Form 10-K
OCULAR THERAPEUTIX, INC filed this Form 10-K on 03/07/2019
Document Outline
Entire Document (8640.3 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - FORWARD-LOOKING STATEMENTS
Page 4 - N/A
Page 5 - PART I
Page 6 - DEXTENZA (dexamethasone ophthalmic insert)
Page 7 - OTX-TIC (intracanalicular travoprost implant)
Page 8 - ReSure Sealant
Page 9 - Additional Potential Areas for Growth
Page 10 - Our Strategy
Page 11 - N/A
Page 12 - Eye Disease
Page 13 - Post-Surgical Ocular Pain and Inflammation
Page 14 - Market Data
Page 15 - Back-of-the-Eye Diseases and Conditions
Page 16 - Ocular Wound Closure
Page 17 - Intracanalicular Insert-Based Local Programmed-Release Therapies for Front-of-the-Eye Diseases and C
Page 18 - N/A
Page 19 - N/A
Page 20 - Anticipated Benefits of Our Intracanalicular Inserts Compared to Eye Drops
Page 21 - ReSure Sealant for Ocular Wound Closure
Page 22 - Development Pipeline and Marketed Products
Page 23 - Dexamethasone Intracanalicular Insert
Page 24 - Overview of DEXTENZA Clinical Development
Page 25 - Clinical Trials for Post-Surgical Ocular Pain and Inflammation
Page 26 - Efficacy:
Page 27 - Safety:
Page 28 - Completed Phase 3 Clinical Trials
Page 29 - Safety:
Page 30 - Regulatory Pathway
Page 31 - Efficacy:
Page 32 - Efficacy:
Page 33 - Second Phase 3 Clinical Trial
Page 34 - Regulatory Pathway
Page 35 - Travoprost Intracanalicular Insert (OTX-TP)
Page 36 - Overview of OTX-TP Clinical Development
Page 37 - Efficacy:
Page 38 - Safety:
Page 39 - Efficacy:
Page 40 - Safety:
Page 41 - Efficacy:
Page 42 - Clinical and Experimental OptometryAmerican Journal of OphthalmologyActa Ophthalmologica Scandinavic
Page 43 - Regulatory Pathway
Page 44 - Intravitreal Implants for the Treatment of Back-of-the-Eye Diseases
Page 45 - in vivo
Page 46 - Pivotal Clinical Trial
Page 47 - Post-Approval Studies
Page 48 - Foreign Approvals
Page 49 - Manufacturing
Page 50 - Intracanalicular Insert and Intracameral Implant Product Candidates
Page 51 - Licenses
Page 52 - Patent Prosecution and Litigation.
Page 53 - Competition
Page 54 - Competitors of our Intracanalicular Insert Product Candidates
Page 55 - Government Regulation
Page 56 - The IND and IRB Processes
Page 57 - Expanded Access to an Investigational Drug for Treatment Use
Page 58 - in vitro
Page 59 - Accelerated Approval Pathway
Page 60 - The FDA s Decision on an Application
Page 61 - Section 505(b)(2) NDAs
Page 62 - Abbreviated New Drug Applications for Generic Drugs
Page 63 - Hatch-Waxman Patent Certification and the 30-Month Stay
Page 64 - Pediatric Studies and Exclusivity
Page 65 - Review and Approval of Medical Devices in the United States
Page 66 - de novode novo
Page 67 - Investigational Device Exemption
Page 68 - Review and Approval of Combination Products in the United States
Page 69 - Review and Approval of Drug Products in the European Union
Page 70 - Regulatory Data Protection in the European Union
Page 71 - Regulatory Requirements after a Marketing Authorization has been Obtained
Page 72 - Brexit and the Regulatory Framework in the United Kingdom
Page 73 - General Data Protection Regulation
Page 74 - Healthcare Law and Regulation
Page 75 - Healthcare Reform
Page 76 - N/A
Page 77 - Employees
Page 78 - Item 1A.Risk Factors
Page 79 - N/A
Page 80 - We will need substantial additional funding. If we are unable to raise capital when needed, we could
Page 81 - We have included a paragraph relating to our ability to continue as a going concern in the footnotes
Page 82 - Raising additional capital may cause dilution to our stockholders, restrict our operations or requir
Page 83 - Our limited operating history may make it difficult for our stockholders to evaluate the success of
Page 84 - If clinical trials of our intracanalicular insert product candidates or any other product candidate
Page 85 - N/A
Page 86 - N/A
Page 87 - We have conducted, and may in the future conduct, clinical trials for product candidates at sites ou
Page 88 - If we experience delays or difficulties in the enrollment of patients in clinical trials, our receip
Page 89 - If serious adverse or unacceptable side effects are identified during the development or commerciali
Page 90 - We may not be successful in our efforts to develop products and product candidates based on our bior
Page 91 - Risks Related to Manufacturing
Page 92 - If our sole clinical manufacturing facility is damaged or destroyed or production at this facility i
Page 93 - Risks Related to Commercialization
Page 94 - If we are unable to establish and maintain adequate sales, marketing and distribution capabilities,
Page 95 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 96 - DEXTENZA, ReSure Sealant and any product candidates for which we obtain marketing approval may becom
Page 97 - Product liability lawsuits against us could cause us to incur substantial liabilities and to limit c
Page 98 - Risks Related to Our Dependence on Third Parties
Page 99 - We have entered into collaborations with third parties to develop certain product candidates, and in
Page 100 - If we are not able to establish additional collaborations, we may have to alter our development and
Page 101 - Although the majority of our clinical development is administered and managed by our own employees,
Page 102 - N/A
Page 103 - inter partes
Page 104 - We may become involved in lawsuits to protect or enforce our licensed patents or other intellectual
Page 105 - If we fail to comply with our obligations in our intellectual property licenses and funding arrangem
Page 106 - We may be subject to claims by third parties asserting that our employees or we have misappropriated
Page 107 - Risks Related to Regulatory Approval and Marketing of Our Product Candidates and Other Legal Complia
Page 108 - Failure to obtain marketing approval in foreign jurisdictions would prevent our products or product
Page 109 - We may be subject to substantial penalties if we fail to comply with regulatory requirements or if w
Page 110 - Our relationships with healthcare providers, physicians and third-party payors will be subject, dire
Page 111 - N/A
Page 112 - Under the Cures Act and the Trump Administration s regulatory reform initiatives, the FDA s policies
Page 113 - Current and future legislation may increase the difficulty and cost for us and any current or future
Page 114 - N/A
Page 115 - N/A
Page 116 - Governments outside the United States tend to impose strict price controls, which may adversely affe
Page 117 - If we, our collaborators or any third-party manufacturers we engage in the future fail to comply wit
Page 118 - We might not be able to utilize a significant portion of our net operating loss carryforwards and re
Page 119 - Our internal computer systems, or those of our collaborators or other contractors or consultants, ma
Page 120 - We are currently subject to legal actions and proceedings related to the decline in our stock price,
Page 121 - An active trading market for our common stock may not be sustained.
Page 122 - Sales of a substantial number of shares of our common stock in the public market could cause our sto
Page 123 - We incur increased costs as a result of operating as a public company, and our management is now req
Page 124 - Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable futur
Page 125 - Shareholder Derivative Litigation
Page 126 - Brian Robinson v. Sawhney et al.
Page 127 - PART II
Page 128 - Item 6. Selected Financial Data
Page 129 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 130 - OTX-TP (intracanaliculartravoprost insert)
Page 131 - OTX-TKI (intravitreal tyrosine kinase inhibitor implant)
Page 132 - ReSure Sealant
Page 133 - N/A
Page 134 - Financial Operations Overview
Page 135 - N/A
Page 136 - General and Administrative Expenses
Page 137 - Revenue Recognition
Page 138 - Stock-Based Compensation
Page 139 - JOBS Act; Smaller Reporting Company Status
Page 140 - Results of Operations
Page 141 - Research and Development Expenses
Page 142 - General and Administrative Expenses
Page 143 - Research and Development Expenses
Page 144 - General and Administrative Expenses
Page 145 - Cash Flows
Page 146 - Investing activities.
Page 147 - N/A
Page 148 - N/A
Page 149 - Contractual Obligations and Commitments
Page 150 - N/A
Page 151 - N/A
Page 152 - Off-Balance Sheet Arrangements
Page 153 - Management s Annual Report on Internal Control Over Financial Reporting
Page 154 - PART III
Page 155 - Item 13. Certain Relationships and Related Transactions, and Director Independence
Page 156 - PART IV
Page 157 - EXHIBIT INDEX
Page 158 - N/A
Page 159 - N/A
Page 160 - N/A
Page 161 - SIGNATURES
Page 162 - OCULAR THERAPEUTIX, INC.
Page 163 - Report of Independent Registered Public Accounting Firm
Page 164 - OCULAR THERAPEUTIX, INC.
Page 165 - OCULAR THERAPEUTIX, INC.
Page 166 - OCULAR THERAPEUTIX, INC.
Page 167 - OCULAR THERAPEUTIX, INC.
Page 168 - OCULAR THERAPEUTIX, INC.
Page 169 - 2. Summary of Significant Accounting Policies
Page 170 - Inventory Valuation
Page 171 - Fair Value Measurements
Page 172 - Research Contract Costs and Accruals
Page 173 - Segment Data
Page 174 - Recently Adopted Accounting Pronouncements
Page 175 - Recently Issued Accounting Pronouncements
Page 176 - 4. Property and Equipment, net
Page 177 - 7. Notes Payable
Page 178 - 8. Warrants
Page 179 - 11. Stock-Based Awards
Page 180 - Stock Option Valuation
Page 181 - Restricted Common Stock
Page 182 - Intellectual Property Licenses
Page 183 - Indemnification Agreements
Page 184 - Dylan Caraker v. Ocular Therapeutix, Inc., et al.Gallagher
Page 185 - Angel Madera v. Sawhney et al.CorwinAngel Madera v. Sawhney et al.MaderaCorwin Madera
Page 186 - Corwin
Page 187 - Income Taxes
Page 188 - 15. 401(k) Savings Plan
Page 189 - 17. Restructuring and Other Costs
Page 190 - 18. Selected Quarterly Financial Data (Unaudited)
Page 191 - Amendment to Existing Amended Credit Facility
Page 192 - Subordination Agreement
Subdocument 2 - EX-4.2 - EX-4.2
Page 1 - Exhibit 4.2
Page 2 - Registration Statement
Page 3 - Allowed Delay
Page 4 - Company Obligations
Page 5 - N/A
Page 6 - Obligations of the Purchasers
Page 7 - Indemnification
Page 8 - Conduct of Indemnification Proceedings
Page 9 - Miscellaneous
Page 10 - Counterparts
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - SCHEDULE A
Page 15 - EXHIBIT A
Page 16 - N/A
Page 17 - N/A
Subdocument 3 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 4 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 5 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 6 - EX-32.1 - EX-32.1
Page 1 - N/A
Subdocument 7 - EX-32.2 - EX-32.2
Page 1 - N/A
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