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8-K - FORM 8-K - HeartWare International, Inc. | c23780e8vk.htm |
Exhibit 99.1
HEARTWARE INTERNATIONAL REPORTS
THIRD QUARTER 2011 REVENUES OF $21.3 MILLION;
54% INCREASE FROM $13.8 MILLION IN THIRD QUARTER 2010
THIRD QUARTER 2011 REVENUES OF $21.3 MILLION;
54% INCREASE FROM $13.8 MILLION IN THIRD QUARTER 2010
First nine months of 2011 revenues of $59.7 million compared to $34.3 million
in first nine months of 2010
in first nine months of 2010
Conference call tomorrow at 8:00 a.m. U.S. E.T.
Framingham, Mass. and Sydney, Australia, October 27, 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 $21.3 million for the third quarter ended September 30, 2011. This represents a 54
percent increase from $13.8 million in revenues for the same period of 2010. For the nine months
ended September 30, 2011, the Company generated revenues of $59.7 million, compared to $34.3
million in the first nine months of 2010.
During the third quarter, our team generated global sales for the HeartWare®
Ventricular Assist System of 233 units, leading to our highest quarterly revenue to date, stated
Doug Godshall, President and Chief Executive Officer. The international markets contributed 142
units sold and accounted for 64 percent, or approximately $13.7 million, of our 2011 third quarter
revenues, up from $9.9 million in the third quarter of 2010.
In the United States, the pace of clinical enrollment increased 32 percent from the second quarter
of 2011, with 112 patients enrolled in the third quarter, compared with 85 patients enrolled in the
second quarter. Enrollment for the third quarter included 88 patients in ENDURANCE and 24 patients
in the Continued Access Protocol for ADVANCE. Unit sales in the U.S. increased to 91 units in the
third quarter, from 74 units in the preceding quarter of 2011, added Mr. Godshall. During the
third quarter, we also continued to advance the development of our next generation MVAD®
System by completing the GLP studies and we remain on track to commence human clinical trials of
the MVAD System early next year.
Total operating expenses for the third quarter of 2011 were $23.5 million, compared to $16.3
million in the same period of 2010. Research and development expense was $12.7 million for the
third quarter of 2011, compared to $9.3 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 MVAD platform. Selling,
general and administrative expenses were $10.8 million in the third quarter of 2011, compared to
$7.0 million in the third 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.
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Net loss for the third quarter of 2011 was $14.0 million, or a $1.00 loss per basic and diluted
share, compared to a $7.8 million net loss, or a loss of $0.57 per basic and diluted share, in the
third quarter of 2010. For the nine months ended September 30, 2011, the Company recorded a net
loss of $33.5 million, or a $2.41 loss per basic and diluted share, compared to a $22.4 million net
loss, or a loss of $1.66 per basic and diluted share, in the first nine months of 2010.
At September 30, 2011, the Companys balance sheet showed $189.4 million in cash, cash equivalents
and investments, compared to $198.8 million at June 30, 2011 and $217.5 million at December 31,
2010. The decrease in cash, cash equivalents and investments during the first nine months of 2011
primarily reflects the purchase and manufacture of inventories of $14.0 million, the purchase of
property, plant and equipment of $8.5 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 Friday, October 28, 2011 at 8:00 a.m. U.S. Eastern
Daylight Time (11:00 p.m. Australian Eastern Daylight Time, Friday, October 28, 2011) to discuss
the Companys financial results, highlights from the quarter and business outlook. The call may be
accessed by dialing 1-877-941-2068 five minutes prior to the scheduled start time and referencing
HeartWare. For callers outside the U.S., please dial +1-480-629-9712. 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 Third 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.
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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
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 per share data)
(unaudited)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues, net |
$ | 21,340 | $ | 13,817 | $ | 59,704 | $ | 34,277 | ||||||||
Cost of revenues |
7,884 | 6,003 | 23,392 | 15,976 | ||||||||||||
Gross profit |
13,456 | 7,814 | 36,312 | 18,301 | ||||||||||||
Operating expenses: |
||||||||||||||||
Selling, general and administrative |
10,833 | 6,993 | 29,389 | 19,238 | ||||||||||||
Research and development |
12,705 | 9,313 | 32,285 | 21,580 | ||||||||||||
Total operating expenses |
23,538 | 16,306 | 61,674 | 40,818 | ||||||||||||
Loss from operations |
(10,082 | ) | (8,492 | ) | (25,362 | ) | (22,517 | ) | ||||||||
Other income (expense), net |
(3,882 | ) | 648 | (8,129 | ) | 147 | ||||||||||
Net loss |
$ | (13,964 | ) | $ | (7,844 | ) | $ | (33,491 | ) | $ | (22,370 | ) | ||||
Net loss per common share basic and diluted |
$ | (1.00 | ) | $ | (0.57 | ) | $ | (2.41 | ) | $ | (1.66 | ) | ||||
Weighted average shares outstanding basic and diluted |
13,948,162 | 13,752,829 | 13,924,182 | 13,467,540 | ||||||||||||
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HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
September 30, | December 31, | |||||||
2011 | 2010 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 99,124 | $ | 192,148 | ||||
Short-term investments, net |
90,292 | 21,330 | ||||||
Accounts receivable, net |
11,337 | 19,053 | ||||||
Inventories, net |
28,573 | 15,077 | ||||||
Prepaid expenses and other current assets |
5,040 | 2,406 | ||||||
Total current assets |
234,366 | 250,014 | ||||||
Property, plant and equipment, net |
14,828 | 7,484 | ||||||
Long-term investments, net |
| 4,006 | ||||||
Other assets, net |
6,171 | 6,073 | ||||||
Total assets |
$ | 255,365 | $ | 267,577 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 4,568 | $ | 3,890 | ||||
Accrued expenses and other current liabilities |
11,238 | 7,001 | ||||||
Total current liabilities |
15,806 | 10,891 | ||||||
Convertible senior notes, net |
92,877 | 88,922 | ||||||
Other long-term liabilities |
1,947 | | ||||||
Stockholders equity |
144,735 | 167,764 | ||||||
Total liabilities and stockholders equity |
$ | 255,365 | $ | 267,577 | ||||
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