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SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549



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FORM 10-Q



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(Mark One)



|x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|- | ---------------------------------------------------------------------------------------



For the quarterly period ended March 31, 2004



Commission file number 0-16005



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Unigene Laboratories, Inc.

(Exact name of registrant as specified in its charter)



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|                                                               |  |                                     
|-------------------------------------------------------------- |  | ------------------------------------
|Delaware                                                       |  | 22-2328609                          
|(State or other jurisdiction of incorporation or organization) |  | (I.R.S. Employer Identification No.)



|                                             |  |           
|-------------------------------------------- |  | ----------
|110 Little Falls Road, Fairfield, New Jersey |  | 07004     
|(Address of principal executive offices)     |  | (Zip Code)



Registrants
telephone number, including area code: (973) 882-0860





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



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



APPLICABLE ONLY TO CORPORATE ISSUERS



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  77,981,995 shares as of May 10, 2004

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##### Table of Contents

INDEX



UNIGENE LABORATORIES, INC.



|                                                                                        |  |                                                                                       |  |     
|--------------------------------------------------------------------------------------- |  | ------------------------------------------------------------------------------------- |  | ----
|                                                                                        |  |                                                                                       |  | PAGE
|                                                                                        | 
|PART I.
FINANCIAL INFORMATION                                                           |  |                                                                                      
|                                                                                        |  |                                                                                      
|Item 1.                                                                                 |  | Financial Statements (Unaudited)                                                      |  |     
|                                                                                        | 
|Condensed Balance Sheets-March 31, 2004 and December 31, 2003                           |  | 3                                                                                    
|                                                                                        | 
|Condensed Statements of Operations-Three months ended March 31, 2004 and 2003           |  | 4                                                                                    
|                                                                                        | 
|Condensed Statement of Stockholders Equity (Deficit) Three months ended March 31, 2004 |  | 4                                                                                    
|                                                                                        | 
|Condensed Statements of Cash Flows-Three months ended March 31, 2004 and 2003           |  | 5                                                                                    
|                                                                                        | 
|Notes to Condensed Financial Statements-March 31, 2004                                  |  | 6                                                                                    
|                                                                                        |  |                                                                                      
|Item 2.                                                                                 |  | Managements Discussion and Analysis of Financial Condition and Results of Operations |  | 14  
|                                                                                        |  |                                                                                      
|Item 3.                                                                                 |  | Quantitative and Qualitative Disclosures About Market Risk                            |  | 22  
|                                                                                        |  |                                                                                      
|Item 4.                                                                                 |  | Controls and Procedures                                                               |  | 22  
|                                                                                        | 
|PART II.
OTHER INFORMATION                                                              |  |                                                                                      
|                                                                                        |  |                                                                                      
|Item 2.                                                                                 |  | Changes in Securities and Use of Proceeds                                             |  | 23  
|                                                                                        |  |                                                                                      
|Item 3.                                                                                 |  | Defaults Upon Senior Securities                                                       |  | 23  
|                                                                                        |  |                                                                                      
|Item 6.                                                                                 |  | Exhibits and Reports on Form 8-K                                                      |  | 23  
|                                                                                        | 
|SIGNATURES                                                                              |  | 24                                                                                   



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##### Table of Contents

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements



UNIGENE LABORATORIES, INC.

CONDENSED BALANCE SHEETS



|                                                                                                                                       |  |                |              |   |                   |   |              |  
|-------------------------------------------------------------------------------------------------------------------------------------- |  | -------------- | ------------ | - | ----------------- | - | ------------ | -
|                                                                                                                                       |  | March 31, 2004 |              |   | December 31, 2003 |  
|                                                                                                                                       |  | (Unaudited)    |              |   |                   |  
|ASSETS                                                                                                                                 |  |                |              |   |                   |   |              |  
|Current assets:                                                                                                                        |  |                |              |   |                   |   |              |  
|Cash and cash equivalents                                                                                                              |  | $              | 591,100      |   |                   | $ | 511,865      |  
|Accounts receivable                                                                                                                    |  |                | 55,689       |   |                   |   | 184,768      |  
|Prepaid expenses                                                                                                                       |  |                | 157,341      |   |                   |   | 76,400       |  
|Inventory                                                                                                                              |  |                | 1,213,435    |   |                   |   | 641,462      |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|Total current assets                                                                                                                   |  |                | 2,017,565    |   |                   |   | 1,414,495    |  
|Property, plant and equipment, net                                                                                                     |  |                | 1,988,628    |   |                   |   | 2,030,056    |  
|Investment in joint venture                                                                                                            |  |                | 32,725       |   |                   |   | 32,725       |  
|Patents and other intangibles, net                                                                                                     |  |                | 1,079,542    |   |                   |   | 1,094,365    |  
|Other assets                                                                                                                           |  |                | 505,488      |   |                   |   | 494,988      |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|                                                                                                                                       |  | $              | 5,623,948    |   |                   | $ | 5,066,629    |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT)                                                                                         |  |                |              |   |                   |   |              |  
|Current liabilities:                                                                                                                   |  |                |              |   |                   |   |              |  
|Accounts payable                                                                                                                       |  | $              | 1,259,622    |   |                   | $ | 1,022,377    |  
|Accrued expenses                                                                                                                       |  |                | 1,416,172    |   |                   |   | 1,609,621    |  
|Deferred licensing fees                                                                                                                |  |                | 363,895      |   |                   |   | 363,895      |  
|Notes payable - stockholders                                                                                                           |  |                | 11,273,323   |   |                   |   | 11,273,323   |  
|Accrued interest  stockholders                                                                                                        |  |                | 4,877,475    |   |                   |   | 4,541,723    |  
|Due to Covington and Burling                                                                                                           |  |                | 885,002      |   |                   |   | 1,098,270    |  
|Current portion - capital lease obligations                                                                                            |  |                | 163,818      |   |                   |   | 170,852      |  
|Note payable  Tail Wind                                                                                                               |  |                | 977,686      |   |                   |   |             |  
|Advance from Fusion Capital                                                                                                            |  |                | 750,000      |   |                   |   |             |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|Total current liabilities                                                                                                              |  |                | 21,966,993   |   |                   |   | 20,080,061   |  
|                                                                                                                                       |  |               
|Deferred licensing fees, excluding current portion                                                                                     |  |                | 5,082,574    |   |                   |   | 5,173,550    |  
|Note payable-Tail Wind                                                                                                                 |  |                |             |   |                   |   | 977,686      |  
|Capital lease obligations, excluding current portion                                                                                   |  |                | 195,992      |   |                   |   | 222,209      |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|Total liabilities                                                                                                                      |  |                | 27,245,559   |   |                   |   | 26,453,506   |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|Commitments and contingencies                                                                                                          |  |                |              |   |                   |   |              |  
|Stockholders equity (deficit):                                                                                                        |  |                |              |   |                   |   |              |  
|Common Stock - par value $.01 per share, authorized 100,000,000 shares, issued 75,239,099 shares in 2004 and 72,113,147 shares in
2003 |  |                | 752,391      |   |                   |   | 721,131      |  
|Additional paid-in capital                                                                                                             |  |                | 81,664,455   |   |                   |   | 79,477,793   |  
|Accumulated deficit                                                                                                                    |  |                | (104,037,426 | ) |                   |   | (101,584,770 | )
|Less: Treasury stock, at cost, 7,290 shares                                                                                            |  |                | (1,031       | ) |                   |   | (1,031       | )
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|Total stockholders equity (deficit)                                                                                                   |  |                | (21,621,611  | ) |                   |   | (21,386,877  | )
|                                                                                                                                       |  |                |              |   |                   |   |              |  
|                                                                                                                                       |  | $              | 5,623,948    |   |                   | $ | 5,066,629    |  
|                                                                                                                                       |  |                |              |   |                   |   |              |  



See
notes to condensed financial statements.



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##### Table of Contents

UNIGENE LABORATORIES, INC.

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)



|                                                                  |  |                              |            |   |      |   |            |  
|----------------------------------------------------------------- |  | ---------------------------- | ---------- | - | ---- | - | ---------- | -
|                                                                  |  | Three Months Ended March 31, |           
|                                                                  |  | 2004                         |            |   | 2003 |  
|Licensing and other revenue                                       |  | $                            | 323,323    |   |      | $ | 1,738,960  |  
|                                                                  |  |                              |            |   |      |   |            |  
|Operating expenses:                                               |  |                              |            |   |      |   |            |  
|Research and development                                          |  |                              | 1,683,217  |   |      |   | 2,165,645  |  
|                                                                  |  |                             
|General and administrative                                        |  |                              | 797,174    |   |      |   | 692,919    |  
|                                                                  |  |                              |            |   |      |   |            |  
|                                                                  |  |                              | 2,480,391  |   |      |   | 2,858,564  |  
|                                                                  |  |                              |            |   |      |   |            |  
|Operating loss                                                    |  |                              | (2,157,068 | ) |      |   | (1,119,604 | )
|                                                                  |  |                             
|Other income (expense):                                           |  |                              |            |   |      |   |            |  
|Gain on the extinguishment of debt and related interest           |  |                              | 63,269     |   |      |   |           |  
|Interest income                                                   |  |                              | 2,204      |   |      |   | 4,433      |  
|Interest expense  principally to stockholders                    |  |                              | (361,061   | ) |      |   | (349,476   | )
|                                                                  |  |                              |            |   |      |   |            |  
|Net loss                                                          |  | $                            | (2,452,656 | ) |      | $ | (1,464,647 | )
|                                                                  |  |                              |            |   |      |   |            |  
|Net loss per share, basic and diluted                             |  | $                            | (.03       | ) |      | $ | (.02       | )
|                                                                  |  |                              |            |   |      |   |            |  
|Weighted average number of shares outstanding - basic and diluted |  |                              | 74,305,250 |   |      |   | 63,632,958 |  
|                                                                  |  |                              |            |   |      |   |            |  



UNIGENE LABORATORIES, INC.

CONDENSED STATEMENT OF STOCKHOLDERS EQUITY (DEFICIT)

Three Months Ended March 31, 2004

(Unaudited)



|                                                                                                   |  |                 |  |           |         |                          |   |                    |  |   |               |   |  |       |        |   |  |   |             |  
|-------------------------------------------------------------------------------------------------- |  | --------------- |  | --------- | ------- | ------------------------ | - | ------------------ |  | - | ------------- | - |  | ----- | ------ | - |  | - | ----------- | -
|                                                                                                   |  | Common Stock    |  |           |         |                          |   |                    |  |   |               |   | 
|                                                                                                   |  | Number ofShares |  | Par Value |         | AdditionalPaid-inCapital |   | AccumulatedDeficit |  |   | TreasuryStock |   |  | Total |       
|Balance, January 1, 2004                                                                           |  | 72,113,147      |  | $         | 721,131 |                          | $ | 79,477,793         |  | $ | (101,584,770  | ) |  | $     | (1,031 | ) |  | $ | (21,386,877 | )
|Sale of common stock to Fusion at $0.69 to $0.75 per share (net of cash issuance costs of $33,000) |  | 3,124,952       |  |           | 31,250  |                          |   | 2,186,042          |  |   |              |   |  |       |       |   |  |   | 2,217,292   |  
|Exercise of stock options                                                                          |  | 1,000           |  |           | 10      |                          |   | 620                |  |   |              |   |  |       |       |   |  |   | 630         |  
|Net loss                                                                                           |  |                |  |           |        |                          |   |                   |  |   | (2,452,656    | ) |  |       |       |   |  |   | (2,452,656  | )
|                                                                                                   |  |                 |  |           |         |                          |   |                    |  |   |               |   |  |       |        |   |  |   |             |  
|Balance, March 31, 2004                                                                            |  | 75,239,099      |  | $         | 752,391 |                          | $ | 81,664,455         |  | $ | (104,037,426  | ) |  | $     | (1,031 | ) |  | $ | (21,621,611 | )
|                                                                                                   |  |                 |  |           |         |                          |   |                    |  |   |               |   |  |       |        |   |  |   |             |  



See notes to condensed financial
statements.



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UNIGENE LABORATORIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)



|                                                        |  |                             |            |   |      |   |            |  
|------------------------------------------------------- |  | --------------------------- | ---------- | - | ---- | - | ---------- | -
|                                                        |  | Three Months Ended March 31 |           
|                                                        |  | 2004                        |            |   | 2003 |  
|Net cash used in operating activities                   |  | $                           | (2,671,539 | ) |      | $ | (1,264,209 | )
|                                                        |  |                             |            |   |      |   |            |  
|Investing activities:                                   |  |                             |            |   |      |   |            |  
|Purchase of equipment and furniture                     |  |                             | (138,446   | ) |      |   | (82,401    | )
|Increase in patents and other intangibles               |  |                             | (22,952    | ) |      |   | (6,976     | )
|Increase in other assets                                |  |                             | (10,500    | ) |      |   | (21,098    | )
|Construction of leasehold and building improvements     |  |                             | (11,999    | ) |      |   | (7,206     | )
|                                                        |  |                             |            |   |      |   |            |  
|Net cash used in investing activities                   |  |                             | (183,897   | ) |      |   | (117,681   | )
|                                                        |  |                             |            |   |      |   |            |  
|                                                        |  |                            
|Financing activities:                                   |  |                             |            |   |      |   |            |  
|Proceeds and advances from sale of stock, net           |  |                             | 2,967,292  |   |      |   | 10,000     |  
|Repayment of stockholder notes                          |  |                             |           |   |      |   | (100,000   | )
|Repayment of notes payable  Tail Wind                  |  |                             |           |   |      |   | (7,976     | )
|Repayment of capital lease obligations                  |  |                             | (33,251    | ) |      |   | (59,907    | )
|Proceeds from exercise of stock options                 |  |                             | 630        |   |      |   |           |  
|                                                        |  |                             |            |   |      |   |            |  
|Net cash provided by (used for) financing activities    |  |                             | 2,934,671  |   |      |   | (157,883   | )
|                                                        |  |                             |            |   |      |   |            |  
|Net increase (decrease) in cash and cash equivalents    |  |                             | 79,235     |   |      |   | (1,539,773 | )
|                                                        |  |                            
|Cash and cash equivalents at beginning of period        |  |                             | 511,865    |   |      |   | 2,224,198  |  
|                                                        |  |                             |            |   |      |   |            |  
|                                                        |  |                            
|Cash and cash equivalents at end of period              |  | $                           | 591,100    |   |      | $ | 684,425    |  
|                                                        |  |                             |            |   |      |   |            |  
|                                                        |  |                            
|SUPPLEMENTAL CASH FLOW INFORMATION:                     |  |                             |            |   |      |   |            |  
|                                                        |  |                            
|Non-cash investing and financing activities:            |  |                             |            |   |      |   |            |  
|Purchase of equipment through capital leases            |  |                             |           |   |      | $ | 177,115    |  
|                                                        |  |                             |            |   |      |   |            |  
|Issuance of common stock in payment of accounts payable |  |                             |           |   |      | $ | 300,000    |  
|                                                        |  |                             |            |   |      |   |            |  
|Cash paid for interest                                  |  | $                           | 9,600      |   |      | $ | 2,200      |  
|                                                        |  |                             |            |   |      |   |            |  
|Cash paid for income taxes                              |  | $                           | 5,200      |   |      |   |           |  
|                                                        |  |                             |            |   |      |   |            |  



See notes to condensed financial
statements.



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UNIGENE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

MARCH 31, 2004

(Unaudited)



NOTE A - BASIS OF PRESENTATION AND RECENT ACCOUNTING PRONOUNCEMENTS



The accompanying unaudited condensed financial statements have been prepared in accordance
with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by accounting principles generally accepted in the United States of America for complete annual financial statements. In the opinion of management, all adjustments considered necessary for a fair presentation, which are of a
normal and recurring nature only, have been included. Operating results for the three-month period ended March 31, 2004 are not necessarily indicative of the results that may be expected for the year ending December 31, 2004. For further
information, please refer to our financial statements and footnotes thereto included in Unigenes annual report on Form 10-K for the year ended December 31, 2003.



New Accounting Pronouncements



In December 2003, the FASB issued FASB Interpretation No. 46(R), Consolidation of Variable Interest Entities (FIN 46(R)). FIN 46(R) clarifies the
application of Accounting Research Bulletin 51, Consolidated Financial Statements, for certain entities that do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support
from other parties or in which equity investors do not have the characteristics of a controlling financial interest (variable interest entities). Variable interest entities within the scope of FIN 46(R) will be required to be
consolidated by their primary beneficiary. The primary beneficiary of a variable interest entity is determined to be the party that absorbs a majority of the entitys expected losses, receives a majority of its expected returns, or both. FIN
46(R) applies immediately to variable interest entities created after January 31, 2003, and to variable interest entities in which an enterprise obtains an interest after that date. It applies to the first fiscal year or interim period ending after
December 15, 2003, to variable interest entities in which an enterprise holds a variable interest that it acquired before February 1, 2003. Adoption of FIN 46(R) did not have a material effect on our financial position or results of operations.



NOTE B  LIQUIDITY



At March 31, 2004, we had cash and cash equivalents of $591,000, an increase of $79,000 from
December 31, 2003.



We believe that we will generate financial resources to
apply toward funding our operations through the achievement of milestones in the GlaxoSmithKline (GSK), Upsher-Smith Laboratories (USL), or Novartis Pharma AG (Novartis) agreements and through the sale of parathyroid hormone (PTH) and calcitonin to
GSK and Novartis, respectively and, if necessary, with the funds available through our financing with Fusion Capital Fund II, LLC (Fusion). We therefore expect to have sufficient financial resources for the next twelve months. Our financial
situation may be augmented by sales and royalties on our nasal calcitonin product if it receives FDA approval and we are able to launch the product later in 2004. If we are unable to achieve these milestones and sales, or are unable to achieve the
milestones and sales on a timely basis, we would need additional funds to continue our



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operations. We have incurred annual operating losses since our inception and, as a result, at March 31, 2004, had an
accumulated deficit of approximately $104,000,000 and a working capital deficiency of approximately $20,000,000. Our cash requirements to operate our research and peptide manufacturing facilities and develop our products are approximately
$11,000,000 per year. In addition, we have principal and interest obligations under the Tail Wind note, outstanding notes payable to the Levys, our executive officers, as well as obligations relating to our current and former joint venture
agreements in China. As discussed in Note F to the financial statements, we have stockholder demand notes in default at March 31, 2004. These factors, among others, raise substantial doubt about our ability to continue as a going concern. The
financial statements have been prepared on a going concern basis and as such do not include any adjustments that might result from the outcome of this uncertainty.



In April 2002, we signed a licensing agreement with GSK for a value before royalties, PTH sales and reimbursement for development expenses,
of up to $150,000,000 to develop an oral formulation of an analog of PTH currently in preclinical development for the treatment of osteoporosis, of which an aggregate of $4,000,000 in up-front and milestone payments has been received through March
31, 2004. GSK could make additional milestone payments in the aggregate amount of $146,000,000 subject to the progress of the compound through clinical development and through to the market. We have also received an additional $3,900,000 from GSK
for PTH sales and in support of our PTH development activities through March 31, 2004 (see Note C).



In November 2002, we signed an exclusive U.S. licensing agreement with USL for a value before royalties of up to $10,000,000 to market our patented nasal formulation of calcitonin for the treatment of osteoporosis.
Under the terms of the agreement, we received an up-front payment of $3,000,000 from USL in 2002 and a milestone payment of $3,000,000 in 2003 (see Note D).



In April 2004, we signed a worldwide licensing agreement with Novartis for a value before royalties of up to $18,700,000 to allow Novartis to manufacture calcitonin using
our patented peptide production process. We received $5,600,000 in April 2004 from Novartis in an up-front payment and a partial prepayment for calcitonin purchases. These cash payments and any resulting revenue are not included in the financial
statements for the period ended March 31, 2004 (see Note E).



Our future
ability to generate cash from operations will depend primarily in the short-term upon the achievement of milestones in the GSK, USL and Novartis agreements, GSK reimbursed development activities and through the sale of PTH to GSK and calcitonin to
Novartis and, in the long-term, on receiving royalties from the sale of our licensed products and technologies. We are actively seeking additional licensing and/or supply agreements with pharmaceutical companies for oral, nasal and injectable forms
of calcitonin as well as for other oral peptides. However, we may not be successful in achieving milestones in our current agreements, obtaining regulatory approval for our products or in licensing any of our other products. We also have a new
financing agreement in place with Fusion Capital Fund II, LLC (see Note I). During the three-month period ended March 31, 2004, under the new Fusion agreement, we received $2,250,000 from the sale of 3,124,952 shares of common stock to Fusion,
before cash expenses of $33,000. In March 2004, we also received a $750,000 advance from Fusion. The advance was settled in April 2004 with the issuance of 1,071,429 shares of common stock to Fusion.



NOTE C- GLAXOSMITHKLINE AGREEMENT



In April 2002, we signed a licensing agreement with GSK for a value before royalties, PTH
sales and reimbursement for development expenses, of up to $150,000,000 to develop an oral formulation of an analog of PTH currently in preclinical development for the treatment of osteoporosis of which an aggregate of $4,000,000 in up-front and
milestone payments has been received through March 31,



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2004. We have also received an additional $3,900,000 from GSK for PTH sales and in support of our PTH development
activities through March 31, 2004. Under the terms of the agreement, GSK received an exclusive worldwide license to develop and commercialize the product. In return, GSK made a $2,000,000 up-front licensing fee payment and a $1,000,000
licensing-related milestone payment to us in 2002. In addition, GSK will fund all development activities during the program, including our activities in the production of raw material for development and clinical supplies, and will pay us a royalty
on its worldwide sales of the product, if commercialized. The royalty rate will be increased if certain sales milestones are achieved. Revenue recognition of the up-front licensing fee and first milestone payment has been deferred over the estimated
15-year performance period of the license agreement. For the three months ended March 31, 2004, we recognized $122,000 for our GSK development activities and $50,000 in licensing revenue. GSK could make additional milestone payments in the aggregate
amount of $146,000,000 subject to the progress of the compound through clinical development and through to the market. This agreement is subject to certain termination provisions. Either party may terminate the license agreement if the other party
(i) materially breaches the license agreement, which breach is not cured within 60 days (or 30 days for a payment default), (ii) voluntarily files, or has served against it involuntarily, a petition in bankruptcy or insolvency, which, in the case of
involuntary proceedings, remains undismissed for 60 days, or (iii) makes an assignment for the benefit of creditors. Additionally, GSK may terminate the license agreement at any time for various reasons including safety or efficacy concerns of the
PTH product, significant increases in development timelines or costs, or significant changes in the osteoporosis market or in government regulations.



NOTE D  UPSHER-SMITH AGREEMENT



In November 2002, we signed an exclusive U.S. licensing agreement with USL for a value before royalties of up to $10,000,000 to market our patented nasal formulation of
calcitonin for the treatment of osteoporosis. Under the terms of the agreement, we received an up-front payment of $3,000,000 from USL in 2002. During 2003, we received a $3,000,000 milestone payment from USL for the Food and Drug Administration
(FDA)s acceptance for review of our nasal calcitonin New Drug Application (NDA). In addition, we are eligible to receive milestone payments of $4,000,000 and royalty payments on product sales, if commercialized. We will be responsible for
manufacturing the product and will sell filled calcitonin product to USL. USL will package the product and will distribute it nationwide. Revenue recognition of the up-front licensing fee has been deferred over the estimated 19-year performance
period of the license agreement. Revenue for the three-month period ended March 31, 2004 consists of the recognition of $39,000 of licensing revenue from USL. In January 2004 we announced the receipt of an approvable letter from the FDA. The letter
is an official communication from the FDA indicating that the agency is prepared to approve the NDA upon the finalization of the labeling and the resolution of specific remaining issues, including the submission of additional information and data.
However, during this review process additional questions or concerns may be raised by the FDA which could delay product approval. We believe that FDA approval for this product could occur later in 2004. A Citizens Petition, which typically
requests the FDA to reconsider its decisions, was filed on January 9, 2004 on behalf of an anonymous party subsequent to the announcement of our receipt of the FDA approvable letter. Using certain assumptions, the petition questioned the FDAs
ability to grant approval for any recombinant calcitonin product that primarily relies on clinical markers of bone cell activity. We believe that all of the issues raised in the petition have been thoroughly considered by the FDA prior to the
issuance of the approvable letter. This agreement may be terminated by either party by mutual agreement or due to breach of any material provision of the agreement not cured within 60 days. We may terminate in the event of a net sales shortfall. In
addition, USL may terminate the agreement under certain circumstances where USL assigns the agreement and we do not approve the assignment.



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NOTE E  NOVARTIS AGREEMENT (Recent Development)



In April 2004, we signed a worldwide licensing agreement with Novartis for a value before royalties of up to $18,700,000 to allow Novartis
to manufacture calcitonin using our patented peptide production process. We received $5,600,000 from Novartis in April 2004 consisting of a $3,500,000 up-front payment and a partial prepayment on Novartis purchases of calcitonin from us in the
amount of $2,100,000. These cash payments and any resulting revenue are not included in the financial statements for the period ended March 31, 2004. Revenue recognition of the up-front licensing fee has been deferred over the estimated 14-year
performance period of the license agreement. Revenue recognition of the prepayment for calcitonin purchases will be recognized as we ship product to Novartis, which is expected to occur during 2004. Initially, Novartis will purchase calcitonin from
us for use in their oral calcitonin development program. Eventually, Novartis plans to implement our patented manufacturing process at a Novartis facility to support their calcitonin products. We will receive royalties on sales of any existing or
future Novartis products that contain calcitonin manufactured by Novartis using our technology. We will continue to develop our oral, nasal and injectable calcitonin products. If our oral calcitonin product is successfully developed, we would
purchase calcitonin from Novartis, thereby eliminating our need to construct a second, larger-scale calcitonin manufacturing facility. This agreement may be terminated by either party due to a material breach not cured within 60 days or due to
insolvency or bankruptcy proceedings not dismissed within 60 days and for other customary events of default.



NOTE F  NOTES PAYABLE  STOCKHOLDERS



To satisfy our short-term liquidity needs, Jay Levy, the Chairman of the Board and an officer of Unigene, and Warren Levy and Ronald Levy, directors and officers of Unigene, and another Levy family member from time to time have made loans
to us. As of March 31, 2004, total accrued interest on all Levy loans was approximately $4,877,000 and the outstanding loans by these individuals to us, classified as short-term debt, totaled $11,273,323.



In 2001, due to the fact that we did not make principal and interest payments when due, the
interest rate on $3,465,000 (currently $3,185,000), $260,000 and $248,323 of prior demand loans, which are now in default, made to us by Jay Levy, Warren Levy and Ronald Levy, respectively, increased an additional 5% per year to the Merrill Lynch
Margin Loan Rate plus 5.25% (10.5% as of March 31, 2004) and the interest rate on $1,870,000 of term notes evidencing loans made by Jay Levy to us increased an additional 5% per year from 6% to 11%. The increased rate is calculated on both past due
principal and interest.



NOTE G  NOTE PAYABLE  TAIL WIND



In June 1998, we completed a private placement of $4,000,000 in principal
amount of 5% convertible debentures to the Tail Wind Fund, Ltd. (Tail Wind) from which we realized net proceeds of approximately $3,750,000. The 5% debentures were convertible into shares of our common stock. The interest on the debentures, at our
option, was also payable in shares of common stock. Upon conversion, Tail Wind was also entitled to receive warrants to purchase a number of shares of common stock equal to 4% of the number of shares issued as a result of the conversion. Through
December 31, 2002, we issued a total of 3,703,362 shares of common stock upon conversion of $2,000,000 in principal amount of the 5% debentures and in payment of interest on the 5% debentures. Also, we issued an additional 103,032 shares of common
stock in 2000 upon the cashless exercise of all of the 141,123 warrants issued upon conversion of the 5% debentures.



Because of our failure to make certain interest and debenture redemption payments to Tail Wind, an event of default occurred. As a result, Tail Wind filed a demand for
arbitration against us in July 2000.



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In April 2002, we entered into a settlement with Tail Wind. Pursuant to the terms of the settlement agreement, Tail Wind
surrendered to us the $2,000,000 in principal amount of convertible debentures that remained outstanding and released all claims against us relating to Tail Winds purchase of the convertible debentures, which were approximately $4,500,000
including accrued interest and penalties in the approximate amount of $2,500,000. In exchange, we issued to Tail Wind a $1,000,000 promissory note secured by our Fairfield, New Jersey building and equipment and 2,000,000 shares of Unigene common
stock. The note bears interest at a rate of 6% per annum and principal and interest are due in February 2005. Through March 31, 2004, an aggregate of $22,314 in principal had been repaid on the note.



NOTE H  INVENTORY



Inventories are stated at the lower of cost (using the first-in, first-out method) or market and consist of the following:



|                                                                             |  |               |           |                  |   |        
|---------------------------------------------------------------------------- |  | ------------- | --------- | ---------------- | - | -------
|                                                                             |  | March 31,2004 |           | December 31,2003
|Finished goods, net of allowances of $1,670,000 and $1,596,000, respectively |  | $             | 646,384   |                  | $ | 82,399 
|Raw materials                                                                |  |               | 567,051   |                  |   | 559,063
|                                                                             |  |               |           |                  |   |        
|Total                                                                        |  | $             | 1,213,435 |                  | $ | 641,462
|                                                                             |  |               |           |                  |   |        



NOTE I  FUSION CAPITAL FINANCING



On October 9, 2003, we entered into a new common stock purchase agreement, as
amended, with Fusion under which Fusion agreed, if so requested by Unigene and subject to certain conditions, to purchase on each trading day during the term of the agreement $30,000 of our common stock up to an aggregate of $15,000,000. This
agreement terminates in November 2005. We may decrease or suspend purchases or terminate the agreement at any time. If our stock price equals or exceeds $0.80 per share for five consecutive trading days, we have the right to increase the daily
purchase amount above $30,000, providing that the closing sale price of our stock remains at least $0.80. Fusion is not obligated to purchase any shares of our common stock if the purchase price is less than $0.20 per share. Under this agreement, we
must satisfy requirements that are a condition to Fusions obligation including: the continued effectiveness of the registration statement for the resale of the shares by Fusion, no default on, or acceleration prior to maturity of, any of our
payment obligations in excess of $1,000,000, no insolvency or bankruptcy on our part, continued listing of Unigene common stock on the OTC Bulletin Board, and we must avoid suspension of our listing on the OTC Bulletin Board for a period of three
consecutive trading days. The sales price per share to Fusion would be equal to the lesser of: the lowest sale price of our common stock on the day of purchase by Fusion, or the average of the lowest three closing sale prices of our common stock
during the twelve trading days prior to the date of purchase by Fusion. Fusion has agreed that neither it nor any of its affiliates will engage in any direct or indirect short-selling or hedging of our common stock during any time prior to the
termination of the common stock purchase agreement. As compensation for its commitment we issued to Fusion, as of October 9, 2003, 1,000,000 shares of common stock and a five-year warrant, as amended, to purchase 250,000 shares of common stock at an
exercise price of $0.90 per share which was charged to additional paid-in-capital. Fusion may not sell the shares issued as a commitment fee or the shares issuable upon the exercise of the warrant until 25 months from the date of the common stock
purchase agreement or until the date the common stock purchase agreement is terminated. In addition to the issuance of the commitment shares, the Board of Directors has authorized the issuance and sale to Fusion of up to 13,500,000 shares of Unigene
common stock. For the three months ended March 31, 2004, we received $2,250,000 from the sale of 3,124,952 shares of common stock to Fusion, before cash expenses of approximately $33,000. In March 2004,



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we also received a $750,000 advance from Fusion. The advance was settled in April 2004 with the issuance of 1,071,429
shares of common stock to Fusion. As of March 31, 2004, there is an outstanding warrant to purchase 373,002 shares of Unigene common stock issued to an investment banker as a fee in connection with the original Fusion financing agreement which has
an exercise price of $1.126 and expires in December 2005 and a five-year warrant issued to Fusion in 2001 to purchase 1,000,000 shares of common stock at an exercise price of $ 0.50 per share.



NOTE J  CHINA JOINT VENTURES



Current joint venture



In June 2000, we entered into a joint venture agreement with Shijiazhuang Pharmaceutical Group (SPG), a pharmaceutical company in the
Peoples Republic of China, formally creating a contractual joint venture between the two entities. Upon approval of an official business license from the Chinese authorities, which we anticipate will follow the approval of the NDA, we expect
that the resulting joint venture will manufacture and distribute injectable and nasal calcitonin products in China (and possibly, with our approval, other selected Asian markets) for the treatment of osteoporosis. We own 45% of the contractual joint
venture and will have a 45% interest in the entitys profits and losses. In the first phase of the collaboration, SPG will contribute its existing injectable calcitonin license to the joint venture, which will allow the entity to sell its
injectable calcitonin product in China. An NDA for injectable and nasal calcitonin products was filed in China in the third quarter of 2003. Approvals of NDAs in China may require approximately 12-18 months or more. In addition, brief local human
trials may be required. If the product is successful, the joint venture may establish a facility in China to fill injectable and nasal calcitonin products using bulk calcitonin supplied by us. Eventually the joint venture may manufacture bulk
calcitonin in China at a new facility that would be constructed by it. This would require local financing by the joint venture. The existing joint venture began operations in March 2002 and sales of its injectable calcitonin product began in April
2002. Initial sales will be used by the joint venture to offset startup costs. The existing joint ventures net losses for the periods ended December 31, 2003 and March 31, 2004 were immaterial to our overall results of operations. We account
for our investment in the joint venture under the equity method. Our investment in the existing joint venture has been immaterial to date.



Under the terms of the joint venture agreement in China with SPG, we are obligated to contribute up to $405,000 in cash after approval of its Chinese NDA and up to an
additional $495,000 in cash within two years thereafter. However, these amounts may be reduced or offset by our share of joint venture profits, if any.



Former joint venture



We are obligated to pay to the Qingdao General Pharmaceutical Company (Qingdao), our former joint venture partner in China, an aggregate of $350,000 in monthly principal installment payments of $5,000 in order to
terminate this joint venture of which $120,000 is remaining as of March 31, 2004 and is included in accrued expenses - other. We recognized the entire $350,000 obligation as an expense in 2000.



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NOTE K  DUE TO COVINGTON AND BURLING



In July 2003, we were named in a lawsuit filed in the Superior Court of the District of Columbia by Covington and Burling, our former
attorneys. Covington and Burling alleged that we failed to pay certain statements rendered by the law firm for legal services and costs advanced and that we failed to pay the principal and interest on two promissory notes executed by us in favor of
the law firm. Covington and Burling sought damages in the amount of $918,209, which amount had been accrued, plus interest and counsel fees. On December 18, 2003 we entered into a settlement agreement with Covington and Burling. Under the agreement,
any payments we make to Covington and Burling before December 31, 2004 will reduce our total obligation of $1,098,000, consisting of principal and interest, by a multiple of the payment (multiples range from 1.46 to 1.19 depending on the month of
payment). Until the obligation is paid in full, we have agreed to remit to Covington and Burling certain percentages or dollar amounts of funds we receive from licensing or financing arrangements and Covington and Burling has received a security
interest in certain of our assets. During the three-month period ended March 31, 2004, we made payments to Covington and Burling in the aggregate amount of $150,000. These payments had an average multiple of 1.42 and reduced our debt to Covington
and Burling by $213,269. We therefore recognized a gain on extinguishment of debt in the amount of $63,269 in the first quarter of 2004. In April 2004, pursuant to the terms of the settlement agreement, we paid Covington and Burling $660,725, at a
multiple of 1.33944, which resulted in full satisfaction of the outstanding indebtedness of $885,002, thereby recognizing a gain on extinguishment of debt in the amount of $224,277 in the second quarter of 2004.



NOTE L  STOCK OPTIONS



We account for stock options issued to employees and directors in accordance with the provisions of APB Opinion No. 25, Accounting for
Stock Issued to Employees, and related interpretations. As such, compensation expense is recorded on fixed stock option grants for employees and directors only if the current market price of the underlying stock exceeded the exercise price of
the option at the date of grant and it is recognized on a straight-line basis over the vesting period; compensation expense on variable stock option grants is estimated until the measurement date. As permitted by SFAS No. 123, Accounting for
Stock-Based Compensation and SFAS No. 148, we provide pro forma net loss and pro forma loss per share disclosures for employee and director stock option grants as if the fair-value-based method defined in SFAS No. 123 had been applied. We
account for stock options and warrants issued to consultants on a fair value basis in accordance with SFAS No. 123 and Emerging Issues Task Force Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services.



Had
compensation cost for options granted to employees and directors been determined consistent with the fair value method under SFAS No. 123, our pro forma net loss and pro forma net loss per share would have been as follows for the three-month periods
ended March 31, 2004 and 2003:



|                                                                                                                |  |                              |            |   |      |   |            |  
|--------------------------------------------------------------------------------------------------------------- |  | ---------------------------- | ---------- | - | ---- | - | ---------- | -
|                                                                                                                |  | Three Months Ended March 31, |           
|                                                                                                                |  | 2004                         |            |   | 2003 |  
|Net loss:                                                                                                       |  |                              |            |   |      |   |            |  
|As reported                                                                                                     |  | $                            | (2,452,656 | ) |      | $ | (1,464,647 | )
|Add: Total employee and director stock-based compensation recognized                                            |  |                              |           |   |      |   | 10,005     |  
|Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards |  |                              | (15,774    | ) |      |   | (1,000     | )
|                                                                                                                |  |                              |            |   |      |   |            |  
|Pro forma net loss                                                                                              |  | $                            | (2,468,430 | ) |      | $ | (1,455,642 | )
|                                                                                                                |  |                              |            |   |      |   |            |  
|Basic and diluted net loss per share:                                                                           |  |                              |            |   |      |   |            |  
|As reported                                                                                                     |  | $                            | (.03       | ) |      | $ | (.02       | )
|Pro forma                                                                                                       |  |                              | (.03       | ) |      |   | (.02       | )
|                                                                                                                |  |                              |            |   |      |   |            |  



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NOTE MNET LOSS PER SHARE



We compute and present both basic and diluted earnings per share (EPS) on the face of the statement of operations. Basic EPS is computed
using the weighted average number of common shares outstanding during the period being reported on. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into
common stock at the beginning of the period being reported on, and the effect was dilutive. Our net loss and weighted average shares outstanding used for computing diluted loss per share were the same as those used for computing basic loss per share
for the three-month period ended March 31, 2004 and 2003 because our stock options and warrants (approximately 6,469,000 and 5,604,000 potential shares of Common Stock for the three-month periods ended March 31, 2004 and March 31, 2003,
respectively,) would be antidilutive.



NOTE N  PATENTS AND OTHER
INTANGIBLES



Amounts paid for patents and trademarks are
capitalized. Patent and trademark costs are deferred pending the successful outcome of the relevant applications. Successful patent costs are amortized using the straight-line method over the lives of the patents, typically five to fifteen years.
Unsuccessful patent costs are expensed when determined worthless or when patent applications will no longer be pursued. As of March 31, 2004, eleven of our patents are issued in the U.S. and thirty-four are issued in various foreign countries.
Various other patent and trademark applications are still pending. Such pending patents and trademarks had a cost basis of $560,000 at March 31, 2004, and will be amortized over their useful lives once the patents are issued. Other intangibles are
recorded at cost and are amortized over their estimated useful lives. Accumulated amortization on patents and other intangibles is $628,000 and $590,000 at March 31, 2004 and December 31, 2003, respectively.



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



The following Managements Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with Unigenes Annual Report
on Form 10-K for the year ended December 31, 2003, including the financial statements and notes contained therein.



SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS



Various statements in this Form 10-Q constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the Reform Act). These forward-looking statements
involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or activities of our business, or industry results, to be materially different from any future results, performance or activities
expressed or implied by such forward-looking statements. These factors include: general economic and business conditions, our financial condition, competition, our dependence on other companies to commercialize, manufacture and sell products using
our technologies, the uncertainty of results of animal and human testing, the risk of product liability and liability for human clinical trials, our dependence on patents and other proprietary rights, dependence on key management officials, the
availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, the failure to obtain regulatory approvals for our products, litigation and other factors discussed in
our various filings with the SEC, including Unigenes Annual Report on Form 10-K for the year ended December 31, 2003.



RESULTS OF OPERATIONS



Introduction



Unigene is a
biopharmaceutical company with two locations in New Jersey. Our single business segment focuses on research, production and delivery of peptides for medical use. We have concentrated most of our efforts to date on one peptide, calcitonin, for the
treatment of osteoporosis and other indications. Our first approved product in Europe was injectable calcitonin, and our first approved product in the United States is expected to be nasal calcitonin. We are also developing other potential peptide
products including parathyroid hormone, or PTH, for osteoporosis. Our peptide products require clinical trials and/or approvals from regulatory agencies as well as acceptance in the marketplace. We compete with specialized biotechnology companies,
major pharmaceutical and chemical companies and universities and research institutions. Most of these competitors have substantially greater resources than we do.



We generate revenue through licensing agreements with pharmaceutical companies and by achieving milestones in these agreements. These
agreements, to date, have not been sufficient to generate all of the cash to meet our needs. In addition, there are risks that current agreements will not be successful and that future agreements will not be consummated. We have tried to mitigate
these risks by developing additional proprietary technologies and by pursuing additional licensing opportunities but there is no guarantee that these efforts will be successful. We are also seeking to generate future revenue from sales of our nasal
calcitonin product, but there is no guarantee that the product will be approved by the FDA or, if approved, that it will generate significant revenue.



We have also generated cash from officer loans and from stock offerings. The officer loans have added debt to our balance sheet and will require repayment at some time in
the future. Our various stock offerings have provided needed cash but it is uncertain whether they will be available in the future or, if available, on favorable terms.



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The current need of major pharmaceutical companies to add products to their pipeline may be favorable for us and for
other small biopharmaceutical companies. But this need is subject to rapid change and it is uncertain whether any additional pharmaceutical companies would have interest in our products or technologies. In addition, there is continuing consolidation
within the pharmaceutical industry. Its effect on Unigene is uncertain.



Revenue



Revenue is summarized as follows for the three-month
periods ended March 31, 2004 and 2003:



|                     |  |      |         |      |   |          
|-------------------- |  | ---- | ------- | ---- | - | ---------
|                     |  | 2004 |         | 2003
|Licensing Revenue    |  | $    | 90,975  |      | $ | 1,089,474
|Development Services |  |      | 122,172 |      |   | 88,697   
|Product Sales        |  |      | 48,700  |      |   | 560,600  
|Other                |  |      | 61,476  |      |   | 189      
|                     |  |      |         |      |   |          
|                     |  | $    | 323,323 |      | $ | 1,738,960
|                     |  |      |         |      |   |          



Revenue for the three months ended
March 31, 2004 decreased 81% to $323,000 from $1,739,000 in the comparable period in 2003. Revenue for the three months ended March 31, 2004 consisted primarily of licensing revenue from GSK and USL as well as development activities under the GSK
agreement. Licensing revenue was significantly higher in the first quarter of 2003 due to the receipt of a $1,000,000 milestone payment from GSK for a successful animal study. Milestone revenue is based upon one time events and is therefore not
predictive of future revenue. Reimbursement from GSK for development activities increased this quarter due to the variability of research requirements, but may decline in the future due to our decreased responsibilities as the oral PTH program
progresses and GSKs responsibilities increase. There were no PTH sales to GSK for the quarter ended March 31, 2004 due to the fact that we have already supplied sufficient bulk PTH to GSK to meet their short term needs for upcoming studies.
Revenue for the three months ended March 31, 2003 included the $1,000,000 milestone payment as well as bulk PTH sales to GSK in the amount of $520,000. In 2002, we received a $2,000,000 up-front payment under an agreement for an oral PTH product
licensed to GSK. We also received a $1,000,000 licensing-related milestone payment from GSK in 2002. These $3,000,000 in payments are being deferred in accordance with SEC Staff Accounting Bulletin No. 104 (SAB 104) and recognized as revenue over a
15-year period, which is our estimated performance period of the license agreement. Therefore, $50,000 of the initially deferred up-front and milestone payments from GSK was recognized as revenue during each of the three-month periods ended March
31, 2004 and March 31, 2003. Also in 2002, we received a $3,000,000 up-front payment under an agreement for a nasal calcitonin product licensed to USL. This $3,000,000 is being deferred in accordance with SAB 104 and recognized as revenue over a
19-year period, which is our estimated performance period of the license agreement. Therefore, $39,000 of the up-front payment from USL was recognized as revenue during the three-month periods ended March 31, 2004 and March 31, 2003. In September
2003, we received a $60,000 up-front payment for our nasal calcitonin license in Greece. This revenue is being deferred in accordance with SAB 104 and recognized as revenue over a 10-year period, which is our estimated performance period of



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the license agreement. In a recent development, we signed a worldwide licensing agreement with Novartis in April 2004 for
a value before royalties of up to $18,700,000 to allow Novartis to manufacture calcitonin using our patented peptide production process. We received $5,600,000 in April 2004 consisting of a $3,500,000 up-front payment and a partial prepayment on
Novartis purchases of calcitonin from us in the amount of $2,100,000. Revenue recognition of the up-front licensing fee will be deferred over the estimated 14-year performance period of the license agreement. Revenue recognition of the
prepayment for calcitonin purchases will be recognized as we ship product to Novartis which is expected to occur during 2004.



Research and development, our largest expense, decreased 22% to $1,683,000 from $2,166,000 for the three months ended March 31, 2004, as compared to the same period in
2003. The three-month decrease was primarily attributable to a reduction in production costs in the amount of $431,000 due to the capitalization into inventory of certain manufacturing expenses due to our calcitonin production in anticipation of the
Novartis agreement, a reduction in depreciation expense of $199,000 and a reduction in nasal calcitonin development expenses of $106,000, partially offset by increased personnel costs of $108,000 and increased lab supplies, consulting and outside
testing in the aggregate amount of $96,000.



General and administrative
expenses increased 15% to $797,000 from $693,000 for the three months ended March 31, 2004 as compared to the same period in 2003. The three-month increase was primarily due to increased personnel costs of approximately $58,000, legal expenses of
$31,000 and increased insurance expense of $20,000.



Gain on the extinguishment
of debt and related interest in 2004 resulted from our December 2003 settlement agreement with Covington and Burling. Under the agreement, any payments that we make to Covington and Burling before December 31, 2004 will reduce our total obligation
of $1,098,000, consisting of principal and interest, by a multiple of the amount of the payment (multiples range from 1.46 to 1.19 depending on the month of payment). Until the obligation is paid in full, we have agreed to remit to Covington and
Burling certain percentages or dollar amounts of funds we receive from licensing or financing arrangements and Covington and Burling has received a security interest in certain of our assets. During the three-month period ended March 31, 2004, we
made payments to Covington and Burling in the aggregate amount of $150,000. These payments had an average multiple of 1.42 and reduced our debt to Covington and Burling by $213,269. We therefore recognized a gain on extinguishment of debt in the
amount of $63,269 in the first quarter of 2004.



Interest expense for the first
quarters of 2003 and 2004 was affected by the fact that in 2001 we did not make principal and interest payments on certain officers loans when due. Therefore, the interest rate on certain prior loans increased an additional 5% per year and
applied to both past due principal and interest. This additional interest was approximately $179,000 for the first three months of 2004 and $152,000 for the first three months of 2003 and total interest expense on officers loans for the three
months ended March 31, 2004 and 2003 was $336,000 and $313,000, respectively.



Due to the decrease in revenue from GSK partially offset by a decrease in operating expenses, net loss for the three months ended March 31, 2004 increased 67% or approximately $988,000 to $2,453,000 from $1,465,000 for the corresponding
period in 2003.



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LIQUIDITY AND CAPITAL RESOURCES



We have a number of future payment obligations under various agreements. They are summarized at March 31, 2004 as follows:



|                                       |  |       |            |      |            |      |           |      |         |      |         |            |          
|-------------------------------------- |  | ----- | ---------- | ---- | ---------- | ---- | --------- | ---- | ------- | ---- | ------- | ---------- | ---------
|Contractual Obligations                |  | Total |            | 2004 |            | 2005 |           | 2006 |         | 2007 |         | Thereafter
|Chinese joint ventures (SPG & Qingdao) |  | $     | 982,500    |      | 45,000     |      | 427,500   |      | 15,000  |      | 495,000 |            |         
|Tail Wind Note                         |  |       | 977,686    |      |           |      | 977,686   |      |        |      |        |            |         
|Notes payable  stockholders           |  |       | 11,273,323 |      | 11,273,323 |      |          |      |        |      |        |            |         
|Capital leases                         |  |       | 359,810    |      | 128,139    |      | 219,709   |      | 3,120   |      | 3,120   |            | 5,722    
|Operating leases                       |  |       | 2,038,602  |      | 174,481    |      | 225,002   |      | 212,269 |      | 201,438 |            | 1,225,412
|Executive compensation                 |  |       | 303,750    |      | 303,750    |      |          |      |        |      |        |            |         
|Due to Covington and Burling           |  |       | 885,002    |      | 885,002    |      |          |      |        |      |        |            |         
|Accrued interest  stockholders        |  |       | 4,877,475  |      | 4,877,475  |      |          |      |        |      |        |            |         
|Accrued interest  Tail Wind           |  |       | 116,139    |      |           |      | 116,139   |      |        |      |        |            |         
|                                       |  |       |            |      |            |      |           |      |         |      |         |            |          
|Total Contractual Obligations          |  | $     | 21,814,287 |      | 17,687,170 |      | 1,966,036 |      | 230,389 |      | 699,558 |            | 1,231,134
|                                       |  |       |            |      |            |      |           |      |         |      |         |            |          



At March 31, 2004, we had cash and
cash equivalents of $591,000, an increase of $79,000 from December 31, 2003.



We believe that we will generate financial resources to apply toward funding our operations through the achievement of milestones in the GSK, USL, or Novartis agreements and through the sale of PTH and calcitonin to GSK and Novartis,
respectively and, if necessary, with the funds available through our financing with Fusion. We therefore expect to have sufficient financial resources for the next twelve months. Our financial situation may be augmented by sales and royalties on our
nasal calcitonin product if it receives FDA approval and we are able to launch the product later in 2004. If we are unable to achieve these milestones and sales, or are unable to achieve the milestones and sales on a timely basis, we would need
additional funds to continue our operations. We have incurred annual operating losses since our inception and, as a result, at March 31, 2004, had an accumulated deficit of approximately $104,000,000 and a working capital deficiency of approximately
$20,000,000. Our cash requirements to operate our research and peptide manufacturing facilities and develop our products are approximately $11,000,000 per year. In addition, we have principal and interest obligations under the Tail Wind note,
outstanding notes payable to the Levys, our executive officers, as well as obligations relating to our current and former joint venture agreements in China. As discussed in Note F to the financial statements, we have stockholder demand notes in
default at March 31, 2004. These factors, among others, raise substantial doubt about our ability to continue as a going concern. The financial statements have been prepared on a going concern basis and as such do not include any adjustments that
might result from the outcome of this uncertainty.



In April 2002, we signed a
licensing agreement with GSK for a value before royalties, PTH sales and reimbursement for development expenses, of up to $150,000,000 to develop an oral formulation of an analog of PTH currently in preclinical development for the treatment of
osteoporosis, of which an aggregate of $4,000,000 in up-front and milestone payments has been received through March 31, 2004. GSK could make additional milestone payments in the aggregate amount of $146,000,000 subject to the progress of the
compound through clinical development and through to the market. We have also received an additional $3,900,000 from GSK for PTH sales and in support of our PTH development activities through March 31, 2004. Under the terms of the agreement, GSK
received an exclusive worldwide license to develop and commercialize the product. In return, GSK made a $2,000,000 up-front licensing fee payment and a $1,000,000 licensing-related milestone payment to us in 2002, and we received an additional
$1,000,000 milestone payment in January 2003. In addition, GSK will fund all development activities during the program, including our activities in the production of raw material for development and clinical supplies, and will pay us a royalty on
its worldwide sales of the product, once commercialized.





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In November 2002, we signed an exclusive U.S. licensing agreement with USL for a value before royalties of up to
$10,000,000 to market our patented nasal formulation of calcitonin for the treatment of osteoporosis. Under the terms of the agreement, we received an up-front payment of $3,000,000 in 2002 from USL and are eligible to receive milestone payments up
to $7,000,000 and royalty payments on product sales. In the second quarter of 2003, we received a $3,000,000 milestone payment from USL for the FDAs acceptance for review of our nasal calcitonin NDA. We will be responsible for manufacturing
the product and will sell filled calcitonin product to USL. USL will package the product and will distribute it nationwide.



In April 2004, we signed a worldwide licensing agreement with Novartis for a value before royalties of up to $18,700,000 to allow Novartis to manufacture calcitonin using
our patented peptide production process. We received $5,600,000 from Novartis in April 2004 consisting of a $3,500,000 up-front payment and a partial prepayment on Novartis purchases of calcitonin from us in the amount of $2,100,000.
Initially, Novartis will purchase calcitonin from us for use in their oral calcitonin development program. Eventually, Novartis plans to implement our patented manufacturing process at a Novartis facility to support their calcitonin products. We
will receive royalties on sales of any existing or future Novartis products that contain calcitonin manufactured by Novartis using our process. We will continue to develop our oral, nasal and injectable calcitonin products. If our oral calcitonin
product is successfully developed, we would purchase calcitonin from Novartis, thereby eliminating our need to construct a second, larger-scale calcitonin manufacturing facility.



Our future ability to generate cash from operations will depend primarily in the short-term upon the achievement of milestones in the GSK,
USL and Novartis agreements, GSK reimbursed development activities and through the sale of PTH to GSK and calcitonin to Novartis and, in the long-term, by receiving royalties from the sale of our licensed products and technologies. We have licensed
distributors in Greece, where the product is not yet approved, for our nasal calcitonin product and in the United Kingdom, Ireland and Israel for our injectable product. However, these agreements have not produced significant revenues. In June 2000,
we entered into an agreement in China with SPG to create a joint venture to manufacture and market our injectable and nasal calcitonin products. We are actively seeking additional licensing and/or supply agreements with pharmaceutical companies for
oral, nasal and injectable forms of calcitonin as well as for other oral peptides. However, we may not be successful in achieving milestones in our current agreements, obtaining regulatory approval for our products or in licensing any of our other
products.



We are engaged in the research, production and delivery of
peptide-related products. Our primary focus has been on the development of various peptide products for the treatment of osteoporosis, including nasal and oral calcitonin and oral PTH. In general, we seek to develop the basic product and then
license the product to an established pharmaceutical company to complete the development, clinical trials and regulatory process. As a result, we will not control the nature, timing or cost of bringing our products to market. Each of these products
is in various stages of completion. For nasal calcitonin, we filed an Investigational New Drug application (IND) with the FDA in February 2000 and successfully completed human studies using our product. A license agreement was signed in November
2002 with USL and an NDA was filed with the FDA in March 2003. The NDA was accepted for review by the FDA in May 2003. In January 2004 we announced the receipt of an approvable letter from the FDA. The letter is an official communication from the
FDA indicating that the agency is prepared to approve the NDA upon the finalization of the labeling and the resolution of specific remaining issues, including the submission of additional information and data. However, during this review process
additional questions or concerns may be raised by the FDA, which could delay product approval. A Citizens Petition, which typically requests the FDA to reconsider its decisions, was filed on January 9, 2004 on behalf of an anonymous party
subsequent to the announcement of our receipt of the FDA approvable letter. Using certain assumptions, the petition



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questioned the FDAs ability to grant approval for any recombinant calcitonin product that primarily relies on
clinical markers of bone cell activity. We believe that all of the issues raised in the petition have been thoroughly considered by the FDA prior to the issuance of the approvable letter. For oral calcitonin, Pfizer terminated its license agreement
with us in March 2001 and as a result we are seeking a new licensee to repeat a Phase I/II clinical trial and also to conduct a Phase III clinical trial. We expect that the costs of these trials would be borne by our future licensee due to our
limited financial resources. Because multiple clinical trials are still necessary for our oral calcitonin product, the product launch would take at least several years. PTH is in very early stages of development and it is too early to speculate on
the probability or timing of a marketable product using our PTH. A license agreement for the product was signed with GSK in April 2002. Due to our limited financial resources, the delay in achieving milestones in our existing GSK, USL or Novartis
agreements, or in signing new license or distribution agreements for our products, or the delay in obtaining regulatory approvals for our products would have an adverse effect on our operations and our cash flow.



We maintain our peptide production facility on leased premises in Boonton, New Jersey. We
began production under cGMP guidelines at this facility in 1996. The lease was renewed and now expires in 2014. We have a ten-year renewal option under the lease, as well as an option to purchase the facility. During the first three months of 2004,
we invested approximately $150,000 in fixed assets and leasehold improvements. Currently, we have no material purchase commitments outstanding.



Under the terms of the joint venture agreement in China with SPG, we are obligated to contribute up to $405,000 in cash after approval of its Chinese NDA (which was filed
in September 2003) and up to an additional $495,000 in cash within two years thereafter. Approvals of NDAs in China may require approximately twelve to eighteen months or more. These amounts may be reduced or offset by our share of the entitys
profits, if any.



In addition, we are obligated to pay to Qingdao an aggregate
of $350,000 in monthly principal installment payments of $5,000 in order to terminate our former joint venture in China, of which $120,000 is remaining as of March 31, 2004. We recognized the entire $350,000 obligation as an expense in 2000.



Pursuant to the terms of the April 2002 settlement agreement, Tail Wind
surrendered to us the $2,000,000 principal amount of convertible debentures that remained outstanding and released all claims against us relating to Tail Winds purchase of the convertible debentures, which were approximately $4,500,000
including accrued interest and penalties in the approximate amount of $2,500,000. In exchange, we issued to Tail Wind a $1,000,000 promissory note secured by our Fairfield, New Jersey building and equipment and 2,000,000 shares of Unigene common
stock. The note bears interest at a rate of 6% per annum and principal and interest are due in February 2005.



To satisfy our short-term liquidity needs, Jay Levy, the Chairman of the Board and an officer of Unigene, and Warren Levy and Ronald Levy, directors and officers of Unigene, and another Levy family member from time to
time have made loans to us. We have not made principal and interest payments on certain loans when due. However, the Levys waived all default provisions including additional interest penalties due under these loans through December 31, 2000.
Beginning January 1, 2001, interest on loans originated through March 4, 2001 increased an additional 5% per year and is calculated on both past due principal and interest. This additional interest was approximately $179,000, and total interest
expense on all Levy loans was approximately $336,000 for the three months ended March 31, 2004. As of March 31, 2004, total accrued interest on all Levy loans was approximately $4,877,000 and the outstanding loans by these individuals to us,
classified as short-term debt, totaled $11,273,323. These loans are secured by security interests in our equipment, real property and/or certain of our patents.



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Under our new agreement with Fusion, we have the contractual right to sell to Fusion, subject to certain conditions, at
the then current market price, on each trading day during the term of the agreement, $30,000 of our common stock up to an aggregate of $15,000,000. See Note I to our financial statements. The Board of Directors has authorized the sale to Fusion of
up to 13,500,000 shares of Unigene common stock under this agreement. Under this agreement, from January 1, 2004 through March 31, 2004, we have received $2,250,000 through the sale of 3,124,952 shares to Fusion, before cash expenses of
approximately $33,000. Our ability to realize additional funds will depend on our continuing compliance with the new Fusion agreement. Our new agreement with Fusion expires in November 2005, unless we decide to terminate earlier.



The extent to which we intend to utilize Fusion as a source of financing will depend on a
number of factors, including the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources, such as through the achievement of milestones and the generation of sales through our
existing agreements, or by entering into new licensing agreements or the sale of bulk calcitonin, both of which we are actively exploring. If we are unable to achieve milestones or sales under our existing agreements or enter into a new significant
revenue generating license or other arrangement in the near term, we would need either to utilize Fusion or secure another source of funding in order to satisfy our working capital needs or significantly curtail our operations. We also could
consider a sale or merger of Unigene. Should the funding we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequence would be a material adverse effect on our business, operating
results, financial condition and prospects. We believe that satisfying our capital requirements over the long term will require the successful commercialization of one or more of our oral or nasal calcitonin products, our oral PTH product or another
peptide product in the U.S. and abroad. However, it is uncertain whether or not any of our products will be approved or will be commercially successful. In addition, the commercialization of an oral peptide product may require us to incur additional
capital expenditures to expand or upgrade our manufacturing operations. We cannot determine either the cost or the timing of such capital expenditures at this time.



As of December 31, 2003, we had available for federal income tax reporting purposes net operating loss carryforwards in the approximate
amount of $85,000,000, expiring from 2004 through 2023, which are available to reduce future earnings which would otherwise be subject to federal income taxes. Our ability to use such net operating losses may be limited by change in control
provisions under Internal Revenue Code Section 382. In addition, as of December 31, 2003, we have research and development credits in the approximate amount of $3,000,000, which are available to reduce the amount of future federal income taxes.
These credits expire from 2004 through 2023. We have New Jersey operating loss carryforwards in the approximate amount of $29,600,000, expiring from 2006 through 2010, which are available to reduce future earnings, otherwise subject to state income
tax. However, changes in the law in 2002 do not allow the use of a companys own New Jersey net operating losses to offset its current taxable income. As of December 31, 2003, approximately $22,600,000 of these New Jersey loss carryforwards
have been approved for future sale under a program of the New Jersey Economic Development Authority (NJEDA). In order to realize these benefits, we must apply to the NJEDA each year and must meet various requirements for continuing eligibility. In
addition, the program must continue to be funded by the State of New Jersey, and there are limitations based on the level of participation by other companies. As a result, future tax benefits will be recognized in the financial statements as
specific sales are approved.



SUMMARY OF CRITICAL ACCOUNTING POLICIES



The Securities and Exchange Commission defines critical accounting
policies as those that are both important to the portrayal of a companys financial condition and results, and require managements most difficult, subjective or complex judgments, often as a result of the need to make estimates
about the effect of matters that are inherently uncertain.





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The following discussion of critical accounting policies represents our attempt to bring to the attention of the readers
of this report those accounting policies which we believe are critical to our financial statements and other financial disclosure. It is not intended to be a comprehensive list of all of our significant accounting policies which are more fully
described in Note 3 of the Notes to the Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2003. In many cases, the accounting treatment of a particular transaction is specifically dictated by generally
accepted accounting principles, with no need for managements judgment in their application. There are also areas in which the selection of an available policy would not produce a materially different result.



Revenue Recognition: Revenue from the sale of product is recognized upon shipment to the
customer. We occasionally apply to various government agencies for research grants. Revenue from such research grants is recognized when earned. Such revenues generally do not involve difficult, subjective or complex judgments. Non-refundable
milestone payments that represent the completion of a separate earnings process and a significant step in the research and development process are recognized as revenue when earned if they meet the definition of SAB 104. This sometimes requires
management to judge whether or not a milestone has been met, and when it should be recognized in the financial statements. Non-refundable license fees received upon execution of license agreements where we have continuing involvement are deferred
and recognized as revenue over the life of the agreement. This requires management to estimate the expected term of the agreement or, if applicable, the estimated life of its licensed patents. In addition, EITF No. 00-21 requires companies to
evaluate its arrangements under which it will perform multiple revenue-generating activities. For example, a license agreement with a pharmaceutical company may involve a license, research and development activities and/or contract manufacturing.
Management is required to determine if the separate components of the agreement have value on a standalone basis and qualify as separate units of accounting whereby consideration is allocated based upon their relative fair values or, if
not, the consideration should be allocated based upon the residual method. The adoption of EITF No. 00-21 has not had a material impact on the financial statements to date.



Accounting for Stock Options: We account for stock options granted to employees and directors in accordance with the provisions of APB
Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations. As such, compensation expense is recorded on fixed stock option grants only if the current fair value of the underlying stock exceeds the exercise
price of the option at the date of grant and it is recognized on a straight-line basis over the vesting period. We account for stock options granted to non-employees on a fair value basis in accordance with SFAS No. 123, Accounting for
Stock-Based Compensation, and Emerging Issues Task Force Issue No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. As a result, the
non-cash charge to operations for non-employee options with vesting or other performance criteria is affected each reporting period by changes in the fair value of our common stock.



Use of Estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States
of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of
revenues and expenses during the reporting period. Actual results could differ from those estimates.



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Item 3. Quantitative and Qualitative Disclosures About Market Risk



In the normal course of business, we are exposed to fluctuations in interest rates due to the use of debt as a component of the funding of our operations. We do not employ specific strategies, such as the use of
derivative instruments or hedging, to manage our interest rate exposure. Beginning in the first quarter of 2001, our interest rate exposure on our notes payable-stockholders has been affected by our failure to make principal and interest payments
when due. Our exposure to interest rate fluctuations over the near-term will continue to be affected by these events.



The information below summarizes our market risks associated with debt obligations as of March 31, 2004. The table below presents principal cash flows and related
interest rates by year of maturity based on the terms of the debt.



Variable
interest rates disclosed represent the rates at March 31, 2004. Given our financial condition described in Liquidity and Capital Resources it is not practicable to estimate the fair value of our debt instruments.



|                             |  |                |           |                  |           |      |         |      |       |      |       |  |      
|---------------------------- |  | -------------- | --------- | ---------------- | --------- | ---- | ------- | ---- | ----- | ---- | ----- |  | -----
|                             |  | CarryingAmount |           | Year of Maturity
|                             |  | 2004           |           | 2005             |           | 2006 |         | 2007 |       | 2008
|Notes payable - stockholders |  | $              | 3,693,323 |                  | 3,693,323 |      |        |      |      |      |      |  |     
|Variable interest rate (1)   |  |                | 10.5%     |                  |          |      |        |      |      |      |      |  |     
|Notes payable - stockholders |  | $              | 5,710,000 |                  | 5,710,000 |      |        |      |      |      |      |  |     
|Variable interest rate       |  |                | 5.5%      |                  |          |      |        |      |      |      |      |  |     
|Notes payable - stockholders |  | $              | 1,870,000 |                  | 1,870,000 |      |        |      |      |      |      |  |     
|Fixed interest rate (2)      |  |                | 11%       |                  |           |      |         |      |       |      |       |  |      
|Tail Wind note               |  | $              | 977,686   |                  |          |      | 977,686 |      |      |      |      |  |     
|Fixed interest rate          |  |                | 6%        |                  |           |      |         |      |       |      |       |  |      
|Capital leases               |  | $              | 359,810   |                  | 128,139   |      | 219,709 |      | 3,120 |      | 3,120 |  | 5,722
|Fixed interest rate          |  |                | 13% - 16% |                  |           |      |         |      |       |      |       |  |      

---

|(1) | Due to the fact that we did not make principal and interest payments on our notes payable to stockholders when due, the variable interest rate on these notes has increased from the
Merrill Lynch Margin Loan Rate plus .25% to the Merrill Lynch Margin Loan Rate plus 5.25%.
|--- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

|(2) | Due to the fact that we did not make principal and interest payments on our notes payable to stockholders when due, the fixed interest rate on these notes has increased from 6% to
11%.
|--- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Item 4. Controls and Procedures



|(a) | Within 90 days prior to the date of the filing of this report, we carried out an evaluation, under the supervision and with the participation of our principal executive officer and
principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls
and procedures are effective in timely alerting them to material information required to be included in our periodic SEC reports.
|--- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



|(b) | In addition, we reviewed our internal controls, and there have been no significant changes in our internal controls or in other factors that could significantly affect those
controls subsequent
|--- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



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to the date of their last evaluation. In response to Grant Thornton LLPs comments resulting from
their audit of our 2003 financial statements included on Form 10-K, we are assessing the best way to implement an IT disaster recovery plan and off-site storage of our IT system backups, but have not yet modified our internal controls in these
areas. We have implemented improved oversight and review by appropriate personnel of payroll processing activities. We considered these matters in connection with the preparation of the March 31, 2004 financial statements included in this Form 10-Q
and determined that no financial statements were affected by these matters.



PART II. OTHER INFORMATION



Item 2. Changes in Securities and Use of Proceeds



(a) Not applicable.



(b) Not
applicable.



(c) Recent Sales of Unregistered Securities.



In the quarter ended March 31, 2004, Unigene sold 3,124,952 shares of common
stock to Fusion Capital Fund II, LLC for gross proceeds of $2,250,000. All of such shares were issued by Unigene without registration in reliance on an exemption under Section 4(2) of the Securities Act of 1933, because the offer and sale was made
to a limited number of investors in a private transaction.



(d) Not applicable.



Item 3. Defaults Upon Senior Securities



See
description of notes payable to stockholders in Part I, Item 2: Managements Discussion and Analysis of Financial Condition and Results of Operations  Liquidity and Capital Resources.



Item 6. Exhibits and Reports on Form 8-K



(a) Exhibits:



|       |  |                                                                                           
|------ |  | ------------------------------------------------------------------------------------------
|Number |  | Description                                                                               
|31.1   |  | Certification by Warren P. Levy pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|       | 
|31.2   |  | Certification by Jay Levy pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.      
|       | 
|32.1   |  | Certification by Warren P. Levy pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|       | 
|32.2   |  | Certification by Jay Levy pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.      



(b) Reports on Form
8-K: None



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SIGNATURES



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



|             |  |                             
|------------ |  | ----------------------------
|             |  | UNIGENE LABORATORIES, INC.  
|             |  | (Registrant)                
|             | 
|May 17, 2004 |  | /s/ Warren P. Levy          
|             |  | Warren P. Levy, President   
|             |  | (Chief Executive Officer)   
|             | 
|May 17, 2004 |  | /s/ Jay Levy                
|             |  | Jay Levy, Treasurer         
|             |  | (Chief Financial Officer and
|             |  | Chief Accounting Officer)   





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