SEC Filings

Form 10-Q
KALA PHARMACEUTICALS, INC. filed this Form 10-Q on 05/09/2019
Document Outline
Entire Document (3585.7 KB)
Subdocument 1 - 10-Q - 10-Q
Page 1 - UNITED STATES
Page 2 - TABLE OF CONTENTS
Page 3 - PART I FINANCIAL INFORMATION
Page 4 - KALA PHARMACEUTICALS, INC.
Page 5 - KALA PHARMACEUTICALS, INC.
Page 6 - KALA PHARMACEUTICALS, INC.
Page 7 - KALA PHARMACEUTICALS, INC.
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Page 23 - Item 2. Management s Discussion and Analysis of Financial Condition and Results of Operations.
Page 24 - N/A
Page 25 - Financial Operations Overview
Page 26 - Research and Development Expenses
Page 27 - Critical Accounting Policies and Significant Judgments and Estimates
Page 28 - Selling, general and administrative expenses
Page 29 - Liquidity and Capital Resources
Page 30 - Cash Flows
Page 31 - Funding Requirements
Page 32 - N/A
Page 33 - Off Balance Sheet Arrangements
Page 34 - Item 3.Quantitative and Qualitative Disclosures About Market Risk.
Page 35 - Item 1A RISK FACTORS
Page 36 - N/A
Page 37 - Our limited operating history may make it difficult for you to evaluate the success of our business
Page 38 - We may need substantial additional funding. If we are unable to raise capital when needed, we could
Page 39 - Raising additional capital may cause dilution to our stockholders, restrict our operations or requir
Page 40 - Our substantial indebtedness may limit cash flow available to invest in the ongoing needs of our bus
Page 41 - Risks Related to Product Development
Page 42 - If clinical trials of KPI 121 0.25% or any other product candidate that we develop fail to demonstra
Page 43 - If we experience any of a number of possible unforeseen events in connection with our clinical trial
Page 44 - If we experience delays or difficulties in the enrollment of patients in clinical trials, our receip
Page 45 - If serious adverse or unacceptable side effects are identified during the development or commerciali
Page 46 - We may expend our limited resources to pursue a particular product candidate or indication and fail
Page 47 - N/A
Page 48 - Even if we are able to commercialize INVELTYS or any product candidate that we may develop, includin
Page 49 - If we are unable to establish sales, marketing and distribution capabilities or enter into sales, ma
Page 50 - We face substantial competition, which may result in others discovering, developing or commercializi
Page 51 - If our contracted manufacturing facilities experience production issues for any reason, we may be un
Page 52 - Product liability lawsuits against us could divert our resources and could cause us to incur substan
Page 53 - Risks Related to Our Dependence on Third Parties
Page 54 - N/A
Page 55 - We may enter into collaborations with third parties for the development or commercialization of our
Page 56 - If we are not able to establish collaborations, we may have to alter our development and commerciali
Page 57 - Risks Related to Our Intellectual Property
Page 58 - Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecut
Page 59 - We may become involved in lawsuits to protect or enforce our patents or other intellectual property,
Page 60 - Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or ot
Page 61 - INVELTYS, KPI 121 0.25% and certain aspects of our AMPPLIFY technology are protected by patents excl
Page 62 - If we fail to comply with our obligations in our intellectual property licenses and funding arrangem
Page 63 - We may not be able to protect our intellectual property and proprietary rights throughout the world.
Page 64 - Intellectual property litigation or other legal proceedings relating to intellectual property could
Page 65 - If the FDA does not conclude that KPI 121 0.25% satisfies the approval requirements under Section 50
Page 66 - Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates f
Page 67 - The terms of approvals, ongoing regulations and post marketing restrictions for our products may lim
Page 68 - Under the CURES Act and the Trump Administration s regulatory reform initiatives, the FDA s policies
Page 69 - Inadequate funding for the FDA, the Securities and Exchange Commission and other government agencies
Page 70 - N/A
Page 71 - Recently enacted and future legislation may affect our ability to commercialize and the prices we ob
Page 72 - N/A
Page 73 - N/A
Page 74 - If we or any third party manufacturers we engage fail to comply with environmental, health and safet
Page 75 - The recently passed comprehensive tax reform bill could adversely affect our business and financial
Page 76 - Risks Related to Employee Matters and Managing Growth
Page 77 - Our internal computer systems, or those of our contractors or consultants, may fail or suffer securi
Page 78 - An active trading market for our common stock may not be sustained.
Page 79 - Sale of a substantial number of shares of our common stock into the market could cause the market pr
Page 80 - We are an emerging growth company and a smaller reporting company , and the reduced disclosure requi
Page 81 - We have incurred and will continue to incur increased costs as a result of operating as a public com
Page 82 - Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Page 83 - Item 6. Exhibits
Page 84 - SIGNATURES
Subdocument 2 - EX-10.1 - EX-10.1
Page 1 - Exhibit 10.1
Page 2 - Offerings
Page 3 - Interest
Page 4 - Exercise of Option
Page 5 - Reorganization Events
Page 6 - Amendment of the Plan
Page 7 - Authorization of Sub-Plans
Subdocument 3 - EX-31.1 - EX-31.1
Page 1 - N/A
Subdocument 4 - EX-31.2 - EX-31.2
Page 1 - N/A
Subdocument 5 - EX-32.1 - EX-32.1
Page 1 - N/A
Subdocument 6 - EX-32.2 - EX-32.2
Page 1 - N/A
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