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 maintaining 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.
Each calendar year the Medicare reimbursement rate for Cooled ThermoTherapy is determined by the Centers for Medicare and Medicaid Services (CMS). The Medicare reimbursement rate for physicians varies depending on the site of service, wage indexes and geographic location. The national average reimbursement rate is the fixed rate for the year without any geographic adjustments, but does vary based on site of service. Cooled ThermoTherapy can be performed in the urologist’s office, an ambulatory surgery center (ASC), or a hospital as an outpatient procedure.
CMS published the Physician Fee Schedule (PFS) final rule for calendar 2010 on October 30, 2009. From the date of publication to the end of 2010, Congress acted four times to temporarily adjust the 2010 Medicare reimbursement for all physician payments, with the final short term patch occurring in November 2010 to stabilize the rate through the end of calendar 2010. These adjustments were to offset broader prescribed reimbursement cuts to Medicare driven by the Sustainable Growth Rate (SGR) formula.
In December of 2010, the Congress and the President acted to stabilize reimbursement for all of calendar 2011. While the law that was passed eliminated the cuts which were to take effect from the SGR formula, the law also resulted in a slight reduction to the Conversion Factor that applies to all Medicare Physician Fee Schedule reimbursement rates. The result for all transurethral microwave therapy procedures is that the national average of Medicare reimbursement in the physician office setting for calendar 2011 is $2,350 per procedure compared to $2,430 at the end of calendar year 2010. We continue to monitor all reimbursement developments closely and will continue to execute on our active reimbursement strategy.
Cooled ThermoTherapy procedures are reimbursed when performed in an ASC or a hospital outpatient setting, but these are a small portion of our business and the CMS changes to these rates will not have a material effect on our financial performance.
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 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, nor reimbursement determinations for Cooled ThermoTherapy from these payers or that amounts reimbursed to urologists for performing Cooled ThermoTherapy procedures will be sufficient to encourage urologists to use Urologix’ product and service offerings.
As a result of recently enacted federal health care reform legislation, substantial changes are anticipated in the United States health care system. Such legislation includes numerous provisions affecting the delivery of health care services, the financing of health care costs, reimbursement of health care providers and the legal obligations of health insurers, providers and employers. These provisions are currently slated to take effect at specified times over approximately the next decade. The federal health care reform legislation did not directly affect our fiscal year 2010 financial statements and we do not expect the legislation to affect our financial results for fiscal year 2011.
We will continue to invest in research and development and clinical trials to improve our products and our therapy. These investments are intended to broaden our product offering and expand the clinical evidence supporting our proprietary Cooled ThermoTherapy treatment for BPH. We continue to highlight our five year durability data and the ability of urologists using our system to customize the treatment for patients.
Critical Accounting Policies:
A description of our critical accounting policies was provided in theManagement’s Discussion and Analysis of Financial Condition and Results of Operations section of our Annual Report on Form 10-K for the year ended June 30, 2010. At December 31, 2010, our critical accounting policies and estimates continue to include revenue recognition, allowance for doubtful accounts, inventories, valuation of long-lived assets, income taxes, and stock-based compensation.
RESULTS OF OPERATIONS
Net Sales
Net sales for the three and six-month periods ended December 31, 2010 were $3.3 million and $6.7 million, respectively, compared to $4.1 million and $7.9 million, respectively, during the same periods of the prior fiscal year. The $743,000 or 18 percent decrease in net sales, and the $1.2 million, or 16 percent decrease in net sales, for the comparable three and six-month periods ended December 31, 2010 and December 31, 2009, is primarily attributable to the temporary market withdrawal of a competitive product in the prior fiscal year, as well as reduced utilization from our customer base in 2010.
During the second quarter of fiscal 2011, revenue derived from the Urologix-owned Cooled ThermoTherapy mobile service constituted 44 percent of overall revenue in the current quarter compared to 48 percent of revenues in the second quarter of fiscal 2010. Revenue derived from treatment catheter sales to direct accounts constituted 36 percent of sales compared to 35 percent in the same quarter of the prior fiscal year. Third party mobile catheter revenue remained constant at 15 percent of overall revenue in the second quarter of fiscal 2011 and 2010.
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 the three-month period ended December 31, 2010 decreased $262,000, or 15 percent, to $1.5 million, and for the six-month period ended December 31, 2010 decreased $453,000, or 13 percent, to $3.0 million, from $1.7 million and $3.4 million during the respective periods of the prior year. The decrease in costs of goods sold for the three and six-month periods ended December 31, 2010 is primarily a result of the lower sales mentioned above.
Gross profit as a percentage of sales decreased to 56 percent and 55 percent for the three and six-month periods ended December 31, 2010 from 57 percent and 56 percent, respectively, for the three and six-month periods ended December 31, 2009. The decrease in gross margin rate is due to a decrease in the number of kits produced resulting in higher fixed costs per unit.
Selling, General & Administrative
Selling, general and administrative expenses of $2.0 million for the second quarter of fiscal 2011 decreased $180,000, or 8 percent when compared to selling, general and administrative expenses of $2.2 million in the same period of fiscal 2010. The decrease in selling, general and administrative expenses for the three-month period ended December 31, 2010 is largely due to a $176,000 decrease in commission expense as a result of lower sales. For the six-month period ended December 31, 2010, selling, general and administrative expenses decreased $571,000, or 12 percent, to $4.0 million from $4.6 million reported for the same six-month period of fiscal year 2010. The decrease in expense when compared to the six-month period ended December 31, 2009 is primarily the result of a decrease in commissions of $371,000 and a decrease in the bonus accrual of $166,000.
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Research and Development
Research and development expenses, which include expenditures for product development, regulatory compliance and clinical studies, increased to $556,000 and $1.1 million, for the three and six-month periods ended December 31, 2010, respectively, from $418,000 and $860,000 in the same respective periods of the prior fiscal year. The increase in expense of $138,000, or 33 percent, and $242,000 or 28 percent, for the three and six-month periods ended December 31, 2010, respectively, is due to increased wages and consulting expenses as we have increased our research and development activities.
Provision for Income Taxes
We recognized an income tax benefit of $9,000 and $3,000 for the three and six-month periods ended December 31, 2010, respectively, compared to an income tax benefit of $9,000 and $12,000 for the comparable prior year fiscal periods. The tax benefit in the three and six-month periods ended December 31, 2010 and 2009 relates to estimates for research and development credits, partially offset by provisions for state taxes.
LIQUIDITY AND CAPITAL RESOURCES
We have financed our operations since inception through sales of equity securities and sales of our Cooled ThermoTherapy system control units, single-use treatment catheters and mobile service offerings. As of December 31, 2010, we had total cash and cash equivalents of $4.3 million compared to $5.7 million as of June 30, 2010. Working capital decreased to $5.8 million at December 31, 2010 from $6.7 million at June 30, 2010. This decrease in working capital is primarily due to the $1.4 million decrease in the cash balance and a $292,000 increase in accounts payable, offset by the $186,000 increase in accounts receivable as well as the $180,000 increase in inventories.
During the six-month period ended December 31, 2010, we used $1.2 million of cash for operating activities. The net loss of $1.4 million included non-cash charges of $309,000 from depreciation and amortization expense and $200,000 from stock-based compensation expense. Changes in operating items resulted in the use of $286,000 of operating cash flow for the period as a result of lower accrued expense and deferred income of $259,000, higher accounts receivable of $186,000, and increased inventories of $180,000, which was partially offset by an increase in accounts payable of $292,000. The decrease in accrued expenses and deferred income is a result of a decrease in our payroll accrual due to timing and a decrease in the bonus accrual as a result of the payout of fiscal 2010 bonuses during the first quarter of fiscal 2011. The decrease in accounts receivable is the result of the decrease in sales, and the increase in inventories is a result of an increase in finished goods inventory. The slight increase in our year-over-year cash used in operations of $243,000 is largely due to the decrease in sales, partially offset by our increase in accounts payable.
During the six-months ended December 31, 2010, we used $191,000 for investing activities primarily to purchase property and equipment related to a tenant improvement allowance as a result of signing a building lease extension.
During the six-months ended December 31, 2010, we did not generate any cash from financing activities.
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. We also will continue to provide physicians and patients with efficient access to our Cooled ThermoTherapy system control units on a pre-scheduled basis through our mobile service. As of December 31, 2010, our property and equipment, net, included approximately $637,000 of control units used in evaluation or longer-term use programs and in our Company-owned mobile service.
We believe our $4.3 million in cash and cash equivalents at December 31, 2010 will be sufficient to fund our working capital and capital resource needs beyond the next twelve months. In addition, we believe the majority of our cash equivalents are secure as they are backed by United States Government Treasuries.
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Our business plan and financing needs are subject to change depending on, among other things, the success of our efforts to increase revenue and 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.
Off Balance Sheet Arrangements
We do not have any off balance sheet arrangements.
Recently Issued Accounting Standards
Information regarding recently issued accounting pronouncements is included in Note 10 to the condensed financial statements in this Quarterly Report on Form 10-Q.
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ITEM 3. | QUALITATIVE AND QUANTITATIVE DISCLOSURE ABOUT MARKET RISK |
Our financial instruments include cash equivalent instruments. Increases and decreases in prevailing interest rates generally translate into decreases and increases, respectively, in the fair value of these instruments, as our investments are variable rate investments. 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 equivalent instruments, 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. 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 4. | CONTROLS AND PROCEDURES |
(a)Evaluation of Disclosure Controls and Procedures
The Company’s Chief Executive Officer, Stryker Warren, Jr., and Chief Financial Officer, Brian J. Smrdel, have evaluated the Company’s “disclosure controls and procedures,” as defined in the Exchange Act Rule 13a-15(e), as of the end of the period covered by this report. Based upon this review, they have concluded that these controls and procedures are effective.
(b)Changes in Internal Control Over Financial Reporting
There have been no changes in internal control over financial reporting that occurred during the fiscal period covered by this report that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II - OTHER INFORMATION
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 our financial position, liquidity or results of operations.
The most significant risk factors applicable to the Company are described in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended June 30, 2010, as updated by our subsequent filings with the Securities and Exchange Commission. There have been no material changes from the risk factors previously disclosed in our Annual Report on Form 10-K.
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ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
Not applicable.
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ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
Not applicable.
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ITEM 4. | [REMOVED AND RESERVED] |
On August 19, 2010, the Company received a letter from The Nasdaq Stock Market stating that the bid price of the Company’s common stock was below $1.00 per share for 30 consecutive business days and that the Company was therefore not in compliance with Listing Rule 5550(a)(2) requiring a minimum bid price of $1.00 per share. The letter stated that under the Listing Rules, the Company has 180 days, or until February 15, 2011, to regain compliance with the minimum bid price requirement for continued listing.
Subsequent to the August 2010 letter, the Nasdaq Stock Market changed its Listing Rules to permit eligible companies to receive a second 180 day compliance period to cure a deficiency in the minimum bid price requirement.
On January 13, 2011, the Company submitted a letter to The Nasdaq Stock Market requesting the grant of an additional 180 day compliance period ending August 15, 2011 and agreeing to effect a reverse stock split should the Company not cure the bid price deficiency during the second compliance period. The Company believes that it is eligible to receive this second 180 day compliance period under the Listing Rules. The Nasdaq Stock Market has informed the Company that it will make a determination as to the Company’s eligibility and the availability of the second cure period on or about February 15, 2011.
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Exhibit 31.1 | Certification of Chief Executive Officer Pursuant to Section 13a-14(a) and 15d-14(a) of the Exchange Act. |
Exhibit 31.2 | Certification of Chief Financial Officer Pursuant to Section 13a-14(a) and 15d-14(a) of the Exchange Act. |
Exhibit 32 | Certification pursuant to 18 U.S.C. §1350. |
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SIGNATURES
Pursuant to the requirements 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.
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| Urologix, Inc. |
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| (Registrant) |
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| /s/ Stryker Warren, jr. |
| Stryker Warren, jr. Chief Executive Officer (Principal Executive Officer) |
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| /s/ Brian J. Smrdel |
| Brian J. Smrdel Chief Financial Officer (Principal Financial and Accounting Officer) |
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| Date February 11, 2011 |
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