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ASNB > SEC Filings for ASNB > Form 10-Q on 14-Nov-2012All Recent SEC Filings

Show all filings for ADVANSOURCE BIOMATERIALS CORP | Request a Trial to NEW EDGAR Online Pro

Form 10-Q for ADVANSOURCE BIOMATERIALS CORP


14-Nov-2012

Quarterly Report

Management's Discussion and Analysis of Financial Condition and Results of Operations

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, 2012 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.

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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.

We 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 which generates royalty income for the Company.

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 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 has 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.

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Critical Accounting Policies

Our critical accounting policies are summarized in Note B to our consolidated financial statements included in Item 8 of our annual report on Form 10-K for the fiscal year ended March 31, 2012. 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. There have been no changes to our critical accounting policies during the fiscal quarter ended September 30, 2012.

Results of Operations

Three Months Ended September 30, 2012 vs. September 30, 2011

Revenues

Total revenues for the three months ended September 30, 2012 were $451,000 as compared with $848,000 for the prior year period, a decrease of $397,000, or 46.8%.

Product sales of our biomaterials for the three months ended September 30, 2012 were $331,000 as compared with $321,000 for the prior year period, an increase of $10,000, or 3.1%. The increase is due to the growth in sales from existing and new customers.

License, royalty and development fees for the three months ended September 30, 2012 were $120,000 as compared with $527,000 for the prior year period, a decrease of $407,000 or 77.2%. 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 decrease in license, royalty and development fees is primarily due to the recognition of revenue related to a long-term license and consulting agreement (the "Agreements") with a major international developer and manufacturer of medical devices, which was entered into in June 2011. In June 2011, we received an initial payment of $150,000 (the "Initial Payment") upon the execution of the Agreements. In July 2011, we received a subsequent payment of $250,000 (the "Subsequent Payment") upon the transfer of certain technology and know-how. The Agreements also provide for additional payments upon the achievement of certain milestones. As of June 30, 2011, the Initial Payment of $150,000 was deferred and revenue was recognized, along with the Subsequent Payment of $250,000, during the three months ended September 30, 2011 when the requirements for recognition of revenue were achieved. Any future payments with respect to the Agreements will also be deferred until said requirements for recognition of revenue are met. Since the receipt of the Initial and Subsequent Payments, there have been no additional payments or the achievement of additional milestones through September 30, 2012.

Gross Profit

Gross profit on total revenues for the three months ended September 30, 2012 was $266,000, or 60.0% of total revenues, compared with $674,000, or 79.5% of total revenues, for the prior year period. The decrease in gross profit dollars and gross profit as a percentage of total revenues is primarily due to the effect of the license fees recognized in connection with the Agreements during the three months ended September 30, 2011, whereas no licensing fees from the Agreements were recognized during the three months ended September 30, 2012.

Gross profit on product sales for the three months ended September 30, 2012 was $146,000, or 44.1% of product sales, compared with $147,000, or 45.8% of product sales, for the prior year period. The slight decrease in gross profit dollars and gross profit as a percentage of product sales is primarily due to additional costs incurred in connection with the evaluation of second sources for certain production materials. We believe our efforts to improve manufacturing overhead costs and processes have stabilized, and future growth in product sales should benefit gross profit on product sales.

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Research, Development and Regulatory Expenses

Research and development expenses for the three months ended September 30, 2012 were $112,000 as compared with $142,000 for the prior year period, a decrease of $30,000 or 21.1%. Our research and development efforts are focused on developing new applications for our biomaterials. Research and development expenditures consist primarily of the salaries of full time employees and related expenses, and are expensed as incurred. The decrease in research and development expenses is primarily a result of the elimination of non-essential departmental resources. Management believes its current research and development resources meet the needs of our customers and internal development needs.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended September 30, 2012 were $393,000 as compared with $457,000 for the prior year period, a decrease of $64,000, or 14.0%. The decrease is primarily due to reductions in legal, accounting and regulatory fees, and insurance costs.

Six Months Ended September 30, 2012 vs. September 30, 2011

Revenues

Total revenues for the six months ended September 30, 2012 were $916,000 as compared with $1,163,000 for the prior year period, a decrease of $247,000, or 21.2%.

Product sales of our biomaterials for the six months ended September 30, 2012 were $674,000 as compared with $515,000 for the prior year period, an increase of $159,000, or 30.9%. The increase is due to the growth in sales from existing and new customers.

License, royalty and development fees for the six months ended September 30, 2012 were $242,000 as compared with $648,000 for the prior year period, a decrease of $406,000 or 62.7%. 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 decrease in license, royalty and development fees is primarily due to the recognition of revenue related to a long-term license and consulting agreement (the "Agreements") with a major international developer and manufacturer of medical devices, which was entered into in June 2011. In June 2011, we received an initial payment of $150,000 (the "Initial Payment") upon the execution of the Agreements. In July 2011, we received a subsequent payment of $250,000 (the "Subsequent Payment") upon the transfer of certain technology and know-how. The Agreements also provide for additional payments upon the achievement of certain milestones. As of June 30, 2011, the Initial Payment of $150,000 was deferred and revenue was recognized, along with the Subsequent Payment of $250,000, during the three months ended September 30, 2011 when the requirements for recognition of revenue were achieved. Any future payments with respect to the Agreements will also be deferred until said requirements for recognition of revenue are met. Since the receipt of the Initial and Subsequent Payments, there have been no additional payments or the achievement of additional milestones through September 30, 2012.

Gross Profit

Gross profit on total revenues for the six months ended September 30, 2012 was $550,000, or 60.0% of total revenues, compared with $789,000, or 67.8% of total revenues, for the prior year period. The decrease in gross profit dollars and gross profit as a percentage of total revenues is primarily due to the effect of the license fees recognized in connection with the Agreements during the six months ended September 30, 2011, whereas no licensing fees from the Agreements were recognized during the six months ended September 30, 2012.

Gross profit on product sales for the six months ended September 30, 2012 was $308,000, or 45.7% of product sales, compared with $141,000, or 27.4% of product sales, for the prior year period. The improvement in gross profit dollars and gross profit as a percentage of product sales is primarily due to continued improvement in our manufacturing cost structure and efficiencies in our manufacturing processes. 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.

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Research, Development and Regulatory Expenses

Research and development expenses for the six months ended September 30, 2012 were $243,000 as compared with $308,000 for the prior year period, a decrease of $65,000 or 21.1%. 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 expenses is primarily a result of the elimination of non-essential departmental resources. Management believes its current research and development resources meet the needs of our customers and internal development needs.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the six months ended September 30, 2012 were $855,000 as compared with $953,000 for the prior year period, a decrease of $98,000 or 10.3%. The decrease is primarily due to reductions in legal, accounting and regulatory fees and insurance costs.

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 during the six months ended September 30, 2011 and, accordingly, recorded an impairment charge of $15,000 for this period. No such impairment was recorded during the six months ended September 30, 2012.

Liquidity and Capital Resources

As of September 30, 2012, we had cash of $136,000. This represents a decrease of $188,000 when compared to a balance of $324,000 as of June 30, 2012 and a decrease of $348,000 when compared with a balance of $484,000 as of March 31, 2012.

During the six months ended September 30, 2012, we had net cash outflows of $373,000 from operating activities as compared with net cash outflows of $537,000 for the 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 $164,000, as compared to the prior year period, primarily due to (i) increased product sales and timely collection of receivables; and ii) improvements in gross profits from product sales due to the positive effect of our cost containment efforts and increased efficiencies with respect to production.

With respect to cash flows from financing activities, during the six months ended September 30, 2012, we had net cash inflows of $25,000 from accrued interest on financing obligations as compared to net cash inflows of $741,000 for the prior year period from the issuance of a Commercial Real Estate Promissory Note in the principal amount of $800,000, net of financing costs of $67,000, and the issuance of 107,175 shares of common stock pursuant to our employee stock purchase plan which provided cash in the amount of $8,000.

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 six months ended September 30, 2012, we incurred a net loss of $717,000 and used cash from operating activities of $373,000. During the fiscal year ended March 31, 2012, we incurred a net loss of $1,812,000 and used cash from operating activities of $1,752,000. We anticipate incurring losses at least through fiscal 2013 as we continue our attempt to grow revenues, expand selling and marketing activities, expand into new sales territories, and continue research and development activities to promote new product introductions and enhancements to existing products. As of September 30, 2012, we had an accumulated deficit of $37,087,000 and cash of $136,000.

The ability to attract additional capital investments in the future will depend on many factors, including the availability of credit, rate of revenue growth, expansion of selling and marketing activities, continuing research and development efforts, and the timing of new product introductions and enhancements to existing products. We believe that as of September 30, 2012 our cash position and cash flows from our fiscal 2013 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, 2013.

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Off-Balance Sheet Arrangements

As of September 30, 2012, 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.

Item 3.

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