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

Cash

At September 30, 2012, Unigene Laboratories, Inc. (the “Company”) had cash and cash equivalents of $3,999,000, a decrease of $683,000 from December 31, 2011.  The decrease is primarily due to net cash used in operating and investing activities of $3,120,000 and $969,000, respectively, partially offset by the $3,500,000 in proceeds received (following the deposit of $500,000 for fees of the lenders) as a result of refinancing our debt in September 2012 (see Note H). The Company has incurred annual operating losses since its inception, including a loss of $18,945,000 during the nine months ended September 30, 2012, and, as a result, at September 30, 2012, had an accumulated deficit of $201,286,000.  The Company expects to incur net losses and cash flow deficiencies from operating activities for the foreseeable future.

Debt

As of September 30, 2012, the Company’s total principal debt, inclusive of capital lease obligations and accrued interest, was approximately $74,500,000, inclusive of an additional $4,000,000 note issued in September 2012 as further described below.  Based on managements’ current cash flow projections, the Company will need to obtain significant additional financing in the near term to fund operations, address its current debt and restructure its balance sheet.   Management’s cash flow projections at the time of the issuance of the $4,000,000 note estimated that cash on hand would be sufficient to fund operations through at least June 2013.  These estimates included the assumption that our Biotechnologies Strategic Business Unit (“Biotechnologies SBU”) would be able to convert at least one of its ongoing oral peptide delivery feasibility partnerships into a definitive license agreement bearing a significant up-front cash payment, on or before December 31, 2012.  While the Company is still actively pursuing such opportunities, the Company did not enter into a license agreement with a significant upfront cash component by December 31, 2012.  This change in the Company’s projections is the result of an ongoing review of our Biotechnologies SBU and the status of its feasibility programs, including recent feedback from the Biotechnologies SBU’s feasibility partners regarding the criteria and timing for each partners’ decision to license our technology, as well as delays to our ongoing feasibility and partner sponsored Peptelligence™ research programs.  In particular, several early stage development partners have indicated that, in the current funding environment until they themselves are able to partner, they may not have sufficient discretionary cash resources to satisfy commercially reasonable licensing terms. In addition, certain feasibility partners participating in longer-term research oriented feasibility work have decided to extend or expand their current feasibility programs but are not yet ready to enter into a definitive licensing agreement until the ongoing feasibility studies yield certain desired targets. As a result of the corresponding anticipated reduction in the Biotechnologies SBU’s forecasted revenues, management is actively pursuing various alternatives to extend the Company’s cash runway.  In accordance with guidance previously issued by the Company, in the event that the Company is unable to secure additional sources of revenue, it will not be able to fund operations beyond the first quarter of 2013. Additionally, our current projections would result in the Company defaulting on the minimum cash requirement as of March 31, 2013 under its forbearance agreement.

On September 21, 2012 (the “First Amendment Effective Date”), the Company entered into a Forbearance Agreement and First Amendment to Amended and Restated Financing Agreement, by and among the Company, Victory Park Management, LLC, as administrative agent and collateral agent (the “Agent”), Victory Park Credit Opportunities, L.P., VPC Fund II, L.P., VPC Intermediate Fund II (Cayman) L.P., and Victory Park Credit Opportunities Intermediate Fund, L.P. (collectively, the “Lenders” and together with the Agent, the “VPC Parties” and “Victory Park”) (together with all exhibits and schedules thereto, and as amended from time to time, the “Forbearance Agreement”). The Forbearance Agreement evidenced (i) the forbearance by the VPC Parties with respect to the exercise of certain of their rights and remedies arising as a result of the existence of certain events of default under the Restated Financing Agreement; (ii) the amendment of certain provisions of the Amended and Restated Financing Agreement dated as of March 16, 2010, by and among the Company, the Agent, as administrative agent and collateral agent, and the Lenders party thereto (the “Restated Financing Agreement”); and (iii) the other agreements contemplated by the Forbearance Agreement  (collectively the “2012 Restructuring”).  Pursuant to the Forbearance Agreement, the Company issued to the Lenders a $4,000,000 senior secured note, resulting in a total liability to the Lenders of $51,448,000 as of September 30, 2012, inclusive of principal and interest. As a result of the financial restatement described above and in Note B, the Company was unable to finalize and file this Form 10-Q by the Securities and Exchange Commission’s (the “SEC”) extended filing deadline of November 21, 2012.  Therefore, the Company gave the VPC Parties notice that an event of default occurred under the Forbearance Agreement by virtue of the Company’s failure to timely file this Form 10-Q.  Refer to Note H for additional details in regards to the terms of the Forbearance Agreement and the implications of the event of default.

As of the First Amendment Effective Date, the Company lacked sufficient shares of Common Stock to deliver all of the shares of Common Stock issuable to the Lenders upon conversion of the Victory Park notes (the “Conversion Shares”).  The Company is required to obtain stockholder approval to amend its certificate of incorporation to increase the number of authorized shares to allow for the conversion of the notes in full and until such time as the Company receives approval to increase the authorized shares, Victory Park has the ability to demand payment in cash for any shortfall in authorized shares upon a notice of conversion. See Note H below for information on the impact of the restatement on certain default provisions under the Restated Finance Agreement, as amended by the Forbearance Agreement.

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” and 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.  In light of the recent EMA recommendation, the expected financial impact on business operations and the inability of the Company to raise funds, the Company was not in a position to fund the debt settlement with the Founders and, as a result, remains in debt to the Founders for a total of $22,990,000 in principal and accrued interest as of September 30, 2012. On December 21, 2012, the Company entered into a further agreement with the Levys regarding the timing of the foregoing installment payments.  See Note G below for details regarding such agreement.

Recent developments impacting business operations

On December 21, 2012, the Company settled all claims with its former patent counsel regarding certain fees.  See Note R below for further details.

On December 11, 2012, the Company announced that it has retained an investment banker to assist the Company with its exploration and evaluation of a broad range of strategic options, including, but not limited to, the strategic partnering of its technology, the out-licensing of intellectual property and divestiture of certain assets, and the possible sale of the Company or one of its business units.

On November 27, 2012, the Company announced that certain previously issued financial statements should no longer be relied upon.  See Note B below for details regarding the Company’s restatement of previously issued financial statements.  See also Note H below for information on the impact of such restatement on certain default provisions under the Restated Finance Agreement, as amended by the Forbearance Agreement.

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 the curtailment of calcitonin usage.  On August 1, 2012, Health Canada announced that it is reviewing whether to follow the 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.  On October 12, 2012, Tarsa announced an agreement in principle with Therapicon® Slr to provide consulting assistance to the Italian firm in its appeal of the recent EMA recommendation. In November 2012, the EMA announced that it has reconfirmed its original conclusion that the benefits of calcitonin-containing medicines do not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition. 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.  On January 14, 2013, the FDA posted notice of an Advisory Committee Meeting scheduled on March 5, 2013 to discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis outweighs a potential risk of cancer.

In the third quarter of 2012 and through the date of this filing, the following events and circumstances indicated that the carrying value of the Company’s long lived assets may not be recoverable: (i) potential impact of the EMA press release; (ii) continuing operating losses; (iii) significant revisions to internal revenue forecasts; and (iv) a significant decline in the Company’s stock price. The Company is in the process of evaluating whether the undiscounted expected future cash flows from the long-lived assets are less than their carrying amount.  If undiscounted expected future cash flows are not sufficient to support the recorded value of the assets, an impairment loss may be recognized for the difference between fair value and the carrying value to reduce the long lived assets to their estimated recoverable value.  Such analysis could result in a material impairment charge for the twelve months ended December 31, 2012.

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, H, J, N,  and R).  As a result of advancing purchase orders from USL previously scheduled for the first quarter of 2013, the Company received approximately $1,255,000 in additional cash in the fourth quarter of 2012.  Additionally, the Company was advanced $400,000 from USL in the fourth quarter of 2012 for the production of additional batches in 2013. This will reduce sales of Fortical in future periods.  

If the Company is unable to achieve significant milestones or sales under its existing agreements and/or enter into new significant revenue generating licenses or other arrangements in the near-term, the Company will need to secure another source of funding in order to satisfy its working capital needs. The Company will also need to avoid further events of default under and maintain compliance with the covenants in its financing agreement with Victory Park (see Note H). If the Company is not able to generate additional cash, it will need to significantly curtail its operations. Should the funding required to sustain the Company’s working capital needs be unavailable or prohibitively expensive, the Company would not have the ability to continue as a going concern. 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 or the obesity program. 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. In 2010, since the Company had an adequate inventory of enzyme to support expected future Fortical production needs, it temporarily suspended manufacturing of those materials at its Boonton facility. However, the Company is maintaining the cGMP status of the facility and the ability to manufacture and tablet solid dosage forms of peptides at that location.  This cessation of production continued through 2012, however, the Company plans to engage in the production of calcitonin in the first quarter of 2013.  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 decreased from 2011 due to the December 2011 restructuring.

Cash received during the nine months ended September 30, 2012 was primarily from the net proceeds of $3,500,000 as a result of the Victory Park refinancing (see Note H); Fortical sales and royalties received under the agreement with 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. 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 recombinant peptide manufacturing technology. In October 2011, the Company announced its decision to establish a Joint Development Vehicle with Nordic Bioscience (see Note N).  Licensing fees from new collaborations are dependent upon the successful completion of complex and lengthy negotiations and are often subject to the completion of successful feasibility programs. 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 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

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern; however, the above conditions raise substantial doubt about the Company’s ability to do so. 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 and restated, 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 Quarterly Report on Form 10-Q 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, including the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities.