10-K 1 t72589_10k.htm FORM 10-K t72589_10k.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, 2011
 
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
 
58-1528626
(State of incorporation)
 
(I.R.S. Employer Identification Number)
     
5203 Bristol Industrial Way
   
Buford, Georgia
 
30518
(Address of principal executive offices)
 
(Zip Code)
 
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
 
 
Title of each class
   
which registered
 
           
 
Common stock, $.01 par value,
   
New York Stock Exchange
 
 
Together with associated
       
 
Common Stock Purchase Rights
       
 
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 x 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 June 30, 2011, the last business day of the registrant’s most recently completed second fiscal quarter, was $57,252,205.
 
As of February 29, 2012 the number of shares of Common Stock, $.01 par value, outstanding was 34,641,590.
 
Documents incorporated by reference: Proxy Statement for the registrant’s 2011 Annual Meeting of Stockholders, to be filed with the Securities and Exchange Commission not later than 120 days after December 31, 2011 is incorporated by reference in Part III herein.
 


 
 

 

 
THERAGENICS CORPORATION® AND SUBSIDIARIES
 
TABLE OF CONTENTS
 
       
Page
   
PART I
   
Item 1.
 
Business
 
I-1
Item 1A.
 
Risk Factors
 
I-12
Item 1B.
 
Unresolved Staff Comments
 
I-21
Item 2.
 
Properties
 
I-21
Item 3.
 
Legal Proceedings
 
I-21
Item 4.
 
Mine Safety Disclosures
 
I-21
         
   
PART II
   
Item 5.
 
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
 
II-1
Item 6.
 
Selected Financial Data
 
II-2
Item 7.
 
Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
II-3
Item 7A.
 
Quantitative and Qualitative Disclosures About Market Risk
 
II-16
Item 8.
 
Financial Statements and Supplementary Data
 
II-17
Item 9.
 
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
 
II-17
Item 9A.
 
Controls and Procedures
 
II-17
Item 9B.
 
Other Information
 
II-18
         
   
PART III
   
Item 10.
 
Directors, Executive Officers and Corporate Governance
 
III-1
Item 11.
 
Executive Compensation
 
III-1
Item 12.
 
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
 
III-1
Item 13.
 
Certain Relationships and Related Transactions, Director Independence
 
III-1
Item 14.
 
Principal Accounting Fees and Services
 
III-1
         
   
PART IV
   
Item 15.
 
Exhibits and Financial Statement Schedules
 
IV-1
         
   
Signatures
 
IV-5

 
 

 

Part I
 
Item 1. BUSINESS
 
Overview and Business Strategy
 
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 manufactures, markets and sells disposable devices primarily utilized in certain surgical procedures.  Our brachytherapy seed business manufactures, markets and sells radioactive “seeds” primarily utilized in the treatment of early stage prostate cancer.  At the present time, both of our segments do business primarily in the United States.  Our surgical products business is the faster growing of our businesses and has been supported by the cash flows generated by our market leading brachytherapy seed business and our flagship TheraSeed® brand.  In our surgical products business we plan to grow and diversify revenues by adding product offerings and manufacturing capabilities, expanding the applications and markets in which we compete, and gaining scale to improve profitability.
 
Our surgical products business was built through the acquisitions of CP Medical Corp. in May 2005, Galt Medical Corporation in August 2006, and NeedleTech Products, Inc. in July 2008.  We currently manufacture almost 3,500 products in this business as part of three broad product platforms; wound closure, vascular access and specialty needles.  To date we have maintained the names and brands under which each of these companies previously manufactured, marketed and sold their products.  We serve a number of markets and applications, including, among other areas, interventional cardiology, interventional radiology, vascular surgery, orthopedics, plastic surgery, dental surgery, urology, veterinary medicine (sutures), pain management, endoscopy, and spinal surgery. With the exception of veterinary sutures, our surgical products hold relatively small market shares.  Our products include both finished goods and components.  Our products are sold primarily to original equipment manufacturers (“OEMs”) and to a network of distributors.  On a pro forma basis, our surgical products business has achieved a compound annual revenue growth rate of 8.3% from 2006 through 2011 (pro forma, assuming all acquisitions had been made at the beginning of 2006).  We have accomplished this primarily by increasing sales to existing customers and, to a lesser extent, adding new customers.  Further, we achieved this revenue growth during a period which included severe economic difficulties.  Our strategy for increasing sales and scale going forward includes: becoming more integral within the supply chain of our customers both for existing products and for our customers’ development programs (which may allow us to increase sales to existing and new customers from all product platforms); developing new products internally; acquiring products, licenses, and other intellectual property; acquiring businesses and; entering certain markets outside the United States.
 
We have operated our brachytherapy seed business since 1987, emerging from the development stage in 1990.  Historically our brachytherapy seed segment has generated strong cash flows, which have enabled us to diversify our business substantially.  Positive cash flows from our brachytherapy seed business continue despite an industry-wide decline in brachytherapy procedures in the United States which began about six years ago.  The overall brachytherapy industry in the United States is now experiencing difficulties primarily due to competition from other treatments.  Many of these competing treatments enjoy favorable Medicare reimbursement rates relative to brachytherapy reimbursement rates.  We believe this results in a non-level playing field for brachytherapy device manufacturers, providers, and patients.  One of the primary competitive treatments provided by our radiation oncologist customers is Intensity Modulated Radiation Therapy, or “IMRT”.  IMRT enjoys substantially higher reimbursement rates than brachytherapy, yet clinical studies do not indicate that IMRT delivers improved outcomes.   We believe the market positioning and heavy promotion of robotic surgery for prostate cancer treatment has also adversely affected the number of brachytherapy procedures performed.  Despite these industry-wide difficulties we have maintained positive cash flows in our brachytherapy business for a variety of reasons including, among other things, the relatively fixed nature of our brachytherapy seed manufacturing costs; our ability to anticipate changes in market conditions; our ability to respond to government controlled pricing policies surrounding reimbursement of our products and, more recently; increasing our overall market share.
 
At the present time we believe that we have additional opportunities to increase our market share through additional strategic agreements, diversification of our product and service offerings, and potential opportunities in markets outside of the United States.   One such opportunity was the February 2012 acquisition of Core Oncology, Incs prostate brachytherapy customer base (see below).  We believe we have these opportunities to expand and broaden our distribution channels because of, among other things, the reliability of our supply, the quality of our products, the quality of our direct sales force, and our long-term commitment to the brachytherapy industry including patient education, direct to consumer advertising, and congressional lobbying for fair reimbursement.
 
 
I-1

 
 
Acquisition of Core Oncology’s Prostate Brachytherapy Customers
 
On February 17, 2012, we acquired Core Oncology’s prostate brachytherapy customer base.  This transaction is expected to substantially increase our share of the iodine-125 segment of the prostate brachytherapy market.  We expect $5 million to $6 million of incremental revenue in our brachytherapy segment for the remaining portion of calendar 2012 from this transaction and for the transaction to be accretive to earnings and to generate positive operating cash flow in 2012.  Our total brachytherapy segment revenue was $24.1 million in 2011.  In addition to the customer base, we also acquired certain packaging technologies. We did not acquire Core’s facilities, manufacturing equipment or processes, or Core’s employees. The total earn-out based purchase price is expected to be approximately $7.5 million to $10.5 million.  We paid $3.8 million in cash as a prepayment for a portion of the earn-out at closing and will make six quarterly earn-out payments thereafter, beginning in June 2012. Core’s prostate brachytherapy sales were approximately $13 million for their fiscal year ended June 30, 2011 and $4 million for the six months ended December 31, 2011.
 
Operating Segments
    
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 M 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.  We believe the wound closure market 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 worldwide 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 with various dimensions, configurations, and types of materials, depending on the application.  We produce and distribute over 850 wound closure line items, including sterile and non-sterile products.  Sutures represent the majority of wound closure products we sell.  In 2011, approximately 82% of our suture product sales were in veterinary applications and 18% in human applications.  During 2010, approximately 83% of our suture product sales were in veterinary applications and 17% in human applications.
 
Vascular access products include a variety of introducer sheaths, guidewires and accessories used in interventional radiology, interventional cardiology and vascular surgery.  We believe the interventional radiology and interventional cardiology markets to be in excess of $12.0 billion.  The market for access devices is estimated to be over $1.6 billion by 2015.  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 with various dimensions, configurations and types of material, depending upon the application.  We produce and distribute approximately 2,000 products and components in this product line, some 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 in sterile and bulk, non-sterile configurations to OEMs.
 
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 we believe to be approximately $800 million, 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.   We produce specialty needles in various forms depending upon the application, and we manufacture over 600 line items for sale primarily to OEMs in sterile private label, and bulk, non-sterile configurations.
 
 
I-2

 
 
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 suture’s 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”), and gold 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 stiffened 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 including the Fluent™ transitionless Micro-Introducer and non-vascular GaltStick® introducer.
 
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.
 
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.  The 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. The 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.
 
 
I-3

 
 
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 sterile private label and 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 Food and Drug Administration (“FDA”) cleared materials. These devices are primarily 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 different 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.
 
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, Argon, 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, Teleflex, 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.  
 
 
I-4

 
 
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
 
We produce, market and sell TheraSeed® and I-Seed,  FDA-cleared devices for treatment of all solid localized tumors and currently used principally for the treatment of localized prostate cancer. TheraSeed® is based on the radioactive isotope palladium-103, and I-Seed is based on the radioactive isotope iodine-125.  We also have FDA clearance for AgX100, our new iodine-125 based device.  These devices are commonly referred to as “seeds” and are utilized in a procedure referred to as “brachytherapy”.  Currently our TheraSeed® product comprises the substantial portion of our product sales in this business.  Our seed devices can be packaged in a number of different configurations.  Our TheraSeed®, I-Seed and AgX100 products each have CE Marking.  To date, substantially all of our seed product sales have been in the United States.  While we believe we may have opportunities for sales outside the U.S., we do not expect sales of our seeds outside of the United States to be material in the near future.
 
In February 2012 we acquired Core’s prostate brachytherapy customer base (see “Acquisition of Core Oncologys Prostate Brachytherapy Customers” below).  In connection with this transaction and during a transition period, we will distribute Core Oncology’s iodine-125 based seed under a temporary supply agreement with Core.  During this transition period we expect to transition the acquired customers to an iodine-125 seed manufactured by us.
 
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 estimates that there will be 241,740 new cases of prostate cancer diagnosed and an estimated 28,170 deaths associated with the disease in the United States during 2012. 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).
 
In a prostate brachytherapy application, the seeds 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 remain permanently in the prostate after delivering their radiation dose. 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.
 
These radioactive “seeds” are roughly the size of a grain of rice. Each seed consists of biocompatible titanium that encapsulates a radioactive isotope.  TheraSeed®, which we have produced since 1987 and is currently our primary seed product, utilizes 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, resulting in the loss of almost all radioactivity in less than six months.  Our iodine seed devices utilize the radioactive isotope iodine-125 (“I-125”). The half-life of I-125 is approximately 60 days resulting in the loss of almost all radioactivity in approximately 20 months.
 
 
I-5

 
 
We believe brachytherapy offers significant advantages over other options for the treatment of early stage prostate cancer, including reduced incidence of side effects, such as impotence and incontinence. Recent multi-year clinical studies indicate that brachytherapy 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 lengthy treatment periods, extended hospital stays and long recovery periods. In addition, the total cost of a brachytherapy treatment is typically lower than other treatment options for early stage prostate cancer.
 
We believe the number of brachytherapy procedures performed in the United States has declined in recent years. 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.  A number of media stories and publications have speculated that physician establishment of IMRT centers has led to IMRT popularity, including a December 7, 2010 article in the Wall Street Journal and an article published in the International Journal of Radiation Oncology by physicians at the Yale University School of Medicine (Falit, Gross and Roberts, Int. J. Radiation Oncology Biol. Phys., Vol 76, No. 5).  Despite the favorable reimbursement and potential physician financial incentive enjoyed by IMRT relative to seeding, brachytherapy outcomes continue to be equal to or better than IMRT at a lower overall cost.  However, we believe that brachytherapy will continue to lose market share to IMRT (and other technologies that enjoy favorable reimbursement) as long as the current Medicare reimbursement policies provide favorable reimbursement levels for competing therapies.
 
Acquisition of Core Oncology’s Prostate Brachytherapy Customers
 
On February 17, 2012, we acquired Core Oncology’s prostate brachytherapy customer base.  This transaction is expected to substantially increase our share of the iodine-125 segment of the prostate brachytherapy market.  We expect $5 million to $6 million of incremental revenue in our brachytherapy segment for the remaining portion of calendar 2012 from this transaction and for the transaction to be accretive to earnings and to generate positive operating cash flow in 2012.  Our total brachytherapy segment revenue was $24.1 million in 2011.  In addition to the customer base, we also acquired certain packaging technologies. We did not acquire Core’s facilities, manufacturing equipment or processes, or Core’s employees. The total earn-out based purchase price is expected to be approximately $7.5 million to $10.5 million.  We paid $3.8 million in cash as a prepayment for a portion of the earn-out at closing and will make six quarterly earn-out payments thereafter, beginning in June 2012. Core’s prostate brachytherapy sales were approximately $13 million for their fiscal year ended June 30, 2011 and $4 million for the six months ended December 31, 2011.
  
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. 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. 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”), Image Guided Radiation Therapy (“IGRT”) stereotactic radiotherapy and proton therapy. These treatments generally utilize high-energy and computerized mapping. We believe these forms of external beam radiation, including IMRT and IGRT, 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.
 
 
I-6

 
 
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. We believe active surveillance has become more popular in recent years.
 
In addition to the treatment options described above, other forms of treatment and prevention, including drugs, vaccines, focal cryotherapy, high-intensity focused ultrasound (HIFU) and other forms of radiation are also in use in the United States and other areas of the world.  Additionally, newer treatment alternatives 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 men of all ages with low-, intermediate-and high-risk early-stage prostate cancer that are comparable to or better than those of RP or EBRT. Such clinical studies include:
 
      
“Comparative Analysis of Prostate-Specific Antigen Free Survival Outcomes for Patients with Low, Intermediate and High Risk Prostate Cancer Treatment by Radical Therapy.  Results from the Prostate Cancer Results Study Group:  Grimm et al, British Journal of Urology, volume 109, supplement 1, 2012.  A detailed comparison of peer reviewed literature showing therapy outcomes for surgery, EBRT, proton therapy, cryotherapy, HIFU and brachytherapy.  In all risk groups, brachytherapy exhibited equal or better outcomes than the other therapies compared.
 
      
 “Long Term Outcomes for Patients with Prostate Cancer Having Intermediate and High Risk Disease, Treated with External Beam Irradiation and Brachytherapy”, (Dattoli, et al, Journal of Oncology, December 2010).  Results of combination treatment (brachytherapy and external beam radiation) for intermediate and high risk patients were 81% successful at 17 years.
 
      
Brachytherapy in Men Aged <= 54 Years with Clinically Localized Prostate Cancer”, (Merrick, et al, British Journal of Urology, Vol. 98, 2006).  Results of brachytherapy for men aged 54 years and younger 8 years after treatment.  96% of the 108 men showed biochemical progression free survival.
 
 
“103-Pd Brachytherapy versus radical Prostatectomy in Patients with Clinically Localized Prostate Cancer: a 12 Year Experience from a Single Group Practice”, (Sharkey, et al, Brachytherapy, Vol. 4, Issue 1, 2005).  Brachytherapy compared favorably to RP for low-, intermediate- and high-risk patients.
 
Production - Brachytherapy Seed Business
 
With the exception of rhodium-103 (“Rh-103”), all raw materials used in the production of our 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.
 
We produce our Pd-103 by proton bombardment of Rh-103 in cyclotrons (accelerators). There are other methods of producing Pd-103. We currently have eight cyclotrons in operation.
 
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.
 
Marketing and Major Customers - Brachytherapy Seed Business
 
We sell our brachytherapy seed products directly to healthcare providers and to third-party distributors.  During 2010, we added two new third-party distributors.  In January 2010 we announced a new distribution agreement with Core Oncology, and in July 2010 we announced a new distribution agreement with Oncura, Inc, a unit of GE Healthcare.  We also sell our I-Seed I-125 device, and other brachytherapy related products, directly to healthcare providers.
 
 
I-7

 
 
Under our third party distribution agreements, we are the exclusive palladium-103 seed supplier for the treatment of prostate cancer for each distributor, and each distributor has the non-exclusive right to sell TheraSeed® in the U.S. and Canada.  Certain agreements also provide distributors with the right to distribute TheraSeed® for the treatment of solid localized tumors other than in the prostate, and with rights to distribute to certain locations outside of North America.  Such applications (non-prostate and outside of North America) have not been material and are not expected to become material in the near future. Our principal non-exclusive distribution agreement is with C.R. Bard (“Bard”).  Our agreement with Bard provides 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, 2013 and will be automatically extended for one additional year unless either party gives notice of its intent not to extend by December 31, 2012. Sales to Bard by our brachytherapy segment represented 28% and 33% of brachytherapy seed segment revenue in 2011 and 2010, 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 10% and 11% of consolidated revenue in 2011 and 2010, respectively).
 
Core became an additional non-exclusive distributor of TheraSeed® in January 2010.  In February 2011, we terminated our agreement with Core due to Core’s failure to satisfy its financial obligation to us in accordance with the contractual terms of the agreement. Core had been attempting to become current with amounts due to us.  However, litigation filed against Core by a third party in January 2011 created what we viewed as an unacceptable level of uncertainty surrounding Core’s ability to satisfy their financial obligations to us for both current and ongoing sales.  Subsequent to termination of the agreement we continued to supply TheraSeed® to Core on a prepaid basis.  Sales to Core in our brachytherapy segment totaled approximately 8% and 14% of total brachytherapy seed segment revenue for in 2011 and 2010, respectively.  In the latter half of 2011, certain customers who previously purchased TheraSeed® through Core began purchasing either from us on a direct basis or through one of our other TheraSeed distributors.  In February 2012 we acquired Core’s prostate brachytherapy customers (see “Acquisition of Core Oncologys Prostate Brachytherapy Customers” above).
 
We also currently have non-exclusive distribution agreements for TheraSeed® in place with Oncura (a unit of GE Healthcare) and Biocompatibles (formerly known as BrachySciences).  Sales under each of these agreements were less than 10% of our brachytherapy product sales in 2011.  We may pursue additional distribution agreements for both palladium-103 and iodine-125 products in an effort to increase market share.  We may also have opportunities to enter certain markets outside of the United States with an iodine-125 device.
 
We maintain an internal brachytherapy sales force that sells the TheraSeed® and I-Seed devices directly to hospitals, doctors, and clinics. Direct product sales comprised approximately 42% and 40% of brachytherapy segment revenue in 2011 and 2010, respectively.  We expect to continue direct to consumer advertising and other activities to support demand for brachytherapy, including direct to consumer print advertising, support for clinical studies aimed at showing the advantages of brachytherapy in the treatment of prostate cancer, technical field support to customers and health care providers that utilize our brachytherapy products, 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 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 July 2025.  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 $450,000 for the twelve months ended May 31, 2012.
 
 
I-8

 
 
Competition - Brachytherapy Seed Business
 
Our brachytherapy business competes in a market characterized by technological innovation, extensive research efforts and significant competition. In general, our 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 IMRT, as well as competing permanently and temporarily implanted devices. We believe that the industry-wide decline in prostate brachytherapy procedure volume continued in 2011, though we believe the rate of decline has slowed.  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 the industry-wide decline in brachytherapy procedures is likely to continue as long as other treatment options, especially IMRT, continue to enjoy favorable Medicare reimbursement rates.
 
 Several companies produce and distribute Pd-103 and I-125 seeds, which compete directly with our seed devices. C.R. Bard, Inc., Best Medical, Oncura (a unit of GE Healthcare) and others 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 24 year history of manufacturing radioactive medical devices with 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 our iodine devices 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 our iodine devices.  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 $1.6 million, $1.9 million and $2.2 million in 2011, 2010 and 2009, respectively.  Our R&D investments are primarily focused on opportunities in our surgical products business.  Substantially all R&D expenses have been related to our surgical products segment in the 2009 to 2011 period.   Our 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 that have an established market and not on products that require lengthy and expensive clinical trials.  Looking forward, we expect our R&D expenses to remain at levels comparable to 2011.   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 expect that our R&D investments will accelerate our entrance into new markets, expand our offerings to new and existing customers, and support growth in our surgical products business.  The 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-9

 
 
Government Regulation
 
Our present and future intended activities in the development, manufacture and sale of wound closure, vascular access, specialty needle, 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 Managements 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 Regulation” 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 United 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.
 
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, Managements Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies, and other information contained herein.
 
 
I-10

 
 
Employees
 
As of December 31, 2011, we had approximately 500 full time employees.  We also utilize temporary and contract employees to manage fluctuations in headcount requirements.  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-11

 

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 medical devices used primarily in the treatment of early stage prostate cancer 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 (including companies, product lines and intellectual property) 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 Corp. in May 2005, Galt Medical Corporation in August 2006 and NeedleTech Products, Inc. in July 2008. We acquired Core Oncology’s prostate brachytherapy customers in February 2012.  Further transactions of this nature could result in potentially dilutive issuance of equity securities, use of cash and/or the incurrence 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 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:
 
 
integrating the operations and technologies of the acquired companies;
 
retaining and assimilating the key personnel of each company;
 
retaining existing customers of each company and attracting additional customers;
 
retaining strategic partners of each company and attracting new strategic partners; and
 
creating uniform standards, controls, procedures, policies and information systems.
 
The execution of these post-acquisition events will involve considerable risks and may not be successful. These risks include:
 
 
the potential disruption of the combined companies’ ongoing businesses and distraction of management;
 
the potential strain on the combined companies’ financial and managerial controls and reporting systems and procedures; and
 
the potential unknown liabilities associated with the acquisition and the combined operations.
 
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-12

 
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, changes in our customer base, 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 smaller 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 to 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:
 
 
the size and timing of orders from our customers;
 
the demand for and acceptance of our products;
 
the success of our competition;
 
our ability to command favorable pricing for our products;
 
the growth of the market for our devices;
 
the expansion and rate of success of our sales channels;
 
actions relating to ongoing FDA compliance;
 
the effect of intellectual property disputes;
 
the attraction and retention of key personnel;
 
an inability to control costs; and
 
general economic conditions as well as those specific to our customers and markets.
 
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-13

 
 
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, False Claims Acts, 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, 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 our brachytherapy products 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 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 and/or criminal prosecution and materially adversely affect our business, financial condition and results of operations.
 
We face risks related to our dependence on the medical device business, and specifically the brachytherapy and surgical products markets.
 
All of our revenues are generated from the medical device business, specifically the surgical products and brachytherapy seed markets.  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-14

 
 
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.  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. In our brachytherapy seed business, competing treatments such as IMRT and robotic surgery have been gaining market share, which we believe is due primarily to favorable reimbursement rates set by Medicare.  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 or to resist price increases. 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, and we do not retain the ultimate customers or develop additional relationships, our product sales could decline, and our ability to grow our product lines could be adversely affected.
 
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 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 28% of our brachytherapy seed segment revenue in 2011. 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 10% of consolidated revenue in 2011.
 
 
I-15

 
We also had a supply and reseller agreement in our brachytherapy seed business with Core Oncology under which Core became a non-exclusive distributor of our TheraSeed® device in 2010.  Sales to Core were approximately 8% of our brachytherapy segment revenue in 2011. The terms of our brachytherapy related distribution agreement with Bard is currently less than two years.  In February 2011, we terminated our distribution agreement with Core. In February 2012 we acquired Cores prostate brachytherapy customers. There is no assurance that any of our distribution agreements will be extended and if they are not extended, or they are otherwise terminated (such as the Core agreement), 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:
 
 
doctor and/or patient awareness and acceptance of our products;
 
the real or perceived effectiveness and safety of our products;
 
the relationship between the cost of our products and the real or perceived medical benefits of our products;
 
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
 
market perception of our ability to continue to grow our business and develop enhanced products.
 
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, the Dodd-Frank Wall Street Reform and Consumer Protection Act, 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 or 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-16

 
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 re-sterilize 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 our brachytherapy products 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.
 
 
I-17

 
 
We believe that Medicare reimbursement policies have affected the brachytherapy market and will continue to affect the brachytherapy market.  Prior to 2010, Medicare provided reimbursement 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.  The Centers for Medicare & Medicaid Services (“CMS”) published a final hospital outpatient prospective payment system (“OPPS”) on November 20, 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. The fixed per seed rate at which Medicare reimburses hospitals for the purchase of seeds is established annually by CMS.  We expect to continue to support efforts to urge Congress and CMS to replace this “fixed reimbursement” rule by returning to 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 coincide with 1) competition from competing technologies for the treatment of early stage prostate cancer, which enjoy favorable CMS reimbursement rates even though these technologies are less proven than brachytherapy and 2) uncertainties regarding the implementation and impact of healthcare reform generally.  These factors could have an adverse effect on brachytherapy revenue.
 
See Medicare Developments included in Managements Discussion and Analysis below for additional information regarding CMS reimbursement policies for brachytherapy seeds.
 
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.
 
 
I-18

 
 
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.
 
Our brachytherapy seed products 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 financial condition and operating results. Any such claim brought against us, with or without merit, could result in significant damage to our business.
 
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 the planning and dose calculation software systems that we use internally 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 our surgical products are Class II devices subject to certain special controls by the FDA, many of our 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.
 
 
I-19

 
 
 
New product developments in the healthcare industry are inherently risky and unpredictable. These risks include:
 
 
failure to prove feasibility;
 
time required from proof of feasibility to routine production;
 
timing and cost of product development and regulatory approvals and clearances;
 
competitors’ response to new product developments;
 
development, launch, manufacturing, installation, warranty and maintenance cost overruns;
 
failure to obtain customer acceptance and payment;
 
customer demands for retrofits of both old and new products; and
 
excess inventory caused by phase-in of new products and phase-out of old products.
 
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.
 
Our cash balances and marketable securities are subject to risks, which may cause losses and affect the liquidity of these investments.
 
Our cash and cash equivalents represent cash deposits, money market funds, and commercial paper and are invested with a limited number of financial institutions. 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.  These risks 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 causing 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 economic climate.
 
Financial markets and the economies in the United States and internationally have experienced extreme disruption in recent periods and volatility and conditions could recur. This can result in severely diminished liquidity and credit availability in the market, which could impair our ability to access capital or adversely affect our operations. An economic downturn may also, among other things:
 
create downward pressure on the pricing of our products;
 
affect the collection of accounts receivable;
 
increase the sales cycle for certain of our products;
 
slow the adoption of new products and technologies;
 
adversely affect our customers, causing them to reduce spending; or
 
adversely affect our suppliers, which could adversely affect our ability to produce our products.
 
Any of these conditions could have a material adverse effect on our business, financial position, liquidity and results of operations.
 
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 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-20

 
 
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 malfunctions 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.
 
The adoption of healthcare reform in the United States may adversely affect our business, results of operations and/or financial condition.

In March 2010, significant reforms to the healthcare system were adopted in the form of the Patient Protection and Affordable Care Act (the “PPACA”). The PPACA includes provisions that, among other things, reduce and/or limit Medicare reimbursement to certain providers, require all individuals to have health insurance (with limited exceptions) and impose new and/or increased taxes. Specifically, the law requires the medical device industry to subsidize healthcare reform in the form of a 2.3% excise tax on U.S. sales of most medical devices beginning in 2013.  Regulations implementing the tax have been proposed, but not finalized.  In addition, some members of Congress are working to repeal the tax. While we continue to evaluate the impact of this tax on our overall business, if this tax was applicable to all of our product sales this would have equated to an excise tax of approximately $2 million in 2011. Various healthcare reform proposals have also emerged at the state level. The PPACA and these proposals could reduce medical procedure volumes and impact the demand for our products or the prices at which we sell our products. In addition, the excise tax will increase our cost of doing business. The impact of the PPACA and these proposals could have a material adverse effect on our business and/or results of operations.

There have been a number of lawsuits filed that challenge all or part of the healthcare reform law.  A number of the lawsuits have been ruled on by federal appeals courts, and those rulings were not consistent.  The U,S, Supreme Court has agreed to hear these cases, but we cannot predict how it will rule.   Further, we cannot predict whether Congress may revisit some or all of the healthcare reform law during 2012.  Because of these uncertainties, we cannot predict whether any or all of the legislation will be overturned, repealed, or modified and what the impact on our business may be resulting from any such changes.
 
Item 1B. Unresolved Staff Comments.
 
None.
 
Item 2. Properties
 
Our executive offices are located in Buford, Georgia.  Our manufacturing and development operations are carried out at four principal plants.  We own our brachytherapy seed manufacturing facility, located in Buford, Georgia.  In our surgical products segment, we own a manufacturing facility located in Massachusetts and lease facilities located in Oregon and Texas.  All of our owned and leased spaces are well maintained and suitable for the operations conducted within.
 
Item 3. Legal Proceedings
 
From time to time, we are subject to certain legal proceedings and claims in the ordinary course of business. We currently are not aware of any such legal proceedings or claims that we believe will have, individually or in aggregate, a material adverse effect on our business, financial condition, or operating results.
 
Item 4.  Mine Safety Disclosures
 
Not applicable.
 
 
I-21

 
 
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 2011 and 2010 are as follows:
 
   
High
   
Low
 
2011
           
First Quarter
  $ 2.19       1.50  
Second Quarter
    2.29       1.75  
Third Quarter
    1.85       1.23  
Fourth Quarter
    1.73       1.18  
                 
2010
               
First Quarter
  $ 1.84     $ 1.25  
Second Quarter
    1.80       1.04  
Third Quarter
    1.40       1.10  
Fourth Quarter
    1.57       1.18  
 
As of February 29, 2012, the closing price of our Common Stock was $1.59 per share. Also, as of that date, there were approximately 367 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 Shareholder 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 the 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.
 
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.
 
 
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 Managements Discussion and Analysis of Financial Condition and Results of Operations included elsewhere herein.
 
(Amounts in thousands, except per share data)
 
Year ended December 31,
 
   
2011
   
2010
   
2009
   
2008
   
2007
 
Statement of Operations Data:
                             
Product sales
  $ 80,454       80,683     $ 77,151     $ 66,447     $ 61,286  
License and fee income
    2,276       1,501       1,175       911       924  
Total revenue
    82,730       82,184       78,326       67,358       62,210  
                                         
Cost of sales
    50,073       49,155       44,953       36,264       31,994  
Gross profit
    32,657       33,029       33,373       31,094       30,216  
                                         
Selling, general and administrative
    22,685       24,013       22,020       20,500       19,131  
Amortization of purchased intangibles
    2,793       3,077       3,441       2,410       1,875  
Research and development
    1,649       1,942       2,160       1,300       1,365  
Impairment of goodwill and tradenames
                      70,376        
Other operating items
    34       111       3       (147 )     500  
Total operating expenses
    27,161       29,143       27,624       94,439       22,871  
                                         
Earnings (loss) from operations
    5,496       3,886       5,749       (63,345 )     7,345  
                                         
Other income (expense), net
    (530 )     (583 )     (837 )     277       1,502  
                                         
Earnings (loss) before income taxes
    4,966       3,303       4,912       (63,068 )     8,847  
                                         
Income tax expense (benefit)
    1,902       1,233       1,837       (4,528 )     3,212  
                                         
Net earnings (loss)
  $ 3,064       2,070     $ 3,075     $ (58,540 )   $ 5,635  
                                         
Net earnings (loss) per share
                                       
Basic and Diluted
  $ 0.09       0.06     $ 0.09     $ (1.77 )   $ 0.17  
 
   
December 31,
 
(In thousands)
 
2011
   
2010
   
2009
   
2008
   
2007
 
Balance Sheet Data:
                             
Cash and cash equivalents
  $ 29,553     $ 29,674     $ 45,326     $ 39,088     $ 28,666  
Marketable securities
    11,625       10,949             1,507       20,123  
Goodwill and other intangible assets, net
    9,459       12,319       15,464       18,720       50,539  
Total assets
    115,818       115,187       116,108       114,419       148,821  
Long-term borrowings
          23,667       27,000             7,500  
Total debt
    23,667       27,000       30,333       32,000       7,500  
Shareholders’ equity
  $ 84,122     $ 80,279     $ 77,653     $ 74,110     $ 132,619  
 
Comparability of the selected financial data above is affected by certain material changes in our business, including:
 
 
The acquisitions of NeedleTech in July 2008.  The results of operations of an acquired company are included in our consolidated results for periods subsequent to each respective acquisition date,
 
impairment charges related to the write off of goodwill and tradenames in 2008, and
 
refinancing of our credit agreement in 2009.
 
The above list is not intended to identify all material changes in our business in the periods presented.  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, Managements 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-2

 

THERAGENICS CORPORATION
 
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
 
Overview and Business Strategy
 
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 manufactures, markets and sells disposable devices primarily utilized in certain surgical procedures.  Our brachytherapy seed business manufactures, markets and sells radioactive “seeds” primarily utilized in the treatment of early stage prostate cancer.  At the present time, both of our segments do business primarily in the United States.  Our surgical products business is the faster growing of our businesses and has been supported by the cash flows generated by our market leading brachytherapy seed business and our flagship TheraSeed® brand.  In our surgical products business we plan to grow and diversify revenues by adding product offerings and manufacturing capabilities, expanding the applications and markets in which we compete, and gaining scale to improve profitability.
 
Our surgical products business was built through the acquisitions of CP Medical Corp. in May 2005, Galt Medical Corporation in August 2006, and NeedleTech Products, Inc. in July 2008.  We currently manufacture almost 3,500 products in this business as part of three broad product platforms; wound closure, vascular access and specialty needles.  To date we have maintained the names and brands under which each of these companies previously manufactured, marketed and sold their products.  We serve a number of markets and applications, including, among other areas, interventional cardiology, interventional radiology, vascular surgery, orthopedics, plastic surgery, dental surgery, urology, veterinary medicine (sutures), pain management, endoscopy, and spinal surgery. With the exception of veterinary sutures, our surgical products hold relatively small market shares.  Our products include both finished goods and components.  Our products are sold primarily to original equipment manufacturers (“OEMs”) and to a network of distributors.  On a pro forma basis, our surgical products business has achieved a compound annual revenue growth rate of 8.3% from 2006 through 2011 (pro forma, assuming all acquisitions had been made at the beginning of 2006).  We have accomplished this primarily by increasing sales to existing customers and, to a lesser extent, adding new customers.  Further, we achieved this revenue growth during a period which included severe economic difficulties.  Our strategy for increasing sales and scale going forward includes: becoming more integral within the supply chain of our customers both for existing products and for our customers’ development programs (which may allow us to increase sales to existing and new customers from all product platforms); developing new products internally; acquiring products, licenses, and other intellectual property; acquiring businesses and; entering certain markets outside the United States.
 
We have operated our brachytherapy seed business since 1987, emerging from the development stage in 1990.  Historically our brachytherapy seed segment has generated strong cash flows, which have enabled us to diversify our business substantially.  Positive cash flows from our brachytherapy seed business continue despite an industry-wide decline in brachytherapy procedures in the United States which began about six years ago.  The overall brachytherapy industry in the United States is now experiencing difficulties primarily due to competition from other treatments.  Many of these competing treatments enjoy favorable Medicare reimbursement rates relative to brachytherapy reimbursement rates.  We believe this results in a non-level playing field for brachytherapy device manufacturers, providers, and patients.  One of the primary competitive treatments provided by our radiation oncologist customers is Intensity Modulated Radiation Therapy, or “IMRT”.  IMRT enjoys substantially higher reimbursement rates than brachytherapy yet, clinical studies do not indicate that IMRT delivers improved outcomes.   We believe the market positioning and heavy promotion of robotic surgery for prostate cancer treatment has also adversely affected the number of brachytherapy procedures performed.  Despite these industry-wide difficulties we have maintained positive cash flows in our brachytherapy business for a variety of reasons including, among other things, the relatively fixed nature of our brachytherapy seed manufacturing costs; our ability to anticipate changes in market conditions; our ability to respond to government controlled pricing policies surrounding reimbursement of our products and, more recently; increasing our overall market share.
 
At the present time we believe that we have additional opportunities to increase our market share through additional strategic agreements, diversification of our product and service offerings, and potential opportunities in markets outside of the United States.   One such opportunity was the February 2012 acquisition of Core Oncology’s prostate brachytherapy customer base (see below).  We believe we have these opportunities to expand and broaden our distribution channels because of, among other things, the reliability of our supply, the quality of our products, the quality of our direct sales force, and our long-term commitment to the brachytherapy industry including patient education, direct to consumer advertising, and congressional lobbying for fair reimbursement.
 
 
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Acquisition of Core Oncology’s Prostate Brachytherapy Customers
 
On February 17, 2012, we acquired Core Oncology’s prostate brachytherapy customer base.  This transaction is expected to substantially increase our share of the iodine-125 segment of the prostate brachytherapy market.  We expect $5 million to $6 million of incremental revenue in our brachytherapy segment for the remaining portion of calendar 2012 from this transaction and for the transaction to be accretive to earnings and to generate positive operating cash flow in 2012.  Our total brachytherapy segment revenue was $24.1 million in 2011.  In addition to the customer base, we also acquired certain packaging technologies. We did not acquire Core’s facilities, manufacturing equipment or processes, or Core’s employees. The total earn-out based purchase price is expected to be approximately $7.5 million to $10.5 million.  We paid $3.8 million in cash as a prepayment for a portion of the earn-out at closing and will make six quarterly earn-out payments thereafter, beginning in June 2012. Core’s prostate brachytherapy sales were approximately $13 million for their fiscal year ended June 30, 2011 and $4 million for the six months ended December 31, 2011.
 
Results of Operations
 
Year Ended December 31, 2011 Compared to Year Ended December 31, 2010
 
Revenue
Following is a summary of revenue by segment for each of the three years in the period ended December 31, 2011 (in thousands):
 
Revenue by segment
 
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Surgical products
                 
    Product sales
  $ 59,258     $ 58,991     $ 53,591  
    License and fee income
    151       36       69  
        Total surgical products
    59,409       59,027       53,660  
                         
Brachytherapy seed
                       
Product sales
    21,952       22,287       23,860  
License and fee income
    2,125       1,465       1,106  
Total brachytherapy seed
    24,077       23,752       24,966  
                         
Intersegment eliminations
    (756 )     (595 )     (300 )
                         
Consolidated
                       
    Product sales
    80,454       80,683       77,151  
    License and fee income
    2,276       1,501       1,175  
      Total consolidated
  $ 82,730     $ 82,184     $ 78,326  
 
Surgical Products Segment
 
Revenue in our surgical products business increased 1% in 2011 over 2010.  We believe this reflects the variable and unpredictable ordering patterns of our larger customers, especially on a quarter to quarter basis.  Also, it has been widely reported that consumers are making fewer visits to doctors’ offices, which in turn is reducing demand for medical devices.  This trend may have a negative effect on revenue.
 
Open orders in our surgical products segment were $13.9 million at December 31, 2011 compared to $13.0 million at December 31, 2010.  Open orders represent orders from customers for future delivery that we believe to be firm.  Open orders are not guaranteed shipments, and they are subject to cancellation or delay.  Backlog in our surgical products business was $379,000 at December 31, 2011 and $345,000 at December 31, 2010.  Backlog represents orders included in open orders, but for which we have missed promised shipment dates.
 
A significant portion of the products in our surgical business continue to be 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, revenue has been and will continue to be affected by our customers’ response to efforts by hospitals to reduce inventories and to conserve cash due to the difficult economic climate and macroeconomic uncertainties.  All of these factors may cause the fluctuations in our results to be even more volatile from period to period.
 
 
II-4

 
 
Brachytherapy Seed Segment
 
We sell our TheraSeed® palladium-103 device directly to healthcare providers and to third-party distributors.  We also sell iodine-125 based devices, and other brachytherapy related products, directly to healthcare providers.
 
Our brachytherapy product sales decreased 2% in 2011 from 2010.  We believe that the prostate brachytherapy industry in the United States continues to experience pressure from newer forms of treatment.  Some competitive forms of treatment have increased their market share, especially those with Medicare reimbursement levels that are higher than reimbursement levels for brachytherapy.  These competitive forms of alternative treatments include IMRT and robotic surgery.  In addition to competing treatment options that enjoy favorable reimbursement rates, we believe brachytherapy seed volume and revenue are also affected by disruptive pricing from other brachytherapy providers and uncertainties surrounding reimbursement.  In February 2012 we acquired Core Oncology’s prostate brachytherapy customer base (see above under “Overview and Business Strategy”).  This transaction is expected to result in $5 million to $6 million of incremental revenue in our brachytherapy segment in calendar 2012.
 
We have non-exclusive distribution agreements in place for our TheraSeed® device.  Under our third party distribution agreements, we are the exclusive palladium-103 seed supplier for the treatment of prostate cancer for each distributor, and each distributor has the non-exclusive right to sell TheraSeed® in the U.S. and Canada.  Certain agreements also provide distributors with the right to distribute TheraSeed® for the treatment of solid localized tumors other than in the prostate and with rights to distribute to certain locations outside of North America.  Such applications (non-prostate and outside of North America) have not been material and are not expected to become material in the near future. Our principal non-exclusive distribution agreement is with C.R. Bard (“Bard”).  Our agreement with Bard provides 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, 2013 and will be automatically extended for one additional year unless either party gives notice of its intent not to extend by December 31, 2012.  Sales to Bard by our brachytherapy segment represented 28% and 33% of brachytherapy seed segment revenue in 2011 and 2010, 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 10% and 11% of consolidated revenue in 2011 and 2010, respectively).
 
Core became an additional non-exclusive distributor of TheraSeed® in January 2010.  In February 2011, we terminated our agreement with Core due to Core’s failure to satisfy its financial obligation to us in accordance with the contractual terms of the agreement. Core had been attempting to become current with amounts due to us.  However, litigation filed against Core by a third party in January 2011 created what we viewed as an unacceptable level of uncertainty surrounding Core’s ability to satisfy their financial obligations to us for both current and ongoing sales.  Subsequent to termination of the agreement, we continued to supply TheraSeed® to Core on a prepaid basis.  Sales to Core in our brachytherapy segment totaled approximately 8% and 14% of total brachytherapy seed segment revenue for in 2011 and 2010, respectively.  In the latter half of 2011, certain customers who previously purchased TheraSeed® through Core began purchasing either from us on a direct basis or through one of our other TheraSeed® distributors. In February 2012 we acquired Core’s prostate brachytherapy customer base.  See above under “Overview and Business Strategy”.
 
We also currently have other non-exclusive distribution agreements in place for TheraSeed®, none of which represented 10% or more of our brachytherapy product sales in 2011 and 2010.  We may pursue additional distribution agreements for both palladium-103 and iodine-125 products in an effort to increase market share.  We may also have opportunities to enter certain markets outside of the United States with an iodine-125 device.
 
We believe that Medicare reimbursement policies have affected the brachytherapy market and will continue to affect the brachytherapy market.  Prior to 2010, Medicare provided reimbursement 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.  The Centers for Medicare & Medicaid Services (“CMS”) published a final hospital outpatient prospective payment system (“OPPS”) on November 20, 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. The fixed per seed rate at which Medicare reimburses hospitals for the purchase of seeds is established annually by CMS.  We expect to continue to support efforts to urge Congress and CMS to replace this “fixed reimbursement” rule by returning to 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 coincide with 1) competition from competing technologies for the treatment of early stage prostate cancer, which enjoy favorable CMS reimbursement rates even though these technologies are less proven than brachytherapy and 2) uncertainties regarding the implementation and impact of healthcare reform generally.  These factors could have an adverse effect on brachytherapy revenue.
 
 
II-5

 
 
License fees in our brachytherapy segment increased $660,000 or 45%, in 2011 over 2010.  License fees 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 a brachytherapy catheter-based delivery system that we developed. This delivery system is primarily utilised in the treatment of breast cancer. The licensing 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. Cost and expenses associated with our license agreements are not material.
 
Operating income and costs and expenses
 
Following is a summary of operating income by segment for each of the three years in the period ended December 31, 2011 (in thousands):
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
                   
Surgical products
    607       215       1,664  
Brachytherapy seed
    4,923       3,685       4,081  
Intersegment eliminations
    (34 )     (14 )     4  
                         
Consolidated
  $ 5,496     $ 3,886     $ 5,749  
 
Surgical Products Segment
 
Operating income in our surgical products segment increased to $607,000 in 2011 from $215,000 in 2010.  Our gross profit margins on sales were approximately 35% in 2011 compared to 36% in 2010.  Gross margins continue to be affected by changes in product and customer mix.  During 2011 we were also impacted by changes in customer ordering patterns, ERP implementation and severe winter storms causing the closure of our Dallas, Texas plant for several days in the first quarter.  As a result of these and other items, our backlog fluctuated and we incurred higher overtime, utilized more temporary workers and experienced operating inefficiencies.    Gross margins were also affected in 2011 by increased material costs; some of which were not passed on to our customers.
 
Items affecting comparability between the 2011 and 2010 periods include certain expenses that were only incurred in either 2011 or 2010, including the following (in thousands):
 
   
Year Ended
 December 31,
 
   
2011
   
2010
 
             
 Acquisition proposal expenses (a)
  $ 218     $  
 Professional fees (b)
          629  
 Moving related expenses (c)
          570  
  Core receivables (d)
          380  
 
(a)
Acquisition proposal expenses related to expenses to consider, address, and respond to an unsolicited acquisition proposal.
(b)
Professional fees related to our legal action against the former owner of CP Medical to enforce certain non-compete agreements and to protect the trade secrets and other assets of that business.
(c)
Moving related expenses associated with the move into our new specialty needle manufacturing facility.
(d)
Core receivables represent amounts due from Core Oncology for which we believed collectability was doubtful.
 
In addition, corporate overhead allocated to our surgical products segment increased in 2011 primarily due to higher professional fees, compensation, and depreciation associated with our new ERP system.  These increases were partially offset by a decline in amortization of purchased intangibles in the 2011 periods as certain intangible assets have become fully amortized.
 
Research and development (“R&D”) expenses decreased $128,000, or 7%, in 2011 from 2010.  Our 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 that have an established market and not on products that require lengthy and expensive clinical trials.  Looking forward, our results are expected to be affected by the timing of these investments.
 
 
II-6

 
 
During 2011, we have continued development of a corporate-wide Enterprise Resource Planning (“ERP”) system. As our ERP system was under development, we capitalized certain internal costs associated with its development.  These costs, which consisted primarily of employee payroll and related expenses, totaled $240,000 and $331,000 in 2011 and 2010, respectively, in our surgical products segment.  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 the remaining location within the next twelve months.
 
Looking forward, we expect a number of items to continue to affect the profitability in our surgical products business including, among other things:
 
ordering patterns of our larger OEM and distributor customers,
 
costs incurred to address significant changes in demand,
 
continued investments in infrastructure, R&D, products, and companies 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 implementation of our new, corporate-wide ERP systems,
 
the increasing scale of our surgical products business, and
 
trends of consumers making fewer visits to doctors’ offices and the effect on demand for medical devices.
 
Brachytherapy Seed Segment
 
Operating income in our brachytherapy business increased to $4.9 million in 2011 from $3.7 million in 2010.  Manufacturing related expenses in our brachytherapy business tend to be relatively fixed in nature.  Accordingly, even modest changes in revenue can have a significant impact on operating income.  Gross margin and operating income in our brachytherapy seed business are expected to continue to be highly dependent on sales levels due to this high fixed cost component.   The increase in license and fee income in 2011 offset the decline in product sales.  The primary expense item affecting comparability between the periods was bad debt expense related to Core Oncology.  In 2011 we recorded $215,000 as bad debt expense related to amounts due from Core for which we believed collectability was doubtful.  In 2010 we recorded $1.6 million of bad debt expense related to Core. In February 2012 we acquired Core’s prostate brachytherapy customers.  See above under “Overview and Business Strategy”.   Corporate overhead costs allocated to our brachytherapy segment increased from 2010 due to increases in professional fees, compensation, and depreciation associated with our new ERP system.  We were able to reduce some operating expenses during 2011 including advertising and personnel related costs.  Looking forward, we may not be able to continue to reduce our operating costs.
 
Non-operating income/expense
 
A summary of our interest expense is as follows:
 
   
Year Ended December 31,
 
   
2011
   
2010
 
2009
 
                 
  Interest paid or accrued, including loan fees
  $ 866     $ 982     $ 822  
  Fair value adjustment
    (130 )     107       80  
  Interest capitalized
    (39 )     (113 )     (37 )
                         
Total interest expense
  $ 697     $ 976     $ 865  
 
Interest expense paid or accrued, including loan fees, is related to our effective interest rates and the level of our outstanding borrowings under our credit agreement.  Fair value adjustments are related to our interest rate swaps.  Such fair value adjustments are unrealized (gains) and losses and reflect the period to period changes in the estimated fair value of our swaps.  Interest capitalized primarily relates to the development of our ERP system.  Interest capitalized in 2012 is expected to be similar to 2011 levels.  Our weighted average effective rate was 3.0% at December 31, 2011.
 
 
II-7

 
 
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 Financial Accounting Standards Board (“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 its credit rating and the rating of its parent company. We continue to monitor our counterparty credit risk.
 
Other income in 2010 includes $200,000 received in the settlement of the lawsuit with the former owner of CP Medical.  Interest income was not material in 2011 or 2010.
 
Income tax expense
 
Our effective income tax rate, which includes federal and state income taxes, was approximately 38% and 37% in 2011 and 2010, respectively.  Looking forward, state and investment tax and R&D credits may cause fluctuations in our effective income tax rate for financial reporting purposes.  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.
 
Year Ended December 31, 2010 Compared to Year Ended December 31, 2009
 
Revenue
 
Surgical Products Segment
 
Revenue in our surgical products business increased 10% in 2010 over 2009.  All three of our general product categories, including wound closure, vascular access, and specialty needles, recorded organic growth during 2010.   The majority of our 2010 revenue growth was driven by our vascular access and wound closure products.  Our organic revenue growth was primarily a result of increased sales to existing customers.
 
Backlog in our surgical products business was $345,000 at December 31, 2010 and $931,000 at December 31, 2009.  Backlog represents orders included in open orders, but for which we have missed promised shipment dates. During the first quarter of 2010, we experienced a spike in demand and changes in customer purchasing behavior.  These factors increased our backlog early in 2010. This increase in our backlog added to an already high level of open orders (including backlog) that we had entering into the year.  In an attempt to compensate for the additional lead time we were experiencing in shipping orders, some customers added to existing orders.  We incurred overtime, hired temporary labor, and added shifts, among other actions, to help relieve our backlog and address opportunities during the first quarter.  A portion of the increase in product sales experienced in 2010 resulted from reducing our backlog.
 
Brachytherapy Seed Segment
 
Our brachytherapy product sales decreased 7% in 2010 from 2009.  Our strategy of increasing market share through new distribution agreements helped to offset the continued year over year industry-wide decline in procedures.  This reduced the decline in product sales we would have otherwise experienced in 2010.  Indeed, our product sales increased 3% in the second half of 2010 compared to the second half of 2009.
 
License fees in our brachytherapy segment increased $359,000, or 32%, in 2010 over 2009.  License fees include fees from the licensing of our TheraSphere® product, a medical device used for the treatment of liver cancer.  License 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-8

 
 
Operating income (loss) and costs and expenses
 
Surgical Products Segment
 
Operating income in our surgical products segment decreased to $215,000 in 2010 from $1.7 million in 2009.  Affecting profitability in the 2010 periods was a decline in our gross profit margins on product sales. Our gross profit margins were approximately 36% in 2010 compared to 39% in 2009.  This decline was driven by several factors: spikes in demand early in 2010; continuing changes in customer behavior; pricing pressures; changes in product mix and distribution channels; and the move to our new specialty needle manufacturing facility.
 
We experienced a spike in demand during the first quarter of 2010, increasing our backlog and putting pressure on certain facilities that were already at or near capacity.  To address the spike in demand and backorders, we ran overtime, brought in temporary labor and implemented a third shift at one plant, among other things. These additional costs eroded our gross margins.  Amplifying the costs associated with these actions were changes in customer behavior.  Recurring changes in order quantities and requested delivery dates of orders reduced the ability of our operations to efficiently address production requirements.  Our former specialty needle manufacturing plant was running at near capacity, putting a strain on operations.  We also saw an increase in our OEM sales relative to our dealer sales during 2010.  OEM sales generally carry a lower gross profit margin.  Additionally, we experienced pricing pressure from customers and from the need to respond to aggressive pricing behavior of competitors.
 
We were able to reduce the backlog experienced early in 2010 and reduce or eliminate some of the additional costs we had incurred to address the circumstances that existed during that time.  We also implemented certain measures to better control costs and margins on an ongoing basis. However, we continued to experience changes in customer behavior, ordering and pricing pressures which in turn, caused variability in our gross margins from period to period.
 
Also affecting our 2010 gross margins was the move to our new specialty needle facility in July 2010.  We experienced inefficiencies, such as planned downtime, to facilitate the move.  Our new facility, which is 43% larger than our previous operating facilities, also has higher operating costs associated with it.
 
Another factor reducing income in the 2010 periods was legal fees of $629,000 associated with our initiation of legal action against the former owner of CP Medical.  This legal action was intended to enforce certain non-compete agreements and to protect the trade secrets and other assets of that business, which we acquired in 2005.  We had no such legal fees in 2009.  The action was settled in October 2010, and no further significant legal fees are expected to be incurred in this matter.
 
Moving related expenses of $570,000 were incurred in 2010 in connection with the move to our new, larger specialty needle manufacturing facility.  These expenses were included in selling, general and administrative expenses and in loss on disposal of assets in our 2010 statement of earnings.  We completed the move to the new facility in the third quarter of 2010.
 
Bad debt expense also increased in 2010, primarily a result of amounts due from Core for which we believed collection was doubtful of approximately $380,000.  Selling, general and administrative expenses, other than the aforementioned legal, moving and bad debt expenses, were 24% of revenue in 2010 compared to 25% in 2009.
 
Research and development (“R&D”) expenses decreased $380,000, or 18%, in 2010 from 2009.
 
During 2010, we continued development of a corporate-wide Enterprise Resource Planning (“ERP”) system. As our ERP system was under development, we capitalized certain internal costs associated with its development.  These costs, which consisted primarily of employee payroll and related expenses, totaled $331,000 and $247,000 in 2010 and 2009, respectively, in our surgical products segment.
 
Brachytherapy Seed Segment
 
Operating income in our brachytherapy business decreased to $3.7 million in 2010 from $4.1 million in 2009.  Manufacturing related expenses in our brachytherapy business tend to be relatively fixed in nature.  Accordingly, even modest changes in revenue can have a significant impact on operating income.  The decline in product sales had a negative effect on operating income in 2010.  Increases in our license and fee income contributed to profitability as there were minimal costs associated with those licensing agreements.  The increase in license and fee income in 2010 partially offset the declines in product sales.  We were able to decrease some operating expenses during 2010, including personnel related costs, advertising and professional fees.  Our brachytherapy business also absorbed fewer corporate overhead costs since we allocate corporate costs based upon the relative revenue of our business segments.  Corporate overhead costs allocated to our brachytherapy business declined $320,000 in 2010 from 2009.
 
 
II-9

 
 
Partially offsetting reductions in operating expenses noted in the preceding paragraph was $1.6 million of bad debt expense related to amounts due from Core for which we believe collection is doubtful.  We terminated our distribution agreement with Core in February 2011 and in February 2012 we acquired Core’s prostate brachytherapy customers.  See above under “Overview and Business Strategy”.
 
Non-operating income/expense
 
Other income in 2010 includes $200,000 received in the settlement of the lawsuit with the former owner of CP Medical.  Interest income was not material in 2010 or 2009.
 
Income tax expense
 
Our effective income tax rate, which includes federal and state income taxes, was approximately 37% in 2010 and 2009.  In 2010, our tax rate was reduced by approximately $227,000 of state investment tax credits and R&D tax credits.  A significant portion of these credits in 2010 related to the construction of our new needle manufacturing facility.
 
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 effect the 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 D in the accompanying consolidated financial statements, Liquidity and Capital Resources in Managements 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 property and equipment includes cyclotrons, which are utilized in our brachytherapy business, and manufacturing buildings. As of December 31, 2011, we owned and operated eight cyclotrons, the first of which entered service in 1998. The estimated service life of our cyclotron equipment is 15 years. At December 31, 2011, the net book value of our cyclotrons was $1.2 million. The estimated service life of our buildings is 30 years.
 
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 and equipment) 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.
 
 
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Intangible assets. Our intangible assets are determined to have finite lives and 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.  Our asset retirement obligations consist primarily of decommissioning obligations related to our brachytherapy seed manufacturing equipment and facilities.
 
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 fair 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.
 
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. We evaluate the realizability of the deferred tax assets and assess the need for the valuation allowance each reporting period.  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. 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, 2011 and 2010. Our policy is to recognize accrued interest expense and penalties associated with uncertain tax positions as a component of income tax expense.
 
 
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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 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 August 2016. We also have $23.7 million of borrowings outstanding under our credit agreement. Our contractual obligations as of December 31, 2011 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 (1)
                             
Rental space and equipment
  $ 687     $ 443     $ 232     $ 12     $  
                                         
 Borrowings under credit agreement (2)
    23,667       23,667                    
 Interest payable on borrowings (3)
    566       566                    
Total borrowings
    24,233       24,233                    
                                         
Other obligations
    454       57       397              
                                         
Total
  $ 25,374     $ 24,733     $ 629     $ 12     $  
 
(1)
Represents minimum rental payments for operating leases, one of which is subject to adjustment based on the Consumer Price Index.
(2)
Includes $1.7 million outstanding under a term loan payable at $278,000 monthly through June 1, 2012, and $22.0 million outstanding under $30.0 million revolving credit facility, which matures October 2012.
(3)
Interest on outstanding borrowings under credit agreement at December 31, 2011 is based on effective interest rates at December 31, 2011.
 
Letter of Credit
 
We have a letter of credit outstanding under the credit facility as of December 31, 2011 totaling $946,000. This letter of credit is related to asset retirement obligations 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, cash equivalents and marketable securities of $41.2 million and $40.6 million at December 31, 2011 and 2010, respectively.  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.
 
Working capital was $42.3 million and $57.1 million at December 31, 2011 and 2010, respectively. The decrease in working capital is primarily due to the classification of $22.0 million of borrowings under our revolving credit facility as a short-term liability at December 31, 2011. Our credit facility expires on October 31, 2012.  At December 31, 2010, all outstanding borrowings under our revolving credit facility were classified as long-term and, accordingly, were not a part of working capital.
 
 
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Cash provided by operations was $6.1 million in 2011 compared to $7.9 million in 2010.  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 and higher income tax payments. The decline in 2011 was primarily a result of the increase in inventories to support growth in our surgical products segment and higher income taxes paid.
 
Capital expenditures totaled $2.0 million in 2011 and $9.1 million in 2010. The 2011 expenditures were primarily for the development of our new ERP system.  The 2010 expenditures were primarily for the construction of our new specialty needle manufacturing facility and, to a lesser extent, the development of our new ERP system.  Construction of our new facility was completed in July 2010.   Looking forward, we expect our rate of 2012 capital expenditures, exclusive of the Core asset acquisition, to be consistent with 2011 levels.
 
Cash used by financing activities was $3.3 million in both 2011 and 2010.  Cash used for financing activities primarily consisted of principal repayments of our outstanding borrowings, in accordance with the terms of our credit agreement.  The terms of our credit agreement require monthly principal payments of $278,000 through June 1, 2012.
 
R&D expenses were $1.6 million in 2011 and $1.9 million in 2010. We expect to continue to use cash in 2012 to support growth in the surgical products segment, especially for R&D.  Looking forward, we expect R&D expense levels in 2012 to be similar to the 2011 level.  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.
 
On February 17, 2012, we acquired Core Oncology’s prostate brachytherapy customer base.  In addition to the customer base, we also acquired certain packaging technologies.  We did not acquire Core’s facilities, manufacturing equipment or processes, or Core’s employees. The total purchase price is expected to be approximately $7.5 million to $10.5 million. We paid $3.8 million in cash as a prepayment of a portion of the earn-out at closing, and will make six quarterly earn-out payments thereafter, beginning in June 2012.
 
We may also continue to use cash for increased marketing and support activities in our brachytherapy seed business and in the pursuit of additional diversification efforts such as product development, the purchase of technologies, products, companies, and other strategic initiatives. 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.
 
Credit Agreement
 
We have a Credit Agreement with a financial institution which 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 lender under an accordion feature.  As of December 31, 2011, borrowings of $22.0 million and $1.7 million were outstanding under the Revolver and Term Loan, respectively, and letters of credit totaling $946,000, representing decommission funding required by the Georgia Department of Natural Resources, were outstanding under the Credit Agreement. The Term Loan is payable in equal monthly installments of $278,000 plus interest at LIBOR plus 1.75%, through June 1, 2012.  We intend to seek renewal or replacement of this Credit Agreement during 2012. 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 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, as amended, as of December 31, 2011.
 
We also have 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 entire 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 $6.0 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, 2011 was 3.0%.
 
 
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Cash, Cash Equivalents and Marketable Securities
 
Our cash and cash equivalents include bank deposits, money market funds, U.S. Treasury securities, and commercial paper held at a limited number of financial institutions. 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
 
Prior to 2010, Medicare provided reimbursement 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. CMS published a final hospital OPPS on November 20, 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.  Under the fixed opps, CMS establishes the fixed per seed rate on an annual basis. We continue to support efforts that urge Congress and CMS to replace this “fixed reimbursement” rule by returning to 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 coincide with 1) competition from competing technologies for the treatment of early stage prostate cancer, which enjoy favorable CMS reimbursement rates even though these are less proven technologies and 2) uncertainties regarding the implementation and impact of healthcare reform generally.
 
In August 2011, the Budget Control Act of 2011 was enacted into law to increase the federal debt ceiling. The law provided for spending cuts of nearly $1 trillion over the next 10 years, including proposed cuts to Medicare providers. The law further created a Congressional committee that was given a deadline of November 23, 2011 to develop recommendations for further reducing the federal deficit by another $1.2 trillion over 10 years. The committee was unable to agree on a plan by the November deadline, and as a result, automatic spending cuts, including a likely 2% cut to Medicare providers, will become effective beginning in 2013. Medicaid is exempted from the automatic cuts.  Any cuts to Medicare reimbursement which affect our products could have a material adverse effect on our business and/or our results of operations.

Other Regulatory Developments

In March 2010, significant reforms to the healthcare system were adopted in the form of the Patient Protection and Affordable Care Act (the “PPACA”). The PPACA includes provisions that, among other things, reduce and/or limit Medicare reimbursement to certain providers, require all individuals to have health insurance (with limited exceptions) and impose new and/or increased taxes. Specifically, the law requires the medical device industry to subsidize healthcare reform in the form of a 2.3% excise tax on U.S. sales of most medical devices beginning in 2013.  Regulations implementing the tax have been proposed, but not finalized.  In addition, some members of Congress are working to repeal the tax. While we continue to evaluate the impact of this tax on our overall business, if this tax was applicable to all of our product sales this would have equated to an excise tax of approximately $2 million in 2011. Various healthcare reform proposals have also emerged at the state level. The PPACA and these proposals could reduce medical procedure volumes and impact the demand for our products or the prices at which we sell our products. In addition, the excise tax will increase our cost of doing business. The impact of the PPACA and these proposals could have a material adverse effect on our business and/or results of operations.
 
On December 19, 2011, CMS published proposed regulations that would implement provisions in PPACA related to disclosure of payments made by manufacturers to physicians and teaching hospitals.  Because we manufacture a number of devices that are covered by the regulations, all payments that we make to physicians and teaching hospitals would be subject to this reporting requirement even if the payment relates to a device that is not considered a covered device.   CMS has accepted public comments on the proposed regulations and will publish final regulations at some point in the future.  The tracking and reporting of these payments could have an adverse impact on our business and/or results of operations and on our relationships with customers and potential customers.
 
 
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Forward Looking and Cautionary Statements
 
This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding sales, expected impact of the acquisition of Cores prostate brachytherapy customers, marketing and distribution efforts, ordering patterns of customers and our ability to fill our backlog, our expectation regarding 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, effects of healthcare reform, third-party reimbursement, CMS policy, sales mix, effectiveness and continuation of non-exclusive distribution agreements, anticipated growth in the surgical products business segment, the increasing scale of our surgical products business, future cost of sales and gross margins, R&D efforts and expenses, investment in additional personnel, infrastructure and capital assets, implementation of a new ERP system, future SG&A expenses, potential new products and opportunities, 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.
 
Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, the following factors. You should not consider this list to be a complete statement of all potential risks and uncertainties:
 
 
changes in the U.S. healthcare industry and regulatory environment;
 
competition;
  ability to successfully retain acquired customers;
 
new product development cycles;
 
development and growth of new applications within our markets;
 
changes in FDA regulatory approval processes;
 
effectiveness and execution of marketing and sales programs, including those of our distributors;
 
changes in third-party reimbursement, including CMS and private payors;
 
potential changes in product pricing;
 
changes in costs and availability of materials and other operating costs;
 
continued acceptance of our products in the marketplace;
 
changes in demand for products;
 
our ability to meet customer demands and/or the need to incur additional costs and inefficiencies to meet such demand;
 
a reduction in the number of procedures utilizing our devices caused by cost containment pressures, alternative therapies, or  by other reasons;
 
our ability to successfully identify, consummate and integrate strategic acquisitions or otherwise capitalize on opportunities for growth;
 
increased costs or product delays required to comply with existing and changing regulations applicable to our businesses, operations and products;
 
effectiveness of implementation of our new ERP system;
 
ability to realize our estimate of fair value upon sale or liquidation of cash, cash equivalents and marketable securities that we may hold;
 
retention of key employees;
 
damage to one or more of our facilities;
 
volatility in U.S. and global financial markets;
 
substantial defaults in payments or a material reduction in purchases by, or loss of, a large customer;
 
changes in circumstances that could impair our intangible assets;
 
new or revised tax legislation or challenges to our tax positions;
 
changes in accounting principles generally accepted in the United States of America;
 
general economic conditions, including changes in the financial markets that may affect the availability and cost of credit to us, our customers or our suppliers; and
 
the other factors set forth or incorporated by reference under “Risk Factors”.
 
These and other risks and uncertainties are described herein and in other information contained in our publicly available SEC filings and press releases.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements were first made. Except to the extent required by federal securities laws, we undertake no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
 
 
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Recent Accounting Pronouncements
 
In June 2011, the FASB issued an accounting standards update that eliminates the current option to present the components of other comprehensive income as part of the statement of changes in shareholders’ equity.  Under this statement, we can elect to present the total of comprehensive income, the components of net income, and the components of other comprehensive income in a single continuous statement of comprehensive income or in two separate but consecutive statements.  This statement will be effective for us in our first quarter 2012 Form 10-Q and will be applied retrospectively to all prior periods presented.
 
Quarterly Results
 
The following table sets forth certain statement of earnings 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.
 
   
2011
   
2010
 
   
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
  $ 20,253     $ 21,536     $ 21,062     $ 19,879     $ 20,318     $ 20,777     $ 20,412     $ 20,677  
Cost of sales
    12,286       12,828       12,293       12,666       12,471       11,953       11,919       12,812  
Gross profit
    7,967       8,708       8,769       7,213       7,847       8,824       8,493       7,865  
Selling, general and administrative
    5,847       5,546       5,651       5,641       5,904       6,118       5,889       6,102  
Amortization of purchased intangibles
    698       698       698       699       846       805       728       698  
Research and development
    535       460       380       274       440       414       529       559  
Loss on sale of assets
    1       1       2       30             39       72        
Other income (expense)
    (136 )     (141 )     (126 )     (127 )     (287 )     (161 )     (230 )     95  
Earnings before income taxes
    750       1,862       1,912       442       370       1,287       1,045       601  
Income tax expense
    292       677       771       162       226       505       274       228  
Net earnings
  $ 458     $ 1,185     $ 1,141     $ 280     $ 144     $ 782     $ 771     $ 373  
                                                                 
Earnings per share:
                                                               
Basic
  $ 0.01     $ 0.04     $ 0.03     $ 0.01     $ 0.00     $ 0.02     $ 0.02     $ 0.01  
Diluted
  $ 0.01     $ 0.04     $ 0.03     $ 0.01     $ 0.00     $ 0.02     $ 0.02     $ 0.01  
Weighted average shares outstanding:
                                                               
Basic
    33,338       33,418       33,442       33,455       33,213       33,266       33,276       33,280  
Diluted
    33,645       33,753       33,727       33,793       33,362       33,374       33,407       33,508  
 
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 $1.7 million under our Credit Agreement in the form of a Term Loan that is payable in equal monthly installments of approximately $278,000 plus interest through June 1, 2012.  Interest is payable at LIBOR plus 1.75%.  We have entered into a floating to fixed rate swap agreement that expires June 1, 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 June 1, 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 in excess of $6 million under our Revolver.  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.
 
 
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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.
 
Our Credit Agreement expires on October 31, 2012.  Continued disruption in U.S. and global markets could adversely affect our ability to renew or replace this Credit Agreement, and any new or replacement agreement may not be as favorable as the current Credit Agreement.  The negative impact of recent and continuing adverse changes in the economy and credit markets generally or our inability to obtain financing on favorable terms, if at all, may have a material adverse effect on our results of operations and business.
 
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. 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, 2011, 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. 
 
 
II-17

 
 
We assessed the effectiveness of our internal control over financial reporting as of December 31, 2011. 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, 2011, our internal control over financial reporting is effective based on those criteria.
 
Changes in Internal Control over Financial Reporting
 
During 2011, we have continued development of a corporate-wide Enterprise Resource Planning (“ERP”) system.  Our new ERP system is expected to standardize and automate business processes, to improve operational and financial performance, and to enhance internal controls.  We implemented our new ERP system at one of our four primary locations during the first quarter of 2011. The implementation of our new ERP system at this location has resulted in changes to our business processes and internal controls over financial reporting.
 
No changes in our internal control over financial reporting were identified as having occurred during the quarter ended December 31, 2011, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.  Further changes in our internal control over financial reporting are expected as we complete the implementation of our new ERP system at our remaining location.
 
 Item 9B. Other Information
 
None.
 
 
II-18

 
 
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, including Directors. 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 1, 2011. This report 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, 2011, 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
 
2.1
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).
 
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 September 14, 2011)
 
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 10.19
 
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 Bank, National Association, together with related Term Loan Note and Amended, Restated and Consolidated Line of Credit Note (incorporated by reference to Exhibit 10.1 of the Company’s report on Form 10-Q for the quarterly period ended July 5, 2009)
 
10.4A
First Amendment dated August 4, 2010 and effective as of June 30, 2010 to the Amended and Restated Credit Agreement dated May 27, 2009 among the Company, C.P. Medical Corporation, Galt Medical Corp., NeedleTech Products, Inc. and Wells Fargo Bank, National Association, successor in interest by merger to Wachovia Bank, National Association (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed August 6, 2010)
 
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 the Companys 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)
 
 
IV-2

 
 
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)
 
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 10.12F of the Company’s 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 3, 2011 with John Herndon* (incorporated by reference to Exhibit 10.12 of the Company’s Form 10-K for the year ended December 31, 2010)
 
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* (incorporated by reference to Exhibit 10.20A of the Company’s Form 10-K for the year ended December 31, 2008)
 
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
Theragenics Corporation Incentive Stock Option Award for 2008-2011 grants* (incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K dated February 25, 2008)
 
10.22
Restricted Stock Award for 2008-2011 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)
 
10.23
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

 
10.24
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).
 
10.24A
Amendment to Employment Agreement dated December 31, 2008, between NeedleTech Products, Inc. and Ronald Routhier* (incorporated by reference to Exhibit 10.36A of the Companys Form 10-K for the year ended December 31, 2008)
 
10.25
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)
 
10.25A
 Amendment to Employment Agreement dated December 31, 2008, between NeedleTech Products, Inc. and Russell Small* (incorporated by reference to Exhibit 10.37A of the Company’s Form 10-K for the year ended December 31, 2008)
 
10.26
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)
 
10.26A
 Amendment to Employment Agreement dated December 31, 2008, between CP Medical Corporation and Janet Zeman* (incorporated by reference to Exhibit 10.38 of the Company’s Form 10-K for the year ended December 31, 2008)
 
10.27
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)
 
10.28
Employment Agreement between Theragenics Corporation and Joseph Plante, dated as of January 6, 2011* (incorporated by reference to Exhibit 10.31 of the Company’s Form 10-K for the year ended December 31, 2010)
 
10.29
Theragenics Corporation Cash Incentive Plan* (incorporated by reference to Exhibit 10.31 of the Company’s Form 10-K for the year ended December 31, 2009)
 
10.30
Theragenics Corporation 2012 Omnibus Incentive Plan* (incorporated by reference to Exhibit 10.1 of the Company’s Form 8-K dated March 1, 2012)
 
23.1
Consent of Dixon Hughes Goodman LLP
 
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
 
101
Interactive Data Files providing financial information from the Registrant's Annual Report on Form 10-K for the year ended December 31, 2011 in XBRL (eXtensible Business Reporting Language).  Pursuant to Regulation 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Section 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Exchange Act of 1934, as amended, and are otherwise not subject to liability.
 
 
 
* 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 6, 2012
     
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
 
3/6/12
M. Christine Jacobs
 
(Principal Executive Officer)
   
   
President and Chairman
   
         
/s/ Francis J. Tarallo
   
Chief Financial Officer (Principal Financial
 
3/6/12
Francis J. Tarallo
 
and Accounting Officer) and Treasurer
   
         
/s/ Kathleen A. Dahlberg
   
Director
 
3/6/12
Kathleen A. Dahlberg
       
         
/s/ K. Wyatt Engwall
   
Director
 
3/6/12
K. Wyatt Engwall
       
         
/s/ John V. Herndon
   
Director
 
3/6/12
John V. Herndon
       
         
/s/ C. David Moody, Jr.
   
Director
 
3/6/12
C. David Moody, Jr.
       
         
/s/ Peter A.A. Saunders
   
Director
 
3/6/12
Peter A. A. Saunders
       
 
 
IV-5

 
 
THERAGENICS CORPORATION®
 
TABLE OF CONTENTS
 
   
Page
     
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
F-2
     
CONSOLIDATED FINANCIAL STATEMENTS
   
     
Consolidated Statements of Earnings and Comprehensive Earnings for each of the three years in the period ended December 31, 2011
 
F-3
     
Consolidated Balance Sheets as of December 31, 2011 and 2010
 
F-4
     
Consolidated Statements of Shareholders’ Equity for each of the three years in the period ended December 31, 2011
 
F-5
     
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2011
 
F-6
     
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
 
F-8
     
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, 2011
 
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, 2011 and 2010, and the related consolidated statements of earnings, comprehensive earnings, shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2011. 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, 2011 and 2010, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2011, in conformity with accounting principles generally accepted in the United States of America.
 
The Company was not required to have, nor were we engaged to perform, an examination of management’s assessment of the effectiveness of the Company’s internal control over financial reporting as of December 31, 2011, included in Management’s Report on Internal Control over Financial Reporting, referred to in Item 9A of the Company’s Annual report on Form 10-K, and, accordingly, we do not express an opinion thereon.
 
/s/ DIXON HUGHES GOODMAN LLP
 
Atlanta, Georgia
March 6, 2012
 
 
F-2

 
 
Theragenics Corporation and Subsidiaries
 
CONSOLIDATED STATEMENTS OF EARNINGS
AND COMPREHENSIVE EARNINGS
 
 Year ended December 31,
 
(Amounts in thousands, except per share data)
 
   
2011
   
2010
   
2009
 
Revenue
                 
Product sales
  $ 80,454     $ 80,683     $ 77,151  
License and fee income
    2,276       1,501       1,175  
      82,730       82,184       78,326  
Cost of sales
    50,073       49,155       44,953  
Gross profit
    32,657       33,029       33,373  
                         
Operating expenses
                       
Selling, general and administrative
    22,685       24,013       22,020  
Amortization of purchased intangibles
    2,793       3,077       3,441  
Research and development
    1,649       1,942       2,160  
Loss on sale of equipment
    34       111       3  
      27,161       29,143       27,624  
                         
Earnings from operations
    5,496       3,886       5,749  
                         
Other income (expense)
                       
Interest income
    162       99       25  
Interest expense
    (697 )     (976 )     (865 )
Other, net
    5       294       3  
      (530 )     (583 )     (837 )
                         
Earnings before income taxes
    4,966       3,303       4,912  
                         
Income tax expense
    1,902       1,233       1,837  
                         
NET EARNINGS
  $ 3,064     $ 2,070     $ 3,075  
                         
NET EARNINGS PER SHARE
                       
    Basic
  $ 0.09       0.06     $ 0.09  
    Diluted
  $ 0.09       0.06     $ 0.09  
                         
WEIGHTED AVERAGE SHARES
                       
    Basic
    33,414       33,259       33,145  
    Diluted
    33,820       33,485       33,269  
                         
COMPREHENSIVE EARNINGS
                       
  Net earnings
  $ 3,064       2,070       3,075  
  Other comprehensive earnings (loss), net of taxes
                       
      Reclassification adjustment for (gain) loss included in net earnings
    (2 )     1        
      Unrealized (loss) gain on securities arising during the year
    (26 )     11        
          Total other comprehensive (loss) earnings
    (28 )     12        
  Total comprehensive earnings
  $ 3,036       2,082       3,075  
 
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)
 
 
 
   
2011
   
2010
 
             
ASSETS
             
CURRENT ASSETS
           
Cash and cash equivalents
  $ 29,553     $ 29,674  
Marketable securities
    11,625       10,949  
Trade accounts receivable, less allowance of $2,757 in 2011 and $2,413 in 2010
    11,375       9,567  
Inventories
    15,771       13,116  
Deferred income tax asset
    2,028       1,843  
Refundable income taxes
    401        
Prepaid expenses and other current assets
    985       917  
Total current assets
    71,738       66,066  
                 
Property and equipment, net
    34,519       36,722  
Intangible assets, net
    9,459       12,319  
Other assets
    102       80  
                 
Total assets
  $ 115,818     $ 115,187  
 
LIABILITIES AND SHAREHOLDERS’ EQUITY
 
CURRENT LIABILITIES
           
Accounts payable
  $ 1,816     $ 1,887  
Accrued salaries, wages and payroll taxes
    2,861       2,340  
Short-term borrowings
    23,667       3,333  
Other current liabilities
    1,104       1,408  
Total current liabilities
    29,448       8,968  
                 
Long-term borrowings
          23,667  
Deferred income taxes
    1,043       1,213  
Asset retirement obligations
    807       749  
Other long-term liabilities
    398       311  
Total liabilities
    31,696       34,908  
                 
COMMITMENTS AND CONTINGENCIES
               
                 
SHAREHOLDERS’ EQUITY
               
Common stock - authorized 100,000 shares of $.01 par value; issued and outstanding, 33,991 in 2011 and 33,651 in 2010
    340       336  
Additional paid-in capital
    74,705       73,902  
Retained earnings
    9,093       6,029  
    Accumulated other comprehensive gain (loss)
    (16 )     12  
       Total shareholders’ equity
    84,122       80,279  
                 
Total liabilities and shareholders’ equity
  $ 115,818     $ 115,187  
 
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, 2011
 
(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
income (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  
                                                 
Issuance of restricted shares
    205       2       (2 )                  
                                                 
Employee stock purchase plan
    11             11                   11  
                                                 
Share-based compensation
                533                   533  
                                                 
Other comprehensive income
                            12       12  
                                                 
Net earnings for the year
                      2,070             2,070  
                                                 
Balance, December 31, 2010
    33,651     $ 336     $ 73,902     $ 6,029     $ 12     $ 80,279  
                                                 
Issuance of restricted shares
    298       3       (3 )                  
                                                 
Restricted shares retired
    (8 )           (14 )                 (14 )
                                                 
Employee stock purchase plan
    50       1       61                   62  
                                                 
Share-based compensation
                759                   759  
                                                 
Other comprehensive loss
                            (28 )     (28 )
                                                 
Net earnings for the year
                      3,064             3,064  
                                                 
Balance, December 31, 2011
    33,991     $ 340     $ 74,705     $ 9,093     $ (16 )   $ 84,122  
 
The accompanying notes are an integral part of these consolidated statements.
 
 
F-5

 
 
 Theragenics Corporation and Subsidiaries
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
Year ended December 31,
 
(Amounts in thousands)
 
   
2011
   
2010
   
2009
 
Cash flows from operating activities:
                 
Net earnings
  $ 3,064       2,070     $ 3,075  
Adjustments to reconcile net earnings to net cash provided by operating activities:
                       
Depreciation and amortization
    7,225       7,207       6,927  
Deferred income taxes
    (338 )     (907 )     421  
Share-based compensation
    759       533       450  
Provision for allowances
    396       1,959       (82 )
(Gain) loss on marketable securities
    (2 )     1       2  
Decommissioning retirement liability
    58       53       50  
Loss on sale of equipment
    34       111       3  
   Changes in assets and liabilities:
                       
Accounts receivable
    (2,156 )     (2,628 )     (462 )
Inventories
    (2,703 )     (1,379 )     108  
Refundable income taxes
    (401 )     645       859  
Prepaid expenses and other current assets
    (68 )     (60 )     272  
Other assets
    (22 )     6       (7 )
Trade accounts payable
    (28 )     (1 )     408  
Accrued salaries, wages and payroll taxes
    521       37       335  
Income taxes payable
    (8 )     8       (209 )
Other current liabilities
    (328 )     342       (838 )
Other
    87       (111 )     275  
                         
Net cash provided by operating activities
    6,090       7,886       11,587  
                         
Cash flows from investing activities:
                       
Purchases and construction of property and equipment
    (2,026 )     (9,065 )     (4,980 )
Proceeds from sale of equipment
    36       7        
Purchases of marketable securities
    (10,879 )     (14,927 )      
Maturities of marketable securities
    9,575       3,095       500  
Proceeds from sales of marketable securities
    368       674       1,005  
                         
Net cash used in investing activities
    (2,926 )     (20,216 )     (3,475 )
 
 
F-6

 
 
Theragenics Corporation and Subsidiaries
 
CONSOLIDATED STATEMENTS OF CASH FLOWS - Continued
 
Year ended December 31,
 
(Amounts in thousands)
 
   
2011
   
2010
   
2009
 
Cash flows from financing activities:
                 
Repayment of borrowings
    (3,333 )     (3,333 )     (1,667 )
Loan fees on refinancing of credit facility
                (225 )
Retirement of common stock
    (14 )           (8 )
Proceeds from stock purchase plan
    62       11       26  
                         
Net cash used by financing activities
    (3,285 )     (3,322 )     (1,874 )
                         
Net (decrease) increase in cash and cash equivalents
    (121 )     (15,652 )     6,238  
                         
Cash and cash equivalents at beginning of year
    29,674       45,326       39,088  
                         
Cash and cash equivalents at end of year
  $ 29,553     $ 29,674     $ 45,326  
                         
Supplementary Cash Flow Disclosure
                       
                         
Interest paid
  $ 806     $ 920     $ 842  
Income taxes paid
  $ 2,650     $ 1,486     $ 766  
                         
Non-cash investing and financing activities:
                       
                         
Liability for property and equipment acquired
  $ 32     $ 43     $ 433  
 
The accompanying notes are an integral part of these consolidated statements.
 
 
F-7

 
 
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, markets, and distributes “seeds” used primarily in the minimally invasive treatment of localized prostate cancer. Our brachytherapy product line includes our palladium-103 TheraSeed® device, the iodine-125 based device I-Seed, and other related products and services, all of 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 Corporation and our wholly owned subsidiaries.  We have no unconsolidated entities and no special purpose entities.  All significant intercompany accounts and transactions have been eliminated in consolidation.
 
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 the 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 collectability 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-8

 
 
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 income (loss).
 
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 collectability of the amounts. Outstanding receivables are considered past due based upon invoice due dates. The collectability 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,
 
   
2011
   
2010
 
             
Raw materials
  $ 7,756     $ 5,709  
Work in progress
    3,724       2,423  
Finished goods
    3,988       4,625  
Spare parts and supplies
    920       928  
      16,388       13,685  
Allowance for obsolete inventory
    (617 )     (569 )
Inventories, net
  $ 15,771     $ 13,116  
 
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. Estimated service lives are 30 years for buildings and improvements, and 3 to 15 years for machinery, equipment, furniture, and land improvements. 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.
 
10. Impairment of Long-Lived Assets
 
We 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 or 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.
 
 
F-9

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
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 asset carrying value will be adjusted to its fair value. 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, 2011.
 
11. Intangible Assets
 
Our intangible assets are determined to have finite lives and 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.
 
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, 2011 and 2010. 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.
 
14. Earnings Per Share
 
Basic net earnings per common share is based upon the weighted average number of common shares outstanding during the period. Diluted net earnings 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.
 
 
F-10

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
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 $504,000, $799,000 and $1,365,000 for the years ended December 31, 2011, 2010 and 2009, 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 $1.3 million, $1.5 million, and $1.4 million for the years ended December 31, 2011,  2010, and 2009, respectively.
 
19. Recently Issued Accounting Standard
 
In June 2011, the Financial Accounting Standards Board (“FASB”) issued an accounting standards update that eliminates the current option to present the components of other comprehensive income as part of the statement of changes in shareholders’ equity.  Under this statement, we can elect to present the total of comprehensive income, the components of net income, and the components of other comprehensive income in a single continuous statement of comprehensive income or in two separate but consecutive statements.  This statement will be effective for us in our first quarter 2012 Form 10-Q and will be applied retrospectively to all prior periods presented.
 
20. Reclassifications
 
We reclassified certain prior year amounts to conform to the current year presentation.  These reclassifications did not affect the total consolidated amounts previously reported.
 
 
F-11

 

Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
NOTE C – PROPERTY AND EQUIPMENT
 
Property and equipment is summarized as follows (in thousands):
 
   
December 31,
 
   
2011
   
2010
 
Buildings and improvements
  $ 29,251     $ 29,230  
Machinery and equipment
    48,170       45,842  
Office furniture and equipment
    1,251       1,209  
Land improvements
    992       992  
      79,664       77,273  
Less accumulated depreciation
    47,837       43,770  
      31,827       33,503  
Land
    1,368       1,373  
Construction in progress
    1,324       1,846  
                 
Property and equipment, net
  $ 34,519     $ 36,722  
 
Construction in progress consists primarily of costs capitalized for the development of enterprise resource planning software for our internal use. Depreciation expense related to property and equipment charged to operations was approximately $4,148,000, $3,834,000 and $3,446,000 for 2011, 2010 and 2009, respectively. We capitalized $39,000, $113,000, and $37,000 of interest expense in 2011, 2010, and 2009, respectively, during the construction of our major capital projects.
 
NOTE D FINANCIAL INSTRUMENTS
 
Interest Rate Swaps
 
We are exposed to certain risks relating to our ongoing business operations. Since 2009 we have managed 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 adjustments to interest expense in our consolidated statements of earnings.  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.
 
A roll forward of the notional value of our interest rate swaps for the two years ended December 31, 2011 is as follows (in thousands):
 
Balance, December 31, 2009
 
$
 14,333
 
Matured contracts
   
 (3,333
Balance, December 31, 2010
 
$
11,000
 
Matured contracts
   
   (3,333
Balance, December 31, 2011
 
$
    7,667
 
 
The location and fair value of our derivative financial instruments not designated as hedging instruments in our consolidated balance sheets were as follows (in thousands):
 
 
 
 
 
 
December 31,
 
Type
 
Maturity
 
Balance Sheet Location
 
2011
   
2010
 
Interest rate swaps
 
June 2012
 
Other current liabilities
  $ 57        
Interest rate swaps
 
June 2012
 
Other long-term liabilities
  $     $ 187  
 
 
F-12

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
The following table includes information about gains and losses recognized on our derivative financial instruments not designated as hedging instruments in our consolidated statements of earnings (in thousands):
 
   
 
 
Location of
   
Year Ended December 31,
 
(Gain) Loss
                   
Recognized in
   
2011
   
2010
   
2009
 
Income
Periodic settlements
  $ 145     $ 192     $ 112  
Interest expense
Change in fair value
  $ (130 )   $ 107     $ 80  
Interest expense
 
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. 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.
 
Available-for-sale securities consisted of the following (in thousands):
 
   
December 31,
 
   
2011
   
2010
 
   
Amortized
Cost
   
Gross
Unrealized
Gain (Loss)
   
Estimated Fair Value
   
Amortized
Cost
   
Gross
Unrealized
Gain (Loss)
   
Estimated
Fair
Value
 
US Treasury and other US government securities
  $ 4,308     $ 6     $ 4,314     $ 4,373     $ 4     $ 4,377  
State and municipal securities
    689       4       693       1,014       (3 )     1,011  
Corporate and other securities
    6,654       (36 )     6,618       5,542       19       5,561  
Total
  $ 11,651     $ (26 )   $ 11,625     $ 10,929     $ 20     $ 10,949  
 
The estimated fair value of marketable securities by contractual maturity at December 31, 2011 is as follows (in thousands):
 
Due in one year or less
  $ 6,218  
Due after one year through five years
    5,407  
Total
  $ 11,625  
 
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.
 
 
F-13

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
•  
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, 2011
                       
Money market funds
  $ 8,483     $     $     $ 8,483  
Marketable securities
    11,625                   11,625  
Total assets
  $ 20,108     $     $     $ 20,108  
                                 
Interest rate swaps
  $     $ (57 )   $     $ (57 )
                                 
December 31, 2010
                               
Money market funds
  $ 8,053     $     $     $ 8,053  
Marketable securities
    10,949                   10,949  
Total assets
  $ 19,002     $     $     $ 19,002  
                                 
Interest rate swaps
  $     $ (187 )   $     $ (187 )
 
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 from the values that would have been used had a ready market for our interest rate swaps existed.
 
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 estimate that the carrying value of our borrowings approximates fair value at December 31, 2011.
 
Other Fair Value Measurements
 
There were no nonfinancial assets or nonfinancial liabilities measured at fair value at December 31, 2011 or 2010.
 
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.  We maintain our cash and cash equivalents with a limited number of 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 N.
 
 
F-14

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
NOTE E - INTANGIBLE ASSETS
 
Intangible assets include the following (in thousands):
 
   
December 31, 2011
 
December 31, 2010
   
   
 
Gross
Carrying
Amount
 
Accum
Amort
 
Net
Book
Value
 
Gross
Carrying
Amount
 
Accum
Amort
 
Net
Book
Value
 
Weighted
Average
Life
                                   
Customer relationships
 
$
16,268
 
10,019
 
6,249
 
$
16,268
 
7,854
   
8,414
 
8 years
Tradenames
   
3,240
 
972
 
2,268
   
3,240
 
648
   
2,592
 
10 years
Non-compete agreements
   
3,543
 
3,244
 
299
   
3,543
 
3,056
   
487
 
5 years
Developed technology
   
1,260
 
691
 
569
   
1,260
 
576
   
684
 
12 years
Loan fees and other
   
260
 
186
 
74
   
260
 
118
   
142
 
5 years
   
$
24,571
 
15,112
 
9,459
 
$
24,571
 
12,252
   
12,319
   
 
At December 31, 2011, the weighted average life of intangible assets subject to amortization was 8 years.
 
As of December 31, 2011, future approximate aggregate amortization expense for intangible assets subject to amortization is as follows (in thousands):
 
Year Ending
December 31,
       
2012
 
$
2,815
 
2013
   
2,664
 
2014
   
1,672
 
2015
   
1,029
 
2016
   
390
 
Beyond
   
889
 
   
$
9,459
 
 
NOTE F - 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  
   
2011
   
2010
 
Asset retirement obligation at beginning of period
  $ 749     $ 696  
Accretion expense
    58       53  
Asset retirement obligation at end of period
  $ 807     $ 749  
 
 
F-15

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
NOTE G - 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”).  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, 2011. The Term Loan is payable in thirty-six equal monthly installments of principal plus interest at LIBOR plus 1.75%, commencing July 1, 2009 through June 1, 2012.  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, as amended, as of December 31, 2011.
 
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, 2011 was 3.0%.
 
NOTE H - INCOME TAXES
 
The income tax provision consisted of the following (in thousands):
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Current
                 
Federal
  $ 1,965     $ 1,901     $ 1,276  
State
    275       239       140  
      2,240       2,140       1,416  
Deferred
                       
Federal
    (299 )     (691 )     340  
State
    (213 )     (234 )     152  
Change in allowance
    174       18       (71 )
      (338 )     (907 )     421  
Income tax expense
  $ 1,902     $ 1,233     $ 1,837  
 
 
F-16

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
Our temporary differences are summarized as follows (in thousands):
 
   
December 31,
 
   
2011
   
2010
 
Deferred tax assets:
           
Goodwill and intangible assets
  $ 1,669     $ 1,251  
Inventories
    451       408  
Non-deductible accruals and allowances
    1,428       1,185  
Net operating loss carryforwards
    180       209  
Asset retirement obligation
    299       276  
Share-based compensation
    207       143  
Tax credit carryforwards
    205       140  
Capital loss carryforwards
    121       136  
Other
    76       192  
Gross deferred tax assets
    4,636       3,940  
Deferred tax liabilities:
               
Property and equipment
    (3,311 )     (3,137 )
Other
          (7 )
Gross deferred tax liabilities
    (3,311 )     (3,144 )
                 
Valuation allowance
    (340 )     (166 )
                 
Net deferred tax asset
  $ 985     $ 630  
 
The net deferred tax asset is classified in our accompanying consolidated balance sheets as follows (in thousands):
 
      December 31,  
    2011     2010  
Current deferred tax asset
  $ 2,028     $ 1,843  
Long-term deferred tax liability
    (1,043 )     (1,213 )
Net deferred tax asset (liability)
  $ 985     $ 630  
 
Activity in the valuation allowance for deferred tax assets is as follows (amounts in thousands):
 
   
Year ended December 31,
 
   
2011
 
2010
 
2009
 
Valuation allowance, beginning of period
 
$
166
 
148
 
$
219
 
Increase in allowance
   
174
 
18
   
 
Release of allowance
   
 
   
(71
)
Valuation allowance, end of period
 
$
340
 
166
 
$
148
 
 
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, 2011 relates primarily to certain capital loss carryforwards and certain state net operating loss carryforwards for which we believe it is more likely than not that the benefit will not be realized.
 
 
F-17

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
A reconciliation of the statutory federal income tax rate and our effective tax rate follows:
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Tax expense at applicable federal rates
    34.0 %     34.0 %     34.0 %
State tax, net of federal tax effect
    2.6       2.8       2.9  
Non-deductible share-based compensation
    2.2       3.0       3.0  
Non-deductible lobbying expenses
    .3       1.1       1.7  
Non-deductible compensation (162m)
    2.3       2.4        
Valuation allowance
    3.5              
Domestic production deduction
    (4.2 )     (5.0 )     (1.8 )
Federal tax credits
    (1.1 )     (2.0 )     (2.2 )
State investment tax credit
    (2.0 )     (1.4 )      
Other
    .7       2.4       (0.2 )
Effective tax expense
    38.3 %     37.3 %     37.4 %
 
Substantially all our state net operating loss carryforwards expire in 2025.
 
We account for investment tax credits under the flow-though method, which results in the recognition of the credit as a reduction of income taxes in the year in which the credit arises. We have state investment tax credit carryforwards of $205,000, which expires in 2020.
 
We have evaluated our tax positions for the tax years ended December 31, 2008, 2009 and 2010, the tax years that remain subject to examination by major tax jurisdictions as of December 31, 2011. 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 2008. We have concluded that there are no significant uncertain tax positions requiring recognition in our consolidated financial statements.
 
NOTE I - 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 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 earnings.
 
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 July 2025. 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 earnings. Minimum annual royalties are based on the contract year, which ends each May, and are $450,000 for the contract year ended May 31, 2012, and $1 million annually thereafter through July 2025.
 
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.
 
 
F-18

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
Lease Commitments and Obligations
 
We lease equipment and production, warehouse, office and other space under non-cancelable leases that expire at various dates through August 2016. Approximate minimum lease payments under the leases are as follows: 2012, $443,000; 2013, $206,000; 2014, $26,000; 2015, $7,000; and 2016, $5,000.
 
Rent expense was approximately $578,000, $819,000 and $976,000 for the years ended December 31, 2011, 2010 and 2009, respectively.
 
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.
 
NOTE J – 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, 2011 there were 710,032 shares 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, 2011 (shares in thousands):
 
   
Shares
   
Weighted
average
exercise
price
   
Weighted
average
remaining
contractual
life (yrs)
   
Aggregate
intrinsic
value
 
Outstanding, beginning of period
    1,258     $ 3.27              
Granted
    424       1.71              
Exercised
                       
Forfeited
    (2 )     3.95              
Expired
    (10 )     5.38              
Outstanding, end of period
    1,670     $ 2.86       6.2     $ 273  
Exercisable at end of period
    832     $ 4.13       4.0     $ 116  
 
A summary of grant date fair values and intrinsic values follows (in thousands, except per share amounts):
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Weighted average grant date fair value of options granted
  $ 1.15     $ 0.96     $ 0.58  
Total intrinsic value of options exercised
  $ N/A     $ N/A     $ N/A  
Total fair value of options vested
  $ 282     $ 196     $ 195  
 
The fair values were estimated using the Black-Scholes options-pricing model with the following weighted average assumptions:
 
   
2011
   
2010
   
2009
 
Expected dividend yield
    0.0 %     0.0 %     0.0 %
Expected stock price volatility
    62.8 %     63.4 %     60.7 %
Risk-free interest rate
    3.0 %     3.3 %     2.7 %
Expected life of option (years)
    8.0       8.0       7.0  
                         
 
 
F-19

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
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 $368,000, $272,000 and $184,000 for the year ended December 31, 2011, 2010 and 2009, respectively. As of December 31, 2011, there was approximately $356,000 of unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over a weighted average period of approximately two years.
 
We may issue restricted stock to employees, directors and others. Non-vested restricted stock is included in our outstanding common shares. 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, 2011 follows (shares in thousands):
Non-vested Restricted Stock
 
Shares
   
Weighted
average grant
date fair
value
 
Non-vested at January 1, 2011
    364     $ 1.76  
Granted
    298       1.76  
Vested
    (131 )     2.20  
Forfeited
           
Non-vested at December 31, 2011
    531     $ 1.65  
 
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 $1.76, $1.43, and $.94 in 2011, 2010, and 2009, respectively. Compensation expense related to the restricted stock totaled approximately $379,000, $257,000, and $262,000 in 2011, 2010 and 2009, respectively. As of December 31, 2011, there was approximately $371,000 of unrecognized compensation cost related to the restricted shares, which is expected to be recognized over a weighted average period of approximately two years.
 
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 $12,000, $4,000 and $4,000 in 2011, 2010 and 2009, respectively.   250,000 shares of Common Stock are authorized under our current ESPP, and 186,100 shares remained available for issuance under the ESPP at December 31, 2011.
 
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 the then current market prices.
 
NOTE K – 401(K) SAVINGS PLANS
 
We sponsor a 401(k) defined contribution retirement savings plan for our employees. Matching contributions were made in Company stock in 2011.  Prior to 2011, we sponsored more than one 401(k) defined contribution retirement savings plans for our employees, and matching contributions were made in stock or in cash in 2010 and 2009.  Matching contributions are charged to operating expenses and totaled approximately $297,000, $222,000 and $325,000 in 2011, 2010, and 2009, respectively.
 
 
F-20

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
NOTE L – EARNINGS PER SHARE
 
Earnings per common share was computed as follows (in thousands, except per share data):
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Net earnings
  $ 3,064       2,070     $ 3,075  
                         
Weighted average common shares outstanding
    33,414       33,259       33,145  
Incremental common shares issuable from stock options and awards
    406       226       124  
Weighted average common shares outstanding assuming dilution
    33,820       33,485       33,269  
                         
Basic earnings per share
  $ 0.09       0.06     $ 0.09  
Diluted earnings per share
  $ 0.09       0.06     $ 0.09  
 
Diluted earnings per share does not include the effect of certain stock options and awards as their impact would be anti-dilutive. Approximately 1,077,000, 1,011,000 and 864,000 stock options and awards for the years ended December 31, 2011, 2010 and 2009, respectively, were not included in the computation of diluted earnings per share for those years because their effect would be anti-dilutive.
 
NOTE M - 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 distributes “seeds” primarily in the minimally invasive treatment of localized prostate cancer.  Our brachytherapy product line includes our palladium-103 TheraSeed® device and our iodine-125 based devices, all of which are used primarily in the minimally invasive treatment of localized prostate cancer and services.
 
 The following tables provide certain information for these segments (in thousands):
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Revenue
                 
Surgical products
  $ 59,409       59,027     $ 53,660  
Brachytherapy seed
    24,077       23,752       24,966  
Intersegment eliminations
    (756 )     (595 )     (300 )
    $ 82,730       82,184     $ 78,326  
                         
Earnings from operations
                       
Surgical products
  $ 607       215     $ 1,664  
Brachytherapy seed
    4,923       3,685       4,081  
Intersegment eliminations
    (34 )     (14 )     4  
    $ 5,496       3,886     $ 5,749  
                         
Capital expenditures,
                       
Surgical products
  $ 1,780       8,316     $ 3,934  
Brachytherapy seed
    246       749       1,046  
    $ 2,026       9,065     $ 4,980  
                         
Depreciation and amortization
                       
Surgical products
  $ 4,536       4,686     $ 4,851  
Brachytherapy seed
    2,689       2,521       2,076  
    $ 7,225       7,207     $ 6,927  
 
 
F-21

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
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. Corporate expenses are allocated based upon the relative revenue for each segment.
 
Segment information related to significant assets follows (in thousands):
   
December 31,
 
   
2011
   
2010
 
Identifiable assets
           
Surgical products
  $ 72,475     $ 71,944  
Brachytherapy seed
    60,791       63,699  
Corporate investment in subsidiaries
    111,439       111,439  
Intersegment eliminations
    (128,887 )     (131,895 )
    $ 115,818     $ 115,187  
                 
Intangible assets
               
Surgical products
  $ 9,404     $ 12,198  
Brachytherapy seed
    55       121  
    $ 9,459     $ 12,319  
                 
 
Segment information for capital expenditures and identifiable assets for periods prior to 2011 have been reclassed to be consistent with the manner in which the 2011 corporate assets were classified.
 
Information regarding revenue by geographic regions follows (in thousands):
 
   
Year ended December 31,
 
   
2011
   
2010
   
2009
 
Product sales
                 
United States
  $ 70,836     $ 71,853     $ 69,330  
Europe
    7,663       7,544       6,140  
Other foreign countries
    1,955       1,286       1,681  
      80,454       80,683       77,151  
License and fee income
                       
United States
    953       603       507  
Canada
    1,323       898       668  
      2,276       1,501       1,175  
                         
    $ 82,730     $ 82,184     $ 78,326  
 
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 N - DISTRIBUTION AGREEMENTS AND MAJOR CUSTOMERS
 
Our brachytherapy seed business sells our TheraSeed® device directly to healthcare providers and to third-party distributors.  Under our third-party distribution agreements, we are the exclusive palladium-103 seed supplier for the treatment of prostate cancer for each distributor, and each distributor has the non-exclusive right to sell TheraSeed® in the U.S. and Canada.  Certain agreements also provide distributors with rights to distribute TheraSeed® for the treatment of solid localized tumors other than in the prostate and with rights to distribute to certain locations outside of North America.  Such applications (non-prostate and outside of North America) have not been material.  Our principal non-exclusive distribution agreement is with C. R. Bard (“Bard”).  Our agreement with Bard provides 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, 2013 and will be automatically extended for one additional year unless either party gives notice of its intent not to extend by December 31, 2012.   Sales to Bard under the Bard agreement represented approximately 28%, 33% and 44% of brachytherapy segment revenue in 2011, 2010, and 2009, 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 10%, 11% and 16% of consolidated revenue in 2011, 2010, and 2009, respectively.  Accounts receivable from Bard represented approximately 19% of brachytherapy accounts receivable at both December 31, 2011 and 2010 and 6% and 10% of consolidated accounts receivable at December 31, 2011 and 2010, respectively.
 
 
F-22

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
Core Oncology (“Core”) became an additional non-exclusive distributor of TheraSeed® in January 2010.  In February 2011, we terminated our agreement with Core due to Core’s failure to satisfy its financial obligation to us in accordance with the contractual terms of the agreement. Core had been attempting to become current with amounts due to us.  However, litigation filed against Core by a third party in January 2011 created what we viewed as an unacceptable level of uncertainty surrounding Core’s ability to satisfy their financial obligations to us for both current and ongoing sales.  Subsequent to termination of the agreement, we continued to supply TheraSeed® to Core on a prepaid basis.  Sales to Core in our brachytherapy segment totaled approximately 8% and 14% of total brachytherapy seed segment revenue for in 2011 and 2010, respectively.  In the latter half of 2011, certain customers who previously purchased TheraSeed® through Core began purchasing either from us on a direct basis or through one of our other TheraSeed® distributors. On February 2012, we acquired Core's prostate brachytherapy customer base. See Note R. Brachytherapy accounts receivable due from Core at December 31, 2011 and 2010 totaled $1.8 million and $1.7 million, respectively (consolidated accounts receivable due from Core totaled $2.2 million and $2.1 million at December 31, 2011, and 2010, respectively).  An allowance for doubtful accounts has been established for all unpaid amounts due from Core at December 31, 2011 and 2010.
 
NOTE O – NON-OPERATING INCOME/(EXPENSE)
 
Other non-operating income/(expense) consists of the following (in thousands):
 
   
Year Ended December 31,
 
   
2011
   
2010
   
2009
 
Litigation settlement
  $     $ 200     $  
Gain (loss) on marketable securities
    2       (2 )     (2 )
Other
    3       96       5  
Total other
  $ 5       294     $ 3  
 
NOTE P - RELATED PARTY TRANSACTIONS
 
During 2010 and 2009, we utilized the services of a real estate firm whose principal owner is related to one of our executive officers. Payments of $131,000 and $99,000 were made to this firm during 2010 and 2009 for construction and real estate consulting services. No such payments were made in 2011.
 
 
NOTE Q - QUARTERLY FINANCIAL DATA (UNAUDITED)
 
The following summarizes certain quarterly results of operations (in thousands, except per share data):
 
Year ended December 31, 2011:
  Quarter ended  
    March 31     June 30     September 30     December 31  
Net revenue
  $ 20,253     $ 21,536     $ 21,062     $ 19,879  
Gross profit
    7,967       8,708       8,769       7,213  
Net earnings
    458       1,185       1,141       280  
Net earnings  per common share
                               
Basic
  $ 0.01     $ 0.04     $ 0.03     $ 0.01  
Diluted
  $ 0.01     $ 0.04     $ 0.03     $ 0.01  
                                 
Year ended December 31, 2010:
  Quarter ended  
   
March 31
   
June 30
   
September 30
   
December 31
 
Net revenue
  $ 20,318     $ 20,777     $ 20,412     $ 20,677  
Gross profit
    7,847       8,824       8,493       7,865  
Net earnings
    144       782       771       373  
Net earnings per common share
                               
Basic
  $ 0.00     $ 0.02     $ 0.02     $ 0.01  
Diluted
  $ 0.00     $ 0.02     $ 0.02     $ 0.01  
 
 
F-23

 
 
Theragenics Corporation and Subsidiaries
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
 
NOTE R – SUBSEQUENT EVENT
 
Acquisition of Core Oncology’s Prostate Brachytherapy Customer Base
 
On February 17, 2012, we acquired Core Oncology’s prostate brachytherapy customer base.  This transaction is expected to substantially increase our share of the iodine-125 segment of the prostate brachytherapy market. In addition to the customer base, we also acquired certain packaging technologies.  We did not acquire Core’s facilities, manufacturing equipment or processes, or Core’s employees.  The total earn-out based purchase price is expected to be approximately $7.5 million to $10.5 million. We paid $3.8 million in cash as a prepayment of a portion of the earn-out at closing and will make six quarterly earn-out payments thereafter, beginning in June 2012.
 
 
F-24

 
 
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, 2011, as referred to in our report dated February 28, 2012, 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 GOODMAN LLP
 
Atlanta, Georgia
 
March 6, 2012
 
 
S-1

 
 
Theragenics Corporation and Subsidiaries
 
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
 
For each of the three years in the period ended December 31, 2011
(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, 2011
                             
Allowance for doubtful accounts receivable
  $ 2,413     $ 348     $     $ 4 (c)   $ 2,757  
                                         
Allowance for obsolete inventory
  $ 569     $ 89     $     $ 41 (d)   $ 617  
                                         
Year ended December 31, 2010
                                       
Allowance for doubtful accounts receivable
  $ 384     $ 2,060     $     $ 31 (c)   $ 2,413  
                              18 (a)        
Allowance for obsolete inventory
  $ 670     $     $     $ 83 (d)   $ 569  
                                         
Year ended December 31, 2009
                                       
                              5 (b)        
Allowance for doubtful accounts receivable
  $ 481     $     $     $ 92 (c)   $ 384  
Allowance for obsolete inventory
  $ 747     $ 251     $     $ 328 (d)   $ 670  
 
(a) - reduction in allowance for obsolete inventory amounts
(b) – reduction in allowance for doubtful accounts receivable amounts
(c) - write-off of uncollectible amounts
(d) - disposal of inventory
 
 
S-2