FRAMINGHAM, Mass. and SYDNEY, Nov. 4 /PRNewswire-FirstCall/ -- HeartWare
International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator and provider
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 Company's 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 Company's 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(TM) 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 company's website at
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.
For further information:
U.S. Investor Relations
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
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 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-
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
========= ========= ========= =========
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
======= =======
SOURCE HeartWare International, Inc.
Matt Clawson of Allen & Caron, Inc., +1-949-474-4300, matt@allencaron.com, for
HeartWare International
