Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Jul. 31, 2016 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | CYTORI THERAPEUTICS, INC. | |
Entity Central Index Key | 1,095,981 | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 20,492,643 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 |
CONSOLIDATED CONDENSED BALANCE
CONSOLIDATED CONDENSED BALANCE SHEETS (UNAUDITED) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 20,042,000 | $ 14,338,000 |
Accounts receivable, net of reserves of $785,000 and $797,000 in 2016 and 2015, respectively | 911,000 | 1,052,000 |
Inventories, net | 4,534,000 | 4,298,000 |
Other current assets | 1,263,000 | 1,555,000 |
Total current assets | 26,750,000 | 21,243,000 |
Property and equipment, net | 1,380,000 | 1,631,000 |
Restricted cash and cash equivalents | 350,000 | 350,000 |
Other assets | 1,449,000 | 1,521,000 |
Intangibles, net | 8,829,000 | 9,031,000 |
Goodwill | 3,922,000 | 3,922,000 |
Total assets | 42,680,000 | 37,698,000 |
Current liabilities: | ||
Accounts payable and accrued expenses | 6,585,000 | 6,687,000 |
Current portion of long-term obligations, net of discount | 3,494,000 | 0 |
Joint venture purchase obligation | 1,750,000 | |
Total current liabilities | 10,079,000 | 8,437,000 |
Deferred revenues | 106,000 | 105,000 |
Long-term deferred rent and other | 111,000 | 269,000 |
Long-term obligations, net of discount, less current portion | 13,663,000 | 16,681,000 |
Total liabilities | 23,959,000 | 25,492,000 |
Commitments and contingencies | ||
Stockholders’ equity (deficit): | ||
Series A 3.6% convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 13,500 shares issued; no shares outstanding in 2016 and 2015 | 0 | 0 |
Common stock, $0.001 par value; 75,000,000 shares authorized; 20,492,601 and 13,003,893 shares issued and outstanding in 2016 and 2015, respectively | 20,000 | 13,000 |
Additional paid-in capital | 386,845,000 | 368,214,000 |
Accumulated other comprehensive income | 617,000 | 996,000 |
Accumulated deficit | (368,761,000) | (357,017,000) |
Total stockholders’ equity | 18,721,000 | 12,206,000 |
Total liabilities and stockholders’ equity | $ 42,680,000 | $ 37,698,000 |
CONSOLIDATED CONDENSED BALANCE3
CONSOLIDATED CONDENSED BALANCE SHEETS (UNAUDITED) (Parenthetical) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Current assets: | ||
Accounts receivable, reserves | $ 785,000 | $ 797,000 |
Stockholders’ equity (deficit): | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | |
Preferred stock, shares authorized (in shares) | 5,000,000 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 |
Common stock, shares issued (in shares) | 20,492,601 | 13,003,893 |
Common stock, shares outstanding (in shares) | 20,492,601 | 13,003,893 |
Series A Preferred Stock [Member] | ||
Stockholders’ equity (deficit): | ||
Convertible preferred stock | 3.60% | 3.60% |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 13,500 | 13,500 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
CONSOLIDATED CONDENSED STATEMEN
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME (UNAUDITED) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Income Statement [Abstract] | ||||
Product revenues | $ 1,126,000 | $ 1,614,000 | $ 2,459,000 | $ 2,516,000 |
Cost of product revenues | 585,000 | 1,296,000 | 1,152,000 | 1,894,000 |
Gross profit | 541,000 | 318,000 | 1,307,000 | 622,000 |
Development revenues: | ||||
Government contracts and other | 1,699,000 | 1,847,000 | 3,284,000 | 3,291,000 |
Total development revenues | 1,699,000 | 1,847,000 | 3,284,000 | 3,291,000 |
Operating expenses: | ||||
Research and development | 5,247,000 | 6,048,000 | 9,374,000 | 10,012,000 |
Sales and marketing | 889,000 | 654,000 | 1,924,000 | 1,493,000 |
General and administrative | 2,328,000 | 2,793,000 | 4,614,000 | 5,292,000 |
Change in fair value of warrant liabilities | (13,122,000) | 0 | 2,322,000 | |
Total operating expenses | 8,464,000 | (3,627,000) | 15,912,000 | 19,119,000 |
Operating (loss) income | (6,224,000) | 5,792,000 | (11,321,000) | (15,206,000) |
Other income (expense): | ||||
Income (loss) on asset disposal | (1,000) | 2,000 | 8,000 | |
Loss on debt extinguishment | (260,000) | 0 | (260,000) | |
Interest income | 2,000 | 3,000 | 4,000 | 3,000 |
Interest expense | (645,000) | (936,000) | (1,302,000) | (2,007,000) |
Other income (expense), net | 462,000 | (148,000) | 874,000 | (47,000) |
Total other expense | (181,000) | (1,342,000) | (422,000) | (2,303,000) |
Net (loss) income | (6,405,000) | 4,450,000 | (11,743,000) | (17,509,000) |
Beneficial conversion feature for convertible preferred stock | (661,000) | |||
Net (loss) income allocable to common stockholders | $ (6,405,000) | $ 4,450,000 | $ (11,743,000) | $ (18,170,000) |
Net income (loss) per share allocable to common stockholders | ||||
Basic | $ (0.43) | $ 0.48 | $ (0.84) | $ (2.22) |
Diluted | $ (0.43) | $ 0.45 | $ (0.84) | $ (2.22) |
Weighted average shares used in calculating net income (loss) per share allocable to common stockholders | ||||
Basic | 14,778,616 | 9,266,141 | 13,932,496 | 8,179,403 |
Diluted | 14,778,616 | 9,824,538 | 13,932,496 | 8,179,403 |
Comprehensive (loss) income: | ||||
Net (loss) income | $ (6,405,000) | $ 4,450,000 | $ (11,743,000) | $ (17,509,000) |
Other comprehensive (loss) income – foreign currency translation adjustments | (130,000) | 215,000 | (379,000) | 251,000 |
Comprehensive (loss) income | $ (6,535,000) | $ 4,665,000 | $ (12,122,000) | $ (17,258,000) |
CONSOLIDATED CONDENSED STATEME5
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (11,743,000) | $ (17,509,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 574,000 | 510,000 |
Amortization of deferred financing costs and debt discount | 468,000 | 500,000 |
Joint Venture acquisition obligation accretion | 24,000 | 307,000 |
Provision for expired inventory | 26,000 | 0 |
Change in fair value of warrants | 0 | 2,322,000 |
Stock-based compensation expense | 645,000 | 1,146,000 |
Loss on asset disposal | 2,000 | 0 |
Loss on debt extinguishment | 0 | 260,000 |
Increases (decreases) in cash caused by changes in operating assets and liabilities: | ||
Accounts receivable | 66,000 | 544,000 |
Inventories | (380,000) | 730,000 |
Other current assets | 137,000 | (106,000) |
Other assets | 34,000 | 407,000 |
Accounts payable and accrued expenses | (431,000) | 1,089,000 |
Deferred revenues | 1,000 | 151,000 |
Long-term deferred rent | (158,000) | (139,000) |
Net cash used in operating activities | (10,735,000) | (9,788,000) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (105,000) | (497,000) |
Expenditures for intellectual property | 0 | (13,000) |
Net cash used in investing activities | (105,000) | (510,000) |
Cash flows from financing activities: | ||
Principal payments on long-term obligations | 0 | (25,032,000) |
Proceeds from long-term obligations | 0 | 17,700,000 |
Debt issuance costs and loan fees | 0 | (1,854,000) |
Joint Venture purchase payments | (1,774,000) | (1,123,000) |
Proceeds from exercise of employee stock options and warrants | 0 | 4,986,000 |
Proceeds from sale of common stock, net | 18,179,000 | 24,930,000 |
Dividends paid on preferred stock | 0 | (75,000) |
Net cash provided by financing activities | 16,405,000 | 19,532,000 |
Effect of exchange rate changes on cash and cash equivalents | 139,000 | (14,000) |
Net increase in cash and cash equivalents | 5,704,000 | 9,220,000 |
Cash and cash equivalents at beginning of period | 14,338,000 | 14,622,000 |
Cash and cash equivalents at end of period | 20,042,000 | 23,842,000 |
Cash paid during period for: | ||
Interest | 805,000 | 1,202,000 |
Supplemental schedule of non-cash investing and financing activities: | ||
Conversion of preferred stock into common stock | 0 | 10,000 |
Declared dividend related to preferred stock | $ 0 | $ 3,000 |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | 1. Basis of Presentation Our accompanying unaudited consolidated condensed financial statements as of June 30, 2016 and for the three and six months ended June 30, 2016 and 2015 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. Our consolidated condensed balance sheet at December 31, 2015 has been derived from the audited financial statements at December 31, 2015, but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of Cytori Therapeutics, Inc., and our subsidiaries (the Company) have been included. Operating results for the three and six months ended June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. These financial statements should be read in conjunction with the consolidated financial statements and notes therein included in our annual report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 11, 2016. On May 10, 2016, following stockholder and Board approval, an amendment (the “Amendment”) to the Company’s amended and restated certificate of incorporation, as amended was filed and declared effective, which Amendment effectuated a one-for-fifteen (1:15) reverse stock split of the Company’s (i) outstanding common stock, and (ii) common stock reserved for issuance upon exercise of outstanding warrants and options (the “1:15 Reverse Stock Split”). Upon effectiveness of the 1:15 Reverse Stock Split, the number of shares of the Company’s common stock (x) issued and outstanding decreased from approximately 200 million shares (as of May 10, 2016) to approximately 13.3 million shares; (y) reserved for issuance upon exercise of outstanding warrants and options decreased from approximately 16 million shares to approximately 1.1 million shares, and (z) reserved but unallocated under our current equity incentive plans (including the stockholder-approved share increase to the Company’s 2014 Equity Incentive Plan) decreased from approximately 6.5 million common shares to approximately 0.4 million common shares. In connection with the 1:15 Reverse Stock Split, the Company also decreased the total number of its authorized shares of common stock from 290 million to 75 million. The number of authorized shares of preferred stock remained unchanged. Following the 1:15 Reverse Stock Split, certain reclassifications have been made to the prior periods’ shareholders’ Reverse Stock Split The Company’s shares of common stock commenced trading on a split-adjusted basis on May 12, 2016. The following table provides a brief description of recent accounting pronouncements that had and/or could have a material impact on the Company’s consolidated condensed financial statements. The Company is currently evaluating the impact of adopting the following standards on its consolidated financial statements. New Accounting Standards Issued But Not Yet Effective ASU Number and Name Description Date of Adoption 2016-09, Compensation — Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting The standard simplifies the following aspects of accounting for share-based payments awards: accounting for income taxes, classification of excess tax benefits on the statement of cash flows, forfeitures, statutory tax withholding requirements, classification of awards as either equity or liabilities and classification of employee taxes paid on statement of cash flows when an employer withholds shares for tax-withholding purposes. Transition method: Various. January 1, 2017. Early adoption is permitted. 2016-02, Leases (Topic 842) The standard creates Topic 842, Leases which supersedes Topic 840, Leases, and introduces a lessee model that brings substantially all leases onto the balance sheet while retaining most of the principles of the existing lessor model in U.S. GAAP and aligning many of those principles with ASC 606, Revenue from Contracts with Customers. Transition method: modified retrospective approach with certain practical expedients. January 1, 2019. Early adoption is permitted. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory The standard replaces the current lower of cost or market test with a lower of cost or net realizable value test. Transition method: prospectively. January 1, 2017. Early adoption is permitted. 2014-09, Revenue from Contracts with Customers (Topic 606) The standard provides a single and comprehensive revenue recognition model for all contracts with customers to improve comparability. The revenue standard contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The standard requires an entity to recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. Transition method: a full retrospective or modified retrospective approach. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2016-08, Revenue from Contracts with Customers (Topic 606) — Principal versus Agent Considerations (Reporting Revenue Gross versus Net) The standard clarifies how an entity should identify the unit of accounting for the principal versus agent evaluation and apply the control principle to certain types of arrangements. The amendments also re-frame the indicators to focus on evidence that an entity is acting as a principal rather than as an agent, revise existing examples and add new ones. Transition method: a full retrospective or modified retrospective approach. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing This standard clarifies the following two aspects of Topic 606: identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. This standard reduces the cost and complexity of applying Topic 606 to the identification of promised goods or services, and it also includes implementation guidance on licensing. Transition method: a full retrospective or modified retrospective approach. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2016-12, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing This standard addresses narrow-scope improvements to the guidance on collectability, noncash consideration, and completed contracts at transition as well as providing a practical expedient for contract modifications. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The amendments in this update will require management to assess, at each annual and interim reporting period, the entity’s ability to continue as a going concern and, if management identifies conditions or events 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, to disclose in the notes to the entity’s financial statements the principal conditions or events that raised substantial doubt about the entity’s ability to continue as a going concern, management’s evaluation of their significance, and management’s plans that alleviated or are intended to alleviate substantial doubt about the entity’s ability to continue as a going concern. January 1, 2017. Early adoption is permitted. |
Use of Estimates
Use of Estimates | 6 Months Ended |
Jun. 30, 2016 | |
Use Of Estimates [Abstract] | |
Use of Estimates | 2. Use of Estimates The preparation of Consolidated Condensed Financial Statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions affecting the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Our most significant estimates and critical accounting policies involve recognizing revenue, reviewing goodwill and intangible assets for impairment, valuing warrants, determining the assumptions used in measuring share-based compensation expense, measuring accretion expense related to our acquisition of the joint venture, and valuing allowances for doubtful accounts and inventories. Actual results could differ from these estimates. Management’s estimates and assumptions are reviewed regularly, and the effects of revisions are reflected in the Consolidated Condensed Financial Statements in the periods they are determined to be necessary. |
Liquidity
Liquidity | 6 Months Ended |
Jun. 30, 2016 | |
Liquidity [Abstract] | |
Liquidity | 3. Liquidity We incurred net losses of $6.4 million and $11.7 million for the three and six months ended June 30, 2016, respectively, and incurred net income of $4.5 million and net losses of $17.5 million for the three and six months ended June 30, 2015, respectively. We have an accumulated deficit of $369 million as of June 30, 2016. Additionally, we have used net cash of $10.7 million and $9.8 million to fund our operating activities for the six months ended June 30, 2016 and 2015, respectively. To date, these operating losses have been funded primarily from outside sources of invested capital including our recently completed Rights Offering (discussed below), our At the Market equity facility, Loan and Security Agreement and gross profits. We have had, and we will likely continue to have, an ongoing need to raise additional cash from outside sources to fund our future clinical development programs and other operations. On June 15, 2016, the Company closed a Rights Offering originally filed under Form S-1 registration statement in April 2016. Pursuant to the Rights Offering, the Company sold an aggregate of 6,704,852 units consisting of a total of 6,704,852 shares of common stock and 3,352,306 warrants, with each warrant exercisable for one share of common stock at an exercise price of $3.06 per share, resulting in total gross proceeds to Cytori of $17.1 million. See Note 12 for further discussion on the June 2016 Rights Offering. The Company continues to seek additional capital through product revenues, strategic transactions, including extension opportunities under the awarded U.S. Department of Health and Human Service’s Biomedical Advanced Research and Development Authority (“BARDA”) contract, and from other financing alternatives. Should we be unable to raise additional cash from outside sources, this will have an adverse impact on our operations. |
Transactions with Olympus Corpo
Transactions with Olympus Corporation | 6 Months Ended |
Jun. 30, 2016 | |
Business Combinations [Abstract] | |
Transactions with Olympus Corporation | 4. Transactions with Olympus Corporation Under our Joint Venture Termination Agreement (“Termination Agreement”), dated May 8, 2013, with Olympus Corporation (“Olympus”), we were required to pay Olympus a total purchase price of $6 million within two years of the date of the Termination Agreement. Pursuant to amendments to the Joint Venture Termination Agreement, dated April 30, 2015 and January 8, 2016, the Company’s repayment obligations were extended through May 8, 2016. We made payments under the Termination Agreement totaling approximately $4.2 million through December 31, 2015, as well as separate payments of $0.5 million each in January 2016 and April 2016, and paid the remaining balance of $0.8 million before the May 8, 2016 due date. There were no outstanding obligations to Olympus as of June 30, 2016. |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 5. Long-term Debt On May 29, 2015, we entered into the Loan Agreement with Oxford Finance LLC, pursuant to which it funded an aggregate principal amount of $17.7 million (“Term Loan”), subject to the terms and conditions set forth in the Loan Agreement. The Term Loan accrues interest at a floating rate of at least 8.95% per annum, comprised of three-month LIBOR rate with a floor of 1.00% plus 7.95%. Pursuant to the Loan Agreement, we were previously required to make interest only payments through June 1, 2016 and thereafter we were required to make payments of principal and accrued interest in equal monthly installments sufficient to amortize the Term loan through June 1, 2019, the maturity date. On February 23, 2016, we received an acknowledgement and agreement from Oxford related to the positive data on our U.S. ACT-OA clinical trial. As a result, pursuant to the Loan Agreement, the period for which the Company is required to make interest-only payments was extended from July 1, 2016 to January 1, 2017. All unpaid principal and interest with respect to the Term Loan is due and payable in full on June 1, 2019. At maturity of the Term Loan, or earlier repayment in full following voluntary prepayment or upon acceleration, the Company is required to make a final payment fee in an aggregate amount equal to approximately $1.1 million. In connection with the Term Loan, on May 29, 2015, we issued to the Lender warrants to purchase an aggregate of 94,441 shares of our common stock at an exercise price of $10.35 per share. These warrants are exercisable on or after November 30, 2015 and will expire on May 29, 2025 and, following the authoritative accounting guidance, are equity classified. In connection with the Loan Agreement, we prepaid all outstanding amounts under our prior loan agreement with Oxford and Silicon Valley Bank, at which time the Company’s obligations under the prior loan agreement immediately terminated. The Company paid to the prior agent and the prior lenders (Oxford and Silicon Valley Bank) approximately $25.4 million, consisting of the then outstanding principal balance due of approximately $23.4 million, accrued but unpaid interest of approximately $0.2 million, final payment and other agency fees of approximately $1.8 million and other customary lender fees and expenses. For Oxford, we accounted for this Term Loan as a debt modification. The Company retired $3.1 million of the principal of the previous loan and the corresponding unamortized fees were expensed. The remaining fees of $0.8 million were recorded as debt discount, and along with the new loan fees, will be amortized as an adjustment of interest expense using the effective interest method. For Silicon Valley Bank, which did not participate in the Term Loan, the payoff of the loan was accounted for as debt extinguishment. Accordingly, a total loss on debt extinguishment of $0.3 million was recorded in the second quarter of 2015, which includes the unamortized fees and discounts along with final payment fees. We allocated the aggregate proceeds of the Term Loan between the warrants and the debt obligations based on their relative fair values. The fair value of the warrants issued to the Lender was calculated utilizing the Black-Scholes option pricing model. The Black-Scholes option-pricing model incorporates various and highly sensitive assumptions including expected volatility, expected term and risk-free interest rates. The expected volatility is based on the historical volatility of the Company’s common stock over the most recent period. The risk-free interest rate for period within the contractual life of the warrant is based on the U.S. Treasury yield in effect at the time of grant. We will amortize the relative fair value of the warrants at the issuance date as a discount of $0.8 million over the term of the loan using the effective interest method, with an effective interest rate of 14.95%. The Term Loan is collateralized by a security interest in substantially all of the Company’s existing and after-acquired assets, subject to certain exceptions set forth in the Loan Agreement and excluding its intellectual property assets, which are subject to a negative pledge. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2016 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 6. Revenue Recognition Concentration of Significant Customers Two distributors and two direct customers comprised 76% of our revenue recognized for the six months ended June 30, 2016. Two distributors and one direct customer accounted for 75% of total outstanding accounts receivable (excluding receivables from U.S. Department and Human Service’s Biomedical Advanced Research and Development Authority (BARDA)) as of June 30, 2016. Two distributors and three direct customers comprised 68% of our revenue recognized for the six months ended June 30, 2015. Two direct customers accounted for 73% of total outstanding accounts receivable as of June 30, 2015. Product revenues, classified by geographic location, are as follows: Three months ended Six months ended June 30, 2016 June 30, 2015 June 30, 2016 June 30, 2015 Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Americas $ 356,000 31 % $ 272,000 17 % $ 591,000 24 % $ 477,000 19 % Japan 690,000 61 % 352,000 22 % 1,657,000 67 % 957,000 38 % EMEA 74,000 7 % 328,000 20 % 205,000 8 % 416,000 17 % Asia Pacific 6,000 1 % 662,000 41 % 6,000 1 % 666,000 26 % Total product revenues $ 1,126,000 100 % $ 1,614,000 100 % $ 2,459,000 100 % $ 2,516,000 100 % Research and Development We earn revenue for performing tasks under research and development agreements with governmental agencies like the Biomedical Advanced Research and Development Authority (“BARDA”). Revenues derived from reimbursement of direct out-of-pocket expenses for research costs associated with government contracts are recorded as government contract and other within development revenues. Government contract revenue is recorded at the gross amount of the reimbursement. The costs associated with these reimbursements are reflected as a component of research and development expense in our statements of operations. We recognized $1.7 million and $3.3 million in BARDA revenue for the three and six months ended June 30, 2016, respectively, as compared to $1.8 million and $3.3 million for the three and six months ended June 30, 2015, respectively. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Inventories | 7. Inventories Inventories are carried at the lower of cost or market, determined on the first-in, first-out (FIFO) method. Inventories consisted of the following: June 30, 2016 December 31, 2015 Raw materials $ 972,000 $ 1,009,000 Work in process 1,205,000 816,000 Finished goods 2,357,000 2,473,000 $ 4,534,000 $ 4,298,000 |
Earnings per Share
Earnings per Share | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Earnings per Share | 8. Earnings per Share Basic per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted per share data is computed by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding during the period increased to include, if dilutive, the number of additional common shares that would have been outstanding as calculated using the treasury stock method. Potential common shares were related entirely to outstanding but unexercised options and warrants for all periods presented. We have excluded all potentially dilutive securities, including unvested performance-based restricted stock, from the calculation of diluted loss per share attributable to common stockholders for the three and six month periods ended June 30, 2016 and six month period ended June 30, 2015, as their inclusion would be antidilutive. We have included 0.6 million dilutive securities for the purposes of calculating earnings per share for the three months ended June 30, 2015. Potentially dilutive common shares excluded from the calculations of diluted loss per share were 4.4 million for the six month periods ended June 30, 2016 and 3.7 million for the six month period ended June 30, 2015, respectively. The following securities that could potentially decrease net loss per share in the future are not included in the determination of diluted loss per share as they are anti-dilutive: For the three months ended June 30, For the six months ended June 30, 2016 2015 2016 2015 Outstanding stock options 803,507 528,429 803,507 570,214 Outstanding warrants 3,571,765 2,542,255 3,571,765 3,058,868 Restricted stock 17,960 41,677 17,960 41,677 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies We have entered into agreements with various research organizations for pre-clinical and clinical development studies, which have provisions for cancellation. Under the terms of these agreements, the vendors provide a variety of services including conducting research, recruiting and enrolling patients, monitoring studies and data analysis. Payments under these agreements typically include fees for services and reimbursement of expenses. The timing of payments due under these agreements is estimated based on current study progress. As of June 30, 2016, we have clinical research study obligations of $4.8 million ($3.8 million of which are expected to be complete within a year). Should the timing of the clinical trials change, the timing of the payment of these obligations would also change. We lease facilities for our headquarters office location as well as international office locations. As of June 30, 2016, we have remaining lease obligations of $ ($ We are party to an agreement with Roche Diagnostics Corporation which requires us to make certain product purchase minimums. Pursuant to the agreement, as of June 30, 2016, we have a minimum purchase obligation of $5.9 million, $1.3 million of which is expected to be completed within a year. We are subject to various claims and contingencies related to legal proceedings. Due to their nature, such legal proceedings involve inherent uncertainties including, but not limited to, court rulings, negotiations between affected parties and governmental actions. Management assesses the probability of loss for such contingencies and accrues a liability and/or discloses the relevant circumstances, as appropriate. Management believes that any liability to us that may arise as a result of currently pending legal proceedings will not have a material adverse effect on our financial condition, liquidity, or results of operations as a whole. See Note 4 for a discussion of our commitments and contingencies related to our transactions with Olympus. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 10. Fair Value Measurements Fair value measurements are market-based measurements, not entity-specific measurements. Therefore, fair value measurements are determined based on the assumptions that market participants would use in pricing the asset or liability. We follow a three-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below: · Level 1: Quoted prices in active markets for identical assets or liabilities. · Level 2: Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations in which all significant inputs are observable in active markets. · Level 3: Valuations derived from valuation techniques in which one or more significant inputs are unobservable in active markets. As of June 30, 2016 and as of December 31, 2015, the Company did not have any assets or liabilities measured at fair value presented on the Company’s balance sheets. Warrants with exercise price reset features (down-round protection) were accounted for as liabilities, with changes in the fair value included in net loss for the respective periods. Because some of the inputs to our valuation model were either not observable or were not derived principally from or corroborated by observable market data by correlation or other means, the warrant liability was classified as Level 3 in the fair value hierarchy. All of these warrants were cashless exercised on or before December 31, 2015. |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2016 | |
Financial Instruments Financial Liabilities Balance Sheet Groupings [Abstract] | |
Fair Value | 11. Financial Instruments We disclose fair value information about all financial instruments, whether or not recognized in the balance sheet, for which it is practicable to estimate fair value. The disclosures of estimated fair value of financial instruments at June 30, 2016 and December 31, 2015, were determined using available market information and appropriate valuation methods. Considerable judgment is necessary to interpret market data and develop estimated fair value. The use of different market assumptions or estimation methods may have a material effect on the estimated fair value amounts. The carrying amounts for cash and cash equivalents, accounts receivable, inventories, other current assets, accounts payable, accrued expenses and other liabilities approximate fair value due to the short-term nature of these instruments. We utilize quoted market prices to estimate the fair value of our fixed rate debt, when available. If quoted market prices are not available, we calculate the fair value of our fixed rate debt based on a currently available market rate assuming the loans are outstanding through maturity and considering the collateral. In determining the current market rate for fixed rate debt, a market spread is added to the quoted yields on federal government treasury securities with similar terms to the debt. At June 30, 2016 and December 31, 2015, the aggregate fair value and the carrying value of the Company’s long-term debt were as follows: June 30, 2016 December 31, 2015 Fair Value Carrying Value Fair Value Carrying Value Long-term debt $ 17,187,000 $ 17,157,000 $ 16,844,000 $ 16,681,000 Carrying value is net of debt discount of $1.6 million and $2.1 million as of June 30, 2016 and December 31, 2015, respectively. The fair value of debt is classified as Level 3 in the fair value hierarchy as some of the inputs to our valuation model are either not observable quoted prices or are not derived principally from or corroborated by observable market data by correlation or other means. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | 12. Preferred Stock We have authorized 5 million shares of $0.001 par value preferred stock. Our Board of Directors is authorized to designate the terms and conditions of any preferred stock we issue without further action by the common stockholders. There were 13,500 shares of Series A 3.6% Convertible Preferred Stock that had been issued at June 30, 2016 and December 31, 2015, none of which were outstanding as of either date. All outstanding shares of the Series A 3.6% Convertible Preferred Stock were converted into common stock during the fourth quarter of 2014 and the first quarter of 2015 at the option of the holders. The fair value of the common stock into which the Series A 3.6% Convertible Preferred Stock was convertible on the date of issuance exceeded the proceeds allocated to the preferred stock, resulting in the beneficial conversion feature that we recognized as a dividend to the preferred stockholders and, accordingly, an adjustment to net loss to arrive at net loss allocable to common stockholders. Certain shares of Series A 3.6% Convertible Preferred Stock were not convertible until stockholder approval, which occurred in January 2015. As a result, a dividend for the beneficial conversion feature of $0.7 million was recorded during the quarter ended March 31, 2015. In connection with the 3.6% Convertible Preferred Stock outstanding at December 31, 2014, we declared a cash dividend of $0.08 million. The cash dividend was paid in January and April 2015. Common Stock In May 2015, the Company entered into a Securities Purchase Agreement with certain institutional investors pursuant to which the Company agreed to sell up to $25 million of units, with each unit consisting of one share of its common stock and one warrant to purchase one share of its common stock, in a registered direct offering. The purchase and sale of the units took place in two separate closings. At the initial closing, which took place on May 8, 2015, the Company received approximately $17.4 million in net proceeds from the sale of units. The second closing of the purchase and sale of the units occurred on August 27, 2015 upon satisfaction of certain conditions, including, without limitation, stockholder vote, and the Company received approximately $2.1 million in net proceeds from the sale of 500,000 units of the 1,000,000 units available for sale at the second closing. On December 17, 2015, the Company and the holders of October 2014 warrants agreed to amend the October 2014 Warrants pursuant to an Amendment to Common Stock Purchase Warrant (the “2014 Amendment”). Also on December 17, 2015, the Company and the holders of the May 2015 Warrants and the August 2015 Warrants (collectively the “2015 Warrants”) agreed to amend the 2015 Warrants pursuant to an Amendment to Series A-1 Warrant to Purchase Common Stock and Amendment to Series A-2 Warrant to Purchase Common Stock, respectively (the “2015 Amendment” and, together with the 2014 Amendment, the “Warrant Amendments”). The Warrant Amendments provide that the holders may exercise their warrants on a “cashless exercise” basis in whole on or prior to December 31, 2015, whereby each exercising holder of the amended 2015 Warrants would receive 0.75 shares for each warrants share exercised and each exercising holder of the amended 2014 Warrants would receive 0.69 shares for each warrant share exercised. In addition, the Warrant Amendments removed certain provisions which provided that the exercise price of the Warrants would be reset in the event of certain equity issuances by the Company for a price below the exercise price of the Warrants as of the time of such issuance. All 2014 Warrants and all 2015 Warrants were cashless exercised on or before December 31, 2015. From January 1, 2016 and through June 30, 2016, we sold 766,382 shares of our common stock under an at-the-market offering program (“ATM”), receiving total net proceeds of approximately $2.7 million. Pursuant to a registration statement on Form S-1, originally filed on April 6, 2016, as amended (the “Registration Statement”), and declared effective by the U.S. Securities and Exchange Commission (“SEC”) on May 26, 2016, and related prospectus (as supplemented), the Company registered, offered and sold to its participating stockholders of record as of the announced May 20, 2016 record date, one non-transferable subscription right for each share of common stock held by each stockholder as of the record date (the “Rights Offering”). Each right entitled the holder thereof to purchase one unit at the subscription price of $2.55 per unit, composed of one share of common stock and 0.5 of a warrant, with each whole warrant exercisable to purchase one share of common stock at an exercise price of $3.06 per share for 30 months from the date of issuance. Pursuant to the Rights Offering, which closed on June 15, 2016, the Company sold an aggregate of 6,704,852 units, resulting in total net proceeds to the Company of $15.3 million, respectively. The warrants issued pursuant to the Rights Offering are currently listed on NASDAQ under the symbol “CTYXW.” The warrants may be redeemed by the Company at $0.01 per warrant prior to their expiration if the Company’s common stock closes above $7.65 per share for 10 consecutive trading days. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Basis of Presentation | Our accompanying unaudited consolidated condensed financial statements as of June 30, 2016 and for the three and six months ended June 30, 2016 and 2015 have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. Our consolidated condensed balance sheet at December 31, 2015 has been derived from the audited financial statements at December 31, 2015, but does not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of Cytori Therapeutics, Inc., and our subsidiaries (the Company) have been included. Operating results for the three and six months ended June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. These financial statements should be read in conjunction with the consolidated financial statements and notes therein included in our annual report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on March 11, 2016. On May 10, 2016, following stockholder and Board approval, an amendment (the “Amendment”) to the Company’s amended and restated certificate of incorporation, as amended was filed and declared effective, which Amendment effectuated a one-for-fifteen (1:15) reverse stock split of the Company’s (i) outstanding common stock, and (ii) common stock reserved for issuance upon exercise of outstanding warrants and options (the “1:15 Reverse Stock Split”). Upon effectiveness of the 1:15 Reverse Stock Split, the number of shares of the Company’s common stock (x) issued and outstanding decreased from approximately 200 million shares (as of May 10, 2016) to approximately 13.3 million shares; (y) reserved for issuance upon exercise of outstanding warrants and options decreased from approximately 16 million shares to approximately 1.1 million shares, and (z) reserved but unallocated under our current equity incentive plans (including the stockholder-approved share increase to the Company’s 2014 Equity Incentive Plan) decreased from approximately 6.5 million common shares to approximately 0.4 million common shares. In connection with the 1:15 Reverse Stock Split, the Company also decreased the total number of its authorized shares of common stock from 290 million to 75 million. The number of authorized shares of preferred stock remained unchanged. Following the 1:15 Reverse Stock Split, certain reclassifications have been made to the prior periods’ shareholders’ Reverse Stock Split The Company’s shares of common stock commenced trading on a split-adjusted basis on May 12, 2016. |
New Accounting Standards Issued But Not Yet Effective | New Accounting Standards Issued But Not Yet Effective ASU Number and Name Description Date of Adoption 2016-09, Compensation — Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting The standard simplifies the following aspects of accounting for share-based payments awards: accounting for income taxes, classification of excess tax benefits on the statement of cash flows, forfeitures, statutory tax withholding requirements, classification of awards as either equity or liabilities and classification of employee taxes paid on statement of cash flows when an employer withholds shares for tax-withholding purposes. Transition method: Various. January 1, 2017. Early adoption is permitted. 2016-02, Leases (Topic 842) The standard creates Topic 842, Leases which supersedes Topic 840, Leases, and introduces a lessee model that brings substantially all leases onto the balance sheet while retaining most of the principles of the existing lessor model in U.S. GAAP and aligning many of those principles with ASC 606, Revenue from Contracts with Customers. Transition method: modified retrospective approach with certain practical expedients. January 1, 2019. Early adoption is permitted. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory The standard replaces the current lower of cost or market test with a lower of cost or net realizable value test. Transition method: prospectively. January 1, 2017. Early adoption is permitted. 2014-09, Revenue from Contracts with Customers (Topic 606) The standard provides a single and comprehensive revenue recognition model for all contracts with customers to improve comparability. The revenue standard contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The standard requires an entity to recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. Transition method: a full retrospective or modified retrospective approach. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2016-08, Revenue from Contracts with Customers (Topic 606) — Principal versus Agent Considerations (Reporting Revenue Gross versus Net) The standard clarifies how an entity should identify the unit of accounting for the principal versus agent evaluation and apply the control principle to certain types of arrangements. The amendments also re-frame the indicators to focus on evidence that an entity is acting as a principal rather than as an agent, revise existing examples and add new ones. Transition method: a full retrospective or modified retrospective approach. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing This standard clarifies the following two aspects of Topic 606: identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. This standard reduces the cost and complexity of applying Topic 606 to the identification of promised goods or services, and it also includes implementation guidance on licensing. Transition method: a full retrospective or modified retrospective approach. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2016-12, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing This standard addresses narrow-scope improvements to the guidance on collectability, noncash consideration, and completed contracts at transition as well as providing a practical expedient for contract modifications. January 1, 2018 (as deferred by ASU No. 2015-14). Earlier application is permitted only as of January 1, 2017. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The amendments in this update will require management to assess, at each annual and interim reporting period, the entity’s ability to continue as a going concern and, if management identifies conditions or events 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, to disclose in the notes to the entity’s financial statements the principal conditions or events that raised substantial doubt about the entity’s ability to continue as a going concern, management’s evaluation of their significance, and management’s plans that alleviated or are intended to alleviate substantial doubt about the entity’s ability to continue as a going concern. January 1, 2017. Early adoption is permitted. |
Use of Estimates | The preparation of Consolidated Condensed Financial Statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions affecting the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Our most significant estimates and critical accounting policies involve recognizing revenue, reviewing goodwill and intangible assets for impairment, valuing warrants, determining the assumptions used in measuring share-based compensation expense, measuring accretion expense related to our acquisition of the joint venture, and valuing allowances for doubtful accounts and inventories. Actual results could differ from these estimates. Management’s estimates and assumptions are reviewed regularly, and the effects of revisions are reflected in the Consolidated Condensed Financial Statements in the periods they are determined to be necessary. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Revenue Recognition [Abstract] | |
Product Revenues by Geographic Location | Product revenues, classified by geographic location, are as follows: Three months ended Six months ended June 30, 2016 June 30, 2015 June 30, 2016 June 30, 2015 Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Product Revenues % of Total Americas $ 356,000 31 % $ 272,000 17 % $ 591,000 24 % $ 477,000 19 % Japan 690,000 61 % 352,000 22 % 1,657,000 67 % 957,000 38 % EMEA 74,000 7 % 328,000 20 % 205,000 8 % 416,000 17 % Asia Pacific 6,000 1 % 662,000 41 % 6,000 1 % 666,000 26 % Total product revenues $ 1,126,000 100 % $ 1,614,000 100 % $ 2,459,000 100 % $ 2,516,000 100 % |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventories consisted of the following: June 30, 2016 December 31, 2015 Raw materials $ 972,000 $ 1,009,000 Work in process 1,205,000 816,000 Finished goods 2,357,000 2,473,000 $ 4,534,000 $ 4,298,000 |
Earnings per Share (Tables)
Earnings per Share (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive Securities Not Included in Determination of Diluted Loss per Share | The following securities that could potentially decrease net loss per share in the future are not included in the determination of diluted loss per share as they are anti-dilutive: For the three months ended June 30, For the six months ended June 30, 2016 2015 2016 2015 Outstanding stock options 803,507 528,429 803,507 570,214 Outstanding warrants 3,571,765 2,542,255 3,571,765 3,058,868 Restricted stock 17,960 41,677 17,960 41,677 |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Financial Instruments Financial Liabilities Balance Sheet Groupings [Abstract] | |
Fair Value and Carrying Value of Long-term Debt | At June 30, 2016 and December 31, 2015, the aggregate fair value and the carrying value of the Company’s long-term debt were as follows: June 30, 2016 December 31, 2015 Fair Value Carrying Value Fair Value Carrying Value Long-term debt $ 17,187,000 $ 17,157,000 $ 16,844,000 $ 16,681,000 |
Basis of Presentation (Details)
Basis of Presentation (Details) | May 10, 2016shares | Jun. 30, 2016shares | Jun. 15, 2016shares | Mar. 31, 2016shares | Dec. 31, 2015shares |
Subsequent Event [Line Items] | |||||
Reverse stock split of common stock | 15 | ||||
Common stock, shares outstanding (in shares) | 13,300,000 | 20,492,601 | 6,704,852 | 200,000,000 | 13,003,893 |
Number of shares callable by warrants (in shares) | 1,100,000 | 1 | 16,000,000 | ||
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 | 290,000,000 | 75,000,000 | |
2014 Equity Incentive Plan [Member] | |||||
Subsequent Event [Line Items] | |||||
Number of shares callable by warrants (in shares) | 400,000 | 6,500,000 |
Liquidity (Details)
Liquidity (Details) - USD ($) | Jun. 16, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 15, 2016 | May 10, 2016 | Mar. 31, 2016 | Dec. 31, 2015 |
Liquidity [Abstract] | |||||||||
Net loss | $ (6,405,000) | $ 4,450,000 | $ (11,743,000) | $ (17,509,000) | |||||
Accumulated deficit | $ 368,761,000 | 368,761,000 | $ 357,017,000 | ||||||
Net cash used in operating activities | $ 10,735,000 | $ 9,788,000 | |||||||
Common stock issued (in shares) | 6,704,852 | ||||||||
Common stock, shares outstanding (in shares) | 20,492,601 | 20,492,601 | 6,704,852 | 13,300,000 | 200,000,000 | 13,003,893 | |||
Each unit consist of number of warrant | 3,352,306 | ||||||||
Number of shares callable by warrants (in shares) | 1 | 1,100,000 | 16,000,000 | ||||||
Warrant exercise price (in dollars per share) | $ 3.06 | ||||||||
Proceeds from issuance warrants | $ 17,100,000 |
Transactions with Olympus Cor25
Transactions with Olympus Corporation (Details) - USD ($) | Apr. 30, 2015 | Jun. 30, 2016 |
Acquisition of Olympus' Interest in the Joint Venture [Abstract] | ||
Total purchase price | $ 6,000,000 | |
Purchase price payment agreement term | 2 years | |
Amendment One to Joint Venture Termination Agreement [Member] | ||
Acquisition of Olympus' Interest in the Joint Venture [Abstract] | ||
Purchase price payment termination agreement total | 4,200,000 | |
Purchase price principal amount payable on January 31, 2016 | 500,000 | |
Purchase price principal amount payable on April 30, 2016 | 500,000 | |
Purchase price principal amount and accrued interest payable on May 8, 2016 | $ 800,000 | |
Purchase price payable obligations outstanding balance. | $ 0 |
Long-term Debt (Details)
Long-term Debt (Details) - USD ($) | May 29, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 15, 2016 | May 10, 2016 | Mar. 31, 2016 |
Debt Instrument [Line Items] | ||||||||
Number of shares callable by warrants (in shares) | 1 | 1,100,000 | 16,000,000 | |||||
Warrant exercise price (in dollars per share) | $ 3.06 | |||||||
Repayment of long term debt | $ 0 | $ 25,032,000 | ||||||
Loss on debt extinguishment | $ (260,000) | $ 0 | $ (260,000) | |||||
LIBOR [Member] | Interest Rate Floor [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Basis variable rate | 1.00% | |||||||
Term Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Origination date | May 29, 2015 | |||||||
Original loan amount | $ 17,700,000 | |||||||
Basis variable rate | 7.95% | |||||||
Maturity date | Jun. 1, 2019 | |||||||
Fees amount associated with loan | $ 1,100,000 | |||||||
Date from which warrants are exercisable | Nov. 30, 2015 | |||||||
Number of shares callable by warrants (in shares) | 94,441 | |||||||
Warrant exercise price (in dollars per share) | $ 10.35 | |||||||
Warrant expiration date | May 29, 2025 | |||||||
Repayment of long term debt | $ 25,400,000 | |||||||
Term Loan remaining balance at date of Amendment | 23,400,000 | |||||||
Accrued but unpaid interest | 200,000 | |||||||
Final payment fee | 1,800,000 | |||||||
Principal amount of previous loan retired | 3,100,000 | |||||||
Unamortized debt discount | $ 800,000 | |||||||
Loss on debt extinguishment | $ 300,000 | |||||||
Effective interest rate | 14.95% | |||||||
Term Loan [Member] | Final Payment [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Fees amount associated with loan | $ 800,000 | |||||||
Minimum | Term Loan [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest rate | 8.95% |
Revenue Recognition (Details)
Revenue Recognition (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016USD ($) | Jun. 30, 2015USD ($) | Jun. 30, 2016USD ($)DistributorCustomer | Jun. 30, 2015USD ($)DistributorCustomer | |
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 100.00% | 100.00% | 100.00% | 100.00% |
Revenues | $ 1,126,000 | $ 1,614,000 | $ 2,459,000 | $ 2,516,000 |
BARDA Contract [Member] | ||||
Concentration Risk [Line Items] | ||||
Revenue recognized | $ 1,700,000 | $ 1,800,000 | $ 3,300,000 | $ 3,300,000 |
Americas [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 31.00% | 17.00% | 24.00% | 19.00% |
Revenues | $ 356,000 | $ 272,000 | $ 591,000 | $ 477,000 |
Japan [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 61.00% | 22.00% | 67.00% | 38.00% |
Revenues | $ 690,000 | $ 352,000 | $ 1,657,000 | $ 957,000 |
EMEA [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 7.00% | 20.00% | 8.00% | 17.00% |
Revenues | $ 74,000 | $ 328,000 | $ 205,000 | $ 416,000 |
Asia Pacific [Member] | ||||
Concentration Risk [Line Items] | ||||
Concentration risk percentage | 1.00% | 41.00% | 1.00% | 26.00% |
Revenues | $ 6,000 | $ 662,000 | $ 6,000 | $ 666,000 |
Customer Concentration Risk [Member] | Revenue Recognized [Member] | ||||
Concentration Risk [Line Items] | ||||
Number of distributors | Distributor | 2 | 2 | ||
Number of customers | Customer | 2 | 3 | ||
Concentration risk percentage | 76.00% | 68.00% | ||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | ||||
Concentration Risk [Line Items] | ||||
Number of distributors | Distributor | 2 | |||
Number of customers | Customer | 1 | 2 | ||
Concentration risk percentage | 75.00% | 73.00% |
Inventories (Details)
Inventories (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 972,000 | $ 1,009,000 |
Work in process | 1,205,000 | 816,000 |
Finished goods | 2,357,000 | 2,473,000 |
Inventory, net | $ 4,534,000 | $ 4,298,000 |
Earnings per Share (Details)
Earnings per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Potentially dilutive securities included for the calculating earnings per share (in shares) | 600,000 | |||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 4,400,000 | 3,700,000 | ||
Outstanding Stock Options [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 803,507 | 528,429 | 803,507 | 570,214 |
Outstanding Warrants [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 3,571,765 | 2,542,255 | 3,571,765 | 3,058,868 |
Restricted Stock [Member] | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Dilutive common shares excluded from the calculations of diluted loss per share (in shares) | 17,960 | 41,677 | 17,960 | 41,677 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Jun. 30, 2016USD ($) |
Pre-clinical Research Study Obligations [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligation | $ 4.8 |
Purchase obligation, due in next twelve months | 3.8 |
Operating Lease Obligations [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Contractual obligation | 3.1 |
Contractual obligation, due in next twelve months | 2.3 |
Roche Diagnostics Corporation [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligation | 5.9 |
Purchase obligation, due in next twelve months | $ 1.3 |
Fair Value (Details)
Fair Value (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Fair Value [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Long-term debt | $ 17,187,000 | $ 16,844,000 |
Carrying Value [Member] | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Long-term debt | 17,157,000 | 16,681,000 |
Debt discount | $ 1,600,000 | $ 2,100,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | Jun. 16, 2016shares | Aug. 27, 2015USD ($)shares | May 08, 2015USD ($) | May 31, 2015USD ($)Closingshares | Jun. 30, 2016USD ($)$ / sharesshares | Jun. 30, 2015USD ($) | Dec. 31, 2015$ / sharesshares | Dec. 31, 2014USD ($) | Jun. 15, 2016$ / sharesshares | May 10, 2016shares | Mar. 31, 2016shares | Dec. 17, 2015shares | Mar. 31, 2015USD ($) |
Preferred Stock [Abstract] | |||||||||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | ||||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | ||||||||||||
Common Stock [Abstract] | |||||||||||||
Number of shares callable by warrants (in shares) | 1 | 1,100,000 | 16,000,000 | ||||||||||
Common stock issued (in shares) | 6,704,852 | ||||||||||||
Common stock, shares authorized (in shares) | 75,000,000 | 75,000,000 | 75,000,000 | 290,000,000 | |||||||||
Proceeds from sale of common stock, net | $ | $ 18,179,000 | $ 24,930,000 | |||||||||||
Each unit consist of number of warrant | 3,352,306 | ||||||||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.06 | ||||||||||||
Securities Purchase Agreement [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Common stock issued, value | $ | $ 25,000,000 | ||||||||||||
Number of closings | Closing | 2 | ||||||||||||
Securities Purchase Agreement [Member] | Initial Closing [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Proceeds from private placement of stock | $ | $ 17,400,000 | ||||||||||||
Securities Purchase Agreement [Member] | Second Closing [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Proceeds from private placement of stock | $ | $ 2,100,000 | ||||||||||||
Common stock issued (in shares) | 500,000 | ||||||||||||
Common stock, shares authorized (in shares) | 1,000,000 | ||||||||||||
Common Stock [Member] | Securities Purchase Agreement [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Number of shares callable by warrants (in shares) | 1 | ||||||||||||
Number of shares callable by each warrant (in shares) | 1 | ||||||||||||
Warrants [Member] | Securities Purchase Agreement [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Number of shares callable by warrants (in shares) | 1 | ||||||||||||
ATM [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Common stock issued (in shares) | 766,382 | ||||||||||||
Proceeds from sale of common stock, net | $ | $ 2,700,000 | ||||||||||||
Series A Preferred Stock [Member] | |||||||||||||
Preferred Stock [Abstract] | |||||||||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 | |||||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | |||||||||||
Preferred stock, shares issued (in shares) | 13,500 | 13,500 | |||||||||||
Convertible preferred stock | 3.60% | 3.60% | 3.60% | ||||||||||
Series A Preferred Stock [Member] | Dividend Paid [Member] | |||||||||||||
Preferred Stock [Abstract] | |||||||||||||
Dividends payable | $ | $ 700,000 | ||||||||||||
Series A Preferred Stock [Member] | Dividend Declared [Member] | |||||||||||||
Preferred Stock [Abstract] | |||||||||||||
Dividends payable | $ | $ 80,000 | ||||||||||||
Common Stock [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Number of shares callable by warrants (in shares) | 1 | ||||||||||||
Common stock issued (in shares) | 6,704,852 | ||||||||||||
Common Stock Subscription Price | $ / shares | $ 2.55 | ||||||||||||
Each unit consist of number of common stock | 1 | ||||||||||||
Each unit consist of number of warrant | 0.5 | ||||||||||||
Warrant exercise price (in dollars per share) | $ / shares | $ 3.06 | ||||||||||||
Period exercisable from the date of issuance | 30 months | ||||||||||||
Gross proceeds from private placement of stock | $ | $ 15,300,000 | ||||||||||||
Redemption price of warrant prior to expiration | $ / shares | $ 0.01 | ||||||||||||
Common stock price per share for warrant redemption | $ / shares | $ 7.65 | ||||||||||||
Number of consecutive trading days for warrant redemption | 10 days | ||||||||||||
Common Stock [Member] | 2015 Amendment [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Number of shares callable by each warrant (in shares) | 0.75 | ||||||||||||
Common Stock [Member] | 2014 Amendment [Member] | |||||||||||||
Common Stock [Abstract] | |||||||||||||
Number of shares callable by each warrant (in shares) | 0.69 |