Attached files
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EX-23 - EXHIBIT 23 - MEDTOX SCIENTIFIC INC | ex23.htm |
EX-31.1 - EXHIBIT 31.1 - MEDTOX SCIENTIFIC INC | ex31-1.htm |
EX-31.2 - EXHIBIT 31.2 - MEDTOX SCIENTIFIC INC | ex31-2.htm |
EX-21.1 - EXHIBIT 21.1 - MEDTOX SCIENTIFIC INC | ex21-1.htm |
EX-32.1 - EXHIBIT 32.1 - MEDTOX SCIENTIFIC INC | ex32-1.htm |
EX-32.2 - EXHIBIT 32.2 - MEDTOX SCIENTIFIC INC | ex32-2.htm |
EX-10.36 - EXHIBIT 10.36 - MEDTOX SCIENTIFIC INC | ex10-36.htm |
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
[X] ANNUAL REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2009
[ ] TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Commission
file number 1-11394
MEDTOX SCIENTIFIC,
INC.
(Exact
name of Registrant as specified in its charter)
Delaware
|
95-3863205
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
incorporation
or organization)
|
Identification
No.)
|
402 West County Road D, St. Paul,
Minnesota
|
55112
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant's
telephone number, including area code: (651)
636-7466
Securities
registered pursuant to Section 12(b) of the Act:
Common Stock, par value $0.15 per
share
|
NASDAQ
Global Select Market
|
(Title
of Class)
|
Name
of Exchange on Which Registered
|
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the Registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes [ ] No
[X]
Indicate
by check mark 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 Web site, if any, every Interactive Data File required 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
[ ] 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. [ ]
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.
Large accelerated filer
[ ] Accelerated
filer [X
] Non-accelerated
filer
[ ] Smaller
reporting company [ ]
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes [ ] No
[X]
As of
June 30, 2009, the aggregate market value of the registrant’s Common Stock held
by non-affiliates of the registrant was $70,337,974 on the closing price as
reported on the NASDAQ Global Select Market.
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date:
Class
|
Outstanding
at February 18, 2010
|
Common
Stock, $0.15 par value per share
|
8,671,746
shares
|
DOCUMENTS
INCORPORATED BY REFERENCE
Document
|
Parts
Into Which Incorporated
|
|
Definitive
Proxy Statement for the 2010 Annual Meeting of Stockholders to be held
June 15, 2010 (Proxy Statement)
|
Part
III
|
MEDTOX
SCIENTIFIC, INC.
ANNUAL
REPORT ON FORM 10-K
FOR THE
YEAR ENDED DECEMBER 31, 2009
Table
of Contents
|
||
ITEM NO.
|
PAGE
|
|
Part
I
|
||
1.
|
Business
|
4
|
1A.
|
Risk
Factors
|
15
|
2.
|
Properties
|
19
|
|
||
3.
|
Legal
Proceedings
|
20
|
4.
|
Submission
of Matters to a Vote of Security Holders
|
20
|
Part
II
|
||
5.
|
Market
for the Registrant's Common Equity, Related Stockholder
|
|
Matters
and Issuer Purchases of Equity Securities
|
21
|
|
6.
|
Selected
Financial Data
|
22
|
7.
|
Management's
Discussion and Analysis
|
|
of
Financial Condition and Results of Operations
|
23
|
|
7A.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
35
|
8.
|
Financial
Statements and Supplementary Data
|
35
|
9.
|
Changes
in and Disagreements With Accountants on
|
|
Accounting
and Financial Disclosure
|
35
|
|
9A.
|
Controls
and Procedures
|
35
|
9B.
|
Other
Information
|
36
|
Part
III
|
||
|
||
10.
|
Directors,
Executive Officers and Corporate Governance
|
37
|
11.
|
Executive
Compensation
|
37
|
12.
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
37
|
13.
|
Certain
Relationships and Related Transactions, and
Director Independence
|
37
|
|
||
14.
|
Principal
Accountant Fees and Services
|
37
|
Part
IV
|
||
15.
|
Exhibits,
Financial Statement Schedules
|
38
|
Signatures
|
43
|
2
PART
I
CAUTIONARY
STATEMENT IDENTIFYING IMPORTANT FACTORS
THAT
COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER
FROM
THOSE PROJECTED IN FORWARD LOOKING STATEMENTS
In
connection with the “safe harbor” provisions of the Private Securities
Litigation Reform Act of 1995, readers of this document and any document
incorporated by reference herein are advised that this document and documents
incorporated by reference into this document contain both statements of
historical facts and forward looking statements. Forward looking
statements are subject to certain risks and uncertainties, which could cause
actual results to differ materially from those indicated by the forward looking
statements. Examples of forward looking statements include, but are
not limited to (i) projections of, or statements regarding, future revenues,
income or loss, earnings or loss per share, capital expenditures, dividends,
capital structure, margins and other financial items, (ii) statements regarding
our plans and objectives and the impacts thereof, including planned
introductions of new products and services, planned exiting of lines of business
and planned regulatory filings, or estimates or predictions of actions by
customers, suppliers, competitors or regulatory authorities, (iii) estimates of
market sizes and market opportunities, (iv) statements regarding economic
conditions, (v) statements regarding the sufficiency of our existing resources
to fund our planned operations through 2010 and the sufficiency of future
profitable operations and access to additional capital to fund our operations
beyond 2010, and (vi) statements of assumptions underlying other statements and
statements about our business.
This
document and any documents incorporated by reference herein also identify
important factors which could cause actual results to differ materially from
those indicated by the forward looking statements. The factors that
could affect our actual results include the following:
·
|
increased
competition, including price
competition
|
·
|
changes
in demand for our services and products by our
customers
|
·
|
changes
in general economic and business conditions, both nationally and
internationally, which can influence the level of job growth and, in turn,
the level of pre-employment drug screening
activity
|
·
|
technological
or regulatory developments, or evolving industry standards, that could
affect or delay the sale of our
products
|
·
|
our
ability to attract and retain experienced and qualified
personnel
|
·
|
risks
and uncertainties with respect to our patents and proprietary rights,
including:
|
o
|
other
companies challenging our patents
|
o
|
patents
issued to other companies that may harm our ability to do
business
|
o
|
other
companies designing around technologies we have
developed
|
o
|
our
inability to obtain appropriate licenses from third
parties
|
o
|
our
inability to protect our trade
secrets
|
o
|
risk
of infringement upon the proprietary rights of
others
|
o
|
our
inability to prevent others from infringing on our proprietary
rights
|
·
|
our
inability to control the costs in our
business
|
·
|
our
inability to obtain sufficient financing to continue to sustain or expand
our operations
|
·
|
adverse
results in litigation matters
|
·
|
our
inability to continue to develop innovative products and
services
|
3
·
|
our
inability to provide our services in a timely
manner
|
·
|
an
unforeseen decrease in the acceptance of current new products and
services, including in the market for clinical laboratory testing for
physicians offices and patients
|
·
|
fluctuations
in clinical trial activities, including cancellations of signed
protocols
|
·
|
inaccurate
information regarding market
opportunities
|
·
|
failure
to receive regulatory approvals and
clearances
|
·
|
other
factors, including those set forth in Item 1A of this Annual Report on
Form 10-K
|
Many
factors could cause our actual results, performance or achievements to be
materially different from those anticipated in our forward looking
statements. Any written or oral forward looking statements made by us
or on our behalf are subject to these factors. Should one or more of
these risks or uncertainties materialize, or should assumptions underlying the
forward looking statements prove incorrect, actual results, performance or
achievements may vary materially from those described in this Annual Report on
Form 10-K as intended, planned, anticipated, believed, estimated or
expected. The risk factors included in this Annual Report on Form
10-K are not necessarily all of the important factors that could cause actual
results to differ materially from those expressed in any of our forward looking
statements. Other unknown or unpredictable factors could also harm
our future results. Given these uncertainties, readers are cautioned
not to place undue reliance on such forward looking statements.
The
forward looking statements included in this Annual Report on Form 10-K are made
only as of the date of this Annual Report on Form 10-K. We do not
intend, and do not assume any obligations, to update these forward looking
statements, except as required by law.
ITEM
1. BUSINESS.
1. General.
MEDTOX
Scientific, Inc., a Delaware corporation, was organized in September 1986.
MEDTOX Scientific, Inc. and its wholly-owned subsidiaries: MEDTOX Laboratories,
Inc., MEDTOX Diagnostics, Inc. and New Brighton Business Center, LLC are
collectively referred to herein as the “Company”, “MEDTOX”, “we”, “us” or
“our”.
We are
engaged primarily in two distinct, but related businesses. MEDTOX
Laboratories, Inc., based in St. Paul, Minnesota, provides forensic and clinical
laboratory services. MEDTOX Diagnostics, Inc., based in Burlington,
North Carolina, manufactures and distributes diagnostic devices and other
similar products. For the year ended December 31, 2009, MEDTOX
Laboratories, Inc. and MEDTOX Diagnostics, Inc. accounted for 78% and 22% of our
consolidated revenues, respectively.
2.
|
Principal Services,
Products and Markets.
|
General. We have
two reportable segments: “Laboratory Services”, which consists of the activities
conducted by MEDTOX Laboratories, Inc. and New Brighton Business Center, LLC,
and “Product Sales”, conducted by MEDTOX Diagnostics, Inc. Laboratory
Services includes drugs of abuse testing services. MEDTOX
Laboratories also provides clinical and other laboratory services which consist
of clinical toxicology, clinical testing for occupational health clinics,
clinical testing for physician offices, pediatric lead testing, and analysis of
heavy and trace metal. We also provide services in the area of
logistical support, data management and overall program management
services. Additionally, MEDTOX Laboratories provides clinical trial
services which include central laboratory services, assay (test) development,
bio-analytical, bio-equivalence and pharmacokinetic testing. The
Product Sales segment includes sales of a variety of on-site drug screening
products and contract manufacturing. For financial information
relating to our segments, see Note 2 of notes to the consolidated financial
statements included in this Annual Report on Form 10-K.
4
Laboratory Services
A. Drugs-of-Abuse Testing
Services. As reflected in the table below, our Laboratory
Services segment derives a substantial percentage of its revenues from
laboratory testing services for the identification of
drugs-of-abuse.
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
Drugs-of-abuse
testing services revenues
|
$ | 36,040 | $ | 40,021 | $ | 38,673 | ||||||
%
of Laboratory Services revenues
|
55 | % | 61 | % | 63 | % |
Industry
analysts have estimated that the industry-wide revenues derived from workplace
laboratory-based drugs-of-abuse testing in the United States are in excess of
$500 million. Public information highlights the motivations behind
such testing. For example, according to results of a National
Institute of Drug Abuse-sponsored survey, drug using employees are 2.2 times
more likely to require early dismissal or request time off, 2.5 times more
likely to have absences of eight days or more, 3 times more likely to be late
for work, 3.6 times more likely to be involved in a workplace accident, and 5
times more likely to file a workers’ compensation claim. We believe
the percentage of employers with drug testing programs has remained fairly
consistent over the past five years, with drug testing more prevalent among
larger employers. The number of SAMHSA (Substance Abuse Mental Health Services
Administration)-certified laboratory service providers has declined in recent
years, providing opportunities for the remaining industry
participants.
Drugs-of-abuse
testing remains predominately laboratory-based. However, we do offer
on-site drug testing devices through our Product Sales segment. Our
sale of on-site drug testing devices supports our Laboratory Services business
as confirmation testing, logistics, data and program management services are
often sold along with on-site testing devices.
Our
customers for substance abuse testing include public and private companies, as
well as service firms; such as, drug treatment counseling centers, criminal
justice facilities, occupational health clinics, third party administrators and
hospitals.
B. Clinical & Other Laboratory
Services. As reflected in the table below, our
Laboratory Services segment also derives revenues from other services,
including: clinical toxicology; heavy metal, trace element and solvent analyses;
pain management; physician office-based clinical testing; and logistics, data
and program management services.
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
Clinical
& Other Laboratory Services revenues
|
$ | 22,885 | $ | 19,306 | $ | 18,099 | ||||||
%
of Laboratory Services revenues
|
35 | % | 29 | % | 30 | % |
The
services we provide within the clinical laboratory industry market enable us to
leverage our core competencies and expertise.
Clinical
Toxicology. We have a fully certified clinical toxicology
reference laboratory specializing in esoteric therapeutic drug monitoring and
emergency toxicology. Esoteric tests are more sophisticated tests
used to obtain information not provided by routine tests and generally involve a
higher level of complexity and more substantial human involvement than routine
tests. The tests performed in the clinical laboratory are conducted
using methodologies such as various immunoassays (a test that uses binding of
antibodies to antigens to identify and measure certain substances), gas liquid
chromatography, high performance liquid chromatography, gas chromatography/mass
spectrometry and tandem mass spectrometry. Chromatography is a
technique for separating, identifying and quantifying the individual chemical
components of substances based on the physical and chemical characteristics
specific to each component. Mass spectrometry is a technique for
analyzing the individual chemical components of substances by breaking molecules
into multiple electrically charged ions that are then sorted for analysis
according to their mass-to-charge ratios.
5
We
perform analytical testing for a wide variety of drug classes including:
analgesic, antianxiety, anticholinergic, anticoagulant, anticonvulsant,
antidepressant, antidiabetic, antiemetic, antihistamine, antiinflammatory,
antimicrobial, antipsychotic, bronchodilator, cardiovascular, stimulant,
decongestant, immunosuppressant, local anesthetic, muscle relaxant, narcotic
analgesic and sedative medications. Clients for our clinical
toxicology services consist of hospitals, clinics and other
laboratories.
Clinical Testing for Occupational
Health Clinics. We perform basic clinical testing for our
occupational clinic clients that send us drug testing samples. The
most common clinical testing includes blood chemistries, complete blood cell
counts, lead/zinc protoporphyrin (ZPP) testing, urinalysis and lipid
panels.
Clinical Testing for Physician
Offices. We offer laboratory tests used by physicians and
other healthcare providers for the purpose of diagnosing or treating disease or
illness or the assessment of health in humans. Testing is performed
on blood, body fluids or tissues. Our comprehensive clinical
laboratory services include clinical chemistry, hematology, coagulation,
urinalysis, immunology/serology (viruses, infectious diseases, immune system),
immunohematology (blood typing, antibody screens), microbiology (bacteria,
parasites), anatomical pathology/cytology (tissue biopsies, cancer) molecular
diagnostics (infectious diseases, genetic disorders) and sub-specialties of
these categories.
Heavy Metal, Trace Element and
Solvent Analyses. We operate a laboratory in which blood and
urine are tested for heavy metals (for example, lead), trace elements and
solvents. Our clients for these services are other laboratories,
occupational health clinics, companies that are required to comply with OSHA
(Occupational Safety and Health Administration) guidelines for monitoring
occupational exposure to hazardous materials, and pediatricians who test
children for exposure to lead. Current Centers for Medicare and Medicaid
Services policy requires a screening blood lead test for all Medicaid-eligible
children at 12 and 24 months of age. In addition, children over the
age of 24 months, up to 72 months of age, should receive a lead screening test
if there is no record of a previous test.
Pain Management. In
2009, we continued to expand our Pain Management product line. In the
past, we provided toxicology testing for local hospital-based pain management
groups. In the past few years, there has been a rapidly growing
number of pain management clinics throughout the United States. We
now offer a comprehensive testing program serving this market under the name
ToxAssure®.
Logistics, Data and Program
Management Services. MEDTOX also provides services in the
areas of logistics management, data management and program
management. These services support our underlying business of
laboratory analysis and provide added value to our
clients. Value-added services include courier services for medical
specimen transportation, management programs for laboratory-based and on-site
drug testing, coordination of specimen collection sites, and data
collection/reporting services including the use of our WEBTOX®
internet-based reporting system. In the data management area we have
eChain®, our
web-based electronic chain-of-custody and donor tracking system.
C. Clinical Trial
Services. We provide central laboratory services, assay (test)
development, bio-analytical, bio-equivalence and pharmacokinetic testing (a
process by which a drug is absorbed, distributed, metabolized and eliminated by
the body) for Phase I-IV clinical trials. Phase I clinical trials
focus primarily on testing the safety of the drug and involve generally only a
small number of patients. In Phase II trials, the results of people
taking a new treatment are compared with results of people taking standard
treatment or a placebo. A Phase II trial typically involves hundreds
of patients. A Phase III trial involves several thousands of patients
and is designed to further evaluate the efficacy and safety of the
drug. Phase IV clinical trials involve further evaluation of the
study drug generally after the drug is already approved and in the market
place. Central laboratory services include tests that are used to
monitor the safety and efficacy of a drug. These tests or “safety
labs” include tests that are performed in our general clinical laboratory and
pathology laboratory such as clinical chemistries (liver function, kidney
function, cardiac and bone), hematology (blood count), immunology (immune
status), and flow cytometry (cell identification). Assay development,
bio-analytical and bio-equivalence studies are performed in our bio-analytical
laboratory. These tests are conducted using methodologies such as
immunoassay, gas chromatography, high performance liquid chromatography, gas
chromatography/mass spectrometry and tandem mass spectrometry. MEDTOX
Laboratories is a FDA registered establishment and adheres to applicable GLP
(Good Laboratory Practices) requirements.
6
Clients
for our clinical testing services include clinical trial sponsors
(pharmaceutical and biotech companies), clinical research organizations (CROs),
research organizations, and investigators with trial management, patient
recruitment/enrollment and site management.
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
Clinical
Trial Services revenues
|
$ | 6,926 | $ | 6,800 | $ | 4,538 | ||||||
%
of Laboratory Services revenues
|
10 | % | 10 | % | 7 | % |
Clinical trial services revenues can
fluctuate from quarter-to-quarter based on the project nature, size, and the
actual timing of clinical trials as shown in the table below:
First
|
Second
|
Third
|
Fourth
|
|||||||||||||
(In
thousands)
|
Quarter
|
Quarter
|
Quarter
|
Quarter
|
||||||||||||
Clinical
Trial Services revenues:
|
||||||||||||||||
2009
|
$ | 2,315 | $ | 1,592 | $ | 2,000 | $ | 1,019 | ||||||||
2008
|
1,260 | 1,463 | 1,935 | 2,142 |
Product Sales
A. Substance Abuse Testing Products.
The table below reflects information regarding the revenues derived by
our Product Sales segment during the last three years from the sale of
point-of-collection testing (POCT) products for drugs-of-abuse, the primary
component of Product Sales segment revenues.
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
POCT
product revenues
|
$ | 16,431 | $ | 17,787 | $ | 16,632 | ||||||
%
of Product Sales revenues
|
90 | % | 91 | % | 88 | % |
The
primary markets for our POCT products for drugs-of-abuse are workplace
drugs-of-abuse testing and testing in support of hospital emergency departments,
the criminal justice system and rehabilitation centers. We
manufacture and distribute our PROFILE®-II,
PROFILE®-II A,
PROFILE®-III, and
PROFILE®-III A
POCT products into this market. These products are often sold in
conjunction with confirmation testing, logistic, data management, and program
management services provided by our Laboratory Services segment. Our
customers for substance abuse testing products include public and private
companies, as well as occupational health clinics and third party
administrators.
7
Drug
abuse is frequently a factor in emergency room treatment of patients. We
manufacture and distribute the PROFILE-II ER® and
PROFILE®-III
ER, and PROFILE®-IV
line of diagnostic drug screening products to hospital markets for drug
detection in patients seen in the hospital and emergency rooms. The
PROFILE-II ER®,
PROFILE®-III
ER, PROFILE -IV
and PROFILE®-V
devices are Food and Drug Administration (FDA)-cleared one step qualitative
screening assays for the detection of the following drugs and/or their
metabolites (any substance produced by metabolism):
·
|
amphetamines
|
·
|
methamphetamines/methylenedioxymethyl
amphetamine (ecstasy, speed,
crystal)
|
·
|
barbiturates
(Phenobarbital)
|
·
|
benzodiazepines
(Valium, Librium, Halcion)
|
·
|
cannabinoids/THC
(pot, marijuana)
|
·
|
cocaine
(crack)
|
·
|
methadone
(Methadose)
|
·
|
opiates
(heroin)
|
·
|
oxycodone
|
·
|
phencyclidine/PCP
(angel dust)
|
·
|
propoxyphene
(Darvon)
|
·
|
tricyclic
antidepressants
|
We also
market the MEDTOXScan®
Reader, an electronic reader, for use with our new PROFILE®-V
device in hospital laboratories and emergency rooms.
We also
manufacture and distribute diagnostic drug screening products within the
criminal justice and drug rehabilitation markets. Our VERDICT®-II
and SURE-SCREEN®
product lines are primarily sold within these markets and are sold alone or as
part of our comprehensive drug testing program solution, ClearCourse®. ClearCourse® is a
unique and comprehensive drug testing program that combines four essential
components: Drug Abuse Recognition System (DARS™) training, SURE-SCREEN®
on-site drug screening devices, laboratory based confirmation testing and
WEBTOX®
online data management.
SURE-SCREEN® is a
diagnostic device utilizing lower drug cut-off levels that assists criminal
justice agencies in their "no drug use" mandate and supports efforts at early
intervention. The chart below shows the specific cut-offs for the
SURE-SCREEN®
device as compared to the traditional National Institute of Drug Abuse (NIDA)
cut-offs:
Drug
|
Screening
Cut-Off
|
|
Traditional
|
SURE-SCREEN®
|
|
Amphetamine
|
1000
ng/ml
|
300
ng/ml
|
Methamphetamine
|
1000
ng/ml
|
300
ng/ml
|
Benzoylecgonine
|
300
ng/ml
|
100
ng/ml
|
Morphine
|
NA
|
100
ng/ml
|
Methadone
|
NA
|
200
ng/ml
|
Phencyclidine
|
25
ng/ml
|
25
ng/ml
|
Benzodiazepines
|
NA
|
200
ng/ml
|
Cannabinoids
|
50
ng/ml
|
40
ng/ml
|
B. Contract Manufacturing Services and
Other Diagnostic Products. In addition to the sale of POCT products for
drugs-of-abuse, our Product Sales segment derives revenues from the manufacture
of coagulation (blood clotting) market controls for various
customers. We anticipate that our activity relative to manufacturing
and sales of coagulation controls will decline and we are phasing out contract
manufacturing services. We also distribute other diagnostic tests,
including diagnostic tests for the detection of alcohol with the EZ-SCREEN®
Breath Alcohol Test. The table below reflects information regarding
the revenues derived by our Product Sales segment from contract manufacturing
services and the distribution of other diagnostic products.
8
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
Contract
manufacturing services revenues
|
$ | 1,391 | $ | 1,469 | $ | 1,437 | ||||||
%
of Product Sales revenues
|
8 | % | 7 | % | 7 | % | ||||||
Other
diagnostic products revenues
|
$ | 435 | $ | 430 | $ | 906 | ||||||
%
of Product Sales revenues
|
2 | % | 2 | % | 5 | % |
3. Marketing and
Sales.
We
believe that the combined operations of the Laboratory Services business and the
on-site test kits manufactured by the Product Sales segment have created synergy
in the marketing of comprehensive, on-site and laboratory testing programs to a
common customer base. We are in a position to offer a full line of products and
services for the substance abuse testing and occupational medicine marketplace,
including (1) on-site tests for the detection of drugs-of-abuse; (2) SAMHSA
(Substance Abuse Mental Health Services Administration) certified laboratory
testing (screening and confirmation); (3) biological monitoring of occupational
toxins; (4) consultation; and (5) logistics, data management and program
management services.
We have
expanded our sales effort in the pharmaceutical market by offering testing
services for Phase I-IV clinical trials and working with sponsors and CROs on
assay development and bio-analytical and pharmacokinetic studies. In
addition, we have begun to market clinical diagnostic testing services to
clinics, hospitals and physician offices on a regional basis.
We use
several distribution channels to sell our products and services. We
employ a direct sales force which consists of 47 sales representatives and four
sales managers. In addition, we are a party to a distribution agreement
with Cardinal Health for our PROFILE®
products sold into the hospital laboratory market. We also benefit
from sales efforts on our behalf conducted by third party administrator
organizations and occupational health clinic groups.
We have a
strategic relationship in the area of pediatric lead testing with Sustainable
Resource Center (SRC), a not-for-profit organization dedicated to the
eradication of lead exposure in homes within the United States. We
provide monthly funding of approximately $1,250 to SRC which is primarily
utilized for educational purposes.
We have
developed strategic sales plans for each of the primary markets
served. These plans include the utilization of supporting materials
for advertising and direct marketing efforts, lead generation activities and
attending pertinent industry tradeshows.
Major Customers. No
single customer had sales that amounted to more than 10% of our consolidated
revenues during 2009, 2008 or 2007.
4. New Products, Research and
Development.
Laboratory
Services. Our Laboratory Services’
research and development group develops: assays for new drugs and compounds; new
assays for existing drugs and other toxins; and improves existing assays with
the goal of improving assay robustness, sensitivity, accuracy, precision,
specificity and efficiency. This group also investigates and develops
assays for commonly tested compounds in alternative matrices and novel
formats. During 2009, this group developed and validated
approximately 45 new laboratory-based assays using immunochemistry, liquid
chromatography (LC), gas chromatography (GC), gas chromatography with mass
spectrometry (GC/MS), inductively coupled plasma mass spectrometry (ICP/MS), and
LC with tandem mass spectrometry (LC/MS/MS). These activities
continue to enhance our test menu and ability to realize efficiencies of new
technologies.
9
We have
made efforts to enter the market for full service clinical laboratory testing
for physicians offices and patients on a regional basis. As mentioned
in prior reports, we added to our test menu in clinical chemistry and diagnostic
immunology (immune system) virology (viruses), endocrinology (hormones),
serology (infectious diseases) and allergy. We added staffing, state
of the art instrumentation and laboratory build out for full service
pathology/histology/cytology, molecular diagnostics and microbiology. These new
specialties include tests for infectious diseases, viruses, tissue biopsies,
cancer, genetic disorders, bacteria and parasites. Based on our
local presence, company-owned courier network and advanced instrumentation and
technology, we believe we will be able to offer superior turn- around times for
physicians and patients than our national competitors.
Product Sales. We
continue to develop new and innovative products and services for the drug
testing market. We are continually improving our product performance,
result hold time (length of time the result is readable on the device) and cost
effectiveness in order to meet the evolving demands of the
marketplace.
In 2009,
we continued improvement in our manufacturing processes in the diagnostic area,
resulting in greater flexibility of product configurations for clients,
increased efficiency in manufacturing and improved device
performance. We can now offer a higher degree of customization to our
clients, both in terms of specific assays on a particular device, and supplying
a “private label” device to large clients.
In 2009,
we continued to see growth of our PROFILE®-III
cup products. These products test for THC, cocaine, opiates,
amphetamine, methamphetamine and PCP at standard SAMHSA sensitivity levels, and
benzodiazepines, barbiturates, methadone, tricyclic antidepressants and
propoxyphene at standard industry levels. The PROFILE®-III
cup is targeted for the corporate and occupational health clinic
markets. The use of a cup format in these markets is advantageous due
to the elimination of the standard pipette (laboratory instrument used to
transport a measured quantity of liquid) used in a cassette
device. The cup format provides an enclosed system where the testing
personnel are not exposed to the urine sample. The PROFILE®-III
cup design adds simplicity and time savings to the drug screening
process.
Research and
Development. We incurred costs of $2.3 million, $2.4 million,
and $2.6 million for research and development activities in 2009, 2008, and
2007, respectively. At December 31, 2009, we employed 14 scientists
in research and development activities for the Laboratory Services and Product
Sales segments. Their primary duties are focused on new methods and assay
development for Laboratory Services and developing on-site, rapid in vitro
diagnostic devices at the Product Sales facility.
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5.
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Raw
Materials.
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Laboratory
Services. The raw materials required by the laboratory for
urine drug testing consist primarily of two types: specimen collection supplies
and reagents for laboratory analysis. The collection supplies include
drug testing custody and control forms that identify the specimen and the
client, as well as document the chain-of-custody. Collection supplies
also consist of specimen bottles and shipping supplies. Reagents for
drug testing are primarily immunoassay screening products and various chemicals
used for confirmation testing. We believe all of these materials are
available at competitive prices from numerous suppliers.
Product Sales. The
primary raw materials required for the immunoassay-based test kits produced by
us consist of antibodies, antigens and other reagents, plastic molded devices,
wicking materials, filter materials, absorbent materials and packaging
materials. We maintain an inventory of raw materials which, to date,
has been acquired primarily from third parties. Currently, most raw
materials are available from several sources. The molds and tooling
for plastic-molded components are owned by us, which provides supply chain
management flexibility. We possess the technical capability to
produce our own antibodies and antigens and have initiated production of
antibodies and antigens for certain tests. Antibodies are part of the
immune system and are proteins which are produced by white blood
cells. Their task is to circulate in the body and to attach
themselves to any foreign particles (antigen) which they may come
across. If we were to change certain raw materials used in a specific
test, additional development, validation and accompanying costs may be required
to adapt the alternate material to the specific diagnostic test.
10
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6.
|
Patents, Trademarks,
Licensing and Other Proprietary
Information.
|
Laboratory
Services. We believe that the basic technologies requisite to
the production of antibodies are in the public domain and are not
patentable. We rely upon trade secret protection of certain
proprietary information, rather than patents, where we believe disclosure could
cause us to be vulnerable to competitors that could successfully replicate our
techniques and processes.
Product Sales. We file patent
applications to protect our intellectual property as it relates to our
technologies, inventions and improvements which can be utilized in the
development and manufacture of our Product Sales business, as protection of this
intellectual property is very important to our Product Sales
segment. These patents relate to our core technologies and designs
for diagnostic testing, screening and services. We hold eight United
States issued patents with expiration dates ranging from 2010 to
2025.
General. At
December 31, 2009, we held 26 registered trade names and/or trademarks in
reference to our products and corporate names. Our trade names and/or
trademarks range in duration from 10 to 20 years with expiration dates ranging
from 2012 to 2019. Applications have also been made for additional
trade names.
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7.
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Seasonality.
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Laboratory
Services. We believe that the laboratory testing business is
subject to seasonal fluctuations in pre-employment screening. These
seasonal fluctuations include reduced volume in the year-end holiday periods and
other major holidays. In addition, inclement weather may have a
negative impact on volume thereby reducing revenues and cash flow.
Product Sales. We do not
believe that seasonality is a significant factor in the sale of our on-site
immunoassay testing devices.
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8.
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Backlog.
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Laboratory
Services. At December 31, 2009, MEDTOX Laboratories, Inc. did
not have any significant backlog. We do not believe that sales
backlog is a significant factor in the Laboratory Services segment of our
business. However, the time from when an account becomes a client to
the time the laboratory starts receiving specimens may be up to four
months. The delay in receiving samples is primarily due to the
necessity of establishing communication capabilities between the client and us,
the requirement to ship out collection kits and forms, and the establishment of
a collection site network. At December 31, 2009, we had several
accounts that were in the process of being set up where revenues will not be
realized until 2010.
Product Sales. At
December 31, 2009, MEDTOX Diagnostics, Inc. did not have any significant
backlog. We do not believe that sales backlog is a significant factor
in the Product Sales segment of our business.
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9.
|
Competition.
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Laboratory
Services. Our Laboratory Services segment competes in a
fragmented, though highly competitive, industry. At December 31,
2009, 39 labs, including MEDTOX Laboratories, Inc., were certified by the
Department of Health and Human Services as having met the standards for Subpart
C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR
29916, 29925) and were involved in workplace drugs-of-abuse
testing. Without ongoing certification in this program, a laboratory
would not be permitted to conduct drug testing for Federal Workplace Drug
Testing Programs such as testing for the Department of Transportation and other
similar programs. Competitors include Quest Diagnostics and
Laboratory Corporation of America, as well as the testing units of other
clinical laboratories, including independent laboratories, specialized
laboratories and in-house testing facilities maintained by
hospitals.
11
Our
Laboratory Services segment competes on the basis of the reliability and
accuracy of its test results, price structure, service, transportation and
collection network, and the ability to establish relationships with hospitals,
physicians and users of drug abuse testing programs. Many of the
segment’s competitors and potential competitors have substantially greater
financial and other resources than we do.
The
laboratory services drugs-of-abuse industry is consolidating. The
consolidation is being driven by customers’ desires to minimize the number of
laboratories they work with, the need for operating efficiencies in the form of
critical mass (testing volumes), required investment levels and government
regulation. In light of these forces, we face an increasing challenge
to differentiate ourselves through our technology and value-added services, such
as data management, collection site management, training and technical support
and expertise. Our ability to successfully compete in the future and
maintain our margins will be based on our ability to maintain our quality and
customer service while maintaining efficiencies and low cost
operations.
Product Sales. Many
large companies with greater research and development, marketing, financial and
other capabilities, as well as smaller research firms, are engaged in research,
development and marketing of diagnostic assays for application in the areas for
which we produce our products.
The
diagnostics market has become highly competitive with respect to the price,
quality and ease of use of various tests, and is characterized by rapid
technological changes. We have designed our diagnostic screening
products to be inexpensive, on-site tests for use by unskilled personnel, and
have not endeavored to compete with laboratory-based systems. These
laboratory-based systems consist of bench-top auto analyzers that have fast,
automated throughput. Our POCT devices are not designed to compete
with such automated systems.
The
recent downturn in the economy has led to increased price competition for
certain diagnostic testing devices. Competitors of this nature
include Phamatech, Princeton BioMeditech, American Bio Medica, ABI, Abbott
Laboratories, and Inverness Medical Innovations.
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10.
|
Government
Regulation.
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Our
products and services are subject to the regulations of a number of governmental
agencies as listed below. We believe we are currently in compliance
with all applicable regulations. We cannot predict whether future
changes in governmental regulations might significantly increase compliance
costs or adversely affect the time or cost required to develop and introduce new
products.
A. Substance Abuse and Mental
Health Services Administration (SAMHSA). MEDTOX Laboratories, Inc. has
been certified by SAMHSA since 1988. SAMHSA certifies laboratories
meeting strict standards under Subpart C of the Mandatory Guidelines for Federal
Workplace Drug Testing Programs. Continued certification is
accomplished through periodic inspection by SAMHSA to assure compliance with
applicable regulations. Without ongoing certification in this
program, our laboratory would not be permitted to conduct drug testing for
Federal Workplace Drug Testing Programs such as testing for the Department of
Transportation and other similar programs. Testing performed under the SAMHSA
program comprises 25% to 30% of our workplace drug testing customer
base.
B. Food and Drug Administration
(FDA). Certain tests for human diagnostic purposes must be
cleared by the FDA prior to their marketing for in vitro diagnostic use in the
United States. In vitro diagnostic products are those reagents,
instruments and systems intended for use in diagnosis of disease or other
conditions, including a determination of the state of health, in order to cure,
mitigate, treat or prevent disease or its complications. Such
products are intended for use in the collection, preparation and examination of
specimens taken from the human body. The FDA provides clear guidance
that in vitro diagnostic devices used for workplace drug testing must be cleared
by the FDA prior to being marketed. The FDA-regulated products we
produce are in vitro diagnostic products subject to FDA clearance through the
Federal Food, Drug and Cosmetic Act, Section 510(k) process, which requires the
submission of information and data to the FDA that demonstrates that the device
to be marketed is substantially equivalent to a currently marketed
device. This data is generated by performing clinical studies
comparing the results obtained using our device to those obtained using an
existing test product. Although no maximum statutory response time
has been set for review of a 510(k) submission, as a matter of policy the FDA
has attempted to complete review of 510(k) submissions within 90
days. To date, we have received 510(k) clearance for 22 different
products. Products subject to 510(k) regulations may not be marketed
for in vitro diagnostic use until the FDA issues a letter stating that a finding
of substantial equivalence has been made.
12
As a registered manufacturer of
FDA-regulated products, we are subject to a variety of FDA regulations including
the Good Manufacturing Practices (GMP) regulations, which define the conditions
under which FDA regulated products are to be produced. These
regulations are enforced by the FDA and failure to comply with GMP or other FDA
regulations can result in the delay of pre-market product reviews, fines, civil
penalties, recalls, seizures, injunctions and/or criminal
prosecution. With the exception of the forensic market, FDA clearance
of our diagnostic products is required by our clients and regulatory
agencies.
As an
accredited laboratory performing testing for clinical trials, our laboratory is
subject to FDA regulations including Good Laboratory Practices (GLP) and related
requirements.
C. Drug Enforcement
Administration (DEA). Our primary business involves either
testing for drugs-of-abuse or developing test kits for the detection of
drugs/drug metabolites in urine. MEDTOX Laboratories, Inc. is
registered with the DEA to conduct chemical analyses with controlled
substances. The MEDTOX Diagnostics, Inc. facility in Burlington,
North Carolina is registered by the DEA to manufacture and distribute controlled
substances and to conduct research with controlled
substances. Maintenance of these registrations requires that we
comply with applicable DEA regulations.
D. Canadian Medical Devices
Conformity Assessment System (CMDCAS). MEDTOX Diagnostics, Inc. maintains
a quality system which satisfies the requirements for ensuring the safety and
effectiveness of our products and meeting the customer needs in accordance with
FDA requirements as described in 21 CFR Part 820 (Quality Systems), and that
satisfies the requirements of the Canadian Medical Devices Regulations (CMDR)
and CAN/CSA ISO 13485:1998 and ISO 9001:2003. Our product sales to
Canada are immaterial to our overall operations.
CMDCAS addresses the quality
system requirements found in the CMDR. To sell a medical device in Canada,
manufacturers must meet the regulatory requirements as defined in the CMDR. The
quality system implemented by the manufacturer for design and manufacture of
medical devices must satisfy the quality system requirements of ISO 13485 and
the manufacturer is required to have its quality system registered by an
approved CMDCAS registrar. A CMDCAS approved registrar audits the manufacturer’s
quality system to ISO 13485:1998 and ISO 9001:2003. MEDTOX Diagnostics, Inc.
maintains a quality system fulfilling the requirements of EN ISO 13485 and
CMDCAS ISO 13485, Quality Systems – Medical Devices and ISO 9001:2000 — Quality
Management Systems – Requirements. MEDTOX Diagnostics, Inc. has been issued the
TUV Rheinland Product Safety GmbH quality system certificate to EN ISO
13485:2000 and the TUV Rheinland of North America Inc. quality system
certificate to ISO 13485 under CMDCAS.
E. Centers for Medicare and
Medicaid Services (CMS). The Clinical Laboratory Improvement
Act (CLIA) introduced in 1992 requires that all in vitro diagnostic products be
categorized as to level of complexity. A request for CLIA
categorization of any new clinical laboratory test system must be made
simultaneously with FDA 510(k) submission. The PROFILE®,
PROFILE®-II,
PROFILE®-III,
PROFILE®-IV,
PROFILE®-V,
VERDICT®,
VERDICT®-II
and MEDTOXScan®
drugs-of-abuse tests currently marketed by MEDTOX Diagnostics, Inc. have been
categorized as moderately complex. The complexity category to which a
clinical laboratory test system is assigned may limit the number of laboratories
qualified to use the test system, thus impacting product
sales. MEDTOX Laboratories, Inc. is a CLIA-licensed high complexity
laboratory and is accredited by the College of American Pathologists (CAP)
Laboratory Accreditation Program. All laboratory specialties and
sub-specialties, as they relate to the expanded laboratory test menu, have been
added to MEDTOX Laboratories, Inc.’s CLIA/CAP certificates.
13
F. Health Insurance Portability
and Accountability Act (HIPAA). MEDTOX Laboratories, Inc. is
committed to safeguarding the privacy and confidentiality of its patients’
protected health information. Our policy is to be in compliance with
the requirements of federal and Minnesota state law related to protecting the
privacy of health information, including the Standards for Privacy of
Individually Identifiable Health Information (45 CFR, Parts 160 and 164 -
commonly called the “HIPAA Final Privacy Rule”). MEDTOX Laboratories,
Inc. complies with out-of-state regulations as applicable. MEDTOX
Laboratories, Inc. has compiled several policies and procedures that outline the
steps that are taken to ensure compliance with the HIPAA privacy standards and
Minnesota state laws related to protected health information. All
employees receive appropriate training on these policies and procedures, and it
is the responsibility of each individual to follow the policies and procedures
in the performance of their jobs. The “Notice of Privacy Practices”
and “HIPAA Privacy Policy” for MEDTOX Laboratories, Inc. are posted on our
website (www.medtox.com).
G. Additional Laboratory
Regulations. MEDTOX Laboratories, Inc. and certain of its
laboratory personnel are licensed or otherwise regulated by certain federal
agencies, states and localities in which it conducts
business. Federal, state and local laws and regulations require
MEDTOX Laboratories, Inc., among other things, to meet standards governing the
qualifications of laboratory owners and personnel, as well as the maintenance of
proper records, facilities, equipment, test materials and quality control
programs. In addition, the laboratories are subject to a number of
other federal, state and local requirements that provide for inspection of
laboratory facilities and participation in proficiency testing, as well as
govern the transportation, packaging and labeling of specimens
tested. The laboratories are also subject to laws and regulations
prohibiting the unlawful rebate of fees and limiting the manner in which
business may be solicited.
Our laboratory located in St. Paul,
Minnesota receives and uses small quantities of hazardous chemicals and
radioactive materials in its operations and is licensed to handle and dispose of
such chemicals and materials. We comply with all federal, state and
local regulations regarding the safe handling, storage and disposal of such
chemicals and materials. Employees working with chemicals are trained
initially regarding safe practices, procedures and policies and also participate
in annual safety reviews. Periodic inspections by laboratory
accrediting agencies and local authorities assure adherence to safe practices
and compliance with applicable regulations.
11. Product and Professional
Liability.
Laboratory
Services. Our laboratory testing services are primarily
diagnostic and expose us to the risk of liability claims. Our
laboratories have maintained continuous professional and general liability
insurance since 1984. The insurance policy covers those amounts we
are legally obligated to pay for damages resulting from a medical incident,
which arises out of a failure to render professional services. To
date, we have not paid any material amounts for claims of this type and no
material professional service claims are currently pending.
Product
Sales. Manufacturing and marketing of products by us entails a
risk of product liability claims. Since 1993, we have maintained
insurance coverage against the risk of product liability arising out of events
after such date. As of the date of filing this Annual Report on Form 10-K, no
product liability claims are pending.
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12.
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Employees.
|
At
December 31, 2009, we had a total of 621 full-time employee equivalents compared
to 582 full-time employee equivalents at December 31, 2008.
Our
employees are not covered by any collective bargaining agreements and we have
not experienced any work stoppages. We believe that we maintain good relations
with our employees.
13.
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Available
Information.
|
We make
available free of charge on or through our website (www.medtox.com) our
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K, and, if applicable, amendments to those reports filed or furnished
pursuant to Section 13(a) of the Exchange Act as soon as reasonably practicable
after we electronically file such material with, or furnish it to, the U.S.
Securities and Exchange Commission.
14
ITEM
1A. RISK
FACTORS.
A
substantial portion of our revenue is derived from the provision of testing
services for the identification of drugs-of-abuse in the workplace and
government markets, a business that is influenced by general economic
conditions. As such, our operating results are subject to
volatility.
In 2009, approximately 55% and 64% of
our Laboratory Services and Product Sales segment’s revenues, respectively, were
derived from the provision of testing services for the identification of
drugs-of-abuse in the workplace and government markets. We expect
that a substantial percentage of our revenues will continue to be derived from
the provision of such services for the foreseeable future. This
business is influenced by the strength of the U.S. economy. When the
U.S. economy is growing and characterized by job creation, this business tends
to experience increased testing levels. Conversely, lower testing
levels tend to be associated with periods of job contraction in the
U.S. As a result, our revenues and operating results are subject to
volatility.
The
laboratory services drugs-of-abuse industry is consolidating. With
the market forces driving such consolidation tending to favor the larger
industry participants, we face an increasing challenge to differentiate
ourselves through our technology and value-added services.
Our Laboratory Services segment
competes in what is currently a fragmented, but highly competitive,
industry. At December 31, 2009, 39 labs, including MEDTOX
Laboratories, Inc., were certified by the Department of Health and Human
Services as having met the standards for Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing Programs and were involved in workplace
drugs-of-abuse testing. Our major competitors include Quest Diagnostics,
Laboratory Corporation of America as well as the testing units of other clinical
laboratories, including independent laboratories, specialized laboratories, and
in-house testing facilities maintained by hospitals. Many of our
competitors have substantially greater financial and other resources than we
do. The laboratory services, drugs-of-abuse industry is
consolidating. The consolidation is being driven by the larger
laboratories whose greater resources enable them to be more responsive and
better able to increase operating efficiencies in the form of critical mass
(testing volumes) and required investment levels. In
light of these forces, we face an increasing challenge to differentiate
ourselves through our technology and value-added services, such as data
management, collection site management, training and technical support and
expertise. If we are unsuccessful in these differentiation efforts,
we may experience declining revenues and gross margins, and reduced cash
flows.
We
are experiencing increased competition in our Product Sales business
segment. Such competition may have a negative effect on our business
and future financial prospects.
We are experiencing increased
competition, including increased price competition, in our Product Sales
business segment. We have experienced increased competition with
respect to our immunoassay tests from systems and products developed by others,
many of whom compete solely on price. As the number of firms
marketing diagnostic tests has grown, we have experienced increased price
competition for certain diagnostic testing devices, particularly in the
probation, parole and rehabilitation market. A further increase in
competition may reduce our ability to compete in the diagnostic market and have
a negative effect on our financial results and future prospects.
Our
quarterly operating results may vary.
Clinical
trial services testing for the pharmaceutical industry is project-based, and as
such, may vary from quarter to quarter due to factors over which we have little
control such as the commencement, completion or cancellation of clinical trial
contracts and the progress of ongoing clinical trial contracts.
Such
variations may cause operating results to vary quarter to quarter,
negatively or positively affecting the market price of our common
stock. We believe that such variations in any particular quarter are
not necessarily a meaningful indication of future results and that these
fluctuations may not be related to our future overall operating
performance.
15
If
reimbursement for our services by third party payers is reduced, our net
revenues could diminish.
There has
been and will likely continue to be significant efforts by both federal and
state agencies to reduce costs in government healthcare programs and otherwise
implement government control of healthcare costs. In addition,
increasing emphasis on managed care in the U.S. may continue to put pressure on
the pricing of healthcare services. Third party payers, including
state payers and Medicare, are challenging the prices charged for medical
products and services. Government and other third party payers increasingly are
limiting both coverage and the level of reimbursement for our
services. In 2009 and 2008, third party payers accounted for
approximately 6.1% and 4.7%, respectively, of our net revenues. A
portion of the testing for which we bill our hospital and laboratory clients is
ultimately paid by third party payers. Any pricing pressure exerted
by these third party payers on our customers may, in turn, be exerted by our
customers on us. If government and other third party payers do not
provide adequate coverage and reimbursement for our services, our net revenues
could decline. If we cannot offset additional reductions in the payments we
receive for our services by reducing costs, increasing test volume and/or
introducing new procedures, our net revenues and profitability could
decline.
We
could face significant monetary damages and penalties and/or exclusion from the
Medicare and Medicaid programs if we violate health care anti-fraud and abuse
laws.
We are
subject to extensive government regulation at the federal, state and local
levels. Our failure to meet governmental requirements under these
regulations, including those relating to billing practices and relationships
with physicians and hospitals, could lead to civil and criminal penalties,
exclusion from participation in Medicare and Medicaid and possible prohibitions
or restrictions on the use of our laboratory. While we believe that
we conduct our operations and relationships with care in an effort to meet all
statutory and regulatory requirements, there is a risk that government
authorities might take a contrary position. Such occurrences,
regardless of their outcome, could damage our reputation and adversely affect
important business relationships we have with third parties.
If
we fail to keep up with technological advancements and fail to develop our
products, we may be at a competitive disadvantage and our products may become
less attractive or obsolete.
The
continuing changes in modern biotechnology could render our products or services
as unmarketable or obsolete. These changes come in the form of
technological innovation, changes in customer requirements, declining prices and
evolving industry requirements. Historically, our product and service
obsolescence has not had a material impact on our profitability. New
products and services, as well as new technology, may render existing technology
products and services obsolete, or too costly and unmarketable. If we
do not commit the resources necessary to develop and sell products incorporating
new technologies as demanded by our markets, our products and services may be
rendered obsolete, impacting our revenues and profitability. Even
with the development of new technologically advanced products and services, we
cannot assure you that they will gain market acceptance. Lack of
market acceptance for any of these products and services could reduce our
revenues and negatively affect our profitability.
Our business and products are subject
to stringent laws and regulations and if we are unable to comply, our business
may be significantly harmed.
Our
products and services are subject to the regulations of a number of governmental
agencies as listed in Item I, “Business” under the heading “10. Government
Regulation”. We cannot predict whether future changes in governmental
regulations might significantly increase compliance costs or adversely affect
the time or cost required to develop and introduce new products. In
addition, our products are or may become subject to foreign
regulations. If we do not comply with existing or additional laws or
regulations, or if we incur penalties, it could increase our expenses, prevent
us from increasing net revenues, or hinder our ability to conduct our
business.
16
Our
operations might be affected by the occurrence of a natural disaster or other
catastrophic event.
We depend
on our customers and our laboratory in St. Paul, Minnesota and the production
facilities in Burlington, North Carolina for the continued operation of our
business. Although we have contingency plans in effect for natural
disasters or other catastrophic events, these events could still disrupt our
operations or those of our customers, which could also affect
us. Even though we carry business interruption insurance policies and
typically have provisions in our contracts that protect us in certain events, we
might suffer losses as a result of business interruptions that exceed the
coverage available under our insurance policies or for which we do not have
coverage. Any natural disaster or catastrophic event affecting us or
our customers could have a significant negative impact on our operations and
financial performance.
We
may be exposed to liability claims.
We are
exposed to the risk of liability claims from our testing services and other
aspects of our business. We currently maintain insurance with
coverage up to $10 million for all of our entities to cover professional and
general liability claims. In the past, all professional and general
liability claims have been covered under our insurance
policy. However, in the future, we may be faced with litigation
claims which exceed our insurance coverage or are not covered under our
insurance policy, which could have a significant impact on our results of
operations and financial condition.
We
may have product liability exposure not covered by insurance.
We face
financial exposure to product liability claims if the use of our products
results in an improper diagnosis, bodily injury or property damage. Potential
product liability claims may exceed the amount of our insurance coverage or may
be excluded from coverage under the terms of our insurance policy. We
currently maintain insurance with coverage up to $2 million to cover such
product liability claims. To the extent any such claim is uncovered
or our insurance coverage is inadequate, we could be required to pay any and all
costs associated with such claim, the cost of defense whatever the outcome of
the action, and possible settlement or damages if a court rendered a judgment in
favor of any plaintiff asserting such claim against us. Damages
assessed in connection with, and the costs of defending, any legal action could
be substantial. Damages may include punitive damages, which may
substantially exceed actual damages. The obligation to pay such
damages could exceed our ability to pay such damages, which could have a
significant impact on our results of operations and financial
condition.
We
rely on intellectual property, which we may not be able to protect fully or
effectively.
We rely
on a combination of patents, copyrights, trademarks, trade secret rights,
employee confidentiality agreements and non-disclosure agreements in order to
develop and protect our proprietary technology and
information. Notwithstanding our efforts to protect our proprietary
rights, existing trade secret, copyright, and trademark laws afford only limited
protection. Despite our efforts to protect our proprietary rights and
other intellectual property, unauthorized parties may attempt to copy aspects of
our products, obtain and use information that we regard as proprietary or
misappropriate our copyrights, trademarks, tradenames and similar proprietary
rights. Our means of protecting our proprietary rights may not be
adequate. In addition, our competitors might independently develop
similar technology or duplicate our products or circumvent any patents or our
other intellectual property rights.
The
technologies used in all of our diagnostic POCT products are covered by one or
more patents. As these patents expire over the next several years, we
will no longer have protection from competitors, unless we develop new
technology, which could impact our ability to compete in the biotechnology
industry and reduce our revenues.
17
If
our tests and business processes infringe on the intellectual property rights of
others, we could be forced to engage in costly litigation, pay substantial
damages or be prohibited from selling certain tests or products.
Other
companies or individuals, including our competitors, may obtain patents or other
property rights that would prevent, limit or interfere with our ability to
develop, perform or sell our tests or products or operate our
business. As a result, we may be involved in intellectual property
litigation and we may be found to infringe on the proprietary rights of others,
which could force us to do one or more of the following:
·
|
cease
developing, performing or selling tests of products that incorporate the
challenged intellectual property;
|
·
|
change
our business processes; or
|
·
|
pay
substantial damages, court costs and attorneys' fees, including
potentially increased damages for any infringement held to be
willful.
|
Patents
generally are not issued until several years after an application is filed. Our
performing a test or other activity prior to the issuance of a patent to a third
party is not a defense to an infringement claim. Thus, even tests or
products that we develop could become the subject of infringement claims if a
third party obtains a patent covering those tests or products.
Infringement
and other intellectual property claims, regardless of their merit, can be
expensive and time consuming to litigate. In addition, any
requirement to reengineer our tests or products or change our business processes
could substantially increase our costs, force us to interrupt product sales or
delay new test releases. In the past, we have not been subject to a
dispute regarding infringement of intellectual property of third
parties. However, infringement claims could arise in the future as
patents could be issued on tests or processes that we may be
performing.
Adverse
results in material litigation matters could have a material adverse effect upon
our business.
We may
become subject in the ordinary course of business to material legal action
related to, among other things, professional liability and employee-related
matters, as well as inquiries from governmental agencies and Medicare or
Medicaid carriers regarding billing issues. Legal actions could
result in substantial monetary damages as well as damage to our reputation with
customers, which could have a material adverse effect upon our
business.
If
we lose our key personnel or are unable to attract and retain qualified
personnel as necessary, our business could be harmed.
We are
dependent on the expertise and experience of our senior management team,
including Richard Braun, Chairman, President, and Chief Executive Officer; Kevin
Wiersma, Vice President, Chief Financial Officer and Chief Operating Officer of
MEDTOX Laboratories; James Schoonover, Vice President and Chief Marketing
Officer; B. Mitchell Owens, Vice President and Chief Operating Officer of MEDTOX
Diagnostics; and Susan Puskas, Vice President, Quality, Regulatory Affairs and
Human Resources, for our future success. Although we have employment
contracts with all members of our senior management team listed above, we do not
maintain any key man life insurance policies on any management
personnel. The loss of services of any of our key employees could
delay the development of our business and have a negative impact on our
operating results and financial condition.
18
The
current global financial crisis may have significant effects on our customers
that would result in material adverse effects on our business, operating
results, and stock price.
The
current global financial crisis, which has included, among other things,
significant reductions in available capital and liquidity from banks and other
providers of credit, substantial reductions and/or fluctuations in equity and
currency values worldwide, reduced sales of products and services, and concerns
that the worldwide economy may enter into a prolonged recessionary period, may
materially adversely affect our customers’ access to capital or willingness to
spend capital on our products and services, their levels of cash liquidity and
willingness to pay for products and services that they will order or have
already ordered from us, and/or their hiring and other employment-related
decisions. These potential effects of the current global financial
crisis are difficult to forecast and mitigate. As a consequence, our operating
results for a particular period are difficult to predict, and, therefore, prior
results are not necessarily indicative of results to be expected in future
periods. Any of the foregoing effects could have a material adverse effect on
our business, results of operations, and financial condition and could adversely
affect our stock price.
We
have goodwill and any future impairment of our goodwill could have a material
negative impact on our financial results.
We test
goodwill for impairment at least annually and potentially more frequently in
accordance with generally accepted accounting principles. Any
impairment of the value of goodwill will result in a charge against earnings
which could materially adversely affect our reported results of operations in
future periods.
ITEM
2. PROPERTIES.
The
administrative offices and laboratory operations for the Laboratory Services
segment of our business are located primarily in a 98,000 square foot facility
in St. Paul, Minnesota. Until March 2001, we leased this
space. In March 2001, we purchased the entire three building complex
with a total of 129,000 square feet, which includes the 98,000 square feet
utilized by our Laboratory Services segment and an additional 11,000 square feet
held for future expansion of our Laboratory Services segment. The
purchasing entity was New Brighton Business Center, LLC, a limited liability
company, established by us for the sole purpose of purchasing the entire three
building complex. The facility includes other commercial tenants that
have individual leases that range from ten years to less than one year in
duration. In 2009, the annual rent paid by such third-party tenants,
excluding their pro-rata share of operating expenses, was approximately
$150,000.
In
addition, effective September 2000, the Laboratory Services segment entered into
a seven year lease for a 30,000 square foot facility to be used in connection
with its courier business and also as additional warehouse and shipping
space. In May 2007, we amended this lease, effective August 31,
2007. The Amendment extends the term of the lease to August 31,
2012. This building is a special purpose facility and enables us to
store our vehicles indoors, when appropriate, and to perform routine maintenance
on the vehicles. The annual base rent on this second facility, exclusive of
operating expenses, is currently $152,000 per year.
The
operations for the Product Sales segment of our business are located in
Burlington, North Carolina where we maintain the offices, research and
development laboratories, production operations and warehouse for MEDTOX
Diagnostics, Inc. In March 2001, we entered into a 10-year lease of
the entire building (approximately 39,500 square feet) for an annual base rent
of $197,000, exclusive of operating expenses. In addition, under the
lease, $600,000 of tenant improvements made to the building by us are being
amortized over the life of the lease as additional rent. Effective
February 2003, we entered into a month-to-month lease for an additional 30,000
square feet of space located in an adjacent building. The additional
space is used for warehousing and distribution for a monthly base rent of
$9,400, exclusive of operating expenses. In November 2003, we amended
and restated these leases. Under the terms of the amended and
restated lease, the original leases have been combined and the expiration of the
amended and restated lease has been extended to March 31, 2016. In
January 2008, we prepaid approximately $430,000 of the lease agreement for the
facilities in Burlington, North Carolina relating to the leasehold improvements
after determining that the prepayment would be financially beneficial to the
Company. The prepayment was recorded as prepaid rent and will
continue to be amortized over the remaining life of the lease as additional
rent. In 2009, the annual base rent was approximately $401,000,
exclusive of operating expenses, and including a Consumer Price Index adjustment
and amortization of the $600,000 of improvements.
19
We
believe that our existing facilities are adequate for the purposes being used to
accommodate our product development, manufacturing and laboratory testing
requirements.
ITEM
3. LEGAL
PROCEEDINGS.
Not
applicable.
ITEM
4. SUBMISSION OF MATTERS TO A
VOTE OF SECURITY HOLDERS.
No matter was submitted to a vote of the security holders during the fourth quarter of the fiscal year covered by this report.
20
PART
II
ITEM
5.
|
MARKET FOR THE
REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY
SECURITIES.
|
Common
Stock
Our
common stock is listed on the Nasdaq Global Select Market under the symbol
“MTOX”. At February 18, 2010, the number of holders of record of our
common stock was 878. The following tables set forth, for the
calendar quarters indicated, the high, low, and closing prices per share for our
common stock, as reported by the Nasdaq Global Select Market. The
quotations shown represent inter dealer prices without adjustment for retail
markups, markdowns or commissions, and do not necessarily reflect actual
transactions.
2009:
|
High
|
Low
|
Close*
|
|||||||||
First
Quarter
|
$ | 8.20 | $ | 5.95 | $ | 6.66 | ||||||
Second
Quarter
|
10.30 | 5.98 | 9.43 | |||||||||
Third
Quarter
|
10.19 | 8.25 | 9.10 | |||||||||
Fourth
Quarter
|
10.25 | 7.30 | 7.75 |
2008:
|
High
|
Low
|
Close*
|
|||||||||
First
Quarter
|
$ | 18.65 | $ | 12.75 | $ | 13.19 | ||||||
Second
Quarter
|
16.98 | 11.52 | 13.85 | |||||||||
Third
Quarter
|
18.05 | 11.00 | 12.34 | |||||||||
Fourth
Quarter
|
14.03 | 7.50 | 8.22 |
*Closing
price as of the last day of the calendar quarter
Dividends
No cash
dividends have been declared or paid by the Board of Directors of the Company
since its inception and the Board of Directors of the Company has no plans to
pay a cash dividend in the foreseeable future. Our financial
covenants under our credit agreement may effectively preclude us from paying
cash dividends without approval.
Issuer
Purchases of Equity Securities
Not applicable.
21
ITEM
6. SELECTED FINANCIAL
DATA.
The
following selected financial data is derived from the consolidated financial
statements of the Company included elsewhere in this Annual Report on Form 10-K
and should be read in conjunction with such consolidated financial statements,
the related notes and other financial information included in this Annual Report
on Form 10-K.
(In
thousands, except share and per share data)
|
2009
|
2008
|
2007
|
2006
|
2005
|
|||||||||||||||
STATEMENT
OF OPERATIONS DATA:
|
||||||||||||||||||||
Revenues
|
$ | 84,108 | $ | 85,813 | $ | 80,285 | $ | 69,804 | $ | 63,047 | ||||||||||
Cost
of revenues
|
53,213 | 49,487 | 43,929 | 38,799 | 35,927 | |||||||||||||||
Selling,
general, and administrative
|
26,663 | 24,327 | 23,737 | 20,648 | 19,309 | |||||||||||||||
Research
and development
|
2,264 | 2,352 | 2,603 | 2,156 | 2,287 | |||||||||||||||
Other
income (expense)
|
79 | (991 | ) | (707 | ) | (1,006 | ) | (1,319 | ) | |||||||||||
Income
tax expense
|
748 | 3,084 | 2,619 | 2,647 | 887 | |||||||||||||||
Net
income
|
$ | 1,299 | $ | 5,572 | $ | 6,690 | $ | 4,548 | $ | 3,318 | ||||||||||
Basic
earnings per common share
|
$ | 0.15 | $ | 0.66 | $ | 0.80 | $ | 0.56 | $ | 0.43 | ||||||||||
Diluted
earnings per common share
|
$ | 0.15 | $ | 0.62 | $ | 0.75 | $ | 0.52 | $ | 0.40 | ||||||||||
Weighted
average number of shares outstanding:
|
||||||||||||||||||||
Basic
|
8,536,768 | 8,455,092 | 8,322,092 | 8,148,726 | 7,785,037 | |||||||||||||||
Diluted
|
8,788,663 | 8,938,213 | 8,907,320 | 8,802,470 | 8,199,650 | |||||||||||||||
BALANCE
SHEET DATA:
|
||||||||||||||||||||
Total
assets
|
$ | 76,117 | $ | 73,526 | $ | 69,949 | $ | 59,874 | $ | 59,390 | ||||||||||
Total
debt
|
302 | 979 | 1,656 | 2,732 | 6,329 | |||||||||||||||
Total
stockholders’ equity
|
61,432 | 60,465 | 55,656 | 47,944 | 44,845 | |||||||||||||||
SEGMENT
DATA:
|
||||||||||||||||||||
Net
revenues:
|
||||||||||||||||||||
Laboratory
Services
|
$ | 65,851 | $ | 66,127 | $ | 61,310 | $ | 54,045 | $ | 48,582 | ||||||||||
Product
Sales
|
18,257 | 19,686 | 18,975 | 15,759 | 14,465 | |||||||||||||||
Total
net revenues
|
$ | 84,108 | $ | 85,813 | $ | 80,285 | $ | 69,804 | $ | 63,047 | ||||||||||
Operating
income (loss):
|
||||||||||||||||||||
Laboratory
Services
|
$ | (1,037 | ) | $ | 5,364 | $ | 6,387 | $ | 6,139 | $ | 4,722 | |||||||||
Product
Sales
|
3,005 | 4,283 | 3,629 | 2,062 | 802 | |||||||||||||||
Total
operating income
|
$ | 1,968 | $ | 9,647 | $ | 10,016 | $ | 8,201 | $ | 5,524 | ||||||||||
Assets:
|
||||||||||||||||||||
Laboratory
Services
|
$ | 60,630 | $ | 59,812 | $ | 56,430 | $ | 47,259 | $ | 44,504 | ||||||||||
Product
Sales
|
11,884 | 10,102 | 8,701 | 6,737 | 6,775 | |||||||||||||||
Corporate
(unallocated)
|
3,603 | 3,612 | 4,818 | 5,878 | 8,111 | |||||||||||||||
Total
assets
|
$ | 76,117 | $ | 73,526 | $ | 69,949 | $ | 59,874 | $ | 59,390 | ||||||||||
22
ITEM
7.
|
MANAGEMENT'S
DISCUSSION AND ANALYSIS
|
|
OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS.
|
This
Annual Report on Form 10-K contains certain forward looking statements within
the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, which are intended to be covered by the safe
harbors created by such acts. For this purpose, any statements that
are not statements of historical fact may be deemed to be forward looking
statements, including the statements under this “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” regarding our
strategy, future operations, future expectations and future estimates, future
financial position or results and future plans and objectives of
management. Those statements in this Annual Report on Form 10-K
containing the words “believes”, “anticipates”, “plans”, “expects” and similar
expressions constitute forward looking statements, although not all forward
looking statements contain such identifying words.
The
forward looking statements contained in this Annual Report on Form 10-K are
based on our current expectations, assumptions, estimates and projections about
our Company and its businesses. All such forward looking statements
involve significant risks and uncertainties, including those risks identified in
Item 1A of this Annual Report on Form 10-K and in the Cautionary Statement
appearing at the beginning of Part I of this Annual Report on Form 10-K, many of
which are beyond our control. Although we believe that the
assumptions underlying our forward looking statements are reasonable, any of the
assumptions could prove inaccurate. Actual results may differ
materially from those indicated by the forward looking statements included in
this Annual Report on Form 10-K. In light of the significant
uncertainties inherent in the forward looking statements included in this Annual
Report on Form 10-K, you should not consider the inclusion of such information
as a representation by us or anyone else that we will achieve such
results. Moreover, we assume no obligation to update these forward
looking statements to reflect actual results or changes in assumptions,
expectations or projections, except as otherwise required by law. In
addition, our financial and performance outlook concerning future revenues,
margins, earnings, earnings per share and other operating or performance results
does not include the impact of any future acquisitions, future
acquisition-related expenses or accruals, or any future restructuring or other
charges that may occur from time-to-time due to management decisions and
changing business circumstances and conditions.
Executive
Overview
Our
Business
We are
engaged primarily in distinct, but very much related businesses, which for
financial reporting purposes are divided into two reportable segments:
Laboratory Services and Product Sales. For financial information relating to our
segments, see Note 2 of Notes to the Consolidated Financial
Statements.
Laboratory
Services
Our
“Laboratory Services” business segment includes the activities of our
wholly-owned subsidiary, MEDTOX Laboratories, Inc. MEDTOX
Laboratories, Inc. engages in drugs-of-abuse testing services, providing these
services to private and public companies, drug treatment counseling centers,
criminal justice facilities, occupational health clinics and hospitals, as well
as third party administrators.
MEDTOX
Laboratories, Inc. also provides clinical and other laboratory services which
consist of clinical toxicology, clinical testing for occupational health
clinics, and heavy metal, trace element and solvent analyses. We
provide these services to hospitals, clinics, HMOs and other
laboratories. Testing is conducted using methodologies that include
various immunoassays, gas liquid chromatography, gas chromatography/mass
spectrometry, and high performance liquid chromatography with tandem mass
spectrometry. We recently expanded our clinical & other
laboratory services to include laboratory tests used by physicians and other
healthcare providers for the purpose of diagnosing or treating disease or
illness or the assessment of health in humans. Testing is performed
on blood, body fluids or tissues. Our comprehensive clinical
laboratory services include clinical chemistry, hematology, coagulation,
urinalysis, immunology/serology (viruses, infectious diseases, immune system),
immunohematology (blood typing, antibody screens), microbiology (bacteria,
parasites), anatomical pathology/cytology (tissue biopsies, cancer), molecular
diagnostics (infectious diseases, genetic disorders) and sub-specialties of
these categories. We also provide services in the areas of logistics
management, data management and program management. These services
support our underlying business of laboratory analysis and provide added value
to our clients.
23
MEDTOX Laboratories, Inc.
also provides clinical trial services which includes central laboratory
services, assay (test) development, bio-analytical, bio-equivalence and
pharmacokinetic testing. Central
laboratory services include tests that are used to monitor the safety and
efficacy of a drug. These tests or “safety labs” include tests that are
performed in our general clinical laboratory and
pathology
laboratory
such as clinical chemistries (liver function, kidney function, cardiac
and bone), hematology (blood count), immunology (immune status), and flow
cytometry (cell identification). Assay development, bio-analytical
and bio-equivalence studies are performed in our bio-analytical
laboratory. These tests
are conducted using methodologies such as immunoassay, gas chromatography, high
performance liquid chromatography, gas chromatography/mass spectrometry and
tandem mass spectrometry. Clients for
our clinical testing services include clinical trial sponsors (pharmaceutical
and biotech companies), clinical research organizations (CROs), research
organizations, and investigators with trial management, patient
recruitment/enrollment and site management.
The New
Brighton Business Center, LLC (NBBC) is a wholly-owned limited liability company
formed for the sole purpose of acquiring the facilities in St. Paul, Minnesota,
where our Laboratory Services administrative offices and laboratory operations
are located.
Product Sales
Our
“Product Sales” business segment consists of our wholly-owned subsidiary, MEDTOX
Diagnostics, Inc. MEDTOX Diagnostics, Inc. is engaged in the
development, manufacturing, and distribution of a variety of POCT diagnostic
drug screening devices, such as our PROFILE®-II, PROFILE®-II A, PROFILE®-III,
PROFILE®-III A, PROFILE-II ER®, PROFILE®-III ER, PROFILE®-IV, PROFILE®-V,
MEDTOXScan® reader, VERDICT®-II, and SURE-SCREEN® products, in addition to other
diagnostic tests for the detection of alcohol. MEDTOX Diagnostics,
Inc. also provides contract manufacturing services, such as coagulation market
controls. The operations of the Product Sales segment are located in
Burlington, North Carolina, where we maintain the offices, research and
development laboratories, production operations, and warehouse/distribution
facilities.
In
January 2008, we announced that we were voluntarily recalling approximately 400
MEDTOXScan® electronic readers because of mis-branding. The
PROFILE®-III ER devices sold for use with the readers and which are properly
cleared for sale by the FDA, can be read visually without the
reader. The readers were provided to customers at no cost, therefore
the direct financial impact of the recall is limited to shipping fees which are
estimated to be less than $10,000. It had been our original intention
to replace these readers with a new generation of reader having over-the-counter
(OTC) approval in 2008. As a result of the recall, we sought
“prescription use” clearance for the new reader. We filed a 510(k)
application in March 2008. In February 2009, we received 510(k)
clearance from the FDA to market our MEDTOXScan® electronic readers to be used
with nine drugs. In May 2009, we filed a 510(k) application with the
FDA for three more drugs to be added to the reader menu. In July
2009, we received 510(k) clearance from the FDA to market our PROFILE®-V
MEDTOXScan® Drugs-of-Abuse Test System with the three additional
drugs. The total number of drugs detectable on the system is now
twelve. Currently, we have between 300 to 400 hospital clients utilizing our
PROFILE® visually read cassettes for drugs-of-abuse detection. The
new Test System will be marketed not only to those clients, but to the broader
hospital market which is estimated in excess of 2,500
hospitals. Since receiving FDA clearance for the expanded panel, we
have shipped over 400 units.
24
Key Trends Influencing Our Operating
Results
Our management believes that there are several notable trends that are currently influencing, and are expected in the foreseeable future to continue to influence, our operating results. These include:
Economic
Uncertainties Causing Variability in Testing Volumes in the Laboratory Services
and Product Sales, Drugs-of-Abuse Business
In 2009,
testing volume from our existing workplace drugs-of-abuse clients was lower than
in the prior year, which we primarily attributed to lower new job creation and
reduced employment levels and corresponding drops in hiring caused by economic
uncertainties. We feel economic uncertainties may continue to cause
variability in our workplace drugs-of-abuse testing volume in the foreseeable
future.
Increased
POCT Diagnostic Device Test Competition
We have
experienced increased competition with respect to our POCT diagnostic tests from
systems and products developed by others, many of whom compete solely on
price. Due to the recent downturn in the economy, we have experienced
increased price competition for certain diagnostic testing devices, particularly
in the probation, parole and rehabilitation market.
Our
Strategy
Our
strategy is to drive profitable growth by building market share, leveraging our
existing infrastructure and technical expertise, and driving
innovation. We maintain a disciplined culture, focused on the
successful execution of our strategy and plans.
Building
Market Share
We have
solid niche positions in large markets, relative to our size, that allow us to
build market share by offering high quality products and services that are
delivered rapidly, priced competitively, and supported by excellent customer
service and value-added services. Our value added services include
data management, collection site management, training, technical support and
expertise, as well as review of drug testing policies for clients.
Our
success in penetrating new accounts has represented a significant component of
our growth in market share. Over the past four years, we have
expanded our number of sales representatives from 23 to 47. The
increase in sales representatives has increased our business from new accounts
in 2009 and helps offset risks from uncertain economic conditions that may cause
lower activity from existing workplace drugs-of-abuse clients.
Leveraging
Existing Infrastructure and Technical Expertise
We
leverage our existing infrastructure and technical expertise to facilitate top
line growth and improve operating margins.
In 2008,
we expanded our clinical laboratory capabilities to include clinical and
anatomic pathology, microbiology, molecular diagnostics, and other specialized
testing capabilities. This expansion leverages existing capabilities
and opens up new revenue opportunities by offering full-service testing
capabilities to the physician office market.
Our LEAN
and Six-Sigma initiatives support our effort to leverage existing infrastructure
by improving quality and productivity, cutting costs, and increasing
throughput. LEAN is a highly disciplined process that helps us focus
on reducing waste and eliminating unnecessary steps in our business
processes. Our Six-Sigma initiatives address quality and variability
within processes. While all key departments in the Laboratory Services and
Product Sales segments have now been through initial LEAN processes, as an
organization we recognize that LEAN is an ongoing philosophy, not a project to
be “finished.”
25
Driving
Innovation
We have
introduced a number of innovative products and services.
In 2009,
we introduced the next generation PROFILE®-V MEDTOXScan® Drugs-of-Abuse Test
System with added functionality for hospital laboratories and emergency
rooms.
In 2008,
we introduced ToxAssure®, a
comprehensive program for effective pain management testing.
In 2007,
we continued improvement in our manufacturing processes in the diagnostic area,
resulting in greater flexibility of product configurations for clients,
increased efficiency in manufacturing and improved device
performance. We can now offer a higher degree of customization to our
clients, both in terms of specific assays on a particular device, and supplying
a “private label” device to large clients. In 2007, we initiated a
relationship with one private label client.
In 2006,
we developed and introduced MEDTOXScan®, an
electronic reader, which we provide to hospitals for use with our PROFILE-II
ER® and
PROFILE®-III
ER POCT devices in hospital laboratories and emergency rooms.
In 2005,
we developed and introduced eChain®, our
web-based electronic chain-of-custody and donor tracking system. We
currently have over 1,500 clinics and collection sites utilizing eChain®
throughout the country.
In 2005,
we also introduced SURE-SCREEN®, our
lower detection level POCT device targeted for the government and rehabilitation
markets and our PROFILE®-III
device, an integrated cup and testing device for sale to the workplace drug
testing market.
ClearCourse®,
another innovative solution we offer, is a comprehensive drug testing program
that combines four essential components: Drug Abuse Recognition System (DARS™)
training, SURE-SCREEN®
on-site drug screening devices, laboratory based confirmation testing and
WEBTOX®
online data management.
Critical
Accounting Policies
We have identified the policies
outlined below as critical to understanding our business and results of
operations. The listing is not intended to be a comprehensive list of
all of our accounting policies. In many cases, the accounting treatment of a
particular transaction is specifically dictated by accounting principles
generally accepted in the United States of America, with no need for
management's judgment in their application. The impact and any associated risks
related to these policies on the Company’s business operations is discussed
throughout Management's Discussion and Analysis of Financial Condition and
Results of Operations where such policies affect reported and expected financial
results. For a detailed discussion on the application of these and
other accounting policies, see Note 1 of Notes to the Consolidated Financial
Statements in Item 15. Note that the preparation of this Annual
Report on Form 10-K requires management to make estimates and assumptions that
affect the reported amount of assets and liabilities, disclosure of contingent
assets and liabilities at the date of our consolidated financial statements, and
the reported amounts of revenues and expenses during the reporting period. There
can be no assurance that actual results will not differ from those
estimates.
26
Our critical accounting policies are as
follows:
Accounts
Receivable:
We
perform ongoing credit evaluations of our customers and adjust credit limits
based upon payment history and the customers' current creditworthiness, as
determined by management’s review of their current credit
information. We continuously monitor collections and payments from
our customers and maintain a provision for estimated credit losses based upon
our historical experience and any specific customer collection issues that have
been identified. While such credit losses have generally been within
our historical expectations and the provisions established, we cannot guarantee
that we will continue to experience the same credit loss rates that have
occurred in the past. Our consolidated trade accounts receivable
balance at December 31, 2009, was $14.9 million, net of allowance for doubtful
accounts of $0.5 million.
Revenue
Recognition:
Revenues
from Laboratory Services are recognized as earned when we have performed the
applicable laboratory testing services and the results have been sent to our
customers or posted to our secure website.
Some of
our Laboratory Services revenues for certain types of tests are billed to
third-party payers including insurance companies, state Medicaid and Medicare
agencies. These payers pay for such services at established amounts,
which are typically lower than gross amounts billed by us. However,
the tests are sometimes billed directly to patients or other parties and paid at
the gross amount billed for these tests. In addition, billings for
the tests are occasionally re-billed to alternative payers in situations where
incorrect billing information was submitted to us by the
customer. Historically, the amounts of such incorrect billings have
not been material. We estimate a discount on the billings for these
tests and recognize revenues and related accounts receivable at a net amount,
after discount, in order to state revenues and accounts receivable at the amount
expected to be paid. While we believe that estimated discounts and the related
net revenues and net accounts receivable from these testing services are
materially correct, there can be differences in amounts ultimately paid compared
to estimated amounts. These differences are recorded upon payment and
may affect previously recorded amounts. We consider contracted rates
with payers and historical discounts when estimating future discounts on a
monthly basis.
Revenues
from Product Sales are recognized FOB shipping point net of an allowance for
estimated returns. When shipment occurs, the sales price is fixed and
determinable, and collection of the resulting receivable is reasonably
assured.
Goodwill:
Goodwill
is reviewed for impairment at least annually and between annual test dates if
events or changes in circumstances indicate potential impairment. We
perform our annual impairment test for goodwill in the fourth quarter of each
year. The entire amount of goodwill is included within the Laboratory
Services segment.
The
impairment test is performed using a two-step process. In the first
step, the fair value of the reporting unit is compared with the carrying amount
of the reporting unit, including goodwill. If the estimated fair
value is less than the carrying amount of the reporting unit, an indication that
goodwill impairment exists and a second step must be completed in order to
determine the amount of the goodwill impairment, if any that should be
recorded. In the second step, an impairment loss is recognized for
any excess of the carrying amount of the reporting unit’s goodwill over the
implied fair value of that goodwill. The implied fair value of
goodwill is determined by allocating the fair value of the reporting unit in a
manner similar to a purchase price allocation.
27
The fair
value of the reporting unit is determined using a discounted cash flow
analysis. Projected discounted future cash flows requires us to make
significant estimates regarding future revenues and expenses, projected capital
expenditures, changes in working capital and the appropriate discount
rate. In developing this discounted cash flow analysis, assumptions
about future revenues and expenses, capital expenditures and changes in working
capital are based on our annual forecast for the reporting unit, historical
experience, and anticipated future economic conditions. Discount rate
assumptions for the reporting unit take into consideration our assessment of
risks inherent in the future cash flows of the reporting unit and our
weighted-average cost of capital. To assess the reasonableness of the
fair value of the reporting unit, we use a market approach which consists of
comparisons to comparable publicly-traded companies in our
industry.
At
December 31, 2009, our goodwill was $16.0 million. If we experience
significant negative economic trends or disruptions to our business, we may be
subject to future impairments. Additionally, changes in assumptions
regarding the future performance of our business, an increase in the discount
rate used to determine the discounted cash flows, or significant declines in our
stock price or the market as a whole could result in additional impairment
indicators. Any future impairment of goodwill could have a material
adverse effect on our financial results.
Accounting
for Income Taxes:
As part
of the process of preparing the consolidated financial statements, we are
required to estimate income taxes in each of the jurisdictions in which we
operate. This process involves estimating actual current tax exposure together
with assessing temporary differences resulting from differing treatment of items
for tax and accounting purposes. These differences result in deferred
tax assets and liabilities. We must then assess the likelihood that
deferred tax assets will be recovered from future taxable income and tax
planning strategies, and to the extent management believes that recovery is not
likely, we must establish a valuation allowance. To the extent we
increase or decrease the valuation allowance in a period, we must include an
expense or benefit within the tax provision in the consolidated statement of
operations.
Significant
management judgment is required in determining the provision for income taxes,
deferred tax assets and liabilities, and any valuation allowance recorded
against net deferred tax assets. Our deferred tax assets primarily
consist of certain net operating losses (NOLs) carried forward. In
the future, revisions to the estimated net realizable value of these deferred
tax assets could cause the provision for income taxes to vary significantly from
period-to-period, although our cash payments would remain unaffected until the
benefit of the NOLs is completely utilized or expires unused. At
December 31, 2009, we did not have a valuation allowance on deferred tax
assets.
We
account for uncertain tax positions in accordance with generally accepted
accounting principles. The application of income tax law is
inherently complex. Laws and regulations in this area are voluminous
and are often ambiguous. As such, we are required to make many
subjective assumptions and judgments regarding our income tax
exposures. Interpretations of and guidance surrounding income tax
laws and regulations change over time. As such, changes in our
subjective assumptions and judgments can materially affect amounts recognized in
the consolidated balance sheets and statements of income. At December
31, 2009, we did not have any unrecognized tax benefits.
Results
of Operations
In
evaluating our financial performance, our management has primarily focused on
three objectives: maximizing operating income, increasing our cash flows and
strengthening our balance sheet. The first of these objectives is
discussed in this section. The other two are addressed under
“Liquidity and Capital Resources.”
To
maximize our operating income, we have sought revenue growth, improved gross
margins and reduced selling, general and administrative (SG&A) expense as a
percentage of revenues. As discussed below, during 2009 we were
unable to fully achieve these goals due in part to challenging economic
conditions.
28
Revenues
Year
Ended December 31
|
2009
vs 2008
|
2008
vs 2007
|
||||||||||||||||||||||||||
(In
thousands)
|
2009
|
2008
|
2007
|
$
Change
|
%
Change
|
$
Change
|
%
Change
|
|||||||||||||||||||||
Revenues:
|
||||||||||||||||||||||||||||
Laboratory
Services
|
||||||||||||||||||||||||||||
Drugs-of-abuse
testing services
|
$ | 36,040 | $ | 40,021 | $ | 38,673 | $ | (3,981 | ) | (10 | )% | $ | 1,348 | 3 | % | |||||||||||||
Clinical
& other laboratory services
|
22,885 | 19,306 | 18,099 | 3,579 | 19 | % | 1,207 | 7 | % | |||||||||||||||||||
Clinical
trial services
|
6,926 | 6,800 | 4,538 | 126 | 2 | % | 2,262 | 50 | % | |||||||||||||||||||
Product
Sales
|
18,257 | 19,686 | 18,975 | (1,429 | ) | (7 | )% | 711 | 4 | % | ||||||||||||||||||
$ | 84,108 | $ | 85,813 | $ | 80,285 | $ | (1,705 | ) | (2 | )% | $ | 5,528 | 7 | % |
Our
Laboratory Services segment includes revenues from drugs-of-abuse testing
services, clinical & other laboratory services and clinical trial
services. Our revenues from drugs-of-abuse testing decreased 10% to
$36.0 million in 2009 and increased 3% to $40.0 million in 2008. The
decrease in 2009 was primarily a result of a 24% decline in revenues from our
existing drug-of-abuse clients due to challenging economic conditions affecting
hiring decisions, partially mitigated by a 14% increase in revenues from new
drugs-of-abuse clients. We expect a continuing negative impact on
revenues from our drugs-of-abuse clients in 2010 caused by the negative economic
conditions affecting hiring. In 2008, new account revenues were
strong, but were offset by an 11% decline in revenues from existing
drugs-of-abuse clients due to challenging economic
conditions. Pricing for our workplace drugs-of-abuse testing services
tends to be fairly stable overall; however, the average price per testing
specimen can vary slightly from quarter-to-quarter. Test price can
vary by client based on the percentage of samples that test positive for
drugs-of-abuse and the average number of samples per shipment.
Revenues
from our clinical and other laboratory services increased 19% to $22.9 million
and 7% to $19.3 million in 2009 and 2008, respectively. The
improvement in 2009 and 2008 was primarily due to growth generated by our
expanded clinical laboratory capabilities and diversification initiatives
undertaken in 2008.
Revenues
from clinical trial services increased 2% to $6.9 million and 50% to $6.8
million in 2009 and 2008, respectively. In 2009, clinical trial
services revenues were impacted, especially during the fourth quarter, by a
slow-down of projects and a deferral of work into 2010. Through the
first three quarters of 2009, revenues from clinical trial services increased
27% over the prior year. In 2008, we experienced a significant
increase in clinical trial services projects. Revenues from clinical
trial services can fluctuate from quarter-to-quarter based on the project
nature, size, and the actual timing of clinical trials as shown in the table
below:
Revenues
from clinical trial services:
First
|
Second
|
Third
|
Fourth
|
|||||||||||||
(In
thousands)
|
Quarter
|
Quarter
|
Quarter
|
Quarter
|
||||||||||||
Revenues:
|
||||||||||||||||
2009
|
$ | 2,315 | $ | 1,592 | $ | 2,000 | $ | 1,019 | ||||||||
2008
|
1,260 | 1,463 | 1,935 | 2,142 |
29
Our
Product Sales segment includes revenues from point-of-collection on site testing
products (POCT), contract manufacturing services and other diagnostic
products.
Sales of
POCT products, which consist of the PROFILE®-II,
PROFILE®-II A,
PROFILE-II ER®,
PROFILE®-III
ER, PROFILE®-III,
PROFILE®-III
A, PROFILE®-IV,
PROFILE®-V,
VERDICT®-II
and SURE-SCREEN®
on-site test kits and other ancillary products for the detection of
abused substances, decreased 8% to $16.4 million in 2009 and increased 7% to
$17.8 million in 2008. The decrease in 2009 was due primarily to a
21% decline in revenues from device sales in the workplace market attributable
to tough economic conditions affecting hiring decisions. Overall,
pricing for our POCT devices in 2009 was slightly lower than the prior
year. The increase in 2008 was primarily due to strong sales of
SURE-SCREEN® devices in the government market as well as growth of our PROFILE®
ER devices in the hospital market. The gain in sales in the
government and hospital markets in 2008 was partially offset by an 8% decrease
in revenues from device sales in the workplace market.
Sales of
contract manufacturing services decreased 5% to $1.4 million in 2009 and
increased 2% to $1.5 million in 2008. After an analysis of this
product category in 2007, we concluded that it had diminishing opportunities for
us, and we are phasing out contract manufacturing services. Based on
the expected increased sales of higher-margin POCT products, we do not
anticipate a significant impact on our results of operations from exiting this
business.
Sales of
other diagnostic products were flat at $0.4 million in 2009 compared to 2008.
Sales of other diagnostic products decreased $0.5 million to $0.4 million in
2008 due to the phase-out of agricultural testing products in late
2007.
Cost
of Revenues and Gross Margin
Year
Ended December 31
|
2009
vs 2008
|
2008
vs 2007
|
||||||||||||||||||||||||||||||||||||||
(In
thousands)
|
2009
|
%
of Revenues
|
2008
|
%
of Revenues
|
2007
|
%
of Revenues
|
$
Change
|
%
Change
|
$
Change
|
%
Change
|
||||||||||||||||||||||||||||||
Cost
of Revenues:
|
||||||||||||||||||||||||||||||||||||||||
Cost
of Services
|
$ | 45,432 | 69.0 | %* | $ | 41,665 | 63.0 | %* | $ | 36,731 | 59.9 | %* | $ | 3,767 | 9 | % | $ | 4,934 | 13 | % | ||||||||||||||||||||
Cost
of Sales
|
7,781 | 42.6 | %** | 7,822 | 39.7 | %** | 7,198 | 37.9 | %** | (41 | ) | (1 | )% | 624 | 9 | % | ||||||||||||||||||||||||
$ | 53,213 | 63.3 | % | $ | 49,487 | 57.7 | % | $ | 43,929 | 54.7 | % | $ | 3,726 | 8 | % | $ | 5,558 | 13 | % |
* Cost
of services as a percentage of Laboratory Services revenues
** Cost
of sales as a percentage of Product Sales revenues
Consolidated
gross margin decreased to 36.7% of revenues in 2009, compared to 42.3% of
revenues in 2008 and 45.3% of revenues in 2007.
Laboratory
Services gross margin was 31.0% in 2009, down from 37.0% in 2008 and 40.1% in
2007. The decrease in 2009 was partly due to the drop in
drugs-of-abuse testing revenues over a highly fixed cost
structure. In 2009 and 2008, gross margins were impacted by higher
costs associated with our clinical laboratory expansion.
30
Gross
margin from Product Sales was 57.4% in 2009, down from 60.3% in 2008 and 62.1%
in 2007. The decrease in 2009 reflects a shift in sales mix of POCT
devices, with a decrease in sales of higher margin PROFILE®
devices in the workplace market and an increase in sales of lower margin
SURE-SCREEN®
devices in the government market. In 2008, gross margin was impacted
by a shift in sales mix of POCT devices, with slowed growth of higher margin
PROFILE® ER
devices in the hospital market and an increase in sales of lower margin
SURE-SCREEN®
devices in the government market.
Operating
Expenses
Year
Ended December 31
|
2009
vs 2008
|
2008
vs 2007
|
||||||||||||||||||||||||||||||||||||||
(In
thousands)
|
2009
|
%
of Revenues
|
2008
|
%
of Revenues
|
2007
|
%
of Revenues
|
$
Change
|
%
Change
|
$
Change
|
%
Change
|
||||||||||||||||||||||||||||||
Operating
Expenses:
|
||||||||||||||||||||||||||||||||||||||||
Selling,
general and administrative
|
$ | 26,663 | 31.7 | % | $ | 24,327 | 28.3 | % | $ | 23,737 | 29.6 | % | $ | 2,336 | 10 | % | $ | 590 | 3 | % | ||||||||||||||||||||
Research
and development
|
2,264 | 2.7 | % | 2,352 | 2.7 | % | 2,603 | 3.2 | % | (88 | ) | (4 | )% | (251 | ) | (10 | )% | |||||||||||||||||||||||
$ | 28,927 | 34.4 | % | $ | 26,679 | 31.1 | % | $ | 26,340 | 32.8 | % | $ | 2,248 | 8 | % | $ | 339 | 1 | % |
Selling, General
and Administrative Expenses. Selling, general and
administrative expenses increased to $26.7 million, or 31.7% of revenues in
2009, compared to $24.3 million, or 28.3% of revenues in 2008 and $23.7 million,
or 29.6% of revenues in 2007. Our increased spending in 2009 was due
to an increase in sales and marketing expense and the reclassification of
$525,000 from Other Income (Expense) which was determined to be more
appropriately classified in SG&A expenses. The increase was also
due to an increase in retirement plan obligation which corresponds to an
increase in the related marketable equity securities held in trust to fund this
obligation. The increase in retirement plan expense associated with
the obligation was offset by a corresponding investment gain being recorded in
Other Income (Expense). The higher spending in 2008 over 2007
reflects an increase in sales and marketing expense and depreciation expense,
partially offset by decreased performance-based compensation.
Research and
Development Expenses. Research and development expenses
decreased 4% to $2.3 million and 10% to $2.4 million in 2009 and 2008,
respectively. The decrease in 2009 was primarily due to decreased
spending for on-going product development projects in our Product Sales
segment. The lower spending in 2008 compared to 2007 was
primarily due to the absence of costs incurred in 2007 related to the
introduction of the MEDTOXScan®
reader and other peripheral materials related to the reader.
Other
Income (Expense)
Other
income and expense consists primarily of interest expense, the net expenses
associated with our building rental activities, and our investment
gains/losses. Other income was $79,000 in 2009 compared to other
expense of $1.0 million and $0.7 million in 2008 and 2007,
respectively. The income in 2009 was due to the reclassification of
$525,000 from Other Income (Expense) which was determined to be more
appropriately classified in SG&A expenses, as well as an investment gain on
our marketable equity securities held in trust. The increase in 2008
compared to 2007 was due primarily to an increase in the investment loss on our
marketable equity securities held in trust.
31
Income
Taxes
In 2009,
we recorded $0.7 million in income tax expense, or an effective rate of 36.5%,
compared to an effective rate of 35.6% in 2008 and 28.1% in 2007. The
decrease in the effective rate in 2007 was primarily due to a $0.4 million tax
benefit (including interest) from the favorable resolution of an examination by
the North Carolina Department of Revenue of MEDTOX Diagnostics,
Inc.
Liquidity
and Capital Resources
Our
working capital requirements have been funded primarily by profitable
operations. Cash and cash equivalents were $4.2 million and $4.1
million at December 31, 2009 and 2008, respectively.
Net cash
provided by operating activities was $5.8 million in 2009 compared to $12.3
million and $12.0 million in 2008 and 2007, respectively. The
decrease in 2009 was primarily due to reduced operating results. The
decrease in 2009 compared to 2008 was also due to an increase in our trade
receivables related to the timing of sales and cash receipts.
Net cash
used in investing activities, consisting primarily of capital expenditures, was
$4.9 million in 2009 compared to $8.5 million and $9.0 million in 2008 and 2007,
respectively. These expenditures consisted of equipment purchased and
costs incurred to continue to improve efficiencies and reduce operating costs
within our Laboratory Services and Product Sales businesses. The
decrease in 2009 was due to the absence of costs incurred in 2008 and 2007
associated with the expansion of our regional clinical laboratory
capabilities. In 2007, we also invested in instrumentation and
capacity in our clinical trials services business.
We expect
equipment and capital improvement expenditures to be between $4.5 million and
$5.5 million in 2010, with increased investment in instrumentation and facility
improvements in support of our regional clinical laboratory and workplace
drugs-of-abuse business. Such expenditures are expected to be funded
through cash provided by operating activities.
Net cash
used in financing activities was $0.8 million in 2009, compared to $1.9 million
and $2.0 million in 2008 and 2007, respectively. The decrease in 2009
was primarily due to a decrease in the repurchase of shares of our common
stock. In 2009, we repurchased 60,644 shares of our common stock in
the open market for a cost of $0.4 million. In 2008, we repurchased 63,140
shares of our common stock from officers of our Company for a cost of $1.0
million. In 2007, we repurchased 32,929 shares of our common stock in
the open market and 33,774 shares of our common stock from an officer and
director of our Company for a combined total cost of $1.1
million. The shares repurchased were placed in trust to fund our
Long-Term Incentive Plan.
We are
party to a credit security agreement (the "Wells Fargo Credit Agreement") with
Wells Fargo Bank, National Association (the “Bank”). The Wells Fargo
Credit Agreement, as amended, consists of a revolving line of credit ("Line of
Credit") of up to $8.0 million bearing interest at a fluctuating rate of 2.25%
above the daily three month LIBOR, as defined and calculated by the
Bank.
Subject
to certain conditions, the Wells Fargo Credit Agreement also provides for the
issuance of letters of credit which, if drawn upon, would be deemed advances
under the Line of Credit. We are required to pay a fee equal to 0.25%
per annum on the average daily unused amount of the Line of
Credit. We have granted the Bank a first priority security interest
in all of the Company’s accounts receivable, other rights to payment, general
intangibles, inventory, and equipment to secure all indebtedness of the Company
to the Bank.
32
Extensions
of credit under the Wells Fargo Credit Agreement are subject to certain
conditions. The Wells Fargo Credit Agreement also requires us to
comply with certain financial covenants, including maintaining, on a
consolidated basis:
·
|
Tangible
Net Worth not less than $40,000,000 at any time, with “Tangible Net Worth”
defined as the aggregate of total stockholders’ equity plus subordinated
debt less any intangible assets.
|
·
|
Current
Ratio not less than 1.3 to 1.0 at each month end, with “Current Ratio”
defined as total current assets divided by total current
liabilities.
|
·
|
Total
Liabilities divided by Tangible Net Worth not greater than 1.75 to 1.0 at
any time, with “Total Liabilities” defined as the aggregate of current
liabilities and non-current liabilities less subordinated debt, and with
“Tangible Net Worth” as defined
above.
|
·
|
A
Debt Service Coverage Ratio not less than 1.5 to 1.0 as of each fiscal
quarter end, determined on a rolling four-quarter basis, with “Debt
Service Coverage Ratio” defined as the aggregate of net income before
non-cash tax expense plus depreciation expense and amortization expense,
divided by the aggregate of the current maturity of long-term debt for the
previous four fiscal quarters plus current capital lease obligations for
the previous four fiscal quarters.
|
We are
relying on expected positive cash flow from operations and our Line of Credit to
fund our future working capital and asset purchases. At December 31,
2009, we had total borrowing capacity of $8.0 million on our Line of
Credit. We did not have an outstanding balance on the Line of Credit
at December 31, 2009.
In the
short term, we believe that the aforementioned resources will be sufficient to
fund our planned operations through 2010. While there can be no
assurance that the available capital will be sufficient to fund our future
operations beyond 2010, we believe that future profitable operations, as well as
access to additional capital through debt or equity financings, will be the
primary means for funding our operations for the long term.
We
continue to follow a plan which includes (i) aggressively monitoring and
controlling costs, (ii) increasing revenues from sales of our existing products
and services, (iii) developing new products and services, as well as (iv)
selectively pursuing synergistic acquisitions to increase our critical
mass. However, there can be no assurance that costs can be
controlled, revenues can be increased, financing may be obtained, acquisitions
successfully consummated, or that we will be profitable.
Disclosures
about Contractual Obligations and Commercial Commitments
The
following table aggregates all contractual commitments and commercial
obligations that affect the Company’s financial condition and liquidity position
at December 31, 2009:
Payments
Due by Period
|
||||||||||||||||||||
(In
thousands)
|
Total
|
Less
than 1 year
|
1-3
years
|
3-5
years
|
More
than 5 years
|
|||||||||||||||
Long-term
debt (1)
|
$ | 304 | $ | 304 | $ | - | $ | - | $ | - | ||||||||||
Operating
leases
|
2,832 | 655 | 1,043 | 698 | 436 | |||||||||||||||
Total
contractual obligations
|
$ | 3,136 | $ | 959 | $ | 1,043 | $ | 698 | $ | 436 |
(1) Amounts
include interest payments based upon contractual or prevailing interest
rates.
33
The table
above excludes our obligation for future payments to participants under our
Supplemental Executive Retirement Plan of approximately $0.8 million at December
31, 2009 as the specific payment dates and amounts are unknown.
Off-Balance
Sheet Transactions
We do not
maintain any off-balance sheet transactions, arrangements, obligations or other
relationships with unconsolidated entities or others that are reasonably likely
to have a material current or future effect on our financial condition, changes
in financial condition, revenues or expenses, results of operations, liquidity,
capital expenditures or capital resources.
Impact
of Inflation and Changing Prices
The
impact of inflation and changing prices in our last three fiscal years has been
primarily limited to salary, laboratory and operating supplies and rent
increases and has historically not been material to our
operations. In the future, we may not be able to increase the prices
of laboratory testing by an amount sufficient to cover the cost of inflation,
although we are responding to these concerns by offering the highest quality
products and services, delivered rapidly, priced competitively and supported by
value-added services for customers.
Seasonality
We
believe that the laboratory testing business is subject to seasonal fluctuations
in pre-employment screening. These seasonal fluctuations include
reduced volume in the year-end holiday periods, and other major
holidays. In addition, inclement weather may have a negative impact
on volume thereby reducing net revenues and cash flow.
Impact
of New Accounting Standards
In June
2009, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Codification (ASC) 105-10, “The FASB Accounting Standards Codification
and the Hierarchy of Generally Accepted Accounting Principles”. This
Statement modifies the Generally Accepted Accounting Principles (GAAP) hierarchy
by establishing only two levels of GAAP, authoritative and nonauthoritative
accounting literature. Effective July 2009, the FASB ASC, also known
collectively as the “Codification,” is considered the single source of
authoritative U.S. accounting and reporting standards, except for additional
authoritative rules and interpretive releases issued by the SEC.
Nonauthoritative guidance and literature would include, among other things, FASB
Concepts Statements, American Institute of Certified Public Accountants Issue
Papers and Technical Practice Aids and accounting textbooks. The
Codification was developed to organize GAAP pronouncements by topic so that
users can more easily access authoritative accounting
guidance. We adopted this Statement effective July 1, 2009, and
accordingly all accounting references have been updated and SFAS references have
been replaced with ASC references.
In May
2009, the FASB issued ASC 855-10, “Subsequent Events”. ASC
855-10 provides guidance on management’s assessment of subsequent events and
incorporates this guidance into accounting literature. ASC 855-10 is
effective prospectively for interim and annual periods ending after June 15,
2009. The adoption of this Statement did not have an impact on our
financial position or results of operations. Effective February
24, 2010, the FASB modified its guidance related to subsequent events and we
have adopted the change. This guidance continues to require entities that file
or furnish financial statements with the SEC to evaluate subsequent events
through the date the financial statements are issued; however, this guidance
removed the requirement for these entities to disclose the date through which
events have been evaluated. The adoption of this guidance did not have an impact
on our financial position or results of operations.
34
ITEM
7A.
|
QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET
RISK.
|
Market
risk is the risk that we will incur losses due to adverse changes in interest
rates or currency exchange rates and prices. Our primary market risk
exposures are to changes in interest rates. During 2009, 2008, and
2007, we did not have sales denominated in foreign currencies nor did we have
any subsidiaries located in foreign countries. As such, we are not
exposed to market risk associated with currency exchange rates and
prices.
At
December 31, 2009 and 2008, we had approximately $0.3 million and $1.0 million,
respectively, outstanding on a Term Note with Wells Fargo Bank bearing interest
at a variable rate of 0.5% below the prime rate. We have cash flow
exposure on our committed and uncommitted line of credit and long-term debt with
Wells Fargo Bank due to its variable prime rate pricing. At December
31, 2009, a 1% change in the prime rate would increase or decrease interest
expense or cash flows by less than $0.1 million.
We do not
enter into derivative or other financial instruments or hedging transactions for
trading or speculative purposes.
ITEM
8.
|
FINANCIAL STATEMENTS
AND SUPPLEMENTARY DATA.
|
Reference
is made to the consolidated financial statements, financial statement schedule,
and notes thereto included later in this Annual Report on Form 10-K under Item
15.
ITEM
9.
|
CHANGES IN AND
DISAGREEMENTS WITH
ACCOUNTANTS
|
|
ON ACCOUNTING AND
FINANCIAL DISCLOSURE.
|
Not
Applicable.
ITEM
9A.
|
CONTROLS AND
PROCEDURES.
|
Evaluation
of Disclosure Controls Procedures
As of the
end of the period covered by this report, we conducted an evaluation under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, regarding the effectiveness of
the design and operation of our disclosure controls and procedures pursuant to
Rules 13a-15(b) and 15d-15(b) of the Securities Exchange Act of 1934 (the
“Exchange Act”). Based upon that evaluation, the Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and
procedures are effective to ensure that information that is required to be
disclosed by us in reports that we file under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the
Securities Exchange Commission’s rules and forms.
Changes
in Internal Controls
There
were no changes in our internal control over financial reporting that occurred
during the period covered by this report that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in Exchange Act
Rules 13a-15(f) and 15d-15(f). Under the supervision and with the
participation of management, including our Chief Executive Officer and Chief
Financial Officer, we conducted an evaluation of the effectiveness of our
internal controls over financial reporting based on the framework in Internal
Control - Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (“COSO”). Based on this evaluation
management has concluded that our internal control over financial reporting was
effective as of December 31, 2009.
35
Deloitte &
Touche LLP, the independent registered public accounting firm that audited the
consolidated financial statements included in this Annual Report on
Form 10-K, has also audited our internal control over financial reporting
as of December 31, 2009, as stated in their attestation report included in
Part IV, Item 15 of this Annual Report on
Form 10-K.
Limitations
on Controls
Our
management, including our Chief Executive Officer and Chief Financial Officer,
does not expect that our disclosure controls or our internal control over
financial reporting will prevent or detect all errors and all fraud. A control
system, no matter how well designed and operated, can provide only reasonable,
not absolute, assurance that the control system’s objectives will be
met. The design of any system of controls is based in part on certain
assumptions about the likelihood of future events, and there can be no assurance
that any design will succeed in achieving its stated goals under all potential
future conditions.
ITEM
9B.
|
OTHER
INFORMATION.
|
Not
Applicable.
|
|
36
PART
III
ITEM
10.
|
DIRECTORS, EXECUTIVE
OFFICERS AND CORPORATE
GOVERANCE.
|
The
information required by this Item is incorporated by reference from the section
labeled “Proposal 1 - Election
of Directors” that will appear in the Definitive Proxy Statement to be
used in connection with the 2010 Annual Meeting of Stockholders of MEDTOX Scientific,
Inc.
The
Company has adopted the MEDTOX Scientific, Inc. Code of Ethics for senior
financial and executive officers and directors ("Code of
Ethics"). The Code of Ethics is available on the Company's website at
www.medtox.com
or at no charge to anyone who sends a request for a paper copy to: MEDTOX
Scientific, Inc. 402 West County Road D, St. Paul, Minnesota,
55112. If the Company makes any substantive amendments to the Code of
Ethics or grants any waiver, including any implicit waiver from a provision of
the Code of Ethics to its directors or executive officers, the Company will
disclose the nature of such amendments or waiver on its website at www.medtox.com or in
a report on Form 8-K.
ITEM
11.
|
EXECUTIVE
COMPENSATION.
|
The
information required by this Item is incorporated by reference from the sections
labeled “Executive
Compensation” and
“Summary Compensation Table” that will appear in the Definitive Proxy
Statement to be used in connection with the 2010 Annual Meeting of
Stockholders of
MEDTOX Scientific, Inc.
ITEM
12.
|
SECURITY OWNERSHIP OF
CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS.
|
The
information required by this Item is incorporated by reference from the sections
labeled “Common Stock
Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan
Information” that will appear in the Definitive Proxy Statement to be
used in connection with the 2010 Annual Meeting of Stockholders of MEDTOX Scientific,
Inc.
ITEM
13.
|
CERTAIN RELATIONSHIPS
AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPEDENCE.
|
The
information required by this Item is incorporated by reference from the section
labeled “Certain Relationships
and Related Transactions” that will appear in the Definitive Proxy
Statement to be used in connection with the 2010 Annual Meeting of Stockholders
of MEDTOX Scientific, Inc.
ITEM
14.
|
PRINCIPAL ACCOUNTANT
FEES AND SERVICES.
|
The
information required by this Item is incorporated by reference from the section
labeled “Fees to Independent Registered Public
Accounting Firm” that will appear in the Definitive Proxy Statement to be
used in connection with the 2010 Annual Meeting of Stockholders of MEDTOX Scientific,
Inc.
37
PART
IV
ITEM
15.
|
EXHIBITS, FINANCIAL
STATEMENT SCHEDULES.
|
a.
|
Financial Statements
|
Page
|
Reports
of Independent Registered Public Accounting Firm
|
44
|
|
Consolidated
Balance Sheets at December 31, 2009 and 2008
|
47
|
|
Consolidated
Statements of Income for the Years Ended December 31, 2009, 2008 and
2007
|
48
|
|
Consolidated
Statements of Stockholders' Equity for the Years Ended December 31, 2009,
2008 and 2007
|
49
|
|
Consolidated
Statements of Cash Flows for the Years Ended December
31, 2009, 2008 and 2007
|
50
|
|
Notes
to Consolidated Financial Statements
|
51
|
|
b.
|
Consolidated Financial Statements
Schedule
|
|
Schedule
II - Valuation and Qualifying Accounts
|
65
|
|
All
other financial statement schedules normally required under Regulation S-X
are omitted as the required information is not
applicable.
|
||
c.
|
Exhibits
|
The
exhibits included in the Report are set forth on the exhibit index and follow
the signature page of this Annual Report on Form 10-K.
3.1
|
Bylaws
of the Registrant, as amended. (Incorporated by reference
to exhibit 3.1 filed with the Registrant’s Report on Form 10-K for the
fiscal year ended December 31,
2007).
|
3.2
|
Restated
Certificate of Incorporation, as amended. (Incorporated by reference to
exhibit 3.2 filed with the Registrant’s Report on Form 10-K for the fiscal
year ended December 31, 2005).
|
3.3
|
Amended
Certificate of Designations of Preferred Stock (Series A Convertible
Preferred Stock) of the Registrant, filed with the Delaware Secretary of
State on January 29, 1996 (incorporated by reference to Exhibit 3.1 filed
with the Registrant’s report on Form 8-K dated January 30, 1996,
Commission File No. 001-11394).
|
10.1
|
Second
Amendment dated December 31, 1986 to Exclusive License Agreement amending
and restating exclusive license granted by the Registrant to Disease
Detection International, Inc. (incorporated by reference to Exhibit 10.25
filed with the Registration Statement on Form S-1 dated August 26, 1987,
Commission File No.
33-15543).
|
38
10.2
|
Agreement
regarding rights to “MEDTOX” name dated as of January 30, 1996 between the
Registrant and Harry G. McCoy. (Incorporated by reference to
Exhibit 10.38 filed with the Registrant’s Report on Form 10-K for the
fiscal year ended December 31, 1995, Commission File No.
001-11394).
|
10.3
|
Registrant’s
Restated Equity Compensation Plan dated May 10,
2000. (Incorporated by reference to exhibit 10.46 filed with
the Registrant’s Report on Form 10-K for the fiscal year ended December
31, 2000, Commission File No.
001-11394).**
|
10.4
|
Registration
Rights Agreement dated July 31, 2000 among the Registrant, certain
investors, and Miller, Johnson, & Kuehn, Inc.
(“MJK”). (Incorporated by reference to exhibit 10.50 filed with
the Registrant’s Report on Form 10-K for the fiscal year ended December
31, 2000, Commission File No.
001-11394).
|
10.5
|
Employment
Agreement dated January 1, 2003, between the Registrant and Richard J.
Braun. (Incorporated by reference to exhibit 10.59 filed with the
Registrant’s Report on Form 10-K for the year ended December 31, 2002,
Commission File No.
001-11394).**
|
10.6
|
Amended
and Restated Nova Building Lease dated November 1, 2003 by and between
Powell Enterprises and MEDTOX Diagnostics, Inc. (Incorporated by reference
to exhibit 10.23 filed with the Registrant’s Report on Form 10-K for the
fiscal year ended December 31,
2003).
|
10.7
|
Credit
Agreement between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and
MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1,
2005. (Incorporated by reference to exhibit 10.1 filed with the
Registrant’s Report on Form 8-K dated December 6,
2005).
|
10.8
|
Revolving
Line of Credit Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics,
Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank dated December 1,
2005. (Incorporated by reference to exhibit 10.2 filed with the
Registrant’s Report on Form 8-K dated December 6,
2005).
|
10.9
|
Security
Agreement: Equipment between MEDTOX Scientific, Inc., MEDTOX
Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank
dated December 1, 2005. (Incorporated by reference to exhibit
10.3 filed with the Registrant’s Report on Form 8-K dated December 6,
2005).
|
10.10
|
Continuing
Security Agreement: Rights to Payment and Inventory between
MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX
Laboratories, Inc. and Wells Fargo Bank dated December 1,
2005. (Incorporated by reference to exhibit 10.4 filed with the
Registrant’s Report on Form 8-K dated December 6,
2005).
|
10.11
|
Term
Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX
Laboratories, Inc. and Wells Fargo Bank dated December 1,
2005. (Incorporated by reference to exhibit 10.5 filed with the
Registrant’s Report on Form 8-K dated December 6,
2005).
|
10.12
|
Agreement
and Acknowledgment of Security Interest between Wells Fargo Bank, MEDTOX
Diagnostics, Inc., and Powell Enterprises, Inc. dated December 1,
2005. (Incorporated by reference to exhibit 10.6 filed with the
Registrant’s Report on Form 8-K dated December 6,
2005).
|
39
10.13
|
Term
Note between MEDTOX Scientific, Inc., MEDTOX Diagnostics, Inc., and MEDTOX
Laboratories, Inc. and Wells Fargo Bank dated March 16, 2006.
(Incorporated by reference to exhibit 10.23 filed with the Registrant’s
Report on Form 10-K for the fiscal year ended December 31,
2005).
|
10.14
|
Continuing
Guaranty between New Brighton Business Center, LLC and Wells Fargo Bank
dated March 16, 2006. (Incorporated by reference to exhibit 10.24 filed
with the Registrant’s Report on Form 10-K for the fiscal year ended
December 31, 2005).
|
10.15
|
First
Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX
Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank
dated March 16, 2006. (Incorporated by reference to exhibit
10.25 filed with the Registrant’s Report on Form 10-K for the fiscal year
ended December 31, 2005).
|
10.16
|
Negative
Pledge Agreement between New Brighton Business Center, LLC and Wells Fargo
Bank dated March 16, 2006. (Incorporated by reference to
exhibit 10.26 filed with the Registrant’s Report on Form 10-K for the
fiscal year ended December 31,
2005).
|
10.17
|
Employment
Agreement dated December 27, 2006, between the Registrant and B. Mitchell
Owens. (Incorporated by reference to exhibit 10.1 filed with the
Registrant’s Report on Form 8-K dated January 4,
2007).**
|
10.18
|
Employment
Agreement dated December 27, 2006, between the Registrant and Susan E.
Puskas. (Incorporated by reference to exhibit 10.2 filed with the
Registrant’s Report on Form 8-K dated January 4,
2007).**
|
10.19
|
Employment
Agreement dated December 27, 2006, between the Registrant and James A.
Schoonover. (Incorporated by reference to exhibit 10.3 filed with the
Registrant’s Report on Form 8-K dated January 4,
2007).**
|
10.20
|
Employment
Agreement dated December 27, 2006, between the Registrant and Kevin J.
Wiersma. (Incorporated by reference to exhibit 10.4 filed with the
Registrant’s Report on Form 8-K dated January 4,
2007).**
|
10.21
|
Registrant’s
Executive Incentive Compensation Plan dated December 27, 2006,
(Incorporated by reference to exhibit 10.5 filed with the Registrant’s
Report on Form 8-K dated January 4,
2007).**
|
10.22
|
Commercial
Lease between MEDTOX Laboratories, Inc. and St. Paul Properties, Inc.
dated July 28, 2000. (Incorporated by reference to exhibit 10.2
filed with the Registrant’s Report on Form 8-K dated May 30,
2007).
|
10.23
|
Amendment
to Lease between MEDTOX Laboratories, Inc. and St. Paul Properties, Inc.
dated May 25, 2007. (Incorporated by reference to exhibit 10.1
filed with the Registrant’s Report on Form 8-K dated May 30,
2007).
|
40
10.24
|
Second
Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX
Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank
dated July 31, 2007. (Incorporated by reference to exhibit
10.29 filed with the Registrant’s Report on Form 10-Q for the quarter
ended June 30, 2007).
|
10.25
|
Third
Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX
Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank
dated October 25, 2007. (Incorporated by reference to exhibit
10.30 filed with the Registrant’s Report on Form 10-Q for the quarter
ended September 30, 2007).
|
10.26
|
Registrant’s
Long-Term Incentive Plan as Amended and Restated dated December 31, 2007,
(Incorporated by reference to exhibit 10.1 filed with the Registrant’s
Report on Form 8-K dated January 7,
2008).**
|
10.27
|
Registrant’s
Supplemental Executive Retirement Plan as Amended and Restated dated
December 31, 2007, (Incorporated by reference to exhibit 10.2 filed with
the Registrant’s Report on Form 8-K dated January 7,
2008).**
|
10.28
|
Amendment
to Employment Agreement, effective January 1, 2009, between the Registrant
and B. Mitchell Owens. (Incorporated by reference to exhibit 10.5 filed
with the Registrant’s Report on Form 8-K dated December 23,
2008).**
|
10.29
|
Amendment
to Employment Agreement, effective January 1, 2009, between the Registrant
and Susan E. Puskas. (Incorporated by reference to exhibit 10.4 filed with
the Registrant’s Report on Form 8-K dated December 23,
2008).**
|
10.30
|
Amendment
to Employment Agreement, effective January 1, 2009, between the Registrant
and James A. Schoonover. (Incorporated by reference to exhibit 10.2 filed
with the Registrant’s Report on Form 8-K dated December 23,
2008).**
|
10.31
|
Amendment
to Employment Agreement, effective January 1, 2009, between the Registrant
and Kevin J. Wiersma. (Incorporated by reference to exhibit 10.3 filed
with the Registrant’s Report on Form 8-K dated December 23,
2008).**
|
10.32
|
Amendment
to Employment Agreement, effective January 1, 2009, between the Registrant
and Richard J. Braun. (Incorporated by reference to exhibit 10.1 filed
with the Registrant’s Report on Form 8-K dated December 23,
2008).**
|
10.33
|
Fourth
Amendment to Credit Agreement between MEDTOX Scientific, Inc., MEDTOX
Diagnostics, Inc., and MEDTOX Laboratories, Inc. and Wells Fargo Bank
dated October 29, 2009. (Incorporated by reference to exhibit
10.1 filed with the Registrant’s Report on Form 10-Q for the quarter ended
September 30, 2009).
|
10.34
|
Registrant’s
Supplemental Executive Retirement Plan as Amended and Restated dated
January 1, 2010. (Incorporated by reference to exhibit 10.1 filed with the
Registrant’s Report on Form 8-K dated January 7,
2010).**
|
10.35
|
Target
Financial Objectives for Fiscal Year 2009 under the Annual Incentive Plan
and Long Term Incentive Plan. (Incorporated by reference to
exhibit 10.1 filed with the Registrant’s Report on Form 10-Q for the
quarter ended March 31, 2009).**
|
10.36
|
Director
Compensation for Fiscal Year
2010.*&**
|
41
21.1
|
Subsidiaries
of Registrant*
|
|
23
|
Consent
of Independent Registered Public Accounting
Firm*
|
31.1
|
Section
302 Certification of Chief Executive Officer pursuant to the
Sarbanes-Oxley Act of 2002.*
|
31.2
|
Section
302 Certification of Chief Financial Officer pursuant to the
Sarbanes-Oxley Act of 2002.*
|
|
32.1
|
Section
906 Certification of Chief Executive Officer pursuant to the
Sarbanes-Oxley Act of 2002.*
|
|
32.2
|
Section
906 Certification of Chief Financial Officer pursuant to the
Sarbanes-Oxley Act of 2002.*
|
|
*
|
Filed
herewith
|
|
**
|
Denotes
a management contract or compensatory plan or
arrangement
|
42
|
SIGNATURES
|
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the Registrant has duly caused this Annual Report to be signed on its
behalf by the undersigned, thereunto duly authorized on the 10th of March,
2010.
MEDTOX
Scientific, Inc.
Registrant
By: /s/ Richard J.
Braun
Richard J. Braun
President, Chief Executive Officer
and
Chairman of the Board of
Directors
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Registrant in the
capacities and on the dates indicated.
Signature
|
Title
|
Date
|
/s/ Richard J. Braun
|
President,
Chief Executive Officer, and
|
March
10, 2010
|
Richard
J. Braun
|
Chairman
of the Board of Directors (Principal Executive Officer)
|
|
/s/ Kevin J. Wiersma
|
Vice
President and Chief Financial Officer
|
March
10, 2010
|
Kevin
J. Wiersma
|
(Principal
Financial Officer)
|
|
/s/ Steven J. Schmidt
|
Vice
President, Finance
|
March
10, 2010
|
Steven
J. Schmidt
|
(Principal
Accounting Officer)
|
|
/s/ Brian P. Johnson
|
Director
|
March
10, 2010
|
Brian
P. Johnson
|
||
/s/ Robert J. Marzec
|
Director
|
March
10, 2010
|
Robert
J. Marzec
|
||
/s/ Samuel C. Powell
|
Director
|
March
10, 2010
|
Samuel
C. Powell, Ph.D.
|
||
/s/ Robert A. Rudell
|
Director
|
March
10, 2010
|
Robert
A. Rudell
|
||
43
To the
Board of Directors and Stockholders of
MEDTOX
Scientific, Inc.
St. Paul,
Minnesota
We have
audited the internal control over financial reporting of MEDTOX Scientific, Inc.
and subsidiaries (the "Company") as of December 31, 2009, based on criteria
established in Internal Control — Integrated Framework issued by the Committee
of Sponsoring Organizations of the Treadway Commission. The Company's
management is responsible for maintaining effective internal control over
financial reporting and for its assessment of the effectiveness of internal
control over financial reporting, included in the accompanying Management’s
Report on Internal Control Over Financial Reporting. Our responsibility is
to express an opinion on the Company's internal control over financial reporting
based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that
we plan and perform the audit to obtain reasonable assurance about whether
effective internal control over financial reporting was maintained in all
material respects. Our audit included obtaining an understanding of
internal control over financial reporting, assessing the risk that a material
weakness exists, testing and evaluating the design and operating effectiveness
of internal control based on the assessed risk, and performing such other
procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
company's internal control over financial reporting is a process designed by, or
under the supervision of, the company's principal executive and principal
financial officers, or persons performing similar functions, and effected by the
company's board of directors, management, and other personnel to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles. A company's internal control
over financial reporting includes those policies and procedures that (1) pertain
to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company's
assets that could have a material effect on the financial
statements.
Because
of the inherent limitations of internal control over financial reporting,
including the possibility of collusion or improper management override of
controls, material misstatements due to error or fraud may not be prevented or
detected on a timely basis. Also, projections of any evaluation of the
effectiveness of the internal control over financial reporting to future periods
are subject to the risk that the controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or
procedures may deteriorate.
In our
opinion, the Company maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2009, based on the criteria
established in Internal Control — Integrated Framework issued by the Committee
of Sponsoring Organizations of the Treadway Commission.
44
We have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated financial statements and
financial statement schedule as of and for the year ended December 31, 2009, of
the Company and our report dated March 10, 2010 expressed an unqualified opinion
on those financial statements and financial statement schedule.
DELOITTE
& TOUCHE LLP
Minneapolis,
Minnesota
March 10,
2010
45
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and Stockholders of
MEDTOX
Scientific, Inc.
St. Paul,
Minnesota
We have
audited the accompanying consolidated balance sheets of MEDTOX
Scientific, Inc. and subsidiaries (the “Company”) as of December 31,
2009 and 2008, and the related consolidated statements of income, stockholders’
equity, and cash flows for each of the three years in the period ended
December 31, 2009. Our audits also included the financial statement
schedule listed in the Index at Item 15.b. These financial statements and
financial statement schedule are the responsibility of the Company’s management.
Our responsibility is to express an opinion on the financial statements and
financial statement schedule based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our
opinion, such consolidated financial statements present fairly, in all material
respects, the financial position of MEDTOX Scientific, Inc. and
subsidiaries as of December 31, 2009 and 2008, and the results of their
operations and their cash flows for each of the three years in the period ended
December 31, 2009, in conformity with accounting principles generally
accepted in the United States of America. Also, in our opinion, the financial
statement schedule, when considered in relation to the basic consolidated
financial statements taken as a whole, presents fairly, in all material
respects, the information set forth therein.
We have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the Company’s internal control over financial
reporting as of December 31, 2009, based on the criteria established in
Internal Control — Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission and our report dated
March 10, 2010, expressed an unqualified opinion on the Company’s internal
control over financial reporting.
DELOITTE
& TOUCHE LLP
Minneapolis,
Minnesota
March 10,
2010
46
MEDTOX
SCIENTIFIC, INC.
CONSOLIDATED
BALANCE SHEETS
DECEMBER
31, 2009 AND 2008
(In
thousands, except share and per share data)
2009
|
2008
|
|||||||
ASSETS
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 4,165 | $ | 4,069 | ||||
Accounts
receivable:
|
||||||||
Trade,
less allowance for doubtful accounts ($529 in 2009 and $362 in
2008)
|
14,916 | 13,304 | ||||||
Other
|
1,257 | 778 | ||||||
Total
accounts receivable
|
16,173 | 14,082 | ||||||
Inventories
|
3,593 | 3,900 | ||||||
Prepaid
expenses and other
|
1,429 | 1,353 | ||||||
Deferred
income taxes
|
3,603 | 3,612 | ||||||
Total
current assets
|
28,963 | 27,016 | ||||||
BUILDING,
EQUIPMENT AND IMPROVEMENTS, net
|
29,509 | 29,204 | ||||||
GOODWILL
|
15,967 | 15,967 | ||||||
OTHER
INTANGIBLE ASSETS, net
|
273 | 400 | ||||||
OTHER
ASSETS
|
1,405 | 939 | ||||||
TOTAL
ASSETS
|
$ | 76,117 | $ | 73,526 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 4,143 | $ | 3,712 | ||||
Accrued
expenses
|
4,670 | 5,235 | ||||||
Current
portion of long-term debt
|
302 | 677 | ||||||
Total
current liabilities
|
9,115 | 9,624 | ||||||
LONG-TERM
DEBT, net of current portion
|
- | 302 | ||||||
OTHER
LONG-TERM LIABILITIES
|
3,224 | 2,057 | ||||||
DEFERRED
INCOME TAXES, net
|
2,346 | 1,078 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Preferred
stock, $1.00 par value; authorized shares, 50,000; none issued and
outstanding
|
- | - | ||||||
Common
stock, $0.15 par value; authorized shares, 28,000,000; issued shares,
8,675,510
|
||||||||
in
2009 and 8,563,087 in 2008
|
1,301 | 1,284 | ||||||
Additional
paid-in capital
|
88,078 | 88,017 | ||||||
Accumulated
deficit
|
(22,923 | ) | (24,222 | ) | ||||
Common
stock held in trust, at cost, 367,911 shares in 2009 and
307,267 shares in 2008
|
(4,024 | ) | (3,614 | ) | ||||
Treasury
stock, at cost, 103,431 shares in 2009 and 2008
|
(1,000 | ) | (1,000 | ) | ||||
Total
stockholders' equity
|
61,432 | 60,465 | ||||||
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$ | 76,117 | $ | 73,526 |
See notes
to consolidated financial statements.
47
MEDTOX
SCIENTIFIC, INC.
CONSOLIDATED
STATEMENTS OF INCOME
YEARS
ENDED DECEMBER 31, 2009, 2008, AND 2007
(In thousands, except share
and per share data)
2009
|
2008
|
2007
|
||||||||||
REVENUES:
|
||||||||||||
Laboratory
services:
|
||||||||||||
Drugs-of-abuse
testing services
|
$ | 36,040 | $ | 40,021 | $ | 38,673 | ||||||
Clinical
& other laboratory services
|
22,885 | 19,306 | 18,099 | |||||||||
Clinical
trial services
|
6,926 | 6,800 | 4,538 | |||||||||
Product
sales
|
18,257 | 19,686 | 18,975 | |||||||||
84,108 | 85,813 | 80,285 | ||||||||||
COST
OF REVENUES:
|
||||||||||||
Cost
of services
|
45,432 | 41,665 | 36,731 | |||||||||
Cost
of sales
|
7,781 | 7,822 | 7,198 | |||||||||
53,213 | 49,487 | 43,929 | ||||||||||
GROSS
PROFIT
|
30,895 | 36,326 | 36,356 | |||||||||
OPERATING
EXPENSES:
|
||||||||||||
Selling,
general and administrative
|
26,663 | 24,327 | 23,737 | |||||||||
Research
and development
|
2,264 | 2,352 | 2,603 | |||||||||
28,927 | 26,679 | 26,340 | ||||||||||
INCOME
FROM OPERATIONS
|
1,968 | 9,647 | 10,016 | |||||||||
OTHER
INCOME (EXPENSE):
|
||||||||||||
Interest
expense
|
(17 | ) | (77 | ) | (180 | ) | ||||||
Other
income (expense)
|
96 | (914 | ) | (527 | ) | |||||||
79 | (991 | ) | (707 | ) | ||||||||
INCOME
BEFORE INCOME TAX EXPENSE
|
2,047 | 8,656 | 9,309 | |||||||||
INCOME
TAX EXPENSE
|
(748 | ) | (3,084 | ) | (2,619 | ) | ||||||
NET
INCOME
|
$ | 1,299 | $ | 5,572 | $ | 6,690 | ||||||
BASIC
EARNINGS PER COMMON SHARE
|
$ | 0.15 | $ | 0.66 | $ | 0.80 | ||||||
WEIGHTED
AVERAGE NUMBER OF BASIC SHARES
OUTSTANDING
|
8,536,768 | 8,455,092 | 8,322,092 | |||||||||
DILUTED
EARNINGS PER COMMON SHARE
|
$ | 0.15 | $ | 0.62 | $ | 0.75 | ||||||
WEIGHTED
AVERAGE NUMBER OF DILUTED SHARES
OUTSTANDING
|
8,788,663 | 8,938,213 | 8,907,320 |
See
notes to consolidated financial
statements.
|
48
MEDTOX
SCIENTIFIC, INC.
|
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
|
YEARS
ENDED DECEMBER 31, 2009, 2008, AND
2007
|
(In thousands, except
share data)
|
Common
Stock
|
||||||||||||||||||||||||||||
Shares
|
Par
Value
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Common
Stock Held in Trust
|
Treasury
Stock
|
Total
|
||||||||||||||||||||||
BALANCE
AT DECEMBER 31, 2006
|
8,213,842 | $ | 1,232 | $ | 85,683 | $ | (36,484 | ) | $ | (1,487 | ) | $ | (1,000 | ) | $ | 47,944 | ||||||||||||
Exercise
of stock options
|
340,063 | 51 | 383 | 434 | ||||||||||||||||||||||||
Traded
shares for payment of
taxes
|
(15,624 | ) | (2 | ) | (224 | ) | (226 | ) | ||||||||||||||||||||
Share-based
compensation
|
65 | 65 | ||||||||||||||||||||||||||
Purchase
of common stock for
incentive plan
|
(1,124 | ) | (1,124 | ) | ||||||||||||||||||||||||
Tax
benefit related to stock-based
compensation
plans
|
1,873 | 1,873 | ||||||||||||||||||||||||||
Net
income
|
6,690 | 6,690 | ||||||||||||||||||||||||||
BALANCE
AT DECEMBER 31, 2007
|
8,538,281 | $ | 1,281 | $ | 87,780 | $ | (29,794 | ) | $ | (2,611 | ) | $ | (1,000 | ) | $ | 55,656 | ||||||||||||
Exercise
of stock options
|
24,713 | 3 | 8 | 11 | ||||||||||||||||||||||||
Traded
shares for payment of
taxes
|
(225 | ) | (225 | ) | ||||||||||||||||||||||||
Share-based
compensation
|
13 | 13 | ||||||||||||||||||||||||||
Purchase
of common stock for
incentive
plan
|
(1,003 | ) | (1,003 | ) | ||||||||||||||||||||||||
Tax
benefit related to stock-based
compensation
plans
|
441 | 441 | ||||||||||||||||||||||||||
Share
exchange
|
93 | |||||||||||||||||||||||||||
Net
income
|
5,572 | 5,572 | ||||||||||||||||||||||||||
BALANCE
AT DECEMBER 31, 2008
|
8,563,087 | $ | 1,284 | $ | 88,017 | $ | (24,222 | ) | $ | (3,614 | ) | $ | (1,000 | ) | $ | 60,465 | ||||||||||||
Exercise
of stock options
|
114,302 | 17 | 328 | 345 | ||||||||||||||||||||||||
Traded
shares for payment of
taxes
|
(1,879 | ) | (72 | ) | (72 | ) | ||||||||||||||||||||||
Share-based
compensation
|
5 | 5 | ||||||||||||||||||||||||||
Purchase
of common stock for
incentive
plan
|
(410 | ) | (410 | ) | ||||||||||||||||||||||||
Tax
expense related to stock-based
compensation
plans
|
(200 | ) | 10 | |||||||||||||||||||||||||
Net
income
|
1,299 | 1,299 | ||||||||||||||||||||||||||
BALANCE
AT DECEMBER 31, 2009
|
8,675,510 | $ | 1,301 | $ | 88,078 | $ | (22,923 | ) | $ | (4,024 | ) | $ | (1,000 | ) | $ | 61,432 |
See notes
to consolidated financial statements.
49
MEDTOX
SCIENTIFIC, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
YEARS
ENDED DECEMBER 31, 2009, 2008, AND 2007
(In
thousands)
2009
|
2008
|
2007
|
||||||||||
CASH
FLOWS PROVIDED BY OPERATING ACTIVITIES:
|
||||||||||||
Net
income
|
$ | 1,299 | $ | 5,572 | $ | 6,690 | ||||||
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
||||||||||||
Depreciation
and amortization
|
5,437 | 4,838 | 4,031 | |||||||||
Provision
for losses on accounts receivable
|
640 | 544 | 377 | |||||||||
Loss
on sale of equipment
|
14 | 7 | 41 | |||||||||
Deferred
and stock-based compensation
|
1,172 | 390 | 764 | |||||||||
Deferred
income taxes
|
748 | 2,725 | 2,933 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Accounts
receivable
|
(2,731 | ) | (816 | ) | (3,120 | ) | ||||||
Inventories
|
307 | 10 | (372 | ) | ||||||||
Prepaid
expenses and other current assets
|
(76 | ) | (171 | ) | 132 | |||||||
Other
assets
|
(466 | ) | (397 | ) | (171 | ) | ||||||
Accounts
payable and accrued expenses
|
(833 | ) | (451 | ) | 657 | |||||||
Other
|
329 | - | - | |||||||||
Net
cash provided by operating activities
|
5,840 | 12,251 | 11,962 | |||||||||
CASH
FLOWS USED IN INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of building, equipment and improvements
|
(4,930 | ) | (8,508 | ) | (8,995 | ) | ||||||
Net
cash used in investing activities
|
(4,930 | ) | (8,508 | ) | (8,995 | ) | ||||||
CASH
FLOWS USED IN FINANCING ACTIVITIES:
|
||||||||||||
Principal
payments on long-term debt
|
(677 | ) | (677 | ) | (1,076 | ) | ||||||
Principal
payments on capital leases
|
- | - | (16 | ) | ||||||||
Purchase
of common stock for incentive plan
|
(410 | ) | (1,003 | ) | (1,124 | ) | ||||||
Net
proceeds from the exercise of stock options
|
345 | 11 | 434 | |||||||||
Payment
of taxes from traded shares
|
(72 | ) | (225 | ) | (226 | ) | ||||||
Net
cash used in financing activities
|
(814 | ) | (1,894 | ) | (2,008 | ) | ||||||
INCREASE
IN CASH AND CASH EQUIVALENTS
|
96 | 1,849 | 959 | |||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF YEAR
|
4,069 | 2,220 | 1,261 | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF YEAR
|
$ | 4,165 | $ | 4,069 | $ | 2,220 | ||||||
SUPPLEMENTAL
DISCLOSURES OF CASH FLOW INFORMATION:
|
||||||||||||
Cash
paid during the year for:
|
||||||||||||
Interest
|
$ | 19 | $ | 84 | $ | 190 | ||||||
Income
taxes
|
49 | 405 | 688 | |||||||||
Supplemental
noncash activities:
|
||||||||||||
Asset
additions and related obligations in payables
|
$ | 1,239 | $ | 541 | $ | 2,099 |
See notes
to consolidated financial statements.
50
MEDTOX
SCIENTIFIC, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
YEARS
ENDED DECEMBER 31, 2009, 2008, AND 2007
1.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
The Company –
The consolidated financial statements include the accounts of MEDTOX Scientific,
Inc. and its wholly-owned subsidiaries: MEDTOX Laboratories, Inc. (MEDTOX
Laboratories), MEDTOX Diagnostics, Inc. (MEDTOX Diagnostics) and New Brighton
Business Center, LLC (NBBC) (collectively referred to as the
"Company").
MEDTOX
Laboratories provides drugs-of-abuse testing services; clinical & other
laboratory services, which include clinical toxicology, clinical testing for
occupational health clinics, clinical testing for physician offices, pediatric
lead testing, heavy metals analyses, courier delivery, and medical surveillance;
and clinical trial services which include central laboratory services, assay
development, bio-analytical, bio-equivalence and pharmacokinetic
testing.
MEDTOX
Diagnostics is engaged in the research, development and sale of products based
upon enzyme immunoassay technology for the detection of antibiotic residues,
mycotoxins, drugs-of-abuse and other hazardous substances as well as
distribution of agridiagnostic and food safety testing products.
NBBC
conducts the Company’s building rental activities that are not related to the
Company’s operations. The operations of NBBC are shown in the
statements of operations as “other expense”.
All
significant intercompany transactions and balances have been
eliminated.
Use of Estimates - The
preparation of the consolidated financial statements in conformity with
accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the amounts
reported in the consolidated financial statements and accompanying
notes. The more significant estimates include the valuation of
accounts receivable, inventories, goodwill and other intangible assets, deferred
income taxes and the recorded amounts for certain accruals. Actual
results could differ from those estimates.
Cash and Cash Equivalents
–
Cash equivalents include highly liquid investments with original maturities of
three months or less from the date of purchase.
Trade Accounts
Receivable – Sales are made to local
and national customers including corporations, clinical laboratories, government
agencies, medical professionals, law enforcement agencies and health care
facilities. The Company extends credit based on an evaluation of the
customer’s financial condition, and receivables are generally
unsecured. The Company provides an allowance for doubtful accounts
equal to the estimated losses expected to be incurred in the collection of
accounts receivable. In addition, some of the Company’s Laboratory
Services revenues for certain types of tests are billed to third-party payers
including insurance companies, state Medicaid and Medicare agencies. These
payers pay for such services at established amounts, which are typically lower
than gross amounts billed by the Company. The Company estimates a
discount on the billings for these tests, and recognizes revenues and related
accounts receivable at a net amount after discount in order to state revenues
and accounts receivable at the amount expected to be paid.
51
Inventories - Inventories are
valued at the lower of cost (first-in, first-out method) or market.
Equipment and Improvements
–
Equipment and improvements are stated at cost. Provisions for
depreciation have been computed using the straight-line method to amortize the
cost of depreciable assets over their estimated useful lives as
follows:
Furniture
and equipment: 3 – 10 years
Building
and improvements: 10 – 39 years
Leasehold
improvements: lesser of 10 years or life of lease
Goodwill and Other Intangible
Assets
– The Company reviews goodwill and indefinite-lived intangible assets for
impairment at least annually and between annual test dates in certain
circumstances. The Company performs its annual impairment test for
goodwill and other intangible assets in the fourth quarter of each year after
the Company’s annual forecasting process. No impairments were
indicated as a result of the annual impairment reviews for goodwill and other
intangible assets in 2009, 2008 or 2007. In assessing the
recoverability of goodwill and other intangible assets, projections regarding
estimated future cash flows and other factors are made to determine the fair
value of the respective assets. If these estimates or related
projections change in the future, the Company may be required to record
impairment charges for these assets.
Goodwill
and other intangible assets are allocated to the Company’s reporting units,
which are either the operating segment or one reporting level below the
operating segment. The Company compares the fair value of the
reporting unit to its carrying amount on an annual basis to determine if there
is potential impairment. If the fair value of the reporting unit is
less than its carrying value, impairment is indicated to the extent that the
fair value of the goodwill and other intangible assets within the reporting unit
is less than their carrying value. If the carrying amount of the
goodwill and other intangible assets exceeds their fair value, an impairment
loss is recognized. Fair values for the reporting units and other
intangible assets are determined based on discounted cash flows.
Amortizable
intangible assets consist of customer lists, technology, patents and trademarks
and are amortized on a straight-line or accelerated basis based upon estimated
useful or contractual lives, ranging from 5 to 20 years.
Revenue Recognition -
Revenues from Laboratory Services are recognized as earned at such time as the
Company has completed services. The Company’s services are considered
to be complete when it has performed the applicable laboratory testing services
and the results have been sent to the Company’s customers or posted to the
Company’s secure website.
Some of
our Laboratory Services revenues for certain types of tests are billed to
third-party payers including insurance companies, state Medicaid and Medicare
agencies. These payers pay for such services at established amounts,
which are typically lower than gross amounts billed by us. However,
the tests are sometimes billed directly to patients or other parties and paid at
the gross amount billed for these tests. In addition, billings for
the tests are occasionally re-billed to alternative payers in situations where
incorrect billing information was submitted to us by the
customer. Historically, the amounts of such incorrect billings have
not been material. We estimate a discount on the billings for these
tests and recognize revenues and related accounts receivable at a net amount,
after discount, in order to state revenues and accounts receivable at the amount
expected to be paid. While we believe that estimated discounts and the related
net revenues and net accounts receivable from these testing services are
materially correct, there can be differences in amounts ultimately paid compared
to estimated amounts. These differences are recorded upon payment and
may affect previously recorded amounts. We consider contracted rates
with payers and historical discounts when estimating future discounts on a
monthly basis.
52
Revenues
from Product Sales are recognized FOB shipping point net of an allowance for
estimated returns. When shipment occurs, the sales price is fixed and
determinable, and collection of the resulting receivable is reasonably
assured.
Freight
charges to customers are included in product sales and freight costs are
included in cost of sales.
Research and Development –
Research and development expenditures are charged to expense as
incurred.
Income Taxes – The Company
uses the liability method of accounting for income taxes. Under this
method, deferred tax assets and liabilities are determined based on differences
between the financial reporting and tax bases of assets and liabilities and are
measured using the enacted tax rates and laws that will be in effect when the
differences are expected to reverse.
The
Company recognizes in its financial statements the tax benefit from an uncertain
tax position only if it is more likely than not that the tax position will be
sustained on examination by the taxing authorities, based on the technical
merits of the position.
Share-Based Compensation –
The Company recognizes compensation expense related to the cost of
employee services received in exchange for Company equity interests over the
award’s vesting period based on the award’s fair value at the date of
grant.
Earnings per Common Share
– Basic earnings per common
share equals net earnings divided by the weighted average common shares
outstanding during the period. Diluted earnings per common share
equals net earnings divided by the sum of weighted average common shares
outstanding during the period plus common stock equivalents. Common
stock equivalents are shares assumed to be issued if outstanding stock options
or warrants were exercised. Common stock equivalents that are
anti-dilutive are excluded from net earnings per common share.
Fair Value of Financial Instruments
– The carrying
amounts of cash and cash equivalents, accounts receivable, accounts payable, and
accrued expenses are considered to be representative of their respective fair
values due to their short-term nature. The carrying amount of our
long-term debt approximated fair value at December 31, 2009 and
2008. The fair value of the Company’s debt was estimated using
interest rates that are representative of debt with similar terms and
maturities.
Concentrations of Credit Risk
– Concentrations of credit risk with respect to accounts receivable are limited
due to the diversity of the Company’s clients as well as their dispersion across
many different geographic regions. The Company had no customers that
accounted for more than 10% of consolidated revenues in 2009, 2008, or 2007 or
accounts receivable at December 31, 2009 or 2008.
Comprehensive Income –
Comprehensive income is a measure of all non-owner changes in shareholders’
equity and includes such items as net income, certain foreign currency
translation items, minimum pension liability adjustments, and changes in the
value of available-for-sale securities. In 2009, 2008, and 2007,
comprehensive income for the Company was equal to net income as
reported.
New
Accounting Standards – In June 2009, the Financial
Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC)
105-10, “The FASB Accounting Standards Codification and the Hierarchy of
Generally Accepted Accounting Principles”. This Statement modifies the
Generally Accepted Accounting Principles (GAAP) hierarchy by establishing only
two levels of GAAP, authoritative and nonauthoritative accounting
literature. Effective July 2009, the FASB ASC, also known
collectively as the “Codification,” is considered the single source of
authoritative U.S. accounting and reporting standards, except for additional
authoritative rules and interpretive releases issued by the SEC.
Nonauthoritative guidance and literature would include, among other things, FASB
Concepts Statements, American Institute of Certified Public Accountants Issue
Papers and Technical Practice Aids and accounting textbooks. The
Codification was developed to organize GAAP pronouncements by topic so that
users can more easily access authoritative accounting
guidance. The Company adopted this Statement effective July 1,
2009 and accordingly all accounting references have been updated and SFAS
references have been replaced with ASC references.
53
In May
2009, the FASB issued ASC 855-10, “Subsequent Events”. ASC
855-10 provides guidance on management’s assessment of subsequent events and
incorporates this guidance into accounting literature. ASC 855-10 is
effective prospectively for interim and annual periods ending after June 15,
2009. The adoption of this Statement did not have an impact on our
financial position or results of operations. Effective February 24,
2010, the FASB modified its guidance related to subsequent events and the
Company has adopted the change. This guidance continues to require entities that
file or furnish financial statements with the SEC to evaluate subsequent events
through the date the financial statements are issued; however, this guidance
removed the requirement for these entities to disclose the date through which
events have been evaluated. The adoption of this guidance did not have an effect
on the results of operations or financial position of the Company.
2.
|
SEGMENTS
|
The
Company has two reportable segments: Laboratory Services and Product
Sales. The Laboratory Services segment consists of MEDTOX
Laboratories and NBBC. Services provided include drugs-of-abuse
testing services; clinical & other laboratory services, which include
clinical toxicology, clinical testing for occupational health clinics, clinical
testing for physician offices, pediatric lead testing, heavy metals analyses,
courier delivery, and medical surveillance; and clinical trial services which
include central laboratory services, assay development, bio-analytical,
bio-equivalence and pharmacokinetic testing. The Product Sales
segment, which includes POCT (point-of-collection testing) disposable diagnostic
devices, consists of MEDTOX Diagnostics, Inc. Products manufactured
include easy to use, inexpensive, on-site drug tests such as PROFILE®-II,
PROFILE®-II
A, PROFILE®-III,
PROFILE®-III
A, PROFILE-II ER®,
PROFILE®-III
ER, PROFILE®-IV,
PROFILE®-V,
MEDTOXScan®,
VERDICT®-II
and SURE-SCREEN®,
in addition to a variety of other diagnostic tests for the detection of
alcohol. MEDTOX Diagnostics also provides contract manufacturing
services in its Food and Drug Administration (FDA) registered/ISO 13845
certified facility.
The
Company’s reportable segments are strategic business units that offer different
products and services. They are managed separately as each business requires
different products, services and marketing strategies.
In
evaluating financial performance, management focuses on income from operations
as a segment’s measure of profit or loss. The accounting policies of
the segments are the same as those described in the summary of significant
accounting policies (see Note 1).
The
following is a summary of certain segment information for the years ended
December 31:
(In
thousands)
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Laboratory
Services:
|
||||||||||||
Revenues
|
$ | 65,851 | $ | 66,127 | $ | 61,310 | ||||||
Depreciation and amortization
|
4,744 | 4,211 | 3,458 | |||||||||
Income (loss) from operations
|
(1,037 | ) | 5,364 | 6,387 | ||||||||
Segment assets
|
60,630 | 59,812 | 56,430 | |||||||||
Capital expenditures for segment assets
|
4,561 | 7,322 | 7,951 |
54
2009 | 2008 | 2007 | ||||||||||
Product
Sales:
|
||||||||||||
Revenues
|
$ | 18,257 | $ | 19,686 | $ | 18,975 | ||||||
Depreciation and amortization
|
693 | 627 | 573 | |||||||||
Income from operations
|
3,005 | 4,283 | 3,629 | |||||||||
Segment assets
|
11,884 | 10,102 | 8,701 | |||||||||
Capital expenditures for segment assets
|
369 | 1,186 | 1,044 | |||||||||
Corporate
(unallocated):
|
||||||||||||
Other income (expense)
|
$ | 79 | $ | (991 | ) | $ | (707 | ) | ||||
Net deferred tax assets
|
3,603 | 3,612 | 4,818 | |||||||||
Company:
|
||||||||||||
Revenues
|
$ | 84,108 | $ | 85,813 | $ | 80,285 | ||||||
Depreciation and amortization
|
5,437 | 4,838 | 4,031 | |||||||||
Income from operations
|
1,968 | 9,647 | 10,016 | |||||||||
Other income (expense)
|
79 | (991 | ) | (707 | ) | |||||||
Income before income taxes
|
2,047 | 8,656 | 9,309 | |||||||||
Total assets
|
76,117 | 73,526 | 69,949 | |||||||||
Capital expenditures for assets
|
4,930 | 8,508 | 8,995 |
The
following is a summary of revenues from external customers for each group of
products and services provided within the Product Sales segment for the years
ended December 31:
(In
thousands)
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
POC
on-site testing products
|
$ | 16,431 | $ | 17,787 | $ | 16,632 | ||||||
Contract
manufacturing services
|
1,391 | 1,469 | 1,437 | |||||||||
Other
diagnostic products
|
435 | 430 | 906 | |||||||||
$ | 18,257 | $ | 19,686 | $ | 18,975 |
3.
|
INVENTORIES
|
Inventories
consisted of the following at December 31:
(In
thousands)
|
2009
|
2008
|
||||||
Raw
materials
|
$ | 653 | $ | 958 | ||||
Work
in process
|
400 | 358 | ||||||
Finished
goods
|
360 | 418 | ||||||
Supplies,
including off-site inventory
|
2,180 | 2,166 | ||||||
$ | 3,593 | $ | 3,900 |
4.
|
GOODWILL
AND OTHER INTANGIBLE ASSETS
|
Intangible
assets, resulting primarily from acquisitions, include the value assigned to
customer lists, trademarks and goodwill. Amortizable intangible
assets are amortized on a straight-line or accelerated basis based upon their
estimated useful lives.
55
The
entire amount of goodwill is included in the Laboratory Services segment, which
is tested annually for impairment during the fourth quarter after the Company’s
annual forecasting process. No goodwill impairment was recognized in
2009, 2008 or 2007. There were no other changes in the carrying
amount of goodwill in 2009, 2008 or 2007.
The
components of other intangible assets were as follows at December
31:
(In
thousands)
|
2009
|
2008
|
|||||||||||||||||||||||
Weighted
average
useful
life
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
Carrying
Amount
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
Carrying
Amount
|
|||||||||||||||||||
Amortizable
intangible assets:
|
|||||||||||||||||||||||||
Customer
lists
|
11.1
years
|
2,416 | (2,188 | ) | 228 | 2,671 | (2,323 | ) | 348 | ||||||||||||||||
Trademarks
and other
|
13.7
years
|
87 | (42 | ) | 45 | 87 | (35 | ) | 52 | ||||||||||||||||
Total
|
11.2
years
|
$ | 2,503 | $ | (2,230 | ) | $ | 273 | $ | 2,758 | $ | (2,358 | ) | $ | 400 |
Amortization
expense for amortizable intangible assets was approximately $127,000, $215,000
and $290,000 during 2009, 2008 and 2007, respectively. Future
amortization expense for amortizable intangible assets is estimated to be as
follows for the years ending December 31:
(In
thousands)
|
||||
2010
|
$ | 75 | ||
2011
|
48 | |||
2012
|
21 | |||
2013
|
19 | |||
2014
|
15 | |||
2015
and thereafter
|
95 | |||
$ | 273 |
5.
|
BUILDING,
EQUIPMENT AND IMPROVEMENTS
|
Building,
equipment and improvements consisted of the following at December
31:
(In
thousands)
|
2009
|
2008
|
||||||
Furniture
and equipment
|
$ | 35,107 | $ | 30,798 | ||||
Building
and improvements
|
8,490 | 8,490 | ||||||
Leasehold
improvements
|
7,523 | 7,212 | ||||||
51,120 | 46,500 | |||||||
Less
accumulated depreciation
|
(21,611 | ) | (17,296 | ) | ||||
$ | 29,509 | $ | 29,204 |
Depreciation
expense was approximately $5.3 million, $4.6 million and $3.7 million during
2009, 2008 and 2007, respectively.
56
6.
|
ACCRUED
EXPENSES
|
Accrued
expenses consisted of the following at December 31:
(In
thousands)
|
2009
|
2008
|
||||||
Accrued
clinic fees
|
$ | 1,300 | $ | 1,573 | ||||
Accrued
bonus
|
- | 415 | ||||||
Accrued
salaries, wages and commissions
|
1,571 | 1,266 | ||||||
Accrued
health insurance
|
337 | 581 | ||||||
Other
accrued expenses
|
1,462 | 1,400 | ||||||
$ | 4,670 | $ | 5,235 |
7.
|
DEBT
|
Long-term
debt consisted of the following at December 31:
(In
thousands)
|
2009
|
2008
|
||||||
Term
loan, due April 2011, 2.75% at December 31, 2009
|
$ | 302 | $ | 979 | ||||
Less
current portion
|
(302 | ) | (677 | ) | ||||
$ | - | $ | 302 |
Wells Fargo Credit Agreement
– The Company is party to a credit security agreement (the "Wells Fargo Credit
Agreement") with Wells Fargo Bank, National Association (the
“Bank”). The Wells Fargo Credit Agreement, as amended, consists of a
revolving line of credit ("Line of Credit") of up to $8.0 million bearing
interest at a fluctuating rate of 2.25% above the daily three month LIBOR, as
defined and calculated by the Bank.
Subject
to certain conditions, the Wells Fargo Credit Agreement also provides for the
issuance of letters of credit which, if drawn upon, would be deemed advances
under the Line of Credit. We are required to pay a fee equal to 0.25%
per annum on the average daily unused amount of the Line of
Credit. We have granted the Bank a first priority security interest
in all of the Company’s accounts receivable, other rights to payment, general
intangibles, inventory, and equipment to secure all indebtedness of the Company
to the Bank.
Extensions
of credit under the Wells Fargo Credit Agreement are subject to certain
conditions. The Wells Fargo Credit Agreement also requires us to
comply with certain financial covenants, including maintaining, on a
consolidated basis:
·
|
Tangible
Net Worth not less than $40,000,000 at any time, with “Tangible Net Worth”
defined as the aggregate of total stockholders’ equity plus subordinated
debt less any intangible assets.
|
·
|
Current
Ratio not less than 1.3 to 1.0 at each month end, with “Current Ratio”
defined as total current assets divided by total current
liabilities.
|
·
|
Total
Liabilities divided by Tangible Net Worth not greater than 1.75 to 1.0 at
any time, with “Total Liabilities” defined as the aggregate of current
liabilities and non-current liabilities less subordinated debt, and with
“Tangible Net Worth” as defined
above.
|
·
|
A
Debt Service Coverage Ratio not less than 1.5 to 1.0 as of each fiscal
quarter end, determined on a rolling four-quarter basis, with “Debt
Service Coverage Ratio” defined as the aggregate of net income before
non-cash tax expense plus depreciation expense and amortization expense,
divided by the aggregate of the current maturity of long-term debt for the
previous four fiscal quarters plus current capital lease obligations for
the previous four fiscal quarters.
|
57
The
Company did not have any borrowings during 2009 under its revolving line of
credit. The weighted average interest rate on borrowings outstanding
during the year under the revolving line of credit was 4.9% and 7.8% during
2008, and 2007, respectively.
Term Loan – The Company has a
Term Note (the "Note") with the Bank for $3.4 million of which $0.3 million was
outstanding at December 31, 2009. The Note requires payment over a
five year term in monthly installments of approximately $56,000 plus interest,
commencing May 2006. Interest is calculated at either (i) a variable
rate of 0.5% below the prime rate or (ii) a fixed rate of 1.9% above LIBOR in
effect on the first day of the applicable fixed rate term.
8.
|
STOCK
BASED-COMPENSATION
|
The
Company has adopted stock-based compensation plans to provide incentives to
eligible employees, officers and directors in the form of incentive stock
options, nonqualified stock options, stock appreciation rights, stock awards,
performance shares and other stock-based awards. All of
the Company’s stock-based compensation plans expired in 2003, and no options or
awards are available for future grant, except as inducement grants to new
employees of the Company.
The
Company recorded approximately $5,000, $13,000 and $65,000 in total share-based
compensation expense for stock options and stock awards in 2009, 2008, and 2007,
respectively.
Stock Options - The
Compensation Committee of the Board of Directors determines the exercise price
(not to be less than the fair market value of the underlying stock) of stock
options at the date of grant. Options generally become exercisable in
installments over a period of one to five years and expire ten years from the
date of grant. The Company estimated the fair value of its stock
options using the Black-Scholes option-pricing model. There were no
options granted during 2009, 2008 or 2007.
The
following table summarizes the stock option transactions for 2009:
Number
of Shares Underlying Options
|
Weighted-Average
Exercise Price of Options
|
Weighted-Average
Remaining Contractual Life
of
Options
|
Aggregate
Intrinsic Value of Options
|
|||||||
(In
thousands)
|
||||||||||
Outstanding
at December 31, 2008
|
714,067 | $ | 4.49 | |||||||
Granted
|
- | - | ||||||||
Exercised
|
(138,849 | ) | $ | 3.58 | ||||||
Forfeited/cancelled
|
- | - | ||||||||
Outstanding,
vested and exercisable at December 31, 2009
|
575,218 | $ | 4.70 |
2.52
|
$ 1,752
|
The
aggregate intrinsic value of options outstanding at December 31, 2009, is
calculated as the difference between the market price of the Company’s common
stock at December 31, 2009, and the exercise price of the underlying options,
multiplied by the number of in-the-money options. The total intrinsic
value of options exercised was approximately $546,000, $615,000 and $6,056,000
in 2009, 2008, and 2007, respectively. Cash received from option
exercises was approximately $345,000, $11,000, and $434,000, in 2009, 2008, and
2007, respectively.
58
Stock Awards - Stock awards
are issued to certain key employees and directors of the Company as an incentive
for the performance of future services that will contribute materially to the
successful operation of the Company. Owners of stock awards have the
rights of shareowners, including the right to vote. Stock awards are
awarded with a fixed restriction period of three to five years. The
market value of the awards on the date of the grant was recorded as deferred
stock-based compensation and additional paid-in capital.
Compensation
is charged to operations on a straight-line basis over the restriction periods
and amounted to approximately $5,000, $13,000 and $64,000, in 2009, 2008, and
2007, respectively.
A summary
of the status of the Company’s non-vested stock awards at December 31, 2009 and
changes during 2008 is presented below:
Stock
Award Shares
|
Weighted-Average
Grant Date Fair Value
|
|||||||
Outstanding
at December 31, 2008
|
5,000 | $ | 7.18 | |||||
Granted
|
- | - | ||||||
Vested
|
(5,000 | ) | $ | 7.18 | ||||
Forfeited
|
- | - | ||||||
Outstanding
and expected to vest at December 31, 2009
|
- | - |
The total
fair value of stock awards vested was approximately $45,000, $844,000, and
$1,091,000 in 2009, 2008, and 2007, respectively.
9.
|
STOCKHOLDERS’
EQUITY
|
Long-Term Incentive Plan
- In
2009, 2008 and 2007, the Company repurchased 60,644, 63,140 and 66,703 shares of
the Company’s common stock, respectively, at a cost of $410,000, $1,003,000 and
$1,124,000, respectively. The shares repurchased were placed in trust
to fund the Long-Term Incentive Plan.
At
December 31, 2009, 575,218 shares of common stock were reserved for future
issuances related to the exercise of stock options previously granted under the
stock option plans discussed in Note 8.
59
10.
|
EARNINGS
PER SHARE
|
The
following table sets forth the computation of basic and diluted earnings per
common share for the years ended December 31:
(In
thousands, except share and per share data)
|
2009
|
2008
|
2007
|
|||||||||
Net
income (A)
|
$ | 1,299 | $ | 5,572 | $ | 6,690 | ||||||
Weighted
average number of basic common shares outstanding (B)
|
8,536,768 | 8,455,092 | 8,322,092 | |||||||||
Dilutive
effect of stock options computed based on the treasury stock method using
average market price
|
251,895 | 483,121 | 585,228 | |||||||||
Weighted
average number of diluted common shares outstanding (C)
|
8,788,663 | 8,938,213 | 8,907,320 | |||||||||
Basic
earnings per common share (A/B)
|
$ | 0.15 | $ | 0.66 | $ | 0.80 | ||||||
Diluted
earnings per common share (A/C)
|
$ | 0.15 | $ | 0.62 | $ | 0.75 |
11.
|
INCOME
TAXES
|
Income
tax expense was as follows for the years ended December
31:
|
||||||||||||
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
Current:
|
||||||||||||
Federal
|
$ | (298 | ) | $ | 341 | $ | 339 | |||||
State
and local
|
(22 | ) | 25 | (360 | ) | |||||||
Deferred
|
1,068 | 2,718 | 2,640 | |||||||||
$ | 748 | $ | 3,084 | $ | 2,619 |
Following
is a reconciliation of federal income tax at the statutory rate of 34% to the
actual income taxes provided for the years ended December 31:
(In
thousands)
|
2009
|
2008
|
2007
|
|||||||||
Computed
expected federal income tax expense (benefit)
|
$ | 696 | $ | 2,943 | $ | 3,165 | ||||||
State
tax, net of federal effect
|
52 | 216 | 233 | |||||||||
Additional
net operating loss carryforwards
|
- | - | (141 | ) | ||||||||
Settlement
of state examination
|
- | - | (384 | ) | ||||||||
Other,
net
|
- | (75 | ) | (254 | ) | |||||||
$ | 748 | $ | 3,084 | $ | 2,619 |
In 2007,
the Company recorded a $141,000 tax benefit from additional net operating loss
carryforwards determined to be available to the Company.
Deferred
income taxes reflect the tax effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and
the amounts used for income tax purposes. Significant components of the
Company’s deferred assets (liabilities) were as follows at December
31:
60
(In
thousands)
|
2009
|
2008
|
||||||
Deferred
income tax assets:
|
||||||||
Accounts
receivable allowances
|
$ | 298 | $ | 444 | ||||
Inventories
|
133 | 159 | ||||||
Accrued
expenses
|
430 | 557 | ||||||
Research
and experimental credit carryforwards
|
602 | 537 | ||||||
Federal
alternative minimum tax credit carryforwards
|
106 | 441 | ||||||
Net
operating loss carryforwards
|
3,086 | 2,666 | ||||||
Other
|
1,165 | 751 | ||||||
Total
deferred tax assets
|
5,820 | 5,555 | ||||||
Deferred
income tax liabilities:
|
||||||||
Building,
equipment and improvements
|
(999 | ) | (188 | ) | ||||
Goodwill
and other intangible assets
|
(3,564 | ) | (2,833 | ) | ||||
Total
deferred tax liabilities
|
(4,563 | ) | (3,021 | ) | ||||
Net
deferred tax assets
|
$ | 1,257 | $ | 2,534 |
At
December 31, 2009, the Company had federal net operating loss carryforwards
(NOLs) of approximately $9.0 million, which are available to offset future
taxable income. The Company's federal NOLs expire in varying amounts each
year from 2018 through 2028 in accordance with applicable federal tax
regulations and the timing of when the NOLs were incurred. Section 382 of
the Internal Revenue Code restricts the annual utilization of certain NOLs
incurred prior to a change in ownership. However, such limitation is not
expected to impair the realization of these NOLs. In the future,
subsequent revisions to the estimated net realizable value of these deferred tax
assets could cause the provision for income taxes to vary significantly from
period to period, although the Company’s cash payments would remain unaffected
until the benefit of the NOLs is completely utilized or expires
unused.
In 2009,
the Company utilized $200,000 of deferred tax assets associated with restricted
stock and stock options and recorded a corresponding reduction to additional
paid-in capital in stockholder’s equity in the accompanying consolidated balance
sheet. In 2008, income tax benefits attributable to share-based
compensation of approximately $441,000 were allocated as an increase to
additional paid-in capital.
In 2007,
the Company decreased its unrecognized tax benefits by $331,000 due to the tax
benefit from the favorable resolution of the North Carolina Department of
Revenue examination of MEDTOX Diagnostics, Inc. The decrease was
recorded as a benefit to income tax expense. The Company does not
have any unrecognized tax benefits at December 31, 2009 or 2008.
The tax
years 2003-2008 remain open to examination by the major taxing jurisdictions to
which the Company is subject.
The
Company records income tax related interest expense, interest income and
penalties in income tax expense in its Consolidated Statements of
Income. The Company did not have any accrued interest related to
uncertain tax positions at December 31, 2009 or 2008.
61
12.
|
EMPLOYEE
BENEFIT PLANS
|
Retirement Savings Plan - The
Company has a defined contribution benefit plan that covers substantially all
employees who meet certain age and length of service
requirements. Contributions to the plan are at the discretion of the
Company’s Board of Directors. The 401(k) expense was approximately
$316,000, $222,000 and $125,000 in 2009, 2008 and 2007,
respectively.
Long-Term Incentive Plan (LTIP)
- The Company adopted the LTIP to provide performance-based compensation
to selected officers of the Company and compensation to non-employee members of
the Board of Directors. Under the LTIP, an officer becomes eligible
for an annual long-term incentive contribution amount based upon performance
objectives established by the Compensation Committee of the Board of
Directors. A non-employee director receives 50% of his or her annual
retainer in the form of an annual LTIP contribution. Annual
contribution amounts for both officers and directors are subject to three to
five year restriction periods with a risk of forfeiture if a participant
terminates service prior to becoming vested. Participants may elect
to allocate LTIP awards in investment options authorized by the Committee,
including shares of the Company’s common stock.
The
Compensation Committee determined the total 2009, 2008 and 2007 contribution
amounts to be $410,000, $1,070,000 and $1,124,000, respectively, allocated among
all participants. To fund the 2009 and 2007 contribution amounts, the
Company purchased 60,644 and 66,703 shares, respectively, of its own stock,
which were contributed to a grantor trust. To fund the 2008
contribution amount, the Company purchased $1,003,000 or 63,140 shares of its
own stock and $67,000 of money market funds, which were contributed to a grantor
trust. The acquired stock was recorded at historical cost and
classified as common stock held in trust in stockholders’ equity in the
accompanying consolidated balance sheet. In 2008, the purchase of the
money market funds was recorded in other assets in the accompanying consolidated
balance sheet. The Company records compensation expense on a
straight-line basis over the three to five year vesting periods, which is
recorded as a deferred compensation obligation in other long-term liabilities in
the accompanying consolidated balance sheet. The Company recorded
approximately $714,000, $553,000 and $513,000 of compensation expense (recorded
in selling, general and administrative expenses) in 2009, 2008 and 2007,
respectively, in conjunction with the LTIP.
Supplemental Executive Retirement
Plan (SERP) – The Company adopted the SERP, which provides supplemental
retirement benefits and allows deferral of a portion of base salary and
performance based short-term bonuses for selected officers of the
Company. The annual supplemental retirement contribution amount to
which an officer is entitled for a plan year is a discretionary amount
determined by the Compensation Committee of the Board of Directors. Under the
SERP, supplemental retirement benefit contribution amounts vest over one to
three year periods.
The
Compensation Committee determined the 2009, 2008 and 2007 contribution amounts
to be $235,000, $242,000 and $225,000, respectively, allocated among all
participants. The plan participants elected to allocate their
contribution amounts for all years into investment options consisting of various
marketable equity securities. The deferred compensation was recorded
as a marketable equity security in other assets in the accompanying consolidated
balance sheet. The Company recorded compensation expense (recorded in
selling, general and administrative expenses) of $159,000,
$81,000 and $225,000 in 2009, 2008 and 2007, respectively, which was classified
as a deferred compensation obligation in other long-term liabilities in the
accompanying consolidated balance sheet. The deferred compensation
liability was increased $294,000 in 2009 with a corresponding charge to
compensation expense, to reflect the change in the fair value of the amount owed
to the participant. The fair value of the marketable equity security
also increased $294,000 in 2009 to reflect the investment earnings (recorded in
other expense). In 2008 and 2007, the deferred compensation
liability was reduced $257,000 and $39,000, respectively, with a corresponding
credit to compensation expense, to reflect the change in the fair value of the
amount owed to the participant. The fair value of the marketable
equity security also decreased approximately $257,000 and $39,000 in 2008 and
2007, respectively, to reflect the investment loss.
62
13.
|
COMMITMENTS
AND CONTINGENCIES
|
Leases - The Company leases
office and research facilities from a director under a fixed term operating
lease. Rental payments to the director were approximately $349,000,
$779,000, and $424,000 during 2009, 2008, and 2007, respectively. In
January 2008, the Company prepaid approximately $430,000 of the lease agreement
for the office and research facilities leased from the director, which is
included in the 2008 rental payment.
The
Company leases other offices and facilities and office equipment under certain
operating leases, which expire on various dates through March
2016. Under the terms of the facility leases, a pro rata share of the
facilities’ operating expenses and real estate taxes are charged as additional
rent.
At
December 31, 2009, the Company was obligated for future minimum lease payments
without regard to sublease payments under noncancelable leases as follows for
the years ending December 31:
(In
thousands)
|
||||
Operating
Leases
|
||||
2010
|
$ | 655 | ||
2011
|
531 | |||
2012
|
512 | |||
2013
|
349 | |||
2014
|
349 | |||
2015
and thereafter
|
436 | |||
$ | 2,832 |
Rent
expense (including amounts for the facilities leased from the director) amounted
to $0.8 million, $1.7 million, and $1.6 million during 2009, 2008, and 2007,
respectively.
Legal - The Company is party
to various legal proceedings arising in the normal course of business
activities, none of which, in the opinion of management, are expected to have a
material adverse impact on the Company's consolidated financial position or
results of operations.
14.
|
RELATED
PARTY TRANSACTIONS
|
In March
2001, the Company entered into a 10-year lease of the Burlington, North Carolina
production facility for an annual base rent of $197,000, exclusive of operating
expenses. In addition, under the lease $600,000 of tenant
improvements made to the building by the Company are being amortized over the
life of the lease as additional rent. The Company received $300,000
for reimbursement of tenant improvements completed in 2001. Effective
February 2003, the Company entered into a month-to-month lease of a warehousing
and distribution facility in an adjacent building for a monthly rent of $9,400,
exclusive of operating expenses. These facilities have always been
owned and leased to the Company by a director of the Company. In
2003, the Company completed additional tenant improvements to the premises of
$300,000. In November 2003, the Company amended and restated these
leases. Under the terms of the amended and restated lease, the
original leases have been combined and the expiration of the amended and
restated lease has been extended to March 31, 2016. In January 2008, the
Company prepaid approximately $430,000 of the lease agreement for the facilities
leased from the director relating to the leasehold improvements after
determining that the prepayment would be financially beneficial to the
Company. The prepayment was recorded as prepaid rent in other assets
(long-term) in the accompanying consolidated balance sheet and will continue to
be amortized over the remaining life of the lease as additional
rent. In 2009, the annual base rent was approximately
$401,000, exclusive of operating expenses, and including a Consumer Price Index
adjustment and amortization of the $600,000 of improvements. The
Company believes it is renting these facilities on terms similar to those
available from third parties for equivalent premises based upon review of
prevailing market rates at the time of lease renewal.
63
15.
|
QUARTERLY
INFORMATION (UNAUDITED)
|
(In
thousands, except per share amounts)
2009
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
||||||||||||
Revenues
|
$ | 20,658 | $ | 21,332 | $ | 22,261 | $ | 19,857 | ||||||||
Gross
profit
|
7,643 | 7,666 | 8,686 | 6,900 | ||||||||||||
Net
income (loss)
|
420 | 311 | 758 | (190 | ) | |||||||||||
Basic
earnings (loss) per share
|
0.05 | 0.04 | 0.09 | (0.02 | ) | |||||||||||
Diluted
earnings (loss) per share
|
0.05 | 0.04 | 0.09 | (0.02 | ) |
2008
|
First
Quarter
|
Second
Quarter
|
Third
Quarter
|
Fourth
Quarter
|
||||||||||||
Revenues
|
$ | 20,705 | $ | 21,877 | $ | 22,410 | $ | 20,821 | ||||||||
Gross
profit
|
9,172 | 9,499 | 9,432 | 8,223 | ||||||||||||
Net
income
|
1,587 | 1,928 | 1,644 | 413 | ||||||||||||
Basic
earnings per share
|
0.19 | 0.23 | 0.20 | 0.05 | ||||||||||||
Diluted
earnings per share
|
0.18 | 0.22 | 0.19 | 0.05 |
64
SCHEDULE
II-VALUATION AND QUALIFYING ACCOUNTS
Balance
at Beginning
of
Period
|
Charged
to
Costs
and
Expenses
|
Deductions
|
Balance
at
the
End of
Period
|
|||||||||||||||||
Year
ended December 31, 2009
|
||||||||||||||||||||
Allowance
for Doubtful Accounts
|
$ | 362,000 | $ | 640,000 | $ | 473,000 | (1 | ) | $ | 529,000 | ||||||||||
Year
ended December 31, 2008
|
||||||||||||||||||||
Allowance
for Doubtful Accounts
|
$ | 264,000 | $ | 544,000 | $ | 446,000 | (1 | ) | $ | 362,000 | ||||||||||
Year
ended December 31, 2007
|
||||||||||||||||||||
Allowance
for Doubtful Accounts
|
$ | 280,000 | $ | 377,000 | $ | 393,000 | (1 | ) | $ | 264,000 | ||||||||||
(1)
|
Uncollectible
accounts written off, net of
recoveries.
|
65