SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)

x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the Quarterly Period Ended March 31, 2001.

¨ 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 0-27976.

GalaGen Inc.

(Exact name of registrant as specified in its charter)

Delaware	41-1719104
(State or other jurisdiction of	(I.R.S. Employer
incorporation or organization)	Identification No.)

301 Carlson Parkway, Suite 301
Minnetonka, Minnesota	55305
(Address of principal executive offices)	(Zip Code)

(952) 258-5500

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange 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 the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. Common Stock, $.01 par value – 12,275,488 shares as of April 30, 2001.

INDEX

GALAGEN INC.

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

Balance Sheets – March 31, 2001 and December 31, 2000

Statements of Operations - Three months ended March 31, 2001 and March 31, 2000

Statements of Cash Flows - Three months ended March 31, 2001 and March 31, 2000

Notes to Financial Statements

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

Item 3. Quantitative and Qualitative Disclosures About Market Risk

PART II. OTHER INFORMATION

Item 6. Exhibits and Reports on Form 8-K

SIGNATURES

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

GALAGEN INC.

BALANCE SHEETS

ASSETS	March 31, 2001	December 31, 2000
	(Unaudited)
Current assets:
Cash and cash equivalents	$396,090	$826,943
Accounts receivable, net of allowance of $13,136 in 2001 and 2000	82,350	554,760
Prepaid expenses	268,055	206,886
Inventory	244,097	224,746
Total current assets	990,592	1,813,335

Property and equipment	860,864	860,864
Less accumulated depreciation	(576,340)	(536,262)
	284,524	324,602

Customer list, net	247,500	270,000
Other intangible assets, net	85,098	106,373
Restricted cash	78,757	77,679
Deferred expenses	16,500	18,000
	427,855	472,052

Total assets	$1,702,971	$2,609,989
LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
Accounts payable	$1,029,313	$949,872
Development contract advance	85,775	89,275
Current portion of deferred revenue	107,140	107,140
Current portion of capital lease obligation	36,213	34,584
Other current liabilities	34,111	32,364
Total current liabilities	1,292,552	1,213,235

Commitments

Capital lease obligations	24,416	34,104
Deferred revenue	490,932	517,716
Other long-term liabilities	45,000	45,000
Total Long-term liabilities	560,348	596,820

Stockholders’ equity:
Preferred stock, $.01 par value:
Authorized shares – 15,000,000 Issued and outstanding shares – none in 2001 and 2000	-	-
Common stock, $.01 par value:
Authorized shares – 40,000,000 Issued and outstanding shares – 12,275,448 in 2001; 12,275,448 in 2000	122,754	122,754
Additional paid–in capital	65,532,809	65,532,809
Accumulated deficit	(65,805,492)	(64,855,629)
Total stockholders’ equity	(149,929)	799,934

Total liabilities and stockholders’ equity	$1,702,971	$2,609,989

See accompanying notes.

Note: The balance sheet at December 31, 2000 has been derived from audited financial statements at that date but does not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

GALAGEN INC.

STATEMENTS OF OPERATIONS
(Unaudited)

	Three Months Ended March 31
	2001	2000
Revenues:
Product licensing revenue	$26,786	$26,786
Product development revenue	3,500	100,928
Royalty revenue	29,880	45,987
	60,166	173,701
Operating expenses:
Selling, general and administrative	463,816	569,139
Product development	470,019	598,922
Depreciation and amortization	83,853	135,075
	1,017,688	1,303,136
Operating loss	(957,522)	(1,129,435)

Interest income	10,721	41,235
Interest expense	(3,062)	-
Net loss before accounting change	(949,863)	(1,088,200)

Cumulative effect of change in accounting principle	-	(732,000)

Net loss	$(949,863)	$(1,820,200)

Net loss per share – basic and diluted
Net loss before accounting change	$(.08)	$(.10)
Cumulative effect of change in accounting principle	-	(.07)

Net loss per share	$(.08)	$(.17)

Weighted average number of common shares outstanding Basic and Diluted	12,275,448	10,451,381

See accompanying notes.

GALAGEN INC.

STATEMENTS OF CASH FLOWS
(Unaudited)

	Three Months Ended March 31
	2001	2000
Operating activities:
Net loss	$(949,863)	$(1,820,200)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization	83,852	135,074
Cumulative effect of accounting change	-	732,000
Changes in operating assets and liabilities	444,295	134,685
Net cash used in operating activities	(421,716)	(818,441)

Investing activities:
Purchase of property, plant and equipment	-	(3,735)
Increase in restricted cash	(1,078)	-
Change in available-for-sale securities, net	-	710,560
Net cash (used in) provided by investing activities	(1,078)	706,825

Financing activities:
Proceeds from issuance of common stock	-	223,469
Payments on capital lease	(8,059)	-
Net cash (used in) provided by financing activities	(8,059)	223,469
(Decrease) increase in cash	(430,853)	111,853
Cash and cash equivalents at beginning of period	826,943	204,817
Cash and cash equivalents at end of period	$396,090	$316,670

See accompanying notes.

GALAGEN INC.

NOTES TO FINANCIAL STATEMENTS
(Unaudited)

1. Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information, pursuant to the rules and regulations of the Securities and Exchange Commission. In the opinion of management, all adjustments (consisting of normal, recurring accruals) considered necessary for fair presentation have been included. Operating results for the three months ended March 31, 2001, are not necessarily indicative of the results that may be expected for the year ended December 31, 2001. These financial statements should be read in conjunction with the audited financial statements and accompanying notes contained in the Annual Report of GalaGen Inc. (the “Company”) on Form 10-K, as amended, for the fiscal year ended December 31, 2000.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has had recurring losses and has negative stockholders equity as of March 31, 2001. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include adjustments to the carrying value of assets and liabilities, which may be necessary should the Company not continue in operation.

2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

Revenue Recognition

Revenues from product sales are recognized at the time of shipment and transfer of title. Revenues from product development fees are recognized as services are rendered and as milestones are achieved. Revenues from non-refundable up-front license fees are recognized over the term of the development agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process.

Effective January 1, 2000, the Company changed its method of accounting for revenue recognition in accordance with Staff Accounting Bulletin (SAB) No. 101, “Revenue Recognition in Financial Statements.” Previously, the Company had recognized revenue for nonrefundable, up-front license fees as revenue upon receipt and signing of the agreement. Under the new accounting method adopted retroactive to January 1, 2000, the Company now recognizes revenue from nonrefundable up-front license fees over the term of the agreement unless the fee is in exchange for products delivered or services performed that represent the culmination of a separate earnings process. The cumulative effect of the change on prior years resulted in a charge to income of $732,000, which is included in the loss for the first quarter of 2000. The effect of the change on the quarter ended March 31, 2001 was to decrease the loss before the cumulative effect of the accounting change by $26,786.

For each of the quarters ended March 31, June 30, September 30, and December 31, 2000, and the quarter ended March 31, 2001 the Company recognized $26,786 in revenue that was included in the cumulative effect adjustment as of January 1, 2000. Additionally, the Company will recognize in revenue $107,144 annually for the years ending December 31, 2001 through 2006 for amounts included in the cumulative effect adjustment.

Net Loss Per Share

Basic loss per share is computed by dividing the net loss by the weighted average number of common shares outstanding for the year. Diluted loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock and resulted in the issuance of common stock. Basic and diluted loss per share are the same in all years presented as all common share equivalents were antidilutive.

Inventory

Inventories are stated at the lower of cost or market using the first-in, first-out method. The Company periodically evaluates the need for reserves associated with obsolete inventory. Inventory at March 31, 2001 and December 31, 2000 consisted of the following:

	2001	2000
Raw materials	$52,007	$46,674
Finished goods	192,090	178,072
	$244,097	$224,746

Reclassifications

Certain items in these financial statements have been reclassified to conform to the current period presentation.

PART I - FINANCIAL INFORMATION

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

Forward-Looking Statements

The information presented in this item contains forward-looking statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such statements are subject to risks and uncertainties, including those discussed below under “Risk Factors” and in the Company’s Annual Report on Form 10-K, as amended, for the year ended December 31, 2000 (“Form 10-K”) under “Risk Factors”, that could cause actual results to differ materially from those projected. Because actual results may differ, readers are cautioned not to place undue reliance on these forward-looking statements.

General

GalaGen’s mission is to become the leading presence in foods, beverages and dietary supplements that help enhance the immune system and to take advantage of all of colostrum’s benefits. A critical factor for success of the Company is its immune-enhancing ingredient, which has been branded Proventraä Brand Natural Immune Components (“Proventra”). Proventra is derived from colostrum; the highly nutritious first milk from a dairy cow after its calf is born. The primary components found in Proventra are naturally occurring broad-spectrum antibodies or specialized proteins that enhance the body’s own immune system to provide protection against harmful micro-organisms. Additional immune-enhancing components found in Proventra include lactoperoxidase, lactoferrin, growth factors and other substances to bolster the body’s resistance.

The Company, in conjunction with strategic partners, continues to expand applications for its technology and is developing a portfolio of Proventra-based products that target the needs of consumers and the healthcare market.

In 1998, the Company entered into a collaboration and license agreement and a manufacturing and supply agreement with Wyeth-Ayerst Laboratories (“Wyeth-Ayerst”), a division of American Home Products Corporation. The two companies will develop and commercialize a proprietary ingredient with unique antibacterial properties for use in pediatric formula and other nutritional products. The collaboration, during the research and development phase of the product, will be funded by Wyeth-Ayerst through payments to the Company.

In January 1999, the Company entered into a collaboration agreement with General Nutrition Corporation, Inc. for product development, manufacturing, supply and retail marketing of its Proventra. The agreement calls for the two companies to develop and market a range of immune-enhancing dietary supplements and nutrition formulas.

In March 1999, the Company entered into an agreement with Tropicana Products, Inc., a division of PepsiCo Inc. Under the agreement, which expired in December 1999, the two companies were exploring development of nutritious beverages for the health-conscious consumer. Subsequent to the expiration of the exploratory agreement in December 1999, the Company and Tropicana continue to work together on various potential products. Additional studies are underway that may lead to product introduction opportunities with Tropicana.

In March 1999, the Company also entered into a licensing and distribution agreement with Hormel HealthLabs (“HHL”), a wholly owned subsidiary of Hormel Foods Corporation. HHL licensed the manufacturing and distribution rights for a new, clinically tested, cultured dairy beverage the Company developed to improve the gastrointestinal health of patients in hospitals and nursing homes. The product includes a patented ingredient combination and will also incorporate the Company’s Proventra.

In July 1999, the Company licensed its line of critical care nutrition products, previously acquired from NM Holdings, Inc. (“NMI”), to HHL. The licensing agreement granted HHL worldwide rights to manufacture, distribute, market and sell the Company’s critical care products. Under the terms of the agreement HHL will pay royalties, subject to an annual minimum royalty, to the Company based upon net sales of the specified products. HHL commenced selling the Company’s critical care products on a limited basis in September 1999, and on an exclusive basis effective October 1999.

In October 1999, the Company entered into a collaborative licensing agreement with Novartis Consumer Health Inc. (“Novartis”) whereby the Company granted Novartis certain rights to defined Proventra technology. Also in October, the Company and Novartis entered into a supply agreement for which the Company will supply the Proventra ingredients.

In December 1999, the Company and Novartis entered into a development agreement for various product development and research projects. Novartis will pay for pre-approved activities related to the research projects. The Company will initially record payments received as an advance, and recognize revenue as the Company incurs the associated expense. The Company also will receive a royalty from future Novartis sales as additional compensation. No royalties were due in 2000 or 1999.

In July 2000, the Company entered into a supply agreement with Estee Lauder Inc., to supply its colostrum-based ingredient for use in cosmetic skin care products.

The Company, in conjunction with Land O’ Lakes, has worked with a marketing/testing firm to develop a yogurt containing Proventra. The Company believes that the future success of a Proventra yogurt product will be enhanced by continuing to follow its strategy of introduction of products through large market leaders. Accordingly, the Company has obtained rights from Land O’Lakes to pursue an alliance with major yogurt manufacturers. The Company is currently exploring alliance relationships with these major companies and any yogurt product introductions will be dependent upon successful completion of a yogurt license agreement.

Results of Operations

For the Three Months ended March 31, 2001 and 2000

General. The net loss decreased by $870,337, or 47.8%, for the three months ended March 31, 2001 to $949,863 from $1,820,200 for the same period in 2000. The loss decrease was due primarily to the cumulative effect adjustment of $732,000 recorded in the first quarter of 2000 offset by decreased product development and royalty revenue. In addition, product development and selling and general expenses were reduced due to decreased marketing and research activities occurring in the first quarter of calendar year 2001.

Revenues. For the three months ended March 31, 2001 revenues of $60,166 consisted of product development and royalty revenue, $3,500 and $29,880 respectively. In addition, $26,786 was recorded as licensing revenue due to the amortization of the cumulative effect adjustment. For the same period in 2000, revenues of $173,701 consisted of $100,928 in product development revenue, $45,987 in royalty revenue and an amortization of the cumulative effect adjustment totaling $26,786. See Note 2.

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased $105,323, or 18.5%, for the three months ended March 31, 2001 to $463,816 from $569,139 for the same period in 2000. The decrease is due to decreased marketing expenses of $84,239 in addition to a decrease in administrative personnel expenses.

Product Development Expenses. Expenses for product development decreased $128,903, or 21.5%, for the three months ended March 31, 2001 to $470,019 from $598,922 for the three months ended March 31, 2000. The decrease was primarily due to decreased expenses in support of the Company’s clinical product efforts and decreased expenses related to the Wyeth contract.

Depreciation and Amortization. Depreciation and amortization for the three months ended March 31, 2001 decreased $51,222, or 37.9%, to $83,853 from $135,075 for the same period in 2000. The decrease was primarily due to decreased amortization of warrants and options issued for services and decreased amortization of goodwill, which was fully amortized as of December 31, 2000.

Other Income/Expense. Interest income for the three months ended March 31, 2001 decreased $30,514, or 74.0%, to $10,721 from $41,235 for the same period in 2000. The decrease is primarily attributable to the decreased level of invested funds. Interest expense of $3,062 for the three months ended March 31, 2001 related to a capital lease entered into in October 2000.

Liquidity and Capital Resources

Cash used in operating activities decreased by $396,725, or 48.5%, for the three months ended March 31, 2001 to $421,716 from $818,441 for the same period in 2000. Cash used in operations for the three months ended March 31, 2001 went primarily to fund operating losses offset by accounts receivable collections of $472,410. For the same period in 2000, cash used in operations went primarily to fund operating losses.

For the three months ended March 31, the Company invested $0 and $3,735, in 2001 and 2000, respectively, in computer and manufacturing equipment to support its operations. The Company sold $710,560 of its available-for-sale securities for the three months ended March 31, 2000.

Proceeds from the exercise of common stock options and warrants for the three months ended March 31, 2000 were $223,469.

The Company anticipates that its existing resources and interest thereon will not be sufficient to satisfy its anticipated cash requirements through the year ending December 31, 2001. The Company’s working capital and capital requirements will depend upon numerous factors, including revenue from product sales and collaboration arrangements, the progress of the Company’s market research, product development and ability to obtain partners with the appropriate manufacturing, sales, distribution and marketing capabilities. The Company’s capital requirements also will depend on the levels of resources devoted to the development of manufacturing capabilities, technological advances, the status of competitive products and the ability of the Company to establish partners or strategic alliances to provide funding to the Company for certain manufacturing, sales, product development and marketing activities.

The Company expects to incur substantial additional marketing expense and product development expense. Capital expenditures may be necessary to establish additional commercial scale manufacturing facilities. The Company will need to raise substantial additional funds for longer-term product development, manufacturing and marketing activities that may be required in the future. The Company’s ability to continue funding its planned operations is dependent upon its ability to generate product revenues or to obtain additional funds through equity or debt financing, strategic alliances, license agreements or from other financing sources. A lack of adequate revenues or funding could eventually result in the insolvency or bankruptcy of the Company. At a minimum, if adequate funds are not available, the Company may be required to delay or to eliminate expenditures for certain of its product development efforts or to license to third parties the rights to commercialize products or technologies that the Company would otherwise seek to develop itself. Because of the Company's significant long–term capital requirements, it may seek to raise funds when conditions are favorable, even if the Company does not have an immediate need for such additional capital at such time. If the Company has not raised funds prior to when its needs for funding become immediate, the Company may be forced to raise funds when conditions are unfavorable, which could result in significant dilution for current stockholders.

Pursuant to a Master Lease Agreement dated as of June 30, 1998 (the “Lease Agreement”), the Company leases certain laboratory equipment, computer equipment and tenant improvements from Transamerica Business Credit Corporation (“Transamerica”). Under a Security Agreement with Transamerica dated as of June 30, 1998 (the “Security Agreement”), the Company’s obligations under the Lease Agreement are secured by a first priority lien on substantially all of the Company’s equipment, fixtures and improvements and personal property. The Lease Agreement requires the Company to make certain monthly lease payments. The Company did not make the full amount of the lease payments in March, April and May. The Company has received notice that Transamerica considers the Company to be in default under the Lease Agreement and the Security Agreement and that Transamerica reserves all of its rights and remedies under such agreements. The Company currently is in negotiations with Transamerica regarding payments to be made under the Lease Agreement.

The Company has had recurring losses and negative cash flows from operations, including a net loss of $949,863 and negative cash flow from operations of $421,716 in the first quarter of fiscal 2001. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

The Company has hired an investment bank to assist management in identifying and evaluating strategic alternatives for the Company, while optimizing shareholder value.

The Company’s common stock, par value $.01 per share, has been publicly traded since the closing of the Company’s initial public offering on April 1, 1996. During 2000 the common stock traded on the Nasdaq National Market tier of The Nasdaq Stock Market under the symbol GGEN through October 1, 2000 and then was traded on the Nasdaq SmallCap tier through December 31, 2000. The common stock was delisted in early January 2001 and now trades on the Over-the-Counter Bulletin Board under the symbol GGEN.

Risk Factors

Certain statements made in this Quarterly Report on Form 10-Q are forward–looking statements based on our current expectations, assumptions, estimates and projections about our business and our industry. These forward–looking statements involve risks and uncertainties. Our business, financial condition and results of operations could differ materially from those anticipated in these forward–looking statements as a result of certain factors, as more fully described below and elsewhere in this Form 10-Q. You should consider carefully the risks and uncertainties described below, which are not the only ones facing our Company. Additional risks and uncertainties also may impair our business operations. We undertake no obligation to update publicly any forward–looking statements for any reason, even if new information becomes available or other events occur in the future.

General

We may not ever achieve a profitable level of operations.

Our ability to achieve profitable operations depends in large part on:
• entering into agreements to develop products and establish markets for those products; and
• making the transition from a research company to an operating and marketing company.

We cannot be sure we will be successful in ever achieving either result. We have experienced significant operating losses in each year since our inception in 1987. We have an accumulated deficit of approximately $65 million as of March 31, 2001. We may continue to lose money in the future.

If we cannot obtain continuing funding, we may be unable to implement our business plans.

If we cannot find adequate funding, we may have to delay or eliminate some of our product development plans. We may be required to grant licenses to others to establish markets for products or technologies that we would otherwise seek to market ourselves.

Our cash requirements for working capital depend on numerous factors. These factors include:
•  our spending on marketing activities, including clinical marketing trials;
•  our progress in finding partners to help us develop products and market those products;
•  the willingness and ability of our partners to provide funding for our activities;
•  our spending on product development programs;
•  the rate of technological advances in the production of our products;
•  our spending on facilities, equipment and personnel to make our products; and
•  the status of competitive products.

Our long-term ability to continue funding our planned operations depends on our ability to obtain additional funds through:

•  product revenues;
•  equity or debt financing;
•  partners to help us develop products and market those products;
•  license agreements; or
•  other financing sources.

Because of our significant long–term capital requirements, we may seek to raise funds when conditions are favorable. We may do so even if we do not have an immediate need for the capital at the time we raise it. If we have not raised funds prior to when our needs for funding become immediate, we may be forced to raise funds when conditions are unfavorable. This could result in significant dilution of our current stockholders.

If we do not achieve a profitable level of operations and cannot find funding in the future, we could become insolvent or bankrupt.

If we do not achieve a profitable level of operations and we do not obtain funding necessary from some source other than operations, we could deplete our cash reserves and become insolvent or bankrupt.

The relatively low level of trading in our common stock may make it highly volatile.

Our Common Stock is traded on the Over-the-Counter Bulletin Board, or OTCBB and the volume of shares of Common Stock traded on that market has been relatively small. Given the small volume of shares traded, market fluctuations may have a particularly adverse effect on the market price of our Common Stock. We cannot be sure of the liquidity of the market for the Common Stock or the price at which any sales may occur. The volume of trading in our Common Stock in the future will depend upon the number of holders of the Common Stock, the interest of securities dealers in maintaining a market in the Common Stock and other factors beyond our control. The market price of our Common Stock could be subject to significant fluctuations in response to:

•  our operating results;
•  the operating results of our competitors or other biotechnology companies;
•  technological developments;
•  government regulations;
•  the status of our proprietary rights to potential products;
•  litigation;
•  public safety concerns; and
•  other factors.

Some of these factors are unrelated to our operating performance and beyond our control.

GalaGen and our stockholders may have difficulty in selling shares of our Common Stock.

The OTCBB is not a listing service, market or exchange. Instead, it is a regulated quotation service that displays real-time quotes, last-sale prices and volume information for securities traded on it. In order for a security to trade on the OTCBB, market makers must be willing to make a market in the security. We cannot be sure that market makers will continue to make a market in shares of our Common Stock. Even if market makers do continue to make a market in our Common Stock, we cannot be sure that they will be successful in executing trades placed with them. The lack of a liquid market for our Common Stock, may make it difficult for us to raise funds through the sale of our Common Stock or securities convertible into Common Stock.

We may be subject to product liability claims that exceed our insurance coverage.

Our business involves exposure to potential product liability risks that are inherent in the production, manufacture and distribution of consumer and clinical food products that are designed to be ingested. The successful assertion or settlement of any uninsured claim, a significant number of insured claims or a claim exceeding our insurance coverage could have a material adverse effect on our business and financial condition. We cannot be sure that we will be able to obtain product liability insurance on acceptable terms or that provides adequate protection. Furthermore, we cannot be sure that we will be able to secure increased insurance coverage as the markets for our products increase.

If we rely on inaccurate market information, we could make a decision that has a material adverse effect on our business and financial condition.

Because we are currently developing our products and markets for those products, we are particularly reliant on market data. If that data is inaccurate, we may commit resources to product development and marketing efforts that do not become profitable. Product development and marketing efforts that do not become profitable may have a material adverse effect on our business and financial condition. We have obtained market and related data from a competitive-market analysis firm. We have not independently verified the accuracy of that information. In any event, the methodology typically used in compiling market and related data makes it subject to inherent uncertainties and estimations. As a result, we cannot be sure as to the accuracy or completeness of our market information.

Inadequate Proventra production could have a material adverse effect on our business and financial condition.

Given our limited experience in manufacturing Proventra, we cannot be sure that we will be successful in producing Proventra of acceptable quality on a commercial scale and at acceptable costs in our manufacturing facility. If we cannot, our business and financial condition could be materially adversely affected. Our production of Proventra will be regulated by the Minnesota Department of Agriculture. We believe that our current manufacturing facility will meet the anticipated requirements for the production of Proventra for use in consumer and clinical nutritional products through the year 2001. Further, we believe that contract manufacturers would be available to increase our Proventra production capacity quickly, if required. However, until we begin producing Proventra on a commercial scale, we cannot be sure that our production capabilities will be adequate.

Failure of our collaborations to develop and market products containing Proventra could have a material adverse effect on our business and financial condition.

We are relying on collaborations with larger more established companies to develop and market products containing Proventra. Our collaborators’ inability to bring products to market could have a material adverse effect on our business and financial condition. Introduction of new products depends on our ability and our collaborators’ ability to accomplish the following:

•  complete market research;
•  complete product development;
•  establish product manufacturing;
•  initiate marketing, sales and distribution activities related to such products; and
•  provide the funding necessary to accomplish such activities.

Delays or high costs in product development could have a material adverse effect on our business and financial condition.

If we, or our strategic partners, cannot obtain accurate marketing data, or develop a product responsive to the needs identified by that data, our business and financial condition could be materially adversely affected. The amount of time it will take us, together with our strategic partners, to develop consumer and clinical nutrition products and the associated costs of developing those products depends on, among other things, the results of our market research for consumer and clinical products. It also depends on our discussions with certain end users or purchasers of the potential products. Market research and discussions may give us indications of potential customers, what types of products they may desire and what clinical information is necessary for effective marketing and sales.

Risks Specific to Functional Food and Nutraceutical Products

Consumer fear of Bovine Songiform Encephalopahy, or BSE, may impair our ability to commercialize products containing bovine colostrum.

Occurrences of BSE, or “mad cow disease,” in certain parts of the world may lead to consumer resistance to product containing bovine derived ingredients. Such consumer resistance, or concerns on the part of consumer product developers and manufacturers about such consumer resistance, may impair our ability to commercialize products containing our proprietary bovine colostrum ingredients.

Public misperception of the safety of our product could have a material adverse effect on our business and financial condition.

We are highly dependent upon consumers’ perception of the safety and quality of our products as well as of similar products distributed by other companies. Thus, for example, the publication of reports asserting that such products may be harmful could have a material adverse effect on our business and financial condition, regardless of whether such reports are scientifically supported and regardless of whether the alleged harmful effects would be present at the dosages recommended for such products.

Innovative ingredients may produce unwanted effects and expose us to product liability claims or loss of consumer confidence.

If we develop products with innovative ingredients that over time are shown to produce unwanted effects, we could be exposed to product liability claims and lose consumer confidence, which could have a material adverse effect on our business and financial condition. Some of our future products may contain innovative ingredients or combinations of ingredients that do not have a long history of human consumption. While we believe all of our products will be safe when taken as we direct, there is little long-term experience with human consumption of certain of these innovative product ingredients or combinations thereof in concentrated form. Although we perform research and/or test the formulation and production of our products, we will sponsor only limited clinical studies or rely on other outside published data.

If larger companies with greater access to capital and product markets enter our segment of the nutritional products market, we may be materially adversely affected.

Because the nutritional products industry generally has low barriers to entry, additional competitors could enter the market at any time. Potential competitors could be larger than we are, have greater access to capital than we do and may be better able to withstand volatile market conditions than we are. Although the nutritional products industry to date has been characterized by many relatively small participants, national or international companies (which may include pharmaceutical companies or other suppliers to mass merchandisers) may seek to enter or to increase their presence in this industry or to consolidate it. Increased competition in the industry could have a material adverse effect on our business and financial condition.

Our failure to obtain necessary approvals or otherwise comply with government regulations could have a material adverse effect on our business and financial condition.

Our current and potential functional foods and nutraceutical products may become subject to governmental regulation in the future. The burden of such regulation could add materially to the costs and risks of our development and marketing efforts. There can be no assurance that we could obtain the required approvals or comply with new regulations if our products are subject to additional governmental regulation in the future.

Some of our products in development may be subject to regulation by one or more federal agencies, principally the Food and Drug Administration and the Federal Trade Commission, and to a lesser extent the Consumer Product Safety Commission and the United States Department of Agriculture regarding the formulation, manufacturing, processing, packaging, labeling, advertising, distribution and sale of nutritional supplements. These activities are also regulated by various governmental agencies for the states and localities in which the Company's products are sold, as well as by governmental agencies in certain foreign countries in which the Company's products are sold. Among other matters, regulation of the Company by the FDA and FTC is concerned with claims made with respect to a product which refer to the value of the product in treating or preventing disease or other adverse health conditions.

Risks Specific to Critical Care Nutrition Products

If Hormel HealthLabs does not increase the sales volume of our critical care nutrition products, our business and financial condition may be materially adversely affected.

We rely on Hormel HealthLabs and its distribution network to sell and distribute our critical care products. Because we entered into our sales and distribution arrangement with Hormel HealthLabs in August of 1999, we cannot be sure that its sales force will actively promote our critical care products or that the sales force will be successful in generating increased sales of those products. If the sales volume of our critical care nutrition products is not increased, our business and financial condition may be materially adversely affected.

If marketing efforts do not generate the name recognition for our critical care products necessary to significantly enhance revenues, our business and financial condition may be materially adversely affected.

We cannot be sure that our marketing efforts, or the marketing efforts of Hormel Health Labs, will achieve the name recognition of our critical care nutrition products necessary to significantly enhance revenues. If they do not, our business and financial condition could be materially adversely affected. Our products, with the exception of Glutasorb, are designed to be substantially equivalent to existing branded competitive products. Although we believe that the quality and efficacy of our critical care nutrition products are comparable to branded competitive products, no independent comparison between our critical care nutrition products and competitive products has been completed. We cannot be sure that the efficacy or quality of our critical care nutrition products is, or will be perceived by our consumers to be, comparable to branded competitive products. Furthermore, our products are relatively unknown to large segments of our target markets.

Price reductions by competitors could have a material adverse effect on our business and financial condition.

Much of our marketing strategy for our critical care nutrition products is focused on the price advantage of our critical care nutrition products. If a competitor reduces or eliminates the price advantage of our products, we cannot be sure that we will be able to compete successfully with the competitor, or operate profitably under such conditions. If we could not, our business and financial condition could be materially adversely affected. We believe that the principal advantage of our critical care nutrition products, with the exception of Glutasorb, is cost effectiveness. We believe that any selective price reductions by a competitor may result in lost sales of our competing products.

If the contract manufacturers that produce our products cannot do so adequately, our business and financial condition may be materially adversely affected.

We rely on contract manufacturers to produce our critical care nutrition products according to our specifications. Any interruption in supply from these manufacturers of any of our products could have a material adverse effect on our business and financial condition. We cannot be sure that contract manufacturers will consistently supply adequate quantities of our products on a timely basis or that the quality of such products will be consistently maintained. We also rely on these manufacturers to comply with all applicable government regulations and manufacturing guidelines. We cannot be sure these contract manufacturers will consistently comply with government regulations. In the event of a sale of a defective product, we would be exposed to product liability claims and could lose customer confidence. In addition, minimum quantity order requirements imposed by manufacturers may result in excess inventory levels, requiring additional working capital and increasing exposure to losses from inventory obsolescence.

Because the way we distribute our products may result in a relatively small number of customers, the loss of particular customers could have a material adverse effect on our business and financial condition.

Our critical care nutrition product sales may become concentrated with a few large distributors and certain customers. We cannot be sure that orders from such customers will continue or that our future orders will not significantly decline, which could have a material adverse effect on our business and financial condition.

We may become involved in litigation with competitors that may have a material adverse effect on our business and financial condition.

Companies in the private label industry are commonly the subject of claims and lawsuits brought by brand name competitors alleging that the private label products have formulas, labeling or packaging similar to competing brand name products. Such litigation may require the commitment of substantial management time and legal fees. Accordingly, such litigation may have a material adverse effect on our business and financial condition. Certain of the critical care nutrition products we acquired from NMI were the subject of a lawsuit alleging patent infringement. The suit was favorably resolved before we acquired the products. Similar claims may be made against us by competitors in the future. Competitors may also respond to our marketing strategy by more aggressively seeking patents on their products to limit our future product development efforts. If similar infringement allegations are made against us in the future, some of our current and future products may need to be reformulated or repackaged in order for us to continue to market products that are comparable to competitors' patented products. We may be unable to effectively reformulate certain of our products. Furthermore, we cannot be sure that a reformulated product would be viewed by customers to be essentially equivalent to the patented product. Moreover, we cannot be sure that any future lawsuits could be satisfactorily settled by reformulating, relabeling or repackaging a product.

Direct competition from larger companies with significant financial resources may have a material adverse effect on our business and financial condition.

Our competitors in the critical care nutrition products market are established companies that sell branded products that have achieved a high level of customer awareness. If we are not able to compete successfully or operate profitably, our business and financial condition could be materially adversely affected. Other companies may also enter this market.

If we cannot enforce the trademarks used with our critical care nutrition products our business and financial condition may be materially adversely affected.

We acquired certain of the trademarks used with our critical care nutrition products from third parties and cannot be sure that such trademarks do not violate the proprietary rights of others. Nor can we be sure that our proprietary rights in the marks would be upheld if challenged. If we were prevented from using the marks for any reason, our business and financial condition may be materially adversely affected. In addition, we cannot be sure that we will have the financial resources necessary to enforce or defend our trademarks, which could also have a material adverse effect on our business and financial condition. Under their previous ownership, certain of the trademarks that we have acquired were not registered. Instead their owner relied on common law trademark rights. The lack of registration may impair our ability to successfully register the trademarks or to prosecute successfully an infringement action against other users of these trademarks.

Our failure to obtain necessary approvals or otherwise comply with government regulations could have a material adverse effect on our business and financial condition.

Our critical care products and potential critical care products are, or will be, subject to government regulation. Our current products are regulated as food and medical food by the FDA and are subject to certain labeling requirements, current good manufacturing practice regulations and certain other regulations designed to ensure the safety of the products.

Our current and potential products may become subject to further governmental regulation in the future. The burden of such regulation could add materially to the costs and risks of our development and marketing efforts. There can be no assurance that we could obtain the required approvals or comply with new regulations if our products are subject to additional governmental regulation in the future.

Claims we make in labeling and advertising our products are subject to regulation by the FDA, the FTC and various state agencies under their general authority to prevent false, misleading and deceptive trade practices. These regulations involve stringent tracking, testing and documentation standards. Failure to comply with such requirements can result in adverse regulatory action, including injunctions, civil or criminal penalties, product recalls or the relabeling, reformulation or possible termination of certain products.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

The Company’s market risk is unlikely to have a material adverse effect on the Company’s business, results of operations or financial condition. PART II. OTHER INFORMATION

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

(a.) Exhibits

Exhibit No.	Description	Method of Filing
3.1	Second Restated Bylaws of the Company.(10)	Incorporation By Reference

3.2	Restated Certificate of Incorporation of the Company.(3)	Incorporated By Reference

4.1	Specimen Common Stock Certificate.(1)	Incorporated By Reference

4.2-4.18	Intentionally left blank.

4.19	Form of Subscription Agreement and Investment Letter (8)	Incorporated By Reference

4.20-4.23	Intentionally left blank.

4.24	Stock Purchase Warrant issued to CPR (USA) Inc. dated November 18, 1997.(13)	Incorporated By Reference

4.25	Stock Purchase Warrant issued to Libertyview Plus Fund dated November 18, 1997.(14)	Incorporated By Reference

4.26	Stock Purchase Warrant issued to Libertyview Fund, LLC dated November 18, 1997.(15)	Incorporated By Reference

4.27	Warrant issued to CLARCO Holdings dated as of December 1,1997.(16)	Incorporated By Reference

4.28	Warrant issued to CLARCO Holdings dated as of December 1,1997.(17)	Incorporated By Reference

4.29	Intentionally left blank.

4.30	Warrant issued to Henry J. Cardello dated as of April 13, 1998. (20)	Incorporated By Reference

4.31	Warrant issued to Henry J. Cardello dated as of April 30, 1998. (20)	Incorporated By Reference

4.32	Warrant issued to Henry J. Cardello dated as of June 19, 1998. (20)	Incorporated By Reference

4.33	Warrant issued to William Young and Rebecca Young dated as of August 12, 1998.(24)	Incorporated By Reference

4.34	Warrant issued to Henry J. Cardello dated as of September 30, 1998.(24)	Incorporated By Reference

4.35	Warrant issued to American Home Products Corporation dated as of October 15, 1998.(24)	Incorporated By Reference

4.36	Form of Registration Rights Agreement dated April 20, 1999.(25)	Incorporated By Reference

4.37	Subscription Agreement and Investment Letter dated April 20, 1999 (Lombard Odier & Cie).(26)	Incorporated By Reference

4.38	Subscription Agreement and Investment Letter dated April 20, 1999 (H. Leigh Severance).(27)	Incorporated By Reference

4.39	Subscription Agreement and Investment Letter dated April 20, 1999 (H. L. Severance, Inc. Profit Sharing Plan and Trust).(28)	Incorporated By Reference

4.40	Subscription Agreement and Investment Letter dated April 20, 1999 (H. L. Severance, Inc. Pension Plan and Trust).(29)	Incorporated By Reference

4.41	Subscription Agreement and Investment Letter dated April 20, 1999 (Winston R. Wallin).(30)	Incorporated By Reference

4.42	Warrant issued to Carlson Real Estate Company, Inc. dated June 12, 2000 (34)	Incorporated By Reference

#10.1	License Agreement between the Company and Land O’Lakes dated May 7, 1992.(1)	Incorporated By Reference

#10.2	Royalty Agreement between the Company and Land O’Lakes dated May 7, 1992.(1)	Incorporated By Reference

10.3	Intentionally left blank.

10.4	Master Services Agreement between the Company and Land O’Lakes dated May 7, 1992.(1)	Incorporated By Reference

*10.5	GalaGen Inc. 1992 Stock Plan, as amended. (5)	Incorporated By Reference

10.6-10.7	Intentionally left blank.

#10.8	License and Collaboration Agreement between the Company and Chiron Corporation dated March 20, 1995.(1)	Incorporated By Reference

*10.9	GalaGen Inc. Employee Stock Purchase Plan, as amended. (2)	Incorporated By Reference

10.10-10.11	Intentionally left blank.

10.12	Master Equipment Lease between the Company and Cargill Leasing Corporation, dated June 6, 1996. (2)	Incorporated By Reference

10.13	Agreement for Progress Payments between the Company and Cargill Leasing Corporation, dated June 6, 1996. (2)	Incorporated By Reference

10.14	Agreement for Lease between the Company and Land O’Lakes, dated June 3, 1996. (2)	Incorporated By Reference

10.15-10.18	Intentionally left blank.

*10.19	GalaGen Inc. Annual Short Term Incentive Cash Compensation Plan. (4)	Incorporated By Reference

*10.20	GalaGen Inc. Annual Long Term Incentive Stock Option Compensation Plan. (4)	Incorporated By Reference

*10.21	GalaGen Inc. 1997 Incentive Plan. (6)	Incorporated By Reference

10.22	Master Loan and Security Agreement with TransAmerica Business Credit Corporation dated June 8, 1997. (7)	Incorporated By Reference

10.23	Amended and Restated License Agreement between the Company and Land O' Lakes dated March 11, 1998. (19)	Incorporated By Reference

#10.24	License Agreement between the Company and Metagenics, Inc. dated April 7, 1998. (20)	Incorporated By Reference

10.25	Intentionally left blank.

10.26	Asset Purchase Agreement between the Company and Nutrition Medical, Inc., dated September 1, 1998.(21)	Incorporated By Reference

10.27	Intentionally left blank.

10.28	Asset Purchase Agreement Amendment 1 between the Company and Nutrition Medical, Inc., dated October 28, 1998.(22)	Incorporated By Reference

10.29	Asset Purchase Agreement Amendment 2 between the Company and Nutrition Medical, Inc., dated December 23, 1998.(23)	Incorporated By Reference

#10.30	Collaboration and License Agreement between the Company and American Home Products Corporation acting through its Wyeth-Ayerst Laboratories Division, dated October 15, 1998. (24)	Incorporated By Reference

#10.31	Manufacturing and Supply Agreement between the Company and American Home Products Corporation acting through its Wyeth-Ayerst Laboratories Division dated October 15, 1998.(24)	Incorporated By Reference

#10.32	Product Development Collaboration, Manufacturing and Supply, and Retail Marketing Agreement between the Company and General Nutrition Corporation, dated December 22, 1998.(24)	Incorporated By Reference

10.33	Intentionally left blank

10.34	Repurchase Agreement by and between GalaGen Inc. and Chiron Corporation, dated April 1, 1999. (31)	Incorporated By Reference

#10.35	Licensing and Distribution Agreement by and between GalaGen Inc. and American Institutional Products, Inc., dated March 15, 1999.(31)	Incorporated By Reference

10.36	Intentionally left blank

10.37	Licensing and distribution agreement between GalaGen Inc. and American Institutional Products, Inc., dated July 15, 1999. (32)	Incorporated By Reference

#10.38	Licensing Agreement by and between GalaGen Inc. and Novartis Consumer Health, Inc., dated October 25, 1999. (33)	Incorporated By Reference

#10.39	Supply Agreement by and between GalaGen Inc. and Novartis Consumer Health, Inc., dated October 25, 1999. (33)	Incorporated By Reference

#10.40	Development Agreement by and between GalaGen Inc. and Novartis Consumer Health, Inc., dated December 17, 1999. (33)	Incorporated By Reference

10.41	301 Carlson Parkway Lease between Carlson Real Estate Company and Galagen, Inc. dated June, 2000. (34)	Incorporated By Reference

#10.42	Supply Agreement between Estee Lauder, Inc. and Galagen, Inc. (34)	Incorporated By Reference

*10.43	Employment Agreement with Robert Hoerr, M.D., dated December 6, 2000. (35)	Incorporated By Reference

*10.44	Employment Agreement with Henry J. Cardello, dated December 6, 2000. (35)	Incorporated By Reference

*10.45	Employment Agreement with Franklin L. Kuhar, dated December 6, 2000. (35)	Incorporated By Reference

(1)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Registration Statement on Form S-1 (Registration No. 333-1032).

(2)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1996 (File No. 0-27976).

(3)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 1996 (File No. 0-27976).

(4)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Annual Report on Form 10-K for the period ended December 31, 1996 (File No. 0-27976).

(5)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 1997 (File No. 0-27976).

(6)		Incorporated herein by reference to Appendix A to the Company’s 1997 Definitive Proxy Statement on Schedule 14A (File No. 0-27976).

(7)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 1997 (File No. 0-27976).

(8)		Incorporated herein by reference to Exhibit No. 99 to the Company’s Report on Form 8-K, dated October 13, 2000 (File No. 0-27976).

(9)		Intentionally not used.

(10)		Incorporated by reference to the same numbered exhibit to the Company’s Current Report on Form 8-K dated December 6, 2000 (File No. 0-27976).

(11)		Intentionally not used.

(12)		Intentionally not used.

(13)		Incorporated herein by reference to Exhibit No. 4.9 to the Company’s Registration Statement on Form S-3 (Registration No. 333-41151).

(14)		Incorporated herein by reference to Exhibit No. 4.10 to the Company’s Registration Statement on Form S–3(Registration No. 333-41151).

(15)		Incorporated herein by reference to Exhibit No. 4.11 to the Company’s Registration Statement on Form S–3 (Registration No. 333-41151).

(16)		Incorporated herein by reference to Exhibit No. 4.12 to Amendment No. 1 to the Company’s Registration Statement on Form S-3 (Registration No. 333-41151).

(17)		Incorporated herein by reference to Exhibit No. 4.13 to Amendment No. 1 to the Company’s Registration Statement on Form S-3 (Registration No. 333-41151).

(18)		Intentionally not used.

(19)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Annual Report on Form 10-K for the period ended December 31, 1997 (File No. 0-27976).

(20)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 1998 (File No. 0-27976).

(21)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 1998 (File No. 0-27976).

(22)		Incorporated herein by reference to Exhibit No. 2.2 to the Company’s Report on Form 8-K, dated December 23, 1998 (File No. 0-27976).

(23)		Incorporated herein by reference to Exhibit No. 2.3 to the Company’s Report on Form 8-K, dated December 23, 1998 (File No. 0-27976).

(24)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Annual Report on Form 10-K for the period ended December 31, 1998 (File No. 0-27976).

(25)		Incorporated herein by reference to Exhibit No. 4.5 to Amendment No. 2 to the Company’s Registration Statement on Form S-3/A (Registration No. 333-71883).

(26)		Incorporated herein by reference to Exhibit No. 4.6 to Amendment No. 2 to the Company’s Registration Statement on Form S-3/A (Registration No. 333-71883).

(27)		Incorporated herein by reference to Exhibit No. 4.7 to Amendment No. 2 to the Company’s Registration Statement on Form S-3/A (Registration No. 333-71883).

(28)		Incorporated herein by reference to Exhibit No. 4.8 to Amendment No. 2 to the Company’s Registration Statement on Form S-3/A (Registration No. 333-71883).

(29)		Incorporated herein by reference to Exhibit No. 4.9 to Amendment No. 2 to the Company’s Registration Statement on Form S-3/A (Registration No. 333-71883).

(30)		Incorporated herein by reference to Exhibit No. 4.10 to Amendment No. 2 to the Company’s Registration Statement on Form S-3/A (Registration No. 333-71883).

(31)		Intentionally not used

(32)		Intentionally not used

(33)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Annual Report on Form 10-K for the Year Ended December 31, 1999. (File No. 0-27976)

(34)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2000. (File No. 0-27976)

(35)		Incorporated herein by reference to the same numbered Exhibit to the Company’s Annual Report on fForm 10K, as amended, for the year ended December 31, 2000. (File No. 0-27976)

*		Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K.

#		Contains portions for which confidential treatment has been granted to the Company.

(b) Reports on Form 8-K

Form 8-K dated January 8, 2001 regarding the initiation of trading in the Company’s common stock on the Over-the-Counter Bulletin Board.

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.

	GalaGen Inc.
	(Registrant)

Date: May 15, 2001	By: /s/ Henry J. Cardello
	Henry J. Cardello,
	Chief Executive Officer


Date: May 15, 2001	By: /s/ Franklin L. Kuhar
	Franklin L. Kuhar,
	Vice President, Chief Financial Officer, Secretary (Principal Financial Officer and Principal Accounting Officer

GALAGEN INC 10-Q