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Form 10-K
HEARTWARE INTERNATIONAL, INC. filed this Form 10-K on 02/27/2013
Document Outline
Entire Document (3980.2 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 - Market Opportunity
Page 8 - VAD Treatment for Advanced Heart Failure
Page 9 - Bridge-to-recovery therapy
Page 10 - The HeartWare MVAD System
Page 11 - Expand U.S. Market Penetration
Page 12 - Intellectual Property
Page 13 - Government Regulation
Page 14 - Pervasive and Continuing FDA Regulation
Page 15 - European Union
Page 16 - Healthcare Regulation
Page 17 - Third Party Reimbursement
Page 18 - Research and Development
Page 19 - Item 1A. Risk Factors
Page 20 - We have a significant amount of indebtedness consisting primarily of our convertible senior notes. W
Page 21 - We may need substantial additional funding and may be unable to raise capital when needed, which wou
Page 22 - We currently rely entirely on sales of our sole product, the HeartWare System, to generate revenue.
Page 23 - If we are unable to manage our expected growth, we may not be able to meet market demand, generate e
Page 24 - We are still building our sales, marketing and distribution experience.
Page 25 - We manufacture a Class III device implanted in the heart that subjects us to numerous risks.
Page 26 - Product deficiencies could result in field actions, recalls, substantial costs and write-downs; this
Page 27 - Destination therapy procedures represent an increasing share of ventricular assist device implants.
Page 28 - Adverse changes in general economic conditions in the United States and overseas could adversely aff
Page 29 - Healthcare policy changes, including the Patient Protection and Affordable Care Act, may have a mate
Page 30 - If we are found to have violated laws protecting the confidentiality of patient health information,
Page 31 - We may not be able to effectively protect our intellectual property rights which could have an adver
Page 32 - Claims that our current or future products infringe or misappropriate the proprietary rights of othe
Page 33 - We may be subject to claims that our employees or we have inadvertently or otherwise used or disclos
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 - Item 4. Mine Safety Disclosures
Page 40 - Part II
Page 41 - Stock Price Performance Graph
Page 42 - Equity Compensation Plans
Page 43 - Item 6. Selected Financial Data
Page 44 - Item 7. Management s Discussion and Analysis of Financial Condition and Results of Operations
Page 45 - Critical Accounting Policies and Estimates
Page 46 - Share-Based Compensation
Page 47 - Income Taxes
Page 48 - Results of Operations
Page 49 - Selling, General and Administrative
Page 50 - Foreign Exchange
Page 51 - Income Taxes
Page 52 - Selling, General and Administrative
Page 53 - Income Taxes
Page 54 - Cash Provided by Investing Activities
Page 55 - Contractual Obligations
Page 56 - Item 7A. Quantitative and Qualitative Disclosures About Market Risk
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 - HEARTWARE INTERNATIONAL, INC.
Page 87 - Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Page 88 - Internal Control-Integrated Framework
Page 89 - Changes in Internal Control over Financial Reporting
Page 90 - Part III
Page 91 - Peter McAree.
Page 92 - Item 11. Executive Compensation
Page 93 - Distribution of equity security holders as at 18 February 2013
Page 94 - Required Statements
Page 95 - General Information
Page 96 - Recommendation 1.2 Disclose the process for evaluating the performance of senior executives
Page 97 - Independent advice
Page 98 - Reporting Requirement
Page 99 - Recommendation 3.5 Disclosure of information indicated in the guide to reporting on Principle 3 of t
Page 100 - Principle 5 Make timely and balanced disclosure
Page 101 - Reporting requirement
Page 102 - Recommendation 7.3 Disclose whether the Board has received assurance from the Chief Executive Office
Page 103 - Recommendation 8.3 Clearly distinguish the structure of non-executive directors remuneration from th
Page 104 - Item 14. Principal Accounting Fees and Services
Page 105 - SIGNATURES
Page 106 - Exhibit Index
Page 107 - N/A
Page 108 - N/A
Page 109 - N/A
Subdocument 2 - EX-10.29 - EX-10.29
Page 1 - FIRST LEASE AMENDMENT
Page 2 - EXECUTED
Subdocument 3 - EX-21.1 - EX-21.1
Page 1 - Exhibit 21.1
Subdocument 4 - EX-23.1 - EX-23.1
Page 1 - Exhibit 23.1
Subdocument 5 - EX-31.1 - EX-31.1
Page 1 - Exhibit 31.1
Subdocument 6 - EX-31.2 - EX-31.2
Page 1 - Exhibit 31.2
Subdocument 7 - EX-32.1 - EX-32.1
Page 1 - Exhibit 32.1
Subdocument 8 - EX-32.2 - EX-32.2
Page 1 - Exhibit 32.2
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