2Q results. WHT is now saying late 1Q or 2Q 2001 for human trials. A subtle change in language from the AGM, but I suspect we can count on it being 2Q at the earliest...
World Heart Corporation announces results for the second quarter of fiscal 2000
OTTAWA, ON, Canada July 25 /CNW/ - World Heart Corporation (WorldHeart or
the Corporation) today announced results for the second quarter of fiscal
2000, which ended on June 30th.
Roderick M. Bryden, President and Chief Executive Officer said, "With the
acquisition of the Novacor division, the quarter marked the beginning of
commercial operation for the Corporation, after four years of research and
development since the business began in May, 1996. July 1st began our first
quarter in which patients will be supported by WorldHeart products, and in
which revenues begin to flow to the Corporation. Revenues are expected to be
modest during the second half of this year, but the clinical experience and
the benefit to patients will provide a basis for increased revenues from
Novacor LVAS in 2001, and the channel for introduction of HEARTSAVERvad(TM)
after regulatory approval. The Corporation's cash resources of $59.5 million
provide a strong financial base for development of the business. The alliance
with Edwards Lifesciences Inc. provides us with strong sales and customer
service and access to the best in valves and technical support."
Short-term in vivo trials continued during the second quarter. Pre-
clinical long term trials, in vivo and in vitro, will begin in the next few
weeks, with HEARTSAVERvad(TM) systems now completed and in bench testing. As
previously announced, proprietary material for production of the flexible
components of HEARTSAVERvad(TM) which was acquired as part of the Novacor
transaction, will be incorporated into HEARTSAVERvad(TM). Systems made with
this material, and incorporating final technical improvements are scheduled
for availability in the fourth quarter. In vivo and in vitro trials of these
devices will be added to the trials in December.
Application to Health Canada for clinical trial approval is planned for
late first or early second quarter next year, and application for U.S.
clinical trial approval (IDE) is expected in the second half of 2001.
Mr. Michael Mussallem, Chairman and Chief Executive Officer, Edwards
Lifesciences Inc., was appointed to the Board of Directors of WorldHeart at
today's Board meeting. "We at Edwards are enthusiastic about this alliance to
bring implantable assist devices to the benefit of many thousands of heart
failure patients. The Novacor LVAS is a leading product in the current
generation of pulsatile devices, and HEARTSAVERvad(TM) holds great promise as
a next generation device that can provide an alternative for near normal life
for many heart failure patients", he said.
As expected, no revenues were earned in the second quarter of 2000,
unchanged from the second quarter of 1999. The net loss of $3,954,000, or $.27
for the period was lower than forecast, although an increase over the
$2,199,000 or $.16 per share for the second quarter of 1999. The increase in
expense for the period was attributable to research and development expenses
of $3,256,000 or $.22 per share compared with $1,297,000 or $.10 per share for
the second quarter of 1999. As previously reported, in connection with
WorldHeart's purchase of its Novacor division, Edward Lifescience Inc,
purchased US $20 million of WorldHeart convertible preferred shares,
increasing the Corporation's cash and short term investment position from
$35,865,000 at June 30, 1999 to $59,490,000 at the end of the quarter. All
financial figures are expressed in Canadian dollars and are prepared in
accordance with generally accepted accounting principles (GAAP) in Canada.
WorldHeart is a medical devices business based initially on pulsatile
ventricular assist devices technology and WorldHeart's related Transcutaneous
Energy Transfer and Biotelemetry technologies. HEARTSAVERvad(TM), which is
under development, is designed to be fully implanted in the chest, remotely
powered, monitored and controlled and requiring no holes in the diaphragm or
skin of the patient. The patient is expected to leave the hospital and resume
relatively normal activities. WorldHeart's newly acquired Novacor Left
Ventricular Assist System (LVAS) has been implanted around the world in more
than 1,150 patients with end-stage heart failure. In Europe, the U.S. and
Canada, the Novacor LVAS is approved as a bridge-to-transplant. This device is
approved in Europe also as an alternate-to-transplant and to support patients
who have an ability to recover use of their natural heart. In the U.S., the
Novacor LVAS is undergoing a clinical trial as an alternate-to-transplant.
WorldHeart is a public company whose stock trades on the NASDAQ National
Market (ticker symbol: WHRT) and The Toronto Stock Exchange (ticker symbol:
WHT). Additional information about WorldHeart can be found at:
www.worldheart.com.
Any forward-looking statements in this release are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act of
1995. Investors are cautioned that all forward-looking statements involve risk
and uncertainties, including without limitation, risks in product development
and market acceptance of and demand for the Corporation's products, risks of
downturns in economic conditions generally, and in the medical devices
markets, risks associated with costs and delays posed by government
regulation, limitations on third party reimbursement, inability to protect
proprietary technology, potential product liability and other risks detailed
in the Corporation's filings with the U.S. Securities and Exchange Commission.
All financial figures are prepared in accordance with Canadian generally
accepted accounting principles (GAAP) and are expressed in Canadian dollars.
World Heart Corporation
Highlights of Statement of Loss (Unaudited)
(Numbers in thousands, except per share data)
Six Months Ended June 30, June 30,
2000 1999
Expenses:
General and administrative $(2,925) $(2,349)
Research and development $(6,377) $(3,058)
Total expenses $(9,302) $(5,407)
Investment income $789 $504
Net loss $(8,513) $(4,903)
Basic and fully diluted loss
per common share $(0.58) $(0.38)
Shares used to compute basic and
diluted loss per share 14,660,503 12,824,990
Highlights of Balance Sheet (Unaudited)
(Numbers in thousands)
Current Assets $75,960 $37,254
Fixed Assets 6,453 904
Total Assets $137,780 $38,849
Current Liabilities $7,336 $1,781
Total Liabilities $69,425 $2,230
Shareholders' Equity $68,355 $36,619
Total Liabilities & Equity $137,780 $38,849
-0- 07/25/2000
For further information: Ian W. Malone, Vice President Finance and Chief Financial Officer, World Heart Corporation, Tel:
(613) 226-4278, Fax: (613) 226-4744, E-mail: ian.malone@worldheart.com |
