8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 22, 2011

HEARTWARE INTERNATIONAL, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-34256	26-3636023
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

205 Newbury Street, Suite 101 Framingham, MA	01701
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: 508.739.0950

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On February 24, 2011, HeartWare International, Inc. (Nasdaq: HTWR — ASX: HIN) issued a press release announcing financial results for the year ended December 31, 2011. A copy of the release is furnished with this report as Exhibit 99.1.

The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filing.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Bonus Plan for Executive Officers — Omnibus Plan Document. On February 22, 2011, the Compensation Committee adopted a new Bonus Plan for Executive Officers that sets forth a list of performance goals and criteria to choose from in setting each fiscal period’s specific metrics. The material terms of the plan are as follows:

• Purpose: to provide incentives in the form of cash bonuses to the Company’s executive officers to make significant contributions to the Company’s success;

• Administration: the plan shall be administered by the Compensation Committee, who shall determine the executive officers who will participate in the plan, set the plan periods, set target bonus amounts (including weightings and threshold/target/maximum amounts), establish performance goals, and make other determinations under the plan;

• Performance Goals: goals related to the performance of the Company, any of its divisions, business units, subsidiaries, regions, products or lines of business, and/or the Participant personally may be based on any one or more of the following criteria: number of units; revenue; revenue growth; sales; expenses; margins; net income; earnings or earnings per share; cash flow; cash use; shareholder return; return on investment; return on invested capital, assets, or equity; profit before or after tax; operating profit (GAAP or non-GAAP); return on research and development investment; market capitalization; clinical trials (enrollment; completion; other factors); product development and improvements and milestones; commercialization of devices; FDA and other regulatory filings, milestones and approvals; audit results; market share; cycle time reductions; customer satisfaction measures; strategic positioning or marketing programs; business/information systems improvements; expense management; infrastructure support programs; human resource programs; customer programs; technology development programs; and any other financial metric(s) and/or operational or strategic programs. Personal performance may be a multiplier against other Performance Goals.

• Determinations: the Committee shall determine the extent to which the respective performance goals and any other material terms of the bonus awards have been satisfied, and may determine to accelerate achievement or waive criteria in its discretion; and

• Unfunded Nature: the plan shall be unfunded.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.	Description
99.1	Press Release issued by HeartWare International, Inc. dated February 24, 2011.
10.1	HeartWare International, Inc. Bonus Plan for Executive Officers, dated February 22, 2011.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	HeartWare International, Inc.
Date: February 24, 2011	By:	/s/ David McIntyre
		Name:	David McIntyre
		Title:	Chief Financial Officer and Chief Operating Officer

EX-10.1

Exhibit 10.1

HeartWare International, Inc.
Bonus Plan for Executive Officers

Adopted by the Compensation Committee of the Board of Directors on February 22, 2011

1. Purpose. The Compensation Committee of the Board of Directors of HeartWare International, Inc. (together with its affiliates, the “Company”) has adopted this Plan in order to provide incentives in the form of cash bonuses to the Company’s executive officers to make significant contributions to the Company’s success.

2. Administration.

(a) This Plan shall be administered by the Compensation Committee (the “Committee”) of the Company’s Board of Directors. Subject to the express terms of the Plan, the Committee shall have full power and authority to construe, interpret and administer the Plan. The Committee’s decisions hereunder shall be final and binding.

(b) The Committee shall from time to time: (i) determine the executive officers who will participate in the Plan (each, a “Participant”) for any fiscal year or other period (a “Performance Period”); (ii) set a target bonus amount and any additional potential bonus amounts for each Participant for each Performance Period; and (iii) establish Performance Goals in accordance with Section 3 and any other terms and conditions applicable to participants’ incentive bonuses for each Performance Period.

(c) A Participant’s potential bonus and applicable Performance Goals established under the Plan shall be evidenced by a writing delivered to the Participant and containing such other terms and conditions not inconsistent with the provisions of the Plan as the Committee considers necessary or advisable to achieve the purposes of the Plan or to comply with applicable tax and regulatory laws and accounting principles.

3. Performance Goals.

(a) The Committee shall establish for each Participant and for each Performance Period one or more goals related to the performance (defined by absolute and/or relative measures) of the Company, any of its divisions, business units, subsidiaries, regions, products or lines of business, and/or the Participant personally (“Performance Goals”). Such Goals may be based on any one or more of the following criteria: number of units; revenue; revenue growth; sales; expenses; margins; net income; earnings or earnings per share; cash flow; cash use; shareholder return; return on investment; return on invested capital, assets, or equity; profit before or after tax; operating profit (GAAP or non-GAAP); return on research and development investment; market capitalization; clinical trials (enrollment; completion; other factors); product development and improvements and milestones; commercialization of devices; FDA and other regulatory filings, milestones and approvals; audit results; market share; cycle time reductions; customer satisfaction measures; strategic positioning or marketing programs; business/information systems improvements; expense management; infrastructure support programs; human resource programs; customer programs; technology development programs; and any other financial metric(s) and/or operational or strategic programs. Personal performance may be a multiplier against other Performance Goals.

(b) The Committee may determine threshold, target(s), or other levels of performance that must be achieved, with corresponding threshold, target, maximum, upside, or other bonus payments contingent upon the attainment of the relevant Performance Goals. In establishing the performance levels, the Committee may specify the measures to be used to evaluate Performance Goal achievement and the weighting of each Performance Goal.

4. Bonus Payments.

(a) Within a reasonable time after the end of any Performance Period and before payment of any bonus, the Committee shall determine the extent to which the respective Performance Goals and any other material terms of the bonus awards have been satisfied.

(b) The Committee shall determine the effect on any payment under the Plan of the disability, death, retirement or other termination of service of a Participant. The Committee may in its discretion at any time modify or terminate any Participant’s eligibility for any payment hereunder if the Committee determines that the Participant has engaged in activity in competition with, or otherwise harmful to the interests of, the Company. No benefit under the Plan may be assigned or transferred by a Participant during the Participant’s lifetime.

(d) Participants may defer receipt of all or any portion of a bonus under this Plan if and to the extent permitted under any deferred compensation plan of the Company.

(e) A Participant shall pay to the Company, or make provision satisfactory to the Committee for payment of, any taxes required by law to be withheld in respect of payments under the Plan no later than the date of the event creating the tax liability. The Company may, to the extent permitted by law, deduct any such tax obligations from the Participant’s respective bonus or from any other payment due to the Participant.

5. Change in Control. In addition to any rights a Participant may have under a Change of Control Agreement with the Company, in order to preserve a Participant’s rights hereunder in the event of a change in control of the Company (as defined by the Committee), the Committee in its discretion may, at any time, take one or more of the following actions: (i) provide for the acceleration of any time period relating to any payment hereunder, (ii) provide for payment to the Participant upon the change in control of cash or other property equal to the amount that would otherwise have been paid hereunder, (iii) adjust the criteria applicable to the payment of any amount hereunder in a manner determined by the Committee to reflect the change in control, (iv) cause the Company’s obligations under this Plan to be assumed, or new obligations substituted therefor, by another entity, or (v) make such other provision as the Committee may consider equitable to Participants and in the best interests of the Company.

6. Unfunded Plan. The Plan shall be unfunded. The Company shall not be required to segregate any assets for payment under the Plan, nor shall the Plan be construed as providing for such segregation, nor shall the Company, the Board of Directors or the Committee be deemed to be a trustee of any amount payable under the Plan. Any liability of the Company to any Participant under the Plan shall be based solely upon any contractual obligations that may be created pursuant to the Plan, and no such obligation of the Company shall be deemed to be secured by any pledge or other encumbrance on any property of the Company.

7. No Right to Continued Employment. No person shall have any claim or right to participate in the Plan. Participation in any period shall not confer any right to participate in any subsequent period. Neither the adoption, maintenance or operation of the Plan nor any notification of a potential bonus hereunder shall confer upon any person any right with respect to continued employment with the Company nor shall they interfere with the rights of the Company at any time to terminate or otherwise change the terms of his or her employment, including, without limitation, the right to promote, demote or otherwise re-assign any employee from one position to another within the Company.

8. Amendment and Termination of Plan. The Committee may amend, suspend or terminate the Plan in order to comply with any legal requirements or for any other purpose permitted by law. The Committee shall determine the effect of such action on any proposed payment(s) under the Plan.

9. Governing Law. The Plan shall be governed by, and construed in accordance with, the internal laws of the Commonwealth of Massachusetts.

EX-99.1

Exhibit 99.1

HEARTWARE INTERNATIONAL REPORTS
FOURTH QUARTER 2010 REVENUES OF $20.9 MILLION;
71% INCREASE FROM $12.2 MILLION IN FOURTH QUARTER 2009

— Full year 2010 revenues of $55.2 million; more than double $24.2 million in 2009—

— Conference call today at 8:00 a.m. U.S. ET —

Framingham, Mass. and Sydney, Australia, February 24, 2011 — HeartWare International, Inc. (NASDAQ: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenues of $20.9 million for the fourth quarter ended December 31, 2010. This compares to $12.2 million in revenues for the fourth quarter of 2009, and revenues of $13.8 million in the third quarter of 2010. For the 2010 fiscal year, the Company generated revenues of $55.2 million, compared with $24.2 million in 2009.

“Our results for 2010 reflect increasing demand throughout the year, particularly in the fourth quarter during which we saw the largest number of units sold — 236 pumps worldwide — of the HeartWare^® Ventricular Assist System in any quarter to date,” explained Doug Godshall, President and Chief Executive Officer. “The international markets accounted for approximately 69 percent of our revenues for the quarter, as we increased the number of implanting sites to 47 hospitals, from only 16 at the start 2010.

“In the U.S., the rate of implant procedures remained variable, as hospital sites went through the re-initiation process to participate in the second allotment of 54 patients granted by the Food and Drug Administration (FDA) in September under the Continued Access Protocol (CAP) for our bridge-to-transplant clinical study,” Mr. Godshall added. “In our 450-patient destination therapy study, we now have 30 of the planned 50 U.S. sites approved for implantation, and 78 patients have been randomized and enrolled in the study to date.”

Total operating expenses for the fourth quarter of 2010 were $18.9 million, compared to $9.8 million in the prior year period. Research and development expense was $11.5 million for the fourth quarter of 2010, primarily attributable to costs associated with the Company’s Pre-Market Approval (PMA) application, which was submitted to the FDA for a bridge-to-transplant indication in late December 2010, together with increased expenditure on HeartWare’s pipeline technologies. Selling, general and administrative expenses were $7.4 million in the fourth quarter of 2010. For the full fiscal year of 2010, total operating expenses were $59.8 million compared to $31.5 million for the same period of 2009. The increases described above also reflect ongoing expansion of commercialization activities in Europe and other countries outside the U.S., additional investment in HeartWare’s technology pipeline and increased recruitment for key positions to meet rising demand for the Company’s products and the need to support clinicians in a larger number of centers.

- more -

Net loss for the fourth quarter of 2010 was $7.0 million, or a $0.51 loss per basic and diluted share, compared to a $1.9 million net loss, or a loss of $0.17 per basic and diluted share, in the fourth quarter of 2009. For the full fiscal year 2010, the Company recorded a net loss of $29.4 million, or a $2.17 loss per basic and diluted share, compared to a $20.9 million net loss, or a loss of $2.15 per basic and diluted share, in 2009.

“Today, nearly 900 advanced heart failure patients globally have received the HVAD^® pump,” added Mr. Godshall. “Our current priorities include: working to obtain FDA approval for our PMA submission for BTT; initiation of all 50 sites in our destination therapy trial; expanding our international footprint and preparing our next generation, miniaturized MVAD^® pump for Good Laboratory Practice (GLP) animal studies, which are expected to commence this quarter.”

At December 31, 2010, the Company’s balance sheet showed $217.5 million in cash, cash equivalents and investments. This compares to approximately $50.8 million in cash and cash equivalents at December 31, 2009, and reflects incorporation of proceeds from the Company’s common stock and convertible notes public offerings in 2010.

HeartWare will host a conference call on Thursday, February 24, 2011 at 8:00 a.m. U.S. Eastern Standard Time (being midnight Australian Eastern Daylight Time, between February 24 and February 25, 2011) to discuss the Company’s financial results, highlights from the quarter and full year, and business outlook. The call may be accessed by dialing 1-877-941-2322 five minutes prior to the scheduled start time and referencing “HeartWare.” For callers outside the United States, dial +1-480-629-9715. Doug Godshall, President and Chief Executive Officer and David McIntyre, Chief Financial Officer and Chief Operating Officer, will host the conference call.

A live webcast of the call will also be available at the Company’s website (www.heartware.com) by selecting “HeartWare Fourth Quarter Conference Call” under the section titled “Corporate Presentations” on the Home Page. A replay of the conference call will be available through the above weblink immediately following completion of the call.

- more -

2

About HeartWare International

HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIB / IV patients suffering from advanced heart failure. The HeartWare^® Ventricular Assist System features the HVAD^® pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of United States clinical trials for two indications: bridge-to-transplant under a continued access protocol and destination therapy. For additional information, please visit www.heartware.com.

HeartWare International, Inc. is a member of the Russell 2000 ^® and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.

HEARTWARE, HVAD, MVAD and HeartWare logos are registered trademarks of HeartWare, Inc.

Forward-Looking Statements

This announcement contains forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the timing and progress of, and presentation of data related to, clinical trials, expected timing of FDA regulatory filings, FDA acceptance of our filings and research and development activities. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation, the possibility the FDA does not accept our PMA application or approve the marketing of the HeartWare^® Ventricular Assist System in the U.S., and those described in “Item 1A. Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. We may update our risk factors from time to time in “Part II, Item 1A “Risk Factors” in our Quarterly Reports on Form 10-Q, Form 8-K, or other current reports, as filed with the Securities and Exchange Commission.

For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864

- Tables to Follow-

3

HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)

(unaudited)

	Three Months Ended						Year Ended
	December 31,						December 31,
	2010			2009			2010			2009
Revenues, net	$	20,887		$	12,219		$	55,164		$	24,172
Cost of revenues		8,465			6,809			24,441			13,211
Gross profit		12,422			5,410			30,723			10,961
Operating expenses:
Selling, general and administrative		7,404			4,723			26,642			16,444
Research and development		11,528			5,073			33,108			15,067
Total operating expenses		18,932			9,796			59,750			31,511
Loss from operations		(6,510	)		(4,386	)		(29,027	)		(20,550	)
Other income (expense), net		(516	)		2,475			(370	)		(359	)
Net loss	$	(7,026	)	$	(1,911	)	$	(29,397	)	$	(20,909	)
Net loss per common share — basic and diluted	$	(0.51	)	$	(0.17	)	$	(2.17	)	$	(2.15	)
Weighted average shares outstanding — basic and diluted		13,873,547			11,369,289			13,569,876			9,713,925

4

HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)

	December 31, 2010		December 31, 2009
ASSETS
Current assets:
Cash and cash equivalents	$	192,148	$	50,835
Short-term investments, net		21,330		—
Accounts receivable, net		19,053		11,385
Inventories, net		15,077		8,871
Prepaid expenses and other current assets		2,406		1,663
Total current assets		250,014		72,754
Property, plant and equipment, net		7,484		3,719
Other intangible assets, net		1,596		1,192
Long-term investments, net		4,006		—
Deferred financing costs, net		2,939		—
Restricted cash		1,538		288
Total assets	$	267,577	$	77,953
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	3,890	$	3,122
Accrued expenses and other current liabilities		7,001		3,848
Total current liabilities		10,891		6,970
Convertible senior notes, net		88,922		—
Stockholders’ equity		167,764		70,983
Total liabilities and stockholders’ equity	$	267,577	$	77,953

# # # #

5