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Delaware
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001-31564
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87-0458888
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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Title of Each Class
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Name of each exchange on which registered
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Common Stock, $.001 par value
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The NASDAQ Stock Market LLC
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Large accelerated filer
o
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Accelerated filer
x
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Non-accelerated filer
¨
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Smaller reporting company
¨
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(Do not check if a smaller reporting company)
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Page
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•
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the progress and results of our pre-clinical studies and clinical trials of our cell therapy applications, including whether our clinical human trials relating to the use of autologous cell and gene therapy applications, in particular, for vocal cord scars and gene therapy orphan indications, and such other target indications as we may identify and pursue can be conducted within the timeframe that we expect, whether such studies and trials will yield positive results, or whether additional applications for the commercialization of autologous cell therapy can be identified by us and advanced into human clinical trials;
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the cost of manufacturing related to our pre-clinical studies and clinical trials;
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our ability to meet requisite regulations or receive regulatory approvals in the United States and in Europe, our ability to retain any regulatory approvals that we may obtain and the absence of adverse regulatory developments in the United States and Europe;
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the costs, timing and outcome of regulatory review of our product candidates;
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the dependence on our facility in Exton, Pennsylvania for our research, development and manufacturing operations, and the potential that such facility is damaged or if we are otherwise required to discontinue research, development and production at such facility;
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whether our collaboration with Intrexon can be advanced with positive results within the timeframe and budget that we expect;
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our dependence on suppliers for gene therapy products which are critical to the completion of our gene therapy applications;
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the scope, progress, results and costs of pre-clinical development, laboratory testing and clinical trials for our cell therapy applications;
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the number and development requirements of other product candidates that we pursue;
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the emergence of competing technologies and other adverse market developments;
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the extent to which we acquire or invest in businesses, products and technologies;
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our ability to establish collaborations and obtain milestone, royalty or other payments from any such collaborators;
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any adverse claims relating to our intellectual property and the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property related claims; and
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our dependence on physicians to correctly follow our established protocols for the safe and optimal administration of our product.
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Intrexon’s UltraVector® technology is designed to facilitate the assembly and delivery of the necessary target gene constructs for delivery to autologous fibroblasts. Access to this platform allows us a rapid method to screen and construct gene therapy solutions for rare and serious skin and connective tissue diseases.
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•
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In certain therapeutic applications with our Gene Therapy Product Engine, we will also deploy Intrexon’s proprietary RheoSwitch Therapeutic System® technology
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which is a biologic switch activated by a small molecule ligand that provides the ability to control level and timing of protein expression in those diseases where such control is critical.
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Program
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Indication
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Status
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azficel-T sBLA
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Vocal Cord Scarring
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Phase II Clinical Trial
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GM-HDF
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RDEB
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Pre-clinical
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GM-HDF
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Linear Scleroderma
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Pre-clinical
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•
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completion of pre-clinical laboratory tests or trials and formulation studies;
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submission to the FDA of an Investigational New Drug (“IND”) application for a new drug or biologic, which must become effective before human clinical trials may begin;
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performance of adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug or biologic for its intended use;
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detailed information on product characterization and manufacturing process; and
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submission and approval of a New Drug Application (“NDA”) for a drug, or a BLA for a biologic.
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Phase I: The product is usually first introduced into healthy humans or, on occasion, into patients, and is tested for safety, dosage tolerance, absorption, distribution, excretion and metabolism;
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Phase II: The product is introduced into a limited patient population to:
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Phase III: These are commonly referred to as pivotal studies. If a product is found to have an acceptable safety profile and to be potentially effective in Phase II clinical trials, clinical trials in Phase III will be initiated to further demonstrate clinical efficacy, optimal dosage and safety within an expanded and diverse patient population at geographically dispersed clinical study sites; and
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If the FDA does ultimately approve the product, it may require post-marketing testing, including potentially expensive Phase IV studies, to confirm or further evaluate its safety and effectiveness. Continued ability to commercialize the product may be based on the successful completion of these additional studies.
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continue our research and pre-clinical and clinical development of our product candidates;
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initiate additional pre-clinical, clinical or other studies or trials for our product candidates, including under our collaboration agreement with Intrexon;
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continue or expand our collaboration with Intrexon and our other collaborators;
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further develop the manufacturing process for our product candidates;
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change or add additional manufacturers or suppliers;
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seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials;
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establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
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seek to identify and validate additional product candidates;
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acquire or in-license other product candidates and technologies;
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maintain, protect and expand our intellectual property portfolio;
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attract and retain skilled personnel;
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create additional infrastructure to support our product development and planned future commercialization efforts; and
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experience any delays or encounter issues with any of the above.
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completing research and pre-clinical and clinical development of our product candidates;
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seeking and obtaining regulatory and marketing approvals for product candidates for which we complete clinical trials;
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developing a sustainable, scalable, reproducible, and transferable manufacturing process for our product candidates;
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establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products and services to support clinical development and the market demand for our product candidates, if approved;
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launching and commercializing product candidates for which we obtain regulatory and marketing approval, either by collaborating with a partner or, if launched independently, by establishing a sales force, marketing and distribution infrastructure;
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obtaining market acceptance of our product candidates and cell therapy as a viable treatment option;
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addressing any competing technological and market developments;
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implementing additional internal systems and infrastructure, as needed;
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identifying and validating new cell therapy product candidates;
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negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter;
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maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and
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attracting, hiring and retaining qualified personnel.
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significantly delay, scale back or discontinue the development or, if/when applicable, the commercialization, of our product candidates;
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seek collaborators for one or more of our current or future product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;
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relinquish or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seek to develop or commercialize ourselves; or
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significantly curtail operations.
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severity of the disease under investigation;
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design of the study protocol;
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size of the patient population;
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eligibility criteria for the clinical trial in question;
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perceived risks and benefits of the product candidate under study;
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proximity and availability of clinical trial sites for prospective patients;
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availability of competing therapies and clinical trials;
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efforts to facilitate timely enrollment in clinical trials;
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patient referral practices of physicians; and
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ability to monitor patients adequately during and after treatment.
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delays in obtaining regulatory approvals to commence a study or trial;
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delays in identifying and reaching agreement on acceptable terms with prospective clinical trial sites;
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delays or failures in obtaining approval of our clinical trial protocol from an IRB to conduct a clinical trial at a prospective study site;
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delays in the enrollment of patients;
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manufacturing difficulties;
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failure of our clinical trials and clinical investigators to be in compliance with the FDA’s GCP;
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failure of our third-party contract research organizations, clinical site organizations or other clinical trial managers, to satisfy their contractual duties, comply with regulations or meet expected deadlines;
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lack of efficacy during clinical trials; or
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unforeseen safety issues.
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administrative or judicial enforcement actions;
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changes to advertising;
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failure to obtain marketing approvals for our product candidates;
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revocation or suspension of regulatory approvals of products;
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product seizures or recalls;
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court-ordered injunctions;
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import detentions;
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delay, interruption or suspension of product manufacturing, distribution, marketing and sales; or
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civil or criminal sanctions.
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incurring substantial expenses, including fines, penalties, legal fees and costs to comply with the FDA’s requirements;
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changes in the methods of marketing and selling products;
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taking FDA mandated corrective action, which may include placing advertisements or sending letters to physicians rescinding previous advertisements or promotions; or
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disruption in the distribution of products and loss of sales until compliance with the FDA’s position is obtained.
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others may be able to make compounds that are the same as or similar to our product candidates, but that are not covered by the claims of the patents that we own or have exclusively licensed;
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we or our licensors or any strategic partners might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or have exclusively licensed;
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we or our licensors might not have been the first to file patent applications covering certain of our inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
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it is possible that our pending patent applications will not lead to issued patents;
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issued patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;
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our competitors might conduct research and development activities in the U.S. and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
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we may not develop additional proprietary technologies that are patentable; and
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the patents of others may have an adverse effect on our business.
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availability or contamination of raw materials and components used in the manufacturing process, particularly those for which we have no other source or supplier;
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capacity of our facility and those of our suppliers;
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the performance of our information technology systems;
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compliance with regulatory requirements;
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inclement weather and natural disasters;
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changes in forecasts of future demand for product components;
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timing and actual number of production runs for product components;
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potential facility contamination by microorganisms or viruses;
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updating of manufacturing specifications; and
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product quality success rates and yields.
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•
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whether our clinical human trials relating to the use of autologous cell therapy applications, in particular, for vocal cord scars, and such other indications as we may identify and pursue can be conducted within the timeframe that we expect, whether such trials will yield positive results, or whether additional applications for the commercialization of autologous cell therapy can be identified by us and advanced into human clinical trials;
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•
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whether our collaboration with Intrexon can be advanced with positive results within the timeframe and budget that we expect;
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changes in laws or regulations applicable to our products or product candidates, including but not limited to clinical trial requirements for approvals;
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unanticipated serious safety concerns related to the use of our products or product candidates;
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a decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
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our ability to increase our manufacturing capacity and reduce our manufacturing costs through the improvement of our manufacturing process, our ability to validate any such improvements with the relevant regulatory agencies and our ability to accomplish the foregoing on a timely basis, if at all;
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adverse regulatory decisions;
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the introduction of new products or technologies offered by us or our competitors;
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the inability to effectively manage our growth;
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actual or anticipated variations in quarterly operating results;
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the failure to meet or exceed the estimates and projections of the investment community;
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the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
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the overall performance of the U.S. equity markets and general political and economic conditions;
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announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
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disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
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additions or departures of key personnel;
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the trading volume of our common stock; and
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•
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other events or factors, many of which are beyond our control.
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•
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the timing, implementation and cost of our clinical trials;
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•
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expenses in connection with our exclusive channel collaboration arrangement with Intrexon;
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the level of demand and profitability of LAVIV®;
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the timely and successful implementation of improved manufacturing processes;
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our ability to attract and retain personnel with the necessary strategic, technical and creative skills required for effective operations;
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the amount and timing of expenditures by practitioners and their patients;
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introduction of new technologies;
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product liability litigation, class action and derivative action litigation, or other litigation;
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the amount and timing of capital expenditures and other costs relating to the expansion of our operations;
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the state of the debt and/or equity markets at the time of any proposed offering we choose to initiate;
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our ability to successfully integrate new acquisitions into our operations;
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government regulation and legal developments regarding LAVIV® and our product candidates in the United States and in the foreign countries in which we may operate in the future; and
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general economic conditions.
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High
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Low
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||||
Year Ended December 31, 2014
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First Quarter
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$
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6.30
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$
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4.00
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Second Quarter
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$
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5.23
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$
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2.70
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Third Quarter prior to August 29, 2014 (the date we began trading on the NASDAQ)
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$
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4.31
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$
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2.88
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Third Quarter (from August 29, 2014 to September 30, 2014))
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$
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3.40
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$
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2.60
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Fourth Quarter
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$
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3.25
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$
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2.28
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Year Ended December 31, 2013
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|
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||
First Quarter
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$
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4.25
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$
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3.25
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Second Quarter prior to May 17, 2013 (the date we began trading on the NYSE MKT)
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$
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5.05
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$
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3.00
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Second Quarter (from May 17, 2013 to June 30, 2013)
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$
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7.20
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$
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4.50
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Third Quarter
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$
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6.23
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$
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4.10
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Fourth Quarter
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$
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4.44
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|
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$
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3.28
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|
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As of
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||||||||||||||||
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12/31/2009
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12/31/2010
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12/31/2011
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12/31/2012
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12/31/2013
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12/31/2014
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||||||
Fibrocell Science, Inc.
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62.16
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|
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27.57
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|
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21.62
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|
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8.11
|
|
|
8.78
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|
|
5.60
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NASDAQ Composite Index
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105.51
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|
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123.35
|
|
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121.13
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140.39
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194.19
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220.21
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NASDAQ Biotechnology Index
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104.89
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120.63
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134.88
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|
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177.91
|
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294.64
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395.11
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$ in thousands, except share data
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||||||||||||||||||
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Twelve Months Ended
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||||||||||||||||||
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12/31/2014
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12/31/2013
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12/31/2012
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12/31/2011
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12/31/2010
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Income Statement
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|||||
Total revenue
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$
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180
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|
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$
|
200
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|
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$
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153
|
|
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$
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—
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|
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$
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936
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|
Cost of sales
|
|
2,312
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|
|
7,501
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|
|
7,804
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|
|
13
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|
|
503
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|||||
Gross loss
|
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(2,132
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)
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|
(7,301
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)
|
|
(7,651
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)
|
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(13
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)
|
|
433
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|
|||||
Selling, general and administrative expenses
|
|
11,623
|
|
|
9,440
|
|
|
11,546
|
|
|
12,795
|
|
|
6,516
|
|
|||||
Research and development expenses
|
|
16,199
|
|
|
13,762
|
|
|
10,193
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|
|
7,171
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|
|
5,486
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|
|||||
Warrant revaluation and other finance income (expense)
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|
3,930
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|
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(1,053
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)
|
|
20,404
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|
|
2,562
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|
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(465
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)
|
|||||
Derivative revaluation income
|
|
—
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|
|
—
|
|
|
(23
|
)
|
|
(5,452
|
)
|
|
—
|
|
|||||
Interest expense
|
|
6
|
|
|
2
|
|
|
(1,017
|
)
|
|
(1,062
|
)
|
|
(1,045
|
)
|
|||||
Loss on extinguishment of debt
|
|
—
|
|
|
—
|
|
|
(5,617
|
)
|
|
—
|
|
|
—
|
|
|||||
Other income
|
|
368
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
248
|
|
|||||
Loss from continuing operations before income tax
|
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(15,643
|
)
|
|
(23,931
|
)
|
|
(12,831
|
)
|
|||||
Income taxes
|
|
—
|
|
|
—
|
|
|
2,500
|
|
|
—
|
|
|
—
|
|
|||||
Loss from continuing operations
|
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(13,143
|
)
|
|
(23,931
|
)
|
|
(12,831
|
)
|
|||||
Loss from discontinued operations, net of tax
|
|
—
|
|
|
—
|
|
|
(11
|
)
|
|
(94
|
)
|
|
(49
|
)
|
|||||
Gain on sale of discontinued operations, net of tax
|
|
—
|
|
|
—
|
|
|
467
|
|
|
—
|
|
|
—
|
|
|||||
Net loss
|
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(12,687
|
)
|
|
(24,025
|
)
|
|
(12,880
|
)
|
|||||
Net loss attributable to noncontrolling interest
|
|
—
|
|
|
—
|
|
|
(24
|
)
|
|
(18
|
)
|
|
(52
|
)
|
|||||
Net loss attributable to common shareholders
|
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(12,711
|
)
|
|
(24,043
|
)
|
|
(12,932
|
)
|
|||||
Loss from continuing operations per common share - basic
|
|
$
|
(0.63
|
)
|
|
$
|
(1.06
|
)
|
|
$
|
(1.47
|
)
|
|
$
|
(10.91
|
)
|
|
$
|
(17.10
|
)
|
Loss from continuing operations per common share - diluted
|
|
$
|
(0.70
|
)
|
|
$
|
(1.12
|
)
|
|
$
|
(2.65
|
)
|
|
$
|
(10.99
|
)
|
|
$
|
(17.10
|
)
|
Net loss per common share - basic
|
|
$
|
(0.63
|
)
|
|
$
|
(1.06
|
)
|
|
$
|
(1.42
|
)
|
|
$
|
(10.96
|
)
|
|
$
|
(17.23
|
)
|
Net loss per common share - diluted
|
|
$
|
(0.70
|
)
|
|
$
|
(1.12
|
)
|
|
$
|
(2.60
|
)
|
|
$
|
(11.04
|
)
|
|
$
|
(17.23
|
)
|
Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash and cash equivalents
|
|
$
|
37,495
|
|
|
$
|
60,033
|
|
|
$
|
31,346
|
|
|
$
|
10,799
|
|
|
$
|
868
|
|
Total current assets
|
|
39,348
|
|
|
61,860
|
|
|
33,156
|
|
|
12,499
|
|
|
1,916
|
|
|||||
Total assets
|
|
45,634
|
|
|
69,014
|
|
|
40,603
|
|
|
20,274
|
|
|
8,278
|
|
|||||
Total current liabilities
|
|
3,493
|
|
|
3,593
|
|
|
1,554
|
|
|
9,612
|
|
|
1,943
|
|
|||||
Warrant liability
|
|
11,286
|
|
|
15,216
|
|
|
14,515
|
|
|
23,754
|
|
|
8,172
|
|
|||||
Total liabilities
|
|
15,225
|
|
|
19,348
|
|
|
16,413
|
|
|
36,542
|
|
|
22,281
|
|
|||||
Mezzanine preferred stock
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,070
|
|
|||||
Total equity/(deficit) and noncontrolling interest
|
|
30,409
|
|
|
49,666
|
|
|
24,190
|
|
|
(16,268
|
)
|
|
(15,073
|
)
|
|
Year Ended
December 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2014
|
|
2013
|
|
$
|
|
%
|
|||||||
Total revenue
|
$
|
180
|
|
|
$
|
200
|
|
|
$
|
(20
|
)
|
|
(10.0
|
)%
|
Cost of sales
|
2,312
|
|
|
7,501
|
|
|
(5,189
|
)
|
|
(69.2
|
)%
|
|||
Gross loss
|
$
|
(2,132
|
)
|
|
$
|
(7,301
|
)
|
|
$
|
5,169
|
|
|
70.8
|
%
|
|
Year Ended
December 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2014
|
|
2013
|
|
$
|
|
%
|
|||||||
Compensation and related expense
|
$
|
4,727
|
|
|
$
|
3,841
|
|
|
$
|
886
|
|
|
23.1
|
%
|
Professional fees
|
1,713
|
|
|
964
|
|
|
749
|
|
|
77.7
|
%
|
|||
Marketing expense
|
57
|
|
|
295
|
|
|
(238
|
)
|
|
(80.7
|
)%
|
|||
Legal fees
|
1,056
|
|
|
697
|
|
|
359
|
|
|
51.5
|
%
|
|||
Facilities and related expense and other
|
4,070
|
|
|
3,643
|
|
|
427
|
|
|
11.7
|
%
|
|||
Total selling, general and administrative expense
|
$
|
11,623
|
|
|
$
|
9,440
|
|
|
$
|
2,183
|
|
|
23.1
|
%
|
|
Year Ended
December 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2014
|
|
2013
|
|
$
|
|
%
|
|||||||
Direct costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Vocal Cord Scarring
|
$
|
778
|
|
|
$
|
322
|
|
|
$
|
456
|
|
|
141.6
|
%
|
RDEB
|
3,800
|
|
|
1,773
|
|
|
2,027
|
|
|
114.3
|
%
|
|||
Restrictive Burn Scarring
|
645
|
|
|
344
|
|
|
301
|
|
|
87.5
|
%
|
|||
Autoimmune diseases
|
558
|
|
|
7,140
|
|
|
(6,582
|
)
|
|
(92.2
|
)%
|
|||
azficel-T
|
549
|
|
|
1,555
|
|
|
(1,006
|
)
|
|
(64.7
|
)%
|
|||
Ehlers-Danlos Syndrome hypermobility type
|
5,171
|
|
|
—
|
|
|
5,171
|
|
|
100.0
|
%
|
|||
Other
|
460
|
|
|
631
|
|
|
(171
|
)
|
|
(27.1
|
)%
|
|||
Total direct costs
|
11,961
|
|
|
11,765
|
|
|
196
|
|
|
1.7
|
%
|
|||
Indirect costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Regulatory costs
|
1,012
|
|
|
923
|
|
|
89
|
|
|
9.6
|
%
|
|||
Intangible amortization
|
551
|
|
|
551
|
|
|
—
|
|
|
—
|
%
|
|||
Indirect lab costs and other expenses
|
2,402
|
|
|
253
|
|
|
2,149
|
|
|
849.4
|
%
|
|||
Compensation and related expenses
|
273
|
|
|
270
|
|
|
3
|
|
|
1.1
|
%
|
|||
Total indirect costs
|
4,238
|
|
|
1,997
|
|
|
2,241
|
|
|
112.2
|
%
|
|||
Total research and development expense
|
$
|
16,199
|
|
|
$
|
13,762
|
|
|
$
|
2,437
|
|
|
17.7
|
%
|
|
Year Ended
December 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2013
|
|
2012
|
|
$
|
|
%
|
|||||||
Total revenue
|
$
|
200
|
|
|
$
|
153
|
|
|
$
|
47
|
|
|
30.7
|
%
|
Cost of sales
|
7,501
|
|
|
7,804
|
|
|
(303
|
)
|
|
(3.9
|
)%
|
|||
Gross loss
|
$
|
(7,301
|
)
|
|
$
|
(7,651
|
)
|
|
$
|
350
|
|
|
(4.6
|
)%
|
|
Year Ended
December 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2013
|
|
2012
|
|
$
|
|
%
|
|||||||
Compensation and related expense
|
$
|
3,841
|
|
|
$
|
4,336
|
|
|
$
|
(495
|
)
|
|
(11.4
|
)%
|
Professional fees
|
964
|
|
|
877
|
|
|
87
|
|
|
9.9
|
%
|
|||
Marketing expense
|
295
|
|
|
2,203
|
|
|
(1,908
|
)
|
|
(86.6
|
)%
|
|||
Legal fees
|
697
|
|
|
527
|
|
|
170
|
|
|
32.3
|
%
|
|||
Facilities and related expense and other
|
3,643
|
|
|
3,603
|
|
|
40
|
|
|
1.1
|
%
|
|||
Total selling, general and administrative expense
|
$
|
9,440
|
|
|
$
|
11,546
|
|
|
$
|
(2,106
|
)
|
|
(18.2
|
)%
|
|
Year Ended
December 31, |
|
Increase
(Decrease)
|
|||||||||||
($ in thousands)
|
2013
|
|
2012
|
|
$
|
|
%
|
|||||||
Direct costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Vocal Cord Scarring
|
$
|
322
|
|
|
158
|
|
|
$
|
164
|
|
|
103.8
|
%
|
|
RDEB
|
1,773
|
|
|
6,979
|
|
|
(5,206
|
)
|
|
(74.6
|
)%
|
|||
Restrictive Burn Scarring
|
344
|
|
|
163
|
|
|
181
|
|
|
111.0
|
%
|
|||
Autoimmune diseases
|
7,140
|
|
|
—
|
|
|
7,140
|
|
|
100.0
|
%
|
|||
azficel-T
|
1,555
|
|
|
293
|
|
|
1,262
|
|
|
430.7
|
%
|
|||
Other
|
631
|
|
|
554
|
|
|
77
|
|
|
13.9
|
%
|
|||
Total direct costs
|
11,765
|
|
|
8,147
|
|
|
3,618
|
|
|
44.4
|
%
|
|||
Indirect costs:
|
|
|
|
|
|
|
|
|
|
|
|
|||
Regulatory costs
|
923
|
|
|
978
|
|
|
(55
|
)
|
|
(5.6
|
)%
|
|||
Intangible amortization
|
551
|
|
|
551
|
|
|
—
|
|
|
—
|
%
|
|||
Indirect lab costs and other
|
253
|
|
|
194
|
|
|
59
|
|
|
30.4
|
%
|
|||
Compensation and related expense
|
270
|
|
|
323
|
|
|
(53
|
)
|
|
(16.4
|
)%
|
|||
Total indirect costs
|
1,997
|
|
|
2,046
|
|
|
(49
|
)
|
|
(2.4
|
)%
|
|||
Total research and development expense
|
$
|
13,762
|
|
|
$
|
10,193
|
|
|
$
|
3,569
|
|
|
35.0
|
%
|
|
Year Ended December 31,
|
||||||||||
($ in thousands)
|
2014
|
|
2013
|
|
2012
|
||||||
Statement of Cash Flows Data:
|
|
|
|
|
|
|
|
|
|||
Total cash provided by (used in):
|
|
|
|
|
|
|
|
|
|||
Operating activities
|
$
|
(22,296
|
)
|
|
$
|
(20,075
|
)
|
|
$
|
(22,575
|
)
|
Investing activities
|
(242
|
)
|
|
(360
|
)
|
|
509
|
|
|||
Financing activities
|
—
|
|
|
49,122
|
|
|
42,613
|
|
|
Payments due by period
|
||||||||||||||||||
($ in thousands)
|
Total
|
|
2015
|
|
2016 and
2017
|
|
2018 and 2019
|
|
2020 and
thereafter
|
||||||||||
License fee obligations
(1)
|
$
|
950
|
|
|
$
|
483
|
|
|
$
|
308
|
|
|
$
|
106
|
|
|
$
|
53
|
|
Operating lease obligations
(2)
|
$
|
11,168
|
|
|
$
|
1,211
|
|
|
$
|
2,508
|
|
|
$
|
2,670
|
|
|
$
|
4,779
|
|
Total
|
$
|
12,118
|
|
|
$
|
1,694
|
|
|
$
|
2,816
|
|
|
$
|
2,776
|
|
|
$
|
4,832
|
|
EXHIBIT
NO.
|
|
IDENTIFICATION OF EXHIBIT
|
2.1
|
|
Debtors’ First Amended Joint Plan of Reorganization dated July 30, 2009 and Disclosure Statement (incorporated by reference to as Exhibit 10.2 to the Company’s Form 10-Q for quarter ended June 30, 2009, filed on August 12, 2009 and as Exhibit 99.1 to our Form 8-K filed September 2, 2009)
|
3.1
|
|
Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to our Form 8-K filed December 13, 2012)
|
3.2
|
|
Certificate of Amendment of the Restated Certificate of Incorporation filed April 26, 2013 (incorporated by reference to Exhibit 3.1 of the Form 8-K filed on April 29, 2013)
|
3.3
|
|
Certificate of Amendment to the Company’s Restated Certificate of Incorporation, as amended, filed July 19, 2013 (incorporated by reference to Exhibit 3.1 of the Form 8-K filed on July 22, 2013)
|
3.4
|
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to our Form 8-K filed September 2, 2009)
|
4.1
|
|
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to our Form 10-Q filed November 23, 2009)
|
4.2
|
|
Form of Class A/B Common Stock Purchase Warrant issued in October 2009 offering (incorporated by reference to Exhibit 4.1 to our Form 8-K filed October 14, 2009)
|
4.3
|
|
Form of Placement Agent Warrant issued in November 2009 offering (incorporated by reference to Exhibit 4.2 to our Form 10-Q filed November 23, 2009)
|
4.4
|
|
Form of Common Stock Purchase Warrant issued in March 2010 offering (incorporated by reference to Exhibit 4.1 to our Form 8-K filed March 3, 2010)
|
4.5
|
|
Form of Common Stock Purchase Warrant issued in July 2010 Series B Preferred Stock offering (incorporated by reference to Exhibit 4.1 to our Form 8-K filed July 20, 2010)
|
4.6
|
|
Form of Placement Agent Warrant issued in July 2010 Series B Preferred Stock offering (incorporated by reference to Exhibit 4.2 to our Form 8-K filed July 20, 2010)
|
4.7
|
|
Form of Common Stock Purchase Warrant used for Series B Preferred Stock offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed October 22, 2010).
|
4.8
|
|
Form of Common Stock Purchase Warrant used for the Series D Preferred Stock offering (incorporated by reference to Exhibit 4.1 of the Form 8-K filed February 15, 2011).
|
4.9
|
|
Form of Common Stock Purchase Warrant issued in August 2011 offering (incorporated by reference to Exhibit 4.1 to our Form 8-K filed August 4, 2011)
|
4.10
|
|
Form of Amended and Restated Common Stock Purchase Warrant issued to our prior 12.5% Note holders (incorporated by reference to Exhibit 10.5 of the Form 8-K filed October 9, 2012).
|
10.1
|
|
Lease Agreement between Isolagen, Inc. and The Hankin Group dated April 7, 2005 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed on April 12, 2005)
|
10.2
|
|
Amendment to Lease Agreement between Fibrocell Science, Inc. and The Hankin Group dated February 17, 2012 (incorporated by reference to Exhibit 10.17 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2011)
|
10.3
|
|
Securities Purchase Agreement dated October 5, 2012 (incorporated by reference to Exhibit 10.1 to our Form 8-K filed October 9, 2012)
|
10.4
|
|
Registration Rights Agreement dated October 5, 2012 (incorporated by reference to Exhibit 10.2 to our Form 8-K filed October 5, 2012)
|
10.5
|
|
Stock Issuance Agreement dated October 5, 2012 between the Company and Intrexon Corporation (incorporated by reference to Exhibit 10.3 to our Form 8-K filed October 5, 2012)
|
10.6
|
|
Amendment and Conversion Agreement dated October 5, 2012 between the Company and the Holders of the Company’s Notes (incorporated by reference to Exhibit 10.4 to our Form 8-K filed October 5, 2012)
|
10.7
|
|
Exclusive Channel Collaboration Agreement between Intrexon Corporation and Fibrocell Science, Inc. (incorporated by reference to Exhibit 10.21 of the Form 10-K filed on April 1, 2013)
|
**10.8
|
|
Employment Transition Letter between Fibrocell Science, Inc. and Declan Daly dated June 28, 2013 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed on June 28, 2013)
|
10.9
|
|
First Amendment to Exclusive Channel Collaboration Agreement between the Company and Intrexon Corporation dated June 28, 2013 (incorporated by reference to Exhibit 10.1 of the Form 8-K filed on July 1, 2013)
|
10.10
|
|
Supplemental Stock Issuance Agreement between the Company and Intrexon Corporation dated June 28, 2013 (incorporated by reference to Exhibit 10.2 of the Form 8-K filed on July 1, 2013)
|
10.11
|
|
Massachusetts Institute of Technology Office of Sponsored Programs Research Agreement (incorporated by reference to Exhibit 10.1 of the Form 10-Q filed on November 14, 2013)
|
*
|
Filed herewith.
|
**
|
Indicates management contract or compensatory plan or arrangement.
|
U
|
Confidential treatment has been granted as to certain portions of this exhibit pursuant to Rule 406 of the Securities Act of 1933, as amended, or Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
|
(1)
|
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
|
FIBROCELL SCIENCE, INC.
|
|
|
|
|
|
By:
|
/s/ David Pernock
|
|
|
David Pernock
|
|
|
Chief Executive Officer
|
|
|
|
|
Date: March 13, 2015
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ David Pernock
|
|
Chief Executive Officer and Chairman of the Board of Directors
|
|
March 13, 2015
|
David Pernock
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ Kimberly M. Smith
|
|
Interim Chief Financial Officer
|
|
March 13, 2015
|
Kimberly M. Smith
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/ Kelvin Moore
|
|
Director
|
|
March 13, 2015
|
Kelvin Moore
|
|
|
|
|
|
|
|
|
|
/s/ Marc Mazur
|
|
Director
|
|
March 13, 2015
|
Marc Mazur
|
|
|
|
|
|
|
|
|
|
/s/ Julian Kirk
|
|
Director
|
|
March 13, 2015
|
Julian Kirk
|
|
|
|
|
|
|
|
|
|
/s/ Marcus Smith
|
|
Director
|
|
March 13, 2015
|
Marcus Smith
|
|
|
|
|
|
|
|
|
|
/s/ Christine St.Clare
|
|
Director
|
|
March 13, 2015
|
Christine St.Clare
|
|
|
|
|
|
|
|
|
|
/s/ Douglas J. Swirsky
|
|
Director
|
|
March 13, 2015
|
Douglas J. Swirsky
|
|
|
|
|
|
PAGE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
2014 |
|
December 31,
2013 |
||||
|
|
|
|
||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
37,495
|
|
|
$
|
60,033
|
|
Accounts receivable, net of allowance for doubtful accounts of $17 and $5, respectively
|
4
|
|
|
28
|
|
||
Inventory
|
571
|
|
|
597
|
|
||
Prepaid expenses and other current assets
|
1,278
|
|
|
1,202
|
|
||
Total current assets
|
39,348
|
|
|
61,860
|
|
||
Property and equipment, net
|
1,598
|
|
|
1,701
|
|
||
Intangible assets, net of accumulated amortization of $1,653 and $1,102, respectively
|
4,687
|
|
|
5,238
|
|
||
Other assets
|
1
|
|
|
215
|
|
||
Total assets
|
$
|
45,634
|
|
|
$
|
69,014
|
|
|
|
|
|
||||
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
1,124
|
|
|
$
|
2,958
|
|
Accrued expenses
|
1,675
|
|
|
487
|
|
||
Deferred revenue
|
416
|
|
|
148
|
|
||
Warrant liability, current
|
278
|
|
|
—
|
|
||
Total current liabilities
|
3,493
|
|
|
3,593
|
|
||
Warrant liability, long term
|
11,008
|
|
|
15,216
|
|
||
Other long term liabilities
|
724
|
|
|
539
|
|
||
Total liabilities
|
15,225
|
|
|
19,348
|
|
||
|
|
|
|
||||
Commitments:
|
|
|
|
|
|
||
|
|
|
|
||||
Common stock, $0.001 par value; 100,000,000 shares authorized; 40,856,815 and 39,832,225 shares issued and outstanding, respectively
|
41
|
|
|
40
|
|
||
Additional paid-in capital
|
143,086
|
|
|
136,694
|
|
||
Accumulated deficit
|
(112,718
|
)
|
|
(87,068
|
)
|
||
Total stockholders’ equity
|
30,409
|
|
|
49,666
|
|
||
Total liabilities and stockholders’ equity
|
$
|
45,634
|
|
|
$
|
69,014
|
|
Year Ended
|
Year Ended
December 31, 2014 |
|
Year Ended
December 31, 2013 |
|
Year Ended
December 31, 2012 |
||||||
|
|
|
|
|
|
||||||
Revenue from product sales
|
$
|
180
|
|
|
$
|
200
|
|
|
$
|
153
|
|
Cost of sales
|
2,312
|
|
|
7,501
|
|
|
7,804
|
|
|||
Gross loss
|
(2,132
|
)
|
|
(7,301
|
)
|
|
(7,651
|
)
|
|||
Selling, general and administrative expenses
|
11,623
|
|
|
9,440
|
|
|
11,546
|
|
|||
Research and development expenses
|
16,199
|
|
|
13,762
|
|
|
10,193
|
|
|||
Operating loss
|
(29,954
|
)
|
|
(30,503
|
)
|
|
(29,390
|
)
|
|||
Other income (expense):
|
|
|
|
|
|
|
|
|
|||
Warrant revaluation and other finance income (expense)
|
3,930
|
|
|
(1,053
|
)
|
|
20,404
|
|
|||
Derivative revaluation expense
|
—
|
|
|
—
|
|
|
(23
|
)
|
|||
Interest income (expense)
|
6
|
|
|
2
|
|
|
(1,017
|
)
|
|||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
(5,617
|
)
|
|||
Other income
|
368
|
|
|
—
|
|
|
—
|
|
|||
Loss from continuing operations before income taxes
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(15,643
|
)
|
|||
Deferred tax benefit
|
—
|
|
|
—
|
|
|
2,500
|
|
|||
Loss from continuing operations
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(13,143
|
)
|
|||
Loss from discontinued operations, net of tax
|
—
|
|
|
—
|
|
|
(11
|
)
|
|||
Gain on sale of discontinued operations, net of tax
|
—
|
|
|
—
|
|
|
467
|
|
|||
Net loss
|
(25,650
|
)
|
|
(31,554
|
)
|
|
(12,687
|
)
|
|||
Net loss attributable to non-controlling interest
|
—
|
|
|
—
|
|
|
(24
|
)
|
|||
Net loss attributable to Fibrocell Science, Inc. common stockholders
|
$
|
(25,650
|
)
|
|
$
|
(31,554
|
)
|
|
$
|
(12,711
|
)
|
|
|
|
|
|
|
||||||
Per Share Information:
|
|
|
|
|
|
|
|
|
|||
Loss from continuing operations - basic
|
$
|
(0.63
|
)
|
|
$
|
(1.06
|
)
|
|
$
|
(1.47
|
)
|
Gain on sale of discontinued operations, net of tax - basic
|
—
|
|
|
—
|
|
|
0.05
|
|
|||
Net loss per common share - basic
|
(0.63
|
)
|
|
(1.06
|
)
|
|
(1.42
|
)
|
|||
|
|
|
|
|
|
||||||
Loss from continuing operations - diluted
|
(0.70
|
)
|
|
(1.12
|
)
|
|
(2.65
|
)
|
|||
Gain on sale of discontinued operations, net of tax - diluted
|
—
|
|
|
—
|
|
|
0.05
|
|
|||
Net loss per common share - diluted
|
(0.70
|
)
|
|
(1.12
|
)
|
|
(2.60
|
)
|
|||
|
|
|
|
|
|
||||||
Weighted average number of common shares outstanding
|
|
|
|
|
|
|
|
|
|||
— Basic
|
40,789,445
|
|
|
29,830,207
|
|
|
8,965,098
|
|
|||
— Diluted
|
40,969,399
|
|
|
30,196,616
|
|
|
9,147,060
|
|
|
Common
Stock
|
|
Subscription receivable
|
|
Additional
paid-in capital
|
|
Accumulated deficit
|
|
Non-controlling interest
|
|
Total Equity (Deficit)
|
|||||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|
||||||||||||||||||
Balance, December 31, 2011
|
3,827,132
|
|
|
$
|
4
|
|
|
$
|
(550
|
)
|
|
$
|
27,081
|
|
|
$
|
(43,271
|
)
|
|
$
|
468
|
|
|
$
|
(16,268
|
)
|
Proceeds from equity financing, net
|
18,203,000
|
|
|
18
|
|
|
(2,004
|
)
|
|
42,171
|
|
|
—
|
|
|
—
|
|
|
40,185
|
|
||||||
Fair value of warrants issued with financing
|
—
|
|
|
—
|
|
|
—
|
|
|
1,098
|
|
|
—
|
|
|
—
|
|
|
1,098
|
|
||||||
Preferred stock series D and E converted
|
2,021,120
|
|
|
2
|
|
|
—
|
|
|
1,348
|
|
|
—
|
|
|
—
|
|
|
1,350
|
|
||||||
Conversion of note payable
|
898,641
|
|
|
1
|
|
|
—
|
|
|
2,384
|
|
|
—
|
|
|
—
|
|
|
2,385
|
|
||||||
Issuance of common stock
|
1,317,520
|
|
|
1
|
|
|
—
|
|
|
6,916
|
|
|
—
|
|
|
—
|
|
|
6,917
|
|
||||||
Cancellation of certificate
|
(40,000
|
)
|
|
—
|
|
|
550
|
|
|
(550
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
1,224
|
|
|
—
|
|
|
—
|
|
|
1,224
|
|
||||||
Exercise of warrants
|
2,496
|
|
|
—
|
|
|
—
|
|
|
10
|
|
|
—
|
|
|
—
|
|
|
10
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(12,243
|
)
|
|
(468
|
)
|
|
(12,711
|
)
|
||||||
Balance, December 31, 2012
|
26,229,909
|
|
|
$
|
26
|
|
|
$
|
(2,004
|
)
|
|
$
|
81,682
|
|
|
$
|
(55,514
|
)
|
|
$
|
—
|
|
|
$
|
24,190
|
|
Proceeds from equity financing, net
|
12,311,698
|
|
|
12
|
|
|
—
|
|
|
47,106
|
|
|
—
|
|
|
—
|
|
|
47,118
|
|
||||||
Subscription received
|
—
|
|
|
—
|
|
|
2,004
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,004
|
|
||||||
Issuance of common stock
|
1,243,781
|
|
|
2
|
|
|
—
|
|
|
6,404
|
|
|
—
|
|
|
—
|
|
|
6,406
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
1,150
|
|
|
—
|
|
|
—
|
|
|
1,150
|
|
||||||
Exercise of warrants
|
46,837
|
|
|
—
|
|
|
—
|
|
|
352
|
|
|
—
|
|
|
—
|
|
|
352
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(31,554
|
)
|
|
—
|
|
|
(31,554
|
)
|
||||||
Balance, December 31, 2013
|
39,832,225
|
|
|
$
|
40
|
|
|
$
|
—
|
|
|
$
|
136,694
|
|
|
$
|
(87,068
|
)
|
|
$
|
—
|
|
|
$
|
49,666
|
|
Issuance of common stock
|
1,024,590
|
|
|
1
|
|
|
—
|
|
|
5,153
|
|
|
—
|
|
|
—
|
|
|
5,154
|
|
||||||
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
—
|
|
|
1,239
|
|
|
—
|
|
|
—
|
|
|
1,239
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(25,650
|
)
|
|
—
|
|
|
(25,650
|
)
|
||||||
Balance, December 31, 2014
|
40,856,815
|
|
|
$
|
41
|
|
|
$
|
—
|
|
|
$
|
143,086
|
|
|
$
|
(112,718
|
)
|
|
$
|
—
|
|
|
$
|
30,409
|
|
|
Year Ended
December 31, 2014 |
|
Year Ended
December 31, 2013 |
|
Year Ended
December 31, 2012 |
||||||
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|||
Net loss
|
$
|
(25,650
|
)
|
|
$
|
(31,554
|
)
|
|
$
|
(12,687
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
5,617
|
|
|||
Gain on sale of Agera
|
—
|
|
|
—
|
|
|
(467
|
)
|
|||
Stock issued for exclusive channel collaboration agreement
|
5,154
|
|
|
6,406
|
|
|
6,917
|
|
|||
Stock-based compensation expense
|
1,239
|
|
|
1,150
|
|
|
1,224
|
|
|||
Warrant revaluation and other finance (income) expense
|
(3,930
|
)
|
|
1,053
|
|
|
(20,404
|
)
|
|||
Derivative revaluation expense
|
—
|
|
|
—
|
|
|
23
|
|
|||
Deferred tax benefit
|
—
|
|
|
—
|
|
|
(2,500
|
)
|
|||
Loss on disposal of property and equipment
|
13
|
|
|
5
|
|
|
—
|
|
|||
Depreciation and amortization
|
883
|
|
|
863
|
|
|
821
|
|
|||
Provision for doubtful accounts
|
12
|
|
|
(20
|
)
|
|
25
|
|
|||
Amortization of debt issuance costs
|
—
|
|
|
—
|
|
|
146
|
|
|||
Change in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|||
Accounts receivable
|
12
|
|
|
54
|
|
|
(60
|
)
|
|||
Inventory
|
26
|
|
|
(120
|
)
|
|
(477
|
)
|
|||
Prepaid expenses
|
(76
|
)
|
|
69
|
|
|
(196
|
)
|
|||
Other assets
|
214
|
|
|
(215
|
)
|
|
—
|
|
|||
Accounts payable
|
(1,834
|
)
|
|
2,037
|
|
|
(966
|
)
|
|||
Accrued expenses and other liabilities
|
1,373
|
|
|
188
|
|
|
407
|
|
|||
Deferred revenue
|
268
|
|
|
9
|
|
|
83
|
|
|||
Miscellaneous other
|
—
|
|
|
—
|
|
|
(81
|
)
|
|||
Net cash used in operating activities
|
(22,296
|
)
|
|
(20,075
|
)
|
|
(22,575
|
)
|
|||
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|||
Purchase of property and equipment
|
(242
|
)
|
|
(360
|
)
|
|
(493
|
)
|
|||
Proceeds from the sale of Agera
|
—
|
|
|
—
|
|
|
1,002
|
|
|||
Net cash (used in) provided by investing activities
|
(242
|
)
|
|
(360
|
)
|
|
509
|
|
|||
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|||
Debt issuance costs
|
—
|
|
|
—
|
|
|
(46
|
)
|
|||
Net proceeds from preferred stock
|
—
|
|
|
—
|
|
|
7,864
|
|
|||
Net proceeds from common stock
|
—
|
|
|
47,118
|
|
|
40,185
|
|
|||
Subscription received
|
—
|
|
|
2,004
|
|
|
—
|
|
|||
Payments on insurance loan
|
—
|
|
|
—
|
|
|
(97
|
)
|
|||
Principal payments on note payable
|
—
|
|
|
—
|
|
|
(4,823
|
)
|
|||
Dividends paid on preferred stock
|
—
|
|
|
—
|
|
|
(470
|
)
|
|||
Net cash provided by financing activities
|
—
|
|
|
49,122
|
|
|
42,613
|
|
|||
Net (decrease) increase in cash and cash equivalents
|
(22,538
|
)
|
|
28,687
|
|
|
20,547
|
|
|||
Cash and cash equivalents, beginning of period
|
60,033
|
|
|
31,346
|
|
|
10,799
|
|
|||
Cash and cash equivalents, end of period
|
$
|
37,495
|
|
|
$
|
60,033
|
|
|
$
|
31,346
|
|
|
|
Balance at beginning of year
|
|
Additions charged to earnings
|
|
Uncollectible receivables written off, net of recoveries
|
|
Balance at end of year
|
||||
December 31, 2014
|
|
5
|
|
|
12
|
|
|
(2
|
)
|
|
17
|
|
December 31, 2013
|
|
25
|
|
|
(20
|
)
|
|
—
|
|
|
5
|
|
December 31, 2012
|
|
—
|
|
|
25
|
|
|
—
|
|
|
25
|
|
Property and equipment category
|
|
Useful life
|
Laboratory equipment
|
|
6 years
|
Computer equipment and software
|
|
3 years
|
Furniture and fixtures
|
|
10 years
|
Leasehold improvements
|
|
Lesser of remaining lease term or life of asset
|
|
For the Twelve Months Ended December 31,
|
||||||||||
($ in thousands except share and per share data)
|
2014
|
|
2013
|
|
2012
|
||||||
Loss per share — Basic:
|
|
|
|
|
|
|
|
||||
Numerator for basic loss per share
|
$
|
(25,650
|
)
|
|
$
|
(31,554
|
)
|
|
$
|
(12,711
|
)
|
Denominator for basic loss per share
|
40,789,445
|
|
|
29,830,207
|
|
|
8,965,098
|
|
|||
Basic loss per common share
|
$
|
(0.63
|
)
|
|
$
|
(1.06
|
)
|
|
$
|
(1.42
|
)
|
Loss per share — Diluted:
|
|
|
|
|
|
|
|
|
|||
Numerator for basic loss per share
|
$
|
(25,650
|
)
|
|
$
|
(31,554
|
)
|
|
$
|
(12,711
|
)
|
Adjust: Fair value of dilutive warrants outstanding
|
2,840
|
|
|
2,270
|
|
|
11,091
|
|
|||
Numerator for diluted loss per share
|
$
|
(28,490
|
)
|
|
$
|
(33,824
|
)
|
|
$
|
(23,802
|
)
|
|
|
|
|
|
|
||||||
Denominator for basic loss per share
|
40,789,445
|
|
|
29,830,207
|
|
|
8,965,098
|
|
|||
Plus: Incremental shares underlying “in the money” warrants outstanding
|
179,954
|
|
|
366,409
|
|
|
181,962
|
|
|||
Denominator for diluted loss per share
|
40,969,399
|
|
|
30,196,616
|
|
|
9,147,060
|
|
|||
Diluted loss per common share
|
$
|
(0.70
|
)
|
|
$
|
(1.12
|
)
|
|
$
|
(2.60
|
)
|
|
For the Twelve Months Ended December 31,
|
|||||||
|
2014
|
|
2013
|
|
2012
|
|||
Shares underlying “out of the money” options outstanding
|
2,086,450
|
|
|
1,070,720
|
|
|
562,025
|
|
Shares underlying “in the money” options outstanding
|
—
|
|
|
998,000
|
|
|
—
|
|
Shares underlying “out of the money” warrants outstanding
|
4,831,352
|
|
|
4,831,352
|
|
|
4,845,352
|
|
Shares underlying “in the money” warrants outstanding
|
—
|
|
|
—
|
|
|
1,320
|
|
($ in thousands)
|
December 31,
2014 |
|
December 31,
2013 |
||||
Raw materials
|
$
|
357
|
|
|
$
|
511
|
|
Work-in-process
|
214
|
|
|
86
|
|
||
Inventory
|
$
|
571
|
|
|
$
|
597
|
|
($ in thousands)
|
December 31,
2014 |
|
December 31,
2013 |
||||
Laboratory equipment
|
$
|
1,279
|
|
|
$
|
1,045
|
|
Computer equipment and software
|
206
|
|
|
179
|
|
||
Furniture and fixtures
|
49
|
|
|
15
|
|
||
Leasehold improvements
|
772
|
|
|
448
|
|
||
Construction-in-process
|
343
|
|
|
749
|
|
||
|
2,649
|
|
|
2,436
|
|
||
Less: Accumulated depreciation
|
(1,051
|
)
|
|
(735
|
)
|
||
Property and equipment, net
|
$
|
1,598
|
|
|
$
|
1,701
|
|
($ in thousands)
|
December 31,
2014 |
|
December 31,
2013 |
||||
Accrued professional fees
|
$
|
881
|
|
|
$
|
194
|
|
Accrued compensation
|
540
|
|
|
40
|
|
||
Accrued other
|
254
|
|
|
253
|
|
||
Accrued expenses
|
$
|
1,675
|
|
|
$
|
487
|
|
|
Number of Warrants
|
|
|
|
|
||||||
|
December 31, 2014
|
|
December 31, 2013
|
|
Exercise
Price
|
|
Expiration Dates
|
||||
Issued in Series A, B and D Preferred Stock offering
|
2,247,118
|
|
|
2,247,118
|
|
|
$
|
6.25
|
|
|
Oct 2015 - Dec 2016
|
Issued in March 2010 financing
|
393,416
|
|
|
393,416
|
|
|
$
|
6.25
|
|
|
Mar 1, 2016
|
Issued in June 2011 financing
|
6,113
|
|
|
6,113
|
|
|
$
|
22.50
|
|
|
Jun 1, 2016
|
Issued in August 2011 financing
|
565,759
|
|
|
565,759
|
|
|
$
|
18.75
|
|
|
Aug 1, 2016
|
Issued to placement agents in August 2011 financing
|
50,123
|
|
|
50,123
|
|
|
$
|
13.635
|
|
|
Aug 1, 2016
|
Issued in Series B, D and E Preferred Stock offerings
|
76,120
|
|
|
76,120
|
|
|
$
|
2.50
|
|
|
Nov 2015 - Dec 2017
|
Issued with Convertible Notes
|
1,125,578
|
|
|
1,125,578
|
|
|
$
|
2.50
|
|
|
Jun 1, 2018
|
Issued in Series E Preferred Stock offering
|
1,568,823
|
|
|
1,568,823
|
|
|
$
|
7.50
|
|
|
Dec 1, 2018
|
Total
|
6,033,050
|
|
|
6,033,050
|
|
|
|
|
|
|
($ in thousands, except per share data)
|
December 31,
2014 |
|
December 31,
2013 |
|
December 31,
2012 |
||||||
Calculated aggregate value
|
11,281
|
|
|
15,216
|
|
|
14,515
|
|
|||
Weighted average exercise price per share of warrant
|
7.08
|
|
|
7.08
|
|
|
7.04
|
|
|||
Closing price per share of common stock
|
$
|
2.59
|
|
|
$
|
4.06
|
|
|
$
|
3.75
|
|
Volatility
|
68
|
%
|
|
70
|
%
|
|
65
|
%
|
|||
Weighted average remaining expected life (years)
|
2 years, 7 months
|
|
|
3 years, 6 months
|
|
|
4 years, 6 months
|
|
|||
Risk-free interest rate
|
0.86
|
%
|
|
1.20
|
%
|
|
0.60
|
%
|
|||
Dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
•
|
The Notes accrued interest at a rate of
12.5%
per annum payable quarterly in cash or, at the Company’s option,
15%
per annum payable in kind by capitalizing such unpaid amount and adding it to the principal as of the date it was due.
|
•
|
The maturity date of the Notes was September 1, 2013, provided that the Holders may require the Company to redeem
25%
of the principal amount of the Notes on each of
December 1, 2012
,
March 1, 2013
,
June 1, 2012
and
September 1, 2013
.
|
•
|
To the extent that Holders of the Notes converted any portion of the Notes prior to any such redemption date, the amount of all future redemption payments will be reduced by such converted amount on a
pro rata
basis over the remaining redemption dates.
|
•
|
The Notes were convertible at a conversion price of
$6.25
per share, provided that, with certain exceptions, if, at any time while the Notes are outstanding, the Company issues any Company common stock or common stock equivalents at an effective price per share that is lower than the then the conversion price of the Notes, then the conversion price of the Notes will be reduced to equal the lower price.
|
•
|
The Notes may be accelerated if any events of default occur, which include, in addition to certain customary default provisions, if at any time on or after
October 1, 2012
the Company fails to have reserved, for conversion of the Notes and exercise of the Warrants, a sufficient number of available authorized but unissued shares of common stock.
|
|
Series D
Preferred
|
|
Series E
Preferred
|
|
Total
|
|||
Balance at December 31, 2011
|
3,641
|
|
|
—
|
|
|
3,641
|
|
Issuance of Series E Preferred stock
|
—
|
|
|
9,141
|
|
|
9,141
|
|
Series D and Series E Preferred converted to common stock
|
(3,641
|
)
|
|
(9,141
|
)
|
|
(12,782
|
)
|
Balance at December 31, 2012
|
—
|
|
|
—
|
|
|
—
|
|
Date of financing
|
# of shares
of Series E
Preferred
|
|
Net Proceeds
($ in 000’s)
|
|
Warrant
Exercise
Price
|
|
# of Warrants
Issued
|
||||||
May 14, 2012
|
3,353
|
|
|
$
|
2,843
|
|
|
$
|
7.50
|
|
|
590,128
|
|
May 24, 2012
|
2,364
|
|
|
2,042
|
|
|
7.50
|
|
|
416,064
|
|
||
June 2, 2012
|
945
|
|
|
822
|
|
|
7.50
|
|
|
166,320
|
|
||
June 7, 2012
|
1,192
|
|
|
1,037
|
|
|
7.50
|
|
|
209,792
|
|
||
June 28, 2012
|
507
|
|
|
441
|
|
|
7.50
|
|
|
89,232
|
|
||
July 16, 2012
|
780
|
|
|
679
|
|
|
7.50
|
|
|
137,280
|
|
||
|
9,141
|
|
|
$
|
7,864
|
|
|
|
|
1,608,816
|
|
•
|
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).
|
|
Fair value measurement using
|
||||||||||||||
($ in thousands)
|
Quoted prices in
active markets
(Level 1)
|
|
Significant
other
observable
inputs (Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Balance at December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
37,495
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
37,495
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11,286
|
|
|
$
|
11,286
|
|
|
Fair value measurement using
|
||||||||||||||
($ in thousands)
|
Quoted prices in
active markets
(Level 1)
|
|
Significant
other
observable
inputs (Level 2)
|
|
Significant
unobservable
inputs
(Level 3)
|
|
Total
|
||||||||
Balance at December 31, 2013
|
|
|
|
|
|
|
|
|
|
|
|
||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents
|
$
|
60,033
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
60,033
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Warrant liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
15,216
|
|
|
$
|
15,216
|
|
($ in thousands)
|
Warrant Liability
|
||
Balance at December 31, 2011
|
$
|
23,754
|
|
Issuance of additional warrants
|
6,766
|
|
|
Exercise of warrants
|
(11
|
)
|
|
Extinguishment of debt related to warrants
|
4,410
|
|
|
Change in fair value of warrant liability
|
(20,404
|
)
|
|
Balance at December 31, 2012
|
$
|
14,515
|
|
Exercise of warrants
|
(352
|
)
|
|
Cancellation of warrants
|
(41
|
)
|
|
Change in fair value of warrant liability
|
1,094
|
|
|
Balance at December 31, 2013
|
$
|
15,216
|
|
Exercise of warrants
|
—
|
|
|
Cancellation of warrants
|
—
|
|
|
Change in fair value of warrant liability
|
(3,930
|
)
|
|
Balance at December 31, 2014
|
$
|
11,286
|
|
|
Derivative
Liability
|
|
Balance at January 1, 2012
|
534
|
|
Issuance of additional preferred stock and other
|
793
|
|
Conversion of preferred stock
|
(1,350
|
)
|
Change in fair value of derivative liability
|
23
|
|
Balance at December 31, 2012
|
—
|
|
($ in thousands)
|
2014
|
|
2013
|
|
2012
|
||||||
Stock option compensation expense for employees and directors
|
$
|
1,236
|
|
|
$
|
1,045
|
|
|
$
|
1,200
|
|
Equity awards for nonemployees issued for services
|
3
|
|
|
105
|
|
|
24
|
|
|||
Total stock-based compensation expense
|
$
|
1,239
|
|
|
$
|
1,150
|
|
|
$
|
1,224
|
|
|
2014
|
|
2013
|
|
2012
|
|||
Expected life
|
5 years, 11 months
|
|
|
5 years, 7 months
|
|
|
5 years, 8 months
|
|
Interest rate
|
1.9
|
%
|
|
1.6
|
%
|
|
1.6
|
%
|
Dividend yield
|
—
|
|
|
—
|
|
|
—
|
|
Volatility
|
70
|
%
|
|
71
|
%
|
|
64
|
%
|
|
Number of shares
|
|
Weighted-
average
exercise
price
|
|
Weighted-
average
remaining
contractual term
(in years)
|
|
Aggregate
intrinsic
value
|
|||||
Outstanding at December 31, 2011
|
544,340
|
|
|
$
|
19.25
|
|
|
7 years, 6 months
|
|
$
|
—
|
|
Granted
|
38,000
|
|
|
$
|
8.02
|
|
|
|
|
|
|
|
Forfeited
|
(20,315
|
)
|
|
$
|
15.48
|
|
|
|
|
|
|
|
Outstanding at December 31, 2012
|
562,025
|
|
|
$
|
18.56
|
|
|
7 years
|
|
$
|
—
|
|
Granted
|
1,532,000
|
|
|
$
|
4.15
|
|
|
|
|
|
|
|
Forfeited
|
(25,305
|
)
|
|
$
|
14.71
|
|
|
|
|
|
|
|
Outstanding at December 31, 2013
|
2,068,720
|
|
|
$
|
7.93
|
|
|
8 years, 5 months
|
|
$
|
544
|
|
Granted
|
348,000
|
|
|
$
|
4.19
|
|
|
|
|
|
|
|
Expired
|
(51,637
|
)
|
|
$
|
21.61
|
|
|
|
|
|
||
Forfeited
|
(278,633
|
)
|
|
$
|
4.45
|
|
|
|
|
|
|
|
Outstanding at December 31, 2014
|
2,086,450
|
|
|
$
|
7.43
|
|
|
7 years, 2 months
|
|
$
|
—
|
|
Exercisable at December 31, 2014
|
1,100,250
|
|
|
$
|
10.63
|
|
|
7 years, 2 months
|
|
$
|
—
|
|
|
Year ended December 31,
|
|
Year ended December 31,
|
|
Year ended December 31,
|
||||||
($ in thousands)
|
2014
|
|
2013
|
|
2012
|
||||||
U.S. Federal:
|
|
|
|
|
|
|
|
|
|||
Current
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Deferred
|
—
|
|
|
—
|
|
|
(2,068
|
)
|
|||
U.S. State:
|
|
|
|
|
|
|
|
|
|||
Current
|
—
|
|
|
—
|
|
|
—
|
|
|||
Deferred
|
—
|
|
|
—
|
|
|
(432
|
)
|
|||
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(2,500
|
)
|
|
Year ended December 31,
|
|
Year ended December 31,
|
|
Year ended December 31,
|
||||||
($ in thousands)
|
2014
|
|
2013
|
|
2012
|
||||||
Tax benefit at U.S. federal statutory rate
|
$
|
(8,977
|
)
|
|
$
|
(11,044
|
)
|
|
$
|
(5,475
|
)
|
Increase in domestic valuation allowance
|
11,109
|
|
|
11,626
|
|
|
11,127
|
|
|||
State income taxes/(benefit) before valuation allowance, net of federal benefit
|
(846
|
)
|
|
(1,026
|
)
|
|
(1,971
|
)
|
|||
Capital loss limitation
|
—
|
|
|
—
|
|
|
(817
|
)
|
|||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
1,966
|
|
|||
Derivative revaluation expense
|
—
|
|
|
—
|
|
|
8
|
|
|||
Warrant revaluation and other finance (income)/expense
|
(1,375
|
)
|
|
369
|
|
|
(7,141
|
)
|
|||
Other
|
89
|
|
|
75
|
|
|
(197
|
)
|
|||
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(2,500
|
)
|
($ in thousands)
|
December 31, 2014
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|||
Intangible assets
|
$
|
2,001
|
|
|
$
|
2,247
|
|
|
$
|
2,282
|
|
Total deferred tax liabilities
|
$
|
2,001
|
|
|
$
|
2,247
|
|
|
$
|
2,282
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|||
Loss carryforwards
|
$
|
63,560
|
|
|
$
|
54,253
|
|
|
$
|
49,598
|
|
Capital loss carryforward
|
841
|
|
|
844
|
|
|
817
|
|
|||
Property and equipment
|
1,135
|
|
|
1,149
|
|
|
1,327
|
|
|||
License fees
|
7,055
|
|
|
5,393
|
|
|
—
|
|
|||
Accrued expenses and other
|
602
|
|
|
412
|
|
|
360
|
|
|||
Stock compensation
|
2,953
|
|
|
2,698
|
|
|
2,492
|
|
|||
Total deferred tax assets
|
76,146
|
|
|
64,749
|
|
|
54,594
|
|
|||
Less: valuation allowance
|
(74,145
|
)
|
|
(62,502
|
)
|
|
(52,312
|
)
|
|||
Total deferred tax assets
|
$
|
2,001
|
|
|
$
|
2,247
|
|
|
$
|
2,282
|
|
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Payments due by period
|
||||||||||||||||||
($ in thousands)
|
Total
|
|
2015
|
|
2016
and 2017
|
|
2018
and 2019
|
|
2020
and thereafter
|
||||||||||
License fee obligations
(1)
|
$
|
950
|
|
|
$
|
483
|
|
|
$
|
308
|
|
|
$
|
106
|
|
|
$
|
53
|
|
Operating lease obligations
(2)
|
$
|
11,168
|
|
|
$
|
1,211
|
|
|
$
|
2,508
|
|
|
$
|
2,670
|
|
|
$
|
4,779
|
|
Total
|
$
|
12,118
|
|
|
$
|
1,694
|
|
|
$
|
2,816
|
|
|
$
|
2,776
|
|
|
$
|
4,832
|
|
($ in thousands)
|
December 31, 2014
|
|
December 31, 2013
|
|
December 31, 2012
|
||||||
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|||
Cash paid for interest
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,885
|
|
Cash paid for income taxes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|||
Subscription receivable
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,004
|
|
Conversion of note payable
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,385
|
|
Issuance of additional warrants
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11,077
|
|
Conversion of preferred stock derivative balance into common stock
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,350
|
|
Cashless exercise of warrants previously recorded as a liability
|
$
|
—
|
|
|
$
|
298
|
|
|
$
|
17
|
|
Warrant liability reclassified to equity
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
15,048
|
|
Accrued derivative liability
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
793
|
|
($ in thousands)
|
Year ended, December 31, 2012
|
||
Product sales
|
$
|
516
|
|
Cost of sales
|
275
|
|
|
Gross profit
|
241
|
|
|
Operating income (loss)
|
$
|
27
|
|
Net loss
|
$
|
(2
|
)
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
2014 Quarter Ended
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net product sales
|
$
|
46
|
|
|
$
|
58
|
|
|
$
|
20
|
|
|
$
|
56
|
|
Cost of sales
|
793
|
|
|
547
|
|
|
512
|
|
|
460
|
|
||||
Gross loss
|
(747
|
)
|
|
(489
|
)
|
|
(492
|
)
|
|
(404
|
)
|
||||
Operating expenses
|
10,253
|
|
|
6,107
|
|
|
5,699
|
|
|
5,763
|
|
||||
Other income (expense)
|
(3,009
|
)
|
|
4,339
|
|
|
179
|
|
|
2,795
|
|
||||
Net loss
|
$
|
(14,009
|
)
|
|
$
|
(2,257
|
)
|
|
$
|
(6,012
|
)
|
|
$
|
(3,372
|
)
|
Basic net loss per share
|
$
|
(0.35
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.15
|
)
|
|
$
|
(0.08
|
)
|
Diluted net loss per share
|
$
|
(0.35
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(0.17
|
)
|
|
$
|
(0.09
|
)
|
2013 Quarter Ended
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net product sales
|
$
|
26
|
|
|
$
|
62
|
|
|
$
|
68
|
|
|
$
|
44
|
|
Cost of sales
|
2,213
|
|
|
2,104
|
|
|
1,792
|
|
|
1,392
|
|
||||
Gross loss
|
(2,187
|
)
|
|
(2,042
|
)
|
|
(1,724
|
)
|
|
(1,348
|
)
|
||||
Operating expenses
|
3,721
|
|
|
3,777
|
|
|
11,401
|
|
|
4,303
|
|
||||
Other income (expense)
|
1,338
|
|
|
(8,818
|
)
|
|
6,520
|
|
|
(91
|
)
|
||||
Net loss
|
$
|
(4,570
|
)
|
|
$
|
(14,637
|
)
|
|
$
|
(6,605
|
)
|
|
$
|
(5,742
|
)
|
Basic net loss per share
|
$
|
(0.17
|
)
|
|
$
|
(0.63
|
)
|
|
$
|
(0.24
|
)
|
|
$
|
(0.15
|
)
|
Diluted net loss per share
|
$
|
(0.18
|
)
|
|
$
|
(0.63
|
)
|
|
$
|
(0.31
|
)
|
|
$
|
(0.15
|
)
|
EXHIBIT
NO.
|
|
IDENTIFICATION OF EXHIBIT
|
*10.22
|
|
Amendment to Stock Option Agreement by and between the Company and David Pernock dated March 11, 2015
|
*23.1
|
|
Consent of BDO USA, LLP
|
*31.1
|
|
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
*31.2
|
|
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), required under Section 302 of the Sarbanes-Oxley Act of 2002
|
*32.1
|
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
*32.2
|
|
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
*
|
Filed herewith.
|
By:
|
/s/ Kimberly M. Smith
|
|
Name:
|
Kimberly M. Smith
|
|
Its:
|
Interim Chief Financial Officer
|
|
By:
|
/s/ David Pernock
|
|
Name:
|
David Pernock
|
|
/s/ BDO USA, LLP
|
Philadelphia, Pennsylvania
|
March 13, 2015
|
Dated: March 13, 2015
|
|
|
By:
|
/s/ David Pernock
|
|
|
David Pernock
|
|
|
Chief Executive Officer
|
|
Dated: March 13, 2015
|
|
|
By:
|
/s/ Kimberly M. Smith
|
|
|
Kimberly M. Smith
|
|
|
Interim Chief Financial Officer
|
|
By:
|
/s/ David Pernock
|
|
|
David Pernock
|
|
|
Chief Executive Officer
|
|
|
Fibrocell Science, Inc.
|
|
|
By:
|
/s/ Kimberly M. Smith
|
|
|
Kimberly M. Smith
|
|
|
Interim Chief Financial Officer
|
|
|
Fibrocell Science, Inc.
|
|
|