SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

 

FORM 10-Q

 

 

POLYDEX PHARMACEUTICALS LIMITED

(Exact Name of Registrant as Specified in Its Charter)

 

 

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   ý                  No   o

 

Indicate by check whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2).  Yes   o                  No   ý

 

Indicate the number of shares outstanding of each of the issuer’s classes of common shares, as of the latest practicable date.

 

 

 

POLYDEX PHARMACEUTICALS LIMITED

 

TABLE OF CONTENTS

 

PART I	FINANCIAL INFORMATION	3
Item 1	CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)	3
	Consolidated Balance Sheets October 31, 2003 and January 31, 2003	3
	Consolidated Statements of Operations and Comprehensive Income Three months ended October 31, 2003 and October 31, 2002 Nine months ended October 31, 2003 and October 31, 2002	5
	Consolidated Statements of Shareholders’ Equity Nine months ended October 31, 2003 and October 31, 2002	6
	Consolidated Statements of Cash Flows Nine months ended October 31, 2003 and October 31, 2002	7
	Segmented Information Three months ended October 31, 2003 and October 31, 2002 Nine months ended October 31, 2003 and October 31, 2002	8
	Notes to Consolidated Financial Statements (Unaudited)	9
Item 2	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	15
Item 3	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	29
Item 4	CONTROLS AND PROCEDURES	31
PART II	OTHER INFORMATION	32
Item 6	EXHIBITS AND REPORTS ON FORM 8-K	32
	Signatures	33

 

2

 

PART I

FINANCIAL INFORMATION

 

Item 1.  Consolidated Financial Statements (unaudited).

 

POLYDEX PHARMACEUTICALS LIMITED

 

Consolidated Balance Sheets

(Expressed in United States dollars)

 

		(Unaudited)
		October 31 2003			January 31 2003
Assets
Current assets:
Cash		$	434,469		$	280,748
Trade accounts receivable		988,723			1,351,515
Inventories:
Finished goods		2,061,235			1,678,250
Work in process		167,234			59,478
Raw materials		675,297			528,235
Inventories		2,903,766			2,265,963
Prepaid expenses and other current assets		102,590			80,324
		4,429,548			3,978,550
Property, plant and equipment:
Land and buildings		3,593,752			3,346,727
Machinery and equipment		8,513,377			7,564,097
		12,107,129			10,910,824
Less accumulated depreciation		(7,228,493		)	(6,245,015		)
Property, plant and equipment, net		4,878,636			4,665,809
Patents and intangible assets, net		149,624			87,062
Due from shareholder		923,719			981,153
		$	10,381,527		$	9,712,574

 

3

 

		(Unaudited)
		October 31 2003			January 31 2003
Liabilities and Shareholders’ Equity
Current liabilities:
Bank indebtedness		$	202,657		$	—
Accounts payable		1,310,885			1,205,383
Accrued liabilities		609,432			423,059
Due to Sparhawk Laboratories, Inc.		101,453			101,453
Customer deposits received		40,663			137,343
Income taxes payable		53,422			33,010
Current portion of long-term debt		500,154			439,059
Current portion of capital lease obligations		134,941			110,387
		2,953,607			2,449,694
Long-term debt		137,000			186,776
Capital lease obligations		264,524			319,602
Due to shareholder		683,569			682,225
Deferred income taxes		211,184			49,750
		1,296,277			1,238,353
Total liabilities		4,249,884			3,688,047
Shareholders’ equity:
Capital stock
Authorized:
100,000 Class A preferred shares, par value $0.10 per share
899,400 Class B preferred shares, par value $0.0167 per share
10,000,000 common shares, par value $0.0167 per share
Issued and outstanding:
899,400 Class B preferred shares		15,010			15,010
3,027,796 common shares (January 1, 2003 - 3,027,777)		50,434			50,434
Contributed surplus		23,224,128			23,224,128
Deficit		(17,006,070		)	(16,278,269		)
Accumulated other comprehensive loss		(151,859		)	(986,776		)
		6,131,643			6,024,527
		$	10,381,527		$	9,712,574

 

See accompanying notes.

 

4

 

POLYDEX PHARMACEUTICALS LIMITED

Consolidated Statements of Operations and Comprehensive Income (Unaudited)

(Expressed in United States dollars)

 

 

		Three Months Ended October 31 2003			Three Months Ended October 31 2002			Nine Months Ended October 31 2003			Nine Months Ended October 31 2002
Sales		$	3,681,305		$	3,455,665		$	10,036,192		$	9,427,675
Cost of products sold		2,817,652			2,696,798			7,709,246			6,998,366
		863,653			758,867			2,326,946			2,429,309
Expenses:
General and administrative		495,920			416,644			1,459,777			1,204,145
Depreciation		151,863			137,342			442,921			410,973
Research and development		23,702			29,358			45,474			141,900
Interest expense		31,960			36,355			101,536			116,452
Selling and promotion		30,173			41,183			112,571			106,384
Foreign exchange (gain) loss		196,388			7,894			420,771			35,968
Amortization		6,688			5,546			17,779			16,637
		936,694			674,322			2,600,829			2,032,459
Income (loss) from operations		(73,041		)	84,545			(273,883		)	396,850
Other income (loss):
Other income (expense) (note 5)		(76,099		)	2,363			(270,794		)	7,227
Income (loss) before provision for income taxes		(149,140		)	86,908			(544,677		)	404,077
Provision for income taxes		52,286			98,420			183,124			306,427
Net income (loss) for the period		(201,426		)	(11,512		)	(727,801		)	97,650
Currency translation adjustment for the period		347,781			64,782			834,917			99,617
Comprehensive income for the period		$	146,355		$	53,270		$	107,116		$	197,267
Per share information:
Earnings (loss) per common share for the period:
Basic		$	(0.07	)	$	—		$	(0.24	)	$	0.03
Diluted		$	(0.07	)	$	—		$	(0.24	)	$	0.03
Weighted average number of common shares outstanding for the period		3,027,796			3,027,777			3,027,796			3,027,777

 

See accompanying notes.

 

5

 

POLYDEX PHARMACEUTICALS LIMITED

Consolidated Statements of Shareholders’ Equity (Unaudited)

(Expressed in United States dollars)

 

 

		Nine Months Ended October 31 2003			Nine Months Ended October 31 2002
Preferred Shares:
Balance, beginning and end of period		$	15,010		$	15,010
Common Shares:
Balance, beginning and end of period		$	50,434		$	50,434
Contributed Surplus:
Balance, beginning and end of period		$	23,224,128		$	23,224,128
Deficit:
Balance, beginning of period		$	(16,278,269	)	$	(15,604,528	)
Net income (loss) for the period		(727,801		)	97,650
Balance, end of period		$	(17,006,070	)	$	(15,506,878	)
Accumulated Other Comprehensive Loss:
Balance, beginning of period		$	(986,776	)	$	(1,199,627	)
Currency translation adjustment for the period		834,917			99,617
Balance, end of period		$	(151,859	)	$	(1,100,010	)

 

See accompanying notes.

 

6

 

POLYDEX PHARMACEUTICALS LIMITED

Consolidated Statements of Cash Flows (Unaudited)

(Expressed in United States dollars)

 

		Nine Months Ended October 31 2003			Nine Months Ended October 31 2002
Cash provided by (used in):
Operating activities:
Net income (loss) for the period		$	(727,801	)	$	97,650
Add (deduct) items not affecting cash:
Depreciation and amortization		460,700			427,610
Imputed interest on long-term debt		18,802			9,422
Deferred tax provision		146,701			191,794
Net change in non-cash working capital balances related to operations		65,680			61,734
		(35,918		)	788,210
Investing activities:
Additions to property, plant and equipment, patents and intangible assets		(163,862		)	(260,788		)
Decrease in due from shareholder		57,434			35,830
Acquisition of minority interest (note 3)		(5,860		)	—
Advance to Sparhawk Laboratories, Inc.		—			(5,023		)
		(112,288		)	(229,981		)
Financing activities:
Repayment of long-term debt		(135,295		)	(228,262		)
Repayment of capital lease obligations		(89,628		)	(73,496		)
Increase in due to shareholder		1,344			470
Increase (decrease) in bank indebtedness		202,657			(134,423		)
		(20,922		)	(435,711		)
Effect of exchange rate changes on cash		322,848			23,844
Increase in cash position		153,721			146,362
Cash, beginning of period		280,748			123,418
Cash, end of period		$	434,469		$	269,780

 

See accompanying notes.

 

7

 

POLYDEX PHARMACEUTICALS LIMITED

Segmented Information (Unaudited)

(Expressed in United States dollars)

 

All operations are carried out through Dextran Products Limited (“Dextran”) in Canada and through Chemdex, Inc. (“Chemdex”) in the United States.  The operations of Chemdex represent the veterinary products business and the operations are carried out through its wholly-owned subsidiary, Veterinary Laboratories, Inc. (“Vet Labs”).  Vet Labs carries on its business through a Joint Venture with Sparhawk Laboratories, Inc.  Each of Dextran and Chemdex operates as a strategic business unit offering different products.  Each subsidiary comprises 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 these products.

 

		Three Months Ended October 31 2003			Three Months Ended October 31 2002			Nine Months Ended October 31 2003			Nine Months Ended October 31 2002
Sales:
Dextran		$	1,394,439		$	1,226,725		$	4,026,384		$	3,706,211
Less:  intercompany sales elimination		89,888			42,606			264,628			342,087
		1,304,551			1,184,119			3,761,756			3,364,124
Chemdex		2,376,754			2,271,546			6,274,436			6,063,551
Total consolidated sales		$	3,681,305		$	3,455,665		$	10,036,192		$	9,427,675
Income (loss) before provision for income taxes:
Dextran		$	(37,368	)	$	188,875		$	111,908		$	708,612
Chemdex		47,819			41,852			(179,686		)	141,969
Total pre-tax income (loss) from segments		10,451			230,727			(67,778		)	850,581
Less:  Unallocated corporate expenses		159,591			143,819			476,899			446,504
Total consolidated pre-tax income (loss)		$	(149,140	)	$	86,908		$	(544,677	)	$	404,077
Total Revenue by significant customer:
Customer A		$	583,844		$	488,291		$	1,423,231		$	1,197,532
Customer B		628,856			416,440			1,206,811			1,338,773
Customer C		227,713			395,352			911,906			1,082,931
Sales Revenue by product group:
Bulk Dextran and derivatives		$	1,304,551		$	1,184,119		$	3,761,756		$	3,364,124
Sterile injectible veterinary products		1,458,522			1,155,230			3,625,585			3,358,698
Oral and topical veterinary products		918,232			1,116,316			2,648,851			2,704,853
Total consolidated sales		$	3,681,305		$	3,455,665		$	10,036,192		$	9,427,675

 

 

		October 31, 2003			January 31, 2003
Assets:
Dextran		$	5,399,896		$	4,918,829
Chemdex		3,827,697			3,569,090
Total assets from segments		9,227,593			8,487,919
Corporate assets		1,153,934			1,224,655
Total consolidated assets		$	10,381,527		$	9,712,574

 

See accompanying notes.

 

8

 

1.             Basis of Presentation:

 

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 2003 Annual Report on Form 10-K for the fiscal year ended January 31, 2003 as filed by Polydex Pharmaceuticals Limited (the “Company”) with the Securities and Exchange Commission.  The unaudited interim consolidated financial statements as of October 31, 2003 and 2002 include all normal recurring adjustments which management considers necessary for a fair presentation.  The results of operations for the interim periods 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.

 

2.                                      Significant Accounting Policies:

 

Basis of consolidation

 

The 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 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 consolidated financial statements and the reported amounts of revenue and expenses during the reporting period.  Actual results could differ from these estimates.

 

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 labour and overhead expenses.

 

Long-lived assets

 

Property, plant and equipment are recorded at cost.  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

 

9

 

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 Company’s 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 Company’s 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

 

All revenue is from sales of bulk and finished dosage 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.

 

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 classified as cost of goods sold.

 

Research and development

 

Research and development costs are expensed as incurred and are stated net of investment tax credits earned.

 

10

 

Foreign currency translation

 

The functional currency of the Company’s 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 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 other comprehensive loss within shareholders’ equity.

 

Stock options

 

The Company has elected to follow Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” [“APB 25”] and related interpretations in accounting for its employee stock options rather than the alternative fair value accounting provided for under Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” [“SFAS 123”].  Under APB 25, because the exercise price of the Company’s employee stock options equals the market price of the underlying stock on the date of grant, no compensation expense is recognized.

 

Earnings (loss) per common share

 

Basic earnings (loss) per common share are computed using the weighted average number of shares outstanding of 3,027,796 at October 31, 2003 (2002 - 3,027,777).  Diluted earnings (loss) per common share are computed using the weighted average number of 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 nil at October 31, 2003 and October 31, 2002, respectively, were used in the calculation of diluted earnings per common share.  Options to purchase 431,550 and 419,550 common shares at October 31, 2003 and October 31, 2002, respectively, were not included in the computation of diluted earnings per common share because their effect was anti-dilutive.

 

3.             Acquisition of Minority Interest:

 

On September 19, 2003, Chemdex, Inc. (“Chemdex”) redeemed all of the common shares held by the 10% minority interest shareholder, which results in the Company controlling 100% of the issued and outstanding shares of Chemdex.  The redemption amount was $146,500, which is to be paid in twenty-five equal monthly installments of $5,860, which commenced on September 19, 2003.  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 $134,602, which has been recorded in long-term debt. The Company has recorded this acquisition as a step purchase and has allocated the purchase price based on fair values of the assets as follows:

 

Land and building		$	43,549
Equipment		10,712
Patents and intangible assets		80,341
Purchase price		$	134,602

 

11

 

4.             Stock-based Employee Compensation:

 

The Company maintains an incentive share option plan for management personnel which provides 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 ranging from two to five years and vest immediately.  At October 31, 2003, the Company had 431,550 options outstanding at exercise prices ranging from $2.50 to $6.80 and a weighted average exercise price of $3.88.  The options, which are immediately exercisable and expire on dates between January 11, 2004 and January 31, 2008, entitle the holder of an option to acquire one common share of the Company.

 

The Company uses the intrinsic value method in accordance with APB Opinion No. 25 to account for awards of stock-based employee compensation.  No stock-based employee compensation expense was recorded during the period from February 1, 2003 to October 31, 2003, because there were no options granted during this period.  Similarly, no stock-based employee compensation expense was recorded during the period from February 1, 2002 to October 31, 2002, because there were no options granted during this period.  There would be no changes to reported net income (loss), basic earnings (loss) per share or diluted earnings (loss) per share if the Company were to use the fair value method to account for stock options granted under the provisions of SFAS 148.

 

5.             The Vet Labs – Sparhawk Joint Venture:

 

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 own 50% of the Joint Venture.  The Joint Venture is governed by the Agreement for the Operation of Veterinary Laboratories, Inc.’s Lenexa Facility and Sparhawk Lab of K.C. 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 (the “Policy Committee”) is 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 consists of five members, three of which are selected by Vet Labs and two of which are selected by Sparhawk.  Decisions of the Policy Committee require a simple majority vote.

 

Because the Company controls the operating, financing and investing decisions of the Joint Venture through Vet Labs’ control of the Policy Committee, it consolidates the Joint Venture’s assets, liabilities, revenue and expenses in the Company’s financial statements.  The Company has funded the Joint Venture’s cumulative losses since 1992 and, accordingly, has recorded 100% of these losses in the consolidated financial statements.  At a future point in time, if the cumulative deficit of the Joint Venture is eliminated, a minority interest will be recorded.

 

12

 

The Joint Venture Agreement contained a stated termination date of December 1, 2002.  In anticipation of the Joint Venture’s termination, on November 4, 2002, Sparhawk filed a petition in the District Court of Johnson County, Kansas (the “Court”), against Vet Labs, Chemdex and the Company seeking, among other things, judicial supervision during the winding up of the Joint Venture.

 

On December 16, 2002, each of the parties to the Joint Venture Agreement agreed to the appointment by the Court of a Receiver, whose duties include (i) the supervision of the wind-up of the Joint Venture, including the submission to the Court of a proposed plan for the disposal or distribution of the property of the Joint Venture and the allocation of the Joint Venture’s assets and liabilities among the parties, and (ii) the oversight of the operations of the Joint Venture during the winding-up period in order to keep and preserve the assets thereof.  Legal and receiver costs of $276,617 for the nine-month period ended October 31, 2003 are included in other income (expense) on the consolidated statements of operations.

 

Sparhawk had an option to purchase 40% of the assets held by Vet Labs.  The purchase price would be equal to 40% of the fair market value of the land, building and equipment owned by Vet Labs plus $1,000,000.  The land and building have been appraised at a valuation of $2,450,000 as of November 15, 2002.  The equipment has been appraised at a valuation of $230,900 as of January 22, 2003.  Sparhawk notified the Company of its intention to exercise this Option in October 2002, but has not yet delivered the purchase price.  The existence and alleged exercise of the Option is one of the outstanding litigation matters.  The Company cannot at this time estimate the likelihood of Sparhawk consummating the exercise of the Option and delivering the purchase price.

 

Subject to the exercise of the Option, upon winding up of the Joint Venture, all assets used in the Joint Venture operations that were owned by the respective members of the Joint Venture prior to the formation of the Joint Venture are expected to be returned to the respective owner.  There are no assets of Sparhawk included in the consolidated financial statements of the Company.  Sparhawk does own rights to certain generic products currently produced by the Joint Venture, all of which belong to the liquids product line, which would be returned to Sparhawk upon wind-up.  Sales of these products amounted to approximately $1,065,000 in fiscal 2003, and $691,000 in the nine month peroid ended October 31, 2003.  Rights to several of the products currently produced by the Joint Venture, including iron dextran, are owned by the Company and are expected to be returned to the Company, although ownership of certain of these product rights may be disputed by Sparhawk.  Sales of these products amounted to approximately $5,112,000 in fiscal 2003 and $3,515,000 for the nine month period ended October 31, 2003.  The Company plans to continue production of the products to which Vet Labs owns the rights after the winding up of the Joint Venture.  However, no assurance can be given that sales of these products by the Company after the dissolution of the Joint Venture will be consistent with those achieved by the Joint Venture.

 

Assets purchased by the Joint Venture and rights to products developed by the Joint Venture are expected to be distributed to the members of the Joint Venture as part of the winding-up process.  Assets and liabilities owned by the Joint Venture are currently included in the Company’s financial

 

13

 

statements.  Depending upon the allocation of the Joint Venture assets upon dissolution, the Company may not receive ownership of the rights to products developed by the Joint Venture.  Sales of these products amounted to approximately $2,034,000 in fiscal 2003 and $2,069,000 during the nine-month period ended October 31, 2003.

 

It is possible that a negotiated settlement with Sparhawk will be reached that would prevent the allocation of Joint Venture assets by the Court.  Such a settlement would likely result in one of the parties purchasing the other party’s interest in the Joint Venture at an agreed upon price.  Because the Joint Venture operations are currently fully consolidated in the Company’s financial statements, the Company’s results of operations would not be significantly impacted if the Company were to purchase Sparhawk’s interest in the Joint Venture, other than with respect to the cost of the consideration given to Sparhawk in the transaction.

 

If such a settlement resulted in Vet Labs selling its interest in the Joint Venture to Sparhawk, the Company’s financial statements would show a significant decline in revenues and possibly a small decline in income before income taxes.  The sale proceeds in excess of the carrying value of the Joint Venture assets and liabilities would be recorded as a gain.  At October 31, 2003, the carrying value of the Joint Venture assets and liabilities is $2,441,124 and $1,054,590, respectively.  During the year ended January 31, 2003, sales of the Joint Venture operations totaled $8,209,947 and net income before income taxes was $31,520.  During the nine month period ended October 31, 2003, sales of the Joint Venture amounted to $6,274,436, and net income before taxes totaled $184,370.  A sale of Vet Labs’ interest in the Joint Venture may have a material adverse effect on the Company’s business and results of operations.

 

The Company does not expect that a sale of Vet Labs’ Joint Venture interest would have an adverse effect on the operations of Dextran Products Limited (“Dextran Products”), the subsidiary through which the Company carries out its Canadian operations, because sales by Dextran Products to Chemdex and the Joint Venture are not significant.

 

6.             Recent Accounting Pronouncements:

 

In May 2003, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 150, “Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity”.  SFAS No. 150 establishes standards for the measurement and classification of certain financial instruments with characteristics of both liabilities and equity.  SFAS No. 150 is effective for financial instruments entered into or modified after May 31, 2003.  Effective June 1, 2003, the Company accounts for financial instruments in accordance with SFAS No. 150.  The adoption of this standard had no impact on the consolidated financial statements.

 

In April 2003, the FASB issued SFAS No. 149, “Amendment of Statement 133 on Derivative Instruments and Hedging Activities.”  SFAS 149 is intended to result in more consistent reporting of contracts as either freestanding derivative instruments subject to Statement 133 in their entirety, or as hybrid instruments with debt host contracts and embedded derivative features.  The Statement is effective for contracts entered into or modified after June 30, 2003, and hedging relationships designated after June 30, 2003.  Effective July 1, 2003, the Company accounts for any derivative instruments and hedging activities in accordance with SFAS 149.  The adoption of this amendment had no impact on the consolidated financial statements.

 

In January 2003, the FASB issued FASB Interpretation (“FIN”) No. 46, “Consolidation of Variable Interest Entities an interpretation of ARB No. 51” (the “Interpretation”). The Interpretation introduces a new consolidation model - - the variable interests model - which determines control (and consolidation) based on potential variability in gains and losses of the entity being evaluated for consolidation. The Interpretation requires disclosure of certain information in financial statements initially issued after January 31, 2003, if it is reasonably possible that an enterprise will consolidate or disclose information about a variable interest entity when Interpretation 46 becomes effective. The Company will account for any variable interest entities in accordance with FIN 46. The adoption of this Interpretation had no impact on the Company’s consolidated financial statements.

 

In December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation - Transition and Disclosure.”  SFAS No. 148 amends SFAS No. 123, “Accounting for Stock-Based Compensation,” to provide alternative methods of transition to SFAS No. 123’s fair value method of accounting for stock-based employee compensation.  SFAS No. 148 also amends the disclosure provisions of SFAS No. 123 and Accounting Principles Board Opinion (“APB”) No. 28, “Interim Financial Reporting,” to require disclosure in the summary of significant accounting policies of the effects of an entity’s accounting policy with respect to stock-based employee compensation on reported net income and earnings per share in annual and interim financial statements.  SFAS No. 148 is effective for fiscal years ending after December 15, 2002.  The Company has elected to continue to use the intrinsic value based method under the provisions of APB No. 25, “Accounting for Stock Issued to Employees,” and has adopted the required disclosures of SFAS No. 148 effective January 31, 2003.

 

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Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The fiscal year of Polydex Pharmaceuticals Limited (the “Company”) ends on January 31 of each year.  Therefore fiscal year 2004 refers to the Company’s fiscal year ended January 31, 2004.  The following discussion should be read in conjunction with the October 31, 2003 consolidated financial statements and notes thereto included elsewhere in this report.  Operating results for the third quarter ended October 31, 2003 are not necessarily indicative of the results that may be expected for the fiscal year ended January 31, 2004.  For further information, refer to the consolidated financial statements and footnotes thereto included in the Company’s annual report on Form 10-K for the fiscal year ended January 31, 2003.  All amounts are in United States dollars unless otherwise denoted.

 

Results of Operations

 

The operations of the Company are carried on through Dextran Products Limited (“Dextran Products”) in Canada and through Chemdex, Inc. (“Chemdex”) in the United States.  The operations of Chemdex are carried on through its wholly-owned subsidiary, Veterinary Laboratories, Inc. (“Vet Labs”).  Each of Dextran Products and Chemdex operates as a strategic business unit.  Dextran Products 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 these products.

 

Net loss for the third quarter ended October 31, 2003 was $201,426, or $0.07 per share, as compared to a net loss of $11,512, or less than $0.01 per share, for the quarter ended October 31, 2002.  This decline is primarily due to foreign exchange losses at Dextran Products, legal and receiver fees at Chemdex and increased corporate administrative costs, including insurance. This foreign exchange loss at Dextran Products is due to an increase in the value of the Canadian dollar relative to the value of the U.S. dollar.  Dextran Products has a significant net asset exposure to the U.S. dollar because the majority of its accounts receivable balance and significant intercompany receivables are denominated in U.S. dollars, while the majority of its liabilities and expenses are in Canadian dollars.  The legal and receiver fees at Chemdex are a result of the winding up of the Vet Labs – Sparhawk Joint Venture (the “Joint Venture”), as described below in “The Vet Labs – Sparhawk Joint Venture.”

 

During the third quarter ended October 31, 2003, the Company had a loss from operations of $73,041, as compared to income from operations of $84,545 for the third quarter of fiscal 2003.  This decline from operations is primarily due to the foreign exchange loss at Dextran Products and increased corporate administrative costs which are partially offset by an increase in margins at Chemdex as compared to the same quarter last year.

 

Sales volume for the third quarter of fiscal 2004 increased from $3,455,665 to $3,681,305, representing an increase of $225,640 or 7%, as compared to the third quarter of fiscal 2003.  Sales to

 

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third parties by Dextran Products increased by $120,432 or 10% as compared to the same quarter in fiscal 2003.  This increase in sales at Dextran Products is primarily due to increased product demand.  Sales by Chemdex during the third quarter of fiscal 2004 increased by $105,208 or 5% as compared to the same quarter in fiscal 2003.  This increase at Chemdex is primarily due to the introduction of a new contract fill product and a new injectable product.

 

Overall, the Company’s gross margin increased from 22% in the third quarter of fiscal 2003 to 24% in the third quarter of fiscal 2004.  Dextran Products’ gross margin decreased from 37% in the third quarter of fiscal 2003 to 35% during the third quarter of fiscal 2004.  Chemdex’ gross margin increased from 13% in the third quarter of fiscal 2003 to 16% in the third quarter of fiscal 2004.

 

The margin decrease at Dextran Products is primarily a result of a large increase in the value of the Canadian dollar in relation to the U.S. dollar.  The majority of the sales at Dextran Products are denominated in U.S. dollars, but all costs are incurred in Canadian dollars.

 

The margin increase at Chemdex is a result of a product mix variance, as Chemdex experienced increased sales in the injectables product line, its highest margin product line, and particularly in iron dextran, as compared to the third quarter of fiscal 2003.

 

General and administrative expenses in the third quarter of fiscal 2004 were $495,920, representing an increase of $79,276 or 19%, from the third quarter of fiscal 2003.  This increase is due primarily to increased insurance and other corporate administrative costs and the hiring of a new general manager at Chemdex in the fourth quarter of fiscal 2003 to oversee the Joint Venture operations and management on behalf of the Company.  Selling and promotional expenses in the third quarter of fiscal 2004 were generally consistent with the same period in fiscal 2003.

 

Interest expense in the third quarter of fiscal 2004 was $31,960, representing a decrease of $4,395, or 12%, as compared to the third quarter in fiscal 2003, due to the repayment of long-term debt and capital lease obligations.  Depreciation and amortization in the third quarter of fiscal 2004 was $158,551, representing an increase of $15,663, or 11%, from the third quarter of fiscal 2003 primarily due to the installation of new equipment at Dextran Products.

 

Other expenses in the third quarter of fiscal 2004 consist of $77,927 of legal and receiver fees relating to the winding up of the Joint Venture.  The Company did not incur similar expenses during the same period in fiscal 2003.

 

Due to continued direct funding of research and development expenses by third party public and/or private sector groups, the Company’s research and development costs in the third quarter of fiscal 2004 decreased by $5,656, or 19%, to $23,702 as compared to the third quarter of fiscal 2003.  Funding from existing third-party sources for existing research and development projects is expected to continue at historic levels for the foreseeable future.  The Company’s research and development expenditures are expected to increase over the remainder of the year due to additional development activities the Company expects to perform and fund outside of its partnership relationships.

 

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Research and development with respect to the Company’s cellulose sulphate product as a contraceptive gel with antiviral capabilities is being conducted with the assistance and financial support of the Contraceptive Research and Development Program, Consortium for Industrial Collaboration in Contraceptive Research and Global Microbicide Program (collectively, “CONRAD”).  CONRAD provides direct financial assistance in support of, and/or actually conducts specific research studies involving the cellulose sulphate product in conjunction with, various public health-oriented entities.  In exchange for this research assistance, the Company makes its intellectual property, namely patent rights and know-how, available for use in the preparation, clinical evaluation and development of the product.  The Company has no commitments to repay the funding or to purchase the results of the research.

 

At the present time the following four Safety Studies are underway and further studies are in the planning stages:

 

•                  A Phase I Expanded Safety Study is underway in collaboration with the World Health Organization in Uganda, Nigeria and India.  This study will involve 180 women in two treatment groups and two cohorts.  The final report on this study is expected during the fourth quarter of fiscal 2004;

 

•                  A Safety Study in HIV-Infected women is being carried out in collaboration with the HIV Prevention Trials Network of the National Institute of Allergy and Infectious Diseases at four sites in the United States.  The study will involve 96 women and 48 male partners.  Although recruitment has taken longer than expected, the study is expected to be completed during the fourth quarter of fiscal 2004;

 

•                  An Expanded Safety Study at three sites in the United States involves 60 healthy women and is expected to be completed by the fourth quarter of fiscal 2004; and

 

•                  A Safety Study in Cameroon is being carried out in collaboration with Family Health International.  The final report is expected by the fourth quarter of fiscal 2004.

 

Research and development relating to the Company’s cystic fibrosis product, Usherdex (now identified as DCF 987), is being conducted and funded directly by BCY Lifesciences Inc. (“BCY”) pursuant to a license agreement.  BCY has identified DCF 987 as its lead drug candidate and has completed the Phase II human clinical trial to assess the efficacy of DCF 987.  The results of this clinical trial were positive with DCF 987 demonstrating a strong safety profile and data suggesting positive improvements in lung function and a reduction of bacterial load.  BCY was also granted a patent entitled “Use of Dextran and Other Polysaccharides to Improve Mucus Clearance” by the European Patent Office.  The Company will receive royalty payments from BCY based upon sales and other revenues upon approval of any developed product pursuant to its license agreement with BCY.

 

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Liquidity and Capital Resources

 

In the third quarter of fiscal 2004, the Company had negative cash flow from operations of $232,090, compared to positive cash flow of $267,813 in the third quarter of fiscal 2003.  This decrease of $499,903, or 187%, is primarily attributable to losses during the quarter and increases in receivables and inventory.

 

At October 31, 2003, the Company had trade accounts receivable of $988,723 compared to $1,351,515 at January 31, 2003 and $765,675 at July 31, 2003.  The increase in trade accounts receivable during the third quarter of fiscal 2004 was primarily due to increased sales at Chemdex during the quarter and timing of collections at Dextran Products.

 

At October 31, 2003, the Company had inventory valued at $2,903,766 compared to $2,265,963 at January 31, 2003 and $2,738,753 at July 31, 2003. The increase in inventory at Chemdex is in anticipation of fourth quarter sales and stocking of new products.

 

The Company had accounts payable of $1,310,885 at October 31, 2003 as compared to $1,215,734 at July 31, 2003 and $1,205,383 at January 31, 2003.  This increase in accounts payable is due to the increase in inventory at Chemdex.

 

The Company had customer deposits received of $40,663 at October 31, 2003 as compared to $110,687 at July 31, 2003 and $137,343 at January 31, 2003.  The change in the customer deposits received balance is due to timing of collections from customers.

 

The Company experienced no significant changes in financing or investing activities and made no significant capital expenditures during the third quarter of 2004.

 

The Company experienced a currency translation adjustment gain of $347,781 during the third quarter of fiscal 2004 as compared to a gain of $64,782 during the third quarter of fiscal 2003.  Dextran Products’ functional currency is the Canadian dollar.  This currency translation adjustment is entirely attributable to the translation of Dextran Products financial statements to U.S. dollars.  The large gain is due to a significant strengthening of the Canadian dollar against the U.S. dollar.

 

Dextran Products has a CDN$1,250,000 (US$938,000) line of credit, of which $202,657 was utilized at October 31, 2003.  The Joint Venture has a $175,000 line of credit to fund operations, none of which was utilized at October 31, 2003.  There have been no new capital lease obligations during the third quarter of fiscal 2004.  All long-term debt is due in the next two years, while capital lease obligations are due over the next four years.

 

On September 19, 2003, Chemdex redeemed all of the common shares held by the 10% minority interest shareholder, which results in the Company controlling 100% of the issued and outstanding shares of Chemdex.  The redemption amount was $146,500, which is to be paid in twenty-five equal monthly installments of $5,860, which commenced on September 19, 2003.  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 $134,602, which has been recorded in long-term debt. The

 

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Company has recorded this acquisition as a step purchase and accordingly allocated the fair value increment to the respective assets acquired.

 

Management expects the primary source of its future capital needs to be a combination of Company earnings and borrowings.  The Company, at present, does not have any material commitments for capital expenditures.

 

The Company believes that based upon current levels of revenues and spending, and taking into account the Joint Venture litigation, its existing working capital resources will be sufficient to support continuing operations for at least the next twelve months.

 

No changes in accounting principles or their application have been implemented in the reporting period that would have a material effect on reported income.  Changes in the relative values of the Canadian dollar and the U.S. dollar occur from time to time and may, in certain instances, materially affect the Company’s 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.

 

The Vet Labs – Sparhawk Joint Venture

 

In 1992, Vet Labs and Sparhawk Laboratories, Inc. (“Sparhawk”) entered into the Joint Venture for the manufacture and sale of veterinary pharmaceutical products.  Vet Labs and Sparhawk each own 50% of the Joint Venture.  The Joint Venture is governed by the Agreement for the Operation of Veterinary Laboratories, Inc.’s Lenexa Facility and Sparhawk Lab of K.C. 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 (the “Policy Committee”) is 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 consists of five members, three of which are selected by Vet Labs and two of which are selected by Sparhawk.  Decisions of the Policy Committee require a simple majority vote.

 

Because the Company controls the operating, financing and investing decisions of the Joint Venture through Vet Labs’ control of the Policy Committee, it consolidates the Joint Venture’s assets, liabilities, revenue and expenses in the Company’s financial statements.  The Company has funded the Joint Venture’s cumulative losses since 1992 and, accordingly, has recorded 100% of these losses in the consolidated financial statements.  At a future point in time, if the cumulative deficit of the Joint Venture is eliminated, a minority interest will be recorded.

 

The Joint Venture Agreement contained a stated termination date of December 1, 2002.  In

 

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anticipation of the Joint Venture’s termination, on November 4, 2002, Sparhawk filed a petition in the District Court of Johnson County, Kansas (the “Court”), against Vet Labs, Chemdex and the Company seeking, among other things, judicial supervision during the winding up of the Joint Venture.

 

On December 16, 2002, each of the parties to the Joint Venture Agreement agreed to the appointment by the Court of a Receiver, whose duties include (i) the supervision of the wind-up of the Joint Venture, including the submission to the Court of a proposed plan for the disposal or distribution of the property of the Joint Venture and the allocation of the Joint Venture’s assets and liabilities among the parties, and (ii) the oversight of the operations of the Joint Venture during the winding-up period in order to keep and preserve the assets thereof.  Legal and receiver costs of $276,617 for the nine-month period ended October 31, 2003 are included in other income (expense) on the consolidated statements of operations.

 

Sparhawk had an option to purchase 40% of the assets held by Vet Labs.  The purchase price would be equal to 40% of the fair market value of the land, building and equipment owned by Vet Labs plus $1,000,000.  The land and building have been appraised at a valuation of $2,450,000 as of November 15, 2002.  The equipment has been appraised at a valuation of $230,900 as of January 22, 2003.  Sparhawk notified the Company of its intention to exercise this Option in October 2002, but has not yet delivered the purchase price.  The existence and alleged exercise of the Option is one of the outstanding litigation matters.  The Company cannot at this time estimate the likelihood of Sparhawk consummating the exercise of the Option and delivering the purchase price.

 

Subject to the exercise of the Option, upon winding up of the Joint Venture, all assets used in the Joint Venture operations that were owned by the respective members of the Joint Venture prior to the formation of the Joint Venture are expected to be returned to the respective owner.  There are no assets of Sparhawk included in the consolidated financial statements of the Company.  Sparhawk does own rights to certain generic products currently produced by the Joint Venture, all of which belong to the liquids product line, which would be returned to Sparhawk upon wind-up.  Sales of these products amounted to approximately $1,065,000 in fiscal 2003, and $691,000 in the nine month peroid ended October 31, 2003.  Rights to several of the products currently produced by the Joint Venture, including iron dextran, are owned by the Company and are expected to be returned to the Company, although ownership of certain of these product rights may be disputed by Sparhawk.  Sales of these products amounted to approximately $5,112,000 in fiscal 2003 and $3,515,000 for the nine month period ended October 31, 2003.  The Company plans to continue production of the products to which Vet Labs owns the rights after the winding up of the Joint Venture.  However, no assurance can be given that sales of these products by the Company after the dissolution of the Joint Venture will be consistent with those achieved by the Joint Venture.

 

Assets purchased by the Joint Venture and rights to products developed by the Joint Venture are expected to be distributed to the members of the Joint Venture as part of the winding-up process.  Assets and liabilities owned by the Joint Venture are currently included in the Company’s financial statements.  Depending upon the allocation of the Joint Venture assets upon dissolution, the Company may not receive ownership of

 

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the rights to products developed by the Joint Venture.  Sales of these products amounted to approximately $2,034,000 in fiscal 2003 and $2,069,000 during the nine-month period ended October 31, 2003.

 

It is possible that a negotiated settlement with Sparhawk will be reached that would prevent the allocation of Joint Venture assets by the Court.  Such a settlement would likely result in one of the parties purchasing the other party’s interest in the Joint Venture at an agreed upon price.  Because the Joint Venture operations are currently fully consolidated in the Company’s financial statements, the Company’s results of operations would not be significantly impacted if the Company were to purchase Sparhawk’s interest in the Joint Venture, other than with respect to the cost of the consideration given to Sparhawk in the transaction.

 

If such a settlement resulted in Vet Labs selling its interest in the Joint Venture to Sparhawk, the Company’s financial statements would show a significant decline in revenues and possibly a small decline in income before income taxes.  The sale proceeds in excess of the carrying value of the Joint Venture assets and liabilities would be recorded as a gain.  At October 31, 2003, the carrying value of the Joint Venture assets and liabilities is $2,441,124 and $1,054,590, respectively.  During the year ended January 31, 2003, sales of the Joint Venture operations totaled $8,209,947 and net income before income taxes was $31,520.  During the nine month period ended October 31, 2003, sales of the Joint Venture amounted to $6,274,436, and net income before taxes totaled $184,370.  A sale of Vet Labs’ interest in the Joint Venture may have a material adverse effect on the Company’s business and results of operations.

 

The Company does not expect that a sale of Vet Labs’ Joint Venture interest would have an adverse effect on the operations of Dextran Products, because sales by Dextran Products to Chemdex and the Joint Venture are not significant.

 

Related Party Transactions

 

In August 1997, the Company loaned Thomas C. Usher, its Vice-Chairman, Director of Research and Development, and a member of its Board of Directors, $691,500 at an 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 October 31, 2003 was $483,241, as compared to $517,190 at January 31, 2003, including accrued interest.  The Company has taken a cumulative provision of $235,976 against accrued interest on this loan at October 31, 2003, compared to a cumulative provision of $212,491 at January 31, 2003.

 

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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 October 31, 2003 was $426,454, representing no change from January 31, 2003.  Thomas C. Usher also owes $250,000 to a subsidiary of the Company, Novadex International Limited, as of October 31, 2003.  The outstanding amount of this loan has not changed from January 31, 2003.

 

The Company also has an outstanding loan payable to Ruth Usher, a member of the Board of Directors.  The amount due from the Company pursuant to this loan increased to $683,589 at October 31, 2003 from $682,225 at January 31, 2003 due to interest charges less monthly payments by the Company.

 

Risk Factors

 

In addition to the risks and uncertainties discussed in the Joint Venture section above, the risks, uncertainties and other factors described below could materially and adversely affect the Company’s business, financial condition, operating results and prospects.

 

The Company’s 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 Company’s 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 product’s marketing for a considerable period of time and impose costly procedures upon the Company’s activities;

 

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•                  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 FDA’s 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 Company’s developmental product commercialization efforts may not be successful.

 

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 Company’s 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.  If any of the Company’s

 

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current research and development partnerships are 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 Company’s developmental products that receive FDA approval will depend upon the Company’s 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 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 Company’s 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 Company’s 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 Company’s patents may infringe on patents or other rights owned by

 

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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.

 

Critical Accounting Policies

 

The critical accounting policies of the Company include the use of estimates and allowances and their impact on accounts receivable, the useful lives of assets and the realizability of deferred tax assets.

 

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.

 

Revenue Recognition

 

All revenue is from sales of bulk and finished dosage 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.  A significant change in these estimates could have a material impact on the results of operations.

 

Allowance for Doubtful Accounts

 

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.

 

Long-Lived Assets

 

Long-lived assets are stated at cost, less accumulated depreciation or amortization computed using

 

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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 Company’s cash flows.  A significant change in these estimates 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 Company’s ability to recover the carrying value of the asset from the expected future pre-tax cash flows (undiscounted and without interest charges) 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.  The measurement of impairment requires management to make estimates of these cash flows related to long-lived assets as well as other fair value determinations.

 

Deferred Tax Assets

 

The Company has recorded a valuation allowance on deferred tax assets primarily related to operating loss carryforwards of the U.S. operations based on the uncertainty involved with the Joint Venture.

 

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Forward-Looking Statements

 

This Form 10-Q, including the Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains various “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which represent the Company’s expectations or beliefs concerning future events, including, but not limited to statements regarding management’s expectations of regulatory approval and the commencement of sales.  In addition, statements containing expressions such as “believes”, “anticipates”, “plans” or “expects” used in this Form 10-Q, the Company’s Annual Report, and the Company’s periodic reports on Forms 10-K and 10-Q previously filed with the Securities and Exchange Commission are intended to identify forward-looking statements.  The Company cautions that various risks and uncertainties and other factors 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, the timely development, FDA approval and market acceptance of the Company’s products, and the other risks discussed above, none of which can be assured.

 

The forward-looking statements contained in this quarterly report speak only as to the date of this report.  Except as otherwise required by federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements or the risk factors described in this quarterly report, 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

 

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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.

 

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Item 3.  Quantitative and Qualitative Disclosures about Market Risk.

 

Exchange Rate Sensitivity

 

The Company’s operations consist of manufacturing activities in the United States and Canada.  The Company’s products are sold in North America, Europe and the Pacific Rim.

 

While the majority of the sales of Dextran Products, the Company’s 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 financial statements of the Company contained in this report.  Therefore, Dextran Products has a net asset exposure to the United States dollar.  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 loss when the Canadian dollar rises in relation to the United States dollar due to this net asset exposure.  Similarly, a decline in the Canadian dollar relative to the United States dollar results in a foreign exchange gain 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 Company’s 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
		1/31/04		1/31/05		1/30/06		1/31/07		1/31/08		Thereafter		Total		Fair Value
		(US$ Equivalent)
Liabilities:
Long-term debt:
Fixed rate ($CDN)		125,024		133,310		114,432		114,237		—		—		487,003		487,003
Average interest rate		8.45	%	8.49	%	9.00	%	9.00	%	—		—		8.73	%

 

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Interest Rate Sensitivity

 

The Company has no significant interest earning assets and the majority of its debt is at fixed rates.  The variable rate debt represents the shareholder loan payable, which is approximately offset with 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 Company’s 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
		1/31/04		1/31/05		1/30/06		1/31/07		1/31/08		Thereafter		Total		Fair Value
		(US$ Equivalent)
Assets:
Notes receivable:
Variable rate ($US)		48,878		56,832		60,242		63,856		67,668		219,695		517,190		517,190
Average interest rate		6.00	%	6.00	%	6.00	%	6.00	%	6.00	%	6.0	%	6.00	%
Liabilities:
Long-term debt:
Fixed rate ($US)		280,365		—		—		—		—		—		280,365		280,365
Average interest rate		4.25	%	—		—		—		—		—		4.25	%
Fixed rate ($CDN)		125,024		133,310		114,432		114,237		—		—		487,003		487,003
Average interest rate		8.45	%	8.49	%	9.00	%	9.00	%	—		—		8.73	%
Variable rate ($US)		(432	)	1,042		1,104		1,170		1,241		678,083		682,207		682,207
Average interest rate		6.00	%	6.00	%	6.00	%	6.00	%	6.00	%	6.00	%	6.00	%

 

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Item 4.  Controls and Procedures.

 

(a)           Evaluation of Controls and Procedures

 

Within 90 days prior to the date of filing of this report, the Company carried out an evaluation, under the supervision and with the participation of its management, including the Chief Executive Officer and the Chief Financial Officer, of the design and operation of its disclosure controls and procedures.  Based on this evaluation, its Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures are effective for gathering, analyzing and disclosing the information the Company is required to disclose in the reports it files under the Securities Exchange Act of 1934, within the time periods specified in the SEC’s rules and forms.

 

(b)           Changes in Controls and Procedures

 

There have been no significant changes in the Company’s internal controls or in other factors that could significantly affect internal controls subsequent to the date of the Company’s most recent evaluation.

 

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PART II

OTHER INFORMATION

 

Item 6.  Exhibits and Reports on Form 8-K.

 

(a)		Exhibits
		3.1	Memorandum of Association of Polydex Pharmaceuticals Limited, as amended to date (filed as Exhibit 3.1 to the Registrant’s 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 Registrant’s 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
There were no reports on Form 8-K filed during the fiscal quarter ended October 31, 2003.

 

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SIGNATURES

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date:  December 15, 2003
	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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Exhibit Index

 

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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