Attached files
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EX-32.1 - EXHIBIT 32.1 - THERAGENICS CORP | ex32-1.htm |
EX-31.1 - EXHIBIT 31.1 - THERAGENICS CORP | ex31-1.htm |
EX-23.1 - EXHIBIT 23.1 - THERAGENICS CORP | ex23-1.htm |
EX-32.2 - EXHIBIT 32.2 - THERAGENICS CORP | ex32-2.htm |
EX-31.2 - EXHIBIT 31.2 - THERAGENICS CORP | ex31-2.htm |
EX-10.31 - EXHIBIT 10.31 - THERAGENICS CORP | ex10-31.htm |
UNITED
STATES
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
OR
o TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
FOR THE
TRANSITION PERIOD FROM _________ TO ________
COMMISSION
FILE NO. 001 - 14339
THERAGENICS
CORPORATION®
(Exact
name of registrant as specified in its charter)
Delaware
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58-1528626
|
|
(State
of incorporation)
|
(I.R.S.
Employer Identification Number)
|
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5203
Bristol Industrial Way
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Buford,
Georgia
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30518
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code:
(770)
271-0233
Securities
registered pursuant to Section 12(b) of the Act:
Name
of each exchange on
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|||||
Title
of each class
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which
registered
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Common
stock, $.01 par value,
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New
York Stock Exchange
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||||
Together
with associated
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|||||
Common
Stock Purchase Rights
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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 o 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 Exchange Act. Yes o 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 o
Indicate
by check mark whether the registrant has submitted electronically and posted on
its 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 o No o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
definition of “large accelerated filer”, “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. Large
accelerated filer o Accelerated
filer o Non-accelerated
filer o Smaller
reporting company x
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No x
The
aggregate market value of the common stock of the registrant held by
non-affiliates of the registrant, as determined by reference to the closing
price of the Common Stock as reported on the New York Stock Exchange on July
5, 2009, the last business day of the registrant’s most recently completed
second fiscal quarter, was $41,953,665.
As of
March 11, 2010 the number of shares of Common Stock, $.01 par value, outstanding
was 33,615,530.
Documents
incorporated by reference: Proxy Statement for the registrant’s 2009 Annual
Meeting of Stockholders, to be filed with the Securities and Exchange Commission
not later than 120 days after December 31, 2009 is incorporated by reference in
Part III herein.
THERAGENICS
CORPORATION® AND
SUBSIDIARIES
TABLE OF
CONTENTS
Page
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PART
I
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Item
1.
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Business
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I-1
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Item
1A.
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Risk
Factors
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I-11
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Item
1B.
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Unresolved
Staff Comments
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I-20
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Item
2.
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Properties
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I-20
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Item
3.
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Legal
Proceedings
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I-20
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Item
4.
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Reserved
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I-20
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PART
II
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||||
Item
5.
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Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
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II-1
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Item
6.
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Selected
Financial Data
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II-2
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Item
7.
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Management’s
Discussion and Analysis of Financial Condition and
Operations
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II-4
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Item
7A.
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Quantitative
and Qualitative Disclosures About Market Risk
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II-20
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Item
8.
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Financial
Statements and Supplementary Data
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II-21
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Item
9.
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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II-21
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Item
9A(T).
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Controls
and Procedures
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II-21
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Item
9B.
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Other
Information
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II-23
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PART
III
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||||
Item
10.
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Directors,
Executive Officers and Corporate Governance
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III-1
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Item
11.
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Executive
Compensation
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III-1
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||
Item
12.
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
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III-1
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||
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
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III-1
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||
Item
14.
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Principal
Accounting Fees and Services
|
III-1
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||
PART
IV
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||||
Item
15.
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Exhibits
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IV-1
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||
Signatures
|
IV-5
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Part
I
Item
1. BUSINESS
Overview
Theragenics
Corporation®, a
Delaware corporation formed in 1981, is a medical device company serving the
surgical products and cancer treatment markets, operating in two business
segments. The terms “Company”, “we”, “us”, or “our” mean Theragenics
Corporation and all entities included in our consolidated financial
statements.
Our
surgical products business consists of wound closure, vascular access and
specialty needle products. Wound closure products include sutures,
needles and other surgical products. Vascular access includes introducers,
guidewires and related products. Specialty needles include coaxial, biopsy,
spinal and disposable veress needles, access trocars, and other needle-based
products. Our surgical products segment serves a number of markets and
applications, including, among other areas, interventional cardiology,
interventional radiology, vascular surgery, orthopedics, plastic surgery, dental
surgery, urology, veterinary medicine, pain management, endoscopy, and spinal
surgery. Our surgical products business sells its devices and components
primarily to original equipment manufacturers (“OEMs”) and to a network of
distributors.
In our
brachytherapy seed business, we produce, market and sell TheraSeed®, our
premier palladium-103 prostate cancer treatment device; I-Seed, our iodine-125
based prostate cancer treatment device; and other related products and services.
We are the world’s largest producer of palladium-103, the radioactive isotope
that supplies the therapeutic radiation for our TheraSeed®
device. Physicians, hospitals and other healthcare providers, primarily located
in the United States, utilize the TheraSeed®
device. Almost half of our TheraSeed® sales
were channeled through one third-party distributor in 2009. We also maintain an
in-house sales force that sells our TheraSeed® and
I-Seed devices directly to physicians.
We have
substantially diversified our operations and revenues in recent years. In May
2005, we expanded into the surgical products business with the acquisition of CP
Medical Corporation (“CP Medical”). In August 2005 we restructured our
brachytherapy seed business in order to sharpen our focus on our two business
segments and provide a more focused platform for continued
diversification. In August 2006 we acquired Galt Medical Corp.
(“Galt”) and in July 2008, we acquired NeedleTech Products, Inc.
(“NeedleTech”). CP Medical, Galt and NeedleTech comprise our surgical
products business, which accounted for 69% of consolidated revenue in 2009.
Prior to 2005, the brachytherapy seed business constituted 100% of our
revenue.
Description
of the Business
Financial
Information about Operating Segments and Geographic Areas
We
operate in two business segments; the surgical products segment and the
brachytherapy seed segment. Information related to revenue from external
customers, measure of profit and loss by segment, total assets by segment, and
geographic areas, is contained in Note O to the consolidated financial
statements included in Part IV of this report.
Surgical
Products Business
Overview
Our
surgical products segment manufactures and distributes wound closure, vascular
access, and specialty needle products, all of which are considered medical
devices. Sales are primarily to OEMs
and to a network of distributors.
Wound
closure products include sutures and other surgical products with applications
in veterinary, urology, cardiology, orthopedics, plastic surgery, and other
fields. The wound closure market is estimated by industry sources to
be a $2.0 billion annual worldwide market, and a $1.2 billion annual market in
the United States. We believe sutures represent approximately $700
million of the world wide wound closure market. Our wound closure
products are used to hold skin, internal organs, blood vessels and other tissue
together, after they have been severed by injury or surgery. Wound
closure products such as sutures are produced in various dimensions,
configurations, and types of materials, depending on the
application. We produce and distribute over 800 wound closure line
items, including sterile and non-sterile products. Sutures represent
the majority of wound closure products we sell. During 2009,
approximately 63% of our suture product sales were in veterinary applications
and 37% were in human applications. In 2008 and 2007,
approximately 60% of our suture product sales were in veterinary applications
and 40% were in human applications.
I-1
Vascular access products include a variety of introducer
sheaths, guidewires and accessories used in interventional radiology,
interventional cardiology and vascular surgery. The interventional
radiology and interventional cardiology markets are estimated by industry
sources to be in excess of $12.0 billion. The market for access
devices is estimated to be approximately 5% of the total market, or $600
million. Our introducers are used to create a conduit through which a
physician can insert a device, such as a catheter, into a blood
vessel. Such a device is introduced into the vasculature by
first using a needle to access the vein. A guidewire is then inserted through
the needle and the needle is removed. The introducer, consisting of a hollow
sheath and a dilator, is then inserted over the guidewire to expand the opening.
The guidewire and dilator are then removed, leaving only the hollow sheath
through which the catheter or other device is inserted. Once the device is in
place, the introducer sheath is removed. This is typically done by splitting the
introducer in half when the “tear away” version of the product is utilized.
Introducers and guidewires are produced in various dimensions, configurations
and types of material, depending upon the application. We produce and
distribute over 200 introducer line items, many of which are procedure kits
that, in addition to introducers and guidewires, may include needles, scalpels
and other components. These products are sold sterile to distributors
and to OEMs in sterile and bulk, non-sterile configurations.
Specialty
needle products include coaxial needles, biopsy needles, access trocars,
brachytherapy needles, guidewire introducer needles, spinal needles, disposable
veress needles, and other needle-based products. End markets served
include the cardiology, orthopedic, pain management, endoscopy, spine, urology,
and veterinary markets. The United States is the largest market for
specialty purpose needles, which was estimated to be approximately $800 million
in 2005, with our specialty needle products addressing approximately 10% of this
market. Our specialty needle products are used for a number of
purposes including: retrieval of samples of tissue or bone (biopsies) that will
be examined for disease; delivery of therapeutic materials such as drugs,
radioactive sources, and bone cement and; providing access to a specific area of
the body to allow passage for other instruments. Our specialty
needles are typically constructed of stainless steel wire and tubing with
special cutting edges which are ground to
specification. Specialty needles are produced in various forms
depending upon the application, and we manufacture over 2,500 line items for
sale to OEMs in sterile private label, and bulk, non-sterile
configurations.
Major
product lines in our surgical products business include:
Sutures:
Sutures
are classified as absorbable or non-absorbable; monofilament, multifilament or
braided; and natural or synthetic. Absorbable or non-absorbable describes the
sutures effective life within tissue. Absorbable sutures lose the majority of
their tensile strength within 60 days after use. Non-absorbable sutures are
resistant to living tissue and do not break down. Monofilament, multifilament
and braided describes the structure or configuration of the suture and is based
on the number of strands used to manufacture the product. Natural or synthetic
describes the origin of the suture. Natural suture materials include surgical
gut, chromic gut, and silk. Synthetic suture materials include nylon, polyester,
stainless steel, polypropylene, polyglycolic acid, polyglycolide-cocaprolactone,
and polydioxanone.
Needles
and Brachytherapy Accessories:
Needles used in general surgery,
including a line of needles and related products used in brachytherapy surgical
procedures. Smooth and echogenic introducer needles are also
available as sterile products.
Guidewires:
Guidewires
function as a mechanical assist for the percutaneous introduction and exchange
of various types of plastic catheters or introducer systems into the
vasculature. Once the catheter is in place, the guidewire is removed
and serves no other function. Materials commonly used in the production of
guidewires are stainless steel, Nitinol, precoated Teflon
(polytetrafluoroethylene, or “PTFE”) stainless steel wire, tungsten alloys and
platinum alloys. Guidewires are sold to OEMs on a bulk, non-sterile
basis as well as packaged sterile. We have the technological and
manufacturing capability to produce diagnostic and interventional guidewires and
currently offer a sterile product line with approximately 40 line
items.
Micro-Introducer
Kits:
Micro-Introducers
are commonly called coaxial dilators and are utilized when a small entry site
(21 gauge needle) is desirable. Micro-Introducers are introduced over
a guidewire. These introducers are typically packaged in a sterile
kit that includes a Micro-Introducer set, a 21-gauge needle and a .018” diameter
guidewire. The standard product offerings consist of standard and
stiffen variations. Various iterations are accomplished by using
three different needle types and four different mandrel type
guidewires. The current sterile product line consists of
approximately 60 line items.
Tearaway
Introducer Sets and Kits:
This
product consists of a Teflon sheath and a High Density Polyethylene (“HDPE”)
dilator set that is introduced over a guidewire. Once that
introduction is made, the guidewire and the dilator are removed leaving the
sheath in place as a vascular access. Once the definitive device
(catheter) is introduced through the sheath, the sheath is easily split and
removed leaving the desired catheter in place. These products are
offered sterile as an introducer sheath/dilator set or as a complete introducer
kit that includes a needle and a guidewire. The sterile product line
consists of approximately 150 line items with lengths from 5cm to
50cm. Additionally, the components are sold on a bulk, non-sterile
basis to OEMs.
I-2
Elite HV™ Introducer Kits:
This
product consists of a sheath that incorporates a hemostasis valve and an HDPE
dilator for arterial access. It is introduced into the vasculature as
a set over a guidewire. The guidewire and dilator are removed leaving
a “closed” vascular access system. The product line consists of
standard .035” compatible sheaths, as well as .018” Micro-access kits, which
allows for a less invasive entry. Recent enhancements include a line
of 24 cm sheaths, as well as the option of a radiopaque band to assist in tip
visibility under fluoroscopy. The present product line consists of 45
line items and is sold sterile and bulk, non-sterile.
ReDial™ 4cm High Flow Introducer
Sheath:
This product consists of a
sheath that incorporates a hemostasis valve, HDPE dilator, larger bore tubing,
side holes, and color coded clamps for use in de-clotting dialysis shunts. The
larger bore tubing and side holes allow for high flow procedures. The ReDial™ is
available with or without a radiopaque band, and consists of 24 line items. A
recent enhancement includes larger bore sizes. The present product
line is sold sterile and bulk, non sterile.
Radial
Artery Access Kits:
This product consists of a
sheath that incorporates a hemostasis valve and an HDPE dilator for arterial
access via the radial artery. Radial artery access reduces trauma and
recovery time. The radial artery access kits are available in 24 line
items to meet the preference of the physician, and include a needle and
guidewire. These introducer sheaths are typically used during coronary
angioplasty procedures.
Biopsy
Needles:
These needles consist of a
stainless steel stylet and cannula combination sharpened in such a way as to
facilitate entry into the body to cut and retrieve a sample of tissue for
examination or testing. This family of needles contains three major
types: Core Biopsy Needles used to obtain a soft tissue sample for Histology in
areas such as the breast or prostate; Aspiration Biopsy Needles used to obtain a
sample of cells for Cytology in areas such as the lung or liver and; Bone Biopsy
Needles that core and retrieve a sample of marrow, generally from the pelvic
area. They are sold bulk non-sterile to OEMs.
Orthopedic
Needles:
These needles are large diameter
(up to 8 gauge) stainless steel stylet and cannula combinations attached to a
large handle that provides the significant leverage needed to gain access to the
vertebral body of the spine. This family of devices provides a system
for harvesting bone marrow, collecting biopsy samples and delivering bone
cement or any other FDA cleared materials. These devices are sold bulk
non-sterile or sterile with private labeling.
Pain
Management Needles:
These needles are also referred
to as “denervation needles”. These devices are manufactured from 18
to 21-gauge stainless steel tubing that have a sharpened distal end and are
insulated along the entire length of the needle except for the most distal
end. The distal tip of the device is placed into contact with the
nerve responsible for patient pain and then energized, usually with radio
frequency energy, causing the needle distal end to heat. Heat applied
to the target nerve reduces the pain signal to the brain providing patient
relief. These products are generally sold sterile with private
labeling.
Access
Needles:
Access needles are a broad term
used to describe devices that are used for less invasive entry during
Laparoscopic type procedures, vascular access for delivery of guidewires into
the circulatory system and to create a channel by which any other instrument can
pass.
Production
- Surgical Products Business
We
design, manufacture, assemble, package and distribute our surgical products in
three primary production facilities, each of which manufactures unique
products. Component raw materials primarily include natural and
synthetic sutures, plastic and stainless steel tubing, wire, plastic resins and
other components, which are generally readily available from third party
suppliers. Suppliers are located in the United States, as well as in Latin
America, Europe, and Asia. A significant portion of our products in the surgical
products segment is produced for OEMs as private labeled products or in a bulk,
non-sterile configuration.
Marketing
and Major Customers - Surgical Products Business
Our
surgical products are primarily sold to OEMs and through a network of
distributors in the United States and Europe. A small direct sales force is
maintained for direct sales to healthcare providers (human use and veterinary)
and group purchasing organizations, as well as to service the needs of
distributors.
I-3
Competition
- Surgical Products Business
Our surgical products business operates primarily in the
wound closure, interventional radiology, interventional cardiology, vascular
surgery, and specialty needle markets. These markets are dominated by
a few large suppliers and a number of smaller suppliers, potentially limiting
the growth opportunities available to smaller participants. The primary
suppliers include Angiodynamics, Angiotech Pharmaceuticals, Covidien Ltd.,
Boston Scientific, Cook Medical, Inc., C.R. Bard, Inc., Greatbatch, Inc., Hart
Enterprises, Cordis and Ethicon, Inc. (subsidiaries of Johnson and Johnson),
Merit Medical, Needle Specialty Products, Terumo Medical and Tegra Medical.
Many of our competitors have substantially greater financial, technical
and marketing resources than we do. Our surgical
products business competes in these markets by providing custom labeled
products, high quality, timely and cost effective products, and a high level of
customer service in niche markets underserved by the larger suppliers or where
customers lack the expertise or resources to manufacture the products that they
need. Our surgical products business also has extensive experience and knowledge
of the markets as well as many established relationships with distributors and
providers.
The
current environment of managed care is characterized by economically motivated
buyers, consolidation among healthcare providers, increased competition and
declining reimbursement rates. In addition, healthcare providers may
attempt to simplify the procurement process which may affect, among other
things, the number of suppliers in the supply chain. As a supplier to
OEMs and distributors, we do not sell directly to the end user and may be
affected by these and other changes in the structure of the business
relationships between the healthcare provider and the OEM or
distributor. We believe our future competitive success will depend on
our ability to integrate ourselves into the supply chain by providing
outstanding value to our customers. This may include, among other
things, developing new products (including extensions of current products),
offering competitive pricing, and providing value added services to our
customers that will contribute to their efficiencies and profitability. Also
critical to our continued competitive success is our ability to attract and
retain skilled product development personnel, obtain patents or other protection
for our products, obtain required regulatory and reimbursement approvals,
successfully market and manufacture our products and maintain sufficient
inventory to meet demand.
Patents
and Licenses; Trade Secrets - Surgical Products Business
Our
surgical products business holds several U.S. patents related to suture
dispensing systems, suture and needle design, vascular introducer system design,
and bone biopsy and vertebroplasty needles. Our policy is to file patent
applications in the United States and foreign countries where rights are
available and when we believe it is commercially advantageous to do
so. We consider the ownership of patents important, but not
necessarily essential, to our surgical products business. A strategy
of confidentiality agreements and trade secret treatment is also utilized to
protect non-patented proprietary information.
Brachytherapy
Seed Business
Overview
Excluding
skin cancer, prostate cancer is the most common form of cancer, and the second
leading cause of cancer deaths, in men. The American Cancer Society estimated
that there were 192,280 new cases of prostate cancer diagnosed and an estimated
27,360 deaths associated with the disease in the United States during
2009.
According
to the American Cancer Society, more than 90% of all prostate cancers are found
in the local and regional stages (local means it is still confined to the
prostate; regional means it has spread from the prostate to nearby areas, but
not to distant sites such as other organs).
We
produce TheraSeed®, an
FDA-cleared device for treatment of all solid localized tumors and currently
used principally for the treatment of prostate cancer. In the prostate
application, TheraSeed®
devices are implanted throughout the prostate gland in a minimally
invasive surgical technique, assisted by transrectal ultrasound guidance. The
radiation emitted by the seeds is contained within the immediate prostate area
for the purpose of killing the tumor while attempting to spare surrounding
organs of significant radiation exposure. The seeds are biocompatible and remain
permanently in the prostate after delivering their radiation dose.
We
believe the TheraSeed®
device offers significant advantages over other treatment options, including
reduced incidence of side effects such as impotence and incontinence. Recent
multi-year clinical studies indicate that seeding offers success rates for
early-stage prostate cancer that are comparable to or better than alternative
treatment options and is associated with reduced complication rates. In
addition, brachytherapy is a one-time outpatient procedure with a typical two to
three day recovery period. By comparison, certain other treatment modalities
typically require a lengthy hospital stay and recovery period.
I-4
The
TheraSeed®
device is a radioactive “seed” roughly the size of a grain of rice. Each seed
consists of biocompatible titanium that encapsulates the radioactive isotope
palladium-103 (“Pd-103”). The half-life of Pd-103, or the time required to
reduce the emitted radiation to one-half of its initial level, is 17 days. The
half-life characteristics result in the loss of almost all radioactivity in less
than four months. The number of seeds implanted normally ranges from 50 to 150.
The procedure is usually performed under local anesthesia in an outpatient
setting. An experienced practitioner typically performs the procedure in
approximately 45 minutes, with the patient often returning home the same
day.
We also
offer the I-Seed device, which is a “seed” device similar to TheraSeed®,
except that it utilizes the radioactive isotope iodine-125 (“I-125”). The
half-life of I-125 is approximately 60 days. The half-life characteristics
result in the loss of almost all radioactivity in approximately 20
months. We believe that Pd-103 continues to have certain advantages
over I-125, including (i) higher dose rates without the risk of side effects
that may be associated with even higher dose rates; (ii) a shorter half-life,
which shortens the duration of some radiation induced side effects by
two-thirds; and (iii) reduced radiation exposure to medical personnel in
treatment follow-up. However the offering of our I-Seed iodine
product enables us to compete more effectively for those direct customers who
prefer to buy both seeds from a single source.
Treatment
Options - Brachytherapy Seed Business
In
addition to brachytherapy, there are many treatment options for localized
prostate cancer. Some therapies may be combined to address a specific cancer
stage or patient need. Treatment options for prostate cancer other
than seeding include, among other treatments:
Radical Prostatectomy is the
most common surgical procedure. Radical Prostatectomy (“RP”) involves the
complete surgical removal of the prostate gland and has been used for over 30
years in treating early-stage, localized tumors. RP typically requires a
three-day average hospital stay and a lengthy recovery period (generally three
to five weeks). Possible side effects include impotence and incontinence.
Alternative forms of radical prostatectomy include laparoscopic radical
prostatectomy (“LRP”) and robotic radical prostatectomy
(“RRP”). These forms of radical prostatectomy are intended to be less
invasive than a traditional radical prostatectomy and are more complex to
perform.
External Beam Radiation
Therapy (“EBRT”) involves directing a beam of radiation at the prostate
gland from outside the body to destroy tumorous tissue and has been a common
technique for treating many kinds of cancer since the 1950s. Patients are
usually treated five days per week in an outpatient center over a period of
eight to nine weeks. Side effects include impotence, incontinence and rectal
complications.
Certain
forms of external beam radiation include Intensity Modulated Radiation Therapy
(“IMRT”) and stereotactic radiotherapy. These treatments generally utilize
high-energy and computerized mapping. We believe these forms of external beam
radiation, including IMRT, are gaining market share in the treatment of early
stage prostate cancer. We are not aware of long-term data documenting
outcomes for these treatments, but we believe they enjoy favorable reimbursement
rates relative to brachytherapy. Conformal proton radiation is
another newer form of radiation therapy that uses proton beams to treat
cancer.
Active Surveillance, while
not a treatment, is recommended by some physicians in certain circumstances
based on the severity and growth rate of the disease, as well as on the age and
life expectancy of the patient. The aim of active surveillance is to monitor the
patient, treat some of the attendant symptoms and determine when more active
intervention is required.
In
addition to the treatment options described above, other forms of treatment and
prevention, including drugs, vaccines, high-intensity focused ultrasound (HIFU)
and other forms of radiation, may be undergoing development and testing in
clinical settings.
Clinical Results - Brachytherapy Seed
Business
Strong Efficacy Results.
Clinical data indicates that seeding offers success rates for early-stage
prostate cancer treatment that are comparable to or better than those of RP or
EBRT.
A
twelve-year study published in the Volume 4, Issue 1 (2005) edition of the
journal Brachytherapy
revealed that high-risk prostate cancer patients treated with
brachytherapy using Pd-103 experienced greater success than patients treated
with radical prostatectomy. The study was conducted by Dr. Jerrold Sharkey of
the Urology Health Center in New Port Richey, Florida, Dr. Alan Cantor, et. al,
and retrospectively reviewed 1,707 prostate cancer patients treated from 1992 to
2004. 80% were treated with brachytherapy and 20% were treated with
surgery. High-risk patients treated with seeding showed an 88% cure rate
compared to a 43% cure rate obtained from surgery at 12 years. Intermediate-risk
patients reflected a success rate of 89% with seed therapy compared to a 58%
success rate with surgery at 12 years, and for low-risk patients the success
rate for seeding was 99% compared to a 97% success rate with surgery at 10
years.
I-5
An 8-year
study by Dr. Gregory Merrick, Dr. Kent Wallner, et. al, of the Schiffler Cancer
Center and Wheeling Jesuit Hospital, disputes a common view that men under the
age of 60 should be treated with radical prostatectomy. The study,
published in the British
Journal of Urology, 2006, showed that men aged 54 and younger have a high
probability of a good 8-year BPFS (biochemical progression-free survival) when
treated with permanent interstitial brachytherapy, with or without supplemental
external beam radiation therapy. For the entire group, the actuarial
BPFS rate was 96%. For low- (57 men), intermediate- (47 men) and
high- (4 men) risk patients, the BPFS rates were 96%, 100%, and three of four,
respectively.
Combination
Treatment: Seeding treatment in combination with EBRT has also
recorded impressive results in the treatment of higher risk prostate cancer
patients.
A study
published in June 2007 by Michael Dattoli, M.D. of the Dattoli Cancer Center
& Brachytherapy Research Institute, Kent Wallner, M.D., of the Department of
Radiation Oncology, University of Washington, et al showed that high tumor
control rates are possible with brachytherapy and supplemental conformal
radiation even in patients having intermediate- and high-risk
disease. The study summarized long-term outcomes from treatment of
prostate cancer among patients with increased risk of extracapsular cancer
extension who had brachytherapy-based treatment. Two hundred
eighty-two (282) patients were treated between 1992 and 1996 with external beam
radiation followed by treatment with Pd-103 seeds. Overall actuarial
freedom from biochemical progression at 14 years was 81%, including the 87% and
72% of patients having intermediate and high-risk disease,
respectively. The study confirmed the effectiveness of treatment with
the TheraSeed®
device combined with EBRT in patients with aggressive cancer who previously were
considered poor candidates for seeding.
Isotope
Selection: The following publication demonstrated that isotope
selection has an effect on treatment outcome.
A study
conducted between 1992 and 2005 following 1,512 patients treated with Pd-103
seeds and 2,119 patients treated with I-125 brachytherapy seeds identified a
significant benefit in treatment with Pd-103 seeds over I-125
seeds. The authors of the study, J.S. Cho, C. Morgenstern, B.
Napolitano, L. Richstone, and L. Potters, reported that at a mean follow-up of
58.2 months, the overall 10-year freedom from progression (FFP) was
85.6%. The FFP for those treated with I-125 seeds was 76.2%, while
those treated with Pd-103 had an 89.5% FFP. Cox regression identified
isotope selection as significant in predicting FFP, with patients who received
I-125 being 2.26 times more likely to progress when compared to patients
receiving Pd-103. This study was published as an abstract from the
proceedings of the 50th
annual meeting of the American Society for Therapeutic Radiation and
Oncology.
Lower Treatment Cost. The
total one-time cost of seeding is typically lower than the cost of RP, which
usually requires a three-day average hospital stay, and EBRT, which requires a
six-to-eight week course of treatment.
Production
- Brachytherapy Seed Business
With the exception of rhodium-103 (“Rh-103”), all raw
materials used in the production of the TheraSeed® and I-Seed devices are relatively inexpensive and
readily available from third party suppliers. Rh-103 is relatively expensive but
readily available on the open market. Our brachytherapy seed
production does not require significant amounts of Rh-103. In
addition, for reasons of quality assurance, sole source availability or cost
effectiveness, certain components and raw materials are available only from sole
suppliers.
Since
1993 we have produced our Pd-103, a radioactive isotope, by proton bombardment
of Rh-103 in cyclotrons. There are other methods of producing Pd-103. We
currently have eight cyclotrons in operation.
We began
production of the I-Seed product early in 2004. We do not produce the I-125
isotope. This isotope is relatively inexpensive and is readily
available from multiple suppliers.
Since
1997, our quality control system related to our medical device manufacturing has
been certified as meeting all the requirements of the International Organization
for Standards (ISO) Quality System Standard, and is currently certified to ISO
13485:2003.
I-6
Marketing
and Major Customers - Brachytherapy Seed Business
We sell
our TheraSeed®
device directly to health care providers and to third party distributors through
non-exclusive distribution agreements. We sell our I-Seed device
directly to health care providers. One TheraSeed®
distribution agreement is in place with C. R. Bard, Inc. (“Bard”). The terms of
the distribution agreement with Bard (the “Bard Agreement”) provide for
automatic one-year extensions of the term, unless either party gives notice of
its intent not to renew at least twelve months prior to the end of the current
term. The current term expires on December 31, 2011 and will be automatically
extended for one additional year unless either party gives notice of its intent
not to extend by December 31, 2010. Under the Bard Agreement, we are Bard’s
exclusive supplier of palladium-103 seeds for the treatment of prostate
cancer. Bard has the right to distribute the TheraSeed®
device in the U.S., Canada, Puerto Rico and other international
locations. Bard can also sell TheraSeed® for
the treatment of other solid localized cancerous tumors. Sales to Bard under the
Bard Agreement represented approximately 46% of product revenue in our
brachytherapy seed segment in 2009. Our surgical products segment
also sells to Bard. Total sales to Bard, including sales in our
brachytherapy seed segment and our surgical products segment represented
approximately 16% of consolidated product revenue in 2009.
In January 2010 we announced a supply and reseller
agreement with Core Oncology (the “Core Agreement”). Under the
terms of the Core Agreement, we are the exclusive palladium-103 seed supplier to
Core for the treatment of prostate cancer in the U.S. and
Canada. Core can also sell TheraSeed® for
the treatment of other solid localized cancerous tumors. The term of
the agreement is through November 30, 2011, and is automatically extended for
additional one-year terms unless terminated by either party upon prior written
notice. We had no brachytherapy segment sales to Core prior to
December 31, 2009. Sales to Core under the Core Agreement are
expected to be 10% or more of total brachytherapy product revenue in
2010.
We maintain an internal brachytherapy sales force that
sells the TheraSeed® and I-Seed devices directly to hospitals,
doctors, and clinics. Direct sales comprised approximately 49% of brachytherapy
product revenue in 2009. We also expect
to continue direct to consumer advertising and other activities to support the
brand name and to increase demand for the TheraSeed® device, including direct to consumer print advertising,
clinical studies aimed at showing the advantages of the TheraSeed® device in the treatment of prostate cancer, technical
field support to TheraSeed® customers, and other customer service and patient
information activities.
Patents
and Licenses; Trade Secrets - Brachytherapy Seed Business
We
hold a number of United States patents pertaining to radiation delivery
devices for therapeutic uses, as well as certain corresponding international
patents. Our policy is to file patent applications in the United
States and foreign countries where rights are available and when we believe it
is commercially advantageous to do so. We consider the ownership of
patents important, but not necessarily essential, to our brachytherapy seed
business. We also use a strategy of confidentiality agreements and trade secret
treatment to provide primary protection to a number of proprietary design
modifications in the cyclotrons, as well as various production
processes.
We also
hold a worldwide exclusive license from the University of Missouri for the use
of technology required for producing the TheraSphere®
device; the underlying patents for this technology have since expired. We
continue to hold the rights to all improvements developed by the University of
Missouri on this technology. In turn, we sublicense exclusive
worldwide rights to this technology and all improvements, along with trademarks
and other intellectual property owned by us, to Nordion International, Inc.
(“Nordion”). Pursuant to our licensing agreement with the University
of Missouri, we are obligated to pay the university a small fixed annual amount
for these rights.
We have
an exclusive license agreement under which we license the rights to certain
intellectual property related to an expandable brachytherapy delivery system
that we developed. The term of the agreement is through the
expiration of the last of the patents licensed under the agreement, which is
currently November 2024. The term may be altered if such patents are
found to be invalid. The agreement provides for a minimal
non-refundable initial license fee and non-refundable continuing royalties based
upon sales subject to certain minimums. The minimum annual royalty based upon
the contract year of the agreement, which ends each May, is $250,000 for the
twelve months ended May 31, 2010.
I-7
Competition
- Brachytherapy Seed Business
Our brachytherapy business competes in a market
characterized by technological innovation, extensive research efforts and
significant competition. In general, the TheraSeed® and I-Seed devices compete with conventional methods of
treating localized cancer, including, but not limited to, radical prostatectomy,
which includes laparoscopic radical prostatectomy and robot-assisted radical
prostatectomy, and external beam radiation therapy which includes intensity
modulated radiation therapy (“IMRT”), as well as competing permanently and
temporarily implanted devices. We believe that the industry wide decline
in prostate brachytherapy procedure volume continued in 2009. Some
newer forms of treatment have increased their market share, especially those
with Medicare reimbursement levels that are higher than reimbursement levels for
brachytherapy. These alternative treatment forms include IMRT and robotic surgery. We believe that if general
conversion from these treatment options (or other established or conventional
procedures) to brachytherapy treatment does occur, such conversion will likely
be the result of a combination of equivalent or better efficacy, reduced
incidence of side effects and complications, comparatively improved physician
reimbursement versus other treatment options, lower cost, other quality of life
issues and pressure by health care providers and patients.
Several companies produce and distribute Pd-103
and I-125 seeds, which compete directly with our TheraSeed® and I-Seed devices. C.R. Bard, Inc., Best
Medical, Core Oncology, Oncura (a part of GE Healthcare) and others all
manufacture and/or sell brachytherapy seeds. Other forms
of brachytherapy seeds that utilize other isotopes, including both low dose
radiation and high dose radiation, also compete directly with our
devices. We believe that we have
competitive advantages over these companies including, but not limited to: (i)
our proprietary production processes that have been developed and patented; (ii)
our 22 year history of manufacturing radioactive medical devices and a record of
reliability and safety in our manufacturing operations; (iii) vertical
integration of production and related services, (iv) the time and resources
required for competitors’ production capabilities to ramp up to commercial
production on a scale comparable to ours; (v) maintenance of our cancer
information center, (vi) our direct sales force, (vii) our direct to consumer
advertising programs and (viii) the non-exclusive distribution agreements that
we currently have in place.
In early
2010, we reduced the transfer price to our non-exclusive distributors in
recognition of the competitive environment and new distributor
strategies. At any point in time, we and/or our non-exclusive
distributors may continue to change their respective pricing policies for the
TheraSeed®
device, and we may change our pricing policies for the I-Seed device, in order
to take advantage of market opportunities or respond to competitive situations.
Responding to market opportunities and competitive situations, including but not
limited to competitor selling tactics, could have an adverse effect on the
prices of the TheraSeed® or
I-Seed device. Responding to market opportunities and competitive
situations may also have a favorable effect on market share and volumes, while
failure to do so could adversely affect market share and volumes although per
unit pricing could possibly be maintained.
In
addition to the competition from the procedures and companies noted above, many
companies, both public and private, are researching new and innovative methods
of preventing and treating cancer. In addition, many companies, including many
large, well-known pharmaceutical, medical device and chemical companies that
have significant resources available to them, are engaged in radiological
pharmaceutical and device research. These companies are located in the United
States, Europe and throughout the world. Significant developments by any of
these companies either in refining existing treatment protocols (such as
enhancements in surgical techniques) or developing new treatment protocols could
have a material adverse effect on the demand for our products.
Seasonality
Although
we have not identified seasonal effects in relation to a specific quarter or
quarters for either business segment, we believe that holidays, major medical
conventions and vacations taken by physicians, patients and patients’ families,
may have a seasonal impact on sales particularly in the brachytherapy seed
segment.
Research
and Development
Research
and development (“R&D”) expenses were $2.2 million, $1.3 million and $1.4
million in 2009, 2008 and 2007, respectively. In both 2009 and 2008,
substantially all R&D expenses have been related to our surgical products
segment. We implemented a R&D program to support new product
development in our surgical products business in the third quarter of
2008. Looking forward, we expect our R&D expenses to remain at
levels comparable to 2009. However, the rate of R&D
spending going forward could change based on the opportunities
identified. The amounts invested will be dependent upon a number of
factors, including our ability to obtain qualified personnel and the types of
activities required for our product development. We have recently
been reassessing the projects in our R&D program, in an effort to focus on
opportunities with a more immediate impact. We believe that
opportunities to support programs for our customers may be more attractive for
us than developing new products. In some cases, we will develop
extensions of current products. In other cases we will develop
products that are complementary to our existing product line and also develop
new products. Any new product development activities will be focused
on products that can be marketed once they have received 510(k) clearance by the
U.S. Food and Drug Administration, rather than products that would require
costly and lengthy clinical trials. We expect that this investment
will accelerate our entrance into new markets, expand our offerings to new and
existing customers, and support growth in our surgical products
business. The U.S. Food and Drug Administration (“FDA”) has recently
announced that it is reviewing the 510(k) process, and many commentators expect
the 510(k) rules to become more stringent. Any such changes in the
510(k) rules may increase the cost and time to market of our product development
activities.
I-8
In 2007,
approximately one-half of our R&D expenses related to our brachytherapy seed
segment. We developed a new device to assist with the configuration
of seeds, allowing a physician to perform real time stranding of seeds and
customize the brachytherapy procedure while in the operating room. R&D in
the surgical products segment in 2007 was primarily related to new product
development.
Government
Regulation
Our
present and future intended activities in the development, manufacture and sale
of wound closure, vascular access and specialty needle products, and cancer
therapy products, are subject to extensive laws, regulations, regulatory
approvals and guidelines. Within the United States, our medical devices must
comply with the U.S. Federal Food, Drug and Cosmetic Act, which are enforced by
the FDA. We are also subject to regulation by other governmental agencies,
including the Occupational Safety and Health Administration (OSHA), the
Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC),
and other federal and state agencies. We must also comply with the regulations
of the Competent Authorities of the European Union for our products that have
been CE Marked and are sold in the member nations of the European
Union.
Medicare
covers a substantial percentage of the patients treated for prostate cancer in
the United States, and consequently, the costs for prostate cancer treatment are
subject to Medicare’s prescribed rates of reimbursement. The
utilization of TheraSeed®,
I-Seed and many of the products in our surgical products business may be
influenced by Medicare’s reimbursement levels, and the policies of other third
party payors, which can change periodically. See Management’s Discussion and Analysis
of Financial Condition and Results of Operations – Medicare
Developments.
We are
also required to adhere to applicable FDA regulations for Quality System
Regulation (previously known as Good Manufacturing Practices), including
extensive record keeping and periodic inspections of manufacturing
facilities.
We have
obtained FDA 510(k) clearances to the extent required for our medical devices in
our surgical products and brachytherapy seed businesses. New FDA
clearances would be required for any modifications in such products or its
labeling that could significantly affect the safety or effectiveness of the
original product. However, not all of our products require FDA 510(k)
clearances.
Our
manufacturing, distribution and security of radioactive materials are governed
by the State of Georgia in agreement with the NRC. The users of the
TheraSeed®
device are also required to possess licenses issued either by the states in
which they reside or the NRC depending upon the state involved and the
production process used.
Our
facilities and operations are subject to extensive environmental, nuclear,
regulatory and occupational health and safety laws at the federal, state and
local levels (which we refer to as “Environmental Laws and Regulations” in this
section under the heading of “Government Regulation”). We
are also subject to similar foreign laws and regulations under certain
circumstances when our products are distributed outside of the Untied
States. These Environmental Laws and Regulations govern, among other
things, air emissions; wastewater discharges; the generation, storage, handling,
use and transportation of hazardous materials; the handling and disposal of
hazardous wastes; the cleanup of contamination; and the health and safety of our
employees. In our brachytherapy seed business, we are required to maintain
radiation control and to properly dispose of radioactive waste. We
are required to maintain radiation safety personnel, procedures, equipment and
processes, and to monitor our facilities and our employees and contractors. We
are also required to provide financial assurance that adequate funding will
exist for end-of-life radiological decommissioning of our cyclotrons and other
areas of our property where radioactive materials are handled. We
transfer low-level radioactive waste to licensed commercial radioactive waste
treatment or disposal facilities for incineration or land disposal. We provide
training and monitoring of our personnel to facilitate the proper handling of
all materials. Under these Environmental Laws and Regulations, we are
required to obtain certain permits from governmental authorities for some
portions of our operations.
We
continue to make capital and operational expenditures relating to compliance
with existing Environmental Laws and Regulations in the normal course of
business. We budget for these expenditures and believe that our
compliance with the Environmental Laws and Regulations will not have a material
effect on our business, results of operations, financial condition and/or
liquidity, relative to the effect such expenditures have had in recent
years. However, Environmental Laws and Regulations tend to
become more stringent over time, and we could incur additional material costs
and expenses in the future relating to compliance with such future laws and
regulations. In addition,
if we violate or fail to comply with applicable Environmental Laws and
Regulations, we could be fined or otherwise sanctioned by regulators. Such
fines, sanctions or other related costs could have a material adverse effect on
our business, results of operations and/or liquidity. We cannot completely
eliminate the risk of violation of Environmental Laws and Regulation, and we may
incur additional material liabilities as a result of any such
violations.
I-9
For
more information on the effect of environmental, nuclear, regulatory and
occupational health and safety laws and regulations on our business, please read
the information included elsewhere in this Form 10-K, including Risk Factors, Management’s Discussion and Analysis
of Financial Condition and Results of Operations – Critical Accounting Policies,
and other information contained herein.
Employees
As of
December 31, 2009, we had 525 full time employees. None of our employees
are represented by a union or a collective bargaining agreement, and we consider
employee relations to be good.
Available
Information
Our
website address is http://www.theragenics.com.
Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K and all amendments to those reports filed pursuant to Section 13(a)
or 15(c) of the Securities and Exchange Act of 1934 are available free of charge
through our website by clicking on the “Investor Relations” page and selecting
“SEC Filings.” These reports will be available as soon as reasonably practicable
after such material has been electronically filed with, or furnished to, the
SEC. These reports are also available through the SEC’s website at http://www.sec.gov.
The information on these websites and the information contained therein or
connected thereto are not intended to be incorporated by reference into this
Form 10-K. In addition we will provide paper copies of these filings (without
exhibits) free of charge to our shareholders upon request.
I-10
Item
1A. Risk Factors
We
operate in continually changing business environments and new risk factors may
emerge from time to time. We cannot predict such new risk factors, nor can we
assess the impact, if any, of such new risk factors on our business or to the
extent to which any factor or combination of factors may cause actual results to
differ materially from those expressed in any forward looking statement.
Additional risks and uncertainties not currently known to us or that we might
currently deem to be immaterial also may adversely affect our business,
financial condition and/or operating results.
We
operate multiple businesses. When we refer to “surgical products” or the
“surgical products business”, we are referring to the business that produces,
markets and sells wound closure products, disposable medical devices used for
vascular access, specialty needles, and other surgical related products. When we
refer to “brachytherapy” or the “brachytherapy business”, we are referring to
the business that produces, markets and sells TheraSeed®, our
premier palladium-103 prostate cancer treatment device, I-Seed, our iodine-125
based prostate cancer treatment device, and related products and
services.
Risks
Related to our Business
There
are risks associated with our acquisitions, potential acquisitions and joint
ventures.
An
important element of our strategy is to seek acquisition prospects and
diversification opportunities that we believe will complement or diversify our
existing product offerings, augment our market coverage and customer base,
enhance our technological capabilities or offer revenue and profit growth
opportunities. We acquired CP Medical in May 2005, Galt in August 2006 and
NeedleTech in July 2008. Further transactions of this nature could result in
potentially dilutive issuance of equity securities, use of cash and/or the
incurring of debt and the assumption of contingent liabilities.
Acquisitions
entail numerous costs, challenges and risks, including difficulties in the
assimilation of acquired operations, technologies, personnel and products and
the retention of existing customers and strategic partners, diversion of
management’s attention from other business concerns, risks of entering markets
in which we have limited or no prior experience and potential loss of key
employees of acquired organizations. Other risks include the potential strain on
the combined companies’ financial and managerial controls and reporting systems
and procedures, greater than anticipated costs and expenses related to
integration, and potential unknown liabilities associated with the acquired
entities. No assurance can be given as to our ability to successfully integrate
the businesses, products, technologies or personnel acquired in past
acquisitions or those of other entities that may be acquired in the future or to
successfully develop any products or technologies that might be contemplated by
any future joint venture or similar arrangement. A failure to integrate CP
Medical, Galt, NeedleTech or future potential acquisitions could result in our
failure to achieve our revenue growth or other objectives associated with
acquisitions, or recover costs associated with these acquisitions, which could
affect our profitability or cause the market price of our common stock to
fall.
We
may not realize the benefits of acquisitions.
The
process of integrating our acquisitions may be complex, time consuming and
expensive and may disrupt our businesses, and could affect our financial
condition, results of operations or future prospects. We will need to overcome
significant challenges in order to realize benefits or synergies from the
acquisitions. These challenges include the timely, efficient and successful
execution of a number of post-acquisition events, including:
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integrating
the operations and technologies of the acquired
companies;
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retaining
and assimilating the key personnel of each
company;
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retaining
existing customers of each company and attracting additional
customers;
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retaining
strategic partners of each company and attracting new strategic partners;
and
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creating
uniform standards, controls, procedures, policies and information
systems.
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The execution of these post-acquisition
events will involve considerable risks and may not be successful. These risks
include:
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the
potential disruption of the combined companies’ ongoing businesses and
distraction of management;
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the
potential strain on the combined companies’ financial and managerial
controls and reporting systems and procedures;
and
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the
potential unknown liabilities associated with the acquisition and the
combined operations.
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We may
not succeed in addressing these risks or any other problems encountered in
connection with the acquisitions. The inability to successfully integrate the
operations, technology and personnel of acquired companies, or any significant
delay in achieving integration, could have a material adverse effect on
us.
I-11
The
cost of acquisitions could harm our financial results.
If the
benefits of acquisitions do not exceed the associated costs, including costs
related to integrating the companies acquired and dilution to our stockholders
resulting from the issuance of shares in connection with the acquisitions, our
financial results, including earnings per share, could be materially
harmed.
We
are dependent on key personnel.
We are
highly dependent upon our ability to attract and retain qualified management,
scientific and technical personnel. Therefore, our future success is dependent
on our key employees. If the services of our chief executive or other key
employees cease to be available, the loss could adversely affect our business
and financial results. We carry key employee insurance for M. Christine Jacobs,
our Chief Executive Officer.
Our
stock price has been and may continue to be subject to large
fluctuations.
The
trading price of our Common Stock has been and may continue to be subject to
wide fluctuations in response to quarter-to-quarter variations in operating
results, announcements of technological innovations, new products or
acquisitions by us or our competitors, developments with respect to patents or
proprietary rights, general conditions in the medical device and surgical
products industries, or other events or factors. In addition, the stock market
can experience extreme price and volume fluctuations, which can particularly
affect the market prices of technology companies and which can be unrelated to
the operating performance of such companies. Average daily trading volume in our
Common Stock is not significant and can cause significant price fluctuations.
Specific factors applicable to broad market fluctuations or us may materially
adversely affect the market price of our Common Stock. We have experienced
significant fluctuations in our stock price and share trading volume in the past
and may continue to do so.
Our
future operating results are difficult to predict and may vary significantly
from quarter to quarter.
Comparisons
of our quarterly operating results are an unreliable indication of our future
performance because they are likely to vary significantly based on many factors,
including:
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the
size and timing of orders from our
customers;
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the
demand for and acceptance of our
products;
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the
success of our competition;
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our
ability to command favorable pricing for our
products;
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the
growth of the market for our
devices;
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the
expansion and rate of success for our sales
channels;
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actions
relating to ongoing FDA compliance;
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the
effect of intellectual property
disputes;
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the
attraction and retention of key
personnel;
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an
inability to control costs; and
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general
economic conditions as well as those specific to our customers and
markets.
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We
face production risks.
We
operate four primary production facilities, each of which manufactures unique
products. Each facility also utilizes unique equipment that can be expensive and
time consuming to replace. If an event occurred that resulted in
damage to one or more of our production facilities or certain equipment, we may
be unable to produce the relevant products at previous levels or at all. In
addition, for reasons of quality assurance, sole source availability or cost
effectiveness, certain components and raw materials are available only from a
sole supplier. Due to the FDA’s and other stringent regulations regarding the
manufacture of our products, we may not be able to quickly establish replacement
sources for certain component materials. Any interruption in manufacturing, or
in the ability to obtain raw materials and component supplies, could have a
material adverse effect on our business.
Manufacturing
or quality control problems may arise in any of our businesses as we increase
production or as additional manufacturing capacity is required in the future.
These factors may have an adverse impact on our business, financial condition
and results of operations.
Surgical
product components are obtained from suppliers located in the United States, as
well as in Latin America, Europe, and Asia. While we believe there is adequate
access to alternative suppliers, any disruption in supply could have a material
adverse effect on our business, financial condition and results of
operations.
I-12
We
are subject to a comprehensive system of federal, state and international laws
and regulations, and we could be the subject of an enforcement action or face
lawsuits and monetary or equitable judgments.
Our
operations are affected by various state, federal and international healthcare,
environmental, antitrust, anti-corruption and employment laws, including for
example various FDA regulations, the federal Anti-Kickback Statute and the
Foreign Corrupt Practices Act (“FCPA”). We are subject to periodic inspections
to determine compliance with the FDA’s Quality System Regulation requirements,
current medical device adverse event reporting regulations and foreign rules and
regulations. Product approvals by the FDA and other foreign regulators can be
withdrawn due to failure to comply with regulatory standards or the occurrence
of unforeseen problems following initial approval. The failure to comply with
regulatory standards or the discovery of previously unknown problems with a
product or manufacturer could result in FDA Form-483 notices and/or Warning
Letters, fines, delays or suspensions of regulatory clearances, detainment,
seizures or recalls of products (with the attendant expenses), the banning of a
particular device, an order to replace or refund the cost of any device
previously manufactured or distributed, operating restrictions and civil or
criminal prosecution, as well as decreased sales as a result of negative
publicity and product liability claims, and could have a material adverse effect
on our business, financial condition and results of operations.
In
addition, the healthcare industry is under scrutiny from state governments and
the federal government with respect to industry practices in the area of sales
and marketing. If our marketing or sales activities fail to comply with the
FDA’s regulations or guidelines, or other applicable laws, we may be subject to
warnings from the FDA or enforcement actions from the FDA or other enforcement
bodies. In the recent past, medical device manufacturers have been the subject
of investigations from state and federal prosecutors related to their
relationships with doctors, among other activities or practices. If
an enforcement action involving us were to occur, it could result in penalties,
fines, the exclusion of our products from reimbursement under federally-funded
programs and/or prohibitions on our ability to sell our products, and could have
a material adverse effect on our business and results of
operations.
Our
brachytherapy manufacturing operations involve the manufacturing and possession
of radioactive materials, which are subject to stringent regulation. The users
of our brachytherapy seed products are required to possess licenses issued by
the states in which they reside or the NRC. User licenses are also required by
some of the foreign jurisdictions in which we may seek to market our products.
There can be no assurance that current licenses held by us for our manufacturing
operations will remain in force or that additional licenses required for our
operations will be issued. There also can be no assurance that our customers
will receive or retain the radioactive materials licenses required to possess
and use TheraSeed® or
I-Seed or that delays in the granting of such licenses will not hinder our
ability to market our products. Furthermore, regulation of our radioactive
materials manufacturing processes involves the imposition of financial
requirements related to public safety and decommissioning, and there are costs
and regulatory uncertainties associated with the disposal of radioactive waste
generated by our manufacturing operations. There can be no assurance that the
imposition of such requirements and the costs and regulatory restrictions
associated with disposal of waste will not, in the future, adversely affect our
business, financial condition and results of operations.
We are
required under our radioactive materials license to maintain radiation control
and radiation safety personnel, procedures, equipment and processes, and to
monitor our facilities and our employees and contractors. We are also required
to provide financial assurance that adequate funding will exist for end-of-life
radiological decommissioning of our cyclotrons and other radioactive areas of
our properties that contain radioactive materials. We have provided this
financial assurance through the issuance of letters of credit. We have so far
been successful in explaining to the Georgia Department of Natural Resources
that we will not have to dispose of our cyclotrons, but instead will be able to
sell them for re-use or use for spare parts if we cease to operate them. Thus,
we are only required to estimate and provide financial assurance for the
end-of-life remediation and disposal costs associated with ancillary structures,
such as plumbing, laboratory equipment and chemical processing facilities.
However, if the Georgia Department of Natural Resources was to require that we
include the cost of decommissioning our cyclotrons in our financial assurance
demonstration, the amount of funds required to be set aside by us to cover
decommissioning costs could dramatically increase.
Failure
to obtain and maintain regulatory approvals, licenses and permits could
significantly delay our manufacturing and/or marketing efforts.
Furthermore, changes in existing regulations, or interpretations of existing
regulations or the adoption of new restrictive regulations could adversely
affect us from obtaining, or affect the timing of, future regulatory approvals.
Failure to comply with applicable regulatory requirements could result in, among
other things, significant fines, suspension of approvals, seizures or recalls of
products, operating restrictions or criminal prosecution and materially
adversely affect our business, financial condition and results of
operations.
We
face risks related to lack of diversification.
Through
April 2005, virtually all of our revenues were generated from the brachytherapy
seed market. The growth of our surgical products business has reduced our
dependence on the brachytherapy business. However, there is no assurance that we
can continue to successfully diversify our business, and a lack of
diversification or over reliance on any one of our businesses can be a
risk.
I-13
We
are dependent on new technological development.
We
compete in markets characterized by technological innovation, extensive research
efforts and significant competition. New developments in technology may have a
material adverse effect on the development or sale of our products and may
render such products noncompetitive or obsolete. Other companies, many of which
have substantially greater capital resources, marketing experience, research and
development staffs and facilities than us, are currently engaged in the
development of products and innovative methods for treating cancer, and for
competing with our wound closure, vascular access and specialty needle products.
Significant developments by any of these companies or advances by medical
researchers at universities, government research facilities or private research
laboratories could reduce or eliminate the entire market for any or all of our
products.
We
face significant competition.
Our
surgical products business competes with other suppliers of wound closure,
vascular access and specialty needle products. The primary suppliers include
Angiodynamics, Angiotech Pharmaceuticals, Covidien Ltd., Boston Scientific, Cook
Medical, Inc., C.R. Bard, Inc. (“Bard”), Greatbatch, Inc., Hart Enterprises,
Cordis and Ethicon, Inc. (subsidiaries of Johnson and Johnson), Merit Medical,
Needle Specialty Products, Terumo Medical and Tegra Medical. Our brachytherapy
business is also subject to intense competition within the brachytherapy seed
market. Bard, Best Medical, Oncura (a part of GE Healthcare), Core Oncology and
others all manufacture and/or sell Pd-103 and/or I-125 brachytherapy
seeds.
Many of
our competitors have substantially greater financial, technical, sales,
marketing and other resources, as well as greater name recognition and a larger
customer base, than we do. Additionally, many companies located outside of the
United States, in particular in Asia, produce and supply similar surgical
products. These companies may have access to substantially lower costs of
production. Accordingly, such competitors or future competitors may be able to
respond more quickly to new or emerging technologies and changes in customer
requirements or to devote greater resources to the development, promotion and
sale of their products than us. As a result, we may be at a disadvantage when
competing with these larger companies. If we fail to compete effectively, our
business, financial condition and results of operations may be adversely
affected.
We
face pricing pressures.
Our
businesses are subject to intense pressure to lower pricing as our customers are
leveraging current economic conditions to demand reduced pricing or more
favorable payment discounts. Accordingly, we could find it difficult to offset
discounts with in-house cost savings measures. Failure to offer satisfactory
savings to our customers or to successfully reduce our costs may adversely
affect our revenue and results of operations.
We
are highly dependent on our marketing and advertising specialists and our direct
sales organization in the brachytherapy business. Any failure to build and
manage our direct sales organization could negatively affect our
revenues.
We are
highly dependent on our direct sales organization comprised of brachytherapy
specialists who promote and support our brachytherapy products. There is intense
competition for skilled sales and marketing employees, particularly for people
who have experience in the radiation oncology market. Accordingly, we could find
it difficult to hire or retain skilled individuals to sell our products. Failure
to retain our direct sales force could adversely affect our growth and our
ability to meet our revenue goals. There can be no assurance that our direct
sales and marketing efforts will be successful. If we are not successful in our
direct sales and marketing, our sales revenue and results of operations are
likely to be materially adversely affected.
We
depend partially on our relationships with distributors and other industry
participants to market our surgical and brachytherapy products, and if these
relationships are discontinued or if we are unable to develop new relationships,
our revenues could decline.
A
significant portion of our surgical products revenue is derived from our
relationships with OEMs, dealers and distributors. There is no assurance that we
will be able to maintain or develop these relationships with OEMs, agents and
distributors and other industry participants or that these relationships will
continue to be successful. If any of these relationships is terminated, not
renewed or otherwise unsuccessful, or if we are unable to develop additional
relationships, our product sales could decline, and our ability to grow our
product lines could be adversely affected.
I-14
We rely,
and will continue to rely, upon collaborative relationships with agents and
distributors and other industry participants to maintain market access to
potential customers. Some of the entities with which we have relationships to
help market and distribute our products also produce or distribute products that
directly compete with our products. In particular, Bard is one of our primary
competitors in the brachytherapy seed market, and also a competitor for certain
of our surgical products segment applications. Yet Bard is also a
non-exclusive distributor of our TheraSeed®
product and a customer of our surgical products business. Sales to Bard under
the Bard Agreement represented 46% of product revenue in our brachytherapy seed
segment in 2009. Our surgical products segment
also sells to Bard. Total sales to Bard, including sales in our
brachytherapy seed segment and our surgical products segment, represented
approximately 16% of consolidated product revenue in 2009. In
January 2010 we announced a supply and reseller agreement in our brachytherapy
seed business with Core Oncology (“Core”), under which Core became a
non-exclusive distributor of our TheraSeed® device. Sales to Core are
expected to comprise 10% or more of our brachytherapy product revenue in
2010. Core is also a competitor of ours in the brachytherapy
market. The terms of our brachytherapy related distribution
agreements with Bard and Core are currently less than two
years. There is no assurance that these distribution agreements will
be extended and if they are not, how much unit volume being sold through them
will be able to be captured by our direct sales force or other distributors that
we may utilize.
Doctors
and hospitals may not adopt our products and technologies at levels sufficient
to sustain our business or to achieve our desired growth rate.
To date,
we have attained only limited penetration of the total potential market for most
of our products. Our future growth and success depends upon creating broad
awareness and acceptance of our products by doctors, hospitals and freestanding
clinics, as well as patients. This will require substantial marketing and
educational efforts, which will be costly and may not be successful. The target
customers for our products may not adopt these technologies or may adopt them at
a rate that is slower than desired. In addition, potential customers who decide
to utilize any of our devices may later choose to purchase competitors’
products. Important factors that will affect our ability to attain broad market
acceptance of our products include:
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doctor
and/or patient awareness and acceptance of our
products;
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the
real or perceived effectiveness and safety of our
products;
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the
relationship between the cost of our products and the real or perceived
medical benefits of our products;
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the
relationship between the cost of our products and the financial benefits
to our customers using our products, which will be greatly affected by the
coverage of, and reimbursement for, our products by governmental and
private third-party payors; and
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market
perception of our ability to continue to grow our business and develop
enhanced products.
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Failure
of our products to gain broad market acceptance could cause our revenues to
decline and our business to suffer.
Evolving
regulation of corporate governance and public disclosure may result in
additional expenses and continuing uncertainty.
Changing
laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and
NYSE rules are creating uncertainty for public companies, and are particularly
burdensome for smaller public companies such as ours. We cannot predict or
estimate the amount of the additional costs we may incur relating to regulatory
developments or the timing of such costs. These new or changed laws, regulations
and standards are subject to varying interpretations, in many cases due to their
lack of specificity, and as a result, their application in practice may evolve
over time as new guidance is provided by regulatory and governing bodies. This
could result in continuing uncertainty regarding compliance matters and higher
costs necessitated by ongoing revisions to disclosure and governance
practices.
We are
committed to maintaining high standards of corporate governance and public
disclosure. As a result, we have invested resources to comply with evolving
laws, regulations and standards, and this investment may result in increased
general and administrative expenses and a diversion of management time and
attention from revenue-generating activities to compliance activities. If our
efforts to comply with new or changed laws, regulations and standards differ
from the activities intended by regulatory or governing bodies due to
ambiguities related to practice, regulatory authorities may initiate legal
proceedings against us and our business, financial position and results of
operations may be adversely affected.
There
are limitations on our ability to protect our intellectual property, and we are
dependent on trade secrets.
Our
success will depend, in part, on our ability to obtain, assert and defend patent
rights, protect trade secrets and operate without infringing the proprietary
rights of others. We hold rights to issued United States and foreign patents.
There can be no assurance that rights under patents held by or licensed to us
will provide us with competitive advantages that others will not independently
develop similar products or design around or infringe the patents or other
proprietary rights owned by or licensed to us. In addition, there can be no
assurance that any patent obtained or licensed by us will be held to be valid
and enforceable if challenged by another party.
I-15
There can
be no assurance that patents have not been issued or will not be issued in the
future that conflict with our patent rights or prevent us from marketing our
products. Such conflicts could result in a rejection of our or our licensors’
patent applications or the invalidation of patents, which could have a material
adverse effect on our business, financial condition and results of operations.
In the event of such conflicts, or in the event we believe that competitive
products infringe patents to which we hold rights, we may pursue patent
infringement litigation or interference proceedings against, or may be required
to defend against litigation or proceedings involving, holders of such
conflicting patents or competing products. There can be no assurance that we
will be successful in any such litigation or proceeding, and the results and
cost of such litigation or proceeding may materially adversely affect our
business, financial condition and results of operations. In addition, if patents
that contain dominating or conflicting claims have been or are subsequently
issued to others and such claims are ultimately determined to be valid, we may
be required to obtain licenses under patents or other proprietary rights of
others. No assurance can be given that any licenses required under any such
patents or proprietary rights would be made available on terms acceptable to us,
if at all. If we do not obtain such licenses, we could encounter delays or could
find that the development, manufacture or sale of products requiring such
licenses is foreclosed.
We rely
to a significant degree on trade secrets, proprietary know-how and technological
advances that are either not patentable or that we choose not to patent. We seek
to protect non-patented proprietary information, in part, by confidentiality
agreements with suppliers, employees and consultants. There can be no assurance
that these agreements will not be breached, that we would have adequate remedies
for any breach, or that our trade secrets and proprietary know-how will not
otherwise become known or be independently discovered by others. The disclosure
to third parties of proprietary non-patented information could have a material
adverse effect on our business, financial condition and results of
operations.
Domestic
and foreign legislative or administrative reforms resulting in restrictive
reimbursement practices of third-party payors and cost containment measures
could decrease the demand for products purchased by our customers, the prices
that our customers are willing to pay for those products and the number of
procedures using our devices.
Our
products are purchased principally by hospitals or physicians, which typically
bill various third-party payors, such as governmental programs (e.g., Medicare
and Medicaid), private insurance plans and managed care plans, for the
healthcare services provided to their patients. The ability of our customers to
obtain appropriate reimbursement for products and services from third-party
payors is critical to the success of medical device companies because it affects
which products customers purchase and the prices they are willing to pay.
Reimbursement can significantly impact the acceptance of new technology.
Implementation of healthcare reforms in the United States may limit, reduce or
eliminate reimbursement for our products and adversely affect both our pricing
flexibility and the demand for our products. Even when we develop a promising
new product, we may find limited demand for the product unless reimbursement
approval is obtained from private and governmental third-party
payors.
Major
third-party payors for hospital services in the United States and abroad
continue to work to contain healthcare costs through, among other things, the
introduction of cost containment incentives and closer scrutiny of healthcare
expenditures by both private health insurers and employers. For example, in an
effort to decrease costs, certain hospitals and other customers sometimes
resterilize products otherwise intended for a single use or purchase reprocessed
products from third-party reprocessors.
Further
legislative or administrative reforms to the U.S. reimbursement systems in a
manner that significantly reduces reimbursement for procedures using our medical
devices or denies coverage for these procedures, or adverse decisions relating
to our products by administrators of these systems in coverage or reimbursement
issues, would have an adverse impact on the acceptance of our products and the
prices that our customers are willing to pay for them. These outcomes, along
with cost containment measures, could have a material adverse effect on our
business and results of operations.
In
addition, Medicare covers a substantial percentage of the patients treated for
prostate cancer in the United States, and consequently, the costs for prostate
cancer treatment are subject to Medicare’s prescribed rates of reimbursement.
The utilization of TheraSeed®,
I-Seed and many of the products in our surgical products business may be
influenced by Medicare’s reimbursement levels, and the policies of other third
party payors, which can change periodically. Unfavorable reimbursement levels
and confusion regarding potential changes in Medicare have adversely affected
sales of our brachytherapy products in the past, and could do so in the
future.
We
believe that Medicare reimbursement policies have affected the brachytherapy
market and will continue to affect the brachytherapy market. Prior to
2010, Medicare continued to reimburse for brachytherapy seeds under the “charges
adjusted to costs” methodology, which is based on the actual invoiced cost of
the seeds and which we sometimes refer to as a “pass-through”
methodology. Consistent with proposals that the Centers for
Medicare & Medicaid Services (“CMS”) attempted unsuccessfully to implement
in recent years, CMS posted a final hospital outpatient prospective payment
system (“OPPS”) on October 30, 2009 with fixed prospective payment rates for
brachytherapy seeds. This fixed OPPS, which we sometimes refer to as
“fixed reimbursement”, went in effect on January 1, 2010 and fixes the per seed
rate at which Medicare reimburses hospitals for the purchase of
seeds. We expect to continue to support efforts to urge Congress and
CMS to replace this “fixed reimbursement” rule by obtaining a new extension of
the “pass-through” reimbursement policies which existed prior to
2010. Fixed reimbursement policies at CMS can be expected to lead to
pricing pressure from hospitals and other healthcare providers, and to have an
adverse effect on our brachytherapy revenue. The extent of the effect
is impossible for us to predict, especially when fixed reimbursement policies
are being introduced at a time that coincides with 1) an industry wide decline
in procedures being experienced due, at least in part, to favorable CMS
reimbursement rates enjoyed by alternative, less proven, technologies and 2)
uncertainties regarding healthcare reform generally. These factors
could have an adverse effect on brachytherapy revenue. See “Medicare Developments”
included in “Management’s Discussion and
Analysis” below for additional information regarding CMS reimbursement
policies for brachytherapy seeds.
I-16
Responding
to market opportunities and competitive situations could have an adverse effect
on average selling prices. Responding to market opportunities and competitive
situations could also have a favorable effect or prevent an unfavorable effect
on market share and volumes. Conversely, we or our non-exclusive distributors
could individually and independently decide to maintain per unit pricing under
certain competitive situations that could adversely affect current or potential
market share and volumes.
There can
be no assurance (i) that current or future limitations or requirements for
reimbursement by Medicare or other third party payors for prostate cancer
treatment will not materially adversely affect the market for our brachytherapy
or other products, (ii) that health administration authorities outside of the
United States will provide reimbursement at acceptable levels, if at all or
(iii) that any such reimbursement will be continued at rates that will enable us
to maintain prices at levels sufficient to realize an appropriate return. Any of
these factors could have an adverse effect on brachytherapy
revenue.
We
may be unable to maintain sufficient liability insurance.
Our
business is subject to product liability risks inherent in the testing,
manufacturing and marketing of medical devices. We maintain product liability
and general liability coverage. These coverages are subject to annual
renewal. There can be no assurance that liability claims will not exceed the
scope of coverage or limits of such policies or that such insurance will
continue to be available on commercially reasonable terms or at all. If we do
not or cannot maintain sufficient liability insurance, our ability to market our
products may be significantly impaired. In addition, product liability claims,
as well as negative publicity arising out of such claims, could have a material
adverse effect on our business, financial condition and results of
operations.
If
we do not comply with laws and regulations relating to our use of hazardous
materials, we may incur substantial liabilities.
We use
hazardous materials and chemicals in our manufacturing operations. We are
required to comply with increasingly rigorous laws and regulations governing
environmental protection and workplace safety, including requirements governing
the handling, storage and disposal of hazardous substances and the discharge of
materials into the environment generally. Although, we believe that we handle,
store and dispose of these materials in a manner that complies with state and
federal regulations, the risk of accidental contamination or injury exists. In
the event of an accident, we could be held liable for decontamination costs,
other clean-up costs and related damages or liabilities. To help minimize these
risks, we employ a full-time Environmental Health and Safety Officer and, when
appropriate, we utilize outside professional services organizations to help us
evaluate environmental regulations and monitor our compliance with such
regulations. In addition, we procure insurance specifically designed to mitigate
environmental liability exposures.
Litigation
may harm our business or otherwise distract our management.
Substantial, complex or extended
litigation could cause us to incur large expenditures and distract our
management, and could result in significant monetary or equitable judgments
against us. For example, lawsuits by employees, patients, customers, licensors,
licensees, suppliers, business partners, distributors, stockholders, or
competitors could be very costly and could substantially disrupt our business.
Disputes from time to time with such companies or individuals are not uncommon,
and we cannot assure that we will always be able to resolve such disputes out of
court or on terms favorable to us.
Defects
in, or misuse of, our products, or any detrimental side effects that result from
the use of our products, could result in serious injury or death and could
require costly recalls or subject us to costly and time-consuming product
liability claims. This could harm future sales and require us to pay substantial
damages.
TheraSeed® and
I-Seed deliver a highly concentrated and confined dose of radiation directly to
the prostate from within the patient’s body. Surrounding tissues and organs are
typically spared excessive radiation exposure. Our wound closure, vascular
access and specialty needle products are also utilized directly on patients. It
is an inherent risk of the industries in which we operate that we might be sued
in a situation where one of our products results in, or is alleged to result in,
a personal injury to a patient, health care provider, or other user. Although we
believe that as of the current date we have adequate insurance to address
anticipated potential liabilities associated with product liability, any
unforeseen product liability exposure in excess of, or outside the scope of,
such insurance coverage could adversely affect our operating results. Any such
claim brought against us, with or without merit, could result in significant
damage to our business.
I-17
The FDA’s
medical device reporting regulations require us to report any incident in which
our products may have caused or contributed to a death or serious injury, or in
which our products malfunctioned in a way that would be likely to cause or
contribute to a death or serious injury if the malfunction reoccurred. Any
required filing could result in an investigation of our products and possibly
subsequent regulatory action against us if it is found that one of our products
caused the death or serious injury of a patient.
Because
of the nature of our products, the tolerance for error in the design,
manufacture or use of our products may be small or nonexistent. If a product
designed or manufactured by us is defective, whether due to design or
manufacturing defects, or improper assembly, use or servicing of the product or
other reasons, the product may need to be recalled, possibly at our expense.
Furthermore, the adverse effect of a product recall might not be limited to the
cost of the recall. For example, a product recall could cause applicable
regulatory authorities to investigate us as well as cause our customers to
review and potentially terminate their relationships with us. Recalls,
especially if accompanied by unfavorable publicity or termination of customer
contracts, could cause us to suffer substantial costs, lost revenues and a loss
of reputation, each of which could harm our business. Products as complex as our
planning and dose calculation software systems may also contain undetected
software errors or defects when they are first introduced or as new versions are
released. Our products may not be free from errors or defects even after they
have been tested, which could result in the rejection of our products by our
customers and damage to our reputation, as well as lost revenue, diverted
development resources and increased support costs. We may also be subject to
claims for damages related to any errors in our products.
Although
a number of the surgical products are Class II devices subject to certain
special controls by the FDA, many of the products are Class I devices, meaning
that the FDA considers these products to present minimal potential for harm to
the user. Nonetheless, if there is an error in the design, manufacture or use of
any of these products, there remains a risk of recall, rejection of our product
by our customers, damage to our reputation, lost revenue, diverted development
of resources and increased support costs. We may also be subject to claims for
damages related to any error in such products.
We
may require additional capital in the future and we may be unable to obtain
capital on favorable terms or at all.
Although
we expect our existing capital resources and future operating cash flows to be
sufficient for the foreseeable future, certain events, such as operating losses
or unavailability of credit could significantly reduce our remaining cash, cash
equivalents and investments in marketable securities. Furthermore, we may
require additional capital for research and development, the purchase of other
businesses, technologies or products. Our capital requirements will depend on
numerous factors, including the time and cost involved in expanding production
capacity, the cost involved in protecting our proprietary rights and the time
and expense involved in completing product development
programs.
If
we are unable to develop new enhancements and new generations, we may be unable
to retain our existing customers or attract new customers.
Rapid and
significant technological change in products offered as well as enhancements to
existing products and surgical techniques coupled with evolving industry
standards and new product introductions characterize the market for our
brachytherapy, wound closure, vascular access, and specialty needle products.
Many of our brachytherapy and surgical products are technologically innovative
and require significant planning, design, development and testing. These
activities require significant capital commitments and investment. If we are
unable to raise needed capital on favorable terms or at all, we may be unable to
maintain our competitive advantage in the marketplace.
New
product developments in the healthcare industry are inherently risky and
unpredictable. These risks include:
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failure
to prove feasibility;
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time
required from proof of feasibility to routine
production;
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timing
and cost of product development and regulatory approvals and
clearances;
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competitors’
response to new product
developments;
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development,
launch, manufacturing, installation, warranty and maintenance cost
overruns;
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failure
to obtain customer acceptance and
payment;
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customer
demands for retrofits of both old and new products;
and
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excess
inventory caused by phase-in of new products and phase-out of old
products.
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The high
cost of technological innovation is coupled with rapid and significant change in
the regulations governing the products that compete in both our surgical
products and brachytherapy markets. We may also be affected by industry
standards that could change on short notice, and by the introduction of new
products and technologies that could render existing products and technologies
uncompetitive. We cannot be sure that we will be able to successfully develop
new products or enhancements to our existing brachytherapy products and
innovative surgical products. Without new product introductions, our revenues
will likely suffer. Even if customers accept new enhanced products, the costs
associated with making these products available to customers, as well as our
ability to obtain capital to finance such costs, could reduce or prevent us from
increasing our operating margins.
I-18
Our
cash balances and marketable securities are subject to risks, which may cause
losses and affect the liquidity of these investments.
At
December 31, 2009, we had $45.3 million in cash and cash
equivalents. We may also invest in marketable securities. Our cash
and cash equivalents represent cash deposits and money market funds, and are
invested with five financial institutions. Any investments in marketable
securities are made in accordance with our investment policies, which generally
allow investments in high-credit quality corporate and municipal obligations.
All of these cash, cash equivalents and marketable securities investments are
subject to general credit, liquidity, market, interest rate and counterparty
risks, which may be exacerbated by the disruptions and volatility in the
economic climate, lack of liquidity in the credit and investment markets,
economic difficulties encountered by many financial institutions and other
economic uncertainties that have in the past and may in the future affect
various sectors of the financial markets and caused credit and liquidity issues.
These market risks associated with our investment portfolio may have a negative
adverse effect on our results of operations, liquidity and financial
condition.
We
face unknown and unpredictable risks related to the current economic
instability.
Financial
markets and the economies in the United States and internationally have
experienced extreme disruption and volatility and conditions could worsen. This
has resulted in severely diminished liquidity and credit availability in the
market, which could impair our ability to access capital or adversely affect our
operations. The economic downturn may also, among other things:
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create
downward pressure on the pricing of our
products;
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affect
the collection of accounts
receivable;
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increase
the sales cycle for certain of our
products;
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slow
the adoption of new products and technologies;
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adversely
affect our customers, causing them to reduce
spending;
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adversely
affect our suppliers, which could adversely affect our ability to produce
our products.
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Any of
these conditions could have a material adverse effect on our business, financial
position, liquidity and results of operations.
The
adoption of healthcare reform in the United States may adversely affect our
business, financial condition and results of operations.
Various
committees of the U.S. Congress have proposed significant reforms to the U.S.
healthcare system. The proposals include provisions that, among other things,
could reduce and/or limit Medicare reimbursement, create a national healthcare
system and impose new and/or increased taxes. One proposed bill would require
the medical device industry to subsidize healthcare reform in the form of a
substantial annual excise tax on medical device sales. We cannot predict what
healthcare initiatives, if any, will be implemented. Many of the proposed
reforms, if enacted at the federal or state level, could reduce medical
procedure volumes, impact the demand for our products or prices at which we sell
our products, and/or increase our cost of doing business, any of which could
have a material adverse effect on our business, financial condition and results
of operations. In addition, the uncertainties associated with the current state
of potential healthcare reform may also harm our business, as customers and
others delay and/or cancel expansion and development plans due to a lack of
ability to adequately assess the potential effect of any healthcare reform that
might be enacted.
Changes
in FDA requirements for obtaining 510(k) approval to market and sell medical
device products in the U.S. may adversely affect our business, financial
condition and results of operations.
The FDA
has recently been considering legislative, regulatory and/or administrative
changes to the FDA’s 510(k) program. Various committees of the
U.S. Congress have also indicated that they may consider investigating the FDA’s
510(k) process. Under the current 510(k) rules, certain types of
medical devices can obtain FDA approval without lengthy and expensive clinical
trials. Among our product offerings, those products that require FDA
approval have received such approval under the 510(k) rules. Our
R&D programs and new product programs contemplate obtaining any required FDA
approvals under the current 510(k) rules. Any changes to the current
510(k) or related FDA rules that make such rules more stringent or require more
clinical data, can significantly increase the time and costs associated with
bringing new products to market. This may have a material adverse
effect on our business, financial condition and results of
operations.
I-19
We
face risks in connection with our current project to install a new ERP
system.
We are
currently replacing our multiple legacy business systems with a corporate wide
ERP system to handle various business, operating and financial
processes. ERP implementations are complex and time-consuming
projects that can involve substantial expenditures for system hardware,
software, and implementation activities. Such an integrated, wide-scale
implementation is extremely complex and may require transformation of business
and financial processes in order to reap the benefits of the ERP
system. Problems or delays in our ERP implementation could result in
operational issues including delayed shipments or production, missed sales,
inefficiencies in our business operations, billing and accounting errors and
other operational issues. Our business and results of operations may be
adversely affected if we experience operating problems and/or cost overruns
during the ERP implementation process or if the ERP system and the associated
process changes do not function as expected or do not give rise to the expected
benefits. System delays or malfunctioning could also disrupt our ability to
timely and accurately process and report the results of our consolidated
operations, financial position, and cash flows. This may have a material adverse
effect on our business, financial condition and results of
operations.
Item
1B. Unresolved Staff Comments.
None.
Item
2. Properties
Our
executive offices are located in Buford, Georgia, in a facility that we own.
Approximately 144,000 square feet of manufacturing and development facilities in
the brachytherapy seed business are also located in Buford, Georgia, and are
owned by us. Approximately 123,000 square feet of space in leased facilities in
the surgical products business are located in Portland, Oregon, Garland, Texas
and the Boston, Massachusetts area. Upon completion of our specialty
needle manufacturing facility, we will add approximately 70,000 square feet that
we own and will no longer lease approximately 36,000 square feet of space in the
Boston, Massachusetts area.
We also
own approximately 32 acres in Buford, Georgia on which our executive offices and
facilities for our brachytherapy seed business are located. There is land
available for future development adjacent to our current Buford
facility.
The
surgical products business leases approximately 34,500 square feet of
production, warehouse, and office space from entities controlled by certain
related parties. Our CP Medical facility is owned by an
entity controlled by the former owner and officer of CP
Medical. Our NeedleTech facility is owned by an entity controlled by
the former principal owners of NeedleTech, one of whom is a current executive
officer and one of whom is a former executive officer.
All of
our owned and leased space that is currently in service is well maintained and
suitable for the operations conducted in it. The capacity of our specialty
needle manufacturing facility will be increased with the addition of our new
facility.
Item
3. Legal Proceedings
From time
to time we may be a party to claims that arise in the ordinary course of
business, none of which, in our view, is expected to have a material adverse
effect on our consolidated financial position or results of
operations.
Item
4. Reserved.
I-20
PART
II
Item
5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
Our
Common Stock, $.01 par value, (“Common Stock”) is traded on the New York Stock
Exchange (NYSE) under the symbol “TGX”. The high and low prices for our Common
Stock for each fiscal quarterly period in 2009 and 2008 are as
follows:
High
|
Low
|
|||||||
2009
|
||||||||
First
Quarter
|
$ | 1.39 | 0.79 | |||||
Second
Quarter
|
1.48 | 0.86 | ||||||
Third
Quarter
|
1.89 | 1.04 | ||||||
Fourth
Quarter
|
1.59 | 1.23 | ||||||
2008
|
||||||||
First
Quarter
|
$ | 4.00 | $ | 3.23 | ||||
Second
Quarter
|
4.25 | 3.20 | ||||||
Third
Quarter
|
3.76 | 2.69 | ||||||
Fourth
Quarter
|
3.25 | 0.96 |
As of
March 11, 2010, the closing price of our Common Stock was $1.49
per share. Also, as of that date, there were approximately 406
holders of record of our Common Stock. The number of record holders does not
reflect the number of beneficial owners of our Common Stock for whom shares are
held by depositary trust companies, brokerage firms and others.
We have a
Stockholder Rights Plan (the “Rights Plan”), which contains provisions designed
to protect our stockholders. Pursuant to the Rights Plan, each share of our
Common Stock contains a share purchase right (a “Right”). The Rights expire in
February 2017, and do not become exercisable unless certain events occur
including the acquisition of, or commencement of a tender offer for, 20% or more
of the outstanding Common Stock. In the event certain triggering events occur,
including the acquisition of 20% or more of the outstanding Common Stock, each
Right that is not held by the 20% or more stockholders will entitle its holder
to purchase additional shares of Common Stock at a substantial discount to then
current market prices. The Rights Plan and the terms of the Rights, which are
set forth in a Rights Agreement between us and Computershare Investor Services
LLC, as Rights Agent, could add substantially to the cost of acquiring us and
consequently could delay or prevent a change in control of us.
Dividend
Policy
We have
not previously declared or paid a cash dividend on our Common Stock. It is the
present policy of our Board of Directors to retain all earnings to support
operations and our strategy of continued diversification and expansion.
Consequently, the Board of Directors does not anticipate declaring or paying
cash dividends on our Common Stock in the foreseeable future.
II-1
Item
6. Selected Financial Data
The
following selected financial data are derived from our consolidated financial
statements. The selected financial data set forth below should be read in
conjunction with our consolidated financial statements and related notes thereto
and Management’s Discussion
and Analysis of Financial Condition and Results of Operations included
elsewhere herein.
(Amounts
in thousands, except per share data)
|
Year
ended December 31,
|
|||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Statement
of Operations Data:
|
||||||||||||||||||||
Product
sales
|
$ | 77,151 | 66,447 | $ | 61,286 | $ | 53,076 | $ | 43,693 | |||||||||||
License
and fee income
|
1,175 | 911 | 924 | 1,020 | 577 | |||||||||||||||
Total
revenue
|
78,326 | 67,358 | 62,210 | 54,096 | 44,270 | |||||||||||||||
Cost
of sales
|
44,953 | 36,264 | 31,994 | 27,752 | 23,763 | |||||||||||||||
Gross
profit
|
33,373 | 31,094 | 30,216 | 26,344 | 20,507 | |||||||||||||||
Selling,
general and administrative
|
22,020 | 20,500 | 19,131 | 19,951 | 19,652 | |||||||||||||||
Amortization
of purchased intangibles
|
3,441 | 2,410 | 1,875 | 1,371 | 500 | |||||||||||||||
Research
and development
|
2,160 | 1,300 | 1,365 | 805 | 3,632 | |||||||||||||||
Impairment
of goodwill and tradenames
|
— | 70,376 | — | — | — | |||||||||||||||
Change
in estimated value of asset held for sale
|
— | (142 | ) | 500 | — | — | ||||||||||||||
Restructuring
expenses
|
— | — | — | 369 | 33,390 | |||||||||||||||
(Gain)
loss on sale of assets
|
3 | (5 | ) | — | (201 | ) | 14 | |||||||||||||
Total
operating expenses
|
27,624 | 94,439 | 22,871 | 22,295 | 57,188 | |||||||||||||||
Earnings
(loss) from operations
|
5,749 | (63,345 | ) | 7,345 | 4,049 | (36,681 | ) | |||||||||||||
Other,
net
|
(837 | ) | 277 | 1,502 | 1,104 | 1,281 | ||||||||||||||
Earnings
(loss) before income taxes
|
4,912 | (63,068 | ) | 8,847 | 5,153 | (35,400 | ) | |||||||||||||
Income
tax expense (benefit)
|
1,837 | (4,528 | ) | 3,212 | (1,712 | ) | (6,394 | ) | ||||||||||||
Net
earnings (loss)
|
$ | 3,075 | (58,540 | ) | $ | 5,635 | $ | 6,865 | $ | (29,006 | ) | |||||||||
Net
earnings (loss) per share
|
||||||||||||||||||||
Basic
|
$ | 0.09 | (1.77 | ) | $ | 0.17 | $ | 0.21 | $ | (0.93 | ) | |||||||||
Diluted
|
$ | 0.09 | (1.77 | ) | $ | 0.17 | $ | 0.21 | $ | (0.93 | ) | |||||||||
Weighted
average common shares
|
||||||||||||||||||||
Basic
|
33,145 | 33,066 | 33,103 | 32,452 | 31,273 | |||||||||||||||
Diluted
|
33,269 | 33,066 | 33,299 | 32,540 | 31,273 |
December
31,
|
||||||||||||||||||||
(In
thousands)
|
2009
|
2008
|
2007
|
2006
|
2005
|
|||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||||||
Cash
and cash equivalents
|
$ | 45,326 | $ | 39,088 | $ | 28,666 | $ | 18,258 | $ | 10,073 | ||||||||||
Marketable
securities
|
— | 1,507 | 20,123 | 14,722 | 35,535 | |||||||||||||||
Property
and equipment, net
|
31,999 | 30,035 | 27,972 | 30,901 | 32,766 | |||||||||||||||
Goodwill,
net
|
— | — | 38,658 | 38,824 | 18,370 | |||||||||||||||
Total
assets
|
116,108 | 114,419 | 148,821 | 146,244 | 122,064 | |||||||||||||||
Short-term
borrowings
|
3,333 | 32,000 | — | — | — | |||||||||||||||
Long-term
borrowings
|
27,000 | — | 7,500 | 7,500 | — | |||||||||||||||
Shareholders’
equity
|
$ | 77,653 | $ | 74,110 | $ | 132,619 | $ | 126,141 | $ | 115,683 |
II-2
Comparability
of the selected financial data above is affected by certain material changes in
our business, including:
●
|
The
acquisitions of CP Medical in May 2005, Galt in August 2006, and
NeedleTech in July 2008. The results of operations of acquired
companies are included in our consolidated results for periods subsequent
to each respective acquisition
date,
|
●
|
restructuring
of our brachytherapy segment in
2005,
|
●
|
impairment
charges related to the write off of goodwill and tradenames in 2008,
and
|
●
|
refinancing
of our credit facility in 2009.
|
The above
list is not intended to identify all material changes in our business from 2005
to 2009. Rather, we believe the above information is useful in
understanding the period to period comparability of the above selected financial
data. Please read the information included elsewhere in this Form
10-K, including Business, Risk
Factors, Management’s
Discussion and Analysis of Financial Condition and Results of Operations,
Financial Statements and Supplementary Data, as well as other information
contained herein for a more complete discussion of our business, financial
condition, and results of operations.
II-3
THERAGENICS
CORPORATION
Item
7. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
Overview
Theragenics
Corporation is a medical device company serving the surgical products and cancer
treatment markets, operating in two business segments. The terms “Company”,
“we”, “us”, or “our” mean Theragenics Corporation and all entities included in
our consolidated financial statements.
Our
surgical products business consists of wound closure, vascular access, and
specialty needle products. Wound closure includes sutures, needles and other
surgical products. Vascular access includes introducers, guidewires, and related
products. Specialty needles include coaxial, biopsy, spinal and disposable
veress needles, access trocars, and other needle based products. This segment
serves a number of markets and applications, including among other areas,
interventional cardiology, interventional radiology, vascular surgery,
orthopedics, plastic surgery, dental surgery, urology, veterinary medicine, pain
management, endoscopy, and spinal surgery. Our surgical products business sells
its devices and components primarily to original equipment manufacturers
(“OEMs”) and to a network of distributors.
In our
brachytherapy seed business, we produce, market and sell TheraSeed®, our
premier palladium-103 prostate cancer treatment device; I-Seed, our iodine-125
based prostate cancer treatment device; and other related products and services.
We are the world’s largest producer of palladium-103, the radioactive isotope
that supplies the therapeutic radiation for our TheraSeed®
device. Physicians, hospitals and other healthcare providers, primarily located
in the United States, utilize the TheraSeed®
device. The majority of TheraSeed® sales
are channeled through third-party distributors. We also maintain an in-house
sales force that sells our TheraSeed® and
I-Seed devices directly to physicians.
We have
substantially diversified our operations and revenues in recent years. In May
2005, we expanded into the surgical products business with the acquisition of CP
Medical Corporation (“CP Medical”). In August 2005, we restructured
our brachytherapy seed business to sharpen our focus on our two business
segments and provide a more focused platform for continued
diversification. In August 2006, we acquired Galt Medical Corp.
(“Galt”); and in July 2008, we acquired NeedleTech Products, Inc.
(“NeedleTech”). CP Medical, Galt, and NeedleTech comprise our
surgical products business, which accounted for 69% of consolidated revenue in
2009. Prior to May 2005, the brachytherapy seed business constituted
100% of our revenue.
New
Credit Agreement
In May
2009, we executed an Amended and Restated Credit Agreement (the “Credit
Agreement”) with a financial institution. The Credit Agreement
provides for up to $30 million of borrowings under a revolving credit facility
(the “Revolver”) and a $10 million term loan (the “Term Loan”), payable in equal
monthly installments over three years. This new Credit Agreement
replaced our prior credit agreement which had a maturity date of October
2009. See “Liquidity and Capital
Resources” below for additional information.
Acquisition
of NeedleTech Products in 2008
We
acquired all of the outstanding common stock of NeedleTech on July 28, 2008. The
total purchase price, including transaction costs, was approximately $44.1
million (net of cash, cash equivalents, and marketable securities acquired with
an estimated fair value of approximately $5.8 million). The purchase price was
paid in cash, including $24.5 million from borrowings under our $40 million
credit facility. NeedleTech is a manufacturer of specialty needles and related
medical devices. NeedleTech’s current products include coaxial needles, biopsy
needles, access trocars, brachytherapy needles, guidewire introducer needles,
spinal needles, disposable veress needles, and other needle-based products. End
markets served include cardiology, orthopedics, pain management, endoscopy,
spinal surgery, urology, and veterinary medicine. This transaction provided
further diversification in our surgical products business and allowed us to
leverage our existing strengths within these markets. The acquisition of
NeedleTech is designed to forward our stated strategy of becoming a diversified
medical device manufacturer, increase our breadth of offerings to existing
customers, and expand our customer base of large leading-edge original equipment
manufacturers.
We
accounted for the acquisition of NeedleTech under the purchase method of
accounting. Accordingly, the purchase price was allocated based on the fair
values of the assets acquired and liabilities assumed at the date of
acquisition, with the excess of the purchase price over the fair value of the
net assets acquired recorded as goodwill. Results of operations of NeedleTech
were included for the period subsequent to the acquisition date.
II-4
Results
of Operations
Change
in Segment Reporting
We
changed the manner in which we allocate the cost of corporate activities to our
business segments during 2009. Operating expenses associated with
corporate activities are now allocated based on the relative revenue of each
business segment. With the acquisition of NeedleTech in July 2008,
the continued integration of acquired companies, the launch of our R&D
program for our surgical products segment in late 2008, and our program to
standardize our information technology systems across all of our businesses,
among other things, we believe this method more accurately reflects the
utilization of corporate resources. We also utilize this method
internally to review results and allocate resources. Previously, we
charged the significant portion of expenses associated with corporate activities
to our brachytherapy segment. We have restated our segment results
for 2008 and 2007 to reflect this change in the method of allocating corporate
expenses. This change did not affect the reported amounts of segment
revenue, nor did this change have any effect on our consolidated results of
operations previously reported for 2008 and 2007.
Year
Ended December 31, 2009, Compared to Year Ended December 31, 2008
Revenue
Following
is a summary of revenue by segment for each of the three years in the period
ended December 31, 2009 (in thousands):
Revenue
by segment
|
Year
ended December 31,
|
|||||||||||
2009
|
2008
|
2007
|
||||||||||
Surgical
products
|
$ | 53,660 | $ | 38,779 | $ | 28,896 | ||||||
Brachytherapy
seed
|
||||||||||||
Product
sales
|
23,860 | 27,910 | 32,596 | |||||||||
Licensing
fees
|
1,106 | 877 | 924 | |||||||||
Total
brachytherapy seed
|
24,966 | 28,787 | 33,520 | |||||||||
Intersegment
eliminations
|
(300 | ) | (208 | ) | (206 | ) | ||||||
Consolidated
|
$ | 78,326 | $ | 67,358 | $ | 62,210 |
Surgical Products
Segment
Revenue
in our surgical products business increased 38% in 2009 over 2008, primarily as
a result of our NeedleTech acquisition. On a pro forma basis, as if
the NeedleTech acquisition had occurred on January 1, 2008, revenue in our
surgical products segment would have increased 10% in 2009 over
2008. All three of our general product categories, including wound
closure, introducers and guidewires, and specialty needles, recorded organic
growth during 2009. Our wound closure products performed
particularly well, as we believe we provided exceptional value in that
application. Open orders in our surgical products segment were $13.5
million at December 31, 2009 compared to $11.4 million at December 31,
2008. Open orders are not guaranteed shipments, and they are subject
to cancellation or delay. A significant portion of the revenues in
our surgical business is generated by sales to OEMs and a network of
distributors. Ordering patterns of these customers vary and are
difficult to predict. Accordingly, surgical products revenue is
subject to fluctuation, especially on a quarter-to-quarter basis. In
addition, the volatility and disruptions in the U.S. and global economies and
credit markets, and other uncertainties due to the economic slowdown have had an
effect on our surgical product revenue. As general economic
conditions worsened in the fourth quarter of 2008, scheduled shipping dates for
our open orders during the fourth quarter were farther out than we historically
experienced. We have not experienced a similar delay in requested
shipping dates at the end of 2009. However, we expect that the
difficult economic climate and macroeconomic uncertainties generally will
continue to affect our surgical products business at least through 2010, and
perhaps make the fluctuations in our results even more volatile from period to
period.
II-5
Brachytherapy Seed
Segment
Brachytherapy
product sales decreased 15% in 2009 from 2008. We believe that the
industry wide decline in prostate brachytherapy procedure volume experienced in
2008 continued in 2009. Some newer forms of treatment have increased
their market share, especially those with Medicare reimbursement levels that are
higher than reimbursement levels for brachytherapy. These newer forms
of alternative treatments include Intensity
Modulated Radiation Therapy (“IMRT”) and robotic surgery. We
cannot predict when this industry wide decline in procedure volume will
stabilize and expect continued softness in brachytherapy revenue into
2010. Our revenues also continue to be affected by the performance of
our main distributor. Sales to this distributor declined 22% from
2008 to 2009. We also maintain our own internal brachytherapy sales force that
sells TheraSeed® and
I-Seed directly to hospitals and physicians. Our direct sales declined 11% in
from 2008 to 2009. Revenue from direct sales was 49% of total
brachytherapy segment product revenue in 2009 compared to 47% in
2008. In addition to competition from treatment options that enjoy
favorable reimbursement rates, we believe brachytherapy seed revenue is affected
by disruptive pricing from other brachytherapy providers and uncertainties
surrounding reimbursement as discussed below. The average selling
price of the TheraSeed®
device sold directly to hospitals and physicians during 2009 was comparable to
the 2008 period.
We have
non-exclusive distribution agreements in place for the distribution of our TheraSeed® device. The primary distribution
agreement is with C. R. Bard (“Bard”), which is effective through December 31,
2011 (the “Bard Agreement”). Sales under the Bard Agreement represented 46% of
brachytherapy product revenue in 2009 compared to 51% in
2008. The terms of the Bard Agreement provide for
automatic one-year extensions of the term, unless either party gives notice of
its intent not to renew at least twelve months prior to the end of the current
term. The current term expires on December 31, 2011 and will be automatically
extended for one additional year unless either party gives notice of its intent
not to extend by December 31, 2010.
In January 2010 we announced a supply and reseller
agreement with Core Oncology (the “Core Agreement”). Under the
terms of the Core Agreement, we are the exclusive palladium-103 seed supplier to
Core for the treatment of prostate cancer in the U.S. and
Canada. Core can also sell TheraSeed® for
the treatment of other solid localized cancerous tumors. The term of
the agreement is through November 30, 2011, and is automatically extended for
additional one-year terms unless terminated by either party upon prior written
notice. We had no brachytherapy segment sales to Core prior to
2010. Sales to Core under the Core Agreement are expected to be 10%
or more of total brachytherapy product revenue in 2010.
We
believe that Medicare reimbursement policies have affected the brachytherapy
market and will continue to affect the brachytherapy market. Prior to
2010, Medicare continued to reimburse for brachytherapy seeds under the “charges
adjusted to costs” methodology, which is based on the actual invoiced cost of
the seeds and which we sometimes refer to as a “pass-through”
methodology. Consistent with proposals that the Centers for
Medicare & Medicaid Services (“CMS”) attempted unsuccessfully to implement
in recent years, CMS posted a final hospital outpatient prospective payment
system (“OPPS”) on October 30, 2009 with fixed prospective payment rates for
brachytherapy seeds. This fixed OPPS, which we sometimes refer to as
“fixed reimbursement”, went in effect on January 1, 2010 and fixes the per seed
rate at which Medicare reimburses hospitals for the purchase of
seeds. We expect to continue to support efforts to urge Congress and
CMS to replace this “fixed reimbursement” rule by obtaining a new extension of
the “pass-through” reimbursement policies which existed prior to
2010. Fixed reimbursement policies at CMS can be expected to lead to
pricing pressure from hospitals and other healthcare providers, and to have an
adverse effect on our brachytherapy revenue. The extent of the effect
is impossible for us to predict, especially when fixed reimbursement policies
are being introduced at a time that coincides with 1) an industry wide decline
in procedures being experienced due, at least in part, to favorable CMS
reimbursement rates enjoyed by alternative, less proven, technologies and 2)
uncertainties regarding healthcare reform generally. These factors
could have an adverse effect on brachytherapy revenue. See “Medicare Developments” below
for additional information regarding CMS reimbursement policies for
brachytherapy seeds.
License
fees increased from $877,000 in 2008 to $1.1 million in 2009, and include fees
from the licensing of our TheraSphere®
product, a medical device used for the treatment of liver
cancer. Licensing fees also includes fees related to the licensing of
certain intellectual property related to an expandable brachytherapy delivery
system that we developed. This agreement, which was executed in May 2008,
provides for a minimal non-refundable initial license fee and non-refundable
continuing royalties based upon sales subject to certain minimums.
II-6
Operating
income (loss) and costs and expenses
Following
is a summary of operating income (loss) by segment for each of the three years
in the period ended December 31, 2009 (in thousands):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Surgical
products
|
||||||||||||
Operating
income (loss)
|
$ | 1,664 | $ | (66,595 | ) | $ | 1,420 | |||||
Impairment
of goodwill and tradenames
|
— | 67,798 | — | |||||||||
Surgical
products excluding special items
|
1,664 | 1,203 | 1,420 | |||||||||
Brachytherapy
seed
|
||||||||||||
Operating
income
|
4,081 | 3,233 | 5,960 | |||||||||
Impairment
of goodwill and tradenames
|
— | 2,578 | — | |||||||||
Change
in estimated value of asset held for sale
|
— | (142 | ) | 500 | ||||||||
Brachytherapy
seed excluding special items
|
4,081 | 5,669 | 6,460 | |||||||||
Intersegment
eliminations
|
4 | 17 | (35 | ) | ||||||||
Operating
income (loss)
|
||||||||||||
Consolidated
|
$ | 5,749 | $ | (63,345 | ) | $ | 7,345 | |||||
Excluding
special items
|
$ | 5,749 | $ | 6,889 | $ | 7,845 |
Operating
income excluding special items is a non-GAAP financial measure. In
addition to calculations measuring operating income (loss) as calculated and
presented in accordance with accounting principles generally accepted in the
United States of America (“GAAP”), we utilize operating income excluding special
items to make operational decisions, evaluate performance, prepare internal
forecasts and allocate resources. Operating income excluding special
items is a non-GAAP financial measure which, when compared with operating income
(loss) calculated in accordance with GAAP, allows us to more accurately
determine whether a given increase or decrease in operations for a given segment
is a result of an event that is non-recurring in nature or is reflective of an
on-going performance issue. We believe presentation of this non-GAAP financial
measure provides supplemental information that is helpful to an understanding of
the operating results of our businesses and period-to-period comparisons of
performance. However, we recognize that the use of non-GAAP measures
has limitations, including the fact that they may not be directly comparable
with similar non-GAAP financial measures used by other companies. We compensate
for these limitations by providing full disclosure of each non-GAAP financial
measure and providing a reconciliation to the most directly comparable GAAP
financial measure. All non-GAAP financial measures are intended to
supplement the applicable GAAP disclosures and should not be considered in
isolation from, or as a substitute for, financial information prepared in
accordance with GAAP.
Surgical Products
Segment
Operating
income excluding special items in our surgical products segment was $1.7 million
in 2009 compared to $1.2 million in 2008. Operating income in our
surgical products segment included the results of NeedleTech subsequent to our
acquisition on July 28, 2008. Accordingly, NeedleTech was included in
our consolidated results for all of 2009 but only for five months
in 2008.
Our gross
profit margin on products sales was 39% in 2009 compared with 41% in
2008. A number of factors affected the comparability between the 2009
and 2008 periods. In 2008, our gross profit and operating income was
reduced by $885,000 of non-cash charges related to the acquisition of
NeedleTech. These non-cash charges were related primarily to the fair
value adjustments to NeedleTech inventory at acquisition and did not recur in
2009. Excluding these non-cash acquisition related charges, our gross
profit margin on product sales was 43% in 2008. Items affecting our
gross profit margins in 2009 included, among other things, our product and sales
channel mix changed subsequent to the NeedleTech acquisition, with a larger
proportion of sales being made to OEM customers which generally carry lower
gross profit margins relative to our other channels; continued
investments in infrastructure to address expected future growth; and pricing
pressures from our customers in 2009, which we believe were at least in part
caused by the general macroeconomic uncertainties. Part of our
investments to support future growth in this segment includes the construction
of a new specialty needle manufacturing
facility. We expect to move into this new facility during
2010. We expect to be completely moved out of our main existing
leased facility by the end of 2010. Our new facility should
significantly increase the capacity of this operation. In
anticipation of the move, we may build inventory of our specialty needle
products.
II-7
Selling,
general and administrative (“SG&A”) expenses in our surgical products
segment was 25% of revenue in 2009 compared with 28% in 2008. The decline in
SG&A as a percentage of revenue is due to the increasing scale of our
surgical products segment, partially offset by the change in method of
allocating our corporate costs. We now allocate corporate costs based
on the relative revenue of each of our two business segments. Because
our surgical products segment comprised more of our consolidated revenue in the
2009 periods, primarily due to the inclusion of NeedleTech in our consolidated
results, corporate costs allocated to our surgical products segment increased by
$1.2 million in 2009 from 2008.
Amortization
of purchased intangibles increased by $1.0 million in 2009 from
2008. This is primarily due to the inclusion of amortization related
to NeedleTech purchased intangibles for a full year in 2009. We also
recorded amortization expense related to our tradenames intangible assets
totaling $324,000 in 2009. We did not record any tradename
amortization in 2008. Amortization of our tradenames intangible
assets resulted from our reassessment of their useful lives during our
impairment testing at December 31, 2008.
Operating
income in our surgical products business in 2009 was also affected by increased
investments in our research and development (“R&D”)
program. R&D expenses increased $927,000 in 2009 from
2008. Our R&D program was launched in the second half of
2008. This R&D program is intended to focus on product
extensions, next generation products, and new products that are complementary to
our current product lines and that support our customers’ product
lines. Our R&D program is directed toward 510(k) products, and
not on products that require lengthy and expensive clinical
trials. We have recently been reassessing the projects in our R&D
program in an effort to focus on opportunities with a more immediate
impact. We believe that opportunities to support programs for our
customers may be more attractive for us than developing new
products. Looking forward, we expect R&D expense levels in 2010
to be similar to 2009. However, R&D activities can be complex,
and expense levels are also dependent upon the discovery of opportunities of
which we are not currently aware. Accordingly, R&D expenses are
subject to significant variability from period to period.
During 2009 we began developing a new,
corporate wide Enterprise Resource Planning (“ERP”) information technology
system. As our ERP system was under development during 2009, we
capitalized certain internal costs associated with its development, totaling
$247,000 in our surgical products segment. These internal costs
consisted primarily of employee payroll and related expenses. Upon
completion of the ERP system development at each location, these development
costs will no longer be capitalized but will be charged as operating expenses.
We expect to complete the system development at most of our locations in
2010.
Looking
forward to 2010, we expect a number of items to affect our profitability
including, among other things:
●
|
ordering
patterns of our larger OEM and distributor
customers,
|
●
|
continued
investments in infrastructure and R&D as we make investments to
support anticipated future growth and to develop products to address
growth opportunities,
|
●
|
changes
in product mix and sales channels, with sales through OEM channels
generally carrying a relatively lower gross profit margin and sales
through distributor channels generally carrying a somewhat higher gross
profit margin,
|
●
|
continued
pricing pressure from customers,
|
●
|
the
move to a new and larger specialty needle manufacturing facility, which is
expected during 2010, incurring moving and transition costs, as well as
incurring higher maintenance and operating
costs,
|
●
|
the
implementation of our new, corporate wide ERP systems,
and
|
●
|
increasing
scale of our surgical products
business.
|
Brachytherapy Seed
Segment
Operating
income excluding special items in our brachytherapy seed business was $4.1
million in 2009 compared to $5.7 million in 2008. Manufacturing
related expenses in our brachytherapy business tend to be relatively fixed in
nature. Accordingly, even modest declines in revenue have a
significant negative impact on operating income. Offsetting the
decline in profitability from the decrease in revenue was a decrease in SG&A
expenses of $935,000 from 2008. A portion of this decline was from a
reduction in the allocation of corporate costs in the 2009. We now
allocate corporate costs based on the relative revenue of each of our two
business segments. Because our brachytherapy revenue comprised less
of our consolidated revenue in 2009, mainly due to the inclusion of NeedleTech
in our consolidated results, corporate costs allocated to our brachytherapy
business declined $539,000 in 2009. SG&A in 2009 was also reduced
from the elimination of maintenance and carrying costs related to our former Oak
Ridge facility, which we sold in July 2008, and a decrease in advertising
related expenses. Operating income for 2008 also included a
$142,000 benefit from the sale of our Oak Ridge facility. No such
benefit was realized in 2009. Looking forward, operating income in
our brachytherapy seed business is expected to continue to be highly dependent
on sales levels due to the relatively fixed nature of our manufacturing
costs.
II-8
Our new
ERP system is also being developed for our brachytherapy seed
business. Internal costs, including capitalized interest, totaling
$138,000 were capitalized in this segment during 2009 as our ERP system was
under development. These internal costs consisted primarily of employee payroll
and related expenses. Upon completion of the development of our ERP
system, which is expected during 2010, these development costs will no longer be
capitalized but will be charged as operating expenses.
Non-operating
income/expense
Interest
income decreased from $1.1 million in 2008 to $25,000 in 2009 due to
significantly lower yields on our investment portfolio. During 2008
we had significant investments in auction rate securities. These
investments provided relatively higher returns than we experienced in 2009, but
they also turned out to be illiquid and riskier than expected. We
liquidated our auction rate securities in late 2008 and early 2009 at full value
and without incurring any losses to principal. However, due to the
uncertainties and risks inherent in the current investment and credit markets,
our investment portfolio in 2009 was much more conservatively invested than it
was in 2008. All of our investments are currently held in banks, U.S.
Treasury Bills or highly rated money market accounts. Looking
forward, we may invest our funds in higher yielding investments if those
investments meet the conservative criteria established by our investment
policies and the macroeconomic outlook becomes clearer. Funds
available for investment have and will continue to be utilized for our current
and future expansion programs, for strategic opportunities for growth and
diversification, and for installment payments on the Term Loan. As funds
continue to be used for these purposes, and as interest rates continue to
change, we expect interest income to fluctuate accordingly. For more
information on the risks related to our investments, see Critical Accounting Policies,
Liquidity and Capital Resources – Cash, Cash Equivalents and Marketable
Securities, and Item
7A, Quantitative and Qualitative Disclosures About Market Risk, all of
which are included in this report.
Interest
expense was $865,000 in 2009 compared to $841,000 in 2008. We
maintained higher weighted average outstanding balances under our credit
facility during 2009. This was offset by a lower effective interest
rate. Our weighted average effective interest rate was 3.1% at
December 31, 2009. In addition, fair value adjustments related to our
interest rate swaps are included in interest expense in 2009. Such
fair value adjustments are unrealized losses and totaled $80,000 in
2009.
We manage
our interest rate risk using interest rate swaps associated with outstanding
borrowings under our credit agreement, as our interest rates are floating rates
based on LIBOR. We do not hold or issue interest rate swaps for
trading purposes, and we hold no other derivative financial instruments other
than interest rate swaps. We enter into interest rate swaps that are designed to
hedge the interest rate risk but are not designated as “hedging instruments”, as
defined under guidance issued by the FASB. Changes in the fair value
of these instruments are recognized as interest expense. Such changes
in fair value are based on, among other things, discounted cash flows based upon
current market expectations about future amounts, yield curves, and mid-market
pricing. Accordingly, the fair value of our interest rate swaps is
subject to fluctuation and may have a significant effect on our results of
operations in future periods. Additionally, the counterparty to
our interest rate swaps is the lender under our Credit
Agreement. Accordingly, we are exposed to counterparty credit risk
from this financial institution. We entered into interest rate swaps based on
the relationship with this financial institution as our lender and on their
credit rating and the rating of their parent company. We continue to monitor our
counterparty credit risk.
Income
tax expense
Our
effective income tax rate was 37% in 2009. Our effective income
tax rate for 2008 was a benefit of 7%. These rates include federal and state
income taxes. Our effective income tax rate in 2008 was significantly
affected by our non-cash impairment charges of goodwill and tradenames. The
majority of these impairment charges were not deductible for income tax purposes
and, accordingly, the associated tax benefit was not significant. Future tax
rates can be affected by, among other things, tax expense for items unrelated to
actual taxable income (such as the write-off of deferred tax assets associated
with share based compensation), changes in tax regulations, changes in statutory
tax rates, changes in the tax jurisdictions in which we must file income tax
returns, and many other items that affect the taxability and deductibility of
our revenue and expenses and for which we cannot currently predict.
II-9
Year
Ended December 31, 2008, Compared to Year Ended December 31, 2007
Revenue
Surgical Products
Segment
Revenue
in our surgical products segment increased 34% over 2007 as a result of the
acquisition of NeedleTech, organic growth, and expanded programs for existing
customers. On a pro forma basis, as if the NeedleTech acquisition had occurred
on January 1, 2007, revenue in our surgical products segment would have
increased 7% over 2007. A significant portion of the products in our surgical
business is sold to OEMs and a network of distributors. Ordering patterns of
these customers vary and are difficult to predict. Accordingly, surgical
products revenue is subject to fluctuation, especially on a quarter-to-quarter
basis. In addition, the volatility and disruptions in the U.S. and global
economies and credit markets, and other uncertainties due to the economic
slowdown in the U.S. and around the world, had a negative effect on our surgical
product revenue, especially as general economic conditions worsened in the
fourth quarter of 2008. Scheduled shipping dates for orders were farther out
than we have typically experienced. We believe the lengthening lead times were,
at least in part, our customers’ response to hospitals’ efforts to reduce
inventories and conserve cash. We believe this affected all companies in the
supply chain, including ours.
Brachytherapy Seed
Segment
Brachytherapy
product sales decreased 14% in 2008 compared to 2007. The decrease in product
sales included a decline in sales to our main distributor of 18%. We believe
there was an industry wide decline in prostate brachytherapy procedure volume in
2008. Some newer forms of treatment increased their market share, especially
those with Medicare reimbursement levels that are higher than reimbursement
levels for brachytherapy. These newer forms of alternative treatments include
IMRT and robotic surgery. Our revenues also continued to be affected by the
disappointing performance of our main distributor. We also maintained our own
internal brachytherapy sales force that sells TheraSeed® and
I-Seed directly to hospitals and physicians. Revenue from direct sales was 47%
of total brachytherapy segment revenue in 2008 and 46% in 2007. In addition to
treatment options that enjoy favorable reimbursement rates, we believe that our
brachytherapy seed revenue was also affected by disruptive pricing from other
brachytherapy providers and uncertainties surrounding reimbursement. The average
selling price of the TheraSeed®
device sold directly to hospitals and physicians was down slightly in 2008
compared to 2007.
We have
non-exclusive distribution agreements in place for the distribution of the
TheraSeed® device. During
2008 the primary distribution agreement was with Bard. Sales to Bard
under the Bard agreement represented 51% of brachytherapy product revenue in
2008 compared with 53% in 2007.
Operating
income (loss) and costs and expenses
Surgical Products
Segment
Operating
income in the surgical products segment included the results of NeedleTech
subsequent to acquisition on July 28, 2008. Surgical products operating income
excluding special items was $1.2 million in 2008 compared to $1.4 million in
2007. Gross margins in our surgical products segment were 41% in 2008 compared
to 43% in 2007. Our gross margins in 2008 were negatively affected by $885,000
of non-cash acquisition related charges related to the NeedleTech acquisition.
These non-cash charges were related primarily to the fair value adjustments to
NeedleTech inventory at acquisition. Gross margins are also dependent on sales
channel and product mix. SG&A expenses in our surgical products business
were 28% and 29% of revenue in 2008 and 2007, respectively. In 2008, SG&A as
a percentage of revenue declined due to the increasing scale of our surgical
products segment offset somewhat by higher recruiting, relocation, and
information technology infrastructure costs as compared to 2007. SG&A also
increased in 2008 because of the change in method of allocating our corporate
costs. We allocate corporate costs based on the relative revenue of
each of our two business segments. Because our surgical products
segment comprised more of our consolidated revenue in the 2008 periods,
primarily due to the inclusion of NeedleTech in our consolidated results,
corporate costs allocated to our surgical products segment increased by $1.1
million in 2008 from 2007. We also implemented a new R&D
program in our surgical products business in the fourth quarter of 2008. This
R&D program is intended to focus on product extensions, next generation
products and new products that are complementary to our current product lines.
R&D expenses in our surgical products segment were $1.2 million in 2008
compared to $639,000 in 2007.
II-10
Brachytherapy Seed
Segment
Operating
income excluding special items in the brachytherapy seed segment was $5.7
million in 2008 compared to $6.5 million in 2007. In December 2007 we increased
the estimated service lives of our cyclotron equipment from 10 years to 15
years. This change reduced manufacturing related depreciation expense by
approximately $1.4 million in 2008 from what would have otherwise been reported.
Despite the lower depreciation expense, our operating income declined in 2008
primarily as a result of lower revenue. Manufacturing related expenses in our
brachytherapy business tend to be relatively fixed in nature. Accordingly, even
modest declines in revenue have a significant negative impact on operating
income. Partially offsetting the lower revenue was a $1.2 million decrease in
SG&A expenses compared to 2007 primarily as a result of lower compensation
related expenses and the elimination of maintenance expenses and carrying costs
related to our Oak Ridge facility, which we sold in July 2008. SG&A also
declined because of the change in method of allocating our corporate
costs. We allocate corporate costs based on the relative revenue of
each of our two business segments. Because our brachytherapy revenue
comprised less of our consolidated revenue in 2008, mainly due to the inclusion
of NeedleTech in our consolidated results, corporate costs allocated to our
brachytherapy business declined $367,000 in 2008 from 2007. R&D expenses in
the brachytherapy seed segment also declined in 2008.
Sale
of asset held for sale in 2008
We
completed the sale of our Oak Ridge facility in July 2008. This facility was
previously classified as a long-term asset held for sale on our consolidated
balance sheet. As part of this transaction, the facility was sold and the
underlying land sublease was terminated. The significant portion of the present
value of the future payments due under that sublease was previously classified
as a long-term contract termination liability in our consolidated balance sheet.
The $142,000 gain realized from the completion of the sale in July, including
the termination of the sublease, was recognized as an adjustment to the carrying
value of the asset held for sale in 2008. During 2007 we recorded a $500,000
write down of the carrying value of the Oak Ridge facility based on the general
deterioration of the commercial real estate markets and in the overall economy
at the time.
Impairment
of goodwill and tradenames in 2008
Goodwill
and intangible assets with indefinite lives are not amortized to expense and
must be reviewed for impairment annually or more frequently if events or changes
in circumstances indicate that such assets might be impaired. The first step of
the impairment test, used to identify potential impairment, compares the fair
value of a reporting unit with its carrying amount, including goodwill and
intangible assets with indefinite lives. If fair value exceeds book value,
goodwill is considered not impaired, and the second step of the impairment test
is not required. If book value exceeds fair value, the second step of the
impairment test is performed to measure the amount of impairment loss, if any.
For this step the implied fair value of the goodwill is compared with the book
value of the goodwill. If the book value amount of the goodwill exceeds the
implied fair value of the goodwill, an impairment loss would be recognized in an
amount equal to that excess. Any loss recognized cannot exceed the carrying
amount of goodwill. After an impairment loss is recognized, the adjusted
carrying amount of goodwill is its new accounting basis. Subsequent reversal of
a previously recognized impairment loss is prohibited once the measurement of
that loss is completed.
When we
have goodwill or other intangible assets not subject to amortization recorded in
our consolidated balance sheet, we perform impairment testing at the reporting
unit level. A reporting unit is the same as, or one level below, an
operating segment. Our annual impairment testing is typically
performed during the fourth quarter of each year, which coincides with the
timing of our annual budgeting and forecasting process. We also make
judgments about goodwill and other intangible assets not subject to amortization
whenever events or changes in circumstances indicate that impairment in the
value of such asset recorded on our consolidated balance sheet may exist. The
timing of an impairment test may result in charges to our consolidated
statements of operations in future reporting periods that could not have
been reasonably foreseen in prior periods.
In order
to estimate the fair value of goodwill and other intangible assets not subject
to amortization, we typically prepare discounted cash flow analyses (“income
approach”) and comparable company market multiples analyses (“market approach”)
to determine the fair value of our reporting units.
For the
income approach, we project future cash flows for each reporting unit. This
approach requires significant judgments including the projected net cash flows,
the weighted average cost of capital (“WACC”) used to discount the cash flows
and terminal value assumptions. We derive the assumptions related to cash flows
primarily from our internal budgets and forecasts. These budgets and
forecasts include information related to our current and future products,
revenues, capacity, operating costs, and other information. All such
information is derived in the context of our long-term operational
strategies. The WACC and terminal value assumptions are based on the
capital structure, cost of capital, inherent business risk profiles, and
industry outlooks for each of our reporting units, and for our Company on a
consolidated basis.
II-11
For the
market approach, we identify reasonably similar public companies for each of our
reporting units, analyze the financial and operating performance of these
similar companies relative to our financial and operating performance, calculate
market multiples primarily based on the ratio of Business Enterprise Value
(“BEV”) to revenue and BEV to earnings before interest, taxes, depreciation and
amortization (“EBITDA”), adjust such multiples for differences between the
similar companies and our reporting units, and apply the resulting multiples to
the fundamentals of our reporting units to arrive at an indication of fair
value.
To assess
the reasonableness of our valuations under each method, we reconcile the
aggregate fair values of our reporting units to our market
capitalization.
The most
recent goodwill and intangible asset impairment assessment was performed in the
fourth quarter of 2008. We determined that all of our goodwill was
impaired and that a portion of our tradenames intangible asset was
impaired. These impairment charges were recorded in the fourth
quarter of 2008. A summary of impairment charges by segment follows
(amounts in thousands):
Goodwill
|
Tradenames
|
Total
|
||||||||||
Surgical
products segment
|
$ | 65,283 | $ | 2,515 | $ | 67,798 | ||||||
Brachytherapy
seed segment
|
2,578 | — | 2,578 | |||||||||
Total
impairment charges in 2008
|
$ | 67,861 | $ | 2,515 | $ | 70,376 | ||||||
Our
market capitalization declined significantly in the fourth quarter of 2008,
along with the significant declines in the overall market value of all of the
major stock markets in the United States and around the world. We
considered our market capitalization when we developed the appropriate discount
rates and comparable company market multiples for purposes of estimating the
fair value of our reporting units. The significant decline in our
market capitalization resulted in discount rates that were considerably higher,
and comparable company market multiples that were considerably lower, than the
discount rates and comparable company market multiples we previously considered
appropriate. The most significant assumption leading to our
impairment charges in the fourth quarter of 2008 was the various discount rates
for our reporting units, all of which exceeded 20% at that point in
time. We attempted to identify the underlying reasons for this
circumstance. We considered many factors, including: the conditions
of the companies in our sectors; unusual short selling or other unusual activity
in the trading of our common stock; and whether the overall general economic
outlook and stock market declines could be considered as
“temporary.” We were unable to identify any of these factors as
directly affecting the decline in our market capitalization. The
long-term expectations for our reporting units did not materially change during
the period. We concluded that the significant increase in our
discount rates and decrease in our comparable company market multiples was a
result of the increased risk associated with the distressed equity and credit
markets generally, especially as these factors relate to a small company such as
ours. In addition, we believe the increasing prevalence of
shareholders and investors trading securities outside of traditional stock
exchanges contributes to share price volatility, especially over the short
term. Finally, the scarcity of capital, especially for smaller
companies such as ours, affects the risks associated with investments in its
common stock and its share price.
In
connection with our goodwill and tradenames impairment testing in the fourth
quarter of 2008, we also assessed the estimated useful lives of our
tradenames. At December 31, 2008, we determined that current facts
and circumstances no longer supported an indefinite life for our tradenames
intangible asset. In considering all of the facts and circumstances
at that time, including the increased risk associated with our businesses as
perceived by investors, the distressed general equity and credit markets,
especially as these factors relate to smaller companies such as ours, and the
significant economic uncertainties caused by the worsening overall economic
conditions, we concluded that an indefinite life for our tradenames intangible
assets was no longer supportable. We also considered changes to our
terminal value assumptions in our estimate of fair value for each reporting
unit, which affected assumptions beyond year 10 in our cash flow
forecasts. Accordingly, we estimated that the remaining useful life
of the recorded amount of our tradenames was 10 years, and we began to amortize
tradenames over 10 years beginning in 2009. Prior to December 31, 2008, we
estimated that our tradenames intangible assets had indeterminate lives and,
accordingly, were not subject to amortization.
We also
review long-lived assets, including our intangible assets subject to
amortization, for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. We
group these assets at the lowest level that we could reasonably estimate the
identifiable cash flows. Recoverability of assets to be held and used is
measured by a comparison of the carrying amount of long-lived assets to the
future undiscounted net cash flows expected to be generated by these assets. If
the carrying amounts exceed the future undiscounted cash flows, then the
impairment recognized is the amount by which the carrying amount of the assets
exceeds their fair value. As a result of the impairment indicators related to
goodwill and tradenames, we tested our long-lived assets for impairment at
December 31, 2008, and determined that there was no impairment.
II-12
Non-operating income/expense
Interest
income was $1.1 million in 2008 compared with $2.2 million in 2007. The 2007
amount included $309,000 of one-time interest income related to $1.9 million of
refunded federal income taxes. Interest income also decreased in 2008 as a
result of cash used for the NeedleTech acquisition and lower yields due to a
more conservative investment mix and declining market interest
rates.
Interest
expense increased to $841,000 in 2008 from $691,000 in 2007. The increase was
due to an additional $24.5 million of borrowings under our credit facility for
the NeedleTech acquisition.
Other
non-operating income in 2008 totaled $53,000. This amount consisted of gains
from the sale of scrap metal from one of our operating facilities of
$457,000. Offsetting this gain in 2008 was $347,000 in losses in our
marketable securities, which included a $93,000 impairment charge related to a
decline in market value of one of our investments that we considered to be a
permanent decline.
Income
tax expense
Our
effective income tax rate for 2008 was a benefit of 7%. In 2007 our effective
income tax rate was 36%. Our effective income tax rate in 2008 was significantly
affected by our non-cash impairment charges of goodwill and tradenames. The
majority of these impairment charges were not deductible for income tax purposes
and, accordingly, the associated tax benefit was not
significant. During 2007, the IRS completed an examination of our
2004 and 2005 federal income tax returns with no significant adjustments. Upon
settlement of the 2004 audit, during 2007 we received a refund of federal income
tax previously paid of $1.9 million. This refund resulted from the carryback of
tax losses that were reported in our 2004 federal income tax return. We also
received $309,000 of interest income related to this refund, which was
recognized upon settlement of the IRS examination in 2007.
Critical
Accounting Policies and Estimates
The
preparation of financial statements requires us to make estimates and
assumptions that affect the reported amount of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. The SEC defines “critical accounting policies” as those that
require application of our most difficult, subjective or complex judgments,
often as a result of the need to make estimates about the effect of matters that
are inherently uncertain and may change in subsequent periods. The following is
not intended to be a comprehensive list of our accounting policies. Our
significant accounting policies are more fully described in the notes to our
consolidated financial statements. In many cases, the accounting treatment of a
particular transaction is specifically dictated by GAAP, with no need for our
judgment in their application. The accounting policies described below are those
which we believe are most critical to aid in fully understanding and evaluating
our reported financial results, and are areas in which our judgment in selecting
an available alternative might produce a materially different
result.
Marketable securities. We
review our investments in marketable securities for impairment based on both
quantitative and qualitative criteria that include the extent to which cost
exceeds market value, the duration of any market decline, our intent and ability
to hold to maturity or expected recovery, and the creditworthiness of the
issuer. We perform research and analysis, and monitor market conditions to
identify potential impairments.
Due to
the severe volatility and disruptions related to the U.S. and global investment
and credit markets, we are exposed to the risk of changes in fair value of our
marketable securities in future periods, which may cause us to take impairment
charges that we do not currently anticipate. While we will continue to research,
analyze and monitor our investments, we cannot predict what the effect of
current investment and credit market circumstances might have on our portfolio
going forward. You can find more information related to the valuation of our
marketable securities in Note E in the accompanying consolidated financial
statements, Liquidity and
Capital Resources in Management’s Discussion and
Analysis, and Item 7A,
Quantitative and Qualitative Disclosures About Market Risk, all of which
are included in this report.
Property and equipment.
Property and equipment are recorded at cost and depreciated on a
straight-line basis over the estimated useful lives of such assets. Our
estimates can result in differences from the actual useful lives of certain
assets. The significant portion of equipment is comprised of cyclotrons, which
are utilized in the brachytherapy business. As of December 31, 2009, we owned
and operated eight cyclotrons, the first of which entered service in 1998. In
December 2007 we changed the estimated service lives of certain depreciable
assets, mainly the cyclotron equipment. The estimated service life of the
cyclotron equipment was increased from 10 years to 15 years, and was based on,
among other things, an assessment of the equipment’s operating and maintenance
history and expected future performance. We accounted for this change as a
change in estimate. Accordingly, this change was accounted for in the period of
the change and will be accounted for in future periods. This change reduced
depreciation expense by approximately $490,000 and $1.4 million in 2009 and
2008, respectively, compared to what it would have been using the former
estimated useful life. The effect of this change was not significant in
2007.
II-13
We will
continue to periodically examine estimates used for depreciation for
reasonableness. If we determine that the useful life of property or equipment
should be shortened or lengthened, depreciation expense would be adjusted
accordingly for the remaining useful lives of the identified
assets.
We assess
the impairment of our depreciable assets (including property, equipment, and
intangible assets subject to amortization) whenever events or circumstances
indicate that such assets might be impaired. In the event the expected
undiscounted future cash flow attributable to the asset is less than the
carrying value of the asset, an impairment loss equal to the excess of the
asset’s carrying value over its fair value is recorded. The estimation of fair
value, whether in conjunction with an asset to be held and used or with an asset
held for sale, also involves judgment. It is possible that our estimates of fair
value may change and impact our financial condition and results of operations.
As a result of the impairment indicators related to goodwill in the fourth
quarter of 2008, we performed an assessment of our long-lived assets and
determined that there was no impairment. See Impairment of goodwill and
tradenames in 2008
above under Results of
Operations.
Goodwill and other intangible
assets. Goodwill and intangible assets with indefinite lives are not
amortized to expense and must be reviewed for impairment annually or more
frequently if events or changes in circumstances indicate that such assets might
be impaired. The first step of the impairment test, used to identify potential
impairment, compares the fair value of a reporting unit with its carrying
amount, including goodwill and intangible assets with indefinite lives. If fair
value exceeds book value, goodwill is considered not impaired, and the second
step of the impairment test is not required. If book value exceeds fair value,
the second step of the impairment test is performed to measure the amount of
impairment loss, if any. For this step the implied fair value of the goodwill is
compared with the book value of the goodwill. If the carrying amount of the
goodwill exceeds the implied fair value of the goodwill, an impairment loss
would be recognized in an amount equal to that excess. Any loss recognized
cannot exceed the carrying amount of goodwill. After an impairment loss is
recognized, the adjusted carrying amount of goodwill is its new accounting
basis. Subsequent reversal of a previously recognized impairment loss is
prohibited once the measurement of that loss is completed.
When we
have goodwill or other intangible assets not subject to amortization recorded in
our consolidated balance sheet, we perform impairment testing at the reporting
unit level. A reporting unit is the same as, or one level below, an
operating segment. Our annual impairment testing is typically
performed during the fourth quarter of each year, which coincides with the
timing of our annual budgeting and forecasting process. We also make judgments
about goodwill and other intangible assets not subject to amortization whenever
events or changes in circumstances indicate that impairment in the value of such
asset recorded on our consolidated balance sheet may exist. The timing of an
impairment test may result in charges to our consolidated statements
of operations in future reporting periods that could not have been
reasonably foreseen in prior periods.
In order
to estimate the fair value of goodwill and other intangible assets not subject
to amortization, we typically prepare discounted cash flow analyses (“income
approach”) and comparable company market multiples analyses (“market approach”)
to determine the fair value of our reporting units.
For the
income approach, we project future cash flows for each reporting unit. This
approach requires significant judgments including the projected net cash flows,
the weighted average cost of capital (“WACC”) used to discount the cash flows
and terminal value assumptions. We derive the assumptions related to cash flows
primarily from our internal budgets and forecasts. These budgets and
forecasts include information related to our current and future products,
revenues, capacity, operating costs, and other information. All such
information is derived in the context of our long-term operational
strategies. The WACC and terminal value assumptions are based on the
capital structure, cost of capital, inherent business risk profiles, and
industry outlooks for each of our reporting units, and for our Company on a
consolidated basis.
For the
market approach, we identify reasonably similar public companies for each of our
reporting units, analyze the financial and operating performance of these
similar companies relative to our financial and operating performance, calculate
market multiples primarily based on the ratio of Business Enterprise Value
(“BEV”) to revenue and BEV to earnings before interest, taxes, depreciation and
amortization (“EBITDA”), adjust such multiples for differences between the
similar companies and our reporting units, and apply the resulting multiples to
the fundamentals of our reporting units to arrive at an indication of fair
value.
To assess
the reasonableness of our valuations under each method, we reconcile the
aggregate fair values of our reporting units to our market
capitalization.
The most
recent goodwill and intangible asset impairment assessment was performed in the
fourth quarter of 2008. We determined that all of our goodwill was
impaired and that a portion of our tradenames intangible asset was
impaired. See Impairment of Goodwill and
Tradenames in 2008
above.
II-14
Other intangible assets determined to have finite lives are amortized over their
useful lives using a method that is expected to reflect the pattern of its
economic benefit. When a pattern of economic benefit cannot be determined, or if
the straight-line method results in greater amortization, then the straight-line
method is used. To date, all finite lived intangible assets have been amortized
using the straight-line method. We also review finite lived intangible assets
for impairment to ensure they are appropriately valued if conditions exist that
indicate the carrying value may not be recoverable.
Allowance for doubtful accounts and
returns. We make estimates and use our judgments in connection with
establishing an allowance for the possibility that portions of our accounts
receivable balances may become uncollectible or subject to return. Accounts
receivable are reduced by this allowance. Specifically, we analyze accounts
receivable in relation to customer creditworthiness, current economic trends,
changes in our customer payment history, and changes in sales returns history in
establishing this allowance. It is possible that these or other underlying
factors could change and impact our financial position and results of
operations.
Allowance for obsolete
inventory. We review inventory periodically and record an estimated
allowance for inventory that has become obsolete, that has a cost basis in
excess of its expected net realizable value, or that is in excess of expected
requirements. Specifically, we analyze inventory in relation to sales
history, inventory turnover and days supply on hand, competing products, current
economic trends, changes in our customers’ ordering histories, and historical
write-offs. Our estimate is subjective and dependent on our estimates of future
demand for a particular product. If our estimate of future demand
exceeds actual demand, we may have to increase the allowance for obsolete
inventory for that product and record a charge to cost of product
sales.
Asset Retirement Obligations.
We estimate the future cost of asset retirement obligations, discount
that cost to its present value, and record a corresponding asset and liability
in our consolidated balance sheet. The values ultimately derived are based on
many significant estimates, including future decommissioning costs, inflation,
cost of capital, and market risk premiums. The nature of these estimates
requires us to make judgments based on historical experience and future
expectations. Revisions to the estimates may be required based on such things as
changes to cost estimates or the timing of future cash outlays. Any such changes
that result in upward or downward revisions in the estimated obligation will
result in an adjustment to the related capitalized asset and corresponding
liability on a prospective basis.
Share-based
compensation. We account for share-based compensation in accordance
with the fair value recognition provisions of guidance issued by
FASB. Under this method, share-based compensation cost is measured at
the grant date based on the value of the award and is recognized as expense over
the vesting period. In order to determine the fair value of stock options on the
date of grant, we utilize the Black Scholes model. Inherent in this model are
assumptions related to expected stock-price volatility, option life, risk-free
interest rate and dividend yield. The risk-free interest rate and dividend yield
are based on factual data derived from public sources. The expected stock-price
volatility and option life assumptions require significant judgment, which makes
them critical accounting estimates. Our expected volatility is based upon
weightings of the historical volatility of our stock. With respect to the
weighted-average option life assumption, we consider the exercise behavior of
past grants and model the pattern of aggregate exercises.
The grant
date fair value of Restricted Stock Units and Performance Restricted Stock
Units (collectively, the “Stock Units”) are based on the fair value of the
underlying common stock and is recognized over the requisite service period. For
Stock Units containing performance conditions, the grant date fair value is
adjusted each period for the number of shares ultimately expected to be issued.
For Stock Units subject to discretionary performance conditions, the grant date
has not been established and accordingly, the fair value of the award is updated
each period for changes in the fair value of the underlying common stock. To the
extent that the underlying fair value of our common stock varies significantly,
and/or the number of shares issuable is determined, we may record additional
compensation expense or adjust previously recognized compensation
expense.
Accounting for income taxes.
Our judgments, assumptions and estimates relative to the provision for income
taxes take into account current tax laws and our interpretation of current tax
laws. We must make assumptions, judgments and estimates to determine our tax
provision and our deferred income tax assets and liabilities, including the
valuation allowance to be recorded against a deferred tax asset. Actual
operating results and the underlying amount and category of income
in future years could differ materially from our current assumptions,
judgments and estimates of recoverable net deferred taxes.
We
periodically evaluate the recoverability of our deferred tax assets and
recognize the tax benefit only as reassessment demonstrates that they are
realizable. At such time, if it is determined that it is more likely than not
that the deferred tax assets are realizable, the valuation allowance is
adjusted. We evaluate the realizability of the deferred tax assets and assess
the need for the valuation allowance each reporting period. In the future if,
based on the facts and circumstances surrounding our ability to generate
adequate future taxable income, it becomes more likely than not that some or all
of the deferred tax asset will not be realized, the valuation allowance may be
required to be increased.
We review
all of our tax positions. The tax benefits of uncertain tax positions are
recognized only if it is more likely than not that we will be able to sustain a
position taken on an income tax return. We have concluded that there were no
significant uncertain tax positions as of December 31, 2009 and 2008. Our policy
is to recognize accrued interest expense and penalties associated with uncertain
tax positions as a component of income tax expense.
II-15
Contingencies. From
time to time we may be subject to various legal proceedings and claims,
including, for example, disputes, disputes on agreements, employment disputes
and other commercial disputes, the outcomes of which are not within our complete
control and may not be known for extended periods of time. In some cases, the
claimants seek damages, as well as other relief, which, if granted, could require significant expenditures. We
record a liability in our consolidated financial statements for damages and/or
costs related to claims, settlements and judgments where we have assessed that a
loss is probable and an amount can be reasonably estimated. If the estimate of a
probable loss is a range and no amount within the range is more likely, we
accrue the minimum amount of the range. Legal costs associated with these
matters are expensed as incurred.
Commitments
and Other Contractual Obligations
Contractual
Obligations
We lease
equipment and production, warehouse, office and other space under non-cancelable
leases that expire at various dates through May 2013. We also have $32 million
of borrowings outstanding under our credit facility. Approximate minimum
payments of these obligations are as follows (amounts in
thousands):
Total
|
Less
than
1
year
|
1-3
years
|
3-5
years
|
More
than
5
years
|
||||||||||||||||
Obligation
|
||||||||||||||||||||
Operating
lease obligations
|
||||||||||||||||||||
Rental
space and equipment
|
$ | 866 | $ | 353 | $ | 513 | $ | — | $ | — | ||||||||||
Production,
office and warehouse space - related parties (1)
|
812 | 278 | 534 | — | — | |||||||||||||||
Total
operating lease obligations
|
1,678 | 631 | 1,047 | — | — | |||||||||||||||
Borrowings
under credit agreement (2)
|
30,333 | 3,333 | 27,000 | — | — | |||||||||||||||
Interest
payable on short-term borrowings (3)
|
2,199 | 874 | 1,325 | — | — | |||||||||||||||
Total
short-term borrowings
|
32,532 | 4,207 | 28,325 | — | — | |||||||||||||||
Contractual
obligations for new building construction
|
5,100 | 5,100 | — | — | — | |||||||||||||||
Other
obligations
|
640 | 218 | 80 | 342 | — | |||||||||||||||
Total
|
$ | 39,950 | $ | 10,156 | $ | 29,452 | $ | 342 | $ | — |
(1)
|
The
surgical products business leases approximately 34,500 square feet of
production, warehouse, and office space from two related entities. See
Item 2 – Properties above and Note K to our consolidated financial
statements.
|
(2)
|
Includes
$8.3 million term loan payable at $3.3 million annually through June 2012,
and $22.0 million outstanding under $30.0 million revolving credit
facility, which matures October
2012.
|
(3)
|
Interest
on outstanding borrowings under credit facility at the December 31, 2009
based on effective interest rates at December 31,
2009.
|
Letter of
Credit
We have a
letter of credit outstanding under the credit facility as of December 31, 2009
totaling $946,000. This letter of credit is related to asset retirement
liabilities of long-lived assets.
Liquidity
and Capital Resources
We assess
our liquidity in terms of our ability to generate cash to fund our operating,
investing and financing activities. Significant factors affecting the management
of liquidity are: cash flows generated from operating activities, capital
expenditures, operational investments to support growth (such as research and
development programs), and acquisitions of businesses and
technologies.
We have
cash and cash equivalents of $45.3 million at December 31, 2009. At
December 31, 2008 we had $40.6 million of cash, cash equivalents and marketable
securities. Marketable securities consisted primarily of high-credit quality
corporate and municipal obligations, in accordance with our investment policies.
See Cash, Cash Equivalents, and Marketable Securities below
for more information.
II-16
We
acquired all of the outstanding common stock of NeedleTech Products, Inc.
(“NeedleTech”) on July 28, 2008 for $49.8 million in cash including transaction
costs. We retained the cash, cash equivalents and marketable securities held by
NeedleTech, which had an estimated fair value of approximately $5.8 million at
the acquisition date. We financed $24.5 million of the purchase price with
borrowings on our existing $40.0 million credit facility and paid the remainder
from our current cash and investment balances.
Working
capital was $59.6 million and $28.1 million at December 31, 2009 and 2008,
respectively. The increase in working capital is primarily due to the
classification of $32.0 million of borrowings under our credit facility as a
short-term liability at December 31, 2008, thus reducing working capital. During
2009 we refinanced our credit facility; and $27.0 million of our borrowings are
classified as long-term at December 31, 2009 and, accordingly, were not a part
of working capital.
In May 2009, we executed an Amended and
Restated Credit Agreement (the “Credit Agreement”) with a financial
institution. The Credit Agreement provides for up to $30 million of
borrowings under a revolving credit facility (the “Revolver”) and a $10 million
term loan (the “Term Loan”). The Revolver matures on October 31,
2012 with interest payable at the London Interbank Offered Rate (“LIBOR”) plus
2.25%. Maximum borrowings under the Revolver can be increased to $40
million with the prior approval of the financial institution under an accordion
feature. The Revolver also provides for a $5 million sub-limit for
trade and stand-by letters of credit. Letters of credit totaling $946,000, representing
decommission funding required by the Georgia Department of Natural Resources,
were outstanding under the Credit Agreement as of December 31, 2009. The
Term Loan is payable in thirty-six equal monthly installments of principal plus
interest at LIBOR plus 1.75%, commencing July 1, 2009. The
Credit Agreement is unsecured, but provides for a lien to be established on
substantially all of our assets upon certain events of default. The
Credit Agreement contains representations and warranties, as well as
affirmative, reporting and negative covenants customary for financings of this
type. Among other things, the Credit Agreement restricts the
incurrence of certain additional debt and certain capital expenditures, and
requires the maintenance of certain financial ratios, including a minimum fixed
charge coverage ratio, a maximum liabilities to tangible net worth ratio, and
the maintenance of minimum liquid assets of $10 million, as all such ratios and
terms are defined in the Credit Agreement. We were in compliance with
all covenants at December 31, 2009. This Credit Agreement amended and
restated our prior credit agreement, which was scheduled to mature on
October 31, 2009 and provided for a $40 million revolving loan and letter
of credit commitment.
Cash
provided by operations was $11.6 million in 2009, compared to $12.3 million in
2008. Cash provided by operations consists of net earnings, plus non-cash
expenses such as depreciation, amortization, deferred income taxes, and changes
in balance sheet items such as accounts receivable, inventories, prepaid
expenses and payables. The decline in 2009 was primarily a result of the decline
in net income in 2009, excluding the effects of our non-cash impairment charges
in 2008. Cash from operations in 2009 also benefited from a $1.5
million tax refund received during the year as a result of the use of an income
tax loss generated in 2008. The use of this loss also allowed us to
reduce income tax payable in 2009. We have no significant remaining
tax loss carryforwards and expect to pay income taxes at normal rates going
forward.
Capital
expenditures totaled $5.0 million in 2009 and $1.5 million in 2008. The increase
in capital expenditures was primarily due to the development of enterprise
resource planning (“ERP”) software for internal use, in connection with our
corporate wide upgrades to our information technology systems. In
2009, we also purchased a facility for our specialty needle operations and began
renovating and adding onto that facility. Capital expenditures
are expected to increase in 2010 as we complete work on our new manufacturing
facility and continue development of our new ERP systems. These
programs, along with our capital expenditures in the normal course, could
increase our capital expenditure level to as much as $12.0 million in
2010.
In 2009
we used $1.9 million in cash for financing activities, primarily for scheduled
principal payments under our credit facility. In 2008, cash provided
by financing activities was $23.8 million, consisting primarily of the $24.5
million proceeds from our credit facility, which was used in our NeedleTech
acquisition, offset by $695,000 for the payment of certain expenses for which we
were indemnified and reimbursed by receipt of 202,000 shares of our common
stock.
R&D
expenses were $2.2 million in 2009. We expect to continue to use cash in 2010 to
support growth in the surgical products segment, especially for the R&D
program implemented in late 2008. Looking forward, we expect R&D
expense levels in 2010 to be similar to 2009. However, R&D
activities can be complex, and expense levels are also dependent upon the
discovery of opportunities of which we are not currently
aware. Accordingly, R&D expenses are subject to significant
variability form period to period.
We may
also continue to use cash for increased marketing and TheraSeed®
support activities, and in the pursuit of additional diversification
efforts such as product development and the purchase of technologies, products
or companies. We believe that current cash, cash equivalents, and investment
balances and cash from future operations will be sufficient to meet our current
short-term anticipated working capital and capital expenditure requirements.
However, continued disruption and instability in the U.S. and global financial
markets and worldwide economies may hinder our ability to take advantage of
opportunities for long-term growth in our businesses. In the event additional
financing becomes necessary, we may choose to raise those funds through other
means of financing as appropriate.
II-17
Cash, Cash Equivalents and Marketable Securities
We did
not hold any marketable securities at December 31, 2009. Looking
forward, we may invest our funds in marketable securities and higher yielding
investments than those we held at December 31, 2009, if those investments meet
the conservative criteria established by our investment policies and the
macroeconomic outlook becomes clearer. Our cash equivalents include $45.3
million of bank deposits, money market funds, and U.S. Treasury securities. We
review our investments in marketable securities and cash equivalents for
impairment based on both quantitative and qualitative criteria that include the
extent to which cost exceeds market value, the duration of any market decline,
our intent and ability to hold to maturity or expected recovery, and the
creditworthiness of the issuer. We perform research and analysis, and monitor
market conditions to identify potential impairments. Looking forward,
we may invest our funds in higher yielding investments if those investments meet
the conservative criteria established by our investment policies and the
macroeconomic outlook becomes clearer. Funds available for investment
have and will continue to be utilized for our current and future expansion
programs, for strategic opportunities for growth and diversification, and for
installment payments on the Term Loan. As funds continue to be used for these
purposes, and as interest rates continue to change, we expect interest income to
fluctuate accordingly. Due to the disruptions, volatility and
uncertainties related to the U.S. and global investment and credit markets we
are exposed to the risk of further changes in fair value of our cash equivalents
and marketable securities in future periods, which may cause us to take
impairment charges that are not currently anticipated. While we will continue to
research, analyze and monitor our investments, we cannot predict what the effect
of current investment and credit market circumstances might have on our
portfolio going forward.
Medicare
Developments
Background
The
Medicare Prescription Drug, Improvement and Modernization Act of 2003 (the “2003
Act”), which went into effect on January 1, 2004, contained brachytherapy
provisions requiring Medicare to reimburse hospital outpatient
departments for each brachytherapy seed/source furnished between January 1,
2004 to December 31, 2006 based on the hospital’s costs for each patient
(calculated from the hospital’s charges adjusted by the hospital’s specific
cost-to-charge ratio). The 2003 Act also directed the U.S. Government
Accountability Office (“GAO”) to conduct a study examining future payment
policies for brachytherapy seeds. The GAO published its report on July 25, 2006,
concluding that the Centers for Medicare & Medicaid Services (“CMS”), the
regulatory body that sets Medicare reimbursement policies, could establish
separate prospective payment rates effective in 2007 for palladium-103
brachytherapy seeds/sources (such as TheraSeed®) and
iodine-125 seeds/sources using Medicare’s hospital outpatient data.
Although
subsequently superseded by Congress, CMS posted a final rule on November 1, 2006
with fixed prospective payment rates for brachytherapy seeds for Medicare’s
hospital outpatient prospective payment system (“OPPS”) that would have applied
to calendar year 2007. The use of prospective payment rates would have fixed the
per seed rate at which Medicare would have reimbursed hospitals in 2007. We
believed that CMS’ approach to determining the fixed prospective reimbursement
rate for brachytherapy seeds was fundamentally flawed. For example, CMS did not
stratify cost data on differing seed configurations, such as loose versus
“stranded” seeds. Accordingly, we continued to work with policy makers in an
effort to rectify the shortcomings we believed to be contained in the new CMS
rule.
In
December 2006, Congress enacted the Tax Relief and Health Care Act of 2006 (the
“2006 Act”), which extended and refined the Medicare safeguards initially
enacted by Congress in 2003 for brachytherapy seeds administered in the hospital
outpatient setting. The 2006 Act’s provisions on brachytherapy superseded the
final rule published by CMS on November 1, 2006 by extending the existing
“charges adjusted to cost” reimbursement policies (which we sometimes refer to
as a “pass-through” methodology) for brachytherapy seeds through the end of
2007, ensuring that the Medicare program would not implement potentially
restrictive caps on reimbursement during that period. In addition, the
legislation recognized that prostate cancer patients must have meaningful access
to stranded brachytherapy seeds, which increasingly are used in clinical
practice to further enhance the safety and efficacy of treatment. The 2006 Act
also established a permanent requirement for Medicare to use separate codes for
the reimbursement of stranded brachytherapy devices. Stranded seeds are becoming
a larger portion of our brachytherapy business.
Effective
July 2007, CMS issued new reimbursement codes for brachytherapy sources. The
codes are isotope specific and recognize the distinction between non-stranded
versus stranded seeds, as mandated by the 2006 Act. In early November 2007, CMS
again posted a final OPPS rule for calendar year 2008 with fixed prospective
reimbursement rates for all brachytherapy source codes, including the new codes
established in July 2007.
In
December 2007, Congress passed the Medicare, Medicaid and SCHIP Extension Act of
2007 (the “2007 Act”), which once again superseded another CMS final OPPS rule
by extending the existing “pass-through” reimbursement policies for
brachytherapy seeds through June 30, 2008. Fixed reimbursement rates would have
become effective on January 1, 2008 without the enactment of the 2007 Act. As a
result of the 2007 Act, fixed reimbursement rates for seeds were delayed until
July 1, 2008.
II-18
On July
15, 2008, the Medicare Improvements for Patients and Providers Act of 2008 (the
“2008 Act”) was enacted into law. The 2008 Act extends Medicare’s
longstanding “pass-through” reimbursement policies for brachytherapy seeds
administered in the hospital outpatient setting through December 31, 2009,
ensuring that the Medicare program does not implement potentially restrictive
caps on reimbursement during this period. The 2008 Act was
retroactive to July 1, 2008.
Current
Status
Prior to
2010, Medicare continued to reimburse for brachytherapy seeds under the “charges
adjusted to costs” methodology, which is based on the actual invoiced cost of
the seeds and which we sometimes refer to as a “pass-through”
methodology. Consistent with proposals that CMS attempted
unsuccessfully to implement in recent years, CMS posted a final hospital OPPS on
October 30, 2009 with fixed prospective payment rates for brachytherapy
seeds. This fixed OPPS, which we sometimes refer to as “fixed
reimbursement”, went in effect on January 1, 2010 and fixes the per seed rate at
which Medicare reimburses hospitals for the purchase of seeds. We
continue to support efforts that urge Congress and CMS to replace this “fixed
reimbursement” rule by obtaining a new extension of the “pass-through”
reimbursement policies which existed prior to 2010. Fixed
reimbursement policies at CMS can be expected to lead to pricing pressure from
hospitals and other healthcare providers, and to have an adverse effect on our
brachytherapy revenue. The extent of the effect is impossible for us
to predict, especially when fixed reimbursement policies are being introduced at
a time that coincides with 1) an industry wide decline in procedures being
experienced due, at least in part, to favorable CMS reimbursement rates enjoyed
by alternative, less proven, technologies and 2) uncertainties regarding
healthcare reform generally. These factors could have an adverse
effect on brachytherapy revenue.
Forward
Looking and Cautionary Statements
This
document contains certain forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including, without limitation,
statements regarding sales, marketing and distribution efforts, ordering
patterns of customers, short term volatility of our results, our sales channels
including our OEM, distributor and direct sales channels organization and their
growth and effectiveness, third-party reimbursement, CMS policy, sales mix,
effectiveness and continuation of non-exclusive distribution agreements,
expected effect of our new TheraSeed®
distribution agreement with Core Oncology, pricing for the TheraSeed® and
I-Seed devices, anticipated growth in the surgical products business segment,
plans to increase our specialty needle manufacturing capacity, future cost of
sales and gross margins, R&D efforts and expenses (including our
centralized, corporate-wide R&D initiative), investment in additional
personnel, infrastructure and capital assets, implementation of a new Enterprise
Resource Planning system, future SG&A expenses, other income, potential new
products and opportunities, potential effects of environmental, nuclear,
regulatory and occupational health and safety laws and regulations, future
results in general, plans and strategies for continuing diversification,
valuation of marketable securities and cash equivalents we may hold, and the
sufficiency of our liquidity and capital resources. From time to time, we may
also make other forward-looking statements relating to such matters as well as
statements relating to anticipated financial performance, business prospects,
technological developments and similar matters. These forward-looking statements
are subject to certain risks, uncertainties and other factors which could cause
actual results to differ materially from those anticipated, including risks
associated with new product development cycles, effectiveness and execution of
marketing and sales programs of our business segments and their distributors,
competitive conditions and selling tactics of our competitors, potential changes
in third-party reimbursement (including CMS), changes in product pricing,
changes in cost of materials used in production processes, continued acceptance
of our products by the market, potential changes in demand for the products
manufactured and sold by our brachytherapy and surgical products segments,
integration of acquired companies into the Theragenics organization,
capitalization on opportunities for growth within our surgical products business
segment, competition within the medical device industry, development and growth
of new applications within our markets, competition from other methods of
treatment, ability to execute on acquisition opportunities on favorable terms
and successfully integrate any acquisitions, unanticipated expenditures required
to maintain compliance with current or new environmental, nuclear, regulatory
and occupational and safety laws and regulations, the risk that the
implementation of our new ERP system will not be effective, the risk that we
will not be able to meet customer demands and/or will incur additional costs and
inefficiencies due to the relocation of our NeedleTech facility, the ability to
realize our estimate of fair value upon sale or other liquidation of marketable
securities that we hold and cash equivalents we may hold, volatility in U.S. and
global stock markets, economic conditions generally, potential changes in tax
rates and market interest rates, the effect of current difficulties in the
credit markets on our business, and the risks identified elsewhere in this
report. All forward looking statements and cautionary statements included in
this document are made as of the date hereof based on information available to
us, and we assume no obligation to update any forward looking statement or
cautionary statement.
II-19
Quarterly
Results
The
following table sets forth certain statement of operations data for each of the
last eight quarters. This unaudited quarterly information has been prepared on
the same basis as the annual audited information presented elsewhere in this
Form 10-K, reflects all adjustments (consisting only of normal, recurring
adjustments) which are, in our opinion, necessary for a fair presentation of the
information for the periods covered and should be read in conjunction with the
consolidated financial statements and notes thereto. The operating results for
any quarter are not necessarily indicative of results for any future period.
Quarterly data presented may not reconcile to totals for full year results due
to rounding.
2009
|
2008
|
|||||||||||||||||||||||||||||||
First
Qtr
|
Second
Qtr
|
Third
Qtr
|
Fourth
Qtr
|
First
Qtr
|
Second
Qtr
|
Third
Qtr
|
Fourth
Qtr
|
|||||||||||||||||||||||||
(Amounts
in thousands, except per share data)
|
||||||||||||||||||||||||||||||||
Total
revenue
|
$ | 20,077 | $ | 20,219 | $ | 19,344 | $ | 18,686 | $ | 15,235 | $ | 15,914 | $ | 18,106 | $ | 18,103 | ||||||||||||||||
Cost
of sales
|
11,370 | 11,082 | 10,783 | 11,718 | 7,578 | 7,664 | 10,292 | 10,730 | ||||||||||||||||||||||||
Gross
profit
|
8,707 | 9,137 | 8,561 | 6,968 | 7,657 | 8,250 | 7,814 | 7,373 | ||||||||||||||||||||||||
Selling,
general and administrative
|
6,029 | 5,509 | 5,607 | 4,875 | 4,803 | 5,167 | 5,608 | 4,922 | ||||||||||||||||||||||||
Amortization
of purchased intangibles
|
871 | 871 | 853 | 846 | 469 | 468 | 683 | 790 | ||||||||||||||||||||||||
Research
and development
|
603 | 588 | 521 | 448 | 133 | 161 | 373 | 633 | ||||||||||||||||||||||||
Change
in estimated value of asset held for sale
|
— | — | — | — | — | (142 | ) | — | — | |||||||||||||||||||||||
Impairment
charges of goodwill and tradenames
|
— | — | — | — | — | — | — | 70,376 | ||||||||||||||||||||||||
(Gain)
loss on sale of assets
|
— | 2 | 1 | — | 2 | 1 | (8 | ) | — | |||||||||||||||||||||||
Other
income (expense)
|
(120 | ) | (149 | ) | (354 | ) | (214 | ) | 317 | 98 | 141 | (279 | ) | |||||||||||||||||||
Earnings
(loss) before income taxes
|
1,084 | 2,018 | 1,225 | 585 | 2,567 | 2,693 | 1,299 | (69,627 | ) | |||||||||||||||||||||||
Income
tax expense (benefit)
|
477 | 747 | 426 | 187 | 931 | 1,055 | 658 | (7,172 | ) | |||||||||||||||||||||||
Net
earnings (loss)
|
$ | 607 | $ | 1,271 | $ | 799 | $ | 398 | $ | 1,636 | $ | 1,638 | $ | 641 | $ | (62,455 | ) | |||||||||||||||
Earnings
per share:
|
||||||||||||||||||||||||||||||||
Basic
|
$ | 0.02 | $ | 0.04 | $ | 0.02 | $ | 0.01 | $ | 0.05 | $ | 0.05 | $ | 0.02 | $ | (1.89 | ) | |||||||||||||||
Diluted
|
$ | 0.02 | $ | 0.04 | $ | 0.02 | $ | 0.01 | $ | 0.05 | $ | 0.05 | $ | 0.02 | $ | (1.89 | ) | |||||||||||||||
Weighted
average shares outstanding:
|
||||||||||||||||||||||||||||||||
Basic
|
33,104 | 33,145 | 33,161 | 33,176 | 33,162 | 33,106 | 33,000 | 33,002 | ||||||||||||||||||||||||
Diluted
|
33,133 | 33,198 | 33,244 | 33,304 | 33,286 | 33,246 | 33,139 | 33,002 |
Inflation
We do not
believe that the relatively moderate levels of inflation, which have been
experienced in the United States in recent years, have had a significant effect
on our results of operations.
Item
7A. Quantitative and Qualitative Disclosure about Market Risk
We have
exposure to market risk as a result of changing interest rates on a portion of
our borrowings under our Credit Agreement. We have outstanding
borrowings of $8.3 million under our Credit Agreement in the form of a Term Loan
that is payable in equal monthly installments of approximately $278,000 through
July 2012. Interest is payable at LIBOR plus 1.75%. We
have entered into a floating to fixed rate swap agreement that expires in July
2012 with respect to the outstanding amount of the Term Loan at a fixed interest
rate of 3.27%. We also have outstanding borrowings of $22 million
under the Revolver component of our Credit Agreement. The Revolver
matures in October 2012. Interest on outstanding borrowings under the Revolver
is payable at LIBOR plus 2.25%. We entered into a separate floating to fixed
rate swap that expires in July 2012 with respect to $6 million of the principal
amount outstanding under the Revolver at a fixed interest rate of
4.26%. Accordingly, we are exposed to changes in interest rates
on outstanding borrowings under our Revolver in excess of $6
million. A hypothetical 1% change in the interest rate applicable to
the borrowings in excess of $6 million would result in an increase or decrease
in interest expense of $160,000 per year before income taxes, assuming the same
level of borrowings.
II-20
We review
our investments in marketable securities and cash equivalents for impairment
based on both quantitative and qualitative criteria that include the extent to
which cost exceeds market value, the duration of any market decline, our intent
and ability to hold to maturity or expected recovery, and the creditworthiness
of the issuer. We perform research and analysis, and monitor market conditions
to identify potential impairments. Due to the uncertainties related to the U.S.
and global investment and credit markets we are exposed to the risk of further
changes in fair value of our cash equivalents and marketable securities in
future periods, which may cause us to take impairment charges that are not
currently anticipated. While we will continue to research, analyze and monitor
our investments, we cannot predict what the effect of current investment and
credit market circumstances might have on our portfolio going
forward.
Item
8. Financial Statements and Supplementary Data
See index
to Financial Statements (Page F-1) and following pages.
Item
9. Changes in and Disagreements With Accountants on Accounting and Financial
Disclosure.
None
Item
9A(T). Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Under the
supervision and with the participation of our management, including our Chief
Executive Officer and Chief Financial Officer, we conducted an evaluation of our
disclosure controls and procedures, as such term is defined under Rule 13a-15(e)
promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). Based on this evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that our disclosure controls and procedures were effective as
of December 31, 2009, the end of the period covered by this annual
report.
Management’s
Report on Internal Control over Financial Reporting
We are
responsible for preparing our annual consolidated financial statements and for
establishing and maintaining adequate internal control over financial reporting.
Internal control over financial reporting is defined in Rule 13a-15(f) or
15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as
a process designed by, or under the supervision of, a company’s principal
executive and principal financial officers and effected by a 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 and includes those policies and procedures
that:
|
●
|
Pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of the assets of the
company;
|
|
●
|
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
|
|
●
|
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.
|
All
internal control systems, no matter how well designed, have inherent limitations
and can provide only reasonable, not absolute, assurance that the objectives of
the control system are met. Further, the design of a control system must reflect
the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent limitations in
all control systems, no evaluation of controls can provide absolute assurance
that all control issues and instances of fraud, if any, within the Company have
been detected. Therefore, even those systems determined to be effective can
provide only reasonable assurance with respect to financial statement
preparation and presentation.
We
assessed the effectiveness of our internal control over financial reporting as
of December 31, 2009. In making our assessment, we used the criteria set forth
by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”)
in Internal Control-Integrated Framework. Based on that assessment, we believe
that, as of December 31, 2009, our internal control over financial reporting is
effective based on those criteria.
Dixon
Hughes PLLC, an independent registered public accounting firm, has audited the
effectiveness of our internal control over financial reporting as of
December 31, 2009, as stated in their report, which is included
below.
Changes
in Internal Control over Financial Reporting
No
changes in our internal control over financial reporting were identified as
having occurred during the quarter ended December 31, 2009 that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
II-21
Report of Independent
Registered Public Accounting Firm – Internal Controls Over Financial
Reporting
To the
Board of Directors and
Shareholders
of Theragenics Corporation
We have
audited Theragenics Corporation and subsidiaries’ (the “Company”) internal
control over financial reporting 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 (“COSO”). 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, and
testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk. Our audit also included 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 to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with accounting principles generally accepted in the United States of America
(“GAAP”). 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 GAAP, 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 its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that 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 criteria
established in Internal
Control—Integrated Framework issued by COSO.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of the Company
as of December 31, 2009 and 2008, and the related consolidated statements of
operations and comprehensive earnings (loss), shareholders’ equity,
and cash flows for each of the three years in the period ended December 31,
2009 and our report dated March 15, 2010, expressed an unqualified opinion
on those consolidated financial statements.
/s/ DIXON
HUGHES PLLC
Atlanta,
Georgia
March 15,
2010
II-22
Item
9B. Other Information
None.
II-23
PART
III
Item
10. Directors, Executive Officers and Corporate Governance*
We have
adopted a Code of Ethics for the Chief Executive Officer and Senior Financial
Officers and a Code of Conduct for all employees. These codes are available on
our website at http://www.theragenics.com.
These codes are also available without charge upon request directed to Investor
Relations, Theragenics Corporation, 5203 Bristol Industrial Way, Buford, Georgia
30518. We intend to disclose amendments or waivers of these codes with respect
to the Chief Executive Officer, Senior Financial Officers or Directors required
to be disclosed by posting such information on our website.
Our Chief
Executive Officer is required to certify to the New York Stock Exchange each
year that she was not aware of any violation by us of the Exchange’s corporate
governance listing standards. Our Chief Executive Officer made her annual
certification to that effect to the New York Stock Exchange on June 5, 2009. Our
Form 10-K on file with the Securities and Exchange Commission includes the
certifications of our Chief Executive Officer and Chief Financial Officer
required by Rule 13a-14 and Section 302 of the Sarbanes-Oxley Act of
2002.
Item
11. Executive Compensation*
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters*
Item
13. Certain Relationships and Related Transactions, Director
Independence*
Item
14. Principal Accounting Fees and Services*
* Except
as set forth above, the information called for by Items 10, 11, 12, 13 and
14 is omitted from this Report and is incorporated by reference to the
definitive Proxy Statement to be filed by us not later than 120 days after
December 31, 2009, the close of our fiscal year.
III-1
PART
IV
Item
15. Exhibits and Financial Statement Schedules
(a) The following documents
are filed as part of this Report.
|
1.
|
Financial
Statements.
|
|
See
index to financial statements on page
F-1.
|
|
2.
|
Financial
Schedules.
|
|
See financial
statement schedule on page S-2.
|
IV-1
Exhibits
3.1
|
Certificate
of Incorporation as amended through July 29, 1998 (incorporated by
reference to Exhibit 3.1 of the Company’s report on Form 10-Q for the
quarterly period ended June 30,
1998)
|
3.2
|
Amended
and Restated By-Laws (incorporated by reference to Exhibit 3.1 of the
Company’s Current Report on Form 8-K filed August 17,
2007)
|
4.1
|
See
Exhibits 3.1 - 3.2 for provisions in the Company’s Certificate of
Incorporation and By-Laws defining the rights of holders of the Company’s
Common Stock
|
4.2
|
See
Exhibit 10.20
|
10.1
|
License
Agreement with University of Missouri, as amended (incorporated by
reference to Exhibit 10.3 of the Company’s registration statement on Form
S-1, File No. 33-7097, and post-effective amendments
thereto)
|
10.2
|
Reassignment
and Release Agreement among the Company, John L. Russell, Jr., and Georgia
Tech Research Institute (incorporated by reference to Exhibit 10.8 of the
Company’s registration statement on Form S-1, File No. 33-7097, and
post-effective amendments thereto)
|
10.3
|
Agreement
with Nordion International Inc. (incorporated by reference to the
Company’s report on Form 8-K dated March 23,
1995)
|
10.4
|
Amended
and Restated Credit Agreement dated May 27, 2009 among the Company, C.P.
Medical Corporation, Galt Medical Corp., NeedleTech Products, Inc. and
Wachovia, together with related Term Loan Note and Amended, Restated and
Consolidated Line of Credit Note (incorporated by reference to Exhibit
10.1 of our report on Form 10-Q for the quarterly period ended July 5,
2009)
|
10.5
|
Theragenics
Corporation 1995 Stock Option Plan* (incorporated by reference to Exhibit
10.1 of the Company’s common stock registration statement on Form S-8,
file no. 333-15313)
|
10.6
|
1997
Stock Incentive Plan* (incorporated by reference to Appendix B of the
Company’s Proxy Statement for its 1997 Annual Meeting of Stockholders
filed on Schedule 14A)
|
10.7
|
Theragenics
Corporation 2000 Stock Incentive Plan* (incorporated by reference to
Exhibit 10.16 of the Company’s report on Form 10-K for the year ended
December 31, 1999)
|
10.8
|
Employment
Agreement dated April 13, 2000 of M. Christine Jacobs* (incorporated by
reference to Exhibit 10.1 of the Company’s report on Form 10-Q for the
quarterly period ended March 31,
2000)
|
10.8A
|
First
Amendment dated July 8, 2003 to Executive Employment Agreement for M.
Christine Jacobs* (incorporated by reference to Exhibit 10.1 of the
Company’s report on Form 10-Q for the quarterly period ended June 30,
2003)
|
10.8B
|
Amendment
to Employment Agreement dated August 8, 2006, between Theragenics
Corporation and M. Christine Jacobs* (incorporated by reference to Exhibit
10.3 of the Company’s report on Form 10-Q for the quarterly period ended
July 2, 2006)
|
10.8C
|
Amendment
to Employment Agreement dated December 31, 2008, between Theragenics
Corporation and M. Christine Jacobs* (incorporated by reference to Exhibit
10.11C of our report on Form 10-K for the year ended December 31,
2008)
|
10.9
|
Employment
Agreement dated January 1, 1999 of Bruce W. Smith* (incorporated by
reference to Exhibit 10.22 of the Company’s report on Form 10-K for the
year ended December 31, 1998)
|
10.9A
|
Amendment
to Executive Employment Agreement dated June 29, 1999 for Bruce W. Smith*
(incorporated by reference to Exhibit 10.18 of the Company’s report on
Form 10-K for year ended December 31,
2002)
|
10.9B
|
Second
Amendment dated June 15, 2001 to Executive Employment Agreement for Bruce
W. Smith* (incorporated by reference to Exhibit 10.19 of the Company’s
report on Form 10-K for year ended December 31,
2002)
|
10.9C
|
Third
Amendment dated September 3, 2002 to Executive Employment Agreement for
Bruce W. Smith* (incorporated by reference to Exhibit 10.20 of the
Company’s report on Form 10-K for year ended December 31,
2002)
|
10.9D
|
Fourth
Amendment dated May 28, 2003 to Executive Employment Agreement for Bruce
W. Smith* (incorporated by reference to Exhibit 10.2 of the Company’s
report on Form 10-Q for the quarterly period ended June 30,
2003)
|
IV-2
10.9E
|
Fifth
Amendment to Executive Employment Agreement for Bruce W. Smith*
(incorporated by reference to Exhibit 10.15E of the Company’s report on
Form 10-K for the year ended December 31,
2005)
|
10.9F
|
Amendment
to Employment Agreement dated December 31, 2008, between Theragenics
Corporation and Bruce W. Smith* (incorporated by reference to Exhibit
10.11C of our report on Form 10-K for the year ended December 31,
2008)
|
10.10
|
Forms
of Option Award for grants prior to 2007* (incorporated by reference to
Exhibit 10.22 of the Company’s report on Form 10-K for the year ended
December 31, 2004)
|
10.11
|
Advisor
to the Chief Executive Officer Agreement dated February 18, 2008 with John
Herndon* (incorporated by reference to Exhibit 10.15 of the Company’s
report on Form 10-K for the year ended December 31,
2007)
|
10.12
|
Form
of Directors and Officers Indemnification Agreement* (incorporated by
reference to Exhibit 10.28 of the Company’s report on Form 10-K for the
year ended December 31, 2003)
|
10.13
|
Form
of Restricted Stock Agreement for directors as of May 2005* (incorporated
by reference to Exhibit 10.1 of the Company’s report on Form 10-Q for the
quarterly period ended July 3,
2005)
|
10.14
|
Employment
Agreement between the Company and Francis J. Tarallo dated August 10,
2005* (incorporated by reference to Exhibit 10.5 of the Company’s report
on Form 10-Q for the quarterly period ended July 3,
2005)
|
10.14A
|
Amendment
to Employment Agreement dated December 31, 2008, between Theragenics
Corporation and Francis J. Tarallo*
|
10.15
|
Theragenics
Corporation Incentive Stock Option Award for 2007 grants* (incorporated by
reference to Exhibit 10.1 of the Company’s Form 8-K dated February 20,
2007)
|
10.16
|
Restricted
Stock Award Pursuant to the Theragenics Corporation 2006 Stock Incentive
Plan for 2007 grants* (incorporated by reference to Exhibit 10.2 of the
Company’s Form 8-K dated February 20,
2007)
|
10.17
|
Theragenics
Corporation Amended and Restated 2007 Long-Term Cash Incentive Plan*
(incorporated by reference to Exhibit 10.24 of the Company’s Form 10-K for
the year ended December 31, 2007)
|
10.18
|
Employment
Agreement dated May 6, 2005 by and between the Company and Patrick
Ferguson* (incorporated by reference to Exhibit 10.1 of the Company’s Form
8-K filed May 12, 2005)
|
10.19
|
Theragenics
Corporation 2006 Stock Incentive Plan* (incorporated by reference to
Appendix A to the Company’s definitive proxy statement for its May 9, 2006
annual meeting of stockholders filed with the Securities and Exchange
Commission on March 27, 2006).
|
10.19A
|
First
Amendment to Theragenics Corporation 2006 Stock Incentive Plan*
(incorporated by reference to Exhibit 18.1 on Form 8-K filed November 13,
2006)
|
10.20
|
Rights
Agreement dated February 14, 2007 between the Company and Computershare
Investor Services LLC (incorporated by reference to Exhibit 99.1 of the
Company’s registration statement on Form 8-A/A filed February 16,
2007)
|
10.21
|
Employment
Agreement between Galt Medical Corp. and Michael F. Lang dated August 21,
2007* (incorporated by reference to Exhibit 10.1 of the Company’s Form
10-Q filed November 8, 2007)
|
10.21A
|
Amendment
to Employment Agreement dated December 31, 2008, between Galt Medical
Corp. and Michael F. Lang*
|
10.22
|
Theragenics
Corporation Incentive Stock Option Award for 2008, 2009 and 2010
grants* (incorporated by reference to Exhibit 10.1 of the Company’s
Form 8-K dated February 25, 2008)
|
10.23
|
Restricted
Stock Award for 2008, 2009 and 2010 grants, pursuant to the Theragenics
Corporation 2006 Stock Incentive Plan* (incorporated by
reference to Exhibit 10.2 of the Company’s Form 8-K dated February
25, 2008)
|
10.24
|
Theragenics
Corporation 2008 Long-Term Cash Incentive Plan* (incorporated by
reference to Exhibit 10.3 of the Company’s Form 8-K dated February
25, 2008)
|
IV-3
10.25
|
Stock
Purchase Agreement dated as of July 16, 2008 with respect to NeedleTech
Products, Inc. by and among Theragenics Corporation, as Purchaser, Ronald
Routhier, as Sellers’ Representative, the individual Stockholders of
NeedleTech Products, Inc. listed on Schedule 1 to the Agreement, as
Sellers, and Rockland Trust Company, as Special Fiduciary and Trustee
(incorporated by reference to Exhibit 2.1 of the Company’s form 8-K filed
on July 21, 2008).
|
10.26
|
Employment
Agreement between NeedleTech Products, Inc. and Ronald Routhier, dated as
of July 28, 2008* (incorporated by reference to Exhibit 10.1 of the
Company’s form 8-K filed on July 31,
2008).
|
10.26A
|
Amendment
to Employment Agreement dated December 31, 2008, between NeedleTech
Products, Inc. and Ronald Routhier*
|
10.27
|
Employment
Agreement between NeedleTech Products, Inc. and Russell Small, dated as of
July 28, 2008* (incorporated by reference to Exhibit 10.2 of the Company’s
form 8-K filed on July 31, 2008)
|
10.27A
|
Amendment
to Employment Agreement dated December 31, 2008, between NeedleTech
Products, Inc. and Russell Small*
|
10.28
|
Employment
Agreement between CP Medical Corporation and Janet Zeman dated August 6,
2008 (incorporated by reference to Exhibit 10.1 of the Company’s Form 10-Q
filed on November 6, 2008)
|
10.28A
|
Amendment
to Employment Agreement dated December 31, 2008, between CP Medical
Corporation and Janet Zeman*
|
10.29
|
Theragenics
Corporation 2009 Long-Term Cash Incentive Plan* (incorporated by
reference to Exhibit 10.1 of the Company’s Form 8-K dated March 4,
2009)
|
10.30
|
Standard
Form Commercial Lease between Chartier-Tate, LLC and NeedleTech Products,
Inc. dated April 19, 2006 and Amendment dated May 22,
2008
|
10.31
|
Theragenics
Corporation Cash Incentive Plan*
|
23.1
|
Consent
of Dixon Hughes PLLC
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rule 13a-14(a) and Section 302 of
the Sarbanes-Oxley Act of 2002
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rule 13a-14(a) and Section 302 of
the Sarbanes-Oxley Act of 2002
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 1350, Chapter 63 of Title
18, United States Code, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 1350, Chapter 63 of Title
18, United States Code, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
*
Management contract or compensatory plan.
IV-4
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
THERAGENICS
CORPORATION
|
|||
(Registrant)
|
|||
By:
|
/s/
M. Christine Jacobs
|
||
M.
Christine Jacobs
|
|||
Chief
Executive Officer
|
|||
Dated:
March 15, 2010
|
|||
Buford,
Georgia
|
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 and in the
capacities and on the dates indicated.
Name
|
Title
|
Date
|
|||||||||
/s/
M. Christine Jacobs
|
Chief
Executive Officer
|
3/15/10
|
|||||||||
M.
Christine Jacobs
|
(Principal
Executive Officer)
|
||||||||||
President
and Chairman
|
|||||||||||
/s/
Francis J. Tarallo
|
Chief
Financial Officer (Principal Financial
|
3/15/10
|
|||||||||
Francis
J. Tarallo
|
and
Accounting Officer) and Treasurer
|
||||||||||
/s/
Kathleen A. Dahlberg
|
Director
|
3/15/10
|
|||||||||
Kathleen
A. Dahlberg
|
|||||||||||
/s/
K. Wyatt Engwall
|
Director
|
3/15/10
|
|||||||||
K.
Wyatt Engwall
|
|||||||||||
/s/
John V. Herndon
|
Director
|
3/15/10
|
|||||||||
John
V. Herndon
|
|||||||||||
/s/
C. David Moody, Jr.
|
Director
|
3/15/10
|
|||||||||
C.
David Moody, Jr.
|
|||||||||||
/s/
Peter A.A. Saunders
|
Director
|
3/15/10
|
|||||||||
Peter
A. A. Saunders
|
IV-5
THERAGENICS
CORPORATION®
TABLE
OF CONTENTS
Page
|
||
REPORTS
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-2
|
|
CONSOLIDATED
FINANCIAL STATEMENTS
|
||
Consolidated
Statements of Operations and Comprehensive Earnings (Loss) for each of the
three years in the period ended December 31, 2009
|
F-3
|
|
Consolidated
Balance Sheets as of December 31, 2009 and 2008
|
F-4
|
|
Consolidated
Statements of Shareholders’ Equity for each of the three years in the
period ended December 31, 2009
|
F-5
|
|
Consolidated
Statements of Cash Flows for each of the three years in the period ended
December 31, 2009
|
F-8
|
|
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
|
F-10
|
|
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON
SCHEDULE
|
S-1
|
|
Schedule
II - Valuation and Qualifying Accounts for each of the three years in the
period ended December 31, 2009
|
S-2
|
F-1
Report of Independent
Registered Public Accounting Firm
To the
Board of Directors and
Shareholders
of Theragenics Corporation
We have
audited the accompanying consolidated balance sheets of Theragenics Corporation
and subsidiaries (the “Company”) as of December 31, 2009 and 2008, and the
related consolidated statements of operations and comprehensive earnings (loss),
shareholders’ equity, and cash flows for each of the three years in the period
ended December 31, 2009. These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an
opinion on these consolidated financial statements 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, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of the Company 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.
We also
have 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 criteria established in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission and our report dated March 15, 2010, expressed an
unqualified opinion thereon.
/s/ DIXON
HUGHES PLLC
Atlanta,
Georgia
March 15,
2010
F-2
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
STATEMENTS OF OPERATIONS
AND
COMPREHENSIVE EARNINGS (LOSS)
Year
ended December 31,
(Amounts
in thousands, except per share data)
2009
|
2008
|
2007
|
||||||||||
Revenue
|
||||||||||||
Product
sales
|
$ | 77,151 | $ | 66,447 | $ | 61,286 | ||||||
License
and fee income
|
1,175 | 911 | 924 | |||||||||
78,326 | 67,358 | 62,210 | ||||||||||
Cost
of sales
|
44,953 | 36,264 | 31,994 | |||||||||
Gross
profit
|
33,373 | 31,094 | 30,216 | |||||||||
Operating
expenses
|
||||||||||||
Selling,
general and administrative
|
22,020 | 20,500 | 19,131 | |||||||||
Amortization
of purchased intangibles
|
3,441 | 2,410 | 1,875 | |||||||||
Research
and development
|
2,160 | 1,300 | 1,365 | |||||||||
Change
in estimated value of asset held for sale
|
— | (142 | ) | 500 | ||||||||
Impairment
of goodwill and tradenames
|
— | 70,376 | — | |||||||||
Loss
(gain) on sale of equipment
|
3 | (5 | ) | — | ||||||||
27,624 | 94,439 | 22,871 | ||||||||||
Earnings
(loss) from operations
|
5,749 | (63,345 | ) | 7,345 | ||||||||
Other
income (expense)
|
||||||||||||
Interest
income
|
25 | 1,065 | 2,192 | |||||||||
Interest
expense
|
(865 | ) | (841 | ) | (691 | ) | ||||||
Other,
net
|
3 | 53 | 1 | |||||||||
(837 | ) | 277 | 1,502 | |||||||||
Earnings
(loss) before income taxes
|
4,912 | (63,068 | ) | 8,847 | ||||||||
Income
tax expense (benefit)
|
1,837 | (4,528 | ) | 3,212 | ||||||||
NET
EARNINGS (LOSS)
|
$ | 3,075 | $ | (58,540 | ) | $ | 5,635 | |||||
NET
EARNINGS (LOSS) PER SHARE
|
||||||||||||
Basic
|
$ | 0.09 | (1.77 | ) | $ | 0.17 | ||||||
Diluted
|
$ | 0.09 | (1.77 | ) | $ | 0.17 | ||||||
WEIGHTED
AVERAGE SHARES
|
||||||||||||
Basic
|
33,145 | 33,066 | 33,103 | |||||||||
Diluted
|
33,269 | 33,066 | 33,299 | |||||||||
COMPREHENSIVE
EARNINGS (LOSS)
|
||||||||||||
Net
earnings (loss)
|
$ | 3,075 | (58,540 | ) | $ | 5,635 | ||||||
Other
comprehensive earnings, net of taxes
|
||||||||||||
Reclassification
adjustment for loss included in net earnings (loss)
|
— | 347 | 5 | |||||||||
Unrealized
gain (loss) on securities arising during the year
|
— | (291 | ) | 21 | ||||||||
Total
other comprehensive earnings
|
— | 56 | 26 | |||||||||
Total
comprehensive earnings (loss)
|
$ | 3,075 | (58,484 | ) | $ | 5,661 | ||||||
The
accompanying notes are an integral part of these consolidated financial
statements.
|
F-3
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
BALANCE SHEETS
December
31,
(Amounts
in thousands, except per share data)
2009
|
2008
|
|||||||
ASSETS | ||||||||
CURRENT
ASSETS
|
||||||||
Cash
and cash equivalents
|
$ | 45,326 | $ | 39,088 | ||||
Marketable
securities
|
— | 1,507 | ||||||
Trade
accounts receivable, less allowance of $384 in 2009 and $481 in
2008
|
8,999 | 8,532 | ||||||
Inventories
|
11,636 | 11,667 | ||||||
Deferred
income tax asset
|
1,096 | 2,158 | ||||||
Refundable
income taxes
|
645 | 1,504 | ||||||
Prepaid
expenses and other current assets
|
857 | 1,129 | ||||||
Total
current assets
|
68,559 | 65,585 | ||||||
|
||||||||
Property
and equipment, net
|
31,999 | 30,035 | ||||||
Intangible
assets, net
|
15,464 | 18,720 | ||||||
Other
assets
|
86 | 79 | ||||||
Total
assets
|
$ | 116,108 | $ | 114,419 |
LIABILITIES
AND SHAREHOLDERS’ EQUITY
CURRENT
LIABILITIES
|
||||||||
Accounts
payable
|
$ | 1,845 | $ | 1,437 | ||||
Accrued
salaries, wages and payroll taxes
|
2,303 | 1,968 | ||||||
Short-term
borrowings
|
3,333 | 32,000 | ||||||
Income
taxes payable
|
— | 209 | ||||||
Other
current liabilities
|
1,491 | 1,896 | ||||||
Total
current liabilities
|
8,972 | 37,510 | ||||||
Long-term
borrowings
|
27,000 | — | ||||||
Deferred
income taxes
|
1,365 | 2,006 | ||||||
Decommissioning
retirement
|
696 | 646 | ||||||
Other
long-term liabilities
|
422 | 147 | ||||||
Total
liabilities
|
38,455 | 40,309 | ||||||
COMMITMENTS
AND CONTINGENCIES
|
||||||||
SHAREHOLDERS’
EQUITY
|
||||||||
Common
stock - authorized 100,000 shares of $.01 par value; issued and
outstanding, 33,435 in 2009 and 33,243 in 2008
|
334 | 332 | ||||||
Additional
paid-in capital
|
73,360 | 72,894 | ||||||
Retained
earnings
|
3,959 | 884 | ||||||
Total
shareholders’ equity
|
77,653 | 74,110 | ||||||
Total
liabilities and shareholders’ equity
|
$ | 116,108 | $ | 114,419 |
The
accompanying notes are an integral part of these consolidated financial
statements.
F-4
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY
For the
three years ended December 31, 2009
(Amounts
in thousands, except per share data)
Common
Stock
|
||||||||||||||||||||||||
Number
of
Shares
|
Par
value
$0.01
|
Additional
paid-in
capital
|
Retained
earnings
|
Accumulated
other
comprehensive
loss
|
Total
|
|||||||||||||||||||
Balance,
December 31, 2006
|
33,096 | $ | 331 | $ | 72,103 | $ | 53,789 | $ | (82 | ) | $ | 126,141 | ||||||||||||
Exercise
of stock options
|
30 | — | 126 | — | — | 126 | ||||||||||||||||||
Tax
benefit related to stock plans
|
— | — | 15 | — | — | 15 | ||||||||||||||||||
Issuance
of restricted shares
|
135 | 1 | (1 | ) | — | — | — | |||||||||||||||||
Restricted
shares forfeited
|
(1 | ) | — | — | — | — | — | |||||||||||||||||
Issuance
of common stock upon vesting of restricted units
|
23 | — | — | — | — | — | ||||||||||||||||||
Retirement
of common stock received in settlement for other
receivable
|
(21 | ) | — | (83 | ) | — | — | (83 | ) | |||||||||||||||
Employee
stock purchase plan
|
12 | 1 | 35 | — | — | 36 | ||||||||||||||||||
Share
based compensation
|
— | — | 723 | — | — | 723 | ||||||||||||||||||
Other
comprehensive earnings
|
— | — | — | — | 26 | 26 | ||||||||||||||||||
Net
earnings for the year
|
— | — | — | 5,635 | — | 5,635 | ||||||||||||||||||
Balance,
December 31, 2007
|
33,274 | $ | 333 | $ | 72,918 | $ | 59,424 | $ | (56 | ) | $ | 132,619 |
F-5
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY – Continued
For
the three years ended December 31, 2009
(Amounts
in thousands, except per share data)
Common
Stock
|
||||||||||||||||||||||||
Number
of
Shares
|
Par
value
$0.01
|
Additional
paid-in
capital
|
Retained
earnings
|
Accumulated
other
comprehensive
loss
|
Total
|
|||||||||||||||||||
Balance,
December 31, 2007
|
33,274 | $ | 333 | $ | 72,918 | $ | 59,424 | $ | (56 | ) | $ | 132,619 | ||||||||||||
Tax
benefit related to stock plans
|
— | — | 7 | — | — | 7 | ||||||||||||||||||
Issuance
of restricted shares
|
159 | 1 | (1 | ) | — | — | — | |||||||||||||||||
Restricted
shares forfeited
|
(23 | ) | — | — | — | — | — | |||||||||||||||||
Issuance
of common stock upon vesting of restricted units
|
27 | — | — | — | — | — | ||||||||||||||||||
Retirement
of common stock received in settlement for other
receivable
|
(202 | ) | (2 | ) | (695 | ) | — | — | (697 | ) | ||||||||||||||
Employee
stock purchase plan
|
8 | — | 31 | — | — | 31 | ||||||||||||||||||
Share
based compensation
|
— | — | 634 | — | — | 634 | ||||||||||||||||||
Other
comprehensive earnings
|
— | — | — | — | 56 | 56 | ||||||||||||||||||
Net
loss for the year
|
— | — | — | (58,540 | ) | — | (58,540 | ) | ||||||||||||||||
Balance,
December 31, 2008
|
33,243 | $ | 332 | $ | 72,894 | $ | 884 | $ | — | $ | 74,110 |
F-6
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
STATEMENTS OF SHAREHOLDERS’ EQUITY – Continued
For the
three years ended December 31, 2009
(Amounts
in thousands, except per share data)
Common
Stock
|
||||||||||||||||||||||||
Number
of
Shares
|
Par
value
$0.01
|
Additional
paid-in
capital
|
Retained
earnings
|
Accumulated
other
comprehensive
loss
|
Total
|
|||||||||||||||||||
Balance,
December 31, 2008
|
33,243 | $ | 332 | $ | 72,894 | $ | 884 | $ | — | $ | 74,110 | |||||||||||||
Issuance
of restricted shares
|
166 | 2 | (2 | ) | — | — | — | |||||||||||||||||
Restricted
shares retired and forfeited
|
(64 | ) | (1 | ) | (7 | ) | — | — | (8 | ) | ||||||||||||||
Issuance
of common stock upon vesting of restricted units
|
64 | 1 | (1 | ) | — | — | — | |||||||||||||||||
Employee
stock purchase plan
|
26 | — | 26 | — | — | 26 | ||||||||||||||||||
Share
based compensation
|
— | — | 450 | — | — | 450 | ||||||||||||||||||
Net
earnings for the year
|
— | — | — | 3,075 | — | 3,075 | ||||||||||||||||||
Balance,
December 31, 2009
|
33,435 | $ | 334 | $ | 73,360 | $ | 3,959 | $ | — | $ | 77,653 |
The
accompanying notes are an integral part of these consolidated
statements.
F-7
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Year
ended December 31,
(Amounts
in thousands)
2009
|
2008
|
2007
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
earnings (loss)
|
$ | 3,075 | (58,540 | ) | $ | 5,635 | ||||||
Adjustments to reconcile net earnings (loss) to net cash provided by
operating activities:
|
||||||||||||
Impairment
of goodwill and tradenames
|
— | 70,376 | — | |||||||||
Depreciation
and amortization
|
6,927 | 5,626 | 6,146 | |||||||||
Deferred
income taxes
|
421 | (4,535 | ) | 1,300 | ||||||||
Share-based
compensation
|
450 | 634 | 723 | |||||||||
Gain
on sale of scrap metal
|
— | (457 | ) | — | ||||||||
Contract
termination liability
|
— | (15 | ) | (26 | ) | |||||||
Provision
for allowances
|
(82 | ) | 362 | 19 | ||||||||
Loss
on marketable securities
|
2 | 347 | 5 | |||||||||
Change
in estimated value of asset held for sale
|
— | (142 | ) | 500 | ||||||||
Decommissioning
retirement liability
|
50 | 44 | 41 | |||||||||
Loss
(gain) on sale of equipment
|
3 | (5 | ) | — | ||||||||
Changes
in assets and liabilities, net of acquisitions:
|
||||||||||||
Accounts
receivable
|
(462 | ) | 984 | (124 | ) | |||||||
Inventories
|
108 | (244 | ) | (325 | ) | |||||||
Refundable
income taxes
|
859 | (1,504 | ) | — | ||||||||
Prepaid
expenses and other current assets
|
272 | 458 | 2,140 | |||||||||
Other
assets
|
(7 | ) | 19 | 19 | ||||||||
Trade
accounts payable
|
408 | (380 | ) | (238 | ) | |||||||
Accrued
salaries, wages and payroll taxes
|
335 | (236 | ) | 356 | ||||||||
Income
taxes payable
|
(209 | ) | (1,235 | ) | 970 | |||||||
Other
current liabilities
|
(838 | ) | 802 | (277 | ) | |||||||
Other
|
275 | (108 | ) | 255 | ||||||||
Net
cash provided by operating activities
|
11,587 | 12,251 | 17,119 | |||||||||
Cash
flows from investing activities:
|
||||||||||||
Cash
paid for acquisition, net of cash acquired of $3.8 million
|
— | (46,063 | ) | — | ||||||||
Purchases
and construction of property and equipment
|
(4,980 | ) | (1,531 | ) | (1,450 | ) | ||||||
Proceeds
from sale of equipment and asset held for sale
|
— | 1,576 | — | |||||||||
Purchases
of marketable securities
|
— | (8,000 | ) | (29,493 | ) | |||||||
Maturities
of marketable securities
|
500 | 6,399 | 21,658 | |||||||||
Proceeds
from sales of marketable securities
|
1,005 | 21,949 | 2,480 | |||||||||
Net
cash used in investing activities
|
(3,475 | ) | (25,670 | ) | (6,805 | ) |
F-8
Theragenics
Corporation and Subsidiaries
CONSOLIDATED
STATEMENTS OF CASH FLOWS - Continued
Year
ended December 31,
(Amounts
in thousands)
2009
|
2008
|
2007
|
||||||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from borrowings under credit facility
|
— | 24,500 | — | |||||||||
Repayment
of borrowings
|
(1,667 | ) | — | — | ||||||||
Loan
fees on refinancing of credit facility
|
(225 | ) | — | — | ||||||||
Retirement
of common stock
|
(8 | ) | (697 | ) | (83 | ) | ||||||
Proceeds
from exercise of stock options and stock purchase plan
|
26 | 31 | 162 | |||||||||
Excess
tax benefit related to share plans
|
— | 7 | 15 | |||||||||
Net
cash provided (used) by financing activities
|
(1,874 | ) | 23,841 | 94 | ||||||||
Net
increase in cash and cash equivalents
|
6,238 | 10,422 | 10,408 | |||||||||
Cash
and cash equivalents at beginning of year
|
39,088 | 28,666 | 18,258 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 45,326 | $ | 39,088 | $ | 28,666 | ||||||
Supplementary Cash
Flow Disclosure
|
||||||||||||
Interest
paid
|
$ | 842 | $ | 793 | $ | 662 | ||||||
Income
taxes paid (received), net
|
$ | 766 | $ | 2,282 | $ | (928 | ) | |||||
Non-cash investing and
financing activities:
|
||||||||||||
Liability
for property and equipment acquired
|
$ | 433 | $ | — | $ | — | ||||||
Termination
of lease underlying contract termination liability
|
$ | — | $ | 1,498 | $ | — |
The
accompanying notes are an integral part of these consolidated
statements.
F-9
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS
NOTE
A - ORGANIZATION AND DESCRIPTION OF BUSINESS
The terms
“Company”, “we”, “us”, or “our” mean Theragenics Corporation and all entities
included in our consolidated financial statements.
We are a
medical device company serving the surgical products and cancer treatment
markets, operating in two business segments. Our surgical products business
consists of wound closure, vascular access, and specialty needle
products. Wound closure includes sutures, needles, and other surgical
products. Vascular access includes introducers, guidewires, and
related products. Specialty needles include coaxial, biopsy, spinal
and disposable veress needles, access trocars, and other needle based
products. Our surgical products segment serves a number of markets
and applications, including among other areas, interventional cardiology,
interventional radiology, vascular surgery, orthopedics, plastic surgery, dental
surgery, urology, veterinary medicine, pain management, endoscopy, and spinal
surgery. Our brachytherapy seed business manufactures and markets our premier
brachytherapy product, the palladium-103 TheraSeed®
device, and I-Seed, an iodine-125 based device, which are used primarily
in the minimally invasive treatment of localized prostate
cancer.
NOTE
B - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A summary
of the significant accounting policies consistently applied in the preparation
of the accompanying financial statements follows:
1. Consolidation
These
consolidated financial statements include the accounts of Theragenics and our
wholly owned subsidiaries, CP Medical Corporation (“CP Medical”, acquired in May
2005), Galt Medical Corporation (“Galt”, acquired in
August 2006), and NeedleTech Products, Inc. (“NeedleTech”, acquired in July
2008). We have no unconsolidated entities and no special purpose
entities. Results of operations of acquired companies are included in
our consolidated results for periods subsequent to the acquisition date. All
significant intercompany accounts and transactions have been eliminated in
consolidation. We have evaluated subsequent events
through the date of our financial statement issuance.
2. Use of
Estimates
The
preparation of our financial statements in conformity with accounting principles
generally accepted in the United States of America (“GAAP”) requires us to make
estimates and judgments that affect reported amounts of assets, liabilities,
revenues and expenses, and the related disclosure of contingent assets and
liabilities at the date of the financial statements. We evaluate these estimates
and judgments on an ongoing basis and base our estimates on historical
experience, current conditions and various other assumptions that we believe to
be reasonable under the circumstances. The results of these estimates form the
basis for making judgments about the carrying values of assets and liabilities
as well as identifying and assessing the accounting treatment with respect to
commitments and contingencies. Actual results may differ from these estimates
under different assumptions or conditions
3. Revenue Recognition and Cost
of Sales
We
recognize revenue when persuasive evidence of a sales arrangement exists, title
and risk of loss have transferred, the selling price is fixed or determinable,
contractual obligations have been satisfied, and collectibility is reasonably
assured. Revenue for product sales is recognized upon
shipment. License fees are recognized in the periods to which they
relate.
Charges
for returns and allowances are recognized as a deduction from revenue on an
accrual basis in the period in which the related revenue is
recorded. The accrual for product returns and allowances is based on
our history. We allow customers to return defective
products. In our brachytherapy segment, we also allow customers to
return products in cases where the attending physician or hospital has certified
that the brachytherapy procedure was unable to be performed as scheduled due to
the patient’s health or other valid reason. Historically, product
returns and allowances have not been material.
Shipping
and handling costs are included in cost of sales. Billings to customers to
recover such costs are included in product sales. Any sales taxes charged to
customers are excluded from both net sales and expenses.
4. Cash and Cash
Equivalents
For
purposes of reporting cash flows, cash and cash equivalents include cash on
hand, cash in banks, variable rate demand notes, treasury investments and U.S.
obligations and commercial paper with original maturities equal to or less than
90 days from purchase.
F-10
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
5. Marketable
Securities
Marketable
securities are classified as available-for-sale and are reported at fair value,
with unrealized gains or losses reported net of tax in accumulated other
comprehensive (loss) income.
6. Interest Rate Swap
Derivative Instruments
We
recognize our interest rate swap derivative instruments at fair value as either
assets or liabilities in our consolidated balance sheet. Changes in fair value
of derivative instruments are recorded in each period in current earnings as
interest expense.
7. Accounts Receivable and
Allowance for Doubtful Accounts and Returns
Trade
accounts receivable arise from sales in our various markets, are stated at the
amount expected to be collected and do not bear interest. We maintain an
allowance for doubtful accounts based upon reviewing our accounts receivable
aging and our estimate of the expected collectibility of the amounts.
Outstanding receivables are considered past due based upon invoice due dates.
The collectibility of trade receivable balances is regularly evaluated based on
a combination of factors such as customer credit-worthiness, past transaction
history with the customer, current economic industry trends, and changes in
customer payment terms. If we determine that a customer will be unable to fully
meet its financial obligation, such as in the case of a bankruptcy filing or
other material events impacting its business, we record a specific reserve for
bad debt to reduce the related receivable to the amount expected to be
recovered.
8. Inventories
Inventories
are stated at the lower of cost or market. Cost is determined using the
first-in, first-out (FIFO) method or weighted average cost method, which
approximates FIFO. Market is replacement cost or net realizable value. We
estimate reserves for inventory obsolescence based on our judgment of future
realization. Inventories consist of the following (in
thousands):
December
31,
|
||||||||
2009
|
2008
|
|||||||
Raw
materials
|
$ | 5,100 | $ | 5,024 | ||||
Work
in progress
|
2,609 | 3,054 | ||||||
Finished
goods
|
3,842 | 3,488 | ||||||
Spare
parts and supplies
|
755 | 848 | ||||||
12,306 | 12,414 | |||||||
Allowance
for obsolete inventory
|
(670 | ) | (747 | ) | ||||
Inventories,
net
|
$ | 11,636 | $ | 11,667 |
9. Property, Equipment, and
Depreciation
Property
and equipment are recorded at historical cost. Depreciation is provided for in
amounts sufficient to relate the cost of depreciable assets to operations over
their estimated service lives on a straight-line basis. Leasehold
improvements are amortized over the useful life of the asset or the lease term,
whichever is shorter. Depreciation expense related to property and equipment
charged to operations was approximately $3,446,000, $3,056,000 and $4,272,000
for 2009, 2008 and 2007, respectively. Estimated service lives are 30 years for
buildings and improvements, and 3 to 15 years for machinery, equipment and
furniture. Expenditures for repairs and maintenance not considered to
substantially lengthen the life of the asset or increase capacity or efficiency
are charged to expense as incurred.
We
reassess the estimated service lives of our depreciable assets on a periodic
basis. In December 2007, we changed the estimated service lives of certain
depreciable assets, mainly the cyclotron equipment used in our brachytherapy
segment. The estimated service life of the cyclotron equipment was increased
from 10 years to 15 years, and was based on, among other things, an assessment
of the equipment’s operating and maintenance history and expected future
performance. We accounted for this change as a change in
estimate. Accordingly, this change was accounted for on a prospective
basis beginning in December 2007. The effect of this change was not significant
in 2007. This change reduced depreciation expense by approximately $490,000 and
$1.4 million in 2009 and 2008, respectively, from what would have been reported
otherwise. Periods prior to this change have not been restated or
retrospectively adjusted.
F-11
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
10. Impairment of Long-Lived
Assets
We
periodically evaluate long-lived assets, including property and equipment and
finite lived intangible assets whenever events or changes in conditions may
indicate that the carrying value may not be recoverable. Factors that we
consider important that could initiate an impairment review include the
following:
|
●
|
Significant
operating losses;
|
|
●
|
Recurring
operating losses;
|
|
●
|
Significant
adverse change in legal factors or in the business
climate;
|
|
●
|
Significant
declines in demand for a product produced by an asset capable of producing
only that product;
|
|
●
|
Assets
that are idled or held for sale;
and
|
|
●
|
Assets
that are likely to be divested
|
The
impairment review requires us to estimate future undiscounted cash flows
associated with an asset or group of assets. If the future undiscounted cash
flows are less than the carrying amount of the asset, we must estimate the fair
value of the asset. If the fair value of the asset is below the carrying value,
then the difference will be written-off. Estimating future cash flows
requires us to make judgments regarding future economic conditions, product
demand and pricing. Although we believe our estimates are appropriate,
significant differences in the actual performance of the asset or group of
assets may materially affect the values of our asset and our results of
operations.
No
impairment charges related to long-lived assets subject to depreciation and
amortization were recorded in any of the three years in the period ended
December 31, 2009.
11. Goodwill and Intangible
Assets
We do not
amortize goodwill and intangible assets with indefinite lives. We
test such goodwill and other intangible assets with indefinite lives for
impairment annually, or more frequently if events or circumstances indicate that
an asset might be impaired. We recorded impairment charges related to all of our
goodwill and a portion of our tradenames in the fourth quarter of 2008. We have
no recorded goodwill in our consolidated balance sheet at December 31, 2009 or
2008.
Other
intangible assets determined to have finite lives are amortized over their
useful lives using a method that is expected to reflect the pattern of its
economic benefit. When a pattern of economic benefit cannot be determined, or if
the straight-line method results in greater amortization, then the straight-line
method is used. To date, all finite lived intangible assets have been amortized
using the straight-line method. We also review finite lived intangible assets
for impairment to ensure they are appropriately valued if conditions exist that
indicate the carrying value may not be recoverable.
12. Income
Taxes
We
account for income taxes using the asset and liability method. Under this
method, we recognize deferred tax assets and liabilities for the future tax
consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax
bases. Deferred tax assets and liabilities are measured using enacted tax rates
applied to taxable income. The effect on deferred tax assets and liabilities of
a change in tax rates is recognized in income in the period that includes the
enactment date. A valuation allowance is provided for deferred tax assets when
it is more likely than not that the asset will not be realized.
We review
all of our tax positions and the tax benefits of uncertain tax positions are
recognized only if it is more likely than not that we will be able to sustain a
position taken on an income tax return. We have concluded that there were no
significant uncertain tax positions as of December 31, 2009 and 2008. Our policy
is to recognize accrued interest expense and penalties associated with uncertain
tax positions as a component of income tax expense.
13. Contingencies
From time
to time we may be subject to various legal proceedings and claims, including,
for example, disputes on agreements, employment disputes and other
commercial disputes, the outcomes of which are not within our complete control
and may not be known for extended periods of time. In some cases, the claimants
seek damages, as well as other relief, which, if granted, could require significant expenditures. We
record a liability for damages and/or costs related to claims, settlements and
judgments where we have assessed that a loss is probable and an amount can be
reasonably estimated. If the estimate of a probable loss is a range and no
amount within the range is more likely, we accrue the minimum amount of the
range. Legal costs associated with these matters are expensed as
incurred.
F-12
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
14. Earnings (Loss) Per
Share
Basic net
earnings (loss) per common share is based upon the weighted average number of
common shares outstanding during the period. Diluted net earnings (loss) per
common share is based upon the weighted average number of common shares
outstanding plus dilutive potential common shares, including options and awards
outstanding during the period.
15. Share-Based
Compensation
Compensation
costs related to share based payments, including stock options and other equity
awards, are measured at the grant date fair value of the award. To estimate the
fair value of stock options, we use the Black-Scholes options-pricing model.
Inherent in this model are assumptions related to expected stock price
volatility, option life, risk-free interest rate and dividend
yield. Expected stock price volatility is primarily based on the
historical volatility of our stock price over the most recent period
commensurate with the expected option life. When determining the expected
life of stock options, we classify options into groups for employees where
relatively homogeneous exercise behavior is expected. The vesting period of the
options, the length of time similar grants have remained outstanding in the
past, and the expected volatility of the stock are also considered. These
factors may cause the expected volatility and expected life of options granted
to differ from period to period. The
risk-free interest rate is based on the U.S. Treasury yield curve in effect at
the grant date with a term equal to the expected term of the stock
option. Fair value of restricted shares is based on the fair
value of the underlying common stock at the grant date. The fair value of the
restricted shares granted to non-employees is remeasured each period until they
are vested based on the fair value of the underlying common
stock. Share based compensation costs are recognized as expense over
the requisite service period of each award, which is generally equal to the
vesting period.
16. Research and Development
Costs
Research
and development (R&D) costs are expensed as incurred.
17. Advertising
Advertising
costs are expensed as incurred and totaled approximately $1,365,000, $1,523,000
and $1,589,000 for the years ended December 31, 2009, 2008 and 2007,
respectively.
18. Software
Capitalization
Internally
used software, whether purchased or developed, is capitalized and amortized
using the straight-line method over an estimated useful life of five to seven
years. Capitalized software costs are included in machinery and equipment. We
capitalize certain costs associated with internal-use software, such as the
payroll costs of employees devoting time to the projects and external direct
costs for materials and services. Costs associated with internal-use software
are expensed during the design phase until the point at which the project has
reached the application development stage. Subsequent additions, modifications
or upgrades to internal-use software are capitalized only to the extent that
they allow the software to perform a task it previously did not perform.
Software maintenance and training costs are expensed in the period in which they
are incurred. Capitalized costs related to internally used software, including
payroll costs and external direct costs, totaled approximately $1.4 million for
the year ended December 31, 2009. Such costs were not material in
2008 or 2007.
NOTE
C – ACQUISITION OF NEEDLETECH
We
acquired all of the outstanding common stock of NeedleTech on July 28, 2008. The
total purchase price, including transaction costs, was approximately $44.1
million (net of cash, cash equivalents, and marketable securities acquired with
an estimated fair value of approximately $5.8 million). The purchase price was
paid in cash, including $24.5 million from borrowings under our credit facility.
NeedleTech is a manufacturer of specialty needles and related medical devices.
NeedleTech’s current products include coaxial needles, biopsy needles, access
trocars, brachytherapy needles, guidewire introducer needles, spinal needles,
disposable veress needles, and other needle-based products. End markets served
include the cardiology, orthopedics, pain management, endoscopy, spinal surgery,
urology, and veterinary medicine. This transaction further diversifies our
surgical products business and leverages our existing strengths within these
markets. The acquisition of NeedleTech is designed to forward our stated
strategy of becoming a diversified medical device manufacturer, increase our
breadth of offerings to existing customers, and expand our customer base of
large leading-edge original equipment manufacturers.
We
accounted for the acquisition of NeedleTech under the purchase method of
accounting. Accordingly, the purchase price was allocated based on the fair
values of the assets acquired and liabilities assumed at the date of
acquisition, with the excess of the purchase price over the fair value of the
net assets acquired recorded as goodwill. Results of operations of NeedleTech
were included for the period subsequent to the acquisition date.
F-13
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Pro Forma
Information
The
following unaudited pro forma summary combines our results with those of
NeedleTech as if the acquisition had occurred at the beginning of each of the
periods. This unaudited pro forma information is not intended to represent or be
indicative of our consolidated results of operations that would have been
reported for the period presented had the acquisition been completed at the
beginning of each of the period presented, and should not be taken as indicative
of our future consolidated results of operations (in thousands, except per share
data):
Year
Ended December 31,
|
||||||||
2008
|
2007
|
|||||||
Revenue
|
$ | 77,419 | $ | 79,118 | ||||
Net
earnings (loss)
|
$ | (58,306 | ) | $ | 6,285 | |||
Net
earnings (loss) per share
|
||||||||
Basic
|
$ | (1.76 | ) | $ | 0.19 | |||
Diluted
|
$ | (1.76 | ) | $ | 0.19 | |||
Certain
pro forma adjustments have been made to reflect the impact of the purchase
transaction, primarily consisting of amortization of intangible assets with
determinate lives, reductions in interest income as a result of cash used in the
acquisition, increases in interest expense resulting from borrowings under our
credit facility and income taxes to reflect our effective tax rate for the
period. Pro forma net earnings (loss) include pre-tax charges of
$885,000 in each of the periods presented for amortization of the fair market
value adjustments for inventory and backlog.
NOTE
D – PROPERTY AND EQUIPMENT
Property
and equipment is summarized as follows (in thousands):
December
31,
|
||||||||
2009
|
2008
|
|||||||
Buildings
and improvements
|
$ | 22,955 | $ | 22,930 | ||||
Machinery
and equipment
|
43,125 | 41,771 | ||||||
Office
furniture and equipment
|
1,100 | 1,072 | ||||||
67,180 | 65,773 | |||||||
Less
accumulated depreciation
|
40,095 | 36,868 | ||||||
27,085 | 28,905 | |||||||
Land
and improvements
|
1,200 | 822 | ||||||
Construction
in progress
|
3,714 | 308 | ||||||
Property
and equipment, net
|
$ | 31,999 | $ | 30,035 |
Construction
in progress consists primarily of costs capitalized for the development of
enterprise resource planning software for our internal use and the construction
on a new manufacturing facility for our specialty needle
operations. We capitalized $37,000 of interest expense in 2009 during
the construction of our major capital projects. No interest expense
was capitalized in 2008 or 2007.
NOTE E – FINANCIAL
INSTRUMENTS
Interest Rate
Swaps
We are
exposed to certain risks relating to our ongoing business operations. During
2009 we began to manage our interest rate risk using interest rate swaps
associated with outstanding borrowings under our Credit Agreement, as our
interest rates are floating rates based on LIBOR. Our interest rate
swaps are intended to convert a portion of our floating rate debt to a fixed
rate. We do not use interest rate swap agreements for speculative or
trading purposes, and we hold no other derivative financial instruments other
than interest rate swaps. Our interest rate swaps are recorded as
either assets or liabilities at fair value on our consolidated balance
sheet. We enter into interest rate swaps that are designed to hedge
our interest rate risk but are not designated as “hedging instruments”, as
defined under guidance issued by the FASB. Changes in the
fair value of these instruments are recognized as interest expense in our 2009
consolidated statement of operations. The counterparty to our
interest rate swaps is the lender under our Credit
Agreement. Accordingly, we are exposed to counterparty credit risk
from this financial institution. We entered into interest rate swaps based on
the relationship with this financial institution as our lender and on their
credit rating and the rating of their parent company. We continue to monitor our
counterparty credit risk.
F-14
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Balance,
December 31, 2008
|
$
|
—
|
||
New
contracts
|
16,000
|
|||
Matured
contracts
|
(1,667
|
) | ||
Balance,
December 31, 2009
|
$
|
14,333
|
The
location and fair value of our interest rate swaps in our consolidated balance
sheet at December 31, 2009 was as follows (in thousands):
Type
|
Notional
Amount
|
Maturity
|
Balance
Sheet Location
|
Fair
Value Liability
|
||||
Interest
rate swaps
|
$14,333 |
June
2012
|
Other
long-term liabilities
|
$80 |
The
following table includes information about gains and losses recognized on our
derivative financial instruments not designated as hedging instruments in
our consolidated statement of operations for the year ended December
31, 2009 (in thousands):
Interest
rate swaps loss
|
Amount
|
Location
of Loss
Recognized
in
Income
|
|||
Periodic
settlements
|
$
|
112
|
Interest
expense
|
||
Change
in fair value
|
$
|
80
|
Interest
expense
|
We did not have any derivative financial instruments prior
to 2009.
Cash, Cash Equivalents and
Marketable Securities
The
carrying value of our cash and cash equivalents approximates fair value due to
the relatively short period to maturity of the instruments. At December 31,
2008, marketable securities, which consisted primarily of high-credit quality
corporate and municipal obligations, were classified as available-for-sale and
were reported at fair value based upon quoted market prices, with unrealized
gains or losses excluded from earnings and included in other comprehensive
earnings (loss), net of applicable taxes. The cost of marketable securities sold
is determined using the specific identification method. We evaluate individual
securities to determine whether a decline in fair value below the amortized cost
basis is other-than-temporary. We consider, among other factors, the length of
the time and the extent to which the market value has been less than cost, the
financial condition and near-term prospects of the issuer, including any
specific events which may influence the operations of the issuer and our intent
and ability to retain our investment in the issuer for a period of time
sufficient to allow for any anticipated recovery in market value. Declines in
value that are other-than-temporary are charged to earnings.
We had no
available-for-sale securities at December 31, 2009. At December 31,
2008, available-for-sale securities consisted of the following (in
thousands):
Amortized
Cost
|
Gross
Unrealized
Loss
|
Estimated
Fair
Value
|
||||||||||
State
and municipal securities
|
$ | 500 | $ | — | $ | 500 | ||||||
Corporate
and other securities
|
1,007 | — | 1,007 | |||||||||
Total
|
$ | 1,507 | $ | — | $ | 1,507 |
F-15
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Financial Instruments
Measured at Fair Value on a Recurring Basis
We
measure fair value as the exchange price that would be received for an asset or
paid to transfer a liability (an exit price) in the principal or most
advantageous market for the asset or liability in an orderly transaction between
market participants at the measurement date. In accordance with guidance issued
by the FASB, we use a three-level fair value hierarchy to prioritize the inputs
used to measure fair value. The hierarchy maximizes the use of observable inputs
and minimizes the use of unobservable inputs. The three levels of inputs used to
measure fair value are as follows:
● | Level 1 — Quoted prices in active markets for identical assets or liabilities. |
● | Level 2 — Observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data. |
● | Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar techniques that use significant unobservable inputs. |
We had
the following assets (liabilities) measured at fair value on a recurring
basis:
Quoted
Prices
in
Active
Markets
(Level
1)
|
Significant
Other
Observable
Inputs
(Level
2)
|
Significant
Unobservable
Inputs
(Level
3)
|
Total
|
|||||||||||||
December 31,
2009
|
||||||||||||||||
Treasury
money market funds
|
$ | 32,581 | $ | — | $ | — | $ | 32,581 | ||||||||
Interest rate swaps
|
$ | — | $ | (80 | ) | $ | — | $ | (80 | ) | ||||||
December 31,
2008
|
||||||||||||||||
Marketable
securities
|
$ | 1,007 | $ | 500 | $ | — | $ | 1,507 |
Our
interest rate swaps are contracts with our financial institution and are not
contracts that can be traded in a ready market. We estimate the
fair value of our interest rate swaps based on, among other things, discounted
cash flows based upon current market expectations about future amounts, yield
curves, and mid-market pricing. Accordingly, we classify our interest
rate swap agreements as Level 2. Due to the uncertainty inherent in
the valuation process, such estimates of fair value may differ significantly
from the values that would have been used had a ready market for our interest
rate swaps existed.
The
following table provides a reconciliation between the beginning and ending
balances of items measured at fair value on a recurring basis in the table above
that used significant unobservable inputs (Level 3) (in thousands):
Auction
Rate
Securities
|
||||
Balance
at January 1, 2008
|
$
|
—
|
||
Realized
gain (loss) included in earnings
|
—
|
|||
Unrealized
gain (loss) included in other comprehensive income
|
—
|
|||
Transfers
into Level 3
|
8,500
|
|||
Purchases,
sales and settlements, net
|
(8,000
|
)
|
||
Transfers
out of Level 3
|
(500
|
)
|
||
Balance
at December 31, 2008
|
$
|
—
|
At
December 31, 2008, $1.0 million of marketable securities consisted of A+ rated
corporate bond funds and AAA rated asset backed securities. These securities
were valued at fair value based on quoted market prices.
F-16
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
At
December 31, 2007, we held Auction Rate Securities (“ARS”) at a recorded value
of $13.9 million, which equaled the par value of the ARS. ARS totaling $5.4
million were liquidated at par through successful auctions in the first half of
2008. Subsequently, auctions for the remaining $8.5 million of ARS continuously
failed and no market activity was available with which we could value these in
accordance with the accounting guidance issued by FASB. Accordingly,
this $8.5 million of ARS was considered as “Level 3” under GAAP and was valued
by us based on, among other things, security yield, credit rating and the
average life of the assets in the portfolio. In November 2008, $8.0 million of
these ARS were liquidated at par under a buy back program with one of our
investment banks. The remaining $500,000 of ARS was successfully liquidated at
par in January 2009 when the issuer refinanced the obligation. Accordingly, this
$500,000 of ARS was considered as Level 2 at December 31, 2008.
When we
hold marketable securities, we review those investments for impairment based on
both quantitative and qualitative criteria that include the extent to which cost
exceeds market value, the duration of any market decline, our intent and ability
to hold to maturity or expected recovery, and the creditworthiness of the
issuer. We perform research and analysis, and monitor market conditions to
identify potential impairments. In 2008 we realized a loss of $256,000 when a
highly rated bond fund that we were invested in unexpectedly liquidated at less
than full value. In addition, we also recognized a $93,000 other-than-temporary
impairment related to a bond fund at December 31, 2008 based upon the duration
and severity of the impairment as well as an assessment of the potential
recovery period.
Financial Instruments Not
Measured at Fair Value
Our
financial instruments not measured at fair value consist of cash and cash
equivalents, accounts receivable, and accounts payable, the carrying value of
each approximating fair value due to the nature of these accounts. Our financial
instruments not measured at fair value also include borrowings under our Credit
Agreement. We estimate the fair value of outstanding borrowings under
our Credit Agreement based on the current market rates applicable to borrowers
with credit profiles similar to us. We entered into our current
Credit Agreement in May 2009, and we estimate that the carrying value of our
borrowings approximates fair value at December 31, 2009.
Other Fair Value
Measurements
Except
for the impairment analysis discussed in Note F, there were no nonfinancial
assets or nonfinancial liabilities measured at fair value at December 31, 2009
or 2008.
Concentrations
We are
potentially subject to financial instrument concentration of credit risk through
our cash and cash equivalents, marketable securities and trade accounts
receivable. To mitigate these risks, we have policies, which require minimum
credit ratings, and restrict the amount of credit exposure with any one
counterparty for short-term investments and marketable securities. For cash and
cash equivalents, we maintained approximately $45 million with five financial
institutions. We periodically evaluate the credit standing of these financial
institutions. Trade accounts receivable are subject to risks related to the
medical device industry generally, and the wound closure, vascular access,
specialty needle and prostate cancer treatment markets specifically. These
industries are in turn largely dependent upon the health care market generally,
which can be affected by, among other things, innovation and advances in
treatments and procedures, insurance and government reimbursement policies,
preferences of physicians and other health care providers, demographics and
patient requirements, and government regulation. The significant portion of our
trade accounts receivable is with customers based in the United States. We have
certain customers which comprise ten percent or more of our trade accounts
receivable and net revenue. See Note P.
NOTE
F - GOODWILL AND INTANGIBLE ASSETS
Goodwill
and tradenames are assigned to reporting units and are not amortized. We perform
tests for impairment of goodwill and other intangible assets that are not
amortized on an annual basis or more frequently if events or circumstances
indicate it might be impaired. We completed our most recent annual impairment
assessments in the fourth quarter of 2008 after our 2008 annual forecasting and
budgeting process, and determined that all of our goodwill was impaired and a
portion of our tradenames intangible asset was impaired. See Impairment of goodwill and
tradenames below. At December 31, 2009, our consolidated
balance sheet included no goodwill or other intangible assets not subject to
amortization.
F-17
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Changes
in the carrying amount of goodwill are as follows (in thousands):
Surgical
products
|
Brachytherapy
|
Total
|
||||||||||
Balance,
January 1, 2007
|
$ | 36,246 | $ | 2,578 | $ | 38,824 | ||||||
Goodwill
acquired during the year
|
— | — | — | |||||||||
Adjustments
to purchase price allocation
|
(166 | ) | — | (166 | ) | |||||||
Balance,
December 31, 2007
|
36,080 | 2,578 | 38,658 | |||||||||
Goodwill
acquired during the year
|
29,203 | — | 29,203 | |||||||||
Goodwill
impairment charges
|
(65,283 | ) | (2,578 | ) | (67,861 | ) | ||||||
Balance,
December 31, 2008
|
— | $ | — | $ | — | |||||||
Goodwill
acquired during the year
|
— | — | — | |||||||||
Balance,
December 31, 2009
|
$ | — | $ | — | $ | — |
Intangibles
assets include the following (in thousands):
December
31, 2009
|
December
31, 2008
|
||||||||||||||||||||||||||
Gross
Carrying
Amount
|
Accum
Amort
|
Net
Book
Value
|
Gross
Carrying
Amount
|
Accum
Amort
|
Net
Book
Value
|
Weighted
Average
Life
|
|||||||||||||||||||||
Customer
relationships
|
$ | 16,268 | $ | 5,690 | $ | 10,578 | $ | 16,268 | $ | 3,526 | $ | 12,742 |
8
years
|
||||||||||||||
Tradenames
|
3,240 | 324 | 2,916 | 3,240 | — | 3,240 |
10
years
|
||||||||||||||||||||
Non-compete
agreements
|
3,543 | 2,583 | 960 | 3,843 | 2,046 | 1,797 |
5
years
|
||||||||||||||||||||
Developed
technology
|
1,260 | 460 | 800 | 1,260 | 344 | 916 |
12
years
|
||||||||||||||||||||
Loan
fees and other
|
260 | 50 | 210 | 553 | 528 | 25 |
5
years
|
||||||||||||||||||||
$ | 24,571 | $ | 9,107 | $ | 15,464 | $ | 25,164 | $ | 6,444 | $ | 18,720 |
At
December 31, 2009, the weighted average life of intangible assets subject to
amortization was 8 years. Amortization expense related to purchased intangibles
was $3,441,000, $2,410,000 and $1,875,000 in 2009, 2008 and 2007, respectively,
and is disclosed as such in the accompanying consolidated statements of
operations and comprehensive earnings (loss). Amortization expense related to
other intangibles was $40,000 in 2009 and $5,000 in 2007 and is included in
selling, general and administrative expenses. There was no amortization expense
related to other intangibles for 2008.
As of
December 31, 2009, future approximate aggregate amortization expense for
intangible assets subject to amortization is as follows (in
thousands):
Year
Ending
December
31,
|
||||
2010
|
$
|
3,145
|
||
2011
|
2,861
|
|||
2012
|
2,815
|
|||
2013
|
2,664
|
|||
2014
|
1,672
|
|||
Beyond
|
2,307
|
|||
$
|
15,464
|
F-18
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Impairment of Goodwill and
Tradenames in 2008
Goodwill
and intangible assets with indefinite lives are not amortized to expense and
must be reviewed for impairment annually or more frequently if events or changes
in circumstances indicate that such assets might be impaired. The first step of
the impairment test, used to identify potential impairment, compares the fair
value of a reporting unit with its carrying amount, including goodwill and
intangible assets with indefinite lives. If fair value exceeds book value,
goodwill is considered not impaired, and the second step of the impairment test
is not required. If book value exceeds fair value, the second step of the
impairment test is performed to measure the amount of impairment loss, if any.
For this step the implied fair value of the goodwill is compared with the book
value of the goodwill. If the book value amount of the goodwill exceeds the
implied fair value of the goodwill, an impairment loss would be recognized in an
amount equal to that excess. Any loss recognized cannot exceed the carrying
amount of goodwill. After an impairment loss is recognized, the adjusted
carrying amount of goodwill is its new accounting basis. Subsequent reversal of
a previously recognized impairment loss is prohibited once the measurement of
that loss is completed.
When we
have goodwill or other intangible assets not subject to amortization recorded in
our consolidated balance sheet, we perform impairment testing at the reporting
unit level. A reporting unit is the same as, or one level below, an
operating segment. Our annual impairment testing is typically
performed during the fourth quarter of each year, which coincides with the
timing of our annual budgeting and forecasting process. We also make judgments
about goodwill and other intangible assets not subject to amortization whenever
events or changes in circumstances indicate that impairment in the value of such
asset recorded on our consolidated balance sheet may exist. The timing of an
impairment test may result in charges to our consolidated statements
of operations in future reporting periods that could not have been
reasonably foreseen in prior periods.
In order
to estimate the fair value of goodwill and other intangible assets not subject
to amortization, we typically prepare discounted cash flow analyses (“income
approach”) and comparable company market multiples analyses (“market approach”)
to determine the fair value of our reporting units.
For the
income approach, we project future cash flows for each reporting unit. This
approach requires significant judgments including the projected net cash flows,
the weighted average cost of capital (“WACC”) used to discount the cash flows
and terminal value assumptions. We derive the assumptions related to cash flows
primarily from our internal budgets and forecasts. These budgets and
forecasts include information related to our current and future products,
revenues, capacity, operating costs, and other information. All such
information is derived in the context of our long-term operational
strategies. The WACC and terminal value assumptions are based on the
capital structure, cost of capital, inherent business risk profiles, and
industry outlooks for each of our reporting units, and for our Company on a
consolidated basis.
For the
market approach, we identify reasonably similar public companies for each of our
reporting units, analyze the financial and operating performance of these
similar companies relative to our financial and operating performance, calculate
market multiples primarily based on the ratio of Business Enterprise Value
(“BEV”) to revenue and BEV to earnings before interest, taxes, depreciation and
amortization (“EBITDA”), adjust such multiples for differences between the
similar companies and our reporting units, and apply the resulting multiples to
the fundamentals of our reporting units to arrive at an indication of fair
value.
To assess
the reasonableness of our valuations under each method, we reconcile the
aggregate fair values of our reporting units to our market
capitalization.
The most
recent goodwill and intangible asset impairment assessment was performed in the
fourth quarter of 2008. We determined that all of our goodwill was
impaired and that a portion of our tradenames intangible asset was
impaired. These impairment charges were recorded in the fourth
quarter of 2008. A summary of impairment charges by segment follows
(amounts in thousands):
Goodwill
|
Tradenames
|
Total
|
||||||||||
Surgical
products segment
|
$ | 65,283 | $ | 2,515 | $ | 67,798 | ||||||
Brachytherapy
seed segment
|
2,578 | — | 2,578 | |||||||||
Total
impairment charges in 2008
|
$ | 67,861 | $ | 2,515 | $ | 70,376 | ||||||
F-19
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Our
market capitalization declined significantly in the fourth quarter of 2008,
along with the significant declines in the overall market value of all of the
major stock markets in the United States and around the world. We
considered our market capitalization when we developed the appropriate discount
rates and comparable company market multiples for purposes of estimating the
fair value of our reporting units. The significant decline in our
market capitalization resulted in discount rates that were considerably higher,
and comparable company market multiples that were considerably lower, than the
discount rates and comparable company market multiples we previously considered
appropriate. The most significant assumption leading to our
impairment charges in the fourth quarter of 2008 was the various discount rates
for our reporting units, all of which exceeded 20% at that point in
time. We attempted to identify the underlying reasons for this
circumstance. We considered many factors, including: the conditions
of the companies in our sectors; unusual short selling or other unusual activity
in the trading of our common stock; and whether the overall general economic
outlook and stock market declines could be considered as
“temporary.” We were unable to identify any of these factors as
directly affecting the decline in our market capitalization. The
long-term expectations for our reporting units did not materially change during
the period. We concluded that the significant increase in our
discount rates and decrease in our comparable company market multiples was a
result of the increased risk associated with the distressed equity and credit
markets generally, especially as these factors relate to a small company such as
ours. In addition, we believe the increasing prevalence of
shareholders and investors trading securities outside of traditional stock
exchanges contributes to share price volatility, especially over the short
term. Finally, the scarcity of capital, especially for smaller
companies such as ours, affects the risks associated with investments in its
common stock and its share price.
In
connection with our goodwill and tradenames impairment testing in the fourth
quarter of 2008, we also assessed the estimated useful lives of our
tradenames. At December 31, 2008, we determined that current facts
and circumstances no longer supported an indefinite life for our tradenames
intangible asset. In considering all of the facts and circumstances
at that time, including the increased risk associated with our businesses as
perceived by investors, the distressed general equity and credit markets,
especially as these factors relate to smaller companies such as ours, and the
significant economic uncertainties caused by the worsening overall economic
conditions, we concluded that an indefinite life for our tradenames intangible
assets was no longer supportable. We also considered changes to our
terminal value assumptions in our estimate of fair value for each reporting
unit, which affected assumptions beyond year 10 in our cash flow
forecasts. Accordingly, we estimated that the remaining useful life
of the recorded amount of our tradenames was 10 years, and we began to amortize
tradenames over 10 years beginning in 2009. Prior to December 31, 2008, we
estimated that our tradenames intangible assets had indeterminate lives and,
accordingly, were not subject to amortization. Amortization expense related to
our tradenames was $324,000 in 2009. Periods prior to this change
were not restated or retrospectively adjusted.
We also
review long-lived assets, including our intangible assets subject to
amortization, for impairment whenever events or changes in circumstances
indicate that the carrying amount of such assets may not be recoverable. We
group these assets at the lowest level that we could reasonably estimate the
identifiable cash flows. Recoverability of assets to be held and used is
measured by a comparison of the carrying amount of long-lived assets to the
future undiscounted net cash flows expected to be generated by these assets. If
the carrying amounts exceed the future undiscounted cash flows, then the
impairment recognized is the amount by which the carrying amount of the assets
exceeds their fair value. As a result of the impairment indicators related to
goodwill and tradenames, we tested our long-lived assets for impairment at
December 31, 2008 and determined that there was no impairment.
NOTE
G –ASSET HELD FOR SALE AND CONTRACT TERMINATION LIABILITY
We
completed the sale of our Oak Ridge, Tennessee facility in July 2008. At the
time of the sale, this facility was classified as a long-term asset held for
sale, with an associated contract termination liability, representing the
underlying land sublease, classified as a liability. As part of this
transaction, the facility was sold and the underlying land sublease was
terminated. The $142,000 gain realized from the completion of the sale,
including the termination of the sublease, was recognized as a change in the
estimate of the fair value of the asset held for sale in 2008. Previously, in
2007, we recorded a write down to the carrying value of this facility of
$500,000 based upon the length of time the facility had been for sale, the
commercial real estate market in the Oak Ridge area specifically and, more
broadly, in the United States, and other economic factors in the United
States.
F-20
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
NOTE H - ASSET RETIREMENT OBLIGATIONS
We
provide for retirement obligations relating to future decommissioning costs
associated with certain of our equipment and buildings. The liability is
recorded at present value by discounting our estimated future cash flows
associated with future decommissioning activities using our estimated
credit-adjusted borrowing rate. The asset retirement obligation has been
recorded in the accompanying consolidated balance sheets and will be adjusted to
fair value over the estimated useful lives of the assets as an accretion
expense. Changes in estimated future cash flows are adjusted in the
period of change.
The
following summarizes activity in our asset retirement obligation liability (in
thousands):
Year
ended
|
||||||||
2009
|
2008
|
|||||||
Asset
retirement obligation at beginning of period
|
$ | 646 | $ | 602 | ||||
Accretion
expense
|
50 | 44 | ||||||
Revision
in estimated cash flows
|
— | — | ||||||
Asset
retirement obligation at end of period
|
$ | 696 | $ | 646 |
NOTE
I - CREDIT FACILITY
In May
2009, we executed an Amended and Restated Credit Agreement (the “Credit
Agreement”) with a financial institution. The Credit Agreement
provides for up to $30 million of borrowings under a revolving credit facility
(the “Revolver”) and a $10 million term loan (the “Term Loan”). The
Revolver matures on October 31, 2012 with interest payable at the London
Interbank Offered Rate (“LIBOR”) plus 2.25%. Maximum borrowings under
the Revolver can be increased to $40 million with the prior approval of the
financial institution under an accordion feature. The Revolver also
provides for a $5 million sub-limit for trade and stand-by letters of
credit. Letters of credit totaling
$946,000, representing decommission funding required by the Georgia Department
of Natural Resources, were outstanding under the Credit Agreement as of December
31, 2009. The Term Loan is payable in thirty-six equal monthly
installments of principal plus interest at LIBOR plus 1.75%, commencing
July 1, 2009. The Credit Agreement is unsecured, but provides
for a lien to be established on substantially all of our assets upon certain
events of default. The Credit Agreement contains representations and
warranties, as well as affirmative, reporting and negative covenants customary
for financings of this type. Among other things, the Credit Agreement
restricts the incurrence of certain additional debt and certain capital
expenditures, and requires the maintenance of certain financial ratios,
including a minimum fixed charge coverage ratio, a maximum liabilities to
tangible net worth ratio, and the maintenance of minimum liquid assets of $10
million, as all such ratios and terms are defined in the Credit
Agreement. We were in compliance with all covenants at December 31,
2009. This Credit Agreement amended and restated our prior credit
agreement, which was scheduled to mature on October 31, 2009 and provided
for a $40 million revolving loan and letter of credit commitment.
Future
maturities under our Credit Agreement as of December 31, 2009 are as
follows:
2010
|
2011
|
2012
|
Total
|
|||||||||||||
Term
loan
|
$ | 3,333 | $ | 3,333 | $ | 1,667 | $ | 8,333 | ||||||||
Revolver
|
— | — | 22,000 | 22,000 | ||||||||||||
Total
|
$ | 3,333 | $ | 3,333 | $ | 23,667 | $ | 30,333 |
In May
2009 we also entered into certain interest rate swap agreements to manage our
variable interest rate exposure. We entered into a floating to fixed
rate swap with respect to the outstanding principal amount of the Term Loan, at
a fixed interest rate of 3.27%, and a separate floating to fixed rate swap with
respect to $6 million of the principal amount outstanding under the Revolver, at
a fixed interest rate of 4.26%. Both interest rate swaps expire on
June 1, 2012. Our weighted average effective interest rate at
December 31, 2009 was 3.1%.
F-21
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
NOTE
J - INCOME TAXES
The
income tax provision (benefit) consisted of the following (in
thousands):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Current
|
||||||||||||
Federal
|
$ | 1,276 | $ | (56 | ) | $ | 1,743 | |||||
State
|
140 | 63 | 169 | |||||||||
1,416 | 7 | 1,912 | ||||||||||
Deferred
|
||||||||||||
Federal
|
340 | (4,172 | ) | 1,392 | ||||||||
State
|
152 | (394 | ) | (41 | ) | |||||||
Change
in allowance
|
(71 | ) | 31 | (51 | ) | |||||||
421 | (4,535 | ) | 1,300 | |||||||||
Income
tax expense (benefit)
|
$ | 1,837 | $ | (4,528 | ) | $ | 3,212 |
Our
temporary differences are summarized as follows (in thousands):
December
31,
|
||||||||
2009
|
2008
|
|||||||
Deferred
tax assets:
|
||||||||
Goodwill
and intangible assets
|
$ | 729 | $ | 56 | ||||
Inventories
|
499 | 970 | ||||||
Non-deductible
accruals and allowances
|
478 | 423 | ||||||
Net
operating loss carryforwards
|
258 | 922 | ||||||
Asset
retirement obligation
|
257 | 225 | ||||||
Share
based compensation
|
169 | 222 | ||||||
Deferred
revenue
|
99 | 120 | ||||||
Capital
loss and tax credit carryforwards
|
167 | 96 | ||||||
Other
|
41 | 46 | ||||||
Gross
deferred tax assets
|
2,697 | 3,080 | ||||||
Deferred
tax liabilities:
|
||||||||
Property
and equipment
|
(2,818 | ) | (2,709 | ) | ||||
Gross
deferred tax liabilities
|
(2,818 | ) | (2,709 | ) | ||||
Valuation
allowance
|
(148 | ) | (219 | ) | ||||
Net
deferred tax asset (liability)
|
$ | (269 | ) | $ | 152 |
The net
deferred tax asset is classified in our accompanying consolidated balance sheets
as follows (in thousands):
December 31, | ||||||||
2009 | 2008 | |||||||
Current
deferred tax asset
|
$ | 1,096 | $ | 2,158 | ||||
Long-term
deferred tax liability
|
(1,365 | ) | (2,006 | ) | ||||
Net
deferred tax asset (liability)
|
$ | (269 | ) | $ | 152 |
F-22
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Activity
in the valuation allowance for deferred tax assets is as follows (amounts in
thousands):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Valuation
allowance, beginning of period
|
$ | 219 | 188 | $ | 239 | |||||||
Increase
in allowance
|
— | 31 | — | |||||||||
Release
of allowance
|
(71 | ) | — | (51 | ) | |||||||
Valuation
allowance, end of period
|
$ | 148 | 219 | $ | 188 |
We
periodically evaluate the recoverability of the deferred tax assets and
recognize the tax benefit only if reassessment demonstrates that they are
realizable. At such time, if it is determined that it is more likely than not
that the deferred tax assets are realizable, the valuation allowance is
adjusted. The remaining allowance at December 31, 2009 relates primarily to
certain capital loss carryforwards for which we believe it is more likely than
not that the benefit will not be realized.
A
reconciliation of the statutory federal income tax rate and our effective tax
rate follows:
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Tax
expense (benefit) at applicable federal rates
|
34.0 | % | (34.0 | )% | 34.0 | % | ||||||
State
tax, net of federal income tax
|
2.9 | (0.1 | ) | 1.1 | ||||||||
Non-deductible
stock compensation
|
3.0 | 0.1 | 0.9 | |||||||||
Non-deductible
lobbying expenses
|
1.7 | 0.1 | 0.4 | |||||||||
Deferred
tax rate adjustment
|
0.4 | 0.5 | 0.6 | |||||||||
Non-deductible
impairment loss
|
— | 26.7 | — | |||||||||
Deferred
tax asset valuation allowance
|
(1.4 | ) | 0.1 | (0.5 | ) | |||||||
Domestic
production deduction
|
(1.8 | ) | — | (1.5 | ) | |||||||
Tax
credits
|
(2.2 | ) | — | — | ||||||||
Other
|
0.8 | (0.6 | ) | 1.3 | ||||||||
Effective
tax expense (benefit)
|
37.4 | % | (7.2 | )% | 36.3 | % |
We have
various state net operating loss carryforwards that expire in various years
through 2028. During 2007, the IRS completed an examination of our 2004 and 2005
federal income tax returns with no significant adjustments. Upon settlement of
the 2004 audit, during 2007 we received a refund of federal income tax
previously paid of $1.9 million. This refund resulted from the carryback of tax
losses that were reported in our 2004 federal income tax return. We also
received $309,000 of interest income related to this refund, which was
recognized upon settlement of the IRS examination in 2007.
We have
evaluated our tax positions for the tax years ended December 31, 2005,
2006, 2007 and 2008, the tax years that remain subject to examination by major
tax jurisdictions as of December 31, 2009. With few exceptions, we are no longer
subject to U.S. federal, state and local, or income tax examinations by tax
authorities for years prior to 2005. We have concluded that there are no
significant uncertain tax positions requiring recognition in our consolidated
financial statements.
NOTE
K - COMMITMENTS AND CONTINGENCIES
Licensing
Agreements
We hold a
worldwide exclusive license from the University of Missouri for the use of
technology patented by the University, used in our TheraSphere®
product. Royalties to the University of Missouri are no longer due from us under
this licensing agreement. We do reimburse the University for certain
administrative fees associated with the patents related to the
technology.
We have
granted certain of our geographical rights under the licensing agreement with
the University of Missouri to Nordion International, Inc., a Canadian company
that is a producer, marketer and supplier of radioisotope products and related
equipment. Under the Nordion agreement, we are entitled to licensing fees for
each geographic area in which Nordion receives new drug approval. We are also
entitled to a percentage of revenues earned by Nordion as royalties under the
agreement. Royalties from this agreement are recorded as license and fee income
in the accompanying consolidated statements of operations.
F-23
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
In May
2008, we entered into an exclusive license agreement for the rights to certain
intellectual property related to an expandable brachytherapy delivery system
developed by us. The term of the agreement is through the expiration of the last
of the patents licensed under the agreement, which is currently November 2024.
The term may be altered if such patents are found to be invalid. The agreement
provides for a minimal non-refundable initial license fee and non-refundable
continuing royalties based upon sales subject to certain minimums. Royalties
from this agreement are recorded as license and fee income in the accompanying
consolidated statements of operations. Minimum annual royalties are based on the
contract year, which ends each May, and are as follows (in thousands): year
ended May 31, 2010, $250; 2011, $450; 2012, $450; 2013, $1,000; 2014, $1,000;
annually thereafter through November 2024, $1,000.
The
minimum royalties are subject to increase under certain circumstances. The
licensee has the right to terminate the agreement without penalty until May 2012
if the product is found to be technically or commercially impracticable, as
defined in the agreement. After May 2012, the licensee can terminate the
agreement for any reason upon payment of the minimum annual royalties due for
that contract year, plus a termination fee of $1 million. In the event the
licensee terminates the agreement for any reason, the initial license fee and
all royalties previously paid are non-refundable and all rights granted by the
license terminate. The licensee can assign its rights to the agreement upon
payment of an assignment fee.
Lease Commitments and
Obligations
The
Company leases equipment and production, warehouse, office and other space under
non-cancelable leases that expire at various dates through May 2013. Approximate
minimum lease payments under the leases are as follows: 2010, $631,000; 2011,
$440,000; 2012, $417,000; and 2013, $190,000.
We lease
certain production, warehouse and office space from entities controlled by
certain related parties. Our CP Medical facility is owned by an entity
controlled by the former owner and officer of CP Medical. Our NeedleTech
facility is owned by an entity controlled by the former principal owners of
NeedleTech, one of whom is a current executive officer and one of whom is a
former executive officer. Approximate minimum lease payments under these
leases are as follows: 2010, $278,000; 2011, $234,000; 2012, $212,000; and 2013,
$88,000.
Rent
expense was approximately $976,000, $746,000 and $589,000 for the years ended
December 31, 2009, 2008 and 2007, respectively, including rent expense of
approximately $278,000, $237,000 and $185,000 in 2009, 2008 and 2007,
respectively, under the related party leases referred to above.
Building
Commitments
We are
constructing a manufacturing facility for our specialty needle manufacturing
operation, which we expect to be completed during 2010. We have
contracts in place associated with constructing this new facility that result in
a minimum purchase commitment of approximately $5.1 million in
2010.
Litigation and
Claims
From time
to time we may be a party to claims that arise in the ordinary course of
business, none of which, in our view, is expected to have a material adverse
effect on our consolidated financial position or our results of
operations.
F-24
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
NOTE
L - SHARE BASED COMPENSATION AND SHAREHOLDERS’ EQUITY
We
provide share-based compensation under equity incentive plans approved by
stockholders, which provide for the granting of stock options, restricted stock
and other equity incentives. As of December 31, 2009 there were 1,303,032
options and restricted stock shares outstanding and 1,847,855 shares of common
stock remaining available for issuance under our equity incentive plans. We
issue new shares from our authorized but unissued share pool.
Stock
Options
Stock
options granted to date have had an exercise price at least equal to 100% of
market value of the underlying common stock on the date granted. These options
expire ten years from the date of grant and become exercisable over a three to
five-year vesting period.
The
following is a summary of activity in stock options outstanding during the year
ended December 31, 2009 (shares in thousands):
Shares
|
Weighted
average
exercise
price
|
Weighted
average
remaining
contractual
life
(yrs)
|
Aggregate
intrinsic
value
|
|||||||||||||
Outstanding,
beginning of period
|
1,396 | $ | 6.48 | |||||||||||||
Granted
|
334 | 0.94 | ||||||||||||||
Exercised
|
— | — | ||||||||||||||
Forfeited
|
(243 | ) | 4.02 | |||||||||||||
Expired
|
(441 | ) | 8.89 | |||||||||||||
Outstanding,
end of period
|
1,046 | $ | 4.26 | 5.3 | $ | 99 | ||||||||||
Exercisable
at end of period
|
621 | $ | 5.60 | 3.1 | $ | — |
A summary
of grant date fair values and intrinsic values follows (in thousands, except per
share amounts):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Weighted
average grant date fair value of options granted
|
$ | 0.58 | $ | 1.93 | $ | 2.68 | ||||||
Total
intrinsic value of options exercised
|
$ | N/A | $ | N/A | $ | 45 | ||||||
Total
fair value of options vested
|
$ | 195 | $ | 19 | $ | 75 |
The fair
values were estimated using the Black-Scholes options-pricing model with the
following weighted average assumptions:
2009
|
2008
|
2007
|
||||||||||
Expected
dividend yield
|
0.0 | % | 0.0 | % | 0.0 | % | ||||||
Expected
stock price volatility
|
60.7 | % | 50.6 | % | 49.9 | % | ||||||
Risk-free
interest rate
|
2.7 | % | 3.2 | % | 4.8 | % | ||||||
Expected
life of option (years)
|
7.0 | 6.0 | 6.0 | |||||||||
We
recognize compensation expense for awards with graded vesting on a straight-line
basis over the requisite service period for each separately vesting portion of
the award. Compensation cost related to stock options totaled $184,000, $275,000
and $228,000 for the year ended December 31, 2009, 2008 and 2007 respectively.
As of December 31, 2009, there was approximately $174,000 of unrecognized
compensation cost related to non-vested stock options, which is expected to be
recognized over a weighted average period of approximately 1.7
years.
F-25
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
We may
issue restricted stock to employees, directors and others. Restrictions limit
the sale or transfer of the shares until vested. Vesting of restricted stock is
time-based over a three to four-year period. A summary of activity in non-vested
restricted stock awards for the year ended December 31, 2009 follows (shares in
thousands):
Non-vested
Restricted Stock
|
Shares
|
Weighted
average
grant
date
fair
value
|
||||||
Non-vested
at January 1, 2009
|
231 | $ | 3.70 | |||||
Granted
|
166 | 0.94 | ||||||
Vested
|
(84 | ) | 3.60 | |||||
Forfeited
|
(56 | ) | 1.93 | |||||
Non-vested
at December 31, 2009
|
257 | $ | 2.35 |
Fair
value of restricted shares granted to employees and directors is based on the
fair value of the underlying common stock at the grant date. The fair value of
the restricted shares granted to non-employees is remeasured each period until
they are vested based on the fair value of the underlying common stock.
Compensation cost related to the restricted shares is based on the grant date
fair value of the common stock granted and is recorded over the requisite
service period of three to four years. The weighted average per share grant date
fair value of restricted shares issued was $0.94, $3.70 and $4.89 in 2009, 2008
and 2007, respectively. Compensation expense related to the restricted stock
totaled approximately $262,000, $393,000 and $363,000 in 2009, 2008 and 2007,
respectively. As of December 31, 2009, there was approximately $192,000 of
unrecognized compensation cost related to the restricted shares, which is
expected to be recognized over a weighted average period of 1.6
years.
Performance Restricted Stock
Units
In
February 2006, 104,000 performance restricted stock units were issued to
executive officers, which vested on December 31, 2008 (the “2006 Performance
Restricted Stock Units”). The number of shares issuable was determined partly
based on our revenue and earnings per share from 2006 to 2008, relative to our
strategic objectives over the same period, and partly based on the subjective
discretion of the Compensation Committee. All of the 2006 Restricted Stock Units
were vested on December 31, 2008 and resulted in the issuance of approximately
64,000 shares. The grant date fair value of the 2006 Performance Restricted
Stock Units was based on the fair value of the underlying common stock and was
recognized over the three-year requisite service period. For the portion of the
2006 Performance Restricted Stock Units containing performance conditions, the
grant date fair value was adjusted each period for the number of shares
ultimately expected to be issued. For the portion of the 2006 Performance
Restricted Stock Units subject to discretionary performance conditions, the fair
value of the award was determined based on the fair value of the underlying
common stock at December 31, 2008.
In 2008,
we recorded a benefit of $39,000 related to the Performance Restricted Stock
Units. Compensation cost related to Performance Restricted Stock Units totaled
$126,000 in 2007. No Performance Restricted Stock Units were
outstanding at December 31, 2009.
Employee Stock Purchase
Plan
The
Theragenics Corporation Employee Stock Purchase Plan (the “ESPP”) allows
eligible employees the right to purchase common stock on a quarterly basis at
the lower of 85% of the market price at the beginning or end of each quarterly
offering period. Compensation cost related to the ESPP totaled approximately
$4,000, $5,000 and $6,000 in 2009, 2008 and 2007,
respectively. 200,000 shares had been issued under the plan as of
December 31, 2009, and no shares remained available for issuance under the
ESPP.
Shareholder Rights
Plan
We have a
Shareholder Rights Plan (the “Rights Plan”), which contains provisions designed
to protect our shareholders in the event of an unsolicited takeover attempt. It
is not intended to prevent a takeover on terms that are favorable and fair to
all shareholders and will not interfere with a merger approved by the Board of
Directors. Pursuant to the Rights Plan each share of our Common Stock contains a
share purchase right (a “Right”), which expires in February 2017 and does not
become exercisable unless a group acquires or announces a tender or exchange
offer for 20% or more of our outstanding Common Stock. Upon a triggering event,
each Right that is not held by the 20% or more shareholders will entitle its
holder to purchase additional shares of Common Stock at a substantial discount
to then current market prices.
F-26
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
NOTE
M – 401(K) SAVINGS PLANS
We
sponsor 401(k) defined contribution retirement savings plans for our employees.
Matching contributions are made in Company stock or in cash, depending on the
plan. Matching contributions are charged to operating expenses and totaled
approximately $325,000, $221,000 and $313,000 in 2009, 2008 and 2007,
respectively.
NOTE
N – EARNINGS (LOSS) PER SHARE
Earnings
(loss) per common share was computed as follows (in thousands, except per share
data):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Net
earnings (loss)
|
$ | 3,075 | (58,540 | ) | $ | 5,635 | ||||||
Weighted
average common shares outstanding
|
33,145 | 33,066 | 33,103 | |||||||||
Incremental
common shares issuable from stock options and awards
|
124 | — | 196 | |||||||||
Weighted
average common shares outstanding assuming dilution
|
33,269 | 33,066 | 33,299 | |||||||||
Basic
earnings (loss) per share
|
$ | 0.09 | (1.77 | ) | $ | 0.17 | ||||||
Diluted
earnings (loss) per share
|
$ | 0.09 | (1.77 | ) | $ | 0.17 |
Diluted
earnings (loss) per share does not include the effect of certain stock options
and awards as their impact would be anti-dilutive. Approximately 864,000,
1,396,000 and 1,236,000 stock options and awards for the years ended
December 31, 2009, 2008 and 2007, respectively, were not included in the
computation of diluted earnings (loss) per share for those years because their
effect would be anti-dilutive.
NOTE
O - SEGMENT REPORTING
We are a
medical device company serving the surgical product and cancer treatment
markets, operating in two business segments. Our surgical products
segment consists of wound closure, vascular access, and specialty needle
products. Our brachytherapy seed business produces, markets and sells
TheraSeed®, our
premier palladium-103 prostate cancer treatment device, I-Seed, our iodine-125
based prostate cancer treatment device, and related products and
services.
In 2009
we changed the manner in which we allocate the cost of corporate activities to
our business segments. Operating expenses associated with corporate
activities are now allocated based on the relative revenue of each business
segment. With the acquisition of NeedleTech in July 2008, the
continued integration of acquired companies, the launch of our R&D program
for our surgical products segment, and the program to standardize our
information technology systems across all of our businesses, among other things,
we believe this method more accurately reflects the utilization of our corporate
resources. This is also the method we now utilize internally to
review results and allocate resources. Previously, we charged the
significant portion of expenses associated with corporate activities to the
brachytherapy segment. We have restated our segment results for the
2008 and 2007 periods to reflect this change in the method of allocating
corporate expenses. This change had no effect on our consolidated
results of operations previously reported for the 2008 and 2007
periods.
F-27
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
The
following tables provide certain information for these segments (in
thousands):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Revenue
|
||||||||||||
Surgical
products
|
$ | 53,660 | 38,779 | $ | 28,896 | |||||||
Brachytherapy
seed
|
24,966 | 28,787 | 33,520 | |||||||||
Intersegment
eliminations
|
(300 | ) | (208 | ) | (206 | ) | ||||||
$ | 78,326 | 67,358 | $ | 62,210 | ||||||||
Earnings
(loss) from operations
|
||||||||||||
Surgical
products
|
$ | 1,664 | (66,595 | ) | $ | 1,420 | ||||||
Brachytherapy
seed
|
4,081 | 3,233 | 5,960 | |||||||||
Intersegment
eliminations
|
4 | 17 | (35 | ) | ||||||||
$ | 5,749 | (63,345 | ) | $ | 7,345 | |||||||
Write
(up)/down of asset held for sale
|
||||||||||||
Surgical
products
|
$ | — | — | $ | — | |||||||
Brachytherapy
seed
|
— | (142 | ) | 500 | ||||||||
$ | — | (142 | ) | $ | 500 | |||||||
Impairment
charges of goodwill
|
||||||||||||
and
tradenames
|
||||||||||||
Surgical
products
|
$ | — | 67,798 | $ | — | |||||||
Brachytherapy
seed
|
— | 2,578 | — | |||||||||
$ | — | 70,376 | $ | — | ||||||||
Capital
expenditures,
|
||||||||||||
excluding
acquisition of businesses
|
||||||||||||
Surgical
products
|
$ | 3,345 | 1,153 | $ | 1,105 | |||||||
Brachytherapy
seed
|
1,635 | 378 | 345 | |||||||||
$ | 4,980 | 1,531 | $ | 1,450 | ||||||||
Depreciation
and amortization
|
||||||||||||
Surgical
products
|
$ | 4,851 | 3,519 | $ | 2,414 | |||||||
Brachytherapy
seed
|
2,076 | 2,107 | 3,732 | |||||||||
$ | 6,927 | 5,626 | $ | 6,146 |
We
evaluate business segment performance based on segment revenue and segment
earnings from operations. Earnings from operations by segment do not include
interest expense, interest income, other income and expense, or provisions for
income taxes. Intersegment eliminations are primarily for surgical products
segment sales transactions.
Segment
information related to significant assets follows (in thousands):
December
31,
|
||||||||
2009
|
2008
|
|||||||
Identifiable
assets
|
||||||||
Surgical
products
|
$ | 62,902 | $ | 62,738 | ||||
Brachytherapy
seed
|
53,273 | 51,731 | ||||||
Corporate
investment in subsidiaries
|
111,439 | 111,439 | ||||||
Intersegment
eliminations
|
(111,506 | ) | (111,489 | ) | ||||
$ | 116,108 | $ | 114,419 | |||||
Other
intangible assets
|
||||||||
Surgical
products
|
$ | 15,277 | $ | 18,719 | ||||
Brachytherapy
seed
|
187 | 1 | ||||||
$ | 15,464 | $ | 18,720 |
F-28
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
Information
regarding revenue by geographic regions follows (in thousands):
Year
ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Product
sales
|
||||||||||||
United
States
|
$ | 69,330 | $ | 60,406 | $ | 57,643 | ||||||
Europe
|
6,140 | 5,147 | 2,978 | |||||||||
Other
foreign countries
|
1,681 | 894 | 665 | |||||||||
77,151 | 66,447 | 61,286 | ||||||||||
License
and fee income
|
||||||||||||
United
States
|
507 | 162 | — | |||||||||
Canada
|
668 | 749 | 924 | |||||||||
1,175 | 911 | 924 | ||||||||||
$ | 78,326 | $ | 67,358 | $ | 62,210 |
Foreign
sales are attributed to countries based on location of the customer. The license
fees attributed to Canada are with Nordion, a Canadian based company, for the
license of our TheraSphere®
product. Almost all other foreign sales are related to the surgical products
segment. All of our long-lived assets are located within the United
States.
NOTE P - DISTRIBUTION AGREEMENT AND
MAJOR CUSTOMERS
Distribution
Agreement
Our
brachytherapy business sells our TheraSeed®
device directly to health care providers and to third party distributors. Our
primary non-exclusive distribution agreement is with C. R. Bard (“Bard”) (the
“Bard Agreement”). The terms of the Bard Agreement provide for automatic
one-year extensions of the term, unless either party gives notice of its intent
not to renew at least twelve months prior to the end of the current term. The
current term expires December 31, 2011 and will be automatically extended for
one additional year unless either party gives notice of its intent not to extend
by December 31, 2010. The Bard Agreement gives Bard the non-exclusive right to
distribute the TheraSeed®
device in the U.S., Canada, and other international locations for the treatment
of prostate cancer and other solid localized cancerous tumors.
Major
Customers
Sales to
Bard under the Bard agreement represented approximately 46%, 51% and 53% of
brachytherapy product revenue in 2009, 2008 and 2007,
respectively. Our surgical products segment also sells to
Bard. Total consolidated sales to Bard, including sales in our
brachytherapy seed segment and our surgical products segment, represented
approximately 16%, 22% and 29% of consolidated product revenue in 2009, 2008 and
2007, respectively.
Accounts
receivable from Bard represented approximately 11% and 48% of brachytherapy
accounts receivable and 3% and 21% of consolidated accounts receivable at
December 31, 2009 and 2008, respectively.
One
customer represented approximately 13% of surgical products accounts receivable
and 10% of consolidated accounts receivable at December 31, 2009.
NOTE Q – NON-OPERATING
INCOME/(EXPENSE)
Other
non-operating income/(expense) consists of the following (in
thousands):
Year
Ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Loss
on marketable securities, including impairment
|
$ | (2 | ) | (347 | ) | $ | — | |||||
Gain
on sale of scrap metal
|
— | 457 | — | |||||||||
Other
|
5 | (57 | ) | 1 | ||||||||
Total
other
|
$ | 3 | 53 | $ | 1 |
F-29
Theragenics
Corporation and Subsidiaries
NOTES TO
CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
NOTE R - RELATED PARTY TRANSACTIONS
CP
Medical leases production, warehouse and office space from an entity owned by
the former owner and officer of CP Medical. NeedleTech leases production and
warehouse space from an entity owned by the former principal owners of
NeedleTech, one of whom is currently an officer. See Note K.
During
2009 and 2008 we utilized the services of a real estate firm whose principal
owner is related to one of our executive officers. Payments of $99,000 and
$41,000 were made to this firm during 2009 and 2008 for real estate consulting
services.
NOTE S - QUARTERLY FINANCIAL DATA
(UNAUDITED)
The
following summarizes certain quarterly results of operations (in thousands,
except per share data):
Year
ended December 31, 2009:
|
Quarter ended | |||||||||||||||
April
5
|
July
5
|
October
4
|
December
31
|
|||||||||||||
Net
revenue
|
$ | 20,077 | $ | 20,219 | $ | 19,344 | $ | 18,686 | ||||||||
Gross
profit
|
8,707 | 9,137 | 8,561 | 6,968 | ||||||||||||
Net
earnings
|
607 | 1,271 | 799 | 398 | ||||||||||||
Net
earnings per common share
|
||||||||||||||||
Basic
|
$ | 0.02 | $ | 0.04 | $ | 0.02 | $ | 0.01 | ||||||||
Diluted
|
$ | 0.02 | $ | 0.04 | $ | 0.02 | $ | 0.01 | ||||||||
Year
ended December 31, 2008:
|
Quarter ended | |||||||||||||||
March
30
|
June
29
|
September
28
|
December
31
|
|||||||||||||
Net
revenue
|
$ | 15,235 | $ | 15,914 | $ | 18,106 | $ | 18,103 | ||||||||
Gross
profit
|
7,657 | 8,250 | 7,814 | 7,373 | ||||||||||||
Impairment
of goodwill and tradenames
|
— | — | — | 70,376 | ||||||||||||
Write-up
of estimated value of asset held for sale
|
— | (142 | ) | — | — | |||||||||||
Net
earnings (loss)
|
1,636 | 1,638 | 641 | (62,455 | ) | |||||||||||
Net
earnings (loss) per common share
|
||||||||||||||||
Basic
|
$ | 0.05 | $ | 0.05 | $ | 0.02 | $ | (1.89 | ) | |||||||
Diluted
|
$ | 0.05 | $ | 0.05 | $ | 0.02 | $ | (1.89 | ) |
F-30
Report of Independent
Registered Public Accounting Firm on Schedule
To the
Board of Directors and
Shareholders
of Theragenics Corporation
We have
audited in accordance with the standards of the Public Company Accounting
Oversight Board (United States) the consolidated financial statements of
Theragenics Corporation and subsidiaries for each of the three years in the
period ended December 31, 2009, as referred to in our report dated March 15,
2010, which is included in the annual report to security holders and included in
Part II of this form. Our audits were conducted for the purpose of forming an
opinion on the basic consolidated financial statements taken as a whole.
Schedule II is presented for purposes of additional analysis and is not a
required part of the basic consolidated financial statements. The information in
Schedule II has been subjected to the auditing procedures applied in the audit
of the basic consolidated financial statements and, in our opinion,
the information is fairly stated in all material respects in relation to
the basic consolidated financial statements taken as a whole.
/s/ DIXON
HUGHES PLLC
Atlanta,
Georgia
March 15,
2010
S-1
Theragenics
Corporation and Subsidiaries
SCHEDULE
II - VALUATION AND QUALIFYING ACCOUNTS
For each
of the three years in the period ended December 31, 2009
(Amounts
in thousands)
Column
A - Description
|
Column
B
|
Column
C - Additions
|
Column
D
|
Column
E
|
||||||||||||||||
Balance
at
beginning
of
period
|
(1)
Charged
to
costs
and
expenses
|
(2)
Charged
to
other
accounts
|
Deductions
|
Balance
at
end of
period
|
||||||||||||||||
Year
ended December 31, 2009
|
||||||||||||||||||||
5 | (a) | |||||||||||||||||||
Allowance
for doubtful accounts receivable
|
$ | 481 | $ | — | $ | — | $ | 92 | (b) | $ | 384 | |||||||||
Allowance
for obsolete inventory
|
$ | 747 | $ | 251 | $ | — | $ | 328 | (c) | $ | 670 | |||||||||
Year
ended December 31, 2008
|
||||||||||||||||||||
Allowance
for doubtful accounts receivable
|
$ | 372 | $ | 162 | $ | 18 | (d) | $ | 71 | (b) | $ | 481 | ||||||||
Allowance
for obsolete inventory
|
$ | 645 | $ | 28 | $ | 90 | (d) | $ | 16 | (c) | $ | 747 | ||||||||
Year
ended December 31, 2007
|
202 | (a) | ||||||||||||||||||
Allowance
for doubtful accounts receivable
|
$ | 617 | $ | — | $ | — | $ | 43 | (b) | $ | 372 | |||||||||
Allowance
for obsolete inventory
|
$ | 469 | $ | 282 | $ | — | $ | 106 | (c) | $ | 645 |
(a) -
reduction in allowance for doubtful accounts
receivable amounts
(b) -
write-off of uncollectible amounts
(c) -
disposal of inventory
(d) -
acquisition of NeedleTech
S-2