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8-K - FORM 8-K - HeartWare International, Inc. | c13106e8vk.htm |
EX-10.1 - EXHIBIT 10.1 - HeartWare International, Inc. | c13106exv10w1.htm |
Exhibit 99.1
HEARTWARE INTERNATIONAL REPORTS
FOURTH QUARTER 2010 REVENUES OF $20.9 MILLION;
71% INCREASE FROM $12.2 MILLION IN FOURTH QUARTER 2009
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 Companys 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 HeartWares 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 HeartWares technology pipeline and increased recruitment for
key positions to meet rising demand for the Companys products and the need to support clinicians
in a larger number of centers.
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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 Companys 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 Companys 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 Companys 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 Companys 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.
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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 managements 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
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864
- Tables to Follow-
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HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
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 | ||||||||||||
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HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
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 | ||||
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