Document and Entity Information
Document and Entity Information - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 08, 2016 | Jun. 30, 2015 | |
Document Information [Line Items] | |||
Entity Registrant Name | SECOND SIGHT MEDICAL PRODUCTS INC | ||
Entity Central Index Key | 1,266,806 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Is Entity a Well-known Seasoned Issuer? | No | ||
Is Entity a Voluntary Filer? | No | ||
Is Entity's Reporting Status Current? | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 183,000 | ||
Entity Common Stock, Shares Outstanding | 36,019,086 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,015 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash | $ 239 | $ 619 |
Money market funds | 15,721 | 34,000 |
Accounts receivable | 1,501 | 708 |
Inventories, net | 8,209 | 5,722 |
Prepaid expenses and other current assets | 1,094 | 927 |
Total current assets | 26,764 | 41,976 |
Property and equipment, net | 1,432 | 1,005 |
Deposits and other assets | 49 | 88 |
Total assets | 28,245 | 43,069 |
Current liabilities: | ||
Accounts payable | 710 | 513 |
Accrued expenses | 2,068 | 1,412 |
Accrued compensation expense | 2,069 | 1,362 |
Accrued clinical trial expense | 616 | 489 |
Deferred revenue | 322 | 600 |
Deferred grant revenue | 2,197 | 4,075 |
Total current liabilities | $ 7,982 | $ 8,451 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, no par value, 10,000 shares authorized; none outstanding | ||
Common stock, no par value; 200,000 shares authorized; shares issued and outstanding: 35,942 and 35,241 at December 31, 2015 and December 31, 2014, respectively | $ 166,049 | $ 163,171 |
Common stock to be issued | 205 | 166 |
Additional paid-in capital | 27,277 | 24,590 |
Notes receivable to finance stock option exercises | (5) | (171) |
Accumulated other comprehensive loss | (581) | (474) |
Accumulated deficit | (172,682) | (152,664) |
Total stockholders' equity | 20,263 | 34,618 |
Total liabilities and stockholders' equity | $ 28,245 | $ 43,069 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Preferred stock, no par value | ||
Preferred stock, shares authorized | 10,000 | 10,000 |
Preferred stock, shares outstanding | 0 | 0 |
Preferred Stock, Shares Issued | 0 | 0 |
Common stock, no par value | ||
Common stock, shares authorized | 200,000 | 200,000 |
Common stock, shares issued | 35,942 | 35,241 |
Common stock, shares outstanding | 35,942 | 35,241 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Statement [Abstract] | |||
Net sales | $ 8,950 | $ 3,398 | $ 1,565 |
Cost of sales | 5,293 | 3,558 | 5,629 |
Gross profit (loss) | 3,657 | (160) | (4,064) |
Operating expenses: | |||
Research and development, net of grants | 3,036 | 5,041 | 3,249 |
Clinical and regulatory | 3,510 | 2,622 | 3,215 |
Selling and marketing | 8,935 | 6,845 | 3,302 |
General and administrative | 8,223 | 6,565 | 4,168 |
Total operating expenses | 23,704 | 21,073 | 13,934 |
Loss from operations | (20,047) | (21,233) | (17,998) |
Interest income | 2 | 9 | 8 |
Other income, net | $ 27 | 12 | 35 |
Interest expense on convertible promissory notes and loan payable | (1,957) | (1,589) | |
Amortization of discount on convertible promissory notes | (5,077) | $ (3,425) | |
Write-off of unamortized discount on conversion of convertible promissory notes | (6,955) | ||
Net loss | $ (20,018) | $ (35,201) | $ (22,969) |
Net loss per common share - basic and diluted | $ (0.56) | $ (1.41) | $ (1.02) |
Weighted average shares outstanding - basic and diluted | 35,637 | 25,053 | 22,521 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (20,018) | $ (35,201) | $ (22,969) |
Other comprehensive loss: | |||
Foreign currency translation adjustments | (107) | (207) | (82) |
Comprehensive loss | $ (20,125) | $ (35,408) | $ (23,051) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficiency) - USD ($) $ in Thousands | Common Stock | Common Stock Issuable | Additional Paid-in Capital | Notes Receivable for Stock Option Exercise | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Benining balance, shares at Dec. 31, 2012 | 22,375 | ||||||
Benining balance, amount at Dec. 31, 2012 | $ 85,566 | $ 6,420 | $ (351) | $ (185) | $ (94,494) | $ (3,044) | |
Issuance of shares of common stock in connection with private placement, shares | 343 | ||||||
Issuance of shares of common stock in connection with private placement, amount | $ 2,400 | 2,400 | |||||
Issuance of common stock in connection with conversion of convertible promissory notes, Shares | |||||||
Issuance of common stock in connection with conversion of convertible promissory notes, amount | $ 3,107 | 3,107 | |||||
Fair value of beneficial conversion feature in connection with convertible promissory notes | $ 10,488 | 10,488 | |||||
Exercise of stock options, shares | 332 | ||||||
Exercise of stock options, amount | $ 345 | 345 | |||||
Stock-based compensation expense | $ 770 | 770 | |||||
Notes receivable, including amount due from officer of $100 for stock option exercises, net | $ (236) | $ (236) | |||||
Common stock cancelled, shares | |||||||
Stock issued in connection with professional services, amount | |||||||
Net loss | $ (22,969) | $ (22,969) | |||||
Foreign currency translation adjustment | $ (82) | (82) | |||||
Comprehensive loss | (82) | $ (22,969) | (23,051) | ||||
Ending balance, shares at Dec. 31, 2013 | 23,050 | ||||||
Ending balance, amount at Dec. 31, 2013 | $ 88,311 | $ 20,785 | $ (587) | $ (267) | $ (117,463) | (9,221) | |
Issuance of common stock in connection with initial public offering, shares | 4,025 | ||||||
Issuance of common stock in connection with initial public offering, amount | $ 36,225 | 36,225 | |||||
Issuance costs of initial public offering | $ (4,971) | (4,971) | |||||
Fair value of warrants issued in connection with initial public offering | $ 2,772 | 2,772 | |||||
Issuance of common stock in connection with warrant exercise, shares | 2 | ||||||
Issuance of common stock in connection with warrant exercise, amount | $ 10 | 10 | |||||
Issuance of shares of common stock in connection with private placement, shares | 1,300 | ||||||
Issuance of shares of common stock in connection with private placement, amount | $ 9,099 | 9,099 | |||||
Issuance of common stock in connection with conversion of convertible promissory notes, Shares | 6,639 | ||||||
Issuance of common stock in connection with conversion of convertible promissory notes, amount | $ 33,196 | $ 33,196 | |||||
Finders' fee paid on private placement, shares | 64 | ||||||
Finders' fee paid on private placement, amount | $ 451 | $ (451) | |||||
Exercise of stock options, shares | 115 | ||||||
Exercise of stock options, amount | $ 506 | $ 506 | |||||
Stock-based compensation expense | $ 1,475 | $ 1,475 | |||||
Common stock cancelled, shares | (1) | ||||||
Common stock cancelled, amount | $ (9) | $ 9 | |||||
Stock issued in connection with professional services, shares | 22 | ||||||
Stock issued in connection with professional services, amount | $ (178) | $ 166 | |||||
Common stock issuable for services, shares | 16 | ||||||
Common stock issuable for services, amount | $ 166 | 166 | |||||
Stock grant in connection with services by a director, shares | 25 | ||||||
Stock grant in connection with services by a director, amount | $ 175 | 175 | |||||
Repayment of notes receivable for stock option exercises, net | $ (7) | (7) | |||||
Forgiveness of notes receivable from an officer for stock option exercises | $ 423 | 423 | |||||
Net loss | $ (35,201) | (35,201) | |||||
Foreign currency translation adjustment | $ (207) | (207) | |||||
Comprehensive loss | (207) | $ (35,201) | (35,408) | ||||
Ending balance, shares at Dec. 31, 2014 | 35,241 | 16 | |||||
Ending balance, amount at Dec. 31, 2014 | $ 163,171 | $ 166 | $ 24,590 | $ (171) | $ (474) | $ (152,664) | $ 34,618 |
Issuance of common stock in connection with cashless exercise of warrants, shares | 1 | ||||||
Issuance of common stock in connection with cashless exercise of warrants, amount | |||||||
Issuance of common stock in connection with warrant exercise, shares | 140 | ||||||
Issuance of common stock in connection with warrant exercise, amount | $ 702 | $ 702 | |||||
Issuance of common stock in connection with Employee Stock Purchase Plan, shares | 53 | ||||||
Issuance of common stock in connection with Employee Stock Purchase Plan, amount | $ 226 | 226 | |||||
Exercise of stock options, shares | 574 | ||||||
Exercise of stock options, amount | $ 2,782 | 2,782 | |||||
Stock-based compensation expense | $ 2,687 | 2,687 | |||||
Stock issued in connection with professional services, amount | 324 | ||||||
Common stock tendered to exercise stock options, shares | (78) | ||||||
Common stock tendered to exercise stock options, amount | $ (993) | (993) | |||||
Stock issued or issuable in connection with professional services, shares | 23 | 17 | |||||
Stock issued or issuable in connection with professional services, amount | $ 285 | $ 39 | 324 | ||||
Common stock tendered to pay taxes on stock option exercise, shares | (12) | ||||||
Common stock tendered to pay taxes on stock option exercise, amount | $ (124) | (124) | |||||
Repayment of notes receivable for stock option exercises, net | $ 166 | 166 | |||||
Net loss | $ (20,018) | (20,018) | |||||
Foreign currency translation adjustment | $ (107) | (107) | |||||
Comprehensive loss | (107) | $ (20,018) | (20,125) | ||||
Ending balance, shares at Dec. 31, 2015 | 35,942 | 33 | |||||
Ending balance, amount at Dec. 31, 2015 | $ 166,049 | $ 205 | $ 27,277 | $ (5) | $ (581) | $ (172,682) | $ 20,263 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash flows from operating activities: | |||
Net loss | $ (20,018) | $ (35,201) | $ (22,969) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of property and equipment | 335 | 279 | 316 |
Stock-based compensation | $ 2,687 | 1,475 | $ 770 |
Stock grant in connection with services by a director | 175 | ||
Forgiveness of notes receivable related to stock option exercise | 423 | ||
Amortization of discount on convertible notes payable | 5,077 | $ 3,425 | |
Non-cash interest accrued on convertible notes payable | 1,952 | $ 1,589 | |
Write off of unamortized discount on conversion of convertible promissory notes | 6,955 | ||
Common stock issued for research and development agreement | 9 | ||
Common stock issuable for services | $ 324 | $ 166 | |
Changes in operating assets and liabilities: | |||
Restricted cash | $ 163 | ||
Accounts receivable | $ (793) | $ (239) | (148) |
Grants receivable | 47 | ||
Inventories | $ (2,488) | $ (3,375) | (560) |
Prepaid expenses and other assets | (127) | (556) | (34) |
Accounts payable | 197 | 199 | (417) |
Accrued expenses | 656 | 749 | 176 |
Accrued compensation expenses | 707 | 216 | 284 |
Accrued clinical trial expenses | 127 | (2) | 29 |
Deferred revenue | (278) | 531 | $ (98) |
Deferred grant revenue | (1,878) | 4,075 | |
Net cash used in operating activities | (20,549) | (17,092) | $ (17,427) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (762) | (560) | (246) |
Proceeds (investment) in money market funds | 18,279 | (25,388) | (4,302) |
Net cash provided (used) in investing activities | $ 17,517 | (25,948) | (4,548) |
Cash flows from financing activities: | |||
Proceeds from sale of common stock | 43,295 | 2,400 | |
Proceeds from exercise of options, warrants and employee stock purchase plan options | $ 2,883 | $ 509 | 109 |
Repayment of convertible promissory note | (54) | ||
Proceeds from issuance of convertible notes payable | $ 19,519 | ||
Payment of employment taxes related to stock option exercises | $ (124) | ||
Net cash provided by financing activities | 2,759 | $ 43,804 | $ 21,974 |
Effect of exchange rate changes on cash | (107) | (207) | (82) |
Cash: | |||
Net increase (decrease) | (380) | 557 | (83) |
Balance at beginning of year | 619 | 62 | 145 |
Balance at end of year | $ 239 | $ 619 | 62 |
Non-cash financing and investing activities: | |||
Fair value of warrants issued in connection with convertible promissory notes | $ 3,107 | ||
Fair value of warrant issued as part of underwriting fee for the Company's initial public offering | $ 2,772 | ||
Fair value of beneficial conversion feature issued in connection with convertible promissory notes | $ 10,488 | ||
Employee exercise of stock options through secured promissory notes | $ 252 | ||
Principal and accrued interest on notes payable converted to common stock | $ 33,196 | ||
Common stock issued in connection with finder fees paid on private placements | 451 | ||
Common stock issued for professional services rendered in connection with initial public offering | $ 170 |
Organization and Business Opera
Organization and Business Operations | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Business Operations | 1. Organization and Business Operations Second Sight Medical Products, Inc. (“Second Sight” or “the Company”), formerly Second Sight LLC, was founded in 1998 as a limited liability company and was subsequently incorporated in the State of California in 2003. Second Sight develops, manufactures and markets implantable prosthetic devices that can restore some functional vision to patients blinded by outer retinal degenerations, such as Retinitis Pigmentosa. In 2007, Second Sight formed Second Sight (Switzerland) Sarl, initially to manage clinical trials for its products in Europe, and later to manage sales and marketing in Europe and the Middle East. As the laws of Switzerland require at least two corporate stockholders, Second Sight (Switzerland) Sarl is 99.5% owned directly by the Company and 0.5% owned by an executive of Second Sight, who is acting as a nominee of the Company. Accordingly, Second Sight (Switzerland) Sarl is considered 100% owned for financial statement purposes and is consolidated with Second Sight for all periods presented. The Company’s current product, the Argus II system, entered clinical trials in 2006, received CE Mark approval for marketing and sales in the European Union (“EU”) in 2011, and approval by the United States Food and Drug Administration (“FDA”) for marketing and sales in the United States in 2013. The Company began selling its product in Europe in 2011, in Saudi Arabia in 2013, in the United States and Canada in 2014, and in Turkey in 2015. Going Concern From inception, the Company’s operations have been funded primarily through the sales of its common stock, as well as from the issuance of convertible debt, research and clinical grants, and product revenue generated by the sale of its Argus II System. During the years ended December 31, 2015, 2014 and 2013, the Company funded its business primarily through: • Revenue of $8.9 million, $3.4 million, and $1.6 million in 2015, 2014 and 2013, respectively, generated by sales of the Company’s Argus II System, • Issuance of convertible debt with the face value of $19.5 million in 2013, • A $4.1 million grant under Joint Research and Development Agreement with The Johns Hopkins University Applied Physics Laboratory in 2014, • Issuance of common stock in a private placements aggregating $9.1 million and $2.4 million in 2014 and 2013, respectively, and • Issuance of common stock in the Company’s initial public offering in November 2014, which generated net proceeds of $34.2 million of cash after offering expenses. The Company’s financial statements have been presented on the basis that its business is a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company is subject to the risks and uncertainties associated with a business with one product line and limited commercial product revenues, including limitations on the Company’s operating capital resources and uncertain demand for its products. The Company has incurred recurring operating losses and negative operating cash flows since inception, and it expects to continue to incur operating losses and negative operating cash flows for at least the next few years. As a result, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern, and the Company’s independent registered public accounting firm, in its report on the Company’s 2015 consolidated financial statements, has raised substantial doubt about the Company’s ability to continue as a going concern. On January 25, 2016, the Company filed a registration statement with the Securities and Exchange Commission to conduct a registered rights offering as of a future record date to allow the holders of its common stock to purchase newly-issued shares of common stock. The shares will be offered at the lower of $4.25 per share or 85% of the closing price of the Company’s common stock as reported by Nasdaq on the last day of the offering period. Assuming full subscription and a closing stock price of between $4.00 and $6.00 per share on the last day of the offering period, the Company expects to sell between 4.6 million and 5.8 million shares of common stock for gross proceeds of approximately $19.8 million. The actual number of shares sold and proceeds raised will depend on, among other factors, the extent to which current shareholders participate in the rights offering and the final price per share at which the Company sells its common stock. The Company intends to use the proceeds from this rights offering to invest in its business to expand sales and marketing efforts, enhance current products, gain regulatory approvals for additional indications, and continue research and development into next generation technology. However, there can be no assurances that the Company will ultimately be successful in completing this rights offering, or if unsuccessful, that the Company will be able to raise sufficient funds through other means so as to be able to continue to operate its business beyond the fourth quarter of fiscal 2016. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the financial statements of Second Sight and Second Sight Switzerland. Intercompany balances and transactions have been eliminated in consolidation. Accounts receivable Trade accounts receivable are stated net of an allowance for doubtful accounts. The Company performs ongoing credit evaluations of its customers’ financial condition and generally requires no collateral from its customers or interest on past due amounts. Management estimates the allowance for doubtful accounts based on review and analysis of specific customer balances that may not be collectible and how recently payments have been received. Accounts are considered for write-off when they become past due and when it is determined that the probability of collection is remote. There was no allowance for doubtful accounts at December 31, 2015 and 2014. Inventories Inventories are stated at the lower of cost or market, determined by the first-in, first-out method. Inventories consist primarily of raw materials, work in progress and finished goods, which includes all direct material, labor and other overhead costs. The Company establishes a reserve to mark down its inventory for estimated unmarketable inventory equal to the difference between the cost of inventory and the estimated net realizable value based on assumptions about the usability of the inventory, future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory reserve may be required. Property and Equipment Property and equipment are recorded at historical cost less accumulated depreciation and amortization. Improvements are capitalized, while expenditures for maintenance and repairs are charged to expense as incurred. Upon disposal of depreciable property, the appropriate property accounts are reduced by the related costs and accumulated depreciation. The resulting gains and losses are reflected in the consolidated statements of operations. Depreciation is provided for using the straight-line method in amounts sufficient to relate the cost of assets to operations over their estimated service lives. Leasehold improvements are amortized over the shorter of the life of the asset or the related lease term. Estimated useful lives of the principal classes of assets are as follows: Lab equipment 5 – 7 years Computer hardware and software 3 – 7 years Leasehold improvements 1 – 5 years or the term of the lease, if shorter Furniture, fixtures and equipment 5 – 10 years The Company reviews its property and equipment for impairment annually or whenever events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. There were no impairment losses recognized in 2015 and 2014. Depreciation and amortization of property and equipment amounted to $335,000, $279,000 and $316,000 for the years ended December 31, 2015, 2014 and 2013, respectively. Research and Development Research and development costs are charged to operations in the period incurred and amounted to $3.0 million, $5.0 million and $3.2 million net of grant revenue, for the years ended December 31, 2015, 2014 and 2013, respectively. Patent Costs The Company has over 345 domestic and foreign patents. Due to the uncertainty associated with the successful development of one or more commercially viable products based on Company’s research efforts and any related patent applications, all patent costs, including patent-related legal, filing fees and other costs, including internally generated costs, are expensed as incurred. Patent costs were $679,000, $666,000 and $669,000 for the years ended December 31, 2015, 2014 and 2013, respectively, and are included in general and administrative expenses in the consolidated statements of operations. Revenue Recognition The Company’s revenue is derived primarily from the sale of its Argus II retinal implant, which is implanted during retinal surgery to restore some functional vision to patients blinded by Retinitis Pigmentosa. The Company sells to a variety of customers including university hospitals, large medical centers and distributors. Revenue is recognized when persuasive evidence of an arrangement exists, the fee is fixed or determinable, collectability is probable, and delivery has occurred. Revenue is generated under sales agreements with multiple deliverables (multiple-element arrangements), comprising the following deliverables: • Hospital start up kits (one per site), • Surgical support, • Training, and • The Argus II System The deliverables may vary by transaction. The Company evaluates each deliverable in a multiple-element arrangement to determine whether it represents a separate unit of accounting. An element constitutes a separate unit of accounting when the delivered item has standalone value and delivery of the undelivered element is probable and within the Company's control. The Company has determined that the elements listed above do not have standalone value to the customer until delivery of all components has occurred. Accordingly, revenue from multiple-element arrangements is recognized when delivery of all of deliverables has taken place and all other revenue recognition criteria have been met. Generally, revenue recognition occurs at the time of implantation, but revenue recognition can be delayed if certain training has not been delivered to the implanting sites, or if other revenue recognition criteria have not been met. In the United States, the amount of revenue recognized per unit has been limited in some situations due to the uncertainties of the reimbursement environment and payment terms. In such cases, revenue is not recognized until the consideration becomes fixed, generally when paid to the Company. In order to determine whether collection is reasonably assured, the Company assesses a number of factors, including creditworthiness of the customer and medical insurance coverage. The Company may periodically grant extended payment terms to customers. In such situations, the Company defers the recognition of revenue until collection becomes probable, which is generally upon receipt of payment. The Company also sells surgical supplies to customers and recognizes revenue on these products when they are shipped and other revenue recognition criteria have been met. The Company sells through distributors in certain countries. The Company provides these distributors with clinical start-up kits, surgical supplies and the Argus II System, as well as training them to provide pre- and post-surgical support. The Company monitors the surgery. Other than surgical support which is provided by the Company, the distributor is responsible for delivering products and services to its customers. In the past, the Company has allowed distributors to return or exchange products in certain situations. Due to the Company’s continuing involvement and its returns policy, the Company recognizes revenue from distributors when the implantation procedure has been performed by the distributor’s customer, and all other revenue recognition criteria between the Company and the distributor have been met. Grant Receipts and Liabilities From time to time, the Company receives grants that help fund specific development programs. Any amounts received pursuant to grants are offset against the related operating expenses as the costs are incurred. During the years ended December 31, 2015, 2014 and 2013 grants offset against operating expenses were $1,878,000, $19,000 and $175,000, respectively. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions. These estimates and assumptions affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ materially from those estimates. Concentration of Risk Credit Risk Financial instruments that subject the Company to concentrations of credit risk consist primarily of cash, money market funds, and trade accounts receivable. The Company maintains cash and money market funds with financial institutions that management deems reputable, and at times, cash balances may be in excess of FDIC and SIPC insurance limits. The Company extends differing levels of credit to customers, and typically does not require collateral. The Company also maintains a cash balance at a bank in Switzerland. Accounts at such bank are insured up to an amount specified by the deposit insurance agency of Switzerland. Customer Concentration During the years ended December 31, 2015, 2014 and 2013, the following customers comprised more than 10% of revenues : 2015 2014 2013 Customer 1 14 % 7 % 0 % Customer 2 7 % 21 % 0 % Customer 3 4 % 10 % 0 % Customer 4 0 % 6 % 13 % Customer 5 0 % 0 % 31 % Customer 6 0 % 3 % 13 % Customer 7 0 % 0 % 12 % As of December 31, 2015 and 2014, the following customers comprised more than 10% accounts receivable: 2015 2014 Customer 1 19 % 0 % Customer 2 17 % 32 % Customer 3 10 % 2 % Customer 4 10 % 0 % Customer 5 10 % 0 % Customer 6 4 % 13 % Customer 7 0 % 13 % Customer 8 0 % 20 % Geographic Concentration During the years ended December 31, 2015, 2014 and 2013, regional revenue, based on customer locations which comprised more than 10% of revenues, consisted of the following: 2015 2014 2013 United States 46 % 47 % 0 % Italy 20 % 8 % 18 % France 16 % 3 % 7 % Germany 6 % 16 % 32 % Canada 5 % 10 % 0 % Saudi Arabia 0 % 3 % 31 % Netherlands 0 % 0 % 13 % Sources of Supply Several of the components, materials and services used in the Company’s current Argus II product are available from only one supplier, and substitutes for these items cannot be obtained easily or would require substantial design or manufacturing modifications. Any significant problem experienced by one of the Company’s sole source suppliers could result in a delay or interruption in the supply of components to the Company until that supplier cures the problem or an alternative source of the component is located and qualified. Even where the Company could qualify alternative suppliers, the substitution of suppliers may be at a higher cost and cause time delays that impede the commercial production of the Argus II, reduce gross profit margins and impact the Company’s abilities to deliver its products as may be timely required to meet demand. Foreign Operations The accompanying consolidated financial statements as of December 31, 2015 and 2014 include assets amounting to approximately $3.0 million and $2.1 million, respectively, relating to operations of the Company in Switzerland. It is always possible unanticipated events in foreign countries could disrupt the Company’s operations. Fair Value of Financial Instruments The authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. Money market funds are the only financial instrument that is measured and recorded at fair value on the Company’s balance sheet, and they are considered Level 1 valuation securities in both 2015 and 2014. Stock-Based Compensation Pursuant to Financial Accounting Standards Board (“FASB”) ASC 718 Share-Based Payment (“ASC 718”), the Company records stock-based compensation expense for all stock-based awards. Under ASC 718, the Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The fair value for awards that are expected to vest is then amortized on a straight-line basis over the requisite service period of the award, which is generally the option vesting term. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option valuation model. The assumptions used in the Black-Scholes valuation model are as follows: • The grant price of the issuances, with certain exceptions, is determined based on the estimated fair value of the shares at the date of grant. • The risk free interest rate for periods within the contractual life of the option is based on the U.S. treasury yield in effect at the time of grant. • As permitted by SAB 107, due to the Company’s insufficient history of option activity, management utilizes the simplified approach to estimate the options expected term, which represents the period of time that options granted are expected to be outstanding. • Volatility is determined based on average historical volatilities of comparable companies in similar industry. • Expected dividend yield is based on current yield at the grant date or the average dividend yield over the historical period. The Company has never declared or paid dividends and has no plans to do so in the foreseeable future. Long Term Investor Right Each beneficial owner (“IPO Shareholder”) of the Company’s common stock, who purchased shares directly in the offering (“IPO Shares”), may qualify to receive up to one additional share of common stock from the Company for each share purchased in the offering (“IPO Supplemental Shares”) pursuant to the Long Term Investor Right that was included with each IPO Share. To receive IPO Supplemental Shares, within 90 days following the closing date of the offering, or by February 22, 2015, an IPO Shareholder was required to take action to become the direct registered owner of its IPO Shares. Furthermore, IPO Shareholders are required to hold their IPO Shares in their own name and not place them in “street name” or trade them at any time during the 24 month period immediately following the IPO closing date. This Long Term Investors Right is non-detachable and transferable only in limited circumstances. The Company will issue IPO Supplemental Shares to IPO Shareholders who have not otherwise forfeited their Long Term Investor Right if, during the two-year period immediately following the IPO closing date, the Company’s common stock does not trade at or above $18.00 per share (200% of the IPO price per share) for any five consecutive day period. If the Company’s common stock trades on its principal exchange at 200% of the IPO price per share or greater on five consecutive trading days during the two years after the IPO closing date, the Long Term Investor Right will terminate. The formula to determine the number of IPO Supplemental Shares to be issued on a trigger of the Long Term Investor Right will be: (i) $18.00 minus (ii) the average of the highest consecutive closing prices in any 90 day trading period on the principal exchange during the two years after the Closing Date (the “Measurement Average”) divided by the Measurement Average. Fractional shares issuable to a qualifying IPO Shareholder resulting from the calculation will be rounded up to the next whole share of Common Stock, taking into account the aggregate number of Long Term Investor Rights of a holder. As an illustrative example, if the highest average of consecutive closing prices over any 90 calendar day period is $10.00 per share, each Long-Term Investor Right will be entitled to 0.80 additional shares of common stock, which is calculated as: ($18.00 - $10.00)/$10.00. The IPO offering price for purposes of the calculation of the amount of common stock to be issued on a Long Term Investor Right will be subject to adjustment in the event of a reorganization, recapitalization or split-up of the Company’s shares, the issuance of a stock dividend or any similar event. The amount of IPO Supplemental Shares, if any, to be issued will be computed by an independent public accountant as soon as practicable following the second anniversary of the Closing Date. The determination by such independent public accountant will be final and binding on the Company and on all qualifying IPO Shareholders and the Company will within 15 days after receipt of written determination deliver to shareholders certificates evidencing the additional shares. The Company has identified and will track IPO Investors who have perfected their Long Term Investor Rights on a quarterly basis. At the end of each reporting period, the Company will disclose the potential dilutive effect of the Long Term Investor Rights, including the number of common shares that would be issuable on such date, based on the actual share price movements since the IPO. The Long Term Investor Right is an equity instrument that is accounted for as a component of the actual price per common share paid by the investor in the IPO. For basic earnings per share, the common shares associated with the Long Term Investor Right are treated as contingently issuable shares and will not be included in basic earnings per share until the actual number of shares can be calculated and the shares have been issued. As of December 31, 2015 there were 400,057 shares of common stock issuable under outstanding Long Term Investor Rights. Convertible Promissory Notes and Warrants The warrants and embedded beneficial conversion feature of convertible promissory notes are classified as equity under FASB ASC Topic 815-40 “Derivatives and Hedging — Contracts in Entity’s Own Equity”. The Company allocates the proceeds of the convertible promissory notes between convertible promissory notes and the financial instruments related to warrants associated with convertible promissory notes based on their relative fair values at the commitment date. The fair value of the financial instruments related to warrants associated with convertible promissory notes is determined utilizing the Black-Scholes option pricing model and the respective allocated proceeds to the warrants is recorded in additional paid-in capital. The Company utilized the Black-Scholes option valuation model using the same valuation assumptions as described herein for Stock Based Compensation. The embedded beneficial conversion feature associated with convertible promissory notes is recognized and measured by allocating a portion of the proceeds equal to the intrinsic value of that feature to additional paid-in capital in accordance with ASC Topic 470-20 “Debt — Debt with Conversion and Other Options.” The portion of debt discount resulting from the allocation of proceeds to the financial instruments related to warrants associated with convertible promissory notes is being amortized over the life of the convertible promissory notes. For the portion of debt discount resulting from the allocation of proceeds to the beneficial conversion feature, it is amortized over the term of the notes from the respective dates of issuance. Comprehensive Income or Loss The Company complies with provisions of FASB ASC 220, Comprehensive Income, which requires companies to report all changes in equity during a period, except those resulting from investment by owners and distributions to owners, for the period in which they are recognized. Comprehensive income is defined as the change in equity during a period from transactions and other events from non-owner sources. Comprehensive and other comprehensive income (loss) is reported on the face of the financial statements. For the years ended December 31, 2015, 2014 and 2013 comprehensive income (loss) is the total of net income (loss) and other comprehensive income (loss) which, for the Company, consists entirely of foreign currency translation adjustments and there were no material reclassifications from other comprehensive loss to net loss during the years ended December 31, 2015, 2014 and 2013. Foreign Currency Translation and Transactions The financial statements and transactions of the subsidiary’s operations are reported in the local (functional) currency of Swiss francs (CHF) and translated into US dollars in accordance with U.S. GAAP. Assets and liabilities of those operations are translated at exchange rates in effect at the balance sheet date. The resulting gains and losses from translating foreign currency financial statements are recorded as other comprehensive income (loss). Revenues and expenses are translated at the average exchange rate for the reporting period. Foreign currency translation gains (losses) resulting from exchange rate fluctuations on transactions denominated in a currency other than the foreign operations’ functional currencies are included in expenses in the consolidated statements of operations. Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. 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 its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company has incurred losses for tax purposes since inception and has significant tax losses and tax credit carryforwards. These amounts are subject to valuation allowances as it is not likely that they will be realized in the next few years. Product Warranties The Company’s policy is to warrant all shipped products against defects in materials and workmanship for two years by replacing failed parts. The Company also provides a three-year manufacturer’s warranty covering implant failure by providing a functionally-equivalent replacement implant. Accruals for product warranties are estimated based on historical warranty experience and current product performance trends, and are recorded at the time revenue is recognized as a component of cost of sales. The warranty liabilities are reduced by material and labor costs used to replace parts over the warranty period in the periods in which the costs are incurred. The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary. Although any such adjustments were not material in the years ended December 31, 2015, 2014 and 2013, any such adjustments could be material in the future if estimates differ significantly from actual warranty expense. The warranty liabilities are included in accrued expenses in the consolidated balance sheets. Presentation of sales and value added taxes The Company collects value added tax on its sales in Europe and certain states in the United Sates impose a sales tax on the Company’s sales to nonexempt customers. The Company collects that valued added and sales tax from customers and remits the entire amount to the respective authorities. The Company’s accounting policy is to exclude the tax collected and remitted to the authorities from revenues and cost of revenues. Net Loss per Share The Company’s computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) available to common shareholders divided by the weighted average number of common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., convertible notes payable, convertible preferred stock, preferred stock warrants and common stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share is the same for all periods presented because all convertible notes payable, common stock warrants and common stock options outstanding were anti-dilutive. At December 31, 2015, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to ultimately acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. 2015 2014 2013 Long Term Investor Rights 400,057 1,021,021 — Underwriter’s warrants 802,000 805,000 — Convertible notes payable — — 6,248,652 Warrants associated with convertible debt 1,038,403 1,178,707 1,180,766 Common stock options 3,472,146 3,251,627 2,240,568 Restricted stock units 190,000 — — Employee stock purchase plan 93,000 — — Total 5,995,606 6,256,355 9,669,986 Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. Based on the FASB’s Exposure Draft Update issued on April 29, 2015, and approved in July 2015, Revenue from Contracts With Customers (Topic 606): Deferral of the Effective Date, ASU 2014-09 is now effective for reporting periods beginning after December 15, 2017, with early adoption permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. Entities will be able to transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. The Company is evaluating ASU 2014-9, and has not yet determined its impact to the Company’s financial statements, nor decided the transition approach it will take. In August 2014, the FASB issued Accounting Standards Update No. 2014-15 (ASU 2014-15), Presentation of Financial Statements – Going Concern (Subtopic 205-10). ASU 2014-15 provides guidance as to 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. In connection with preparing financial statements for each annual and interim reporting period, an entity’s management should evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable). Management’s evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued (or at the date that the financial statements are available to be issued when applicable). Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued (or available to be issued). ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The adoption of ASU 2014-15 is not expected to have any impact on the Company’s financial statement presentation and disclosures. In January 2015, the FASB issued Accounting Standards Update No. 2015-01 (ASU 2015-01), Income Statement – Extraordinary and Unusual Items (Subtopic 225-20). ASU 2015-01 eliminates from GAAP the concept of extraordinary items. Subtopic 225-20, Income Statement – Extraordinary and Unusual Items, required that an entity separately classify, present, and disclose extraordinary events and transactions. Presently, an event or transaction is presumed to be an ordinary and usual activity of the reporting entity unless evidence clearly supports its classification as an extraordinary item. Paragraph 225-20-45-2 contains the following criteria that must both be met for extraordinary classification: (1) Unusual nature. The underlying event or transaction should possess a high degree of abnormality and be of a type clearly unrelated to, or only incidentally related to, the ordinary and typical activities of the entity, taking into account the environment in which the entity operates. (2) Infrequency of occurrence. The underlying event or transaction should be of a type that would not reasonably be expected to recur in the foreseeable future, taking into account the environment in which the entity operates. If an event or transaction meets the criteria for extraordinary classification, an entity is required to segregate the extraordinary item from the results of ordinary operations and show the item separately in the income statement, net of tax, after income from continuing operations. The entity also is required to disclose applicable income taxes and either present or disclose earnings-per-share data applicable to the extraordinary item. ASU 2015-01 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. A reporting entity may apply the guidance prospectively. A reporting entity also may apply the guidance retrospectively to all prior periods presented in the financial statements. Early adoption is permitted provided that the guidance is applied from the beginning of the fiscal year of adoption. The adoption of ASU 2015-01 is not expected to have any impact on the Company’s financial statement presentation or disclosures. In February 2015, the FASB issued Accounting Standards Update No. 2015-02 (ASU 2015-02), Consolidation (Topic 810) . In April 2015, the FASB issued Accounting Standards Update No. 2015-03 (ASU 2015-03), Interest – Imputation of Interest (Subtopic 835-30). ASU 2015-03 simplifies the presentation of debt issuance costs and requires that debt issuance costs related to a |
Money Market Funds
Money Market Funds | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Money Market Funds | 3. Money Market Funds Money market funds at December 31, 2015 totaled $15,721,000 and consisted of $555,000 in the City National Rochdale Government Fund Class S, $14,948,000 in the FFI Institutional Fund, and $218,000 held in a deposit account in Switzerland as security for the performance of contracts. Money market funds at December 31, 2014 totaled $34,000,000 and consisted of $268,000 in the City National Rochdale Government Fund Class S, $1,024,000 in a Preferred Deposit, $7,000 in the BBIF Money Fund Class 4, $32,645,000 in the FFI Institutional Fund, and $56,000 held in a deposit account in Switzerland as security for the performance of a contract. The investment objective of the City National Rochdale Government Money Market Fund is to preserve principal and maintain a high degree of liquidity while providing current income through a portfolio of liquid, high quality, short-term U.S. Government bonds and notes, at least 80% of which is in U.S. Government securities. The City National Rochdale Government Money Market Fund is managed by City National Rochdale, LLC. The Preferred Business Deposit Fund is managed by Merrill Lynch and is designed to provide liquidity, safety and competitive yields. The investment objective of the BBIF Money Fund is to seek current income, preservation of capital and liquidity through a diversified portfolio of U.S. dollar-denominated short-term securities with maturities of not more than 397 days (13 months). The BBIF Money Fund is managed by BlackRock Advisors, LLC. The investment objective of the FFI Institutional Fund is to seek maximum current income consistent with liquidity and the maintenance of a portfolio of high-quality, short-term money market securities. The FFI Institutional Fund is managed by BlackRock Advisors, LLC. The following table presents money market funds at their level within the fair value hierarchy at December 31, 2015 and 2014(in thousands). Total Level 1 Level 2 Level 3 December 31, 2015: Money market funds $ 15,721 $ 15,721 $ — $ — December 31, 2014: Money market funds $ 34,000 $ 34,000 $ — $ — |
Selected Balance Sheet Detail
Selected Balance Sheet Detail | 12 Months Ended |
Dec. 31, 2015 | |
Selected Balance Sheet Detail | |
Selected Balance Sheet Detail | 4. Selected Balance Sheet Detail Inventories, net Inventories consisted of the following at December 31, 2015 and 2014 (in thousands): 2015 2014 Raw materials $ 575 $ 611 Work in process 5,028 4,729 Finished goods 3,156 1,749 8,759 7,089 Allowance for excess and obsolescence (550 ) (1,367 ) Inventories, net $ 8,209 $ 5,722 Property and equipment, net of accumulated depreciation Property and equipment consisted of the following at December 31, 2015 and 2014 (in thousands): 2015 2014 Laboratory equipment $ 3,369 $ 3,286 Computer hardware and software 1,960 1,701 Leasehold improvements 508 362 Furniture, fixtures and equipment 135 135 5,972 5,484 Accumulated depreciation and amortization (4,540 ) (4,479 ) Property and equipment, net $ 1,432 $ 1,005 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 5. Related Party Transactions As of December 31, 2013, three investors who at the time were members of the Company’s Board of Directors and certain of their affiliates (collectively, the “Related Party Investors”) held $23.4 million in face value of the Company’s convertible promissory notes. These convertible notes, which are more-fully described in Note 7, entitled the Related Party Investors to (i) simple interest of 7.5% per annum accrued on the outstanding face value of convertible notes, (ii) warrants to purchase shares of the Company’s common stock at $5.00 per share, and (iii) the right to convert their convertible notes into shares of the Company’s common stock at $5.00 per share upon the occurrence of certain events, one of which was an initial public offering of the Company’s common stock. In June 2014, an entity associated with one of these Related Party Investors assigned $200,000 in face value of these convertible notes payable to unrelated parties. This assignment included all accrued interest pertaining to those notes and the related 8,000 warrants. As more fully described in Note 7, all of the Company’s convertible promissory notes were converted into common stock upon the initial public offering of common stock. Accordingly, the Related Party Investors received 5.2 million shares of the Company’s common stock upon conversion of their convertible promissory notes. As of December 31 2013, the Related Party Investors held convertible promissory notes, including accrued interest, totaling $24.7 million. As of December 31, 2015 and 2014, in connection with the issuance of these convertible notes, the Related Party Investors held warrants to purchase 927,152 shares of the Company’s common stock. During the period January 1, 2014 to November 18, 2014 (the date the notes were converted to common stock of the Company), the Company recorded interest expense to the Related Party Investors of approximately $1.5 million. During the year ended December 31, 2013, in connection with these convertible notes, the Company recorded interest expense to the Related Party Investors of approximately $1.2 million. The Related Party Investors purchased these convertible notes on the same terms and conditions as the other investors in the convertible note financings. The Related Party Investors were also stockholders of the Company at the time that they purchased the convertible notes. Alfred E. Mann, who was the largest stockholder and until August 2015 chairman of the Company, was also a substantial contributor to the Alfred E. Mann Foundation for Scientific Research (the “Foundation”). Beginning February 2007, an officer of the Company also became Chairman of the Board of the Foundation. The Company and the Foundation share certain limited administrative and engineering employees. The shared employees make an allocation of their time between the Company and the Foundation. There are also various other costs shared between the Company and the Foundation. In connection with these shared costs, the Company owed the Foundation $1,000 as of December 31, 2015 and 2014. On May 31, 2011, the Company’s current Chairman, and then Chief Executive Officer, entered into a loan agreement with the Company to finance the exercise of stock options to purchase 100,000 shares for $319,000, with a maturity date of May 31, 2016 and interest accruing at 2.26% per annum. On December 11, 2013, the same individual entered into a second loan agreement with the Company to finance the exercise of stock options to purchase 200,000 shares of common stock for $100,000, with a maturity date of December 31, 2018 and interest accruing at 1.64% per annum. As of December 31, 2013, the balance outstanding pursuant to the two loans, including accrued interest, was $423,000. These loans receivable were recorded in the Company’s financial statements as an offset to stockholders’ equity. In July 2014, the Company’s Board of Directors approved forgiving this note receivable and related accrued interest of $423,000, which amount is included in general and administrative expenses in the Company’s statement of operations for the year ended December 31, 2014. Prior to November 2014, the Company leased its office and laboratory space in Sylmar, California under an operating lease with Mann Biomedical Park, LLC (formerly Sylmar Biomedical Park, LLC), which was wholly owned by Alfred E. Mann, who at the time was a principal stockholder and Chairman of the Company (see Note 13). In November 2014, the Mann Biomedical Park, LLC was sold to an unrelated third party. The Company entered into a loan agreement with an entity affiliated with Mr. Mann, who at the time was a principal stockholder and Chairman of the Company, to lend the Company up to $3.0 million at an annualized interest rate of 1.5% on an unsecured basis. The Company borrowed $2.0 million pursuant to this loan agreement on October 1, 2014, and repaid the loan on November 24, 2014, including $4,000 of interest. As of December 31, 2014, no amounts were due or outstanding under this agreement. |
Grants
Grants | 12 Months Ended |
Dec. 31, 2015 | |
Grants | |
Grants | 6. Grants In April 2010, the Company was awarded a development and testing grant of $3.0 million from the Department of Health and Human Services, National Institutes of Health (NIH). The grant was for three years commencing in May 2010. The grant included managing various subcontracts with designated individuals and their respective institutions. The grant reimburses research costs to develop technology for the prevention, cure and amelioration of the loss of eyesight and other neurologic applications. The Company recorded funding under the grant as an offset to research and development expenses. In 2015, 2014 and 2013, research and development expenses were offset by $0, $19,000 and $175,000, respectively. In September, 2014, the Company entered into a Joint Research and Development Agreement or JRDA with The Johns Hopkins University Applied Physics Laboratory or APL. The JRDA includes a subcontract to do research under a grant received by APL. Under the JRDA, the Company has agreed to perform research regarding integration of APL research in to a visual prosthesis system. In October, 2014, APL paid the Company $4.1 million in one lump sum to conduct its portion of the research. The JRDA also includes a license from APL to the Company, for the life of any patents resulting from APLÂ’s portion of the research. The APL portion of the research includes image processing enhancements for a visual prosthesis. In exchange for the license, the Company issued 1,000 shares of its common stock to APL , |
Convertible Promissory Notes an
Convertible Promissory Notes and Warrants | 12 Months Ended |
Dec. 31, 2015 | |
Warrants and Rights Note Disclosure [Abstract] | |
Convertible Promissory Notes and Warrants | 7. Convertible Promissory Notes and Warrants During 2010 and 2011, the Company borrowed money in a series of financing rounds by issuing $15.4 million of convertible notes (the “2010 - 2011 Notes”) primarily to existing stockholders. The notes accrued interest at 7.5% per annum and had a variety of maturity dates. During 2011, all but two of the 2010 and 2011 Notes, with a combined face value $47,000, were converted into 3.2 million shares of the Company’s common stock at $5.00 per share. In March 2013, the Company redeemed the remaining two notes for $54,000 in cash. During 2012 and 2013, the Company borrowed money primarily from existing investors in three separate rounds through the issuance of convertible promissory notes (collectively, the “Convertible Notes”) totaling $29.5 million. The first round of Convertible Notes in the amount of $5.0 million was issued from July through November 2012 (the “July 2012 Notes). The second round of Convertible Notes in the amount of $5.0 million was issued from October through December 2012 (the “October 2012 Notes”). The third round of Convertible Notes in the amount of $19.5 million was issued from February through December 2013 (the “February 2013 Notes”). There were no placement fees associated with the Convertible Notes, and other administrative costs were nominal and were expensed as incurred. The July 2012 Notes and the October 2012 Notes had maturity dates of July 31, 2015. The February 2013 Notes had a maturity date of February 28, 2016. The Convertible Notes accrued interest at the rate of 7.5% per annum, which is added to the principal amounts. For the year ended December 31, 2014, the annualized effective interest rate on the July 2012 Notes, the October 2012 Notes and the February 2013 Notes were 18.6%, 19.2%, and 63.3%, respectively. For the year ended December 31, 2013, the annualized effective interest rates on the July 2012 Notes, the October 2012 Notes, and the February 2013 Notes were 14.5%, 14.9% and 33.3%, respectively. The Convertible Notes were due on their respective maturity dates or convertible into the Company’s common stock upon the occurrence of a “capital event,” which is defined as (i) a sale of stock to a third party, excluding existing shareholders, of not less than $15.0 million, (ii) an initial public offering, or (iii) a “qualifying reorganization event” as defined in the Convertible Promissory Note agreement. The Convertible Promissory Note agreement contained a beneficial conversion feature that provided that if the notes were converted due to a capital event then all outstanding principal and interest would be converted into shares of common stock at the lower of the purchase price paid pursuant to the capital event, or at $5.00 per share. If no capital event occurred before the maturity date, the Convertible Promissory Note agreement provided that, at the election of the holder, all outstanding principal and interest could be converted to shares of common stock at $5.00 per share. During 2013, the debt issuance discount recorded in connection with this beneficial conversion feature was $10.5 million. In connection with the Convertible Notes, the Company issued warrants to purchase 1,180,766 shares of the Company’s common stock. The warrants grant the holder the right to purchase additional shares of common stock of the Company equal to the product of (a) twenty percent, multiplied by (b) the face amount of the convertible note divided by $5.00. The exercise price for each share purchased under the warrant is $5.00. Until their expiration date, the warrants may be exercised at any time, and from time to time, in whole or in part. As originally issued, the warrants expired on the earlier of their expiration dates, upon a change in control event, or within 30 days of prior written notice of a pending IPO. In June 2014, the board of directors amended the warrants to provide that they will not expire on the occurrence of an IPO. The warrants associated with the July 2012 Notes and the October 2012 Notes have an expiration date of July 31, 2017. The warrants associated with the February 2013 Notes have an expiration date of February 28, 2018. During 2013 the debt issuance discount recorded in connection with the fair value of warrants issued was $3,107,000. As of December 31, 2015, there were outstanding warrants associated with the Convertible Notes to purchase 1,038,403 shares of the Company’s common stock, with a weighted average remaining contractual life of 1.96 years. During the fourth quarter of 2014, because of the successful completion of the Company’s IPO, the Company’s Convertible Notes were automatically converted into 6,639,137 shares of the Company’s common stock, and the unamortized discount on the Convertible Notes of approximately $7.0 million was written off. The calculated value of the warrants associated with the Convertible Notes was estimated on the respective dates of grant using the Black-Scholes option-pricing model with the following assumptions: 2013 Risk-free interest rate 0.65% – 1.68% Expected dividend yield 0% Expected volatility 57.5% Expected term 4.2 – 5.0 years Weighted-average grant date calculated fair value $3.98 A summary of warrant activity for the years ended December 31, 2015, 2014, and 2013 is presented below: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2012 400,000 $ 5.00 Granted 780,766 5.00 Exercised — — Forfeited or expired — — Warrants outstanding at December 31, 2013 1,180,766 $ 5.00 Granted 805,000 11.25 Exercised (2,059 ) 5.00 Forfeited or expired — — Warrants outstanding at December 31, 2014 1,983,707 $ 7.54 Granted — 11.25 Exercised (143,304 ) 5.13 Forfeited or expired — — Warrants outstanding at December 31, 2015 1,840,403 $ 7.72 2.80 Warrants exercisable at December 31, 2015 1,840,403 $ 7.72 2.80 The estimated aggregate intrinsic value of warrants exercisable at December 31, 2015 and 2014 was approximately $924,000 and $6,200,000, respectively. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plans | 8. Employee Benefit Plans The Company has a 401(k) Savings Retirement Plan that covers substantially all full-time employees who meet the planÂ’s eligibility requirements and provides for an employee elective contribution. The Plan provides for employer matching contributions. Employer contributions are discretionary and determined annually by the Board of Directors. For the years ended December 31, 2015, 2014 and 2013, employer contributions to the Plan totaled $137,000, $127,000 and $110,000, respectively. The Company is required to contribute to a government-sponsored pension plan for the employees of its Switzerland-based subsidiary. For the years ended December 31, 2015, 2014 and 2013, the employerÂ’s portion of the amounts contributed to the subsidiaryÂ’s pension plan on behalf of those employees was $134,000, $101,000 and $94,000, respectively. |
Equity Securities
Equity Securities | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Equity Securities | 9. Equity Securities In June 2014, the CompanyÂ’s articles of incorporation were amended to increase authorized common shares to 200,000,000, no par value, and to authorize 10,000,000 shares of preferred stock, no par value. The CompanyÂ’s consolidated financial statements have been retroactively restated to reflect this amendment. The Board of Directors has the authority to establish the rights, preferences, privileges and restrictions granted to and imposed upon the holders of preferred stock and common stock. November 2014 IPO On November 18, 2014, the Company sold 4,025,000 shares of common stock in an IPO, including 525,000 shares sold upon exercise of the underwriterÂ’s over-allotment option. Net proceeds to the Company totaled approximately $34.2 million, net of offering costs of approximately $5.0 million, including approximately $2.9 million for the fair value of warrants and common stock issued in connections with services rendered. The proceeds from the IPO are expected to be used by the Company to invest in its business to expand sales and marketing efforts, enhance current product, gain regulatory approvals for additional indications, and continue research and development into next generation technology. UnderwriterÂ’s Warrant As a component of the IPO underwriting fee, the Company granted the underwriter a warrant to purchase 805,000 shares of the CompanyÂ’s common stock at an exercise price of $11.25 per share, which was 25 percent above the offering price to the investors. The warrant is exercisable, in whole or in part, for a period commencing 180 days after the effective date of the registration statement (November 18, 2014) and ending on the fifth anniversary date of the effective date of the registration statement. The fair value of the warrant issued as part of underwriting fee for the CompanyÂ’s IPO was estimated to be $2,772,000, using the Black-Scholes option-pricing model with the following assumptions: Risk-free rate of return 1.63% Expected dividend yield 0% Expected volatility 49.92% Expected term 5 years Long Term Investor Right As of December 31, 2015, the Company identified investors who had perfected and maintained Long Term Investor Rights in an aggregate of 1,382,218 shares of common stock that were acquired as part of the CompanyÂ’s IPO. The highest average closing price for the CompanyÂ’s common stock on NASDAQ during any consecutive 90 day period ended on or before December 31, 2015 was $13.96. Based on this average closing stock price, an investor who purchased shares as part of the IPO, and who has perfected its Long Term Investor Right, would be entitled to 0.2894 shares for each share purchased in the IPO, rounded up to the next whole share, which represents an aggregate maximum of 400,057 shares that are potentially issuable by the Company pursuant to the Long Term Investor Right at such date. The actual number of common shares issuable pursuant to the Long Term Investor Right is dependent on the future stock price of the Company over the two year period subsequent to the November 24, 2014 closing date of the IPO, and could be as high as 400,057 shares and as low as zero shares. The Long Term Investor Right is an equity instrument that is being accounted for as a component of the actual price per common share paid by the investor in the IPO. For basic earnings per share, the common shares associated with the Long Term Investor Right are treated as contingently issuable shares and are not included in basic earnings per share until the actual number of shares can be calculated and the shares have been issued. 2014 Private Placement During 2014, the Company sold 1,299,853 shares of its common stock to new investors at $7.00 per share in a private placement, raising a total of $9.1 million. Related to this stock placement, the Company paid a finderÂ’s fee of 26,785 shares of common stock to Mendelsohn Investment Services, LLC, an entity affiliated with Aaron Mendelsohn, a member of the CompanyÂ’s Board of Directors. The Company paid an additional finderÂ’s fee of 37,599 shares of common stock to an existing shareholder in connection with this stock placement. 2013 Private Placement From July 1, 2013 through December 31, 2013, the Company sold 342,955 shares of its common stock to new investors at $7.00 per share in a private placement, raising a total of $2.4 million. No costs were incurred in connection with these issuances. Common Stock Issuable Beginning with services rendered in 2014, and with the first payment in June 2015, non-employee members of the Board of Directors will be paid for their services in common stock on June 1 of each year based on the average closing prices for the immediately preceding twenty trading days. For 2015, for these services the Company issued 23,136 shares with a value of $285,000 and accrued $205,000, which equates to 33,293 shares based on the average closing price of $6.15 for the CompanyÂ’s common stock during last 20 trading days as of December 31, 2015. The shares, which have not yet been issued, are excluded from the calculation of weighted average common shares outstanding for EPS purposes. For 2014, the Company accrued $166,000 for these services, which equates to 16,204 shares based on the $10.26 closing price for the CompanyÂ’s common stock on December 31, 2014. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation Under the 2003 Plan, as restated in June 2011, the Company was authorized to issue options covering up to 3,500,000 common stock shares. Effective June 1, 2011, the Company adopted the 2011 Equity Incentive Plan (the “2011 Plan”). The maximum number of shares with respect to which options may be granted under the 2011 Plan is 6,000,000 shares, which is offset and reduced by options previously granted under the 2003 Plan. The option price is determined by the Board of Directors but cannot be less than the fair value of the shares at the grant date. Generally, the options vest ratably over either four or five years and expire ten years from the grant date. Both plans provide for accelerated vesting if there is a change of control, as defined in the plans. No option shall be granted under the 2011 Plan after May 31, 2021. The Company recognized stock-based compensation cost of $2,687,000, $1,475,000 and $770,000 during 2015, 2014 and 2013, respectively. The calculated value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions: 2015 2014 2013 Risk-free interest rate 1.93% – 2.21% 0.3% – 2.2% 1% Expected dividend yield 0% 0% 0% Expected volatility 47.5% – 50.4% 50.0% – 61.2% 61.2% Expected term 6.25 – 6.5 years 1.5 – 6.5 years 6.5 years Weighted-average grant date calculated fair value $ 6.17 $ 4.73 $ 1.58 As the Company has limited stock trading history, the expected volatility is based on the historical volatility of similar companies that have a trading history. The expected term represents the estimated average period of time that the options are expected to remain outstanding. Since the Company does not have sufficient historical data on the exercise of stock options, the expected term is based on the “simplified” method that measures the expected term as the average of the vesting period and the contractual term. The risk free rate of return reflects the grant date interest rate offered for zero coupon U.S. Treasury bonds over the expected term of the options. A summary of stock option activity for the years ended December 31, 2015, 2014 and 2013 is presented below: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Options outstanding at December 31, 2012 2,727,503 $ 4.32 Granted 500 5.00 Exercised (331,871 ) 1.05 Forfeited or expired (155,564 ) 3.73 Options outstanding at December 31, 2013 2,240,568 $ 4.84 Granted 1,377,978 7.62 Exercised (115,029 ) 4.40 Forfeited or expired (251,890 ) 4.44 Options outstanding at December 31, 2014 3,251,627 $ 6.07 Granted 998,348 12.29 Exercised (573,792 ) 4.85 Forfeited or expired (204,037 ) 7.08 Options outstanding at December 31, 2015 3,472,146 $ 8.01 6.39 Options exercisable at December 31, 2015 1,571,255 $ 5.44 3.62 The exercise prices of common stock options outstanding and exercisable are as follows at December 31, 2015: Exercise Price Options Outstanding (Shares) Options Exercisable (Shares) $ 4.25 125,000 125,000 $ 4.88 16,500 — $ 5.00 1,408,553 1,223,965 $ 7.00 252,095 51,969 $ 9.00 699,650 170,121 $ 9.01 34,000 — $ 12.43 420,000 — $ 12.46 246,000 — $ 12.73 150,000 — $ 13.09 116,348 — $ 13.90 3,000 — $ 14.06 1,000 200 3,472,146 1,571,255 The estimated aggregate intrinsic value of stock options exercisable at December 31, 2015 and 2014 was approximately $1,294,000 and $10,080,000, respectively. As of December 31, 2015, there was $9,148,000 of total unrecognized compensation cost related to the outstanding stock options that will be recognized over a weighted average period of 3.17 years. On January 1, 2015, the Company’s current Chairman, who at that time was the Chief Executive Officer, exercised stock options expiring on that date on a cashless basis to purchase 59,063 shares of common stock at an exercise price of $4.75 per share. Based on the closing market price of the Company’s common stock of $10.26 on December 31, 2014, the Chief Executive Officer tendered 27,344 shares of common stock that he owned to satisfy the aggregate exercise price and surrendered 12,055 shares of common stock to satisfy the related $124,000 of income and payroll tax withholding amounts related to the transaction. In June 2015 the Company’s current Chairman, who at that time was the Chief Executive Officer, exercised stock options on a cashless basis to purchase 150,000 shares of common stock at an exercise price of $4.75 per share. Related to these exercises, the Chief Executive Officer tendered 50,753 shares of common stock that he owned to satisfy the aggregate exercise price. In January 2014, the Company granted a stock option to its current Chairman, who at that time was the Chief Executive Officer, to purchase 125,000 shares of common stock at an exercise price of $4.25 per share, exercisable for a period of three years from the date of grant. The stock option grant was fully vested on the date of issuance and was intended to replace an earlier stock option grant with the same exercise price that had expired in January 2014. The stock option was not granted pursuant to the 2011 Plan. The grant date fair value of the stock option, calculated pursuant to the Black-Scholes option-pricing model utilizing a volatility factor of 50% and a dividend rate of 0%, was determined to be $393,000, which was charged to operations as general and administrative expense in the year ended December 31, 2014. During the year ended December 31, 2014, the Company recorded a charge of $235,000 to extend the exercise period of 232,003 options for four employees who resigned and became consultants for the Company. All unvested options for employees were terminated when they ceased full-time employment with the Company. On May 15, 2015 shareholders approved (1) an increase of 2,000,000 shares in the number of shares available for option awards under the 2011 Equity Incentive Plan, and (2) an Employee Stock Purchase Plan, with an initial 250,000 shares with annual increases of shares available equal to the lesser of (i) 1% of outstanding shares or (ii) 100,000 shares. The Company adopted an employee stock purchase plan in June, 2015 for all eligible employees. Under the plan, shares of the Company's common stock may be purchased at six-month intervals at 85% of the lower of the closing fair market value of the common stock (i) on the first trading day of the offering period or (ii) on the last trading day of the purchase period. An employee may purchase in any one calendar year shares of common stock having an aggregate fair market value of up to $25,000 determined as of the first trading day of the offering period. Additionally, a participating employee may not purchase more than 100,000 shares of common stock in any one offering period. At December 31, 2015, 52,469 shares were issued under the plan. The following table summarizes Restricted Stock Unit (RSU) activity for the year ended December 31, 2015: Number Weighted Average Outstanding as of December 31, 2014 - $ - Awarded 190,000 12.43 Vested - - Forfeited/canceled - - Outstanding as of December 31, 2015 190,000 $ 12.43 As of December 31, 2015, there was $2,142,000 of total unrecognized compensation cost related to the outstanding RSUs that will be recognized over a weighted average period of 3.63 years. The total stock-based compensation recognized for stock-based awards granted in the consolidated statements of operations for the years ended December 31, 2015, 2014 and 2013 is as follows (in thousands): 2015 2014 2013 Cost of sales $ 279 $ 192 $ 153 Research and development 208 293 229 Clinical and regulatory 235 113 83 Selling and marketing 442 141 102 General and administrative 1,523 736 203 Total $ 2,687 $ 1,475 $ 770 From time to time, the Company has extended full-recourse loans to certain non-officer employees for the purpose of financing stock option exercises. These loans bear interest ranging from 1.27% to 1.91% per annum and are payable over three years in monthly installments of principal and interest. At December 31, 2015 and 2014, the outstanding balance of such loans, including accrued interest, was $5,000 and $109,000, respectively. These loans receivable are recorded in the Company’s consolidated financial statements as an offset to stockholders’ equity. Additionally at December 31, 2015 and 2014, the Company had a receivable in the amount of $0 and $10,000, respectively, from a non-officer employee for the exercise of options which has been recorded as an offset to stockholders’ equity in the Company’s consolidated financial statements. On December 27, 2013, the Company extended a full-recourse loan totaling $127,000 to a consultant for the purpose of financing the exercise of stock options. The loan bears interest at 1.64% per annum and is repayable in eight equal quarterly installments of $16,000. This loan receivable is recorded in the Company’s consolidated financial statements as an offset to stockholders’ equity. At December 31, 2015 and 2014, the outstanding balance of this loan including accrued interest was $0 and $43,000, respectively. Stock Awards In July 2014, the Company awarded Alfred E. Mann, who at the time the Chairman of the Board of Directors, 25,000 shares of common stock in recognition of services rendered to the Company since inception. These shares were valued at $175,000, or $7.00 per share, and were charged to general and administrative expense in 2014. In 2014, the Company awarded 21,215 shares to an outside attorney and his staff as part of the fee paid for drafting the Company’s prospectus and S-1 filing. These shares were valued at $170,000, with 10,715 shares valued at $7.00 per shares and the balance valued at $9.00 per share. The cost of these shares is treated as an issuance cost of the Company’s initial public offering and was deducted from the gross proceeds from the offering. Employment Agreement On June 19, 2015 the Company entered into an at will employment agreement with Will McGuire to become the Company’s President and Chief Executive Officer. The Company has agreed to pay Mr. McGuire an annual salary of $390,000 and he will also be entitled to receive performance bonuses which will be based on performance standards and goals established by the Company’s Board of Directors. Upon termination without cause, Mr. McGuire will be entitled to receive severance consisting of his salary for a period of 12 months following such termination and his pro-rated target bonus through the balance of the calendar year in which such termination occurs. As part of the agreement, the Company agreed to grant Mr. McGuire, effective on his official start date as an employee, options to purchase 420,000 shares of the Company’s common stock, the fair value of which was determined to be $2,574,000, of which $240,000 was recognized during the year ended December 31, 2015 and 190,000 RSUs the fair value of which was determined to be $2,362,000, of which $220,000 was recognized during the year ended December 31, 2015. The fair value of the RSUs and the exercise price of the options were both marked at $12.43 which was the closing price of the Company’s stock on Nasdaq on August 17, 2015. The options and RSUs will vest over four years, with 25% vesting on the first anniversary of the grant date, and the remainder vesting thereafter in twelve equal installments of 6.25% on the quarterly anniversaries of the grant date. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2015 and 2014 are summarized below (in thousands): 2015 2014 Stock-based compensation $ 2,825 $ 2,489 Research credits 5,401 5,436 Depreciation (12 ) (13 ) Net operating loss carryforwards 47,261 43,700 Inventory reserve 203 544 Other 845 492 Total deferred tax assets 56,523 52,648 Valuation allowance (56,523 ) (52,648 ) Net deferred tax assets $ — $ — In assessing the potential realization of these deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during the periods in which those temporary differences become deductible. As of December 31, 2015 and 2014, management was unable to determine if it is more likely than not that the Company’s deferred tax assets will be realized, and has therefore recorded an appropriate valuation allowance against deferred tax assets at such dates. In accordance with the reporting requirements under ASC 718, the Company did not include excess windfall benefits resulting from stock option exercises as components of the Company's gross deferred tax assets and corresponding valuation allowance disclosures, as the tax attributes related to those windfall tax benefits should not be recognized until they result in a reduction of taxes payable. The tax-effected amount of gross unrealized net operating loss carryforwards excluded under ASC 718 was approximately $1.1 million at December 31, 2015. When realized, those excess windfall benefits are credited to additional paid-in capital. The Company utilizes the with-and-without allocation method to determine when such net operating loss carryforwards have been realized. No federal tax provision has been provided for the years ended December 31, 2015, 2014 and 2013 due to the losses incurred during such periods. The Company’s effective tax rate is different from the federal statutory rate of 34% due primarily to operating losses that receive no tax benefit as a result of a valuation allowance recorded for such losses. As of December 31, 2015, the Company had federal and state income tax net operating loss carryforwards, which may be applied to future taxable income, of approximately $119.1 million and $93.2 million, respectively. The federal net operating loss carryforwards will expire at various dates from 2023 through 2035. The state net operating loss carryforwards began to expire at various dates from 2015 through 2035. The Company also has a federal and state research and development tax credit carryforwards totaling approximately $3,188,000 and $3,353,000, respectively. The federal research and development tax credit carryforwards will expire at various dates from 2023 through 2035. The state research and development tax credit carryforwards do not expire. Pursuant to Internal Revenue Code Sections 382 and 383, use of the Company’s net operating loss and credit carryforwards may be limited if a cumulative change in ownership of more than 50% occurs within any three-year period since the last ownership change. The Company may have had a change in control under these Sections. However, the Company does not anticipate performing a complete analysis of the limitation on the annual use of the net operating loss and tax credit carryforwards until the time that it projects it will be able to utilize these tax attributes. The Company files income tax returns in the U.S. federal jurisdiction and various states and is subject to income tax examinations by federal tax authorities for tax years ended 2012 and later and by state authorities for tax years ended 2011 and later. The Company currently is not under examination by any tax authority. The Company’s policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2015 and 2014, the Company has no accrued interest or penalties related to uncertain tax positions. Second Sight Switzerland, the Company’s foreign subsidiary, has not had any taxable income in the prior and current years. |
Product Warranties
Product Warranties | 12 Months Ended |
Dec. 31, 2015 | |
Product Warranties Disclosures [Abstract] | |
Product Warranties | 12. Product Warranties A summary of activity in the Company’s warranty liabilities, which are included in accrued expenses in the accompanying consolidated balance sheets, for the years ended December 31, 2015, 2014 and 2013 is presented below (in thousands): 2015 2014 2013 Balance, beginning of year $ 556 $ 253 $ 120 Additional accruals 991 415 139 Payments (443 ) (112 ) (6 ) Adjustments and other (38 ) — — Total $ 1,066 $ 556 $ 253 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 13. Commitments and Contingencies Lease Commitment Effective August 2012, the Company entered into a lease agreement (the “Sylmar Lease”) with a company owned by the major stockholder of the Company for office space for a term of five years that was initially set to expire on February 28, 2017. The Sylmar Lease included rental of additional space commencing January 1, 2013 and a five year option to renew. The lease requires the Company to pay real estate taxes, insurance and common area maintenance each year, and is subject to periodic cost of living adjustments. In April 2014, the Sylmar Lease was renegotiated with the term ending on February 28, 2022, and a five year option to renew. The new lease also requires the Company to pay real estate taxes, insurance and common area maintenance each year and includes automatic increases in base rent each year. In November 2014, the property underlying the Sylmar lease was sold to an unrelated party. Second Sight Switzerland rents office space in Switzerland on a month-to-month basis for CHF 8,200 (approximately $8,200, at December 31, 2015) per month. Total rent expense was approximately $954,000, $1,007,000 and $766,000 for the years ended December 31, 2015, 2014 and 2013, respectively, and is allocated based on square footage to general and administrative and manufacturing costs in the accompanying consolidated statement of operations. Future minimum rental payments required under the operating leases are as follows for the years ended December 31 (in thousands). Years Amount 2016 $ 808 2017 833 2018 858 2019 884 2020 910 Thereafter 1,095 Total $ 5,388 License Agreements The Company has exclusive licensing agreements to utilize certain patents. These patents are related to the technology for visual prostheses. There are currently two such agreements that the Company has determined there is a reasonable likelihood of future royalty payments. The Company has agreed to pay the licensors’ royalties for licensed products sold or leased by the Company. The royalty rates range from 0.5% to 3.25%, based on related net sales of the patented portion of licensed products, less a credit for royalties paid to others. The 3.25% rate reflects a .25% credit for royalties paid to others. Additional discounts may be possible if the Company enters into additional licenses. One of the licensing agreements requires the Company to pay the licensors a $5,000 annual maintenance fee for the first seven years and a $10,000 annual maintenance fee each year thereafter for as long as the agreement has not been terminated by the Company. The second of these agreements has no stipulated fees. Pursuant to these agreements, the Company has incurred costs of approximately $93,000, $45,000 and $28,000 for the years ended December 31, 2015, 2014 and 2013, respectively. Clinical Trial Agreements Based upon FDA approval, which was obtained in February 2013, the Company is required to collect follow-up data from subjects enrolled in its pre-approval trial for a period of up to ten years post-implant, which extends this trial through the year 2019. In addition, the Company is conducting three post-market studies to comply with US FDA, French, and European post-market surveillance regulations and requirements. The Company has contracted with various universities, hospitals, and medical practices to provide these services. Payments are based on procedures performed for each subject and are charged to clinical and regulatory expense as incurred. Total amounts charged to expense for the years ended December 31, 2015, 2014 and 2013 were $1,409,000, $602,000 and $481,000, respectively. Litigation, Claims and Assessments Thirteen oppositions have been filed by a third-party in the European Patent Office, each challenging the validity of a European patent owned or exclusively licensed by the Company. The outcome of the challenges is not certain, however, if successful, they may affect the Company’s ability to block competitors from utilizing its patented technology. Management of the Company does not believe a successful challenge will have a material effect on its ability to manufacture and sell its products, or otherwise have a material effect on its operations. The Company is party to litigation arising in the ordinary course of business. It is management’s opinion that the outcome of such matters will have not have a material effect on the Company’s financial statements. |
Quarterly Financial Summary (un
Quarterly Financial Summary (unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Summary (unaudited) | 14. Quarterly Financial Summary (unaudited) Quarters Ended (in thousands, except per share data) December 31, 2015 September 30, 2015 June 30, 2015 March 31, 2015 Product sales $ 2,362 $ 2,227 $ 2,661 $ 1,700 Gross profit $ 691 $ 1,470 $ 1,092 $ 404 Operating loss $ (5,477 ) $ (4,662 ) $ (4,947 ) $ (4,961 ) Net loss $ (5,474 ) $ (4,666 ) $ (4,922 ) $ (4,956 ) Net loss per share – basic and diluted $ (0.15 ) $ (0.13 ) $ (0.14 ) $ (0.14 ) Quarters Ended December 31, 2014(1) September 30, 2014 June 30, 2014 March 31, 2014 Product sales $ 1,521 $ 609 $ 611 $ 657 Gross profit (loss) $ 99 $ 193 $ (382 ) $ (70 ) Operating loss $ (5,565 ) $ (5,649 ) $ (5,563 ) $ (4,456 ) Net loss $ (13,577 ) $ (7,644 ) $ (7,541 ) $ (6,439 ) Net loss per share – basic and diluted $ (0.46 ) $ (0.31 ) $ (0.32 ) $ (0.28 ) (1) During the fourth quarter of 2014, the Company wrote-off the unamortized discount on convertible promissory notes of $6,955 as a result of the automatic conversion of such notes into common stock upon the closing of the Company’s IPO. |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the financial statements of Second Sight and Second Sight Switzerland. Intercompany balances and transactions have been eliminated in consolidation. |
Accounts receivable | Accounts receivable Trade accounts receivable are stated net of an allowance for doubtful accounts. The Company performs ongoing credit evaluations of its customersÂ’ financial condition and generally requires no collateral from its customers or interest on past due amounts. Management estimates the allowance for doubtful accounts based on review and analysis of specific customer balances that may not be collectible and how recently payments have been received. Accounts are considered for write-off when they become past due and when it is determined that the probability of collection is remote. There was no allowance for doubtful accounts at December 31, 2015 and 2014. |
Inventories | Inventories Inventories are stated at the lower of cost or market, determined by the first-in, first-out method. Inventories consist primarily of raw materials, work in progress and finished goods, which includes all direct material, labor and other overhead costs. The Company establishes a reserve to mark down its inventory for estimated unmarketable inventory equal to the difference between the cost of inventory and the estimated net realizable value based on assumptions about the usability of the inventory, future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory reserve may be required. |
Property and Equipment | Property and Equipment Property and equipment are recorded at historical cost less accumulated depreciation and amortization. Improvements are capitalized, while expenditures for maintenance and repairs are charged to expense as incurred. Upon disposal of depreciable property, the appropriate property accounts are reduced by the related costs and accumulated depreciation. The resulting gains and losses are reflected in the consolidated statements of operations. Depreciation is provided for using the straight-line method in amounts sufficient to relate the cost of assets to operations over their estimated service lives. Leasehold improvements are amortized over the shorter of the life of the asset or the related lease term. Estimated useful lives of the principal classes of assets are as follows: Lab equipment 5 – 7 years Computer hardware and software 3 – 7 years Leasehold improvements 1 – 5 years or the term of the lease, if shorter Furniture, fixtures and equipment 5 – 10 years The Company reviews its property and equipment for impairment annually or whenever events or changes in circumstances indicate that the carrying value of such assets may not be recoverable. There were no impairment losses recognized in 2015 and 2014. Depreciation and amortization of property and equipment amounted to $335,000, $279,000 and $316,000 for the years ended December 31, 2015, 2014 and 2013, respectively. |
Research and Development | Research and Development Research and development costs are charged to operations in the period incurred and amounted to $3.0 million, $5.0 million and $3.2 million net of grant revenue, for the years ended December 31, 2015, 2014 and 2013, respectively. |
Patent Costs | Patent Costs The Company has over 345 domestic and foreign patents. Due to the uncertainty associated with the successful development of one or more commercially viable products based on CompanyÂ’s research efforts and any related patent applications, all patent costs, including patent-related legal, filing fees and other costs, including internally generated costs, are expensed as incurred. Patent costs were $679,000, $666,000 and $669,000 for the years ended December 31, 2015, 2014 and 2013, respectively, and are included in general and administrative expenses in the consolidated statements of operations. |
Revenue Recognition | Revenue Recognition The Company’s revenue is derived primarily from the sale of its Argus II retinal implant, which is implanted during retinal surgery to restore some functional vision to patients blinded by Retinitis Pigmentosa. The Company sells to a variety of customers including university hospitals, large medical centers and distributors. Revenue is recognized when persuasive evidence of an arrangement exists, the fee is fixed or determinable, collectability is probable, and delivery has occurred. Revenue is generated under sales agreements with multiple deliverables (multiple-element arrangements), comprising the following deliverables: • Hospital start up kits (one per site), • Surgical support, • Training, and • The Argus II System The deliverables may vary by transaction. The Company evaluates each deliverable in a multiple-element arrangement to determine whether it represents a separate unit of accounting. An element constitutes a separate unit of accounting when the delivered item has standalone value and delivery of the undelivered element is probable and within the Company's control. The Company has determined that the elements listed above do not have standalone value to the customer until delivery of all components has occurred. Accordingly, revenue from multiple-element arrangements is recognized when delivery of all of deliverables has taken place and all other revenue recognition criteria have been met. Generally, revenue recognition occurs at the time of implantation, but revenue recognition can be delayed if certain training has not been delivered to the implanting sites, or if other revenue recognition criteria have not been met. In the United States, the amount of revenue recognized per unit has been limited in some situations due to the uncertainties of the reimbursement environment and payment terms. In such cases, revenue is not recognized until the consideration becomes fixed, generally when paid to the Company. In order to determine whether collection is reasonably assured, the Company assesses a number of factors, including creditworthiness of the customer and medical insurance coverage. The Company may periodically grant extended payment terms to customers. In such situations, the Company defers the recognition of revenue until collection becomes probable, which is generally upon receipt of payment. The Company also sells surgical supplies to customers and recognizes revenue on these products when they are shipped and other revenue recognition criteria have been met. The Company sells through distributors in certain countries. The Company provides these distributors with clinical start-up kits, surgical supplies and the Argus II System, as well as training them to provide pre- and post-surgical support. The Company monitors the surgery. Other than surgical support which is provided by the Company, the distributor is responsible for delivering products and services to its customers. In the past, the Company has allowed distributors to return or exchange products in certain situations. Due to the Company’s continuing involvement and its returns policy, the Company recognizes revenue from distributors when the implantation procedure has been performed by the distributor’s customer, and all other revenue recognition criteria between the Company and the distributor have been met. |
Grant Receipts and Liabilities | Grant Receipts and Liabilities From time to time, the Company receives grants that help fund specific development programs. Any amounts received pursuant to grants are offset against the related operating expenses as the costs are incurred. During the years ended December 31, 2015, 2014 and 2013 grants offset against operating expenses were $1,878,000, $19,000 and $175,000, respectively. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions. These estimates and assumptions affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ materially from those estimates. |
Concentration of Risk | Concentration of Risk Credit Risk Financial instruments that subject the Company to concentrations of credit risk consist primarily of cash, money market funds, and trade accounts receivable. The Company maintains cash and money market funds with financial institutions that management deems reputable, and at times, cash balances may be in excess of FDIC and SIPC insurance limits. The Company extends differing levels of credit to customers, and typically does not require collateral. The Company also maintains a cash balance at a bank in Switzerland. Accounts at such bank are insured up to an amount specified by the deposit insurance agency of Switzerland. Customer Concentration During the years ended December 31, 2015, 2014 and 2013, the following customers comprised more than 10% of revenues : 2015 2014 2013 Customer 1 14 % 7 % 0 % Customer 2 7 % 21 % 0 % Customer 3 4 % 10 % 0 % Customer 4 0 % 6 % 13 % Customer 5 0 % 0 % 31 % Customer 6 0 % 3 % 13 % Customer 7 0 % 0 % 12 % As of December 31, 2015 and 2014, the following customers comprised more than 10% accounts receivable: 2015 2014 Customer 1 19 % 0 % Customer 2 17 % 32 % Customer 3 10 % 2 % Customer 4 10 % 0 % Customer 5 10 % 0 % Customer 6 4 % 13 % Customer 7 0 % 13 % Customer 8 0 % 20 % Geographic Concentration During the years ended December 31, 2015, 2014 and 2013, regional revenue, based on customer locations which comprised more than 10% of revenues, consisted of the following: 2015 2014 2013 United States 46 % 47 % 0 % Italy 20 % 8 % 18 % France 16 % 3 % 7 % Germany 6 % 16 % 32 % Canada 5 % 10 % 0 % Saudi Arabia 0 % 3 % 31 % Netherlands 0 % 0 % 13 % Sources of Supply Several of the components, materials and services used in the CompanyÂ’s current Argus II product are available from only one supplier, and substitutes for these items cannot be obtained easily or would require substantial design or manufacturing modifications. Any significant problem experienced by one of the CompanyÂ’s sole source suppliers could result in a delay or interruption in the supply of components to the Company until that supplier cures the problem or an alternative source of the component is located and qualified. Even where the Company could qualify alternative suppliers, the substitution of suppliers may be at a higher cost and cause time delays that impede the commercial production of the Argus II, reduce gross profit margins and impact the CompanyÂ’s abilities to deliver its products as may be timely required to meet demand. |
Foreign Operations | Foreign Operations The accompanying consolidated financial statements as of December 31, 2015 and 2014 include assets amounting to approximately $3.0 million and $2.1 million, respectively, relating to operations of the Company in Switzerland. It is always possible unanticipated events in foreign countries could disrupt the CompanyÂ’s operations. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels, and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required. Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that the Company has the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives. Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange based derivatives, mutual funds, and fair-value hedges. Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently-traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models. The Company determines the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, the Company performs an analysis of the assets and liabilities at each reporting period end. Money market funds are the only financial instrument that is measured and recorded at fair value on the CompanyÂ’s balance sheet, and they are considered Level 1 valuation securities in both 2015 and 2014. |
Stock-Based Compensation | Stock-Based Compensation Pursuant to Financial Accounting Standards Board (“FASB”) ASC 718 Share-Based Payment (“ASC 718”), the Company records stock-based compensation expense for all stock-based awards. Under ASC 718, the Company estimates the fair value of stock options granted using the Black-Scholes option pricing model. The fair value for awards that are expected to vest is then amortized on a straight-line basis over the requisite service period of the award, which is generally the option vesting term. The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option valuation model. The assumptions used in the Black-Scholes valuation model are as follows: • The grant price of the issuances, with certain exceptions, is determined based on the estimated fair value of the shares at the date of grant. • The risk free interest rate for periods within the contractual life of the option is based on the U.S. treasury yield in effect at the time of grant. • As permitted by SAB 107, due to the Company’s insufficient history of option activity, management utilizes the simplified approach to estimate the options expected term, which represents the period of time that options granted are expected to be outstanding. • Volatility is determined based on average historical volatilities of comparable companies in similar industry. • Expected dividend yield is based on current yield at the grant date or the average dividend yield over the historical period. The Company has never declared or paid dividends and has no plans to do so in the foreseeable future. |
Long Term Investor Right | Long Term Investor Right Each beneficial owner (“IPO Shareholder”) of the Company’s common stock, who purchased shares directly in the offering (“IPO Shares”), may qualify to receive up to one additional share of common stock from the Company for each share purchased in the offering (“IPO Supplemental Shares”) pursuant to the Long Term Investor Right that was included with each IPO Share. To receive IPO Supplemental Shares, within 90 days following the closing date of the offering, or by February 22, 2015, an IPO Shareholder was required to take action to become the direct registered owner of its IPO Shares. Furthermore, IPO Shareholders are required to hold their IPO Shares in their own name and not place them in “street name” or trade them at any time during the 24 month period immediately following the IPO closing date. This Long Term Investors Right is non-detachable and transferable only in limited circumstances. The Company will issue IPO Supplemental Shares to IPO Shareholders who have not otherwise forfeited their Long Term Investor Right if, during the two-year period immediately following the IPO closing date, the Company’s common stock does not trade at or above $18.00 per share (200% of the IPO price per share) for any five consecutive day period. If the Company’s common stock trades on its principal exchange at 200% of the IPO price per share or greater on five consecutive trading days during the two years after the IPO closing date, the Long Term Investor Right will terminate. The formula to determine the number of IPO Supplemental Shares to be issued on a trigger of the Long Term Investor Right will be: (i) $18.00 minus (ii) the average of the highest consecutive closing prices in any 90 day trading period on the principal exchange during the two years after the Closing Date (the “Measurement Average”) divided by the Measurement Average. Fractional shares issuable to a qualifying IPO Shareholder resulting from the calculation will be rounded up to the next whole share of Common Stock, taking into account the aggregate number of Long Term Investor Rights of a holder. As an illustrative example, if the highest average of consecutive closing prices over any 90 calendar day period is $10.00 per share, each Long-Term Investor Right will be entitled to 0.80 additional shares of common stock, which is calculated as: ($18.00 - $10.00)/$10.00. The IPO offering price for purposes of the calculation of the amount of common stock to be issued on a Long Term Investor Right will be subject to adjustment in the event of a reorganization, recapitalization or split-up of the Company’s shares, the issuance of a stock dividend or any similar event. The amount of IPO Supplemental Shares, if any, to be issued will be computed by an independent public accountant as soon as practicable following the second anniversary of the Closing Date. The determination by such independent public accountant will be final and binding on the Company and on all qualifying IPO Shareholders and the Company will within 15 days after receipt of written determination deliver to shareholders certificates evidencing the additional shares. The Company has identified and will track IPO Investors who have perfected their Long Term Investor Rights on a quarterly basis. At the end of each reporting period, the Company will disclose the potential dilutive effect of the Long Term Investor Rights, including the number of common shares that would be issuable on such date, based on the actual share price movements since the IPO. The Long Term Investor Right is an equity instrument that is accounted for as a component of the actual price per common share paid by the investor in the IPO. For basic earnings per share, the common shares associated with the Long Term Investor Right are treated as contingently issuable shares and will not be included in basic earnings per share until the actual number of shares can be calculated and the shares have been issued. As of December 31, 2015 there were 400,057 shares of common stock issuable under outstanding Long Term Investor Rights. |
Convertible Promissory Notes and Warrants | Convertible Promissory Notes and Warrants The warrants and embedded beneficial conversion feature of convertible promissory notes are classified as equity under FASB ASC Topic 815-40 “Derivatives and Hedging — Contracts in Entity’s Own Equity”. The Company allocates the proceeds of the convertible promissory notes between convertible promissory notes and the financial instruments related to warrants associated with convertible promissory notes based on their relative fair values at the commitment date. The fair value of the financial instruments related to warrants associated with convertible promissory notes is determined utilizing the Black-Scholes option pricing model and the respective allocated proceeds to the warrants is recorded in additional paid-in capital. The Company utilized the Black-Scholes option valuation model using the same valuation assumptions as described herein for Stock Based Compensation. The embedded beneficial conversion feature associated with convertible promissory notes is recognized and measured by allocating a portion of the proceeds equal to the intrinsic value of that feature to additional paid-in capital in accordance with ASC Topic 470-20 “Debt — Debt with Conversion and Other Options.” The portion of debt discount resulting from the allocation of proceeds to the financial instruments related to warrants associated with convertible promissory notes is being amortized over the life of the convertible promissory notes. For the portion of debt discount resulting from the allocation of proceeds to the beneficial conversion feature, it is amortized over the term of the notes from the respective dates of issuance. |
Comprehensive Income or Loss | Comprehensive Income or Loss The Company complies with provisions of FASB ASC 220, Comprehensive Income, which requires companies to report all changes in equity during a period, except those resulting from investment by owners and distributions to owners, for the period in which they are recognized. Comprehensive income is defined as the change in equity during a period from transactions and other events from non-owner sources. Comprehensive and other comprehensive income (loss) is reported on the face of the financial statements. For the years ended December 31, 2015, 2014 and 2013 comprehensive income (loss) is the total of net income (loss) and other comprehensive income (loss) which, for the Company, consists entirely of foreign currency translation adjustments and there were no material reclassifications from other comprehensive loss to net loss during the years ended December 31, 2015, 2014 and 2013. |
Foreign Currency Translation and Transactions | Foreign Currency Translation and Transactions The financial statements and transactions of the subsidiaryÂ’s operations are reported in the local (functional) currency of Swiss francs (CHF) and translated into US dollars in accordance with U.S. GAAP. Assets and liabilities of those operations are translated at exchange rates in effect at the balance sheet date. The resulting gains and losses from translating foreign currency financial statements are recorded as other comprehensive income (loss). Revenues and expenses are translated at the average exchange rate for the reporting period. Foreign currency translation gains (losses) resulting from exchange rate fluctuations on transactions denominated in a currency other than the foreign operationsÂ’ functional currencies are included in expenses in the consolidated statements of operations. |
Income Taxes | Income Taxes The Company accounts for income taxes under an asset and liability approach for financial accounting and reporting for income taxes. Accordingly, the Company recognizes deferred tax assets and liabilities for the expected impact of differences between the financial statements and the tax basis of assets and liabilities. The Company records a valuation allowance to reduce its deferred tax assets to the amount that is more likely than not to be realized. 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 its recorded amount, an adjustment to the deferred tax assets would be credited to operations in the period such determination was made. Likewise, should the Company determine that it would not be able to realize all or part of its deferred tax assets in the future, an adjustment to the deferred tax assets would be charged to operations in the period such determination was made. The Company has incurred losses for tax purposes since inception and has significant tax losses and tax credit carryforwards. These amounts are subject to valuation allowances as it is not likely that they will be realized in the next few years. |
Product Warranties | Product Warranties The CompanyÂ’s policy is to warrant all shipped products against defects in materials and workmanship for two years by replacing failed parts. The Company also provides a three-year manufacturerÂ’s warranty covering implant failure by providing a functionally-equivalent replacement implant. Accruals for product warranties are estimated based on historical warranty experience and current product performance trends, and are recorded at the time revenue is recognized as a component of cost of sales. The warranty liabilities are reduced by material and labor costs used to replace parts over the warranty period in the periods in which the costs are incurred. The Company periodically assesses the adequacy of its recorded warranty liabilities and adjusts the amounts as necessary. Although any such adjustments were not material in the years ended December 31, 2015, 2014 and 2013, any such adjustments could be material in the future if estimates differ significantly from actual warranty expense. The warranty liabilities are included in accrued expenses in the consolidated balance sheets. |
Presentation of sales and value added taxes | Presentation of sales and value added taxes The Company collects value added tax on its sales in Europe and certain states in the United Sates impose a sales tax on the CompanyÂ’s sales to nonexempt customers. The Company collects that valued added and sales tax from customers and remits the entire amount to the respective authorities. The CompanyÂ’s accounting policy is to exclude the tax collected and remitted to the authorities from revenues and cost of revenues. |
Net Loss per Share | Net Loss per Share The Company’s computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) available to common shareholders divided by the weighted average number of common shares outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., convertible notes payable, convertible preferred stock, preferred stock warrants and common stock options) as if they had been converted at the beginning of the periods presented, or issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS. Loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share is the same for all periods presented because all convertible notes payable, common stock warrants and common stock options outstanding were anti-dilutive. At December 31, 2015, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to ultimately acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. 2015 2014 2013 Long Term Investor Rights 400,057 1,021,021 — Underwriter’s warrants 802,000 805,000 — Convertible notes payable — — 6,248,652 Warrants associated with convertible debt 1,038,403 1,178,707 1,180,766 Common stock options 3,472,146 3,251,627 2,240,568 Restricted stock units 190,000 — — Employee stock purchase plan 93,000 — — Total 5,995,606 6,256,355 9,669,986 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update No. 2014-09 (ASU 2014-09), Revenue from Contracts with Customers. ASU 2014-09 will eliminate transaction- and industry-specific revenue recognition guidance under current GAAP and replace it with a principle based approach for determining revenue recognition. ASU 2014-09 will require that companies recognize revenue based on the value of transferred goods or services as they occur in the contract. ASU 2014-09 also will require additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. Based on the FASB’s Exposure Draft Update issued on April 29, 2015, and approved in July 2015, Revenue from Contracts With Customers (Topic 606): Deferral of the Effective Date, ASU 2014-09 is now effective for reporting periods beginning after December 15, 2017, with early adoption permitted only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. Entities will be able to transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. The Company is evaluating ASU 2014-9, and has not yet determined its impact to the Company’s financial statements, nor decided the transition approach it will take. In August 2014, the FASB issued Accounting Standards Update No. 2014-15 (ASU 2014-15), Presentation of Financial Statements – Going Concern (Subtopic 205-10). ASU 2014-15 provides guidance as to 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. In connection with preparing financial statements for each annual and interim reporting period, an entity’s management should evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable). Management’s evaluation should be based on relevant conditions and events that are known and reasonably knowable at the date that the financial statements are issued (or at the date that the financial statements are available to be issued when applicable). Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued (or available to be issued). ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The adoption of ASU 2014-15 is not expected to have any impact on the Company’s financial statement presentation and disclosures. In January 2015, the FASB issued Accounting Standards Update No. 2015-01 (ASU 2015-01), Income Statement – Extraordinary and Unusual Items (Subtopic 225-20). ASU 2015-01 eliminates from GAAP the concept of extraordinary items. Subtopic 225-20, Income Statement – Extraordinary and Unusual Items, required that an entity separately classify, present, and disclose extraordinary events and transactions. Presently, an event or transaction is presumed to be an ordinary and usual activity of the reporting entity unless evidence clearly supports its classification as an extraordinary item. Paragraph 225-20-45-2 contains the following criteria that must both be met for extraordinary classification: (1) Unusual nature. The underlying event or transaction should possess a high degree of abnormality and be of a type clearly unrelated to, or only incidentally related to, the ordinary and typical activities of the entity, taking into account the environment in which the entity operates. (2) Infrequency of occurrence. The underlying event or transaction should be of a type that would not reasonably be expected to recur in the foreseeable future, taking into account the environment in which the entity operates. If an event or transaction meets the criteria for extraordinary classification, an entity is required to segregate the extraordinary item from the results of ordinary operations and show the item separately in the income statement, net of tax, after income from continuing operations. The entity also is required to disclose applicable income taxes and either present or disclose earnings-per-share data applicable to the extraordinary item. ASU 2015-01 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. A reporting entity may apply the guidance prospectively. A reporting entity also may apply the guidance retrospectively to all prior periods presented in the financial statements. Early adoption is permitted provided that the guidance is applied from the beginning of the fiscal year of adoption. The adoption of ASU 2015-01 is not expected to have any impact on the Company’s financial statement presentation or disclosures. In February 2015, the FASB issued Accounting Standards Update No. 2015-02 (ASU 2015-02), Consolidation (Topic 810) . In April 2015, the FASB issued Accounting Standards Update No. 2015-03 (ASU 2015-03), Interest – Imputation of Interest (Subtopic 835-30). ASU 2015-03 simplifies the presentation of debt issuance costs and 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 that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the new guidance. ASU 2015-3 is effective for financial statements issued for fiscal years beginning after December 15, 2015, and interim periods within that fiscal year. Early adoption is permitted for financial statements that have not been previously issued. An entity is required to apply the new guidance on a retrospective basis, wherein the balance sheet of each individual period presented is adjusted to reflect the period-specific effects of applying the new guidance. Upon transition, an entity is required to comply with the applicable disclosures for a change in an accounting principle. These disclosures include the nature of and reason for the change in accounting principle, the transition method, a description of the prior-period information that has been retrospectively adjusted, and the effect of the change on the financial statement line items (i.e., debt issuance cost asset and the debt liability). The adoption of ASU 2015-03 is not expected to have any impact on the Company’s financial statement presentation or disclosures. In November 2015, the FASB issued Accounting Standards Update No. 2015-17 (ASU 2015-17), Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. ASU 2015-17 is effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. Earlier application is permitted as of the beginning of an interim or annual reporting period. The adoption of ASU 2015-17 is not expected to have any impact on Company’s financial statement presentation or disclosures. In February 2016, the Financial Accounting Standards Board issued Accounting Standards Update No. 2016-02 regarding leases. The new standard requires lessee recognition on the balance sheet of a right-of-use asset and a lease liability, initially measured at the present value of the lease payments. It further requires recognition in the income statement of a single lease cost, calculated so that the cost of the lease is allocated over the lease term on a generally straight-line basis. Finally, it requires classification of all cash payments within operating activities in the statement of cash flows. It is effective for fiscal years commencing after December 15, 2018 and early adoption is permitted. Management has not yet evaluated the impact of the adoption of ASU 2016-02 on the Company’s financial statement presentation or disclosures. Management does not believe that any other recently issued, but not yet effective, authoritative guidance, if currently adopted, would have a material impact on the Company’s financial statement presentation or disclosures. |
Summary of Significant Accoun23
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary of estimated useful life of property and equipment | Estimated useful lives of the principal classes of assets are as follows: Lab equipment 5 – 7 years Computer hardware and software 3 – 7 years Leasehold improvements 1 – 5 years or the term of the lease, if shorter Furniture, fixtures and equipment 5 – 10 years |
Summary of customer concentration of risk in revenue | During the years ended December 31, 2015, 2014 and 2013, the following customers comprised more than 10% of revenues : 2015 2014 2013 Customer 1 14 % 7 % 0 % Customer 2 7 % 21 % 0 % Customer 3 4 % 10 % 0 % Customer 4 0 % 6 % 13 % Customer 5 0 % 0 % 31 % Customer 6 0 % 3 % 13 % Customer 7 0 % 0 % 12 % |
Summary of customer concentration of risk in accounts receivable | As of December 31, 2015 and 2014, the following customers comprised more than 10% accounts receivable: 2015 2014 Customer 1 19 % 0 % Customer 2 17 % 32 % Customer 3 10 % 2 % Customer 4 10 % 0 % Customer 5 10 % 0 % Customer 6 4 % 13 % Customer 7 0 % 13 % Customer 8 0 % 20 % |
Summary of geographic concentration of risk in revenue | During the years ended December 31, 2015, 2014 and 2013, regional revenue, based on customer locations which comprised more than 10% of revenues, consisted of the following: 2015 2014 2013 United States 46 % 47 % 0 % Italy 20 % 8 % 18 % France 16 % 3 % 7 % Germany 6 % 16 % 32 % Canada 5 % 10 % 0 % Saudi Arabia 0 % 3 % 31 % Netherlands 0 % 0 % 13 % |
Summary of net loss per share | At December 31, 2015, 2014 and 2013, the Company excluded the outstanding securities summarized below, which entitle the holders thereof to ultimately acquire shares of common stock, from its calculation of earnings per share, as their effect would have been anti-dilutive. 2015 2014 2013 Long Term Investor Rights 400,057 1,021,021 — Underwriter’s warrants 802,000 805,000 — Convertible notes payable — — 6,248,652 Warrants associated with convertible debt 1,038,403 1,178,707 1,180,766 Common stock options 3,472,146 3,251,627 2,240,568 Restricted stock units 190,000 — — Employee stock purchase plan 93,000 — — Total 5,995,606 6,256,355 9,669,986 |
Money Market Funds (Tables)
Money Market Funds (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Summary of money market fund | The following table presents money market funds at their level within the fair value hierarchy at December 31, 2015 and 2014(in thousands). Total Level 1 Level 2 Level 3 December 31, 2015: Money market funds $ 15,721 $ 15,721 $ — $ — December 31, 2014: Money market funds $ 34,000 $ 34,000 $ — $ — |
Selected Balance Sheet Detail (
Selected Balance Sheet Detail (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Selected Balance Sheet Detail | |
Summary of inventory | Inventories consisted of the following at December 31, 2015 and 2014 (in thousands): 2015 2014 Raw materials $ 575 $ 611 Work in process 5,028 4,729 Finished goods 3,156 1,749 8,759 7,089 Allowance for excess and obsolescence (550 ) (1,367 ) Inventories, net $ 8,209 $ 5,722 |
Summary of property and equipment | Property and equipment consisted of the following at December 31, 2015 and 2014 (in thousands): 2015 2014 Laboratory equipment $ 3,369 $ 3,286 Computer hardware and software 1,960 1,701 Leasehold improvements 508 362 Furniture, fixtures and equipment 135 135 5,972 5,484 Accumulated depreciation and amortization (4,540 ) (4,479 ) Property and equipment, net $ 1,432 $ 1,005 |
Convertible Promissory Notes 26
Convertible Promissory Notes and Warrants (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Warrants and Rights Note Disclosure [Abstract] | |
Summary of warrants associated with the Convertible Notes Black-Scholes option-pricing model | The calculated value of the warrants associated with the Convertible Notes was estimated on the respective dates of grant using the Black-Scholes option-pricing model with the following assumptions: 2013 Risk-free interest rate 0.65% – 1.68% Expected dividend yield 0% Expected volatility 57.5% Expected term 4.2 – 5.0 years Weighted-average grant date calculated fair value $3.98 |
Summary of warrant activity | A summary of warrant activity for the years ended December 31, 2015, 2014, and 2013 is presented below: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Warrants outstanding at December 31, 2012 400,000 $ 5.00 Granted 780,766 5.00 Exercised — — Forfeited or expired — — Warrants outstanding at December 31, 2013 1,180,766 $ 5.00 Granted 805,000 11.25 Exercised (2,059 ) 5.00 Forfeited or expired — — Warrants outstanding at December 31, 2014 1,983,707 $ 7.54 Granted — 11.25 Exercised (143,304 ) 5.13 Forfeited or expired — — Warrants outstanding at December 31, 2015 1,840,403 $ 7.72 2.80 Warrants exercisable at December 31, 2015 1,840,403 $ 7.72 2.80 |
Equity Securities (Tables)
Equity Securities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Summary of potentially dilutive securities | The fair value of the warrant issued as part of underwriting fee for the CompanyÂ’s IPO was estimated to be $2,772,000, using the Black-Scholes option-pricing model with the following assumptions: Risk-free rate of return 1.63% Expected dividend yield 0% Expected volatility 49.92% Expected term 5 years |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of option grant | The calculated value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions: 2015 2014 2013 Risk-free interest rate 1.93% – 2.21% 0.3% – 2.2% 1% Expected dividend yield 0% 0% 0% Expected volatility 47.5% – 50.4% 50.0% – 61.2% 61.2% Expected term 6.25 – 6.5 years 1.5 – 6.5 years 6.5 years Weighted-average grant date calculated fair value $ 6.17 $ 4.73 $ 1.58 |
Summary of stock option activity | A summary of stock option activity for the years ended December 31, 2015, 2014 and 2013 is presented below: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in Years) Options outstanding at December 31, 2012 2,727,503 $ 4.32 Granted 500 5.00 Exercised (331,871 ) 1.05 Forfeited or expired (155,564 ) 3.73 Options outstanding at December 31, 2013 2,240,568 $ 4.84 Granted 1,377,978 7.62 Exercised (115,029 ) 4.40 Forfeited or expired (251,890 ) 4.44 Options outstanding at December 31, 2014 3,251,627 $ 6.07 Granted 998,348 12.29 Exercised (573,792 ) 4.85 Forfeited or expired (204,037 ) 7.08 Options outstanding at December 31, 2015 3,472,146 $ 8.01 6.39 Options exercisable at December 31, 2015 1,571,255 $ 5.44 3.62 |
Summary of exercise prices of common stock options outstanding and exercisable | The exercise prices of common stock options outstanding and exercisable are as follows at December 31, 2015: Exercise Price Options Outstanding (Shares) Options Exercisable (Shares) $ 4.25 125,000 125,000 $ 4.88 16,500 — $ 5.00 1,408,553 1,223,965 $ 7.00 252,095 51,969 $ 9.00 699,650 170,121 $ 9.01 34,000 — $ 12.43 420,000 — $ 12.46 246,000 — $ 12.73 150,000 — $ 13.09 116,348 — $ 13.90 3,000 — $ 14.06 1,000 200 3,472,146 1,571,255 |
Summarizes Restricted Stock | The following table summarizes Restricted Stock Unit (RSU) activity for the year ended December 31, 2015: Number Weighted Average Outstanding as of December 31, 2014 - $ - Awarded 190,000 12.43 Vested - - Forfeited/canceled - - Outstanding as of December 31, 2015 190,000 $ 12.43 |
Summary of stock-based compensation | The total stock-based compensation recognized for stock-based awards granted in the consolidated statements of operations for the years ended December 31, 2015, 2014 and 2013 is as follows (in thousands): 2015 2014 2013 Cost of sales $ 279 $ 192 $ 153 Research and development 208 293 229 Clinical and regulatory 235 113 83 Selling and marketing 442 141 102 General and administrative 1,523 736 203 Total $ 2,687 $ 1,475 $ 770 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Summary of deferred tax assets | Significant components of the Company’s deferred tax assets as of December 31, 2015 and 2014 are summarized below (in thousands): 2015 2014 Stock-based compensation $ 2,825 $ 2,489 Research credits 5,401 5,436 Depreciation (12 ) (13 ) Net operating loss carryforwards 47,261 43,700 Inventory reserve 203 544 Other 845 492 Total deferred tax assets 56,523 52,648 Valuation allowance (56,523 ) (52,648 ) Net deferred tax assets $ — $ — |
Product Warranties (Tables)
Product Warranties (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Product Warranties Disclosures [Abstract] | |
Summary of activity in the Company's warranty liabilities | A summary of activity in the Company’s warranty liabilities, which are included in accrued expenses in the accompanying consolidated balance sheets, for the years ended December 31, 2015, 2014 and 2013 is presented below (in thousands): 2015 2014 2013 Balance, beginning of year $ 556 $ 253 $ 120 Additional accruals 991 415 139 Payments (443 ) (112 ) (6 ) Adjustments and other (38 ) — — Total $ 1,066 $ 556 $ 253 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary future minimum rental payments | Future minimum rental payments required under the operating leases are as follows for the years ended December 31 (in thousands). Years Amount 2016 $ 808 2017 833 2018 858 2019 884 2020 910 Thereafter 1,095 Total $ 5,388 |
Quarterly Financial Summary (32
Quarterly Financial Summary (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Summary | Quarters Ended (in thousands, except per share data) December 31, 2015 September 30, 2015 June 30, 2015 March 31, 2015 Product sales $ 2,362 $ 2,227 $ 2,661 $ 1,700 Gross profit $ 691 $ 1,470 $ 1,092 $ 404 Operating loss $ (5,477 ) $ (4,662 ) $ (4,947 ) $ (4,961 ) Net loss $ (5,474 ) $ (4,666 ) $ (4,922 ) $ (4,956 ) Net loss per share – basic and diluted $ (0.15 ) $ (0.13 ) $ (0.14 ) $ (0.14 ) Quarters Ended December 31, 2014(1) September 30, 2014 June 30, 2014 March 31, 2014 Product sales $ 1,521 $ 609 $ 611 $ 657 Gross profit (loss) $ 99 $ 193 $ (382 ) $ (70 ) Operating loss $ (5,565 ) $ (5,649 ) $ (5,563 ) $ (4,456 ) Net loss $ (13,577 ) $ (7,644 ) $ (7,541 ) $ (6,439 ) Net loss per share – basic and diluted $ (0.46 ) $ (0.31 ) $ (0.32 ) $ (0.28 ) (1) During the fourth quarter of 2014, the Company wrote-off the unamortized discount on convertible promissory notes of $6,955 as a result of the automatic conversion of such notes into common stock upon the closing of the Company’s IPO. |
Organization and Business Ope33
Organization and Business Operations (Details Narrative) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jan. 25, 2016 | Nov. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2007 | |
Ownership by the Company | 99.50% | |||||
Revenue | $ 8,950 | $ 3,398 | $ 1,565 | |||
Issuance of convertible debt with the face value | 19,500 | |||||
Research and development grant | $ 3,036 | 5,041 | 3,249 | |||
Issuance of common stock in a private placements | 9,100 | 2,400 | ||||
Proceeds from issuance of common stock | $ 34,200 | $ 43,295 | $ 2,400 | |||
Subsequent Event [Member] | ||||||
Proceeds from issuance of common stock | $ 19,800 | |||||
Common stock available for sale | 5,600,000 | |||||
Offer price, lower limit | 425.00% | |||||
Subsequent Event [Member] | Minimum [Member] | ||||||
Offer price, lower limit | 400.00% | |||||
Subsequent Event [Member] | Maximum [Member] | ||||||
Offer price, lower limit | 600.00% | |||||
Executive Officer [Member] | ||||||
Ownership by the Company | 0.50% | |||||
SWITZERLAND | ||||||
Ownership by the Company | 100.00% |
Summary of Significant Accoun34
Summary of Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Lab equipment [Member] | |
Property and equipment estimated useful lives | 5 - 7 years |
Computer hardware and software [Member] | |
Property and equipment estimated useful lives | 3 - 7 years |
Leasehold improvements [Member] | |
Property and equipment estimated useful lives | 1 - 5 years or the term of the lease, if shorter |
Furniture, fixtures and equipment [Member] | |
Property and equipment estimated useful lives | 5 - 10 years |
Summary of Significant Accoun35
Summary of Significant Accounting Policies (Details 1) - Sales Revenue, Net [Member] | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Customer 1 [Member] | |||
Percentage | 14.00% | 7.00% | 0.00% |
Customer 2 [Member] | |||
Percentage | 7.00% | 21.00% | 0.00% |
Customer 3 [Member] | |||
Percentage | 4.00% | 10.00% | 0.00% |
Customer 4 [Member] | |||
Percentage | 0.00% | 6.00% | 13.00% |
Customer 5 [Member] | |||
Percentage | 0.00% | 0.00% | 31.00% |
Customer 6 [Member] | |||
Percentage | 0.00% | 3.00% | 13.00% |
Customer 7 [Member] | |||
Percentage | 0.00% | 0.00% | 12.00% |
Summary of Significant Accoun36
Summary of Significant Accounting Policies (Details 2) - Accounts Receivable [Member] | Dec. 31, 2015 | Dec. 31, 2014 |
Customer 1 [Member] | ||
Percentage | 19.00% | 0.00% |
Customer 2 [Member] | ||
Percentage | 17.00% | 32.00% |
Customer 3 [Member] | ||
Percentage | 10.00% | 2.00% |
Customer 4 [Member] | ||
Percentage | 10.00% | 0.00% |
Customer 5 [Member] | ||
Percentage | 10.00% | 0.00% |
Customer 6 [Member] | ||
Percentage | 4.00% | 13.00% |
Customer 7 [Member] | ||
Percentage | 0.00% | 13.00% |
Customer 8 [Member] | ||
Percentage | 0.00% | 20.00% |
Summary of Significant Accoun37
Summary of Significant Accounting Policies (Details 3) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
United States [Member] | |||
Regional revenue by customer location | 46.00% | 47.00% | 0.00% |
Italy [Member] | |||
Regional revenue by customer location | 20.00% | 8.00% | 18.00% |
France [Member] | |||
Regional revenue by customer location | 16.00% | 3.00% | 7.00% |
Germany [Member] | |||
Regional revenue by customer location | 6.00% | 16.00% | 32.00% |
Canada [Member] | |||
Regional revenue by customer location | 5.00% | 10.00% | 0.00% |
Saudi Arabia [Member] | |||
Regional revenue by customer location | 0.00% | 3.00% | 31.00% |
Netherlands [Member] | |||
Regional revenue by customer location | 0.00% | 0.00% | 13.00% |
Summary of Significant Accoun38
Summary of Significant Accounting Policies (Details 4) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Calculation of earnings per share common stock anti-dilutive securities | 5,995,606 | 6,256,355 | 9,669,986 |
Long Term Investor Rights [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 400,057 | 1,021,021 | |
Underwriter's Warrants [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 802,000 | 805,000 | |
Convertible notes payable [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 6,248,652 | ||
Warrants associated with convertible debt [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 1,038,403 | 1,178,707 | 1,180,766 |
Common stock options [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 3,472,146 | 3,251,627 | 2,240,568 |
Restricted stock units [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 190,000 | ||
Employee stock purchase plan [Member] | |||
Calculation of earnings per share common stock anti-dilutive securities | 93,000 |
Summary of Significant Accoun39
Summary of Significant Accounting Policies (Details Narrative) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) | Oct. 31, 2014shares | |
Assets | $ 28,245 | $ 43,069 | ||
Depreciation and amortization of property and equipment | 335 | 279 | $ 316 | |
Research and development costs | 3,036 | 5,041 | 3,249 | |
Patent costs | 679 | 666 | 669 | |
Grants offset against operating expenses | $ 1,878 | $ 19 | $ 175 | |
Common stock issuable under outstanding | shares | 35,942 | 35,241 | 1 | |
Long Term Investor Right, Description. | The formula to determine the number of IPO Supplemental Shares to be issued on a trigger of the Long Term Investor Right will be: (i) $18.00 minus (ii) the average of the highest consecutive closing prices in any 90 day trading period on the principal exchange during the two years after the Closing Date (the “Measurement Average”) divided by the Measurement Average. Fractional shares issuable to a qualifying IPO Shareholder resulting from the calculation will be rounded up to the next whole share of Common Stock, taking into account the aggregate number of Long Term Investor Rights of a holder. As an illustrative example, if the highest average of consecutive closing prices over any 90 calendar day period is $10.00 per share, each Long-Term Investor Right will be entitled to 0.80 additional shares of common stock, which is calculated as: ($18.00 - $10.00)/$10.00. | |||
Long Term Investor Rights [Member] | ||||
Common stock issuable under outstanding | shares | 400,057 | |||
IPO common stock per price | $ / shares | $ 18 | |||
Switzerland [Member] | ||||
Assets | $ 3,000 | $ 2,100 | ||
Number of domestic and foreign patents | 345 |
Money Market Funds (Details)
Money Market Funds (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Money market funds | $ 15,721 | $ 34,000 |
Level 1 [Member] | ||
Money market funds | $ 15,721 | $ 34,000 |
Level 2 [Member] | ||
Money market funds | ||
Level 3 [Member] | ||
Money market funds |
Money Market Funds (Details Nar
Money Market Funds (Details Narrative) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Money market funds | $ 15,721 | $ 34,000 |
Deposit account | 218 | 56 |
City National Rochdale Government Fund Class S [Member] | ||
Money market funds | 555 | 268 |
FFI Institutional Fund [Member] | ||
Money market funds | $ 14,948 | 32,645 |
BBIF Money Fund Class 4 [Member] | ||
Money market funds | 7 | |
Preferred Deposit [Member] | ||
Deposit account | $ 1,024 |
Selected Balance Sheet Detail42
Selected Balance Sheet Detail (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Selected Balance Sheet Detail | ||
Raw materials | $ 575 | $ 611 |
Work in process | 5,028 | 4,729 |
Finished goods | 3,156 | 1,749 |
Inventory, Gross | 8,759 | 7,089 |
Allowance for excess and obsolescence | (550) | (1,367) |
Inventories, net | $ 8,209 | $ 5,722 |
Selected Balance Sheet Detail43
Selected Balance Sheet Detail (Detail 1) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property and equipment, Gross | $ 5,972 | $ 5,484 |
Accumulated depreciation and amortization | (4,540) | (4,479) |
Property and equipment, net | 1,432 | 1,005 |
Laboratory equipment [Member] | ||
Property and equipment, Gross | 3,369 | 3,286 |
Computer hardware and software [Member] | ||
Property and equipment, Gross | 1,960 | 1,701 |
Leasehold Improvements [Member] | ||
Property and equipment, Gross | 508 | 362 |
Furniture, fixtures and equipment [Member] | ||
Property and equipment, Gross | $ 135 | $ 135 |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Dec. 13, 2013 | Jun. 30, 2014 | May. 31, 2011 | Nov. 18, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2011 |
Convertible promissory notes face value | $ 23,400 | |||||||
Convertible promissory notes interest rate | 7.50% | |||||||
Warrants to purchase shares of common stock per share | $ 5 | |||||||
Convertible notes converted into common stock shares | $ 5 | $ 5 | ||||||
Convertible notes payable to unrelated parties | $ 200 | |||||||
Accrued interest related to notes and warrants | 8,000 | |||||||
Common stock conversion shares | 5,200,000 | 423 | ||||||
Convertible promissory notes accrued interest | $ 24,700 | |||||||
Warrants to purchase shares of common stock | 927,152 | 927,152 | ||||||
Interest expense to Related Party | $ 1,500 | 1,200 | ||||||
Scientific research cost | $ 1 | $ 1 | ||||||
Exercise of stock options to purchase shares | 200,000 | |||||||
Exercise of stock options to purchase shares amount | $ 100 | $ 2,782 | $ 506 | $ 345 | ||||
Exercise of stock options to purchase shares expiration date | Dec. 31, 2018 | |||||||
Exercise of stock options to purchase shares interest rate | 1.64% | |||||||
Chief Executive Officer [Member] | ||||||||
Exercise of stock options to purchase shares | 100,000 | |||||||
Exercise of stock options to purchase shares amount | $ 319 | |||||||
Exercise of stock options to purchase shares expiration date | May 31, 2016 | |||||||
Exercise of stock options to purchase shares interest rate | 2.26% |
Grants (Details Narrative)
Grants (Details Narrative) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2014 | Apr. 30, 2010 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Development and testing grant | $ 3,000 | ||||
Development and testing grant duration | 3 years | ||||
Rresearch and development expenses offset | $ 0 | $ 19 | $ 175 | ||
Lump sum amount paid for research by APL | $ 4,100 | ||||
Common shares issued to APL, | 1 | 35,942 | 35,241 | ||
Royalty of net sales of licensed products | 0.25% | ||||
APL [Member] | |||||
Rresearch and development expenses offset | $ 1,900 |
Convertible Promissory Notes 46
Convertible Promissory Notes and Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2013 | |
Risk-free interest rate | 1.63% | |
Expected dividend yield | 0.00% | |
Expected volatility | 49.92% | |
Expected term | 5 years | |
Warrant [Member] | ||
Expected dividend yield | 0.00% | |
Expected volatility | 57.50% | |
Weighted-average grant date calculated fair value | $ 3.98 | |
Warrant [Member] | Minimum [Member] | ||
Risk-free interest rate | 65.00% | |
Expected term | 4 years 2 months 12 days | |
Warrant [Member] | Maximum [Member] | ||
Risk-free interest rate | 1.68% | |
Expected term | 5 years |
Convertible Promissory Notes 47
Convertible Promissory Notes and Warrants (Details 1) - $ / shares | Dec. 13, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Number of Shares | ||||
Exercised | 200,000 | |||
Weighted Average Remaining Contractual Life (in Years) | ||||
Options outstanding at December 31, 2015 | 1 year 11 months 16 days | |||
Warrant [Member] | ||||
Number of Shares | ||||
Options outstanding at December 31, 2014 | 1,983,707 | 1,180,766 | 400,000 | |
Granted | 805,000 | 780,766 | ||
Exercised | (143,304) | (2,059) | ||
Forfeited or expired | ||||
Options outstanding at December 31, 2015 | 1,840,403 | 1,983,707 | 1,180,766 | |
Options exercisable at December 31, 2015 | 1,840,403 | |||
Weighted Average Exercise Price | ||||
Options outstanding at December 31, 2014 | $ 7.54 | $ 5 | $ 5 | |
Granted | 11.25 | 11.25 | $ 5 | |
Exercised | $ 5.13 | $ 5 | ||
Forfeited or expired | ||||
Options outstanding at December 31, 2015 | $ 7.72 | $ 7.54 | $ 5 | |
Options exercisable at December 31, 2015 | $ 7.72 | |||
Weighted Average Remaining Contractual Life (in Years) | ||||
Options outstanding at December 31, 2015 | 2 years 9 months 18 days | 3 years 9 months | ||
Options exercisable at December 31, 2015 | 2 years 9 months 18 days |
Convertible Promissory Notes 48
Convertible Promissory Notes and Warrants (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 5 Months Ended | 11 Months Ended | 12 Months Ended | |||||
Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2012 | Nov. 30, 2012 | Dec. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2011 | Dec. 31, 2010 | |
Borrowed fund by issuing convertible notes | $ 29,500 | $ 29,500 | $ 29,500 | $ 15,400 | $ 15,400 | |||||
Borrowed fund interest rate | 7.50% | |||||||||
Combined face value of the 2010 and 2011 Notes | $ 47 | |||||||||
Face value converted into shares of common stock | 6,639,137 | 3,200,000 | ||||||||
Common stock conversion price per share | $ 5 | $ 5 | ||||||||
Convertible notes redeemed | $ 54 | |||||||||
Debt issuance discount beneficial conversion feature | $ 10,500 | |||||||||
Warrants to purchase shares of common stock | 927,152 | 927,152 | 927,152 | |||||||
Warrants to purchase shares of common stock per share | $ 5 | $ 5 | ||||||||
Weighted average remaining contractual life | 1 year 11 months 16 days | |||||||||
Warrant outstanding | $ 1,038,403 | |||||||||
Unamortized discount on the Convertible Note | $ 7,000 | $ 7,000 | ||||||||
Intrinsic value of warrants exercisable | 1,008 | $ 1,294 | $ 1,008 | |||||||
July 2012 Notes [Member] | ||||||||||
Borrowed fund interest rate | 7.50% | |||||||||
Convertible notes isuued | $ 5,000 | |||||||||
Maturity dates | Jul. 31, 2015 | |||||||||
Effective interest rate | 18.60% | 14.50% | ||||||||
October 2012 Notes [Member] | ||||||||||
Borrowed fund interest rate | 7.50% | |||||||||
Convertible notes isuued | $ 5,000 | |||||||||
Maturity dates | Jul. 31, 2015 | |||||||||
Effective interest rate | 19.20% | 14.90% | ||||||||
February 2013 Notes [Member] | ||||||||||
Borrowed fund interest rate | 7.50% | |||||||||
Convertible notes isuued | $ 19,500 | |||||||||
Maturity dates | Feb. 28, 2016 | |||||||||
Effective interest rate | 63.30% | 33.30% | ||||||||
Warrant [Member] | ||||||||||
Warrants to purchase shares of common stock | 1,180,766 | |||||||||
Warrants to purchase shares of common stock per share | $ 5 | |||||||||
Weighted average remaining contractual life | 2 years 9 months 18 days | 3 years 9 months | ||||||||
Intrinsic value of warrants exercisable | $ 6,200 | $ 924 | $ 6,200 | |||||||
Warrant [Member] | Maximum [Member] | ||||||||||
Debt issuance discount beneficial conversion feature | $ 3,107 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Benefit Plans Details Narrative | |||
Employer contributions to plan | $ 137 | $ 127 | $ 110 |
Pension plan for the employees | $ 134 | $ 101 | $ 94 |
Equity Securities (Details)
Equity Securities (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Risk-free rate of return | 1.63% |
Expected dividend yield | 0.00% |
Expected volatility | 49.92% |
Expected term | 5 years |
Equity Securities (Details Narr
Equity Securities (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2015 | Nov. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Nov. 18, 2014 | |
Net proceeds from sale of common stock | $ 34,200 | $ 43,295 | $ 2,400 | |||
Purchase of common stock by underwriter, granted | 805,000 | |||||
Exercise price | $ 11.25 | |||||
Exercise price above offering price | 25.00% | |||||
Warrant exercisable period after effective date of registration | 180 days | |||||
Warrant exercisable ending period from effective date of registration | 5 years | |||||
Fair value of warrant issued of underwriting fee | $ 2,772 | |||||
Perfectly maintained Long Term Investor Rights aggregate common stock | 1,382,218 | |||||
Highest average closing price on NASDAQ | $ 13.96 | |||||
Share entitlement price for perfectly maintained Long Term Investor Right | $ 0.2894 | |||||
Rounded up of next whole share aggregate maximum shares | 400,057 | |||||
Shares issued for services to directors | 23,136 | |||||
Shares issued for services to directors, amount | $ 285 | |||||
Accrued services, Value | $ 205 | $ 166 | ||||
Accrued services, Shares | 33,293 | 16,204 | ||||
Accrued services, Closing price per share | $ 6.15 | $ 10.26 | ||||
Common Stock | ||||||
Increase authorized shares | 200,000,000 | |||||
Par value | $ 0 | |||||
Shares issued for services to directors | 22 | |||||
Preferred Stock [Member] | ||||||
Increase authorized shares | 10,000,000 | |||||
Par value | $ 0 | |||||
Minimum [Member] | ||||||
Actual number of common shares issuable pursuant to Long Term Investor Right | 0 | |||||
Maximum [Member] | ||||||
Actual number of common shares issuable pursuant to Long Term Investor Right | 400,057 | |||||
2013 Private Placement [Member] | ||||||
Net proceeds from sale of common stock | $ 2,400 | |||||
Exercise price | $ 7 | |||||
Sale of common stock to new investors | 342,955 | |||||
2014 Private Placement [Member] | ||||||
Net proceeds from sale of common stock | $ 9,100 | |||||
Exercise price | $ 7 | |||||
Sale of common stock to new investors | 1,299,853 | |||||
2014 Private Placement [Member] | Mendelsohn Investment Services, LLC [Member] | ||||||
Payment of finder's fee shares of common stock | $ 26,785 | |||||
Payment of additional finder's fee shares of common stock | $ 37,599 | |||||
November 2014 IPO [Member] | ||||||
Sale of common stock upon exercise of underwriter's over-allotment option | 525,000 | |||||
Net proceeds from sale of common stock | 34,200 | |||||
Net offering costs | $ 5,000 | |||||
Fair value of net offering cost from warrants and common stock | $ 2,900 | |||||
Sale of common stock to new investors | 4,025,000 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Risk-free interest rate | 2.16% | 1.00% | |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 49.30% | 61.20% | |
Expected term | 6 years 4 months 17 days | 6 years 6 months | |
Weighted-average grant date calculated fair value | $ 6.17 | $ 4.73 | $ 1.58 |
Maximum [Member] | |||
Risk-free interest rate | 2.21% | 2.20% | |
Expected volatility | 50.40% | 61.20% | |
Expected term | 6 years 6 months | 6 years 6 months | |
Minimum [Member] | |||
Risk-free interest rate | 1.93% | 0.30% | |
Expected volatility | 47.50% | 50.00% | |
Expected term | 6 years 3 months | 1 year 6 months |
Stock-Based Compensation (Det53
Stock-Based Compensation (Details 1) - $ / shares | Dec. 13, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Number of Shares | ||||
Exercised | 200,000 | |||
Weighted Average Remaining Contractual Life (in Years) | ||||
Options outstanding at December 31, 2015 | 1 year 11 months 16 days | |||
Stock Option [Member] | ||||
Number of Shares | ||||
Options outstanding at December 31, 2014 | 3,251,627 | 2,240,568 | 2,727,503 | |
Granted | 998,348 | 1,377,978 | 500 | |
Exercised | (573,792) | (115,029) | (331,871) | |
Forfeited or expired | (204,037) | (251,890) | (155,564) | |
Options outstanding at December 31, 2015 | 3,472,146 | 3,251,627 | 2,240,568 | |
Options exercisable at December 31, 2015 | 1,571,255 | |||
Weighted Average Exercise Price | ||||
Options outstanding at December 31, 2014 | $ 6.07 | $ 4.84 | $ 4.32 | |
Granted | 12.29 | 7.62 | 5 | |
Exercised | 4.85 | 4.40 | 1.05 | |
Forfeited or expired | 7.08 | 4.44 | 3.73 | |
Options outstanding at December 31, 2015 | 8.01 | $ 6.07 | $ 4.84 | |
Options exercisable at December 31, 2015 | $ 5.44 | |||
Weighted Average Remaining Contractual Life (in Years) | ||||
Options outstanding at December 31, 2015 | 6 years 4 months 21 days | |||
Options exercisable at December 31, 2015 | 3 years 7 months 13 days |
Stock-Based Compensation (Det54
Stock-Based Compensation (Details 2) | Dec. 31, 2015shares |
Exercise Price Range One [Member] | |
Exercise Price | 4.25 |
Outstanding as of December 31, 2015 | 125,000 |
Options Exercisable (Shares) | 125,000 |
Exercise Price Range Two [Member] | |
Exercise Price | 4.88 |
Outstanding as of December 31, 2015 | 16,500 |
Options Exercisable (Shares) | |
Exercise Price Range Three [Member] | |
Exercise Price | 5 |
Outstanding as of December 31, 2015 | 1,408,553 |
Options Exercisable (Shares) | 1,223,965 |
Exercise Price Range Four [Member] | |
Exercise Price | 7 |
Outstanding as of December 31, 2015 | 252,095 |
Options Exercisable (Shares) | 51,969 |
Exercise Price Range Five [Member] | |
Exercise Price | 9 |
Outstanding as of December 31, 2015 | 699,650 |
Options Exercisable (Shares) | 170,121 |
Exercise Price Range Six [Member] | |
Exercise Price | 9.01 |
Outstanding as of December 31, 2015 | 34,000 |
Options Exercisable (Shares) | |
Exercise Price Range Seven [Member] | |
Exercise Price | 12.43 |
Outstanding as of December 31, 2015 | 420,000 |
Options Exercisable (Shares) | |
Exercise Price Range Eight [Member] | |
Exercise Price | 12.46 |
Outstanding as of December 31, 2015 | 246,000 |
Options Exercisable (Shares) | |
Exercise Price Range Nine [Member] | |
Exercise Price | 12.73 |
Outstanding as of December 31, 2015 | 150,000 |
Options Exercisable (Shares) | |
Exercise Price Range Ten [Member] | |
Exercise Price | 13.09 |
Outstanding as of December 31, 2015 | 116,348 |
Options Exercisable (Shares) | |
Exercise Price Range Eleven [Member] | |
Exercise Price | 13.90 |
Outstanding as of December 31, 2015 | 3,000 |
Options Exercisable (Shares) | |
Exercise Price Range Twelve [Member] | |
Exercise Price | 14.06 |
Outstanding as of December 31, 2015 | 1,000 |
Options Exercisable (Shares) | 200 |
Exercise Price Range [Member] | |
Outstanding as of December 31, 2015 | 3,472,146 |
Options Exercisable (Shares) | 1,571,255 |
Stock-Based Compensation (Det55
Stock-Based Compensation (Details 3) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Weighted Average Grant Date Fair Value Per Share | |
Awarded | $ 6.24 |
Restricted stock units [Member] | |
Number of Awards | |
Outstanding as of December 31, 2014 | shares | |
Awarded | shares | 190,000 |
Vested | shares | |
Forfeited/canceled | shares | |
Outstanding as of December 31, 2015 | shares | 190,000 |
Weighted Average Grant Date Fair Value Per Share | |
Outstanding as of December 31, 2014 | |
Awarded | $ 12.43 |
Vested | |
Forfeited/canceled | |
Outstanding as of December 31, 2015 | $ 12.43 |
Stock-Based Compensation (Det56
Stock-Based Compensation (Details 4) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock-based compensation, Total | $ 2,687 | $ 1,475 | $ 770 |
Cost of sales [Member] | |||
Stock-based compensation, Total | 279 | 192 | 153 |
Research and development [Member] | |||
Stock-based compensation, Total | 208 | 293 | 229 |
Clinical and regulatory [Member] | |||
Stock-based compensation, Total | 235 | 113 | 83 |
Selling and marketing [Member] | |||
Stock-based compensation, Total | 442 | 141 | 102 |
General and administrative [Member] | |||
Stock-based compensation, Total | $ 1,523 | $ 736 | $ 203 |
Stock-Based Compensation (Det57
Stock-Based Compensation (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Jun. 02, 2015 | Dec. 13, 2013 | Jun. 30, 2015 | Jun. 19, 2015 | Jan. 02, 2015 | Jul. 31, 2014 | Jan. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 23, 2015 | Jun. 30, 2011 |
Authorized shares | 200,000 | 200,000 | ||||||||||
Estimated aggregate intrinsic value of stock options exercisable | $ 1,294 | $ 1,008 | ||||||||||
Unrecognized compensation cost related to outstanding stock options | $ 9,148 | |||||||||||
Weighted average period, stock options | 3 years 2 months 1 day | |||||||||||
Weighted average remaining contractual life | 1 year 11 months 16 days | |||||||||||
Exercised stock options on cashless basis to purchase, shares | (200,000) | |||||||||||
Options vested perioid | Either four or five years | |||||||||||
Fair value of options | $ 6,126,285 | |||||||||||
Fair value of options, average per share | $ 6.24 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Description | Shareholders approved (1) an increase of 2,000,000 shares in the number of shares available for option awards under the 2011 Equity Incentive Plan, and (2) an Employee Stock Purchase Plan, with an initial 250,000 shares with annual increases of shares available equal to the lesser of (i) 1% of outstanding shares or (ii) 100,000 shares. | The Company recorded a charge of $235,000 to extend the exercise period of 232,003 options for four employees who resigned and became consultants for the Company. | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Purchase Price of Common Stock, Percent | 85.00% | |||||||||||
Common Stock, Capital Shares Reserved for Future Issuance | 52,469 | |||||||||||
Fair value of common stock | $ 25 | |||||||||||
Maximum number of shares purchased by a employee | 100,000 | |||||||||||
Stock-based compensation, Total | $ 2,687 | $ 1,475 | $ 770 | |||||||||
Loans bear interest | 1.64% | |||||||||||
Outstanding balance, Loan | 5 | 109 | ||||||||||
Extended a full-recourse loan | $ 127 | |||||||||||
Quarterly installments, Loan | $ 16 | |||||||||||
Outstanding balance including accrued interest | 0 | 43 | ||||||||||
Issued common stock for services, Shares | 23,136 | |||||||||||
Issued common stock for services, Amount | $ (324) | $ (166) | ||||||||||
Board of Directors Chairman [Member] | ||||||||||||
Issued common stock for services, Shares | 25,000 | |||||||||||
Issued common stock for services, Amount | $ 175 | |||||||||||
Issued common stock for services, per share | $ 7 | |||||||||||
Staff [Member] | ||||||||||||
Issued common stock for services, Shares | 21,215 | |||||||||||
Issued common stock for services, Amount | $ 170 | |||||||||||
Issued common stock for services, per share | $ 7 | |||||||||||
Minimum [Member] | ||||||||||||
Loans bear interest | 1.27% | |||||||||||
Maximum [Member] | ||||||||||||
Loans bear interest | 1.91% | |||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||
Unrecognized compensation cost related to outstanding stock options | $ 2,142 | |||||||||||
Weighted average period, stock options | 3 years 7 months 17 days | |||||||||||
Granted stock options to purchase | 190,000 | |||||||||||
Fair value of options, average per share | $ 12.43 | |||||||||||
General and administrative [Member] | ||||||||||||
Stock-based compensation, Total | $ 1,523 | $ 736 | $ 203 | |||||||||
2003 Plan [Member] | ||||||||||||
Authorized shares | 6,000,000 | |||||||||||
Chief Executive Officer [Member] | ||||||||||||
Exercised stock options on cashless basis to purchase, shares | 150,000 | 59,063 | 27,344 | |||||||||
Exercise price,stock option | $ 4.75 | $ 4.75 | $ 4.25 | $ 10.26 | ||||||||
Surrendered stock options to purchase | 50,753 | 12,055 | ||||||||||
Satisfy Income and payroll tax | $ 123,684 | |||||||||||
Granted stock options to purchase | 125,000 | |||||||||||
Chief Executive Officer [Member] | Employment Agreement [Member] | ||||||||||||
Granted stock options to purchase | 420,000 | |||||||||||
Fair value of stock option granted | $ 2,574 | |||||||||||
Stock option recognized | $ 240 | |||||||||||
Stock-based compensation, Total | $ 390 | |||||||||||
Chief Executive Officer [Member] | Employment Agreement [Member] | Restricted Stock Units (RSUs) [Member] | ||||||||||||
Granted stock options to purchase | 190,000 | |||||||||||
Fair value of stock option granted | $ 2,362 | |||||||||||
Stock option recognized | $ 220 | |||||||||||
Exercise price of the options | $ 12.43 | |||||||||||
Employees [Member] | ||||||||||||
Exercise ranges of stock options, Minimum | 9.01 | |||||||||||
Exercise ranges of stock options, Maximum | $ 13.90 | |||||||||||
Options exercisable period | 10 years | |||||||||||
Non-officer employee [Member] | ||||||||||||
Outstanding balance, Loan | $ 0 | $ 10 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax Disclosure [Abstract] | ||
Stock-based compensation | $ 2,825 | $ 2,489 |
Research credits | 5,401 | 5,436 |
Depreciation | (12) | (13) |
Net operating loss carryforwards | 47,261 | 43,700 |
Inventory reserve | 203 | 544 |
Other | 845 | 492 |
Total deferred tax assets | 56,523 | 52,648 |
Valuation allowance | $ (56,523) | $ (52,648) |
Net deferred tax assets |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Effective federal statutory rate | 34.00% |
Federal [Member] | |
Net operating loss carryforwards | $ 119,100 |
Net operating loss carryforwards expired | 2015 through 2035 |
Research and development tax credit carryforwards | $ 3,188 |
Research and development tax credit carryforwards expired | 2023 through 2035 |
State [Member] | |
Net operating loss carryforwards | $ 93,200 |
Research and development tax credit carryforwards | $ 3,353 |
Product Warranties (Details)
Product Warranties (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Product Warranties Disclosures [Abstract] | |||
Balance, beginning of year | $ 556 | $ 253 | $ 120 |
Additional accruals | 991 | 415 | 139 |
Payments | (443) | $ (112) | $ (6) |
Adjustments and other | (38) | ||
Total | $ 1,066 | $ 556 | $ 253 |
Commitments and Contingencies61
Commitments and Contingencies (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Future minimum rental payments | |
2,016 | $ 808 |
2,017 | 833 |
2,018 | 858 |
2,019 | 884 |
2,020 | 910 |
Thereafter | 1,095 |
Total | $ 5,388 |
Commitments and Contingencies62
Commitments and Contingencies (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Lease commitment | $ 8,200 | ||
Lease rent expense | 954 | $ 1,007 | $ 766 |
License fee | 93 | 45 | 28 |
Clinical and regulatory expense | $ 1,409 | $ 602 | $ 481 |
Minimum [Member] | |||
License royalty rates range | 0.50% | ||
Maintenance fee | $ 5,000 | ||
Maximum [Member] | |||
License royalty rates range | 3.25% | ||
Maintenance fee | $ 10,000 |
Quarterly Financial Summary (63
Quarterly Financial Summary (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | [1] | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||
Product sales | $ 2,362 | $ 2,227 | $ 2,661 | $ 1,700 | $ 1,521 | $ 609 | $ 611 | $ 657 | ||||
Gross profit (loss) | 691 | 1,470 | 1,092 | 404 | 99 | 193 | (382) | (70) | $ 3,657 | $ (160) | $ (4,064) | |
Operating loss | (5,477) | (4,662) | (4,947) | (4,961) | (5,565) | (5,649) | (5,563) | (4,456) | (20,047) | (21,233) | (17,998) | |
Net loss | $ (5,474) | $ (4,666) | $ (4,922) | $ (4,956) | $ (13,577) | $ (7,644) | $ (7,541) | $ (6,439) | $ (20,018) | $ (35,201) | $ (22,969) | |
Net loss per share - basic and diluted | $ (0.15) | $ (0.13) | $ (0.14) | $ (0.14) | $ (0.46) | $ (0.31) | $ (0.32) | $ (0.28) | $ (0.56) | $ (1.41) | $ (1.02) | |
[1] | During the fourth quarter of 2014, the Company wrote-off the unamortized discount on convertible promissory notes of $6,955 as a result of the automatic conversion of such notes into common stock upon the closing of the Company's IPO. |