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Form 10-K
FIBROCELL SCIENCE, INC. filed this Form 10-K on 03/27/2019
Document Outline
Entire Document (5784.9 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Page 2 - DOCUMENTS INCORPORATED BY REFERENCE
Page 3 - TABLE OF CONTENTS
Page 4 - NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 5 - N/A
Page 6 - Part I
Page 7 - N/A
Page 8 - Our Strategy
Page 9 - Reduced rejection and immunogenicity concerns
Page 10 - Development Programs
Page 11 - Phase 1/2 Trial of FCX-007 for RDEB
Page 12 - Proposed Phase 3 Trial Design
Page 13 - FCX-013 for Moderate to Severe Localized Scleroderma
Page 14 - Gene Therapy Research Program for Arthritis and Related Conditions
Page 15 - 2015 Exclusive Channel Collaboration Agreement
Page 16 - Manufacturing
Page 17 - Government Regulation
Page 18 - Domestic Regulation
Page 19 - N/A
Page 20 - N/A
Page 21 - Orphan Drug Designation
Page 22 - Rare Pediatric Disease Designation
Page 23 - Biosimilars
Page 24 - HIPAA Requirements
Page 25 - N/A
Page 26 - N/A
Page 27 - International Regulation
Page 28 - Item 1A. Risk Factors
Page 29 - We have incurred significant losses since our inception and anticipate that we will continue to incu
Page 30 - We do not generate significant revenues from product sales and may never be profitable.
Page 31 - Our failure to comply with the restrictive covenants or other terms of our outstanding convertible n
Page 32 - Provisions of the Notes and certain of our outstanding common stock purchase warrants provide for ce
Page 33 - N/A
Page 34 - If our stockholders equity falls below $2.5 million, our common stock may be subject to delisting fr
Page 35 - If our common stock becomes subject to the penny stock rules, it would become more difficult to trad
Page 36 - Risks Related to Clinical Development, Regulatory Approval and Commercialization of Our Product Cand
Page 37 - In previous clinical trials conducted by sponsors other than us involving viral vectors for gene the
Page 38 - If physicians do not follow our established protocols, the efficacy and safety of our product candid
Page 39 - If we fail to obtain the necessary regulatory approvals, or if such approvals are limited, we will n
Page 40 - N/A
Page 41 - We are subject to significant regulation with respect to the manufacturing of our product candidates
Page 42 - We are largely dependent on the future commercial success of our product candidates.
Page 43 - If the market opportunities for our product candidates are smaller than we believe they are, our res
Page 44 - We may be liable for product liability claims not covered by insurance.
Page 45 - We may not be able to retain the exclusive rights licensed to us by Intrexon to develop and commerci
Page 46 - We receive vectors from our contract manufacturers, but the majority of our research, development an
Page 47 - Third parties may initiate legal proceedings alleging that we are infringing their intellectual prop
Page 48 - Patent terms may be inadequate to protect our competitive position on our product candidates for an
Page 49 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 50 - We may be subject to claims by third parties asserting that our licensors, employees or we have misa
Page 51 - We may need to attract, train and retain additional experienced executives and other key professiona
Page 52 - N/A
Page 53 - If we fail to comply with environmental, health and safety laws and regulations, we could become sub
Page 54 - Risks Related to Ownership of our Common Stock
Page 55 - Randal J. Kirk and certain of his affiliates (including Intrexon) own a substantial percentage of ou
Page 56 - Future sales of our common stock may depress our stock price.
Page 57 - Provisions in our bylaws provide for indemnification of officers and directors, which could require
Page 58 - Part II
Page 59 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 60 - Gene Therapy Research Program for Arthritis and Related Conditions
Page 61 - Critical Accounting Policies
Page 62 - Results of Operations
Page 63 - Selling, General and Administrative Expenses
Page 64 - Interest Expense
Page 65 - Financial Condition, Liquidity and Capital Resources
Page 66 - 2017 Series A Preferred Stock Offering
Page 67 - Risks Related to Our Financial Position and Need for Additional Capital
Page 68 - 2016 Private Placement
Page 69 - Recently Issued Accounting Pronouncements
Page 70 - Changes in Internal Control over Financial Reporting
Page 71 - Part III
Page 72 - Part IV
Page 73 - N/A
Page 74 - Item 16. Form 10-K Summary
Page 75 - SIGNATURES
Page 76 - Fibrocell Science, Inc.
Page 77 - Report of Independent Registered Public Accounting Firm
Page 78 - Fibrocell Science, Inc.
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Page 105 - Note 11. Income Taxes
Page 106 - Fibrocell Science, Inc.
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Page 111 - Fibrocell Science, Inc.
Subdocument 2 - EX-21 - EXHIBIT 21
Page 1 - N/A
Subdocument 3 - EX-23 - EXHIBIT 23
Page 1 - N/A
Subdocument 4 - EX-31 - EXHIBIT 31
Page 1 - N/A
Subdocument 5 - EX-32 - EXHIBIT 32
Page 1 - N/A
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