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8-K - FORM 8-K - HeartWare International, Inc. | c20997e8vk.htm |
Exhibit 99.1
HEARTWARE INTERNATIONAL REPORTS
SECOND QUARTER 2011 REVENUES OF $20.4 MILLION;
109% INCREASE FROM $9.8 MILLION IN SECOND QUARTER 2010
SECOND QUARTER 2011 REVENUES OF $20.4 MILLION;
109% INCREASE FROM $9.8 MILLION IN SECOND QUARTER 2010
First Half 2011 Revenues $38.4 Million Compared
to $20.5 Million in First Half 2010
to $20.5 Million in First Half 2010
Conference call today at 5:00 p.m. U.S. E.T.
Framingham, Mass. and Sydney, Australia, August 4, 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 $20.4 million for the second quarter ended June 30, 2011. This represents a 109
percent increase from $9.8 million in revenues for the same period of 2010. For the six months
ended June 30, 2011, the Company generated revenues of $38.4 million, compared to $20.5 million in
the first half of 2010.
During the second quarter, we generated global sales for the HeartWare® Ventricular
Assist System of 226 units, up from 207 units in the first quarter of 2011, and up from 116 units
in the second quarter of 2010. In international markets, we are fortunate to have the strong
support of our 64 customers in 20 countries, with 152 pumps sold to customers outside of the U.S.,
stated Doug Godshall, President and Chief Executive Officer. The international markets accounted
for 69 percent, or approximately $14.1 million, of our 2011 second quarter revenues, up from $7.9
million in the second quarter of 2010.
In the U.S., where second quarter revenues more than tripled to $6.3 million compared to $1.9
million in the second quarter of 2010, we now have 47 of the planned 50 U.S. sites approved for
implantation in our 450-patient destination therapy study, and 189 patients have been randomized
and enrolled, added Mr. Godshall. In the second quarter, enrollment in our destination therapy
study climbed nearly 50 percent from first quarter levels, from 43 to 63 patients. Enrollment in
the 94-patient Continued Access Protocol (CAP) allotment under our bridge-to-transplant clinical
study decreased from 29 patients in the first quarter 2011 to 22 patients enrolled in the second
quarter of 2011.
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Total operating expenses for the second quarter of 2011 were $20.2 million, compared to $15.2
million in the same period of 2010. Research and development expense was $10.3 million for the
second quarter of 2011, compared to $7.5 million in the same period of 2010, primarily attributable
to the Companys ongoing Pre-Market Approval application process and increased expenditure on
HeartWares pipeline technologies, including the commencement of final preclinical testing for the
next generation MVAD platform. Selling, general and administrative expenses were $9.9 million in
the second quarter of 2011, compared to $7.7 million in the second quarter of 2010. The increase
reflects continued corporate growth to support expanding commercialization activities outside of
the U.S. and the need to support clinicians in a larger number of centers around the globe.
Net loss for the second quarter of 2011 was $10.1 million, or a $0.73 loss per basic and diluted
share, compared to a $10.0 million net loss, or a loss of $0.73 per basic and diluted share, in the
second quarter of 2010. For the six months ended June 30, 2011, the Company recorded a net loss of
$19.5 million, or a $1.40 loss per basic and diluted share, compared to a $14.5 million net loss,
or a loss of $1.09 per basic and diluted share, in the first half of 2010.
At June 30, 2011, the Companys balance sheet showed $198.8 million in cash, cash equivalents and
investments, compared to $217.5 million at December 31, 2010. The decrease in cash, cash
equivalents and investments in the six month period primarily reflects the purchase and manufacture
of inventories of $7.5 million, the purchase of property, plant and equipment of $4.7 million and a
semi-annual interest payment of $2.5 million related to the Companys convertible senior notes.
HeartWare will host a conference call on Thursday, August 4, 2011 at 5:00 p.m. U.S. Eastern
Daylight Time (being 7:00 a.m. Australian Eastern Standard Time, Friday, August 5, 2011) to discuss
the Companys financial results, highlights from the quarter and business outlook. The call may be
accessed by dialing 1-877-941-4775 five minutes prior to the scheduled start time and referencing
HeartWare. For callers outside the U.S., please dial + 1-480-629-9761. 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 Second Quarter 2011 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.
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 and TGA approval
in Australia. The device is currently the subject of United States clinical trials for two
indications: bridge-to-transplant and destination therapy. For additional information, please
visit www.heartware.com.
- more -
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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 regulatory filings and approvals, 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, Current Reports on Form 8-K, or other filings 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)
(unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues, net |
$ | 20,389 | $ | 9,757 | $ | 38,364 | $ | 20,460 | ||||||||
Cost of revenues |
7,913 | 4,293 | 15,509 | 9,974 | ||||||||||||
Gross profit |
12,476 | 5,464 | 22,855 | 10,486 | ||||||||||||
Operating expenses: |
||||||||||||||||
Selling, general and administrative |
9,892 | 7,689 | 18,556 | 12,244 | ||||||||||||
Research and development |
10,280 | 7,511 | 19,580 | 12,267 | ||||||||||||
Total operating expenses |
20,172 | 15,200 | 38,136 | 24,511 | ||||||||||||
Loss from operations |
(7,696 | ) | (9,736 | ) | (15,281 | ) | (14,025 | ) | ||||||||
Other income (expense), net |
(2,400 | ) | (246 | ) | (4,246 | ) | (501 | ) | ||||||||
Net loss |
$ | (10,096 | ) | $ | (9,982 | ) | $ | (19,527 | ) | $ | (14,526 | ) | ||||
Net loss per common share basic
and diluted |
$ | (0.73 | ) | $ | (0.73 | ) | $ | (1.40 | ) | $ | (1.09 | ) | ||||
Weighted average shares
outstanding basic and diluted |
13,923,258 | 13,682,734 | 13,911,993 | 13,322,531 | ||||||||||||
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HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
June 30, 2011 | December 31, 2010 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 118,844 | $ | 192,148 | ||||
Short-term investments, net |
79,998 | 21,330 | ||||||
Accounts receivable, net |
15,248 | 19,053 | ||||||
Inventories, net |
22,522 | 15,077 | ||||||
Prepaid expenses and other current assets |
4,659 | 2,406 | ||||||
Total current assets |
241,271 | 250,014 | ||||||
Property, plant and equipment, net |
11,130 | 7,484 | ||||||
Long-term investments, net |
| 4,006 | ||||||
Other assets, net |
6,125 | 6,073 | ||||||
Total assets |
$ | 258,526 | $ | 267,577 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 3,336 | $ | 3,890 | ||||
Accrued expenses and other current liabilities |
8,331 | 7,001 | ||||||
Total current liabilities |
11,667 | 10,891 | ||||||
Convertible senior notes, net |
91,519 | 88,922 | ||||||
Stockholders equity |
155,340 | 167,764 | ||||||
Total liabilities and stockholders equity |
$ | 258,526 | $ | 267,577 | ||||
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