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EX-32.1 - EXHIBIT 32.1 - BIOANALYTICAL SYSTEMS INCv241598_ex32-1.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 10-K
 
(Mark One)
 
x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended September 30, 2011.
  OR
 
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the transition period from ___________ to _____________.

Commission File Number 000-23357

BIOANALYTICAL SYSTEMS, INC.

(Exact name of the registrant as specified in its charter)

INDIANA
 
35-1345024
(State or other jurisdiction of incorporation or organization)
 
(I.R.S. Employer Identification No.)
     
2701 KENT AVENUE
 
 
WEST LAFAYETTE, INDIANA
 
47906
(Address of principal executive offices)
  (Zip code)

(765) 463-4527
(Registrant's telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act: None

Securities registered pursuant to section 12(g) of the Act: Common Shares

Indicate by checkmark if the registrant is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. YES ¨ NO x

Indicate by checkmark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ¨ NO x

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 has submitted electronically and posted on its corporate website, if any, every Interactive Data File to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES x  NO ¨

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ¨
Accelerated filer ¨
Non-accelerated filer ¨
Smaller Reporting Company x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES ¨ NO x

Based on the closing price on the NASDAQ Global Market on March 31, 2011, the aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was $8,090,000. As of December 22, 2011, 6,945,631 of registrant's common shares were outstanding.

Documents Incorporated by Reference
Portions of the registrant’s definitive proxy statement for its 2012 Annual Meeting of Shareholders are incorporated by reference intoPart III hereof.

 
 

 
 
TABLE OF CONTENTS

   
Page
     
PART I
   
     
 
Item 1.
Business
1
       
 
Item 1A.
Risk Factors
13
       
 
Item 1B.
Unresolved Staff Comments
19
       
 
Item 2.
Properties
19
       
 
Item 3.
Legal Proceedings
20
       
 
Item 4.
(Removed and Reserved)
20
       
PART II
   
     
 
Item 5.
Market for Registrant's Common Equity and Related Stockholder Matters
20
       
 
Item 6.
Selected Financial Data
21
       
 
Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations
22
       
 
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
33
       
 
Item 8.
Financial Statements and Supplementary Data
34
       
 
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
57
       
 
Item 9A.
Controls and Procedures
57
       
 
Item 9B.
Other Information
58
       
PART III
   
     
 
Item 10.
Directors and Executive Officers of the Registrant
58
       
 
Item 11.
Executive Compensation
60
       
 
Item 12.
Security Ownership of Certain Beneficial Owners and Management
60
       
 
Item 13.
Certain Relationships and Related Transactions
60
       
 
Item 14.
Principal Accounting Fees and Services
60
       
PART IV
   
     
 
Item 15.
Exhibits and Financial Statement Schedules
61

 
 

 

PART I

This Report may contain "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and/or Section 21E of the Securities Exchange Act of 1934, as amended. Those statements may include, but are not limited to, discussions regarding our intent, belief or current expectations with respect to (i) our strategic plans; (ii) our future profitability, liquidity and capital resources; (iii) our capital requirements; (iv) industry trends affecting our financial condition or results of operations; (v) our sales or marketing plans; or (vi) our growth strategy. Investors in our common shares are cautioned that reliance on any forward-looking statement involves risks and uncertainties, including the risk factors contained beginning on page 13 of the Report. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could fail to project actual events and, as a result, the forward-looking statements based upon those assumptions could prove to be significantly different from actual results. In light of the uncertainties inherent in any forward-looking statement, the inclusion of a forward-looking statement herein should not be regarded as a representation by us that our plans and objectives will be achieved. We do not undertake any obligation to update any forward-looking statement.
 
(Dollar amounts in thousands, except per share data, unless noted otherwise.)
 
ITEM 1 - BUSINESS
 
General
 
We are an international contract research organization providing drug discovery and development services. Our clients and partners include pharmaceutical, biotechnology, academic and government organizations. We apply innovative technologies and products and a commitment to quality to help clients and partners accelerate the development of safe and effective therapeutics and maximize the returns on their research and development investments. We offer an efficient, variable-cost alternative to our clients' internal product development programs. Outsourcing development work to reduce overhead and speed drug approvals through the Food and Drug Administration ("FDA") is an established alternative to in-house development among pharmaceutical companies. We derive our revenues from sales of our research services and drug development tools, both of which are focused on determining drug safety and efficacy. The Company has been involved in the research of drugs to treat numerous therapeutic areas for over 35 years since its formation as a corporation organized in Indiana in 1974.

We support the preclinical and clinical development needs of researchers and clinicians for small molecule and large biomolecule drug candidates. We believe our scientists have the skills in analytical instrumentation development, chemistry, computer software development, physiology, medicine, analytical chemistry and toxicology to make the services and products we provide increasingly valuable to our current and potential clients. Our principal clients are scientists engaged in analytical chemistry, drug safety evaluation, clinical trials, drug metabolism studies, pharmacokinetics and basic research from small start-up biotechnology companies to many of the largest global pharmaceutical companies. We are committed to bringing scientific expertise, quality and speed to every drug discovery and development program to help our clients develop safe and effective products.

Industry Overview
 
Drug discovery and development is the process of creating drugs for the treatment of human disease. The drug discovery process aims to identify potential drug candidates, while the drug development process involves the testing of these drug candidates in animals and humans to meet regulatory requirements. Discovering and developing new drugs is an extremely expensive, complex, high-risk and time-consuming process. Multiple industry sources estimate the fully capitalized cost of developing and commercializing a new pharmaceutical product ranges from $800 million to over $1 billion. In addition, it generally takes between 10 and 15 years to develop a new prescription drug and obtain approval to market it in the United States.
 
The drug development services industry provides independent product development services to pharmaceutical, biotechnology companies, and government organizations. This industry has evolved from providing limited clinical trial services in the 1970s to a full-service industry today characterized by broader relationships with clients and by service offerings that encompass the entire drug development process, including preclinical evaluations, study design, clinical trial management, data collection, biostatistical analyses, regulatory consulting, clinical laboratory and diagnostic services, pre- and post-approval safety analysis, product registration and post-approval support.

 
1

 
 
Over the past 25 years, technological advances, as well as the emergence of the biotechnology industry, have dramatically changed the drug discovery process. New and improved technologies have evolved such as ultra high-throughput screening, new in vitro and in vivo preclinical profiling techniques and the gene-based drug research commonly referred to as genomics. The objective of these innovations is to find more drug targets and to screen chemical compounds against targets much more quickly, with literally millions of compounds possible. This process is expected to produce many more molecules having the ability to affect biological activity. These molecules then need to be tested quickly and economically to determine their viability as potentially safe and effective drug candidates.
 
Trends Affecting the Drug Discovery and Development Industry
 
Our services and products are marketed globally to pharmaceutical, medical research and biotech companies and institutions engaged in drug research and development. The research services industry is highly fragmented among many niche vendors led by a small number of larger companies; the latter offer an ever-growing portfolio of start-to-finish pharmaceutical development services. Our products are also marketed to academic and governmental institutions. Our services and products may have distinctly different clients (often separate divisions in a single large pharmaceutical company) and requirements. We believe that all clients are facing increased pressure to outsource facets of their research and development activities and that the following factors will increase client outsourcing:
 
Accelerated Drug Development
 
Clients continue to demand faster, more efficient, more selective development of an increasing pool of drug candidates. Consequently, our clients require fast, high-quality service in order to make well-informed decisions to quickly exclude poor candidates and speed development of successful ones. The need for additional development capacity to exploit more opportunities, accelerate development, extend market exclusivity and increase profitability drives the demand for outsourced services.
 
Increase in Potential New Drug Candidates
 
While research and development spending and the number of drug candidates are increasing, the time and cost required to develop a new drug candidate also have increased. Many pharmaceutical and biotechnology companies do not have sufficient internal resources to pursue development of all of these new drug candidates on their own. Consequently, these companies are looking to the drug discovery and development services industry for cost-effective, innovative and rapid means of developing new drugs.
 
Cost Pressures of Introducing New Drugs
 
Market forces, healthcare reform and other governmental initiatives place significant pressures on pharmaceutical and biotechnology companies to reduce drug prices. In addition, increased competition as a result of patent expiration, market acceptance of generic drugs, and governmental and privately managed care organization efforts to reduce healthcare costs have added to drug pricing pressures. The industry is responding by consolidating, streamlining operations, decentralizing internal discovery and development processes, and minimizing fixed costs. In addition, increased pressures to differentiate products and justify drug pricing are resulting in an increased focus on healthcare economics, safety monitoring and commercialization services. Moreover, pharmaceutical and biotechnology companies are attempting to increase the speed and efficiency of internal new drug discovery and development processes.
 
Patent Expiration
 
As exclusivity ends with patent expiry, drug companies defend their proprietary positions against generic competition with various patent extension strategies. Both the drug company creating these extensions and the generic competitors should provide additional opportunities for us.
 
 
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Alliances
 
Strategic alliances allow pharmaceutical companies to share research know-how and to develop and market new drugs faster in more diverse, global markets. We believe that such alliances will lead to a greater number of potential drugs in testing, many under study by small companies lacking broad technical resources. Those small companies can add shareholder value by further developing new products through outsourcing, reducing risk for potential allies.  Clients seek realistic business partnerships with their service provider in an effort to ensure that costs are controlled as their development programs progress. We have long-standing business relationships with many pharmaceutical companies and continue to offer flexible services and adapt to our client’s requirements.
 
Mergers and Acquisitions
 
Consolidation in the pharmaceutical industry is commonplace. As firms blend personnel, resources and business activities, we believe they will continue to streamline operations and minimize staffing, which may lead to more outsourcing. Consolidation may result in a disruption in the progress of drug development programs as merging companies rationalize their respective drug development pipelines.
 
Biotechnology Industry and Virtual Drug Company Growth
 
The U.S. biotechnology industry has grown rapidly over the last decade and has emerged as a key client segment for the drug discovery and development services industry. In recent years, this industry has generated significant numbers of new drug candidates that will require development and regulatory approval. Many biotechnology drug developers do not have in-house resources to conduct development. Many new companies choose only to carry a product to a developed stage sufficient to attract a partner who will manufacture and market the drug. Because of the time and cost involved, these companies rely heavily on CROs to conduct research for their drug candidates.
 
Unique Technical Expertise
 
The increasing complexity of new drugs requires highly specialized, innovative, solution-driven research not available in all client labs. We believe that this need for unique technical expertise will increasingly lead to outsourcing of research activity.
 
Data Management and Quality Expertise
 
Our clients and the FDA require more data, greater access to that data, consistent and auditable management of that data, and greater security and control of that data. We have made significant investments in software throughout our contract services groups to optimize efficiency and ensure compliance with FDA regulations and market expectations.
 
Changes in the Regulatory Environment
 
The drug discovery and development process is heavily regulated by the FDA and its Center for Drug Evaluation and Research. Recent product safety concerns, increases in drug and general healthcare costs and the emergence of importation issues have placed the FDA and other regulatory agencies under increased scrutiny. The war on terror, the risk of global vaccine shortages and the threat of new potential pandemics have elevated the FDA’s focus on research in the areas of bioterrorism and vaccine development. As a result of these and other events, drug safety, cost and availability are under intense monitoring and review by Congress, the FDA and other government agencies. In 2007, primarily in response to the FDA’s handling of postmarket data and recent drug safety concerns, the FDA Act was signed into law. In addition to reauthorizing and amending various provisions that were scheduled to expire, this Act provided the FDA with new regulatory authority to require drug sponsors to run post-approval studies and clinical trials and develop and implement risk evaluation and mitigation strategies. It is also likely that additional legislation will be passed that will impact the FDA and drug development and approval process in the United States. The FDA Act, continued drug safety issues and future legislation could have a lasting and pronounced impact on the drug discovery and development industry.
 
Globalization of the Marketplace
 
Foreign firms rely on independent development companies with experience in the U.S. to provide integrated services through all phases of product development and to assist in preparing complex regulatory submissions. Domestic drug firms are broadening product availability globally, demanding local regulatory approval. We believe that domestic service providers with global reach, established regulatory expertise, and a broad range of integrated development services will benefit from this trend.

 
3

 
 
Our Solution
 
We address the needs of the pharmaceutical and biotechnology industries, as well as academic, non-profit and government organizations, for drug discovery and development by providing integrated services to help our clients maximize the return on their research and development investments. Our application of innovative technologies and products and our commitment to quality throughout the drug discovery and development process offer our clients a way to identify and develop successful drugs and devices more quickly and cost-effectively. We have obtained significant drug development expertise from more than 35 years of operation.
 
The Company's Role in the Drug Development Process
 
After a new drug candidate is identified and carried through preliminary screening, the development process for new drugs has three distinct phases.
 
1)           The preclinical phase includes safety testing to prepare an Investigational New Drug ("IND") application for submission to the FDA. The IND must be accepted by the FDA before the drug can be tested in humans. Once a pharmacologically active molecule is fully analyzed to confirm its integrity, the initial dosage form for clinical trials is created. An analytical chemistry method is developed to enable reliable quantification. Stability and purity of the formulation are also determined.
 
Clients work with our preclinical services group to establish pharmacokinetics (PK), pharmacodynamics (PD) and safety testing of the new drug. These safety studies range from dose ranging studies, that involve acute safety monitoring of drugs and medical devices to chronic, multi-year oncogenicity and reproductive toxicity studies. Dose level confirmation is provided by our pharmaceutical analysis group. Bioanalyses of blood sampled under these protocols by our bioanalytical services group provide pharmacokinetic and metabolism data that is used with the safety and toxicity information to determine the exposure required to demonstrate toxicity. A no effect level is then established for the drug and sets the basis for future dose levels in further safety testing and clinical phase I studies. Upon successful completion of preclinical safety studies, an IND submission is prepared and provided to the FDA for review prior to human clinical trials.
 
Many of our products are designed for use in discovery and preclinical development. The Culex® family of robotic automated dose delivery and blood and other biofluids sampling and physiological parameters measurement systems enable researchers to quickly and cost effectively determine PK/PD profiles of drugs in large and small animal models. The Culex system allows experiments on freely moving conscious animals from early research for therapeutic target validation to lead optimization of compounds. Using the Culex system, researchers are able to automatically dose and sample in-vivo to develop pharmacokinetic and pharmacodynamic profiles of drugs during early screening in rodents and other animals quickly and cost effectively. Our bioanalytical services group utilizes our depth of expertise in liquid chromatography with detection by mass spectrometry as a mainstay of our bioanalytical laboratories to support research, preclinical and clinical programs. We also offer bioanalytical services that utilize electrochemistry, spectrophotometric (UV/Vis or fluorescence) and Corona Discharge detection as options. We have invested heavily in robotics and mass spectrometry systems. Application of this technology allows us to rapidly develop and validate methods for new compounds and obtain information suitable for regulatory submission.
 
2)           The clinical phase further explores the safety and efficacy of the substance in humans. The sponsor conducts Phase I human clinical trials in a limited number of healthy individuals to determine safety and tolerability. Bioanalytical assays determine the availability and metabolism of the active ingredient following administration. Expertise in method development and validation is critical, particularly for new chemical entities.
 
Exhaustive safety, tolerability and dosing regimens are established in sick humans in Phase II trials. Phase III clinical trials verify efficacy and safety. After successful completion of Phase III trials, the sponsor of the new drug submits a New Drug Application ("NDA") or Product License Application ("PLA") to the FDA requesting that the product be approved for marketing. Early manufacturing demonstrates production of the substance in accordance with FDA Good Manufacturing Practices ("GMP") guidelines. Data are compiled in an NDA, or for biotechnology products a PLA, for submission to the FDA requesting approval to market the drug or product. Our bioanalytical work per study grows rapidly from Phase I through Phase III. Phase II and III studies take several years, supported by well-proven, consistently applied analytical methods. It is unusual for a sponsor to change laboratories during these phases unless there are problems in the quality or timely delivery of results.

 
4

 
 
Our services include evaluation of bioequivalence and bioavailability to monitor the rate and extent to which a drug is available in the body and to demonstrate that the availability is consistent between formulations. We additionally offer support and testing services in clinical sample development, release and stability.
 
3)           The Post-approval phase follows FDA approval of the NDA or PLA. This includes production and continued analytical and clinical monitoring of the drug. The post-approval phase also includes development and regulatory approval of product modifications and line extensions, including improved dosage forms. The drug manufacturer must comply with quality assurance and quality control requirements throughout production and must continue analytical and stability studies of the drug during commercial production to continue to validate production processes and confirm product shelf life. Samples from each manufactured batch must be tested prior to release of the batch for distribution to the public.
 
We also provide services in all areas during the post-approval phase, concentrating on bioequivalence studies of new formulations, line extensions, new disease indications and drug interaction studies. Our ability to offer quick sample analysis has provided increased business opportunities for release testing.
 
The increases in our services offerings as a result of both acquisition and internal development have resulted in our ability to provide a broader range of services to our clients, often using combined services of several disciplines to address client needs. Our ability to solve client problems by combining our knowledge base, services and products has been a factor in our selection by major pharmaceutical companies to assist in several preclinical through the post-approval phases.
 
Company Services and Products
 
Overview
 
We focus on developing innovative services and products that increase efficiency and reduce costs associated with taking new drugs to market. We operate in two business segments – contract research services and research products, both of which address the bioanalytical, preclinical, and clinical research needs of drug developers. Both segments arose out of our expertise in a number of core technologies designed to quantify trace chemicals in complex matrices.
 
Services
 
The contract research services segment provides screening and pharmacological testing, preclinical safety testing, formulation development, regulatory compliance and quality control testing. Revenues from the services segment were $25.6 million for fiscal 2011. The following is a description of the services provided by our contract research services segment:
 
 
·
Product Characterization, Method Development and Validation: Analytical methods, primarily performed in West Lafayette, Indiana, determine potency, purity, chemical composition, structure and physical properties of a compound. Methods are validated to ensure that data generated are accurate, precise, reproducible and reliable and are used consistently throughout the drug development process and in later product support.
 
 
·
Bioanalytical Testing: We analyze specimens from preclinical and clinical trials to measure drug and metabolite concentrations in complex biological matrices. Bioanalysis is performed at our facilities in Indiana, Oregon and the United Kingdom (“UK”).
 
 
·
Stability Testing: We test stability of drug substances and formulated drug products and maintain secure storage facilities in West Lafayette, Indiana to establish and confirm product purity, potency and shelf life. We have multiple International Conference on Harmonization validated controlled-climate GMP (Good Manufacturing Practices) systems in place, and the testing capability to complete most stability programs.
 
 
·
In Vivo Pharmacology: We provide preclinical in vivo sampling services for the continuous monitoring of chemical changes in life, in particular, how a drug enters, travels through, and is metabolized in living systems. Most services are performed in customized facilities in Evansville, Indiana using our robotic Culex® APS (Automated Pharmacology System) system.
 
 
·
Preclinical and Pathology Services: We provide pharmacokinetic and safety testing in studies ranging from acute safety monitoring of drugs and medical devices to chronic, multi-year oncogenicity studies in our Evansville, Indiana site. Depending on protocol, multiple tissues may be collected to monitor pathological changes.
 
 
5

 
 
Research Products
 
We focus our products business on expediting preclinical screening of developmental drugs. We compete in small niches of the multibillion dollar analytical instrument industry. The products business targets unique niches in life science research. We design, develop, manufacture and market state-of-the-art:
 
 
·
In vivo sampling systems and accessories (including disposables, training and systems qualification)
 
 
·
Physiology monitoring tools
 
 
·
Liquid chromatography and electrochemistry instruments platforms
 
Revenues for our products segment were $7.5 million for fiscal 2011. We offer three (3) principal product lines: Analytical Products, In vivo Sampling Products and Vetronics’ Products. The following is a brief description of the products offered:
 
 
·
Analytical Products: The analytical products consist of our liquid chromatographic and electrochemical instruments with associated accessories. The critical component of these products is the Epsilon® electrochemical platform. This incorporates all the hardware capabilities needed for most electrochemical experiments but can be modified through software development. The market is principally academic institutions and industrial research companies.
 
 
·
In vivo Sampling Products: The in vivo sampling products consist of the Culex® family of automated in vivo sampling and dosing instruments. These are used by pharmaceutical researchers to dose animals and collect biological samples (blood, bile, urine, microdialysate, feces or any bio-fluid) from the animals. Since dosing and sample collections are automated, animals are not manually handled, reducing stress on the animals and producing more representative pharmacological data. Behavior and other physiological parameters can also be monitored simultaneously. Compared to manual methods, the Culex® products offer significant reduction in test model use and comparable reduction in labor. The line also includes miniaturized in vivo sampling devices sold to drug developers and medical research centers to assist in the study of a number of medical conditions including stroke, depression, Alzheimer’s and Parkinson’s diseases, diabetes and osteoporosis.
 
 
·
Vetronics’ Products: The Vetronics’ products consist of instruments and related software to monitor and diagnose cardiac function (electro-cardiogram) and measure other vital physiological parameters primarily in cats and dogs in veterinary clinics.
 
Clients
 
Over the past five years, we have regularly provided our services and/or products to most of the top 25 pharmaceutical companies in the world, as ranked by the number of research and development projects. Approximately 11% of our revenues are generated from customers outside of North America.
 
We balance our business development effort between large pharmaceutical developers and smaller drug development companies.
 
With the signing of the Preferred Provider Agreement (“PPA”) with Pharmasset, Inc. in the first quarter of the current fiscal year, Pharmasset, Inc. has become our largest client, accounting for approximately 14.5% of our total revenues in fiscal 2011 and 6.3% of our total trade accounts receivable at September 30, 2011. Pfizer, Inc. remains a large client, accounting for approximately 5.2% and 7.0% of our total revenues in fiscal 2011 and 2010, respectively. Pfizer, Inc. accounted for 4.2% and 4.7% of total trade accounts receivable at September 30, 2011 and 2010, respectively.
 
There can be no assurance that our business will not continue to be dependent on continued relationships with Pharmasset, Inc., Pfizer, Inc. or other clients, or that annual results will not be dependent on a few large projects. In addition, there can be no assurance that significant clients in any one period will continue to be significant clients in other periods. In any given year, there is a possibility that a single pharmaceutical company may account for 5% or more of our total revenue. Since we do not have long-term contracts with most of our clients, the importance of a single client may vary dramatically from year to year.
 
 
6

 
 
Sales and Marketing
 
With a primary focus on both large and small pharmaceutical and biotechnology companies, we promote our services through concentrated business development efforts, scientist-to-scientist communications and centralized corporate marketing programs. We recognize that our growth and customer satisfaction depend upon our ability to continually improve and create new client relationships.
 
Our new sales and global marketing initiatives include integrated campaigns designed to help differentiate and promote our products and services. Through trade events, online and print advertising in trade publications, direct communication, newsletters, and our website, we provide our perspective on current industry challenges or developments to create an ongoing dialogue with our clients and to promote our industry expertise, quality, technology and innovation. We reinforce key messages and selling points through client presentations, corporate material, at trade events and industry conferences.
 
We encourage and sponsor the participation of our scientific and technical personnel in a variety of professional endeavors, including speaking and the presentation of papers at national and international professional trade meetings and the publication of scientific articles in medical and pharmaceutical journals. Through these presentations and publications, we seek to further our reputation for professional excellence.

We currently have 16 employees on our sales and marketing staff based in our corporate headquarters located in West Lafayette, Indiana. We have a network of 11 established distributors covering Japan, the Pacific Basin, South America, the Middle East, India, South Africa and Eastern Europe. All of our distributor relationships are managed from the corporate headquarters in West Lafayette, Indiana.
 
Contractual Arrangements
 
Our service contracts typically establish an estimated fee to be paid for identified services. In most cases, some percentage of the contract costs is paid in advance. While we are performing a contract, clients often adjust the scope of services to be provided based on interim project results. Fees are adjusted accordingly. Generally, our fee-for-service contracts are terminable by the client upon written notice of 30 days or less for a variety of reasons, including the client's decision to forego a particular study, the failure of product prototypes to satisfy safety requirements, and unexpected or undesired results of product testing. Cancellation or delay of ongoing contracts may result in fluctuations in our quarterly and annual results. We are generally able to recover at least our invested costs when contracts are terminated.
 
Our products business offers annual service and maintenance agreements on most product lines.

Backlog
 
The contracts pursuant to which we provide our services are terminable upon written notice of 30 days or less. We maintain projections based on bids and contracts to optimize asset utilization. We have increased the use of sales forecasts in manufacturing our products, with the result that we rarely have a significant backlog for Products. For Services, backlog generally includes work to be performed under signed agreements (i.e., contracts and letters of intent). Once work under a signed agreement begins, net revenues are recognized over the life of the project. Some of our studies and projects are performed over an extended period of time, which may exceed several years. We maintain an order backlog to track anticipated net revenues yet to be earned for work that has not been performed.
 
Although backlog can provide meaningful information to our management with respect to a particular study, we believe that our backlog for Services as of any date is not necessarily a meaningful indicator of our future results for a variety of reasons. Studies vary in duration; the scope of studies may change, which may either increase or decrease their value; and studies may be terminated, or delayed at any time by the client or regulatory authorities.

 
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Competition
 
Services
 
We compete with in-house research, development, quality control and other support service departments of pharmaceutical and biotechnology companies. There are also full-service Contract Research Organizations ("CROs") that compete in this industry. Several of our competitors have significantly greater financial resources than we do. The largest CRO competitors offering similar research services include:
 
 
·
Covance, Inc.;
 
 
·
Pharmaceutical Product Development, Inc.;
 
 
·
Charles River Laboratories, Inc.;
 
 
·
Parexel; and
 
 
·
MDS Health Group Ltd.
 
CROs generally compete on:
 
 
·
regulatory compliance record;
 
 
·
reputation for on-time quality performance
 
 
·
quality system;
 
 
·
previous experience;
 
 
·
medical and scientific expertise in specific therapeutic areas;
 
 
·
scientist-to-scientist relationships;
 
 
·
quality of contract research;
 
 
·
financial viability;
 
 
·
database management;
 
 
·
statistical and regulatory services;
 
 
·
ability to recruit investigators;
 
 
·
ability to integrate information technology with systems to optimize research efficiency;
 
 
·
quality of facilities;
 
 
·
an international presence with strategically located facilities; and
 
 
·
price.
 
Products
 
Founded as a provider of instrumentation and products utilized in life and physical sciences research laboratories, we continue to serve these product niches today. Though many global analytical instruments competitors exist, we have an extensive, long standing network of customers who are repeat buyers and recommend our products. In contrast, there are few competitors for our in vivo sampling products. The primary market is large pharmaceutical research departments. Our differentiators are high quality, flexibility to meet customers’ specific needs and superior technical support and service. We provide equipment that enables our customers to attain premium scientific laboratory information on a reasonable operating investment. As customers’ needs constantly change, we continually invest in the refinement of our products and in new product opportunities that meet our operating objectives.

 
8

 
 
Government Regulation
 
We are subject to various regulatory requirements designed to ensure the quality and integrity of our data and products. These regulations are promulgated primarily under the Federal Food, Drug and Cosmetic Act, and include Good Laboratory Practice ("GLP"), Good Manufacturing Practice ("GMP"), and Good Clinical Practice ("GCP") guidelines administered by the FDA. The standards of GLP, GMP, and GCP are required by the FDA and by similar regulatory authorities around the world. These guidelines demand rigorous attention to employee training; detailed documentation; equipment validation; careful tracking of changes and routine auditing of compliance. Noncompliance with these standards could result in disqualification of project data collected by the Company. Material violation of GLP, GMP, or GCP guidelines could result in regulatory sanctions and, in severe cases, could also result in a discontinuance of selected operations. Since October 2004, we have been audited, on a routine basis, by the FDA and UK’s MHRA twenty times. The FDA has visited seven times in West Lafayette, three times each at the Oregon and Evansville locations and twice at the UK location. MHRA has visited the UK facility five times. Of the fifteen FDA audits, seven were without findings.  Where the FDA had findings, which have not been significant to our operations, we have taken actions to address the findings. The UK facility was found to be compliant with GLP and GCP.
 
We have not experienced any significant problems to date in complying with the regulations of such agencies and do not believe that any existing or proposed regulations will require material capital expenditures or changes in our method of operation.
 
Analytical Services
 
Laboratories that provide information included in INDs, NDAs and PLAs must conform to regulatory requirements that are designed to ensure the quality and integrity of the testing process. Most of our contract research services are subject to government standards for laboratory practices that are embodied in guidelines for GLP. The FDA and other regulatory authorities require that test results submitted to such authorities be based on studies conducted in accordance with GLP. These guidelines are set out to help the researcher perform work in compliance with a pre-established plan and standardized procedures. These guidelines include but are not restricted to:
 
 
·
Resources – organization, personnel, facilities and equipment
 
 
·
Rules – protocols and written procedures
 
 
·
Characterization – test items and test systems
 
 
·
Documentation – raw data, final report and archives
 
 
·
Quality assurance unit – formalized internal audit function
 
We must also maintain reports for each study for specified periods for auditing by the study sponsor and by the FDA or similar regulatory authorities in other parts of the world. Noncompliance with GLP can result in the disqualification of data collected during the preclinical trial.
 
Preclinical Services
 
Our animal research facilities are subject to a variety of federal and state laws and regulations, including The Animal Welfare Act and the rules and regulations enforced by the United States Department of Agriculture ("USDA") and the National Institutes of Health ("NIH"). These regulations establish the standards for the humane treatment, care and handling of animals by dealers and research facilities. Our animal research facilities maintain detailed standard operating procedures and other documentation necessary to comply with applicable regulations for the humane treatment of the animals in our custody. Besides being licensed by the USDA as a research facility, we are also accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International ("AAALAC") and have registered assurance with the NIH.

 
9

 
 
Quality Assurance and Information Technology
 
To assure compliance with applicable regulations, we have established quality assurance programs at our facilities that audit test data, train personnel and review procedures and regularly inspect facilities. In addition, FDA regulations and guidelines serve as a basis for our Standard Operating Procedures (“SOPs”) where applicable. On an ongoing basis, we endeavor to standardize SOPs across all relevant operations. In addition, we have both developed and purchased software to ensure compliant documentation, handling and reporting of all laboratory-generated study data. In fiscal 2004, we purchased similar 21 CFR Part 11 (FDA guidelines on electronic records and electronic signatures that define the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records) compliant software for our preclinical research group. At the end of fiscal 2011, the majority of our laboratory operations in the U.S. were fully in compliance with 21 CFR Part 11, in our analytical, bioanalytical, toxicology, lab information management, and document management systems. Systems compliant with 21 CFR Part 11 were formally validated and released for use in regulated studies.
 
We manage our business systems through the use of an Enterprise Resource Planning ("ERP") system. We are continually refining and adjusting our ERP system to improve efficiency, provide better management tools and address changes in our business. These changes are appropriately documented and tested before implementation. We also test these systems in connection with management’s annual review of our internal control systems. Management’s assessment and report on internal controls over financial reporting is included in Item 9A.
 
Controlled, Hazardous, and Environmentally Threatening Substances
 
Some of our development and testing activities are subject to the Controlled Substances Act administered by the Drug Enforcement Agency ("DEA"), which strictly regulates all narcotic and habit-forming substances. We maintain restricted-access facilities and heightened control procedures for projects involving such substances due to the level of security and other controls required by the DEA. In addition, we are subject to other federal and state regulations concerning such matters as occupational safety and health and protection of the environment.
 
Our U.S. laboratories are subject to licensing and regulation under federal, state and local laws relating to hazard communication and employee right-to-know regulations, the handling and disposal of medical specimens and hazardous waste, as well as the safety and health of laboratory employees. All of our laboratories are subject to applicable federal and state laws and regulations relating to the storage and disposal of all laboratory specimens, including the regulations of the Environmental Protection Agency, the Department of Transportation, the National Fire Protection Agency and the Resource Conservation and Recovery Act. Although we believe that we are currently in compliance in all material respects with such federal, state and local laws, failure to comply could subject us to denial of the right to conduct business, fines, criminal penalties and other enforcement actions.
 
The regulations of the U.S. Department of Transportation, the U.S. Public Health Service and the U.S. Postal Service apply to the surface and air transportation of laboratory specimens. Our laboratories also comply with the International Air Transport Association regulations which govern international shipments of laboratory specimens. Furthermore, when materials are sent to a foreign country, the transportation of such materials becomes subject to the laws, rules and regulations of such foreign country.
 
Safety
 
In addition to comprehensive regulation of safety in the workplace, the Occupational Safety and Health Administration has established extensive requirements relating to workplace safety for health care employers whose workers may be exposed to blood-borne pathogens such as HIV and the hepatitis B virus. These regulations, among other things, require work practice controls, protective clothing and equipment, training, medical follow-up, vaccinations and other measures designed to minimize exposure to chemicals, and transmission of blood-borne and airborne pathogens. Furthermore, relevant employees receive initial and periodic training focusing on compliance with applicable hazardous materials regulations and health and safety guidelines.
 
HIPAA
 
The U.S. Department of Health and Human Services has promulgated final regulations under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") that govern the disclosure of confidential medical information in the United States. We have had a global privacy policy in place since January 2001 and believe that we are in compliance with the current European Union and HIPAA requirements. We continue to monitor our compliance with these regulations, and we intend to take appropriate steps to ensure compliance as these and other privacy regulations are revised or come into effect.

 
10

 
 
Product Liability and Insurance
 
We maintain product liability and professional errors and omissions liability insurance, providing approximately $3.0 million in coverage on a claims-made basis. Additionally, in certain circumstances, we seek to manage our liability risk through contractual provisions to be indemnified by the client or covered by the client’s liability insurance policies. Also, in certain types of engagements, we seek to limit our contractual liability to clients to the amount of fees received. The contractual arrangements are subject to negotiation with clients, and the terms and scope of such indemnification, liability limitation and insurance coverage vary by client and project.

Research and Development
 
In fiscal 2011 and 2010, we spent $534 and $546, respectively, on research and development. Separate from our contract research services business, we maintain applications research and development to enhance our products business.
 
Expenditures cover hardware and software engineering costs, laboratory supplies, labor, prototype development and laboratory demonstrations of new products and applications for those products.
 
Intellectual Property
 
We believe that our patents, trademarks, copyrights and other proprietary rights are important to our business. Accordingly, we actively seek protection for those rights both in the United States and abroad. Where we deem it to be an appropriate course of action, we will vigorously prosecute patent infringements. We do not believe, however, that the loss of any one of our patents, trademarks, copyrights or other proprietary rights would be material to our consolidated revenues or earnings.
 
We currently hold three federally registered trademarks. We also have two pending patents, one on the Dried Blood Spot (DBS) sampling card for the Culex Automated Blood Sampling Instrumentation and the second for the No Blood Waste technology also for the Culex instrument. The former (DBS) reduces the cost of bio-sample collection, shipment and storage and the latter is important for the precise sampling of bio-fluids of very small volume from animals such as mice. We also generate client value through continuing client support, hardware and software upgrades, system reliability and accuracy. In addition to these formal intellectual property rights, we rely on trade secrets, unpatented know-how and continuing applications research which we seek to protect through means of reasonable business procedures, such as confidentiality agreements. We believe that the greatest value that we generate for our clients comes from these trade secrets, know-how and applications research.

Raw Materials
 
There are no specialized raw materials that are particularly essential to our business. We have a variety of alternative suppliers for our essential components.

Employees
 
At September 30, 2011, we had 251 full-time employees and 16 part-time employees. All employees enter into confidentiality agreements intended to protect our proprietary information. We believe that our relations with our employees are good. None of our employees are represented by a labor union. Our performance depends on our ability to attract and retain qualified professional, scientific and technical staff. The level of competition among employers for skilled personnel is high. We believe that our employee benefit plans enhance employee morale, professional commitment and work productivity and provide an incentive for employees to remain with the Company.

 
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Executive Officers of the Registrant

The following table illustrates information concerning the persons who served as our executive officers as of September 30, 2011. Except as indicated in the following paragraphs, the principal occupations of these persons have not changed in the past three years. Officers are elected annually at the annual meeting of the board of directors.
 
Name
 
Age
 
Position
Anthony S. Chilton, Ph.D.
 
55
 
President, Chief Executive Officer
Michael R. Cox
 
64
 
Vice President, Finance; Chief Financial and Administrative Officer; Treasurer
Alberto Hidalgo
 
46
 
Vice President, Business Development and Marketing
Craig S. Bruntlett, Ph.D.
 
62
 
Senior Vice President, Instruments Division
Lina L. Reeves-Kerner
 
60
 
Senior Vice President, Human Resources
 
Anthony S. Chilton, Ph.D. was named as the Chief Executive Officer, effective May 13, 2010. Dr. Chilton had previously served as Chief Operating Officer since December 1, 2008 and interim President since January 27, 2010. Dr. Chilton has over 30 years of experience as a scientist and executive in leading life sciences companies in England, Canada and the United States. For the two years prior to joining the Company, Dr. Chilton was in charge of early development programs at Atherogenics, Inc. of Alpharetta, Ga. In the two years prior to that, Dr. Chilton provided consulting and advisory services to various pharmaceutical companies. Prior to that, he was Vice President of the Biopharmaceutical Development Division of Cardinal Health Inc., which he joined through a predecessor company in 1998 that was acquired by Cardinal in 2002. Previously, Dr. Chilton spent three years with life sciences companies in Canada, prior to which he held positions in his native United Kingdom. Dr. Chilton received his bachelor’s degree in Chemistry from the University of East Anglia in 1981, and his Ph.D. in Analytical Chemistry from the University of Hertfordshire in 1993.

Michael R. Cox has been Vice President, Finance, Chief Financial Officer and Treasurer since April 2004. In October 2007, he assumed the additional duties of Chief Administrative Officer. He was Vice President, Finance and CFO of Integrity Pharmaceutical Corporation, a private specialty pharmaceutical company, from October 2003 until its acquisition and merger in March 2004. Prior to that he was Senior Vice President, Finance of Intergen Company, a private biotech manufacturing and research products company, from 1997 until its acquisition in 2001, and continued with the acquirer, Serologicals Corporation, on special projects until joining Integrity. Prior to that, Mr. Cox held various executive positions in two environmental services firms and an investment firm. He was a partner in Touche Ross & Co., where he began his career after obtaining a BS in business administration from the University of North Carolina. The Company notified Mr. Cox of its intention not to renew his contract on September 27, 2011. His amended agreement would have expired on December 31, 2011, but was extended until March 31, 2012.

 
Alberto Hildago was hired as the Vice President of Business Development and Marketing, effective August 18, 2010. Mr. Hidalgo has over 15 years of senior-level sales experience in both domestic and international markets including 13 years in the CRO Market. Most recently he consulted with companies to develop and implement new sales and marketing strategies. Prior to that he served as Area Director of Sales with Covance Central Laboratory Services and held various positions including Director of Sales, for Eli Lilly Export, Puerto Rico. He has a strong history of developing new business relationships and sales strategies resulting in exceptional sales growth.

Craig S. Bruntlett, Ph.D. has been Senior Vice President of the Instruments Division since September 2005. Prior to that, he was Senior Vice President of International Sales from 1999. From 1992 to 1999 he was Vice President, Electrochemical Products. From 1980 to 1990, Dr. Bruntlett was Director of New Products Development for the Company. Dr. Bruntlett has a Bachelor of Arts degree in Chemistry and Mathematics from St. Cloud State University in Minnesota and a Ph.D. in Chemistry from Purdue University.

Lina L. Reeves-Kerner has been Vice President, Human Resources since 1995 and is responsible for the administrative support functions of the Company, including shareholder relations, human resources and community relations. From 1980 to 1990, Ms. Reeves-Kerner served as an Administrative Assistant with the Company. Ms. Reeves-Kerner has a Bachelor of Science degree in Business Administration from Indiana Wesleyan University.

 
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Investor Information
 
We file various reports with, or furnish them to, the Securities and Exchange Commission (the “SEC”), including our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to such reports. These reports are available free of charge upon written request or by visiting www.BASinc.com/invest. Other media inquiries and requests for reports or investor’s kits should be directed to:
 
BASi Investor Relations, Corporate Center
2701 Kent Avenue, West Lafayette, IN 47906 USA
Phone 765-463-4527, Fax 765-497-1102, basi@BASinc.com

Inquiries from shareholders, security analysts, portfolio managers, registered representatives and other interested parties should be directed to:
 
Neil G. Berkman Associates
11835 West Olympic Blvd., Suite 405E, Los Angeles, CA 90064
Phone 310-477-3118, nberkman@berkmanassociates.com
 
ITEM 1A - RISK FACTORS
 
Risks Related to Our Business
 
Our business is subject to many risks and uncertainties, which may affect our future financial performance. If any of the events or circumstances described below occurs, our business and financial performance could be adversely affected, our actual results could differ materially from our expectations and the market value of our stock could decline. The risks and uncertainties discussed below are not the only ones we face. There may be additional risks and uncertainties not currently known to us or that we currently do not believe are material that may adversely affect our business and financial performance.
 
A reduction in research and development budgets at pharmaceutical and biotechnology companies may adversely affect our business.
 
Our customers include researchers at pharmaceutical and biotechnology companies. Our ability to continue to grow and win new business is dependent in large part upon the ability and willingness of the pharmaceutical and biotechnology industries to continue to spend on research and development and to outsource the products and services we provide. Fluctuations in the research and development budgets of these researchers and their organizations could have a significant effect on the demand for our products and services. Research and development budgets fluctuate due to changes in available resources, mergers of pharmaceutical and biotechnology companies, spending priorities and institutional budgetary policies. Our business could be adversely affected by any significant decrease in life sciences research and development expenditures by pharmaceutical and biotechnology companies. Similarly, economic factors and industry trends that affect our clients in these industries also affect our business.
 
In recent years, we have seen evidence that suggests that many customers have reduced their research and development budgets. We believe that this is in connection with the general economic slowdown and consolidation in our target industry. While this condition continues, our revenues will be negatively impacted.
 
Our future success depends on our ability to keep pace with rapid technological changes that could make our services and products less competitive or obsolete.
 
The biotechnology, pharmaceutical and medical device industries generally, and contract research services more specifically, are subject to increasingly rapid technological changes. Our competitors or others might develop technologies, services or products that are more effective or commercially attractive than our current or future technologies, services or products, or that render our technologies, services or products less competitive or obsolete. If competitors introduce superior technologies, services or products and we cannot make enhancements to ours to remain competitive, our competitive position, and in turn our business, revenues and financial condition, would be materially and adversely affected.

 
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Hardware or software failures, delays in the operations of our computer and communications systems or the failure to implement system enhancements could harm our business.
 
Our success depends on the efficient and uninterrupted operation of our computer and communications systems. A failure of our network or data gathering procedures could impede the processing of data, delivery of databases and services, client orders and day-to-day management of our business and could result in the corruption or loss of data. While some of our operations have disaster recovery plans in place, they might not adequately protect us. Despite any precautions we take, damage from fire, floods, hurricanes, power loss, telecommunications failures, computer viruses, break-ins and similar events at our computer facilities could result in interruptions in the flow of data to our servers and from our servers to our clients. In addition, any failure by our computer environment to provide our required data communications capacity could result in interruptions in our service. In the event of a delay in the delivery of data, we could be required to transfer our data collection operations to an alternative provider of server hosting services. Such a transfer could result in delays in our ability to deliver our products and services to our clients. Additionally, significant delays in the planned delivery of system enhancements, improvements and inadequate performance of the systems once they are completed could damage our reputation and harm our business. Finally, long-term disruptions in the infrastructure caused by events such as natural disasters, the outbreak of war, the escalation of hostilities and acts of terrorism, particularly involving cities in which we have offices, could adversely affect our businesses. Although we carry property and business interruption insurance, our coverage might not be adequate to compensate us for all losses that may occur.
 
 We operate in a highly competitive industry.

The CRO services industry is highly competitive. We often compete for business not only with other, often larger and better capitalized, CRO companies, but also with internal discovery and development departments within our clients, some of which are large pharmaceutical and biotechnology companies with greater resources than we have. If we do not compete successfully, our business will suffer. The industry is highly fragmented, with numerous smaller specialized companies and a handful of full-service companies with global capabilities much larger than ours. Increased competition might lead to price and other forms of competition that might adversely affect our operating results. As a result of competitive pressures, our industry experienced consolidation in recent years. This trend is likely to produce more competition among the larger companies for both clients and acquisition candidates. In addition, there are few barriers to entry for smaller specialized companies considering entering the industry. Because of their size and focus, these companies might compete effectively against larger companies such as us, which could have a material adverse impact on our business.
 
The loss of our key personnel could adversely affect our business.

Our success depends to a significant extent upon the efforts of our senior management team and other key personnel. The loss of the services of such personnel could adversely affect our business. Also, because of the nature of our business, our success is dependent upon our ability to attract, train, manage and retain technologically qualified personnel. There is substantial competition for qualified personnel, and an inability to recruit or retain qualified personnel may impact our ability to grow our business and compete effectively in our industry. The Company notified Michael R. Cox, the Vice President, Finance, Chief Financial Officer and Treasurer, of its intention not to renew his contract on September 27, 2011. His amended agreement would have expired on December 31, 2011, but was extended until March 31, 2012. If we are unsuccessful at recruiting and retaining his replacement, our financial performance could be negatively impacted.

Any failure by us to comply with existing regulations could harm our reputation and operating results.
 
Any failure on our part to comply with existing regulations could result in the termination of ongoing research or the disqualification of data for submission to regulatory authorities. For example, if we were to fail to properly monitor compliance with study protocols, the data collected could be disqualified. If this were to happen, we could be contractually required to repeat a study at no further cost to the customer, but at substantial cost to us. This would harm our reputation, our prospects for future work and our operating results. Furthermore, the issuance of a notice from the FDA based on a finding of a material violation by us of good clinical practice, good laboratory practice or good manufacturing practice requirements could materially and adversely affect our business and financial performance.

 
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Our business uses biological and hazardous materials, which could injure people or violate laws, resulting in liability that could adversely impact our financial condition and business.

Our activities involve the controlled use of potentially harmful biological materials, as well as hazardous materials, chemicals and various radioactive compounds. We cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for damages that result, and any liability could exceed our insurance coverage and ability to pay. Any contamination or injury could also damage our reputation, which is critical to getting new business. In addition, we are subject to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations is significant and if changes are made to impose additional requirements, these costs could increase and have an adverse impact on our financial condition and results of operations.
 
The majority of our customers’ contracts can be terminated upon short notice.
 
Most of our contracts for CRO services are terminable by the client upon 30 to 90 days’ notice. Clients terminate or delay their contracts for a variety of reasons, including but not limited to:
 
 
·
products being tested fail to satisfy safety requirements;
 
 
·
products have undesired clinical results;
 
 
·
the client decides to forego a particular study;
 
 
·
inability to enroll enough patients in the study;
 
 
·
inability to recruit enough investigators;
 
 
·
production problems cause shortages of the drug; and
 
 
·
actions by regulatory authorities.
 
The loss, reduction in scope or delay of a large contract or the loss or delay of multiple contracts could materially adversely affect our business, although our contracts frequently entitle us to receive the costs of winding down the terminated projects, as well as all fees earned by us up to the time of termination. Some contracts also entitle us to a termination fee.

We may bear financial risk if we under price our contracts or overrun cost estimates.

Since some of our contracts are structured as fixed price or fee-for-service, we bear the financial risk if we initially under price our contracts or otherwise overrun our cost estimates. Such under pricing or significant cost overruns could have a material adverse effect on our business, results of operations, financial condition, and cash flows.

Our products business depends on our intellectual property.

Our products business is dependent, in part, on our ability to obtain patents in various jurisdictions on our current and future technologies and products, to defend our patents and protect our trade secrets and to operate without infringing on the proprietary rights of others. There can be no assurance that our patents will not be challenged by third parties or that, if challenged, those patents will be held valid. In addition, there can be no assurance that any technologies or products developed by us will not be challenged by third parties owning patent rights and, if challenged, will be held not to infringe on those patent rights. The expense involved in any patent litigation can be significant. We also rely on unpatented proprietary technology, and there can be no assurance that others will not independently develop or obtain similar products or technologies.
 
We might incur substantial expense to develop products that are never successfully commercialized.
 
We have incurred and expect to continue to incur substantial research and development and other expenses in connection with our products business. The potential products to which we devote resources might never be successfully developed or commercialized by us for numerous reasons, including:
 
 
·
inability to develop products that address our customers’ needs;
 
 
·
competitive products with superior performance;

 
15

 

 
·
patent conflicts or unenforceable intellectual property rights;
 
 
·
demand for the particular product; and
 
 
·
other factors that could make the product uneconomical.
 
Incurring significant expenses for a potential product that is not successfully developed and/or commercialized could have a material adverse effect on our business, financial condition, prospects and stock price.

Providing CRO services creates a risk of liability.

In certain circumstances, we seek to manage our liability risk through contractual provisions with clients requiring us to be indemnified by the clients or covered by the clients’ product liability insurance policies. Although most of our clients are large, well-capitalized companies, the financial performance of these indemnities is not secured. Therefore, we bear the risk that the indemnifying party may not have the financial ability to fulfill its indemnification obligations or the liability would exceed the amount of applicable insurance. Furthermore, we could be held liable for errors and omissions in connection with the services we perform. There can be no assurance that our insurance coverage will be adequate, or that insurance coverage will continue to be available on acceptable terms, or that we can obtain indemnification arrangements or otherwise be able to limit our liability risk.

We may expand our business through acquisitions.

We occasionally review acquisition candidates and acquisitions which we have already made. We have faced substantial problems integrating acquisitions in the past. Factors which may affect our ability to grow successfully through acquisitions include:

 
·
inability to obtain financing due to our financial condition and recent performance;
 
·
difficulties and expenses in connection with integrating the acquired companies and achieving the expected benefits;
 
·
diversion of management’s attention from current operations;
 
·
the possibility that we may be adversely affected by risk factors facing the acquired companies;
 
·
acquisitions could be dilutive to earnings, or in the event of acquisitions made through the issuance of our common stock to the shareholders of the acquired company, dilutive to the percentage of ownership of our existing stockholders;
 
·
potential losses resulting from undiscovered liabilities of acquired companies not covered by the indemnification we may obtain from the seller; and
 
·
loss of key employees of the acquired companies.

Changes in government regulation or in practices relating to the pharmaceutical industry could change the need for the services we provide.

Governmental agencies throughout the world, but particularly in the United States, strictly regulate the drug development process. Our business involves helping pharmaceutical and biotechnology companies comply with the regulatory drug approval process. Changes in regulation, such as a relaxation in regulatory requirements or the introduction of simplified drug approval procedures, or an increase in regulatory requirements that we have difficulty satisfying, or that make our services less competitive, could substantially change the demand for our services. Also, if the government increases efforts to contain drug costs and pharmaceutical and biotechnology company profits from new drugs, our customers may spend less, or reduce their growth in spending on research and development.
 
Privacy regulations could increase our costs or limit our services.

The US Department of Health and Human Services has issued regulations under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). These regulations demand greater patient privacy and confidentiality. Some state governments are considering more stringent regulations. These regulations might require us to increase our investment in security or limit the services we offer. We could be found legally liable if we fail to meet existing or proposed regulation on privacy and security of health information.

 
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We may be affected by health care reform.

In March 2010, the United States Congress enacted health care reform legislation intended over time to expand health insurance coverage and impose health industry cost containment measures.  This legislation may significantly impact the pharmaceutical and biotechnology industries.  In addition, the U.S. Congress, various state legislatures and European and Asian governments may consider various types of health care reform in order to control growing health care costs. We are presently uncertain as to the effects of the recently enacted legislation on our business and are unable to predict what legislative proposals will be adopted in the future, if any.

Implementation of health care reform legislation may have certain benefits but also may contain costs that could limit the profits that can be made from the development of new drugs. This could adversely affect research and development expenditures by pharmaceutical and biotechnology companies, which could in turn decrease the business opportunities available to us both in the United States and abroad. In addition, new laws or regulations may create a risk of liability, increase our costs or limit our service offerings.

We rely on air transportation to serve our customers.

Our laboratories and certain of our other businesses are heavily reliant on air travel for transport of samples and other material, products and people. A significant disruption to the air travel system, or our access to it, could have a material adverse effect on our business.

We have experienced periods of losses on our operating activities.

Our overall strategy includes increasing revenue and reducing/controlling operating expenses. We have concentrated our efforts in ongoing, Company-wide efficiency activities intended to increase productivity and reduce costs including personnel reductions, reduction or elimination of non-personnel expenses and realigning and streamlining operations. We cannot assure that our efforts will result in any increased profitability, or if our efforts result in profit, that profits will continue, for any meaningful period of time.

We depend on the pharmaceutical and biotechnology industries.
 
Over the past several years, some areas of our businesses have grown significantly as a result of the increase in pharmaceutical and biotechnology companies outsourcing their preclinical and clinical research support activities. We believe that due to the significant investment in facilities and personnel required to support drug development, pharmaceutical and biotechnology companies look to outsource some or all of those services. By doing so, they can focus their resources on their core competency of drug discovery, while obtaining the outsourced services from a full-service provider like us. Our revenues depend greatly on the expenditures made by these pharmaceutical and biotechnology companies in research and development. In some instances, companies in these industries are reliant on their ability to raise capital in order to fund their research and development projects. Accordingly, economic factors and industry trends that affect our clients in these industries also affect our business. If companies in these industries were to reduce the number of research and development projects they conduct or outsource, our business could be materially adversely affected.

 
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Unfavorable general economic conditions may materially adversely affect our business.

Unfavorable global economic conditions, including the recent recession in the United States and the recent financial crisis affecting the banking system and financial markets, could negatively affect our business. While it is difficult for us to predict the impact of general economic conditions on our business, these conditions could reduce customer demand for some of our services, which could cause our revenue to decline. Also, our customers, particularly smaller biotechnology companies which are especially reliant on the credit and capital markets, may not be able to obtain adequate access to credit or equity funding, which could affect their ability to make timely payments to us. Moreover, we rely on credit facilities to provide working capital to support our operations. We regularly evaluate alternative financing sources. Further changes in the commercial credit market or in the financial stability of our creditors may impact the ability of our creditors to provide additional financing. In addition, the financial condition of our credit facility providers, which is beyond our control, may adversely change. Any decrease in our access to borrowings under our credit facility, tightening of lending standards and other changes to our sources of liquidity could adversely impact our ability to obtain the financing we need to continue operating the business in our current manner. For these reasons, among others, if the economic conditions stagnate or decline, our operating results and financial condition could be adversely affected.
 
We have limited ability to raise additional cash.

Substantially all of our assets are encumbered as security for our existing indebtedness. It could be difficult to raise additional debt without additional collateral for security. There is also a limited market for our common shares, which could make it difficult to issue additional equity. It could therefore be difficult to raise additional cash if our revolving line of credit and operations do not generate sufficient cash to fund our operations.
 
Noncompliance with debt covenants contained in our credit agreements could adversely affect our ability to borrow under our credit agreements and could ultimately render a substantial portion of our outstanding indebtedness immediately due and payable.
 
Certain of the Company’s credit agreements contain certain affirmative and negative financial covenants. A breach of any of these covenants or our inability to comply with any required financial ratios could result in a default under one or more credit agreements, unless we are able to obtain the necessary waivers or amendments to the credit agreements. Upon the occurrence of an event of default that is not waived, and subject to any appropriate cure periods, the lenders under the affected credit agreements could elect to exercise any of their available remedies, which may include the right to not lend any additional amounts to us or, in certain instances, to declare all outstanding borrowings, together with accrued interest and other fees, to be immediately due and payable. If we are unable to repay the borrowings with respect to such credit facility when due the lenders could be permitted to proceed against their collateral. The election to exercise any such remedy could have a material adverse effect on our business and financial condition.

The global credit crisis and market downturn has had a negative impact on our ability to obtain additional financing. The inability to obtain additional financing could have a significant adverse effect on our operations.

 The global credit crisis destabilized the global economy and adversely impacted consumer confidence and spending. We believe this global credit crisis has also negatively impacted our ability to obtain additional financing. Our inability to obtain additional financing could have a significant adverse effect on our operations. Uncertainty about current global economic conditions could also continue to increase the volatility of the Company’s stock price.
 
Risks Related to Share Ownership

Our share price could be volatile and our trading volume may fluctuate substantially.

The market price of our common stock has historically experienced and might continue to experience volatility. Many factors could have a significant impact on the future price of our common shares, including:

 
·
our failure to successfully implement our business objectives;
 
·
compliance with ongoing regulatory requirements;
 
·
market acceptance of our products;
 
·
technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors;
 
·
changes in government regulations;
 
·
general economic conditions and other external factors;
 
·
actual or anticipated fluctuations in our quarterly financial and operating results;
 
·
the degree of trading liquidity in our common shares; and
 
·
our ability to meet the minimum standards required for remaining listed on the NASDAQ Capital Market.

 
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These factors also include ones beyond our control, such as market conditions within our industry and changes in pharmaceutical and biotechnology industries. In addition, in recent years, the stock market has experienced significant price and volume fluctuations. The stock market, and in particular the market for pharmaceutical and biotechnology company stocks, has also experienced significant decreases in value in the past. This volatility and valuation decline have affected the market prices of securities issued by many companies, often for reasons unrelated to their operating performance, and might adversely affect the price of our common stock.

Although we currently meet the listing requirements for the NASDAQ Capital Market, our common stock could be de-listed from the NASDAQ Capital Market.

The National Association of Securities Dealers, Inc. has certain standards for the continued listing of a security on The NASDAQ Capital Market.  These standards require, among other things, that a listed issuer have either (i) listed securities with a market value of at least $1.0 million and (ii) a bid price of at least $1 per share, and either (i) minimum stockholders’ equity of $2.5 million, (ii) net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years, or (iii) market value of the listed securities of at least $35.0 million.
 
If we are unsuccessful in maintaining our NASDAQ listing, then we may pursue listing and trading of our common stock on the Over-The-Counter Bulletin Board or another securities exchange or association with different listing standards than NASDAQ. A change in listings may result in a reduction in some or all of the following, each of which could have a material adverse effect on our shareholders:
 
 
·
the liquidity of our common stock;

 
·
the market price of our common stock;

 
·
our ability to obtain financing for the continuation of our operations;

 
·
the number of institutional and general  investors that will consider investing in our common stock;

 
·
the number of investors in general that will consider investing in our common stock;

 
·
the number of market makers in our common stock;

 
·
the availability of information concerning the trading prices and volume of our common stock; and

 
·
the number of broker-dealers willing to execute trades in shares of our common stock.
 
ITEM 1B- UNRESOLVED STAFF COMMENTS
 
None.
 
ITEM 2-PROPERTIES
 
We operate in the following locations, all of which we own, except as otherwise indicated:
 
·            Our principal executive offices are located at 2701 Kent Avenue, West Lafayette, Indiana 47906, with approximately 117,000 square feet of operations, manufacturing, and administrative space. Both the services segment and the products segment conduct operations at this facility. The building has been financed by mortgages.
 
·            BAS Evansville Inc., is in Evansville, Indiana. We occupy 10 buildings with roughly 92,000 square feet of operating and administrative space on 52 acres. Most of this site is engaged in preclinical toxicology testing of developmental drugs in animal models. A recent addition was financed by a mortgage.
 
 
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·            Bioanalytical Systems, Ltd. is in Warwickshire, UK.  This facility contains our contract services and instruments operations for laboratories, sales and technical support services in the UK.  During fiscal 2008, we moved into a newly constructed laboratory space in the same office park as the previous leased space.  Our space of approximately 8,000 square feet is specifically designed for laboratory use and will allow us to potentially double capacity over the previous space.
 
·            BASi Northwest Laboratory is in McMinnville, Oregon, approximately 40 miles from Portland. We lease roughly 8,600 square feet of laboratory and administrative space, principally used for bioanalytical services.
 
We believe that our facilities are adequate for our operations and that suitable additional space will be available if and when needed. The terms of any mortgages and leases for the above properties are detailed in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, and Notes 6 and 7 to the Notes to Consolidated Financial Statements.

ITEM 3-LEGAL PROCEEDINGS

We currently do not have any material pending legal proceedings.
 
ITEM 4- REMOVED AND RESERVED
 
 
PART II
 
ITEM 5-MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
 
Market Information
 
As of September 30, 2011, our common stock was traded on NASDAQ Capital Market under the symbol “BASi”.  The following table sets forth the quarterly high and low sales price per share of our common stock from October 1, 2009 through September 30, 2011.
 
   
High
   
Low
 
Fiscal Year Ended September 30, 2010
           
First Quarter
  $ 2.42     $ 0.81  
Second Quarter
    1.42       0.65  
Third Quarter
    1.50       0.74  
Fourth Quarter
    1.22       0.77  
                 
Fiscal Year Ended September 30, 2011
               
First Quarter
  $ 3.55     $ 0.84  
Second Quarter
    2.60       1.84  
Third Quarter
    2.75       1.83  
Fourth Quarter
    2.00       1.19  
Holders
 
There were approximately 2,700 holders of record of our common stock as of December 22, 2011.
 
Dividends
 
We did not pay any cash dividends on our common shares in fiscal years 2010 or 2011 and do not anticipate paying cash dividends in the foreseeable future.
 
 
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Equity Compensation Plan Information
 
We maintain a stock option plan that allows for the granting of common stock options to certain key employees and directors. The following table gives information about equity awards under our stock option plans as of September 30, 2011 (in thousands except per share amounts):
 
Plan Category
 
Number of Securities to be
Issued upon Exercise of
Outstanding Options
   
Weighted Average
Exercise Price per share
of Outstanding Options
   
Number of Securities
Remaining Available for Future
Issuance under the Equity
Compensation Plan
(Excluding Securities Reflected
in First Column)
 
                   
Equity compensation plans approved by security holders
    648     $ 2.57       35  
                         
Equity compensation plans not approved by security holders (1)
    25     $ 4.58        
                         
Total
    673     $ 2.65       35  

(1) Includes option to purchase 25 shares at $4.58 granted to Michael R. Cox on April 1, 2004.
 
For additional information regarding our stock option plans approved by security holders, please see Note 9 to the Notes to Consolidated Financial Statements included in Item 8 of this report.
 
ITEM 6 – SELECTED FINANCIAL DATA
 
Not applicable.
 
[Remainder of page intentionally left blank.]

 
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ITEM 7-MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
This report contains statements that constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Those statements appear in a number of places in this Report and may include statements regarding our intent, belief or current expectations with respect to, but are not limited to (i) our strategic plans; (ii) trends in the demand for our products and services; (iii) trends in the industries that consume our products and services; (iv) our ability to develop new products and services; (v) our ability to make capital expenditures and finance operations; (vi) global economic conditions, especially as they impact our markets; (vii) our cash position; and (viii) our ability to integrate a new sales and marketing team. Readers are cautioned that any such forward looking statements are not guarantees of future performance and involve risks and uncertainties. Actual results may differ materially from those in the forward looking statements as a result of various factors, many of which are beyond our control.
 
In addition, we have based these forward-looking statements on our current expectations and projections about future events. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, actual events may differ from those assumptions, and as a result, the forward-looking statements based upon those assumptions may not accurately project future events. The following discussion and analysis should be read in conjunction with the Consolidated Financial Statements and notes thereto included or incorporated by reference elsewhere in this Report. In addition to the historical information contained herein, the discussions in this Report may contain forward-looking statements that may be affected by risks and uncertainties, including those discussed in Item 1A, Risk Factors. Our actual results could differ materially from those discussed in the forward-looking statements.
 
The following amounts are in thousands unless otherwise indicated.
 
Business Overview
 
We are an international contract research organization providing drug discovery and development services. Our clients and partners include pharmaceutical, biotechnology, academic and governmental organizations. We apply innovative technologies and products and a commitment to quality to help clients and partners accelerate the development of safe and effective therapeutics and maximize the returns on their research and development investments. We offer an efficient, variable-cost alternative to our clients' internal product development programs. Outsourcing development work to reduce overhead and speed drug approvals through the Food and Drug Administration ("FDA") is an established alternative to in-house development among pharmaceutical companies. We derive our revenues from sales of our research services and drug development tools, both of which are focused on determining drug safety and efficacy.  The Company has been involved in the research of drugs to treat numerous therapeutic areas for over 35 years.

We support the preclinical and clinical development needs of researchers and clinicians for small molecule and large biomolecule drug candidates. We believe our scientists have the skills in analytical instrumentation development, chemistry, computer software development, physiology, medicine, analytical chemistry and toxicology to make the services and products we provide increasingly valuable to our current and potential clients. Our principal clients are scientists engaged in analytical chemistry, drug safety evaluation, clinical trials, drug metabolism studies, pharmacokinetics and basic research at many of the small start-up biotechnology companies and the largest global pharmaceutical companies.
 
Our business is largely dependent on the level of pharmaceutical and biotechnology companies' efforts in new drug discovery and approval. Our services segment is a direct beneficiary of these efforts, through outsourcing by these companies of research work. Our products segment is an indirect beneficiary of these efforts, as increased drug development leads to capital expansion, providing opportunities to sell the equipment we produce and the consumable supplies we provide that support our products.
 
Research services are capital intensive. The investment in equipment and facilities to serve our markets is substantial and continuing. While our physical facilities are adequate to meet market needs for the near term, rapid changes in automation, precision, speed and technologies necessitate a constant investment in equipment and software to meet market demands. We are also impacted by the heightened regulatory environment and the need to improve our business infrastructure to support our increasingly diverse operations, which will necessitate additional capital investment. Our ability to generate capital to reinvest in our capabilities, both through operations and financial transactions, is critical to our success. While we are currently committed to fully utilizing recent additions to capacity, sustained growth will require additional investment in future periods.  Our financial position could limit our ability to make such investments.

 
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Executive Overview

Our revenues are dependent on a relatively small number of industries and clients. As a result, we closely monitor the market for our services. For a discussion of the trends affecting the market for our services, see “Item 1. Business – Trends Affecting the Drug Discovery and Development Industry.” In fiscal 2011, we experienced increased demand for our products and services as compared to fiscal 2010. We believe in the fundamentals of the market and that it will continue to slowly rebound in future periods. For fiscal 2012, we plan to focus on sales execution, operational excellence and building strategic partnerships with pharmaceutical and biotechnology companies, to differentiate our company and create value for our clients and shareholders.

We review various metrics to evaluate our financial performance, including period-to-period changes in new orders, revenue, margins and earnings. In fiscal 2011, we had new authorizations of $38.0 million, a small decrease of 1% over the same period in fiscal 2010 mainly due to pricing declines. Combined with the new authorizations in fiscal 2010 and similar total in fiscal 2011, our revenues in fiscal 2011 increased over 15% versus fiscal 2010.  Gross margin increased 43.3% and operating expenses declined 1.2% from the prior fiscal year due to cost containment measures and operational efficiencies.  As a result, we reported net income for fiscal 2011 of $543 versus a net loss of $2,691 in fiscal 2010.   Fiscal 2011 represents our first year of net income since fiscal 2007.  We will continue initiatives to control costs and improve productivity to achieve our fiscal 2012 financial objectives.  For a detailed discussion of our revenue, margins, earnings and other financial results for the fiscal year ended September 30, 2011, see “Results of Operations – 2011 Compared to 2010” below.
 
As of September 30, 2011, we had $2,963 of cash and cash equivalents as compared to $1,422 of cash and cash equivalents at the end of fiscal 2010. In fiscal 2011, we generated $1,088 in cash from operations primarily from the net income we achieved versus a net loss in fiscal 2010.  During fiscal 2011, we also paid down our long-term debt by an additional $1,000 and accounts payable by $482.  Likewise in the current fiscal year, we successfully closed our registered public equity offering, which netted cash of $4.6 million.

We believe that the development of innovative new drugs is going through an evolution, evidenced by the significant reduction of expenditures on research and development at several major international pharmaceutical companies, accompanied by increases in outsourcing and investments in smaller start-up companies that are performing the early development work on new compounds.  Many of these companies are funded by either venture capital or pharmaceutical investment, or both, and generally do not build internal staffs that possess the extensive scientific and regulatory capabilities to perform the various activities necessary to progress a drug candidate to the filing of an Investigative New Drug (“IND”) application with the FDA.

While continuing to maintain and develop our relationships with large pharmaceutical companies, we intend to aggressively promote our services to developing businesses, which will require us to expand our existing capabilities to provide services early in the drug development process, and to consult with clients on regulatory strategy and compliance leading to their FDA filings.  We have recently launched our Enhanced Drug Discovery services as part of this strategy, utilizing our proprietary Culex® technology to provide early experiments in our laboratories that previously would have been conducted in the sponsor’s facilities.  As we move forward, we must balance the demands of the large pharmaceutical companies with the personal touch needed by smaller biotechnology companies to develop a competitive advantage.  We intend to accomplish this through the use of and expanding upon our existing project management skills, strategic partnerships and progressive relationship management.
 
Net Income (loss) attributable to common shareholders and net income (loss) per share:
 
Net loss attributable to common shareholders was $3,725 and $2,691 for the fiscal years ended September 30, 2011 and 2010, respectively.  The diluted net loss per share was $0.66 for the fiscal year ended September 30, 2011 compared to diluted net loss per share of $0.55 for the fiscal year ended September 30, 2010.   The net loss available to common shareholders and diluted net loss per share in fiscal 2011 was impacted by dividends on the Series A preferred shares issued on May 11, 2011 of $3,277 and $991 as described in Note 3 to the consolidated financial statements.   The net income available to common shareholders would have been $543 for the fiscal year ended September 30, 2011, exclusive of the preferred dividends.   The diluted net income per share exclusive of the preferred dividends was $0.09 for the fiscal year ended September 30, 2011.  We consider the income available to common shareholders and diluted earnings per share exclusive of the dividends to be a useful measure in comparing operating results of the Company because the preferred dividends are considered nonrecurring items since they are associated with this offering only. The diluted weighted average common shares outstanding include the dilutive effects of the Series A preferred shares, warrants and stock options. We compute diluted earnings per share using the if-converted method for preferred stock and the treasury stock method for stock options and warrants.  The following table reconciles GAAP net income (loss) per share to the net income (loss) per share exclusive of the preferred dividends.
 
 
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The following table reconciles GAAP net income (loss) per share to the adjusted net income (loss) per share.
 
   
2011
 
       
GAAP basic net income (loss)applicable to common shareholders:
     
       
Net income
  $ 543  
         
Less:  Deemed dividend for Series A preferred shares
    (3,277 )
Less:  Preferred dividend
    (991 )
         
GAAP net loss applicable to common shareholders
  $ (3,725 )
         
Diluted net income per share, exclusive of the preferred dividends:
       
         
GAAP net loss applicable to common shareholders
  $ (3,725 )
         
Plus:  Deemed dividend for Series A preferred shares
    3,277  
Plus:  Preferred dividend
    991  
         
Adjusted net income applicable to common shareholders
  $ 543  
         
GAAP weighted average common shares outstanding
    5,667  
         
Plus:  Incremental shares from assumed conversions
       
Series A preferred shares
    526  
Warrants
     
Stock options
    90  
Adjusted diluted weighted average common shares outstanding
    6,283  
         
Diluted net income per share, exclusive of the deemed dividend
  $ 0.09  

Patient Protection and Affordable Care Act

In March 2010, the Patient Protection and Affordable Care Act (the “Act”) was enacted by the U.S. Congress and signed into law by the President.  The purpose of the legislation is to extend medical insurance coverage to a higher percentage of U.S. citizens.  Many of the provisions in the Act have delayed effective dates over the next decade, and will require extensive regulatory guidance.  Companies in our principal client industry, pharmaceuticals, will be required under the Act to provide additional discounts on medicines provided under Medicare and Medicaid to assist in the funding of the program; however, government estimates are that over 31 million additional citizens will eventually be covered by medical insurance as a result of the Act, which should expand the markets for their products.  It is premature to accurately predict the impacts these and other competing forces will have on our basic client market, drug development.  Additionally, the Act does not directly impact spiraling health care costs in the U.S., which could lead to additional legislation impacting our target markets in the future.

 
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We maintain an optional health benefits package for all of our full-time employees, which is largely paid by our contributions with employees paying a portion of the cost, generally less than 20% of the total.  Based on our current understanding of the Act, we do not anticipate significant changes to our programs or of their costs to the Company or our employees as a result of the Act.

We have experienced increases in the costs of our health benefit programs in excess of inflation rates, and expect those trends to continue.  We are exploring options in plan funding, delivery of benefits and employee wellness in our continuing effort to obtain maximum benefit for our health care expenditures, while maintaining quality programs for our employees.  We do not expect these efforts to have a material financial impact on the Company.
 
Results of Operations
 
The following table summarizes the consolidated statement of operations as a percentage of total revenues:
 
   
Year Ended September 30,
 
   
2011
   
2010
 
             
Service revenue
    77.3 %     76.0 %
Product revenue
    22.7       24.0  
Total revenue
    100.0 %     100.0 %
                 
Cost of service revenue (a)
    76.8       85.0  
Cost of product revenue (a)
    39.3       41.6  
Total cost of revenue
    68.3       74.5  
                 
Gross profit
    31.7       25.5  
                 
Total operating expenses
    27.8       32.4  
Operating income (loss)
    3.9       (6.9 )
                 
Other expense
    2.1       (3.6 )
                 
Income (loss) before income taxes
    1.8       (10.5 )
                 
Income tax expense (benefit)
    0.2       (1.2 )
                 
Net income (loss)
    1.6 %     (9.3 )%

(a) Percentage of service and product revenues, respectively.

2011 Compared to 2010

Service and Product Revenues
 
Revenues for the year ended September 30, 2011 increased 15.2% to $33,144 compared to $28,781 for the year ended September 30, 2010.
 
Our Services revenue increased 17.1% to $25,613 compared to $21,864 for the prior fiscal year primarily as a result of increases in each of the revenue groups of bioanalytical analysis, toxicology, and other laboratory services.  Increases in these groups from the same period in fiscal 2010 are mainly due to increases in new bookings and volumes of studies as well as number of samples to assay, even though pricing still lags pre-recession levels.  We have also recently launched our Enhanced Drug Discovery services which have contributed to the revenue increase.  The following table shows more detail for our Service revenue.

 
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Fiscal Year Ended
             
   
September 30,
             
   
2011
   
2010
   
Change
   
%
 
Bioanalytical analysis
  $ 13,634     $ 12,779     $ 855       6.7 %
Toxicology
    9,952       7,543       2,409       31.9 %
Other laboratory services
    2,027       1,542       485       31.5 %
 
Sales in our Products segment increased 8.9% from $6,917 to $7,531 when compared to the prior fiscal year.  The majority of the increase stems from higher sales of our Culex automated in vivo sampling system over prior fiscal year as customers began to release capital funds for larger projects. Other instruments revenue was negatively impacted in fiscal 2011 as a grant funded by the NIH expired in January 2010.  The following table shows more detail for our Product revenue.
 
   
Fiscal Year Ended
             
   
September 30,
             
   
2011
   
2010
   
Change
   
%
 
Culex, in-vivo sampling systems
  $ 4,028     $ 3,150     $ 878       27.9 %
Analytical instruments
    2,971       3,070       (99 )     -3.2 %
Other instruments
    532       697       (165 )     -23.7 %
 
Cost of Revenue
 
Cost of revenue for the year ended September 30, 2011 was $22,638 or 68.3% of revenue compared to $21,448, or 74.5% of revenue for the comparable prior period.
 
Cost of Service revenue as a percentage of Service revenue decreased to 76.8% in the current fiscal year from 85.0% in the prior year.  The principal cause of this decrease was the increase in revenues which led to higher absorption of the fixed costs in our Service segment as well as other cost containment measures.  A significant portion of our costs of productive capacity in the Service segment are fixed.   Thus, increases in revenues lead to decreases in costs as a percentage of revenue.
 
Cost of Product revenue as a percentage of Product revenue in the current fiscal year decreased to 39.3% from 41.6% in the prior fiscal year.  This decrease is mainly due to expense reductions and a reduction in the cost of obsolete and slow moving inventory in the current fiscal year compared to the cost recognized in the prior fiscal year.

Operating Expenses
 
Selling expenses for the year ended September 30, 2011 increased by 17.1% to $3,121 from $2,665 for the year ended September 30, 2010.   This increase was primarily driven by an increase in salaries and higher spending for marketing expenditures and consulting services as we implement our new sales and marketing strategy.
 
Research and development expenses for the year ended September 30, 2011 decreased 2.2% to $534 from $546 for the year ended September 30, 2010. The decrease was primarily due to a reduction in spending on temporary labor as we completed a project funded by an NIH grant in fiscal 2010.
 
General and administrative expenses for the current fiscal year decreased 9.1% to $5,564 from $6,119 for the prior year.  The decrease is mainly due to the following:  1) severance expenses for former employees recorded in the first quarter of fiscal 2010 from the reduction in force; 2) a retirement payment accrual for our former CEO in the prior year; 3) lease settlement costs in fiscal 2010; and 4) company-wide efforts at cost containment.

Other Income/Expense
 
Other income (expense), net, was $(694) for the year ended September 30, 2011 as compared to $(1,027) for the year ended September 30, 2010. The primary reasons for the decrease are lower mortgage interest in fiscal 2011 as a result of the two separate $500 principal payments made in fiscal 2011, as well as lower lease interest resulting from maturing leases.  Plus, in fiscal 2010, we incurred additional costs for our new line of credit agreement,
 
 
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Income Taxes
 
Our effective tax rate for the year ended September 30, 2011 was 8.5% compared to (11.0%) for the prior fiscal year.  The current year expense primarily relates to cash tax expense for U.S. corporate alternative minimum tax.  The benefit in fiscal 2010 is the result of resolving an uncertain state tax liability for less than the recorded amount.  No net benefits have been provided on taxable losses in the current fiscal year.

Liquidity and Capital Resources
 
Comparative Cash Flow Analysis
 
At September 30, 2011, we had cash and cash equivalents of $2,963 compared to $1,422 at September 30, 2010.
 
Net cash provided by operating activities was $1,088 for the year ended September 30, 2011, compared to $2,441 for the year ended September 30, 2010. The decrease in cash provided by operating activities in the current fiscal year mainly results from a decrease in customer advances from the prior fiscal year.   Other contributing factors to our cash from operations were $2,134 of depreciation and amortization and stock option expense of $153.  Included in operating activities for fiscal 2010 are non-cash charges of $2,323 for depreciation and amortization, net collections on accounts receivable of $650, an increase in customer advances of $1,719 as we booked new business and the recording of a $216 long-term liability in settlement of a contingent lease liability on our former Baltimore facility.  The impact on operating cash flow of other changes in working capital was not material.
 
In January 2010, we completed a reduction in work force, through both attrition and terminations, which impacted all areas of operations and reduced our annual compensation expense by approximately 10% and impacted our cash flow from operations in fiscal 2011 as well.

We have seen increased order activity in the calendar year 2010 as well as the first nine months of calendar 2011, which we expect will translate into earned revenues in fiscal 2012 due to the long term nature of some of our contracts.  Operating expenses declined approximately 1.2% in fiscal 2011 from the prior year period from continued cost containment initiatives even as we absorbed increased expenses for our new sales and marketing team and strategy.  We expect to experience selective cost increases in fiscal 2012 as we invest in personnel and technologies for our future growth.

Investing activities used $1,174 in fiscal 2011 for capital expenditures.  Our principal investments were for new laboratory equipment, replacements and upgrades in all of our facilities as well as general building and information technology infrastructure expenditures at all sites.  The increase in capital spending from fiscal 2010 is a result of the availability of financing from our improved financial performance in the current fiscal year.  We intend to spend a similar amount for capital expenditures, particularly for laboratory equipment, in our next fiscal year when financing becomes available to fund our purchases.
 
Financing activities provided $1,660 in the current fiscal year as compared to $1,458 used for fiscal 2010. The main source of cash in fiscal 2011 was the completion of our May 2011 equity offering, which netted $4,606, as well as net borrowings on our line of credit of $151, offset by long-term debt and capital lease payments of $3,097, including the two $500 individual principal payments on one mortgage and one note payable and the down payments of $618 for the new capital leases for laboratory equipment.  In fiscal 2010, we had long-term debt and capital lease payments of $1,325, as well as net payments on our line of credit of $564.  Also in fiscal 2010, we conducted a sale and leaseback of some of our unencumbered laboratory equipment which netted us $431 of cash.
 
Capital Resources
 
Property and equipment spending totaled $1,174 and $450 in fiscal 2011 and 2010, respectively. The increase in spending in fiscal 2011 is the result of new laboratory equipment financed mainly through capital leases in our bioanalytical laboratories in Indiana, Oregon and the U.K. Capital investments for the purchase of additional laboratory equipment are driven by anticipated increases in research services, and by the replacement or upgrading of our equipment. Although we may consider strategic acquisition opportunities, we do not intend to aggressively pursue additional acquisitions until we fully utilize existing capacity.
 
 
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We have notes payable to Regions Bank (“Regions”) aggregating approximately $6,500. Regions notes payable currently include two outstanding mortgages on our facilities in West Lafayette and Evansville, Indiana, which total $5,247.  The mortgages mature in November 2012 with an interest rate fixed at 4.1% and monthly principal payments of approximately $38 plus interest.
 
On November 29, 2010, we executed amendments on two loans with Regions.  Regions agreed to accept a $500 principal payment on the note payable maturing on December 18, 2010 and a $500 principal payment on one mortgage maturing on February 11, 2011.  The principal payments were made on December 17, 2010 and February 11, 2011, respectively.  Upon receipt of these two payments, Regions incorporated the two loans into a replacement note payable for $1,341 maturing on November 1, 2012. The replacement note payable bears interest at a per annum rate equal to the 30-day LIBOR plus 300 basis points (minimum of 4.5%) with monthly principal payments of approximately $14 plus interest.   The replacement note payable is secured by real estate at our West Lafayette and Evansville, Indiana locations.  At September 30, 2011, the replacement note payable had a balance of $1,245.

As part of the amendment, Regions also agreed to amend the loan covenants for the related debt to be more favorable to us.  Regions requires us to maintain certain ratios including a fixed charge coverage ratio and total liabilities to tangible net worth ratio.  The fixed charge coverage ratio calculation has been adjusted with an ending ratio required of not less than 1.25 to 1.00.  Also, the total liabilities to tangible net worth ratio has been adjusted to not greater than 2.10 to 1.00.  Provided we comply with the revised covenant ratios, which are common to such agreements, the amendment removes limitations on the Company’s purchase of fixed assets.  At September 30, 2011, we were in compliance with these covenants.    Based on projections for fiscal 2012, we expect to be in breach of the Regions fixed charge covenant for our first fiscal quarter due to lower than expected income, which we do not expect to continue into the remainder of fiscal 2012.  On December 20, 2011, Regions waived compliance with this covenant for the period ending December 31, 2011.  As a result of our  first fiscal quarter results, we will likely be out of compliance with the fixed charge coverage for the second fiscal quarter ending March 31, 2012, as our covenants are calculated on a fiscal year cumulative basis, when we will again need to obtain a waiver from Regions.  Failure to obtain such waiver could accelerate the maturity of the loans and cause a cross default with our other lender.
 
Borrowings under our credit agreements are collateralized by substantially all assets related to our operations and all common stock of our U.S. subsidiaries and 65% of the common stock of our non-United States subsidiaries. Under the terms of our credit agreements, we have agreed to restrict advances to subsidiaries and limit additional indebtedness. The Regions loan agreements both contain cross-default provisions with each other and with the revolving line of credit with Entrepreneur Growth Capital LLC (“EGC”) described below.
 
The mortgages and replacement note payable with Regions mature in the first quarter of fiscal 2013.  We intend to refinance the amounts in lieu of making balloon payments for the remaining principal balances.  We may be unsuccessful in renegotiating the terms of the debt or they may be unfavorable to us.  For these reasons, if we are unsuccessful at refinancing our long-term debt, our operating results and financial condition could be adversely affected.
 
Revolving Line of Credit
 
On January 13, 2010, we entered into a new $3,000 revolving line of credit agreement (“Credit Agreement”) with EGC to replace the PNC Bank line of credit that expired on January 15, 2010.  The initial term of the Credit Agreement was set to expire on January 31, 2011.  If we prepay prior to the expiration of the initial term (or any renewal term), then we are subject to an early termination fee equal to the minimum interest charges of $15 for each of the months remaining until expiration.
 
Borrowings bear interest at an annual rate equal to Citibank’s Prime Rate plus five percent (5%), or 8.25% as of September 30, 2011, with minimum monthly interest of $15.  Interest is paid monthly.  The line of credit also carries an annual facilities fee of 2% and a 0.2% collateral monitoring fee.  Borrowings under the Credit Agreement are secured by a blanket lien on our personal property, including certain eligible accounts receivable, inventory, and intellectual property assets, and a second mortgage on our West Lafayette and Evansville real estate and all common stock of our U.S. subsidiaries and 65% of the common stock of our non-United States subsidiary. Borrowings are calculated based on 75% of eligible accounts receivable.  Under the Credit Agreement, the Company has agreed to restrict advances to subsidiaries, limit additional indebtedness and capital expenditures and comply with certain financial covenants outlined in the Credit Agreement.
 
 
28

 
 
On December 23, 2010, we negotiated an amendment to this Credit Agreement.  As part of the amendment, the maturity date was extended to January 31, 2013.  The Amendment reduced the minimum tangible net worth covenant requirement from $9,000 to $8,500 and waived all non-compliances with this covenant through the date of the Amendment. The Credit Agreement also contains cross-default provisions with the Regions loans and any future EGC loans. At September 30, 2011, we were in compliance with the minimum tangible net worth covenant requirement.
 
Based on our current business activities and cash on hand, we expect to borrow on our revolving credit facility in fiscal 2012 to finance working capital.  To conserve cash, we instituted a freeze on non-essential capital expenditures.  As of September 30, 2011, we had $2,462 of total borrowing capacity with the line of credit, of which $1,346 was outstanding, and $2,963 of cash on hand.

For fiscal 2012, we expect to see slow but continued improvement in the volume of new bookings, but little improvement in pricing.  We also expect improved gross profit margins due to cost controls implemented.  Based on our expected increase in revenue, the availability on our line of credit, the impact of the cost reductions implemented and our successful equity offering in May 2011, we project that we will have the liquidity required to meet our fiscal 2012 operations and debt obligations.   Should operations materially fail to meet our expectations for the coming fiscal year, we may not be able to comply with all of our debt covenants, requiring that we obtain a waiver at that time.  If that situation arises, we will be required to negotiate with our lending bank again to obtain loan modifications or waivers as described above.  We cannot predict whether our lenders will provide those waivers, if required, what the terms of any such waivers might be or what impact any such waivers will have on our liquidity, financial condition or results of operations.
 
We had an increase in our total borrowing capacity of $688, from $1,774 to $2,462, from the fiscal year ended September 30, 2010 primarily as a result of higher accounts receivable from higher revenues as well as our success in collecting receivables.

The following table summarizes the cash payments under our contractual term debt and other obligations at September 30, 2011 and the effect such obligations are expected to have on our liquidity and cash flows in future fiscal periods (amounts in thousands). The table does not include our revolving line of credit.  Additional information on the debt is described in Note 7, Debt Arrangements.
 
   
2012
   
2013
   
2014
   
2015
   
2016
   
After 2016
   
Total
 
                                           
Notes payable
  $ 735     $ 5,842     $     $     $     $     $ 6,577  
Capital lease obligations
    730       368       295       295       245             1,933  
Operating leases
    432       421       417       351       342       2,240       4,203  
                                                         
    $ 1,897     $ 6,631     $ 712     $ 646     $ 587     $ 2,240     $ 12,713  

We anticipate spending approximately $2.0 million in fiscal 2012 on capital assets, primarily laboratory equipment which will be financed using capital leases.

Equity Offering (amounts in this section not in thousands)

On May 11, 2011, we completed a registered public offering of 5,506 units at a price of $1,000 per unit. Each unit consists of one 6% Series A convertible preferred share which is convertible into 500 common shares at a conversion price of $2.00 per share, one Class A Warrant to purchase 250 common shares at an exercise price of $2.00 per share, and one Class B Warrant to purchase 250 common shares at an exercise price of $2.00 per share.

The designation, rights, preferences and other terms and provisions of the Preferred Shares are set forth in the Certificate of Designation.  Until May 11, 2014, the Series A preferred shares have a stated dividend rate of 6% per annum, payable quarterly in cash or, subject to certain conditions, in common shares or a combination of cash and common shares, at our election.  After May 11, 2014, the Series A preferred shares will participate in any dividends payable upon our common shares on an "as converted" basis. If the preferred shares are converted prior to May 11, 2014, we must also pay to the converting holder in cash, or subject to certain conditions, in common shares or a combination thereof, $180 per $1,000 of the stated value of the preferred shares less any dividends paid prior to conversion (a “make-whole” payment).  Class A Warrants are exercisable immediately and expire in May 2016.  Class B Warrants are exercisable immediately and expire in May 2012. The net proceeds from the sale of the units, after deducting the fees and expenses of the placement agent and other expenses were $4.6 million.  We intend to use the proceeds for the purchase of laboratory equipment and for working capital and general corporate purposes. Because the preferred dividend or make-whole payment is triggered at the option of the preferred share holder, we recorded the dividend liability at the time of the offering close and will not have any preferred dividends subsequent to the fiscal quarter ended June 30, 2011.

 
29

 

As of September 30, 2011, 3,371 preferred shares have been converted into 1,997,193 common shares, including the make-whole payments and 33,120 common shares have been issued for quarterly preferred dividends for remaining outstanding, unconverted preferred shares.  At September 30, 2011, 2,135 preferred shares remain outstanding.  No warrants have been exercised as of September 30, 2011.

Inflation
 
We do not believe that inflation has had a material adverse effect on our business, operations or financial condition.

Critical Accounting Policies
 
"Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Liquidity and Capital Resources" discusses the consolidated financial statements of the Company, which have been prepared in accordance with accounting principles generally accepted in the United States. Preparation of these financial statements requires management to make judgments and estimates that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosures of contingent assets and liabilities. Certain significant accounting policies applied in the preparation of the financial statements require management to make difficult, subjective or complex judgments, and are considered critical accounting policies. We have identified the following areas as critical accounting policies.

Revenue Recognition

The majority of our service contracts involve the processing of bioanalytical samples for pharmaceutical companies. These contracts generally provide for a fixed fee for each assay method developed or sample processed and revenue is recognized under the specific performance method of accounting. Under the specific performance method, revenue and related direct costs are recognized when services are performed. Other service contracts generally consist of preclinical studies for pharmaceutical companies. Service revenue is recognized based on the ratio of direct costs incurred to total estimated direct costs under the proportional performance method of accounting. Losses on contracts are provided in the period in which the loss becomes determinable. Revisions in profit estimates are reflected on a cumulative basis in the period in which such revisions become known. The establishment of contract prices and total contract costs involves estimates made by the Company at the inception of the contract period. These estimates could change during the term of the contract which could impact the revenue and costs reported in the consolidated financial statements. Projected losses on contracts are provided for in their entirety when known. Revisions to estimates have not been material. Service contract fees received upon acceptance are deferred and classified within customer advances, until earned. Unbilled revenues represent revenues earned under contracts in advance of billings.
 
Product revenue from sales of equipment not requiring installation, testing or training is recognized upon shipment to customers. One product includes internally developed software and requires installation, testing and training, which occur concurrently. Revenue from these sales is recognized upon completion of the installation, testing and training when the services are bundled with the equipment sale.

Long-Lived Assets, Including Goodwill

Long-lived assets, such as property and equipment, and purchased intangibles subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized of the amount by which the carrying amount of the asset exceeds the fair value of the asset.

 
30

 
 
We carry goodwill at cost. Other intangible assets with definite lives are stated at cost and are amortized on a straight-line basis over their estimated useful lives. All intangible assets acquired that are obtained through contractual or legal right, or are capable of being separately sold, transferred, licensed, rented, or exchanged, are recognized as an asset apart from goodwill. Goodwill is not amortized.
 
Goodwill is tested annually for impairment, and more frequently if events and circumstances indicate that the asset might be impaired, using a two-step process.  In the first step, we compare the fair value of each reporting unit, as computed primarily by present value cash flow calculations, to its book carrying value, including goodwill. If the fair value exceeds the carrying value, no further work is required and no impairment loss is recognized. If the carrying value exceeds the fair value, the goodwill of the reporting unit is potentially impaired and we would then complete step 2 in order to measure the impairment loss. In step 2, the implied fair value is compared to the carrying amount of the goodwill. If the implied fair value of goodwill is less than the carrying value of goodwill, we would recognize an impairment loss equal to the difference. The implied fair value is calculated by allocating the fair value of the reporting unit (as determined in step 1) to all of its assets and liabilities (including unrecognized intangible assets) and any excess in fair value that is not assigned to the assets and liabilities is the implied fair value of goodwill.
 
The discount rate and sales growth rates are the two material assumptions utilized in our calculations of the present value cash flows used to estimate the fair value of the reporting units when performing the annual goodwill impairment test. Our reporting units with goodwill at September 30, 2011 are Vetronics, which is included in our Products segment, McMinnville, Oregon and Evansville, Indiana, which are both included in our Services segment, based on the discrete financial information available which is reviewed by management.  We utilize a cash flow approach in estimating the fair value of the reporting units, where the discount rate reflects a weighted average cost of capital rate. The cash flow model used to derive fair value is sensitive to the discount rate and sales growth assumptions used.
 
We performed our annual impairment test for all reporting units mentioned above at September 30, 2011.  Using a discount rate of 22% and a revenue growth rate of 0%, the fair values of our Vetronics, Oregon and Evansville reporting units is greater than the carrying values by approximately $12.7 million.
 
Considerable management judgment is necessary to evaluate the impact of operating and macroeconomic changes and to estimate future cash flows. Assumptions used in our impairment evaluations, such as forecasted sales growth rates and our cost of capital or discount rate, are based on the best available market information. Changes in these estimates or a continued decline in general economic conditions could change our conclusion regarding an impairment of goodwill and potentially result in a non-cash impairment loss in a future period.  The assumptions used in our impairment testing could be adversely affected by certain of the risks discussed in “Risk Factors” in Item 1A of this report.  There have been no significant events since the timing of our impairment tests that would have triggered additional impairment testing.
 
At September 30, 2011, remaining recorded goodwill was $1,383, and the net balance of other intangible assets was $54.

Stock-Based Compensation

We recognize the cost resulting from all share-based payment transactions in our financial statements using a fair-value-based method.  We measure compensation cost for all share-based awards based on estimated fair values and recognize compensation over the vesting period for awards. We recognized stock-based compensation related to stock options of $153 and $226 during the fiscal years ended September 30, 2011 and 2010, respectively.

We use the binomial option valuation model to determine the grant date fair value. The determination of fair value is affected by our common stock price as well as assumptions regarding subjective and complex variables such as expected employee exercise behavior and our expected stock price volatility over the term of the award. Generally, our assumptions are based on historical information and judgment is required to determine if historical trends may be indicators of future outcomes. We estimated the following key assumptions for the binomial valuation calculation:
   
 
·
Risk-free interest rate. The risk-free interest rate is based on U.S. Treasury yields in effect at the time of grant for the expected term of the option.
 
 
·
Expected volatility. We use our historical stock price volatility on our common stock for our expected volatility assumption.
 
31

 

 
 
·
Expected term. The expected term represents the weighted-average period the stock options are expected to remain outstanding. The expected term is determined based on historical exercise behavior, post-vesting termination patterns, options outstanding and future expected exercise behavior.

 
·
Expected dividends. We assumed that we will pay no dividends.
 
Employee stock-based compensation expense recognized in fiscal 2011 and 2010 was calculated based on awards ultimately expected to vest and has been reduced for estimated forfeitures. Forfeitures are revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates and an adjustment will be recognized at that time.
 
Changes to our underlying stock price, our assumptions used in the binomial option valuation calculation and our forfeiture rate as well as future grants of equity could significantly impact compensation expense recognized in future periods.

Income Tax Accounting

As described in Note 8 to the consolidated financial statements, we use the asset and liability method of accounting for income taxes.  We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. We measure deferred tax assets and liabilities using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. We recognize the effect on deferred tax assets and liabilities of a change in tax rates in income in the period that includes the enactment date.  We record valuation allowances based on a determination of the expected realization of tax assets.
 
We recognize the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. We measure the amount of the accrual for which an exposure exists as the largest amount of benefit determined on a cumulative probability basis that we believe is more likely than not to be realized upon ultimate settlement of the position.
 
 We record interest and penalties accrued in relation to uncertain income tax positions as a component of income tax expense. Any changes in the accrued liability for uncertain tax positions would impact our effective tax rate. Over the next twelve months we do not anticipate resolution to the carrying value of our reserve.  Interest and penalties are included in the reserve.
 
As of September 30, 2011 and 2010, we had a $16 and $30 liability for uncertain income tax positions, respectively.
 
We file income tax returns in the U.S., several U.S. states, and the foreign jurisdiction of the United Kingdom.  We remain subject to examination by taxing authorities in the jurisdictions in which we have filed returns for years after 2006.

In April 2010, we settled state tax litigation relating to our fiscal tax years 2003 through 2006 by agreeing to pay $35 and foregoing a refund claim for $63.  Because we had previously recorded a $443 liability for this uncertain tax position, we recognized a net tax benefit of $345 in our second fiscal quarter ended March 31, 2010.
 
We have an accumulated net deficit in our UK subsidiary. Consequently, United States deferred tax assets on such earnings have not been recorded.  Also, a valuation allowance was established in fiscal 2009 against the U.S. deferred income tax balance.  We had previously recorded a valuation allowance on the UK subsidiary deferred income tax balance.

Inventories
 
Inventories are stated at the lower of cost or market using the first-in, first-out (FIFO) cost method of accounting.
 
 
32

 
 
New Accounting Pronouncements
 
In October 2009, the FASB issued an Accounting Standards Update on the accounting for revenue recognition that amends the previous guidance on arrangements with multiple deliverables. This guidance provides principles and application guidance on whether multiple deliverables exist, how the arrangements should be separated, and how the consideration should be allocated. It also clarifies the method to allocate revenue in an arrangement using the estimated selling price. This guidance was effective for revenue arrangements entered into or materially modified beginning October 1, 2010. We adopted this update during fiscal 2011.  This adoption did not materially impact revenue in the periods presented or the methods in which we have historically reported revenues.

In May 2011, the FASB issued updated fair value measurement and disclosure guidance that clarifies how to measure fair value and requires additional disclosures regarding Level 3 fair value measurements, as well as any transfers between Level 1 and Level 2 fair value measurements. The updated accounting guidance is effective for fiscal years and interim periods beginning on or after December 15, 2011 on a prospective basis. The Company is currently evaluating the impact of adopting the updated fair value guidance, and it does not expect the adoption to have a material impact on its consolidated financial statements.

In June 2011, the FASB amended the manner in which an entity presents the total of comprehensive income, the components of net income and the components of other comprehensive income either in a single, continuous statement of comprehensive income or in two separate but consecutive statements. The amendment eliminates the option to present the components of other comprehensive income as part of the statement of equity. The amendment is effective for fiscal years and interim periods beginning on or after December 15, 2011 on a retrospective basis. The adoption of this guidance will not change the previously reported amounts of comprehensive income but will change the Company’s presentation of comprehensive income in the condensed consolidated financial statements for the period ending December 31, 2011.

In September 2011, the FASB issued an accounting standards update that amends the two-step goodwill impairment test by permitting an entity to first assess qualitative factors in determining whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. If the entity determines that it is not more likely than not that the fair value of a reporting unit is less than its carrying amount, then performing the two-step goodwill impairment test is unnecessary. The amendment is effective for fiscal years and interim periods beginning on or after December 15, 2011 on a prospective basis, early adoption is permitted. The Company will consider adopting the guidance when completing its annual impairment test during the fourth quarter of 2012 and does not believe the adoption of this guidance will have an impact on its consolidated financial statements.

ITEM 7A – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not applicable.
 
[Remainder of page intentionally left blank.]
 
 
33

 

 
ITEM 8-FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Index to Consolidated Financial Statements

 
Page
   
Consolidated Financial Statements of Bioanalytical Systems, Inc.
 
   
Consolidated Balance Sheets as of September 30, 2011 and 2010
35
   
Consolidated Statements of Operations for the Years Ended September 30, 2011 and 2010
36
   
Consolidated Statements of Shareholders’ Equity and Comprehensive Income (Loss) for the Years Ended September 30, 2011 and 2010
37
   
Consolidated Statements of Cash Flows for the Years Ended September 30, 2011 and 2010
38
   
Notes to Consolidated Financial Statements
39
   
Report of Independent Registered Public Accounting Firm
56

Financial Statement Schedules:

Schedules are not required, are not applicable or the information is shown in the Notes to the Consolidated Financial Statements.
 
 
34

 

BIOANALYTICAL SYSTEMS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)

   
As of September 30,
 
   
2011
   
2010
 
Assets
           
Current assets:
           
Cash and cash equivalents
  $ 2,963     $ 1,422  
Accounts receivable
               
Trade
    4,073       3,670  
Unbilled revenues and other
    1,116       1,298  
Inventories
    1,636       1,673  
Refundable income taxes
          16  
Prepaid expenses
    585       555  
Total current assets
    10,373       8,634  
                 
                 
Property and equipment, net
    20,399       19,439  
Goodwill
    1,383       1,383  
Intangible assets, net
    54       84  
Debt issue costs, net
    75       123  
Other assets
    62       80  
                 
Total assets
  $ 32,346     $ 29,743  
                 
Liabilities and shareholders’ equity
               
Current liabilities:
               
Accounts payable
  $ 1,764     $ 1,911  
Accrued expenses
    1,762       1,848  
Customer advances
    3,571       4,582  
Income tax accruals
    56       30  
Revolving line of credit
    1,346       1,195  
Fair value of interest rate swaps
          31  
Current portion of capital lease obligation
    613       524  
Current portion of long-term debt
    735       1,855  
Total current liabilities
    9,847       11,976  
                 
Capital lease obligation, less current portion
    1,071       623  
Long-term debt, less current portion
    5,842       6,477  
                 
Shareholders’ equity:
               
Preferred shares, authorized 1,000,000 shares, no par value: 2,135 Series A shares at $1,000 stated value issued and outstanding at September 30, 2011 and none at September 30, 2010
    2,135        
Common shares, no par value: Authorized 19,000,000 shares; 6,945,631 issued and outstanding at September 30, 2011 and 4,915,318 at September 30, 2010
    1,698       1,191  
Additional paid-in capital
    19,408       13,357  
Accumulated deficit
    (7,706 )     (3,981 )
Accumulated other comprehensive income
    51       100  
                 
Total shareholders’ equity
    15,586       10,667  
                 
Total liabilities and shareholders’ equity
  $ 32,346     $ 29,743  
 
The accompanying notes are an integral part of the consolidated financial statements.

 
35

 

BIOANALYTICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)

   
For the Years Ended
September 30,
 
   
2011
   
2010
 
Service revenue
  $ 25,613     $ 21,864  
Product revenue
    7,531       6,917  
Total revenue
    33,144       28,781  
                 
Cost of service revenue
    19,679       18,574  
Cost of product revenue
    2,959       2,874  
Total cost of revenue
    22,638       21,448  
                 
Gross profit
    10,506       7,333  
Operating expenses:
               
Selling
    3,121       2,665  
Research and development
    534       546  
General and administrative
    5,564       6,119  
Total operating expenses
    9,219       9,330  
                 
Operating income (loss)
    1,287       (1,997 )
                 
Interest expense
    (706 )     (1,028 )
Other income
    12       1  
Income (loss) before income taxes
    593       (3,024 )
                 
Income tax expense (benefit)
    50       (333 )
                 
Net income (loss)
  $ 543     $ (2,691 )
                 
Less:  Deemed dividend on Series A preferred shares
    (3,277 )      
                 
Less:  Preferred stock dividends
    (991 )      
                 
Net loss attributable to common shareholders
  $ (3,725 )   $ (2,691 )
                 
Basic net loss per share:
  $ (0.66 )   $ (0.55 )
Diluted net loss per share:
  $ (0.66 )   $ (0.55 )
                 
Weighted common shares outstanding:
               
Basic
    5,667       4,915  
Diluted
    5,667       4,915  
 
The accompanying notes are an integral part of the consolidated financial statements.

 
36

 
 
BIOANALYTICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except number of shares)

                                        
Accumulated
       
                           
Additional
         
other
   
Total
 
   
Preferred Shares
   
Common Shares
   
paid-in
   
Accumulated
   
comprehensive
   
shareholders'
 
   
Number
   
Amount
   
Number
   
Amount
   
capital
   
deficit
   
income (loss)
   
equity
 
                                                 
Balance at October 1, 2009
    -     $ -       4,915,318     $ 1,191     $ 13,131     $ (1,290 )   $ 88     $ 13,120  
                                                                 
Comprehensive loss:
                                                               
Net loss
    -       -       -       -       -       (2,691 )     -       (2,691 )
Foreign currency translation adjustments
    -       -       -       -       -       -       12       12  
Total comprehensive loss
                                                            (2,679 )
                                                                 
Stock based compensation expense
    -       -       -       -       226       -       -       226  
                                                                 
Balance at September 30, 2010
    -     $ -       4,915,318     $ 1,191     $ 13,357     $ (3,981 )   $ 100     $ 10,667  
                                                                 
Comprehensive income:
                                                               
Net income
    -       -       -       -       -       543       -       543  
Foreign currency translation adjustments
    -       -       -       -       -       -       (49 )     (49 )
Total comprehensive income
                                                            494  
                                                                 
Stock based compensation expense
    -       -       -       -       153       -       -       153  
                                                                 
Issuance of preferred shares, net of issuance costs of $900,281
    5,506       5,506       -       -       (900 )     -       -       4,606  
                                                                 
Fair value attributed to warrants
    -       (1,831 )     -       -       1,831       -       -       -  
                                                                 
Preferred stock - beneficial conversion feature
    -       (1,446 )     -       -       1,446       -       -       -  
                                                                 
Preferred stock - deemed dividend
    -       3,277       -       -       -       (3,277 )     -       -  
                                                                 
Preferred stock - recognition of full dividend/make-whole
    -       -       -       -       -       (991 )     -       (991 )
                                                                 
Conversion of preferred shares to common shares
    (3,371 )     (3,371 )     1,685,500       421       2,950       -       -       -  
                                                                 
Common shares issued for dividends/make-whole payment
    -       -       344,813       86       571       -       -       657  
                                                                 
Balance at September 30, 2011
    2,135     $ 2,135       6,945,631     $ 1,698     $ 19,408     $ (7,706 )   $ 51     $ 15,586  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
37

 

BIOANALYTICAL SYSTEMS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

   
Years Ended September 30,
 
   
2011
   
2010
 
Operating activities:
           
Net income (loss)
  $ 543     $ (2,691 )
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
               
Depreciation and amortization
    2,134       2,323  
Employee stock compensation expense
    153       226  
Provision for doubtful accounts
    16       61  
Liability incurred on settlement of lease
          216  
Gain on interest rate swaps
    (31 )     (72 )
Gain on sale of property and equipment
    (9 )     (1 )
Deferred income taxes
    (14 )     12  
Changes in operating assets and liabilities:
               
Accounts receivable
    (236 )     650  
Inventories
    37       174  
Refundable income taxes
    56       529  
Prepaid expenses and other assets
    17       90  
Accounts payable
    (482 )     (86 )
Accrued expenses
    (86 )     (709 )
Customer advances
    (1,010 )     1,719  
Net cash provided by operating activities
    1,088       2,441  
                 
Investing activities:
               
Capital expenditures
    (1,174 )     (450 )
Net cash used by investing activities
    (1,174 )     (450 )
                 
Financing activities:
               
Net proceeds from registered direct offering
    4,606        
Payments of long-term debt
    (1,756 )     (599 )
Payments on revolving line of credit
    (30,917 )     (28,948 )
Borrowings on revolving line of credit
    31,068       28,384  
Proceeds from sale and leaseback
          431  
Payments on capital lease obligations
    (1,341 )     (726 )
Net cash provided (used) by financing activities
    1,660       (1,458 )
                 
Effect of exchange rate changes
    (33 )     19  
                 
Net increase in cash and cash equivalents
    1,541       552  
Cash and cash equivalents at beginning of year
    1,422       870  
Cash and cash equivalents at end of year
  $ 2,963     $ 1,422  
                 
Supplemental disclosure of non-cash financing activities:
               
Preferred stock dividends accrued, but not paid
  $ 991     $  
Preferred stock dividends paid in common shares
  $ (657 )   $  
Equipment financed under capital leases
  $ 1,888     $  
 
The accompanying notes are an integral part of the consolidated financial statements.
 
 
38

 

BIOANALYTICAL SYSTEMS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
 
(Amounts in thousands unless otherwise listed)
 
1.
DESCRIPTION OF THE BUSINESS
 
Bioanalytical Systems, Inc. and its subsidiaries (the “Company” or “BASi” or “we”) engage in research services and other services related to pharmaceutical development. We also manufacture scientific instruments for medical research, which we sell with related software for use in industrial, governmental and academic laboratories. We conduct our businesses through our research facilities in Indiana, Oregon, and the United Kingdom and our manufacturing facility in Indiana. Our customers are located throughout the world.
 
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
 
(a)
Principles of Consolidation
 
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant inter-company accounts and transactions have been eliminated.
 
 
(b)
Revenue Recognition
 
The majority of our service contracts involve the development of analytical methods and the processing of bioanalytical samples for pharmaceutical companies and generally provide for a fixed fee for each sample processed. Revenue is recognized under the specific performance method of accounting and the related direct costs are recognized when services are performed. Our research service contracts generally consist of preclinical studies, and revenue is recognized based on the ratio of direct costs incurred to total estimated direct costs under the proportional performance method of accounting. Losses on both types of contracts are provided in the period in which the loss becomes determinable. Revisions in profit estimates, if any, are reflected on a cumulative basis in the period in which such revisions become known. The establishment of contract prices and total contract costs involves estimates we make at the inception of the contract. These estimates could change during the term of the contract and impact the revenue and costs reported in the consolidated financial statements. Revisions to estimates have generally not been material. Research service contract fees received upon acceptance are deferred until earned, and classified within customer advances. Unbilled revenues represent revenues earned under contracts in advance of billings.
 
Product revenue from sales of equipment not requiring installation, testing or training is recognized upon shipment to customers. One product includes internally developed software and requires installation, testing and training, which occur concurrently. Revenue from these sales is recognized upon completion of the installation, testing and training when the services are bundled with the equipment sale.
 
 
(c)
Cash Equivalents
 
We consider all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents.
 
One or more of the financial institutions holding the Company’s cash accounts are participating in the FDIC’s Transaction Account Guarantee Program. Under that program, through December 31, 2010, all noninterest-bearing transaction accounts are fully guaranteed by the FDIC for the entire amount in the account. Pursuant to legislation enacted in 2010, the FDIC will fully insure all noninterest-bearing transaction accounts beginning December 31, 2010 through December 31, 2012, at all FDIC-insured institutions.

For financial institutions opting out of the FDIC’s Transaction Account Guarantee Program or interest-bearing cash accounts, the FDIC’s insurance limits were permanently increased to $250,000, effective July 21, 2010. At September 30, 2011, the Company did not have any cash accounts that exceeded federally insured limits.

 
39

 
 
 
(d)
Accounts Receivable
 
We perform periodic credit evaluations of our customers’ financial conditions and generally do not require collateral on trade accounts receivable. We account for trade receivables based on the amounts billed to customers. Past due receivables are determined based on contractual terms. We do not accrue interest on any of our trade receivables.  The allowance for doubtful accounts is determined by management based on our historical losses, specific customer circumstances, and general economic conditions.  Periodically, management reviews accounts receivable and adjusts the allowance based on current circumstances and charges off uncollectible receivables when all attempts to collect have failed.  Our allowance for doubtful accounts was $108 and $165 at September 30, 2011 and 2010, respectively.
 
A summary of activity in our allowance for doubtful accounts is as follows:
 
   
2011
   
2010
 
             
Opening balance
  $ 165     $ 110  
Charged to expense, net
    (48 )     61  
Accounts written off
    (9 )     (6 )
Ending balance
  $ 108     $ 165  
 
 
(e)
Inventories
 
Inventories are stated at the lower of cost or market using the first-in, first-out (FIFO) cost method of accounting.
 
 
(f)
Property and Equipment
 
We record property and equipment at cost, including interest capitalized during the period of construction of major facilities. We compute depreciation, including amortization on capital leases, using the straight-line method over the estimated useful lives of the assets, which we estimate to be: buildings and improvements, 34 to 40 years; machinery and equipment, 5 to 10 years, and office furniture and fixtures, 10 years. In our European operations, we depreciate leasehold improvements, using the straight-line method, over 7 years, corresponding to the terms of the operating lease for the European facility.  Depreciation expense was $2,085 in fiscal 2011 and $2,287 in fiscal 2010. Expenditures for maintenance and repairs are expensed as incurred.

Property and equipment, net, as of September 30, 2011 and 2010 consisted of the following:

   
2011
   
2010
 
             
Land and improvements
  $ 527     $ 488  
Buildings and improvements
    21,433       21,296  
Machinery and equipment
    22,361       20,652  
Office furniture and fixtures
    949       952  
Construction in progress
    493       109  
      45,763       43,497  
Less: accumulated depreciation
    (25,364 )     (24,058 )
Net property and equipment
  $ 20,399     $ 19,439  
 
 
(g)
Long-Lived Assets including Goodwill
 
Long-lived assets, such as property and equipment, and purchased intangibles subject to amortization, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized of the amount by which the carrying amount of the asset exceeds the fair value of the asset.

 
40

 

We carry goodwill at cost. Other intangible assets with definite lives are stated at cost and are amortized on a straight-line basis over their estimated useful lives. All intangible assets acquired that are obtained through contractual or legal right, or are capable of being separately sold, transferred, licensed, rented, or exchanged, are recognized as an asset apart from goodwill. Goodwill is not amortized.
 
Goodwill is tested annually for impairment, and more frequently if events and circumstances indicate that the asset might be impaired, using a two-step process.  In the first step, we compare the fair value of each reporting unit, as computed primarily by present value cash flow calculations, to its book carrying value, including goodwill.  If the fair value exceeds the carrying value, no further work is required and no impairment loss is recognized. If the carrying value exceeds the fair value, the goodwill of the reporting unit is potentially impaired and we would then complete step 2 in order to measure the impairment loss. In step 2, the implied fair value is compared to the carrying amount of the goodwill. If the implied fair value of goodwill is less than the carrying value of goodwill, we would recognize an impairment loss equal to the difference. The implied fair value is calculated by allocating the fair value of the reporting unit (as determined in step 1) to all of its assets and liabilities (including unrecognized intangible assets) and any excess in fair value that is not assigned to the assets and liabilities is the implied fair value of goodwill.
 
The discount rate and sales growth rates are the two material assumptions utilized in our calculations of the present value cash flows used to estimate the fair value of the reporting units when performing the annual goodwill impairment test. Our reporting units with goodwill at September 30, 2011 are Vetronics, which is included in our Products segment, McMinnville, Oregon and Evansville, Indiana, which are both included in our Services segment, based on the discrete financial information available which is reviewed by management.  We utilize a cash flow approach in estimating the fair value of the reporting units, where the discount rate reflects a weighted average cost of capital rate. The cash flow model used to derive fair value is sensitive to the discount rate and sales growth assumptions used. We performed our annual impairment test for all reporting units mentioned above at September 30, 2011.  Using a discount rate of 22% and a revenue growth rate of 0%, the fair values of our Vetronics, McMinnville, Oregon and Evansville, Indiana reporting units is greater than the carrying values by approximately $12.7 million.
 
Considerable management judgment is necessary to evaluate the impact of operating and macroeconomic changes and to estimate future cash flows. Assumptions used in our impairment evaluations, such as forecasted sales growth rates and our cost of capital or discount rate, are based on the best available market information. Changes in these estimates or a continued decline in general economic conditions could change our conclusion regarding an impairment of goodwill and potentially result in a non-cash impairment loss in a future period.  The assumptions used in our impairment testing could be adversely affected by certain of the risks discussed in “Risk Factors” in Item 1A of this report.  There have been no significant events since the timing of our impairment tests that would have triggered additional impairment testing.
 
At September 30, 2011 and 2010, remaining recorded goodwill was $1,383, and the net balance of other intangible assets was $54 and $84, respectively. The components of intangible assets subject to amortization are as follows:
 
         
September 30, 2011
 
   
Weighted
average life
(years)
   
Gross Carrying
Amount
   
Accumulated
Amortization
 
                   
FDA compliant facility
  10     $ 302     $ 248  
                       
         
September 30, 2010
 
   
Weighted
average life
(years)
   
Gross Carrying
Amount
   
Accumulated
Amortization