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8-K - FORM 8-K - HeartWare International, Inc. | c92016e8vk.htm |
Exhibit 99.1
HEARTWARE INTERNATIONAL REPORTS THIRD
QUARTER REVENUES OF $7.5 MILLION
QUARTER REVENUES OF $7.5 MILLION
Framingham, MA and Sydney, Australia (November 4, 2009) HeartWare International, Inc. (NASDAQ:
HTWR ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support
technologies revolutionizing the treatment of advanced heart failure, today announced a significant
increase in revenues to $7.5 million for the third quarter ended September 30, 2009. This compares
to approximately $3.0 million in revenues in the second quarter ended June 30, 2009, and
approximately $4.4 million in revenues for the six months ended June 30, 2009.
HeartWare President and Chief Executive Officer Doug Godshall said that both European selling
efforts and U.S. trial progress are tracking well to date and he noted, Physician feedback has
been positive and consistently supportive as we commence the early phases of marketing our device
in approved countries.
Total operating expenses for the 2009 third quarter were $6.8 million as compared to $8.7 million
in the prior year comparative period. For the first nine months of 2009, total operating expenses
were $21.7 million compared to $22.8 million in the equivalent 2008 period. The decreases are
attributable to the re-allocation of production related costs to cost of revenues following the
commencement of commercial sales and are also partially offset by expansion of commercialization
activities in Europe following the receipt of CE Marking in January 2009, costs associated with the
proposed Thoratec merger and the expansion of the Companys U.S. clinical trial.
Net loss
for the 2009 third quarter was $5.9 million, or a $0.60 loss per basic and diluted share,
compared to a $4.9 million net loss, or a loss of $0.57 per basic and diluted share, in the 2008
third quarter. For 2009 year to date, net loss was $19.0 million, or a loss of $2.07 per basic and
diluted share, compared to a $19.8 million net loss, or a loss of $2.61 per basic and diluted
share, in the prior year nine-month period. These figures include a $2.2 million (non-cash) charge
recorded during the 2009 period associated with a change in the fair value of a derivative
instrument embedded in the $20 million loan facility provided by Thoratec Corporation.
Godshall continued, We are making the necessary investments in our operating infrastructure,
staffing and clinical trials so as to lay the foundation for our continued growth.
The balance sheet was strengthened during the third quarter as a result of a $60 million private
placement of common stock entered into in mid August 2009. At September 30, 2009 the balance sheet
showed $31.4 million in cash and cash equivalents, with the outstanding $30.7 million of the $60
million private placement having been released from escrow to the Company following stockholder
approval of the private placement on October 26, 2009.
The Company will host a conference call on Thursday, November 5, 2009 at 8.00 a.m. U.S. Eastern
time (being 12:00 a.m. Australian Eastern Daylight Time between November 5 and 6, 2009) to discuss
its third quarter results. The call may be accessed by dialing
1-877-407-4018 five minutes prior to the scheduled start time and
referencing HeartWare. For callers outside the United
States, dial +1-201-689-8471. Doug Godshall, Chief Executive Officer, President and Executive
Director, and David McIntyre, Chief Financial Officer and Chief Operating Officer, will host the
conference call.
A live web cast of the call will also be available at the Companys website (www.heartware.com) by
selecting HeartWare Third Quarter and Nine Months 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 and Class 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® Ventricular Assist System in the
European Union. The device is currently the subject of a 150-patient clinical trial in the United
States for a Bridge-to-Transplant indication. For additional information, please visit the
companys website at www.heartware.com.
HeartWare International, Inc. is a member of the Russell 2000(R) and its securities are
publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.
For further information:
US Investor Relations
Matt Clawson
Allen & Caron, Inc.
Email. matt@allencaron.com
Tel. +1 949 474 4300
Matt Clawson
Allen & Caron, Inc.
Email. matt@allencaron.com
Tel. +1 949 474 4300
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 progress of clinical trials. 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. We do not assume any
obligation to publicly update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise. We 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 those
described in Item 1A. Risk Factors in our Annual Report on Form 10-K filed with the SEC on
February 26, 2009 and Part II, Item 1A. Risk Factors in our Quarterly Reports on Form 10-Q for
the quarters ended March 31, 2009 and June 30, 2009 filed with the SEC on May 8, 2009 and August
14, 2009, respectively, and those described in other reports filed from time to time with the SEC.
- Tables to Follow -
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HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except share and per share data)
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
Revenues, net |
$ | 7,506 | $ | 88 | $ | 11,952 | $ | 88 | ||||||||
Cost of revenues |
4,103 | | 6,401 | | ||||||||||||
Gross profit |
3,403 | 88 | 5,551 | 88 | ||||||||||||
Operating expenses: |
||||||||||||||||
Selling,
general and administrative expenses |
3,149 | 3,181 | 11,721 | 7,993 | ||||||||||||
Research and development expenses |
3,646 | 5,478 | 9,994 | 14,801 | ||||||||||||
Total operating expenses |
6,795 | 8,659 | 21,715 | 22,794 | ||||||||||||
Loss from operations |
(3,392 | ) | (8,571 | ) | (16,164 | ) | (22,706 | ) | ||||||||
Other income (expense): |
||||||||||||||||
Foreign exchange gain (loss) |
108 | 3,196 | (260 | ) | 1,925 | |||||||||||
Interest expense |
(351 | ) | (2 | ) | (351 | ) | (17 | ) | ||||||||
Interest income |
7 | 475 | 26 | 1,052 | ||||||||||||
Change in
fair value of derivative instrument |
(2,224 | ) | | (2,224 | ) | | ||||||||||
Other, net |
(22 | ) | | (25 | ) | (92 | ) | |||||||||
Loss before income taxes |
(5,874 | ) | (4,902 | ) | (18,998 | ) | (19,838 | ) | ||||||||
Provision for income taxes |
| | | | ||||||||||||
Net loss |
$ | (5,874 | ) | $ | (4,902 | ) | $ | (18,998 | ) | $ | (19,838 | ) | ||||
Net loss per common share
basic and diluted |
$ | (0.60 | ) | $ | (0.57 | ) | $ | (2.07 | ) | $ | (2.61 | ) | ||||
Weighted average shares
outstanding basic and diluted |
9,715,577 | 8,654,660 | 9,156,074 | 7,614,416 | ||||||||||||
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HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands except share and per share data)
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 31,421 | $ | 20,804 | ||||
Accounts receivable |
6,138 | 244 | ||||||
Inventories, net |
8,008 | 3,508 | ||||||
Prepaid expenses and other current assets |
1,140 | 1,062 | ||||||
Total current assets |
46,707 | 25,618 | ||||||
Property, plant and equipment, net |
3,914 | 3,609 | ||||||
Other intangible assets, net |
1,118 | 823 | ||||||
Deferred financing costs, net |
3,603 | | ||||||
Restricted cash |
288 | 288 | ||||||
Total assets |
$ | 55,630 | $ | 30,338 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 3,404 | $ | 699 | ||||
Accrued expenses and other current liabilities |
2,496 | 2,883 | ||||||
Total current liabilities |
5,900 | 3,582 | ||||||
Long-term convertible debt |
4,000 | | ||||||
Derivative instrument |
6,115 | | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Common stock, $.001 par value; 25,000,000
shares authorized; 10,316,809 and 8,866,702
shares issued and outstanding at September 30,
2009 and December 31, 2008, respectively |
10 | 9 | ||||||
Additional paid-in capital |
143,447 | 112,401 | ||||||
Accumulated
deficit |
(95,961 | ) | (76,963 | ) | ||||
Accumulated other comprehensive loss: |
| | ||||||
Cumulative translation adjustments |
(7,881 | ) | (8,691 | ) | ||||
Total stockholders equity |
39,615 | 26,756 | ||||||
Total liabilities and stockholders equity |
$ | 55,630 | $ | 30,338 | ||||
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