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 June 30, 1996. -------------- 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 (I.R.S. Employer incorporation or organization) Identification No.) 4001 Lexington Ave. North Arden Hills, Minnesota 55126 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) (612) 481-2105 - -------------------------------------------------------------------------------- (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-- 7,129,377 shares as of July 26, 1996. INDEX GalaGen Inc. (A Development Stage Company) Page ---- PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) Balance Sheets - June 30, 1996 and December 31, 1995...................3 Statements of Operations - Three month periods ended June 30, 1996 and June 30, 1995, six month periods ended June 30, 1996 and June 30, 1995, and for the period November 17, 1987 (inception) through June 30, 1996....................5 Statements of Cash Flows - Six months ended June 30, 1996 and June 30, 1995 and for the period November 17, 1987 (inception) through June 30, 1996....................6 Notes to Financial Statements..........................................7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations......................10 PART II. OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K......................................13 SIGNATURES....................................................................15 2 PART I - FINANCIAL INFORMATION Item 1. Financial Statements GalaGen Inc. (A Development Stage Company) Balance Sheets June 30, 1996 December 31, 1995 ---------------------------------------- (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 9,075,598 $ 509,339 Available-for-sale securities 6,460,894 - Prepaid and deferred expenses 30,859 81,703 ------------- ------------- Total current assets 15,567,351 591,042 Property, plant, & equipment: 379,993 230,484 Less accumulated depreciation (169,811) (149,783) ------------- ------------- Net property, plant, and equipment 210,182 80,701 Deferred financing expenses - 146,487 ------------- ------------- Total assets $ 15,777,533 $ 818,230 ------------- ------------- ------------- ------------- LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIENCY) Current liabilities: Accounts payable and accrued expenses 667,021 1,623,949 ------------- ------------- Total current liabilities 667,021 1,623,949 Convertible promissory notes, net of discount - 8,198,900 Other long-term liabilities 45,000 698,404 Shareholders' equity(deficiency): Series A Preferred Stock, $.01 par value: - 25,000 Authorized shares - 2,500,000 Issued and outstanding shares - 0 - June 30, 1996 Series B Preferred Stock, $.01 par value: - 12,347 Authorized shares - 1,300,000 Issued and outstanding shares - 0 - June 30, 1996 Series C Preferred Stock, $.01 par value: - 5,510 Authorized shares - 551,000 Issued and outstanding shares - 0 - June 30, 1996 Series E Preferred Stock, $.01 par value: - 3,385 Authorized shares - 5,000,000 Issued and outstanding shares - 0 - June 30, 1996 Series F-1 Preferred Stock, $.01 par value: - 171 Authorized shares - 34,287 Issued and outstanding shares - 0 - June 30, 1996 Preferred Stock, $.01 par value: - - Authorized shares - 15,000,000 pro forma Issued and outstanding shares - none Common stock, $.01 par value: 71,294 19,521 Authorized shares - 40,000,000 Issued and outstanding shares - 7,129,377 - June 30, 1996 Additional paid-in capital 59,125,877 23,812,106 Accumulated deficit (43,105,721) (32,400,329) Deferred compensation (1,010,701) (1,180,734) Unrealized gain/(loss) on available-for- sale securities (15,237) - ------------- ------------- Total shareholders' equity (deficiency) $ 15,065,512 $ (9,703,023) ------------- ------------- Total liabilities and shareholders' equity (deficiency) $ 15,777,533 $ 818,230 ------------- ------------- ------------- ------------- 3 SEE ACCOMPANYING NOTES Note: The balance sheet at December 31, 1995 has been derived from the 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. 4 GalaGen Inc. (A Development Stage Company) Statements of Operations (Unaudited) Period from For the Three Months Ended For the Six Months Ended November 17, 1987 -------------------------- ------------------------ (inception) to June 30, 1996 June 30, 1995 June 30, 1996 June 30, 1995 June 30, 1996 ------------------------------------------------------------------------------- Revenues: Product sales $ - $ - $ - $ - $ 1,449,593 Product royalties - - - - 62,747 Research and development revenues - - - 100,000 396,350 ---------- ---------- ---------- ---------- ------------ - - - 100,000 1,908,690 Operating costs and expenses: Cost of goods sold - - - - 3,468,711 Research and development 1,088,862 1,010,539 1,785,721 2,269,165 19,723,637 General and administrative 437,419 401,673 912,670 703,025 13,071,906 ---------- ---------- ---------- ---------- ------------ Operating loss (1,526,281) (1,412,212) (2,698,391) (2,872,190) (34,355,564) Interest income 202,865 1,236 207,945 4,174 359,749 Interest expense (613,899) (116,515) (918,102) (214,435) (2,418,483) ---------- ---------- ---------- ---------- ------------ Net loss before extraordinary gain (1,937,315) (1,527,491) (3,408,548) (3,082,451) (36,414,298) Extraordinary gain on extinguishment of debt - - - - 605,421 ---------- ---------- ---------- ---------- ------------ Net loss for the period and deficit accumulated during the development stage (1,937,315) (1,527,491) (3,408,548) (3,082,451) (35,808,877) Less preferred stock dividends (7,296,844) - (7,296,844) - (7,296,844) ---------- ---------- ---------- ---------- ------------ Net loss applicable to common shareholders $(9,234,159) $(1,527,491) $(10,705,392) $(3,082,451) $(43,105,721) ---------- ---------- ---------- ---------- ------------ ---------- ---------- ---------- ---------- ------------ Net loss per share applicable to common shareholders: Primary $ (1.30) $ (.76) $ (1.75) $ (1.52) $ (26.65) Fully diluted $ (1.30) $ (.33) $ (1.75) $ (.67) $ (18.59) Weighted average number of common shares outstanding: Primary 7,129,263 2,021,857 6,105,442 2,021,752 1,617,617 Fully diluted 7,129,263 4,593,793 6,105,442 4,616,826 2,318,910 SEE ACCOMPANYING NOTES 5 GalaGen Inc. (A Development Stage Company) Statements of Cash Flows (Unaudited) Period from For the Six Months Ended November 17, 1987 ------------------------ (inception) to June 30, 1996 June 30, 1995 June 30, 1996 ----------------------------------------------------------- OPERATING ACTIVITIES: Net loss $(10,705,392) $ (3,082,451) $(43,105,721) Adjustments to reconcile net loss to cash used in operating activities: Depreciation and amortization 213,157 48,448 1,734,306 Preferred stock dividend 7,296,844 - 7,296,844 Interest expense 768,064 - 768,064 Extraordinary gain - - (605,421) Equity issued for services - 311,078 3,115,224 Changes in operating assets and liabilities (1,457,226) 1,567,936 612,034 ------------ ------------ ------------ Net cash used in operating activities $ (3,884,553) $ (1,154,989) $(30,184,670) ------------ ------------ ------------ INVESTING ACTIVITIES: Purchase of plant, property and equipment, net (149,509) (21,097) (2,136,039) Purchase of available-for-sale securities (29,044,635) - (29,044,635) Sale and maturities of available-for-sale securities 22,583,741 - 22,583,741 ------------ ------------ ------------ Net cash from investing activities $ (6,610,403) $ (21,097) $ (8,596,933) FINANCING ACTIVITIES: Proceeds from equity offering 19,067,619 125,197 32,745,185 Proceeds from notes 500,000 700,000 15,618,420 Payment of notes, including interest (506,404) (506,404) ------------ ------------ ------------ Net cash used in financing activities $ 19,061,215 $ 825,197 $ 47,857,201 ------------ ------------ ------------ Increase (decrease) in cash 8,566,259 (350,889) 9,075,598 Cash and cash equivalents at beginning of period 509,339 430,153 - ------------ ------------ ------------ Cash and cash equivalents at end of period $ 9,075,598 $ 79,264 $ 9,075,598 ------------ ------------ ------------ ------------ ------------ ------------ SCHEDULE OF NON CASH INVESTING AND FINANCING ACTIVITIES: Deferred compensation for employee options - - 1,657,000 Value of convertible debt warrants - 9,333 114,333 Conversion of convertible promissory notes plus related accrued interest, net of financing costs 9,469,075 9,469,075 SEE ACCOMPANYING NOTES. 6 GalaGen Inc. (A Development Stage Company) 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 six month period ended June 30, 1996 are not necessarily indicative of the results that may be expected for the year ended December 31, 1996. These financial statements should be read in conjunction with the audited financial statements and accompanying notes for the fiscal year ended December 31, 1995, contained in the Company's Prospectus dated March 27, 1996. 2. CASH AND CASH EQUIVALENTS Cash equivalents include short-term highly liquid investments purchased at cost, which approximates market, with original maturities of three months or less. 3. INVESTMENTS Investments in debt securities with a remaining maturity of more than 90 days at the date of purchase are classified as marketable securities. Management determines the appropriate classification of debt securities at the time of purchase and reevaluates such designation as of each balance sheet date. Debt securities are classified as available- for-sale as of June 30, 1996. The Company considers the net unrealized gain (loss) on these investments to be temporary, and as such has recorded it through shareholders' equity. The amortized cost and estimated market value of investments are as follows: Amortized Cost Gross Gross Estimated Unrealized Gains Unrealized Losses Market Value ---------------------------------------------------------------------------- As of June 30, 1996 Commercial paper $ 967,272 $ 0 $ 0 $ 967,272 U.S. Government agency securities 990,539 0 (126) 990,413 U.S. Treasury securities 2,487,372 0 0 2,487,372 Investment grade debt securities 2,030,948 0 (15,111) 2,015,837 ---------------- ---------------- ---------------- ---------------- $ 6,476,131 $ 0 $ (15,237) $ 6,460,894 The amortized cost and estimated market value of investments by contractual maturity are as follows: Amortized Cost Gross Gross Estimated Unrealized Gains Unrealized Losses Market Value ---------------------------------------------------------------------------- As of June 30, 1996 Due in one year or less $ 4,445,183 $ 0 $ (126) $ 4,445,057 Due after one year through two years 2,030,948 0 (15,111) 2,015,837 ---------------- ---------------- ---------------- ---------------- $ 6,476,131 $ 0 $ (15,237) $ 6,460,894 4. PROPERTY, PLANT AND EQUIPMENT Property, plant and equipment are recorded at cost. Depreciation and amortization are provided for on the straight line method. At June 30, 1996 construction in progress consisted of leasehold improvements in connection with the Company's pilot plant manufacturing facility (see Note 5 of Notes to Financial Statements below). At June 30, 1996, property and equipment consisted of the following: Furniture, fixtures and equipment $ 250,929 Construction in progress 129,064 --------- 379,993 Less accumulated depreciation (169,811) --------- $ 210,182 7 5. COMMITMENTS During June 1996 the Company entered into a series of leasing agreements with Cargill Leasing Corporation ("Cargill") which includes a Commitment Letter, Master Equipment Lease and an Agreement for Progress Payments (the "Agreements"). The Agreements provide that the Company may purchase up to $1,100,000 of manufacturing equipment for the Company's pilot plant facility through lease take-downs from Cargill. The lease take-down at June 30, 1996 was apprioximately $111,000. The Company expects that the lease take-downs will end in September 1996 at which time full lease payments will commence for a period of seven years with the Company's option to extend for an additional 12 months. Interest upon commencement of full lease payments will be computed on a weighted average of LIBOR and the rate on five year U.S Treasury Notes. Prior to the commencement of full lease payments, the Company is required to make interest payments at prime plus 2% on the lease take- down. The lease is guaranteed by Land O' Lakes, Inc. This lease will be structured as an operating lease in accordance with FASB 13. During June 1996, the Company entered into a five year lease agreement with Land O' Lakes, Inc. for specified space within the Land O' Lakes facility in connection with the Company's pilot plant manufacturing facility. The lease calls for annual payments of approximately $86,000 and can be extended for additional one year periods at the option of the Company. 6. LINE OF CREDIT In January 1996, the Company entered into a $2.7 million line of credit agreement with a commercial bank, which expired with the closing of the Company's initial public offering (the "Offering") on April 1, 1996. Loans under this line of credit were to be guaranteed by six parties and the guarantee was collateralized by letters of credit posted by them in the aggregate amount of $2.7 million. In consideration for the guarantees and letters of credit posted by these parties, the Company issued warrants to purchase an initial aggregate of 162,014 shares of common stock at an exercise price equal to 70% of the Offering price, or $7.00 per share. In connection with this transaction, each of John Pappajohn and Land O'Lakes, Inc., guaranteed $500,000 of the $2.7 million line of credit, and in exchange received a warrant to purchase 30,003 shares of common stock at $7.00 per share. John Pappajohn is a director and shareholder of the Company. Land O'Lakes, Inc. is a shareholder and has a representative serving on the board of directors of the Company. In January 1996, the Company issued two convertible promissory notes for $375,000 and $125,000 to two investment funds controlled by Investment Advisers, Inc., which is a shareholder and has a representative serving on the board of directors of the Company. The notes became due on completion of the Offering. The notes were convertible into Series E Preferred Stock at the option of the holder. In connection with these notes, the Company issued warrants to purchase 30,003 shares which are identical to the line of credit warrants described above. The notes have been repaid. 7. REVERSE STOCK SPLIT On January 19, 1996, the Board approved a reverse stock split of 3.6923-for-1 for the Company's outstanding common stock. The Company's shareholders approved this reverse stock split in March 1996. All information in the financial statements with respect to the common stock and to the conversion prices and ratios of all the preferred stock have been adjusted to reflect this change. The reverse stock split had no effect on the numbers of shares of preferred stock issued and outstanding (as opposed to the conversion prices of all the preferred stock and the numbers of shares of common stock into which the preferred stock will convert). 8. INITIAL PUBLIC OFFERING GalaGen Inc. consummated the Offering on April 1, 1996, which consisted of 2,000,000 shares of common stock at a $10 per share price to the public. All of the Company's preferred stock mandatorily converted into common stock immediately prior to the closing of the Offering. Series A Preferred Stock converted on a 1-for-1 basis, Series B Preferred Stock converted on a 1.625-for-1 basis, Series C Preferred Stock converted on a 1.667-for-1 basis. The terms of the Series D, Series E and Series F-1 Preferred Stock provided that the conversion prices of such stock be automatically adjusted to reflect the lower of their effective conversion price at the time of closing or 70% of the initial public offering price in the Offering. The $7,296,844 value of the additional shares received due to such adjustments by the holders of Convertible Promissory Notes (which converted into Series D Preferred Stock) and the Series E and Series F-1 Preferred Stock upon conversion, based 8 on a conversion price of 70% of the Offering price of $10 per share, was recorded in the second quarter of 1996 as a preferred stock dividend and an increase to the net loss to arrive at net loss available to holders of common stock in the calculation of net loss per share in the second quarter. Additionally, the 192,017 common stock warrants issued for consideration for the guarantee of the Company's $2,700,000 line of credit and for the $375,000 and $125,000 promissory notes described above in Note 6 provide that the exercise price be equal to 70% of the Offering price. The difference between the Offering price and exercise price multiplied by the number of warrants, plus the intrinsic value of the warrants was $768,064. Of that amount, $160,000 was recorded in the first quarter of 1996 as interest expense, and $608,064 was recorded as interest expense in the second quarter of 1996. 9. LOSS PER SHARE The primary loss per share is based on the weighted average common shares outstanding during the period. The fully diluted loss per share assumes the conversion of preferred shares outstanding prior to the initial public offering to common shares as of the beginning of the period. The loss per share for periods prior to April 1, 1996, the closing date of the Offering, also gives effect to the requirements of Staff Accounting Bulletin No. 83 (SAB 83). 9 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations GENERAL GalaGen Inc. is developing oral therapeutics that target life-threatening and infectious diseases such as those caused by antibiotic-resistant and emerging pathogens. The Company's naturally derived immunotherapeutics are comprised of concentrated pathogen-specific polyclonal antibodies which the Company produces in concentrated form using its proprietary immunization technology. The Company's products in development address serious gastrointestinal infections complicating AIDS, cancer and antibiotic therapy, as well as peptic ulcer disease. GalaGen's lead product in development, Sporidin-G, is a polyclonal antibody product with specificity for Cryptosporidium parvum, a parasite which causes chronic, life-threatening diarrhea in AIDS and other immunocompromised patients. RESULTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 1996 AND JUNE 30, 1995 GENERAL. The net loss before preferred stock dividends of $1,937,315 for the three months ended June 30, 1996 is greater than the net loss of $1,527,491 for the three months ended June 30, 1995. Historical spending levels are not indicative of future spending levels because the Company is entering a period of rapid growth in product development activity, which is planned to include substantial increases in costs relating to personnel, research and development activity, small-scale manufacturing facilities and accelerated clinical trial activity. For these reasons, the Company believes its expenses and losses will increase dramatically before any material product revenues are generated. RESEARCH AND DEVELOPMENT EXPENSES. Expenses for research and development increased to $1,088,862 for the three months ended June 30, 1996 from $1,010,539 for the three months ended June 30, 1995. The increase of $78,323 was due primarily to increased spending on clinical trials and research and development personnel expense partially offset by decreased expenses associated with the Company's transgenics program, which was terminated in May 1995. The Company expects research and development expenses to increase as the Company's clinical trials activity accelerates, particularly expenses associated with the development of SPORIDIN-G, the Company's lead product in development aimed at treating C. parvum. GENERAL AND ADMINISTRATIVE EXPENSES. General and administrative expenses increased to $437,419 for the three months ended June 30, 1996 from $401,673 for the three months ended June 30, 1995. The increase of $35,746 was due to increases during the 1996 period in deferred compensation, outside services and expenses associated with additional staffing. INTEREST INCOME AND EXPENSE. Interest income increased to $202,865 for the three months ended June 30, 1996 from $1,236 for the three months ended June 30, 1995. This increase is attributable to the Company's increased level of investable funds which resulted from the Offering. Interest expense increased to $613,899 for the three months ended June 30, 1996 from $116,515 for the three months ended June 30, 1995. The $497,384 increase was due primarily to the value of warrants issued to guarantors of a line of credit and to the purchasers of two promissory notes (see Note 6 of Notes to Financial Statements), offset by decreased Convertible Promissory Note interest expense due to the conversion of such notes into common stock upon the Offering. EXTRAORDINARY GAIN ON EXTINGUISHMENT OF DEBT. The extraordinary gain on extinguishment of debt of $605,421 in 1995 related to certain debt reduction settlements regarding the Company's terminated transgenics program. PREFERRED STOCK DIVIDENDS. The preferred stock dividends of $7,296,844 for the three months ended June 30, 1996 is a result of the value of the additional shares issued to holders of the Series D, Series E and Series F-1 Preferred Stock upon conversion to common stock (see Note 8 of Notes to Financial Statements). 10 SIX MONTHS ENDED JUNE 30, 1996 AND JUNE 30, 1995 GENERAL. The net loss before preferred stock dividends of $3,408,548 for the six months ended June 30, 1996 is greater than the net loss of $3,082,451 for the three months ended June 30, 1995. Historical spending levels are not indicative of future spending levels because the Company is entering a period of rapid growth in product development activity, which is planned to include substantial increases in costs relating to personnel, research and development activity, small-scale manufacturing facilities and accelerated clinical trial activity. For these reasons, the Company believes its expenses and losses will increase dramatically before any material product revenues are generated. RESEARCH AND DEVELOPMENT EXPENSES. Expenses for research and development decreased to $1,785,721 for the six months ended June 30, 1996 from $2,269,165 for the six months ended June 30, 1995. The decrease of $483,444 was due primarily to a onetime $300,000 license fee paid by the Company in March 1995 and the lack of activity during the six months ended June 30, 1996 in the Company's transgenics program, which was terminated in May 1995. GENERAL AND ADMINISTRATIVE EXPENSES. General and administrative expenses increased to $912,670 for the six months ended June 30, 1996 from $703,025 for the six months ended June 30, 1995. The increase of $209,645 was due to increases during the 1996 period in deferred compensation, outside services, and expenses associated with additional staffing. INTEREST INCOME AND EXPENSE. Interest income increased to $207,945 for the six months ended June 30, 1996 from $4,174 for the six months ended June 30, 1995, This increase is attributable to the Company's increased level of investable funds which resulted from the Offering. Interest expense increased to $918,102 for the six months ended June 30, 1996 from $214,435 for the six months ended June 30, 1995. The $703,667 increase was due primarily to the value of warrants issued to guarantors of a line of credit and to the purchasers of additional Convertible Promissory Notes, offset by decreased Convertible Promissory Note interest expense due to the conversion of such notes into common stock. EXTRAORDINARY GAIN ON EXTINGUISHMENT OF DEBT. The extraordinary gain on extinguishment of debt of $605,421 in 1995 related to certain debt reduction settlements regarding the Company's terminated transgenics program. PREFERRED STOCK DIVIDENDS. The preferred stock dividends of $7,296,844 for the six months ended June 30, 1996 is a result of the value of the additional shares issued to holders of the Series D, Series E and Series F-1 Preferred Stock upon conversion to common stock (see Note 8 of Notes to Financial Statements) . LIQUIDITY AND CAPITAL RESOURCES Proceeds from the Company's Offering totalled $17.9 million (after payment of related offering costs of approximately $1.4 million for underwriting fees and $0.7 million for associated offering expenses). The Company anticipates that these resources and interest thereon will enable it to fund its operating expenses and capital requirements as currently planned through approximately the end of the third quarter of 1997. Cash used in operations were $3,884,553 and $1,154,989 for the six months ended June 30, 1996 and 1995, respectively. Cash used in operations went primarily to fund operating losses. The increase of $2,729,564 was due primarily to repayment of certain obligations. The Company invested a net amount of $6,460,894 in available-for-sale debt securities (see Note 3 of Notes to Financial Statements) for the six months ended June 30, 1996 and invested $149,509 and $21,097 for the six months ended June 30, 1996 and 1995, respectively, in computer equipment used to support Company operations. The Company expects to incur substantial additional research and development and other costs, including costs related to clinical studies, as well as capital expenditures necessary to establish commercial scale cGMP manufacturing facilities. The Company will need to raise substantial additional funds for longer term product development, manufacturing and marketing activities it plans to undertake in the future. The Company's ability to continue funding its planned operations beyond the third quarter of 1997 is dependent upon its ability to obtain additional funds through equity or debt financing, strategic alliances, license agreements or from other financing sources. A lack of adequate 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 11 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 it does not have an immediate need for such additional capital at such time. Except for the historical information contained herein, matters discussed in this Management's Discussion and Analysis of Financial Condition and Results of Operations are forward-looking statements that involve risks and uncertainties, and actual results may be materially different. Factors that could cause actual results to differ include: levels of resources devoted by the Company to the development of its manufacturing and marketing capabilities, risks generally associated with construction of manufacturing facilities, the ability of the Company to make technological advances, the status of competitive products, the ability of the Company to establish strategic alliances to provide research and development funding to the Company and other risk factors listed in the Company's Prospectus dated March 27, 1996. 12 Item 6. Exhibits and Reports on Form 8-K. (a) EXHIBITS Exhibit Description ------- ----------- 3.2 Restated Certificate of Incorporation of the Company.(1) 3.4 Restated Bylaws of the Company.(1) 4.1 Specimen Common Stock Certificate.(1) 4.2 Warrant to purchase 13,541 shares of common stock of the Company issued to Piper Jaffray Inc., dated January 26, 1993.(1) 4.3 Warrant to purchase 20,312 shares of common stock of the Company issued to Gus A. Chafoulias, dated October 12, 1993.(1) 4.4 Warrant to purchase 20,312 shares of common stock of the Company issued to John Pappajohn, dated October 12, 1993.(1) 4.5 Warrant to purchase 9,479 shares of common stock of the Company issued to Cato Holding Company, dated June 21, 1994.(1) 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) 4.7 Warrant to purchase 17,144 shares of Series F-1 Convertible Preferred Stock of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.8 Warrant to purchase 42,856 shares of Series F-2 Convertible Preferred Stock of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.9 Warrant to purchase 60,000 shares of Series F-3 Convertible Preferred Stock of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.10 Warrant to purchase 80,000 shares of Series F-3 Convertible Preferred Stock of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.11 Warrant to purchase 18,750 shares of common stock of the Company issued to IAI Investment Funds VI, Inc. (IAI Emerging Growth Fund), dated January 30, 1996.(1) 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) 4.13 Warrant to purchase 25,000 shares of common stock of the Company issued to John Pappajohn, dated February 2, 1996.(1) 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) 4.15 Warrant to purchase 10,000 shares of common stock of the Company issued to Joseph Giamenco, dated February 2, 1996.(1) 4.16 Warrant to purchase 25,000 shares of common stock of the Company issued to Gus A. Chafoulias, dated February 2, 1996.(1) 4.17 Warrant to purchase 25,000 shares of common stock of the Company issued to JIBS Equities, dated February 2, 1996.(1) 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) 13 Exhibit Description ------- ----------- 4.19 Bridge Note (Promissory Note Convertible into Series E Convertible Preferred Stock) payable to IAI Investment Funds VI, Inc. (IAI Emerging Growth Fund), in the amount of $375,000 dated January 30, 1996.(1) 4.20 Bridge Note (Promissory Note Convertible into Series E Convertible Preferred Stock) payable to IAI Investment Funds IV, Inc. (IAI Regional Fund), in the amount of $125,000 dated January 30, 1996.(1) 10.1 License Agreement between the Company and Land O'Lakes dated May 7, 1992.(1) 10.2 Royalty Agreement between the Company and Land O'Lakes dated May 7, 1992.(1) 10.3 Supply Agreement between the Company and Land O'Lakes dated May 7, 1992.(1) 10.4 Master Services Agreement between the Company and Land O'Lakes dated May 7, 1992.(1) 10.5 GalaGen Inc. 1992 Stock Plan.(1) 10.7 Stock and Warrant Purchase Agreement between the Company and Chiron Corporation dated March 20, 1995.(1) 10.8 License and Collaboration Agreement between the Company and Chiron Corporation dated March 20, 1995.(1) 10.9 GalaGen Inc. Employee Stock Purchase Plan., as amended 10.10 Credit Agreement between the Company and Norwest Bank Minnesota, N.A., dated as of January 24, 1996.(1) 10.11 Committment Letter between the Company and Cargill Leasing Corporation, dated June 5, 1996 10.12 Master Equipment Lease between the Company and Cargill Leasing Corporation, dated June 6, 1996 10.13 Agreement for Progress Payments between the Company and Cargill Leasing Corporation, dated June 6, 1996 10.14 Agreement for Lease between the Company and Land O'Lakes, dated June 3, 1996 11.1 Statement re: computation of per share earnings (loss) 27 Financial Data Schedule ------------------------ (1) Incorporated herein by reference to the same numbered Exhibit to the Company's Registration Statement on Form S-1 (Registration No. 333-1032). (b) Reports on Form 8-K No reports on Form 8-K were filed during the quarter ended June 30, 1996. 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: August , 1996 By: /s/ Robert A. Hoerr ---- ------------------- Robert A. Hoerr, President and Chief Executive Officer (Principal Executive Officer) Date: August , 1996 By: /s/ Gregg A. Waldon ---- ------------------- Gregg A. Waldon, Vice President, Chief Financial Officer, Secretary and Treasurer (Principal Financial and Accounting Officer) 15 EXHIBIT INDEX Method of Exhibit Description Filing ------- ----------- --------- 3.2 Restated Certificate of Incorpor- Incorporated ation of the Company.(1) By Reference 3.4 Restated Bylaws of the Company.(1) Incorporated By Reference 4.1 Specimen Common Stock Certificate.(1) Incorporated By Reference 4.2 Warrant to purchase 13,541 shares of Incorporated common stock of the Company issued By Reference to Piper Jaffray Inc., dated January 26, 1993.(1) 4.3 Warrant to purchase 20,312 shares of Incorporated common stock of the Company issued to By Reference Gus A. Chafoulias, dated October 12, 1993. 4.4 Warrant to purchase 20,312 shares of Incorporated common stock of the Company issued to By Reference John Pappajohn, dated October 12, 1993.(1) 4.5 Warrant to purchase 9,479 shares of Incorporated common stock of the Company issued to By Reference Cato Holding Company, dated June 21, 1994.(1) 4.6 Form of Common Stock Warrant to Incorporated purchase shares of common stock of the By Reference Company, issued in connection with the sale of Convertible Promissory Notes.(1) 4.7 Warrant to purchase 17,144 shares of Incorporated Series F-1 Convertible Preferred Stock By Reference of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.8 Warrant to purchase 42,856 shares of Incorporated Series F-2 Convertible Preferred Stock By Reference of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.9 Warrant to purchase 60,000 shares of Incorporated Series F-3 Convertible Preferred Stock By Reference of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.10 Warrant to purchase 80,000 shares of Incorporated Series F-3 Convertible Preferred Stock By Reference of the Company issued to Chiron Corporation, dated March 29, 1995.(1) 4.11 Warrant to purchase 18,250 shares of Incorporated common stock of the Company issued to By Reference IAI Investment Funds VI, Inc. (IAI Emerging Growth Fund), dated January 30, 1996.(1) 4.12 Warrant to purchase 6.250 shares of Incorporated common stock of the Company issued By Reference to IAI Investment Funds IV, Inc. (IAI Regional Fund), dated January 30, 1996.(1) 4.13 Warrant to purchase 25,000 shares of Incorporated common stock of the Company issued to By Reference John Pappajohn, dated February 2, 1996.(1) 4.14 Warrant to purchase 25,000 shares of Incorporated common stock of the Company issued to By Reference Edgewater Private Equity Fund, L.P., dated February 2, 1996.(1) 4.15 Warrant to purchase 10,000 shares of Incorporated common stock of the Company issued to By Reference Joseph Giamenco, dated February 2, 1996. 4.16 Warrant to purchase 25,000 shares of Incorporated common stock of the Company Method of Exhibit Description Filing ------- ----------- --------- issued to Gus A. Chafoulias, dated By Reference February 2, 1996.(1) 4.17 Warrant to purchase 25,000 shares of Incorporated common stock of the Company issued to By Reference JIBS Equities, dated February 2, 1996.(1) 4.18 Warrant to purchase 25,000 shares of Incorporated common stock of the Company issued to By Reference Land O'Lakes, Inc., dated February 2, 1996.(1) 4.19 Bridge Note (Promissory Note Convert- Incorporated ible into Series E Convertible Prefer- By Reference red Stock) payable to IAI Investment Funds VI, Inc. (IAI Emerging Growth Fund), in the amount of $375,000 dated January 30, 1996.(1) 4.20 Bridge Note (Promissory Note Convert- Incorporated ible into Series E Convertible Prefer- By Reference red Stock) payable to IAI Investment Funds IV, Inc. (IAI Regional Fund), in the amount of $125,000 dated January 30, 1996.(1) 10.1 License Agreement between the Company Incorporated and Land O'Lakes dated May 7, 1992.(1) By Reference 10.2 Royalty Agreement between the Company Incorporated and Land O'Lakes dated May 7, 1992.(1) By Reference 10.3 Supply Agreement between the Company Incorporated and Land O'Lakes dated May 7, 1992.(1) By Reference 10.4 Master Services Agreement between the Incorporated Company and Land O'Lakes dated May 7, By Reference 1992.(1) 10.5 GalaGen Inc. 1992 Stock Plan.(1) 10.7 Stock and Warrant Purchase Agreement Incorporated between the Company and Chiron By Reference Corporation dated March 20, 1995.(1) 10.8 License and Collaboration Agreement Incorporated between the Company and Chiron By Reference Corporation dated March 20, 1995.(1) 10.9 GalaGen Inc. Employee Stock Purchase Electronic Plan, as amended Transmission 10.10 Credit Agreement between the Company Incorporated and Norwest Bank Minnesota, N.A., By Reference dated as of January 24, 1996.(1) 10.11 Committment Letter between the Company Electronic and Cargill Leasing Corporation, dated Transmission June 5, 1996 10.12 Master Equipment Lease between the Electronic Company and Cargill Leasing Corporation, Transmission dated June 6, 1996. 10.13 Agreement for Progress Payments between Electronic the Company and Cargill Leasing Transmission Corporation, dated June 6, 1996. 10.14 Agreement for Lease between the Company Electronic and Land O'Lakes, dated June 3, 1996. Transmission 11.1 Statement re: computation of per share Electronic earnings (loss). Transmission 27 Financial Data Schedule. 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).