Hemosol (NASDAQ:HMSL)
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TORONTO, Aug. 12 /PRNewswire-FirstCall/ -- Hemosol Corp. (NASDAQ:HMSLNASDAQ: TSX:NASDAQ:HML) today announced financial results and reviewed operations for the second quarter ended June 30, 2005. Unless otherwise stated, all dollar amounts presented herein are in Canadian dollars.
Highlights of the quarter included:
- The kick-off of the Company's strategy to capitalize on the
opportunity represented by the therapeutic plasma proteins market,
through the choice of Immune Globulin Intravenous 10% (IGIV) as the
first product that the Company will advance through clinical
development and the regulatory process; and
- Shipment of Hepalean(R) products under Hemosol's contract with
Organon Canada began. The initial order was fulfilled after Hemosol
received a license from Health Canada following the regulatory
agency's recent successful inspection of the Company's Meadowpine
facility.
Subsequent to the end of the quarter the Company completed initial discussions with the US Food and Drug Administration (FDA) with respect to the clinical development of IGIV. During these discussions the FDA agreed with the Company's basic proposed clinical development plans and offered valuable guidance. If clinical development of the Company's IGIV product is completed successfully in line with these discussions, the clinical data would support the approval of a Biological License Application for the treatment of patients with Primary Immune Deficiency.
"The second quarter marked the initiation of two important components of our growth strategy," said Lee Hartwell, President and CEO of Hemosol. "In addition to choosing IGIV as our first entry into the multi-billion dollar therapeutic plasma protein market, we began shipments of Hepalean products to Organon Canada under our first contract manufacturing relationship."
Financial Results
The Company's net loss during the second quarter was $6.9 million or ($0.39) per share compared to net income of $2.9 million or $0.21 per share for the quarter ended June 30, 2004. The results for the quarter ended June 30, 2004 contained a one-time gain of $6.8 million related to the Company's Plan of Arrangement. For the first six months of 2005, Hemosol's net loss was $12.8 million or ($0.79) per share compared to a loss of $2.1 million or ($0.15) per share in the first half of 2004.
Total operating expenses for the quarter ended June 30, 2005 increased to $6.6 million from $4.5 million for the quarter ended June 30, 2004. Scientific and process costs comprised the biggest portion of the increased expense, rising to $4.9 million in the second quarter of 2005 compared to $2.7 million in the second quarter of 2004.
As of June 30, 2005 the Company had $3.8 million of cash and cash- equivalents and working capital of $4.6 million. During the quarter Hemosol closed financings generating gross proceeds of approximately $13.4 million. Subsequent to quarter-end, the Company received just over $1 million which was released from an escrow account established as part of the Plan of Arrangement completed on April 30, 2004. The Company's monthly cash used in operating activities is approximately $1.5 million and the Company is implementing cash conservation measures in an effort to reduce cash utilization.
The Company also continues to undertake a number of initiatives with respect to generating the necessary capital required to execute its therapeutic protein strategy. These activities include advanced discussions with strategic and financial partners in addition to initiatives to raise the requisite funds by way of the capital markets. Hemosol will require additional capital early in the fourth quarter in order to continue as a going concern.
Plasma Protein Market Opportunity
The market opportunity for the Company's plasma protein products is substantial. In 2004 the North American market for all therapeutic plasma proteins was approximately US$2.4 billion. The Company initially intends to seek regulatory approval to manufacture and market three therapeutic proteins isolated using its technology:
- Immune Globulins Intravenous (IGIV);
- Alpha1 Proteinase Inhibitor (A1PI); and
- von Willebrand Factor/Factor VIII (vWF/VIII)
Sales of IGIV in the US in 2004 were estimated to be U.S. $1.2 billion, a rise of 10% over the prior year and growth of 7-10% per year is expected to continue. The market for A1PI was approximately $175 million. The demand for these therapeutic proteins is expected to increase (i) as new indications for these products are discovered and approved, and (ii) as the number of patients requiring therapy under the existing indications increase
Hemosol continues to work closely with it's partner, ProMetic Life Sciences in the implementation of the Cascade technology which can also extract proteins such as fibrinogen, plasmin, and albumin. These additional proteins could represent additional near-term development opportunities.
More Financial Results
Scientific and process development expenses increased to $5.0 million for the quarter ended June 30, 2005 from $2.7 million for the quarter ended June 30, 2004. This increase was mainly due to increased activity related to bio-manufacturing as the Company prepared its vial filling facility for the ultimately successful Health Canada licensing inspection. The facility was subsequently put into use to fulfil the Organon Canada initial order.
Regulatory and clinical expenses of $0.3 million for the quarter ended June 30, 2005 were modestly lower than $0.4 million of such costs in the same period in fiscal 2004.
Administrative expenses decreased to $1.0 million from $1.3 million primarily due to lower estimates for capital taxes, reduction in salaries and lower insurance costs.
Marketing and business development expenses increased to $0.3 million in the second quarter from $0.04 million for the same period in 2004 primarily related to increased activity for business development costs associated with bio-manufacturing and pipeline partnering activities.
Amortization of deferred charges for the quarter ended June 30, 2005, were $0.2 million, representing the charge related to the maintenance of the guarantee of the Company's $20.0 million credit facility as well as charges related to the convertible note issued April 8, 2005.
Financial Statements to Follow:
The following statements should be read in conjunction with the applicable notes, which can be found on the Company's website at http://www.hemosol.com/.
Hemosol Corp. (A development stage company)(Incorporated under the laws
of Ontario)
CONSOLIDATED BALANCE SHEETS
(unaudited)
June 30 December 31
2005 2004
(in thousands of dollars) $ $
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ASSETS
Current
Cash and cash equivalents 3,812 4,230
Cash held in escrow 1,000 1,000
Prepaids and other assets 623 366
Inventory 1,571 1,329
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Total current assets 7,006 6,925
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Property, plant and equipment, net 80,435 83,104
Patents and trademarks, net 1,108 1,164
License technology, net 8,772 5,022
Deferred charges, net 1,378 177
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Total other assets 91,693 89,467
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98,699 96,392
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LIABILITIES AND SHAREHOLDERS' EQUITY
Current
Accounts payable and accrued liabilities 2,380 2,538
Short-term portion of convertible note 350 -
Short-term debt - 20,000
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Total current liabilities 2,730 22,538
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Long-term debt 20,000 -
Convertible note 3,650 -
Minority interest 4,195 5,163
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Total long term liabilities 27,845 5,163
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Total liabilities 30,575 27,701
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Shareholders' equity
Common shares 320,294 311,711
Equity portion related to convertible note 1,453 -
Warrants and options 16,250 14,080
Contributed surplus 9,125 9,125
Deficit (278,998) (266,225)
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Total shareholders' equity 68,124 68,691
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98,699 96,392
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Hemosol Corp.
(A development stage company)(Incorporated under the laws of Ontario)
CONSOLIDATED STATEMENTS OF LOSS
(unaudited)
Three months ended Six months ended
June 30 June 30
(in thousands of dollars 2005 2004 2005 2004
except per share data) $ $ $ $
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EXPENSES
Research and development
Scientific and process 4,937 2,676 9,569 4,731
Regulatory and clinical 296 364 575 663
Administration 1,035 1,340 1,457 2,169
Marketing and business
development 260 43 450 150
Support services 142 77 325 261
Foreign currency translation
gain (61) 18 (62) 9
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Loss from operations 6,609 4,518 12,314 7,983
Amortization of deferred
charges 246 434 593 1,687
Interest income (42) (51) (60) (87)
Interest expense 431 243 690 506
Net gain on Arrangement - (6,838) - (6,838)
Accretion in carrying value
of convertible note 174 - 174 -
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Loss (income) before minority
interest and income taxes 7,418 (1,694) 13,711 3,251
Minority interest (520) (256) (968) (256)
Provision for (recovery of)
income taxes
Current 20 50 30 100
Future - (1,029) - (1,029)
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Net loss (income) for the
period 6,918 (2,929) 12,773 2,066
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Basic and diluted loss
(income) per share 0.39 (0.21) 0.80 0.15
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Weighted average number of
common shares outstanding
(000's) 17,590 14,113 15,945 14,041
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CONSOLIDATED STATEMENTS OF DEFICIT
(unaudited)
Three months ended Six months ended
June 30 June 30
2005 2004 2005 2004
(in thousands of dollars) $ $ $ $
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Deficit, beginning of period 272,080 258,172 266,225 253,177
Net loss (income) for the
period 6,918 (2,929) 12,773 2,066
Distribution - 2,900 - 2,900
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Deficit, end of period 278,998 258,143 278,998 258,143
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Hemosol Corp.
(A development stage company)(Incorporated under the laws of Ontario)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three months ended Six months ended
June 30 June 30
2005 2004 2005 2004
(in thousands of dollars) $ $ $ $
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OPERATING ACTIVITIES
Net (loss) income for the
period (6,918) 2,929 (12,773) (2,066)
Add (deduct) items not
involving cash
Amortization of property,
plant and equipment 1,560 567 3,124 1,110
Amortization of license
technology 162 42 250 84
Amortization of patents
and trademarks 29 41 56 70
Amortization of deferred
charges 246 434 593 1,687
Stock-based compensation 120 1,053 184 1,053
Accretion in carrying value
of convertible note 174 - 174 -
Future tax liability - (1,029) - (1,029)
Minority interest (520) (256) (968) (256)
Net gain on arrangement - (6,838) - (6,838)
Foreign currency translation
(gain) loss - (8) - -
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(5,147) (3,065) (9,360) (6,185)
Net change in non-cash working
capital balances related to
operations (1,868) (282) (659) (1,975)
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Cash used in operating
activities (7,015) (3,347) (10,019) (8,160)
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INVESTING ACTIVITIES
Patents and trademark costs - (4) - (6)
Purchase of property, plant
and equipment (45) (125) (455) (255)
Purchase of license technology (1,070) (1,500) (1,070) (1,500)
Proceeds from arrangement,
net of transaction cost - 12,898 - 12,898
Purchase of short term
investments - (6,965) - (6,965)
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Cash provided by (used in)
investing activities (1,115) 4,304 (1,525) 4,172
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FINANCING ACTIVITIES
Proceeds on issuance of
common shares, warrants
and options 6,118 - 6,118 180
Issuance of convertible
debentures 5,633 - 5,633 -
Increase in deferred charges (116) - (625) -
Proceeds from bulge facility 500 - 500 -
Payment of bulge facility (500) - (500) -
Cash released from escrow - - - 448
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Cash provided by financing
activities 11,635 - 11,126 628
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Effect of exchange rates on
cash and cash equivalents - 8 - -
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Net increase (decrease) in
cash and cash equivalents
during the period 3,505 965 (418) (3,360)
Cash and cash equivalents,
beginning of period 307 3,800 4,230 8,125
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Cash and cash equivalents,
end of period 3,812 4,765 3,812 4,765
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About Hemosol
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Hemosol is an integrated biopharmaceutical developer and manufacturer of biologics, particularly blood-related protein based therapeutics. The Company is deploying a novel technology, Plasma Protein Chromatography (PPC), which has the potential to change the business dynamics of the therapeutic plasma proteins sector. Hemosol also continues to develop its rich and diverse therapeutic pipeline that includes three technology platforms - Oxygen Therapeutics for the treatment of high volume blood loss; Drug Delivery for the treatment of Hepatitis C and liver cancer; and Cell Therapeutics for the treatment of chronic myelogenous leukemia and chemotherapy-induced anemia.
For more information visit Hemosol's website at http://www.hemosol.com/.
The Common Shares are listed on the NASDAQ Stock Market under the trading symbol "HMSL" and on the TSX under the trading symbol "HML".
Certain statements concerning Hemosol's future prospects are "forward- looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and other applicable securities legislation. There can be no assurances that future results will be achieved, and actual results could differ materially from forecasts and estimates. Important factors that could cause actual results to differ materially from forecasts and estimates include, but are not limited to: Hemosol's ability to successfully implement the Cascade technology and commercialize products derived from that technology; Hemosol's ability to obtain additional financing which is critical to the implementation of the Cascade technology and to Hemosol's continued viability as a going concern; Hemosol's ability to obtain regulatory approvals for its products; Hemosol's ability to successfully complete clinical trials for its products; Hemosol's ability to enter into satisfactory arrangements for the supply of materials used in its manufacturing operations and the sale of resulting products to customers; technical, manufacturing or distribution issues; the competitive environment for Hemosol's products and services; the degree of market penetration of Hemosol's products; Hemosol's ability to attract and retain clients for its bio-manufacturing services; the risk that Hemosol may not become profitable; and other factors set forth in filings with Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission. These risks and uncertainties, as well as others, are discussed in greater detail in the filings of Hemosol with Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission. Hemosol makes no commitment to revise or update any forward-looking statements in order to reflect events or circumstances after the date any such statement is made.
DATASOURCE: Hemosol Corp.
CONTACT: Jason Hogan, Investor & Media Relations,
(416) 361-1331, 800-789-3419, fax: (416) 815-0080, ,
http://www.hemosol.com/;
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