SEC Filings

Form 10-K
KALA PHARMACEUTICALS, INC. filed this Form 10-K on 03/12/2019
Document Outline
Entire Document (7550.1 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - Table of Contents
Page 3 - References to Kala
Page 4 - N/A
Page 5 - Part I
Page 6 - Our Product
Page 7 - Our Product Candidates
Page 8 - rTKI Program for Retinal Diseases
Page 9 - Other Potential Applications of our AMPPLIFY Technology
Page 10 - Our MPP Technology
Page 11 - N/A
Page 12 - LE in Aqueous Humor
Page 13 - LE in Cornea
Page 14 - Our Product and Product Candidates
Page 15 - American Journal of Ophthalmology
Page 16 - Limitations of Existing Treatments for Dry Eye Disease
Page 17 - KPI 121 0.25% Clinical Development Program
Page 18 - N/A
Page 19 - N/A
Page 20 - INVELTYS for Post Operative Inflammation and Pain
Page 21 - Other Preclinical Opportunities for Dry Eye Disease
Page 22 - Retinal Vein Occlusion (RVO)
Page 23 - Potential Applications in Other Diseases
Page 24 - Competition in Inflammation and Pain Following Ocular Surgery
Page 25 - Competition in Retinal Disease
Page 26 - Catalent Commercial Supply Agreement.
Page 27 - Intellectual Property
Page 28 - Trade Secrets
Page 29 - Diligence Obligations
Page 30 - Financial Terms
Page 31 - Approval and Regulation of Drugs in the United States
Page 32 - Preclinical Studies
Page 33 - Expanded Access to an Investigational Drug for Treatment Use
Page 34 - Phase 1
Page 35 - Review and Approval of an NDA
Page 36 - Fast Track, Breakthrough Therapy, Priority Review and Regenerative Advanced Therapy Designations
Page 37 - Accelerated Approval Pathway
Page 38 - Post-Approval Regulation
Page 39 - Section 505(b)(2) NDAs
Page 40 - Hatch-Waxman Patent Certification and the 30-Month Stay
Page 41 - Pediatric Studies and Exclusivity
Page 42 - Orphan Drug Designation and Exclusivity
Page 43 - FDA approval and regulation of companion diagnostics
Page 44 - Health care Law and Regulation
Page 45 - Pharmaceutical Insurance Coverage and Health Care Reform
Page 46 - N/A
Page 47 - N/A
Page 48 - Review and Approval of Medicinal Products in the European Union
Page 49 - Marketing Authorization
Page 50 - N/A
Page 51 - Regulatory Data Protection in the EU
Page 52 - Orphan Drug Designation and Exclusivity
Page 53 - Pricing Decisions for Approved Products
Page 54 - Employees
Page 55 - Item 1A RISK FACTORS
Page 56 - N/A
Page 57 - Our limited operating history may make it difficult for you to evaluate the success of our business
Page 58 - N/A
Page 59 - Raising additional capital may cause dilution to our stockholders, restrict our operations or requir
Page 60 - Our substantial indebtedness may limit cash flow available to invest in the ongoing needs of our bus
Page 61 - N/A
Page 62 - If clinical trials of KPI 121 0.25% or any other product candidate that we develop fail to demonstra
Page 63 - If we experience any of a number of possible unforeseen events in connection with our clinical trial
Page 64 - If we experience delays or difficulties in the enrollment of patients in clinical trials, our receip
Page 65 - If serious adverse or unacceptable side effects are identified during the development or commerciali
Page 66 - We may in the future conduct clinical trials for product candidates at sites outside the United Stat
Page 67 - Even if we are able to commercialize INVELTYS or any product candidate that we may develop, includin
Page 68 - If we are unable to establish sales, marketing and distribution capabilities or enter into sales, ma
Page 69 - N/A
Page 70 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 71 - If our contracted manufacturing facilities experience production issues for any reason, we may be un
Page 72 - Product liability lawsuits against us could divert our resources and could cause us to incur substan
Page 73 - We contract with third parties for the manufacture of INVELTYS and KPI 121 0.25% for commercializati
Page 74 - We may enter into collaborations with third parties for the development or commercialization of our
Page 75 - N/A
Page 76 - If we are not able to establish collaborations, we may have to alter our development and commerciali
Page 77 - Risks Related to Our Intellectual Property
Page 78 - Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecut
Page 79 - We may become involved in lawsuits to protect or enforce our patents or other intellectual property,
Page 80 - Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or ot
Page 81 - INVELTYS, KPI 121 0.25% and certain aspects of our AMPPLIFY technology are protected by patents excl
Page 82 - If we fail to comply with our obligations in our intellectual property licenses and funding arrangem
Page 83 - We may not be able to protect our intellectual property and proprietary rights throughout the world.
Page 84 - Intellectual property litigation or other legal proceedings relating to intellectual property could
Page 85 - If the FDA does not conclude that KPI 121 0.25% satisfies the approval requirements under Section 50
Page 86 - Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates f
Page 87 - The terms of approvals, ongoing regulations and post marketing restrictions for our products may lim
Page 88 - Under the CURES Act and the Trump Administration s regulatory reform initiatives, the FDA s policies
Page 89 - Inadequate funding for the FDA, the Securities and Exchange Commission and other government agencies
Page 90 - Recently enacted and future legislation may affect our ability to commercialize and the prices we ob
Page 91 - N/A
Page 92 - N/A
Page 93 - If we or any third party manufacturers we engage fail to comply with environmental, health and safet
Page 94 - We are subject to anti corruption laws, as well as export control laws, customs laws, sanctions laws
Page 95 - The recently passed comprehensive tax reform bill could adversely affect our business and financial
Page 96 - We have expanded and expect to continue to expand our development, regulatory, commercial and manufa
Page 97 - Provisions in our corporate charter documents and under Delaware law could make an acquisition of ou
Page 98 - An active trading market for our common stock may not be sustained.
Page 99 - Sale of a substantial number of shares of our common stock into the market could cause the market pr
Page 100 - We have incurred and will continue to incur increased costs as a result of operating as a public com
Page 101 - Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable futur
Page 102 - Part II
Page 103 - Use of proceeds from registered securities
Page 104 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations.
Page 105 - N/A
Page 106 - Financial Operations Overview
Page 107 - Selling, General and Administrative Expenses
Page 108 - Interest Expense
Page 109 - Accrued Expenses
Page 110 - Common Stock Valuation
Page 111 - Emerging Growth Company Status
Page 112 - Selling, General and Administrative Expenses
Page 113 - N/A
Page 114 - Cash Flows
Page 115 - Investing Activities
Page 116 - N/A
Page 117 - N/A
Page 118 - Off Balance Sheet Arrangements
Page 119 - Changes in internal control over financial reporting
Page 120 - N/A
Page 121 - Part III
Page 122 - Part IV
Page 123 - N/A
Page 124 - N/A
Page 125 - Item 16. Form 10-K Summary
Page 126 - SIGNATURES
Page 127 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 128 - PART I FINANCIAL INFORMATION
Page 129 - KALA PHARMACEUTICALS, INC.
Page 130 - KALA PHARMACEUTICALS, INC.
Page 131 - KALA PHARMACEUTICALS, INC.
Page 132 - KALA PHARMACEUTICALS, INC.
Page 133 - Note 2: Summary of Significant Accounting Policies
Page 134 - Automatic Conversion of Preferred Stock
Page 135 - Property and Equipment, net
Page 136 - Research and Development Costs
Page 137 - Preferred Stock Warrants
Page 138 - Comprehensive Loss
Page 139 - Compensation Stock Compensation ( Topic 718 ): Scope of Modification Accounting (
Page 140 - Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement
Page 141 - Note 5: Inventory
Page 142 - N/A
Page 143 - Note 8: Debt
Page 144 - Athyrium Credit Facility
Page 145 - N/A
Page 146 - Note 9: Warrants
Page 147 - Note 11: Preferred Stock
Page 148 - Series Seed Convertible Preferred Stock
Page 149 - Series C Convertible Preferred Stock
Page 150 - Conversion
Page 151 - Liquidation Rights
Page 152 - Employee Stock Purchase Plan
Page 153 - Note 14: Income Taxes
Page 154 - N/A
Page 155 - Note 15: Commitments and Contingencies
Page 156 - Other Commitments
Page 157 - Note 18: Selected Quarterly Financial Data
Subdocument 2 - EX-10.3 - EX-10.3
Page 1 - Exhibit 10.3
Page 2 - Offerings
Page 3 - Interest
Page 4 - Return of Unused Payroll Deductions
Page 5 - Reorganization Events
Page 6 - Amendment of the Plan
Page 7 - Authorization of Sub-Plans
Subdocument 3 - EX-10.30 - EX-10.30
Page 1 - Exhibit 10.30
Page 2 - Exhibit [A/B]
Page 3 - Excise TaxFull PaymentReduced PaymentAcquisition
Page 4 - Post Change in Control Reasonable Compensation
Page 5 - COMPANY:
Subdocument 4 - EX-21.1 - EX-21.1
Page 1 - N/A
Subdocument 5 - EX-23.1 - EX-23.1
Page 1 - N/A
Subdocument 6 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 7 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 8 - EX-32.1 - EX-32.1
Page 1 - N/A
Subdocument 9 - EX-32.2 - EX-32.2
Page 1 - N/A
XBRL Item - EX-101.INS - EX-101.INS (What's this?)
XBRL Item - EX-101.SCH - EX-101.SCH (What's this?)
XBRL Item - EX-101.CAL - EX-101.CAL (What's this?)
XBRL Item - EX-101.DEF - EX-101.DEF (What's this?)
XBRL Item - EX-101.LAB - EX-101.LAB (What's this?)
XBRL Item - EX-101.PRE - EX-101.PRE (What's this?)
XBRL Viewer