CMS published their final rule in November 2012 for implementation during calendar year 2013. In addition, in January of 2013, the government acted to keep the Sustainable Growth Rate (SGR) from taking effect as part of the Taxpayer Relief Act. The final rule and the impacts from the Taxpayer Relief Act resulted in an average reimbursement rate in the physician office setting for calendar year 2013 of $2,102 for Cooled ThermoTherapy and $1,933 for Prostiva RF Therapy. In addition, beginning April 1, 2013, there was an additional 2 percent reduction to all Medicare payments to providers that is a result of the Sequester. It is unclear how long this incremental reduction will remain in effect.
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.
Internationally, reimbursement approvals for the Cooled ThermoTherapy and Prostiva procedures are awarded on an individual-country basis.
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 the next decade. The Federal health care reform legislation, beginning in January 2013, imposed significant new taxes on medical device makers in the form of a 2.3% excise tax on all U.S. medical device sales. As a result, we incurred approximately $61,000 in medical device excise tax for the three-month period ended September 30, 2013. This significant increase in the tax burden on our industry could have a material, negative impact on our results of operations and our cash flows.
We continue to invest in research, development, and clinical trials to build upon our intellectual property, and our scientific and clinical knowledge to develop innovative future generations of BPH products and services. These investments are intended to improve our product offerings and expand the clinical evidence supporting each of our therapies for BPH. Our research and development efforts and goals are currently focused primarily on improving the features and functions of the technologies used in our Cooled ThermoTherapy and Prostiva RF Therapy procedures; improving the ease of use, patient comfort and clinical response to treatment; reducing the manufacturing cost of our products, and expanding the evidence of the cost effectiveness of our technologies.
As of September 30, 2013, the Company’s cash and cash equivalents balance was $1,551,000. The Company incurred net losses of $1,334,000 for the three-month period ended September 30, 2013 and $4,292,000 and $4,695,000 in the fiscal years ended June 30, 2013 and 2012, respectively. In addition, the Company has accumulated aggregate net losses from the inception of business through September 30, 2013 of $120,352,000.
Under the license agreement, royalty payments for Prostiva products are paid one year in arrears based on the contract year. The royalty payment due on October 6, 2013 of $565,000 has not been paid. The Company will owe Medtronic an additional $85,000 in December 2013 for the difference between the annual minimum royalty amount and the $565,000 royalty due and unpaid as of October 6, 2013. Both of these amounts are included in the short-term deferred acquisition payment liability as of September 30, 2013. In addition, we did not pay the annual $65,000 licensing maintenance fee due on October 6, 2013 which is included in other accrued expenses as of September 30, 2013. 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 contributed 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 is also developing expense reduction plans that will be executed, if necessary, if the Company does not generate revenues commensurate with the Company’s expenses. 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.
As stated in our press release issued on October 29, 2013, we expect revenues in fiscal year 2014 to be in the range of $15 to $17 million.
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, 2013. At September 30, 2013, our critical accounting policies and estimates continue to include revenue recognition, inventories, valuation of long-lived assets and goodwill, income taxes, stock-based compensation and fair value of contingent consideration.
RESULTS OF OPERATIONS
Net Sales
Net sales for the three-months ended September 30, 2013 were $3.8 million, compared to $4.0 million during the same period of the prior fiscal year. The $191,000, or 5 percent decrease in net sales for the comparable prior year period is primarily the result of a decrease in Prostiva sales, including a significant slowdown in international Prostiva sales.
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, 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, 2013 decreased $39,000, or 2 percent, to $1.9 million, from $2.0 million for the three-month period ended September 30, 2012. The slight decrease in costs of goods sold for the three-months ended September 30, 2013 is a result of the decrease in sales, partially offset by higher per unit manufacturing costs due to lower production volumes resulting in higher fixed costs per unit.
Gross profit as a percentage of net sales decreased to 49 percent from 51 percent for the three-month periods ended September 30, 2013 and 2012, respectively. The decrease in the gross profit rate for the three-month period ended September 30, 2013 is a result of higher fixed costs per unit as a result of lower production volumes as mentioned above.
Sales and Marketing
Sales and marketing expense of $1.8 million for the first quarter of fiscal 2014 increased by $128,000, or 7 percent, when compared to sales and marketing expense of $1.7 million in the same period of fiscal 2013. The increase in sales and marketing expense for the three-months ended September 30, 2013 is largely due to increases in headcount related expenses.
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General and Administrative
General and administrative expense decreased $53,000, or 7 percent, to $685,000 for the three-month period ended September 30, 2013 compared to $737,000 for the three-month period ended September 30, 2012. The decrease in general and administrative expense is a result of a decrease in wages and benefits due to lower headcount.
Research and Development
Research and development expense, which includes expenditures for product development, regulatory compliance and clinical studies, decreased $194,000 or 32 percent to $421,000 from $615,000 for the three-month period ended September 30, 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 consulting expenses, net of increased compensation expense of $127,000 due to open headcount positions in the prior year period as well as decreases in product testing of $37,000.
Change in Value of Acquisition Consideration
The change in the value of acquisition consideration was $9,000 compared to $154,000 for the three month periods ended September 30, 2013 and 2012, respectively. For the three month period ended September 30, 2013, the change in the value of acquisition consideration represents the net effect of a reduction in fair value of contingent consideration of $9,000. For the three-month period ended September 30, 2012, the change in the value of acquisition consideration represents the net effect of a reduction in fair value of contingent consideration of $380,000, partially offset by an increase of $226,000 in non-contingent consideration. These changes are due to an increase in the projected time it will 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.
Medical Device Tax
The medical device excise tax expense of $61,000 for the three-month periods ended September 30, 2013 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.
Amortization of Identifiable Intangible Assets
Amortization of identifiable intangible assets was $23,000 and $26,000 for the three-month period ended September 30, 2013 and 2012. The slight decrease in the amortization expense 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 6 percent interest expense on the Note entered into with Medtronic on June 28, 2013. Interest expense increased to $161,000 from $123,000 for the three-months ended September 30, 2013 and 2012, respectively. The increase in interest expense is due to $84,000 of accrued interest on the Medtronic Note agreement, 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 $12,000 for the three-months ended September 30, 2013, compared to income tax expense of $16,000 for the three-month period ended September 30, 2012. The tax expense in the three-months ended September 30, 2013 consists of $7,000 of deferred tax expense recorded on the amortization for tax purposes of indefinite-lived goodwill intangibles acquired in the Prostiva acquisition, as well as $5,000 for state taxes. The tax expense in the three-month period ended September 30, 2012 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 September 30, 2013, we had cash of $1.6 million.
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.
Under the license agreement, royalty payments for Prostiva products are paid one year in arrears based on the contract year. The royalty payment due on October 6, 2013 of $565,000 has not been paid. The Company will owe Medtronic an additional $85,000 in December 2013 for the difference between the annual minimum royalty amount and the $565,000 royalty due and unpaid as of October 6, 2013. Both of these amounts are included in the short-term deferred acquisition payment liability as of September 30, 2013. In addition, we did not pay the annual $65,000 licensing maintenance fee due on October 6, 2013 which is included in other accrued expenses as of September 30, 2013. 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 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 September 30, 2013 the Company’s cash and cash equivalents 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 entered into on January 11, 2012 and aggressively manage our expenses, including those associated with our acquisition of the Prostiva product line from Medtronic. 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. As of September 30, 2013, the Company has not borrowed against this facility. The Company’s ability to continue as a going concern is also dependent upon avoiding an event of default under the Note (which would entitle Medtronic to accelerate all amounts due 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.
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. 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. Further, upon an event of default under the Note (which includes a material breach of the license agreement or other transaction documents after written notice and if the Company fails to cure), Medtronic may accelerate and declare due all amounts outstanding under the Note. In addition, upon a material breach of the license agreement or event of default under the Note with Medtronic, the Company may not be able to access the line of credit with Silicon Valley Bank. 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. If Medtronic accelerated and declared due all amounts outstanding under the Note, the Company would not have adequate cash to repay the amounts due, resulting in a loss of control of our business or bankruptcy.
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 first 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 three-months ended September 30, 2013, we used $734,000 of cash for operating activities. The net loss of $1.3 million included non-cash charges of $157,000 from depreciation and amortization expense, $68,000 from stock-based compensation expense and $110,000 of accreted interest expense. Changes in operating items resulted in the generation of $286,000 of operating cash flow for the period as a result of higher accounts payable of $485,000 and interest payable of $84,000, partially offset by higher prepaids and other assets of $260,000. The increase in accounts payable is the result of the timing of receipts and services versus payment. Interest payable represents the 6 percent interest accrued on the Note agreement entered into with Medtronic in June, 2013. 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 three-months ended September 30, 2013, we used $5,000 for investing activities related to the purchase of property and equipment and investments in intellectual property.
During the three-months ended September 30, 2013, 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, 2013, our property and equipment, net, included approximately $396,000 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 14 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, 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.
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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, 2013, as updated by this Part II, Item 1A “Risk Factors” and 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 except as follows:
We have not paid certain amounts due to Medtronic under the license agreement, which with proper notice and opportunities to cure would entitle Medtronic to terminate the license agreement for breach and entitle Medtronic to accelerate and demand repayment of our $5.3 million promissory note to Medtronic.
Under the license agreement, royalty payments for Prostiva products are paid one year in arrears based on the contract year. The royalty payment due on October 6, 2013 of approximately $565,000 has not been paid. We will owe Medtronic an additional $85,000 in December 2013 for the difference between the annual minimum royalty amount and the $565,000 royalty due and unpaid as of October 6, 2013. Both of these amounts are included in the short-term deferred acquisition payment liability as of September 30, 2013. In addition, we did not pay the annual $65,000 licensing maintenance fee due on October 6, 2013 which is included in other accrued expenses as of September 30, 2013. As of September 30, 2013, we had cash of $1.6 million.
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 our promissory note to Medtronic dated June 28, 2013 in the principal amount of approximately $5.3 million (the “Note”) unless Medtronic provides written notice and an opportunity to cure the default.
Medtronic may terminate the license agreement by written notice for breach after an opportunity to cure and in the event of our bankruptcy or insolvency. If the license agreement is terminated, our rights to sell the Prostiva product would be terminated. Further, upon an event of default under the Note (which includes a material breach of the license agreement or other transaction documents after written notice and an opportunity to cure), Medtronic may accelerate and declare due all amounts outstanding under the Note. In addition, upon a material breach of the license agreement or event of default under the Note with Medtronic, we may not be able to access the line of credit with Silicon Valley Bank. 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. If Medtronic accelerated and declared due all amounts outstanding under the Note, we would not have adequate cash to repay the amounts due, resulting in a loss of control of our business or bankruptcy.
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 can be no assurance that we 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 our agreements with Medtronic, raise additional capital or otherwise improve our liquidity, or improve our operating or financial performance. The Company’s cash needs and availability will be determined by a number of factors including operating performance, the availability of borrowing under our line of credit with Silicon Valley Bank, and the timing of payment of the $650,000 in annual royalties.
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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. | |
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| (Registrant) | |
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| /s/ Gregory J. Fluet | |
| Gregory J. Fluet | |
| 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 November 13, 2013 | |
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