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BioCardia, Inc. Index

Key Takeaway: December 31, 2015 and 2014 Page Report of Independent Registered Public Accounting Firm 2 Balance Sheets 3 Statements of Operations 4 Statements of Convertible Preferred Stock and Stockholders' Deficit 5 Statements of Cash Flows 6 Notes to Financial Statements 7 Report of Inde

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December 31, 2015 and 2014
Page
Report of Independent Registered Public Accounting Firm 2
Balance Sheets 3
Statements of Operations 4
Statements of Convertible Preferred Stock and Stockholders' Deficit 5
Statements of Cash Flows 6
Notes to Financial Statements 7
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
We have audited the accompanying balance sheets of BioCardia, Inc. as of December 31, 2015 and 2014, and the related statements of operations, convertible preferred stock and stockholders' deficit, and cash flows for the years then ended. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of BioCardia, Inc. as of December 31, 2015 and 2014, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in note 1(c) to the financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in note 1(c). The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
San Francisco, California
October 17, 2016, except for Note 19(d), as to which the date is October 27, 2016
(In thousands, except share and per share amounts)
December 31,
2015 2014
Assets
Current assets:
Cash and cash equivalents $ 3,557 3,184
Accounts receivable, net of allowance for doubtful accounts of $4 and $0 for the years ended, December 31, 2015 and 2014, respectively. 107 172
Inventory 759 677
Prepaid expenses and other current assets 246 367
Deferred financing costs - 48
Total current assets 4,669 4,448
Property and equipment, net 150 72
Other assets 43 43
Total assets $ 4,862 4,563
Liabilities, Convertible Preferred Stock and Stockholders' Deficit
Current liabilities:
Accounts payable $ 542 314
Accrued liabilities 692 1,003
Deferred rent 30 22
Deferred revenue 39 39
Convertible preferred stock warrant liability 275 558
Maturity date preferred stock warrant liability 10 -
Convertible shareholder notes derivative liability 1,044 -
Convertible shareholder notes, net of debt discount of $1,528 and $0 for the years ended, December 31, 2015 and 2014, respectively. 5,672 7,500
Total current liabilities 8,304 9,436
Deferred rent - 31
Total liabilities 8,304 9,467
Convertible preferred stock, $0.001 par value, 38,930,696 shares authorized, 98,354,514 issued and outstanding; liquidation preference of $46,020 - 38,213
Stockholders' deficit:
Convertible preferred stock, $0.001 par value, 43,502,124 shares authorized, 110,500,514 shares issued and outstanding, liquidation preference of $46,019 46,030 -
Common stock, $0.001 par value, 60,000,000 shares authorized, 18,947,536 and 18,494,023 shares issued and outstanding at December 31, 2015 and 2014, respectively 19 18
Additional paid-in capital 341 -
Accumulated deficit (49,832 ) (43,135 )
Total stockholders' deficit (3,442 ) (43,117 )
Total liabilities, convertible preferred stock and stockholders' deficit $ 4,862 4,563
See accompanying notes to financial statements.
Statements of Operations
Years ended December 31, 2015 and 2014
2015 2014
Revenue:
Net product revenue $ 860 787
Collaboration agreement revenue 44 35
Total revenue 904 822
Costs and expenses:
Cost of goods sold 1,061 1,181
Research and development 1,518 1,523
Selling, general and administrative 3,734 4,467
Total costs and expenses 6,313 7,171
Operating loss (5,409 ) (6,349 )
Other income (expense):
Write-off of deferred financing costs (1,634 ) -
Interest expense (1,386 ) (269 )
Change in fair value of convertible preferred stock warrant liability 274 56
Change in fair value of maturity date preferred stock warrants liability 87 -
Change in fair value of convertible shareholder notes derivative liability 1,373 -
Other expense (2 ) -
Total other income (expense), net (1,288 ) (213 )
Net loss $ (6,697 ) (6,562 )
Net loss attributable to common stockholders $ (6,697 ) (10,206 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.36 ) (0.55 )
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 18,723,511 18,489,993
See accompanying notes to financial statements.
BIOCARDIA, INC.
Statements of Convertible Preferred Stock and Stockholders' Deficit
Years ended December 31, 2015 and 2014
(In thousands, except share data)
Convertible preferred stock Convertible preferred stock Common stock Additional
Shares Cost Shares Cost Shares Cost paid in capital Accumulated deficit Total
Balance at December 31, 2013 - $ - 97,482,546 $ 34,000 18,481,552 $ 18 1,376 (34,543 ) 851
Reclassification from permanent equity to temporary equity 97,482,546 34,000 (97,482,546 ) (34,000 ) - - - - (34,000 )
Accretion of convertible preferred stock to redemption value - 3,644 - - - - (1,614 ) (2,030 ) (3,644 )
Exercise of convertible preferred stock warrants for series F preferred shares 871,995 569 - - - - - - -
Exercise of stock options - - - - 12,471 - - - -
Stock-based compensation - - - - - - 238 - 238
Net loss - - - - - - - (6,562 ) (6,562 )
Balance at December 31, 2014 98,354,541 38,213 - - 18,494,023 18 - (43,135 ) (43,117 )
Reclassification from temporary equity to permanent equity (98,354,541 ) (38,213 ) 98,354,541 38,213 - - - - 38,213
Conversion of convertible notes into series F preferred shares - - 12,075,610 7,781 - - - - 7,781
Exercise of convertible preferred stock warrants for series D preferred shares - - 67,884 34 - - - - 34
Exercise of convertible preferred stock warrants for series F preferred shares - - 2,479 2 - - - - 2
Exercise of stock options - - - - 453,513 1 58 - 59
Stock-based compensation - - - - - - 283 - 283
Net loss - - - - - - - (6,697 ) (6,697 )
Balance at December 31, 2015 - - 110,500,514 46,030 18,947,536 19 341 (49,832 ) (3,442 )
See accompanying notes to financial statements.
BIOCARDIA, INC.
Statements of Cash Flows
Years ended December 31, 2015 and 2014
(In thousands)
2015 2014
Operating activities:
Net loss $ (6,697 ) (6,562 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 47 47
Change in fair value of convertible preferred stock warrant liability (274 ) (56 )
Change in fair value of maturity date preferred stock warrant liability (87 ) -
Change in fair value of convertible shareholder notes derivative liability (1,373 ) -
Stock based compensation 283 238
Non-cash interest expense on convertible shareholder notes 1,387 269
Changes in operating assets and liabilities:
Accounts receivable 65 78
Inventory (82 ) (37 )
Prepaid expenses and other current assets (129 ) (15 )
Deferred financing costs 48 (48 )
Accounts payable 228 195
Accrued liabilities excluding accrued interest on convertible note (416 ) (105 )
Deferred revenue - 39
Deferred rent (23 ) 9
Net cash used in operating activities (7,023 ) (5,948 )
Investing activities:
Purchase of property and equipment (125 ) (53 )
Net cash used in investing activities (125 ) (53 )
Financing activities:
Proceeds from the exercise of convertible preferred stock warrants 27 562
Proceeds from issuance of convertible notes and warrants 7,435 7,250
Proceeds from the exercise common stock options 59 -
Net cash provided by financing activities 7,521 7,812
Net increase in cash and cash equivalents 373 1,811
Cash and cash equivalents at beginning of year 3,184 1,373
Cash and cash equivalents at end of year $ 3,557 3,184
Supplemental disclosure for cash flow activities:
Cash paid for income taxes $ 1 1
Supplemental disclosure for noncash investing and financing activities:
Convertible shareholder notes funds received subsequent to year end - 250
Conversion of convertible shareholder note and related accrued interest payable 7,781 -
Accretion of series F convertible preferred stock - 3,644
See accompanying notes to financial statements.
BioCardia was incorporated in Delaware in March 2002. The Company is a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. Its lead therapeutic candidate is the CardiAMP cell therapy system and its second therapeutic candidate for heart failure is the CardiALLO cell therapy system. To date the Company has devoted substantially all of its resources to research and development efforts relating to its therapeutic candidates and biotherapeutic delivery systems including conducting clinical trials, developing manufacturing and sales capabilities, in-licensing related intellectual property, providing general and administrative support for these operations and protecting its intellectual property.
The Company has two enabling device product lines: the Helix biotherapeutic delivery system ("Helix") product line offers a catheter system for the local delivery of cells, gene and protein therapeutics to the heart; and the Morph vascular access ("Morph") product line offers advanced catheter products for interventional medicine. The Helix biotherapeutic delivery system is available for commercial sale in Europe and is approved for investigational use in the United States. The Morph line consists of the Morph Universal Deflectable Guide Catheter and the Morph AccessPro steerable introducer. The Morph Universal Deflector Guide Catheter and the Morph AccessPro steerable introducer lines currently generate commercial revenues. The Morph Universal Deflectable Guide Catheter is sold commercially in the United States. The Morph AccessPro steerable introducer line is sold commercially in the Unites States and in Europe.
These financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions.
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. The Company has incurred significant net losses and negative cash flows from operations since its inception and had an accumulated deficit of $49.8 million as of December 31, 2015 that raise substantial doubt about its ability to continue as a going concern. Management expects operating losses and negative cash flows to continue through at least 2018.
As discussed in Note 19, on August 22, 2016 the Company signed an Agreement and Plan of Merger with Tiger X. Upon closing of the Merger, which is anticipated in October 2016, the combined company is expected to have approximately $23 million in additional capital. Management believes cash as of December 31, 2015, when combined with the cash raised in connection with the Merger, is sufficient to fund the Company through at least the next twelve months. The Company also plans to raise other additional capital potentially including debt and equity arrangements, to finance the Companies future net cash needs. If adequate funds are not available, the Company may be required to reduce operating expenses, delay or reduce the scope of its product development programs, obtain funds through arrangements with others that may require the Company to relinquish rights to certain of its technologies or products that the Company would otherwise seek to develop or commercialize itself, or cease operations. While the Company believes in the viability of its strategy to raise additional funds, there can be no assurances to that effect. The accompanying financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The preparation of the financial statements in accordance with GAAP requires Company management to make certain estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ materially from those estimates. Significant items subject to such estimates and assumptions include the useful lives of fixed assets; allowances for doubtful accounts and sales returns; inventory valuation and reserves; fair value of the convertible preferred stock warrant liability; fair value of the maturity date preferred stock warrant liability; fair value of the convertible shareholder notes derivative liability; share-based compensation; and valuation of inventory.
The Company classifies all highly liquid investments with original maturities of three months or less at the date of purchase as cash equivalents. The Company maintains its cash and cash equivalents with reputable financial institutions.
Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company considers the creditworthiness of its customers, but does not require collateral in advance of a sale. The Company evaluates collectability and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable portfolio when necessary. The estimate is based on the Company's historical write-off experience, customer creditworthiness, facts and circumstances specific to outstanding balances and payment terms. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The allowance for doubtful accounts was approximately $4,000 and $0 as of December 31, 2015 and 2014, respectively. Account balances written off totaled $0 and $1,000 during the year's ended December 31, 2015 and 2014, respectively.
Inventory is stated at the lower of cost or market. Cost is determined using the average-cost method. The Company analyzes its inventory levels quarterly and writes down inventory that has become obsolete or has a cost basis in excess of its expected net realizable value or inventory quantities in excess of expected requirements. Excess requirements are determined based on comparison of existing inventories to forecasted sales, with consideration given to inventory shelf life. Expired inventory is disposed of and the related costs are recognized in cost of goods sold.
Deferred financing costs represent direct costs associated with future issuances of our corporate securities. Direct costs include, but are not limited to the legal, accounting and printing costs. Indirect costs associated with future issuance of corporate securities are expensed as incurred. Upon the completion of the proposed issuances, the deferred financing costs will be offset against the proceeds from the security issuance. If the proposed issuances are not completed, the deferred financing costs will be charged to expense. The Company deferred costs incurred for an initial public offering ("IPO") of common stock totaling approximately $1,586,000 and $48,000 in 2015 and 2014, respectively. In 2015, the IPO was delayed and subsequently withdrawn. The deferred offering costs for that offering in the amount of $1,634,000 were expensed in 2015.
Property and equipment, net are carried at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets, as described in the table below. Maintenance and repairs are expensed as incurred. When assets are retired or otherwise disposed of, the cost and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is reflected in the accompanying statements of operations:
Asset Estimated useful lives (in years)
Computer equipment and software 3
Laboratory and manufacturing equipment 3
Furniture and fixtures 3
Leasehold improvements 5 years or lease term, if shorter
The Company evaluates long-lived assets such as property and equipment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset and its eventual disposition is less than the carrying amount. When undiscounted future cash flows are not expected to be sufficient to recover an asset's carrying amount, the asset is written down to its fair value. Where available, quoted market prices are used to determine fair value. When quoted market prices are not available, various valuation techniques, including the discounted value of estimated future cash flows, are utilized. There have been no impairments of the Company's long-lived assets in any of the years presented.
As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors and consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiation and may result in payment flows that do not match the periods over which materials or services are provided by the vendor under the contracts. The Company's objective is to reflect the clinical trial expenses in its financial statements by matching those expenses with the period in which the services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company makes estimates of its accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances known at that time. Although, the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services relative to the actual status and timing of services performed may vary and may result in reported amounts that differ from the actual amounts incurred.
Fair value accounting requires bifurcation of embedded derivative instruments such as conversion features in equity instruments and warrants granted, and measurement of their fair value. In determining the appropriate fair value, the Company uses Monte Carlo simulation to calculate potential payouts in each of the three conversion scenarios. In cases where the payout includes newly created equity shares and warrants, the Black-Scholes based option pricing method is used to calculate the amounts due to investors. Derivative instruments are subsequently adjusted to reflect fair value at the end of each reporting period. Any increase or decrease in the fair value is recorded in results of operations as a change in the fair value of derivatives. Once a derivative liability ceases to exist any remaining fair value is reclassified to additional paid-in capital if redeemed or through earnings if forfeited or expired.
The Company's lease for its facility provides for fixed increases in minimum annual rental payments. The total amount of rental payments due over the lease term is charged to rent expense ratably over the life of the lease. Deferred rent consists of the difference between cash payments and the recognition of rent expense on a straight-line basis.
The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred, the price to the buyer is fixed or determinable, and collection from the customer is reasonably assured.
Net product revenue - The Company currently has a portfolio of enabling and delivery products. The Company recognizes revenue from product sales when title and risk of loss have passed to the customer, which typically occurs upon delivery. Product sale transactions are evidenced by customer purchase orders, customer contracts, invoices and/or related shipping documents.
Revenue is recognized net of provisions made for discounts, expected sales returns and allowances. Estimated returns and allowances are based on historical experience and other relevant factors. The Company accepts returns for unused, unopened and resellable product in its original packaging, subject to a restocking fee. The sales returns reserve was approximately $3,000 and $5,000 as of December 31, 2015 and 2014, respectively.
Amounts received from customers in advance of revenue recognition are recorded as deferred revenue on the balance sheet.
Collaboration agreement revenue - Collaboration agreement revenue is income from agreements under partnering programs with corporate and academic institutions, wherein the Company provides biotherapeutic delivery systems and customer training and support for their use in clinical trials and studies. These programs provide additional clinical data, intellectual property rights and opportunities to participate in the development of combination products for the treatment of cardiac disease. The Company evaluates activities under these agreements to determine if they represent a multiple element arrangement by identifying the deliverables included within the agreements. The Company accounts for these deliverables as separate units of accounting if the following two criteria are met:
Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the customer could use the delivered item for its intended purpose without receipt of the remaining deliverables.
If an arrangement includes multiple deliverables that are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting based on their relative selling prices and recognizes the associated revenue when the appropriate recognition criteria are met for those deliverables. The amount of allocable arrangement consideration is limited to the amounts that are fixed and determinable.
Costs incurred for the shipping of products to customers totaled approximately $11,000 and $16,000 in 2015 and 2014, respectively, and are included in cost of goods sold in the accompanying statements of operations.
The Company provides a standard warranty of serviceability on all its products for the duration of the product's two year shelf life. Estimated future warranty costs, if any, are accrued and charged to cost of goods sold in the period that the related revenue is recognized. Historical data and trends of product reliability and costs of repairing or replacing defective products are considered. Due to the low historical warranty claims experience, a general warranty accrual has not been required or recorded.
The Company's research and development costs are expensed as incurred. Research and development expense includes the costs of basic research activities as well as other research, engineering, and technical effort required to develop new products or services or make significant improvement to an existing product or manufacturing process. Research and development costs also include pre-approval regulatory and clinical trial expenses and support costs for collaborative partnering programs wherein the Company provides biotherapeutic delivery systems and customer training and support for their use in clinical trials and studies. The Company's research and development costs consist primarily of:
The Company measures and recognizes stock-based compensation expense for equity awards to employees, directors and consultants based on fair value at the grant date. Nonemployee awards are remeasured at each reporting date. The Company uses the Black-Scholes-Merton ("BSM") option pricing model to calculate fair value. Stock-based compensation expense recognized in the statements of operations is based on options ultimately expected to vest, taking into consideration estimated forfeitures, and is recognized in the period the services are performed. Stock-based compensation expense is revised in subsequent periods, if necessary, if actual forfeitures differ from these estimates. When estimating forfeitures, the Company considers historic voluntary termination behaviors as well as trends of actual option forfeitures. For options granted to nonemployees, the Company revalues the unearned portion of the stock-based compensation and the resulting change in fair value is recognized in the statements of operations over the period the related services are rendered.
The BSM option pricing model requires the input of highly subjective assumptions, including the risk-free interest rate, the expected volatility in the value of the Company's common stock, and the expected term of the option. These estimates involve inherent uncertainties and the application of management's judgment. If factors change and different assumptions are used, our stock-based compensation expense could be materially different in the future. These assumptions are estimated as follows:
Risk-free Interest Rate
The risk free interest rate assumption is based on the zero-coupon U.S. Treasury instruments appropriate for the expected term of the stock option grants.
As the Company does not have a trading history for its common stock, the expected stock price volatility is estimated based on volatilities of a peer group of similar companies by taking the average historic volatility for these peers for a period equivalent to the expected term of the stock option grants. The peer group was developed based on companies in the biotechnology and medical device industries whose shares are publicly-traded.
The expected term represents the period of time that options are expected to be outstanding. As the Company does not have sufficient historical experience for determining the expected term of the stock options awards granted, the expected life is determined using the simplified method, which is an average of the contractual terms of the option and its ordinary vesting period.
Common Stock Valuation
Due to the absence of a public market for the Company's common stock, it is necessary to estimate the fair value of the common stock underlying the stock-based awards when performing fair value calculations using the BSM option pricing model. The fair value of the common stock underlying the stock-based awards was assessed on each grant date by management and the Company's board of directors. All options to purchase shares of the Company's common stock have been granted with an exercise price per share no less than the fair value per share of the common stock underlying those options on the grant date.
In the absence of a public trading market for the Company's common stock, the estimated fair value was determined using methodologies, approaches and assumptions consistent with American Institute of Certified Public Accountants, or AICPA, Audit and Accounting Practice Aid Series: Valuation of Privately Held Company Equity Securities Issued as Compensation, or the AICPA Practice Aid. These estimates require considerable judgment and the consideration of numerous objective and subjective factors to determine fair value. The Company engages third-party consultants with the requisite expertise to assist in the valuations. These estimates will not be necessary to determine fair value of new awards once the underlying shares are publicly traded.
The Company accounts for income taxes based on the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets, liabilities, operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized.
In evaluating the ability to recover its deferred income tax assets, the Company considers all available positive and negative evidence, including its operating results, forecasts of future taxable income, and ongoing tax planning. In the event the Company was to determine that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, it would make an adjustment to the valuation allowance, which would reduce the provision for income taxes. Conversely, in the event that all or part of the net deferred tax assets are determined not to be realizable in the future, an adjustment to the valuation allowance would be charged to earnings in the period such determination is made.
The Company recognizes and measures benefits for uncertain tax positions using a two-step approach. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that the tax position will be sustained upon audit, including resolution of any related appeals or litigation processes. For tax positions that are more likely than not to be sustained upon audit, the second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon settlement. Significant judgment is required to evaluate uncertain tax positions. The Company evaluates its uncertain tax positions annually. Evaluations are based upon a number of factors, including the technical merits of the tax position, changes in facts or circumstances, changes in tax law, interactions with tax authorities during the course of audits, and effective settlement of audit issues. The Company's policy is to recognize interest and penalties related to unrecognized tax benefits as a component of income tax expense in the statements of operations and accrued interest and penalties within accrued liabilities in the balance sheets. No such interest and penalties have been recorded to date.
The Company applies fair value accounting for all financial assets and liabilities and nonfinancial assets and liabilities that are required to be recognized or disclosed at fair value in the financial statements. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Where observable prices or inputs are not available, valuation models are applied. These valuation techniques involve some level of management estimation and judgment, the degree of which is dependent on the price transparency for the instruments or market and the instruments complexity.
The Company's financial assets and liabilities consist principally of cash and cash equivalents, accounts receivable, accounts payable, warrants for convertible preferred stock, convertible notes and the convertible shareholder notes derivative liability. The fair value of the Company's cash equivalents is determined based on quoted prices in active markets for identical assets. The recorded values of the Company's accounts receivable and accounts payable approximate their current fair values due to the relatively short-term nature of these accounts. The fair value of the Company's convertible preferred stock warrants is measured using the BSM option pricing model. Convertible notes are recorded at amortized cost. Based on borrowing rates currently available for loans with similar terms, the carrying value of convertible notes approximates fair value.
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders to by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are comprised of convertible preferred stock, notes convertible into preferred stock, warrants to purchase convertible preferred stock and options outstanding under our stock option plan. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position.
On July 2, 2015, the Company effected a 1-for-7.131 reverse stock split of the Company's common stock and convertible preferred stock. Neither the par value nor the authorized number of shares was not adjusted as a result of the reverse stock split. All issued and outstanding common stock, convertible preferred stock, warrants, stock options and per share amounts contained in the accompanying financial statements and notes to the financial statements have been retroactively adjusted to give effect to the reverse stock split for all periods presented.
In April 2015, the FASB issued ASU 2015-03 Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of the related debt liability, consistent with debt discounts, instead of being presented as an asset. Early adoption is permitted. The Company adopted ASU 2015-03 effective December 31, 2015. The adoption did not have a material impact on our financial position, results of operations or cash flows.
In August 2014, the Financial Accounting Standards Board ("FASB") issued ASU No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern, which requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity's ability to continue as a going concern within one year after the date that the financial statements are issued and provide related disclosures. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its financial statements.
In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides comprehensive guidance for revenue recognition. ASU 2014-09 affects any entity which either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets. The core principle of the guidance provides that a company should recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. Companies can adopt the new standard either using the full retrospective approach, a modified retrospective approach with practical expedients, or a cumulative effect upon adoption approach.
In August 2015, the FASB issued ASU 2015-14 Revenue from Contracts with Customers, which deferred the effective date for implementation of the standard. Nonpublic companies must apply the standard for annual reporting periods beginning after December 15, 2018 and interim reporting periods within annual reporting periods beginning after December 15, 2019. Early adoption for nonpublic entities is permitted as of an annual reporting period beginning after December 15, 2016, including interim reporting periods within that reporting period. Public entities are to apply the new standard for annual and interim reporting periods beginning after December 15, 2017 and earlier application is permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company is currently assessing the future impact of this ASU on its financial statements.
In July 2015, the FASB issued Accounting Standard Update ("ASU") No. 2015-11, "Inventory: Simplifying the Measurement of Inventory", that requires inventory not measured using either the last in, first out (LIFO) or the retail inventory method to be measured at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable cost of completion, disposal and transportation. The new standard will be effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years, and will be applied prospectively. Early adoption is permitted. The adoption of this guidance is not expected to have a material impact on our financial position, results of operations or cash flows.
In February 2016, the FASB issued ASU 2016-02 Leases (Topic 842), which supersedes existing guidance on accounting for leases in "Leases (Topic 840)" and generally requires all leases to be recognized in the consolidated balance sheet. ASU 2016-02 is effective for annual and interim reporting periods beginning after December 15, 2018; early adoption is permitted. The provisions of ASU 2016-02 are to be applied using a modified retrospective approach. The Company is currently assessing the future impact of this ASU on its financial statements.
In March 2016, the FASB issued ASU 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. The standard is intended to simplify several areas of accounting for share-based compensation arrangements, including the income tax impact, classification in the statement of cash flows and forfeitures. ASU 2016-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016, and early adoption is permitted. The Company is currently assessing the future impact of this ASU on its financial statements.
Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission, did not or are not believed by management to have a material impact on the Company's financial statement presentation or disclosures.
The fair value of financial instruments reflects the amounts that the Company estimates to receive in connection with the sale of an asset or paid in connection with the transfer of a liability in an orderly transaction between market participants at the measurement date (exit price). The Company follows 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
Level 2 - observable inputs other than quoted prices in active markets for identical assets and liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities
Level 3 - unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The following table sets forth the fair value of our financial liabilities measured on a recurring basis as of December 31, 2015 and indicates the fair value hierarchy utilized to determine such fair value.
Level 1 Level 2 Level 3 Total
Assets:
Cash and cash equivalents $ 3,557 $ - $ - $ 3,557
Liabilities:
Convertible preferred stock warrant liability $ - $ - $ 275 $ 275
Maturity date preferred stock warrant liability $ - $ - $ 10 $ 10
Convertible shareholder notes derivative liability $ - $ - $ 1,044 $ 1,044
The following table sets forth the fair value of our financial liabilities measured on a recurring basis as of December 31, 2014 and indicates the fair value hierarchy utilized to determine such fair value.
Level 1 Level 2 Level 3 Total
Assets:
Cash and cash equivalents $ 3,184 $ - $ - $ 3,184
Liabilities:
Convertible preferred stock warrant liability $ - $ - $ 558 $ 558
As discussed more fully in Notes 10, 11 and 12, the Company issued warrants to purchase preferred stock in connection with note agreements to various shareholders. The warrant liabilities were recorded at their fair value on the date of issuance and were remeasured each subsequent balance sheet date and as of the warrant exercise date, with fair value changes recognized as income (decrease in fair value) or expense (increase in fair value) in other income (expense) in the statements of operations. The Company's estimated fair value of the warrant liabilities is calculated using key assumptions, including the probability of an exit event, the enterprise value as determined on an income approach, and a discount for lack of marketability. Management, with the assistance of an independent valuation firm, made these subjective determinations based on available financial information.
As discussed more fully in Note 12, the 2015 Notes include embedded derivative features that were determined to be a compound embedded derivative requiring bifurcation and separate accounting at estimated fair value. The Company estimated the fair value of the compound embedded derivative utilizing a Monte Carlo simulation model. The inputs used to determine the estimated fair value of the compound embedded derivative instrument include the probability of an underlying event triggering the redemption event and its timing prior to the maturity date of the 2015 Notes. The fair value measurement is based upon significant inputs not observable in the market. These assumptions are inherently subjective and involve significant management judgement.
The following table sets forth the fair value of our financial liabilities that the Company remeasured on a recurring basis (in thousands):
Convertible Preferred Stock Warrant Liability Maturity Date Preferred Stock Warrant Liability Convertible Shareholder Note Derivative Liability
Fair value December 31, 2013 $ 621 $ - $ -
Warrants exercised and cancelled (7 ) - -
Change in fair value (56 ) - -
Fair value December 31, 2014 $ 558 $ - $ -
Warrants exercised and cancelled (9 )
Issuance of convertible shareholder notes - 97 2,417
Change in fair value (274 ) (87 ) (1,373 )
Fair value December 31, 2015 $ 275 $ 10 $ 1,044
In March 2014, the Company announced a voluntary recall of its Morph Access Pro (MAP) Steerable Introducer Guide Catheter due to the potential presence of loose particulates that might present health risks to patients. As a result of the voluntary recall, the Company suspended all marketing activity related to the MAP products, halted production of the devices, and implemented a recall of all non-expired product with its customers. No customers reported safety issues associated with use of the product prior or subsequent to the recall. The products were reintroduced to the market in the second half of 2014.
Customers were offered a choice of three alternatives when returning the product: receive a credit that can be applied to a current or future sale, receive a cash refund or receive an alternative replacement product at no additional cost. The estimated credits and refunds related to the product returns and the associated shipping costs were recorded as a reduction of net product sales and increase in accrued liabilities. The estimated cost of replacement devices, including shipping, was recorded in cost of goods sold and in accrued liabilities. Actual returns and costs did not materially differ from these estimates.
The carrying value of the MAP inventories on hand, both unsold inventories and inventories received from customers in the recall, has been reduced to lower of cost or market with the related charge included in cost of goods sold in the statements of operations.
The following table presents a summary of charges related to the recall recorded for the years ended December 31, (in thousands):
2015 2014
Reduction of net product sales $ - 60
Cost of goods sold - 11
Total $ - 71
Inventories are stated at the lower of cost or market using the average cost method. Inventories consist of the following at December 31, (in thousands):
2015 2014
Raw materials $ 194 339
Work in process 36 205
Finished goods 529 133
$ 759 677
Write downs for excess or expired inventory are based on management's estimates of forecasted usage of inventories and are included in cost of goods sold. A significant change in the timing or level of demand for certain products as compared to forecasted amounts may result in recording additional write downs for excess or expired inventory in the future. Charges to cost of goods sold for inventory write-downs, reserve adjustments, scrap, shrinkage and expired inventories totaled approximately $261,000 and $71,000 in 2015 and 2014, respectively.
Prepaid expenses and other current assets consisted of the following as of December 31, (in thousands):
2015 2014
Prepaid expenses $ 146 117
Refund receivable of deferred financing costs 100 -
Convertible shareholder note receivable - 250
$ 246 367
Property and equipment, net consist of the following at December 31, (in thousands):
2015 2014
Computer equipment and software $ 143 143
Laboratory and manufacturing equipment 366 274
Furniture and fixtures 48 48
Leasehold improvements 325 291
Property and equipment, gross 882 756
Less accumulated depreciation (732 ) (684 )
Property and equipment, net $ 150 72
Depreciation expense totaled approximately $47,000 for the each of the years ended December 31, 2015 and 2014.
The Company leases office and laboratory space under a non-cancelable operating lease that expires in 2016. Rent expense is recognized straight line over the life of the lease. Rental expense was approximately $266,000 for the years ended December 31, 2015 and 2014. Future minimum lease payments under the lease as of December 31, 2015 are as follows (in thousands):
Year ending December 31:
2016 $ 296
Last updated: Oct 27, 2016