Ecopia BioSciences Inc.: 2005 Operating Highlights and Financial Results.MONTREAL Montreal (mŏn'trēôl`), Fr. Montréal (môNrāäl`), city (1991 pop. 1,017,666), S Que., Canada, on Montreal island, surrounded by St. Lawrence River and Rivière des Prairies. -- Ecopia BioSciences Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components. ) today announced operating highlights and financial results for the year ended November November: see month. 30, 2005. Management's discussion and analysis Management's discussion and analysis (MD&A) A report from management to shareholders that accompanies the firm's financial statements in the annual report. It explains the period's financial results and enables management to discuss topics that may not be apparent in the financial of results of operations and financial condition for the years ended November 30, 2005 and November 30, 2004 This Management's Discussion and Analysis of Ecopia's Operations and Financial Condition for the year ended November 30, 2005 dated as of February February: see month. 6, 2006 should be read in conjunction with the financial statements and the accompanying ac·com·pa·ny v. ac·com·pa·nied, ac·com·pa·ny·ing, ac·com·pa·nies v.tr. 1. To be or go with as a companion. 2. notes and the Management's Discussion and Analysis for the year ended November 30, 2004 that can be found in Ecopia's 2004 Annual Report. Ecopia uses the same accounting policies and methods as those used in 2004. Certain statements in this Management's Discussion and Analysis that do not relate exclusively to historical facts are forward-looking for·ward-look·ing adj. Concerned with or making provision for the future: forward-looking educators; a forward-looking corporate plan. Adj. 1. information. When used in this Management's Discussion and Analysis, the words "may", "would", "could", "will", "intend", "anticipate", "believe", "expect" and similar expressions, as they relate to Ecopia or its management, are intended to identify forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . These statements represent the Company's current expectations regarding future events. These forward-looking statements, including the ability to raise future capital to fund our R&D activities, favorable fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. review by regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities of the Company's Clinical Trial Application (CTA An abbreviation for cum testamento annexo, Latin for "with the will annexed." ) and commencement of Phase I clinical trials Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of ECO- eco- pref. Ecology; ecological: ecosystem. 4601 in Canada Canada (kăn`ədə), independent nation (2001 pop. 30,007,094), 3,851,787 sq mi (9,976,128 sq km), N North America. Canada occupies all of North America N of the United States (and E of Alaska) except for Greenland and the French islands of , the pursuit of clinical trials in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , the potential of ECO-4601 as a chemotherapy chemotherapy (kē'mōthĕr`əpē), treatment of disease with chemicals or drugs. One chemotherapeutic approach is the development of selectively toxic substances, i.e. against primary brain cancer, the potential of ECO-4601 in the treatment of breast, prostate prostate /pros·tate/ (pros´tat) a gland surrounding the bladder neck and urethra in the male; it contributes a secretion to the semen.prostat´ic pros·tate n. The prostate gland. adj. , colon colon, in anatomy colon, in anatomy: see intestine. colon, in punctuation colon, in writing: see punctuation. colon Segment that makes up most of the large intestine. , lung and ovarian cancers ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast , the identification of a second-generation sec·ond-gen·er·a·tion adj. 1. Of or relating to a person or persons whose parents are immigrants. 2. Of or relating to a person or persons whose parents are citizens by birth and whose grandparents are immigrants. 3. ECO-4601 compound, the identification of a non-ECO-4601 related compound as a candidate for another regulatory reg·u·late tr.v. reg·u·lat·ed, reg·u·lat·ing, reg·u·lates 1. To control or direct according to rule, principle, or law. 2. filing, the grant by the USPTO USPTO abbr. United States Patent and Trademark Office of a patent directed to ECO-4601 based on the Company's Notice of Allowance and the earning of revenues from the exercise of exclusivity options on out-licensed patent properties may rely on a number of assumptions concerning future events and are therefore subject to a number of risks and uncertainties, many of which are outside Ecopia's control. Actual results may therefore vary materially from the expectations expressed by the Company and depend on a number of factors. These factors include and are not restricted to the possibility of objections or delays in approval by regulatory authorities of the CTA or counterpart counterpart n. in the law of contracts, a written paper which is one of several documents which constitute a contract, such as a written offer and a written acceptance. US Investigational New Drug (IND) applications, scientific uncertainties relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the correlation between preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. animal data and human clinical data, the safety and efficacy efficacy /ef·fi·ca·cy/ (ef´i-kah-se) 1. the ability of an intervention to produce the desired beneficial effect in expert hands and under ideal circumstances. 2. of ECO-4601 as a cancer treatment, success and timely completion of clinical studies, withdrawal of a notice of allowance by the USPTO, uncertainties related to the regulatory process for drug development, the ability for Ecopia to fund its future operations in light of the lack of operating revenues operating revenue Revenue from any regular source. Revenue from sales is adjusted for discounts and returns when calculating operating revenue. Compare other revenue. for the years to come and the impact of general economic conditions. Investors are cautioned against placing undue reliance on forward-looking statements or forward-looking information. These forward-looking statements or forward-looking information should not be relied upon as representing the Company's views as of any date subsequent to the date these statements were originally made or information originally provided. Readers are recommended to consult the more complete discussion of the risks and uncertainties facing the Company included below in this Management's Discussion and Analysis. Except as required by law, Ecopia does not undertake and disclaims any obligation to update or revise its forward-looking statements or forward-looking information whether as a result of new information, future events, or otherwise. Internal Disclosure Controls In accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with Multilateral mul·ti·lat·er·al adj. 1. Having many sides. 2. Involving more than two nations or parties: multilateral trade agreements. Instrument 52-109 - Certification of Disclosure in Issuers' Annual and Interim Filings, the Corporation's President and Chief Executive Officer and Executive Vice-President vice president or vice-pres·i·dent n. Abbr. VP 1. An officer ranking next below a president, usually empowered to assume the president's duties under conditions such as absence, illness, or death. 2. and Chief Financial Officer have designed, or have caused to be designed under their supervision, controls and procedures that provide reasonable assurance that information required to be disclosed dis·close tr.v. dis·closed, dis·clos·ing, dis·clos·es 1. To expose to view, as by removing a cover; uncover. 2. To make known (something heretofore kept secret). by the Corporation in its annual filings, interim filings or other reports filed or submitted by it under provincial Provincial has several meanings and may refer to:
tr.v. spec·i·fied, spec·i·fy·ing, spec·i·fies 1. To state explicitly or in detail: specified the amount needed. 2. To include in a specification. 3. in the provincial and territorial securities legislation. The Corporation's President and Chief Executive Officer and Executive Vice-President and Chief Financial Officer are assisted in such functions by a Disclosure Policy Committee (the "Committee") responsible for the Corporation's disclosure policy established by the Board to ensure that the communication of material information to the public is timely, factual and accurate and broadly disseminated disseminated /dis·sem·i·nat·ed/ (-sem´i-nat?ed) scattered; distributed over a considerable area. dis·sem·i·nat·ed adj. Spread over a large area of a body, a tissue, or an organ. in accordance with all applicable legal and regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. . The Committee is currently composed of the President and Chief Executive Officer, the Executive Vice-President and Chief Financial Officer and all vice-presidents and operational directors. The President and Chief Executive Officer and the Executive Vice-President and Chief Financial Officer, after evaluating the effectiveness of the Corporation's disclosure controls and procedures as at November 30, 2005, have concluded that the Corporation's disclosure controls and procedures are adequate and effective to ensure that material information relating to the Corporation would have been known to them, particularly during the period in which the annual filings are being prepared. Overview ACCOMPLISHING THE KEY MILESTONE “Milemarker” redirects here. For the American indie rock band, see Milemarker (band). A milestone or kilometre sign is one of a series of numbered markers placed along a road at regular intervals, typically at the side of the road or in a median. As 2005 began, the Company had identified sufficient characteristics of ECO-4601 to invest into its potential as a chemotherapy of choice in the fight against primary brain tumors primary brain tumor Neurology A tumor that arises in the brain–eg, ependymoma, astrocytoma grade 3 or 4, glioblastoma multiforme, glioma, medulloblastoma, meningioma, neuroglioma, oligodendroglioma. See Metastatic brain tumor. . Firstly, the compound shows tumor-reducing efficacy in an animal model where tumor tumor: see neoplasm. growth is very aggressive. Secondly, animal testing Animal testing or animal research refers to the use of animals in experiments. It is estimated that 50 to 100 million vertebrate animals worldwide [4][5][6] suggests that ECO-4601 crosses the blood brain barrier, a critical property in developing compounds with a competitive advantage in the brain cancer market. Finally, because ECO-4601 comes from Ecopia's DECIPHER Same as decrypt. (R) drug discovery platform, it is by definition a novel compound, also a critical property needed in the eventual marketing among leading practicing oncologists. Management gave itself the major task of filing a Clinical Trial Application ("CTA") with the appropriate regulatory authorities before the end of the calendar year and that objective has been accomplished. PREPARING THE CTA The delivery of such an objective required important milestones. Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent" above all, most especially , our preclinical team was asked very early in the year to refine the compound's formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation status, determine its route of administration for preclinical and clinical use and initiate INITIATE. A right which is incomplete. By the birth of a child, the husband becomes tenant by the curtesy initiate, but his estate is not consummate until the death of the wife. 2 Bouv. Inst. n. 1725. a manufacturing process that allows the production of ECO-4601 under current Good Laboratory Practices ("cGLP cGLP Current Good Laboratory Practices ") in order to have sufficient material to identify the compound's safety and tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol levels in GLP See gateway location protocol. preclinical testing Noun 1. preclinical test - a laboratory test of a new drug or a new invasive medical device on animal subjects; conducted to gather evidence justifying a clinical trial preclinical phase, preclinical trial . The process to achieve these milestones was started in the first quarter and completed around the first half of the year. Under a regulatory filing, potential drugs tested in humans must meet very strict criteria criteria (krītēr´ē n. regarding their chemistry, manufacturing and control, or CMC (Common Messaging Calls) A programming interface specified by the XAPIA as the standard messaging API for X.400 and other messaging systems. CMC is intended to provide a common API for applications that want to become mail enabled. 1. . Most importantly, we had to show that ECO-4601 can be produced under a current Good Manufacturing Process ("cGMP cGMP 3'5' cyclic guanosine monophosphate; essential in regulation of sodium channels of the retina. Decrease in cGMP concentration leads to hyperpolarization of the retinal membrane. "). The whole CMC process was initiated in the latter part of 2004 and was completed before the end of 2005, in time for the filing of the CTA. This was accomplished below our budgetary estimates because our production team found a way of producing ECO-4601 using a crystallization Crystallization The formation of a solid from a solution, melt, vapor, or a different solid phase. Crystallization from solution is an important industrial operation because of the large number of materials marketed as crystalline particles. process, which obviates the need for expensive production methods. In the third quarter of the year, rodent rodent, member of the mammalian order Rodentia, characterized by front teeth adapted for gnawing and cheek teeth adapted for chewing. The Rodentia is by far the largest mammalian order; nearly half of all mammal species are rodents. and primate primate, member of the mammalian order Primates, which includes humans, apes, monkeys, and prosimians, or lower primates. The group can be traced to the late Cretaceous period, where members were forest dwellers. GLP toxicology toxicology, study of poisons, or toxins, from the standpoint of detection, isolation, identification, and determination of their effects on the human body. Toxicology may be considered the branch of pharmacology devoted to the study of the poisonous effects of drugs. programs were well under way. By the end of August, Ecopia had sufficient data from these studies to meet on a pre-filing basis with the Therapeutic Product Directorate of Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. and the Food and Drug Administration of the United States. Based on guidance received from these meetings, the Company decided to file for clinical trials in Canada only because patient recruitment and availability of world-class world-class adj. 1. Ranking among the foremost in the world; of an international standard of excellence; of the highest order: a world-class figure skater. 2. technical resources are immediately available in its principal place of business. Management expects no serious difficulties for future clinical trials in the United States, assuming the Phase I trial of 2006 turns out satisfactorily. Ecopia is proposing to conduct a Phase I clinical trial with up to 30 patients who suffer from one of six types of cancers and who are refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. to current chemotherapies. Such cancers are glioblastomas, breast, prostate, ovarian ovarian /ovar·i·an/ (o-var´e-an) pertaining to an ovary or ovaries. ovarian pertaining to an ovary. ovarian agenesis , lung and colon cancers colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. . The purpose of the trial will be to find the ideal dosage dosage /dos·age/ (do´saj) the determination and regulation of the size, frequency, and number of doses. dos·age n. 1. Administration of a therapeutic agent in prescribed amounts. and to test ECO-4601's safety and tolerability. The clinical trial involves a 21-day cycle where different patients will receive escalating dosages of the compound via continuous infusion INFUSION, med. jur. A pharmaceutical operation, which consists in pouring a hot or cold fluid upon a substance, whose medical properties it is desired to extract. Infusion is also used for the product of this operation. Although infusion differs from decoction, (q.v. using ambulatory Movable; revocable; subject to change; capable of alteration. An ambulatory court was the former name of the Court of King's Bench in England. It would convene wherever the king who presided over it could be found, moving its location as the king moved. pumps for 14 days, followed by a seven-day Adj. 1. seven-day - lasting through a week; "her weeklong vacation" weeklong long - primarily temporal sense; being or indicating a relatively great or greater than average duration or passage of time or a duration as specified; "a long life"; "a long boring rest. The trial is expected to last approximately ap·prox·i·mate adj. 1. Almost exact or correct: the approximate time of the accident. 2. 12 months from the date of recruitment. OTHER IMPORTANT MILESTONES Many other important milestones were achieved in 2005, some of which relate to ECO-4601. In November, Ecopia disclosed data at an oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. conference demonstrating that ECO-4601 is active in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. against breast and prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . Enlarging ENLARGING. Extending or making more comprehensive; as an enlarging statute, which is one extending the common law. the medical spectrum of ECO-4601 beyond primary brain tumor can add substantial value to this compound. During the year, our Chemistry Group advanced ECO-4601's analog program that was initiated in 2004. So far, approximately 60 analogs were characterized char·ac·ter·ize tr.v. character·ized, character·iz·ing, character·iz·es 1. To describe the qualities or peculiarities of: characterized the warden as ruthless. 2. . This program provides us with a better understanding of the compound's structure activity relationship. It also allows us to identify a second-generation compound and improve our intellectual property stake beyond the original compound. Ecopia was pleased to announce right after the end of the fiscal year that the United States Patent and Trademark Office The United States Patent and Trademark Office (PTO or USPTO) is an agency in the United States Department of Commerce that provides patent protection to inventors and businesses for their inventions, and trademark registration for product and intellectual property granted a Notice of Allowance on ECO-4601's composition of matter. Obtaining composition of matter claims to the structure of our lead compound is the most solid protection that can be obtained on a potential drug because such claims cover any medical use of the compound. Composition of matter claims are available where novelty Novelty is the quality of being new. Although it may be said to have an objective dimension (e.g. a new style of art coming into being, such as abstract art or impressionism) it essentially exists in the subjective perceptions of individuals. resides in the structure of the compound, as opposed op·pose v. op·posed, op·pos·ing, op·pos·es v.tr. 1. To be in contention or conflict with: oppose the enemy force. 2. to only in its utility. In the first half of 2005, Ecopia raised $9.9 million in order to fund its operations and finance ECO-4601's first clinical trial. Finally, despite restricted resources, our DECIPHER(R) drug discovery platform allowed us to add 40 new chemical entities to our portfolio. Of the 59 novel compounds discovered to date, excluding analogs of ECO-4601, 14 have shown anticancer anticancer, n a medicine or substance used to treat cancer. activities. The Profiling Team is working on these new discoveries to identify the best candidates for another regulatory filing. Although this activity is important, priority will be given to the development of ECO-4601 and to understanding its mechanism of action. LOOKING FORWARD We begin the year 2006 by seeing our first discovery moving into the clinic. ECO-4601 has evolved from a newly discovered compound to Phase I development in approximately three years. Under current standards of our industry, this is rapid progression progression, in mathematics, sequence of quantities, called terms, in which the relationship between consecutive terms is the same. An arithmetic progression is a sequence in which each term is derived from the preceding one by adding a given number, d, . Such an accomplishment is a success onto itself and is a testimonial to the capability of Ecopia's DECIPHER(R) drug discovery platform to come up with novel potential therapies to fight cancer. Our focus on cancer was undoubtedly motivated mo·ti·vate tr.v. mo·ti·vat·ed, mo·ti·vat·ing, mo·ti·vates To provide with an incentive; move to action; impel. mo by the potential of ECO-4601 as a novel chemotherapy. More importantly, however, is the ability of our DECIPHER(R) technology to deliver fundamentally brand new chemical classes of therapies with novel mechanisms of action. This provides us with a distinct competitive advantage in this highly competitive field.
SUMMARY OF OPERATING RESULTS
Years ended November 30
(in thousands of dollars, except per-share amounts) - (audited)
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2005 2004 2003
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$ $ $
Interest revenues 287 293 435
License revenues - 120 -
Research and development expenditures,
before tax credits and grants 8,079 6,819 6,386
General and administrative
expenditures 2,896 2,735 2,436
Net loss 9,612 8,214 7,147
Net basic and diluted loss per share 0.14 0.14 0.14
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Weighted average shares outstanding
(in thousands) 66,939 57,172 50,422
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Revenues Total revenues amounted to $286,709 for the year ended November 30, 2005, compared with $412,956 for the year ended November 30, 2004, representing a decline of approximately 30.6%. This variance The discrepancy between what a party to a lawsuit alleges will be proved in pleadings and what the party actually proves at trial. In Zoning law, an official permit to use property in a manner that departs from the way in which other property in the same locality is explained by the absence of license revenues in 2005. In 2004, Ecopia had earned license revenues of $120,050 under the terms of a license transfer agreement for the use of some of its gene clusters A gene cluster is a set of two or more genes that serve to encode for the same or similar products. Because populations from a common ancestor tend to possess the same varieties of gene clusters, they are useful for tracing back recent evolutionary history. in the licensee's drug discovery efforts. The licensee licensee n. a person given a license by government or under private agreement. (See: license, licensor) LICENSEE. One to whom a license has been given. 1 M. Q. & S. 699 n. has future exclusivity options to use these gene clusters within a specified field of use. Additional revenues may be earned if these options are exercised. R&D Activities Research and development ("R&D") expenditures, before tax credits and grants, amounted to $8,078,665 for the year ended November 30, 2005, compared with $6,818,996 for the year ended November 30, 2004, an increase of 18.5%. This increase in R&D expenses results from preclinical expenses that were 73% higher than those of 2004. These increased costs were needed to prepare the Clinical Trial Application of ECO-4601, including the CMC process, advisory expenses for regulatory filing and the GLP toxicology studies in rodents and primates Primates The mammalian order to which humans belong. Primates are generally arboreal mammals with a geographic distribution largely restricted to the Tropics. . Costs in all other areas of our R&D were lower than those of 2004, principally because of the reduction in the number of employees that was implemented before the end of the second quarter of 2005. This change in the nature of the Company's R&D expenses is consistent with the business objective of focusing on moving our lead cancer candidate into clinical trials as quickly as possible. General and Administrative Expenditures General and administrative ("G&A") expenses amounted to $2,896,195 for the year ended November 30, 2005, compared with $2,734,522 for 2004, an increase of 5.9%. These increases are largely explained by higher costs related to the Company's intellectual property activities. Earnings Results The Company recorded a net loss of $9,611,761 for the year ended November 30, 2005, compared with $8,214,000 for the year ended November 30, 2004. The loss per share amounted to $0.14 for both years. The increase in the loss reflects higher R&D expenditures and G&A expenditures discussed above. Contractual Commitments As of November 30, 2005 Ecopia's future contractual commitments are principally for an operating lease Operating Lease A lease contract that allows the use of an asset, but does not convey rights similar to ownership of the asset. Notes: An operating lease is not capitalized it is accounted for as a rental expense. for facilities. Future rental payments under the operating lease agreement are presented below. The Company does not have any purchase obligations as of November 30, 2005. The Company has not engaged in off-balance sheet financing or commodity contract trading.
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Payments Due by Period
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$
2006 566,000
2007-2008 1,151,000
2009-2010 1,181,000
2011 and after 600,000
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Total 3,498,000
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LIQUIDITY AND FINANCIAL POSITION
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November 30 (in thousands 2005 2004 2003
of dollars) - (audited)
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Cash and bonds(i) $8,810 $6,266 $6,216
Tax credits receivable $905 $797 $1,024
Bonds(ii) $638 $2,753 $2,330
Total assets $13,700 $13,466 $14,052
Capital stock and
contributed surplus $55,021 $44,878 $36,146
Shareholders' equity $11,771 $12,027 $12,227
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(i) Cash invested in investment-grade bonds due in less than one
year.
(ii)Cash invested in investment-grade bonds due in more than one
year.
On November 30, 2005, the Company's cash position amounted to $9,448,048 measured in terms of cash and investments in investment-grade bonds Investment-grade bonds A bond that is assigned a rating in the top four categories by commercial credit rating companies. S&P classifies investment-grade bonds as BBB or higher, and Moody's classifies investment grade bonds as BAA or higher. Related: High-yield bond. . Tax credits receivable amounted to $904,811. Thus, the Company's liquidity position, measured in terms of cash, bonds and tax credits receivable, amounted to $10,352,859 on November 30, 2005, compared with $9,816,390 on November 30, 2004. The increase in the Company's cash position takes into account the issuance of units on March 8, 2005 for gross proceeds of $9.9 million. In 2005, the Company disbursed $538,070 for additions to capital assets capital assets n. equipment, property, and funds owned by a business. (See: capital, capital account) and for costs related to patent acquisitions. Capitalized Capitalized Recorded in asset accounts and then depreciated or amortized, as is appropriate for expenditures for items with useful lives longer than one year. patent costs totaling $113,020 were written-off because of a decision not to pursue patent applications relating to certain genetic pathways A Genetic pathway is the set of interactions occurring between a group of genes who depend on each other's individual functions in order to make the aggregate function of the network available to the cell. that did not assist in discovering NCEs. These applications were abandoned in order to keep our resources for patent applications relating to the discovery of new compounds. Capitalized costs relating to scientific equipment were also written-off by $54,148 because of the reduction in our genomic genomic pertaining to a genome. genomic clone see clone. genomic DNA the DNA sequences making up the genome of an individual. genomic library see gene bank. activities in mid- mid- pref. Middle: midbrain. 2005. Shareholders' equity Shareholders' Equity A firms' total assets minus its total liabilities. Equivalently, it is share capital plus retained earnings minus treasury shares. Shareholders' equity is the amount by which a company is financed through common and preferred shares. amounted to $11,771,255 on November 30, 2005, compared with $12,027,374 on November 30, 2004. Total assets amounted to $13,700,050 on November 30, 2005, compared with $13,466,285 on November 30, 2004. The reductions in shareholders' equity and assets take into account the loss for the year and the issuance of the unit offering for proceeds of $9.9 million less share issue costs. The Company's liquidity position, both in the short term and long term, is allocated to salaries, the funding of R&D activities, patent filings and the acquisition of capital assets. In a manner consistent with a goal of capital preservation and maintaining high levels of liquidity, the Company invests available cash resources in investment grade securities with varying terms to maturity, selected with regard to the expected timing of expenditures to be incurred from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the . Based on its current operating plan, the Company's management believes that its liquidity position will be sufficient to meet all anticipated future cash needs to the end of fiscal 2006. While Ecopia's management believes it can raise additional funding to continue its R&D operations into 2007, fundraising
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies. could be beyond the control of management, given current market conditions. It may be necessary to reduce these operations in the course of 2006 if necessary funds are not available. On February 6, 2006, the number of common shares outstanding totalled 69,871,584, while 4,175,700 options were granted under the share purchase option plan and 7,820,834 share purchase warrants are outstanding pursuant to the unit offerings completed in February 2004 and March 2005. The outstanding options are exercisable at a weighted average price of $1.47 per share. A total of 4,154,167 share purchase warrants are exercisable at a price of $1.28 each and 3,666,667 share purchase warrants are exercisable at a price of $1.03 each. Critical accounting policies In preparing the Company's consolidated financial statements Consolidated Financial Statements The combined financial statements of a parent company and its subsidiaries. Notes: Because consolidated financial statements present an aggregated look at the financial position of a parent and its subsidiaries, they enable you to gauge in conformity with GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). , management is required to make certain estimates, judgments and assumptions that the Company believes are reasonable based upon the information available at the time. These estimates and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The accounting policies which the Company considers to be critical are those that require the most difficult, subjective subjective /sub·jec·tive/ (sub-jek´tiv) pertaining to or perceived only by the affected individual; not perceptible to the senses of another person. sub·jec·tive adj. 1. , or complex judgments and that are the most important to aid in fully understanding and evaluating its consolidated financial statements. These accounting policies are discussed in the following paragraphs. CAPITAL ASSETS AND PATENTS are stated at cost and are amortized on a straight-line straight-line adj. 1. Lying in a straight line. 2. Relating to a device whose linkage produces or copies motion in straight lines. 3. or declining balance basis. The Company regularly reviews capital assets and patents for impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. whenever events or changes in business circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or indicate that the carrying amount of the assets exceeds the sum of the expected cash flows from its uses and disposal. Management's judgment regarding the existence of impairment indicators is based on legal factors, market conditions and operating performances. Future events could cause management to conclude that impairment indicators exist and that the carrying values Carrying Value Also know as "book value," it is a company's total assets minus intangible assets and liabilities, such as debt. Notes: This is different than market value, as it can be higher or lower depending on the circumstances. of the Company's capital assets or patents are impaired See assistive technology. . Any resulting impairment loss could have a material adverse impact on the Company's financial position and results of operations. INCOME TAXES are accounted for under the asset and liability method. In the Company's case, recurrent recurrent /re·cur·rent/ (re-kur´ent) [L. recurrens returning] 1. running back, or toward the source. 2. returning after remissions. re·cur·rent adj. 1. operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. during the development years create tax assets that may reduce future taxable earnings, if any. In assessing whether future tax assets may be realized, management provides valuation allowances by considering the likelihood that some portion or all of the tax assets will not be realized. The ultimate use of these future tax assets is dependent upon the generation of future taxable income Under the federal tax law, gross income reduced by adjustments and allowable deductions. It is the income against which tax rates are applied to compute an individual or entity's tax liability. The essence of taxable income is the accrual of some gain, profit, or benefit to a taxpayer. . Given the high level of risk that is inherent in its industry, management does not recognize any value in the future tax assets that are created in excess of its future tax liabilities. As a result, a valuation allowance was recognized on the same basis as in prior years. RESEARCH AND DEVELOPMENT AND TAX CREDITS consist of direct and indirect expenditures, including a reasonable allocation The apportionment or designation of an item for a specific purpose or to a particular place. In the law of trusts, the allocation of cash dividends earned by a stock that makes up the principal of a trust for a beneficiary usually means that the dividends will be treated as of overhead expenses, associated with the Company's various research and development programs. Research and development costs are expensed as incurred. Overhead expenses comprise general and administrative support provided to the research and development programs and involve costs associated with support activities such as facility maintenance, utilities, office services, information technology and human resources The fancy word for "people." The human resources department within an organization, years ago known as the "personnel department," manages the administrative aspects of the employees. . Refundable Refundable Eligible for refunding under the terms of a bond indenture. research and development tax credits are recorded based on our estimates of amounts expected to be recovered and are subject to audit by the taxation authorities and, accordingly, these amounts may vary materially. STOCK-BASED COMPENSATION represents the accounting cost of stock options awarded to employees and directors under Ecopia's stock option plan. The cost of these options is estimated by using the Black-Scholes option-pricing model Black-Scholes option-pricing model A model for pricing call options based on arbitrage arguments. Uses the stock price, the exercise price, the risk-free interest rate, the time to expiration, and the expected standard deviation of the stock return. that was developed to estimate the fair value of freely-tradable, fully transferable options without vesting Vesting The process by which employees accrue non-forfeitable rights over employer contributions that are made to the employee's qualified retirement plan account. Notes: restrictions. The terms of the options awarded under the stock option plan differ significantly from actual options for which the Black-Scholes model was designed to evaluate. Moreover, the use of this model requires highly subjective assumptions, especially the one relating to future stock price volatility Volatility 1. A statistical measure of the tendency of a market or security to rise or fall sharply within a period of time. 2. A variable in option pricing formulas that denotes the extent to which the return of the underlying asset will fluctuate between now and the , which greatly affects the computed values. Quarterly Financial Data (Unaudited) Fiscal 2005 Quarters ended February 28 May 31 August 31 November 30 --------------------------------------------------------------------- Revenues $44,305 $84,488 $82,772 $75,144 Research and development expenditures, before tax credits and grants $1,760,025 $1,847,053 $2,067,686 $2,403,901 Net loss $2,261,950 $2,288,231 $2,265,561 $2,796,019 Net basic and diluted loss per share $0.04 $0.03 $0.03 $0.04 --------------------------------------------------------------------- Fiscal 2004 Quarters ended February 29 May 31 August 31 November 30 --------------------------------------------------------------------- Revenues $68,970 $88,803 $76,033 $179,150 Research and development expenditures, before tax credits and grants $1,488,238 $1,853,382 $1,720,400 $1,756,976 Net loss $1,899,734 $2,271,839 $2,049,306 $1,993,121 Net loss per share $0.04 $0.04 $0.03 $0.03 --------------------------------------------------------------------- Risks and Uncertainties The Company's operations involve certain risks and uncertainties that are inherent to the Company's industry. The most significant known risks and uncertainties faced by the Company are described below. DEVELOPMENT AND LICENSING The Company is at an early stage of development and has taken steps to license its technologies and develop its products. The Company may not be able to successfully develop or license its technologies. In addition, the Company's novel bioactive bi·o·ac·tive adj. Of or relating to a substance that has an effect on living tissue. bioactive having an effect on or eliciting a response from living tissue. molecules may not be developed as drug candidates for human diseases. SCIENTIFIC UNCERTAINTIES Ecopia is a biotechnology biotechnology, the use of biological processes, as through the exploitation and manipulation of living organisms or biological systems, in the development or manufacture of a product or in the technological solution to a problem. company whose business case is to discover novel drug candidates and move them forward into the clinic as brand new chemotherapies never used before by the medical community. Because of the novelty of our drug candidates, there is no historical background that allows us to predict their outcome in preclinical and clinical trials. As well, drug discovery and development is a scientific discipline that involves uncertainty. Assumptions are made at the outset of experiments and trials, but there is no assurance that such assumptions are the right ones to be made. Such a discipline involves trial and error, and we may encounter serious setbacks that would prevent us from successfully developing, manufacturing and marketing any of our drug candidates. We are also dependent on the work of third parties such as contract research organizations that face the same scientific risks and uncertainties. Such setbacks could be more detrimental det·ri·men·tal adj. Causing damage or harm; injurious. det ri·men to us than to other organizations that have deeper
scientific and financial resources than we have.
HISTORY OF OPERATING LOSSES AND EXPECTATIONS TO INCUR To become subject to and liable for; to have liabilities imposed by act or operation of law. Expenses are incurred, for example, when the legal obligation to pay them arises. An individual incurs a liability when a money judgment is rendered against him or her by a court. LOSSES IN THE FUTURE The Company has experienced operating losses since its inception INCEPTION. The commencement; the beginning. In making a will, for example, the writing is its inception. 3 Co. 31 b; Plowd. 343. Vide Consummation; Progression. and expects that losses will continue for the next several years. The Company may never be profitable or achieve significant revenues. In order to develop and commercialize its products or license its technologies, the Company expects to incur significant increases in expenses over the next several years. ABILITY TO ADAPT TO CHANGING PRIORITIES The Company has experienced changes in its employees and the scope of its operations given its added priorities in drug development. These changes have placed, and may continue to place, a significant strain on the Company's management and operations. The Company's ability to manage such growth effectively will depend on its ability to strengthen its management team and on its ability to attract and retain skilled employees. ADDITIONAL FUNDING The current capital resources of the Company will not be sufficient to fund its long-term Long-term Three or more years. In the context of accounting, more than 1 year. long-term 1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term. business strategy and the Company will therefore need to raise additional capital. To obtain the necessary capital, the Company must rely on government grants and tax credits, additional share issues and collaboration Working together on a project. See collaborative software. agreements or corporate partnerships to provide full or partial funding for its activities. Should the Company fail to obtain the necessary capital, it will have to considerably reduce, or even cease its operations, unless it is able to enter into agreements to obtain financial support from third parties, which may require that the Company waive To intentionally or voluntarily relinquish a known right or engage in conduct warranting an inference that a right has been surrendered. For example, an individual is said to waive the right to bring a tort action when he or she renounces the remedy provided by law for such its rights to some of its eventual products or technologies. PATENTS The Company's success will depend in part on its ability to obtain patents, protect its trade secrets and operate without infringing the exclusive rights of third parties. There is no guarantee that any patent granted to the Company will bring any competitive advantage to the Company, that its patent protection will not be contested by third parties, or that the patents of competitors COMPETITORS, French law. Persons who compete or aspire to the same office, rank or employment. As an English word in common use, it has a much wider application. Ferriere, Dict. de Dr. h.t. will not be detrimental to the Company's commercial activities. It cannot be assured that competitors will not independently develop products similar to the Company's products, that they will not imitate im·i·tate tr.v. im·i·tat·ed, im·i·tat·ing, im·i·tates 1. To use or follow as a model. 2. a. any of the Company's products or that, if the Company obtains its patents, its competitors will not manufacture products designed to circumvent cir·cum·vent tr.v. cir·cum·vent·ed, cir·cum·vent·ing, cir·cum·vents 1. To surround (an enemy, for example); enclose or entrap. 2. To go around; bypass: circumvented the city. the exclusive patent rights granted to the Company. COMPETITION The Company is subject to significant competition from (i) pharmaceutical companies, (ii) biotechnology companies, (iii) academic and research institutions and (iv) government agencies or other organizations that are pursuing technologies and products that are the same as or similar to its technology and products. Many of the organizations competing with the Company have greater capital resources, research and development staffs and facilities and marketing capabilities. Additional information about the Company can be obtained from Ecopia's website at www.ecopiabio.com. AUDITORS' REPORT TO THE SHAREHOLDERS We have audited the balance sheets of Ecopia BioSciences Inc. as at November 30, 2005 and 2004 and the statements of operations, deficit and cash flows for the years then ended.These financial statements are the responsibility of the Company's management.Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with Canadian Canadian (kənā`dēən), river, 906 mi (1,458 km) long, rising in NE New Mexico. and flowing E across N Texas and central Oklahoma into the Arkansas River in E Oklahoma. generally accepted auditing standards Generally Accepted Auditing Standards, or GAAS, are ten auditing standards, developed by the AICPA, consisting of general standards, standards of field work, and standards of reporting, along with interpretations. .Those standards require that we plan and perform an audit to obtain reasonable assurance whether the financial statements are free of material misstatement mis·state tr.v. mis·stat·ed, mis·stat·ing, mis·states To state wrongly or falsely. mis·state ment n. .An audit 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, as well as evaluating the overall financial statement
presentation.
In our opinion, these financial statements present fairly, in all material respects, the financial position of the Company as at November 30, 2005 and 2004 and the results of its operations and its cash flows for the years then ended in accordance with Canadian generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting . Chartered Accountants char·tered accountant n. Chiefly British Abbr. CA A member of one of the institutes of accountants granted a royal charter. Montreal, Canada January January: see month. 13, 2006
ECOPIA BIOSCIENCES INC.
Balance Sheets
November 30, 2005 and 2004
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---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Assets
Current assets:
Cash $263,198 $152,763
Bonds 8,546,532 6,113,689
Sales tax receivable and other 136,292 45,351
Tax credits receivable 904,811 796,936
Research supplies, at cost - 29,646
Deposits and prepaid expenses 105,096 170,044
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9,955,929 7,308,429
Bonds 638,318 2,753,002
Capital assets (note 3) 2,293,381 2,818,817
Patents (note 4) 812,422 586,037
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$13,700,050 $13,466,285
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued
liabilities $1,928,795 $1,438,911
Shareholders' equity:
Capital stock (note 5) 54,567,028 44,655,975
Contributed surplus 453,660 222,469
Deficit (43,249,433) (32,851,070)
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11,771,255 12,027,374
Commitments (note 9)
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$13,700,050 $13,466,285
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---------------------------------------------------------------------
See accompanying notes to financial statements.
On behalf of the Board.
ECOPIA BIOSCIENCES INC.
Statements of Operations
Years ended November 30, 2005 and 2004
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2005 2004
---------------------------------------------------------------------
Revenues:
Interest $286,709 $292,906
License - 120,050
---------------------------------------------------------------------
286,709 412,956
Costs and expenses:
Research and development 8,078,665 6,818,996
Tax credits and grants (1,076,390) (926,562)
---------------------------------------------------------------------
7,002,275 5,892,434
General and administrative 2,896,195 2,734,522
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9,898,470 8,626,956
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Net loss $(9,611,761) $(8,214,000)
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Net basic and diluted loss per share $(0.14) $(0.14)
---------------------------------------------------------------------
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Weighted average number of
outstanding shares 66,939,214 57,172,017
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---------------------------------------------------------------------
See accompanying notes to financial statements.
ECOPIA BIOSCIENCES INC.
Statements of Operations
Years ended November 30, 2005 and 2004
---------------------------------------------------------------------
---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Revenues:
Interest $286,709 $292,906
License - 120,050
---------------------------------------------------------------------
286,709 412,956
Costs and expenses:
Research and development 8,078,665 6,818,996
Tax credits and grants (1,076,390) (926,562)
---------------------------------------------------------------------
7,002,275 5,892,434
General and administrative 2,896,195 2,734,522
---------------------------------------------------------------------
9,898,470 8,626,956
---------------------------------------------------------------------
Net loss $(9,611,761) $(8,214,000)
---------------------------------------------------------------------
---------------------------------------------------------------------
Net basic and diluted loss per share $(0.14) $(0.14)
---------------------------------------------------------------------
---------------------------------------------------------------------
Weighted average number of
outstanding shares 66,939,214 57,172,017
---------------------------------------------------------------------
---------------------------------------------------------------------
See accompanying notes to financial statements.
ECOPIA BIOSCIENCES INC.
Statements of Deficit
Years ended November 30, 2005 and 2004
---------------------------------------------------------------------
---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Deficit, beginning of year $(32,851,070) $(23,919,440)
Net loss (9,611,761) (8,214,000)
Share issue costs (786,602) (717,630)
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Deficit, end of year $(43,249,433) $(32,851,070)
---------------------------------------------------------------------
---------------------------------------------------------------------
See accompanying notes to financial statements.
ECOPIA BIOSCIENCES INC.
Statements of Cash Flows
Years ended November 30, 2005 and 2004
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---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Cash flows from operating activities:
Net loss $(9,611,761) $(8,214,000)
Adjustments for:
Depreciation on capital assets 683,393 978,383
Depreciation on patents 35,630 25,206
Write-off of capital assets 54,148 95,200
Write-off of patents 113,020 66,295
Loss on disposal of capital asset 3,500 -
Stock-based compensation 233,544 155,403
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(8,488,526) (6,893,513)
Changes in operating assets
and liabilities:
Interest receivable on bonds (28,045) 71,010
Sales tax receivable and other (90,941) 76,329
Tax credits receivable (107,875) 226,720
Research supplies 29,646 12,354
Deposits and prepaid expenses 64,948 114,020
Accounts payable and accrued
liabilities 434,814 68,513
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302,547 568,946
---------------------------------------------------------------------
(8,185,979) (6,324,567)
Cash flows from financing activities:
Proceeds from issuance of shares 9,908,700 8,576,660
Share issue costs (786,602) (717,630)
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9,122,098 7,859,030
Cash flows from investing activities:
Acquisition of bonds (11,327,682) (7,999,921)
Proceeds from disposal of bonds 11,037,568 7,537,247
Additions to capital assets (204,313) (594,457)
Costs relating to patent acquisitions (333,757) (399,631)
Proceeds from disposal of capital assets 2,500 3,800
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(825,684) (1,452,962)
---------------------------------------------------------------------
Net increase in cash 110,435 81,501
Cash, beginning of year 152,763 71,262
---------------------------------------------------------------------
Cash, end of year $263,198 $152,763
---------------------------------------------------------------------
---------------------------------------------------------------------
Supplemental cash flow information (note 6)
See accompanying notes to financial statements.
ECOPIA BIOSCIENCES INC.
Notes to Financial Statements
Years ended November 30, 2005 and 2004
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1. Organization and business activities: Ecopia BioSciences Inc. (the "Company"), incorporated under the Canada Business Corporations Act The Canada Business Corporations Act, also known as Bill C-44, is a Canadian act respecting Canadian business corporations. See also
Microscopic organisms, such as bacteria, viruses, algae and fungi. Mentioned in: Animal Bite Infections using its discovery platform called the Decipher(R) technology.The Company is currently focusing on moving its lead anticancer compound ECO-4601 into phase I clinical trials. The Company is considered to be in the development stage. Substantially all of the Company's research and development expenditures, and all revenues from research contracts, since inception, relate to the Company's core technology and its development program.In addition, the Company's capital expenditures since inception relate principally to the Company's core technology. The following table provides cumulative information for research revenues, and research and development expenditures, since the beginning of operations in 1998:
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---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Revenues from research
contracts and license $256,310 $256,310
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---------------------------------------------------------------------
Research and development
expenditures:
Gross amount $33,541,558 $25,462,893
Research tax credits and grants (6,030,357) (4,953,967)
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$27,511,201 $20,508,926
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As part of its activities, the Company faces certain risks, namely risks that are inherent to the research and development of its technologies and the commercialization of its products or services, the protection of its intellectual property, retaining key employees, as well as obtaining sufficient financing in order to achieve its business plan. 2. Significant accounting policies: (a) Basis of presentation: The financial statements have been prepared on the going concern basis, which assumes that the Company will continue in operational existence for the foreseeable fore·see tr.v. fore·saw , fore·seen , fore·see·ing, fore·sees To see or know beforehand: foresaw the rapid increase in unemployment. future. The Company's ability to continue as a going concern is dependent on raising additional capital and, in the longer term, finding and marketing commercially viable products and attaining financially sustainable operations.Should the Company fail to obtain the necessary capital, it will have to reduce its operations, unless it is able to enter into agreements to obtain financial support from third parties, which may require that the Company waive its right to some of its eventual products or technologies. (b) Cash equivalents: Cash equivalents are limited to investments with maturities of three months or less that are highly liquid and readily convertible into cash.These investments are recorded at cost.As at November 30, 2005 and 2004, there were no cash equivalents. (C) Bonds: Bonds are recorded at the lesser of cost and market value for those classified in current assets Current Assets Appearing on a company's balance sheet, it represents cash, accounts receivable, inventory, marketable securities, prepaid expenses, and other assets that can be converted to cash within one year. .Bonds are classified in current assets with respect to their maturity date or management estimates of cash flow needs for the next year.Long-term investments are recorded at cost less a provision for permanent impairment, if any. Any discount or premium arising on purchase of bonds is amortized using the straight-line method Noun 1. straight-line method - (accounting) a method of calculating depreciation by taking an equal amount of the asset's cost as an expense for each year of the asset's useful life straight-line method of depreciation over the remaining term.These bonds consist of investment-grade investment-grade Of, relating to, or being a bond suitable for purchase by institutions under the prudent man rule. Investment-grade is restricted to those bonds graded BBB and above by Standard & Poor's and graded Baa3 and above by Moody's. instruments that are readily convertible into cash. (d) Capital assets: Capital assets are stated at cost.Depreciation is provided using the following methods and annual rates/periods: --------------------------------------------------------------------- --------------------------------------------------------------------- Asset Method Rate/period --------------------------------------------------------------------- Specialized computer equipment Straight-line 5 years Machinery and equipment Declining balance From 20% to 50% Leasehold improvements Straight-line Term of lease --------------------------------------------------------------------- --------------------------------------------------------------------- The Company performs a review for the impairment of its property and equipment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable.An impairment loss would be recognized when the recoverable value of the capital asset is less than its carrying amount.Fair value, at which the capital asset would be measured, can be established on a quotation QUOTATION, practice. The allegation of some authority or case, or passage of some law, in support of a position which it is desired to establish. 2. Quotations when properly made, assist the reader, but when misplaced, they are inconvenient. price basis or by other valuation methods.Some equipment is no longer utilized in the activities of the Company.As a result, the net book value of specialized spe·cial·ize v. spe·cial·ized, spe·cial·iz·ing, spe·cial·iz·es v.intr. 1. To pursue a special activity, occupation, or field of study. 2. computer equipment has been reduced by $24,482 ($95,200 in 2004) and the net book value of machinery and equipment, by $29,666 (2004 - nil). (e) Patents: The costs relating to patent acquisitions are amortized over a period of 20 years, using the straight-line method.The cost of the patents does not necessarily reflect the present or future value of patents and the amount ultimately recoverable is dependent upon the successful commercialization of the related products.Management reviews the unamortized balance of patent costs on an annual basis, or more frequently if events or changes in circumstances indicate that the carrying amount may not be recoverable, and recognizes any impairment in carrying values in the year of impairment. An impairment would be recognized when the recoverable value of the asset is less than its carrying amount.The fair value, at which the asset would be measured, can be established on the basis of comparable information or transaction or by other valuation methods. In 2005, a write-off Write-Off A reduction in the value of an asset or earnings by the amount of an expense or loss. Companies are able to write off certain expenses that are required to run the business, or have been incurred in the operation of the business and detract from retained revenues. of $113,020 ($66,295 in 2004) was recorded. (f) Revenue recognition: Revenue from research contracts consists of non-refundable research and development funding under collaborative col·lab·o·rate intr.v. col·lab·o·rat·ed, col·lab·o·rat·ing, col·lab·o·rates 1. To work together, especially in a joint intellectual effort. 2. and other agreements.Contract research and development funding generally compensates the Company for discovery, preclinical and clinical expenses related to the collaborative development programs for certain products and product candidates of the Company.Such funding is recognized as revenue at the time research and development activities are performed under the terms of the agreements. License revenues are recorded when the conditions or the obligations have been satisfied under the license agreement and collection is reasonably assured. (g) Research and development: Research expenditures, net of related research tax credits and grants, are charged to earnings in the year in which they are incurred.Development expenditures, net of tax credits, if any, are capitalized when they meet the appropriate criteria for capitalization capitalization n. 1) the act of counting anticipated earnings and expenses as capital assets (property, equipment, fixtures) for accounting purposes. 2) the amount of anticipated net earnings which hypothetically can be used for conversion into capital assets. in accordance with generally accepted accounting principles.At November 30, 2005 and 2004, no development cost was capitalized. (h) Stock-based compensation: Stock option awards to employees are measured based on the fair value of the options at the grant date and a compensation expense is recognized over the vesting period of the options, with a corresponding increase to contributed surplus.When the stock options are exercised, capital stock is credited by the sum of the consideration paid, together with the related portion previously recorded to contributed surplus. (i) Government assistance: Government assistance, consisting of research tax credits and grants, is recorded as a reduction of the related expense or the cost of the asset acquired.Government assistance is recognized when there is reasonable assurance that the Company has met the requirements of the approved grant program or, with regard to tax credits, when there is reasonable assurance that they will be realized. (j) Income taxes: The Company uses the asset and liability method of accounting for income taxes.Under the asset and liability method, future tax assets and liabilities are recognized for the future tax consequences attributable attributable emanating from or pertaining to attribute. attributable proportion see attributable risk (below). attributable risk to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases.As appropriate, a valuation allowance is recorded to bring future assets back to an amount of which the realization (specification) realization - A UML semantic relationship between a classifier that specifies a contract and another classifier that guarantees to carry it out. [Handout by Mr. David Gillibrand]. is more probable PROBABLE. That which has the appearance of truth; that which appears to be founded in reason. than not.Future tax assets and liabilities are measured using enacted or substantively sub·stan·tive adj. 1. Substantial; considerable. 2. Independent in existence or function; not subordinate. 3. Not imaginary; actual; real. 4. enacted tax rates at the balance sheet date which are expected to apply when the asset is realized or the liability settled.The effect of a change in tax rates is recognized in the period during which the tax rates change occurred. (k) Earnings per share: Basic earnings per share are determined using the weighted average number of common shares outstanding during the period.The treasury stock method is used for calculating diluted earnings per share diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of .In connection with such calculation, the number of additional shares is calculated by assuming that outstanding options and warrants were exercised and that the proceeds from such exercises were used to acquire shares of common stock at the average market price during the reporting period. (l) Use of estimates: 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 disclosure of contingent assets Contingent Asset An asset in which the possibility of ownership depends solely upon future events uncontrollable by the company. Notes: An example might be a settlement from a lawsuit. See also: Asset, Balance Sheet, Contingent Liability, Liability and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.Actual results could differ from those estimates.
3. Capital assets:
---------------------------------------------------------------------
---------------------------------------------------------------------
2005
---------------------------------------------------------------------
Accumulated
depreciation and Net book
Cost amortization value
---------------------------------------------------------------------
Specialized computer
equipment $438,000 $438,000 $-
Machinery and
equipment 4,775,706 3,269,264 1,506,442
Leasehold improvements 1,190,247 403,308 786,939
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$6,403,953 $4,110,572 $2,293,381
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---------------------------------------------------------------------
---------------------------------------------------------------------
---------------------------------------------------------------------
2004
---------------------------------------------------------------------
Accumulated
depreciation and Net book
Cost amortization value
---------------------------------------------------------------------
Specialized computer
equipment $1,205,621 $1,109,374 $96,247
Machinery and equipment 4,572,226 2,738,005 1,834,221
Leasehold improvements 1,175,622 287,273 888,349
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$6,953,469 $4,134,652 $2,818,817
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4. Patents:
---------------------------------------------------------------------
---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Cost $995,762 $620,727
Accumulated amortization 183,340 34,690
---------------------------------------------------------------------
$812,422 $586,037
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5. Capital stock:
---------------------------------------------------------------------
---------------------------------------------------------------------
2005 2004
---------------------------------------------------------------------
Authorized in unlimited number
and without par value:
Common shares
Preferred shares, issuable
in series
Issued:
69,871,584 common shares
(58,851,584 in 2004) $54,567,028 $44,655,975
---------------------------------------------------------------------
---------------------------------------------------------------------
(a) Changes in the issued and outstanding capital stock were as
follows:
---------------------------------------------------------------------
---------------------------------------------------------------------
Number Amount
---------------------------------------------------------------------
Balance, November 30, 2003 50,465,200 $36,075,613
Shares issued pursuant to
a private placement 8,333,334 8,500,001
Shares issued pursuant to
exercise of options 40,550 64,361
Shares issued pursuant to
exercise of warrants 12,500 16,000
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Balance, November 30, 2004 58,851,584 44,655,975
Shares issued pursuant to
a private placement 11,000,000 9,900,000
Shares issued pursuant to
exercise of options 20,000 11,053
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Balance, November 30, 2005 69,871,584 $54,567,028
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In March 2005, the Company closed a private placement for the issuance of 11,000,000 units, each unit comprised of one share and one third of one common share purchase warrant.Each unit was sold at $0.90, allowing the Company to raise gross proceeds of approximately $9.9 million.Each full share purchase warrant allows the holders to purchase one common share of the Company at an exercise price of $1.03 and expires in March 2007. In February 2004, the Company closed a private placement for the issuance of 8,333,334 units, each unit comprised of one share and one half of one common share purchase warrant.Each unit was sold at $1.02, allowing the Company to raise gross proceeds of approximately $8.5 million.Each full share purchase warrant allows the holders to purchase one common share of the Company at an exercise price of $1.28 and expires in February 2008. During the years ended November 30, 2005 and 2004, the Company issued 20,000 and 40,550 shares, pursuant to exercise of options for a gross consideration of $8,700 and $60,659 respectively.The stock-based compensation relating to these awards, which had been included in the contributed surplus and then credited to the capital stock during the year, amounted to $2,353 ($3,702 in 2004). In 2004, the Company also issued 12,500 shares pursuant to exercise of warrants for a gross consideration of $16,000. At November 30, 2005, 7,820,834 (4,154,167 in 2004) warrants were outstanding as a result of issuance of units previously mentioned. All issues of shares were made for cash consideration. (b) Stock option plan: The Company has established a stock option plan under which it can grant to its directors, management, employees, researchers and its consultants non-transferable options for the purchase of common shares.During the year, the plan was amended a·mend v. a·mend·ed, a·mend·ing, a·mends v.tr. 1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive. 2. in order to establish the maximum number of common shares available for issuance under options to 10% of the number of common shares outstanding at the time of the grant.Options expire expire /ex·pire/ (ek-spi´er) 1. to exhale. 2. to die. ex·pire v. 1. To breathe one's last breath; die. 2. To exhale. ten years after their initial release. The options vest over an average period of 5 years. Changes in the number of options outstanding during the past two fiscal years were as follows:
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Weighted average
exercise price
Options per share
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Options, November 30, 2003 3,768,350 $1.51
Granted 660,500 1.41
Exercised (40,550) 1.50
Cancelled (111,450) 1.04
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Options, November 30, 2004 4,276,850 1.50
Granted 131,250 0.70
Exercised (20,000) 0.44
Cancelled (212,400) 1.77
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Options, November 30, 2005 4,175,700 $1.47
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The following table summarizes the information on outstanding stock
options at November 30, 2005:
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Outstanding options
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Weighted
average
of remaining Weighted
Price and Number contractual average
range of of options life exercise
prices outstanding (years) price
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$0.20 350,000 2.4 $0.20
$0.35 - $0.50 1,305,200 4.9 0.40
$0.67 - $0.90 277,500 7.5 0.84
$1.03 - $1.35 814,500 8.5 1.14
$1.65 - $2.15 888,500 5.4 1.87
$3.02 15,000 5.4 3.02
$5.00 - $5.35 525,000 4.7 5.08
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4,175,700 5.6 $1.47
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Exercisable options
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Weighted
Number of average
exercisable exercise
options price
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350,000 $0.20
1,123,120 0.40
154,500 0.84
233,400 1.11
824,500 1.85
15,000 3.02
500,000 5.07
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3,200,520 $1.57
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The fair value of the options granted during the year ended November 30, 2005 was estimated at the date of grant using the Black-Scholes option pricing model option pricing model A mathematical formula for determining the price at which an option should trade. The model expresses the value of an option as a function of the value of the underlying asset, length of time until maturity, exercise price, yields on with the following assumptions: risk free interest rate of 4.5%, expected dividend yield Expected dividend yield Total amount of dividends received during the life of a futures contract or total dividends received for holding a particular stock one year. See: Current yield. of nil, expected volatility ranging from 71% to 76% and expected average option life of 5 years.The weighted average fair value of the options granted during the year ended November 30, 2005 is $0.52 ($0.95 in 2004). The Black-Scholes model, used by the Company to calculate option values, was developed to estimate fair value of freely tradable, fully transferable options without vesting restrictions, which significantly differs from the Company's stock option awards.These models also require four highly subjective assumptions, including future stock price volatility and expected time until exercise, which greatly affect the calculated values. (C) Diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. loss per share: Diluted loss per share was not presented as the effect of options and warrants would have been anti-dilutive.Furthermore, for the year ended November 30, 2005, the exercise of 2,520,500 options (1,918,500 in 2004) and 7,820,834 warrants would not have been considered in such computation Computation is a general term for any type of information processing that can be represented mathematically. This includes phenomena ranging from simple calculations to human thinking. since the exercise price of these options was higher than the average market price.
6. Supplemental information:
(i) Cash flow statement:
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2005 2004
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Costs relating to patent acquisitions
included in accounts payable and
accrued liabilities $47,048 $5,770
Acquisition of capital assets
included in accounts payable and
accrued liabilities 16,686 2,894
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(ii) Statement of operations:
Depreciation of is included in the following accounts:
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2005 2004
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Research and development:
Depreciation of capital assets $536,400 $821,973
General and administrative:
Depreciation of capital assets 146,993 156,410
Depreciation of patents 35,630 25,206
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7. Restructuring fees:
In the context of the execution of its business strategy, the Company
reduced, in May 2005, its headcount by 30% and abandoned patents
considered of secondary importance. The Company incurred severance
fees in the amount of $144,626, which were fully paid as of November
30, 2005. In addition, the Company recorded a write-off of $83,366
related to the abandoned patents. These expenses are recorded in the
Statement of Operations and are included in the research and
development costs and the general and administrative costs,
respectively.
8. Income taxes:
Details of the components of income taxes are as follows:
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2005 2004
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Loss before recovery of income
taxes $9,611,761 $8,214,000
Basic income tax rate 31.2% 31.2%
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Computed income tax recovery 2,998,869 2,562,768
Adjustment in income taxes
resulting from:
Unrecorded potential tax
benefits of operating losses (2,941,150) (2,548,015)
Impact of the expected increase
on the provincial tax rate:
Future tax assets increase 1,331,601 -
Valuation allowance (1,331,601) -
Permanent differences and other (57,719) (14,753)
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$- $-
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The income tax effect of temporary differences that give rise to net
future tax assets and future tax liabilities is presented below:
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2005 2004
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Future tax assets:
Net operating loss
carryforwards $5,180,737 $4,141,232
Unused research and development
expenditures 9,376,954 6,126,756
Share issue costs 399,052 366,338
Costs relating to patents and other 87,557 33,771
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15,044,300 10,668,097
Future tax liabilities:
Capital assets (140,138) (307,261)
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14,904,162 10,360,836
Less valuation allowance (14,904,162) (10,360,836)
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Net future tax asset $- $-
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In assessing the ability to realize future tax assets, management
considers whether it is more likely than not that some portion or all
of the future tax assets will not be realized. The ultimate
realization of future tax assets is dependent upon the generation of
future taxable income and available tax planning strategies in making
this assessment. Since the Company is a development stage
corporation, the generation of future taxable income is dependent on
the successful commercialization of its products and technologies.
At November 30, 2005, the Company had the following operating loss
carryforwards and unclaimed deductions and credits available for
carry forward:
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Federal Provincial
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Research and development
expenditures, without time
limitation $24,893,000 $32,569,000
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Losses carried forward:
Expiring:
2006 $417,000 $250,000
2007 419,000 198,000
2008 2,531,000 1,655,000
2009 3,485,000 2,448,000
2010 4,280,000 2,803,000
2014 2,611,000 2,608,000
2015 2,822,000 2,809,000
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$16,565,000 $12,771,000
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Share issue costs $1,174,000 $1,174,000
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Unused tax credits:
Expiring:
2007 $119,000
2008 19,000
2009 213,000
2010 228,000
2011 738,000
2012 883,000
2013 1,005,000
2014 1,077,000
2015 1,329,000
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$5,611,000
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9. Commitments:
The Company rents premises under an operating lease expiring in
November 2011. The minimum payments required, including additional
rent representing operating costs under the terms of the lease, are
as follows:
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2006 $566,000
2007 572,000
2008 579,000
2009 587,000
2010 594,000
Thereafter 600,000
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$3,498,000
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In addition, the Company has issued an irrevocable letter of credit Irrevocable letter of credit Assurance of funds issued by a bank that cannot be canceled or amended without the beneficiary's approval. amounting to $389,282, along with a first rank movable hypothec Hy`poth´ec n. 1. (Scot. Law) A landlord's right, independently of stipulation, over the stocking (cattle, implements, etc.), and crops of his tenant, as security for payment of rent. , which can be subordinated Subordinated A claim ranked lower in priority than other claims. Common stock claims are always subordinated to debt. in regard to lending institutions Noun 1. lending institution - a financial institution that makes loans financial institution, financial organisation, financial organization - an institution (public or private) that collects funds (from the public or other institutions) and invests them in , of $1,000,000 covering the Company's tangible assets Tangible Asset An asset that has a physical form such as machinery, buildings and land. Notes: This is the opposite of an intangible asset such as a patent or trademark. Whether an asset is tangible or intangible isn't inherently good or bad. located in the rented premises premises n. 1) in real estate, land and the improvements on it, a building, store, shop, apartment, or other designated structure. The exact premises may be important in determining if an outbuilding (shed, cabana, detached garage) is insured or whether a person .The lease comprises progressive reduction clauses with respect to the amount of the letter of credit beginning in 2005, and an option for the purchase of the land and building. 10. Financial instruments: The Company has determined that the carrying value of its short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. financial assets Financial assets Claims on real assets. and liabilities, including cash, sales tax sales tax, levy on the sale of goods or services, generally calculated as a percentage of the selling price, and sometimes called a purchase tax. It is usually collected in the form of an extra charge by the retailer, who remits the tax to the government. receivable and other, tax credits receivable and accounts payable and accrued liabilities Accrued liabilities are liabilities which have occurred, but have not been paid or logged under accounts payable during an accounting period; in other words, obligations for goods and services provided to a company for which invoices have not yet been received. , approximates their fair value because of the relatively short periods to maturity of these instruments. Bonds are composed of financial instruments issued from municipal and paragovernmental bodies as well as companies with investment-grade ratings.These investments bear interest at rates varying between 2.46% and 6.25% based on nominal value Nominal Value The stated value of an issued security that remains fixed, as opposed to its market value, which fluctuates. Notes: When referring to fixed-income securities, the nominal value is also the face value. and mature at various dates over the next two years.Fair value of bonds amounted to $9,162,664 and $8,844,564 as at November 30, 2005 and 2004, respectively. Ecopia BioSciences Inc. (TSX:EIA) |
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