Each calendar year the Medicare reimbursement rates for all procedures, including Cooled ThermoTherapy and Prostiva RF Therapy, are determined by the Centers for Medicare and Medicaid Services (CMS). The Medicare reimbursement rate for physicians varies depending on the procedure type, 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 and Prostiva RF Therapy can be performed in the urologist’s office, an ambulatory surgery center (ASC), or a hospital as an outpatient procedure.
CMS published their final rule in November 2013 for implementation during calendar year 2014 and the government acted to keep the Sustainable Growth Rate (SGR) from taking effect. The final rule resulted in an average reimbursement rate in the physician office setting for calendar year 2014 of $2,063 for Cooled ThermoTherapy and $1,899 for Prostiva RF Therapy. On October 31, 2014, CMS published their final rule for reimbursement rates to be implemented in calendar year 2015. Starting January 1, 2015, an average reimbursement rate in the physician office setting for calendar year 2015 will be $2,092 for Cooled ThermoTherapy and $1,928 for Prostiva RF Therapy. The government will need to act again by March 31, 2015 to avoid any impact to reimbursement rates from the SGR. Cooled ThermoTherapy and Prostiva RF Therapy procedures are also reimbursed when performed in an ASC or a hospital outpatient setting, but these are a small portion of our business and the CMS 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 maintain coverage and reimbursement across the United States. There can be no assurance that reimbursement determinations for either Cooled ThermoTherapy or Prostiva RF Therapy from these payers for amounts reimbursed to urologists to perform these procedures will be sufficient to compensate urologists for use of Urologix’ product and service offerings.
As of September 30, 2014, the Company’s cash balance was $545,000. The Company incurred net losses of $437,000 for the three-month period ended September 30, 2014 and $7.6 million and $4.3 million in the fiscal years ended June 30, 2014 and 2013, respectively. In addition, the Company has accumulated aggregate net losses from the inception of business through September 30, 2014 of $127.1 million. We have also not paid Medtronic $650,000 in royalties for the Prostiva RF Therapy System that was due during the second quarter of fiscal year 2014 and also have not paid Medtronic an annual $65,000 license maintenance fee that was due on each of September 6, 2013 and 2014.
As described in Note 3 “Liquidity” and in “Liquidity and Capital Resources” below, as a result of our history of operating losses and negative cash flows from operations, as well as our need for working capital to support operations, there is substantial doubt about our ability to continue as a going concern. Our financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that may be necessary as a result of this uncertainty.
Net sales for the three-months ended September 30, 2014 were $3.0 million, compared to $3.8 million during the same period of the prior fiscal year. The $758,000, or 20 percent, decrease in net sales for the comparable prior year period is the result of lower volume of units sold in both Cooled ThermoTherapy and Prostiva RF Therapy product lines. The decrease in net sales is partially attributable to the restructurings that occurred in the second half of fiscal year 2014, which included changes in the sales organization and were in line with our expectations.
Cost of goods sold includes raw materials, labor, and overhead incurred in connection with the production of our Cooled ThermoTherapy system control units and single-use treatment catheters, amortization related to developed technologies, costs associated with the delivery of our Urologix mobile service, as well as costs for the Prostiva products. Cost of goods sold for the three-months ended September 30, 2014 decreased $356,000, or 19 percent, to $1.6 million, from $1.9 million for the three-month period ended September 30, 2013. The decrease in costs of goods sold for the three-months ended September 30, 2014 is a result of the decrease in unit volume of sales.
Gross profit as a percentage of net sales remained steady at 48 percent, for the three-month period ended September 30, 2014 compared to 49 percent, for the three-month period ended September 30, 2013.
Sales and Marketing
Sales and marketing expense of $810,000 for the first quarter of fiscal year 2015 decreased by $1.0 million, or 56 percent, when compared to sales and marketing expense of $1.8 million in the same period of fiscal 2014. The decrease in sales and marketing expense for the three-months ended September 30, 2014 is due to a $792,000 decrease in headcount related expenses due to decreased commissions and decreased headcount, as well as a $154,000 decrease in travel expenses as a result of the restructuring plans implemented in January and April of 2014. In addition, advertising and promotion expense decreased by $150,000 in the current year period. These decreases were partially offset by modest increases of an aggregate of approximately $108,000 in other areas such as consulting, physician expenses and the allowance for doubtful accounts reserve.
General and Administrative
General and administrative expense decreased $197,000, or 29 percent, to $488,000 for the three-month period ended September 30, 2014 compared to $685,000 for the three-month period ended September 30, 2013. The decrease in general and administrative expense is a result of decreased spending in all general and administrative areas in an effort to manage expenses. In particular, wages and benefits decreased $87,000 due to lower headcount, and legal and accounting fees decreased by approximately $68,000.
Research and Development
Research and development expense, which includes expenditures for product development, regulatory compliance and clinical studies, decreased $87,000 or 21 percent to $334,000 for the three-month period ended September 30, 2014 from $421,000 for the three-month period ended September 30, 2013. The decrease in research and development expense is a result of a $122,000 decrease in wages and benefits due to lower headcount in the current year, partially offset by a $38,000 increase in consulting expenses.
Change in Value of Acquisition Consideration
There was no change in the value of acquisition consideration for the three-month period ended September 30, 2014 compared to $9,000 for the three-month period ended September 30, 2013. For the three-month period ended September 30, 2013, the change in the value of acquisition consideration represents the reduction in fair value of contingent consideration of $9,000 as a result of a reduction in the projected royalty payments in excess of contractual minimums in earlier years.
Medical Device Tax
The medical device tax expense represents the excise tax imposed beginning January 1, 2013 on all U.S. medical device sales as part of the Federal health care reform legislation. The medical device excise tax expense of $48,000 for the three-month period ended September 30, 2014, decreased by $13,000 or 21 percent, when compared to medical device excise tax expense of $61,000 for the three-months ended September 30, 2013. The decrease in the medical device tax expense is a result of the decrease in sales.
Amortization of Identifiable Intangible Assets
Amortization expense represents the amortization of identifiable intangible assets acquired as part of the Prostiva acquisition. Amortization expense was $23,000 for both the three-month periods ended September 30, 2014 and 2013, respectively.
Net Interest Expense
Interest expense is a result of non-cash interest accretion on the deferred acquisition payments for the Prostiva business as well as the interest expense accrued on the Note entered into with Medtronic on June 28, 2013. Interest expense increased to $188,000 from $161,000 for the three-months ended September 30, 2014 and 2013, respectively. The increase in interest expense is due to lower accretion expense in the prior year period due to the true up of the contractual deferred acquisition liability.
Provision for Income Taxes
We recognized income tax expense of $5,000 for the three-months ended September 30, 2014, compared to income tax expense of $12,000 for the three-month period ended September 30, 2013. The tax expense in the three-months ended September 30, 2014 consists of $5,000 for state taxes. The tax expense in the three-month period ended September 30, 2013 relates to $7,000 for the deferred tax liability resulting from the amortization for tax purposes of the goodwill acquired in the Prostiva acquisition, as well as $5,000 for the provision for state taxes. We fully impaired our goodwill balance as of April 30, 2014, and therefore wrote-off the balance of the related deferred tax liability.
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The Company utilizes the asset and liability method of accounting for income taxes. The Company recognizes deferred tax liabilities or assets for the expected future tax consequences of temporary differences between the book and tax basis of assets and liabilities. We have recorded and continue to carry a full valuation allowance against our gross deferred tax assets that will not reverse against deferred tax liabilities. We will continue to assess the assumptions used to determine the amount of our valuation allowance and may adjust the valuation allowance in future periods based on changes in assumptions of estimated future income and other factors.
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 products and, beginning September 6, 2011, sales of the Prostiva RF Therapy System product. As of September 30, 2014, we had cash of $545,000 compared to cash of $718,000 as of June 30, 2014.
During the first quarter of fiscal 2012, the Company entered into a license agreement with Medtronic for the Prostiva RF Therapy System. The Company paid Medtronic $500,000 on September 6, 2011 for half of the $1.0 million initial license fee, with the remaining $500,000 payable on September 6, 2012. On June 28, 2013, we entered into a Restructuring Agreement with Medtronic related to the $7.5 million we then owed to Medtronic under the transaction documents. As part of this agreement, we paid Medtronic $2.0 million in satisfaction of royalties earned for the 12 months ended September 6, 2012, the second half of the initial licensing fee, the license maintenance fee for the 12 month period ended September 6, 2012, outstanding transition services fees, and Prostiva inventory included as part of the acquisition and purchased subsequent to the acquisition. In addition, we entered into a promissory note (the “Note”) with Medtronic for $5.3 million for the remaining amounts owed on Prostiva inventory acquired as part of the acquisition and purchased subsequent to the acquisition. Interest on the Note accrues at a rate of 6 percent, compounded annually, and is payable in five equal installments of principal, plus accrued interest, on March 31st of each year beginning on March 31, 2015. The $206,000 difference between the $7.5 million in obligations owed to Medtronic and the $2.0 million paid and the $5.3 million Note was recorded as a gain on debt extinguishment in fiscal year 2013. The Company does not have adequate cash to repay the full outstanding principal amount of $5.3 million on the Note. Any event of default under the Note may result in a loss of control of our business or bankruptcy.
Under the license agreement, royalty payments for Prostiva products are paid one year in arrears based on the contract year. The royalty payment due during the second quarter of fiscal year 2014 of $650,000 has not been paid as of September 30, 2014. An additional $650,000 royalty payment was due on October 6, 2014, which is in the second quarter of fiscal year 2015. The Company does not have adequate cash at September 30, 2014 to pay the full amount of the royalty payments. Neither of these royalty payments have been paid as of the date of the filing of this Quarterly Report on Form 10-Q. Both royalty payments totaling $1.3 million are included in the short-term deferred acquisition payment liability as of September 30, 2014. In addition, we have not paid, as of September 30, 2014 or as of the date of filing this Quarterly Report on Form 10-Q, the annual $65,000 licensing maintenance fee due on September 6, 2013 and September 6, 2014. The total license maintenance fee of $130,000 is included in other accrued expenses as of September 30, 2014. The non-payment of either the royalty or license maintenance fee does not entitle Medtronic to terminate the license agreement unless Medtronic provides written notice and an opportunity to cure the default. In the event of a material breach of the licensing agreement or other transaction documents, and Medtronic provides written notice to the Company and the Company fails to cure the breach, Medtronic may terminate the license agreement. If the license agreement is terminated, the Company’s rights to sell the Prostiva product would be terminated.
The Company is considering all available alternatives with respect to the business as well as amounts owed to Medtronic to improve its cash and liquidity position. In addition, the Company is attempting to generate revenues both from sales of our Cooled ThermoTherapy and Prostiva products, negotiate payment terms with our vendors, and manage our expenses in order to improve cash flow from our business. The Company implemented restructuring plans in January 2014 and again in April 2014 to reduce our cash utilization. The targeted annual savings from these restructurings total over $4.0 million, compared with the first half of fiscal year 2014. As a result of these restructurings, the Company expects to begin to generate positive cash flow from operations in fiscal year 2015. The Company may also seek to improve its liquidity position by raising capital through additional indebtedness or an offering of its equity securities or both. However, it may be difficult to raise additional capital through a debt offering due to the debt outstanding with Medtronic and its position as a secured lender.
As of September 30, 2014, the Company’s cash may not be sufficient to sustain day-to-day operations for the next 12 months. If the Company is unable to generate sufficient liquidity to meet its needs and in a timely manner, the Company may be required to further reduce expenses and curtail capital expenditures, sell assets, or suspend or discontinue operations.
There can be no assurance that the Company will be able to cure any potential event of default of the Note or cure any breach of any agreement with Medtronic, maintain compliance with its agreements with Medtronic, raise additional capital, or improve its operating or financial performance.
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The September 30, 2014 financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.
During the three-months ended September 30, 2014, we used $170,000 of cash for operating activities. The net loss of $437,000 included non-cash charges of $134,000 from depreciation and amortization expense, $15,000 from stock-based compensation expense and $137,000 of accreted interest expense. Changes in operating items resulted in the utilization of $34,000 of operating cash flow for the period as a result of higher prepaid and other assets of $221,000 and higher accounts receivable of $39,000. These changes were partially offset by lower inventories of $90,000 and higher interest payable of $84,000.
The increase in prepaids and other assets is the result of annual insurance premiums which are paid at the beginning of the fiscal year and amortized over the annual period. The increase in accounts receivable is a result of the timing of sales as well as a slight increase in our days sales outstanding. The decrease in inventories is due to lower volumes of Prostiva hand piece inventory as of September 30, 2014 due to the timing of shipments from our third-party supplier, and the increase in interest payable represents the 6 percent interest accrued on the Note agreement entered into with Medtronic in June, 2013.
During the three-months ended September 30, 2014, we used $3,000 for investing activities related to the purchase of property and equipment and investments in intellectual property.
During the three-months ended September 30, 2014, 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 and Prostiva RF Therapy System generators and scopes in addition to purchase options. We also will continue to provide physicians and patients with efficient access to our Cooled ThermoTherapy system control units and Prostiva RF Therapy System generators and scopes on a pre-scheduled basis through our mobile service. As of September 30, 2014, our property and equipment, net, included approximately $267,000 of control units, generators and scopes used in evaluation or longer-term use programs and units used in our Company-owned mobile service.
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 13 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 and as a result 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 4. | CONTROLS AND PROCEDURES |
(a) Evaluation of Disclosure Controls and Procedures
The Company’s Chief Executive Officer and Interim Chief Financial Officer, Gregory J. Fluet, has 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, he has concluded that these controls and procedures are effective.
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(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.
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, 2014, and our subsequent filings with the Securities and Exchange Commission.
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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. | MINE SAFETY DISCLOSURES |
Not applicable.
None
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ITEM 6. | EXHIBITS |
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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 Interim 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/ Gregory J. Fluet |
| | Gregory J. Fluet |
| | Chief Executive Officer and Interim Chief Financial Officer |
| | (Principal Executive Officer and Principal Financial and Accounting Officer) |
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| | Date: November 13, 2014 |
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