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LPBP Inc · 6-K · For 3/14/03

Filed On 3/14/03, 11:23am ET   ·   Accession Number 909518-3-126   ·   SEC File 0-31102

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  As Of                Filer                Filing    For/On/As Docs:Size              Issuer               Agent

 3/14/03  LPBP Inc                          6-K         3/14/03    1:22K                                    Weil Gotshal & Ma..04/FA

Report of a Foreign Private Issuer   —   Form 6-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 6-K         Report of a Foreign Private Issuer                    10     39K 

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13A-16 OR 15D-16 OF THE SECURITIES EXCHANGE ACT OF 1934 For the month of March 2003 Hemosol Inc. -------------------------------------------------------------------------------- (Translation of registrant's name into English) 2585 Meadowpine Boulevard, Mississauga, Ontario L5N 8H9 -------------------------------------------------------------------------------- (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ ] Form 40-F [X] Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes [ ] No [X]
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The following are included in this Report on Form 6-K: 1. Press Release dated March 13, 2003. 2. Press Release dated March 13, 2003.
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Media Release HEMOSOL ANNOUNCES FOURTH QUARTER AND FULL YEAR 2002 FINANCIAL RESULTS TORONTO, ON, MARCH 13, 2003 - Hemosol Inc. (NASDAQ: HMSL, TSX: HML) today announced financial results for the fourth quarter and year ended December 31, 2002. Unless otherwise stated, all dollar values herein are Canadian dollars. In the fourth quarter of 2002, Hemosol recorded a net loss of $11.4 million or ($0.25) per share, compared to a loss of $10.7 million or ($0.26) per share in the corresponding period of 2001. Net loss for the year ended December 31, 2002 was $54.8 million ($1.23) per share, compared to a loss of $38.6 million or ($0.98) per share for the year ended December 31, 2001. This loss included $6.5 million related to the write off of deferred charges arising from the cancellation of the Company's senior and subordinated debt facilities. The increase in net loss over 2001 was expected as a result of increased development activity related to the commercialization of HEMOLINKTM [hemoglobin raffimer] and completion of the Company's new manufacturing facility. The Company's operating expenses in the fourth quarter totalled $10.5 million, compared to $10.9 million in the corresponding period in 2001. Operating expenses for the 12-month period reached $47.2 million, an increase of $4.7 million or 11% from 2001. The yearly increase was primarily due to increased activities associated with the Company's clinical program. These included factors such as increased clinical grant payments and the hiring of in-house clinical research associates. Additionally, marketing and business development, administration and support services expenses all increased during the first half of the year. During the second half of the year, the Company's cost reduction measures reduced these expenditures, which accounts for the lower year-over-year operating expenses during the third and fourth quarter. Interest income in the quarter was $156,000, bringing total interest income for the year to $842,000 compared to $3.5 million in 2001. The decrease in interest income was due to lower cash and cash-equivalents balances and lower interest rates throughout 2002. Total deferred debt issue costs of approximately $6.5 million were written off during the year as a result of the cancellation of the Company's $35 million senior credit facility and $12.5 million subordinated credit facility. These costs represented both cash and non cash items. These facilities were replaced by a new facility described below. CAPITAL EXPENDITURES AND CASH POSITION Capital expenditures reached $30.4 million in 2002, of which $28.9 million related to the new manufacturing facility and the remainder to production equipment, information technology and lab equipment. The Company has spent $85.8 million on this facility, including $6.5 million in outstanding accounts payable. As such, the plant has been built within budget and on time. At December 31, 2002, Hemosol had $17.6 million in cash and cash equivalents. In October 2002, the Company obtained a $20 million credit facility to fund operations. $10 million of this facility was drawn down in February 2003. Management is in discussions with both investors and potential strategic partners to access cash resources that will be sufficient to fund anticipated operating and capital expenditures during the latter half of 2003 and beyond.
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In December 2002 a wholly owned subsidiary of the Company agreed to explore a joint venture arrangement with two investors pursuant to which they would make a $10 million investment to fund the Company's development programs. This resulted at year end in Hemosol reporting $5 million in cash held in escrow, offset by a debenture liability in the same amount, representing the Company's proportionate share of the joint venture. As of March 13, 2003 final terms of the investment had not been negotiated. CONFERENCE CALL DETAILS The Company will hold a conference call today at 4:30p.m. (Eastern time) to discuss its fourth quarter and year-end results. A live audio webcast of the conference call will be available through www.hemosol.com and www.financialdisclosure.ca. The call will also be archived on these sites for 30 days. ABOUT HEMOSOL INC. Hemosol is a near-term, commercial-stage biopharmaceutical company focused initially on developing life-sustaining therapies for the treatment of acute anemia. Hemosol has a broad range of products in development, including its flagship product HEMOLINK(TM) [hemoglobin raffimer], an oxygen therapeutic, that is designed to rapidly and safely improve oxygen delivery via the circulatory system. HEMOLINK is currently being evaluated in late-stage clinical trials. The Company also is developing additional oxygen therapeutics and a hemoglobin-based drug delivery platform to treat diseases such as hepatitis C and cancers of the liver, as well as a cell therapy initially directed to the treatment of cancer through its cell expansion and stem cell research activities. Hemosol Inc.'s common shares are listed on The NASDAQ Stock Market under the trading symbol "HMSL" and on the Toronto Stock Exchange (TSX) under the trading symbol "HML". HEMOLINK is a registered trademark of Hemosol Inc. Certain statements concerning Hemosol's future prospects are "forward-looking statements" under the United States Private Securities Litigation Reform Act of 1995. 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 obtain regulatory approvals for its products; Hemosol's ability to successfully complete clinical trials for its products; technical or manufacturing or distribution issues; the competitive environment for Hemosol's products; the degree of market penetration of Hemosol's products; 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. Contact: JASON HOGAN Investor Relations 416 361 1331 800 789 3419 416 815 0080 fax ir@hemosol.com www.hemosol.com Financial Statements to Follow:
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Hemosol Inc. consolidated balance sheet [Enlarge/Download Table] ============================================================ =================== ====================== Dec 31, 2002 Dec 31, 2001 $ $ (THOUSANDS OF CANADIAN DOLLARS) audited audited ============================================================ =================== ====================== ASSETS CURRENT Cash and cash equivalents 17,579 2,785 Cash held in escrow 5,000 -- Short-term investments --- 67,052 Amounts receivable and other assets 1,077 3,156 Inventory and supplies 2,877 1,731 ============================================================ =================== ====================== TOTAL CURRENT ASSETS 26,533 74,724 ============================================================ =================== ====================== OTHER Capital assets, net 88,907 60,899 Patents and trademarks, net 2,176 1,964 Deferred charges, net 6,696 6,830 ============================================================ =================== ====================== TOTAL OTHER ASSETS 97,779 69,693 ============================================================ =================== ====================== ============================================================ =================== ====================== TOTAL ASSETS 124,312 144,417 ============================================================ =================== ====================== LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT Accounts payable and accrued liabilities 15,249 13,605 Debenture payable 5,000 ============================================================ =================== ====================== TOTAL CURRENT LIABILITIES 20,249 13,605 ============================================================ =================== ====================== SHAREHOLDERS' EQUITY Share capital 336,289 306,135 Contributed surplus 8,535 8,535 Deficit (240,761) (183,858) ============================================================ =================== ====================== TOTAL SHAREHOLDERS' EQUITY 104,063 130,812 ============================================================ =================== ====================== TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 124,312 144,417 ============================================================ =================== ====================== As at December 31, 2002. There were 46,103,784 issued and outstanding common shares, 2,482,245 outstanding options and 8,977,500 outstanding warrants to purchase common shares.
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Hemosol Inc. consolidated statement of loss and deficit [Enlarge/Download Table] ======================================================= =================================== ==================================== THREE MONTH PERIOD ENDED TWELVE MONTH PERIOD ENDED ======================================================= =================================== ==================================== (THOUSANDS OF CANADIAN DOLLARS, December 31, December 31, December 31, December 31, EXCEPT FOR SHARE DATA) 2002 2001 2002 2001 ======================================================= ================= ================= ================== ================= EXPENSES Research and development Scientific and process 2,600 5,033 15,271 18,386 Regulatory and clinical 4,618 2,327 17,173 11,771 ======================================================= ================= ================= ================== ================= Total research and development 7,218 7,360 32,444 30,157 Administration 1,312 879 6,115 5,137 Marketing and business development 1,051 2,042 6,018 5,561 Support services 873 606 2,602 1,594 ======================================================= ================= ================= ================== ================= 10,454 10,887 47,179 42,449 ======================================================= ================= ================= ================== ================= Loss from operations (10,454) (10,887) (47,179) (42,449) Amortization of deferred charges (836) (360) (1,587) (360) Write off of deferred charges - (6,453) Interest income 156 828 842 3,488 Foreign currency translation gain (loss) (63) (262) (246) 970 ======================================================= ================= ================= ================== ================= Loss before income taxes (11,197) (10,681) (54,623) (38,351) Provision for income taxes (211) (67) (211) (226) ======================================================= ================= ================= ================== ================= NET LOSS FOR THE PERIOD (11,408) (10,748) (54,834) (38,577) Deficit, beginning of period (229,320) (173,110) (183,858) (136,388) Share issue costs (33) (2,069) (8,893) ======================================================= ================= ================= ================== ================= DEFICIT, END OF PERIOD (240,761) (183,858) (240,761) (183,858) ======================================================= ================= ================= ================== ================= BASIC AND DILUTED LOSS PER COMMON SHARE (0.25) (0.26) (1.23) (0.98) ======================================================= ================= ================= ================== ================= WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING [000's] 46,066 40,840 44,514 39,215 ======================================================= ================= ================= ================== =================
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Hemosol Inc. consolidated statement of cash flows [Enlarge/Download Table] ======================================================= =================================== ==================================== THREE MONTH PERIOD ENDED TWELVE MONTH PERIOD ENDED ======================================================= =================================== ==================================== (THOUSANDS OF CANADIAN DOLLARS) December 31, December 31, December 31, December 31, 2002 2001 2002 2001 ======================================================= ================= ================= ================== ================= OPERATING ACTIVITIES Net loss for the period (11,408) (10,748) (54,834) (38,577) Add (deduct) items not requiring an outlay of cash Foreign currency translation (gain) loss (131) 814 52 (42) Amortization of deferred charges 836 360 1,587 360 Write-off of deferred charges - 6,453 Amortization of capital assets and patents and trademarks 502 857 2,565 2,377 Compensation cost for non-employee stock options - 134 - 134 ======================================================= ================= ================= ================== ================= (10,201) (8,583) (44,177) (35,748) Net change in non-cash working capital 2,171 (726) 3,818 (2,186) balances related to operations ======================================================= ================= ================= ================== ================= CASH USED IN OPERATING ACTIVITIES (8,030) (9,309) (40,359) (37,934) ======================================================= ================= ================= ================== ================= INVESTING ACTIVITIES Patent and trademark costs (131) (449) (327) (568) Purchase of capital assets (5,189) (16,168) (31,699) (38,415) Short-term investments - 1,348 67,052 (67,052) ======================================================= ================= ================= ================== ================= CASH PROVIDED BY (USED IN) (5,320) (15,269) 35,026 (106,035) INVESTING ACTIVITIES ======================================================= ================= ================= ================== ================= FINANCING ACTIVITIES Proceeds on issuance of common shares (654) 612 22,170 113,078 Deferred charges (465) (640) Share issue costs 685 (1,351) (8,393) Proceeds on issuance of debenture 5,000 5,000 Increase in cash held in escrow (5,000) (5,000) ======================================================= ================= ================= ================== ================= CASH PROVIDED BY FINANCING ACTIVITIES (434) 612 20,179 104,685 ======================================================= ================= ================= ================== ================= Net increase (decrease) in cash (13,784) (23,966) 14,846 (39,284) and cash equivalents Effect of exchange rate changes on cash and cash equivalents 131 (814) (52) 42 Cash and cash equivalents, beginning of period 31,232 27,565 2,785 42,027 ======================================================= ================= ================= ================== ================= CASH AND CASH EQUIVALENTS, 17,579 2,785 17,579 2,785 END OF PERIOD ======================================================= ================= ================= ================== =================
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Media Release HEMOSOL TO REVIEW SAFETY DATA PRIOR TO CONTINUING ENROLMENT IN CARDIAC TRIAL TORONTO, ON, MARCH 13, 2003 - Hemosol Inc. (NASDAQ: HMSL, TSX: HML) today announced that at the recommendation of the Company's Data Safety Monitoring Board (DSMB) it has elected to review safety data prior to continuing enrolment in its cardiac trial (HLK 213/304). This trial involves the use of HEMOLINK(TM) [hemoglobin raffimer] in patients undergoing cardiac bypass grafting (CABG) surgery. The DSMB's recommendation is based on an observation of an imbalance in the incidence of certain adverse events between the HEMOLINK and control groups. Although the DSMB had recently cleared the trial to continue following the third and final interim safety review, their ongoing review of data indicates that there may be the potential for an increase in certain cardiac adverse events in the HEMOLINK group. "Following an in-depth analysis of the data, and with the advice of the regulatory agencies, we will determine how we will proceed," said John W. Kennedy, President and CEO of Hemosol. "This observation from the HLK 213 interim data may be due to any number of reasons including variables in the patient population." As a precaution the Company has also voluntarily suspended enrolment in its Phase II clinical study involving the use of HEMOLINK in patients undergoing Orthopedic Surgery (HLK 210). CONFERENCE CALL DETAILS The Company will hold a conference call today at 4:30p.m. (Eastern time) to discuss this development and its fourth quarter and year-end results, which will be released later today. A live audio webcast of the conference call will be available through www.hemosol.com and www.financialdisclosure.ca. The call will also be archived on these sites for 30 days. ABOUT HEMOSOL INC. Hemosol is a near-term, commercial-stage biopharmaceutical company focused initially on developing life-sustaining therapies for the treatment of acute anemia. Hemosol has a broad range of products in development, including its flagship product HEMOLINK(TM) [hemoglobin raffimer], an oxygen therapeutic, that is designed to rapidly and safely improve oxygen delivery via the circulatory system. HEMOLINK is currently being evaluated in late-stage clinical trials. The Company also is developing additional oxygen therapeutics and a hemoglobin-based drug delivery platform to treat diseases such as hepatitis C and cancers of the liver, as well as a cell therapy initially directed to the treatment of cancer through its cell expansion and stem cell research activities. Hemosol Inc.'s common shares are listed on The NASDAQ Stock Market under the trading symbol "HMSL" and on the Toronto Stock Exchange (TSX) under the trading symbol "HML". HEMOLINK is a registered trademark of Hemosol Inc. Certain statements concerning Hemosol's future prospects are "forward-looking statements" under the United States Private Securities Litigation Reform Act of 1995. 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 obtain regulatory approvals for its products; Hemosol's ability to successfully complete clinical trials for its products; technical or manufacturing or
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distribution issues; the competitive environment for Hemosol's products; the degree of market penetration of Hemosol's products; 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. Contact: JASON HOGAN Investor Relations 416 361 1331 800 789 3419 416 815 0080 fax ir@hemosol.com www.hemosol.com
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SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. HEMOSOL INC. Date: March 14, 2003 By: /s/ Lee D. Hartwell ---------------------------------------- Name: Lee D. Hartwell Title: Chief Financial Officer and Vice-President Corporate Development

Dates Referenced Herein   and   Documents Incorporated By Reference

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This 6-K Filing   Date First   Last      Other Filings
12/31/013
12/31/023520-F
3/13/0328
Filed On / Filed As Of / For The Period Ended3/14/0310
 
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