ADVANSOURCE BIOMATERIALS CORP - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations
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[February 14, 2012]

ADVANSOURCE BIOMATERIALS CORP - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations

(Edgar Glimpses Via Acquire Media NewsEdge) Cautionary Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q contains certain statements that are "forward-looking" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Litigation Reform Act"). These forward looking statements and other information are based on our beliefs as well as assumptions made by us using information currently available.


The words "anticipate," "believe," "estimate," "expect," "intend," "will," "should" and similar expressions, as they relate to us, are intended to identify forward-looking statements. Such statements reflect our current views with respect to future events and are subject to certain risks, uncertainties and assumptions. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated, expected, intended or using other similar expressions.

In accordance with the provisions of the Litigation Reform Act, we are making investors aware that such forward-looking statements, because they relate to future events, are by their very nature subject to many important factors that could cause actual results to differ materially from those contemplated by the forward-looking statements contained in this Quarterly Report on Form 10-Q. For example, we may encounter competitive, technological, financial and business challenges making it more difficult than expected to continue to develop and market our products; the market may not accept our existing and future products; we may not be able to retain our customers; we may be unable to retain existing key management personnel; and there may be other material adverse changes in our operations or business. Certain important factors affecting the forward-looking statements made herein also include, but are not limited to (i) continued downward pricing pressures in our targeted markets, (ii) the continued acquisition of our customers by certain of our competitors, and (iii) continued periods of net losses, which could require us to find additional sources of financing to fund operations, implement our financial and business strategies, meet anticipated capital expenditures and fund research and development costs. In addition, assumptions relating to budgeting, marketing, product development and other management decisions are subjective in many respects and thus susceptible to interpretations and periodic revisions based on actual experience and business developments, the impact of which may cause us to alter our marketing, capital expenditure or other budgets, which may in turn affect our financial position and results of operations. For all of these reasons, the reader is cautioned not to place undue reliance on forward-looking statements contained herein, which speak only as of the date hereof. We assume no responsibility to update any forward-looking statements as a result of new information, future events, or otherwise except as required by law. For further information you are encouraged to review our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the fiscal year ended March 31, 2011 and the risk factors discussed therein under Part I.


Item 1A.

Overview We develop advanced polymer materials which provide critical characteristics in the design and development of medical devices. Our biomaterials are used in devices that are designed for treating a broad range of anatomical sites and disease states. Our business model leverages our proprietary materials science technology and manufacturing expertise in order to expand our product sales and royalty and license fee income.

Our leading edge technology, notably products such as ChronoFlex®, HydroMed™, and HydroThane™, has been developed to overcome a wide range of design and functional challenges, from the need for dimensional stability, ease of manufacturability and demanding physical properties to overcoming environmental stress cracking and providing heightened lubricity for ease of insertion. Our polymer product lines are compliant with measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies as set forth in European Council Decision 1999/534/EC. Our new product extensions allow us to customize our proprietary polymers for specific customer applications in a wide range of device categories.

-15- --------------------------------------------------------------------------------History We were founded in 1993 as a subsidiary of PolyMedica Corporation ("PolyMedica"). In June 1996, PolyMedica distributed all of the shares of CardioTech International, Inc.'s ("CardioTech") common stock, par value $0.01 per share, which PolyMedica owned, to PolyMedica stockholders of record. Our materials science technology is principally based upon the ChronoFlexTM proprietary polymers which represent our core technology.

In July 1999, we acquired the assets of Tyndale-Plains-Hunter ("TPH"), a manufacturer of specialty hydrophilic polyurethanes.

In July 1999, Dermaphylyx International, Inc. ("Dermaphylyx") was formed by certain of our affiliates to develop advanced wound healing products. Dermaphylyx was merged with and into us, effective March 2004, as a wholly-owned subsidiary. In June 2006, our Board of Directors decided to cease the operations of Dermaphylyx. We considered the net assets of Dermaphylyx to be immaterial.

In April 2001, we acquired Catheter and Disposables Technology, Inc.

("CDT"). CDT, which was located in Minnesota, was an original equipment manufacturer and supplier of private-label advanced disposable medical devices from concept to finished packaged and sterilized products, providing engineering services and contract manufacturing. In the development of our business model, we reviewed the strategic fit of our various business operations and determined that CDT did not fit our strategic direction. CDT was sold in March 2008.

In April 2003, we acquired Gish Biomedical, Inc. ("Gish"). Gish was located in southern California and manufactured single use cardiopulmonary bypass products having a disposable component. In the development of our business model, we reviewed the strategic fit of our various business operations and determined that Gish did not fit our strategic direction. Gish was sold in July 2007.

In March 2004, we joined with Implant Sciences Corporation ("Implant") to participate in the funding of CorNova. CorNova was initially formed to develop a novel coronary drug eluting stent using the combined capabilities and technology of CorNova, Implant Sciences and CardioTech. We currently have an approximate 1.5% equity interest in the issued and outstanding common stock of CorNova, based on the assumed conversion of all outstanding CorNova preferred stock into common stock. Although CorNova is expected to incur future operating losses, we have no obligation to fund CorNova.

At our 2007 Annual Meeting, our stockholders approved our reincorporation from Massachusetts to Delaware. Our Articles of Charter Surrender in Massachusetts and Certificate of Incorporation and Certificate of Conversion in Delaware were effective as of October 26, 2007.

In June 2008, we reorganized our product line as part of our re-branding effort and launched a new website at www.advbiomaterials.com. The information available on or through our website is not a part of this report on Form 10-K. At our 2008 annual meeting of stockholders on October 15, 2008, our stockholders approved the change of our name from CardioTech International, Inc. to AdvanSource Biomaterials Corporation to better reflect our strategic plan. Our Certificate of Amendment to our Certificate of Incorporation filed with the Secretary of State of the State of Delaware effecting this name change was effective October 15, 2008.

Technology and Intellectual Property Our unique materials science strengths are embodied in our family of proprietary polymers. We manufacture and sell our custom polymers under the trade names ChronoFilm, ChronoFlex, ChronoThane, ChronoPrene, ChronoSil, HydroThane, and PolyBlend. The ChronoFlex family of polymers has the potential to be marketed beyond our existing customer base. Our goal is to fulfill the market's need for advanced materials science capabilities, thereby enabling customers to improve devices that utilize polymers. Our chemists continue to develop the ChronoFlex family of medical-grade polymers. Conventional polymers are susceptible to degradation resulting in catastrophic failure of long-term implantable devices such as pacemaker leads. ChronoFlex and ChronoThane polymers are designed to overcome such degradation and reduce the incidents of infections associated with invasive devices.

Key characteristics of our polymers are i) optional use as lubricious coatings for smooth insertion of a device into the body, ii) antimicrobial properties that are part of the polymer itself, and iii) mechanical properties, such as hardness and elasticity sufficient to meet engineering requirements. We believe our technology has wide application in increasing biocompatibility, drug delivery, infection control and expanding the utility of complex devices in the hospital and clinical environment.

-16- --------------------------------------------------------------------------------We also manufacture and sell our proprietary HydroThane polymers to medical device manufacturers that are evaluating HydroThane for use in their products. HydroThane is a thermoplastic, water-absorbing, polyurethane elastomer possessing properties which we believe make it well suited for the complex requirements of a variety of catheters. In addition to its physical properties, we believe HydroThane exhibits an inherent degree of bacterial resistance, clot resistance and biocompatibility. When hydrated, HydroThane has elastic properties similar to living tissue.

We also manufacture specialty hydrophilic polyurethanes that are primarily sold to customers as part of exclusive arrangements. Specifically, one customer is supplied tailored, patented hydrophilic polyurethanes in exchange for a multi-year, royalty-bearing exclusive supply contract from which we generate royalty income.

ChronoFilm is a registered trademark of PolyMedica. ChronoFlex is our registered trademark. ChronoThane, ChronoPrene, ChronoSil, HydroThane, and PolyBlend are our tradenames. CardioPass is our trademark.

We own or license four (4) patents relating to our vascular graft manufacturing and polymer technology and products. While we believe our patents secure our exclusivity with respect to certain of our technologies, there can be no assurance that any patents issued would not afford us adequate protection against competitors which sell similar inventions or devices, nor can there be any assurance that our patents will not be infringed upon or designed around by others. However, we intend to vigorously enforce all patents issued to us.

In October 2009, we filed for a U.S. patent on ChronoSil, our silicone-urethane copolymer product, and methods for making ChronoSil. ChronoSil can have many physical properties which are usually associated with polyurethanes, but also the feel and characteristics of silicones.

In August 2010, the U.S. Patent and Trademark Office issued us a U.S. patent on our proprietary antimicrobial formulation for ChronoFlex. Current technology in the marketplace uses antibiotic drugs. The antimicrobial component of our polymers have been designed to be non-leaching as a result of the polymerization process.

In addition, PolyMedica has granted us an exclusive, perpetual, worldwide, royalty-free license for the use of one polyurethane patent and related technology in the field consisting of the development, manufacture and sale of implantable medical devices and biodurable polymer material to third parties for the use in medical applications (the "Implantable Device and Materials Field"). PolyMedica also owns, jointly with Thermedics, Inc., an unrelated company that manufactures medical grade polyurethane, the ChronoFlex polyurethane patents relating to the ChronoFlex technology. PolyMedica has granted us a non-exclusive, perpetual, worldwide, royalty-free sublicense of these patents for use in the Implantable Devices and Materials Field.

Critical Accounting Policies Our critical accounting policies are summarized in Note C to our consolidated financial statements included in Item 8 of our Annual Report on Form 10-K for the fiscal year ended March 31, 2011. However, certain of our accounting policies require the application of significant judgment by our management, and such judgments are reflected in the amounts reported in our financial statements. In applying these policies, our management uses its judgment to determine the appropriate assumptions to be used in the determination of estimates. Those estimates are based on our historical experience, terms of existing contracts, our observance of market trends, information provided by our strategic partners and information available from other outside sources, as appropriate. Actual results may differ significantly from the estimates contained in our unaudited condensed consolidated financial statements. Other than adopting the provisions of Accounting Standards Update ("ASU") 2009-13, "Multi-Deliverable Revenue Arrangements," and ASU 2010-17, "Milestone Method of Revenue Recognition," there has been no change to our critical accounting policies during the nine months ended December 31, 2011.

-17- --------------------------------------------------------------------------------Results of Operations Three Months Ended December 31, 2011 vs. December 31, 2010 Revenues Total revenues for the three months ended December 31, 2011 were $356,000 as compared with $427,000 for the comparable prior year period, a decrease of $71,000, or 16.6%.

Product sales of our biomaterials for the three months ended December 31, 2011 were $179,000 as compared with $264,000 for the comparable prior year period, a decrease of $85,000, or 32.2%. During the three months ended December 31, 2010, we realized an increase in demand for polymer products from two (2) of our major customers. During the three months ended December 31, 2011, we did not realize this same level of demand from these two (2) customers. Management anticipates a return to increased levels of orders during fiscal 2012 and beyond from these two customers, however, there can be no assurance that such increases in the level of orders will occur. Certain new customers provided incremental sales during the three months ended December 31, 2011 which has had the effect of offsetting the decrease in sales from the two (2) customers previously discussed above.

License, royalty and development fees for the three months ended December 31, 2011 were $177,000 as compared with $163,000 for the comparable prior year period, an increase of $14,000 or 8.6%. We have agreements to license our proprietary biomaterial technology to medical device manufacturers and develop biomaterials for incorporation into medical devices under development by our customers. Royalties are earned when these manufacturers sell medical devices which use our biomaterials. The increase in license, royalty and development fees during the three months ended December 31, 2011 is primarily a result of the recognition of (i) minimum product purchase requirements during calendar year 2011 by one customer pursuant to a supply agreement, and (ii) minimum royalty requirements during calendar year 2011 by a second customer pursuant to the minimum royalty provision of a supply agreement.

Gross Profit Gross profit on total revenues for the three months ended December 31, 2011 was $152,000, or 42.7% of total revenues, compared with $79,000, or 18.5% of total revenues, for the comparable prior year period. The increase in gross profit dollars and gross profit as a percentage of total revenues is primarily due to the (i) increase in license fees and royalties, (ii) positive effect of the restructuring of our manufacturing cost structure during the fourth quarter of fiscal 2011 and first quarter of fiscal 2012, and (iii) efficiencies in our manufacturing processes. The restructuring activities had the effect of lowering our manufacturing overhead costs. The key strategic initiatives that led to the improvements in our manufacturing overhead included the elimination of certain production and quality control management positions considered as non-essential and reduction of outside consultants.

Gross profit on product sales for the three months ended December 31, 2011 was a loss of ($25,000), or (14.0%) of product sales, compared with a loss of ($84,000), or (31.8%) of product sales, for the comparable prior year period. The improvement in gross profit dollars and gross profit as a percentage of product sales is primarily due to the continued improvement in our manufacturing cost structure and efficiencies in our manufacturing process during the three months ended December 31, 2011. Management believes that future growth in product sales should benefit our gross profit on product sales as a result of the strategic initiatives employed to improve our manufacturing overhead costs and processes.

Research, Development and Regulatory Expenses Research and development expenses for the three months ended December 31, 2011 were $147,000 as compared with $215,000 for the comparable prior year period, a decrease of $68,000 or 31.6%. Our research and development efforts are focused on developing new applications for our biomaterials. Research and development expenditures consisted primarily of the salaries of full time employees and related expenses, and are expensed as incurred. The decrease in research and development costs is primarily a result of decreased use of outside laboratory testing services which was required to evaluate a specific raw material that is expected to be used in connection with the manufacture of our finished polymer products. We continue to maintain a relatively stable research and development budget, which management believes meets the needs of our customers and internal development needs.

-18- --------------------------------------------------------------------------------Selling, General and Administrative Expenses Selling, general and administrative expenses for the three months ended December 31, 2011 were $469,000 as compared with $667,000 for the comparable prior year period, a decrease of $198,000 or 29.7%. The decrease is primarily due to lower stock-based compensation charges, elimination of strategic consultants, reduction in legal fees, elimination of non-essential trade shows and advertising programs, and continued cost containment efforts.

Interest and Other Expenses Interest and other expenses for the three months ended December 31, 2011 were $187,000 as compared to $0 for the comparable prior year period. Interest expense of $36,000 is primarily composed of interest incurred on the $800,000 promissory note issued in July 2011, and the amortization of related deferred finance costs. Loss on extinguishment of promissory note of $151,000 is composed of the write-off of remaining deferred finance costs and the prepayment penalties incurred as a result of the early extinguishment of the promissory note.

Nine Months Ended December 31, 2011 vs. December 31, 2010 Revenues Total revenues for the nine months ended December 31, 2011 were $1,519,000 as compared with $1,421,000 for the comparable prior year period, an increase of $98,000, or 6.9%.

Product sales of our biomaterials for the nine months ended December 31, 2011 were $694,000 as compared with $1,027,000 for the comparable prior year period, a decrease of $333,000, or 32.4%. During the nine months ended December 31, 2010, we realized an increase in demand for polymer products from two (2) of our major customers. During the nine months ended December 31, 2011, we did not realize this same level of demand from these two (2) customers. Management anticipates a return to increased levels of orders during fiscal 2012 and beyond from these two customers, however, there can be no assurance that such increases in the level of orders will occur. Certain new customers provided incremental sales during the nine months ended December 31, 2011 which has had the effect of offsetting the decrease in sales from the two (2) customers previously discussed above.

License, royalty and development fees for the nine months ended December 31, 2011 were $825,000 as compared with $394,000 for the comparable prior year period, an increase of $431,000 or 109.4%. We have agreements to license our proprietary biomaterial technology to medical device manufacturers and develop biomaterials for incorporation into medical devices under development by our customers. Royalties are earned when these manufacturers sell medical devices which use our biomaterials. The increase in license, royalty and development fees during the nine months ended December 31, 2011 is primarily a result of the recognition of revenue on a non-exclusive license agreement and consulting agreement (collectively, the "Agreements") entered into with a major international developer and manufacturer of medical devices in June 2011. We also recognized additional fee revenues resulting from (i) the excess of minimum product purchase requirements over the actual amount of product purchased during calendar year 2011 by one customer pursuant to a supply agreement, and (ii) the excess of minimum royalties over the actual amount of royalties received during calendar year 2011 by a second customer pursuant to the minimum royalty provision of a supply agreement.

Gross Profit Gross profit on total revenues for the nine months ended December 31, 2011 was $941,000, or 62.0% of total revenues, compared with $351,000, or 24.7% of total revenues, for the comparable prior year period. The increase in gross profit dollars and gross profit as a percentage of total revenues is primarily due to the (i) increase in licensing fees, (ii) positive effect of the restructuring of our manufacturing cost structure during the fourth quarter of fiscal 2011 and first quarter of fiscal 2012, and (iii) efficiencies in our manufacturing processes. The restructuring activities had the effect of lowering our manufacturing overhead costs. The key strategic initiatives that led to the improvements in our manufacturing overhead included the elimination of certain production and quality control management positions considered as non-essential and reduction of outside consultants.

-19- --------------------------------------------------------------------------------Gross profit on product sales for the nine months ended December 31, 2011 was $116,000, or 16.7% of product sales, compared with a loss of ($43,000), or (4.2%) of product sales, for the comparable prior year period. The improvement in gross profit dollars and gross profit as a percentage of product sales is primarily due to the improvement in our manufacturing cost structure and efficiencies in our manufacturing processes during the nine months ended December 31, 2011. Management believes that future growth in product sales should benefit gross profit on product sales as a result of the strategic initiatives employed to improve our manufacturing overhead costs and processes.

Research, Development and Regulatory Expenses Research and development expenses for the nine months ended December 31, 2011 were $455,000 as compared with $550,000 for the comparable prior year period, a decrease of $95,000 or 17.3%. Our research and development efforts are focused on developing new applications for our biomaterials. Research and development expenditures consisted primarily of the salaries of full time employees and related expenses, and are expensed as incurred. The decrease in research and development costs is primarily a result of decreased of use outside laboratory testing services which was required to evaluate a specific raw material that is expected to be used in connection with the manufacture of our finished polymer products. We continue to maintain a relatively stable research and development budget, which management believes meets the needs of our customers and internal development needs.

Selling, General and Administrative Expenses Selling, general and administrative expenses for the nine months ended December 31, 2011 were $1,422,000 as compared with $1,956,000 for the comparable prior year period, a decrease of $534,000 or 27.3%. The decrease is primarily due to elimination of non-essential sales and administrative staff positions, lower stock-based compensation charges, elimination of strategic consultants, reduction in legal fees, elimination of non-essential trade shows and advertising programs, and continued cost containment efforts.

Impairment of Long-Lived Assets As a result of our evaluation of the recoverability of our property and equipment, we determined an impairment for a single group of production equipment existed as of June 30, 2011. Accordingly, we recorded an impairment charge of $15,000 for the three months ended June 30, 2011. No impairment charges were recorded during the six months ended December 31, 2011.

Interest and Other Expenses Interest and other expenses for the nine months ended December 31, 2011 were $224,000 as compared to $0 for the comparable prior year period. Interest expense of $73,000 is primarily composed of interest incurred on the $800,000 promissory note issued in July 2011, and the amortization of related deferred finance costs. Loss on extinguishment of promissory note of $151,000 is composed of the write-off of remaining deferred finance costs and the prepayment penalties incurred as a result of the early extinguishment of the promissory note.

-20- --------------------------------------------------------------------------------Liquidity and Capital Resources As of December 31, 2011, we had cash and cash equivalents of $860,000, an increase of $383,000 when compared with a balance of $477,000 as of March 31, 2011.

During the nine months ended December 31, 2011, we had net cash outflows of $1,357,000 from operating activities as compared with net cash outflows of $1,701,000 for the comparable prior year period. Our uses of cash for operating activities have primarily consisted of salaries and wages for our employees; facility and facility-related costs, material and overhead costs used in production, laboratory supplies and materials, and professional fees. The sources of our cash flow from operating activities have consisted primarily of payments received from customers on the sale of polymer products and fees earned on license, royalty and development agreements. Net cash flows used in operating activities decreased by approximately $245,000, as compared to the comparable prior year period, primarily due to (i) the receipt of $400,000 in connection with a non-exclusive license agreement and consulting services agreement entered into with a major international developer and manufacturer of medical devices; improvements in gross profits due to the positive effect of the restructuring of our manufacturing cost structure during the fourth quarter of fiscal 2011 and first quarter of fiscal 2012, and efficiencies in the manufacturing processes; and (iii) cost containment measures including the elimination of certain outside consultants and non-essential administrative positions.

During the nine months ended December 31, 2011, we had no net cash flows from investing activities as compared to net cash outflows of $2,000 from investing activities for the comparable prior year period, which represented the purchase of a fixed asset.

During the nine months ended December 31, 2011, we had net cash inflows of $1,740,000 from financing activities. The increase in cash flows from financing activities is primarily due to the sale of our land and building, which was sold for $2,000,000, less approximately $102,000 of transaction costs, and was accounted for as a sale-leaseback financing transaction. During the three months ended September 30, 2011, we issued a Commercial Real Estate Promissory Note in the principal amount of $800,000, net of financing costs of $67,000 (the "Note"). The Note was secured by our land and building pursuant to the terms and conditions of the Note and a mortgage in favor of the lender. The principal amount of the Note was repaid in connection with the December 22, 2011 sale-leaseback financing transaction, and the mortgage was discharged. During the nine months ended December 31, 2011, we also issued 107,175 shares of our common stock pursuant to our employee stock purchase plan, for which we received approximately $8,000. During the nine months ended December 31, 2010 we had net cash inflows of $8,000 from financing activities in connection with the issuance of 33,852 shares of our common stock pursuant to our employee stock purchase plan.

On December 22, 2011, we entered into a sale-leaseback transaction involving our land and building, which was sold for a purchase price of $2,000,000. The transaction did not qualify for sale-leaseback accounting and, as a result, was classified as a financing transaction. Under the financing method, the asset remains on the condensed consolidated balance sheet and the proceeds received by us from this transaction are recorded as a financing liability. Payments under the lease are applied as payments of imputed interest and deemed principal on the underlying financing obligation. The following table summarizes the sale-leaseback financing transaction: Fiscal Years Ending March 31, 2012 $ 70,000 2013 280,000 2014 294,000 2015 335,000 2016 335,000 Thereafter 4,207,000 $ 5,521,000 In connection with the sale-leaseback transaction, we were required to place $280,000 of the net proceeds in escrow as a prepayment of the calendar year 2012 lease payment.

-21- --------------------------------------------------------------------------------Our unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates continuity of operations, realization of assets and satisfaction of liabilities in the ordinary course of business. We have experienced negative operating margins and negative cash flows from operations and expect to continue to incur net losses in the foreseeable future. During the nine months ended December 31, 2011, we incurred a net loss of $1,175,000 and used cash from operating activities of $1,357,000. During the fiscal year ended March 31, 2011, we incurred a net loss of $3,185,000 and used cash from operating activities of $2,592,000. We anticipate incurring losses at least through fiscal 2012 as we continue our attempt to grow revenues, expand selling and marketing activities, expand into new sales territories, and expand research and development activities to promote new product introductions and enhancements to existing products. As of December 31, 2011, we had an accumulated deficit of $35,733,000 and cash and cash equivalents of $860,000.

The ability to attract additional capital investments in the future will depend on many factors, including the availability of credit, rate of revenue growth, the expansion of selling and marketing and research and development activities, and the timing of new product introductions and enhancements to existing products. Management believes that as of December 31, 2011, our cash position and cash flows from our fiscal 2012 operations will be sufficient to fund our working capital and research and development activities through at least the end of the fiscal year ending March 31, 2012.

Any potential future sale of equity or debt securities may result in dilution to our stockholders, and we cannot be certain that additional public or private financing will be available in amounts or on terms acceptable to us, or at all. On November 24, 2010, the NYSE Amex suspended trading in our common stock and filed Form 25 on December 6, 2010 notifying the Securities and Exchange Commission of their decision to delist us because we were not in compliance with Section 1003(a)(iii) of the NYSE Amex Company Guide with stockholders' equity of less than $6,000,000 and losses from continuing operations and net losses in its five most recent fiscal years. On November 24, 2010, our common stock was quoted on the OTCQB tier of The OTC Markets under the ticker symbol "ASNB." Although our common stock is quoted on the OTCQB, the delisting of our common stock from the NYSE Amex could substantially limit our common stock's liquidity and impair our ability to raise capital. If we are required to raise additional financing, but are unable to obtain such financing, we may be required to delay, reduce the scope of, or eliminate one or more aspects of our operations or business development activities.

Off-Balance Sheet Arrangements As of December 31, 2011, we did not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.

-22- --------------------------------------------------------------------------------

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