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Note 1 - Liquidity
6 Months Ended
Jun. 30, 2012
Liquidity Disclosure [Policy Text Block]
NOTE A – LIQUIDITY

Cash

At June 30, 2012, the Company had cash and cash equivalents of $1,749,608, a decrease of $2,932,075 from December 31, 2011.  The Company has incurred annual operating losses since its inception, including a loss of $14,443,000 during the six months ended June 30, 2012, and, as a result, at June 30, 2012, had an accumulated deficit of approximately $197,000,000.  The Company expects to incur net losses and cash flow deficiencies from operating activities for the foreseeable future.

Recent developments impacting business operations

On July 20, 2012 the European Medicines Agency (“EMA”) issued a press release concerning the marketability of approved calcitonin products in Europe, concluding there was evidence of a small increased risk of cancer with long-term use of current calcitonin medications approved and commercially available in Europe since 1973, and calling for curtailment of calcitonin usage.  On August 1, 2012, Health Canada announced that it is reviewing whether to follow European medical authorities and restrict use of a nasal spray prescribed to prevent osteoporosis because of the increased risk of cancer.

The Company has licensed to Upsher-Smith Laboratories, Inc. (“USL”) its patented nasal formulation of calcitonin for commercialization in the United States and has licensed the development and worldwide commercialization rights (except China) for its Phase 3 oral calcitonin to Tarsa Therapeutics, Inc. (“Tarsa”).  However, since neither the Company nor its licensees are Market Authorization Holders in Europe, they do not have the right to appeal the EMA's recommendation.  The potential regulatory and commercial impact of this announcement on calcitonin related products marketed or under development by the Company’s licensees and partners in Europe and other markets as well as the resulting financial impact on its future business operations is currently being evaluated.  There is a possibility that other regulatory authorities, including the United States Food and Drug Administration (“FDA”), could take actions as a result of the EMA recommendation, including withdrawing calcitonin products from the market or limiting their use.  This could materially adversely affect the Company’s finances and operations by reducing or eliminating sales and royalties on Fortical, limiting the value of current calcitonin development projects and limiting the potential value of its investment in Tarsa.  Additionally, this could impact the carrying value of assets, including fixed assets, inventories and patents, as well as the Company’s ability to obtain adequate financing.

Debt

As of June 30, 2012, the Company’s total principal debt, inclusive of its capital lease obligations and accrued interest, was approximately $68,400,000.  Based on managements’ current cash flow projections, the Company will need to obtain significant additional financing to fund operations, address its current debt and restructure its balance sheet.  Without additional financing, the Company is expected to run out of cash in the fourth quarter of 2012.  The Company is currently exploring various alternatives, including financing, debt restructuring and partnering options.  If the Company is unable to obtain financing, it may not be able to continue as a going concern in the near future.

On May 29, 2012, the Company entered into an agreement to settle its obligations to Jay Levy, the estate of Jean Levy, Warren Levy and Ronald Levy (the “Levys” or the “Founders”) (see Note G).  Pursuant to the settlement agreement, the Founders agreed to settle any and all outstanding obligations due from the Company in exchange for (i) two installment payments of $150,000 each due in May and June 2012 (the “Interim Payments”), which were subsequently paid by the Company; (ii) $7,700,000 payable on or before September 30, 2012; and (iii) the issuance of 5,000,000 shares of the Company’s common stock.  Currently, the Company does not have sufficient cash to make the final payment contemplated under the agreement with the Founders.  In light of the recent EMA recommendation, the expected financial impact on business operations and the ability of the Company to raise funds, the Company does not believe it will be in a position to fund the debt settlement with the Founders.  In the event that the Company does not fund the debt settlement, the Company will owe the Founders a total of $23,000,000 in principal and accrued interest as of September 30, 2012.

Under the restated financing agreement with Victory Park Management, LLC (together with its affiliates, “Victory Park”) (see Note H), the Company must maintain a cash balance equal to at least $2,500,000 and its cash flow (as defined in the restated financing agreement) must be at least $2,000,000 in any fiscal quarter or $7,000,000 in any three consecutive quarters.  On May 29, 2012, the Company entered into a letter agreement with Victory Park pursuant to which they agreed to, among other things, waive the financial covenant requirements through September 30, 2012 (see Note H).  As a result of its cash balance being less than $2,500,000 as of June 30, 2012, the Company would have been in default of this provision had Victory Park not agreed to the waiver.  In the event the Company is not able to successfully restructure the Victory Park debt, the Company is expected to be in violation of its covenants with Victory Park in periods subsequent to September 30, 2012. Any such default could result in the Company’s debt owed to Victory Park becoming immediately due and payable.

As previously disclosed, the Company is in discussions with Victory Park (see Note H).  However, there can be no assurance that the Company will be able to reach agreement with Victory Park regarding its debt obligations or on any other matter.

Liquidity

The global credit crisis that began in 2007 was further exacerbated by events occurring in the financial markets in the fall of 2008, and has continued into 2012.  These events have negatively impacted the ability of corporations to raise capital through equity financings or borrowings.  The credit crisis may continue for the foreseeable future. In addition, uncertainty about current and future global economic conditions may impact the Company’s ability to license its products and technologies to other companies and may cause consumers to defer purchases of prescription medicines, such as Fortical, in response to tighter credit, decreased cash availability and declining consumer confidence. Accordingly, future demand for the Company’s products and technologies could differ negatively from its current expectations.

Due to the Company’s limited financial resources, any further significant decline in Fortical sales and/or royalties, or delay in achieving milestones under its existing license agreements, or in signing new license, feasibility or distribution agreements for its products or technologies or loss of patent protection, ability to sell additional shares of its common stock, its inability to restructure its existing Victory Park debt, or ability to not violate its covenants with Victory Park could have a material adverse effect on the Company’s cash flow and operations (see Notes D, E, J, N,  and R).  As a result of advancing Fortical purchase orders from USL previously scheduled for November 2012 and February 2013, the Company expects to receive an additional $1,400,000 in cash in September 2012.   These orders will reduce sales of Fortical in future periods.  Additionally, the Company is in the process of evaluating operating expenses in order to curtail cash expenditures to extend its cash runway.

If the Company is unable to achieve significant milestones or sales under its existing agreements and/or enter into new significant revenue generating license or other arrangements in the near-term, the Company will need to either secure another source of funding in order to satisfy its working capital needs and to remain in compliance with covenants in its financing agreement with Victory Park (see Note H) or significantly curtail its operations. Should the funding required to sustain the Company’s working capital needs be unavailable or prohibitively expensive, the consequence would be a material adverse effect on its business, operating results, financial condition and prospects. The Company believes that satisfying its cash requirements over the long term will require the successful commercialization of its licensed oral or nasal calcitonin products, and one or more of its Peptelligence™ biotechnologies, its oral parathyroid hormone (“PTH”) product, the obesity program or another peptide product in the U.S. and/or abroad. However, it is uncertain whether any new products will be approved or will be commercially successful. The amount of future revenue the Company will derive from Fortical is also uncertain.

In December 2011, the Company announced a restructuring plan that included a reduction in workforce and expenses to improve operational efficiencies and to better match resources with market demand. Under the comprehensive plan, the Company is continuing Fortical production and maintaining all of its core programs and partnered activities while decreasing cash expenditures. Since the Company is currently maintaining an adequate inventory of calcitonin and enzyme to support expected future Fortical production needs, it continues to suspend manufacturing of those materials at its Boonton facility. However, the Company is maintaining the cGMP status of the facility and the ability to manufacture peptides at that location. Implementation of the restructuring plan resulted in an immediate company-wide workforce reduction of approximately 25%. The cash requirements in 2012 to operate the research and peptide manufacturing facilities and develop products have decreased from 2011 due to the December 2011 restructuring.

Cash received during the six months ended June 30, 2012 was primarily from Fortical sales and royalties received under the  agreement with Upsher-Smith Laboratories, Inc. (“USL”); accounts receivable collected from GlaxoSmithKline (“GSK”) for work performed in 2011;  and from development work and fee-for-service feasibility studies for various companies, including Tarsa. The Company’s primary sources of cash have historically been (1) licensing fees for new agreements, (2) milestone and other payments under licensing or development agreements, (3) bulk peptide sales under licensing or supply agreements, (4) loans from its founders and Victory Park, (5) the sale of its common stock, (6) Fortical sales and royalties and (7) the proceeds from the sale of state net operating loss carryforwards. In 2011, the Company divested its equity interest in its former China Joint Venture as well as its Site Directed Bone Growth (“SDBG”) program, which may result in additional sources of cash in the future. There can be no assurance that any of these cash sources will continue to be available to the Company in the future. Licensing fees from new collaborations are dependent upon the successful completion of complex and lengthy negotiations. Milestone payments are based upon progress achieved in collaborations, which cannot be guaranteed, and are often subject to factors that are controlled neither by the Company or its licensees. Product sales to the Company’s partners under these agreements are based upon its licensees’ needs, which are sometimes difficult to predict. Sale of the Company’s common stock is dependent upon its ability to attract interested investors, its ability to negotiate favorable terms and the performance of the stock market in general and biotechnology investments in particular. Future Fortical sales and royalties will be affected by competition and continued acceptance in the marketplace and could be impacted by manufacturing, distribution or regulatory issues.  The Company is actively seeking additional licensing and/or supply agreements with pharmaceutical companies for various oral peptides, including PTH and its obesity peptide, and for its peptide manufacturing technology. In October 2011, the Company announced its decision to establish a Joint Development Vehicle with Nordic Bioscience (see Note N).  The Company may not be successful in achieving milestones under its current agreements, in obtaining regulatory approval for its other products or in-licensing any of its other products or technologies.

Going Concern

These uncertainties raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. Refer to the financial statements and footnotes thereto included in Unigene’s annual report on Form 10-K for the year ended December 31, 2011, as amended, including the accompanying Report of Independent Registered Public Accounting Firm, dated March 15, 2012 (except for Note 29 and the effects thereof, as to which the date is January 31, 2013), of Grant Thornton LLP. The condensed financial statements included in this Form 10-Q/A 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.