GALAGEN INC
10-Q, 1999-11-15
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
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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 September 30, 1999.
 
or
 
/ /
 
 
 
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
incorporation or organization)
  (I.R.S. Employer
Identification No.)
 
1275 Red Fox Road
Arden Hills, Minnesota
 
 
 
 
55112-6943

(Address of principal executive offices)   (Zip Code)
 
(651) 634-4230

(Registrant's telephone number, including area code)
 

(Former name, former address and former fiscal year, if changed since last report)

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 — 10,408,535 shares as of November 5, 1999.




INDEX
GALAGEN INC.

 
 
 
 
 
 

 
 
 
Page

PART I. FINANCIAL INFORMATION    
 
Item 1.
 
 
 
Financial Statements (Unaudited)
 
 
 
 
 
 
 
 
 
Balance Sheets — September 30, 1999 and December 31, 1998
 
 
 
3
 
 
 
 
 
Statements of Operations — Three and nine months ended September 30, 1999 and September 30, 1998
 
 
 
4
 
 
 
 
 
Statements of Cash Flows — Nine months ended September 30, 1999 and September 30, 1998
 
 
 
5
 
 
 
 
 
Notes to Financial Statements
 
 
 
6
 
Item 2.
 
 
 
Management's Discussion and Analysis of Financial Condition and Results of Operations
 
 
 
8
 
PART II. OTHER INFORMATION
 
 
 
 
 
Item 6.
 
 
 
Exhibits and Reports on Form 8-K
 
 
 
15
 
SIGNATURES
 
 
 
20

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

GALAGEN INC.

BALANCE SHEETS

 
 
 
 
 
September 30,
1999

 
 
 
December 31,
1998

 
 
 
  (Unaudited)

   
 
ASSETS              
Current assets:              
Cash and cash equivalents   $ 2,445,630   $ 4,081,733  
Available-for-sale securities     499,158      
Accounts receivable, net of allowance — $24,167 in 1999, $14,020 in 1998     490,074     314,579  
Inventory     210,535     303,150  
Prepaid expenses     154,530     197,994  
   
 
 
Total current assets     3,799,927     4,897,456  
Property and equipment     683,612     671,796  
Less accumulated depreciation     (367,627 )   (270,418 )
   
 
 
      315,985     401,378  
Other assets     602,417     774,659  
Goodwill     122,629     219,847  
   
 
 
      725,046     994,506  
Total assets   $ 4,840,958   $ 6,293,340  
   
 
 
LIABILITIES AND STOCKHOLDERS' EQUITY              
Current liabilities:              
Accounts payable   $ 393,641   $ 641,922  
Other current liabilities     175,184     336,992  
Convertible debentures         193,333  
   
 
 
Total current liabilities     568,825     1,172,247  
Commitments              
Other long-term liabilities     45,000     45,000  
Stockholders' equity:              
Preferred stock, $.01 par value:              
Authorized shares — 15,000,000              
Issued and outstanding shares — none in 1999 and 1998          
Common stock, $.01 par value:              
Authorized shares — 40,000,000              
Issued and outstanding shares — 10,408,535 in 1999; 8,948,446 in 1998     104,085     89,484  
Additional paid-in capital     64,069,760     62,386,292  
Accumulated deficit     (59,931,609 )   (57,339,283 )
Deferred compensation     (15,103 )   (60,400 )
   
 
 
Total stockholders' equity     4,227,133     5,076,093  
   
 
 
Total liabilities and stockholders' equity   $ 4,840,958   $ 6,293,340  
   
 
 

See accompanying notes.

Note: The balance sheet at December 31, 1998 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
September 30

  Nine Months Ended
September 30

 
 
 
 
 
 
1999

 
 
 
1998

 
 
 
1999

 
 
 
1998

 
 
Revenues:                          
Product sales   $ 577,613   $ 160,890   $ 1,494,392   $ 173,699  
Product licensing, development and royalty revenues     319,220         594,416      
   
 
 
 
 
      896,833     160,890     2,088,808     173,699  
Operating expenses:                          
Cost of goods sold     246,620     60,447     635,691     66,852  
Selling, general and administrative     838,029     570,281     2,433,314     1,531,499  
Product development     426,274     217,326     1,208,528     1,489,388  
Depreciation and amortization     157,340     123,894     524,422     530,190  
   
 
 
 
 
      1,668,263     971,948     4,801,955     3,617,929  
   
 
 
 
 
Operating loss     (771,430 )   (811,058 )   (2,713,147 )   (3,444,230 )
Interest income     35,404     42,928     131,548     235,204  
Interest expense         (110,751 )   (10,727 )   (492,725 )
   
 
 
 
 
Net loss   $ (736,026 ) $ (878,881 ) $ (2,592,326 ) $ (3,701,751 )
   
 
 
 
 
Net loss per share                          
Basic and Diluted   $ (0.07 ) $ (0.11 ) $ (0.26 ) $ (0.46 )
Weighted average number of common shares outstanding                          
Basic and Diluted     10,408,535     8,284,673     9,805,215     8,115,654  

See accompanying notes.


GALAGEN INC.
STATEMENTS OF CASH FLOWS
(Unaudited)

 
  Nine Months Ended
September 30

 
 
 
 
 
 
1999

 
 
 
1998

 
 
Operating activities:              
Net loss   $ (2,592,326 ) $ (3,701,751 )
Adjustments to reconcile net loss to cash used in operating activities:              
Depreciation, amortization and other noncash     548,565     845,004  
Changes in operating assets and liabilities     (448,060 )   141,174  
   
 
 
Net cash used in operating activities     (2,491,821 )   (2,715,573 )
   
 
 
Investing activities:              
Payment for asset purchase     (113,901 )    
Purchase of property and equipment     (11,816 )   (34,178 )
Change in available-for-sale securities     (499,158 )   5,128,180  
   
 
 
Net cash provided (used) by investing activities     (624,875 )   5,094,002  
   
 
 
Financing activities:              
Proceeds from common stock     1,894,689     214,304  
Payment for warrant repurchase     (375,000 )    
Net payment on debt     (39,096 )   (139,730 )
   
 
 
Net cash provided by financing activities     1,480,593     74,574  
   
 
 
Increase (decrease) in cash     (1,636,103 )   2,453,003  
Cash and cash equivalents at beginning of period     4,081,733     155,908  
   
 
 
Cash and cash equivalents at end of period   $ 2,445,630   $ 2,608,911  
   
 
 
 
Schedule of noncash investing and financing activities:
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Conversion of convertible promissory notes, plus related accrued interest, to common stock   $ 217,475   $ 1,021,552  
Valuation of issued options and warrants         62,500  
Conversion of note to operating lease         1,047,904  

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 nine months ended September 30, 1999, are not necessarily indicative of the results that may be expected for the year ending December 31, 1999. 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 for the fiscal year ended December 31, 1998.

2. Summary of Significant Accounting Policies

Development Stage

    Prior to 1998 the Company was a development stage company.

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.

Reclassification

    Certain prior year amounts have been reclassified to conform with the current year presentation.

Net Loss Per Share

    Net loss per share is presented in accordance with the provisions of Statement of Financial Accounting Standards No. 128,  Earnings per Share ("Statement 128"). Under Statement 128, basic earnings per share is computed by dividing the net loss by the weighted average number of common shares outstanding for the year. Diluted earnings 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 earnings per share are the same in all periods presented as all potential common shares were antidilutive.

Investments

    Investments in debt securities with a remaining maturity of more than three months at the date of purchase are classified as available-for-sale securities. Management determines the appropriate classification of debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. The carrying value of the investments approximates their estimated market value at September 30, 1999. As of September 30, 1999 the investments were corporate commercial paper securities with a contractual maturity of less than one year.

Inventory

    Inventories are stated at the lower of cost or market using the first-in, first-out method. The Company evaluates the need for reserves associated with obsolete inventory as needed. Inventory at September 30, 1999 and December 31, 1998 consisted of the following:

 
 
 
 
 
1999

 
 
 
1998

Finished goods   $ 54,962   $ 235,155
Raw materials and supplies     155,573     67,995
   
 
    $ 210,535   $ 303,150
   
 

    In accordance with a July 1999 licensing and distribution agreement between the Company and American Institutional Products, Inc. ("AIP"), now known as Hormel Health Labs ("HHL"), a wholly owned subsidiary of Hormel Foods Corporation, the Company sold their clinical nutrition products inventory to HHL at cost. In August 1999, approximately $384,000 of clinical nutrition finished good inventory was shipped to HHL, and in October 1999 approximately $164,000 of clinical nutrition finished good and raw material inventory was shipped to HHL.

3. Equity Financings

    In April 1999, the Company raised $1,972,500 through the private placement sale of 1,315,000 shares of common stock. The shares sold in the private placement were at an 8% discount to the closing price of the common stock on the Nasdaq Stock Market on the closing date.

    In November 1997, the Company raised $1,500,000 through the private placement sale of 6% convertible debentures (the "Debentures") to three institutional investors. Costs associated with the Debentures were amortized over the term of the Debentures. In 1999 and 1998, $200,000 and $1,300,000 of Debenture principal plus accrued interest was converted into the aggregate maximum of 139,927 shares and 1,260,073 shares of common stock, respectively. Under the terms of the Debentures, there was a limitation on the maximum number of shares of common stock that could be issued upon conversion of the Debentures. That maximum was reached through the conversions in 1999 and as a result the Company repaid remaining Debenture principal plus accrued interest of approximately $39,000 in 1999.

4. Operating Lease

    In June 1997, the Company established a note payable for approximately $1,319,000 for fixed assets with Transamerica Business Credit Corporation ("Transamerica"). In June 1998, the Company converted the note payable into an operating lease. At the time of the conversion the net book value of the associated assets approximated the note payable balance. Terms of the operating lease include monthly payments through May 2001 of approximately $36,000 with a final payment of $165,000 in June 2001. The operating lease is secured by the Company's property and equipment. Transamerica received a warrant for 40,000 shares of common stock exercisable at $2.50 per share as part of the June 1997 transaction. The warrant was valued at approximately $79,000 and was amortized to interest expense over the term of the note payable.

5. Subsequent Event

    In November 1999, the Company entered into a licensing agreement and a supply agreement with Novartis Consumer Health, Inc. ("Novartis"). The licensing agreement grants a license in certain Proventra technology to Novartis in exchange for a non refundable license fee, additional payments based upon first product sales, royalty payments and milestone payments based upon total product sales. In addition the Company will provide Proventra ingredients to Novartis under the supply agreement.

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 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Such statements are subject to risks and uncertainties, including those discussed under "Risk Factors" below, 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. Certain forward-looking statements are indicated below by an asterisk. See also "Disclosure Regarding 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. A critical factor for success of the Company is its immune-enhancing ingredient which has been branded Proventra™ 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. The Company is working with Land O'Lakes and an independent third party consumer 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.

    In October 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 this agreement, the two companies will explore development of nutritious beverages for the health-conscious consumer.

    In March 1999, the Company also entered into a licensing and distribution agreement with AIP. AIP 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 it's line of critical care nutrition products, previously acquired from NM Holdings, Inc.("NMI"), to HHL, formerly AIP, a wholly-owned subsidiary of Hormel Foods Corporation. The licensing agreement granted HHL worldwide rights to manufacture, distribute, market and sell the Company's clinical nutrition 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 clinical nutrition critical care products on a limited basis in September 1999, and on an exclusive basis effective October 1999.

    In November 1999, the Company entered into a collaborative licensing and supply agreement with Novartis. The Company granted Novartis rights to certain Proventra technology for which the Company will supply the Proventra ingredients (see Note 5 of Notes to Financial Statements).

Results of Operations

For the Three Months ended September 30, 1999 and 1998

    General.  The net loss decreased by $142,855, or 16.3%, for the three months ended September 30, 1999 to $736,026 from $878,881 for the same period in 1998. The decrease was due primarily to increased product sales and product development revenues and reduced interest expense as a result of the debt conversion (see Note 3 of Notes to Financial Statements). Cost of goods sold increased due to increased product sales and selling, marketing and general and administrative expense increased in support of the consumer and clinical nutrition product programs.

    Revenues.  For the three months ended September 30, 1999 revenues consisted of approximately $459,000 of clinical nutrition product sales, approximately $119,000 of consumer product sales and approximately $319,000 from product development and royalty revenues. For the three months ended September 30, 1998 revenues consisted of approximately $141,000 of clinical nutrition product sales and approximately $20,000 from consumer product sales.

    Cost of Goods Sold.  For the three months ended September 30, 1999 and 1998 the increased cost of goods sold due to increased sales was approximately $247,000 and $60,000, respectively.

    Selling, General and Administrative Expenses.  Selling, general and administrative expenses increased $267,748, or 47.0%, for the three months ended September 30, 1999 to $838,029 from $570,281 for the third quarter of 1998. The increase of approximately $267,000 is due to increased sales, marketing and personnel expense for the Company's consumer and critical care nutrition products.

    Product Development Expenses.  Expenses for product development increased $208,948, or 96.1%, for the three months ended September 30, 1999 to $426,274 from $217,326 for the three months ended September 30, 1998. In the third quarter of 1998 the Company received $250,000, for return of license rights, which reduced product development expenses.

    Depreciation and Amortization.  Depreciation and amortization for the three months ended September 30, 1999 increased $33,446, or 27.0%, to $157,340 from $123,894 for the same period in 1998. The increase was primarily due to increased intangible asset amortization related to the Company's acquisition of certain assets from NMI.

    Interest Income.  Interest income for the three months ended September 30, 1999 decreased $7,524, or 17.5%, to $35,404 from $42,928 for the same period in 1998. The decrease was primarily attributable to the decreased level of invested funds.

    Interest Expense.  Interest expense was zero for the three months ended September 30, 1999 compared to $110,751 for three months ended September 30, 1998. For the three months ended September 30, 1998, interest expense consisted primarily of amortization of the value of the warrants plus the expense of the discount in connection with the Company's convertible debentures issued in November 1997 which were subsequently converted or paid (see Note 3 of Notes to Financial Statements).

For the Nine Months ended September 30, 1999 and 1998

    General.  The net loss decreased by $1,109,425, or 30.0%, for the nine months ended September 30, 1999 to $2,592,326 from $3,701,751 for the same period in 1998. The decrease was due primarily to increased product sales and product development revenues, decreased product development expense due to the discontinuation of the pharmaceutical program and reduced interest expense as a result of the debt conversion. Cost of goods sold increased due to increased product sales and selling, marketing and general and administrative expense increased in support of the consumer and clinical nutrition product programs.

    Revenues.  For the nine months ended September 30, 1999 revenues consisted of approximately $1,344,000 of clinical nutrition product sales, approximately $151,000 of consumer product sales and approximately $594,000 from product development and royalty revenues. For the nine months ended September 30, 1998 revenues consisted of approximately $141,000 from clinical nutrition product sales and approximately $33,000 of consumer product sales.

    Cost of Goods Sold.  For the nine months ended September 30, 1999 and 1998 the increased cost of goods sold due to increased product sales was approximately $636,000 and $67,000, respectively.

    Selling, General and Administrative Expenses.  Selling, general and administrative expenses increased $901,815, or 58.9%, for the nine months ended September 30, 1999 to $2,433,314 from $1,531,499 for the first nine months of 1998. Approximately $848,000 of the increase is due to increased sales, marketing and personnel expense for the Company's consumer and critical care nutrition products, approximately $34,000 of the increase is due to operating lease expenses associated with the Company's June 1998 note payable conversion (see Note 4 of Notes to Financial Statements) and approximately $20,000 of the increase is from increased outside service expense.

    Product Development Expenses.  Expenses for product development decreased $280,860, or 18.9%, for the nine months ended September 30, 1999 to $1,208,528 from $1,489,388 for the same period in 1998. For the nine months ended September 30, 1999 research and personnel expenses associated with the product development programs decreased approximately $394,000 and expenses associated with the Company's terminated pharmaceutical products program decreased approximately $305,000. These decreases were offset by increased pilot plant operating lease expense of approximately $168,000. For the nine months ended September 30, 1998 the Company received $250,000, for return of license rights, which reduced product development expenses.

    Depreciation and Amortization.  Depreciation and amortization for the nine months ended September 30, 1999 decreased $5,768, or 1.1%, to $524,422 from $530,190 for the same period in 1998. The decrease was primarily due to decreased depreciation expense related to the Company's operating lease conversion (see Note 4 of Notes to Financial Statements) partially offset by increased intangible asset amortization related to the Company's acquisition of certain assets from NMI.

    Interest Income.  Interest income for the nine months ended September 30, 1999 decreased $103,656, or 44.1%, to $131,548 from $235,204 for the same period in 1998. The decrease was primarily attributable to the decreased level of invested funds.

    Interest Expense.  Interest expense decreased $481,998, or 97.8%, for the nine months ended September 30, 1999 to $10,727 from $492,725 for the nine months ended September 30, 1998. For the nine months ended September 30, 1998, interest expense consisted primarily of amortization of the value of the warrants plus the value of the discount in connection with the Company's convertible debentures issued in November 1997, which were subsequently converted or paid (see Note 3 of Notes to Financial Statements), and interest expense associated with the Company's note payable (see Note 4 of Notes to Financial Statements).

Liquidity and Capital Resources

    Cash used in operating activities decreased by $223,752, or 8.2%, for the nine months ended September 30, 1999 to $2,491,821 from $2,715,573 for the same period in 1998. Cash used in operations for the nine months ended September 30, 1999 was used primarily to fund operating losses, as well as repayment of current obligations. In August 1999 the Company sold, and HHL paid for, finished goods inventory valued at a cost of approximately $384,000. Cash used in operations for the same period in 1998 was used primarily to fund operating losses.

    For the nine months ended September 30, 1999, the Company invested $499,158 in available-for-sale securities, $113,901 in purchased product development technology and $11,816 in computer equipment and manufacturing equipment in support of Company operations. For the same period in 1998, the Company redeemed $5,128,180 of its available-for-sale securities and invested $34,178 in equipment related to the Company's pilot plant manufacturing facility.

    In April 1999, the Company completed the sale of newly issued common stock that resulted in $1,972,500 of private placement funding. The stock was sold at $1.50 per share. Also in April 1999, the Company repurchased three warrants that were initially granted to Chiron Corporation in March 1995 for $375,000.

    The Company anticipates that its existing resources and interest thereon will be sufficient to satisfy its anticipated cash requirements through approximately the fourth quarter of 2000.* The Company's working capital and capital requirements will depend upon numerous factors, including revenue from product sales, 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 and marketing activities that may be required in the future. The Company's ability to continue funding its planned operations beyond the fourth quarter of 2000 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 it 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.*

Year 2000 Issues

    The Company began the process of assessing its risks associated with Year 2000 date conversion in 1998. This assessment included three main areas:

    The Company concluded that the Year 2000 risk was focused mainly in the area of its business computer hardware and computer software applications. The Company has addressed Year 2000 risks by:


    The Company's manufacturing facility, completed and operational in mid-1997, has been Year 2000 compliant since inception. The most reasonably likely worst case scenario would be the inability of the Company to have its recently licensed critical care nutrition products manufactured and distributed on a timely basis, which could result in decreased royalty revenue for the Company.

Disclosure Regarding Forward-Looking Statements

    This Form 10-Q for the nine months ended September 30, 1999 contains certain forward-looking statements within the meaning of Section 21E of the Exchange Act. Such forward-looking statements are based on the beliefs of the Company's management as well as on assumptions made by and information currently available to the Company at the time such statements were made. When used in this Form 10-Q, the words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to the Company, are intended to identify such forward-looking statements. Although the Company believes these statements are reasonable, readers of this Form 10-Q should be aware that actual results could differ materially from those projected by such forward-looking statements as a result among other things of the risk factors listed below and set forth in the Company's Annual Report on Form 10-K for 1998 ("Form 10-K") under the caption "Risk Factors." Readers of this Form 10-Q should consider carefully the factors listed below and under the caption "Risk Factors" in the Company's Form 10-K, as well as the other information and data contained in this Form 10-Q. The Company cautions the reader, however, that such factors under the caption "Risk Factors" in the Company's Form 10-K may not be exhaustive and that those or other factors, many of which are outside of the Company's control, could have a material adverse effect on the Company and its results of operations. Factors that could cause actual results to differ include, without limitation, the Company's ability to achieve a profitable level of operations, to generate sufficient working capital and obtain necessary financing to meet capital requirements, loss of Nasdaq Stock Market listing, the Company's ability to form strategic alliances with product development, marketing and distribution partners, the Company's exposure to product liability claims, delays or high costs in product development, consumers' perception of product safety and quality, the Company's reliance on flawed market research, potential competitors that are larger and financially stronger, the Company's ability to receive regulatory approval for its products, the Company's ability to manufacture an acceptable product on a commercial scale and risks associated with the Year 2000 computer issue. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth hereunder and under the caption "Risk Factors" in the Company's Form 10-K.

Risk Factors

    Certain statements made above, including those indicated by an asterisk (some of which are summarized below), are forward-looking statements that involve risks and uncertainties, and actual results may differ. Factors that could cause actual results to differ include those identified below.

    We may not ever achieve a profitable level of operations.

    Our ability to achieve profitable operations depends in large part on:


    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 almost $60 million as of September 30, 1999. 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 long-term ability to continue funding our planned operations depends on our ability to obtain additional funds through:


    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 eventually become insolvent or bankrupt.

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

    If we rely on inaccurate market information, we could make decisions that have 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 pilot plant 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 2000. 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 or our collaborators' inability to bring products to market could have a material adverse effect on our business and financial condition. We anticipate that products containing Proventra will be introduced in particular markets in the remainder of 1999 through collaborations we have established with other companies. However, introduction of these products to test markets on schedule depends on our ability and our collaborators' ability to accomplish the following:


    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 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.

PART II. OTHER INFORMATION

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

(a)
Exhibits

 
Exhibit No.
 
 
 
Description

 
 
 
Method of Filing

         
3.1   Intentionally left blank.    
3.2   Restated Certificate of Incorporation of the Company.(3)   Incorporated By Reference
3.3   Intentionally left blank.    
3.4   Restated Bylaws of the Company.(1)   Incorporated By Reference
4.1   Specimen Common Stock Certificate.(1)   Incorporated By Reference
4.2-4.5   Intentionally left blank.    
4.6   Form of Common Stock Warrant to purchase shares of Common Stock of the Company, issued in connection with the sale of Convertible Promissory Notes.(1)   Incorporated By Reference
4.7-4.10   Intentionally left blank.    
4.11   Warrant to purchase 18,250 shares of Common Stock of the Company issued to IAI Investment Funds VI, Inc. (IAI Emerging Growth Fund), dated January 30, 1996.(1)   Incorporated By Reference
4.12   Warrant to purchase 6,250 shares of Common Stock of the Company issued to IAI Investment Funds IV, Inc. (IAI Regional Fund), dated January 30, 1996.(1)   Incorporated By Reference
4.13   Warrant to purchase 25,000 shares of Common Stock of the Company issued to John Pappajohn, dated February 2, 1996.(1)   Incorporated By Reference
4.14   Warrant to purchase 25,000 shares of Common Stock of the Company issued to Edgewater Private Equity Fund, L.P., dated February 2, 1996.(1)   Incorporated By Reference
4.15   Warrant to purchase 10,000 shares of Common Stock of the Company issued to Joseph Giamenco, dated February 2, 1996.(1)   Incorporated By Reference
4.16   Warrant to purchase 25,000 shares of Common Stock of the Company issued to Gus A. Chafoulias, dated February 2, 1996.(1)   Incorporated By Reference
4.17   Warrant to purchase 25,000 shares of Common Stock of the Company issued to JIBS Equities, dated February 2, 1996.(1)   Incorporated By Reference
4.18   Warrant to purchase 25,000 shares of Common Stock of the Company issued to Land O'Lakes, Inc., dated February 2, 1996.(1)   Incorporated By Reference
4.19   6% Convertible Debenture Purchase Agreement dated November 18, 1997 among the Company and the Purchasers named therein.(8)   Incorporated By Reference
4.20   Registration Rights Agreement dated November 18, 1997 among the Company and the Holders named therein.(9)   Incorporated By Reference
4.21-4.23   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
#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   Letter agreement with Henry J. Cardello, dated January 1, 1999.(31)   Incorporated By Reference
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   Letter agreement with Frank L. Kuhar, dated June 3, 1999.   Electronic Transmission
10.37   Licensing and distribution agreement between GalaGen Inc. and American Institutional Products, Inc., dated July 15, 1999.   Electronic Transmission
27.1   Financial Data Schedule for the nine months ended September 30, 1999.   Electronic Transmission

(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. 4.4 to the Company's Registration Statement on Form S-3 (Registration No. 333-41151).

(9)
Incorporated herein by reference to Exhibit No. 4.5 to the Company's Registration Statement on Form S-3 (Registration No. 333-41151).

(10)
Intentionally not used.

(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)
Incorporated herein by reference to the same numbered Exhibit to the Company's Quarterly Report on Form 10-Q for the period ended March 31, 1999 (File No. 0-27976).

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

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

(b)
Reports on Form 8-K

    No reports on Form 8-K were filed during the quarter ended September 30, 1999.


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:
 
 
 
November 15, 1999
 
 
 
By:
 
 
 
/s/  
ROBERT A. HOERR
           
            Robert A. Hoerr,
Chairman and Chief Executive Officer
(Principal Executive Officer)
 
Date:
 
 
 
November 15, 1999
 
 
 
By:
 
 
 
/s/  
FRANK L. KUHAR
           
Frank L. Kuhar
Chief Financial Officer
(Principal Financial and Accounting Officer)


Exhibit Index

 
Exhibit No.
 
 
 
Description

 
 
 
Method of Filing

         
3.1   Intentionally left blank.    
3.2   Restated Certificate of Incorporation of the Company.(3)   Incorporated By Reference
3.3   Intentionally left blank.    
3.4   Restated Bylaws of the Company.(1)   Incorporated By Reference
4.1   Specimen Common Stock Certificate.(1)   Incorporated By Reference
4.2-4.5   Intentionally left blank.    
4.6   Form of Common Stock Warrant to purchase shares of Common Stock of the Company, issued in connection with the sale of Convertible Promissory Notes.(1)   Incorporated By Reference
4.7-4.10   Intentionally left blank.    
4.11   Warrant to purchase 18,250 shares of Common Stock of the Company issued to IAI Investment Funds VI, Inc. (IAI Emerging Growth Fund), dated January 30, 1996.(1)   Incorporated By Reference
4.12   Warrant to purchase 6,250 shares of Common Stock of the Company issued to IAI Investment Funds IV, Inc. (IAI Regional Fund), dated January 30, 1996.(1)   Incorporated By Reference
4.13   Warrant to purchase 25,000 shares of Common Stock of the Company issued to John Pappajohn, dated February 2, 1996.(1)   Incorporated By Reference
4.14   Warrant to purchase 25,000 shares of Common Stock of the Company issued to Edgewater Private Equity Fund, L.P., dated February 2, 1996.(1)   Incorporated By Reference
4.15   Warrant to purchase 10,000 shares of Common Stock of the Company issued to Joseph Giamenco, dated February 2, 1996.(1)   Incorporated By Reference
4.16   Warrant to purchase 25,000 shares of Common Stock of the Company issued to Gus A. Chafoulias, dated February 2, 1996.(1)   Incorporated By Reference
4.17   Warrant to purchase 25,000 shares of Common Stock of the Company issued to JIBS Equities, dated February 2, 1996.(1)   Incorporated By Reference
4.18   Warrant to purchase 25,000 shares of Common Stock of the Company issued to Land O'Lakes, Inc., dated February 2, 1996.(1)   Incorporated By Reference
4.19   6% Convertible Debenture Purchase Agreement dated November 18, 1997 among the Company and the Purchasers named therein.(8)   Incorporated By Reference
4.20   Registration Rights Agreement dated November 18, 1997 among the Company and the Holders named therein.(9)   Incorporated By Reference
4.21-4.23   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

 
Exhibit No.
 
 
 
Description

 
 
 
Method of Filing

         
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
#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

 
Exhibit No.
 
 
 
Description

 
 
 
Method of Filing

         
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   Letter agreement with Henry J. Cardello, dated January 1, 1999.(31)   Incorporated By Reference
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

 
Exhibit No.
 
 
 
Description

 
 
 
Method of Filing

         
*10.36   Letter agreement with Frank L. Kuhar, dated June 3, 1999.   Electronic Transmission
10.37   Licensing and distribution agreement between GalaGen Inc. and American Institutional Products, Inc., dated July 15, 1999.   Electronic Transmission
27.1   Financial Data Schedule for the nine months ended September 30, 1999.   Electronic Transmission

(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. 4.4 to the Company's Registration Statement on Form S-3 (Registration No. 333-41151).

(9)
Incorporated herein by reference to Exhibit No. 4.5 to the Company's Registration Statement on Form S-3 (Registration No. 333-41151).

(10)
Intentionally not used.

(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)
Incorporated herein by reference to the same numbered Exhibit to the Company's Quarterly Report on Form 10-Q for the period ended March 31, 1999 (File No. 0-27976).

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

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

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INDEX GALAGEN INC.
GALAGEN INC. STATEMENTS OF OPERATIONS (Unaudited)
GALAGEN INC. STATEMENTS OF CASH FLOWS (Unaudited)

GALAGEN INC. NOTES TO FINANCIAL STATEMENTS (Unaudited)
SIGNATURES
Exhibit Index



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