e6vk
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of
March 2006
Commission File Number 000-31062
Oncolytics Biotech Inc.
(Translation of registrants name into
English)
Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1): o
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a
Form 6-K if submitted solely to provide an attached annual report to security
holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): o
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a
Form 6-K if submitted to furnish a report or other document that the registrant
foreign private issuer must furnish and make public under the laws of the
jurisdiction in which the registrant is incorporated, domiciled or legally
organized (the registrants home country), or under the rules of the home
country exchange on which the registrants securities are traded, as long as
the report or other document is not a press release, is not required to be and
has not been distributed to the registrants security holders, and, if
discussing a material event, has already been the subject of a Form 6-K
submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this
Form, the registrant is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.
If Yes is marked, indicate below the file number assigned to the registrant
in connection with Rule 12g3-2(b): 82 -
TABLE OF CONTENTS
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.
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Oncolytics
Biotech Inc.
(Registrant) |
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Date March 3, 2006 |
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By: |
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/s/ Doug Ball
Doug Ball
Chief Financial Officer |
Financial Statements
Oncolytics Biotech Inc.
December 31, 2005 and 2004
STATEMENT OF MANAGEMENTS RESPONSIBILITY
Management is responsible for the preparation and presentation of the financial statements,
Managements Discussion and Analysis (MD&A) and all other information in the Annual Report.
In managements opinion, the accompanying financial statements have been properly prepared with
reasonable limits of materiality and within the appropriately selected Canadian generally accepted
accounting principles and policies consistently applied and summarized in the financial
statements.
The MD&A has been prepared in accordance with the requirements of securities regulators as
applicable to Oncolytics Biotech Inc.
The financial statements and information in the MD&A generally include estimates that are
necessary when transactions affecting the current accounting period cannot be finalized with
certainty until future periods. Based on careful judgments by management, such estimates have
been properly reflected in the accompanying financial statements and MD&A. The MD&A also includes
information regarding the impact of current transactions and events, sources of liquidity and
capital resources and risks and uncertainty. Actual results in the future may differ materially
from our present assessment of this information because future events and circumstances may not
occur as expected.
Systems of internal controls, including organizational and procedural controls and internal
controls over financial reporting, assessed as reasonable and appropriate in the circumstances,
are designed and maintained by management to provide reasonable assurance that assets are
safeguarded from loss or unauthorized use and to produce reliable records for financial purposes.
We, as the Chief Executive Officer and Chief Financial Officer will certify to the our annual
filings with the CSA and the SEC as required in Canada by Multilateral Instrument 52-109
(certification of Disclosure in Issuers Annual Interim Filings) and in the United States by the
Sarbanes-Oxley Act.
The external auditors conducted an independent examination of corporate and accounting records in
accordance with generally accepted auditing standards to express their opinion on the financial
statements. Their examination included such tests and procedures as they considered necessary to
provide reasonable assurance that the financial statements are presented fairly. The external
auditors have full and free access to our Board of Directors and its Committees to discuss audit,
financial reporting and related matters.
The Board of Directors is responsible for ensuring that management fulfills its responsibilities
for financial reporting and internal control. The Board exercises this responsibility through the
Audit Committee of the Board. This Committee meets with management and the external auditors to
satisfy itself that managements responsibilities are properly discharged and to review the
financial statements and MD&A before they are presented to the Board of Directors for approval.
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/s/ Brad Thompson
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/s/ Doug Ball |
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Brad Thompson, PhD
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Doug Ball, CA |
Chairman, President and CEO
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Chief Financial Officer |
AUDITORS REPORT
To the Shareholders of
Oncolytics Biotech Inc.
We have audited the balance sheets of Oncolytics Biotech Inc. as at December 31, 2005 and 2004 and
the statements of loss and deficit and cash flows for each of the years in the three year period
ended December 31, 2005 and for the cumulative period from inception on April 2, 1998. These
financial statements are the responsibility of the Companys management. Our responsibility is to
express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with Canadian generally accepted auditing standards and the
standards of the Public Company Accounting Oversight Board (United States). Those standards
require that we plan and perform an audit to obtain reasonable assurance whether the financial
statements are free of material misstatement. We were not engaged to perform an audit of the
Companys internal control over financial reporting. An audit includes consideration of internal
control over financial reporting as a basis for designing audit procedures that are appropriate in
the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, and evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, these financial statements present fairly, in all material respects, the financial
position of the Company at December 31, 2005 and 2004 and the results of its operations and its
cash flows for each of the years in the three year period ended December 31, 2005 and the
cumulative period from inception on April 2, 1998 in accordance with Canadian generally accepted
accounting principles.
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Calgary, Canada
February 8, 2006
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Chartered Accountants |
Oncolytics Biotech Inc.
BALANCE SHEETS
As at December 31
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2005 |
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2004 |
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$ |
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$ |
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ASSETS |
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Current |
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Cash and cash equivalents |
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3,511,357 |
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12,408,516 |
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Short-term investments |
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36,894,810 |
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21,510,707 |
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Accounts receivable |
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47,390 |
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47,767 |
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Prepaid expenses |
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540,368 |
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250,365 |
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40,993,925 |
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34,217,355 |
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Capital assets [note 4] |
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189,863 |
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261,688 |
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Intellectual property [note 5] |
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5,110,538 |
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4,997,598 |
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Investments [notes 7 and 8] |
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¾ |
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12,000 |
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46,294,326 |
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39,488,641 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current |
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Accounts payable and accrued liabilities |
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1,692,481 |
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949,258 |
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Alberta Heritage Foundation loan [note 6] |
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150,000 |
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150,000 |
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Commitments and contingency [notes 9 and 10] |
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Shareholders equity |
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Share capital [note 11] |
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Authorized: unlimited |
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Issued: 36,236,748 (2004 31,915,496) |
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84,341,212 |
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66,643,325 |
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Warrants [note 11] |
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4,429,932 |
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3,347,630 |
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Contributed surplus [notes 2,7, 12 and 13] |
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6,413,243 |
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6,349,139 |
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Deficit |
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(50,732,542 |
) |
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(37,950,711 |
) |
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44,451,845 |
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38,389,383 |
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46,294,326 |
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39,488,641 |
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See accompanying notes |
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On behalf of the Board:
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/s/ Brad Thompson
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/s/ Doug Ball |
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Director
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Director |
Oncolytics Biotech Inc.
STATEMENTS OF LOSS AND DEFICIT
For the periods ended December 31
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Cumulative |
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from inception |
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on April 2, |
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1998 to |
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December 31, |
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2005 |
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2004 |
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2003 |
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2005 |
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$ |
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$ |
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$ |
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$ |
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Revenue |
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Rights revenue |
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¾ |
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¾ |
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¾ |
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310,000 |
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Interest income |
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783,456 |
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699,757 |
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313,305 |
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3,569,196 |
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783,456 |
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699,757 |
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313,305 |
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3,879,196 |
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Expenses |
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Research and development [note 10] |
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9,308,977 |
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7,107,998 |
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2,818,962 |
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32,835,505 |
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Operating |
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3,084,897 |
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2,803,669 |
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2,449,478 |
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13,090,691 |
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Stock based compensation [note 12] |
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64,104 |
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2,668,570 |
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996,707 |
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3,762,099 |
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Foreign exchange loss |
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253,608 |
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358,068 |
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2,881 |
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613,578 |
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Amortization intellectual property |
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786,459 |
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686,717 |
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594,353 |
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3,162,791 |
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Amortization capital assets |
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69,532 |
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65,039 |
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69,171 |
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355,046 |
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13,567,577 |
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13,690,061 |
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6,931,552 |
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53,819,710 |
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Loss before the following: |
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12,784,121 |
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12,990,304 |
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6,618,247 |
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49,940,514 |
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Gain on sale of BCY Life Sciences Inc. [note 8] |
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(765 |
) |
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(34,185 |
) |
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(264,453 |
) |
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(299,403 |
) |
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Loss on sale of Transition Therapeutics Inc. [note 8] |
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¾ |
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¾ |
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2,156,685 |
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2,156,685 |
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Loss before taxes |
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12,783,356 |
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12,956,119 |
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8,510,479 |
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51,797,796 |
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Capital tax (recovery) |
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(1,525 |
) |
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¾ |
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33,552 |
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49,746 |
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Future income tax recovery [note 15] |
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¾ |
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¾ |
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¾ |
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(1,115,000 |
) |
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Net loss for the year |
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12,781,831 |
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12,956,119 |
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8,544,031 |
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50,732,542 |
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Deficit, beginning of year |
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37,950,711 |
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24,994,592 |
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16,450,561 |
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¾ |
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Deficit, end of year |
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50,732,542 |
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37,950,711 |
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24,994,592 |
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50,732,542 |
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Basic and diluted loss per share [note 14] |
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(0.39 |
) |
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(0.45 |
) |
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(0.35 |
) |
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See accompanying notes
Oncolytics Biotech Inc.
STATEMENTS OF CASH FLOWS
For the periods ended December 31
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Cumulative |
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from inception |
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on April 2, |
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1998 to |
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December 31, |
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2005 |
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2004 |
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2003 |
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2005 |
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$ |
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$ |
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$ |
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$ |
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OPERATING ACTIVITIES |
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Net loss for the year |
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(12,781,831 |
) |
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(12,956,119 |
) |
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(8,544,031 |
) |
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(50,732,542 |
) |
Deduct non-cash items |
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Amortization intellectual property |
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786,459 |
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|
686,717 |
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|
594,353 |
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3,162,791 |
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Amortization capital assets |
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|
69,532 |
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|
65,039 |
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|
69,171 |
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|
355,046 |
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Stock based compensation [note 12] |
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64,104 |
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2,668,570 |
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|
996,707 |
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3,762,099 |
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Loss on sale of Transition Therapeutics Inc. |
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2,156,685 |
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2,156,685 |
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Other non-cash items [note 19] |
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224,508 |
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|
379,895 |
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(261,572 |
) |
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(773,148 |
) |
Net changes in non-cash working
capital [note19] |
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584,766 |
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(69,065 |
) |
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(489,051 |
) |
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1,092,999 |
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Cash used in operating activities |
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(11,052,462 |
) |
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(9,224,963 |
) |
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(5,477,738 |
) |
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(40,976,070 |
) |
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INVESTING ACTIVITIES |
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Intellectual property |
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(1,033,035 |
) |
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(958,809 |
) |
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(1,045,869 |
) |
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|
(4,656,670 |
) |
Capital assets |
|
|
(61,309 |
) |
|
|
(15,230 |
) |
|
|
(50,729 |
) |
|
|
(587,511 |
) |
Purchase of short-term investments |
|
|
(22,195,253 |
) |
|
|
(6,777,179 |
) |
|
|
(18,111,608 |
) |
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|
(47,084,040 |
) |
Redemption of short-term investments |
|
|
6,656,746 |
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|
3,114,000 |
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|
|
|
|
|
|
9,770,746 |
|
Investment in BCY LifeSciences Inc. |
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|
7,965 |
|
|
|
133,609 |
|
|
|
450,151 |
|
|
|
464,602 |
|
Investment in Transition Therapeutics Inc. |
|
|
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|
|
|
|
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|
2,552,695 |
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|
|
2,532,343 |
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Cash used in investing activities |
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|
(16,624,886 |
) |
|
|
(4,503,609 |
) |
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|
(16,205,360 |
) |
|
|
(39,560,530 |
) |
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FINANCING ACTIVITIES |
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Alberta Heritage Foundation loan |
|
|
|
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|
|
¾ |
|
|
|
¾ |
|
|
|
150,000 |
|
Proceeds from exercise of stock options and
warrants |
|
|
3,384,787 |
|
|
|
8,121,296 |
|
|
|
700,882 |
|
|
|
14,967,068 |
|
Proceeds from private placements |
|
|
15,395,402 |
|
|
|
6,223,763 |
|
|
|
9,844,700 |
|
|
|
38,137,385 |
|
Proceeds from public offerings |
|
|
|
|
|
|
9,150,902 |
|
|
|
5,459,399 |
|
|
|
30,793,504 |
|
|
Cash provided by financing activities |
|
|
18,780,189 |
|
|
|
23,495,961 |
|
|
|
16,004,981 |
|
|
|
84,047,957 |
|
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Increase (decrease) in cash and cash
equivalents during the period |
|
|
(8,897,159 |
) |
|
|
9,767,389 |
|
|
|
(5,678,117 |
) |
|
|
3,511,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of the
period |
|
|
12,408,516 |
|
|
|
2,641,127 |
|
|
|
8,319,244 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of the period |
|
|
3,511,357 |
|
|
|
12,408,516 |
|
|
|
2,641,127 |
|
|
|
3,511,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash interest received |
|
|
993,097 |
|
|
|
459,757 |
|
|
|
187,843 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash taxes paid (net) |
|
|
¾ |
|
|
|
¾ |
|
|
|
1,552 |
|
|
|
|
|
|
See accompanying notes
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
|
|
|
1. |
|
INCORPORATION AND NATURE OF OPERATIONS |
Oncolytics Biotech Inc. (the Company or Oncolytics) was incorporated on April 2, 1998
under the Business Corporations Act (Alberta) as 779738 Alberta Ltd. On April 8, 1998, the Company
changed its name to Oncolytics Biotech Inc.
The Company is a development stage biopharmaceutical company that focuses on the discovery and
development of pharmaceutical products for the treatment of cancers that have not been successfully
treated with conventional therapeutics. The product being developed by the Company may represent a
novel treatment for Ras mediated cancers which can be used as an alternative to existing cytotoxic
or cytostatic therapies, as an adjuvant therapy to conventional chemotherapy, radiation therapy, or
surgical resections, or to treat certain cellular proliferative disorders for which no current
therapy exists.
|
|
|
2. |
|
BASIS OF FINANCIAL STATEMENT PRESENTATION |
On April 21, 1999, SYNSORB Biotech Inc. (SYNSORB) purchased all of the shares of the
Company. In connection with the acquisition, the basis of accounting for the assets and
liabilities of Oncolytics was changed to reflect SYNSORBs cost of acquiring its interest in such
assets and liabilities (i.e. reflecting SYNSORBs purchase cost in the financial statements of the
Company). The amount by which SYNSORBs purchase price exceeded the underlying net book value of
the Companys assets and liabilities at April 21, 1999 was $2,500,000. Such amount has been
credited to contributed surplus and charged to intellectual property which will be amortized to
income based on the established amortization policies for such assets. Subsequent to April 21,
1999 SYNSORBs ownership has been diluted through public offerings of the Companys common shares,
sales of the Companys shares by SYNSORB and a distribution of SYNSORBS ownership interest in the
Company to its shareholders [note 7]. As a result, SYNSORB no longer has any ownership in the
Company.
|
|
|
3. |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
The financial statements of the Company have been prepared in accordance with Canadian
generally accepted accounting principles. These policies are, in all material respects, in
accordance with United States generally accepted accounting principles except as disclosed in note
20. The financial statements have, in managements opinion, been properly prepared within
reasonable limits of materiality and within the framework of the accounting policies summarized
below.
Use of estimates
Because a precise determination of many assets and liabilities is dependent upon future
events, the preparation of financial statements in conformity with generally accepted accounting
principles requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and the disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of expenses during the reporting periods. Actual
results could differ from those estimates and such differences could be significant. Significant
estimates made by management affecting the Companys financial statements include the assessment of
the net realizable value of long lived assets and the amortization period of intellectual property.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
Cash and cash equivalents
Cash and cash equivalents consists of cash on hand and balances with the Companys bank
including interest bearing deposits earning an average interest rate of 2.9% (2004 2.26%).
Short-term investments
Short-term investments consisting primarily of bankers acceptances, treasury bills and bonds
and are liquid investments that are readily convertible to known amounts of cash and are subject to
an insignificant risk of changes in value and with original maturities less than two years at the
time of purchase, and are carried at the lower of amortized cost and market value. Gains and
losses on disposal of short-term investments are included in income in the period of realization.
Premiums or discounts are amortized over the remaining maturity of the instrument and reported in
interest income.
Capital assets
Capital assets are recorded at cost. Amortization is provided on bases and at rates designed
to amortize the cost of the assets over their estimated useful lives. Amortization is recorded
using the declining balance method at the following annual rates:
|
|
|
Office equipment and furniture |
|
20% |
Medical equipment |
|
20% |
Computer equipment |
|
30% |
Leasehold improvements |
|
Straight line over the term of the lease |
Intellectual property
Costs relating to acquiring and establishing intellectual property (mainly patents) are
recorded at cost, net of recoveries. Amortization of the intellectual property is on a
straight-line basis over seventeen years or estimated useful life (currently estimated to be ten
years) and begins on the earlier of a patent being granted or its utilization. The Company
assesses potential impairment of its intellectual property when any events that might give rise to
impairment are known to the Company by measuring the expected net recovery from products based on
the use of the intellectual property.
Investments
Investments are accounted for at cost and written down only when there is evidence that a
decline in value that is other than temporary has occurred.
Foreign exchange
Transactions originating in foreign currencies are translated into Canadian dollars at the
exchange rate in effect at the date of the transaction. Monetary assets and liabilities are
translated at the year-end rate of exchange and non-monetary items are translated at historic
exchange rates. Exchange gains and losses are included in net loss for the year.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
Research and development
Research costs are expensed as incurred. Development costs that meet specific criteria
related to technical, market and financial feasibility will be capitalized. To date, all of the
development costs have been expensed.
Loss per common share
Basic loss per share is determined using the weighted average number of common shares
outstanding during the period.
The Company uses the treasury stock method to calculate diluted loss per share. Under this method,
diluted loss per share is computed in a manner consistent with basic loss per share except that the
weighted average shares outstanding are increased to include additional shares from the assumed
exercise of options and warrants, if dilutive. The number of additional shares is calculated by
assuming that any outstanding in the money options and warrants were exercised at the later of
the beginning of the period or the date of issue and that the proceeds from such exercises were
used to acquire shares of common stock at the average market price during the reporting period.
Stock option plan
The Company has one stock option plan (the Plan) available to officers, directors,
employees, consultants and suppliers with grants under the Plan approved from time to time by the
Board of Directors. Under the Plan, the exercise price of each option equals the market price of
the Companys stock on the date of grant in accordance with Toronto Stock Exchange guidelines.
Vesting is provided for at the discretion of the Board and the expiration of options is to be no
greater than ten years from the date of grant.
Stock based compensation
Officers, Directors and Employees
Effective January 1, 2003, the Company prospectively adopted the fair value based method of
accounting for employee awards granted under its stock option plan (see note 12). The Company
calculates the fair value of each stock option grant using the Black Scholes Option Pricing Model
and the fair value is recorded over the options vesting period on a straight line basis.
Previously, the intrinsic value method was used. The following tables provide pro forma net loss
and pro forma basic and diluted net loss per share had compensation expense, for awards granted in
2002, been based on the fair value method of accounting for stock based compensation:
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Reported net loss |
|
|
12,781,831 |
|
|
|
12,956,119 |
|
|
|
8,544,031 |
|
Compensation expense |
|
|
983 |
|
|
|
4,425 |
|
|
|
46,533 |
|
|
Pro forma net loss |
|
|
12,782,814 |
|
|
|
12,960,544 |
|
|
|
8,590,564 |
|
|
Reported basic and diluted net loss per share |
|
|
(0.39 |
) |
|
|
(0.45 |
) |
|
|
(0.35 |
) |
|
Pro forma basic and diluted net loss per share |
|
|
(0.39 |
) |
|
|
(0.45 |
) |
|
|
(0.35 |
) |
|
As this policy has been applied prospectively, comparative information has not been restated.
Non-employees
Stock based compensation to non-employees is recorded at the fair market value based on the fair
value of the consideration received, or the fair value of the equity instruments granted, or
liabilities incurred, whichever is more reliably measurable, on the earlier of the date at which a
performance commitment is reached, performance is achieved, or the vesting date of the options.
Future income taxes
The Company follows the liability method of accounting for income taxes. Under the liability
method, future income taxes are recognized for the difference between financial statement carrying
values and the respective income tax basis of assets and liabilities (temporary differences).
Future income tax assets and liabilities are measured using substantively enacted income tax rates
expected to apply in the years in which temporary differences are expected to be recovered or
settled. The effect on future income tax assets and liabilities of a change in tax rates is
included in income in the period of the change.
Newly Adopted Canadian Accounting Standards
GAAP Hierarchy and General Standards of Financial Statement Presentation
In 2005, the Company adopted the new CICA Handbook Sections 1100, Generally Accepted Accounting
Principles, and 1400, General Standards of Financial Statement Presentation. Section 1100
describes what constitutes Canadian GAAP and its sources and provides guidance on sources to
consult when selecting accounting policies and determining appropriate disclosures when a matter is
not dealt with explicitly in the primary sources of generally accepted accounting principles,
thereby re-codifying the Canadian GAAP hierarchy. Section 1400 provides general guidance on
financial statement presentation and further clarifies what constitutes fair presentation in
accordance with GAAP. The application of this standard had no impact on the financial position or
results of operations of the Company.
Future Changes in Accounting Policy
Non-monetary Transactions
In 2006, the Company will prospectively adopt the new Canadian standard, Non-monetary Transactions,
which requires application of fair value measurement to non-monetary transactions determined by a
number of tests. The new standard is consistent with recently amended US standards. The Company
does not expect this standard to have a significant impact on its financial statements upon
adoption.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
Financial Instruments
On January 1, 2007, the Company will prospectively adopt the new Canadian accounting standards for
financial instruments and comprehensive income. These new accounting standards will impact our
accounting policy for investment securities. The new rules will require the Company to classify
these securities as held-to-maturity or available-for-sale. Available-for-sale securities will be
measured at fair value with gains and losses recorded in a new section of shareholders equity
called other comprehensive income. There will be no change in accounting for held-to-maturity
securities. The Company does not expect these standards to have a significant impact on its
financial statements upon adoption as the Companys short-term investments will be classified as
held-to-maturity securities.
4. CAPITAL ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
Accumulated |
|
Net Book |
|
|
Cost |
|
Amortization |
|
Value |
|
Medical equipment |
|
|
30,201 |
|
|
|
7,178 |
|
|
|
23,023 |
|
Office equipment |
|
|
27,869 |
|
|
|
17,627 |
|
|
|
10,242 |
|
Office furniture |
|
|
91,080 |
|
|
|
49,840 |
|
|
|
41,240 |
|
Computer equipment |
|
|
167,111 |
|
|
|
84,561 |
|
|
|
82,550 |
|
Leasehold improvements |
|
|
117,333 |
|
|
|
84,525 |
|
|
|
32,808 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
433,594 |
|
|
|
243,731 |
|
|
|
189,863 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
Accumulated |
|
Net Book |
|
|
Cost |
|
Amortization |
|
Value |
|
Medical equipment |
|
|
191,502 |
|
|
|
82,498 |
|
|
|
109,004 |
|
Office equipment |
|
|
29,576 |
|
|
|
16,163 |
|
|
|
13,413 |
|
Office furniture |
|
|
88,788 |
|
|
|
43,046 |
|
|
|
45,742 |
|
Computer equipment |
|
|
126,322 |
|
|
|
66,205 |
|
|
|
60,117 |
|
Leasehold improvements |
|
|
96,636 |
|
|
|
63,224 |
|
|
|
33,412 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
532,824 |
|
|
|
271,136 |
|
|
|
261,688 |
|
|
In 2005, the Company donated the medical equipment used in its Canadian glioma clinical trial to
the clinical trial site. The amount of the donation was $66,069 and equates to the net book value
of the medical equipment donated. This amount has been recorded as a clinical trial cost within
research and development expenses.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
5. INTELLECTUAL PROPERTY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
Accumulated |
|
Net Book |
|
|
Cost |
|
Amortization |
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property |
|
|
8,273,328 |
|
|
|
3,162,790 |
|
|
|
5,110,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 |
|
|
|
|
|
|
Accumulated |
|
Net Book |
|
|
Cost |
|
Amortization |
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intellectual property |
|
|
7,373,742 |
|
|
|
2,376,144 |
|
|
|
4,997,598 |
|
|
6. ALBERTA HERITAGE FOUNDATION LOAN
The Company has received a loan of $150,000 from the Alberta Heritage Foundation for Medical
Research. Pursuant to the terms of the agreement, the Company is required to repay this amount in
annual installments from the date of commencement of sales in an amount equal to the lesser of:
(a) 5% of the gross sales generated by the Company; or (b) $15,000 per annum until the entire loan
has been paid in full.
7. RELATED PARTY TRANSACTIONS
On May 7, 2002, the shareholders of SYNSORB and the Company approved an arrangement whereby
the Company would release from escrow 4,000,000 common shares held by SYNSORB. As consideration,
SYNSORB provided the Company with 1,500,000 common shares of BCY Life Sciences Inc. (BCY) along
with the rights to receive an additional 400,000 common shares of BCY upon the attainment of
certain milestones by BCY at no cash cost to the Company. The Company received 200,000 of these
400,000 common shares on November 27, 2002. These 1,700,000 common shares in BCY were recorded as
an investment at $170,000 based on the quoted market price of the BCY common shares at that time
with an offsetting credit recorded to contributed surplus.
8. INVESTMENTS
On April 23, 2002, the Company acquired 694,445 common shares of BCY, a public company, for
$0.18 per share, and warrants exercisable until April 23, 2004 to purchase up to 694,445 common
shares in BCY at an exercise price of $0.27 per share for total consideration of $127,123
(including costs of $2,123). After this transaction and the transaction described in note 7, the
Company held a total of 2,394,445 BCY shares. During 2005, the Company sold 120,000 (2004
697,945; 2003 1,496,500) of its BCY shares for net cash proceeds of $7,965 (2004 $133,609; 2003
$450,151) recording a gain on sale of investment of $765 (2004 $34,185; 2003 $264,453). As
at December 31, 2005, the Companys remaining ownership in BCY was 80,000 common shares with a book
value $4,800. These common shares will be released from escrow in February 2006; consequently the
remaining investment in BCY has been reclassified as a short term investment. The warrants expired
out of the money.
On June 14, 2002, the Company acquired 6,890,000 common shares of Transition Therapeutics Inc.
(TTH), a public company, through the issuance of 1,913,889 common shares of the Company from
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
treasury. The investment was recorded at $4,709,380 (including acquisition costs of $20,352) based
on the trading price of the Companys shares at the time of acquisition. On June 6, 2003, the
Company sold all of its 6,890,000 common shares of TTH for net cash proceeds of $2,552,695
recording a loss on sale of investment of $2,156,685.
9. COMMITMENTS
The Company is committed to payments totaling $1,138,000 during 2006 for activities related to
its clinical trial program and collaborations.
The Company is committed to monthly rental payments (excluding the Companys portion of operating
costs) of $7,453 under the terms of a lease for office premises, which expires on May 31, 2011.
Under a clinical trial agreement entered into with the Alberta Cancer Board (ACB), the Company
has agreed to repay the amount funded under the agreement together with a royalty, to a combined
maximum amount of $400,000 plus an overhead repayment of $100,000, upon sales of a specified
product. The Company agreed to repay the ACB in annual installments in an amount equal to the
lesser of: (a) 5% of gross sales of a specified product; or (b) $100,000 per annum.
10. CONTINGENCY
During 1999, the Company entered into an agreement that assumed certain obligations (the
Assumption Agreement) in connection with a Share Purchase Agreement (the Agreement) between
SYNSORB and the former shareholders of the Company to make milestone payments and royalty payments.
As of December 31, 2005, a milestone payment was still outstanding for $1.0 million, due within 90
days of the first receipt from an Appropriate Regulatory Authority, for marketing approval to sell
REOLYSIN® to the public or the approval of a new drug application for REOLYSIN®.
This milestone payment, when payable, will be accounted for as research and development expense and
will not be deductible for tax purposes.
In addition to the milestone payment, payments may become due and payable in accordance with the
Agreement upon realization of sales of REOLYSIN®. In 2003, the Company completed amendments and
revisions to the contingent obligations to its five founding shareholders with respect to these
other contingent payments. The amendments and revisions reduced the amount and clarified the
determination of potential obligations of the Company to these shareholders arising from the
Agreement and Assumption Agreement entered into in 1999. Also, on September 23, 2004, the Company
reached an agreement that further reduced its contingent payments to its founding shareholders
through the cancellation of a portion of these contingent payments from one of its non-management
founding shareholders. The consideration paid by the Company consisted of $250,000 cash and 21,459
common shares valued at $150,000 and has been recorded as research and development expense. The
value of the common shares was based on the closing market price on September 23, 2004.
As a result of the amendments and the cancellation agreement, if the Company receives royalty
payments or other payments as a result of entering into partnerships or other arrangements for the
development of the reovirus technology, the Company is obligated to pay to the founding
shareholders 11.75% (formerly in 2003 14.25% and 2002 20%) of the royalty payments and other
payments received. Alternatively, if the Company develops the reovirus treatment to the point
where it may be marketed at a commercial level, the payments referred to in the foregoing sentence
will be amended to a royalty payment of 2.35% (formerly in 2003 2.85% and 2002 4%) of Net Sales
received by the Company for such products.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
11. SHARE CAPITAL
Authorized:
Unlimited number of common shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued: |
|
Shares |
|
Warrants |
|
|
|
|
|
|
Amount |
|
|
|
|
|
Amount |
|
|
Number |
|
$ |
|
Number |
|
$ |
|
Balance, December 31, 1998 |
|
|
2,145,300 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued on exercise of stock options |
|
|
76,922 |
|
|
|
77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,222,222 |
|
|
|
81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
July 29, 1999 share split (a) |
|
|
6,750,000 |
|
|
|
81 |
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to July 30, 1999
private placement (net of share issue costs of
$45,000) (b) |
|
|
1,500,000 |
|
|
|
855,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to August 24, 1999
private placement |
|
|
1,399,997 |
|
|
|
1,049,998 |
|
|
|
|
|
|
|
|
|
Issued on initial public offering (net of share
issue costs of $317,897) (c) |
|
|
4,000,000 |
|
|
|
3,082,103 |
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to exercise of share
purchase warrants |
|
|
20,000 |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 1999 |
|
|
13,669,997 |
|
|
|
5,002,182 |
|
|
|
|
|
|
|
|
|
Issued on exercise of stock options and warrants |
|
|
573,910 |
|
|
|
501,010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to July 17, 2000
private placement (d) |
|
|
244,898 |
|
|
|
2,998,645 |
|
|
|
|
|
|
|
|
|
Issued on public offering (net of share issue
costs of $998,900) (e) |
|
|
3,000,000 |
|
|
|
13,101,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2000 |
|
|
17,488,805 |
|
|
|
21,602,937 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued on exercise of stock options and warrants |
|
|
1,702,590 |
|
|
|
2,210,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2001 |
|
|
19,191,395 |
|
|
|
23,812,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued on exercise of stock options |
|
|
40,000 |
|
|
|
34,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued on acquisition of the interest in
Transition Therapeutics Inc. [note 8] |
|
|
1,913,889 |
|
|
|
4,689,028 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to December 11, 2002
private placement (f) |
|
|
1,000,000 |
|
|
|
1,896,714 |
|
|
|
550,000 |
|
|
|
114,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
(241,123 |
) |
|
|
|
|
|
|
|
|
|
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued: |
|
Shares |
|
Warrants |
|
|
|
|
|
|
Amount |
|
|
|
|
|
Amount |
|
|
Number |
|
$ |
|
Number |
|
$ |
|
Balance, December 31, 2002 |
|
|
22,145,284 |
|
|
|
30,191,572 |
|
|
|
550,000 |
|
|
|
114,286 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to February 10,
2003 private placement (g) |
|
|
140,000 |
|
|
|
265,540 |
|
|
|
77,000 |
|
|
|
16,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to June 19, 2003
private placement (h) |
|
|
2,120,000 |
|
|
|
5,912,113 |
|
|
|
1,272,000 |
|
|
|
543,287 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to August 21, 2003
private placement (i) |
|
|
1,363,900 |
|
|
|
3,801,778 |
|
|
|
813,533 |
|
|
|
349,176 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to October 14, 2003
public offering (j) |
|
|
1,200,000 |
|
|
|
5,528,972 |
|
|
|
720,000 |
|
|
|
617,428 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
|
64,700 |
|
|
|
149,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants |
|
|
174,378 |
|
|
|
593,194 |
|
|
|
(174,378 |
) |
|
|
(41,927 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
(1,730,195 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2003 |
|
|
27,208,262 |
|
|
|
44,712,589 |
|
|
|
3,258,155 |
|
|
|
1,598,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to April 7, 2004
private placement(k) |
|
|
1,077,100 |
|
|
|
5,924,050 |
|
|
|
646,260 |
|
|
|
1,028,631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to pursuant to
November 23, 2004 public
offering(l) |
|
|
1,504,000 |
|
|
|
8,693,120 |
|
|
|
864,800 |
|
|
|
1,521,672 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued pursuant to cancellation of contingent
payment [note 10] |
|
|
21,459 |
|
|
|
150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants |
|
|
1,907,175 |
|
|
|
8,178,546 |
|
|
|
(1,907,175 |
) |
|
|
(798,096 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired warrants |
|
|
|
|
|
|
2,827 |
|
|
|
(6,700 |
) |
|
|
(2,827 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
|
197,500 |
|
|
|
778,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
(1,796,758 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2004 |
|
|
31,915,496 |
|
|
|
66,643,325 |
|
|
|
2,855,340 |
|
|
|
3,347,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued for cash pursuant to December 29,
2005 private placement(m) |
|
|
3,200,000 |
|
|
|
14,176,000 |
|
|
|
1,920,000 |
|
|
|
2,908,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants |
|
|
771,252 |
|
|
|
3,417,271 |
|
|
|
(771,252 |
) |
|
|
(329,984 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired warrants |
|
|
|
|
|
|
1,496,514 |
|
|
|
(1,219,288 |
) |
|
|
(1,496,514 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
|
350,000 |
|
|
|
297,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issue costs |
|
|
|
|
|
|
(1,689,398 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2005 |
|
|
36,236,748 |
|
|
|
84,341,212 |
|
|
|
2,784,800 |
|
|
|
4,429,932 |
|
|
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
(a) |
|
Pursuant to subsection 167(1)(f) of the Business Corporations Act (Alberta), the Articles of
the Company were amended by subdividing the 2,222,222 issued and outstanding common shares of
the Company into 6,750,000 common shares. |
|
(b) |
|
Pursuant to a private placement, 1,500,000 common share purchase warrants were issued
entitling the holders thereof to acquire one additional share at $0.75 per share until
November 8, 2001. At December 31, 2001, all of the warrants had been exercised. |
|
(c) |
|
Pursuant to the initial public offering, the agent was issued common share purchase warrants
entitling it to acquire 400,000 common shares at $0.85 per share until May 8, 2001. At
December 31, 2001, all of the warrants had been exercised. |
|
(d) |
|
Pursuant to the private placement, 244,898 common shares were issued at an issue price of
$12.25 per share net of issue costs of $1,355. |
|
(e) |
|
Pursuant to a special warrant offering, the Company sold 3,000,000 special warrants for $4.70
per warrant for net proceeds of $13,101,100. Each warrant entitled the holder to one common
share upon exercise. At December 31, 2001, all of the warrants had been exercised. |
|
(f) |
|
Pursuant to a private placement, 1,000,000 units were issued at an issue price of $2.00 per
unit net of issue costs of $241,123. Each unit included one common share (ascribed value of
$1.897) and one-half of one common share purchase warrant (ascribed value of $0.103) for a
total of 500,000 warrants. Each whole common share purchase warrant entitles the holder to
acquire one common share in the capital of the Company upon payment of $3.00 per share until
June 11, 2004. In addition, the Company issued 50,000 common share purchase warrants on the
same terms to the brokerage firm assisting with the transaction. The ascribed value of these
broker warrants was $11,000 ($0.22 per broker warrant) and has been included in the issue
costs. The ascribed values of the warrants were based on the Black Scholes Option Pricing
Model. |
|
(g) |
|
Pursuant to a private placement, 140,000 units were issued at an issue price of $2.00 per
unit net of issue costs of $37,369. Each unit included one common share (ascribed value of
$1.897) and one-half of one common share purchase warrant (ascribed value of $0.103) for a
total of 70,000 warrants. Each whole common share purchase warrant entitles the holder to
acquire one common share in the capital of the Company upon payment of $3.00 per share until
August 10, 2004. In addition, the Company issued 7,000 common share purchase warrants on the
same terms to the brokerage firm assisting with the transaction. The ascribed value of these
broker warrants was $1,540 ($0.22 per broker warrant) and has been included in the issue
costs. The ascribed values of the warrants were based on the Black Scholes Option Pricing
Model. |
|
(h) |
|
Pursuant to a private placement, 2,120,000 units were issued at an issue price of $3.00 per
unit net of issue costs of $637,986. Each unit included one common share (ascribed value of
$2.789) and one-half of one common share purchase warrant (ascribed value of $0.211) for a
total of 1,060,000 warrants. Each whole common share purchase warrant entitles the holder to
acquire one common share in the capital of the Company upon payment of $4.00 per share until
December 19, 2004. In addition, the Company issued 212,000 common share purchase warrants on
the same terms to the brokerage firms assisting with the transaction. The ascribed value of
these broker warrants was $95,400 ($0.45 per broker warrant) and has been included in the
issue costs. The ascribed values of the warrants were based on the Black Scholes Option
Pricing Model. |
|
(i) |
|
Pursuant to a private placement, 1,363,900 common shares and 681,943 common share purchase
warrants were issued for gross proceeds of $4,091,738. Each common share and whole common
share |
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
|
|
purchase warrant have ascribed values of $2.787 and $0.425 respectively. Each common share
purchase warrant entitles the holder to acquire one common share in the capital of the Company
upon payment of $4.00 per share until February 21, 2005. Share issue costs related to this
private placement were $367,839. In addition, the Company issued 131,590 common share purchase
warrants on the same terms to the advisors assisting with the transaction. The ascribed value
of these additional warrants was $59,216 ($0.45 per additional warrant) and has been included
in the issue costs. The ascribed values of the warrants were based on the Black Scholes Option
Pricing Model. |
|
(j) |
|
Pursuant to a public offering, 1,200,000 units were issued at an issue price of $5.00 per
unit net of issue costs of $687,001. Each unit included one common share (ascribed value of
$4.607) and one-half of one common share purchase warrant (ascribed value of $0.393) for a
total of 600,000 warrants. Each whole common share purchase warrant entitles the holder to
acquire one common share in the capital of the Company upon payment of $6.25 per share until
April 14, 2005. In addition, the Company issued 120,000 common share purchase warrants with
an exercise price of $5.00 that expires on April 14, 2005 to the brokerage firms assisting
with the transaction. The ascribed value of these broker warrants was $146,400 ($1.19 per
broker warrant) and has been included in the issue costs. The ascribed values of the warrants
were based on the Black Scholes Option Pricing Model. |
|
(k) |
|
Pursuant to a private placement, the Company sold 1,077,100 units at an average price of
$6.25 per unit for gross cash proceeds of $6,731,875. The units were comprised of 1,077,100
common shares and 538,550 common share purchase warrants and have ascribed values of $5.50 and
$1.50 respectively. Each common share purchase warrant entitles the holder to acquire one
common share in the capital of the Company upon payment of $7.75 per share until October 7,
2005. Share issue costs related to the private placement were $728,918. In addition, the
Company issued 107,710 common share purchase warrants to its advisor entitling the holder to
acquire one common share of the capital of the Company upon payment of $7.00 per share until
October 7, 2005. The ascribed value of these additional warrants was $220,806 ($2.05 per
additional warrant) and has been included in the share issue costs above. The ascribed values
of the warrants were based on the Black Scholes Option Pricing Model. |
|
(l) |
|
Pursuant to a public offering, the Company sold 1,504,000 units at an issue price of $6.65
per unit for gross cash proceeds of $10,001,600. Each unit included one common share
(ascribed value of $5.78) and one-half of one common share purchase warrant (ascribed value of
$0.87) for a total of 752,000 warrants. Each whole common share purchase warrant entitles the
holder to acquire one common share in the capital of the Company upon payment of $8.00 per
share until November 23, 2007. Share issue costs related to this public offering were $
1,063,890. In addition, the Company issued 112,800 common share purchase warrants with an
exercise price of $7.06 that expires on May 23, 2006 to the brokerage firm assisting with the
transaction. The ascribed value of these broker warrants was $213,192 ($1.89 per broker
warrant) and has been included in the share issue costs above. The ascribed values of the
warrants were based on the Black Scholes Option Pricing Model. |
|
(m) |
|
Pursuant to a private placement, 3,200,000 units were issued at an issue price of $5.15 per
unit net of issue costs of $1,689,398. Each unit included one common share (ascribed value of
$4.43) and one-half of one common share purchase warrant (ascribed value of $0.72) for a total
of 1,600,000 warrants. Each whole common share purchase warrant entitles the holder to
acquire one common share in the capital of the Company upon payment of $6.15 per share until
December 29, 2008. In addition, the Company issued 320,000 common share purchase warrants
with an exercise price of $5.65 expiring on December 29, 2008. The ascribed value of these
broker warrants was $604,800 ($1.89 per broker warrant) and has been included in the issue
costs. The ascribed values of the warrants were based on the Black Scholes Option Pricing
Model. |
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
The following table summarizes the Companys outstanding warrants as at December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Outstanding, |
|
Granted |
|
Exercised |
|
Expired |
|
|
|
|
|
Remaining |
Exercise |
|
Beginning of |
|
During the |
|
During |
|
During the |
|
Outstanding, |
|
Contractual |
Price |
|
the Year |
|
Year |
|
the Year |
|
Year |
|
End of Year |
|
Life (years) |
|
$4.00 |
|
|
768,972 |
|
|
|
|
|
|
|
768,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$5.00 |
|
|
45,558 |
|
|
|
|
|
|
|
2,280 |
|
|
|
43,278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$5.65 |
|
|
|
|
|
|
320,000 |
|
|
|
|
|
|
|
|
|
|
|
320,000 |
|
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$6.15 |
|
|
|
|
|
|
1,600,000 |
|
|
|
|
|
|
|
|
|
|
|
1,600,000 |
|
|
|
3.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$6.25 |
|
|
529,750 |
|
|
|
|
|
|
|
|
|
|
|
529,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$7.00 |
|
|
107,710 |
|
|
|
|
|
|
|
|
|
|
|
107,710 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$7.06 |
|
|
112,800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
112,800 |
|
|
|
0.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$7.75 |
|
|
538,550 |
|
|
|
|
|
|
|
|
|
|
|
538,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$8.00 |
|
|
752,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
752,000 |
|
|
|
1.90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,855,340 |
|
|
|
1,920,000 |
|
|
|
771,252 |
|
|
|
1,219,288 |
|
|
|
2,784,800 |
|
|
|
2.60 |
|
|
12. STOCK BASED COMPENSATION
Stock Option Plan
The Company has issued stock options to acquire common stock through its stock option plan of
which the following are outstanding at December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
2004 |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
|
|
Stock |
|
|
Share Price |
|
|
Stock |
|
|
Share Price |
|
|
|
Options |
|
|
$ |
|
|
Options |
|
|
$ |
|
|
Outstanding at beginning of year |
|
|
3,805,550 |
|
|
|
4.39 |
|
|
|
2,800,800 |
|
|
|
3.81 |
|
Granted during year |
|
|
200,000 |
|
|
|
3.18 |
|
|
|
1,202,250 |
|
|
|
5.63 |
|
Cancelled during year |
|
|
(21,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Exercised during year |
|
|
(350,000 |
) |
|
|
0.85 |
|
|
|
(197,500 |
) |
|
|
3.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year |
|
|
3,634,550 |
|
|
|
4.66 |
|
|
|
3,805,550 |
|
|
|
4.39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at end of year |
|
|
3,387,050 |
|
|
|
4.77 |
|
|
|
3,717,050 |
|
|
|
4.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
The following table summarizes information about the stock options outstanding and exercisable at
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
Weighted |
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
Average |
|
|
|
|
|
Average |
|
|
|
|
|
|
Remaining |
|
Exercise |
|
|
|
|
|
Exercise |
Range of Exercise |
|
Number |
|
Contractual |
|
Price |
|
Number |
|
Price |
Prices |
|
Outstanding |
|
Life (years) |
|
$ |
|
Exercisable |
|
$ |
|
$0.75 - $1.00 |
|
|
632,550 |
|
|
|
3.8 |
|
|
|
0.85 |
|
|
|
632,550 |
|
|
|
0.85 |
|
$1.65 - $2.37 |
|
|
281,000 |
|
|
|
6.9 |
|
|
|
1.85 |
|
|
|
246,000 |
|
|
|
1.87 |
|
$2.70 - $3.33 |
|
|
678,750 |
|
|
|
7.9 |
|
|
|
3.10 |
|
|
|
478,750 |
|
|
|
3.06 |
|
$4.00 - $5.00 |
|
|
1,190,750 |
|
|
|
8.7 |
|
|
|
4.89 |
|
|
|
1,178,250 |
|
|
|
4.89 |
|
$6.77 - $9.76 |
|
|
708,500 |
|
|
|
6.2 |
|
|
|
8.66 |
|
|
|
708,500 |
|
|
|
8.66 |
|
$12.15 - $13.50 |
|
|
143,000 |
|
|
|
4.8 |
|
|
|
12.63 |
|
|
|
143,000 |
|
|
|
12.63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,634,550 |
|
|
|
6.4 |
|
|
|
4.66 |
|
|
|
3,387,050 |
|
|
|
4.77 |
|
|
The outstanding options vest annually or after the completion of certain milestones. The
Company has reserved 3,662,461 common shares for issuance relating to outstanding stock options.
As the Company is following the fair value based method of accounting for stock option awards,
compensation expense related to options granted to employees and consultants was $43,886 (2004
$2,537,088; 2003 $812,711) and $20,218 (2004 $131,482; 2003 $102,466) respectively with an
offsetting credit to contributed surplus.
The estimated fair value of stock options issued during the year was determined using the
Black-Scholes model using the following weighted average assumptions and fair value of options:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
Risk-free interest rate |
|
|
3.27 |
% |
|
|
2.83 |
% |
|
|
3.09 |
% |
Expected hold period to exercise |
|
3.5 years |
|
2 years |
|
2 years |
Volatility in the price of the Companys shares |
|
|
64 |
% |
|
|
71 |
% |
|
|
69 |
% |
Dividend yield |
|
Zero |
|
Zero |
|
Zero |
Weighted average fair value of options |
|
$ |
1.51 |
|
|
$ |
2.26 |
|
|
$ |
1.47 |
|
|
In 2002, the Company granted 48,000 share incentive rights to a non-employee which, when exercised
by the holder, would require payment in cash or shares, at the sole option of the Company for
amounts in excess of $2.31 based on the weighted average trading price for the ten trading days
prior to the exercise. The Company accounted for this transaction with a non-employee at fair
value determined using the Black-Scholes model. The related compensation expense recorded in 2003
was $81,530, with an offsetting credit to contributed surplus. During 2005, these share incentive
rights were surrendered. In accordance with generally accepted accounting principles, no credit to
expense was recorded as a result of the surrender.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
13. CONTRIBUTED SURPLUS
The following table summarizes the change in contributed surplus for the period ending
December 31:
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
Balance, beginning of year |
|
|
6,349,139 |
|
|
|
3,699,425 |
|
|
|
|
|
|
|
|
|
|
Stock based compensation |
|
|
64,104 |
|
|
|
2,683,869 |
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
|
|
|
|
(34,155 |
) |
|
|
|
|
|
|
|
|
|
|
Balance end of year |
|
|
6,413,243 |
|
|
|
6,349,139 |
|
|
14. LOSS PER COMMON SHARE
Loss per common share is calculated using the weighted average number of common shares
outstanding for the year ended December 31, 2005 of 32,804,540 (2004 29,028,391; 2003
24,242,845). The effect of any potential exercise of the Companys stock options and warrants
outstanding during the year has been excluded from the calculation of diluted earnings per share,
as it would be anti-dilutive.
15. INCOME TAXES
The provision for income taxes recorded in the financial statements differs from the amount
which would be obtained by applying the statutory income tax rate to the loss before tax as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Loss before taxes |
|
|
(12,783,356 |
) |
|
|
(12,956,119 |
) |
|
|
(8,510,479 |
) |
Statutory Canadian corporate tax rate |
|
|
33.60 |
% |
|
|
33.87 |
% |
|
|
36.75 |
% |
Anticipated tax recovery |
|
|
(4,295,208 |
) |
|
|
(4,388,238 |
) |
|
|
(3,127,601 |
) |
Non-taxable portion of net capital loss (gain) |
|
|
(129 |
) |
|
|
(16,717 |
) |
|
|
347,698 |
|
Employee stock based compensation |
|
|
21,539 |
|
|
|
903,845 |
|
|
|
366,290 |
|
Cancellation of contingent payment obligation
settled in common shares |
|
|
|
|
|
|
50,805 |
|
|
|
|
|
Change in tax rate |
|
|
102,309 |
|
|
|
242,119 |
|
|
|
272,506 |
|
Tax return adjustment |
|
|
78,995 |
|
|
|
(43,509 |
) |
|
|
|
|
Non-deductible expenses |
|
|
8,113 |
|
|
|
8,976 |
|
|
|
9,739 |
|
Change in valuation allowance (a) |
|
|
4,084,381 |
|
|
|
3,242,719 |
|
|
|
2,131,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Future income tax recovery |
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
As of December 31, 2005, the Company has non-capital losses for income tax purposes of
approximately $34,176,000, which are available for application against future taxable income
and expire in 2006 ($663,000) 2007 ($1,033,000), 2008 ($2,898,000), 2009 ($4,483,000), 2010
($4,483,000), 2014 ($9,075,000) and 2015 ($11,541,000). In addition to the loss carry forward |
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
|
|
amounts above, the Company has scientific research and development claims and related
investment tax credits of approximately $8,170,000 and $1,997,000 respectively as at December
31, 2005 which are available for application against future taxable income. The potential
benefits resulting from these tax pools have been recognized in the financial statements only
to the extent they are more likely than not of being realized. |
The components of the Companys future income tax asset are as follows:
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
Non-capital loss carryforwards |
|
|
11,483,387 |
|
|
|
8,010,356 |
|
Scientific research and development |
|
|
2,745,133 |
|
|
|
2,113,447 |
|
Investment tax credits |
|
|
1,997,300 |
|
|
|
1,721,119 |
|
Net capital loss carryforwards |
|
|
283,822 |
|
|
|
283,627 |
|
Undepreciated capital costs in excess
of book value of capital assets and
intellectual property |
|
|
325,377 |
|
|
|
22,269 |
|
Share issue costs |
|
|
772,133 |
|
|
|
683,239 |
|
Valuation allowance |
|
|
(17,607,152 |
) |
|
|
(12,834,057 |
) |
|
|
|
|
|
|
|
|
|
|
Future tax asset |
|
|
|
|
|
|
|
|
|
16. INDEMNIFICATION OF OFFICERS AND DIRECTORS
The Companys corporate by-laws require that, except to the extent expressly prohibited by
law, the Company will indemnify its officers and directors against all costs, charges and expenses,
including an amount paid to settle an action or satisfy a judgment reasonably incurred in respect
of any civil, criminal or administrative action or proceeding as it relates to their services to
the Company. The by-laws provide no limit to the amount of the indemnification. The Company has
purchased directors and officers insurance coverage to cover claims made against the directors
and officers during the applicable policy periods. The amounts and types of coverage have varied
from period to period as dictated by market conditions. The Company believes that it has adequate
insurance coverage; however there is no guarantee that all indemnification payments will be covered
under the Companys existing insurance policies.
There is no pending litigation or proceeding involving any officer or director of the Company as to
which indemnification is being sought, nor is the Company aware of any threatened litigation that
may result in claims for indemnification.
17. FINANCIAL INSTRUMENTS
Financial instruments of the Company consist of cash and cash equivalents, short term
investments, accounts receivable, investments, accounts payable, and the Alberta Heritage
Foundation loan. As at December 31, 2005, there are no significant differences between the
carrying values of these amounts and their estimated market values.
Credit risk
The Company is exposed to credit risk on its short-term investments in the event of non-performance
by counterparties, but does not anticipate such non-performance. The Company mitigates its exposure
to credit
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
risk by restricting its portfolio to investment grade securities with short term
maturities and by monitoring the credit risk and credit standing of counterparties.
Interest rate risk
The Company has exposure to interest income risk through its short-term investments in fixed-income
securities that are sensitive to interest rate fluctuations.
Foreign exchange risk
The Company purchases goods and services denominated primarily in Canadian, U.S. and UK currencies.
To manage its foreign exchange risk, the Company, from time to time, acquires short-term
investments denominated in these securities.
18. ECONOMIC DEPENDENCE
The Company contracts the production and currently receives its supplies of REOLYSIN® from one
toll manufacturer based in the United Kingdom. There are a limited number of potential producers
and suppliers of REOLYSIN®. As a result, any significant disruption of the services provided by
this toll manufacturer has the potential to delay the progress of the Companys clinical trial
program. Management is aware of and is taking actions to minimize this exposure.
19. ADDITIONAL CASH FLOW DISCLOSURE
Net Change In Non-Cash Working Capital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from inception |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
on April 2, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1998 to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2005 |
|
2004 |
|
2003 |
|
2005 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
Change in: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
377 |
|
|
|
16,457 |
|
|
|
(15,688 |
) |
|
|
(47,390 |
) |
Prepaid expenses |
|
|
(290,003 |
) |
|
|
(93,528 |
) |
|
|
(79,679 |
) |
|
|
(540,368 |
) |
Accounts payable and accrued liabilities |
|
|
743,223 |
|
|
|
64,330 |
|
|
|
(378,192 |
) |
|
|
1,692,481 |
|
|
Change in non-cash working capital |
|
|
453,597 |
|
|
|
(12,741 |
) |
|
|
(473,559 |
) |
|
|
1,104,723 |
|
Net change associated with investing
activities |
|
|
131,169 |
|
|
|
(56,324 |
) |
|
|
(15,492 |
) |
|
|
(11,724 |
) |
|
Net change associated with operating
activities |
|
|
584,766 |
|
|
|
(69,065 |
) |
|
|
(489,051 |
) |
|
|
1,092,999 |
|
|
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
Other Non-Cash Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
from inception |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
on April 2, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1998 to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2005 |
|
2004 |
|
2003 |
|
2005 |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
Foreign exchange loss |
|
|
159,204 |
|
|
|
264,080 |
|
|
|
2,881 |
|
|
|
425,186 |
|
Donation of medical equipment [note 4] |
|
|
66,069 |
|
|
|
|
|
|
|
|
|
|
|
66,069 |
|
Gain on sale of BCY LifeSciences Inc. |
|
|
(765 |
) |
|
|
(34,185 |
) |
|
|
(264,453 |
) |
|
|
(299,403 |
) |
Cancellation of contingent payment
obligation settled in common shares
[note 10] |
|
|
|
|
|
|
150,000 |
|
|
|
|
|
|
|
150,000 |
|
Future income tax recovery |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,115,000 |
) |
|
|
|
|
224,508 |
|
|
|
379,895 |
|
|
|
(261,572 |
) |
|
|
(773,148 |
) |
|
20. RECONCILIATION OF CANADIAN GAAP TO US GAAP
The financial statements of the Company are prepared in accordance with Canadian GAAP which,
in most respects, conforms to US GAAP. Significant differences between Canadian and US GAAP are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
inception on April 2, |
|
|
|
|
|
|
Year Ended December 31 |
|
1998 to December |
|
|
Notes |
|
2005 |
|
2004 |
|
2003 |
|
31, 2005 |
|
|
|
|
$ |
|
$ |
|
$ |
|
$ |
|
Net loss Canadian GAAP |
|
|
|
|
|
|
12,781,831 |
|
|
|
12,956,119 |
|
|
|
8,544,031 |
|
|
|
50,732,542 |
|
Amortization of
intellectual property |
|
|
(1 |
) |
|
|
(361,500 |
) |
|
|
(361,500 |
) |
|
|
(361,500 |
) |
|
|
(2,349,750 |
) |
Future income tax recovery |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,115,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss US GAAP |
|
|
|
|
|
|
12,420,331 |
|
|
|
12,594,619 |
|
|
|
8,182,531 |
|
|
|
49,497,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss (gain) on
available-for-sale
securities |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
(45,715 |
) |
|
|
2,423,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reclassification of
unrealized gain (loss) on
available-for-sale
securities |
|
|
(2 |
) |
|
|
|
|
|
|
45,715 |
|
|
|
(2,469,414 |
) |
|
|
(2,423,699 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss US
GAAP |
|
|
|
|
|
|
12,420,331 |
|
|
|
12,640,334 |
|
|
|
5,667,402 |
|
|
|
49,497,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per common share US
GAAP |
|
|
|
|
|
|
(0.38 |
) |
|
|
(0.43 |
) |
|
|
(0.34 |
) |
|
|
|
|
|
There are no differences between Canadian GAAP and US GAAP in amounts reported as cash flows from
(used in) operating, financing and investing activities.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
Balance sheet items in accordance with US GAAP are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
December 31, 2004 |
|
|
|
|
|
|
Canadian |
|
US |
|
Canadian |
|
US |
|
|
Notes |
|
GAAP |
|
GAAP |
|
GAAP |
|
GAAP |
|
Intellectual property |
|
|
(1 |
) |
|
|
5,110,538 |
|
|
|
3,845,288 |
|
|
|
4,997,598 |
|
|
|
3,370,848 |
|
Investments |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
12,000 |
|
|
|
12,000 |
|
Future income taxes |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contributed surplus |
|
|
(1 |
) |
|
|
6,413,243 |
|
|
|
3,913,243 |
|
|
|
6,349,139 |
|
|
|
3,849,139 |
|
Deficit |
|
|
(1 |
) |
|
|
50,732,542 |
|
|
|
49,497,792 |
|
|
|
37,950,711 |
|
|
|
37,077,461 |
|
Other comprehensive loss (income) |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1. |
|
Push-Down Accounting and In Process Research and Development |
|
|
|
Intellectual property of $2,500,000 recorded as a consequence of SYNSORBs acquisition of the
Companys shares comprises intangible assets related to research and development activities.
Under US GAAP, this would not be capitalized on acquisition. |
|
|
|
As a result of removing the $2,500,000 from intellectual property in 1999 for US GAAP purposes,
the amortization of the intellectual property, the future income tax recovery, future income
tax liability and contributed surplus amounts recorded for Canadian GAAP purposes have been
reversed. |
|
2. |
|
Unrealized Gains and Losses on Investments |
|
|
|
Under U.S. GAAP, equity securities, having a readily determinable fair value and not classified
as trading securities, are classified as available-for-sale securities and reported at fair
value, with unrealized gains and losses included in comprehensive income or loss and reported
as a separate component of shareholders equity net of related deferred income taxes. Declines
in the fair value of individual available-for-sale securities below their cost that are other
than temporary result in write-downs of the individual securities to their fair value. The
related write-downs are included in earnings as realized losses. Under Canadian GAAP, these
securities are carried at cost and written down only when there is evidence that a decline in
value that is other than temporary has occurred. |
Stock Based Employee Compensation
On January 1, 2003, the Company prospectively adopted the fair value based method for its
employee options (see note 3). Consequently there were no differences between Canadian GAAP and
U.S. GAAP with respect to options granted subsequent to this date.
In 2002, the Company applied the intrinsic value method for employee stock options and the fair
value method for non-employee options granted after January 1, 2002. Prior to January 1, 2002, for
US GAAP, the Company applied the intrinsic value method prescribed by Accounting Principles Board
Opinion No. 25, Accounting for Stock Issued to Employees and related interpretations in
accounting for its employee stock option plans. As well, the Company provided pro forma disclosure
as required by FAS 123 for those options granted prior to January 1, 2002.
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
The following additional pro-forma disclosure would be provided under US GAAP with respect to the
fair value of employee options granted prior to January 1, 2002. The fair value for these options
granted was estimated at the date of grant using a Black-Scholes Option Pricing Model with the
following weighted-average assumptions:
|
|
|
|
|
|
|
2001 |
|
Risk free interest rate |
|
|
5.0 |
% |
Dividend yield |
|
|
0 |
% |
Volatility factors of expected market price |
|
|
87 |
% |
Weighted average expected life of the options |
|
2 years |
|
Pro forma disclosures of loss and loss per common share are presented below as if the Company had
adopted the cost recognition requirements under FAS 123 from inception.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
|
|
$ |
|
$ |
|
$ |
|
Net Loss |
|
Pro forma Canadian GAAP |
|
|
12,782,814 |
|
|
|
12,960,544 |
|
|
|
8,590,564 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported US GAAP |
|
|
12,420,331 |
|
|
|
12,594,619 |
|
|
|
8,182,531 |
|
|
|
Pro forma US GAAP |
|
|
12,421,314 |
|
|
|
12,599,044 |
|
|
|
8,236,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net |
|
Pro forma Canadian GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
loss per common share |
|
($/share) |
|
|
(0.39 |
) |
|
|
(0.45 |
) |
|
|
(0.35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported US GAAP |
|
|
(0.38 |
) |
|
|
(0.43 |
) |
|
|
(0.34 |
) |
|
|
Pro forma US GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($/share) |
|
|
(0.38 |
) |
|
|
(0.43 |
) |
|
|
(0.34 |
) |
|
Additional Stock Based Payment Disclosure
As at December 31, 2005, the aggregate intrinsic value of the stock options outstanding and
the stock options exercisable were $5,595,845 and $5,058,570, respectively. The total intrinsic
value of the options exercised in 2005 was $1,223,400 (2004 1,253,014; and 2003 195,715).
A summary of the Companys non-vested shares as of December 31, 2005 and changes during the year
ended December 31, 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average Grant |
|
|
Stock |
|
Date Fair Value |
|
|
Options |
|
$ |
|
Non-vested at beginning of year |
|
|
88,500 |
|
|
|
1.06 |
|
Granted during year |
|
|
200,000 |
|
|
|
1.51 |
|
Vested during year |
|
|
(41,000 |
) |
|
|
1.45 |
|
Forfeited during year |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-vested at end of year |
|
|
247,500 |
|
|
|
1.36 |
|
|
|
|
|
|
Oncolytics Biotech Inc.
NOTES TO FINANCIAL STATEMENTS
December 31, 2005 and 2004
As of December 31, 2005, there was $335,750 of total unrecognized compensation costs related to
non-vested stock options granted under the Companys stock option plan. This cost is expected to
be recognized over a weighted average period of 2.12 years. The total fair value of shares vested
during the years ended December 31, 2005, 2004 and 2003 was $59,630, $8,250 and $nil, respectively.
The Company issues shares from treasury to satisfy any exercises of stock options.
21. COMPARATIVE FIGURES
Certain comparative figures have been reclassified to conform with the current years
presentation.
March 2, 2006
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
The following information should be read in conjunction with our 2005 audited financial
statements and notes thereto, which were prepared in accordance with Canadian generally accepted
accounting principles (GAAP).
FORWARD-LOOKING STATEMENTS
The following discussion contains forward-looking statements, within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including our
belief as to the potential of REOLYSIN® as a cancer therapeutic and our expectations as to the
success of our research and development and manufacturing programs in 2006 and beyond, future
financial position, business strategy and plans for future operations, and statements that are not
historical facts, involve known and unknown risks and uncertainties, which could cause our actual
results to differ materially from those in the forward-looking statements. Such risks and
uncertainties include, among others, the need for and availability of funds and resources to pursue
research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and
timely completion of clinical studies and trials, our ability to successfully commercialize
REOLYSIN®, uncertainties related to the research, development and manufacturing of pharmaceuticals,
uncertainties related to competition, changes in technology, the regulatory process and general
changes to the economic environment. Investors should consult our quarterly and annual filings
with the Canadian and U.S. securities commissions for additional information on risks and
uncertainties relating to the forward-looking statements. Forward looking statements are based on
assumptions, projections, estimates and expectations of management at the time such forward looking
statements are made, and such assumptions, projections, estimates and/or expectations could change
or prove to be incorrect or inaccurate. Investors are cautioned against placing undue reliance on
forward-looking statements. We do not undertake to update these forward-looking statements.
OVERVIEW
Oncolytics Biotech Inc. is a Development Stage Company
Since our inception in April of 1998, Oncolytics Biotech Inc. has been a development stage company
and we have focused our research and development efforts on the development of REOLYSIN®, our
potential cancer therapeutic. We have not been profitable since our inception and expect to
continue to incur substantial losses as we continue research and development efforts. We do not
expect to generate significant revenues until, if and when, our cancer product becomes commercially
viable.
General Risk Factors
Prospects for biotechnology companies in the research and development stage should generally be
regarded as speculative. It is not possible to predict, based upon studies in animals, or early
studies in humans, whether a new therapeutic will ultimately prove to be safe and effective in
humans, or whether necessary and sufficient data can be developed through the clinical trial
process to support a successful product application and approval.
If a product is approved for sale, product manufacturing at a commercial scale and significant
sales to end users at a commercially reasonable price may not be successful. There can be no
assurance that we will generate adequate funds to continue development, or will ever achieve
significant revenues or profitable operations. Many factors (e.g. competition, patent protection,
appropriate regulatory approvals) can influence the revenue and product profitability potential.
In developing a pharmaceutical product, we rely upon our employees, contractors, consultants and
collaborators and other third party relationships, including the ability to obtain appropriate
product liability insurance. There can be no assurance that these reliances and relationships will
continue as required.
In addition to developmental and operational considerations, market prices for securities of
biotechnology companies generally are volatile, and may or may not move in a manner consistent with
the progress being made by Oncolytics.
REOLYSIN ® Development Update For 2005
We have been developing our product REOLYSIN® as a possible cancer therapy since our inception in
1998. Our goal each year is to advance REOLYSIN® through the various steps and stages of
development required for potential pharmaceutical products. In order to achieve this goal, we
believe that we have to actively manage the development of our clinical trial program, our
pre-clinical and collaborative programs, our manufacturing process and supply, and our intellectual
property.
Clinical Trial Program
In the first part of 2005, we reported that we received regulatory clearance to commence three
additional clinical trial studies. The first trial approved in 2005 was our first co-therapy study
that is investigating REOLYSIN® in combination with radiation therapy in the United Kingdom
(U.K.). Our second and third trials that received regulatory clearance were two United States
(U.S.) clinical trial studies. The first of these trials was a Phase I/II recurrent malignant
glioma clinical trial. The second was a Phase I systemic delivery clinical trial.
During 2005, we commenced patient enrollment in the U.K. combination radiation therapy and the U.S.
systemic delivery clinical trials while continuing to enroll patients in our ongoing U.K. systemic
delivery and Canadian glioma clinical trials. In the fourth quarter of 2005, we ended patient
treatment in the Canadian glioma study and exited 2005 with three actively enrolling clinical
trials.
In the fourth quarter of 2005, we reported interim results from two of our clinical trials. The
first report was in conjunction with a poster presentation at the AACR-NCI-EORTC conference in
Philadelphia by our principal investigator for our Phase I systemic delivery clinical trial in the
U.K. Our principal investigator presented data on 22 patients and reported that REOLYSIN® is well
tolerated when administered intravenously with minimal toxicity observed and that reovirus
replication in tumours has been identified with evidence of tumor necrosis. The principal
investigator also reported that there have been encouraging hints of activity in prostate and
colorectal cancer. This trial continues to enroll and we expect that patient enrollment will be
completed in 2006. We also reported on the Canadian glioma clinical trial. In this trial a total
of 12 patients were enrolled. A maximum tolerated dose was not reached and REOLYSIN® was well
tolerated.
Pre-Clinical Trial and Collaborative Program
We perform pre-clinical studies and engage in collaborations to help support our clinical trial
programs and expand our intellectual property base. In 2005, we investigated the interaction of
the reovirus with the immune system and the use of reovirus as a co-therapy with existing
chemotherapies and radiation. In the fourth quarter of 2005, we reported in conjunction with one
of our collaborators at the AACR-NCI-EORTC conference in Philadelphia, that reovirus enhances
radiation cytotoxicity in vitro and in vivo. The results of this collaboration were also used to
support our radiation co-therapy clinical trial application in the U.K.
Manufacturing and Process Development
During 2005, we contracted cGMP (current good manufacturing practices) production runs that we
believe produced sufficient REOLYSIN® to supply our existing clinical trials in the U.S. and the
U.K. We also entered into process development activities that examined ways to improve the process
yields.
Intellectual Property
During 2005 four Canadian patents and one European patent were issued. At the end of 2005, we
exited with a total of thirteen U.S., four Canadian and two European patents. We also have other
patent applications filed in the U.S., Europe and Canada and other jurisdictions.
Financial Impact
We estimated at the beginning of 2005 that our cash usage would be approximately $12,000,000 for
2005. Our actual cash usage for the year was $12,146,806 with $11,052,462 from operating
activities and $1,094,344 from the purchases of intellectual property and capital assets. Our net
loss for the year was $12,781,831.
Cash Resources
We have used the equity markets to acquire the cash resources required to fund our operations. In
2005, we received cash proceeds in two types of financing transactions. The first was the exercise
of existing warrants in the first quarter of 2005 and options for total cash proceeds of
$3,384,787. The second occurred in the fourth quarter of 2005 when we issued units comprised of
one common share and one half of one common share purchase warrant for net cash proceeds of
$15,395,402. We exited 2005 with cash resources totaling $40,406,167 (see Liquidity and Capital
Resources).
REOLYSIN® Development For 2006
We believe that patient enrollment in our two U.K. clinical trials and our U.S. systemic trial will
conclude in 2006 and we believe that we will be able to report additional patient data pertaining
to these trials. The timing of when and what we are able to report will be determined in
conjunction with the principal investigator and the clinical trial site.
We believe that the results from our existing clinical trials will provide us with support to
expand our clinical trial program in 2006. We plan to expand our program to focus on specific
cancer indications and drug combinations and move into Phase II clinical trials.
We expect to produce REOLYSIN® in 2006 to supply our expanding clinical trial program. We also
plan to continue process yield improvement and scale up studies in 2006 in an effort to continue to
improve our manufacturing process.
We estimate, based on our expected activity in 2006 that our monthly cash usage for the year will
increase to $1,500,000 per month (see Liquidity and Capital Resources).
Recent 2006 Progress
On January 18, 2006, the U.S. NCI issued a solicitation for Letters of Intent with respect to the
conduct of two human clinical trials using REOLYSIN®. The first is a Phase II study administering
REOLYSIN® systemically in patients with melanoma. The dosage and dosing regimen to be used in the
study will be determined based on data derived from our ongoing U.K. and U.S. Phase I systemic
administration studies. The second solicitation is for proposals for a Phase I/II study of
REOLYSIN® co-administered both systemically and intraperitoneally (IP) in patients with ovarian
cancer. The purpose of the Phase I portion of the trial is to determine the Maximum Tolerated Dose
of REOLYSIN® given by IP administration in combination with a constant systemic dose and dosing
regimen.
On January 24, 2006, we announced that an oral presentation of the preliminary results of our Phase
I combination REOLYSIN®/radiation clinical trial is scheduled to be made at the American
Association of Cancer Researchers annual meeting held April 1 5 in Washington D.C. by our
principal investigator Dr. Kevin Harrington.
ACCOUNTING POLICIES
Critical Accounting Policies and Estimates
In preparing our financial statements, we are required to make certain estimates, judgments and
assumptions that we believe are reasonable based upon the information available. These estimates
and assumptions affect the reported amounts of assets at the date of the financial statements and
the reported amounts of expenses during the periods presented. Significant estimates are used for,
but not limited to, the treatment of our research and development expenditures, the assessment of
realizable value of long-lived assets, the amortization period of intellectual property and the
calculation of stock based compensation.
The significant accounting policies which we believe are the most critical to aid in fully
understanding and evaluating our reported financial results include the following:
Research and Development
Our research and development costs are expensed as they are incurred. Under Canadian generally
accepted accounting principles, development costs should be capitalized if certain criteria are
met. Companies with products in clinical trials do not necessarily meet these criteria. Our
development costs do not meet the following two criteria: (i) the technical feasibility of the
product or process has been established; and (ii) the future market for the product or process is
clearly defined. With regard to (i), we have completed three Phase I clinical trials and are
presently enrolling in three additional Phase I clinical trial studies for REOLYSIN®. We are also
planning to add to our clinical trial program. Until the appropriate clinical studies have been
completed, the technical feasibility of this product will not be known. With regard to (ii), the
future market for the product will not be clearly defined until the completion of the clinical
studies. Clinical studies not only determine the technical feasibility of the product, but also
provide information regarding the proper use of the product and, therefore, the future market.
Once the feasibility is determined a New Drug Application, or equivalent, is made to the
appropriate regulatory body. Regulatory approval is required before the product can be marketed.
For these reasons, our development costs are expensed and not capitalized.
Capitalization and Amortization of Patent Costs
We treat third party costs incurred (primarily legal and registration costs) in the development of
our Patent portfolio as limited-life intangible assets, and we amortize the costs related to these
assets over the lesser of 17 years or their estimated useful life. We also review the valuation of
our Patent costs for impairment when any events that might give rise to impairment are known to us.
If there is an indication of impairment, we would assess the fair value of our Patents and would
record a reduction if the fair value were less than the book value.
In capitalizing these costs, we are recognizing the inherent future benefit of our Patents, not
only in protection of our own potential products, but also as a possible asset that could give rise
to revenues in the future through licensing agreements. While Patent life is different in different
jurisdictions it is normally considered to be 20 years from date of application. With an assumption
of an average of three years from initial Patent application to Patent issuance, we have set a
maximum of 17 years to amortize the costs from the date of issuance. We have then assessed the
nature of the market and the continuing efforts to develop and market new and better products, as
well as the incurrence of costs associated with Patents that have been issued and, as a result, we
have chosen to amortize the costs on a straight-line basis over ten years.
As the product to which the Patents relate is in the development stage, with commercial recognition
and revenue potential highly uncertain, should we experience a significant failure in our clinical
trial program or other areas of risk, then the value of the Patents could be in serious question,
giving rise to a possible write-down or write-off of the asset.
In the event that we are successful in our product development and sales, or other parties enter
into licensing agreements with us, then it is also possible that the Patents may have a life and
value beyond the ten years assumed for the amortization policy.
In any event, the revision to any of these policies or estimates outlined above would impact losses
but not impact cash flows.
Changes in Accounting Policy including Initial Adoption
GAAP Hierarchy and General Standards of Financial Statement Presentation
In 2005, we adopted the new CICA Handbook Sections 1100, Generally Accepted Accounting
Principles, and 1400, General Standards of Financial Statement Presentation. Section 1100
describes what constitutes Canadian GAAP and its sources and provides guidance on sources to
consult when selecting accounting policies and determining appropriate disclosures when a matter is
not dealt with explicitly in the primary sources of generally accepted accounting principles,
thereby re-codifying the Canadian GAAP hierarchy. Section 1400 provides general guidance on
financial statement presentation and further clarifies what constitutes fair presentation in
accordance with GAAP. The application of this standard had no impact on our financial position or
results of operations.
Non-monetary Transactions
In 2006, we will prospectively adopt the new Canadian standard, Non-monetary Transactions, which
requires application of fair value measurement to non-monetary transactions determined by a number
of tests. The new standard is consistent with recently amended US standards. We do not expect this
standard to have a significant impact on our financial statements upon adoption.
Financial Instruments
On January 1, 2007, we will prospectively adopt the new Canadian accounting standards for financial
instruments and comprehensive income. These new accounting standards will impact our accounting
policy for investment securities. The new rules will require us to classify these securities as
held-to-maturity or available-for-sale. Available-for-sale securities will be measured at fair
value with gains and losses recorded in a new section of shareholders equity called other
comprehensive income. There will be no change in accounting for held-to-maturity securities. We
do not expect these standards to have a significant impact on our financial statements upon
adoption as our short-term investments will be classified as held-to-maturity securities.
Fair Presentation
We prepare our financial statements in accordance with GAAP. As a result of complying with GAAP,
we believe that the following should be mentioned in an effort to understand and fairly present our
financial information:
Stock Based Compensation
As required by the fair value based method for measuring stock based compensation, we use the Black
Scholes Option Pricing Model (Black Scholes or the Model) to calculate the fair value of our
options. Though there are other models available to calculate the option values (for example, the
binomial model), Black Scholes is currently widely used and accepted by other publicly traded
companies. Therefore, we have concluded that Black Scholes is the appropriate option pricing model
to use for our stock options at this time. Black Scholes uses inputs in its calculation of fair
value that requires us to make certain estimates and assumptions. For 2005, we used the following
weighted average assumptions:
|
|
|
|
|
|
|
2005 |
|
Risk-free interest rate |
|
|
3.27 |
% |
Expected hold period to exercise |
|
3.5 years |
Volatility in the price of the our shares |
|
|
64 |
% |
Dividend yield |
|
zero |
A change in these estimates and assumptions will impact the value calculated by the Model. For
instance, the volatility in the price of our shares is based on the quoted trading price. We
assume that weekly trading prices best reflects our trading price volatility. However, an entity
can choose between daily, weekly, monthly or quarterly trading prices in the volatility
calculation. For example, based upon periods chosen, if we were to use daily trading prices,
volatility would increase 34%, resulting in an option value increase of 27% from that calculated
from the stated volatility. If we were to use monthly trading prices over the same period,
volatility would increase 17%, resulting in an option value increase of 15%. Also, volatility
would change based on the period chosen and the frequency of price points chosen.
The Model also uses an expected hold period to exercise in its calculation of fair value. When we
are estimating the expected hold period to exercise we take into consideration past history, the
current trading price and volatility of our common shares and have concluded that 3.5 years is an
appropriate estimate. However, our options have a 10 year life and given the fluctuations in our
stock price the expected hold period could be different. If the hold period was to increase 1
year, there would have been a 13% increase in our stock based compensation expense.
Consequently, in complying with GAAP and selecting what we believe are the most appropriate
assumptions under the circumstances, we have increased our reported non-cash employee stock based
compensation expense for the year by $64,104. However, given the above discussion this expense
could be increased between 13% 27% and still be in accordance with GAAP.
Warrant Values
In 2005, we continued to raise cash through the issue of units and the exercise of warrants and
options. Each issued unit consisted of one common share and one half of one common share purchase
warrant with each whole warrant exercisable at a specified price for one additional common share
for up to 36 months from the issue date. GAAP requires that when recording the issued units, a
value should be ascribed to each component of the units based on the components fair value. The
fair value of our common shares is established based on trading on stock exchanges in Canada and
the U.S. However, as the warrants do not trade on an exchange, the Black Scholes Option Pricing
Model was used to determine the fair value of the warrants. In the event that the total calculated
value of each individual component is greater than the price paid for the unit the value of each
component is reduced on a relative basis until the total is equal to the units issue price.
For reasons discussed above under Stock Based Compensation, the Model can produce a wide range of
calculated values for our warrants.
Initial Value of Our Intellectual Property
In 1999, we were acquired by SYNSORB Biotech Inc. (SYNSORB) through the purchase of all of our
share capital for $2,500,000. In connection with this acquisition, the basis of accounting for the
assets and liabilities was changed to reflect SYNSORBs cost of acquiring theses assets and
liabilities. This was achieved through the application of push down accounting. At the time,
our major asset was our intellectual property, therefore the $2,500,000 was allocated to this asset
with the corresponding credit to contributed surplus. This accounting treatment, permitted under
GAAP, increased the value of our assets and shareholders equity. As of December 31, 2005, the net
book value of our original intellectual property was $833,333. Consequently, without the
application of push down accounting the value of our intellectual
property and shareholders equity would be $833,333 lower than presented in the 2005 audited
financial statements.
SELECTED ANNUAL INFORMATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Revenues (1) |
|
|
783,456 |
|
|
|
699,757 |
|
|
|
313,305 |
|
Net loss (2), (4) |
|
|
12,781,831 |
|
|
|
12,956,119 |
|
|
|
8,544,031 |
|
Basic and diluted loss per share (2), (4), (5) |
|
|
0.39 |
|
|
|
0.45 |
|
|
|
0.35 |
|
Total assets (3), (5) |
|
|
46,294,326 |
|
|
|
39,488,641 |
|
|
|
26,050,600 |
|
Total long term financial liabilities (6) |
|
|
150,000 |
|
|
|
150,000 |
|
|
|
150,000 |
|
Cash dividends declared per share(7) |
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Notes:
|
|
|
(1) |
|
Revenue is comprised of interest income and income from short term investments. |
|
(2) |
|
Included in net loss and net loss per share for 2005 is a net gain (net loss) from
sale of investments of $765 (2004 $34,185; 2003 ($1,892,232)). |
|
(3) |
|
Subsequent to the acquisition of Oncolytics Biotech Inc. by SYNSORB in April 1999, we
applied push down accounting. See note 2 to the audited financial statements for 2005. |
|
(4) |
|
Included in net loss and net loss per share is stock based compensation expense of
$64,104 (2004 $2,668,570; 2003 $996,707) |
|
(5) |
|
We issued 4,321,252 common shares for cash proceeds of $18,780,189 in 2005 (2004
4,685,775 common shares for cash proceeds of $23,495,961; 2003 5,062,978 common shares
for $16,004,981). In addition, 21,459 common shares were issued in 2004 as partial
consideration for the cancellation of a portion of our contingent payments (see note 10 to
the audited financial statements for 2005 |
|
(6) |
|
The long-term debt recorded in 2005, 2004 and 2003 represents repayable loans from
the Alberta Heritage Foundation. |
|
(7) |
|
We have not declared or paid any dividends since incorporation. |
RESULTS OF OPERATIONS
Net loss for the year ended December 31, 2005 was $12,781,831 compared to $12,956,119 and
$8,544,031, for 2004 and 2003, respectively.
Research and Development Expenses (R&D)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Manufacturing and related process development expenses |
|
|
4,714,320 |
|
|
|
3,868,883 |
|
|
|
1,328,480 |
|
Clinical trial expenses |
|
|
1,871,942 |
|
|
|
799,990 |
|
|
|
130,034 |
|
Pre-clinical trial expenses and collaborations |
|
|
786,488 |
|
|
|
824,889 |
|
|
|
322,060 |
|
Cancellation of contingent payment obligation |
|
|
|
|
|
|
400,000 |
|
|
|
|
|
Quebec scientific research and experimental development refund |
|
|
|
|
|
|
(21,436 |
) |
|
|
(255,905 |
) |
Other R&D expenses |
|
|
1,936,227 |
|
|
|
1,235,672 |
|
|
|
1,294,293 |
|
|
Research and development expenses |
|
|
9,308,977 |
|
|
|
7,107,998 |
|
|
|
2,818,962 |
|
|
In 2005, R&D was $9,308,977 compared to $7,107,998 and $2,818,962 in 2004 and 2003, respectively.
Manufacturing & Related Process Development (M&P)
M&P expenses include product manufacturing expenses and process development. Production
manufacturing expenses include third party direct manufacturing costs, quality control testing, and
fill costs. Process development expenses include costs associated with studies that examine
components of our manufacturing process looking for improvements and costs associated with the
creation and testing of our master and working viral and cell banks.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Product manufacturing expenses |
|
|
4,326,577 |
|
|
|
2,212,586 |
|
|
|
924,456 |
|
Technology transfer expenses |
|
|
|
|
|
|
656,346 |
|
|
|
|
|
Process development expenses |
|
|
387,743 |
|
|
|
999,951 |
|
|
|
404,024 |
|
|
Manufacturing and related process development expenses |
|
|
4,714,320 |
|
|
|
3,868,883 |
|
|
|
1,328,480 |
|
|
Our M&P expenses in 2005 increased to $4,714,320 compared to $3,868,883 and $1,328,480 in 2004 and
2003, respectively. In 2005, we continued to focus on the production of REOLYSIN® in order to
supply our expanding clinical trial program along with other research activity. In the first part
of 2005, we entered into a multiple cGMP production run supply contract with Cobra Biomanufacturing
Plc (Cobra). Later in 2005, we further expanded our cGMP production contracts by adding
additional manufacturing runs. As well, we contracted Cobra to supply non-cGMP product to be used
in non-human research and collaborative studies. As a result, we believe that the REOLYSIN®
produced in 2004 and 2005 should be sufficient to complete our existing clinical trials.
In 2004, we entered into an agreement to commence the manufacturing of REOLYSIN® and consequently
incurred expenses associated with the technology transfer of our manufacturing process. This
transfer was completed in 2004. In 2003, we were producing REOLYSIN® with our former manufacturer.
We expect that our product manufacturing expenses in 2006 will remain consistent compared to 2005.
We are expecting to enter into additional production run contracts to ensure a supply of REOLYSIN®
for our existing and future clinical trial and collaborative programs and to supply the NCI
clinical studies. However, we may choose to increase our product manufacturing commitments in 2006
if we believe we will need additional REOLYSIN® as our clinical trial program progresses.
Our process development expenses in 2005 were $387,743 compared to $999,951 and $404,024 in 2004
and 2003, respectively. We believe that improvements can be made to increase productivity. In
2005, our
process development activities focused on improving process yields. In 2003 and 2004, our process
development activity mainly related to establishing our own master and working viral and cell
banks.
Our process development expenses in 2006 may increase compared to 2005. We will continue to work
on improving process yields. We are also expecting to incur additional process development
expenses associated with the scale up of our manufacturing process.
Clinical Trial Program
Clinical trial expenses include those costs associated with our clinical trial program in the U.S.,
UK and Canada as well as those incurred in the preparation of commencing other clinical trials.
Included in clinical trial expenses are direct patient costs, contract research organization
(CRO) expenses, clinical trial site costs and other costs associated with our clinical trial
program.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Direct clinical trial expenses |
|
|
1,675,003 |
|
|
|
649,405 |
|
|
|
64,559 |
|
Other clinical trial expenses |
|
|
196,939 |
|
|
|
150,585 |
|
|
|
65,475 |
|
|
Clinical trial expenses |
|
|
1,871,942 |
|
|
|
799,990 |
|
|
|
130,034 |
|
|
In 2005, we incurred costs directly associated with ongoing clinical trials of $1,675,003 compared
to $649,405 and $64,559 in 2004 and 2003, respectively. In 2005, our clinical trial program
expanded to include our two U.S. studies and an additional study in the U.K. Consequently, we
actively enrolled in four clinical trials in 2005 compared to only having two ongoing studies in
2004 and 2003. Also, we concluded our enrollment in the Canadian glioma study and incurred site
closure expenses towards the end of 2005. In 2004, we provided a final update with respect to our
T2 prostate cancer study and incurred site closure costs.
We expect our clinical trial expenses will continue to increase in 2006 compared to 2005. The
increase in these expenses is expected to arise from enrollment in our existing clinical trial
program and expansion into further clinical trials.
Pre-Clinical Trial Expenses and Research Collaborations
Pre-clinical trial expenses include toxicology studies and are incurred by us in support of
expanding our clinical trial program into other indications, drug combinations and jurisdictions.
Research collaborations are intended to expand our intellectual property related to reovirus and
other viruses and identify potential licensing opportunities arising from our technology base.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Research collaboration expenses |
|
|
652,393 |
|
|
|
262,910 |
|
|
|
120,026 |
|
Pre-clinical trial expenses |
|
|
134,095 |
|
|
|
561,979 |
|
|
|
202,034 |
|
|
Pre-clinical trial expenses and research collaborations |
|
|
786,488 |
|
|
|
824,889 |
|
|
|
322,060 |
|
|
In 2005, our research collaboration expenses were $652,393 compared to $262,910 and $120,026 in
2004 and 2003 respectively. In 2005, we expanded our collaborative activities to include studies
investigating the interaction of the reovirus with the immune system and the use of the reovirus as
a co-therapy with existing chemotherapies and radiation. In the fourth quarter of 2005, we
reported the results of our collaboration with The Institute of Cancer Research that examined the
combination of REOLYSIN® and radiation therapy which showed that the combination of REOLYSIN® and
radiation therapy results in enhanced cytotoxicity in a range of tumour cell lines in vitro and in
vivo.
In 2004, our collaborative activities included studies that used reovirus as a co-therapy in
combination with existing chemotherapies and radiation. Data from our collaboration examining the
use of REOLYSIN®
with approved chemotherapeutics in animal models was presented in 2004. In 2003, we entered into a
collaboration to develop modified adenoviruses that are selective for Ras mediated cancers.
In 2005, we incurred pre-clinical trial expenses of $134,095 compared to $561,979 and $202,034 in
2004 and 2003 respectively. The decrease in pre-clinical trial expenses in 2005 compared to 2004
related to toxicology and equivalency studies that were performed in 2004 but not in 2005. As we
move through our clinical trial program the number of pre-clinical studies required will change
from year to year.
In 2006 we expect that pre-clinical trial expenses and research collaborations will remain
consistent compared to 2005 and 2004. We expect to continue expanding our collaborations in order
to provide support for our expanding clinical trial program. However, in our efforts to enter into
additional combination therapy clinical trials we may be required to perform additional
pre-clinical trial studies which could increase these costs compared to 2005 and 2004.
Other Research and Development Expenses
Other R&D expenses include compensation expenses for employees (excluding stock based
compensation), consultant fees, travel and other miscellaneous R&D expenses.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
R&D consulting fees |
|
|
675,530 |
|
|
|
290,135 |
|
|
|
187,513 |
|
R&D salaries and benefits |
|
|
1,018,144 |
|
|
|
722,136 |
|
|
|
815,869 |
|
Other R&D expenses |
|
|
242,553 |
|
|
|
223,401 |
|
|
|
290,911 |
|
|
Other research and development expenses |
|
|
1,936,227 |
|
|
|
1,235,672 |
|
|
|
1,294,293 |
|
|
In 2005, our R&D consulting fees were $675,530 compared to $290,135 and $187,513 in 2004 and 2003,
respectively. For the past three years, we have mainly incurred consulting activity associated
with our clinical trial applications, assistance with our existing and future clinical trial
program and our scientific advisory board. In 2005, we also incurred consulting expenses for
executive search activities associated with the hiring of our Chief Medical Officer which was not
incurred in 2004 or 2003.
Our R&D salaries and benefits were $1,018,144 in 2005 compared to $722,136 and $815,869 in 2004 and
2003, respectively. In 2005, along with increases in salary levels, we hired our Chief Medical
Officer in the third quarter of 2005.
In 2006, we expect that our Other R&D expenses will remain consistent with 2005. We expect that
salaries and benefits will increase as 2006 should include a complete year of salary and benefit
costs for our Chief Medical Officer. Our R&D consulting fees should decline as we do not expect to
incur executive search costs in 2006. However, we may choose to engage additional consultants to
assist us in the development of protocols and regulatory filings for our additional combination
therapy and phase II clinical trial studies possibly causing our R&D consulting expenses to
increase.
Cancellation of Contingent Payment Obligation
On September 23, 2004, we reached an agreement that cancelled a portion of our future contingent
obligation to one of our non-management founding shareholders for consideration of $400,000. The
consideration paid included cash of $250,000 and non-cash consideration of 21,459 common shares
valued at $150,000 and was recorded as additional research and development expense. The value of
the common shares was based on the September 23, 2004 closing price of $6.99. As a result, our
future contingent payment obligations were reduced to 11.75% (formerly in 2003 14.25% and 2002
20%) of payments received associated with a partnership or other arrangement for development.
Similarly, if we develop the reovirus treatment to the point where it may be marketed at a
commercial level, the payment referred to in the foregoing sentence has been amended to a royalty
payment of 2.35% (formerly in 2003 2.85% and 2002 4%) of Net Sales received by us for such
products.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Public company related expenses |
|
|
2,156,614 |
|
|
|
1,910,611 |
|
|
|
1,633,849 |
|
Office expenses |
|
|
928,283 |
|
|
|
893,058 |
|
|
|
815,629 |
|
|
Operating expenses |
|
|
3,084,897 |
|
|
|
2,803,669 |
|
|
|
2,449,478 |
|
|
In 2005, we incurred operating expenses of $3,084,897 compare to $2,803,669 and $2,449,478 in 2004
and 2003 respectively. The reason for the change is as follows:
Public company related expenses include costs associated with investor relations activities, legal
and accounting fees, corporate insurance, and transfer agent and other fees relating to our U.S.
and Canadian stock listings. We incurred public company related expenses of $2,156,614 in 2005
compared to $1,910,611 and $1,633,849 in 2004 and 2003, respectively. In 2005, after receiving
approval to commence our two U.S. clinical trials we initiated an expanded public relations and
investor relations program in the U.S. The increase in 2004 related to the rising cost of
directors and officers liability insurance which increased due to general market conditions for
companies with a U.S. stock listing.
Office expenses include compensation costs (excluding stock based compensation), office rent, and
other office related costs. In 2005, we incurred office expenses of $928,283 compared to $893,058
and $815,629 in 2004 and 2003, respectively. Our office expense activity has remained consistent
over the last three years with increases mainly due to increased compensation and staff levels.
Stock Based Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Stock based compensation |
|
|
64,104 |
|
|
|
2,668,570 |
|
|
|
996,707 |
|
|
Non-cash stock based compensation recorded for 2005 was $64,104 compared to $2,668,570 and $996,707
in 2004 and 2003, respectively. This expense is associated with the granting of stock options to
our employees, directors, and certain consultants and in 2005 there was a reduction in the number
of stock options granted compared to 2004 and 2003.
Foreign Exchange Loss (Gain)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Foreign exchange loss (gain) |
|
|
253,608 |
|
|
|
358,068 |
|
|
|
2,881 |
|
|
We acquire investments in foreign currency to pay for anticipated expenses that are to be incurred
in the U.S. and the U.K. As a result of continued strengthening in the Canadian dollar relative to
the U.S. dollar and British pound, we recorded a foreign exchange loss of $253,608 in 2005 compared
to $358,068 and $2,881 in 2004 and 2003, respectively.
Sale of Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
2003 |
|
|
$ |
|
$ |
|
$ |
|
Gain on partial sale of investment in BCY LifeSciences Inc. |
|
|
(765 |
) |
|
|
(34,185 |
) |
|
|
(264,453 |
) |
Loss on sale of investment in Transition Therapeutics Inc. |
|
|
|
|
|
|
|
|
|
|
2,156,685 |
|
|
Net (gain) loss from sale of investments |
|
|
(765 |
) |
|
|
(34,185 |
) |
|
|
1,892,232 |
|
|
BCY LifeSciences Inc. (BCY)
In 2005, we sold 120,000 (2004 697,945; 2003 1,496,500) common shares of BCY for net cash
proceeds of $7,965 (2004 $133,609; 2003 $450,151). This resulted in an accounting gain of $765
(2004 $34,185; 2003 $264,453). Our total cash invested with respect to our BCY investment was
$127,123.
Transition Therapeutics Inc. (TTH)
In 2003, we sold 6,890,000 common shares of TTH for net cash proceeds of $2,552,695 which had been
acquired through the issuance of 1,913,889 of our common shares. As a result of the sale, an
accounting loss of $2,156,685 was recorded. Our cash expenses with respect to our investment in
TTH were limited to acquisition legal costs of $20,352.
Commitments
As at December 31, 2005, we are committed to payments totaling $1,138,000 during 2006 for
activities related to clinical trial activity and collaborations. All of these committed payments
are considered to be part of our normal course of business.
Subsequent to 2005, we entered into research and development agreements and under these contracts
we have committed to payments totaling $1,451,000.
SUMMARY OF QUARTERLY RESULTS
The following unaudited quarterly information is presented in thousands of dollars except for
per share amounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
Dec. |
|
Sept. |
|
June |
|
March |
|
Dec. |
|
Sept. |
|
June |
|
March |
Revenue(1) |
|
|
160 |
|
|
|
211 |
|
|
|
168 |
|
|
|
245 |
|
|
|
205 |
|
|
|
194 |
|
|
|
183 |
|
|
|
117 |
|
Net loss(2), (5) |
|
|
3,941 |
|
|
|
3,510 |
|
|
|
2,955 |
|
|
|
2,377 |
|
|
|
3,992 |
|
|
|
3,096 |
|
|
|
3,192 |
|
|
|
2,676 |
|
Basic and diluted loss per common
share(2), (5) |
|
$ |
0.12 |
|
|
$ |
0.11 |
|
|
$ |
0.09 |
|
|
$ |
0.07 |
|
|
$ |
0.14 |
|
|
$ |
0.11 |
|
|
$ |
0.11 |
|
|
$ |
0.10 |
|
Total assets(3), (6) |
|
|
46,294 |
|
|
|
34,538 |
|
|
|
38,081 |
|
|
|
40,519 |
|
|
|
39,489 |
|
|
|
29,471 |
|
|
|
31,221 |
|
|
|
25,435 |
|
Total cash(4), (6) |
|
|
40,406 |
|
|
|
28,206 |
|
|
|
31,975 |
|
|
|
34,713 |
|
|
|
33,919 |
|
|
|
23,806 |
|
|
|
25,522 |
|
|
|
20,298 |
|
Total long-term debt(7) |
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
|
|
150 |
|
Cash dividends
declared(8) |
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
|
|
(1) |
|
Revenue is comprised of interest income and income from short term investments. |
|
(2) |
|
Included in net loss and net loss per share between December 2005 and January 2004 is
a quarterly gain (loss) on sale of investment of $nil, $nil, $nil, $765, $nil, ($12,817),
($646), and $47,648, respectively. |
|
(3) |
|
Subsequent to the acquisition of Oncolytics Biotech Inc. by SYNSORB in April 1999, we
applied push down accounting. See note 2 to the audited financial statements for 2005. |
|
(4) |
|
Included in total cash are cash and cash equivalents plus short-term investments. |
|
(5) |
|
Included in net loss and loss per common share between December 2005 and January 2004
are quarterly stock based compensation expenses of $38,152, $4,173, $8,404, $13,375,
$1,870,596, $48,878, $734,670, and $5,426, respectively. |
|
(6) |
|
We issued 4,321,252 common shares for cash proceeds of $18,789,596 during 2005 (2004
4,685,775 common shares for $23,495,961). In addition, 21,459 common shares were issued
in September 2004 as partial consideration for the cancellation of a portion of our
contingent payments (see note 10 to the audited financial statements for 2005). |
|
(7) |
|
The long-term debt recorded represents repayable loans from the Alberta Heritage
Foundation. |
|
(8) |
|
We have not declared or paid any dividends since incorporation. |
FOURTH QUARTER
Statement of loss for the three month period ended December 31, 2005 and 2004
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Interest income |
|
|
159,841 |
|
|
|
204,941 |
|
|
|
Research and development expenses |
|
|
2,809,943 |
|
|
|
1,425,286 |
|
Operating expenses |
|
|
973,470 |
|
|
|
690,628 |
|
Stock based compensation |
|
|
38,152 |
|
|
|
1,879,596 |
|
Foreign exchange loss (gain) |
|
|
55,127 |
|
|
|
4,104 |
|
Amortization |
|
|
223,708 |
|
|
|
197,280 |
|
|
|
|
|
4,100,400 |
|
|
|
4,196,894 |
|
|
Loss before the following: |
|
|
3,940,559 |
|
|
|
3,991,953 |
|
Gain on sale of investment in BCY |
|
|
|
|
|
|
|
|
|
Loss before taxes |
|
|
3,940,559 |
|
|
|
3,991,953 |
|
Capital tax |
|
|
|
|
|
|
|
|
|
Net loss |
|
|
3,940,559 |
|
|
|
3,991,953 |
|
|
REVIEW OF OPERATIONS
For the three month period ended December 31, 2005, our net loss was $3,940,559 compared to
$3,991,953 for the three month period ended December 31, 2004. The reasons for the increase are as
follows:
Research and Development Expenses (R&D)
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Manufacturing and related process development expenses
(M&P) |
|
|
1,129,891 |
|
|
|
507,869 |
|
Clinical trial expenses |
|
|
717,265 |
|
|
|
366,852 |
|
Pre-clinical trial expenses and research collaborations |
|
|
262,015 |
|
|
|
89,425 |
|
Other R&D expenses |
|
|
700,772 |
|
|
|
461,140 |
|
|
Research and development expenses |
|
|
2,809,943 |
|
|
|
1,425,286 |
|
|
Our R&D expenses increased to $2,809,943 in the fourth quarter of 2005 compared to $1,425,286 in
the fourth quarter of 2004.
Manufacturing & Related Process Development (M&P)
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Product manufacturing expenses |
|
|
951,667 |
|
|
|
324,671 |
|
Technology transfer expenses |
|
|
|
|
|
|
120,546 |
|
Process development expenses |
|
|
178,224 |
|
|
|
62,652 |
|
|
Manufacturing and related process development expenses |
|
|
1,129,891 |
|
|
|
507,869 |
|
|
Our M&P expenses increased to $1,129,891 in the fourth quarter of 2005 compared to $507,869 in the
fourth quarter of 2004. In the fourth quarter of 2005, we continued to focus on the production of
REOLYSIN® by commencing additional production runs with Cobra. In the fourth quarter of 2004, we
had finished the technology transfer to Cobra and had begun producing REOLYSIN®.
Our process development costs were $178,224 in the fourth quarter of 2005 compared to $62,652 in
the fourth quarter of 2004. In the fourth quarter of 2005, our process development activities
related to the improvement of process yields. In the fourth quarter of 2004, process development
activities related to the technology transfer to Cobra.
Clinical Trial Program
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Direct clinical trial expenses |
|
|
657,405 |
|
|
|
227,221 |
|
Other clinical trial expenses |
|
|
59,860 |
|
|
|
139,631 |
|
|
Clinical trial expenses |
|
|
717,265 |
|
|
|
366,852 |
|
|
Our clinical trial expenses for the fourth quarter of 2005 were $717,265 compared to $366,852 for
the fourth quarter of 2004. In the fourth quarter of 2005, we were actively enrolling patients in
three clinical trials in the U.S. and the U.K. and incurred clinical trial site closure costs
associated with the Canadian malignant glioma trial. In the fourth quarter of 2004, we were
actively enrolling in the U.K. systemic and the Canadian malignant glioma clinical trials.
Pre-Clinical Trial Expenses and Research Collaborations
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Research collaboration expenses |
|
|
224,673 |
|
|
|
89,425 |
|
Pre-clinical trial expenses |
|
|
37,342 |
|
|
|
|
|
|
Pre-clinical trial expenses and research collaborations |
|
|
262,015 |
|
|
|
89,425 |
|
|
Our pre-clinical trial expenses and research collaborations were $262,015 in the fourth quarter of
2005 compared to $89,425 in the fourth quarter of 2004. In the fourth quarter of 2005, our
research collaborations continued to expand to include the interaction of the immune system and
reovirus and the use of reovirus as a co-therapy with existing chemotherapies. In the fourth
quarter of 2004, our research collaboration activity mainly related to the use of reovirus as a
co-therapy with existing chemotherapies and the development of modified adenoviruses that are
selective for Ras mediated cancers.
Other Research and Development Expenses
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
R&D consulting fees |
|
|
124,936 |
|
|
|
108,697 |
|
R&D salaries and benefits |
|
|
455,771 |
|
|
|
274,640 |
|
Other R&D expenses |
|
|
120,065 |
|
|
|
77,803 |
|
|
Other research and development expenses |
|
|
700,772 |
|
|
|
461,140 |
|
|
Our other research and development expenses were $700,772 for the fourth quarter of 2005 compared
to $461,140 for the fourth quarter of 2004. The increase mainly related to the hiring of our Chief
Medical Officer at the end of the third quarter of 2005.
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Public company related expenses |
|
|
672,010 |
|
|
|
438,349 |
|
Office expenses |
|
|
301,460 |
|
|
|
252,279 |
|
|
Operating expenses |
|
|
973,470 |
|
|
|
690,628 |
|
|
Our operating expenses for the fourth quarter of 2005 were $973,470 compared to $690,628 for the
fourth quarter of 2004. This increase corresponds to an increase in investor relations activity in
the fourth quarter of 2005 compared to the fourth quarter of 2004.
Stock Based Compensation
|
|
|
|
|
|
|
|
|
|
|
2005 |
|
2004 |
|
|
$ |
|
$ |
|
|
(unaudited) |
|
(unaudited) |
|
Stock based compensation |
|
|
38,152 |
|
|
|
1,879,596 |
|
|
Our non-cash stock based compensation recorded for the fourth quarter of 2005 was $38,152 compared
to $1,879,596 for the fourth quarter of 2004. The stock based compensation expense in the fourth
quarter of 2005 related to the vesting of previously granted options. In the fourth quarter of
2004, stock based compensation expense related to the granting of options to officers, directors
and employees.
FINANCING ACTIVITIES
On December 29, 2005, we issued 3,200,000 units for gross cash proceeds of $16,480,000. Each
unit consisted of one common share and one half of one common share purchase warrant. Each whole
common share purchase warrant entitles the holder to acquire on common share in our capital upon
payment of $6.15 per share until December 29, 2008. In addition, we issued 320,000 common share
purchase warrants with an exercise price of $5.65 to the agent of this transaction. The broker
warrants expire on December 29, 2008.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity
As at December 31, 2005, we had cash and cash equivalents (including short-term investments) and
working capital positions of $40,406,167 and $39,301,444, respectively, compared to $33,919,223 and
$33,268,097, respectively, for 2004. The increase in 2005 reflects the cash inflow of $18,780,189
from one private placement and proceeds from the exercise of warrants and options. Cash usage from
operating activities and the purchase of intellectual property and capital assets in 2005 was
$12,146,806 which was in line with our estimate of $12,000,000 for 2005.
We desire to maintain adequate cash and short-term investment reserves to support our planned
activities which include our clinical trial program, product manufacturing, administrative costs,
and our intellectual property expansion and protection. In 2006, we are expecting to expand our
clinical trial program to include additional co-therapy clinical trials and Phase II clinical
trials. We are also expecting to continue with our collaborative studies pursuing support for our
future clinical trial program. Therefore, we will also need to ensure that we have enough
REOLYSIN® to supply our potentially expanding clinical trial and collaborative programs. We
presently estimate the cash usage for 2006 to increase to $1,500,000 per month and we believe our
existing capital resources are adequate to fund our current plans for research and development
activities into 2008. Factors that will affect our anticipated monthly burn rate include, but are
not limited to, the number of manufacturing runs required to supply our clinical trial program and
the cost of each run, the number of clinical trials ultimately approved, the timing of patient
enrollment in the approved clinical trials, the actual costs incurred to support each clinical
trial, the number of treatments each patient will receive, the timing of the NCIs R&D activity,
and the level of pre-clinical activity undertaken.
In the event that we choose to seek additional capital, we will look to fund additional capital
requirements primarily through the issue of additional equity. We recognize the challenges and
uncertainty inherent in the capital markets and the potential difficulties we might face in raising
additional capital. Market prices and market demand for securities in biotechnology companies are
volatile and there are no assurances that we will have the ability to raise funds when required.
Capital Expenditures
We spent $1,033,035 on intellectual property in 2005 compared to $958,809 in 2004. The change in
intellectual property expenditures reflects the timing of filing costs associated with our expanded
patent base. As well, we have benefited from a stronger Canadian dollar as our patent costs are
typically incurred in U.S. currency. In 2005, four Canadian and one European patents were issued
bringing our total patents
issued to thirteen in the U.S., four in Canada and two in Europe.
Contractual Obligations
We have the following contractual obligations as at December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual Obligations |
|
Payments Due by Period |
|
|
|
|
|
|
|
|
Total |
|
Less than 1 year |
|
1 -3 years |
|
4 5 years |
|
After 5 years |
|
|
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
Long term debt (1) |
|
|
150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
150,000 |
|
Capital lease obligations |
|
Nil |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases (2) |
|
|
484,445 |
|
|
|
89,436 |
|
|
|
178,872 |
|
|
|
178,872 |
|
|
|
37,265 |
|
Purchase obligations |
|
|
1,138,000 |
|
|
|
1,138,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other long term obligations |
|
Nil |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
|
1,772,445 |
|
|
|
1,227,436 |
|
|
|
178,872 |
|
|
|
178,872 |
|
|
|
187,265 |
|
|
Note:
|
|
|
(1) |
|
Our long term debt is a $150,000 loan from the Alberta Heritage Foundation. Repayments
are required upon the realization of sales (see note 9 of the Companys audited 2005
financial statements). |
|
(2) |
|
Our operating leases are comprised of our office lease and exclude our portion of
operating costs. |
We will fund our capital expenditure requirements and commitments with existing working
capital.
Investing Activities
Under our Investment Policy, we are permitted to invest in short-term instruments with a rating no
less than R-1 (DBRS) with terms less than two years. We have $36,894,810 invested under this
policy and we are currently earning interest at an effective rate of 2.9%.
OFF-BALANCE SHEET ARRANGEMENTS
As at December 31, 2005, we have not entered into any off-balance sheet arrangements.
TRANSACTIONS WITH RELATED PARTIES
In 2005 and 2004, we did not enter into any related party transactions.
FINANCIAL INSTRUMENTS AND OTHER INSTRUMENTS
We do not use financial derivatives or other financial instruments.
RISKS FACTORS AFFECTING FUTURE PERFORMANCE
All of our potential products, including REOLYSIN®, are in the research and development stage
and will require further development and testing before they can be marketed commercially.
Prospects for companies in the biotechnology industry generally may be regarded as uncertain given
the nature of the industry and, accordingly, investments in biotechnology companies should be
regarded as speculative. We are currently in the research and development stage on one product,
REOLYSIN®, for human application, the riskiest stage for a company in the biotechnology industry.
It is not possible to predict, based upon studies in animals, or early studies in humans, whether
REOLYSIN® will prove to be safe and effective in humans. REOLYSIN® will require additional
research and development, including extensive clinical testing, before we will be able to obtain
the approval of the United States Food and Drug Administration (the FDA) or from similar
regulatory authorities in other countries to market REOLYSIN® commercially. There can be no
assurance that the research and development programs conducted by us will result in REOLYSIN® or
any other products becoming commercially viable products, and in the event that any product or
products result from the research and development program, it is unlikely they will be commercially
available for a number of years.
To achieve profitable operations Oncolytics Biotech Inc., alone or with others, must successfully
develop, introduce and market our products. To obtain regulatory approvals for products being
developed for human use, and to achieve commercial success, human clinical trials must demonstrate
that the product is safe for human use and that the product shows efficacy. Unsatisfactory results
obtained from a particular study relating to a program may cause us to abandon our commitment to
that program or the product being tested. No assurances can be provided that any current or future
animal or human test, if undertaken, will yield favorable results. If we are unable to establish
that REOLYSIN® is a safe, effective treatment for cancer, we may be required to abandon further
development of the product and develop a new business strategy.
There are inherent risks in pharmaceutical research and development.
Pharmaceutical research and development is highly speculative and involves a high and significant
degree of risk. The marketability of any product developed by us will be affected by numerous
factors beyond our control, including:
|
|
|
the discovery of unexpected toxicities or lack of sufficient efficacy of products which
make them unattractive or unsuitable for human use; |
|
|
|
|
preliminary results as seen in animal and/or limited human testing may not be
substantiated in larger controlled clinical trials; |
|
|
|
|
manufacturing costs or other factors may make manufacturing of products impractical and
non-competitive; |
|
|
|
|
proprietary rights of third parties or competing products or technologies may preclude
commercialization; |
|
|
|
|
requisite regulatory approvals for the commercial distribution of products may not be
obtained; and |
|
|
|
|
other factors may become apparent during the course of research, up-scaling or
manufacturing which may result in the discontinuation of research and other critical
projects. |
Our product under development has never been manufactured on a commercial scale, and there can be
no assurance that such products can be manufactured at a cost or in a quantity to render such
products commercially viable. Production and utilization of our products may require the
development of new manufacturing technologies and expertise. The impact on our business in the
event that new manufacturing technologies and expertise are required to be developed is uncertain.
There can be no assurance that we will successfully meet any of these technological challenges, or
others that may arise in the course of development.
Pharmaceutical products are subject to intense regulatory approval processes.
The regulatory process for pharmaceuticals, which includes preclinical studies and clinical trials
of each compound to establish its safety and efficacy, takes many years and requires the
expenditure of substantial resources. Moreover, if regulatory approval of a drug is granted, such
approval may entail limitations on the indicated uses for which it may be marketed. Failure to
comply with applicable regulatory requirements can, among other things, result in suspension of
regulatory approvals, product recalls, seizure of products, operating restrictions and criminal
prosecution. Further, government policy may change, and additional government regulations may be
established that could prevent or delay regulatory approvals for our products. In addition, a
marketed drug and its manufacturer are subject to continual review. Later discovery of previously
unknown problems with the product or manufacturer may result in restrictions on such product or
manufacturer, including withdrawal of the product from the market.
The FDA in the United States and other relevant regulatory authorities may deny approval of a new
drug application (NDA) or its equivalent in the relevant jurisdiction if required regulatory
criteria are not satisfied, or may require additional testing. Product approvals may be withdrawn
if compliance with regulatory standards is not maintained or if problems occur after the product
reaches the market. The FDA may require further testing and surveillance programs to monitor the
pharmaceutical product that has been commercialized. Non-compliance with applicable requirements
can result in fines and other judicially imposed sanctions, including product withdrawals, product
seizures, injunction actions and criminal prosecutions.
In addition to our own pharmaceuticals, we may supply active pharmaceutical ingredients and
advanced pharmaceutical intermediates for use in our customers drug products. The final drug
products in which the pharmaceutical ingredients and advanced pharmaceutical intermediates are
used, however, are subject to regulation for safety and efficacy by the FDA and other
jurisdictions, as the case may be. Such products must be approved by such agencies before they can
be commercially marketed. The process of obtaining regulatory clearance for marketing is uncertain,
costly and time consuming. We cannot predict how long
the necessary regulatory approvals will take or whether our customers will ever obtain such
approval for their products. To the extent that our customers do not obtain the necessary
regulatory approvals for marketing new products, our product sales could be adversely affected.
The FDA and other governmental regulators have increased requirements for drug purity and have
increased environmental burdens upon the pharmaceutical industry. Because pharmaceutical drug
manufacturing is a highly regulated industry, requiring significant documentation and validation of
manufacturing processes and quality control assurance prior to approval of the facility to
manufacture a specific drug, there can be considerable transition time between the initiation of a
contract to manufacture a product and the actual initiation of manufacture of that product. Any lag
time in the initiation of a contract to manufacture product and the actual initiation of
manufacture could cause us to lose profits or incur liabilities.
The pharmaceutical regulatory regime in Europe and other countries is, by and large, generally
similar to that of Canada and the United States. We could face similar risks in these other
jurisdictions, as the risks described above.
Our operations and products may be subject to other government manufacturing and testing
regulations.
Securing regulatory approval for the marketing of therapeutics by the FDA in the United States and
similar regulatory agencies in other countries is a long and expensive process, which can delay or
prevent product development and marketing. Approval to market products may be for limited
applications or may not be received at all.
The products anticipated to be manufactured by us will have to comply with the FDAs current Good
Manufacturing Practices (cGMP) and other FDA and local government guidelines and regulations,
including other international regulatory requirements and guidelines. Additionally, certain of our
customers may require the manufacturing facilities contracted by us to adhere to additional
manufacturing standards, even if not required by the FDA. Compliance with cGMP regulations requires
manufacturers to expend time, money and effort in production, and to maintain precise records and
quality control to ensure that the product meets applicable specifications and other requirements.
The FDA and other regulatory bodies periodically inspect drug-manufacturing facilities to ensure
compliance with applicable cGMP requirements. If the manufacturing facilities contracted by us fail
to comply with the cGMP requirements, the facilities may become subject to possible FDA or other
regulatory action and manufacturing at the facility could consequently be suspended. We may not be
able to contract suitable alternative or back-up manufacturing facilities on terms acceptable to us
or at all.
The FDA or other regulatory agencies may also require the submission of any lot of a particular
product for inspection. If the lot product fails to meet the FDA requirements, then the FDA could
take any of the following actions: (i) restrict the release of the product; (ii) suspend
manufacturing of the specific lot of the product; (iii) order a recall of the lot of the product;
or (iv) order a seizure of the lot of the product.
We are subject to regulation by governments in many jurisdictions and, if we do not comply with
healthcare, drug, manufacturing and environmental regulations, among others, our existing and
future operations may be curtailed, and we could be subject to liability.
In addition to the regulatory approval process, we may be subject to regulations under local,
provincial, state, federal and foreign law, including requirements regarding occupational health,
safety, laboratory practices, environmental protection and hazardous substance control, and may be
subject to other present and future local, provincial, state, federal and foreign regulations.
Our products may fail or cause harm, subjecting us to product liability claims, which are
uninsured.
The sale and use of our products entail risk of product liability. We currently do not have any
product liability insurance. There can be no assurance that we will be able to obtain appropriate
levels of product
liability insurance prior to any sale of our pharmaceutical products. An inability to obtain
insurance on economically feasible terms or to otherwise protect against potential product
liability claims could inhibit or prevent the commercialization of products developed by us. The
obligation to pay any product liability claim or a recall of a product could have a material
adverse effect on our business, financial condition and future prospects.
Our technologies may become obsolete.
The pharmaceutical industry is characterized by rapidly changing markets, technology, emerging
industry standards and frequent introduction of new products. The introduction of new products
embodying new technologies, including new manufacturing processes, and the emergence of new
industry standards may render our products obsolete, less competitive or less marketable. The
process of developing our products is extremely complex and requires significant continuing
development efforts and third party commitments. Our failure to develop new technologies and
products and the obsolescence of existing technologies could adversely affect our business.
We may be unable to anticipate changes in our potential customer requirements that could make our
existing technology obsolete. Our success will depend, in part, on our ability to continue to
enhance our existing technologies, develop new technology that addresses the increasing
sophistication and varied needs of the market, and respond to technological advances and emerging
industry standards and practices on a timely and cost-effective basis. The development of our
proprietary technology entails significant technical and business risks. We may not be successful
in using our new technologies or exploiting the respective niche markets effectively or adapting
our businesses to evolving customer or medical requirements or preferences or emerging industry
standards.
We have no operating revenues and a history of losses.
To date, we have not generated sufficient revenues to offset our research and development costs and
accordingly have not generated positive cash flow or made an operating profit. As of December 31,
2005, we had an accumulated deficit of $50.7 million and we incurred net losses of $12.8 million,
$13.0 million, and $8.5 million for the years ended December 31, 2005, 2004, and 2003,
respectively. We anticipate that we will continue to incur significant losses during 2006 and in
the foreseeable future. We will not reach profitability until after successful and profitable
commercialization of one or more of our products. Even if one or more of our products are
profitably commercialized, the initial losses incurred by us may never be recovered.
We may need additional financing in the future to fund the research and development of our products
and to meet our ongoing capital requirements.
As of December 31, 2005, we had cash and cash equivalents (including short-term investments) of
$40.4 million and working capital of approximately $39.3 million. We anticipate that we may need
additional financing in the future to fund research and development and to meet our ongoing capital
requirements. The amount of future capital requirements will depend on many factors, including
continued scientific progress in our drug discovery and development programs, progress in our
pre-clinical and clinical evaluation of drug candidates, time and expense associated with filing,
prosecuting and enforcing our patent claims and costs associated with obtaining regulatory
approvals. In order to meet such capital requirements, we will consider contract fees,
collaborative research and development arrangements, and additional public or private financings
(including the incurrence of debt and the issuance of additional equity securities) to fund all or
a part of particular programs as well as potential partnering or licensing opportunities. There
can be no assurance that additional funding will be available or, if available, that it will be
available on acceptable terms. If adequate funds are not available on terms favorable to us, we
may have to reduce substantially or eliminate expenditures for research and development, testing,
production and marketing of our proposed product, or obtain funds through arrangements with
corporate partners that require us to relinquish rights to certain of our technologies or product.
There can be no assurance that we will be able to raise additional capital if our current capital
resources are exhausted.
The cost of director and officer liability insurance may continue to increase substantially or may
not be available to us and may affect our ability to retain quality directors and officers.
We carry liability insurance on behalf of our directors and officers. Given a number of large
director and officer liability insurance claims in the U.S. equity markets, director and officer
liability insurance is becoming increasingly more expensive with increased restrictions.
Consequently, there is no assurance that we will continue to be offered this insurance or be able
to obtain adequate coverage. The inability to acquire the appropriate insurance coverage may limit
our ability to attract and maintain directors and officers as required to conduct our business.
We incur some of our expenses in foreign currencies and therefore are exposed to foreign currency
exchange rate fluctuations.
We incur some of our manufacturing, clinical, collaborative and consulting expenses in foreign
currencies, primarily the U.S. dollar and the Great British pound (GBP). Over the past year the
Canadian dollar has appreciated relative to the U.S. dollar and the GBP thereby decreasing the
Canadian dollar equivalent. However, if this trend reverses, our Canadian dollar equivalent costs
will increase.
Also, as we expand to other foreign jurisdictions there may be an increase in our foreign exchange
exposure.
We earn interest income on our excess cash reserves and are exposed to changes in interest rates.
We invest our excess cash reserves in investment vehicles that provide a rate of return with little
risk to principle. As interest rates change the amount of interest income we earn will be directly
impacted.
OTHER MD&A REQUIREMENTS
We have 36,236,748 common shares outstanding at March 2, 2006. If all of our warrants and
options were exercised we would have 42,656,098 common shares outstanding.
Our 2005 Annual Information Form is available on www.sedar.com.
Disclosure Controls and Procedures
As of the year ending December 31, 2005, we carried out an evaluation, under the supervision of our
Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure
controls and procedures. Based upon that evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that our disclosure controls and procedures are effective as of
the end of the period covered by the annual filings based on this evaluation.
Oncolytics
Biotech Inc.
Suite
210, 1167 Kensington Crescent NW, Calgary, AB T2N 1X7
Phone: (403) 670.7377 Fax: (403) 283.0858
www.oncolyticsbiotech.com