(Mark One)
[X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended April 30, 2005 |
[ ] | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _________________________ to ____________________ |
Commission File Number 1-8366
POLYDEX PHARMACEUTICALS LIMITED |
(Exact Name of Registrant as Specified in Its Charter) |
Commonwealth of the Bahamas | None | |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
|
421 Comstock Road, Toronto, Ontario, Canada | M1L 2H5 | |
(Address of Principal Executive Offices) | (Zip Code) |
Registrant's Telephone Number, Including Area Code (416) 755-2231
Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report |
Indicate by check whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ____
Indicate by check whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes ____ No _ X
Indicate the number of shares outstanding of each of the issuers classes of common shares, as of the latest practicable date.
Common Shares, $.0167 Par Value | 3,052,296 shares | |
(Title of Class) | (Outstanding at June 14, 2005) |
PAGE | ||||
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PART I | FINANCIAL INFORMATION CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) | |||
Item 1 | Consolidated Balance Sheets April 30, 2005 and January 31, 2005 | 1 | ||
Consolidated Statements of Operations and Comprehensive Income (Loss) Three months ended April 30, 2005 and 2004 | 3 | |||
Consolidated Statements of Shareholders Equity Three months ended April 30, 2005 and 2004 | 4 | |||
Consolidated Statements of Cash Flows Three months ended April 30, 2005 and 2004 | 5 | |||
Notes to Consolidated Financial Statements (Unaudited) | 6 | |||
Item 2 | MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 13 | ||
Item 3 | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 30 | ||
Item 4 | CONTROLS AND PROCEDURES | 32 | ||
PART II | OTHER INFORMATION | |||
Item 6 | EXHIBITS AND REPORTS ON FORM 8-K | 33 | ||
Signatures and Certifications | 34 |
This Quarterly Report on Form 10-Q contains various forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, which represent the Companys expectations or beliefs concerning future events, including, but not limited to statements regarding the Companys future growth, results of operations, liquidity and capital resources, expectations of regulatory approvals and the commencement of sales of products. The Company has tried to identify such forward-looking statements by use of words such as believes, anticipates, intends, plans, will, should, expects and similar expressions, but these words are not the exclusive means of identifying such statements. The Company cautions that these and similar statements in this Quarterly Report on Form 10-Q and in previously filed periodic reports including reports filed on Forms 10-K and 10-Q are further qualified by various risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements. These factors include, without limitation, changing market conditions, the progress of clinical trials and the results obtained, the establishment of new corporate alliances, the impact of competitive products and pricing, and the timely development, regulatory approval and market acceptance of the Companys products, as well as the other risks discussed herein, none of which can be assured. The forward-looking statements contained herein speak only as to the date of this report. Except as otherwise required by federal securities laws, the Company undertakes no obligation to publicly update or revise any forward-looking statements or the risk factors described in this Quarterly Report on Form 10-Q, whether as a result of new information, future events, changed circumstances or any other reason after the date of this report.
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normally recurring accruals) considered necessary for a fair presentation have been included.
Consolidated Balance Sheets
(Unaudited)
(Expressed in United States dollars)
April
30 2005 |
January
31 2005 |
|||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents (note 3) | $ 2,140,079 | $ 2,401,051 | ||||
Trade accounts receivable | 1,013,806 | 922,267 | ||||
Interest receivable | | 41,511 | ||||
Inventories: | ||||||
Finished goods | 1,015,078 | 1,187,158 | ||||
Work in process | 196,535 | 123,730 | ||||
Raw materials | 186,323 | 206,005 | ||||
1,397,936 | 1,516,893 | |||||
Prepaid expenses and other current assets | 58,836 | 115,542 | ||||
Total current assets | 4,610,657 | 4,997,264 | ||||
Property, plant and equipment, net | 2,969,601 | 3,124,185 | ||||
Patents and intangible assets, net | 66,950 | 68,959 | ||||
Assets held for sale | 11,918 | 12,085 | ||||
Promissory note [net of deferred gain of $350,000][note 7] | 0 | | ||||
Investments available for sale (note 4) | 1,895,533 | 1,909,305 | ||||
Due from shareholder | 643,867 | 643,867 | ||||
Deferred tax assets | 96,754 | 56,208 | ||||
$10,295,280 | $10,811,873 |
1
April
30 2005 |
January
31 2005 |
|||||||||
Liabilities and Shareholders' Equity | ||||||||||
Current liabilities: | ||||||||||
Bank indebtedness | $ | $ 24,170 | ||||||||
Accounts payable | 448,896 | 463,579 | ||||||||
Accrued liabilities | 291,490 | 169,370 | ||||||||
Payroll and related taxes payable | 201,017 | 195,897 | ||||||||
Customer deposits | 110,759 | 97,859 | ||||||||
Income taxes payable | 18,374 | 129,702 | ||||||||
Current portion of long-term debt | 29,606 | 46,353 | ||||||||
Current portion of capital lease obligations | 248,893 | 157,531 | ||||||||
Current portion of due to shareholder | 11,273 | 21,385 | ||||||||
Total current liabilities | 1,360,308 | 1,305,846 | ||||||||
Long-term debt | 4,087 | 4,368 | ||||||||
Capital lease obligations | 35,910 | 169,344 | ||||||||
Due to shareholder | 668,296 | 659,919 | ||||||||
Deferred income taxes | 121,507 | 121,507 | ||||||||
829,800 | 955,138 | |||||||||
Total liabilities | 2,190,108 | 2,260,984 | ||||||||
Shareholders' equity: | ||||||||||
Capital stock | ||||||||||
Authorized: | ||||||||||
100,000 Class A preferred shares of $0.10 each | ||||||||||
899,400 Class B preferred shares of $0.0167 each | ||||||||||
10,000,000 common shares of $0.0167 each | ||||||||||
Issued and outstanding: | ||||||||||
899,400 Class B preferred shares | 15,010 | 15,010 | ||||||||
3,052,296 common shares (January 31, 2005 - 3,042,296) | 50,842 | 50,676 | ||||||||
Contributed surplus | 23,356,052 | 23,303,718 | ||||||||
Deficit | (15,479,986 | ) | (15,144,357 | ) | ||||||
Accumulated other comprehensive income | 163,254 | 325,842 | ||||||||
8,105,172 | 8,550,889 | |||||||||
$ 10,295,280 | $ 10,811,873 |
See accompanying notes.
2
Consolidated Statements of Operations and Comprehensive Income (Loss)(Unaudited)
(Expressed in United States dollars)
Three Months Ended April 30 2005 |
Three Months Ended April 30 2004 |
|||||||
Sales | $ 1,322,684 | $ 2,521,794 | ||||||
Cost of goods sold | 1,199,365 | 1,758,702 | ||||||
123,319 | 763,092 | |||||||
Expenses: | ||||||||
General and administrative | 454,936 | 459,755 | ||||||
Depreciation | 11,368 | 7,430 | ||||||
Research and development | 32,329 | 13,424 | ||||||
Interest expense | 19,782 | 30,691 | ||||||
Selling and promotion | 21,348 | 25,167 | ||||||
Foreign exchange loss | 4,160 | 15,360 | ||||||
Amortization | | 8,518 | ||||||
Gain on sale of assets (note 7) | | (1,859,471 | ) | |||||
Interest and other income | (36,138 | ) | (12,487 | ) | ||||
507,785 | (1,311,613 | ) | ||||||
Income (loss) before income taxes | (384,466 | ) | 2,074,705 | |||||
Provision for (recovery of) income taxes | (48,837 | ) | 814,037 | |||||
Net income (loss) for the period | (335,629 | ) | 1,260,668 | |||||
Unrealized loss on investments available for sale | (67,561 | ) | | |||||
Currency translation adjustment | (95,027 | ) | (214,046 | ) | ||||
Comprehensive income (loss) for the period | $ (498,217 | ) | $ 1,046,622 | |||||
Per share information: | ||||||||
Earnings (loss) per common share: | ||||||||
Basic | $ (0.11 | ) | $ 0.42 | |||||
Diluted | $ (0.11 | ) | $ 0.39 | |||||
Weighted average number of common shares | ||||||||
outstanding for the period: | ||||||||
Basic | 3,052,296 | 3,027,796 | ||||||
Diluted | 3,052,296 | 3,215,047 | ||||||
See accompanying notes.
3
Consolidated Statements of
Shareholders' Equity (Unaudited)
(Expressed in United States dollars)
Three
Months Ended April 30 2005 |
Three
Months Ended April 30 2004 |
||||||
Preferred Shares: | |||||||
Balance, beginning and end of period | $ 15,010 | $ 15,010 | |||||
Common Shares: | |||||||
Balance, beginning of period | $ 50,676 | $ 50,434 | |||||
Common share options exercised | 166 | | |||||
Balance, end of period | $ 50,842 | $ 50,434 | |||||
Contributed Surplus: | |||||||
Balance, beginning of period | $ 23,303,718 | $ 23,236,498 | |||||
Common share options exercised | 52,334 | | |||||
Balance, end of period | $ 23,356,052 | $ 23,236,498 | |||||
Deficit: | |||||||
Balance, beginning of period | $(15,144,357 | ) | $(16,284,268 | ) | |||
Net income (loss) for the period | (335,629 | ) | 1,260,668 | ||||
Balance, end of period | $(15,479,986 | ) | $(15,023,600 | ) | |||
Accumulated Other Comprehensive Income (Loss): | |||||||
Balance, beginning of period | $ 325,842 | $ (110,343 | ) | ||||
Unrealized loss on investments available for sale | (67,561 | ) | | ||||
Currency translation adjustment for the period | (95,027 | ) | (214,046 | ) | |||
Balance, end of period | $ 163,254 | $ (324,389 | ) |
See accompanying notes.
4
Consolidated Statements of Cash
Flows (Unaudited)
(Expressed in United States dollars)
Three Months
Ended April 30 2005 |
Three Months
Ended April 30 2004 |
|||||||
Cash provided by (used in): | ||||||||
Operating activities: | ||||||||
Net income (loss) for the period | $ (335,629 | ) | $ 1,260,668 | |||||
Add (deduct) items not affecting cash: | ||||||||
Depreciation and amortization | 130,812 | 128,021 | ||||||
Imputed interest on long-term debt | 822 | 9,936 | ||||||
Deferred income taxes | (42,144 | ) | 558,955 | |||||
Gain on sale of veterinary products business | | (1,859,471 | ) | |||||
Net change in non-cash working capital balances | ||||||||
related to operations | 75,832 | (278,322 | ) | |||||
(170,307 | ) | (180,213 | ) | |||||
Investing activities: | ||||||||
Additions to property, plant and equipment and patents | (14,932 | ) | (41,075 | ) | ||||
Decrease in due from shareholder | | 22,476 | ||||||
Unrealized loss on commercial paper available for sale | (196 | ) | | |||||
Acquisition of investments available for sale | (81,046 | ) | | |||||
Proceeds from sale of veterinary products business | | 4,599,218 | ||||||
(96,174 | ) | 4,580,619 | ||||||
Financing activities: | ||||||||
Repayment of long-term debt | (17,783 | ) | (242,923 | ) | ||||
Repayment of capital lease obligations | (38,329 | ) | (39,330 | ) | ||||
Increase (decrease) in due to shareholder | (1,735 | ) | 1,248 | |||||
Increase (decrease) in bank indebtedness | (24,314 | ) | (129,131 | ) | ||||
Exercise of common share options | 52,500 | | ||||||
(29,661 | ) | (410,136 | ) | |||||
Effect of exchange rate changes on cash | 35,170 | 33,858 | ||||||
Increase (decrease) in cash and cash equivalents | (260,972 | ) | 4,024,128 | |||||
Cash and cash equivalents, beginning of period | 2,401,051 | 371,528 | ||||||
Cash and cash equivalents, end of period | $ 2,140,079 | $ 4,395,656 | ||||||
Cash and cash equivalents is comprised of the following: | ||||||||
Cash | $ 225,872 | $ 163,016 | ||||||
Cash equivalents | 1,914,207 | 4,232,640 | ||||||
$ 2,140,079 | $ 4,395,656 |
See accompanying notes.
5
The information contained in the interim consolidated financial statements is condensed from that which would appear in annual consolidated financial statements. The interim consolidated financial statements included herein should be read in conjunction with the audited financial statements, and notes thereto, and other financial information contained in the 2005 Annual Report on Form 10-K for the fiscal year ended January 31, 2005 as filed by Polydex Pharmaceuticals Limited (the Company) with the Securities and Exchange Commission. The unaudited interim consolidated financial statements as of April 30, 2005 and 2004 include all normal recurring adjustments which management considers necessary for a fair presentation. The results of operations for the interim periods presented are not necessarily indicative of the results that may be expected for the entire fiscal year. The interim consolidated financial statements include the accounts and transactions of the Company and its majority owned subsidiaries in which the Company has equal to or more than a 50% ownership interest and exercises control.
Basis of consolidation
The interim consolidated
financial statements include the accounts of the Company and its subsidiaries.
All inter-company accounts and transactions have been eliminated on
consolidation.
Use of
estimates
The preparation of
consolidated financial statements in conformity with United States 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 and liabilities at the date of the interim
consolidated financial statements and the reported amounts of revenue and
expenses during the reporting period. Actual results could differ from these
estimates.
Cash and cash
equivalents
Cash and cash equivalents
include cash and short-term deposits with maturities of less than three months
at the date of purchase.
Inventories
Inventories of raw
materials are stated at the lower of cost and net realizable value, cost being
determined on a first-in, first-out basis. Work-in-process and finished goods
are valued at the lower of cost and net realizable value, and include the cost
of raw materials, direct labor and overhead expenses.
Investments
available for sale
Investments available for
sale consist of medium-term fixed income instruments and trust income funds
and are stated at fair market value based on quoted market prices.
Interest income is included in other income (expense) in the
consolidated statement of operations as it is earned. Changes in
market values during the holding period are reported as unrealized gain (loss)
on
6
investments available for sale and are included in other comprehensive income (loss). Realized gains (losses) are reclassified from accumulated other comprehensive income (loss) on a specific item basis when the security is sold or matured.
Property, plant and equipment and patents and intangible assets
Property, plant and
equipment are recorded at cost less accumulated depreciation. Depreciation is
provided on a straight-line basis over the estimated useful lives of the assets
as follows:
Buildings 15 years
Machinery and
equipment 3 to 10 years
Patents and intangible assets are recorded at cost and are amortized on a straight-line basis over their estimated useful lives of ten years. Intangible assets consist of intellectual property, government licenses and government license applications.
Useful life is the period over which the asset is expected to contribute to the Companys future cash flows. The Company reviews the recoverability of its long-lived assets when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on the Companys ability to recover the carrying value of the asset from the expected future pre-tax cash flows of the related operations. If these cash flows are less than the carrying value of such asset, an impairment loss is recognized for the difference between estimated fair value and carrying value.
Costs related to plant refurbishments and equipment upgrades that represent improvements to existing facilities are capitalized. Costs related to repair and maintenance of buildings and equipment are expensed. The Company has no major planned maintenance activity.
Revenue
recognition
The majority of revenue is
from sales of bulk manufactured products. There was also revenue from finished
dosage manufactured products up to March 4, 2004, at which time the
Companys investment in the Vet Labs Sparhawk Joint Venture was sold
(see note 7). Revenue is recognized when title and risk of ownership of products
pass to the customer. Title and risk of ownership pass to the customer pursuant
to the applicable sales contract, either upon shipment of product or upon
receipt by the customer.
Product sold in bulk quantities is tested, prior to release for shipment, to ensure that it meets customer specifications, and in many cases, customers receive samples for their own testing. Approval is obtained from the customer prior to shipping. Further purchases by a customer of a bulk product with the same specifications do not require approvals. Returns of bulk product are rare and generally are not accepted.
No testing and approval is required for finished dosage product because of its nature. Returns of finished dosage product are rare and generally are not accepted.
Shipping and
handling costs
Shipping and handling costs
incurred by the Company for shipment of products to customers are included in
cost of goods sold.
7
Research and
development
Research and development
costs are expensed as incurred and are stated net of investment tax credits
earned.
Foreign
currency translation
The functional currency of
the Companys Canadian operations has been determined to be the Canadian
dollar. All asset and liability accounts of the Company have been translated
into United States dollars using the current exchange rates at the interim
consolidated balance sheet dates. Revenue and expense items are translated using
the average exchange rates for the year. The resulting gains and losses have
been reported separately as accumulated other comprehensive income
within shareholders equity.
Stock options
The Company has elected to
follow Statement of Financial Accounting Standards No. 123,
Accounting for Stock-Based Compensation (SFAS 123).
Under SFAS 123, compensation expense is recognized on the date of grant, based
on the fair value of the options granted.
Earnings
(loss) per common share
Basic earnings (loss) per common share is
computed using the weighted average number of common shares outstanding of
3,052,296 for the three months ended April 30, 2005 (2004 3,027,796).
Diluted earnings (loss) per common share is computed using the weighted average
number of common shares outstanding adjusted for the incremental shares, using
the treasury stock method, attributed to outstanding options to purchase common
stock. Incremental shares of nil and 187,251 at April 30, 2005 and April 30,
2004, respectively, were used in the calculation of diluted earnings (loss) per
common share. Options to purchase 56,300 and 3,885 common shares at April 30,
2005 and April 30, 2004, respectively, were not included in the computation of
diluted earnings (loss) per common share because their effect was
anti-dilutive.
Cash and cash equivalents consist of the following:
April
30 2005 |
January
31 2005 |
|||
Cash | $ 225,872 | $ 129,818 | ||
Short-term deposits | 1,914,207 | 2,271,233 | ||
$2,140,079 | $2,401,051 |
Short-term deposits in the amount of Cdn. $2,409,030 bear interest at 2.46% and mature on May 9, 2005. Short-term deposits consist of commercial paper and are available for sale and are stated at fair market value, based on quoted market prices. An unrealized loss of $196 has been included in accumulated other comprehensive income.
Investments available for sale consist of the following:
8
April 30 2005 |
January 31 2005 |
|||
Canadian medium-term fixed income instruments | $1,706,856 | $1,909,305 | ||
Canadian income trust units | 188,677 | | ||
$1,895,533 | $1,909,305 |
Canadian medium-term fixed income instruments have maturity dates extending from one to three years and interest rates ranging from 2.26% to 2.86%. Investments available for sale are stated at fair market value, based on quoted market prices. An unrealized loss of $67,561 has been included in accumulated other comprehensive income.
During September 2004, the Company entered into an agreement with a research organization to conduct a pilot clinical study on the use of cellulose sulphate for the treatment of bacterial vaginosis. Payments totaling $43,112 were made to the research organization and the principal investigator in September 2004. The Company is committed to make an additional payment of $43,112 upon the completion of patient enrolment, which is expected to occur during the second quarter of fiscal year 2006, and a final payment of $21,556 upon completion of the clinical study, which is expected to be in fourth quarter of fiscal year 2006.
The Company maintains an incentive share option plan for management personnel for options to purchase up to 1,000,000 common shares. The Company also issues options to certain consultants for services provided to the Company.
All options granted have terms of five years and vest immediately. At April 30, 2005, the Company had 56,300 options outstanding at exercise prices ranging from $2.50 to $7.72 and a weighted average exercise price of $4.49. The options, which are immediately exercisable and expire on dates between May 31, 2005 and January 31, 2010, entitle the holder of an option to acquire one common share of the Company.
The Company uses the fair value method in accordance with SFAS 123 to account for awards of stock-based employee compensation. No stock-based employee compensation expense was recorded during the period from February 1, 2005 to April 30, 2005, because there were no options granted during this period. Similarly, no stock-based employee compensation expense was recorded during the period from February 1, 2004 to April 30, 2004, because there were no options granted during this period.
In 1992, Veterinary Laboratories, Inc. ["Vet Labs"] and Sparhawk Laboratories, Inc. ["Sparhawk"] entered into the Vet Labs - Sparhawk Joint Venture [the "Joint Venture"] for the manufacture and sale of veterinary pharmaceutical products. Vet Labs and Sparhawk each owned 50% of the Joint Venture. The Company controlled the Joint Venture through its control of the Joint Venture Policy Committee and therefore consolidated its assets, liabilities, revenue and expenses in these consolidated financial statements until March 4, 2004. The Company had funded the Joint Venture's losses since 1992 and, accordingly, has recorded 100% of these cumulative losses in the consolidated financial statements. 9
On January 13, 2004, the Company entered into an Asset Purchase Agreement with Sparhawk. Pursuant to this Asset Purchase Agreement, the Company agreed to sell the finished product veterinary pharmaceutical business, including substantially all of the assets of Vet Labs, to Sparhawk for $5,500,000 in cash. Effective March 4, 2004, this sale was completed. Simultaneously, on March 4, 2004, Chemdex, Inc. ["Chemdex"], a wholly-owned subsidiary of the Company, advanced $350,000 to Sparhawk in exchange for a promissory note bearing interest at 13% per annum and a warrant to purchase 4% of the equity of Sparhawk for no additional consideration. The promissory note is due in full on March 4, 2009. Interest is payable annually on the anniversary date, but can be deferred and added to the principal balance of the promissory note each year at Sparhawk's discretion. At January 31, 2005, interest of $41,511 was accrued and reported as interest receivable on the balance sheet. On March 3, 2005, Sparhawk paid interest on the promissory note of $45,500 in cash. In fiscal year 2006 and subsequent fiscal years, should Sparhawk pay the interest due subsequent to year end, the amount of interest relating to the period up to January 31 will be accrued as interest receivable at the fiscal year-end. If interest is not paid on the anniversary date, no interest income will be recorded and the interest receivable amount will be fully provided for. The warrant expires at the earlier of payment in full of the promissory note or 10 years from date of issue. The warrant becomes exercisable the day after the fifth anniversary from the date of issue. Pursuant to a definitive supply agreement [the "Supply Agreement"] entered into on March 4, 2004, Chemdex agreed to supply ferric hydroxide and hydrogenated dextran solution to Sparhawk on an exclusive basis in the United States for 10 years. Chemdex also granted to Sparhawk an exclusive license to use the drug master file to manufacture 10% bulk Iron Dextran for veterinary use, and the use of certain equipment during the 10-year period of the Supply Agreement. Pursuant to definitive agreements, the Company made customary representations, warranties and indemnities and agreed to a full release of all claims against Sparhawk arising from the Joint Venture litigation. Similarly, Sparhawk agreed to a full release of all claims against the Company arising from the Joint Venture litigation.
The sale resulted in a gain of $2,209,471, of which $1,859,471 was recognized in the consolidated statements of operations and $350,000 was deferred. The deferred gain of $350,000 is a result of the promissory note receivable from Sparhawk as Sparhawk is thinly capitalized and highly leveraged. The Company will monitor the financial position of Sparhawk and will recognize this deferred gain at such time as Sparhawk's cash flows from operations are sufficient to fund debt service on a full accrual basis.
All operations are carried out through Dextran Products Limited (Dextran) in Canada and through Chemdex in the United States. Each of Dextran and Chemdex operated as separate strategic business units offering different products, until the sale of the finished product veterinary pharmaceutical business on March 4, 2004 [note 7]. Until March 4, 2004, each subsidiary comprised a reportable segment as follows:
Dextran | manufactures and sells bulk quantities of dextran and several of its derivatives to large pharmaceutical companies throughout the world. |
Chemdex | manufactures and sells veterinary pharmaceutical products and specialty chemicals in the United States. The primary customers are distributors and private labelers, who in turn sell to the end user of the products. |
10
After March 4, 2004, Chemdex only sells bulk quantities of a specific dextran derivative to Sparhawk under the Supply Agreement, as described in note 7.
Three
Months Ended April 30 2005 |
Three
Months Ended April 30 2004 |
|||||||
Sales: | ||||||||
Dextran | $ | 1,317,326 | $ | 1,529,824 | ||||
Less: intercompany sales elimination | 101,793 | 99,931 | ||||||
1,215,533 | 1,429,893 | |||||||
Chemdex | 107,151 | 1,091,901 | ||||||
Total consolidated sales | $ | 1,322,684 | $ | 2,521,794 | ||||
Income (loss) before income taxes: | ||||||||
Dextran | $ | (195,259 | ) | $ | 269,279 | |||
Chemdex | 40,350 | 1,980,391 | ||||||
Total pre-tax income (loss) from segments | (154,909 | ) | 2,249,670 | |||||
Less: Unallocated corporate expenses | 229,558 | 174,965 | ||||||
Total consolidated pre-tax income (loss) | $ | (384,467 | ) | $ | 2,074,705 | |||
Total revenue by significant customer: | ||||||||
Customer A | $ | 192,134 | $ | | ||||
Customer B | $ | 181,770 | $ | 246,296 | ||||
Customer C | $ | 173,000 | $ | 172,000 | ||||
Customer D | $ | | $ | 268,186 | ||||
Sales revenue by product group: | ||||||||
Bulk dextran and derivatives | $ | 1,322,684 | $ | 1,429,893 | ||||
Sterile injectible veterinary products | | 663,629 | ||||||
Oral and topical veterinary products | | 428,272 | ||||||
Total consolidated sales | $ | 1,322,684 | $ | 2,521,794 | ||||
April 30, 2005 | January 31, 2005 | |||||||
Assets: | ||||||||
Dextran | $ | 9,475,947 | $ | 9,933,254 | ||||
Chemdex | 213,384 | 233,539 | ||||||
Total assets from segments | 9,689,331 | 10,166,793 | ||||||
Corporate assets | 605,948 | 645,080 | ||||||
Total consolidated assets | $ | 10,295,279 | $ | 10,811,873 |
11
In December 2004, the Financial Accounting Standards Board [the FASB] issued FASB Statement No. 123 (Revised 2004), Share-Based Payment [Statement 123(R)"], which is a revision of FASB Statement No. 123, Accounting for Stock-Based Compensation [Statement 123"]. Statement 123(R) supercedes APB Opinion No. 25, Accounting for Stock Issued to Employees and amends FASB Statement No. 95, Statement of Cash Flows. Generally, the approach in Statement 123(R) is similar to the approach described in Statement 123. However, Statement 123(R) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the income statement based on their fair values. Pro forma disclosure is no longer an alternative. Effective February 1, 2003, the Company has adopted the fair value accounting method provided for under Statement 123 to apply recognition provisions to its employee stock options granted, modified or settled after February 1, 2003. Statement 123(R) will have no impact on the consolidated financial statements of the Company.
In November 2004, the FASB issued Statement 151, Inventory Costs, which clarifies that abnormal amounts of idle facility expense, freight, handling costs and wasted materials should be recognized as current-period charges and requires the allocation of fixed production overheads to inventory based on the normal capacity of the production facilities. This guidance is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The Company does not anticipate that this guidance will impact the consolidated financial statements of the Company.
In December 2004, the FASB issued Statement 153, Exchanges of Nonmonetary Assets, an amendment of APB Opinion No. 29, Accounting for Nonmonetary Transactions. Statement 153 is based on the principle that exchanges of nonmonetary assets should be measured based on the fair value of the assets exchanged. Statement 153 eliminates the narrow exception for nonmonetary exchanges of similar productive assets and replaces it with a broader exception for exchanges of nonmonetary assets that do not have commercial substance. Statement 153 is effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The provisions of Statement 153 should be applied prospectively. The Company does not anticipate that the application of Statement 153 will have an impact on the consolidated financial statements of the Company.
In May 2005, the FASB issued Statement 154, Accounting Changes and Error Corrections a replacement of APB Opinion No. 20 and FASB Statement No. 3, which applies to all voluntary changes in accounting principle. This Statement requires retrospective application to prior periods financial statements of changes in accounting principle, unless it is impracticable to determine either the period-specific effects or the cumulative effect of the change. This Statement is effective for fiscal years beginning after December 15, 2005. The Company does not anticipate that this guidance will impact the consolidated financial statements of the Company.
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The Companys fiscal year ends on January 31st of each year. In this report, fiscal year 2006 refers to the Companys fiscal year ended January 31, 2006. The following discussion should be read in conjunction with the April 30, 2005 interim consolidated financial statements and notes thereto included elsewhere in this report. Operating results for the three months ended April 30, 2005 are not necessarily indicative of the results that may be expected for the fiscal year ended January 31, 2006. For further information, refer to the consolidated financial statements and footnotes thereto included in the Companys annual report on Form 10-K for the fiscal year ended January 31, 2005. The Companys financial statements are prepared in accordance with United States generally accepted accounting principles. All amounts are in United States dollars, unless otherwise denoted.
The Company is engaged in the research, development, manufacture and marketing of biotechnology-based products for the human pharmaceutical market, and also manufactures bulk pharmaceutical intermediates for the worldwide veterinary pharmaceutical industry. The Company conducts its business operations through its subsidiaries, which operate as strategic business units: Dextran Products and Chemdex.
The manufacture and sale of bulk quantities of dextran and derivative products for sale to large pharmaceutical companies throughout the world is conducted through a Canadian subsidiary, Dextran Products.
Management Objectives for Fiscal 2006. In fiscal year 2006, management intends to focus on the core businesses of Dextran Products that have historically been the backbone of the Company. Opportunities to increase distribution chains for existing Dextran products in certain overseas markets, such as India, China and Russia are being explored by management. Expanding current market opportunities and the potential for new market penetration has led management to make plant refurbishments and the expansion of production capacity a priority for fiscal year 2006 with respect to Dextran Products operations.
Research and development of the Companys human pharmaceutical products is coordinated at the Dextran Products facility. Ushercell, the Companys leading human pharmaceutical compound, is a high molecular weight Cellulose Sulphate envisioned for topical vaginal use primarily in the prevention of transmission of AIDS and other sexually transmitted diseases, as well as unplanned pregnancies. Multiple clinical trials have been completed, and additional trials have commenced or are being actively planned, to evaluate various aspects of the use of Cellulose Sulphate as a contraceptive gel with antiviral capabilities. The Company also intends to significantly explore the use of Ushercell as a treatment for Bacterial Vaginosis (BV), the most common vaginal disorder among reproductive-age women. If effective, BV
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treatment may present an opportunity for commercial viability of Ushercell in advance of the completion of the much lengthier required testing for its use as an antiviral contraceptive gel.
During approximately one month of the 2005 fiscal year, the Company also engaged in the finished product veterinary pharmaceutical business through its United States subsidiary Chemdex, which, in turn, conducted its operations through its subsidiary, Vet Labs. On December 1, 1992, Vet Labs and Sparhawk Laboratories Inc. entered into a Joint Venture for the purpose of manufacturing and selling veterinary pharmaceutical products. On January 13, 2004, the Company, Chemdex and Vet Labs entered into an Asset Purchase Agreement with Sparhawk pursuant to which the Company agreed to sell its finished product veterinary pharmaceutical business, including substantially all of the assets of Vet Labs and its ownership interest in the Joint Venture, to Sparhawk for $5,500,000 in cash. The sale was completed on March 4, 2004. Simultaneously with the closing, Chemdex advanced $350,000 to Sparhawk in exchange for an unsecured subordinated promissory note bearing interest at 13% per annum and a warrant to purchase 4% of the equity of Sparhawk. The promissory note is payable in full on March 4, 2009. Interest is payable annually, but can be deferred and added to the principal balance of the promissory note each year at Sparhawks discretion. The warrant becomes exercisable on March 5, 2009 and expires at the earlier of payment in full of the promissory note or March 4, 2014. Chemdex also entered into a supply agreement with Sparhawk to supply ferric hydroxide and hydrogenated dextran solution to Sparhawk on an exclusive basis in the United States for 10 years. In connection with the sale, the litigation involving the Joint Venture, Sparhawk Laboratories, Inc. v. Veterinary Laboratories, Inc., et al, Case No. 02CV07426, County of Johnson, State of Kansas, was settled, and a Motion of Approval of Settlement and Stipulation of Dismissal with Prejudice was filed with the Court on March 4, 2004.
Three months ended April 30, 2005 compared to three months ended April 30, 2004
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
|||
---|---|---|---|---|
Net income (loss) | $(335,629) | $1,260,668 | ||
Earnings (loss) per share | $ (0.11) | $ 0.42 |
The net loss for the first quarter of fiscal year 2006 as compared to the first quarter in fiscal year 2005 is attributable to the net loss at Dextran Products and increased corporate expenses, as discussed below. The year to date net income for fiscal year 2005 is a result of the gain on sale of the Vet Labs assets in March 2004.
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Income
(loss) before income taxes |
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | |||
---|---|---|---|---|---|---|
Consolidated | $(384,466) | $2,074,705 | (119)% | |||
Dextran Products | (195,259) | 269,279 | (173)% | |||
Chemdex | 40,350 | 1,980,391 | (98)% |
The decrease in operating results in the first quarter of fiscal year 2006 is primarily attributable to the decrease in sales at both operating subsidiaries and increased corporate expenses.
Dextran Products. The decrease in operating results at Dextran Products is due to decreased sales and gross margins during the first quarter of fiscal year 2006. The sales decrease in the first quarter of fiscal year 2006 is a result of decreased customer demand. The decrease in gross margins is a result of the lower sales volume and the rise in the value of the Canadian dollar relative to the United States dollar. Sales at Dextran Products are primarily denominated in the United States dollar, while the majority of expenses are incurred in Canadian dollars. Therefore, when the value of the Canadian dollar rises against the United States dollar, the gross margin percentage at Dextran Products declines.
Chemdex. On March 4, 2004, the Company sold its finished product veterinary pharmaceutical business to Sparhawk. The sale included substantially all of the assets of Vet Labs and its ownership interest in the Joint Venture, and settled all outstanding litigation among the parties. The Company did not incur legal or receiver costs in connection with Vet Labs or the Joint Venture following the date of sale. Chemdex operations are now limited to the supply of raw materials to Sparhawk under the terms of the supply agreement between the parties.
Sales | Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | |||
---|---|---|---|---|---|---|
Consolidated | $1,322,684 | $2,521,794 | (48)% | |||
Dextran Products | $1,215,533 | $1,429,893 | (15)% | |||
Percentage of Company sales | 92% | 57% | ||||
Chemdex | $ 107,151 | $1,091,901 | (90)% | |||
Percentage of Company sales | 8% | 43% |
The majority of the first quarter sales decrease in fiscal year 2006 was attributable to the Chemdex operating segment due to the sale of the finished goods veterinary pharmaceutical business in the first quarter of fiscal year 2005. This business represented virtually all of the Chemdex operating segment.
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Dextran Products. Sales of dextran and related products in the first quarter of fiscal year 2006 were less than the sales levels achieved during the first quarter of fiscal year 2005 due to a decrease in customer demand.
Chemdex. As discussed above, the sale of the finished product veterinary pharmaceutical business to Sparhawk on March 4, 2004 resulted in a discontinuance of sales of finished veterinary products, resulting in the significant decline in sales for this operating segment.. Sales for Chemdex since March 4, 2004 have been limited to sales of ferric hydroxide and hydrogenated dextran solution to Sparhawk.
Gross profit | Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | |||
---|---|---|---|---|---|---|
Consolidated | $123,319 | $763,092 | (83)% | |||
Percentage of sales | 9% | 30% | ||||
Dextran Products | $ 90,897 | $430,840 | (79)% | |||
Percentage of sales | 7% | 30% | ||||
Chemdex | $ 2,549 | $261,701 | (99)% | |||
Percentage of sales | 2% | 24% |
The first quarter fiscal year 2006 decrease in consolidated gross profit is a result of the decline in sales and margins at Dextran Products and the sale of the Joint Venture operations during the first quarter of fiscal year 2005. The decrease in gross profit percentage during the first quarter of fiscal year 2006 is primarily due to the decrease in the gross profit percentage realized by Dextran Products.
Dextran Products. Decreased gross profit percentages were experienced at the Dextran Products operating segment because of the decreased sales volume and the rise in the Canadian dollar relative to the United States dollar. Sales at Dextran Products are primarily denominated in the United States dollar, while the majority of expenses are incurred in Canadian dollars. Therefore, when the value of the Canadian dollar rises against the United States dollar, the gross margin percentage at Dextran Products declines.
Chemdex. The Joint Venture operations ceased on March 4, 2004 due to the sale of that business. The decrease in gross profit at Chemdex for the first quarter of fiscal year 2006 is due to the loss of this approximately one month of operations during the first quarter of fiscal year 2005.
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Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | ||||
---|---|---|---|---|---|---|
Selling, promotion, general and administrative expenses | $476,284 | $457,363 | 4% |
The increase during the first quarter of fiscal year 2006 in selling, promotion, general and administrative expenses is primarily due to a death benefit accrual payable to the estate of the former vice-chairman of the Company.
Research and development |
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | |||
---|---|---|---|---|---|---|
Research and development expenditures | $32,329 | $13,424 | 141% |
The increase in research and development expenses during the first quarter of fiscal year 2006 is a result of continued work on the cellulose sulphate project, including further costs of a pilot clinical study on the use of cellulose sulphate for the treatment of bacterial vaginosis. This clinical study is related to an alternate use of cellulose sulphate and therefore is outside the scope of funding provided by the Companys research and development partners for the investigation of this product as a contraceptive gel with antiviral properties. Expenses for this clinical study are expected to continue at similar levels during fiscal year 2006.
Funding for the Companys primary development products is provided directly by third party public and/or private sector groups to the entities carrying out such research. The Company does not take possession or control over these funds. The Company benefits from the results of research projects through the ownership of patents and/or licenses with respect to the products involved. The Company has no commitments to repay the funding or to purchase the results of the research.
Significant funding from research and development partners for the current phase of the project investigating the use of cellulose sulphate as a contraceptive gel with antiviral properties project is expected to continue at necessary levels for the foreseeable future. The Companys total research and development expenditures are expected to increase in fiscal year 2006 over fiscal year 2005 due to additional product development activities the Company expects to perform and fund outside of its partnership relationships.
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | ||||
---|---|---|---|---|---|---|
Depreciation and amortization expense | $130,812 | $128,021 | 2% |
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The increase in depreciation and amortization expense in the first quarter of fiscal year 2006 is attributable to depreciation on equipment additions at Dextran Products subsequent to the first quarter of fiscal year 2005.
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | ||||
---|---|---|---|---|---|---|
Interest expense | $19,782 | $30,691 | (36)% |
The decrease in interest expense in first quarter of fiscal year 2006 is primarily attributable to a decrease in long-term debt and capital lease obligations, as well as the associated decrease in imputed interest due to the continuing repayment of non-interest bearing long-term debt. The share value guarantee payable was paid in full on March 4, 2004 when the Joint Venture operations were sold.
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | ||||
---|---|---|---|---|---|---|
Foreign exchange loss | $4,160 | $15,360 | (73)% |
The decrease in foreign exchange loss at Dextran Products in the first quarter of fiscal year 2006 was due to the significant decline in Dextran Products net exposure to the United States dollar. At April 30, 2005, Dextran Products has a net liability exposure to the United States dollar because intercompany payables denominated in United States dollars exceed its United States dollar denominated accounts receivable balance. A large portion of intercompany receivables balances were repaid in March 2004 when the Joint Venture operations were sold. Management does not expect that the Company will incur significant foreign exchange losses in fiscal year 2006.
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | ||||
---|---|---|---|---|---|---|
Other income (expense) | $36,138 | $(15,072) | 340% |
Other income in the first quarter of fiscal year 2006 is primarily related to interest income earned at Dextran Products. The proceeds from the sale of the Joint Venture operations were used to repay balances owing to Dextran Products and have been invested in short and mid-term interest earning securities. During the first quarter of fiscal year 2005, other expenses consisted of legal and receiver costs associated with the winding-up of the Joint Venture, and the resulting litigation. This litigation was settled with the closing of the sale of the Joint Venture on March 4, 2004. Management expects no similar costs during fiscal year 2006.
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Provision for (recovery of) income taxes |
Three Months Ended April 30, 2005 |
Three Months Ended April 30, 2004 |
Variance | |||
---|---|---|---|---|---|---|
Consolidated | $(48,837) | $814,037 | (106)% | |||
Dextran Products | (64,837) | 92,537 | (170)% | |||
Chemdex | 16,000 | 721,500 | (98)% |
The decrease in tax provision for the first quarter of fiscal year 2006 is a result of a decrease in taxable income. Dextran Products suffered tax losses during the first quarter of fiscal 2006 resulting in a tax recovery. The Canadian operations continue to have significant research and development tax pools to offset current taxes payable. There was a large tax provision required at Chemdex during the first quarter of fiscal year 2005 due to the realization of the gain on sale of the Joint Venture operations. Chemdex now has significantly lower taxable income.
As of April 30, 2005, the Company had cash and cash equivalents of $2,140,079, compared to cash and cash equivalents of $2,401,051 at January 31, 2005. In the first quarter of fiscal year 2006 the Company used cash of $170,307 in its operating activities, compared $180,213 for the first quarter of fiscal year 2005. The use of cash for operations during the first quarter of fiscal year 2006 is primarily due to the loss incurred during the quarter. Although there was a large increase in net income in the first quarter of fiscal year 2005, the increase resulted from the sale of the Vet Labs assets and its interest in the Joint Venture, which was an investing activity. Depreciation and amortization continues to be a large non-cash expense of the Company.
The Company maintained $3,250,349 of working capital and a current ratio of 3.4 to 1 as of April 30, 2005, compared to $3,691,418 and 3.8 to 1 as of January 31, 2005.
Management expects the primary source of its future capital needs to be a combination of company earnings and borrowings.
The Company believes that, based upon the current levels of revenues and spending, its existing working capital resources will be sufficient to support continuing operations for the foreseeable future.
At April 30, 2005, the Company had accounts receivable of $1,013,806 and inventory of $1,397,936, compared to $922,267 and $1,516,893 at January 31, 2005 and $941,720 and $1,214,117 at April 30, 2004. The increase in accounts receivable during the first quarter ended April 30, 2004 is due to increased sales towards the end of the quarter.
At April 30, 2005, the Company had accounts payable of $448,896 compared to $463,579 at January 31, 2005 and $486,841 at April 30, 2004. The decrease in accounts payable was due to timing of supplier payments and the decrease in inventory.
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During the first quarter of fiscal year 2006, capital expenditures totaled $14,932, as compared to $41,075 in the first quarter of fiscal year 2005. All of the capital expenditures were for production equipment at the Dextran Products plant in Toronto during both of these periods. The Company, at present, does not have any material commitments for capital expenditures, although management intends to continue its plant refurbishment and expansion plan at Dextran Products in Toronto during the remainder of fiscal year 2006, and expects capital expenditures to increase during this period.
The change in accumulated other comprehensive income of the Company is primarily attributable to the currency translation adjustment of Dextran Products. Dextran Products functional currency is the Canadian dollar. This currency translation adjustment arises from the translation of Dextran Products financial statements to U.S. dollars.
Dextran Products has a Cdn. $1,250,000 (U.S. $993,000) line of credit, of which none was utilized at April 30, 2005. At January 31, 2005, Cdn. $30,000 (U.S. $24,000) of this line of credit was utilized. This line of credit bears interest at the Canadian banks prime lending rate plus 0.75% (April 30, 2005 5%; January 31, 2005 5%). This indebtedness is collateralized by a general security agreement over the Companys assets and a collateral mortgage of Cdn. $500,000 on the Dextran Products building in Toronto. This line of credit is used periodically by the Company to cover temporary short-term Canadian dollar cash needs. For these short-term cash needs, the interest expense on the credit line is typically less than the transaction costs incurred in selling short-term investments.
Chemdex entered into a long-term debt obligation relating to the redemption of the 10% minority interest in Chemdex in fiscal year 2004. The redemption amount was $146,500, which is to be paid in 25 equal monthly installments of $5,860. The Company has timely made 20 payments through April 30, 2005. Since this installment contract is non-interest bearing, it has been discounted using a discount rate of 9%. The present value of this installment contract is $28,759, which has been recorded as long-term debt.
The decrease in long-term debt and capital lease obligations from January 31, 2005 is due to continuing payments by the Company. The majority of the long-term debt and capital lease obligations are due in the next two years.
Changes in the relative values of the Canadian dollar and the United States dollar occur from time to time and may, in certain instances, materially affect the Companys results of operations.
The Company does not believe that the impact of inflation and changing prices has had a material effect on its operations or financial results at any time in the last three years.
In August 1997, the Company loaned the Late Thomas C. Usher, its Vice-Chairman, Director of Research and Development, a member of its Board of Directors and the beneficial owner of greater than 5% of the outstanding common shares of the Company, $691,500 at an
20
interest rate equal to the prime rate of Toronto Dominion Bank plus 1.50% (the Loan). The Loan was used to partially fund a $1,000,000 payment to the State of Florida in order to allow Thomas C. Usher to regain possession of 430,000 Common Shares of the Company then held by the State as collateral security relating to the liquidation of insurance companies formerly owned by Thomas C. Usher. Repayment of the Loan is accomplished by monthly payments and through offsets by the Company against royalty payments due Thomas C. Usher pursuant to intellectual property license agreements and bonus payments, if any, granted Thomas C. Usher as an employee of the Company. The amount outstanding under the Loan as of April 30, 2005 was $379,882, as compared to $373,373 at January 31, 2005, including accrued interest. The Company has taken a cumulative provision of $271,053 against accrued interest on this loan at April 30, 2005, compared to a cumulative provision of $264,543 at January 31, 2005.
In August 1999, Thomas C. Usher personally assumed all of the assets and liabilities of Novadex Corp., including the balance of receivables (the Receivables) due to the Company from Novadex Corp. The Receivables have no specific repayment terms. The total outstanding amount of the Receivables as of April 30, 2005 and January 31, 2005 was $285,037. Thomas C. Usher also owes $250,000 to a subsidiary of the Company, Novadex International Limited, as of April 30, 2005, pursuant to a non-interest bearing loan with no specific repayment terms. The outstanding amount of this loan has not changed from January 31, 2005.
Thomas C. Usher has pledged 323,051 common shares of the Company as security for these amounts owing to the Company. These common shares have a market value of $1,867,235 at April 30, 2005, based on the closing price of the Companys common shares on the NASDAQ SmallCap Market on April 29, 2005, the last trading day prior to April 30, 2005.
During February 2005, Thomas C. Usher passed away. All assets and liabilities of Thomas C. Usher transferred to his estate. The Company will continue to hold the pledged assets as collateral until the Loan, the Receivables and the non-interest bearing loan discussed above are repaid. The Company has a commitment to pay an amount of $110,000 to Thomas C. Ushers estate within one year of his death, of which $5,000 was paid in the first quarter of fiscal year 2006.
The Company also has an outstanding loan payable to Ruth Usher, a former director and the widow of Thomas C. Usher. The amount due from the Company pursuant to this loan decreased to $679,569 at April 30, 2005 from $681,304 at January 31, 2005 due to monthly payments by the Company less interest charges.
The Company has no off-balance sheet arrangements.
As of April 30, 2005, future minimum cash payments due under contractual obligations, including, among others, the Dextran Products line of credit, the loan payable to Ruth Usher, the
21
long-term debt obligation in connection with the Chemdex redemption, research and development agreements and capital lease agreements, are as follows:
Payment due by period | |||||
---|---|---|---|---|---|
Contractual Obligations |
Total | Less
than 1 year |
1 3 years |
3
5 years |
More
than 5 years |
Long-term debt obligations (1) | $ 715,201 | $ 90,633 | $122,666 | $122,333 | $379,569 |
Capital lease obligations (2) | 301,119 | 177,821 | 113,271 | 10,027 | |
Operating Lease obligations (3) | 641 | 513 | 128 | | |
Purchase obligations (4) | 64,668 | 64,668 | | | |
Revolving loans (5) | | | | | |
Total | $1,081,629 | $333,635 | $236,065 | $132,360 | $379,569 |
__________
1. | Consists of: |
(a) | Note payable in monthly payments of $5,860 maturing September 19, 2005; |
(b) | Note payable in quarterly payments of Cdn. $419 (US $333), bearing interest at 10.43% and maturing December 2009; and |
(c) | Amounts due to shareholder which bear interest at the U.S. bank prime lending rate plus 1.5%, with required minimum monthly payments, including interest, of $5,000. |
2. | Consists of capital lease obligations for: |
(a) | Production equipment of Cdn. $271,371 (US $215,631) repayable in monthly installments, bearing interest at 9% and maturing November 2006; |
(b) | Production equipment of Cdn. $60,365 (US $47,966) repayable in monthly installments, bearing interest at 7.59% and maturing November 2006; and |
(c) | Office equipment of Cdn. $26,688 (US $21,206) repayable in quarterly installments, bearing interest at 10.43% and maturing December 2009. |
3. | Consists of operating lease obligations for office equipment requiring quarterly payments of Cdn. $161 (US $128) terminating June 2006. |
4. | Consists of purchase obligations for research and development services payable as specified milestones are achieved. |
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5. | Consists of Canadian operating line of credit bearing interest at the Canadian banks' prime lending rate plus 0.75%, repayable upon demand. No balance outstanding at April 30, 2005. |
The risks, uncertainties and other factors described below could materially and adversely affect the Companys business, financial condition, operating results and prospects.
The Companys product development efforts may be reduced or discontinued due to difficulties or delays in clinical trials.
To achieve sustained profitability, the Company must, alone or with corporate partners and collaborators, successfully research, develop and commercialize identified technologies or product candidates. Current developmental product candidates are in various stages of clinical and pre-clinical development and will require significant further funding, research, development, preclinical and/or clinical testing, regulatory approval and commercialization testing, and are subject to the risks of failure inherent in the development of products based on innovative or novel technologies. These products are also rigorously regulated by the U.S. federal government, particularly the FDA, and by comparable agencies in state and local jurisdictions and in foreign countries. Specifically, each of the following results is possible with respect to any one of the Companys developmental product candidates:
| that the Company will not be able to maintain its current research and development schedules; |
| that the Company will not be able to enter into human clinical trials because of scientific, governmental or financial reasons, or that it will encounter problems in clinical trials that will cause a delay or suspension of the development of the product candidate; |
| that the developmental product will be found to be ineffective or unsafe; |
| that government regulations will delay or prevent the products marketing for a considerable period of time and impose costly procedures upon the Companys activities; |
| that the FDA or other regulatory agencies will not approve the product or the process by which the product is manufactured, or will not do so on a timely basis; and/or |
| that the FDAs policies may change and additional government regulations and policies may be instituted, which could prevent or delay regulatory approval of the product. |
If any of the risks set forth above occurs, the Company may not be able to successfully develop its identified developmental product candidates.
The Companys developmental product commercialization efforts may not be successful.
23
It is possible that, for reasons including, but not limited to those set forth below, the Company may be unable to commercialize or receive royalties from the sale of any given developmental product, even if it is shown to be effective, if:
| the product is uneconomical or if the market for the product does not develop or diminishes; |
| the Company is not able to enter into arrangements or collaborations to commercialize and/or market the product; |
| the product is not eligible for third-party reimbursement from government or private insurers; |
| others hold proprietary rights that preclude the Company from commercializing the product; |
| others have brought to market similar or superior products; |
| others have superior resources to market similar products or technologies; |
| government regulation imposes limitations on the indicated uses of the product, or later discovery of previously unknown problems with the product results in added restrictions on the product or results in the product being withdrawn from the market; and/or |
| the product has undesirable or unintended side effects that prevent or limit its commercial use. |
The Company depends on partnerships with third parties for the development and commercialization of its products.
The Companys strategy for development and commercialization of its products is to rely on licensing agreements with third party partners. As a result, the ability of the Company to commercialize future products is dependent upon the success of third parties in performing clinical trials, obtaining regulatory approvals, manufacturing and successfully marketing its products. There can be no assurance that such third party collaborations will be successful. Should any of the Companys current research and development partnerships be discontinued, it may not be able to find others to develop and commercialize its current product candidates.
The Company does not currently have agreements with third parties to market its developmental products.
The commercialization of any of the Companys developmental products that receive FDA approval will depend upon the Companys ability to enter into agreements with companies that have sales and marketing capabilities. The Company currently intends to sell its products in the United States and internationally in collaboration with one or more marketing partners. The
24
Company may not be able to enter into any such collaboration to market its developmental products in a timely manner or on commercially reasonable terms, if at all.
The Company may be unable to commercialize its products if it is unable to protect its proprietary rights, and may be liable for significant costs and damages if it faces a claim of intellectual property infringement by a third party.
The Companys success depends in part on its ability to obtain and maintain patents, protect trade secrets and operate without infringing upon the proprietary rights of others. In the absence of patent and trade secret protection, competitors may adversely affect the Companys business by independently developing and marketing substantially equivalent or superior products, possibly at lower prices. The Company could also incur substantial costs in litigation and suffer diversion of attention of technical and management personnel if it is required to defend intellectual property infringement suits brought by third parties, with or without merit, or if required to initiate litigation against others to protect or assert intellectual property rights. Moreover, any such litigation may not be resolved in favor of the Company.
The Company has received various patents covering the uses of its developmental products. However, the patent position of companies in the pharmaceutical industry generally involves complex legal and factual questions, and recently has been the subject of much litigation. Any patents the Company has obtained, or may obtain in the future, may be challenged, invalidated or circumvented. To date, no consistent policy has been developed by the United States Patent and Trademark Office regarding the breadth of claims allowed in biotechnology patents.
In addition, because patent applications in the United States are maintained in secrecy until patents issue, and because publication of discoveries in scientific or patent literature often lags behind actual discoveries, the Company cannot be certain that it and its licensors are the first creators of inventions covered by any licensed patent applications or patents or that the Company or such licensors are the first to file. The United States Patent and Trademark Office may commence interference proceedings involving patents or patent applications, in which the question of first inventorship is contested. Accordingly, the patents owned by or licensed to the Company may not be valid or may not afford the Company protection against competitors with similar intellectual property.
It is also possible that the Companys patents may infringe on patents or other rights owned by others, licenses to which may not be available to the Company. The Company may have to alter its products or processes, pay licensing fees or cease certain activities altogether because of patent rights of third parties.
In addition to the products for which the Company has patents or have filed patent applications, the Company relies upon unpatented proprietary technology and may not be able to meaningfully protect its rights with regard to that unpatented proprietary technology.
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The Companys interim consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States, applied on a consistent basis. The critical accounting policies include the use of estimates of allowance for doubtful accounts, the useful lives of assets and the realizability of deferred tax assets. The Companys accounting policies with respect to the Joint Venture and its disposition are also discussed below.
Management is required to make estimates and assumptions, in preparing the consolidated financial statements, that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the periods. The actual results could differ from these estimates. Significant estimates made by management include the calculation of reserves for uncollectible accounts, inventory allowances, useful lives of long-lived assets and the realizability of deferred tax assets.
Since March 4, 2004, all revenue is from sales of bulk manufactured products and is recognized when title and risk of ownership of products pass to the customer. Title and risk of ownership pass to the customer pursuant to the applicable sales contract, either upon shipment of product or upon receipt by the customer. Since returns are rare and generally not accepted, management has not made provision for returns. In addition, product sold in bulk quantities is tested, prior to release for shipment, to ensure that it meets customer specifications, and in many cases, customers receive samples for their own testing. Approval is obtained from the customer prior to shipping.
Accounts receivable is stated net of allowances for doubtful accounts. Allowances for doubtful accounts are determined by each reporting unit on a specific item basis. Management reviews the credit worthiness of individual customers and past payment history to determine the allowance for doubtful accounts. Since the majority of sales at Dextran Products are export, Dextran Products maintains credit insurance through a crown corporation for the majority of its customers receivables. There has been no allowance for doubtful accounts during the past two fiscal years.
Long-lived assets are stated at cost, less accumulated depreciation or amortization computed using the straight-line method based on their estimated useful lives ranging from three to fifteen years. Useful life is the period over which the asset is expected to contribute to the Companys future cash flows. A significant change in estimated useful lives could have a material impact on the results of operations. The Company reviews the recoverability of its long-lived assets, including buildings, equipment and other intangible assets, when events or changes in circumstances occur that indicate that the carrying value of the asset may not be recoverable. The assessment of possible impairment is based on the Companys ability to recoverthe carrying value of the asset from the expected future pre-tax cash flows (undiscounted
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and without interest charges) of the related operations. If these cash flows are less than thecarrying value of such asset, an impairment loss is recognized for the difference betweenestimated fair value and carrying value. The measurement of impairment requires management tomake estimates of these cash flows related to long-lived assets as well as other fair valuedeterminations.
The Company has recorded a valuation allowance on deferred tax assets where there is uncertainty as to the ultimate realization of the future tax deduction. Dextran Products has incurred capital losses, which are only deductible against capital gains. It is not certain that Dextran Products will realize capital gains in the future to use these Canadian capital loss deductions.
In 1992, Vet Labs and Sparhawk entered into the Joint Venture for the manufacture and sale of veterinary pharmaceutical products. Vet Labs and Sparhawk each owned 50% of the Joint Venture during its operation. The Joint Venture was governed by the Agreement for the Operation of Veterinary Laboratories, Inc.s Lenexa Facility and Sparhawk Lab of KC as a Joint Venture, dated December 1, 1992, by and among Sparhawk, Chemdex and Vet Labs (the Joint Venture Agreement).
Pursuant to the Joint Venture Agreement, the Joint Venture Policy Committee was responsible for the overall management of the Joint Venture, including the direction and control of the persons designated with the daily management responsibilities of the Joint Venture, and the general supervision of the management and conduct of the affairs of the Joint Venture. The Policy Committee consisted of five members, three of which were selected by Vet Labs and two of which were selected by Sparhawk. Decisions of the Policy Committee required a simple majority vote.
Because the Company controlled the operating, financing and investing decisions of the Joint Venture through Vet Labs control of the Policy Committee, it consolidated the Joint Ventures assets, liabilities, revenue and expenses in the Companys financial statements. The Company has funded the Joint Ventures cumulative losses since 1992 and, accordingly, has recorded 100% of these losses in the consolidated financial statements.
On January 13, 2004, the Company, Chemdex and Vet Labs entered into an Asset Purchase Agreement with Sparhawk. Pursuant to the Asset Purchase Agreement, the Company agreed to sell substantially all of the assets of Vet Labs, including its interest in the Joint Venture, to Sparhawk for $5,500,000 in cash. Effective March 4, 2004, this sale was completed and a gain of $1,859,471 was recognized. Simultaneously with the closing, Chemdex advanced $350,000 to Sparhawk in exchange for an unsecured subordinated promissory note bearing interest at 13% per annum and a warrant to purchase 4% of the equity of Sparhawk. The promissory note is payable in full on March 4, 2009. Interest is payable annually, but can be deferred and added to the principal balance of the promissory note each year at Sparhawks
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discretion. The warrant becomes exercisable on March 5, 2009 and expires at the earlier of payment in full of the promissory note or March 4, 2014. Chemdex also entered into a supply agreement with Sparhawk to supply ferric hydroxide and hydrogenated dextran solution to Sparhawk on an exclusive basis in the United States for 10 years. In connection with the sale, the litigation involving the Joint Venture, Sparhawk Laboratories, Inc. v. Veterinary Laboratories, Inc., et al, Case No. 02CV07426, County of Johnson, State of Kansas, was settled, and a Motion of Approval of Settlement and Stipulation of Dismissal with Prejudice was filed with the Court on March 4, 2004.
Since Sparhawk is thinly capitalized and highly leveraged, the Company has deferred $350,000 of the gain relating to the promissory note receivable from Sparhawk. The Company will monitor the financial position of Sparhawk and will recognize this deferred gain at such time as Sparhawks cash flows from operations are sufficient to fund debt service on a full accrual basis.
No changes in accounting principles or their application have been implemented in the reporting period that would have a material effect on reported income.
In December 2004, the Financial Accounting Standards Board [the FASB] issued FASB Statement No. 123 (Revised 2004), Share-Based Payment [Statement 123(R)"], which is a revision of FASB Statement No. 123, Accounting for Stock-Based Compensation [Statement 123"]. Statement 123(R) supercedes APB Opinion No. 25, Accounting for Stock Issued to Employees and amends FASB Statement No. 95, Statement of Cash Flows. Generally, the approach in Statement 123(R) is similar to the approach described in Statement 123. However, Statement 123(R) requires all share-based payments to employees, including grants of employee stock options, to be recognized in the income statement based on their fair values. Pro forma disclosure is no longer an alternative. Effective February 1, 2003, the Company has adopted the fair value accounting method provided for under Statement 123 to apply recognition provisions to its employee stock options granted, modified or settled after February 1, 2003. Statement 123(R) will have no impact on the consolidated financial statements of the Company.
In November 2004, the FASB issued Statement 151, Inventory Costs, which clarifies that abnormal amounts of idle facility expense, freight, handling costs and wasted materials should be recognized as current-period charges and requires the allocation of fixed production overheads to inventory based on the normal capacity of the production facilities. This guidance is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The Company does not anticipate that this guidance will impact the consolidated financial statements of the Company.
In December 2004, the FASB issued Statement 153, Exchanges of Nonmonetary Assets, an amendment of APB Opinion No. 29, Accounting for Nonmonetary Transactions.
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Statement 153 is based on the principle that exchanges of nonmonetary assets should be measured based on the fair value of the assets exchanged. Statement 153 eliminates the narrow exception for nonmonetary exchanges of similar productive assets and replaces it with a broader exception for exchanges of nonmonetary assets that do not have commercial substance. Statement 153 is effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The provisions of Statement 153 should be applied prospectively. The Company does not anticipate that the application of Statement 153 will have an impact on the consolidated financial statements of the Company.
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The Companys operations consist of manufacturing activities in the United States and Canada. The Companys products are sold in North America, Europe and the Pacific Rim.
While the majority of the sales of Dextran Products, the Companys Canadian operation, are denominated in United States dollars, the majority of its expenses are incurred in Canadian dollars. The majority of the assets and liabilities of Dextran Products are denominated in Canadian dollars prior to the currency translation adjustment necessary for preparation of the consolidated financial statements of the Company contained in this report. When the Canadian dollar rises in value relative to the United States dollar, the carrying value of the assets and liabilities of Dextran Products as stated in United States dollars increases. A rise in the Canadian dollar relative to the United States dollar also results in a decrease in gross margins and net income of Dextran Products. Dextran Products also experiences a foreign exchange gain when the Canadian dollar rises in relation to the United States dollar because it has a net liability exposure to the United States dollar resulting from a United States dollar denominated intercompany loan. Similarly, a decline in the Canadian dollar relative to the United States dollar results in a foreign exchange loss and increased gross margins and net income at Dextran Products.
Management monitors currency fluctuations to ensure that an acceptable margin level at Dextran Products is maintained. Management has the ability, to some extent, to adjust sales prices to maintain an acceptable margin level.
The following table presents information about the Companys financial instruments other than accounts receivable that are sensitive to changes in foreign currency exchange rates. All financial instruments are held for other than trading purposes. The table presents principal cash flows and related weighted average interest rates by expected maturity dates.
Expected Maturity Date |
||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1/31/06 |
1/31/07 |
1/31/08 |
1/31/09 |
1/31/10 |
Thereafter |
Total |
Fair Value |
|||||||||||||||||||||||||||||||||
(US$ Equivalent) | ||||||||||||||||||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||||||||||
Short-term investments: | ||||||||||||||||||||||||||||||||||||||||
Fixed rate ($Cdn) | 1,903,919 | | | | | | 1,903,919 | 1,914,207 | ||||||||||||||||||||||||||||||||
Average interest rate | 2.46 | % | | | | | | 2.45 | % | | ||||||||||||||||||||||||||||||
Marketable securities: | ||||||||||||||||||||||||||||||||||||||||
Fixed rate ($Cdn) | 587,994 | 583,357 | 655,383 | | | | 1,826,735 | 1,706,856 | ||||||||||||||||||||||||||||||||
Average interest rate | 2.66 | % | 2.85 | % | 2.86 | % | | | | 2.79 | % | | ||||||||||||||||||||||||||||
Liabilities: | ||||||||||||||||||||||||||||||||||||||||
Long-term debt: | ||||||||||||||||||||||||||||||||||||||||
Fixed rate ($Cdn) | 156,191 | 153,352 | 5,380 | 5,969 | 6,621 | | 327,513 | 327,513 | ||||||||||||||||||||||||||||||||
Average interest rate | 8.78 | % | 8.81 | % | 10.43 | % | 10.43 | 10.43 | % | | 8.88 | % | | |||||||||||||||||||||||||||
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The Company has interest earning assets consisting of investment grade short-term commercial paper and medium-term fixed income instruments. A significant portion of the Companys debt is at fixed rates. The variable rate debt represents the shareholder loan payable, which is partially offset by the shareholder loan receivable. Both of these financial instruments carry the same interest rate. As such, the Company has no significant risk exposure to changes in interest rates.
The following table presents information about the Companys financial instruments that are sensitive to changes in interest rates. All financial instruments are held for other than trading purposes. The table presents principal cash flows and related weighted average interest rates by expected maturity dates.
Expected Maturity Date |
||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1/31/06 |
1/31/07 |
1/31/08 |
1/31/09 |
1/31/10 |
Thereafter |
Total |
Fair Value |
|||||||||||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||||||||||
Short-term investments: | ||||||||||||||||||||||||||||||||||||||||
Fixed rate ($Cdn) | 1,903,919 | | | | | | 1,903,919 | 1,914,207 | ||||||||||||||||||||||||||||||||
Average interest rate | 2.46 | % | | | | | | 2.45 | % | | ||||||||||||||||||||||||||||||
Marketable securities: | | | | | | | | | ||||||||||||||||||||||||||||||||
Fixed rate ($Cdn) | 587,994 | 583,357 | 655,383 | | | | 1,826,735 | 1,706,856 | ||||||||||||||||||||||||||||||||
Average interest rate | 2.66 | % | 2.85 | % | 2.86 | % | | | | 2.79 | % | | ||||||||||||||||||||||||||||
Notes receivable: | ||||||||||||||||||||||||||||||||||||||||
Variable rate ($US) | 53,498 | 57,376 | 61,536 | 65,997 | 70,782 | 64,184 | 373,374 | 373,374 | ||||||||||||||||||||||||||||||||
Average interest rate | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | | |||||||||||||||||||||||||
Liabilities: | ||||||||||||||||||||||||||||||||||||||||
Long-term debt: | ||||||||||||||||||||||||||||||||||||||||
Fixed rate ($Cdn) | 156,191 | 153,352 | 5,380 | 5,969 | 6,621 | | 327,513 | 318,242 | ||||||||||||||||||||||||||||||||
Average interest rate | 8.78 | % | 8.81 | % | 10.43 | % | 10.43 | % | 10.43 | % | | 8.88 | % | | ||||||||||||||||||||||||||
Variable rate ($US) | 9,105 | 11,266 | 12,082 | 12,958 | 13,898 | 621,994 | 681,305 | 681,305 | ||||||||||||||||||||||||||||||||
Average interest rate | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | 7.25 | % | |
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The Company completed an evaluation as of the end of the period covered by this report under the supervision and with the participation of management, including its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of its disclosure controls and procedures pursuant to Rule 13a-14 of the Securities Exchange Act of 1934. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Companys disclosure controls and procedures are effective in alerting them on a timely basis of material information relating to the Company (including its consolidated subsidiaries) required to be included in its periodic Securities and Exchange Commission filings.
There have been no changes in the Companys internal control over financial reporting identified in connection with the evaluation discussed above that occurred in the Companys last fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Companys internal control over financial reporting.
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(a) | Exhibits |
3.1 | Memorandum of Association of Polydex Pharmaceuticals Limited, as amended to date (filed as Exhibit 3.1 to the Annual Report on Form 10-K filed April 30, 1997, and incorporated herein by reference) |
3.2 | Articles of Association of Polydex Pharmaceuticals Limited, as amended to date (filed as Exhibit 3.2 to the Quarterly Report on Form 10-Q filed September 13, 1999, and incorporated herein by reference) |
31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 |
31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 |
32.1 | Certification of Chief Executive Officer pursuant to 19 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
32.2 | Certification of Chief Financial Officer pursuant to 19 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
(b) | Reports on Form 8-K |
None. |
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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.
Date: March 21, 2006
POLYDEX PHARMACEUTICALS LIMITED (Registrant) | |
By /s/ George G. Usher
George G. Usher, Chairman, President and Chief Executive Officer (Principal Executive Officer) | |
By /s/ Sharon L. Wardlaw
Sharon L. Wardlaw, Treasurer, Secretary and Chief Financial and Accounting Officer (Principal Financial Officer) |
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31.1 | Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 |
31.2 | Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 |
32.1 | Certification of Chief Executive Officer pursuant to 19 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
32.2 | Certification of Chief Financial Officer pursuant to 19 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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