-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Vfx4NKv0z/gMj2BpTDA+vyXMOgtwVrq27Rz/t6Gls/hsDnYM+TggkV8rYGbS016z 4ukGrX+tKEwTTRepVixxIw== 0001193125-07-203879.txt : 20070920 0001193125-07-203879.hdr.sgml : 20070920 20070919180833 ACCESSION NUMBER: 0001193125-07-203879 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20070630 FILED AS OF DATE: 20070920 DATE AS OF CHANGE: 20070919 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UROLOGIX INC CENTRAL INDEX KEY: 0000882873 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411697237 STATE OF INCORPORATION: MN FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28414 FILM NUMBER: 071125472 BUSINESS ADDRESS: STREET 1: 14405 21ST AVE N CITY: MINNEAPOLIS STATE: MN ZIP: 55447 BUSINESS PHONE: 6124751400 MAIL ADDRESS: STREET 1: 14405 21ST AVENUE NORTH CITY: MINNEAPOLIS STATE: MN ZIP: 55447 10-K 1 d10k.htm FORM 10-K Form 10-K
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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 June 30, 2007.

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

     For the transition period from              to             .

 

Commission File Number 0-28414

 


 

UROLOGIX, INC.

(Exact name of registrant as specified in its charter)

 


 

Minnesota   41-1697237

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

 

14405 21st Avenue North, Minneapolis, MN 55447

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (763) 475-1400

 

Securities registered pursuant to Section 12(b) of the Act:

Common Stock, $.01 par value

Series A Junior Participating Preferred Stock Purchase Rights

 

Name of Exchange on Which Registered: The NASDAQ Stock Market LLC

 

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

 


 

Indicate by check mark whether the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act:     Yes  ¨    No  x

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act:    Yes  ¨    No  x

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

 

Indicate by check mark 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 or a non-accelerated filer. See definition of “accelerated filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act:

 

Large Accelerated Filer    ¨ Accelerated Filer    ¨ Non-Accelerated Filer    x

 

The aggregate value of the Company’s Common Stock held by non-affiliates of the Company was approximately $33,315,875 as of the last day of the Company’s most recently completed second fiscal quarter, when the last reported sales price was $2.35.

 

As of September 1, 2007, the Company had outstanding 14,333,350 shares of Common Stock, $.01 par value.

 



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DOCUMENTS INCORPORATED BY REFERENCE

 

Certain information is incorporated into Part III of this report by reference to the Proxy Statement for the Registrant’s 2007 Annual Meeting of Shareholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K.

 

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TABLE OF CONTENTS

 

PART I         

Item 1.

  

Business

  4

Item 1A.

  

Risk Factors

  11

Item 1B.

  

Unresolved Staff Comments

  18

Item 2.

  

Properties

  18

Item 3.

  

Legal Proceedings

  18

Item 4.

  

Submission of Matters to a Vote of Security Holders

  18
PART II         

Item 5.

  

Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

 

19

Item 6.

  

Selected Financial Data

  20

Item 7.

  

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

  23

Item 7A.

  

Quantitative and Qualitative Disclosures about Market Risk

  32

Item 8.

  

Financial Statements and Supplementary Data

  33

Item 9.

  

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

  50

Item 9A.

  

Controls and Procedures

  50

Item 9B.

  

Other Information

  50
PART III         

Item 10.

  

Directors, Executive Officers and Corporate Governance

  51

Item 11.

  

Executive Compensation

  51

Item 12.

  

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

51

Item 13.

  

Certain Relationships and Related Transactions, and Director Independence

  51

Item 14.

  

Principal Accountant Fees and Services

  51
PART IV         

Item 15.

  

Exhibits and Financial Statement Schedules

  52
SIGNATURES   53

 

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PART I

 

Forward-Looking Statements

 

Statements included in this Annual Report on Form 10-K that are not historical or current facts are forward-looking statements. In addition, our officers may make forward-looking statements in the future. We wish to caution readers that these statements are not predictions of actual future results. Our actual results could differ materially from any such forward-looking statements as a result of risks and uncertainties, including those set forth below in Item 1A “Risks Factors” and in other documents we file from time to time with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q. Any such forward-looking statements reflect management’s opinions only as of the date of this Annual Report on Form 10-K, and we undertake no obligation to update any such forward-looking statements.

 

ITEM 1. BUSINESS

 

Overview

 

Urologix develops, manufactures, and markets non-surgical, catheter-based therapies that use a proprietary cooled microwave technology for the treatment of benign prostatic hyperplasia (BPH), a disease that affects more than 23 million men worldwide. We market our control units under the Targis,® Prostatron® and CoolWave® names and our procedure kits under the CTC™, Targis and Prostaprobe™ names. We are also in the process of developing our next generation catheter, CoolMax™, in which we are planning to combine durability with increased patient comfort. All systems utilize the Company’s Cooled ThermoTherapy technology, a targeted microwave energy combined with a unique cooling mechanism that protects healthy tissue and enhances patient comfort while providing safe, effective, lasting relief from the symptoms of BPH. Cooled ThermoTherapy can be performed without anesthesia or intravenous sedation and can be performed in a physician’s office or an outpatient clinic. We believe that Cooled ThermoTherapy provides an efficacious, safe and cost-effective solution for BPH with results clinically superior to medication and without the complications and side effects inherent in surgical procedures.

 

We maintain a website at www.urologix.com. Our annual reports on Form 10-K, our quarterly reports on Form 10-Q and our periodic reports on Form 8-K (and any amendments to these reports) are available free of charge on our website as soon as reasonably practical after we file these reports with the SEC. To obtain copies of these reports, go to www.urologix.com.

 

Benign Prostatic Hyperplasia

 

BPH is a non-cancerous disease in which the prostate enlarges and constricts the urethra causing adverse changes in urinary voiding patterns. The prostate is a walnut-size gland surrounding the male urethra (the channel that carries urine from the bladder out of the body) that is located just below the bladder and adjacent to the rectum. While the actual cause of BPH is not fully understood, it is known that as men reach middle age, cells within the prostate begin to grow at an increasing rate. As the prostate expands, it compresses or impinges upon other portions of the prostate gland and the urethra, thereby restricting the normal passage of urine. BPH patients typically suffer from a variety of troubling symptoms that can have a significant impact on their quality of life. Symptoms of BPH include frequent urination during the day and night, urgency and painful urination. A delay in treatment can have serious consequences, including complete obstruction (acute retention of urine), urinary tract infections, loss of bladder functions and, in extreme cases, kidney failure.

 

BPH generally affects men after the age of 50. Medical experts suggest that nearly every man will be affected by this condition at some time in his life. The BPH market is large and can be expected to continue to grow due to the general aging of the world’s population as well as increasing life expectancies.

 

Due in part to the side effects and complications associated with traditional BPH therapies, many patients diagnosed with BPH are regularly monitored by their physicians but elect not to receive active intervention. This

 

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course of inaction is known as “watchful waiting.” If symptoms persist or worsen, drug therapy or surgical intervention has historically been recommended. Drug therapy is usually the first line of treatment. It is estimated that more than 20% of patients who initially pursue drug therapy discontinue treatment within 12 months due to various reasons including cost, ineffectiveness, side effects and the burdens of compliance. Patients may also try multiple drugs or combinations of drugs to improve effectiveness. This leads to a more costly treatment and often more side effects. Traditionally, the most common surgical procedure has been Transurethral Resection of the Prostate (TURP), an invasive surgery in which portions of the prostatic urethra and surrounding tissue are removed, thereby widening the urethra and improving urinary flow. While TURP results in a dramatic improvement in urine flow and reduction in symptoms, the procedure can require a lengthy recovery time and is reported to have a high rate of side effects and complications. Because the TURP procedure requires a highly skilled surgeon with extensive training, the incidence of complications are affected by the experience of the surgeon performing the TURP.

 

Cooled ThermoTherapy

 

Our Targis, Prostatron, and our recently approved CoolWave systems utilize Cooled ThermoTherapy, a catheter-based treatment for BPH that is clinically superior to medication and less invasive than surgery. Cooled ThermoTherapy was developed to be the treatment of choice for patients who have tried drugs unsuccessfully and wish to avoid surgery. Today, some patients choose Cooled ThermoTherapy before trying medications.

 

Cooled ThermoTherapy utilizes a proprietary microwave technology, delivered through a flexible catheter that targets energy into the enlarged area of the prostate to a temperature sufficient to cause cell death, while simultaneously cooling and protecting the healthy, pain-sensitive urethral tissue. During a Cooled ThermoTherapy procedure, a catheter is inserted into the urethra, and a rectal thermosensing unit is placed into the rectum. Chilled water is then circulated through the catheter in order to lower the temperature of the urethra and protect it from heat and discomfort during the treatment. Temperatures in the urethra and rectum are monitored continuously during the treatment while microwave energy is delivered into the prostatic tissue, ultimately resulting in a reduction in the size of the prostate and relief of symptoms as the body re-absorbs the destroyed tissue during the months following treatment.

 

Cooled ThermoTherapy provides significant advantages over other BPH therapies, producing lasting results that are clinically superior to drug therapy while avoiding the complications associated with surgery. Because Cooled ThermoTherapy does not require punctures or incisions and protects the urethra during treatment, it can be performed in the physician’s office or other outpatient environments without the need for anesthesia or intravenous sedation and results in fewer complications.

 

Clinical Studies

 

Clinical trials of the Cooled ThermoTherapy procedure have been performed to obtain data to support new indications and marketing claims, to obtain long-term durability data, and to gather data for Medicare and other reimbursement approvals in various markets. We continue to monitor multi-center, multi-year studies to evaluate the long-term durability of Cooled ThermoTherapy procedures. In our published results from multi-center clinical trials, conducted both in the United States and internationally, the majority of Cooled ThermoTherapy patients for whom follow-up data is available show significant long-term relief from the symptoms of BPH, without significant post-procedure complications.

 

Sales and Marketing

 

Our goal is to grow Cooled ThermoTherapy as a standard of care for the treatment of BPH. Our business strategy to achieve this goal is (i) educate both patients and physicians on the benefits of Cooled Thermotherapy compared to other treatment options, (ii) increase the use of Cooled ThermoTherapy by physicians who already have access to a Cooled ThermoTherapy system, (iii) increase the number of physicians who provide Cooled

 

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ThermoTherapy to their patients, (iv) efficiently provide more physicians with access to Cooled ThermoTherapy through the expansion of our Cooled ThermoTherapy mobile service in the United States, and (v) increase the use of Cooled ThermoTherapy for the treatment of BPH in international markets.

 

United States

 

We have a sales and marketing team consisting of sales and marketing management, marketing communications, clinical, and direct sales representatives, all of whom are dedicated to marketing our Cooled ThermoTherapy products and our Cooled ThermoTherapy mobile service. Our direct sales force and marketing efforts are targeted at urologists who treat BPH patients in their office. Our Cooled ThermoTherapy mobile service employees transport the Cooled ThermoTherapy system control unit, along with the single-use treatment catheters and all necessary supplies, to physician offices and hospitals on a scheduled basis, making the treatment available to physicians and patients on an efficient and economic basis. As of June 30, 2007, our mobile assets included 15 vans with 14 mobile routes resulting in mobile service being offered in select geographies in the United States. In addition to our direct sales force and Cooled ThermoTherapy mobile service employees, we continue to utilize independent third-party mobile service providers to provide hospitals and urology clinics with access to our Cooled ThermoTherapy treatment. As of June 30, 2007, we employed a total of 39 individuals in our sales and marketing department and our Cooled ThermoTherapy mobile service. The expenses for our Cooled ThermoTherapy mobile service are included in cost of goods sold.

 

We offer our Cooled ThermoTherapy systems to our customers on a direct purchase or on an evaluation or longer-term use basis. Pricing for single-use treatment catheters and our Cooled ThermoTherapy mobile service varies based upon volume.

 

International

 

We have distribution agreements for the market development and sale of our products in China, Taiwan, India and Japan. Although our international selling efforts have historically been relatively modest, we believe that there is a potentially significant market for Cooled ThermoTherapy outside of the United States. We will continue to utilize local distributors and independent agents experienced in selling products to hospitals and urologists to assist us in maximizing these opportunities.

 

Manufacturing

 

We manufacture the Targis control unit, CoolWave control unit, and single-use treatment catheters for use with our Targis and CoolWave control units at our suburban Minneapolis facility. We outsource the remaining manufacturing.

 

Our supply agreement with Accellent Endoscopy for the production of the Prostatron disposable treatment catheter was terminated as of April 2007. Prior to this termination, we signed an agreement with The MedTech Group, Inc. to become a qualified supplier of our Cooled ThermoTherapy single-use treatment catheter products. During the fourth quarter of fiscal 2007, in connection with our strategy to develop a next generation catheter, we implemented an end-of-life plan for our Prostatron product line. As a result, we are currently in the process of negotiating an end-of-life build from a supplier so we can continue to support our Prostatron customers without treatment interruption until we can transition them to another of our products.

 

We assemble Targis and CoolWave control units and procedure kits using materials and components supplied by various subcontractors and suppliers, as well as components we fabricate. Several of the components are currently available to us through a single vendor. Wherever possible we attempt to develop alternative sources for critical components. Where alternative sourcing is not possible, we attempt to enter into supply agreements with each component provider. Nevertheless, failure to obtain components from these providers or delays associated with any future component shortages, particularly as we increase our manufacturing level, could have a material adverse effect on our business, financial condition and operating results.

 

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Our manufacturing operations and the operations of our third-party suppliers must comply with the U.S. Food and Drug Administration’s (FDA) quality system regulation, which includes, but is not limited to, the FDA’s Good Manufacturing Practices (GMP) requirements, and with certain requirements of state, local and foreign governments for assuring quality by controlling components, processes and document traceability and retention, among other things.

 

In June 1997, July 1998, September 2000, September 2002, March 2004 and August 2007, the FDA completed inspections of our facility, documentation and quality systems with no significant deficiencies of GMP noted. Our facility will continue to be subject to periodic inspections by the FDA and by other auditors. We believe that our manufacturing and quality control procedures meet the requirements of these regulations and that we have established training and self-audit systems designed to ensure compliance.

 

We have received ISO 13485 certification indicating compliance of our manufacturing facilities with European standards for quality assurance and manufacturing process control. We also have received CE mark certification, which allows us to affix the CE Mark to our Targis, Prostatron, CoolWave and our next generation catheter, CoolMax™ products and market them in the European Union. In addition, the Targis and Prostatron systems have been approved for marketing by the Japanese Ministry of Health and Welfare. As of June 30, 2007, we employed 33 individuals in our manufacturing department.

 

Research and Development

 

We intend to build upon our scientific and clinical knowledge and relationships to develop innovative future generations of BPH and other urology products. Our research and development efforts are currently focused on improving the function and features of our Cooled ThermoTherapy systems, improving the treatable population and clinical response to Cooled ThermoTherapy treatment and reducing the manufacturing cost of our products. During fiscal year 2008, we will dedicate research and development efforts toward the completion of our next generation catheter, CoolMax, which is intended to utilize similar targeted energy to sustain treatment durability while increasing patient comfort.

 

During the fiscal years ended June 30, 2007, 2006, and 2005, we spent $3.0 million, $3.0 million, and $3.1 million, respectively, on our research and development efforts. As of June 30, 2007, we employed 15 individuals in our research and development department.

 

Reimbursement

 

We believe that third-party reimbursement is essential to the continued adoption of Cooled ThermoTherapy, and that clinical efficacy, overall cost-effectiveness and physician advocacy will be keys to obtaining such reimbursement. We estimate that 60% to 80% of patients who receive Cooled ThermoTherapy treatment in the United States will be eligible for Medicare coverage. The remaining patients will either be covered by private insurers, including traditional indemnity health insurers and managed care organizations, or they will be private-paying patients. As a result, Medicare reimbursement is particularly critical for widespread market adoption of Cooled ThermoTherapy in the United States.

 

The level of Medicare reimbursement for Cooled ThermoTherapy is dependent on the site of service. Beginning on August 1, 2000, the Centers for Medicare and Medicaid Services (CMS) replaced the reasonable cost basis of reimbursement for outpatient hospital-based procedures, including Cooled ThermoTherapy, with a new fixed rate or prospective payment system. Under this method of reimbursement, a hospital receives a fixed reimbursement for each Cooled ThermoTherapy treatment performed in its facility, approximately $2,100 in calendar year 2007, although the rate varies depending on a wage index and other factors for each hospital. The urologist performing the Cooled ThermoTherapy treatment receives reimbursement of approximately $500 per procedure.

 

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In January 2001, CMS began to reimburse for Cooled ThermoTherapy treatments performed in the urologist’s office. The reimbursement rate (inclusive of the physician’s fee) in calendar year 2007 for Cooled ThermoTherapy procedures performed in the urologist’s office is approximately $3,562 compared to $3,800 in calendar 2006, which is subject to geographic adjustment. Reimbursement rates for calendar year 2008 will be published in the November 2007 edition of the Federal Register.

 

In July 2003, CMS added the CPT Code covering Cooled ThermoTherapy to the ASC list of Medicare approved procedures providing a reimbursement rate for ambulatory surgical centers (ASC). As a result, procedures performed in an ASC were reimbursed under a two-part system similar to hospitals: the ASC received a fixed fee of approximately $1,300, the highest amount allowable under this system, while the urologist performing the procedure was reimbursed the same amount as if the treatment occurred in a hospital, approximately $500. The relatively low facility reimbursement relative to the cost of the procedure potentially limited the number of Cooled ThermoTherapy treatments done in an ASC. Effective July 2005, the CPT code covering Cooled ThermoTherapy was deleted from the ASC list of Medicare approved procedures. As a result, effective with that change, urologists who performed Cooled ThermoTherapy procedures in an ASC are reimbursed at the office-based reimbursement rates, approximately $3,562 in calendar year 2007, subject to geographic adjustment.

 

Private insurance companies and HMOs make their own determinations regarding coverage and reimbursement based upon “usual and customary” fees. To date, we have received coverage and reimbursement in various geographies from private insurance companies and HMOs throughout the United States. We intend to continue our efforts to gain coverage and reimbursement across the United States. There can be no assurance that we will receive favorable coverage or reimbursement determinations for Cooled ThermoTherapy from these payers or that amounts reimbursed to physicians for performing Cooled ThermoTherapy procedures will be sufficient to encourage physicians to use Cooled ThermoTherapy.

 

Internationally, reimbursement approvals for the Cooled ThermoTherapy procedure are awarded on an individual-country basis.

 

Patents and Proprietary Rights

 

We currently own 46 U.S. and 14 non-U.S. patents. We also have one patent application pending in the United States and in a number of non-U.S. jurisdictions, and we intend to file additional patent applications in the future.

 

Several of our United States patents claim methods and devices that we believe are critical to providing a safe and efficacious treatment for BPH. There can be no assurance that our patents, or any patents that may be issued as a result of existing or future applications, will offer any degree of protection from competitors or that any of our patents or applications will not be challenged, invalidated or circumvented in the future. In addition, there can be no assurance that our competitors, many of which have substantial resources and have made substantial investments in competing technologies, will not seek to apply for and obtain patents that will prevent, limit or interfere with our ability to manufacture or market Cooled ThermoTherapy in the United States or in international markets. Further, there can be no assurance that our Cooled ThermoTherapy system does not infringe upon the patent rights or other intellectual property rights of other companies, that we will not be required to seek licenses from other companies or that other companies will not pursue claims of infringement against us.

 

In addition to patents, we also rely on trade secrets and proprietary know-how that we intend to protect, in part, through proprietary information agreements with employees, consultants and other parties. Our proprietary information agreements with employees and most of our consultants contain standard industry provisions requiring that the individuals assign to us, without additional consideration, any inventions conceived or reduced to practice while employed by or under contract with us, subject to customary exceptions. Our officers and other

 

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key employees also agree not to compete with us for a period following termination. There can be no assurance that proprietary information or non-compete agreements with employees, consultants and others will not be breached, that we will have adequate remedies for any such breach, or that third parties will not otherwise gain access to our technology.

 

Competition

 

Competition in the market for the treatment of BPH comes from invasive surgical therapies, such as TURP and side-firing lasers (Laserscope, recently purchased by American Medical Systems, and Luminess), drug therapy and other minimally invasive, office-based treatments. There are six well-recognized prescription drugs available in the United States for treating the symptoms of BPH: Flomax (Boehringer Ingelheim International GmbH), Hytrin (Abbott Laboratories), Cardura (Pfizer Inc.), UroXatral (Sanofi-Synthelabo), Proscar (Merck & Co., Inc.) and Avodart (GlaxoSmithKline). Drug therapy is currently the first-line therapy prescribed by most physicians in the United States for BPH. Due to the large yet still uninformed marketplace of men suffering from BPH, we do not consider the drug manufacturers as major threats, but more as alternative therapies that have significant resources to bring awareness to this quality of life condition for which we believe our Cooled ThermoTherapy can provide a safe, effective and long-lasting treatment.

 

Competition in the market for minimally invasive office-based treatments for BPH continues to grow. Competitive devices include radio frequency (Medtronic); interstitial laser (Johnson & Johnson); non-cooled, low energy microwave (American Medical Systems); low energy microwave combined with balloon dilatation (Boston Scientific); high energy microwave with limited cooling (Prostalund); and hot water therapy (Gyrus ACMI). Additional competitors may enter the market. We believe Cooled ThermoTherapy provides significant advantages over other office-based BPH therapies. Because Cooled ThermoTherapy does not require punctures or incisions, it can be performed in the physician’s office or other outpatient environments without the need for anesthesia or intravenous sedation. Further, by combining microwave energy with cooling, we can drive more energy deep into the prostate, creating lasting results while preventing damage to the urethra, enhancing patient comfort and reducing complications.

 

Government Regulation

 

Governmental regulation in the United States and other countries is a significant factor affecting the research and development, manufacture and marketing of our products. In the United States, the FDA has broad authority under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act to regulate the distribution, manufacture and sale of medical devices. Foreign sales of medical devices are subject to foreign governmental regulation and restrictions that vary from country to country.

 

Medical devices intended for human use in the United States are classified into one of three categories. Such devices are classified by regulation into either class I (general controls), class II (performance standards) or class III (pre-market approval or PMA) depending upon the level of regulatory control required to provide reasonable assurance of the safety and effectiveness of the device. Good Manufacturing Practices, labeling, maintenance of records and filings with the FDA also apply to medical devices.

 

Our Cooled ThermoTherapy systems have received FDA clearance for sale in the United States as a class III medical device. We have obtained CE Mark certification for distribution in Europe and product registration for distribution in Canada, India and Japan. In addition, we are currently seeking approval of our products in the Peoples Republic of China (SFDA) and Taiwan.

 

The FDA’s regulations require agency approval of a PMA supplement for a class III medical device when certain changes are made to a product if the changes affect the safety and effectiveness of the device. Such changes include, but are not limited to, new indications for use; the use of a different facility or establishment to manufacture, process or package the device; changes in manufacturing methods or quality control systems; changes in vendors used to supply components of the device; changes in performance or design specifications; and certain labeling changes. Any such changes will require FDA approval of a PMA supplement prior to

 

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marketing of the device. There can be no assurance that the required approvals of PMA supplements for any changes will be granted on a timely basis or at all, and delays in receipt of, or failure to receive such approvals, or the loss of the approval of the PMA for either of our Cooled ThermoTherapy systems would have a material adverse effect on our business.

 

The process of obtaining FDA and other required regulatory clearances or approvals is lengthy and expensive. There can be no assurance that we will be able to obtain or maintain the necessary clearances or approvals for clinical testing or for manufacturing or marketing of our products. Failure to comply with applicable regulatory approvals can, among other things, result in warning letters, fines, suspensions of regulatory approvals, product recalls, operating restrictions and criminal prosecution. In addition, government regulation may be established that could prevent, delay, modify or rescind regulatory clearance or approval of our products.

 

Medical device laws are also in effect in many of the countries outside of the United States in which we do business. These laws range from comprehensive device approval and quality system requirements for some or all of our medical device products to simple requests for product data or certifications. The number and scope of these requirements are increasing. All medical devices sold in Europe must meet the European Medical Device Directive standards and receive CE Mark certification. CE Mark certification involves a comprehensive Quality System program and submission of data on a product to the Notified Body in Europe.

 

Health Care Regulatory Issues

 

The health care industry is highly regulated, and there can be no assurance that the regulatory environment in which we operate will not change significantly in the future. In general, regulation of health care related companies is increasing. We anticipate that Congress and state legislatures will continue to review and assess alternative health care delivery and payment systems. We cannot predict what impact the adoption of any federal or state health care reform measures may have on our business.

 

We regularly monitor developments in laws and regulations relating to our business. We may be required to modify our agreements, operations, marketing and expansion strategies from time to time in response to changes in the statutory and regulatory environment. Although we plan to structure all of our agreements, operations, marketing and strategies in accordance with applicable law, there can be no assurance that our arrangements will not be challenged successfully or that required changes will not have a material adverse effect on operations or profitability.

 

Product Liability and Insurance

 

Our business exposes us to potential product liability claims that are inherent in the testing, production, marketing and sale of medical devices. Like other participants in the medical device market, we are from time to time involved in lawsuits, claims and proceedings alleging product liability and related claims such as negligence. If product liability claims become substantial, our reputation could be damaged significantly, thereby harming our business. We may be required to pay substantial damage awards as a result of any successful product liability claims. Any product liability claim against us, whether with or without merit, could result in costly litigation, and divert the time, attention, and resources of our management.

 

As a result of our exposure to product liability claims, we currently carry product liability insurance covering our products with policy limits per occurrence and in the aggregate that we have deemed to be sufficient. We cannot predict, however, whether this insurance is sufficient, or if not, whether we will be able to obtain sufficient insurance to cover the risks associated with our business or whether such insurance will be available at premiums that are commercially reasonable. In addition, these insurance policies must be renewed annually. Although we have been able to obtain liability insurance, such insurance may not be available in the future on acceptable terms, if at all. A successful claim against us or settlement by us with respect to uninsured liabilities or in excess of our insurance coverage, or our inability to maintain insurance in the future, or any claim

 

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that results in significant costs to or adverse publicity against us, could have a material adverse effect on our business, financial condition, results of operations and liquidity.

 

Employees

 

As of June 30, 2007, we employed 95 individuals on a full-time basis. We also had several part-time employees and consultants. Although we believe that we have been successful in attracting experienced and capable personnel, there can be no assurance that we will continue to attract and retain qualified personnel. None of our employees are covered under a collective bargaining agreement. We consider our relationship with our employees to be good.

 

Seasonality

 

We believe that holidays, major medical conventions and vacations taken by physicians, patients and patient families may have a seasonal impact on our sales. We continue to monitor and assess the impact seasonality may have on demand for our products.

 

Backlog

 

As of June 30, 2007, we did not maintain any backlog of product orders. Our policy is to stock enough inventory to be able to ship most orders within a few days of receipt or as requested by our customers. Therefore, we rely on orders placed during a given period for sales during that period. Backlog information as of the end of a particular period is not necessarily indicative of future levels of our revenue.

 

ITEM 1A. RISK FACTORS

 

The occurrence of any of the following risks could harm our business. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our operations. If any of these risks materialize, the trading price of our common stock could decline, and investors may lose all or part of their investment.

 

We are faced with intense competition and rapid technological and industry change.

 

The medical device industry is characterized by rapid technological change, changing customer needs and frequent new product introductions. Our products may be rendered obsolete as a result of future innovations. We face intense competition from other device manufacturers and surgical manufacturers, as well as from pharmaceutical companies. Nearly all of our competitors are significantly larger than we are and have greater financial, technical, research, marketing, sales, distribution and other resources than we do. We believe that price competition will continue among products developed in our markets. Our competitors may develop or market technologies and products, including drug-based treatments that are more effective or commercially attractive than any we are developing or marketing. Our competitors may succeed in obtaining regulatory approval and introducing or commercializing products before we do. Such developments could have a significant negative effect on our business, financial condition and results of operations. Even if we are able to compete successfully, we may not be able to do so in a profitable manner.

 

Our products, including our Cooled ThermoTherapy mobile service and recently approved CoolWave control unit, may not achieve market acceptance, which could limit our future revenue.

 

Physicians will not recommend Cooled ThermoTherapy procedures unless they conclude, based on clinical data and other factors, that it is an effective alternative to other methods of enlarged prostate treatment, including more established methods. Patient acceptance of the procedure will depend in part upon physician recommendations and on other factors, including the degree of invasiveness and the rate and severity of complications associated with the Cooled ThermoTherapy procedure compared with other therapies. Patient

 

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acceptance of the Cooled ThermoTherapy procedure also will depend upon the ability of physicians to educate these patients on their treatment choices. Health care payer acceptance of our procedure will require, among other things, evidence of the cost effectiveness of Cooled ThermoTherapy compared to other BPH therapies. Although we believe Cooled ThermoTherapy offers physicians and patients advantages over competitive therapies for BPH, the success of our product also will depend upon the extent to which physicians and patients perceive our procedure as having these advantages and the extent to which these advantages are relevant to their treatment decision. Our marketing strategy must overcome the difficulties inherent in the introduction of new technology to the medical community. If our Cooled ThermoTherapy procedure is not widely accepted by physicians, patients or payers, or is accepted more slowly than expected, our business will be harmed. Further, we now operate our own Cooled ThermoTherapy mobile service and recently received FDA approval of our CoolWave control unit that we launched in the first quarter of fiscal 2007. As of June 30, 2007 we had an installed base of 31 CoolWave control units, including those installed on our mobile vans, and operated 14 mobile routes. If our mobile service or our CoolWave control unit are not accepted by physicians, patients, or payers, or are accepted more slowly than expected, our business will be harmed.

 

Part of our business strategy involves expanding our product offerings into international markets and we are currently targeting markets in India, Japan, the People’s Republic of China and Taiwan. While we will face some of the same challenges in obtaining market acceptance in these countries as we face in the U.S., we will likely face additional challenges, some of which we cannot yet anticipate. Further, we cannot predict the extent to which these challenges and additional challenges particular to each of these countries and the physicians and patients in these countries will affect our ability to obtain market acceptance of our products in these countries. If our Cooled ThermoTherapy procedure is not widely accepted by physicians and patients in these countries, or is accepted more slowly than expected, the expansion of our international business will be harmed.

 

Third-party reimbursement is critical to market acceptance of our products.

 

Our future revenues are subject to uncertainties regarding health care reimbursement and reform. In the United States, health care providers, such as hospitals and physicians, generally rely on third-party payers. Third-party reimbursement is dependent upon decisions by the CMS, contract Medicare carriers, individual managed care organizations, private insurers, foreign governmental health programs and other payers of health care cost. Failure to receive or maintain favorable coding, coverage and reimbursement determinations for Cooled ThermoTherapy by these organizations could discourage physicians from using our products. We may be unable to sell our products on a profitable basis if third-party payers deny coverage, provide low reimbursement rates or reduce their current levels of reimbursement.

 

The continuing efforts of government, insurance companies, health maintenance organizations and other payers of health care costs to contain or reduce costs of health care may affect our future revenues and profitability. With recent federal and state government initiatives directed at lowering the total cost of health care, the United States Congress and state legislatures will likely continue to focus on health care reform including the reform of Medicare and Medicaid systems, and on the cost of medical products and services. Additionally, third-party payers are increasingly challenging the prices charged for medical products and services. Also, the trend toward managed health care in the United States and the concurrent growth of organizations such as HMO’s that could control or significantly influence the purchase of health care services and products, as well as legislative proposals to reform health care or reduce government insurance programs, may also result in lower prices for, or rejection of, our products. The cost containment measures that health care payers and providers are instituting and the effect of any health care reform could cause reductions in the amount of reimbursement available, and could have a materially adverse effect on our revenues and ability to operate profitably.

 

We depend upon our Cooled ThermoTherapy products for all of our revenues.

 

All of our revenues are derived from sales of our Cooled ThermoTherapy system control units and single-use treatment catheters and treatments delivered through our Cooled ThermoTherapy mobile service. As a

 

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result, our success is solely dependent upon the success of our Cooled ThermoTherapy products. To date, our Cooled ThermoTherapy systems have not achieved widespread market adoption. If we are unable to widely commercialize the use of these systems successfully through our marketing initiatives, including our company-owned Cooled ThermoTherapy mobile service, our business, financial condition and results of operations will be materially and adversely affected. Further, higher than expected manufacturing, marketing and distribution costs, lower than expected reimbursement levels, lower than expected usage by physicians, and/or other competitive forces may require us to alter our pricing or marketing structure in a manner that could have a material adverse effect on us.

 

Government regulation has a significant impact on our business and in particular, on the introduction of our next generation catheter, CoolMax™ .

 

Government regulation in the United States and other countries is a significant factor affecting the research and development, manufacture and marketing of our products. In the United States, the FDA has broad authority under the federal Food, Drug and Cosmetic Act and the Public Health Service Act to regulate the distribution, manufacture and sale of medical devices. Sales of medical devices outside the United States are subject to government regulation and restrictions that vary from country to country. In addition, we, along with our distributors and health care providers who purchase our products and services, are subject to state and federal laws prohibiting kickbacks or other forms of bribery in the health care industry. We may be subject to civil and criminal prosecution for violations of any of these laws by our agents or us.

 

Before our next generation catheter, CoolMax™ may be introduced into the U.S. market, we must obtain prior authorization from the FDA. This authorization is based on a review by the FDA of the medical device’s safety and effectiveness for its intended uses. We are currently seeking the FDA’s approval of CoolMax pursuant to a pre-market approval application. The process of obtaining clearances or approvals from the FDA and other applicable regulatory authorities can be expensive, uncertain and time consuming.

 

While we are in the process of obtaining approval of our next generation catheter, we may not be able to obtain necessary approvals for clinical testing or for the manufacturing or marketing of this product or any of our other products in the United States or in other countries. If regulatory approvals for our next generation catheter, CoolMax™, or any of our other products are not obtained on a timely basis, or not approved as submitted, or at all, it could have a significant negative effect on our financial condition and results of operations. Additionally, delays in receipt of regulatory approvals for our products or failure to receive such approvals, the loss of previously obtained approvals, or failure to comply with existing or future regulatory requirements would have a significant negative effect on our financial condition and results of operations.

 

Even if such an approval is obtained, our failure to comply with applicable regulatory approvals could, among other things, result in fines, suspension of regulatory approvals, product recalls, operating restrictions and criminal prosecution. In addition, government regulations may be established that could prevent, delay, modify or rescind regulatory approval of our products. Any such position or change of position by the FDA may adversely impact our business and financial condition. Regulatory approvals, if granted, may include significant limitations on the indicated uses for which our products may be marketed in the United States or in other countries. In addition to obtaining such approvals, the FDA and foreign regulatory authorities may impose numerous other requirements on us. The FDA prohibits the marketing of approved medical devices for unapproved uses. In addition, product approvals can be withdrawn for failure to comply with regulatory standards or the occurrence of unforeseen problems following initial marketing.

 

In addition, the health care industry in the United States is generally subject to fundamental change due to regulatory, as well as political, influences. We anticipate that Congress and state legislatures will continue to review and assess alternative health care delivery and payment systems. Potential approaches that have been considered include controls on health care spending through limitations on the growth of private purchasing groups and price controls. We cannot predict what impact the adoption of any federal or state health care reform measures may have on our business.

 

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We have been unprofitable recently.

 

We incurred a net loss of $13.2 million (which includes $4.8 million of income tax expense to increase our valuation allowance to fully reserve our deferred tax assets and a $6.4 million charge for long-lived asset impairments and inventory write-downs) for the year ended June 30, 2007. Including the losses described above, since our inception, we have incurred losses of approximately $84.8 million. Although we were profitable in fiscal years 2006, 2005 and 2004, if physicians do not continue to purchase and use our Cooled ThermoTherapy systems to treat patients with BPH, we may not be able to once again achieve profitability. Because we expect to continue to incur additional expenses relating to sales and marketing activities and research and development activities, we will need to increase the revenues we receive from sales of our products in order to operate in a profitable manner. We cannot assure you that we will be able to increase our revenues, once again attain profitable operations, or successfully implement our business plan or future business opportunities.

 

We have limited experience manufacturing some of our products and are dependent upon a limited number of third-party suppliers to manufacture our products.

 

We manufacture the Targis system control unit, our recently approved CoolWave control unit, and single-use treatment catheters for use with our Targis and CoolWave control units at our suburban Minneapolis facility. Our success will depend upon our ability to cost-effectively manufacture a reliable product and deliver that product in a timely manner. Because we lack extensive manufacturing experience, we may encounter difficulties in maintaining production efficiencies, quality control and assurance, component supply and qualified personnel. We cannot assure you that we will be able to manufacture a reliable product and deliver that product to customers in a timely fashion. Our failure to maintain a reputation among our customers as a timely, responsive manufacturer, or our failure to remedy manufacturing issues in a timely manner and to our customers’ satisfaction, or higher than expected manufacturing costs, would adversely affect our business.

 

Other than the Targis and CoolWave system control units and procedure kits, we outsource the remaining manufacturing for our products. We assemble Targis and CoolWave control units and procedure kits using materials and components supplied by various subcontractors and suppliers, as well as components we fabricate. We rely on single sources for several components, one of which is obtained from a source that has a patent for the technology. Our reliance on outside suppliers for our components involves risks including limited control over the price and uncertainty regarding timely delivery and quality of parts. Our supply agreement with Accellent Endoscopy for the production of the Prostatprobe disposable treatment catheter was terminated in April 2007. Prior to this termination, we signed an agreement with The MedTech Group, Inc. to become a qualified supplier of our Cooled ThermoTherapy single-use treatment catheter products. During the fourth quarter of fiscal 2007, in connection with our strategy to develop a next generation catheter, we implemented an end-of-life plan for our Prostatron product line. As a result, we are currently in the process of negotiating an end-of-life build from a supplier so we can continue to support our Prostatron customers without treatment interruption until we can transition them to another of our products.

 

The start-up, transfer, termination or interruption of any of these relationships or products, or the failure of these manufacturers or suppliers, some of which operate in countries outside of the United States, to supply products or components to us on a timely basis or in sufficient quantities, likely would cause us to be unable to meet customer orders for our products and harm our reputation with customers and our business. Identifying and qualifying alternative suppliers of components or manufacturers of products takes time and involves significant additional costs and may delay the production of our products. Further, if we obtain a new supplier for a component, manufacture our product with an alternative component or if our products are manufactured by an alternative manufacturer, we may need to obtain FDA approval of a PMA supplement to reflect changes in product manufacturing and the FDA may require additional testing of any component from new suppliers prior to our use of these components. Further, if FDA approval of a PMA supplement is required, any delays in delivery of our product to customers would be extended and our costs associated with the change in product manufacturing would increase.

 

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The failure of our third-party manufacturers to manufacture the products for us, and the failure of our components suppliers to supply us with the components, consistent with our requirements as to quality, quantity and timeliness, would materially harm our business.

 

We are dependent on adequate protection of our patent and proprietary rights.

 

We rely on patents, trade secrets, trademarks, copyrights, know-how, license agreements and contractual provisions to establish and protect our intellectual property rights. However, these legal means afford us only limited protection and may not adequately protect our rights or remedies to gain or keep any advantages we may have over our competitors.

 

We cannot assure you that others may not independently develop the same or similar technologies or otherwise obtain access to our technology and trade secrets. Our competitors, many of which have substantial resources and may make substantial investments in competing technologies, may apply for and obtain patents that will prevent, limit, or interfere with our ability to manufacture or market our products. Further, while we do not believe that any of our products or processes interfere with the rights of others, third parties may nonetheless assert patent infringement claims against us in the future.

 

Costly litigation may be necessary to enforce patents issued to us, to protect trade secrets or “know-how” we own, to defend us against claimed infringement of the rights of others or to determine the ownership, scope, or validity of our proprietary rights and the rights of others. In connection with the settlement of a patent infringement suit we filed in March 2002, we granted, in January 2004, ProstaLund AB, ProstaLund Operations AB and Circon Corporation (a/k/a ACMI Corporation) a non-exclusive, royalty free license under certain of our patents to sell the ProstaLund transurethral microwave thermotherapy system marketed in the United States by ACMI Corporation as the CoreTherm device.

 

Any claim of infringement against us may involve significant liabilities to third parties, could require us to seek licenses from third parties, and could prevent us from manufacturing, selling, or using our products. The occurrence of this litigation or the effect of an adverse determination in any of this type of litigation could have a material adverse effect on our business, financial condition and results of operations.

 

Our business of the manufacturing, marketing, and sale of medical devices involves the risk of liability claims and such claims could seriously harm our business, particularly if our insurance coverage is inadequate.

 

Our business exposes us to potential product liability claims that are inherent in the testing, production, marketing and sale of medical devices. Like other participants in the medical device market, we are from time to time involved in lawsuits, claims and proceedings alleging product liability and related claims such as negligence. If any current or future product liability claims become substantial, our reputation could be damaged significantly, thereby harming our business. We may be required to pay substantial damage awards as a result of any successful product liability claims. Any product liability claim against us, whether with or without merit, could result in costly litigation, and divert the time, attention, and resources of our management.

 

As a result of our exposure to product liability claims, we currently carry product liability insurance covering our products with policy limits per occurrence and in the aggregate that we have deemed to be sufficient. Our insurance may not cover certain product liability claims or our liability for any claims may exceed our coverage limits. Therefore, we cannot predict whether this insurance is sufficient, or if not, whether we will be able to obtain sufficient insurance to cover the risks associated with our business or whether such insurance will be available at premiums that are commercially reasonable. In addition, these insurance policies must be renewed annually. Although we have been able to obtain liability insurance, such insurance may not be available in the future on acceptable terms, if at all. A successful claim against us or settlement by us with respect to uninsured liabilities or in excess of our insurance coverage, or our inability to maintain insurance in the future, or any claim that results in significant costs to or adverse publicity against us, could have a material adverse effect on our business, financial condition and results of operations.

 

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Our products may be subject to product recalls even after receiving FDA clearance or approval, which would harm our reputation and our business.

 

The FDA and similar governmental authorities in other countries in which our products are sold, have the authority to request and, in some cases, require the recall of our products in the event of material deficiencies or defects in design or manufacture. A government-mandated or voluntary recall by us could occur as a result of component failures, manufacturing errors or design defects. Any recall of product would divert managerial and financial resources, harm our reputation with our customers and damage our business.

 

We are dependent on key personnel.

 

Our failure to attract and retain skilled personnel could hinder the management of our business, our research and development, our sales and marketing efforts, and our manufacturing capabilities. Our future success depends to a significant degree upon the continued services of key senior management personnel, including Fred B. Parks, our Chairman of the Board and Chief Executive Officer. We have an employment agreement with Mr. Parks that provides that Mr. Parks will serve as our Chairman and Chief Executive Officer and that either party may terminate Mr. Parks’ employment at any time with or without cause. If we terminate Mr. Parks’ employment without cause, however, we would be required to make specified payments to him as described in his employment agreement. We do not have key person life insurance on Mr. Parks. Our future success also depends on our continuing ability to attract, retain and motivate highly qualified managerial, technical and sales personnel. Our inability to retain or attract qualified personnel could have a significant negative effect and thereby materially harm our business and financial condition.

 

We may not have additional financing available to us.

 

We generated approximately $1.5 million of net cash from operating activities in the year ended June 30, 2007 and ended that period with approximately $12.3 million of cash and cash equivalents. We believe our $12.3 million in cash and cash equivalents, together with the funds generated from product sales, will be sufficient to fund our working capital and capital resources needs for the next 12 months. Our business plan and financing needs are subject to change depending on, among other things, success of our efforts to continue to effectively manage expenses, market conditions, business opportunities and cash flow from operations, if any. We may require additional financing to continue our business, the receipt of which cannot be assured. Such additional financing could be sought from a number of sources, including possible sales of equity or debt securities or loans from banks or other financial institutions. We may not be able to obtain additional financing from any source on reasonable terms, if at all. Any future capital that is available may be raised on terms that are dilutive to our shareholders.

 

Fluctuations in our future operating results may negatively affect the market price of our common stock.

 

Our operating results have fluctuated in the past and can be expected to fluctuate from time to time in the future. Some of the factors that may cause these fluctuations include but are not limited to:

 

   

the timing, volume and pricing of customer orders for both control units and single-use treatment catheters,

 

   

the impact to the marketplace of competitive products and pricing,

 

   

the timing of expenditures related to sales and marketing, and research and development, and

 

   

product availability.

 

If our operating results are below the expectations of securities analysts or investors, the market price of our common stock may fall abruptly and significantly.

 

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Our stock price may be volatile and a shareholder’s investment could decline in value.

 

Our stock price has fluctuated in the past and may continue to fluctuate significantly, making it difficult for an investor to resell shares or to resell shares at an attractive price. The market prices for securities of emerging companies have historically been highly volatile. Future events concerning us or our competitors could cause such volatility, including:

 

   

actual or anticipated variations in our operating results,

 

   

technological innovations or new commercial products introduced by us or our competitors,

 

   

developments regarding government and third-party reimbursement,

 

   

changes in government regulation,

 

   

government investigation of us or our products,

 

   

result of regulatory process for approval of our next generation catheter,

 

   

changes in reimbursement rates or methods affecting our products,

 

   

developments concerning proprietary rights,

 

   

litigation or public concern as to the safety of our products or our competitors’ products,

 

   

investor perception of us and our industry,

 

   

general economic and market conditions including market uncertainty,

 

   

national or global political events,

 

   

difficulties with international expansion or operations,

 

   

public confidence in the securities markets and regulation by or of the securities markets, and

 

   

changes in senior management.

 

In addition, the stock market is subject to price and volume fluctuations that affect the market prices for companies in general, and small-capitalization, high-technology companies in particular, which are often unrelated to the operating performance of these companies. Any failure by us to meet or exceed estimates of financial analysts is likely to cause a decline in our common stock price.

 

Future sales of shares of our common stock may negatively affect our stock price.

 

Future sales of our common stock could have a significant negative effect on the market price of our common stock. In addition, upon exercise of outstanding options, the number of shares outstanding of our common stock could increase substantially. This increase, in turn, could dilute future earnings per share, if any, and could depress the market value of our common stock. Dilution and potential dilution, the availability of a large amount of shares for sale, and the possibility of additional issuances and sales of our common stock may negatively affect both the trading price of our common stock and the liquidity of our common stock. These sales also might make it more difficult for us to sell equity securities or equity-related securities in the future at a time and price that we would deem appropriate.

 

Provisions of Minnesota law, our governing documents and other agreements may deter a change of control of us and may have a possible negative effect on our stock price.

 

Certain provisions of Minnesota law, our articles of incorporation and bylaws and other agreements may make it more difficult for a third party to acquire, or discourage a third party from attempting to acquire, control of us, including:

 

   

the provisions of Minnesota law relating to business combinations and control share acquisitions;

 

   

the provisions of our bylaws regarding the business properly brought before shareholders;

 

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the provisions of our articles of incorporation and bylaws regarding our staggered board of directors;

 

   

the right of our board of directors to establish more than one class or series of shares and to fix the relative rights and preferences of any such different classes or series; and

 

   

the provisions of our stock option plans allowing for the acceleration of vesting or payments of awards granted under the plans in the event of specified events that result in a “change in control” and provisions of agreements with certain of our executive officers requiring payments if their employment is terminated and there is a “change in control.”

 

These measures could discourage or prevent a takeover of us or changes in our management, even if an acquisition or such changes would be beneficial to our shareholders. This may have a negative effect on the price of our common stock.

 

ITEM 1B. UNRESOLVED STAFF COMMENTS

 

Not applicable.

 

ITEM 2. PROPERTIES

 

We lease approximately 37,000 square feet of office, manufacturing and warehouse space in a suburb of Minneapolis, Minnesota, pursuant to a lease that expires in March 2008. We are currently in the process of negotiating a three-year renewal for this lease. We believe our facilities will be sufficient to meet our current and future requirements and that additional space at or near the current location will be available at a reasonable cost if additional space is required in the future.

 

ITEM 3. LEGAL PROCEEDINGS

 

We have been and are involved in various legal proceedings and other matters that arise in the normal course of our business, including product liability claims that are inherent in the testing, production, marketing and sale of medical devices. Based upon currently available information, we believe that the ultimate resolution of these matters will not have a material effect on the financial position, liquidity or results of operations of the Company.

 

ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

 

Not applicable.

 

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PART II

 

ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

Our common stock is traded on the Nasdaq Global Market System of the NASDAQ Stock Market LLC under the symbol “ULGX.” The following table sets forth quarterly high and low last-sale prices of our common stock for the past two years.

 

          Quarter

Fiscal Year


        First

   Second

   Third

   Fourth

2007

   High    $ 3.53    $ 2.81    $ 3.66    $ 3.02
     Low      2.75      2.28      2.52      2.14
                                  

2006

   High    $ 5.79    $ 4.44    $ 4.17    $ 4.27
     Low      3.89      3.82      3.21      3.00

 

The foregoing prices reflect inter-dealer prices, without dealer markup, markdown or commissions, and may not represent actual transactions.

 

Dividends

 

To date, we have not declared or paid any cash dividends on our common stock, and we do not intend to do so in the foreseeable future.

 

Equity Compensation Plan Information

 

The table below presents our equity compensation plan information as of June 30, 2007:

 

Plan Category


   Number of securities to be
issued upon exercise of
outstanding options,
warrants and rights


   Weighted-average exercise
price of outstanding options,
warrants and rights


   Number of securities
remaining available for
future issuance under equity
compensation plans
(excluding securities
reflected in first column)


Equity compensation plans approved by security holders

   896,134    $ 4.90    2,447,546

Equity compensation plan not approved by security holders

   225,000    $ 2.75    None
    
         

Total

   1,121,134    $ 4.47    2,447,546

 

The “equity compensation plans approved by security holders” listed above represent shares issuable under the Urologix, Inc. Amended and Restated 1991 Stock Option Plan, an “employee benefit plan” as defined by Rule 405 of Regulation C of the Securities Act of 1933. Shareholders approved the most recent amendment to the Amended and Restated 1991 Stock Option Plan, which, among other things, increased the number of shares of common stock available under the plan by 1,000,000 shares at the 2004 Annual Meeting of Shareholders held on November 9, 2004.

 

The 225,000 shares listed under “equity compensation plans not approved by security holders” represent an option to purchase 225,000 shares of the Company’s common stock granted to Fred B. Parks, the Company’s Chairman and Chief Executive Officer. The option was granted to Mr. Parks in connection with his original employment agreement dated May 21, 2003. The option is a non-qualified option exercisable at a price of $2.75 per share. The 225,000 share grant vested over the period commencing on May 27, 2003 and ending on May 27, 2007, with 56,268 shares vesting on May 27, 2004, and 1/36th of the remaining 168,732 shares vesting on the 27th of each of the 36 months following May 27, 2004.

 

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ITEM 6. SELECTED FINANCIAL DATA

 

     Years ended June 30,

 
     2007

    2006

    2005

   2004

    2003

 
     (in thousands, except per share data)  
Statements of Operations Data:                                        

Sales

   $ 21,317     $ 25,885     $ 25,813    $ 24,324     $ 18,775  

Cost of goods sold

     13,893 (1)     8,995       7,810      9,047       8,442 (5)
    


 


 

  


 


Gross profit

     7,424       16,890       18,003      15,277       10,333  
    


 


 

  


 


Costs and Expenses:

                                       

Selling, general and administrative

     11,086       12,940       11,643      12,338       15,390  

Research and development

     3,026       2,987       3,073      2,390       3,675  

Amortization and impairment of identifiable intangible assets

     2,244 (2)     194       164      164       164  

Restructuring(6)

     —         —         —        (200 )     1,275  
    


 


 

  


 


Total costs and expenses

     16,356       16,121       14,880      14,692       20,504  
    


 


 

  


 


Operating earnings (loss)

     (8,932 )     769       3,123      585       (10,171 )

Interest income, net

     554       371       138      57       123  
    


 


 

  


 


Earnings (Loss) before income taxes

     (8,378 )     1,140       3,261      642       (10,048 )

Income tax expense (benefit)

     4,859 (3)     (4,354 )(4)     424      286       286  
    


 


 

  


 


Net earnings (loss)

   $ (13,237 )   $ 5,494     $ 2,837    $ 356     $ (10,334 )
    


 


 

  


 


Basic:

                                       

Net earnings (loss) per common share

   $ (0.92 )   $ 0.38     $ 0.20    $ 0.03     $ (0.74 )

Weighted average shares used in computing net earnings (loss) per share

     14,332       14,319       14,279      14,015       13,915  

Diluted:

                                       

Net earnings (loss) per common share

   $ (0.92 )   $ 0.38     $ 0.19    $ 0.02     $ (0.74 )

Weighted average shares used in computing net earnings (loss) per share

     14,332       14,369       14,759      14,649       13,915  
     2007

    2006

    2005

   2004

    2003

 

Balance Sheet Data:

                                       

Cash, cash equivalents and available-for-sale investments

   $ 12,250     $ 11,054     $ 10,770    $ 7,604     $ 4,619  

Working capital

     16,067       16,926       13,174      8,556       5,023  

Total assets

     32,653       43,898       39,106      36,172       35,862  

Total liabilities

     4,778       3,918       5,961      6,312       7,329  

Shareholders’ equity

     27,875       39,980       33,145      29,860       28,533  

(1) Includes the following non-cash charges as a result of the implementation of an end-of-life plan for our Prostatron control units and Prostaprobe catheters in connection with our strategy to develop a next generation catheter:

 

Inventory write-down

   $ 213,000

Fixed asset impairment

     178,000

Developed technology intangible asset impairment

     4,044,000
    

     $ 4,435,000
    

 

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(2) Includes the following non-cash charges as a result of the implementation of an end-of-life plan for our Prostatron control units and Prostaprobe catheters in connection with our strategy to develop a next generation catheter:

 

Trademark intangible asset impairment

   $ 969,000

Customer base intangible asset impairment

     991,000
    

     $ 1,960,000
    

 

(3) Includes a $4.8 million non-cash income tax expense to increase the valuation allowance to fully reserve our deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period.
(4) Includes a $4.6 million non-cash income tax benefit to reduce the valuation allowance related to deferred tax assets.
(5) Includes a $610,000 lower of cost or market write-down of control unit inventory and future control unit purchase commitments.
(6) Represents a fiscal 2003 fourth quarter restructuring charge related to a workforce reduction and facilities consolidation and subsequent $200,000 recovery in fiscal 2004 due to a reduction in the severance related liabilities.

 

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SELECTED QUARTERLY FINANCIAL DATA

 

     Year Ended June 30, 2007

 
     First
Quarter


    Second
Quarter


   Third
Quarter


    Fourth
Quarter


 
     (in thousands, except per share data)  

Sales

   $ 5,415     $ 6,011    $ 5,073     $ 4,818  

Gross profit

     3,005       3,566      2,709       (1,856 )(1)

Earnings (loss) before income taxes

     (526 )     204      (777 )     (7,279 )(2)

Net earnings (loss)

     (526 )     147      (777 )     (12,081 )(3)

Basic net earnings (loss) per share

   $ (0.04 )   $ 0.01    $ (0.05 )   $ (0.84 )

Diluted net earnings (loss) per share

   $ (0.04 )   $ 0.01    $ (0.05 )   $ (0.84 )
     Year Ended June 30, 2006

 
     First
Quarter


    Second
Quarter


   Third
Quarter


    Fourth
Quarter


 
     (in thousands, except per share data)  

Sales

   $ 6,157     $ 6,535    $ 6,551     $ 6,643  

Gross profit

     4,125       4,353      4,368       4,045  

Earnings before income taxes

     174       393      487       86  

Net earnings

     146       319      364       4,665 (4)

Basic net earnings per share

   $ 0.01     $ 0.02    $ 0.03     $ 0.33  

Diluted net earnings per share

   $ 0.01     $ 0.02    $ 0.03     $ 0.32  

(1) Includes the following non-cash charges as a result of the implementation of an end-of-life plan for our Prostatron control units and Prostaprobe catheters in connection with our strategy to develop a next generation catheter:

 

Inventory write-down

   $ 213,000

Fixed asset impairment

     178,000

Developed technology intangible asset impairment

     4,044,000
    

     $ 4,435,000
    

 

(2) In addition to (1) above, includes the following non-cash charges as a result of the implementation of an end-of-life plan for our Prostatron control units and Prostaprobe catheters in connection with our strategy to develop a next generation catheter:

 

Trademark intangible asset impairment

   $ 969,000

Customer base intangible asset impairment

     991,000
    

     $ 1,960,000
    

 

(3) In addition to (1) and (2) above includes a $4.8 million non-cash income tax expense to increase the valuation allowance to fully reserve our deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period.
(4) Includes a $4.6 million non-cash income tax benefit to reduce the valuation allowance related to deferred tax assets.

 

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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion should be read in conjunction with our financial statements and related notes contained elsewhere in this Annual Report on Form 10-K. This discussion may contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of selected factors, including those set forth under “Risk Factors” in Item 1A. All forward-looking statements included herein are based on information available to us as of the date hereof, and we undertake no obligation to update any such forward-looking statements.

 

OVERVIEW

 

Urologix, Inc., based in Minneapolis, develops, manufactures and markets minimally invasive medical products for the treatment of urological disorders.

 

We have developed technology for the treatment of BPH, a disease that affects more than 23 million men worldwide. We market our control units under the Targis,® Prostatron® and CoolWave ® names and our procedure kits under the CTC™, Targis and Prostaprobe™ names. We are also in the process of developing our next generation catheter, CoolMax™, in which we are planning to combine durability with increased patient comfort. During the fourth quarter of fiscal 2007, in connection with our strategy to develop a next generation catheter, we implemented an end-of-life plan for our Prostatron control units and Prostaprobe catheters which will result in us exiting this product line over approximately the next 2.5 years. All systems utilize the Company’s Cooled ThermoTherapy technology, a targeted microwave energy combined with a unique cooling mechanism that protects healthy tissue and enhances patient comfort while providing safe, effective, lasting relief from the symptoms of BPH. Cooled ThermoTherapy can be performed without anesthesia or intravenous sedation and can be performed in a physician’s office or an outpatient clinic. We believe that Cooled ThermoTherapy provides an efficacious, safe and cost-effective solution for BPH with results clinically superior to medication and without the complications and side effects inherent in surgical procedures.

 

We believe that third-party reimbursement is essential to the continued adoption of Cooled ThermoTherapy, and that clinical efficacy, overall cost-effectiveness and physician advocacy will be keys to obtaining such reimbursement. We estimate that 60% to 80% of patients who receive Cooled ThermoTherapy treatment in the United States will be eligible for Medicare coverage. The remaining patients will either be covered by private insurers, including traditional indemnity health insurers and managed care organizations, or they will be private-paying patients. As a result, Medicare reimbursement is particularly critical for widespread market adoption of Cooled ThermoTherapy in the United States.

 

The level of Medicare reimbursement for Cooled ThermoTherapy is dependent on the site of service. Beginning on August 1, 2000, the Centers for Medicare and Medicaid Services (CMS) replaced the reasonable cost basis of reimbursement for outpatient hospital-based procedures, including Cooled ThermoTherapy, with a new fixed rate or prospective payment system. Under this method of reimbursement, a hospital receives a fixed reimbursement for each Cooled ThermoTherapy treatment performed in its facility, approximately $2,100 in calendar year 2007, although the rate varies depending on a wage index and other factors for each hospital. The urologist performing the Cooled ThermoTherapy treatment receives reimbursement of approximately $500 per procedure.

 

In January 2001, CMS began to reimburse for Cooled ThermoTherapy treatments performed in the urologist’s office. The reimbursement rate (inclusive of the physician’s fee) in calendar year 2007 for Cooled ThermoTherapy procedures performed in the urologist’s office is approximately $3,562 compared to $3,800 in calendar 2006, which is subject to geographic adjustment. Reimbursement rates for calendar year 2008 will be published in the November 2007 edition of the Federal Register.

 

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In July 2003, CMS added the CPT Code covering Cooled ThermoTherapy to the ASC list of Medicare approved procedures providing a reimbursement rate for ambulatory surgical centers (ASC). As a result, procedures performed in an ASC were reimbursed under a two-part system similar to hospitals: the ASC received a fixed fee of approximately $1,300, the highest amount allowable under this system, while the urologist performing the procedure was reimbursed the same amount as if the treatment occurred in a hospital, approximately $500. The relatively low facility reimbursement relative to the cost of the procedure potentially limited the number of Cooled ThermoTherapy treatments done in an ASC. Effective July 2005, the CPT code covering Cooled ThermoTherapy was deleted from the ASC list of Medicare approved procedures. As a result, effective with that change, urologists who performed Cooled ThermoTherapy procedures in an ASC are reimbursed at the office-based reimbursement rates, approximately $3,562 in calendar year 2007, subject to geographic adjustment.

 

Private insurance companies and HMOs make their own determinations regarding coverage and reimbursement based upon “usual and customary” fees. To date, we have received coverage and reimbursement in various geographies from private insurance companies and HMOs throughout the United States. We intend to continue our efforts to gain coverage and reimbursement across the United States. There can be no assurance that we will receive favorable coverage or reimbursement determinations for Cooled ThermoTherapy from these payers or that amounts reimbursed to physicians for performing Cooled ThermoTherapy procedures will be sufficient to encourage physicians to use Cooled ThermoTherapy.

 

Internationally, reimbursement approvals for the Cooled ThermoTherapy procedure are awarded on an individual-country basis.

 

Our goal is to grow Cooled ThermoTherapy as a standard of care for the treatment of BPH. Our business strategy to achieve this goal is (i) educate both patients and physicians on the benefits of CooledThermoTherapy compared to other treatment options, (ii) increase the use of Cooled ThermoTherapy by physicians who already have access to a Cooled ThermoTherapy system, (iii) increase the number of physicians who provide Cooled ThermoTherapy to their patients, (iv) efficiently provide more physicians with access to Cooled ThermoTherapy through the expansion of our Cooled ThermoTherapy mobile service in the United States, and (v) increase the use of Cooled ThermoTherapy for the treatment of BPH in international markets.

 

We expect to continue to invest in sales and marketing programs, the expansion of our Cooled ThermoTherapy mobile service and research and development and clinical trials as we focus on growing revenues and continuing to improve our therapy. In addition, we received FDA approval for our CoolWave control unit which we launched in July of 2006. Our future profitability will be dependent upon, among other factors, our success in achieving increased treatment volume and market adoption of the Cooled ThermoTherapy procedures in the physician’s office, including treatments delivered through our Cooled ThermoTherapy mobile service, our success in obtaining and maintaining necessary regulatory clearances, as well as the risk of FDA mandated recall of our products, our ability to manufacture at the volumes and quantities the market requires, the fact that our products may be subject to product recalls even after receiving FDA clearance or approval, the extent to which Medicare and other health care payers continue to reimburse costs of Cooled ThermoTherapy procedures performed in physicians’ offices, hospitals, and ambulatory surgery centers and the amount of reimbursement provided.

 

Critical Accounting Policies:

 

In accordance with Securities and Exchange Commission guidance, we set forth below those material accounting policies that we believe are the most critical to an investor’s understanding of our financial results and condition, and require complex management judgment.

 

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Revenue Recognition

 

We recognize revenue from the sale of Cooled ThermoTherapy™ system control units upon delivery to the customer. In addition to our sales of Cooled ThermoTherapy system control units, we place our Cooled ThermoTherapy system control units with customers under a variety of programs for both evaluation and long-term use, and also provide access to Cooled ThermoTherapy treatments via our Cooled ThermoTherapy mobile service. We retain title to the control units placed with our customers for evaluation and longer-term use and do not recognize any revenue on these control units until title has transferred. These programs, as well as our Cooled ThermoTherapy mobile service, are designed to expand access to our technology, and thus expand the market for our single-use treatment catheters. Revenue from our mobile service is recognized upon treatment of the patient. Revenue from the sale of single-use treatment catheters is recognized at the time of shipment. Revenue for warranty service contracts is deferred and recognized over the contract period and revenue subject to certain sales incentives is deferred based upon the contract provisions. We record a provision for estimated sales returns on product sales in the same period as the related revenue is recorded. The provision for estimated sales returns is based on historical sales returns, analysis of credit memo data and specific customer-based circumstances. Should actual sales returns differ from our estimates, revisions to the sales return reserve would be required.

 

Allowance for Doubtful Accounts

 

We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. We consider factors such as past experience, credit quality of the customer base, age of the receivable balances, both individually and in the aggregate, and current economic conditions that may affect a customer’s ability to pay when determining the adequacy of the allowance. Accounts receivable are charged off after management determines they are uncollectible. If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required.

 

Product Warranty

 

We record a liability for warranty claims at the time of sale. The amount of the liability is based on the trend in the product failure rates, material usage and service delivery costs, the historical length of time between the sale and resulting warranty claim and other factors. Should actual product failure rates, material usage or repair costs differ from our estimates, revisions to the estimated warranty liability would be required.

 

Inventories

 

We value our inventories, consisting primarily of control units, single-use treatment catheters, and raw materials to produce the control units and treatment catheters, at the lower of cost or market value on the first-in, first-out (“FIFO”) basis. The inventory cost includes both merchandise and freight. A periodic review of the inventory on hand is performed to determine if the inventory is properly stated at the lower of cost or market. In performing this analysis we consider, at a minimum, the following factors: average selling prices, reimbursement changes, and changes in demand for our products due to competitive conditions or market acceptance. Each type of inventory is analyzed to determine net realizable values. A provision is recorded to reduce the cost of inventories to the estimated net realizable values, if required.

 

We also analyze the level of inventory on hand on a periodic basis, in relation to estimated customer requirements to determine whether write-downs for excess, obsolete, or slow-moving inventory are required. Any significant or unanticipated change in the factors noted above could have a significant impact on the value of our inventories and on our reported operating results.

 

At June 30, 2007, we recorded a $213,000 write-down of our Prostatron control unit and Prostaprobe catheter inventory as a result of the implementation of an end-of-life plan for this product family.

 

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Valuation of Identifiable Intangible Assets and Goodwill

 

At June 30, 2007, the carrying value of goodwill was $10.2 million. Goodwill is tested for impairment annually or more frequently if changes in circumstance or the occurrence of events suggests an impairment exists. The test for impairment requires us to make several estimates about fair value which are based on various valuation techniques including projected future cash flows and our market capitalization. The assumptions used in estimating fair value represent management’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment.

 

As of June 30, 2007, identifiable intangible assets consist of customer base, developed technologies, trademarks and patents of $200,000, $81,000, $21,000 and $9,200, respectively. We review identifiable intangible assets for impairment as changes in circumstance or the occurrence of events suggests the remaining value is not recoverable. During the fourth quarter of fiscal 2007, in connection with our strategy to develop a next generation catheter, we implemented an end-of-life plan for our Prostatron control units and Prostaprobe catheters which resulted in asset impairment charges related to our identifiable intangible assets in accordance with Statement of Financial Accounting Standards (SFAS) No. 144 “Accounting for the Impairment or Disposal of Long-Lived Assets” of $6,004,000. These charges consisted of a $4,044,000 write-down of developed technologies, a $991,000 write-down of customer base, and a $969,000 write-down of trademarks. The remaining balances of the developed technologies and trademarks are being amortized using the straight-line method over the next 2.5 years, their estimated remaining useful lives. The remaining balance of the customer base is being amortized using the straight-line method over the next 7.25 years, its estimated remaining useful life.

 

Income Taxes

 

We utilize the asset and liability method of accounting for income taxes. We recognize deferred tax liabilities or assets for the expected future tax consequences of temporary differences between the book and tax bases of assets and liabilities. We regularly assess the likelihood that our deferred tax assets will be recovered from future taxable income. We consider projected future taxable income and ongoing tax planning strategies in assessing the amount of the valuation allowance necessary to offset our deferred tax assets that will not be recoverable. Based on management’s assessment of evidence, including the net loss in fiscal 2007, and in accordance with SFAS No. 109 “Accounting for Income Taxes,” we recorded $4.8 million of tax expense at June 30, 2007 to increase our valuation allowance (which had been reduced at the end of fiscal 2006) to fully reserve our deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period. If we determine in the future that it is more likely than not that we will realize all or a portion of our deferred tax assets, we will adjust our valuation allowance in the period we make the determination. We expect to provide a full valuation allowance on our future tax benefits until we can sustain a level of profitability that demonstrates our ability to realize these assets. At June 30, 2007, we carried a valuation allowance of $34.8 million against our remaining deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period.

 

Stock-Based Compensation

 

On July 1, 2005, we adopted the fair value recognition provisions of SFAS No. 123R “Share-Based Payment” using the modified prospective method. Under the modified prospective method, we recognize compensation expense on all stock option awards granted subsequent to July 1, 2005, as well as on any existing awards modified, repurchased or cancelled after July 1, 2005. In addition, compensation expense is recognized on the unvested portion of stock options granted prior to July 1, 2005. The amount of compensation expense is based on the fair value of the option award at the date of grant and is recognized over the requisite service period which corresponds to the option vesting period. Options typically vest 25 percent after the first year of service with the remaining vesting 1/36th each month thereafter. Generally, options granted to non-employee directors are immediately exercisable at the date of grant. Options are priced based on the closing price of a share of our common stock at the date of grant. The fair value of each option grant is estimated on the date of grant using the

 

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Black-Scholes option-pricing model. To determine the inputs for the Black-Scholes option pricing model we use historical data to estimate expected volatility and the period of time that option grants are expected to be outstanding. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the estimated life of the option. The range of these assumptions and the range of option pricing and number of options granted at the different grant dates will impact our calculation of the fair value of the awards and will therefore impact the amount of expense reflected in our statement of operations for any given period.

 

Results of Operations

 

Fiscal Years Ended June 30, 2007 and 2006

 

Net Sales

 

Net sales decreased to $21.3 million in fiscal 2007 from $25.9 million in fiscal 2006. The decrease in sales from fiscal 2006 is primarily due to reduced orders from our direct accounts, which includes both direct office and third party mobile accounts, as well as reduced average selling prices (ASP’s) for our disposable treatment catheters as a result of pricing pressures created by competition and reduced reimbursement rates. This decrease in sales from direct accounts was partially offset by an increase in sales of 86% from our mobile services that began operations in September 2005.

 

The introduction of our mobile services operations in September 2005 had a direct impact to our overall sales mix. During fiscal 2007, 65 percent of sales were derived from treatment catheters, compared to 82 percent in the prior fiscal year, while our mobile treatments comprised 33 percent of total sales in fiscal 2007 compared to15 percent in the prior year. The remaining 2 percent of our sales in fiscal 2007 were from sales of our control units and warranty service contracts.

 

Cost of Goods Sold and Gross Profit

 

Cost of goods sold includes raw materials, labor, overhead, and royalties incurred in connection with the production of our Cooled ThermoTherapy system control units and single-use treatment catheters, amortization related to developed technologies, as well as costs associated with the delivery of our Cooled ThermoTherapy mobile service. Cost of goods sold for fiscal 2007 increased to $13.9 million from $9.0 million in fiscal 2006. The increase in cost of goods sold is primarily due to $4.2 million in asset impairment charges related to developed technologies and Prostatron fixed assets, as well as a $213,000 write-down of Prostatron inventory as a result of the implementation of an end-of-life plan for our Prostatron control units and Prostaprobe catheters in connection with our strategy to develop a next generation catheter.

 

Gross profit as a percentage of sales decreased to 35% in fiscal 2007 from 65% in the prior fiscal year. Gross profit margin rates decreased 21% as a result of the asset impairment charges and inventory write-down mentioned above, and the remaining decrease resulted from decreased sales and production volume of our treatment catheters, which provide a smaller base to absorb our fixed manufacturing overhead costs, an increase in the number of mobile unit treatments, which have lower overall margins, increases in overall material costs, as well as increased costs during the three month period ended September 30, 2006 related to the resolution of manufacturing issues identified in the fourth quarter of fiscal 2006. These manufacturing issues did not continue into the rest of fiscal 2007.

 

Selling, General & Administrative

 

Selling, general and administrative expenses in fiscal 2007 decreased to $11.1 million from $12.9 million in fiscal 2006. The decrease in selling, general and administrative expense is largely the result of a decrease in wages, benefits, commissions, and travel largely due to a decrease in our sales, the size of our sales force, and a decrease in advertising and promotional expense associated with the launch of the new CoolWave control unit. These expense reductions were partially offset by increased legal, audit and consulting fees when compared to the prior fiscal year, as well as $121,000 of severance expense as a result of a 7% headcount reduction in June 2007.

 

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Research and Development

 

Research and development expenses, which include expenditures for product development, regulatory compliance and clinical studies, remained relatively flat at $3.0 million in both fiscal 2007 and 2006. Research and development expenses for fiscal 2007 relate primarily to expenditures incurred in development of our next generation catheter, as compared with the prior year when expenditures related primarily to activities related to our next generation CoolWave control unit.

 

Amortization and Impairment of Identifiable Intangible Assets

 

Amortization and impairment of identifiable intangible assets increased to $2,244,000 in fiscal 2007 compared to amortization of $194,000 in fiscal 2006. The increase in amortization and impairment expense is the result of the implementation of an end-of-life plan at June 30, 2007 for the Prostatron control units and Prostaprobe catheters in connection with our strategy to develop a next generation catheter. This decision resulted in asset impairment charges, in accordance with SFAS No. 144, of $991,000 related to the Prostatron customer base and $969,000 related to the Prostatron trademarks.

 

Net Interest Income

 

Net interest income for fiscal 2007 increased to $554,000 from $371,000 in the prior fiscal year. The increase is due to higher cash and investment balances and higher interest rates.

 

Provision for Income Taxes

 

We recorded $4.9 million of income tax expense for the fiscal year ended June 30, 2007, compared to an income tax benefit of $4.4 million in fiscal 2006. This increase is a result of our recording $4.8 million of tax expense at June 30, 2007 to increase our valuation allowance to fully reserve our deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period. At the end of fiscal 2006, we had reduced our valuation allowance and recorded an income tax benefit of $4.6 million as we had determined that it was more likely than not that we will be able to realize a portion of our deferred tax assets in the future. At June 30, 2007, we increased our valuation allowance to fully reserve our deferred tax assets that would not reverse against deferred tax liabilities within the scheduled reversal period based on management’s assessment of evidence, including the net loss in fiscal 2007. In addition to the $4.8 million of tax expense to increase our valuation allowance, we also recorded $57,000 of income tax expense during the fiscal year related to state taxes. Our fiscal 2008 tax expense of $286,000, plus some minor amounts for state income taxes, is expected to be primarily non-cash and will represent the indefinite-lived deferred tax liability which can not be offset against definite-lived deferred tax assets resulting from the amortization of goodwill for tax purposes.

 

Fiscal Years Ended June 30, 2006 and 2005

 

Net Sales

 

Net sales increased slightly to $25.9 million in fiscal 2006 from $25.8 million in fiscal 2005. The modest sales growth from fiscal 2005 to fiscal 2006 is attributable to sales from our Cooled ThermoTherapy mobile service which was launched in September 2005. This increase was partially offset by a decrease in average per unit selling prices of single-use treatment catheters primarily due to increased competition for the office-based BPH treatment. Sales of our single-use treatment catheters and mobile treatments accounted for approximately 96% of our revenue for the fiscal year ended June 30, 2006 compared to approximately 95% of revenue in fiscal 2005.

 

Cost of Goods Sold and Gross Profit

 

Cost of goods sold includes raw materials, labor, overhead, and royalties incurred in connection with the production of our Cooled ThermoTherapy system control units and single-use treatment catheters, amortization

 

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related to developed technologies, as well as costs associated with the delivery of our Cooled ThermoTherapy mobile service. Cost of goods sold for fiscal 2006 increased to $9.0 million from $7.8 million in fiscal 2005. The increase in cost of goods sold is primarily the result of an increase in the number of treatment catheters sold, additional costs associated with the delivery of our Cooled ThermoTherapy mobile service that was launched in September 2005, an increase in manufacturing variances as a result of manufacturing challenges incurred in the second half of fiscal 2006, as well as approximately $78,000 of equity-based compensation expense related to the adoption of SFAS No. 123R on July 1, 2005.

 

Gross profit as a percentage of sales decreased to 65% in fiscal 2006 from 70% in the prior fiscal year. The decrease in gross profit rates is primarily the result of decreased year-over-year average per unit selling prices of our single-use treatment catheters, lower overall margins on our mobile unit treatments, as well as the fourth quarter manufacturing variances and the equity-based compensation expense mentioned above.

 

Selling, General & Administrative

 

Selling, general and administrative expenses in fiscal 2006 increased to $12.9 million from $11.6 million in fiscal 2005. The increase in selling, general and administrative expense is largely the result of $1.1 million of equity-based compensation expense, as well as increased expenses associated with sales and marketing programs designed to increase the awareness of Cooled ThermoTherapy.

 

Research and Development

 

Research and development expenses, which include expenditures for product development, regulatory compliance and clinical studies, decreased slightly to $3.0 million in fiscal 2006 from $3.1 million in the prior fiscal year. The decrease in expenses is primarily from decreased expenditures on product development activities related to our CoolWave control unit.

 

Amortization of Identifiable Intangible Assets

 

Amortization of identifiable intangible assets increased to $194,000 in fiscal 2006 from $164,000 fiscal 2005. The increase in amortization expense is the result of the determination in the fourth quarter of fiscal 2006 to begin amortizing our previous indefinite-lived trademark on a straight-line basis over its estimated remaining life of 9.5 years at April 1, 2006. The decision to begin amortizing our trademark, which represents the Prostatron and TUMT trademarks acquired from EDAP on October 1, 2000, was due to the approval of the CoolWave control unit and our intent to focus marketing on this control unit and trademark, and due to the fact that we are not planning to manufacturing additional Prostatron control units.

 

Net Interest Income

 

Net interest income for fiscal 2006 increased to $371,000 from $147,000 in the prior fiscal year. The increase is due to higher cash and investment balances and higher interest rates.

 

Provision for Income Taxes

 

We recognized an income tax benefit of $4.4 million in fiscal 2006 compared to income tax expense of $424,000 in fiscal 2005. Historically we have carried a full valuation allowance against our deferred tax assets, the majority of which represent net operating loss tax carry forwards which we generated prior to achieving profitability. Based upon management’s assessment of all available evidence, including our cumulative net income for fiscal years 2004, 2005 and 2006, and estimates of future profitability and the overall prospects of our business, we determined that it was more likely than not that we would be able to realize a portion of our deferred tax assets in the future, and as a result recorded a $4.6 million income tax benefit in the fourth quarter of fiscal 2006. The deferred tax benefit of $4.6 million was partially offset by $221,000 of income tax expense related to federal alternative minimum taxes and state taxes on fiscal 2006 pre-tax income for financial statement purposes.

 

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Liquidity and Capital Resources

 

We have financed our operations since inception through sales of equity securities and, to a lesser extent, sales of our Cooled ThermoTherapy system control units and single-use treatment catheters. As of June 30, 2007, we had total cash and cash equivalents of $12.3 million compared to cash and cash equivalents of $11.1 million as of June 30, 2006. The increase in cash and cash equivalents resulted primarily from cash provided by operating activities

 

Cash Provided by Operating Activities

 

During fiscal 2007, we generated $1.5 million of cash from operating activities compared to $1.2 million is fiscal 2006 primarily as a result of decreases in accounts receivable of $1.1 million due to improved collection efforts and reduced revenue during fiscal 2007. This increase in cash from operating activities was partially offset by our net loss of $13.2 million, adjusted for $6.0 million of long-lived asset impairments, a $4.8 million increase in our valuation allowance against our deferred tax assets, $2.3 million of depreciation and amortization and $1.1 million of stock-based compensation expense, as well as decreases in inventories of $213,000, which consists of a $416,000 increase in overall inventory offset by $629,000 of transfers of control units to fixed assets, and decreases in our accounts payable of $427,000. The increase in overall inventory is primarily the result of increased finished goods in anticipation of greater sales levels than were achieved in fiscal year 2007. This increase was offset by a portion of inventory transferred to property and equipment in support of our customer evaluation and long-term use programs and to support the expansion of our Cooled ThermoTherapy mobile service. The decrease in accounts payable is mainly due to the timing of receipts and payments of vendor goods and services.

 

Cash Used for Investing Activities

 

We used $312,000 for investing activities as a result of the purchase of property and equipment largely to support the growth of our mobile initiative and as a result of patent fees incurred.

 

Cash Provided by Financing Activities

 

During fiscal 2007 we generated $12,000 from financing activities as a result of proceeds from the exercise of stock options.

 

We plan to continue offering customers a variety of programs for both evaluation and longer-term use of our Cooled ThermoTherapy system control units in addition to purchase options, as well as grow our mobile service which provides physicians and patients with efficient access to our Cooled ThermoTherapy system control units on a pre-scheduled basis. As of June 30, 2007, our property and equipment, net, included approximately $1.5 million of control units used in evaluation or long-term use programs and units used in our Company-owned mobile service. Depending on the growth of these programs, we may use additional capital to finance these programs.

 

Future contractual commitments, including interest, that will affect cash flows are as follows (in thousands):

 

     2008

   2009

   2010

   2011

Building and equipment leases

   272    11    10    3

 

We are currently in the process of negotiating a three-year renewal on our building lease.

 

We believe our $12.3 million in cash and cash equivalents at June 30, 2007, together with the funds generated from operations, will be sufficient to fund our working capital and capital resources needs for at least the next 12 months. There can be no assurance, however, that we will not require additional financing in the future or that any additional financing will be available to us on satisfactory terms, if at all.

 

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Off Balance Sheet Arrangements

 

We do not have any off balance sheet arrangements.

 

Recently Issued Accounting Standards

 

In June 2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109” (FIN 48). This interpretation clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” This interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. This Interpretation is effective for us beginning on July 1, 2007. While we are still evaluating the impact the adoption of this pronouncement will have on our financial statements, we do not expect the adoption of FIN 48 to have a material impact on our financial statements given our historical losses.

 

In September 2006, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 157, “Fair Value Measurements.” SFAS No. 157 establishes a single authoritative definition of fair value, sets out a framework for measuring fair value and requires additional disclosures about fair-value measurements. This Statement applies only to fair-value measurements that are already required or permitted by other accounting standards, except for measurements of share-based payments and measurements that are similar to, but not intended to be, fair value. This statement is expected to increase the consistency of fair value measurements, but imposes no requirements for additional fair-value measures in financial statements. The provisions under SFAS No. 157 are effective for us beginning on July 1, 2008. We are still evaluating the impact the adoption of this pronouncement will have on our financial statements.

 

In February 2007, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 159 “The Fair Value Option for Financial Assets and Liabilities—including and amendment of FASB Statement No. 115.” SFAS No. 159 permits entities to choose to measure eligible financial instruments and certain other items at fair value at specified election dates to mitigate volatility in reported earnings caused by measuring related assets and liabilities differently without having to apply complex hedge accounting provisions. The provisions under SFAS No. 159 are effective for us beginning on July 1, 2008. We believe that the adoption of this pronouncement will not have a material effect on our financial statements.

 

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our financial instruments include cash and cash equivalents. Increases and decreases in prevailing interest rates generally translate into decreases and increases, respectively, in the fair value of these instruments. Also, fair values of interest rate sensitive instruments may be affected by the credit worthiness of the issuer, prepayment options, relative values of alternative instruments, the liquidity of the instrument and other general market conditions.

 

Market risk was estimated as the potential decrease in fair value resulting from a hypothetical 1% change in interest rates and was not materially different from the quarter-end carrying value. Due to the nature of our cash and cash equivalents, we have concluded that we do not have a material market risk exposure.

 

Our policy is not to enter into derivative financial instruments. We do not have any significant foreign currency exposure since we do not generally transact business in foreign currencies. Therefore, we do not have significant overall currency exposure. In addition, we do not enter into any futures or forward commodity contracts since we do not have significant market risk exposure with respect to commodity prices.

 

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

The following financial statements are included in the Form 10-K.

 

Report of Independent Registered Public Accounting Firm

   33

Balance Sheets as of June 30, 2007 and 2006

   34

Statements of Operations for the years ended June 30, 2007, 2006 and 2005

   35

Statements of Shareholders’ Equity for the years ended June 30, 2007, 2006 and 2005

   36

Statements of Cash Flows for the years ended June 30, 2007, 2006 and 2005

   37

Notes to Financial Statements

   38

 

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Table of Contents

Report of Independent Registered Public Accounting Firm

 

The Board of Directors and Shareholders

Urologix, Inc.:

 

We have audited the accompanying balance sheets of Urologix, Inc. (the Company) as of June 30, 2007 and 2006, and the related statements of operations, shareholders’ equity and cash flows for each of the years in the three-year period ended June 30, 2007. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these 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 financial statements referred to above present fairly, in all material respects, the financial position of Urologix, Inc. as of June 30, 2007 and 2006, and the results of its operations and its cash flows for each of the years in the three-year period ended June 30, 2007, in conformity with U.S. generally accepted accounting principles.

 

As disclosed in Notes 3 and 9 to the financial statements, the Company adopted the provisions of Statement of Financial Accounting Standards No. 123 (Revised 2004), Share-Based Payment, on July 1, 2005, and Securities and Exchange Commission Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, as of July 1, 2006.

 

/s/ KPMG LLP

 

Minneapolis, Minnesota

September 18, 2007

 

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Table of Contents

Urologix, Inc.

 

Balance Sheets

(In thousands, except per share data)

 

     June 30,

 
     2007

    2006

 

ASSETS

                

Current assets:

                

Cash and cash equivalents

   $ 12,250     $ 11,054  

Accounts receivable, net of allowance of $224 and $238

     4,071       5,234  

Inventories

     2,421       2,634  

Deferred tax asset

     —         992  

Prepaids and other current assets

     40       184  
    


 


Total current assets

     18,782       20,098  
    


 


Property and equipment:

                

Property and equipment

     12,306       11,562  

Less accumulated depreciation

     (9,973 )     (8,665 )
    


 


Property and equipment, net

     2,333       2,897  

Other assets

     1,034       1,288  

Goodwill

     10,193       10,193  

Identifiable intangible assets, net

     311       7,090  

Deferred tax asset, net

     —         2,332  
    


 


Total assets

   $ 32,653     $ 43,898  
    


 


LIABILITIES AND SHAREHOLDERS’ EQUITY

                

Current liabilities:

                

Accounts payable

   $ 948     $ 1,375  

Accrued compensation

     756       826  

Deferred income

     229       242  

Other accrued expenses

     782       729  
    


 


Total current liabilities

     2,715       3,172  
    


 


Deferred tax liability

     1,519       —    

Deferred income

     544       712  

Other accrued expenses

     —         34  
    


 


Total liabilities

     4,778       3,918  
    


 


Commitments and contingencies (Note 8)

                

SHAREHOLDERS’ EQUITY:

                

Common stock, $.01 par value, 25,000 shares authorized; 14,333 and 14,328 shares issued and outstanding

     143       143  

Additional paid-in capital

     112,545       111,450  

Accumulated deficit

     (84,813 )     (71,613 )
    


 


Total shareholders’ equity

     27,875       39,980  
    


 


Total liabilities and shareholders’ equity

   $ 32,653     $ 43,898  
    


 


 

The accompanying notes to financial statements are an integral part of these statements.

 

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Table of Contents

Urologix, Inc.

 

Statements of Operations

(In thousands, except per share data)

 

     For the Years Ended June 30

 
     2007

    2006

    2005

 

SALES

   $ 21,317     $ 25,885     $ 25,813  

COST OF GOODS SOLD

     13,893       8,995       7,810  
    


 


 


Gross profit

     7,424       16,890       18,003  
    


 


 


COSTS AND EXPENSES

                        

Selling, general and administrative

     11,086       12,940       11,643  

Research and development

     3,026       2,987       3,073  

Amortization and impairment of identifiable intangible assets

     2,244       194       164  
    


 


 


Total costs and expenses

     16,356       16,121       14,880  
    


 


 


OPERATING EARNINGS (LOSS)

     (8,932 )     769       3,123  

INTEREST INCOME

     554       371       147  

INTEREST EXPENSE

     —         —         (9 )
    


 


 


EARNINGS (LOSS) BEFORE INCOME TAXES

     (8,378 )     1,140       3,261  

INCOME TAX EXPENSE (BENEFIT)

     4,859       (4,354 )     424  
    


 


 


NET EARNINGS (LOSS)

   $ (13,237 )   $ 5,494     $ 2,837  
    


 


 


NET EARNINGS (LOSS) PER COMMON SHARE—BASIC

   $ (0.92 )   $ 0.38     $ 0.20  
    


 


 


NET EARNINGS (LOSS) PER COMMON SHARE—DILUTED

   $ (0.92 )   $ 0.38     $ 0.19  
    


 


 


WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—BASIC

     14,332       14,319       14,279  
    


 


 


WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING—DILUTED

     14,332       14,369       14,759  
    


 


 


 

 

The accompanying notes to financial statements are an integral part of these statements.

 

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Table of Contents

Urologix, Inc.

 

Statements of Shareholders’ Equity

(In thousands)

 

     Common Stock

  

Additional

Paid-In

Capital


  

Accumulated

Deficit


   

Accumulated

Other

Comprehensive

Income (Loss)


   

Total

Shareholders’

Equity


 
     Shares

   Amount

         

Balance, June 30, 2004

   14,194    $ 142    $ 109,653    $ (79,944 )   $ 9     $ 29,860  

Change in unrealized gains (losses) on investments

   —        —        —        —         (10 )     (10 )

Net earnings

   —        —        —        2,837       —         2,837  
                                       


Comprehensive income

   —        —        —        —         —         2,827  

Stock options exercised

   114      1      451      —         —         452  

Income tax benefit related to employee stock options

   —        —        6      —         —         6  
    
  

  

  


 


 


Balance, June 30, 2005

   14,308      143      110,110      (77,107 )     (1 )     33,145  
    
  

  

  


 


 


Change in unrealized gains (losses) on investments

   —        —        —        —         1       1  

Net earnings

   —        —        —        5,494       —         5,494  
                                       


Comprehensive income

   —        —        —        —         —         5,495  

Stock options exercised

   20      —        69      —         —         69  

Income tax benefit related to employee stock options

   —        —        1      —         —         1  

Stock-based compensation

   —        —        1,270      —         —         1,270  
    
  

  

  


 


 


Balance, June 30, 2006

   14,328      143      111,450      (71,613 )     —         39,980  

Cumulative effect adjustment as a result of the adoption of SAB 108

                        37               37  

Net loss

   —        —        —        (13,237 )     —         (13,237 )
                                       


Comprehensive loss

   —        —        —        —         —         (13,237 )

Stock options exercised

   5      —        12      —         —         12  

Stock-based compensation

   —        —        1,083      —         —         1,083  
    
  

  

  


 


 


Balance, June 30, 2007

   14,333    $ 143    $ 112,545    $ (84,813 )   $ —       $ 27,875  
    
  

  

  


 


 


 

 

The accompanying notes to financial statements are an integral part of these statements.

 

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Urologix, Inc.

 

Statements of Cash Flows

(In thousands)

 

     For the Years Ended June 30

 
     2007

    2006

    2005

 

OPERATING ACTIVITIES

                        

Net earnings (loss)

   $ (13,237 )   $ 5,494     $ 2,837  

Adjustments to reconcile net earnings (loss) to net cash provided by operating activities:

                        

Depreciation and amortization

     2,260       2,014       1,881  

Employee stock-based compensation expense

     1,083       1,270       —    

Impairment of long-lived assets

     6,004       —         —    

Provision for bad debts

     58       19       63  

Deferred income taxes

     4,842       (4,476 )     294  

Loss on disposal of assets

     20       1       —    

Change in operating assets and liabilities:

                        

Accounts receivable

     1,105       (1,010 )     (1,617 )

Inventories

     (416 )     (1,705 )     (502 )

Prepaids and other assets

     398       450       498  

Accounts payable

     (427 )     (158 )     584  

Accrued expenses and deferred income

     (194 )     (732 )     (1,119 )
    


 


 


Net cash provided by operating activities

     1,496       1,167       2,919  
    


 


 


INVESTING ACTIVITIES

                        

Purchase of property and equipment

     (312 )     (953 )     (91 )

Proceeds from sales or maturities of investments

     —         172       2,281  
    


 


 


Net cash (used for) provided by investing activities

     (312 )     (781 )     2,190  
    


 


 


FINANCING ACTIVITIES

                        

Proceeds from issuance of common stock

     12       69       452  

Payments made on note payable

     —         —         (104 )
    


 


 


Net cash provided by financing activities

     12       69       348  
    


 


 


NET INCREASE IN CASH AND CASH EQUIVALENTS

     1,196       455       5,457  

CASH AND CASH EQUIVALENTS

                        

Beginning of year

     11,054       10,599       5,142  
    


 


 


End of year

   $ 12,250     $ 11,054     $ 10,599  
    


 


 


Supplemental cash-flow information                         

Cash paid during the period for interest

   $ —       $ —       $ 16  

Income taxes paid during the period

   $ 112     $ 93     $ 130  

Net value of inventory transferred to property and equipment

   $ 629     $ 813     $ 904  

 

The accompanying notes to financial statements are an integral part of these statements.

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements

 

1. Nature of Business

 

Description of Operating Activities

 

Urologix develops, manufactures, and markets non-surgical, catheter-based therapies that use a proprietary cooled microwave technology for the treatment of benign prostatic hyperplasia (BPH), a disease that affects more than 23 million men worldwide. We market our control units under the Targis,® Prostatron® and CoolWave® names and our procedure kits under the CTC™, Targis and Prostaprobe™ names. We are also in the process of developing our next generation catheter, CoolMax™, in which we are planning to combine durability with increased patient comfort. During the fourth quarter of fiscal 2007, in connection with our strategy to develop a next generation catheter, we implemented an end-of-life plan for our Prostatron control units and Prostaprobe catheters which will result in us exiting this product line over approximately the next 2.5 years. All systems utilize the Company’s Cooled ThermoTherapy technology, a targeted microwave energy combined with a unique cooling mechanism that protects healthy tissue and enhances patient comfort while providing safe, effective, lasting relief from the symptoms of BPH. Cooled ThermoTherapy can be performed without anesthesia or intravenous sedation and can be performed in a physician’s office or an outpatient clinic.

 

2. Significant Accounting Policies

 

Cash and Cash Equivalents

 

We classify highly liquid investments with original maturities of 90 days or less as cash equivalents. Cash equivalents are stated at cost, which approximates market value.

 

Revenue Recognition

 

We recognize revenue from the sale of Cooled ThermoTherapy™ system control units upon delivery to the customer. In addition to our sales of Cooled ThermoTherapy system control units, we place our Cooled ThermoTherapy system control units with customers under a variety of programs for both evaluation and long-term use, and also provide access to Cooled ThermoTherapy treatments via our Cooled ThermoTherapy mobile service. We retain title to the control units placed with our customers for evaluation and longer-term use and do not recognize any revenue on these control units until title has transferred. These programs, as well as our Cooled ThermoTherapy mobile service, are designed to expand access to our technology, and thus expand the market for our single-use treatment catheters. Revenue from our mobile service is recognized upon treatment of the patient. Revenue from the sale of single-use treatment catheters is recognized at the time of shipment. Revenue for warranty service contracts is deferred and recognized over the contract period and revenue subject to certain sales incentives is deferred based upon the contract provisions. We record a provision for estimated sales returns on product sales in the same period as the related revenue is recorded. The provision for estimated sales returns is based on historical sales returns, analysis of credit memo data and specific customer-based circumstances.

 

Trade Accounts Receivable

 

Trade accounts receivable are recorded at fair value upon the sale of goods or services to customers. They are stated net of allowances for doubtful accounts.

 

Allowance for Doubtful Accounts

 

We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. We consider factors such as past experience, credit quality of the customer base, age of the receivable balances, both individually and in the aggregate, and current economic

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

conditions that may affect a customer’s ability to pay when determining the adequacy of the allowance. Accounts receivable are charged off after management determines they are uncollectible.

 

Bad debt and sales returns provisions and accounts receivable write-offs for the years ended June 30, 2007, 2006 and 2005 were as follows (in thousands):

 

Years Ended


  

Beginning

Balance


   Provisions

   Write-offs

   

Ending

Balance


June 30, 2007

   $ 238    $ 8    $ (22 )   $ 224

June 30, 2006

     167      74      (3 )     238

June 30, 2005

     299      36      (168 )     167

 

Inventories

 

Inventories are stated at the lower of first-in, first-out cost or market and consist of (in thousands):

 

     June 30,
2007


   June 30,
2006


Raw materials

   $ 1,306    $ 1,511

Work-in-process

     118      498

Finished goods

     997      625
    

  

Total inventories

   $ 2,421    $ 2,634
    

  

 

Goodwill and Identifiable Intangible Assets

 

At June 30, 2007, the carrying value of goodwill was $10.2 million. Goodwill is tested for impairment annually or more frequently if changes in circumstance or the occurrence of events suggests an impairment exists. The test for impairment requires us to make several estimates about fair value which are based on various valuation techniques including projected future cash flows and our market capitalization. There was no impairment of our goodwill at June 30, 2007.

 

As of June 30, 2007, identifiable intangible assets consist of customer base, developed technologies, trademarks and patents of $200,000, $81,000, $21,000 and $9,200, respectively. In accordance with SFAS No. 144, we review identifiable intangible assets for impairment as changes in circumstance or the occurrence of events suggests the remaining value is not recoverable. These events include continued losses or a projection of continued losses, a significant decrease in the market value of an asset, or a change in the expected use of an asset. When triggering event occurs, an impairment calculation is performed, comparing projected undiscounted future cash flows, utilizing current cash flow information to the carrying value of those assets. If impairment is identified for long-lived assets, discounted future cash flows are compared to the asset’s current carrying value. Impairment is recorded when the carrying value exceeds the discounted cash flows. See Note 4 for a description of asset impairment charges recorded in fiscal year 2007.

 

Property and Equipment

 

Property and equipment are stated at cost. Company owned Cooled ThermoTherapy system control units located at customer sites for evaluation and longer-term use programs are classified as property and equipment, valued at cost and depreciated over a useful life of four years. Improvements that extend the useful lives of property and equipment are capitalized at cost and depreciated over their remaining useful lives. Repairs and maintenance are charged to expense as incurred. Depreciation is provided using the straight-line method based

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

upon estimated useful lives of three to seven years for machinery, equipment, furniture and vehicles. Leasehold improvements are amortized over the shorter of the useful life of the assets or term of the lease.

 

Property and equipment, net consisted of the following at June 30, 2007 and 2006 (in thousands):

 

     June 30,
2007


   June 30,
2006


Leasehold improvements, equipment, furniture and vehicles

   $ 750    $ 855

Computer equipment

     61      87

Control units

     1,522      1,955
    

  

Total property and equipment, net

   $ 2,333    $ 2,897
    

  

 

Other Assets

 

Other assets consist primarily of prepaid royalties resulting from patent licensing agreements. The agreements require us to pay a royalty on sales of Cooled ThermoTherapy products. Royalties are charged to cost of goods sold as sales are recognized.

 

Warranty Costs

 

Certain of our products are covered by warranties against defects in material and workmanship for periods of up to twenty-four months. We record a liability for warranty claims at the time of sale. The amount of the liability is based on the trend in the historical ratio of product failure rates, material usage and service delivery costs to sales, the historical length of time between the sale and resulting warranty claim and other factors.

 

Warranty provisions and claims for the years ended June 30, 2007, 2006 and 2005 were as follows (in thousands):

 

Years Ended


  

Beginning

Balance


  

Warranty

Provisions


  

Warranty

Claims


   

Ending

Balance


June 30, 2007

   $ 94    $ 100    $ (89 )   $ 105

June 30, 2006

   $ 141    $ 92    $ (139 )   $ 94

June 30, 2005

   $ 215    $ 62    $ (136 )   $ 141

 

Income Taxes

 

We utilize the asset and liability method of accounting for income taxes. We recognize deferred tax liabilities or assets for the expected future tax consequences of temporary differences between the book and tax bases of assets and liabilities. We regularly assess the likelihood that our deferred tax assets will be recovered from future taxable income. We consider projected future taxable income and ongoing tax planning strategies in assessing the amount of the valuation allowance necessary to offset our deferred tax assets that will not be recoverable. Based on management’s assessment of evidence, including the net loss in fiscal 2007, and in accordance with SFAS No. 109 “Accounting for Income Taxes,” we recorded $4.8 million of tax expense at June 30, 2007 to increase our valuation allowance (which had been reduced at the end of fiscal 2006) to fully reserve our deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period. If we determine in the future that it is more likely than not that we will realize all or a portion of our deferred tax assets, we will adjust our valuation allowance in the period we make the determination. We expect to provide a full valuation allowance on our future tax benefits until we can sustain a level of profitability that

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

demonstrates our ability to realize these assets. At June 30, 2007, we carried a valuation allowance of $34.8 million against our remaining deferred tax assets that will not reverse against deferred tax liabilities within the scheduled reversal period.

 

Stock-Based Compensation

 

On July 1, 2005, we adopted the fair value recognition provisions of SFAS No. 123(R) “Share-Based Payment” using the modified prospective method. Under the modified prospective method, we recognize compensation expense on all stock option awards granted subsequent to July 1, 2005, as well as on any existing awards modified, repurchased or cancelled after July 1, 2005. In addition, compensation expense is recognized on the unvested portion of stock options granted prior to July 1, 2005. Expense is determined based on the fair values of the options at their date of grant. Historically we accounted for share-based compensation under the recognition and measurement principles of Accounting Principles Board (APB) Opinion 25, “Accounting for Stock Issued to Employees” and related interpretations. See Note 3 for additional discussion.

 

Net Earnings (Loss) Per Common Share

 

Basic earnings (loss) per share was computed by dividing the net earnings (loss) by the weighted average number of shares of common stock outstanding during the periods presented. Diluted net earnings (loss) per share was computed by dividing the net earnings (loss) by the weighted average number of shares of common stock outstanding plus all potentially dilutive common shares that result from stock options. The number of shares used in earnings per share computations is as follows (in thousands):

 

     For the years ended June 30,

     2007

   2006

   2005

Weighted average common shares outstanding—basic

   14,332    14,319    14,279

Dilutive effect of stock options

   —      50    480
    
  
  

Weighted average common shares outstanding—diluted

   14,332    14,369    14,759
    
  
  

 

The dilutive effect of stock options in the above table excludes 1.3 million, 1.1 million, and 0.4 million of options for which the exercise price was higher than the average market price for the years ended June 30, 2007, 2006 and 2005, respectively. In addition, dilutive potential common shares of a de minimus amount were excluded from diluted weighted average common shares outstanding for the year ended June 30, 2007 as they would be anti-dilutive due to our net loss for the year.

 

Research and Development Costs

 

Research and development costs are charged to expense as incurred.

 

Financial Instruments

 

The carrying amounts of our financial instruments approximate fair value, as the majority of these instruments are short-term in nature.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities,

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

as well as 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. Actual results could differ from those estimates.

 

Reclassification

 

Certain prior year amounts have been reclassified to conform to current year presentation.

 

Recently Issued Accounting Standards

 

In June 2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation No. 48, “Accounting for Uncertainty in Income Taxes—an interpretation of FASB Statement No. 109” (FIN 48). This interpretation clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109, “Accounting for Income Taxes.” This interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. This Interpretation is effective for us beginning on July 1, 2007. While we are still evaluating the impact the adoption of this pronouncement will have on our financial statements, we do not expect the adoption of FIN 48 to have a material impact on our financial statements given our historical losses.

 

In September 2006, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 157, “Fair Value Measurements.” SFAS No. 157 establishes a single authoritative definition of fair value, sets out a framework for measuring fair value and requires additional disclosures about fair-value measurements. This Statement applies only to fair-value measurements that are already required or permitted by other accounting standards, except for measurements of share-based payments and measurements that are similar to, but not intended to be, fair value. This statement is expected to increase the consistency of fair value measurements, but imposes no requirements for additional fair-value measures in financial statements. The provisions under SFAS No. 157 are effective for us beginning on July 1, 2008. We are still evaluating the impact the adoption of this pronouncement will have on our financial statements.

 

In February 2007, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 159 “The Fair Value Option for Financial Assets and Liabilities—including an amendment of FASB Statement No. 115.” SFAS No. 159 permits entities to choose to measure eligible financial instruments and certain other items at fair value at specified election dates to mitigate volatility in reported earnings caused by measuring related assets and liabilities differently without having to apply complex hedge accounting provisions. The provisions under SFAS No. 159 are effective for us beginning on July 1, 2008. We believe that the adoption of this pronouncement will not have a material effect on our financial statements.

 

3. Stock Options

 

We have a stock option plan that provides for the granting of incentive stock options to employees and nonqualified stock options to employees, directors and consultants. As of June 30, 2007, we had reserved 4,450,910 shares of common stock under this plan, and 2,447,546 shares were available for future grants. Options expire ten years from the date of grant and typically vest 25 percent after the first year of service with the remaining vesting 1/36th each month thereafter. Under the current terms of our stock option plan, persons serving as non-employee directors at the date of the annual shareholder meeting automatically receive a grant to purchase 10,000 shares of common stock at a price equal to fair value on the date of grant. Generally, such options are immediately exercisable on the date of grant, and expire 10 years from the date of grant, subject to earlier termination one year after the person ceases to be a director of the Company.

 

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UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

In addition to the stock option plan described above, Fred B. Parks, the Company’s Chairman and Chief Executive Officer, received an option to purchase 225,000 shares in connection with his original employment agreement dated May 21, 2003. The option is a non-qualified option exercisable at a price of $2.75. The 225,000 share grant vested over the period commencing on May 27, 2003 and ending on May 27, 2007, with 56,268 shares vesting on May 27, 2004, and 1/36th of the remaining 168,732 shares vesting on the 27th of each of the 36 months following May 27, 2004.

 

On July 1, 2005 we adopted the fair value recognition provisions of SFAS No. 123R “Share-Based Payment” using the modified prospective method. As a result, our fiscal 2007 and 2006 results of operations reflect compensation expense for new stock options granted and vested under our stock incentive plan, and the unvested portion of previous stock option grants which vested during the year. Amounts recognized in the financial statements related to stock-based compensation for the fiscal years ended June 30, 2007 and 2006 were as follows (in thousands, except per share amounts):

 

     2007

   2006

Cost of goods sold

   $ 140    $ 78

Selling, general and administrative

     777      1,051

Research and development

     166      141
    

  

Total cost of stock-based compensation

     1,083      1,270

Tax benefit of options issued

     —        —  
    

  

Total stock-based compensation, net of tax

   $ 1,083    $ 1,270
    

  

 

Prior to July 1, 2005, we accounted for stock-based employee compensation arrangements in accordance with the provisions and related interpretations of APB 25, “Accounting for Stock Issued to Employees.” Had compensation cost for stock-based compensation been determined consistent with SFAS No. 123, the net earnings and net earnings per share would have been adjusted to the following pro-forma amounts for the fiscal year ended June 30, 2005 (in thousands, except for per share data):

 

     2005

 

Net earnings, as reported

   $ 2,837  

Employee stock-based compensation included in net earnings

     —    

Total stock-based employee compensation expense determined under the fair value based method, net of tax

     (2,387 )
    


Pro forma net earnings

   $ 450  
    


Net earnings per share:

        

Basic—as reported

   $ 0.20  

Basic—pro forma

   $ 0.03  

Diluted—as reported

   $ 0.19  

Diluted—pro forma

   $ 0.03  

 

The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model. We use historical data to estimate expected volatility, the period of time that option grants are expected to be outstanding, as well as employee termination behavior. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the estimated life of the option. The following weighted-average

 

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UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

assumptions were used to estimate the fair value of options granted during the fiscal years ended June 30 2007, 2006 and 2005 using the Black-Scholes option-pricing model:

 

     2007

    2006

    2005

 

Volatility

   69.4 %   86.6 %   88.4 %

Risk-free interest rate

   4.9 %   4.1 %   2.9 %

Expected option life

   3 years     4 years     4 years  

Stock dividend yield

   —       —       —    

 

A summary of our options outstanding and exercisable at June 30, 2007 is as follows:

 

Range of Exercise
Prices


   Outstanding as of
June 30, 2007


   Remaining
Contractual Life


   Weighted-avg.
Exercise Price


   Exercisable as of
June 30, 2007


   Weighted-avg.
Exercise Price


$ —    -  $  2.43    15,000        9.36        $ 2.41    —          $ —  
$ 2.44  -  $  4.86    912,805        6.87        $ 3.55    685,042        $ 3.68
$ 4.87  -  $  7.29    104,757        6.61        $ 5.85    77,320        $ 5.98
$ 7.30  -  $  9.72    13,250        4.57        $ 8.81    12,208        $ 8.87
$   9.73  -  $12.15    12,500        3.5          $ 12.13    12,500        $ 12.13
$ 12.16  -  $14.58    49,095        4.4          $ 12.73    41,100        $ 12.83
$ 14.59  -  $17.01    10,000        4.4          $ 15.82    10,000        $ 15.82
$ 17.02  -  $19.44    3,727        3.7          $ 18.93    3,727        $ 18.93
      
              
      
           1,121,134        6.7          $ 4.47    841,897        $ 4.75
      
              
      

 

A summary of our option activity for the fiscal year ended June 30, 2007 is as follows:

 

     Number of Options

    Weighted-avg.
Exercise Price Per
Option


   Weighted-avg.
Remaining
Contractual Term


Outstanding at July 1, 2006

   1,519,835     $ 5.90     

Options granted

   415,000       2.82     

Options forfeited

   (358,559 )     4.68     

Options expired

   (449,587 )     7.62     

Options exercised

   (5,555 )     2.30     
    

          

Outstanding at June 30, 2007

   1,121,134       4.47    6.7

Exercisable at June 30, 2007

   841,897       4.75    6.0

 

There is no aggregate intrinsic value for options outstanding or exercisable at June 30, 2007 as the price of our stock at June 30, 2007 was less than the exercise price of all options outstanding or exercisable.

 

The weighted average fair value of our options at their grant date was approximately $1.42, $3.16 and $6.56 for the fiscal years ended June 30, 2007, 2006 and 2005, respectively. The total intrinsic value of options exercised during the fiscal years ended June 30, 2007, 2006 and 2005 was $4,000, $15,000 and $572,000, respectively.

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

A summary of the status of our nonvested options as of June 30, 2007 is as follows:

 

     Number of Options

    Weighted-avg. Grant-
Date Fair Value


Nonvested at July 1, 2006

   519,780     $ 3.43

Options granted

   415,000       1.42

Options forfeited

   (358,559 )     2.78

Options vested

   (296,984 )     2.89
    

     

Nonvested at June 30, 2007

   279,237       1.98
    

     

 

As of June 30, 2007, there was $1.2 million of total unrecognized compensation cost related to nonvested share-based compensation granted under our plan. That cost is expected to be recognized over a weighted-average period of 2.0 years. The total fair value of shares vested during the fiscal years ended June 30, 2007, 2006 and 2005 was $0.9 million, $1.4 million and $1.6 million, respectively.

 

Employee Stock Purchase Plan

 

We established an Employee Stock Purchase Plan (the Plan) and reserved 100,000 common shares for issuance under the Plan. Under the terms of the Plan, employees may purchase common shares at prices ranging from 85% to 100% of the shares’ fair value, as determined by the Company’s board of directors. Eligible employees elect to participate through payroll deductions at the maximum level established by the board of directors, but not to exceed 10% of the participant’s base pay, as defined. As of June 30, 2005, all 100,000 shares had been issued under the Plan since inception for gross proceeds of $434,672 and no shares remained available for issuance under the Plan in fiscal 2006 or fiscal 2007.

 

4. Identifiable Intangible Assets, Net

 

Balances of identifiable intangible assets, net, were as follows (in thousands):

 

     As of June 30, 2007

   As of June 30, 2006

     Carrying
Amount


   Accumulated
Amortization


   Impairment

   Net

   Carrying
Amount


   Accumulated
Amortization


   Net

Developed technologies

   $ 7,500    $ 3,375    $ 4,044    $ 81    $ 7,500    $ 2,875    $ 4,625

Customer base

     2,300      1,109      991      200      2,300      945      1,355

Trademarks

     1,140      150      969      21      1,140      30      1,110

Patents

     9      —        —        9                     
    

  

  

  

  

  

  

Total identifiable intangible assets, net

   $ 10,949    $ 4,634    $ 6,004    $ 311    $ 10,940    $ 3,850    $ 7,090
    

  

  

  

  

  

  

 

At June 30, 2007, in connection with our strategy to develop a next generation catheter, we implemented an end-of-life plan for our Prostatron control units and Prostaprobe catheters which resulted in asset impairment charges related to developed technologies, customer base, and trademarks in accordance with SFAS No. 144. The patent intangible assets relate to fees incurred for patents that have not yet been issued. We will begin amortization of these patent costs once the patents have been issued. The impairment charge of $4,044,000 related to developed technologies is reflected in “Cost of Goods Sold,” while the charges related to the customer base and trademark of $991,000 and $969,000, respectively, are reflected in “Amortization and Impairment of Identifiable Intangible Assets” in the fiscal year 2007 Statement of Operations.

 

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UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

Future annual amortization expense for developed technologies, customer base and trademarks is expected to be approximately $68,000 for the next 2.5 years and then $28,000 for the customer base through September 2014, its estimated remaining useful life.

 

5. Other Accrued Expenses

 

Other accrued expenses were comprised of the following as of June 30 (in thousands):

 

     2007

   2006

Accrued severance

   $ 146    $ —  

Other

     636      763
    

  

Total other accrued expenses

   $ 782    $ 763
    

  

 

6. Income Taxes

 

The components of income tax expense (benefit) for each of the years in the three-year period ended June 30, 2007 consist of the following (in thousands):

 

     For the fiscal year ended June 30,

     2007

   2006

    2005

     Current

   Deferred

   Total

   Current

   Deferred

    Total

    Current

   Deferred

   Total

Federal

   $ —      $ 4,158    $ 4,158    $ 48    $ (3,836 )   $ (3,787 )   $ 46    $ 206    $ 252

State

     17      684      701      58      (624 )     (567 )     84      88      172
    

  

  

  

  


 


 

  

  

Total

   $ 17    $ 4,842    $ 4,859    $ 106    $ (4,460 )   $ (4,354 )   $ 130    $ 294    $ 424
    

  

  

  

  


 


 

  

  

 

A reconciliation of our statutory tax expense (benefit) to our actual tax expense (benefit) is as follows:

 

     For the years ended June 30,

 
     2007

    2006

    2005

 

Federal statutory rate at 34 percent

   $ (2,849 )   $ 388     $ 1,109  

State taxes, net of federal tax expense (benefit) and state valuation allowance

     11       38       114  

Nondeductible expenses

     49       (3 )     62  

Stock–based compensation

     253       321       —    

General business credits

     (135 )     —         39  

Other

     —         (24 )     —    

Change in valuation allowance

     7,530       (5,074 )     (900 )
    


 


 


     $ 4,859     $ (4,354 )   $ 424  
    


 


 


 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

The components of our net deferred tax assets and liabilities are as follows (in thousands):

 

     June 30,

 
     2007

    2006

 

Deferred Tax Assets:

                

Net operating loss carry forward

   $ 31,055     $ 30,596  

Property, plant and equipment

     2       —    

Charitable contribution carryforward

     —         83  

Amortization and impairment of definite-lived intangibles

     2,038       —    

Federal and state general business credits

     837       568  

AMT credit

     91       91  

Accrued expenses

     595       522  

Non-qualified stock-based compensation

     245       119  

Other

     —         45  
    


 


Gross deferred tax assets

     34,863       32,024  

Deferred Tax Liabilities:

                

Amortization of definite-lived intangibles

     —         (410 )

Amortization of indefinite-lived intangibles

     (1,610 )     (1,342 )

Property, plant and equipment

     —         (15 )
    


 


Gross deferred tax liabilities

     (1,610 )     (1,767 )
    


 


Net deferred tax assets before valuation allowance

     33,253       30,257  

Less: valuation allowance

     (34,772 )     (26,933 )
    


 


Total net deferred tax (liability)/asset

   $ (1,519 )   $ 3,324  
    


 


 

As of June 30, 2007 and June 30, 2006, the valuation allowance was $34.8 million and $26.9 million, respectively. Of these amounts, $535,000 as of June 30, 2007 and $534,000 as of June 30, 2006 was attributable to increases in the net operating loss carry forwards resulting from the exercise of stock options. These amounts will be recorded as an increase to additional paid-in-capital if it is determined in the future that this portion of the valuation allowance is no longer required.

 

At June 30, 2007, the expiration dates and amounts of our net operating loss carryforwards and credits for federal income tax purposes are as follows:

 

Years expiring (in thousands)


   Net Operating
Loss


   Credits

2008 - 2010

   $ 5,758    $ 132

2011 - 2015

     31,045      156

2016 - 2020

     21,389      —  

2021 - 2027

     20,348      385
    

  

     $ 78,540    $ 673
    

  

 

We also have a credit for alternative minimum tax of approximately $91,000 that has no expiration date.

 

7. Deferred Income

 

Deferred income as of June 30 consisted of the following (in thousands):

 

     2007

   2006

Deferred royalty income

   $ 708    $ 892

Other deferred income

     65      62
    

  

Total deferred income

   $ 773    $ 954
    

  

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

Deferred royalty income consists of a prepaid non-exclusive license previously granted to a third party for the use of certain of our technologies. Deferred royalty income is recognized as the greater of amounts due based on actual sales or amortization of the license fee over the remaining license period of five years.

 

Other deferred income consists of warranty service contracts and rebates. Deferred revenue for prepayments made to us on warranty service contracts is recognized over the contract period ranging from 12 to 24 months.

 

8. Commitments and Contingencies

 

401(k) Plan

 

The Company provides a 401(k) savings plan to which eligible employees may make pretax payroll contributions up to IRS allowed limits. Company matching contributions are discretionary, and none have been made to date.

 

Leases

 

The Company leases its facility and certain equipment under noncancelable operating leases that expire at various dates through fiscal 2008. We are currently in the process of negotiating a three-year renewal on our current building lease. Rent expense related to operating leases was approximately $342,000, $330,000, and $328,000 for the years ended June 30, 2007, 2006 and 2005, respectively. Future minimum annual lease commitments under noncancelable operating leases with initial terms of one year or more are $272,000 in fiscal 2008, $11,000 in fiscal 2009, $10,000 in fiscal 2010, and $2,500 in fiscal 2011. The future minimum lease payments under noncancelable operating leases have not been reduced by sublease rentals under a noncancelable sublease. As of June 30, 2007, future minimum rentals to be received under a noncancelable sublease were approximately $77,000.

 

Contingencies

 

We have been and are involved in various claims, investigations, legal proceedings and other matters that arise in the normal course of our business, including product liability claims that are inherent in the testing, production, marketing and sale of medical devices. The ultimate liabilities, if any, cannot be determined at this time. However, based upon currently available information, we believe that the ultimate resolution of these matters will not have a material effect on the financial position, liquidity or results of operations of the Company.

 

9. Cumulative Effect Adjustment Upon Adoption of SAB 108

 

In September 2006, the Securities and Exchange Commission (“SEC”) released Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, (“SAB 108”), that provides interpretive guidance on how the effects of the carryover or reversal of prior year misstatements should be considered in quantifying a current year misstatement. The SEC staff believes that registrants should quantify errors using both a balance sheet and an income statement approach and evaluate whether either approach results in quantifying a misstatement that, when all relevant quantitative and qualitative factors are considered, is material. This pronouncement is effective for fiscal years ending after November 15, 2006. Registrants are permitted to initially apply the provisions of SAB 108 by either restating prior financial statements or by recording the cumulative effect as an adjustment to the carrying value of assets and liabilities as of the beginning of the fiscal year of adoption with an offsetting adjustment to the opening balance of retained earnings. We applied the provisions of SAB 108 using the cumulative effect transition method in connection with the preparation of our annual financial statements for the year ended June 30, 2007. The application of SAB 108 resulted in an increase in deferred income of approximately $60,000, a decrease in accrued professional fees of $97,000 and a corresponding net decrease in accumulated deficit as of July 1, 2006 of $37,000.

 

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Table of Contents

UROLOGIX, INC.

 

Notes to Financial Statements—(Continued)

 

Prior to the adoption of SAB 108, we quantified misstatements using the income statement approach. We do not believe that any of the errors included in the table below are material under the income statement approach. However, using the balance sheet approach upon the adoption of SAB 108, we have determined that the quantitative errors aggregating approximately $37,000 that existed as of June 30, 2006 are individually material to the fiscal 2006 financial statements. As permitted, when first applying the guidance in SAB 108, prior periods were not restated. The cumulative effect of the initial application of SAB 108 for quantification and correction of the errors is included in the accumulated deficit as of July 1, 2006 in the accompanying balance sheet.

 

Our SAB 108 adjustment relates to a customer arrangement whereby certain revenues of $60,000 that were recorded in fiscal 2006 and 2005 should have been deferred, and the method used to accrue a professional fee which resulted in overstated accrued expenses of $97,000 as of June 30, 2006. In January 2005, we entered into an agreement with a customer in which they were entitled to a partial rebate. Prior to the adoption of SAB 108, we were not properly deferring revenue at the time of sale, but rather we reduced revenue when the rebate requests were received. Additionally, prior to the adoption of SAB108, we had been recording expense for a professional fee ratably throughout the fiscal year. However, this fee should have been recorded as expense as the fee was incurred. Based on our approach for assessing misstatements prior to the adoption of SAB 108, we had previously concluded that these amounts were immaterial under the income statement approach.

 

The following table illustrates the effect of the cumulative effect adjustment recorded as of July 1, 2006 ($ in thousands):

 

     Deferred
income


   Other accrued
expenses


    Accumulated
deficit


 

Balance as of June 30, 2006, as reported

   $ 242    $ 729     $ (71,613 )

Cumulative effect adjustment for adoption of SAB 108

     60      (97 )     37  
    

  


 


Balance as of July 1, 2006, as adjusted

   $ 302    $ 632     $ (71,576 )
    

  


 


 

10. Geographic Segment Data

 

Our business activities include the design, development, marketing and sales of Cooled ThermoTherapy products and have been organized into one operating segment. Our domestic operations primarily consist of product development, sales and marketing. Our foreign operations consist of a network of distributors. There were no long-lived assets located outside of the United States. Revenue attributed to geographic areas based on the location of the customers for the years ended June 30 is as follows (in thousands):

 

     2007

   2006

   2005

United States

   $ 21,091    $ 25,609    $ 25,578

Europe

     57      94      124

Asia

     137      94      103

Canada

     25      56      6

Other

     7      32      2
    

  

  

Total

   $ 21,317    $ 25,885    $ 25,813
    

  

  

 

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Table of Contents
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

 

None.

 

ITEM 9A. CONTROLS AND PROCEDURES

 

(a) Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) that are designed to reasonably ensure that information required to be disclosed by us in the reports we file or submit under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized, and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, we recognize that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we are required to apply our judgment in evaluating the cost-benefit relationship of possible internal controls.

 

The Company’s Chief Executive Officer, Fred B. Parks, and Chief Financial Officer, Elissa J. Lindsoe have evaluated the Company’s disclosure controls and procedures as of the end of the period covered by this report. Based upon their review, they have concluded that these controls and procedures are effective.

 

(b) Changes in Internal Controls over Financial Reporting

 

There have been no changes in internal control over financial reporting that occurred during the most recently completed fiscal quarter covered by this report that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

ITEM 9B. OTHER INFORMATION

 

None.

 

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Table of Contents

PART III

 

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

 

Information required under this item is contained in the following sections of the Company’s Proxy Statement for the 2007 Annual Meeting of Shareholders (the “2007 Proxy Statement”), a definitive copy of which will be filed with the Commission within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K and is incorporated herein by reference: Election of Directors, Information Regarding Executive Officers, Section 16(a) Beneficial Ownership Reporting Compliance, Corporate Governance, and Code of Ethics.

 

ITEM 11. EXECUTIVE COMPENSATION

 

Information required under this item is contained in the following sections of the Company’s 2007 Proxy Statement and is incorporated herein by reference: Executive Compensation, Compensation of Directors, Employment and Change in Control Agreements, and Compensation Committee Report.

 

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

 

The information required under this item with respect to Item 403 of Regulation S-K is contained in the following sections of the Company’s 2007 Proxy Statement and is incorporated herein by reference: Security Ownership of Principal Shareholders and Management. The information required under this item with respect to Item 201(d) of Regulation S-K is contained in Item 5 of this Annual Report on Form 10-K.

 

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

 

Information required under this item is contained in the following sections of the Company’s 2007 Proxy Statement and is incorporated herein by reference: Policy Regarding Transactions with Related Persons and Corporate Governance.

 

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

 

Information required under this item is contained in the following sections of the Company’s 2007 Proxy Statement and is incorporated herein by reference: Independent Registered Public Accountants.

 

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Table of Contents

PART IV

 

ITEM 15. EXHIBITS AND FINANCIAL STATEMENTS SCHEDULES

 

(a) Documents filed as part of this report.

 

(1) Financial Statements.

 

The financial statements of the Company are set forth at Item 8. “Financial Statements and Supplementary Data” of this Annual Report on Form 10-K.

 

(2) Financial Statement Schedules for years ended June 30, 2007, 2006 and 2005.

 

None.

 

(b) Exhibits.

 

Exhibit
Number


  

Document


  

Incorporated by Reference To:


3.1    Amended and Restated Articles of Incorporation.    Exhibit 3.1 of the Company’s Registration Statement on Form S-1 (File No. 333-03304) filed on May 28, 1996 (the “1996 Registration Statement”).
3.2    Amended and Restated Bylaws of Urologix, Inc., as amended on December 5, 2006.    Exhibit 3.2 of the Company’s Form 8-K dated December 5, 2006.
4.1    Certificate of Designation, Preferences and Rights of Series A Junior Participating Preferred Stock    Exhibit 1 of the Company’s Registration Statement on Form 8-A (File No. 000-28414) filed January 16, 1997.
10.1    * Amended and Restated Urologix, Inc. 1991 Stock Option Plan    Exhibit 4.1 of the Company’s Registration Statement on Form S-8 (File No. 333-124939).
10.2    Lease Agreement dated January 20, 1992, between the Company and Parkers Lake Pointe I Limited Partnership, including Addendum to Lease Agreement dated April 5, 1995    Exhibit 10.5 of the Company’s 1996 Registration Statement.
10.3    * Form of Change In Control Agreement between the Company and Certain of its Executive Officers dated as of July 19, 2004.    Exhibit 10.3 to the Company’s Annual Report on Form 10-K for the year ended June 30, 2004.
10.4    * Severance and Change In Control Letter Agreement between Urologix, Inc. and Kirsten Doerfert dated as of August 23, 2007.    Exhibit 10.1 to the Company’s Form 8-K dated August 22, 2007.
10.5    * Letter between Urologix, Inc. and Fred B. Parks dated as of May 29, 2003.    Exhibit 10.11 of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003.
10.6    * Letter between Urologix, Inc. and Fred B. Parks dated as of July 19, 2004.    Exhibit 10.4 to the Company’s Annual Report on Form 10-K for the year ended June 30, 2004.
10.7    * Stock Option Agreement with grant date of May 27, 2003 between the Company and Fred B. Parks.    Exhibit 10.6 to the Company’s Annual Report on Form 10-K for the year ended June 30, 2003.
10.8    Amendment of Lease Agreement dated October 4, 2002 between Parkers Lake I Realty Corp. and the Company.    Exhibit 10.9 to the Company’s Annual Report on Form 10-K for the year ended June 30, 2003.
23.1    Consent of KPMG LLP    Attached hereto.
31.1    Certification of Chief Executive Officer (principal executive officer) pursuant to Rules 13a-14(a) and 15d-14(a) of the Exchange Act.    Attached hereto.
31.2    Certification of Chief Financial Officer (principal financial officer) pursuant to Rules 13a-14(a) and 15d-14(a) of the Exchange Act.    Attached hereto.
32    Certification pursuant to 18 U.S.C. §1350.    Attached hereto.

* Indicates a management contract or compensatory plan or arrangement.

 

52


Table of Contents

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.

 

Dated: September 19, 2007   UROLOGIX, INC.
   

By:

  /s/    FRED B. PARKS        
        Fred B. Parks, Chief Executive Officer
        (principal executive officer)

 

Each person whose signature appears below hereby constitutes and appoints Fred B. Parks and Elissa J. Lindsoe, and each of them, as his true and lawful attorney-in-fact and agent, with full power of substitution, to sign on his behalf, individually and in each capacity stated below, all amendments and post-effective amendments to this Form 10-K and to file the same, with all exhibits thereto and any other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully and to all intents and purposes as each might or could do in person, hereby ratifying and confirming each act that said attorneys-in-fact and agents may lawfully do or cause to be done by virtue thereof.

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below on behalf of the registrant by the following persons in the capacities indicated on September 19, 2007.

 

Signature


  

Title


/s/    FRED B. PARKS        


Fred B. Parks

  

Director and Chief Executive Officer (principal executive officer)

/s/    ELISSA J. LINDSOE        


Elissa J. Lindsoe

  

Chief Financial Officer (principal financial officer)

/s/    JERRY C. CIRINO        


Jerry C. Cirino

  

Director

/s/    SIDNEY W. EMERY, JR.        


Sidney W. Emery, Jr.

  

Director

/s/    DANIEL J. STARKS        


Daniel J. Starks

  

Director

/s/    GUY C. JACKSON        


Guy C. Jackson

  

Director

 

53

EX-23.1 2 dex231.htm CONSENT OF KPMG LLP Consent of KPMG LLP

EXHIBIT 23.1

 

Consent of Independent Registered Public Accounting Firm

 

The Board of Directors

Urologix, Inc.:

 

We consent to the incorporation by reference in the Registration Statements on Form S-8 (File Nos. 333-11981, 333-13271, 333-41385, 333-84869, 333-53634, 333-82854, 333-109259 and 333-124939) of Urologix, Inc. of our report with respect to the balance sheets of Urologix, Inc. as of June 30, 2007 and 2006, and the related statements of operations, shareholders’ equity, and cash flows for each of the years in the three-year period ended June 30, 2007, which report appears in the June 30, 2007 annual report on Form 10-K of Urologix, Inc.

 

Our report refers to the Company’s adoption of the provisions of Statement of Financial Accounting Standards No. 123 (Revised 2004), Share-Based Payment, on July 1, 2005, and Securities and Exchange Commission Staff Accounting Bulletin No. 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements, as of July 1, 2006.

 

/s/ KPMG LLP

 

Minneapolis, Minnesota

September 18, 2007

EX-31.1 3 dex311.htm CERTIFICATION OF CHIEF FINANCIAL OFFICER Certification of Chief FInancial Officer

EXHIBIT 31.1

 

CERTIFICATIONS

 

I, Fred B. Parks, certify that:

 

  1. I have reviewed this Form 10-K of Urologix, Inc.

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;

 

  (c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: September 19, 2007

 

/s/    FRED B. PARKS        

Fred B. Parks

Chief Executive Officer

(principal executive officer)

EX-31.2 4 dex312.htm CERTIFICATION OF CHIEF FINANCIAL OFFICER Certification of Chief Financial Officer

EXHIBIT 31.2

 

CERTIFICATIONS

 

I, Elissa J. Lindsoe, certify that:

 

  1. I have reviewed this Form 10-K of Urologix, Inc.

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;

 

  (c) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: September 19, 2007

 

/S/    ELISSA J. LINDSOE        

Elissa J. Lindsoe

Chief Financial Officer

(principal financial officer and

principal accounting officer)

EX-32 5 dex32.htm CERTIFICATION PURSUANT TO 18 U.S.C. 1350 Certification pursuant to 18 U.S.C. 1350

EXHIBIT 32

 

CERTIFICATION

 

The undersigned certifies pursuant to 18 U.S.C. §1350, that:

 

  (1) The accompanying Annual Report on Form 10-K for the period ended June 30, 2007, fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the accompanying Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: September 19, 2007

 

/s/    FRED B. PARKS        

Fred B. Parks

Chief Executive Officer

(Principal executive officer)

/s/    ELISSA J. LINDSOE        

Elissa J. Lindsoe

Chief Financial Officer

(Principal financial officer and

principal accounting officer)

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