Form 10-K
CHIASMA, INC filed this Form 10-K on 03/08/2019
Document Outline
Entire Document (3782.7 KB)
Subdocument 1 - 10-K - 10-K
Page 1 - UNITED STATES
Page 2 - CHIASMA, INC.
Page 3 - SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Page 4 - N/A
Page 5 - N/A
Page 6 - Strategy
Page 7 - Our Product Candidate, Octreotide Capsules (MYCAPSSA) in Acromegaly
Page 8 - Overview of Acromegaly
Page 9 - Current Therapeutic Options and Their Limitations
Page 10 - Clinical Program for Octreotide Capsules in Acromegaly
Page 11 - Special Protocol Assessment and CHIASMA OPTIMAL Phase 3 Clinical Trial
Page 12 - CHIASMA OPTIMAL Phase 3 Clinical Trial Design
Page 13 - N/A
Page 14 - MPOWERED Phase 3 Design to Support EMA Application
Page 15 - Completed Phase 3 Clinical Trial Design
Page 16 - Overall Phase 3 Response in mITT Group vs. Baseline
Page 17 - GH and IGF-1 Response in mITT Group Throughout the Duration of the Phase 3 Trial
Page 18 - Completed Phase 1 Clinical Trials of Octreotide Capsules
Page 19 - Pharmacokinetics of Octreotide capsules vs. SC Octreotide in Phase 1 Trial
Page 20 - Other Potential Indications for Octreotide Capsules
Page 21 - Our TPE Platform
Page 22 - Commercialization Strategy
Page 23 - Competition
Page 24 - Intellectual Property
Page 25 - Government Regulation
Page 26 - N/A
Page 27 - N/A
Page 28 - N/A
Page 29 - N/A
Page 30 - N/A
Page 31 - N/A
Page 32 - N/A
Page 33 - Coverage and Reimbursement
Page 34 - N/A
Page 35 - N/A
Page 36 - N/A
Page 37 - N/A
Page 38 - N/A
Page 39 - European Union Drug Development
Page 40 - Employees
Page 41 - Corporate Information
Page 42 - N/A
Page 43 - Even though our Phase 3 CHIASMA OPTIMAL trial is being conducted under a SPA agreed to with the FDA,
Page 44 - We are substantially dependent on the regulatory approval and subsequent commercial success of octre
Page 45 - If we are not able to obtain required regulatory approvals for octreotide capsules, particularly in
Page 46 - N/A
Page 47 - Our development, regulatory and commercialization strategy for octreotide capsules depends, in part,
Page 48 - Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and ou
Page 49 - Any negative clinical results from, termination or suspension of, or delays in the commencement or c
Page 50 - N/A
Page 51 - Changes in regulatory requirements and guidance may also occur, and we may need to amend clinical tr
Page 52 - Changes in funding for, or leadership at, the FDA, the SEC and other government agencies could hinde
Page 53 - Even if we receive regulatory approval of octreotide capsules for acromegaly, we may still face futu
Page 54 - We face substantial competition from larger companies with considerable resources that already have
Page 55 - N/A
Page 56 - The number of patients suffering from acromegaly is small, and has not been established with precisi
Page 57 - N/A
Page 58 - We do not have a sales and marketing organization and, as a company, have not commercialized any pro
Page 59 - We do not have a medical affairs organization and, if we are unable to establish effective medical a
Page 60 - Even if we obtain marketing approval of octreotide capsules or any future product candidates we may
Page 61 - If we do not achieve our projected development and commercialization goals in the timeframes we anno
Page 62 - Octreotide capsules and other products we may develop, if approved, may not be commercially viable i
Page 63 - N/A
Page 64 - The longer term growth of our business depends on our efforts to expand the approved uses of octreot
Page 65 - We may be unable to obtain orphan drug designation or exclusivity for future product candidates we m
Page 66 - Our relationships with customers and third-party payors will be subject to applicable anti-kickback,
Page 67 - N/A
Page 68 - Legislative or regulatory reform of the health care system in the United States and foreign jurisdic
Page 69 - We may not be able to maintain our current product liability coverage, and, even if we do, our cover
Page 70 - Risks Related to Our Reliance on Third Parties
Page 71 - If our third-party manufacturers use hazardous and biological materials in a manner that causes inju
Page 72 - An important part of our strategy may be to enter into licensing or collaboration agreements with re
Page 73 - Risks Related to Our Financial Position and Capital Resources
Page 74 - We have not generated revenue from any commercial products and may never be profitable.
Page 75 - We will need additional capital to support our operations, which may be difficult to obtain and rest
Page 76 - Risks Related to Our Business and Industry
Page 77 - Our employees, independent contractors, consultants, commercial partners, principal investigators, C
Page 78 - Laws and regulations governing conduct of international operations may negatively impact our develop
Page 79 - Security breaches and other disruptions could compromise our information and expose us to liability,
Page 80 - Exchange rate fluctuations between the U.S. dollar and non-U.S. currencies may negatively affect our
Page 81 - We may become involved in lawsuits to protect or enforce our patents or the patents of our licensors
Page 82 - We may not be able to protect our intellectual property rights throughout the world.
Page 83 - Obtaining and maintaining our patent protection depends on compliance with various procedural, docum
Page 84 - Octreotide capsules or any future products we may develop may infringe the intellectual property rig
Page 85 - Our competitors may be able to circumvent our patents by developing similar or alternative technolog
Page 86 - If our trademarks are not adequately protected, then we may not be able to build name recognition in
Page 87 - Our development and administrative facilities and one of our third-party manufacturers are located i
Page 88 - Our directors, executive officers and principal stockholders exercise significant influence over our
Page 89 - Our amended and restated certificate of incorporation and amended and restated bylaws provide that t
Page 90 - N/A
Page 91 - We are the subject of securities litigation, which is expensive and may divert our management s atte
Page 92 - We have never paid cash dividends on our capital stock and we do not anticipate paying any dividends
Page 93 - If we fail to maintain proper and effective internal controls, our ability to produce accurate finan
Page 94 - N/A
Page 95 - Market Information
Page 96 - Stock Price Performance Graph
Page 97 - Securities authorized for issuance under equity compensation plans
Page 98 - Statement of Operations
Page 99 - Overview
Page 100 - N/A
Page 101 - Roche License Agreement
Page 102 - Restructuring Charges
Page 103 - General and Administrative
Page 104 - General and Administrative
Page 105 - Liquidity and Capital Resources
Page 106 - Cash Flows
Page 107 - Investing Activities
Page 108 - Stock-based Compensation
Page 109 - Off-Balance Sheet Arrangements
Page 110 - Management s Annual Report on Internal Control over Financial Reporting
Page 111 - PART IV
Page 112 - EXHIBIT INDEX
Page 113 - N/A
Page 114 - SIGNATURES
Page 115 - INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page 116 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 117 - CHIASMA, INC.
Page 118 - CHIASMA, INC.
Page 119 - CHIASMA, INC.
Page 120 - CHIASMA, INC.
Page 121 - CHIASMA, INC.
Page 122 - CHIASMA, INC.
Page 123 - Liquidity
Page 124 - Foreign currency translation
Page 125 - Property and equipment
Page 126 - Patent costs
Page 127 - Contingent liabilities
Page 128 - 4. Fair Value Measurements and Fair Value of Financial Instruments
Page 129 - 5. Earnings per Share
Page 130 - 6. Property and Equipment
Page 131 - 10. Stock Incentive Plan
Page 132 - 11. Income Taxes
Page 133 - N/A
Page 134 - N/A
Page 135 - 12. Commitments and Contingencies
Page 136 - 13. Related Party Transactions
Page 137 - 16. Other Income, net
Subdocument 2 - EX-21.1 - EX-21.1
Page 1 - 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-32.1 - EX-32.1
Page 1 - N/A
XBRL Item - EX-101.INS - XBRL INSTANCE DOCUMENT (What's this?)
XBRL Item - EX-101.SCH - XBRL TAXONOMY EXTENSION SCHEMA (What's this?)
XBRL Item - EX-101.CAL - XBRL TAXONOMY EXTENSION CALCULATION LINKBASE (What's this?)
XBRL Item - EX-101.DEF - XBRL TAXONOMY EXTENSION DEFINITION LINKBASE (What's this?)
XBRL Item - EX-101.LAB - XBRL TAXONOMY EXTENSION LABEL LINKBASE (What's this?)
XBRL Item - EX-101.PRE - XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE (What's this?)
XBRL Viewer