For the first quarter ended January 31, 2004, Haemacure Corporation
(TSX:HAE), Montreal, recorded sales of $1.22 million, compared with
$5.34 million for the first quarter of fiscal 2003. This significant
decrease is attributable to the termination of the sale of the fibrin
sealant Hemaseel APR in November 2003.
The gross margin for the first quarter was 49%, compared with 56%
for the first quarter of 2003. This decrease was attributable to a
declining sale price of Hemaseel APR and the absence of commission
revenues from the sale of Gelfoam.
Operating expenses also decreased significantly in all categories,
down to $1.64 million from $5.08 million for the first quarter of 2003.
The decrease is mainly due to the major downsizing of Haemacure's
US operations as a result of the termination of the sale of Hemaseel
APR.
At the close of the first quarter, the net consolidated loss
amounted to $1.06 million, or $0.04 per share, down from a loss of $2.13
million, or $0.08 per share, for the first quarter of fiscal 2003.
Financial Position
As at January 31, 2004, current assets amounted to $2.26 million,
compared with $9.64 million at the close of fiscal 2003. This decrease
is mainly due to the decrease in trade accounts receivable and
inventories, as a result of the termination of the sale of Hemaseel APR,
and to the decrease in other receivables resulting from the cashing in
November 2003 and January 2004 of amounts to be received from Baxter
Healthcare S.A. (Baxter) under the settlement agreement entered into on
October 31, 2003. The decrease was partly off-set by the increase in
cash and cash equivalents, which went from $618,759 at the close of
fiscal 2003 to $1.39 million at the close of the first quarter.
As at January 31, 2004, current liabilities decreased to $824,046
from $6.99 million at the close of fiscal 2003. This decrease is mainly
the result of the payment to Baxter in November 2003 of outstanding
accounts payable amounting to US$1.6 million ($2.1 million), the full
repayment of the line of credit and the payment of US$675,000 ($890,000)
to Bio Products Laboratory (BPL) both in December 2003, pursuant to the
settlement agreements reached with Baxter and BPL. Part of the decrease
is also due to the payment of severance pay and salaries of $275,000 and
commissions of $270,000, which were accrued at the close of fiscal 2003.
Fixed assets rose to $689,854, up from $565,424 at the close of
fiscal 2003, as a result of the purchase of equipment under leasing
contracts with UPS Capital.
The financial statements include a going concern assumption note as
the corporation's ability to continue operating as a going concern
is dependent on its raising additional financing and achieving a profit
on its business.
Hemaseel HMN and Hemaseel Thrombin
Haemacure is now focusing its efforts and resources on rapidly
developing its proprietary fibrin sealant (Hemaseel HMN) and thrombin
(Hemaseel Thrombin) products, which includes, in the short term,
securing a manufacturing contract and completing Phase III clinical
trials to support the filing of Biologics License Applications (BLAs)
with regulatory authorities in the United States and Europe, in order to
launch these products on the market by early 2007. The company is
currently active in arranging for the manufacture of product for
clinical trials and commercialization.
Phase III clinical trials for Hemaseel HMN were initiated in 1998
and remain to be completed; the related Investigative New Drug
Applications with the U.S. FDA and certain European countries are still
open. The product was tested on 150 patients, no adverse reaction were
reported and the resulting data will be used in support for the BLAs to
be filed. Haemacure plans on resuming the trials during the first of
quarter of fiscal 2005 and on filing BLAs with regulatory authorities
during the fourth quarter of the same year.
Haemacure will have available for this project the US$ 4.5 million
to be received from ZLB Bioplasma AG (ZLB) under the 2002 settlement
agreement, and the US$2 million to be received from Baxter in January
2005 and January 2006. Payment by ZLB is conditional upon achieving
certain milestones related to the completion of the clinical trials and
the manufacture of Hemaseel HMN. Additional financing will be required.
As announced on February 24, 2004 Haemacure has retained PowerOne
Capital Markets Ltd. of Toronto, Ontario to act as agent for a private
placement under which Haemacure would issue a maximum of 10 million
units at a price of $0.50 per unit for total proceeds to the Corporation
of $5 million. In addition, PowerOne will be granted an option to
increase the offering by up to 2 million units. If exercised, the total
proceeds would be $6 million. Each unit will consist of one common share
and one half common share purchase warrant. Each whole warrant will
permit its holder to subscribe for one additional common share for a
period of two years following the closing of the offering, at a price of
$0.60 during the first year and $0.75 during the second year. The net
proceeds will be used to complete the Hemaseel HMN project and the
balance, if any, will be used for working capital purposes.
Target Markets
Haemacure's main product offering consists of all-human fibrin
sealant and thrombin products. The aggregate value of the worldwide
market for these products was in excess of US$ 300 million in 2003 and
is currently estimated to grow to nearly US$500 million in 2007, when
Haemacure plans on launching its products.
The first commercial fibrin sealant approved by the U.S. FDA was
approved in May 1998. Haemacure launched Hemaseel APR in June 1998. By
2003, the U.S. fibrin sealant market had reached approximately US$65
million and is now expected to grow to US$90 million in 2007. The
worldwide fibrin sealant market, excluding the U.S., is currently
expected to reach US$ 150 million in 2007. The U.S. thrombin market has
seen a faster growth, increasing from US$ 15 million in 1998 to US$141.7
million in 2003. The U.S. thrombin market is supplied by one American
manufacturer offering a bovine-derived thrombin. The U.S. and rest of
the world thrombin markets are expected to grow to US$ 250 million in
2007. Bovine-derived thrombin is not approved in Europe.
"Haemacure developed and patented a technology used as a
platform for product development, from which Hemaseel HMN and Hemaseel
Thrombin are derived. Haemacure enjoys exclusive and full ownership of
its technology and intends to exploit it in all major markets. In
addition, we expect that the all-human nature of our fibrin sealant and
thrombin products, as opposed to other products which contain
bovine-derived components, will provide highly valuable clinical
benefits, as growing concerns continue with bovine components."
said Marc Paquin, president and CEO of Haemacure.
Haemacure Corporation is a Canadian company specializing in the
development and commercialization of innovative biological adhesives,
biomaterials and surgical devices for the acute surgical wound care
market. It also operates offices in Sarasota, Florida through a
wholly-owned subsidiary. The Corporation is traded under stock symbol
HAE on the TSX.
All dollar amounts set forth in this press release are in Canadian
dollars, except where otherwise stated.
For more information, call 941/364-3700 or visit
http://www.haemacure.com.
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