SEC Filings

Form S-1/A
AVEXIS, INC. filed this Form S-1/A on 02/09/2016
Document Outline
Entire Document (3642.9 KB)
Subdocument 1 - S-1/A - S-1/A
Page 1 - As filed with the Securities and Exchange Commission on February 9, 2016
Page 2 - The information in this preliminary prospectus is not complete and may be changed. These securities
Page 3 - TABLE OF CONTENTS
Page 4 - PROSPECTUS SUMMARY
Page 5 - Our Product Candidate AVXS-101
Page 6 - in vivo
Page 7 - Recent Developments
Page 8 - N/A
Page 9 - Implications of Being an Emerging Growth Company
Page 10 - The Offering
Page 11 - N/A
Page 12 - Summary Consolidated Financial Data
Page 13 - N/A
Page 14 - RISK FACTORS
Page 15 - We have never generated revenue from product sales and may never be profitable.
Page 16 - Our limited operating history may make it difficult for you to evaluate the success of our business
Page 17 - N/A
Page 18 - Risks related to the development of our current product candidate
Page 19 - AVXS-101 is based on a novel technology, which makes it difficult to predict the time and cost of de
Page 20 - Success in preclinical studies or early clinical trials, including in our ongoing Phase 1 clinical t
Page 21 - We may find it difficult to enroll patients in our clinical trials, which could delay or prevent us
Page 22 - Because the number of subjects in our clinical trial to date is small and have all been treated at o
Page 23 - We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and
Page 24 - As we evaluate and develop manufacturing process improvements to AVXS-101, we may be required to con
Page 25 - AVXS-101 may cause undesirable side effects or have other properties that could delay or prevent its
Page 26 - As an organization, we are in the process of conducting our first Phase 1 clinical trial, and have n
Page 27 - If our competitors are able to obtain orphan drug exclusivity for products that constitute the same
Page 28 - Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain reg
Page 29 - We face significant competition in an environment of rapid technological change and the possibility
Page 30 - Even if we obtain and maintain approval for AVXS-101 from the FDA, we may never obtain approval for
Page 31 - Risks related to our reliance on third parties
Page 32 - We may in the future enter into collaborations with third parties to develop AVXS-101. If these coll
Page 33 - We may not be successful in finding strategic collaborators for continuing development of AVXS-101 o
Page 34 - Our reliance on third parties requires us to share our trade secrets, which increases the possibilit
Page 35 - N/A
Page 36 - To the extent we rely on a third-party manufacturing facility for commercial supply, that third part
Page 37 - Risks related to the commercialization of AVXS-101
Page 38 - If we are unable to establish sales, medical affairs and marketing capabilities or enter into agreem
Page 39 - The commercial success of AVXS-101 will depend upon its degree of market acceptance by physicians, p
Page 40 - Delays in obtaining regulatory approval of our manufacturing process and facility or disruptions in
Page 41 - Failure to comply with ongoing regulatory requirements could cause us to suspend production or put i
Page 42 - The insurance coverage and reimbursement status of newly-approved products is uncertain. Failure to
Page 43 - If we obtain approval to commercialize AVXS-101 outside of the United States, in particular in the E
Page 44 - Interruptions in the supply of product or inventory loss may adversely affect our operating results
Page 45 - Risks related to our business operations
Page 46 - Our future success depends on our ability to retain key employees, consultants and advisors and to a
Page 47 - If we are unable to manage expected growth in the scale and complexity of our operations, our perfor
Page 48 - Healthcare legislative reform measures may have a material adverse effect on our business and result
Page 49 - Our relationships with customers, physicians, and third-party payors will be subject, directly or in
Page 50 - N/A
Page 51 - Product liability lawsuits against us could cause us to incur substantial liabilities and could limi
Page 52 - Third parties on which we rely and we may be adversely affected by natural disasters and our busines
Page 53 - Risks related to our intellectual property
Page 54 - If we are unable to obtain and maintain patent protection for our current product candidate, any fut
Page 55 - N/A
Page 56 - N/A
Page 57 - Our intellectual property licenses with third parties may be subject to disagreements over contract
Page 58 - We may not be successful in obtaining necessary rights to AVXS-101 through acquisitions and in-licen
Page 59 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 60 - We may not be able to protect our intellectual property rights throughout the world.
Page 61 - Issued patents covering AVXS-101 could be found invalid or unenforceable if challenged in court. We
Page 62 - Third parties may initiate legal proceedings alleging that we are infringing their intellectual prop
Page 63 - Intellectual property litigation could cause us to spend substantial resources and distract our pers
Page 64 - We may be subject to claims asserting that our employees, consultants or advisors have wrongfully us
Page 65 - N/A
Page 66 - If we do not obtain patent term extension for AVXS-101, our business may be materially harmed.
Page 67 - Intellectual property rights and regulatory exclusivity rights do not necessarily address all potent
Page 68 - N/A
Page 69 - After this offering, our executive officers, directors and principal stockholders will maintain the
Page 70 - If you purchase shares of common stock in this offering, you will suffer immediate dilution of your
Page 71 - An active trading market for our common stock may not develop.
Page 72 - If we engage in future acquisitions or strategic partnerships, this may increase our capital require
Page 73 - We will incur increased costs as a result of operating as a public company, and our management will
Page 74 - Provisions in our corporate charter documents and under Delaware law could make an acquisition of us
Page 75 - Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be
Page 76 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 77 - INDUSTRY AND OTHER DATA
Page 78 - USE OF PROCEEDS
Page 79 - DIVIDEND POLICY
Page 80 - CAPITALIZATION
Page 81 - N/A
Page 82 - DILUTION
Page 83 - N/A
Page 84 - N/A
Page 85 - SELECTED CONSOLIDATED FINANCIAL DATA
Page 86 - N/A
Page 87 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Page 88 - Licensing Agreements
Page 89 - Asklepios Biopharmaceutical, Inc.
Page 90 - General and Administrative Expense
Page 91 - Critical Accounting Policies and Significant Judgments and Estimates
Page 92 - Equity-Based Payments to Non-Employees
Page 93 - N/A
Page 94 - Determination of the Fair Value of Stock-Based Compensation Grants
Page 95 - Common Stock Valuation Methodology
Page 96 - Tax Indemnity
Page 97 - Emerging Growth Company Status
Page 98 - Determining Whether the Host Contract in a Hybrid Financial Instrument Issued in the Form of a Share
Page 99 - Research and Development
Page 100 - Comparison of the Years Ended December 31, 2013 and 2014
Page 101 - Interest Expense
Page 102 - Cash Flows
Page 103 - Investing Activities
Page 104 - N/A
Page 105 - Contractual Obligations, Commitments and Contingencies
Page 106 - Off-Balance Sheet Arrangements
Page 107 - BUSINESS
Page 108 - in vivo
Page 109 - Our Strategy
Page 110 - Continue to invest in and develop robust and sustainable manufacturing processes and multiple supply
Page 111 - N/A
Page 112 - SMA Type 1
Page 113 - Existing Treatments for SMA
Page 114 - A recombinant AAV9 capsid shell
Page 115 - Preliminary Clinical Results
Page 116 - N/A
Page 117 - N/A
Page 118 - Preclinical Studies
Page 119 - Future SMA Type 1 Clinical Development
Page 120 - Competition
Page 121 - Licensed patents and patent applications
Page 122 - N/A
Page 123 - The Research Institute at Nationwide Children's Hospital
Page 124 - REGENXBIO
Page 125 - Asklepios Biopharmaceutical, Inc.
Page 126 - Government Regulation and Product Approval
Page 127 - U.S. Biologic Products Development Process
Page 128 - Human Clinical Trials Under an IND
Page 129 - Phase 1.
Page 130 - Additional Regulation for Gene Therapy Clinical Trials
Page 131 - N/A
Page 132 - Orphan Drug Designation
Page 133 - Breakthrough therapy designation.
Page 134 - U.S. Patent Term Restoration and Marketing Exclusivity
Page 135 - Other Healthcare Laws and Regulations
Page 136 - Coverage and Reimbursement
Page 137 - Health Reform
Page 138 - Additional Regulation
Page 139 - Employees
Page 140 - MANAGEMENT
Page 141 - Thomas J. Dee
Page 142 - Andrew F. Knudten
Page 143 - Jonathan Leff
Page 144 - Board Composition and Election of Directors
Page 145 - Director Independence
Page 146 - N/A
Page 147 - Compensation Committee
Page 148 - Nominating and Corporate Governance Committee
Page 149 - Compensation Committee Interlocks and Insider Participation
Page 150 - Director Compensation Table
Page 151 - N/A
Page 152 - EXECUTIVE COMPENSATION
Page 153 - Narrative to Summary Compensation Table
Page 154 - Annual Base Salary
Page 155 - Exchange Agreement
Page 156 - Outstanding Equity Awards at December 31, 2015
Page 157 - Employment Agreements
Page 158 - Mr. Dee
Page 159 - Mr. Knudten
Page 160 - Mr. Nolan
Page 161 - Mr. Knudten
Page 162 - Limits.
Page 163 - Tax Limitations on Incentive Stock Options.
Page 164 - Stock Appreciation Rights.
Page 165 - N/A
Page 166 - Other Stock Awards.
Page 167 - Amended and Restated 2014 Stock Plan
Page 168 - Change in Control
Page 169 - Other Terms
Page 170 - CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
Page 171 - Our Relationships with Nationwide Children's Hospital and Ohio State University
Page 172 - Transactions with BioLife Dallas
Page 173 - Transactions with White Rock Capital Partners, L.P.
Page 174 - Class C Preferred Stock Financing
Page 175 - Class D Preferred Stock Financing
Page 176 - REGENXBIO Exclusive License Agreement
Page 177 - Policies and Procedures for Transactions with Related Persons
Page 178 - PRINCIPAL STOCKHOLDERS
Page 179 - N/A
Page 180 - N/A
Page 181 - DESCRIPTION OF CAPITAL STOCK
Page 182 - Preferred Stock
Page 183 - Registration Rights
Page 184 - Certificate of Incorporation and Bylaws to be in Effect Upon the Completion of this Offering
Page 185 - Choice of Forum
Page 186 - Transfer Agent and Registrar
Page 187 - SHARES ELIGIBLE FOR FUTURE SALE
Page 188 - Non-Affiliates
Page 189 - Form S-8 Registration Statements
Page 190 - MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS
Page 191 - Distributions on Our Common Stock
Page 192 - Information Reporting Requirements and Backup Withholding
Page 193 - N/A
Page 194 - UNDERWRITING
Page 195 - N/A
Page 196 - Selling Restrictions
Page 197 - United Kingdom
Page 198 - Japan
Page 199 - Notice to Prospective Investors in Chile
Page 200 - LEGAL MATTERS
Page 201 - AveXis, Inc.
Page 202 - Report of Independent Registered Public Accounting Firm
Page 203 - Consolidated Balance Sheets
Page 204 - Consolidated Balance Sheets (Continued)
Page 205 - N/A
Page 206 - AveXis, Inc.
Page 207 - N/A
Page 208 - Notes to Consolidated Financial Statements
Page 209 - Notes to Consolidated Financial Statements (Continued)
Page 210 - Notes to Consolidated Financial Statements (Continued)
Page 211 - Notes to Consolidated Financial Statements (Continued)
Page 212 - Notes to Consolidated Financial Statements (Continued)
Page 213 - Notes to Consolidated Financial Statements (Continued)
Page 214 - Notes to Consolidated Financial Statements (Continued)
Page 215 - Notes to Consolidated Financial Statements (Continued)
Page 216 - Notes to Consolidated Financial Statements (Continued)
Page 217 - Notes to Consolidated Financial Statements (Continued)
Page 218 - Notes to Consolidated Financial Statements (Continued)
Page 219 - Notes to Consolidated Financial Statements (Continued)
Page 220 - Notes to Consolidated Financial Statements (Continued)
Page 221 - Notes to Consolidated Financial Statements (Continued)
Page 222 - Notes to Consolidated Financial Statements (Continued)
Page 223 - Notes to Consolidated Financial Statements (Continued)
Page 224 - Notes to Consolidated Financial Statements (Continued)
Page 225 - Notes to Consolidated Financial Statements (Continued)
Page 226 - Notes to Consolidated Financial Statements (Continued)
Page 227 - Notes to Consolidated Financial Statements (Continued)
Page 228 - Notes to Consolidated Financial Statements (Continued)
Page 229 - Notes to Consolidated Financial Statements (Continued)
Page 230 - Notes to Consolidated Financial Statements (Continued)
Page 231 - Notes to Consolidated Financial Statements (Continued)
Page 232 - Notes to Consolidated Financial Statements (Continued)
Page 233 - Notes to Consolidated Financial Statements (Continued)
Page 234 - Notes to Consolidated Financial Statements (Continued)
Page 235 - Notes to Consolidated Financial Statements (Continued)
Page 236 - Notes to Consolidated Financial Statements (Continued)
Page 237 - Notes to Consolidated Financial Statements (Continued)
Page 238 - Notes to Consolidated Financial Statements (Continued)
Page 239 - Notes to Consolidated Financial Statements (Continued)
Page 240 - Notes to Consolidated Financial Statements (Continued)
Page 241 - Notes to Consolidated Financial Statements (Continued)
Page 242 - Notes to Consolidated Financial Statements (Continued)
Page 243 - Notes to Consolidated Financial Statements (Continued)
Page 244 - Notes to Consolidated Financial Statements (Continued)
Page 245 - Notes to Consolidated Financial Statements (Continued)
Page 246 - Notes to Consolidated Financial Statements (Continued)
Page 247 - Notes to Consolidated Financial Statements (Continued)
Page 248 - Notes to Consolidated Financial Statements (Continued)
Page 249 - Notes to Consolidated Financial Statements (Continued)
Page 250 - Notes to Consolidated Financial Statements (Continued)
Page 251 - Notes to Consolidated Financial Statements (Continued)
Page 252 - Notes to Consolidated Financial Statements (Continued)
Page 253 - AveXis, Inc.
Page 254 - Part II
Page 255 - Item 15. Recent Sales of Unregistered Securities.
Page 256 - N/A
Page 257 - Stock Option Grants
Page 258 - N/A
Page 259 - SIGNATURES
Page 260 - N/A
Page 261 - Exhibit Index
Page 262 - N/A
Subdocument 2 - EX-3.1 - EX-3.1
Page 1 - Exhibit 3.1
Page 2 - Class A Common Stock
Page 3 - RIGHTS PREFERENCES, PRIVILEGES AND RESTRICTIONS OF COMMON STOCK, CLASS B COMMON STOCK, CLASS C COMMO
Page 4 - Class B Original Issue Price
Page 5 - Class D Protective Provisions
Page 6 - Roche
Page 7 - Class B Protective Provisions
Page 8 - Conversion of Class B Common Stock, Class C Common Stock and Class D Common Stock
Page 9 - Fractional Shares
Page 10 - Converted Shares
Page 11 - SEVENTH
Page 12 - Person
Page 13 - IN WITNESS WHEREOF, this Fourth Amended and Restated Certificate of Incorporation has been executed
Subdocument 3 - EX-4.1 - EX-4.1
Page 1 - Exhibit 4.1
Page 2 - THE CORPORATION WILL FURNISH TO ANY STOCKHOLDER, UPON REQUEST AND WITHOUT CHARGE, A FULL STATEMENT O
Subdocument 4 - EX-5.1 - EX-5.1
Page 1 - EXHIBIT 5.1
Subdocument 5 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Print Page    E-mail Page