Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Oct. 30, 2015 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Fibrocell Science, Inc. | |
Entity Central Index Key | 357,097 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | fcsc | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Entity Common Stock, Shares Outstanding | 43,898,785 | |
Entity Current Reporting Status | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 36,931 | $ 37,495 |
Accounts receivable, net of allowance for doubtful accounts of $12 and $17, respectively | 0 | 4 |
Inventory | 566 | 571 |
Prepaid expenses and other current assets | 467 | 1,279 |
Total current assets | 37,964 | 39,349 |
Property and equipment, net of accumulated depreciation of $1,191 and $1,051, respectively | 1,697 | 1,598 |
Intangible assets, net of accumulated amortization of $2,067 and $1,653, respectively | 4,273 | 4,687 |
Total assets | 43,934 | 45,634 |
Current liabilities: | ||
Accounts payable | 2,624 | 1,124 |
Accrued expenses | 1,731 | 1,675 |
Deferred revenue | 473 | 416 |
Warrant liability, current | 505 | 278 |
Total current liabilities | 5,333 | 3,493 |
Warrant liability, long term | 6,459 | 11,008 |
Deferred rent | 776 | 724 |
Total liabilities | 12,568 | 15,225 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares outstanding | 0 | 0 |
Common stock, $0.001 par value; 100,000,000 shares authorized; 43,898,785 and 40,856,815 shares issued and outstanding, respectively | 44 | 41 |
Additional paid-in capital | 160,842 | 143,086 |
Accumulated deficit | (129,520) | (112,718) |
Total stockholders’ equity | 31,366 | 30,409 |
Total liabilities and stockholders’ equity | $ 43,934 | $ 45,634 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Statement of Financial Position [Abstract] | ||
Accounts receivable, allowance for doubtful accounts (in dollars) | $ 12 | $ 17 |
Property and equipment, accumulated depreciation (in dollars) | 1,191 | 1,051 |
Intangible assets, accumulated amortization (in dollars) | $ 2,067 | $ 1,653 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 43,898,785 | 40,856,815 |
Common stock, shares outstanding | 43,898,785 | 40,856,815 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Income Statement [Abstract] | ||||
Revenue from product sales | $ 49 | $ 20 | $ 217 | $ 124 |
Collaboration revenue | 30 | 0 | 193 | 0 |
Total revenue | 79 | 20 | 410 | 124 |
Cost of product sales | 62 | 512 | 283 | 1,852 |
Cost of collaboration revenue | 142 | 0 | 230 | 0 |
Total cost of revenue | 204 | 512 | 513 | 1,852 |
Gross loss | (125) | (492) | (103) | (1,728) |
Research and development expense | 4,221 | 3,069 | 11,902 | 13,909 |
Selling, general and administrative expense | 2,477 | 2,630 | 9,041 | 8,150 |
Operating loss | (6,823) | (6,191) | (21,046) | (23,787) |
Other income: | ||||
Warrant revaluation and other finance income | 5,301 | 177 | 4,240 | 1,135 |
Other income | 0 | 0 | 0 | 370 |
Interest income | 1 | 2 | 4 | 4 |
Loss before income taxes | (1,521) | (6,012) | (16,802) | (22,278) |
Income tax benefit | 0 | 0 | 0 | 0 |
Net loss | $ (1,521) | $ (6,012) | $ (16,802) | $ (22,278) |
Per Share Information: | ||||
Basic net loss (usd per share) | $ (0.04) | $ (0.15) | $ (0.40) | $ (0.55) |
Diluted net loss (usd per share) | $ (0.07) | $ (0.17) | $ (0.44) | $ (0.60) |
Weighted average number of common shares outstanding: | ||||
Basic weighted average number of common shares outstanding, shares | 43,021,121 | 40,856,815 | 41,598,632 | 40,766,741 |
Diluted weighted average number of common shares outstanding, shares | 43,712,918 | 41,300,105 | 41,829,231 | 41,045,861 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Stockholders' Equity - 9 months ended Sep. 30, 2015 - USD ($) $ in Thousands | Total | Common Stock | Additional paid-in capital | Accumulated deficit |
Balance at Dec. 31, 2014 | $ 30,409 | $ 41 | $ 143,086 | $ (112,718) |
Balance (shares) at Dec. 31, 2014 | 40,856,815 | 40,856,815 | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||
Proceeds from common stock offering, net | $ 15,872 | $ 3 | 15,869 | |
Proceeds from equity financing, net (shares) | 2,974,136 | |||
Stock-based compensation expense | 1,550 | 1,550 | ||
Exercise of stock options | $ 255 | 255 | ||
Exercise of stock options (shares) | 56,250 | 56,250 | ||
Exercise of warrants | $ 82 | 82 | ||
Exercise of warrants (shares) | 11,584 | |||
Net loss | (16,802) | (16,802) | ||
Balance at Sep. 30, 2015 | $ 31,366 | $ 44 | $ 160,842 | $ (129,520) |
Balance (shares) at Sep. 30, 2015 | 43,898,785 | 43,898,785 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities: | ||
Net loss | $ (16,802) | $ (22,278) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,550 | 1,005 |
Stock issued for supplemental stock issuance agreement | 0 | 5,154 |
Warrant revaluation and other finance income | (4,240) | (1,135) |
Depreciation and amortization | 554 | 673 |
Provision for doubtful accounts | (5) | 15 |
Change in operating assets and liabilities: | ||
Accounts receivable | 9 | 11 |
Inventory | 5 | (13) |
Prepaid expenses and other current assets | 812 | 722 |
Other assets | 0 | 214 |
Accounts payable | 1,469 | (1,904) |
Accrued expenses and deferred rent | 111 | 1,693 |
Deferred revenue | 57 | 331 |
Net cash used in operating activities | (16,480) | (15,512) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (208) | (307) |
Net cash used in investing activities | (208) | (307) |
Cash flows from financing activities: | ||
Proceeds from common stock offering, net | 15,872 | 0 |
Proceeds from the exercise of stock options | 255 | 0 |
Principle payments on capital lease obligations | (3) | 0 |
Net cash provided by financing activities | 16,124 | 0 |
Effect of exchange rate changes on cash balances | 0 | 1 |
Net decrease in cash and cash equivalents | (564) | (15,818) |
Cash and cash equivalents, beginning of period | 37,495 | 60,033 |
Cash and cash equivalents, end of period | 36,931 | 44,215 |
Supplemental Cash Flow Disclosures: | ||
Property and equipment in accounts payable | 31 | 0 |
Reduction of warrant liability upon issuance of shares | $ 82 | $ 0 |
Business and Organization
Business and Organization | 9 Months Ended |
Sep. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business and Organization | Business and Organization Organization. Fibrocell Science, Inc. (as used herein, “we,” “us,” “our,” “Fibrocell” or the “Company”) is the parent company of Fibrocell Technologies, Inc. (“Fibrocell Tech”) and Fibrocell Science Hong Kong Limited (“Fibrocell Hong Kong”), a company organized under the laws of Hong Kong. Fibrocell Tech is the parent company of Isolagen International, S.A., a company organized under the laws of Switzerland (“Isolagen Switzerland”). Previously, Fibrocell Tech was the parent of Isolagen Australia Pty Limited, a company organized under the laws of Australia (“Isolagen Australia”), and Isolagen Europe Limited, a company organized under the laws of the United Kingdom (“Isolagen Europe”). During the third quarter of 2015, the Company's board of directors approved the formal dissolution of Isolagen Australia and Isolagen Europe. As these entities had previously ceased to operate, there was no impact on the condensed consolidated financial statements. The Company’s remaining international activities are currently immaterial. Business Overview. Fibrocell is an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs. Fibrocell's most advanced product candidate, azficel-T, uses its proprietary autologous fibroblast technology and is in a Phase II clinical trial for the treatment of chronic dysphonia resulting from vocal cord scarring or atrophy. In collaboration with Intrexon Corporation ("Intrexon") (NYSE:XON), a leader in synthetic biology, Fibrocell is also developing gene therapies for skin diseases using gene-modified autologous fibroblasts. Fibrocell is in preclinical development of FCX-007, its lead gene-therapy product candidate, for the treatment of recessive dystrophic epidermolysis bullosa ("RDEB"). Fibrocell is also in preclinical development of FCX-013, its second gene-therapy product candidate, for the treatment of linear scleroderma. Liquidity. As of September 30, 2015, we had cash and cash equivalents of approximately $ 36.9 million and working capital of approximately $ 32.6 million . We believe that our cash and cash equivalents at September 30, 2015 will be sufficient to fund our operations into the fourth quarter of 2016. However, the Company expects to continue to incur losses and require additional financial resources to advance its product candidates to either commercial stage or liquidity events. There can be no assurance that the Company will be able to generate sufficient revenues or be able to obtain additional debt or equity financing on terms acceptable to the Company, or on a timely basis or at all. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition. |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2015 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnote disclosures required by GAAP for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission (“SEC”). The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or full year. There have been certain reclassifications made to the prior year’s results of operations to conform to the current year’s presentation. Compensation and related expenses for manufacturing and facilities personnel of $0.2 million and $1.0 million were reclassified from selling, general and administrative expense to research and development expense for the three and nine months ended September 30, 2014, respectively. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and notes. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Actual results may differ materially from those estimates. Revenue Recognition. Product Sales. In June 2011, the FDA approved the Company's Biologics License Application ("BLA") for LAVIV (azficel-T) for the treatment of nasolabial fold wrinkles. As one full course of LAVIV therapy includes three series of injections, the Company recognizes associated revenue over the period LAVIV is shipped for injection in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification ("ASC") 605, Revenue Recognition (“ASC 605”). In general, ASC 605 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and determinable and (4) collectability is reasonably assured. Corresponding revenue is recognized on a prorata basis as each of the three series of injections is shipped to the physician. Currently, the Company no longer actively markets or promotes LAVIV to physicians or patients; however, prescriptions are still being accepted and filled. Collaboration Revenue. The Company's collaboration agreements may contain multiple elements, such as fees to perform proof of concept studies, product development, aid in obtaining U.S. patents and trademarks, and provide for royalties based upon future commercial sales. The deliverables under such an arrangement are evaluated under ASC 605-25, Revenue Recognition: Multiple-Element Arrangements . Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. In general, the consideration allocated to each unit of accounting is recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Collaboration revenue is recognized on a gross basis, in accordance with the criteria set forth in ASC 605-45, Revenue Recognition: Principal Agent Considerations . Collaboration revenue for the three and nine months ended September 30, 2015 is related to a research and development agreement that the Company has with an unrelated third party to investigate potential new non-pharmaceutical applications for the Company's conditioned fibroblast media technology. Revenue recognized from this collaboration relates to an upfront license fee and a proof of concept study currently underway. Cost of Revenue. Cost of revenue includes expenses related to product sales and collaboration revenue. Cost of Product Sales . Costs include the processing of cells for LAVIV, including direct and indirect costs. Cost of product sales is accounted for using a standard cost system which allocates the direct costs associated with the Company’s manufacturing, facility, quality control, and quality assurance operations as well as an allocation of overhead costs. Cost of Collaboration Revenue . Costs directly related to deliverables in a revenue-generating collaboration are charged to cost of revenue as incurred. Research and Development Expense. Research and development costs are expensed as incurred and include salaries and benefits, costs paid to third party contractors to perform research, conduct clinical trials, develop and manufacture product candidates, and an allocation of overhead cost. Research and development costs also include costs to develop manufacturing, cell collection and logistical process improvements. Clinical trial costs are a significant component of research and development expenses and include costs associated with third party contractors. Invoicing from third party contractors for services performed can lag several months. The Company accrues the costs of services rendered in connection with third party contractor activities based on its estimate of management fees, site management and monitoring costs and data management costs incurred in a given period. Warrant Liability. The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. Stock warrants are accounted for as a derivative in accordance with ASC 815, Derivatives and Hedging , (“ASC 815”) if the stock warrants contain “down-round protection” or other terms that could potentially require “net cash settlement” and therefore, do not meet the scope exception for treatment as a derivative. Since “down-round protection” is not an input into the calculation of the fair value of the warrants, the warrants cannot be considered indexed to the Company’s own stock which is a requirement for the scope exception as outlined under ASC 815. Warrant instruments that could potentially require “net cash settlement” in the absence of express language precluding such settlement and those which include “down-round protection” are initially classified as derivative liabilities at their estimated fair values, regardless of the likelihood that such instruments will ever be settled in cash. The Company will continue to classify the fair value of the warrants that contain “down-round protection” and “net cash settlement” as a liability until the warrants are exercised, expire or are amended in a way that would no longer require these warrants to be classified as a liability. Income Taxes. In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and nine months ended September 30, 2015 and 2014 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company had not recorded its net deferred tax asset as of either September 30, 2015 or December 31, 2014 , because it maintains a full valuation allowance against all deferred tax assets as management has determined that it is not more likely than not that the Company will realize these future tax benefits. As of September 30, 2015 and December 31, 2014 , the Company had no uncertain tax positions. Intangible Assets. Intangible assets are research and development assets related to the Company’s primary study on azficel-T that was recognized upon emergence from bankruptcy. Azficel-T has three current or target indications: the Company’s FDA-approved biological product, LAVIV; a clinical development program for azficel-T for the treatment of chronic dysphonia resulting from vocal cord scarring or atrophy; and a clinical development program for azficel-T for the treatment of restrictive burn scarring. Effective January 1, 2012, the Company launched LAVIV and as a result, the research and development intangible assets related to the Company’s primary study were considered to be finite-lived intangible assets and are being amortized over 12 years, the estimated useful life of the assets which is analogous with the exclusivity period granted to the Company under the azficel-T BLA. Finite-lived intangible assets are recorded at cost, net of accumulated amortization and, if applicable, impairment charges. Amortization of finite-lived intangible assets is provided over their estimated useful lives on a straight-line basis. The Company reviews the estimated remaining useful life of its intangible assets on an annual basis with any changes, if applicable, accounted for prospectively. In accordance with ASC 360-10-35, Impairment or Disposal of Long-Lived Assets , the Company reviews its finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. There was no impairment expense recognized for either the three or nine months ended September 30, 2015 or 2014 . Clinical trials and the development of biopharmaceutical products is a lengthy and complex process with significant uncertainty and risk. If development programs for azficel-T are not successful and the Company does not obtain regulatory approval, or there is a lack of commercial viability of the product(s), our intangible assets may become impaired. Recently Issued Accounting Pronouncements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory , which requires an entity to measure in scope inventory at the lower of cost and net realizable value rather than at the lower of cost or market, where market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The amendment is effective for public companies for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years and should be applied prospectively. Early application is permitted. The Company has evaluated the effects of the adoption of this ASU on its financial statements and does not believe the impact will be material. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date , which defers by one year the effective date of ASU 2014-09, Revenue from Contracts with Customers. The guidance is effective for public companies with annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Earlier application is permitted. The Company is currently evaluating the effects of the adoption of ASU 2014-09 deferred by this update on its financial statements but does not believe the impact to be material. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventories consist of raw materials and work-in-process intended for use in the manufacture of LAVIV. However, raw materials may be used for clinical trials and are charged to research and development (“R&D”) expense when consumed. Inventories consisted of the following as of: ($ in thousands) September 30, 2015 December 31, 2014 Raw materials (LAVIV and product candidates) $ 398 $ 357 Work in process (LAVIV) 168 214 Total Inventory $ 566 $ 571 |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2015 | |
Warrants [Abstract] | |
Warrants | Warrants The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. See Note 3 for further details on accounting policies related to the Company's common stock warrants. As of September 30, 2015 and December 31, 2014, all of the company's outstanding stock warrants were classified as derivative liabilities. The following table summarizes outstanding liability-classified warrants to purchase common stock as of: Number of Warrants Liability-classified warrants September 30, 2015 December 31, 2014 Exercise Price Expiration Dates Issued in Series A, B and D Preferred Stock offerings 2,231,118 2,247,118 $ 6.25 Oct 2015 - Dec 2016 Issued in March 2010 financing 319,789 393,416 $ 6.25 Mar 2016 Issued in June 2011 financing 6,113 6,113 $ 22.50 Jun 2016 Issued in August 2011 financing 565,759 565,759 $ 18.75 Aug 2016 Issued to placement agents in August 2011 financing 50,123 50,123 $ 13.635 Aug 2016 Issued in Series B, D and E Preferred Stock offerings 74,800 76,120 $ 2.50 Nov 2015 - Dec 2017 Issued with Convertible Notes 1,125,578 1,125,578 $ 2.50 Jun 2018 Issued in Series E Preferred Stock offering 1,568,823 1,568,823 $ 7.50 Dec 2018 Total 5,942,103 6,033,050 The table below is a summary of the Company’s warrant activity during the nine months ended September 30, 2015. Number of warrants Weighted- average exercise price Outstanding at December 31, 2014 6,033,050 $ 7.08 Granted — — Exercised (1) (90,947 ) (6.20 ) Expired — — Outstanding at September 30, 2015 5,942,103 $ 7.09 (1) All warrants were exercised on a cashless basis resulting in the issuance of 11,584 shares of the Company's common stock. Liability-classified Warrants. The foregoing warrants were recorded as derivative liabilities at their estimated fair value at the date of issuance, with the subsequent changes in estimated fair value recorded in other income or expense in the Company’s condensed consolidated statement of operations in each subsequent period. The change in the estimated fair value of the warrant liability for the three and nine months ended September 30, 2015 resulted in non-cash income of approximately $5.3 million and $4.2 million , respectively. The change in the estimated fair value of the warrant liability for the three and nine months ended September 30, 2014 resulted in non-cash income of approximately $0.2 million and $1.1 million , respectively. The Company utilizes a Monte Carlo simulation valuation method to value its liability-classified warrants. The estimated fair value of these warrants is determined using Level 3 inputs. Inherent in the Monte Carlo simulation valuation method are inputs and assumptions related to expected stock-price volatility, expected life, risk-free interest rate and dividend yield. The Company estimates the volatility of its common stock based on historical volatility of a peer group that matches the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon yield curve on the grant date for a maturity similar to the expected remaining life of the warrants. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates will remain at zero. The following table summarizes the calculated aggregate fair values, along with the assumptions utilized in each calculation: ($ in thousands except share and per share data) September 30, 2015 December 31, 2014 Calculated aggregate value $ 6,964 $ 11,286 Weighted average exercise price per share $ 7.09 $ 7.08 Closing price per share of common stock $ 3.85 $ 2.59 Volatility 86.3 % 67.6 % Weighted average remaining expected life 1 year, 10 months 2 years, 7 months Risk-free interest rate 0.60 % 0.86 % Dividend yield — — |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Assets and Liabilities Measured at Fair Value on a Recurring Basis. The Company uses the accounting guidance on fair value measurements for financial assets and liabilities measured on a recurring basis. Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The guidance requires fair value measurements be classified and disclosed in one of the following three categories within the hierarchy: • Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. • Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability. • Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of: September 30, 2015 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 36,931 $ — $ — $ 36,931 Liabilities: Warrant liability $ — $ — $ 6,964 $ 6,964 December 31, 2014 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 37,495 $ — $ — $ 37,495 Liabilities: Warrant liability $ — $ — $ 11,286 $ 11,286 Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis - Common Stock Warrants. The reconciliation of the warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) was as follows: Warrant ($ in thousands) Liability Balance at December 31, 2014 $ 11,286 Exercise of warrants (1) (82 ) Change in fair value of warrant liability (4,240 ) Balance at September 30, 2015 $ 6,964 (1) All warrants were exercised under the cashless exercise method per the corresponding warrant agreement. As a result of such exercises, the Company issued 11,584 shares of common stock. Consequently, these instruments were no longer classified as liabilities. These common stock warrants were remeasured to their fair value as of the exercise date with the change in fair value recorded to other income. The fair value related to the shares issued in connection with the exercised warrants was reclassified from liability to additional paid-in capital in the condensed consolidated balance sheet. Effect of Fibrocell's Stock Price and Volatility Assumptions on the Calculation of Fair Value of Warrant Liabilities. The fair value of the warrant liability is based on Level 3 inputs. As discussed in Note 5, the Company uses a Monte Carlo simulation valuation method to value its liability-classified warrants. The determination of fair value as of the reporting date is affected by Fibrocell's stock price as well as assumptions regarding a number of subjective variables that do not have observable inputs or available market data to support the fair value. These variables include, but are not limited to, expected stock price volatility over the term of the warrants and the risk-free interest rate. The primary factors affecting the fair value of the warrant liability are the Company's stock price and volatility as well as certain assumptions by the Company as to the likelihood of provisions to the underlying warrant agreements being triggered. The methods described above and in Note 5 may produce a fair value calculation that may not be indicative of net realizable value or reflective of future fair values. Furthermore, while the Company believes its valuation method is appropriate and consistent with other market participants, the use of different methodologies or assumptions to determine the fair value could result in a different fair value measurement at the reporting date. Fair Value of Certain Financial Assets and Liabilities. The Company believes that the fair values of the Company’s current assets and liabilities approximate their reported carrying amounts. There were no transfers between Level 1, 2 and 3 during the periods presented. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company’s board of directors (the “Board”) adopted the 2009 Equity Incentive Plan (as amended to date, the “Plan”) effective September 3, 2009. The Plan is intended to further align the interests of the Company and its stockholders with its employees, including its officers, non-employee directors, consultants and advisers by providing incentives for such persons to exert maximum efforts for the success of the Company. The Plan allows for the issuance of up to 5,600,000 shares of the Company’s common stock. The Company previously issued 206,000 options outside of the Plan to consultants. The types of awards that may be granted under the Plan include stock options (both non-qualified stock options and incentive stock options), stock appreciation rights, stock awards, stock units and other stock-based awards. The term of each award is determined by the Compensation Committee of the Board at the time each award is granted, provided that the terms of options do not exceed ten years . Vesting schedules for stock options vary, but generally vest 25% per year, over four years . The Plan had 2,369,409 shares available for future grants as of September 30, 2015 . Total stock-based compensation expense, net of estimated forfeitures, recognized using the straight-line attribution method in the condensed consolidated statements of operations is as follows: Three months ended September 30, Nine months ended September 30, ($ in thousands) 2015 2014 2015 2014 Stock-based compensation expense for employees and directors $ 506 $ 266 $ 1,550 $ 1,002 Equity awards for non-employees issued for services — — — 3 Total stock-based compensation expense $ 506 $ 266 $ 1,550 $ 1,005 The following table summarizes stock option activity for the nine months ended September 30, 2015 : ($ in thousands except share and per share data) Number of shares Weighted- average exercise price Weighted-average remaining contractual term Aggregate intrinsic value Outstanding at December 31, 2014 2,086,450 $ 7.43 8 years $ — Granted 1,352,114 4.48 Exercised (56,250 ) 4.53 Forfeited (178,970 ) 5.63 Expired (12,000 ) 10.50 Outstanding at September 30, 2015 3,191,344 $ 6.32 8 years, 1 month $ 602 Exercisable at September 30, 2015 1,469,897 $ 8.81 7 years $ 189 The total fair value of options vested during the nine months ended September 30, 2015 was approximately $1.3 million . As of September 30, 2015 , there was approximately $4.5 million of total forfeiture adjusted unrecognized compensation cost, related to time-based non-vested stock options. That cost is expected to be recognized over a weighted-average period of 2.9 years. As of September 30, 2015 , there was no unrecognized compensation expense related to non-vested non-employee options. During the nine months ended September 30, 2015 and 2014 , the weighted average fair market value of the options granted was $3.59 and $2.64 , respectively. The fair market value of these options was computed using the Black-Scholes option-pricing model with the following key weighted average assumptions for the nine months ended as of the dates indicated: September 30, 2015 September 30, 2014 Expected life 6 years, 1 month 5 years, 11 months Interest rate 1.56 % 1.91 % Dividend yield — — Volatility 103.2 % 70.3 % The Company uses a peer group to determine historical stock price volatility as it has not had enough standalone trading to satisfy the "look-back" requirements of ASC 718, Compensation: Stock Compensation . For grants issued during the nine months ended September 30, 2015 , the Company reassessed those companies it includes in its peer group, which resulted in an increase in volatility as compared to the nine months ended September 30, 2014 . |
Collaboration Agreement with Re
Collaboration Agreement with Related Party | 9 Months Ended |
Sep. 30, 2015 | |
Collaboration Agreements | |
Collaboration Agreement with Related Party | Collaboration Agreement with Related Party The Company and Intrexon are parties to an exclusive channel collaboration agreement, as amended ("ECC"). Randal J. Kirk is the chairman of the board and chief executive officer of Intrexon and, together with his affiliates, owns more than 50% of Intrexon's common stock. Affiliates of Randal J. Kirk also collectively own more than 35% of our common stock. Our directors, Marcus Smith and Julian Kirk (who is the son of Randal J. Kirk), are employees of Third Security, LLC, which is an affiliate of Randal J. Kirk. For the three months ended September 30, 2015 and 2014 , the Company incurred total expenses of $1.8 million and $1.2 million , respectively, with Intrexon. Of the $1.8 million incurred during the 2015 period, $0.7 million related to direct expenses for work performed by Intrexon and $1.1 million related to pass-through costs. Of the $1.2 million incurred during the 2014 period, $0.5 million related to direct expenses for work performed by Intrexon and $0.7 million related to pass-through costs. For the nine months ended September 30, 2015 and 2014 , the Company incurred total expenses of $4.7 million and $3.0 million , respectively, with Intrexon. Of the $4.7 million incurred during the 2015 period, $2.4 million related to direct expenses for work performed by Intrexon and $2.3 million related to pass-through costs. Of the $3.0 million incurred during the 2014 period, $1.7 million related to direct expenses for work performed by Intrexon and $1.3 million related to pass-through costs. As of September 30, 2015 and December 31, 2014 , the Company had outstanding payables to Intrexon of $1.4 million and $1.0 million , respectively. The Company and Intrexon entered into a letter agreement on September 29, 2015 pursuant to which the parties mutually agreed to terminate their collaboration with respect to the development of potential therapies to treat Ehlers-Danlos Syndrome. As a result, neither party will have any further obligations under the ECC with respect to “autologous human fibroblasts genetically modified to express bioactive Tenascin X locally to correct connective tissue disorders”. All other provisions of the ECC remain in full force and effect. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share Basic loss per share is computed by dividing net loss for the period by the weighted-average number of shares of common stock outstanding during that period. The diluted loss per share calculation gives effect to dilutive stock options, warrants and other potentially dilutive common stock equivalents outstanding during the period. Diluted loss per share is based on the treasury stock method and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options and warrants, assuming the exercise of all in-the-money stock options based on the average market price during the period. Common stock equivalents have been excluded where their inclusion would be anti-dilutive. Details in the computation of basic and diluted loss per share is as follows: For the three months ended September 30, For the nine months ended September 30, ($ in thousands except share and per share data) 2015 2014 2015 2014 Loss per share - basic: Numerator for basic loss per share $ (1,521 ) $ (6,012 ) $ (16,802 ) $ (22,278 ) Denominator for basic loss per share 43,021,121 40,856,815 41,598,632 40,766,741 Basic loss per common share $ (0.04 ) $ (0.15 ) $ (0.40 ) $ (0.55 ) Loss per share - diluted: Numerator for diluted loss per share $ (1,521 ) $ (6,012 ) $ (16,802 ) $ (22,278 ) Adjustment for income (expense) for change in fair value of warrant liability for dilutive warrants 1,529 1,098 1,529 2,364 Net loss attributable to common share $ (3,050 ) $ (7,110 ) $ (18,331 ) $ (24,642 ) Denominator for basic loss per share 43,021,121 40,856,815 41,598,632 40,766,741 Plus: Incremental shares underlying dilutive “in the money” warrants outstanding 691,797 443,290 230,599 279,120 Denominator for diluted loss per share 43,712,918 41,300,105 41,829,231 41,045,861 Diluted net loss per common share $ (0.07 ) $ (0.17 ) $ (0.44 ) $ (0.60 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding, as their effect would be anti-dilutive: Three months ended September 30, Nine months ended September 30, 2015 2014 2015 2014 “In the money” stock options 2,733,864 35,000 1,923,926 741,000 “Out of the money” stock options 457,480 2,231,200 1,113,960 1,571,546 “In the money” warrants — — 801,132 400,566 “Out of the money” warrants 4,741,725 4,831,352 4,801,476 4,831,352 Other securities excluded from the calculation of diluted loss per share: Stock options with performance condition — — 66,667 — |
Equity
Equity | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Equity | Equity Common Stock - 2015 Follow-on Public Offering. On July 27, 2015, the Company closed an underwritten public offering of shares of the Company's common stock at a price per share of $5.80 per share (the "Offering"). The shares sold in the Offering included 2,586,206 shares of common stock plus an additional 387,930 shares of common stock pursuant to the exercise by the underwriters of the over-allotment option the Company granted to them. Total gross proceeds to the Company in the Offering (including the sale of shares of common stock pursuant to the exercise of the over-allotment option) totaled $17.3 million , and resulted in net proceeds of approximately $15.9 million after the deduction of underwriting discounts and other offering expenses. |
Legal Matters
Legal Matters | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Matters | Legal Matters Settlement Agreement and Mutual Release On or about December 19, 2014, Shandong Fabosaier Bio-Tech Co., Ltd. of China (“Shandong”) and Ran Liu of Vancouver, Canada, who is allegedly a director of Shandong, commenced a lawsuit against the Company in the United States District Court for the Eastern District of Pennsylvania, Case No. 2:14-cv-07180-CMR. The Complaint asserted claims for breach of contract, promissory estoppel, and unjust enrichment against Fibrocell relating to the marketing of our LAVIV product in China and Vancouver. On February 12, 2015, the Company filed an amended answer, additional defenses and counterclaims against Shandong and Ms. Liu. Our counterclaims include counts for trademark infringement, violations of the Lanham Act and the Anti-cybersquatting Consumer Protection Act, unfair competition, and tortious interference with contractual relations resulting from Shandong’s repeated, unauthorized use of our marks on Shandong’s website and in other marketing materials. In order to avoid the expense, burden and uncertainties inherent in litigation, we entered into a Settlement Agreement and Mutual Release with Shandong and Ms. Liu on September 14, 2015 (the “Settlement Agreement”) to settle all matters in controversy between us relating to this litigation. The Settlement Agreement does not provide for any payments to be made by the parties and contains a mutual release of all claims relating to the subject matter of the litigation. On September 21, 2015, a Stipulation and Order of Dismissal was entered by the Court dismissing all of the claims and counterclaims asserted by the parties in accordance with the Settlement Agreement. Legal fees related to the matter have been expensed as incurred and are included within selling, general and administrative expense in the condensed consolidated statements of operations. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and notes. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Actual results may differ materially from those estimates. |
Revenue Recognition | Revenue Recognition. Product Sales. In June 2011, the FDA approved the Company's Biologics License Application ("BLA") for LAVIV (azficel-T) for the treatment of nasolabial fold wrinkles. As one full course of LAVIV therapy includes three series of injections, the Company recognizes associated revenue over the period LAVIV is shipped for injection in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification ("ASC") 605, Revenue Recognition (“ASC 605”). In general, ASC 605 requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists, (2) delivery has occurred or services rendered, (3) the fee is fixed and determinable and (4) collectability is reasonably assured. Corresponding revenue is recognized on a prorata basis as each of the three series of injections is shipped to the physician. Currently, the Company no longer actively markets or promotes LAVIV to physicians or patients; however, prescriptions are still being accepted and filled. Collaboration Revenue. The Company's collaboration agreements may contain multiple elements, such as fees to perform proof of concept studies, product development, aid in obtaining U.S. patents and trademarks, and provide for royalties based upon future commercial sales. The deliverables under such an arrangement are evaluated under ASC 605-25, Revenue Recognition: Multiple-Element Arrangements . Each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. In general, the consideration allocated to each unit of accounting is recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. Collaboration revenue is recognized on a gross basis, in accordance with the criteria set forth in ASC 605-45, Revenue Recognition: Principal Agent Considerations . Collaboration revenue for the three and nine months ended September 30, 2015 is related to a research and development agreement that the Company has with an unrelated third party to investigate potential new non-pharmaceutical applications for the Company's conditioned fibroblast media technology. Revenue recognized from this collaboration relates to an upfront license fee and a proof of concept study currently underway. Cost of Revenue. Cost of revenue includes expenses related to product sales and collaboration revenue. Cost of Product Sales . Costs include the processing of cells for LAVIV, including direct and indirect costs. Cost of product sales is accounted for using a standard cost system which allocates the direct costs associated with the Company’s manufacturing, facility, quality control, and quality assurance operations as well as an allocation of overhead costs. Cost of Collaboration Revenue . Costs directly related to deliverables in a revenue-generating collaboration are charged to cost of revenue as incurred. |
Income Taxes | Income Taxes. In accordance with ASC 270, Interim Reporting, and ASC 740, Income Taxes , the Company is required at the end of each interim period to determine the best estimate of its annual effective tax rate and then apply that rate in providing for income taxes on a current year-to-date (interim period) basis. For the three and nine months ended September 30, 2015 and 2014 , the Company recorded no tax expense or benefit due to the expected current year loss and its historical losses. The Company had not recorded its net deferred tax asset as of either September 30, 2015 or December 31, 2014 , because it maintains a full valuation allowance against all deferred tax assets as management has determined that it is not more likely than not that the Company will realize these future tax benefits. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory , which requires an entity to measure in scope inventory at the lower of cost and net realizable value rather than at the lower of cost or market, where market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The amendment is effective for public companies for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years and should be applied prospectively. Early application is permitted. The Company has evaluated the effects of the adoption of this ASU on its financial statements and does not believe the impact will be material. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date , which defers by one year the effective date of ASU 2014-09, Revenue from Contracts with Customers. The guidance is effective for public companies with annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Earlier application is permitted. The Company is currently evaluating the effects of the adoption of ASU 2014-09 deferred by this update on its financial statements but does not believe the impact to be material. |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories consisted of the following as of: ($ in thousands) September 30, 2015 December 31, 2014 Raw materials (LAVIV and product candidates) $ 398 $ 357 Work in process (LAVIV) 168 214 Total Inventory $ 566 $ 571 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Warrants [Abstract] | |
Outstanding Warrants to Purchase Common Stock | The following table summarizes outstanding liability-classified warrants to purchase common stock as of: Number of Warrants Liability-classified warrants September 30, 2015 December 31, 2014 Exercise Price Expiration Dates Issued in Series A, B and D Preferred Stock offerings 2,231,118 2,247,118 $ 6.25 Oct 2015 - Dec 2016 Issued in March 2010 financing 319,789 393,416 $ 6.25 Mar 2016 Issued in June 2011 financing 6,113 6,113 $ 22.50 Jun 2016 Issued in August 2011 financing 565,759 565,759 $ 18.75 Aug 2016 Issued to placement agents in August 2011 financing 50,123 50,123 $ 13.635 Aug 2016 Issued in Series B, D and E Preferred Stock offerings 74,800 76,120 $ 2.50 Nov 2015 - Dec 2017 Issued with Convertible Notes 1,125,578 1,125,578 $ 2.50 Jun 2018 Issued in Series E Preferred Stock offering 1,568,823 1,568,823 $ 7.50 Dec 2018 Total 5,942,103 6,033,050 |
Schedule of Warrants Outstanding Roll Forward | The table below is a summary of the Company’s warrant activity during the nine months ended September 30, 2015. Number of warrants Weighted- average exercise price Outstanding at December 31, 2014 6,033,050 $ 7.08 Granted — — Exercised (1) (90,947 ) (6.20 ) Expired — — Outstanding at September 30, 2015 5,942,103 $ 7.09 (1) All warrants were exercised on a cashless basis resulting in the issuance of 11,584 shares of the Company's common stock. |
Summary of Other Assumptions Used by Entity | The following table summarizes the calculated aggregate fair values, along with the assumptions utilized in each calculation: ($ in thousands except share and per share data) September 30, 2015 December 31, 2014 Calculated aggregate value $ 6,964 $ 11,286 Weighted average exercise price per share $ 7.09 $ 7.08 Closing price per share of common stock $ 3.85 $ 2.59 Volatility 86.3 % 67.6 % Weighted average remaining expected life 1 year, 10 months 2 years, 7 months Risk-free interest rate 0.60 % 0.86 % Dividend yield — — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Company's Financial Assets and Liability Measured at Fair Value on a Recurring Basis | The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liabilities measured at fair value on a recurring basis as of: September 30, 2015 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 36,931 $ — $ — $ 36,931 Liabilities: Warrant liability $ — $ — $ 6,964 $ 6,964 December 31, 2014 ($ in thousands) Level 1 Level 2 Level 3 Total Assets: Cash and cash equivalents $ 37,495 $ — $ — $ 37,495 Liabilities: Warrant liability $ — $ — $ 11,286 $ 11,286 |
Reconciliation of Warrant Liability Measured at Fair Value on Recurring Basis | The reconciliation of the warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) was as follows: Warrant ($ in thousands) Liability Balance at December 31, 2014 $ 11,286 Exercise of warrants (1) (82 ) Change in fair value of warrant liability (4,240 ) Balance at September 30, 2015 $ 6,964 (1) All warrants were exercised under the cashless exercise method per the corresponding warrant agreement. As a result of such exercises, the Company issued 11,584 shares of common stock. Consequently, these instruments were no longer classified as liabilities. These common stock warrants were remeasured to their fair value as of the exercise date with the change in fair value recorded to other income. The fair value related to the shares issued in connection with the exercised warrants was reclassified from liability to additional paid-in capital in the condensed consolidated balance sheet. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Share-Based Compensation Expense | Total stock-based compensation expense, net of estimated forfeitures, recognized using the straight-line attribution method in the condensed consolidated statements of operations is as follows: Three months ended September 30, Nine months ended September 30, ($ in thousands) 2015 2014 2015 2014 Stock-based compensation expense for employees and directors $ 506 $ 266 $ 1,550 $ 1,002 Equity awards for non-employees issued for services — — — 3 Total stock-based compensation expense $ 506 $ 266 $ 1,550 $ 1,005 |
Summary of Stock Option Activity | The following table summarizes stock option activity for the nine months ended September 30, 2015 : ($ in thousands except share and per share data) Number of shares Weighted- average exercise price Weighted-average remaining contractual term Aggregate intrinsic value Outstanding at December 31, 2014 2,086,450 $ 7.43 8 years $ — Granted 1,352,114 4.48 Exercised (56,250 ) 4.53 Forfeited (178,970 ) 5.63 Expired (12,000 ) 10.50 Outstanding at September 30, 2015 3,191,344 $ 6.32 8 years, 1 month $ 602 Exercisable at September 30, 2015 1,469,897 $ 8.81 7 years $ 189 |
Details of Fair Value Option Award | The fair market value of these options was computed using the Black-Scholes option-pricing model with the following key weighted average assumptions for the nine months ended as of the dates indicated: September 30, 2015 September 30, 2014 Expected life 6 years, 1 month 5 years, 11 months Interest rate 1.56 % 1.91 % Dividend yield — — Volatility 103.2 % 70.3 % |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | Basic loss per share is computed by dividing net loss for the period by the weighted-average number of shares of common stock outstanding during that period. The diluted loss per share calculation gives effect to dilutive stock options, warrants and other potentially dilutive common stock equivalents outstanding during the period. Diluted loss per share is based on the treasury stock method and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options and warrants, assuming the exercise of all in-the-money stock options based on the average market price during the period. Common stock equivalents have been excluded where their inclusion would be anti-dilutive. Details in the computation of basic and diluted loss per share is as follows: For the three months ended September 30, For the nine months ended September 30, ($ in thousands except share and per share data) 2015 2014 2015 2014 Loss per share - basic: Numerator for basic loss per share $ (1,521 ) $ (6,012 ) $ (16,802 ) $ (22,278 ) Denominator for basic loss per share 43,021,121 40,856,815 41,598,632 40,766,741 Basic loss per common share $ (0.04 ) $ (0.15 ) $ (0.40 ) $ (0.55 ) Loss per share - diluted: Numerator for diluted loss per share $ (1,521 ) $ (6,012 ) $ (16,802 ) $ (22,278 ) Adjustment for income (expense) for change in fair value of warrant liability for dilutive warrants 1,529 1,098 1,529 2,364 Net loss attributable to common share $ (3,050 ) $ (7,110 ) $ (18,331 ) $ (24,642 ) Denominator for basic loss per share 43,021,121 40,856,815 41,598,632 40,766,741 Plus: Incremental shares underlying dilutive “in the money” warrants outstanding 691,797 443,290 230,599 279,120 Denominator for diluted loss per share 43,712,918 41,300,105 41,829,231 41,045,861 Diluted net loss per common share $ (0.07 ) $ (0.17 ) $ (0.44 ) $ (0.60 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding, as their effect would be anti-dilutive: Three months ended September 30, Nine months ended September 30, 2015 2014 2015 2014 “In the money” stock options 2,733,864 35,000 1,923,926 741,000 “Out of the money” stock options 457,480 2,231,200 1,113,960 1,571,546 “In the money” warrants — — 801,132 400,566 “Out of the money” warrants 4,741,725 4,831,352 4,801,476 4,831,352 Other securities excluded from the calculation of diluted loss per share: Stock options with performance condition — — 66,667 — |
Business and Organization (Deta
Business and Organization (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Dec. 31, 2013 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Cash and cash equivalents | $ 36,931 | $ 37,495 | $ 44,215 | $ 60,033 |
Working capital | $ 32,600 |
Basis of Presentation (Details)
Basis of Presentation (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2014 | Sep. 30, 2014 | |
Selling, General and Administrative Expenses | ||
Prior Period Reclassification Adjustment | $ 0.2 | $ 1 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Accounting Policies [Abstract] | ||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Inventory Disclosure [Abstract] | ||
Raw materials (LAVIV and product candidates) | $ 398 | $ 357 |
Work in process (LAVIV) | 168 | 214 |
Total Inventory | $ 566 | $ 571 |
Warrants (Details)
Warrants (Details) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
Warrants | ||
Warrants issued to purchase common stock | 5,942,103 | 6,033,050 |
Warrant Exercise Price (in dollars per share) | $ 7.09 | $ 7.08 |
Issued in Series A, B and D Preferred Stock offerings | ||
Warrants | ||
Warrants issued to purchase common stock | 2,231,118 | 2,247,118 |
Warrant Exercise Price (in dollars per share) | $ 6.25 | |
Issued in March 2010 financing | ||
Warrants | ||
Warrants issued to purchase common stock | 319,789 | 393,416 |
Warrant Exercise Price (in dollars per share) | $ 6.25 | |
Issued in June 2011 financing | ||
Warrants | ||
Warrants issued to purchase common stock | 6,113 | 6,113 |
Warrant Exercise Price (in dollars per share) | $ 22.50 | |
Issued in August 2011 financing | ||
Warrants | ||
Warrants issued to purchase common stock | 565,759 | 565,759 |
Warrant Exercise Price (in dollars per share) | $ 18.75 | |
Issued to placement agents in August 2011 financing | ||
Warrants | ||
Warrants issued to purchase common stock | 50,123 | 50,123 |
Warrant Exercise Price (in dollars per share) | $ 13.635 | |
Issued in Series B, D and E Preferred Stock offerings | ||
Warrants | ||
Warrants issued to purchase common stock | 74,800 | 76,120 |
Warrant Exercise Price (in dollars per share) | $ 2.50 | |
Issued with Convertible Notes | ||
Warrants | ||
Warrants issued to purchase common stock | 1,125,578 | 1,125,578 |
Warrant Exercise Price (in dollars per share) | $ 2.50 | |
Issued in Series E Preferred Stock offering | ||
Warrants | ||
Warrants issued to purchase common stock | 1,568,823 | 1,568,823 |
Warrant Exercise Price (in dollars per share) | $ 7.50 |
Warrants (Details 2)
Warrants (Details 2) | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Increase (Decrease) in Warrants Outstanding [Roll Forward] | |
Beginning balance, number of warrants outstanding (shares) | 6,033,050 |
Number of warrants exercised during the period (shares) | (90,947) |
Ending balance, number of warrants outstanding (shares) | 5,942,103 |
Beginning balance, weighted-average exercise price (usd per share) | $ / shares | $ 7.08 |
Weighted-average exercise price, warrants exercised during the period (usd per share) | $ / shares | (6.20) |
Ending balance, weighted-average exercise price (usd per share) | $ / shares | $ 7.09 |
Common Stock | |
Increase (Decrease) in Warrants Outstanding [Roll Forward] | |
Issuance of shares from cashless warrant exercises (shares) | 11,584 |
Warrants (Details 3)
Warrants (Details 3) - Warrant Liability - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Fair value assumptions | ||
Calculated aggregate value | $ 6,964 | $ 11,286 |
Weighted average exercise price per share (usd per share) | $ 7.09 | $ 7.08 |
Closing price per share of common stock (usd per share) | $ 3.85 | $ 2.59 |
Volatility (as a percent) | 86.30% | 67.60% |
Weighted average remaining expected life | 1 year 10 months | 2 years 7 months |
Interest rate (as a percent) | 0.60% | 0.86% |
Dividend yield | 0.00% | 0.00% |
Warrants Narrative (Details)
Warrants Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Warrant | Significant unobservable inputs (Level 3) | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Fair Value Adjustment of Warrants | $ 5.3 | $ 0.2 | $ 4.2 | $ 1.1 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Liabilities | ||
Amount transferred from Level 1 to Level 2 | $ 0 | $ 0 |
Amount transferred from Level 2 to Level 1 | 0 | 0 |
Amount transferred from Level 1 to Level 2 | 0 | 0 |
Amount transferred from Level 2 to Level 1 | 0 | 0 |
Amount transferred into Level 3 | 0 | 0 |
Amount transferred out of Level 3 | 0 | 0 |
Amount transferred into Level 3 | 0 | 0 |
Amount transferred out of Level 3 | 0 | 0 |
Recurring | Measured at fair value | ||
Assets | ||
Cash and cash equivalents | 36,931,000 | 37,495,000 |
Liabilities | ||
Warrant liability | 6,964,000 | 11,286,000 |
Recurring | Measured at fair value | Quoted prices in active markets (Level 1) | ||
Assets | ||
Cash and cash equivalents | 36,931,000 | 37,495,000 |
Recurring | Measured at fair value | Significant unobservable inputs (Level 3) | ||
Liabilities | ||
Warrant liability | $ 6,964,000 | $ 11,286,000 |
Fair Value Measurements (Deta33
Fair Value Measurements (Details 2) $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)shares | |
Common Stock | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Common stock issued as a result of warrant exercises (shares) | shares | 11,584 |
Warrant | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
December 31, 2014 | $ 11,286 |
Exercise of warrants | (82) |
Change in fair value of warrant liability | (4,240) |
September 30, 2015 | $ 6,964 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - shares | 9 Months Ended | |
Sep. 30, 2015 | Dec. 31, 2014 | |
Equity-based compensation | ||
Options issued (in shares) | 3,191,344 | 2,086,450 |
The Plan | ||
Equity-based compensation | ||
Number of shares allowed for issuance (in shares) | 5,600,000 | |
The Plan | Options | ||
Equity-based compensation | ||
Vesting percentage per year | 25.00% | |
Vesting period (in years) | 4 years | |
Options available for grant (in shares) | 2,369,409 | |
The Plan | Options | Maximum | ||
Equity-based compensation | ||
Terms of options (in years) | 10 years | |
Equity incentive outside of the Plan | Options | ||
Equity-based compensation | ||
Options issued (in shares) | 206,000 |
Stock-Based Compensation (Det35
Stock-Based Compensation (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Equity-based compensation | ||||
Stock-based compensation expense | $ 506 | $ 266 | $ 1,550 | $ 1,005 |
Options | Equity awards for non-employees issued for services | ||||
Equity-based compensation | ||||
Stock-based compensation expense | 0 | 0 | 0 | 3 |
Options | Stock-based compensation expense for employees and directors | ||||
Equity-based compensation | ||||
Stock-based compensation expense | $ 506 | $ 266 | $ 1,550 | $ 1,002 |
Stock-Based Compensation (Det36
Stock-Based Compensation (Details 3) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Number of shares | ||
Outstanding at beginning of period (in shares) | 2,086,450 | |
Granted (in shares) | 1,352,114 | |
Exercised (shares) | (56,250) | |
Forfeited (in shares) | (178,970) | |
Expired (in shares) | (12,000) | |
Outstanding at end of period (in shares) | 3,191,344 | 2,086,450 |
Exercisable at end of period (in shares) | 1,469,897 | |
Weighted-average exercise price | ||
Outstanding at beginning of period (in dollars per share) | $ 7.43 | |
Granted (in dollars per share) | 4.48 | |
Exercised (in dollars per share) | 4.53 | |
Forfeited (in dollars per share) | 5.63 | |
Expired (in dollars per share) | 10.50 | |
Outstanding at end of period (in dollars per share) | 6.32 | $ 7.43 |
Exercisable at end of period (in dollars per share) | $ 8.81 | |
Additional disclosures | ||
Weighted-average remaining contractual term (in years), Outstanding | 8 years 1 month | 8 years |
Weighted-average remaining contractual term (in years), Exercisable | 7 years | |
Aggregate intrinsic value, Outstanding | $ 602 | $ 0 |
Aggregate intrinsic value, Exercisable | $ 189 |
Stock-Based Compensation (Det37
Stock-Based Compensation (Details 4) - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Equity-based compensation | ||
Fair value of shares vested | $ 1,300,000 | |
Weighted average fair market value of options granted (in dollars per share) | $ 3.59 | $ 2.64 |
Weighted average assumptions | ||
Expected life | 6 years 1 month | 5 years 11 months |
Interest rate | 1.56% | 1.91% |
Volatility | 103.20% | 70.30% |
Time-based stock options | ||
Equity-based compensation | ||
Total unrecognized compensation cost | $ 4,500,000 | |
Weighted-average period to recognize compensation cost (in years) | 2 years 11 months | |
Performance based options | Equity awards for non-employees issued for services | ||
Equity-based compensation | ||
Total unrecognized compensation cost | $ 0 |
Collaboration Agreement with 38
Collaboration Agreement with Related Party (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Affiliated Entity | Intrexon Corporation | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Shareholder ownership percentage of related party in affiliate | 50.00% | 50.00% | |||
Immediate Family Member of Management or Principal Owner | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Shareholder ownership percentage | 35.00% | 35.00% | |||
Intrexon Corporation | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Expenses for work performed | $ 1.8 | $ 1.2 | $ 4.7 | $ 3 | |
Outstanding trade payables | 1.4 | 1.4 | $ 1 | ||
Intrexon Corporation | Direct Expenses for Work Performed | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Expenses for work performed | 0.7 | 0.5 | 2.4 | 1.7 | |
Intrexon Corporation | Pass-through Costs | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Expenses for work performed | $ 1.1 | $ 0.7 | $ 2.3 | $ 1.3 |
Loss Per Share - Earnings Per S
Loss Per Share - Earnings Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Earnings Per Share, Basic [Abstract] | ||||
Numerator for basic loss per share | $ (1,521) | $ (6,012) | $ (16,802) | $ (22,278) |
Denominator for basic loss per share, shares | 43,021,121 | 40,856,815 | 41,598,632 | 40,766,741 |
Basic net loss (usd per share) | $ (0.04) | $ (0.15) | $ (0.40) | $ (0.55) |
Earnings Per Share, Diluted [Abstract] | ||||
Numerator for diluted loss per share | $ (1,521) | $ (6,012) | $ (16,802) | $ (22,278) |
Adjustment for income (expense) for change in fair value of warrant liability for dilutive warrants | 1,529 | 1,098 | 1,529 | 2,364 |
Net loss attributable to common share | $ (3,050) | $ (7,110) | $ (18,331) | $ (24,642) |
Denominator for basic loss per share, shares | 43,021,121 | 40,856,815 | 41,598,632 | 40,766,741 |
Incremental shares underlying in the money warrants outstanding, shares | 691,797 | 443,290 | 230,599 | 279,120 |
Denominator for diluted loss per share, shares | 43,712,918 | 41,300,105 | 41,829,231 | 41,045,861 |
Diluted net loss (usd per share) | $ (0.07) | $ (0.17) | $ (0.44) | $ (0.60) |
Loss Per Share - Antidilutive S
Loss Per Share - Antidilutive Securities (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Performance based options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from EPS, shares | 0 | 0 | 66,667 | 0 |
“In the money” stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from EPS, shares | 2,733,864 | 35,000 | 1,923,926 | 741,000 |
“Out of the money” stock options | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from EPS, shares | 457,480 | 2,231,200 | 1,113,960 | 1,571,546 |
“In the money” warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from EPS, shares | 0 | 0 | 801,132 | 400,566 |
“Out of the money” warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from EPS, shares | 4,741,725 | 4,831,352 | 4,801,476 | 4,831,352 |
Equity (Details)
Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Jul. 27, 2015 | Sep. 30, 2015 | Sep. 30, 2014 |
Class of Stock [Line Items] | |||
Proceeds from common stock offering, gross | $ 17,300 | ||
Proceeds from common stock offering, net | $ 15,900 | $ 15,872 | $ 0 |
Common Stock | |||
Class of Stock [Line Items] | |||
Common stock issued (usd per share) | $ 5.80 | ||
Common stock sold in Offering (shares) | 2,586,206 | ||
Common Stock | Over-Allotment Option | |||
Class of Stock [Line Items] | |||
Common stock sold in Offering (shares) | 387,930 |