Skip to main content

SEC Filings

 
Form 10-K
HEARTWARE INTERNATIONAL, INC. filed this Form 10-K on 02/27/2012
Document Outline
Entire Document (2411.7 KB)
Subdocument 1 - 10-K - FORM 10-K
Page 1 - UNITED STATES
Page 2 - N/A
Page 3 - References
Page 4 - Corporate Information
Page 5 - Part I
Page 6 - Destination Therapy
Page 7 - Other Devices
Page 8 - CHF Treatment Options
Page 9 - Bridge-to-decision therapy
Page 10 - The HeartWare MVAD
Page 11 - Our Business Strategy
Page 12 - Sales and Marketing
Page 13 - Government Regulation
Page 14 - Pervasive and Continuing FDA Regulation
Page 15 - European Union
Page 16 - Regulations related to prohibiting kickbacks and false claims and protecting patient confidentiality
Page 17 - Competition
Page 18 - Manufacturing and Assembly
Page 19 - Legal Proceedings
Page 20 - We have incurred operating losses since our inception and anticipate that we will continue to incur
Page 21 - We may need substantial additional funding and may be unable to raise capital when needed, which wou
Page 22 - N/A
Page 23 - We currently rely entirely on sales of our sole product, the HeartWare System, to generate revenue.
Page 24 - We compete against companies that have longer operating histories, more established or approved prod
Page 25 - We have limited manufacturing capabilities and personnel, and if our manufacturing facilities are un
Page 26 - We may not meet regulatory quality standards applicable to our manufacturing and quality processes,
Page 27 - If we fail to obtain and maintain adequate level of reimbursement for our products by third party pa
Page 28 - The long and variable sales and deployment cycles for our ventricular assist device, or VAD, systems
Page 29 - We rely on specialized suppliers for certain components and materials, and we do not have second-sou
Page 30 - We may not be able to effectively protect our intellectual property rights which could have an adver
Page 31 - Claims that our current or future products infringe or misappropriate the proprietary rights of othe
Page 32 - If we are unable to protect the confidentiality of our proprietary information and know-how, the val
Page 33 - If we fail to successfully introduce next generation products and improvements to our existing produ
Page 34 - If we cannot successfully manage the additional business and regulatory risks that result from our e
Page 35 - Product liability claims could damage our reputation or adversely affect our business.
Page 36 - Risks Related to Our Common Stock
Page 37 - We may be subject to arbitrage risks.
Page 38 - Item 3. Legal Proceedings
Page 39 - Part II
Page 40 - Stock Price Performance Graph
Page 41 - Equity Compensation Plans
Page 42 - N/A
Page 43 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 44 - Critical Accounting Policies and Estimates
Page 45 - Share-Based Compensation
Page 46 - Income Taxes
Page 47 - Results of Operations
Page 48 - Selling, General and Administrative
Page 49 - Research and Development
Page 50 - Income Taxes
Page 51 - Selling, General and Administrative
Page 52 - Interest Expense
Page 53 - Liquidity and Capital Resources
Page 54 - Operating Capital and Capital Expenditure Requirements
Page 55 - Contractual Obligations
Page 56 - Foreign Currency Rate Fluctuations
Page 57 - Item 8. Financial Statements and Supplementary Data
Page 58 - Report of Independent Registered Public Accounting Firm
Page 59 - HEARTWARE INTERNATIONAL, INC.
Page 60 - HEARTWARE INTERNATIONAL, INC.
Page 61 - HEARTWARE INTERNATIONAL, INC.
Page 62 - HEARTWARE INTERNATIONAL, INC.
Page 63 - HEARTWARE INTERNATIONAL, INC.
Page 64 - HEARTWARE INTERNATIONAL, INC.
Page 65 - HEARTWARE INTERNATIONAL, INC.
Page 66 - HEARTWARE INTERNATIONAL, INC.
Page 67 - HEARTWARE INTERNATIONAL, INC.
Page 68 - HEARTWARE INTERNATIONAL, INC.
Page 69 - HEARTWARE INTERNATIONAL, INC.
Page 70 - HEARTWARE INTERNATIONAL, INC.
Page 71 - HEARTWARE INTERNATIONAL, INC.
Page 72 - HEARTWARE INTERNATIONAL, INC.
Page 73 - HEARTWARE INTERNATIONAL, INC.
Page 74 - HEARTWARE INTERNATIONAL, INC.
Page 75 - HEARTWARE INTERNATIONAL, INC.
Page 76 - HEARTWARE INTERNATIONAL, INC.
Page 77 - HEARTWARE INTERNATIONAL, INC.
Page 78 - HEARTWARE INTERNATIONAL, INC.
Page 79 - HEARTWARE INTERNATIONAL, INC.
Page 80 - HEARTWARE INTERNATIONAL, INC.
Page 81 - HEARTWARE INTERNATIONAL, INC.
Page 82 - HEARTWARE INTERNATIONAL, INC.
Page 83 - HEARTWARE INTERNATIONAL, INC.
Page 84 - HEARTWARE INTERNATIONAL, INC.
Page 85 - HEARTWARE INTERNATIONAL, INC.
Page 86 - Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Page 87 - Internal Control-Integrated Framework
Page 88 - Changes in Internal Control over Financial Reporting
Page 89 - Part III
Page 90 - Lauren Farrell.
Page 91 - Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matt
Page 92 - Unmarketable parcels
Page 93 - Required Statements
Page 94 - Australian Corporate Governance Statement
Page 95 - Recommendation 1.3 Disclosure of information indicated in the guide to reporting on Principle 1 of t
Page 96 - Independent advice
Page 97 - Principle 3 Promote ethical and responsible decision-making
Page 98 - Reporting Requirement
Page 99 - Reporting requirement
Page 100 - Recommendation 7.3 Disclose whether the Board has received assurance from the Chief Executive Office
Page 101 - Recommendation 8.3 Clearly distinguish the structure of non-executive directors remuneration from th
Page 102 - Part IV.
Page 103 - SIGNATURES
Page 104 - N/A
Page 105 - Exhibit Index
Page 106 - N/A
Page 107 - N/A
Subdocument 2 - EX-10.38 - EX-10.38
Page 1 - Exhibit 10.38
Page 2 - 4. Vacation, Insurance and Benefits; Expenses.
Page 3 - (b)
Page 4 - (v)
Page 5 - Section 6(e)
Page 6 - 8. Noncompetition.
Page 7 - (b)
Page 8 - N/A
Page 9 - (a)
Page 10 - (g)
Page 11 - /s/ Lawrence J Knopf
Page 12 - EXHIBIT A
Page 13 - N/A
Page 14 - I further represent that I have or will return all property, including documents, memoranda, softwar
Page 15 - /s/ Lawrence J. Knopf
Subdocument 3 - EX-10.39 - EX-10.39
Page 1 - Exhibit 10.39
Page 2 - 4. Vacation, Insurance and Benefits; Expenses.
Page 3 - (b)
Page 4 - (v)
Page 5 - Section 6(e)
Page 6 - 8. Noncompetition.
Page 7 - (b)
Page 8 - Section 8
Page 9 - (c)
Page 10 - N/A
Page 11 - EXHIBIT A
Page 12 - N/A
Page 13 - I further represent that I have or will return all property, including documents, memoranda, softwar
Page 14 - N/A
Subdocument 4 - EX-21.1 - EX-21.1
Page 1 - Exhibit 21.1
Subdocument 5 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 6 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Subdocument 7 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Subdocument 8 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
Subdocument 9 - EX-32.2 - EX-32.2
Page 1 - Exhibit 32.2
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