |
Ending balance | | $ | 961 | | $ | 515 | | | | | | | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
|
|
Deferred Equity Issuance Costs | |
(r) Deferred Equity Issuance Costs |
Deferred equity issuance costs, primarily consisting of legal, accounting and other direct fees and costs relating to the IPO, were capitalized, as incurred, in other current assets prior to the completion of the IPO. Upon completion of the IPO, $3,178 of issuance costs were capitalized, all of which were reclassified to additional-paid-in capital to offset the IPO proceeds. |
|
Segment Information | |
(s) Segment Information |
Management has determined that it has one business activity and operates in one segment as it only reports financial information on an aggregate basis to its Chief Executive Officer, who is the Company's chief operating decision maker. All tangible assets are held in the United States. |
|
Net Loss Per Share | |
(t) Net Loss Per Share |
Basic loss per share attributable to common stockholders is computed by dividing net loss by the weighted average number of common shares outstanding during each period. Diluted loss per common share is computed by dividing net loss available to common stockholders by the weighted average number of common shares and dilutive potential common share equivalents then outstanding, to the extent they are dilutive. Potential common shares consist of shares issuable upon the exercise of stock options and warrants (using the treasury stock method), and the weighted average conversion of the convertible preferred stock into shares of common stock (using the if-converted method). Dilutive loss per share is the same as basic loss per share for all periods presented because the effects of potentially dilutive items were anti-dilutive. |
|
| | December 31, | | | | |
| | 2014 | | 2013 | | 2012 | | | | |
Net loss | | $ | (5,811 | ) | $ | (19,125 | ) | $ | (23,433 | ) | | | |
Weighted average common shares outstanding, basic and diluted | | | 2,545,371 | | | 232,512 | | | 275,642 | | | | |
| | | | | | | | | | | | | |
Net loss per share attributable to common stockholders | | $ | (2.28 | ) | $ | (82.25 | ) | $ | (85.01 | ) | | | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
The Company excluded the following potentially dilutive securities, outstanding as of December 31, 2014, 2013 and 2012 from the computation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2014, 2013 and 2012 because they had an anti-dilutive impact due to the net loss attributable to common stockholders incurred for the periods. |
|
| | December 31, | | | | |
| | 2014 | | 2013 | | 2012 | | | | |
Stock options to purchase common stock | | | 1,613,544 | | | 1,422,315 | | | 1,409,047 | | | | |
Warrants for the purchase of common stock | | | 47,710 | | | 30,670 | | | — | | | | |
Convertible preferred stock (as converted to common stock) | | | — | | | 8,942,925 | | | 8,942,925 | | | | |
| | | | | | | | | | | | | |
| | | 1,661,254 | | | 10,395,910 | | | 10,351,972 | | | | |
| | | | | | | | | | | | | |
| | | | | | | | | | | | | |
|
|
Recent Accounting Pronouncements | |
(u) Recent Accounting Pronouncements |
In May 2014, the FASB issued accounting standard update 2014-09, Revenue from Contracts with Customers. The standard was issued to provide a single framework that replaces existing industry and transaction specific GAAP with a five step analysis of transactions to determine when and how revenue is recognized. This accounting standard update is expected to be effective for the Company beginning in fiscal year 2018. The Company is currently assessing the impact that the standard will have on the financial statements upon adoption of the guidance. |
In August 2014, the FASB issued accounting standard update 2014-15, Presentation of Financial Statement—Going Concern. The standard was issued to provide guidance about management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. This accounting standard updated will be effective for the Company beginning in fiscal year 2016. The Company anticipates there will be no impact on its financial statement upon adoption of this guidance. |
|