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 March 31, 2014 or as of the date of filing this Quarterly Report on Form 10-Q. The $650,000 is included in the short-term deferred acquisition payment liability as of March 31, 2014. In addition, we have not paid, as of March 31, 2014 and 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 which is included in other accrued expenses as of March 31, 2014. The non-payment does not entitle Medtronic to terminate the license agreement unless Medtronic provides written notice and an opportunity to cure the default. The non-payment under the license agreement is also not an event of default under the Note unless Medtronic provides written notice and an opportunity to cure.
During the quarter ended September 30, 2012, the Company completed a follow-on offering in which we sold 5,980,000 shares of common stock at a price of $0.75 per share which resulted in approximately $3.8 million of net proceeds after deducting underwriting discounts and commissions and other expenses payable by the Company. However, as a result of the Company’s history of operating losses and negative cash flows from operations there is substantial doubt about our ability to continue as a going concern. Our cash, cash generated from operations, if any, and available borrowings under our agreement with Silicon Valley Bank, may not be sufficient to fund our anticipated capital needs, operating expenses (including payments under the license agreement), and Note repayments, particularly if product sales do not generate revenues in the amounts currently anticipated, if our operating costs are greater than anticipated or greater than our business can support. Our ability to continue as a going concern is dependent upon improving our liquidity.
The Company is considering all available alternatives to improve its cash and liquidity position. In particular, the Company is attempting to generate revenues both from sales of our Cooled ThermoTherapy and Prostiva products in an amount sufficient to improve cash flow from our business. The Company also implemented restructuring plans in January 2014 and again in April 2014 to reduce our cash utilization (see Footnote 13 for further details). The Company estimates that as a result of the restructurings, it will be able to reduce cost of goods sold and pre-tax operating expenses in total by more than $4.0 million annually, beginning in the fourth quarter of fiscal year 2014. The Company may seek to improve its liquidity position by raising capital through additional indebtedness or an offering of its equity securities or both.
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 March 31, 2014 were $3.4 million, compared to $4.1 million during the same period of the prior fiscal year. The $726,000, or 18 percent, decrease in net sales for the comparable prior year period is primarily the result of lower volume of units sold in both Cooled ThermoTherapy and Prostiva RF Therapy product lines.
Net sales for the nine-months ended March 31, 2014 were $10.9 million, compared to $12.4 million for the nine-months ended March 31, 2013. The decrease in net sales of $1.5 million, or 12 percent, is again a result of decrease in units sold in both product lines, Cooled ThermoTherapy and Prostiva RF Therapy.
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, 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 March 31, 2014 increased $451,000, or 22 percent, to $2.5 million, from $2.1 million for the three-month period ended March 31, 2013. Costs of goods sold of $6.4 million for the nine-month period ended March 31, 2014 increased by $304,000 or 5 percent, compared with the $6.1 million reported for the nine-month period ended March 31, 2013. The increase in costs of goods sold for the three and nine-months ended March 31, 2014 is a result of the $739,000 non-cash write-down of Prostiva capital equipment inventory as a result of lower volume generator and scope sales, as well as the implementations of the recent restructurings that occurred in January and April of fiscal year 2014 as a result of our change in sales strategy. In addition, we incurred approximately $24,000 of expense related to the restructuring plan implemented in January 2014. These increases were partially offset by decreases in costs of goods sold as a result of the decrease in sales.
Gross profit as a percentage of net sales decreased to 25 and 41 percent, respectively, for the three and nine-month periods ended March 31, 2014 from 50 percent and 51 percent, respectively, for the three and nine-month periods ended March 31, 2013. The gross margin rate for the three and nine-month periods ended March 31, 2014 was impacted by 22 percentage points and 7 percentage points, respectively, as a result of the $739,000 Prostiva capital equipment write-down mentioned above. The remaining decrease in gross profit as a percentage of sales is due to higher manufacturing costs per unit due to lower production volumes and higher Prostiva material costs.
Sales and Marketing
Sales and marketing expense of $1.3 million for the third quarter of fiscal year 2014 decreased by $602,000, or 31 percent, when compared to sales and marketing expense of $1.9 million in the same period of fiscal 2014. The decrease in sales and marketing expense for the three-months ended March 31, 2014 is due to a $361,000 decrease in headcount related expenses due to decreased commissions and decreased headcount as a result of the restructuring plan implemented in January 2014. In addition, travel expenses decreased by $83,000 due to lower headcount, advertising and promotions decreased by $71,000, and meeting expenses decreased by $35,000. These decreases were partially offset by approximately $17,000 of expense related to the restructuring previously mentioned.
Sales and marketing expense of $4.8 million for the nine-month period ended March 31, 2014 decreased $800,000, or 14 percent, when compared to sales and marketing expense of $5.6 million in the same period of fiscal 2013. The decrease in sales and marketing expense year-over-year is largely due to decreased wage and benefit and travel related expenses of $446,000 due to decreased headcount, partially as a result of the restructuring plan implemented in January 2014. In addition, marketing expenses decreased by $202,000 and meeting expenses decreased by $90,000.
General and Administrative
General and administrative expense decreased $184,000, or 26 percent, to $527,000 for the three-month period ended March 31, 2014 compared to $711,000 for the three-month period ended March 31, 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 $83,000 due to lower headcount, and public reporting fees decreased $29,000 as a result of our Nasdaq delisting and no longer needing to pay the related listing fees.
For the nine-months ended March 31, 2014, general and administrative expense decreased $321,000 or 15 percent to $1.8 million from $2.1 million for the nine-month period ended March 31, 2013. The decrease in general and administrative expense is again a result of a decrease in wages and benefits of $254,000 due to lower headcount, a $68,000 decrease in public reporting and investor relation fees, and a $30,000 decrease in stock option expense, partially offset by an increase in consulting fees of $60,000.
Research and Development
Research and development expense, which includes expenditures for product development, regulatory compliance and clinical studies, decreased $130,000 or 24 percent to $408,000 for the three-month period ended March 31, 2014 from $538,000 for the three-month period ended March 31, 2013. The decrease in research and development expense is a result of a $90,000 decrease in expense for the monthly transition services fee related to the Prostiva license agreement which was paid in the prior year period. These fees ended when we became the legal manufacturer of Prostiva in April 2013. The remaining decrease is related to decreases in wages and benefits of $47,000 due to lower headcount in the current year.
For the nine-months ended March 31, 2014, research and development expense decreased $475,000, or 27 percent, to $1.3 million from $1.8 million for the nine-month period ended March 31, 2013. The decrease in research and development expense year-over-year is a result of a $270,000 decrease in expense for the monthly transition services fee related to the Prostiva license agreement mentioned above, as well as decreases in consulting expenses.
Change in Value of Acquisition Consideration
The change in the value of acquisition consideration was $12,000 and $105,000, respectively, for the three and nine-month periods ended March 31, 2014, compared to zero and $369,000 for the three and nine- month periods ended March 31, 2013, respectively. For the three and nine-month periods ended March 31, 2014, the change in the value of acquisition consideration represents the reduction in fair value of contingent consideration of $12,000 and $105,000, respectively, as a result of a reduction in the projected royalty payments in excess of contractual minimums in earlier years. For the nine-month period ended March 31, 2013, the change in the value of acquisition consideration represents the net effect of a reduction in fair value of contingent consideration of $791,000, partially offset by an increase of $422,000 in non-contingent consideration. These changes were due to an increase in the projected time it would take the Company to reach the cumulative $10 million of royalty and license fees owed on the Prostiva acquisition, which increased the number of years subject to minimum royalty payments and reduced the projected royalty payments in excess of contractual minimums in earlier years.
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Gain on Demutualization
The gain on demutualization of $321,000 for the three and nine-month periods ended March 31, 2013 represents the gain resulting from the demutualization of our products liability insurance carrier. This event did not repeat in the current fiscal year period.
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 $52,000 for the three-month period ended March 31, 2014, increased by $11,000 or 27 percent, when compared to medical device excise tax expense of $41,000 for the three-months ended March 31, 2013. The increase in the medical device tax expense is due to the fact that we did not become the legal manufacturer of the Prostiva product line until April 2013, and therefore did not pay excise tax on these sales in the prior year period. Medical device excise tax expense of $172,000 for the nine-month period ended March 31, 2014, increased by $131,000 or 320 percent due to the fact that the medical device tax was not implemented until January, 2013 and therefore only represents 3 months of expenses versus 9 months of expense in the current year period.
Amortization of Identifiable Intangible Assets
Amortization of identifiable intangible assets was $28,000 and $26,000 for the three-month period ended March 31, 2014 and 2013, respectively. Amortization of identifiable intangible assets was $72,000 and $78,000 for the nine-month period ended March 31, 2014 and 2013, respectively. The slight increase in amortization expense of the three-month period ended March 31, 2014 is due to the write-off of capitalized patents. The slight decrease in amortization expense for the nine-month period ended March 31, 2014 is a result of the $160,000 impairment charge related to intangible assets acquired as part of the Prostiva acquisition in the fourth quarter of fiscal 2013 which resulted in lower amortization expense over the assets remaining useful lives.
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 $178,000 from $98,000 for the three-months ended March 31, 2014 and 2013, respectively. For the nine-months ended March 31, 2014, interest expense increased $168,000 to $516,000 from $348,000 for the nine-months ended March 31, 2013. The increase in interest expense is due to accrued interest on the Medtronic Note signed at the end of fiscal year 2013, partially offset by lower accretion expense related to the restructuring of the license agreement with Medtronic which resulted in the re-measurement of the contingent consideration.
Provision for Income Taxes
We recognized income tax expense of $18,000 and $46,000 for the three and nine-months ended March 31, 2014, respectively, compared to income tax expense of $17,000 and $48,000 for the three and nine-month periods ended March 31, 2013, respectively. The tax expense in the three and nine-months ended March 31, 2014 consists of $9,000 and $27,000, respectively, of deferred tax expense recorded on the amortization for tax purposes of indefinite-lived goodwill intangibles acquired in the Prostiva acquisition, as well as $9,000 and $19,000, respectively, for state taxes. The tax expense in the three and nine-month periods ended March 31, 2013 also relates to the deferred tax liability resulting from the amortization for tax purposes of the goodwill acquired in the Prostiva acquisition, as well as provisions for state taxes.
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.
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LIQUIDITY AND CAPITAL RESOURCES
We have financed our operations since inception through sales of equity securities, including a follow-on offering completed during the first quarter of fiscal year 2013 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 March 31, 2014, our cash balance was $816,000.
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 $1,000,000 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 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, for outstanding transition services fees, and for 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 March 31, 2014 or as of the date of filing this Quarterly Report on Form 10-Q. The $650,000 is included in the short-term deferred acquisition payment liability as of March 31, 2014. In addition, we did not pay, as of March 31, 2014 and 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 which is included in other accrued expenses as of March 31, 2014. The non-payment does not entitle Medtronic to terminate the license agreement unless Medtronic provides written notice and an opportunity to cure the default. The non-payment under the license agreement is also not an event of default under the Note unless Medtronic provides written notice and an opportunity to cure. 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.
On January 11, 2012, the Company entered into a Loan and Security Agreement with Silicon Valley Bank, as subsequently amended. The line of credit with Silicon Valley Bank allows borrowing by the Company of up to the lesser of $2.0 million or the defined borrowing base consisting of 80% of eligible accounts receivable.
The Company will not be able to draw down our line of credit with Silicon Valley Bank upon a material breach of the license agreement or event of default under the Note with Medtronic, or, as of January 30, 2014, payment to Medtronic of any royalty payment or annual license payment or certain other actions by Medtronic with respect to these payments. The terms of the agreement with Silicon Valley bank state that any default with a third party, the result of which could have a material adverse affect on our business, is considered an event of default under the line of credit agreement and as of January 30, 2014, that it is an event of default if the Company makes any royalty payment and/or annual license payment to Medtronic, if Medtronic threatens to take action against the Company to collect any portion of these payments, or if Medtronic commences any action or proceeding against the Company with respect to these payments. The Company may cure this event of default by receipt within 30 days of its occurrence of net proceeds from a new round of equity or subordinated debt financing of at least $715,000.
In addition, in accordance with a letter agreement between the Company and Medtronic dated March 21, 2014, the Company will not draw down any funds under its line of credit with Silicon Valley Bank without prior approval from Medtronic. The line of credit expires by its terms on June 30, 2014. As of March 31, 2014 the Company has not borrowed against this facility.
During the first quarter of fiscal year 2013 the Company completed a follow-on offering which contributed approximately $3.8 million of net proceeds. However, as a result of the Company’s history of operating losses and negative cash flows from operations there is substantial doubt about our ability to continue as a going concern. As of March 31, 2014, the Company’s cash may not be sufficient to sustain day-to-day operations for the next 12 months.
The Company’s ability to continue as a going concern is dependent upon our ability to generate positive cash flows from our business, maintain available borrowing under our line of credit with Silicon Valley Bank, and aggressively manage our expenses, including those associated with our acquisition of the Prostiva product line from Medtronic. The Company’s ability to continue as a going concern is also dependent upon avoiding an event of default under the Note and avoiding termination of the license relating to the Prostiva product, whether by negotiation with Medtronic, cure of any non-payment giving rise to an event of default or termination, or otherwise. There is no assurance that our cash, cash generated from operations, if any, and available borrowing under our agreement with Silicon Valley Bank will be sufficient to fund our anticipated capital needs, operating expenses (including payments under the license agreement), and Note repayments, particularly if product sales do not generate revenues in the amounts currently anticipated, if our operating costs are greater than anticipated or greater than our business can support.
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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, access available borrowings under the line of credit with SVB, raise additional capital, or improve its operating or financial performance.
The third quarter fiscal year 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 nine-months ended March 31, 2014, we used $1.4 million of cash for operating activities. The net loss of $4.1 million included non-cash charges of $739,000 from the Prostiva inventory reserve, $447,000 from depreciation and amortization expense, $169,000 from stock-based compensation expense and $334,000 of accreted interest expense. Changes in operating items resulted in the generation of $1.0 million of operating cash flow for the period as a result of higher accounts payable of $387,000, lower inventories of $336,000, lower accounts receivable of $342,000 and interest payable of $245,000. These changes were partially offset by lower accrued expenses and deferred income of $187,000 and higher prepaids and other assets of $86,000.
The increase in accounts payable is the result of the timing of receipts and services versus payment. The decrease in inventories is due to lower volumes of Prostiva hand piece inventory as of March 31, 2014 due to the timing of shipments from our third-party supplier, and the decrease in accounts receivable is due to a decrease in revenue. The increase in interest payable represents the 6 percent interest accrued on the Note agreement entered into with Medtronic in June, 2013. The decrease in accrued expenses and deferred income is a result of a decrease in the commission accrual due to lower sales and lower headcount, as well as a decrease in the bonus accrual as a result of the payment of the fiscal 2013 bonuses during the first quarter of fiscal year 2014. The increase in prepaids and other assets is a result of the payment of annual insurance policies at the beginning of the fiscal year which are then amortized over the annual period.
During the nine-months ended March 31, 2014, we used $35,000 for investing activities related to the purchase of property and equipment and investments in intellectual property.
During the nine-months ended March 31, 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 March 31, 2014, our property and equipment, net, included approximately $319,000 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 15 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.
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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, Gregory J. Fluet, 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.
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, 2013, as updated by Part II, Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2013 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 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. |
| | |
| | (Registrant) |
| | |
| | /s/ Gregory J. Fluet |
| | Gregory J. Fluet |
| | Chief Executive Officer |
| | (Principal Executive Officer) |
| | |
| | /s/ Brian J. Smrdel |
| | Brian J. Smrdel |
| | Chief Financial Officer |
| | (Principal Financial and Accounting Officer) |
| | |
| | Date May 14, 2014 |
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